US20130289584A1 - Compliant anastomosis system utilizing suture - Google Patents
Compliant anastomosis system utilizing suture Download PDFInfo
- Publication number
- US20130289584A1 US20130289584A1 US13/930,640 US201313930640A US2013289584A1 US 20130289584 A1 US20130289584 A1 US 20130289584A1 US 201313930640 A US201313930640 A US 201313930640A US 2013289584 A1 US2013289584 A1 US 2013289584A1
- Authority
- US
- United States
- Prior art keywords
- cutter
- connection module
- needle
- surgical apparatus
- target vessel
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0491—Sewing machines for surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1152—Staplers for performing anastomosis in a single operation applying the staples on the outside of the lumen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00681—Aspects not otherwise provided for
- A61B2017/00685—Archimedes screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1103—Approximator
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1132—End-to-end connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
Definitions
- the present invention relates generally to anastomosis, and more particularly to a system for performing a compliant anastomosis.
- Anastomosis is a procedure where two separate tubular or hollow organs are surgically grafted together to form a continuous fluid channel between them.
- Vascular anastomosis involves creating an anastomosis between blood vessels to create or restore blood flow.
- CAD coronary artery disease
- an occlusion or stenosis in a coronary artery restricts blood flow to the heart muscle.
- the area where the occlusion occurs is bypassed to reroute blood flow by grafting a vessel in the form of a harvested artery or vein, or a prosthesis.
- Anastomosis is performed between a graft vessel and two target vessels in order to bypass the blocked coronary artery, circumvent the occlusion and restore adequate blood flow to the heart muscle.
- This treatment is known as a coronary artery bypass graft procedure (CABG).
- CABG coronary artery bypass graft procedure
- An anastomosis may be compliant or noncompliant.
- a noncompliant anastomosis is one in which the anastomosis opening in the target vessel is not substantially free to expand or contract radially.
- a noncompliant anastomosis may be formed with a one-piece or multiple-piece anastomosis device that compresses or otherwise controls tissue in the vicinity of the anastomosis to hold the graft vessel in place relative to the target vessel.
- Noncompliant anastomoses have been successful, such as when utilizing anastomosis devices deployed by Cardica's PAS-PortTM anastomosis system.
- a compliant anastomosis is one in which the target vessel is substantially free to expand or contract circumferentially and longitudinally in proximity to the anastomosis site.
- a traditional sutured anastomosis is compliant, and for this reason some surgeons would prefer to utilize an anastomosis system that provides a compliant anastomosis, particularly between a graft vessel and the aorta or other source of arterial blood.
- an integrated anastomosis tool includes an effector that both creates an opening in the wall of a target vessel and deploys a plurality of independent connectors to connect a graft vessel to the target vessel to form a compliant anastomosis.
- the effector includes a cutter assembly for creating the opening and a connection module for deploying the connectors.
- the connectors may be staples, clips or any other suitable structures or mechanisms.
- the effector is connected to an actuator directly or indirectly.
- the actuator transmits energy to the effector to actuate the cutter assembly and the connection module.
- the actuator may store energy for transmission to the effector in any suitable form and in any suitable structure and/or mechanism.
- the actuator may be connected to an external source of energy, such as compressed gas or electric power, without substantially storing energy within itself.
- the particular energy source used and/or the structure or mechanism for energy storage may be independent from the configuration of the effector.
- the actuator may be part of or connected to a handle graspable by a user.
- the effector is connected to the actuator via an interface member.
- the interface member may be hinged, flexible, articulated or otherwise configured to allow the effector to be positioned at two or more different positions relative to the actuator.
- the effector can be oriented to facilitate the connection of the graft vessel to that target vessel, without the need to hold the actuator in an awkward position. Further, in this way the use of the effector in minimally-invasive surgery through a small incision in the patient is facilitated.
- the cutter assembly and the connection module each may be attached to or otherwise associated with at least one transmission member such as a cable.
- at least one transmission member may be a flexible shaft, a gear or gear assembly, a belt, or any other suitable mechanism.
- Each transmission member is in turn connected to the actuator.
- the cutter assembly may be actuated by motion of at least one transmission member connected to or otherwise associated with it, and the connection module may be actuated by motion of at least one transmission member connected to or otherwise associated with it.
- a transmission member may be attached to and cause motion of a traveler, which in turn causes motion of the connection module.
- the transmission member or members connected to the cutter assembly may be independent from the transmission member or members connected to the connection module, to allow the cutter assembly to be actuated independently from the connection module.
- the cutter assembly and the connection module may be actuated sequentially by sequentially moving different transmission members.
- the cutter assembly includes a cutter member that includes a cutter, and a holder that receives at least a portion of the cutter.
- the cutter may be at least partially cylindrical, and the holder may include a corresponding tubular bore therethrough.
- the distal end of the cutter is a cutting edge that is sharpened as by beveling, and may be circular or otherwise shaped. Further, the distal end of the cutter is tubular or otherwise substantially hollow in order to receive tissue cut from the wall of the target vessel.
- An auger extends from the distal end of the cutter, such as along the longitudinal axis of the tube. The auger may be threaded or fluted, or may be unthreaded and configured like a spike or spear.
- the auger may be fixed translationally and/or rotationally relative to the cutter.
- a transmission member is connected to the cutter member, and may extend through a lateral passage in the holder. Motion of at least one transmission member associated with the cutter assembly may both rotate and advance the cutter.
- a portion of the outer surface of the cutter member is threaded, and the transmission member is a cable wound along the threads, such that motion of the cable rotates and advances the cutter.
- the effector includes at least one registration element that is configured to maintain the effector in substantially the same location relative to the target vessel throughout actuation of the effector.
- a number of registration elements extend distally from the effector and are configured to engage the tissue of the target vessel.
- at least one registration element is configured to test the thickness and/or tissue quality of the wall of the target vessel.
- Each registration element has a cross-section area small enough that its separation from the target vessel causes at most minimal leakage through the wall of the target vessel.
- one or more thickness sensors may be provided independent from the registration element or elements.
- a graft vessel is loaded onto the connection module.
- the connection module is moved to the closed position if it is not already in the closed position, and a graft vessel is pulled through a passage in the connection module such as by a pull-through tool or tools.
- the connection module allows side loading and release of the graft vessel to provide greater surgical flexibility.
- An end of the graft vessel is placed onto at least a part of each connector.
- connection module is loaded into the effector if it is not already in the effector.
- the distal end of the effector may be placed on the target vessel at a potential anastomosis site.
- the effector may include a port or other opening therein to allow the operator to better visualize the intended anastomosis site.
- At least one registration element engages the target vessel as the effector is placed against it.
- At least one registration element is configured to measure the thickness of the wall of the target vessel.
- fluid enters the hollow interior of the registration element through its distal end and exits through the aperture, providing visual confirmation that the tissue of the wall of the target vessel is of suitable thickness and is not calcified.
- the wall of the target vessel is too thick, or is calcified, no fluid exits the aperture because the end of the registration element has not penetrated the wall of the target vessel completely, and the potential anastomosis site is not suitable.
- the operator then removes the effector from the target vessel and places it at a different potential anastomosis site on the target vessel. In this way, an operator can easily determine whether the selected anastomosis site on the target vessel is appropriate.
- the cutter assembly is actuated by the corresponding transmission member to create an opening in the wall of the target vessel.
- the transmission member is a cable wound about at least a portion of the cutter member
- the proximal motion of the cable causes the cutter to advance as well as rotate about its longitudinal axis.
- the bore in the holder guides and stabilizes the cutter as it advances. As the cutter advances and spins, it enters the tissue of the target vessel through the aperture in the stop at the distal end of the effector, and creates an opening therein.
- the auger may be fixed longitudinally relative to the cutter, such that it advances longitudinally at the same rate as the cutter.
- the cutter in another aspect of the invention, after the cutter creates an opening in the wall of the target vessel, it is moved out of the way of the connection module.
- the transmission member attached to the cutter is a cable
- the cutter assembly moves proximally, out of and then away from the opening in the target vessel.
- the cutter assembly then moves in a direction that has a component substantially perpendicular to the direction of its previous longitudinal motion.
- the cutter assembly moves in a different direction relative to the direction of its previous longitudinal motion, such as by rotating on an axis away from that direction.
- the cutter assembly and the connection module initially may be arranged substantially along an axis, where the cutter assembly is movable away from that axis before the connection module is shuttled distally. In this way, the cutter assembly is moved out of the way of the connection module.
- connection module is actuated by a corresponding transmission member, and translates distally toward the opening. Distal motion of the connection module may cease when it contacts a stop. At that time, where the connectors are staples, a tine of each staple may extend through the opening in the wall of the target vessel created by the cutter assembly, and another tine of each staple may penetrate completely through the wall of the target vessel.
- the connection module may include at least one plate that has a number of apertures defined in it and an anvil extending into each aperture. A staple is positioned adjacent to each anvil, and may be held in place by that anvil. Each plate may rotate, such as about the longitudinal centerline of the connection member.
- One or more drivers are located proximal to the staples, and are movable distally to push each staple distally against the corresponding anvil.
- connection module quickly shuttles distally and deploys the connectors after the cutter assembly has been moved out of the way.
- the connection module shuttles distally and deploys the connectors in one second or less. Because of the short duration between creation of the opening in the wall of the target vessel and completion of the anastomosis, hemostasis need not be maintained, as only a small amount of fluid escapes through the opening in the target vessel. In this way, construction of the effector is simplified.
- connection module substantially stops its distal motion
- force is still exerted on the connection module in the distal direction.
- This force pushes on the driver or drivers, which in turn exert a force on the connectors in a distal direction that deploys them, anastomosing the graft vessel to the target vessel.
- the motion of the driver or drivers exerts a force against each connector, which deforms upon contact with the corresponding anvil.
- the connectors are self-deforming, and the force exerted by the driver or drivers is applied to the connection module in a manner that releases the connectors for self-deformation.
- the anastomosis is complete. Each plate is rotated or otherwise moved to clear the anvils out of the way and release the connectors from the connection module through the apertures in the plate.
- one tine of each staple may extend through and bends substantially radially outward from the opening in the wall of the target vessel, thereby contacting the inner surface of the wall of the target vessel without penetrating it in response to the force exerted by the driver or drivers. That tine penetrates the wall of the graft vessel, either as part of the prior preparation of the graft, or in response to the force exerted by the driver or drivers. Further, in response to that force another tine of each staple may penetrate, partially or completely, the wall of the target vessel from the outside. Optionally, that tine may penetrate the wall of the graft vessel.
- connection module may be configured to suture the graft vessel to the target vessel, rather than deploy connectors such as staples or clips to connect the vessels.
- a connection module utilizes a plurality of partially-tied knots that are tightened to form fully-tied knots to connect the graft vessel to the target vessel.
- the connection module may utilize one or more other mechanisms or structures connected to or otherwise associated with suture in order to connect the graft vessel to the target vessel.
- connection module is configured to suture the graft vessel to the target vessel
- the connection module includes a plurality of needles, each movable through the opening in the target vessel created by the cutter. At least one needle may include a detachable tip.
- the needles penetrate the wall of the graft vessel in proximity to its distal end, which may be everted or flapped.
- the connection module further includes a plurality of suture loops, each corresponding to a different needle. After the needles pass through the opening in the target vessel created by the cutter, they penetrate the wall of the target vessel from the inside out. After that penetration, each needle passes through the corresponding suture loop.
- At least one needle includes a detachable tip
- that detachable tip engages a grate at or near the distal end of the connection module.
- the grate is movable proximally, thereby detaching the detachable tips that it has engaged from the corresponding needles.
- the proximal motion of the grate also tensions the suture, converting the partially-tied knots to fully-tied knots.
- the connection module may include a slicer that cuts the suture after the knots have been fully tied.
- the suture may be disconnected from the needle tip and the anastomosis tool by a controlled release crimp that is configured to release the suture under a tension force that is greater than the tension to tighten the knot, but less than the tension to break the suture.
- connection module moves to the open position, releasing the graft vessel.
- the connection module may be biased to the open position, and distal force exerted against the connection module may release a catch that previously had overcome that bias to hold the connection module closed. The effector is then removed from the target vessel.
- FIG. 1 is a schematic view of an integrated anastomosis tool having an actuator and an effector.
- FIG. 2 is a perspective view of an exemplary effector.
- FIG. 3 is a perspective view of an exemplary cutter assembly of an effector.
- FIG. 3A is a perspective view of an exemplary holder that may be used in the cutter assembly.
- FIG. 4 is a cross-section view of a cutter member of the cutter assembly.
- FIG. 5 is a cross-section view of the cutter member showing a cutter cable wrapped around a portion thereof.
- FIG. 6 is a perspective view of one example of a connection module of an effector of an integrated anastomosis tool, where the connection module is in an open position.
- FIG. 7 is a perspective view of the connection module of FIG. 6 in a closed position.
- FIG. 8 is a front view of an exemplary connector that may be used in conjunction with the connection module.
- FIG. 9 is a top view of an anvil plate that may be used in conjunction with the connection module, showing the relationship between the anvil plate and connectors.
- FIG. 10 is a top cross-section view of a traveler.
- FIG. 11 is a side cutaway view of the effector in an initial configuration.
- FIG. 11A is a perspective view of an exemplary poke-through tool.
- FIG. 11B is a perspective view of an end-to-side anastomosis having a cobrahead configuration.
- FIG. 12 is a side cutaway view of the effector in a second configuration after the cutter member of the cutter assembly has moved distally.
- FIG. 13 is a side cutaway view of the effector in a third configuration after the cutter assembly has moved proximally after creating an opening in the target vessel.
- FIG. 14 is a side cutaway view of the effector in a fourth configuration after the cutter assembly has moved off-axis.
- FIG. 15 is a side cutaway view of the effector in a fifth configuration after the connection module has shuttled distally.
- FIG. 16 is a side cross-section view of tines of connectors entering the opening in the target vessel with the graft vessel everted over those tines, as the connection module moves distally to the position of FIG. 15 .
- FIG. 17 is a side cross-section view of a connector positioned in the target vessel after the connection module has moved to the position of FIG. 15 , prior to deployment.
- FIG. 18 is a side cross-section view of a connector positioned in the target vessel after the connection module has moved to the position of FIG. 15 , after deployment.
- FIG. 19 is a side cutaway view of the effector in a sixth configuration after the connection module has deployed connectors to connect the graft vessel to the target vessel and has opened to release the graft vessel.
- FIG. 20 is a perspective view of a second exemplary connection module placed against the target vessel.
- FIG. 21 is a perspective view of a segment of the connection module of FIG. 20 , showing the distal end of that segment and the graft vessel.
- FIG. 22 is a side view of the connection module of FIG. 20 placed against the target vessel.
- FIG. 23 is a perspective view of an inner surface of the distal end of a housing that encloses at least part of a segment of the connection module of FIG. 21 .
- FIG. 24 is a perspective view of an exemplary needle movable relative to the inner surface of the distal end of the housing of FIG. 23 .
- FIG. 25 is a perspective view of a needle tip detachably connectable to the needle of FIG. 24 .
- FIG. 26 is a perspective view of the needle tip of FIG. 26 connected to a length of suture.
- FIG. 27 is a perspective view of a portion of the connection module including the grate, after at least one needle tip has been captured by the grate.
- FIG. 28 is a perspective view of another exemplary needle tip utilized in conjunction with a trap.
- FIG. 29 is a cross-section view of the trap of FIG. 28 .
- FIG. 30 is a detail view of a portion of the connection module utilizing the needle tip and trap of FIG. 28 , showing a first step in actuation.
- FIG. 31 is a detail view of a portion of the connection module utilizing the needle tip and trap of FIG. 28 , showing a second step in actuation.
- FIG. 32 is a detail view of a portion of the connection module utilizing the needle tip and trap of FIG. 28 , showing a third step in actuation.
- FIG. 33 is a detail view of a portion of the connection module utilizing the needle tip and trap of FIG. 28 , showing a fourth step in actuation.
- This specification describes an exemplary embodiment of an integrated anastomosis tool and an exemplary method for using that tool.
- an integrated anastomosis tool 2 includes an effector 4 connected to an actuator 6 , such as by an interface member 8 .
- the interface member 8 may be flexible, articulated, hinged or otherwise configured in any suitable manner to allow the effector 4 to be positioned at two or more different positions relative to the actuator 6 . That is, the interface member 8 may be bent, manipulated or otherwise moved such that the effector 4 may be positioned in more than one orientation relative to the actuator 6 . Articulation or other motion of the interface member 8 may be located anywhere along the length of the interface member 8 , or on the effector 4 or actuator 6 . Alternately, control of the articulation may be integrated into the actuation sequence of the tool 2 .
- the effector 4 can be oriented by the user to facilitate the connection of a graft vessel to a target vessel without the need to hold the actuator 6 in an awkward position.
- the interface member 8 may be rigid.
- the effector 4 may be connected directly to the actuator 6 .
- the effector 4 and actuator 6 may be fixed mechanically relative to one another, such as by securing both the effector 4 and actuator 6 to a common frame or housing.
- the actuator 6 may be connected operationally to the effector 4 by one or more transmission members (not shown). At least one transmission member may be a cable, a rod, a belt, a chain, a tube or other structure for transmitting fluid or hydraulic pressure, one or more electrical wires and/or motors, or any other suitable structure or mechanism. Where more than one transmission member is utilized, one or more of the transmission members may be configured differently from one or more of the others. For example, the transmission members may include a cable used in conjunction with a rod.
- the actuator 6 is operationally connected to the effector 4 by one or more transmission members, and as a result the mechanical configuration of the actuator 6 is independent of the mechanical configuration of the effector 4 .
- the actuator 6 may be any mechanism capable of actuating the transmission members in such a way as to operate the effector 4 .
- the effector 4 presents a standard interface to the actuator 6 , such that any actuator 6 that meets the standard interface may be utilized.
- the design of a particular configuration of the actuator 6 to achieve desired motion of one or more transmission members is within the capability of one skilled in the art.
- the actuator 6 is directly connected to the effector 4 , and transmission members are not used, such that the mechanical configurations of the actuator 6 and of the effector 4 are not independent.
- the actuator 6 transmits energy to the effector 4 to actuate it, such as via the one or more transmission members.
- the actuator 6 may store energy for transmission to the effector 4 .
- Such energy may be stored in any suitable form, and in any suitable structure and/or mechanism.
- a reservoir of compressed gas such as carbon dioxide, argon or nitrogen is included within or connected to the actuator 6 , in which energy is stored in the form of gas pressure.
- a battery or batteries are included within or connected to the actuator 6 , such that electrical energy is stored.
- a spring or springs are included within or connected to the actuator 6 and deformed, such that energy is stored as a result of the deformation of that spring or springs.
- the actuator 6 may be connectable to an external source of energy used to transmit force to the effector 4 , instead of or in conjunction with an internal energy source within the actuator 6 .
- the actuator 6 may be connectable to an external electrical outlet that provides AC or DC power.
- the actuator 6 may be connectable to an external source of compressed gas, such as carbon dioxide or nitrogen.
- the actuator 6 may be connectable to an external vacuum source. Such vacuum may be utilized, for example, to draw ambient air into and/or through the actuator 6 to drive an impeller, thereby generating energy for transmission to the effector 4 .
- energy may be received from an external source by the actuator 6 .
- the particular energy source utilized and/or the structure or mechanism for energy storage is independent from the configuration of the effector 4 . Alternately, energy is stored in the effector 4 , or received from a source other than the actuator 6 by the effector 4 , and the actuator 6 controls the application of such energy without substantially storing or transmitting it.
- the actuator 6 may form, be part of or be connected to a handle (not shown) of the integrated anastomosis tool 2 that is graspable by a user.
- the effector 4 may form, be part of or be connected to a handle (not shown) of the integrated anastomosis tool 2 that is graspable by a user.
- the use of two handles may be advantageous where the interface member or members 8 are substantially flexible.
- At least one handle may be configured to facilitate its handling by a robotic end effector or other mechanism.
- the effector 4 includes a frame 14 , and a cutter assembly 10 and a connection module 12 that are both movable relative to the frame 14 .
- at least one of the cutter assembly 10 and the cutter deployment array 12 is substantially fixed relative to at least part of the frame 14 , where that part of the frame 14 may or may not be movable relative to a remainder of the frame 14 .
- the cutter assembly 10 creates an opening in the wall of a target vessel, and the connection module 12 connects a graft vessel to the target vessel, such as by deploying one or more connectors 90 .
- the effector 4 includes a cutter assembly 10 .
- the cutter assembly 10 includes a cutter member 18 , and a holder 20 with a bore 22 defined therein that receives at least a portion of the cutter member 18 .
- the bore 22 may extend partly into or completely through the holder 20 .
- the cutter member 18 includes a cutter transport 28 connected to a cutter 24 , where the cutter 20 is distal to the cutter transport 28 .
- the cutter 24 may be fixed to an auger 30 , either of which may be configured as described in U.S. patent application Ser. No. 10/054,745 or U.S. patent application Ser. No. 10/659,057, both of which are incorporated by reference herein in their entirety.
- the cutter 24 is constructed from a metal, such as stainless steel, but a different material may be used if desired.
- the cutter 24 may be constructed from biocompatible material, if desired.
- the cutter 24 is a hollow tubular structure with an open distal end.
- the distal end of the cutter 24 has a substantially circular shape, and the cutter 24 has a substantially circular cross-section along its length.
- at least part of the cutter 24 may take another shape, have a different cross section, or vary in cross sectional perimeter or area along its length.
- the cutter 24 may take the shape of a tube having an open slit along its length. That is, the cutter 24 may form the majority of a cylindrical surface, where the cutter 24 extends along, for example, 350° of the complete 360° perimeter of the cylinder.
- the distal end of the cutter 24 may be angled relative to its longitudinal axis, if desired. That is, the distal end of the cutter 24 may be coincident with a plane angled relative to the longitudinal axis of the cutter 24 .
- the proximal end of the cutter 24 has a larger diameter than the cutter transport 28 , such that a shoulder 43 results from that difference in diameter.
- the shoulder 43 may be circumferential. Alternately, the shoulder 43 may include one or more separate segments. Alternately, the cutter 24 has the same diameter or a smaller diameter than the cutter transport 28 , and the shoulder 43 is at least one stub or other structure that extends outward further than the outer surface of the cutter transport 28 adjacent to the cutter 24 .
- the distal end of the cutter 24 is sharpened to cut the wall of a tubular vessel, such as the aorta or other blood vessel.
- the distal end of the cutter 24 may be beveled for sharpness.
- the distal end of the cutter 24 may be beveled inward, such that an inner surface 32 of the cutter 24 contacts a vessel wall before an outer surface 34 of the cutter 24 , or beveled outward, such that the inner surface 32 contacts a vessel wall after the outer surface 34 .
- the distal end of the cutter 24 may be beveled both inward and outward, such that a sharp edge is provided at a location between the inner surface 32 and outer surface 34 of the cutter 24 .
- less than the entire circumference of the distal end of the cutter 24 is sharpened.
- the distal end of the cutter 24 is at least partially serrated.
- the inner surface 32 may be substantially smooth. Alternately, at least a portion of the inner surface 32 may be rough to facilitate capture of tissue removed from the wall of a target vessel by increasing the coefficient of friction between the inner surface 32 and captured tissue. Alternately, the inner surface 32 may include one or more tissue plug capture features (not shown) defined therein to facilitate capture of tissue removed from the wall of a target vessel.
- the outer surface 34 of the cutter 24 may be substantially smooth as well.
- the cutter 24 is connected to an auger 30 , which may be constructed from the same biocompatible metal as the cutter 24 or from a different biocompatible material.
- the auger 30 may be substantially coaxial with the cutter 24 .
- the auger 30 may be connected to the cutter 24 indirectly via the cutter transport 28 . That is, the auger 30 may be connected to or formed integrally with the cutter transport 28 , which in turn is connected to the cutter 24 .
- the auger 30 is fixed relative to the cutter 24 , such that the auger 30 and cutter 24 both translate and rotate together at the same rates. Alternately, the auger 30 is translationally fixed relative to the cutter 24 such that the auger 30 and cutter 24 translate at the same rate, but is at least partially free to rotate relative to the cutter 24 .
- the auger 30 may include a circumferential flange (not shown) held within a corresponding groove (not shown) in the cutter 24 .
- the flange can rotate within the groove, and contact between the flange and the groove causes the auger 30 and cutter 24 to translate together.
- the auger 30 and the cutter 24 are fixed axially, but independent rotationally.
- Other mechanisms or structures may be used to allow the auger 30 and the cutter 24 to translate together axially while having the capability of rotating at least partially independently.
- the auger 30 includes a spike 36 at its distal end, and a shaft 38 extending proximally from the spike 36 .
- the distal end of the spike 36 extends distally to the distal end of the cutter 24 .
- the shaft 38 is substantially cylindrical. Alternately, the shaft 38 may be shaped differently.
- the distal end of the spike 36 is sharp to allow it to readily penetrate tissue.
- the spike 36 may be tapered from its proximal end toward its distal end, and may be substantially axisymmetric.
- the proximal end of the spike 36 may be wider than the shaft 38 , such that a ledge 40 is formed at the proximal end of the spike 36 .
- the spike 36 may be positioned relative to the cutter 24 and is shaped such that the ledge 40 is distal to the distal end of the cutter 24 .
- the ledge 40 is positioned proximal to the distal end of the cutter 24 .
- the auger 30 may be configured differently, if desired.
- the auger 30 may be threaded, with a sharp distal end to facilitate its entry into the wall of a target vessel.
- Such an auger 30 may be tapered as well.
- the auger 30 may be a needle that is solid or at least partially hollow.
- the needle may be simply a length of hypotube.
- the needle is a thin solid rod.
- the needle may be pointed or sharpened at its distal end.
- the needle may have a diameter small enough that its distal end is sharp enough to readily penetrated tissue as a consequence of its size.
- the auger 30 is a barb, harpoon, lance, corkscrew or other suitable symmetrical or non-symmetrical structure. Alternately, more than one auger 30 is utilized, or the auger 30 includes a number of individual components. For example, a number of augers 30 may be clustered together in proximity to the longitudinal axis of the cutter 24 . Alternately, the auger 30 may be omitted altogether.
- the cutter 24 may be attached to the cutter transport 28 and/or the auger 30 by dimpling the cutter 24 against the cutter transport 28 in one or more locations.
- the cutter transport 28 may have a groove (not shown) defined at least partially circumferentially around it.
- Each dimple 42 is formed by pressing the cutter 24 inward toward the groove, causing that location on the cutter 24 to deform into a dimple 42 .
- the dimple 42 expands into a portion of the groove, trapping at least part of the dimple 42 therein.
- the cutter 24 thus is fixed relative to the auger 30 , such that they rotate and translate together.
- the auger 30 may be connected to the cutter 24 using any other or additional suitable mechanism, structure or method.
- the auger 30 and the cutter 24 may be molded or otherwise formed together as a single piece.
- the auger 30 and the cutter 24 may be fixed together by adhesive.
- the auger 30 and the cutter 24 may be fixed together by welding, or may be pinned or screwed together.
- a centerpiece 56 may extend distally from the cutter transport 28 .
- the centerpiece 56 may be formed into the cutter transport 28 as an integral component thereof, or may be a separate piece that is connected to the cutter transport 28 in any suitable manner, such as by welding, soldering, or adhesive.
- the cutter 24 may be connected to the centerpiece 56 , and may be connected to the cutter transport 28 indirectly via the centerpiece 56 .
- At least one cutter vent 44 may be defined in the cutter 24 , providing a pathway for fluid such as air or blood to escape from the cutter 24 when the cutter 24 and auger 30 are deployed into the target vessel.
- the cutter vent or vents 44 prevent fluid from becoming trapped within the cutter 24 , because the pressure of that trapped fluid otherwise could potentially prevent the cutter 24 from penetrating the vessel wall or other anatomical structure.
- the cutter vent or vents 44 are defined in the cutter 24 at or proximal to the proximal end of the cutter 24 . Alternately, the cutter vent or vents 44 are located at the proximal end of the cutter 24 , at its connection to the cutter transport 28 .
- Each cutter vent 44 may be shaped in any appropriate manner.
- a cutter vent 44 in the cutter 24 may be substantially straight, extending longitudinally, transversely or diagonally, or may be curved and extend at least partially in the longitudinal direction; for example, it may be helical or sinusoidal.
- the cutter transport 28 may be any structure or mechanism suitable for advancing the cutter 24 .
- the cutter transport 28 is a rod or other member that is at least partially threaded with a number of threads 48 .
- the crests of the threads 48 may be flat, rounded, angled or shaped in any other appropriate manner.
- a transmission member such as a cutter cable 46 is wound along at least some of the threads 48 of the cutter transport 28 .
- the difference between the major diameter and the minor diameter of the threaded area of the cutter transport 28 may be at least twice the diameter of the cutter cable 46 . In this way, the cutter cable 46 is held within the threads 48 and does not extend outward further than the crests of the threads 48 .
- the cutter cable 46 does extend outward further than the crests of the threads 48 ; for example, where the cutter cable 46 is wound around threads 48 of the cutter transport 28 proximal to the holder 20 .
- An end of the cutter cable 46 may be fixed to the cutter transport 28 in any suitable manner.
- the anchor feature 50 may be located proximal to the threaded area of the cutter transport 28 .
- the anchor feature 50 is a hole or passage extending into or through the cutter transport 28 . An end of the cutter cable 46 is inserted into that anchor feature 50 , then welded, fastened, clipped, tied or otherwise fixed to the anchor feature 50 .
- the anchor feature 50 is a slot at the proximal end of the cutter transport 28 to which an end of the cutter 46 is connected.
- the anchor feature 50 receives the cutter cable 46 and allows the end of the cutter cable 46 to move relative to the cutter transport 28 .
- the anchor feature 50 is located in or distal to the threaded area of the cutter transport 28 . Any suitable structure, mechanism or method may be used to connect the cutter cable 46 to the cutter transport 28 either directly or indirectly.
- the cutter transport 28 may include a bore 49 or other feature to receive the centerpiece 56 of the cutter 24 .
- the cutter transport 28 is received in the bore 22 of the holder 20 .
- the bore 22 may be created in the holder 20 in any suitable manner, such as by molding it into the holder 20 or machining it through the holder 20 .
- the bore 22 may be substantially smooth-walled, with a diameter slightly greater than the major diameter of the threaded area of the cutter transport 28 .
- the fit between the major diameter of the threaded area of the cutter transport 28 and the bore 22 is selected to permit the cutter transport 28 to rotate smoothly within the bore 22 substantially without binding.
- the diameter of the bore 22 and its length are also selected to reduce or eliminate precession of the cutter transport 28 and cutter 24 during operation of the cutter assembly 10 .
- the bore 22 is threaded.
- the threads of the bore 22 and the threads 48 of the cutter transport 28 may be closely matched to one another. Alternately, if the cutter cable 46 enters the bore 22 , the crests of the threads of the bore 22 , and the depth of the roots of the threads 48 of the cutter transport 28 , are sized such that adequate space exists between them to accommodate the cutter cable 46 on the cutter transport 28 .
- a tooth 29 may be located in or at the edge of the bore 22 .
- the tooth 29 is sized to engage the threads 48 of the cutter transport 28 to provide stability to the cutter transport 28 and substantially prevent axial slide of the cutter transport 28 during its actuation, without substantially impeding motion of the cutter transport 28 .
- the cutter cable 46 is wound around at least a portion of the cutter transport 28 proximal to the holder 20 , and remains proximal to the holder 20 and outside of the bore 22 during actuation.
- a cable passage (not shown) extends outward from the bore 22 of the holder 20 to an outer surface of the holder 20 .
- the cutter cable 46 is wound around at least a portion of the cutter transport 28 that is positioned within the bore 22 .
- the cable passage is sized and shaped to receive the cutter cable 46 therethrough.
- the cable passage has a surface finish along its interior and at each end such that the cutter cable 46 can move smoothly through it when the cutter assembly 10 is actuated, as described in greater detail below.
- the cable passage is substantially straight, and may be oriented substantially tangent to the surface of the cutter transport 28 , or in a different direction relative to the cutter transport 28 . Further, the cable passage may be oriented such that its axis, extended outward, intersects the cutter transport 28 at a location between its major diameter and its minor diameter, to facilitate the smooth unwinding of the cutter cable 46 from the cutter transport 28 . Alternately, the cable passage is curved, at least in part. Alternately, the cable passage is oriented differently.
- the holder 20 may include at least one projection 66 extending therefrom.
- two or more projections 66 extend laterally from each side of the holder 20 to provide added stability.
- the projection or projections 66 may be flanges, pins or any other suitable structures that are integral with or that are attached to the holder 20 .
- the projection or projections 66 may extend substantially perpendicular to the longitudinal axis of the cutter member 18 . Alternately, the projection or projections 66 may extend at a different angle relative to the longitudinal centerline of the cutter member 18 .
- the projection or projections 66 may extend from the base of the holder 20 or from any other portion of the holder 20 .
- a knife (not shown) or other structure or mechanism can be provided.
- the knife or other mechanism may be configured to create a linear, rather than curved, opening in the target vessel.
- the knife may be movable in a direction substantially parallel to the longitudinal centerline of the target vessel in order to create a substantially linear incision therein.
- the cutter transport 28 may be configured to move the knife or other mechanism in a linear rather than rotational manner.
- the frame 14 includes one or more first grooves 68 defined therein.
- the frame 14 may be formed of any suitable material, such as polycarbonate or stainless steel, and the groove or first grooves 68 may be formed in any suitable manner, such as by molding or machining.
- Each first groove 68 is configured to receive at least one projection 66 and guide the motion thereof.
- the groove or first grooves 68 form a path along which the projections 66 , and thus the holder 20 and the cutter assembly 10 , can travel, and that path may extend in any direction or combination of directions that allows for motion of the cutter assembly 10 in a desired manner.
- At least one first groove 68 is defined in each side wall 70 of the frame, and the first grooves 68 guide the cutter assembly 10 proximally relative to its original position and away from the line defined by the original position of the longitudinal axis of the cutter member 18 .
- Motion away from the line defined by the original position of the longitudinal axis of the cutter member 18 may be referred to as off-axis motion.
- the cutter assembly 10 is movable out of the way of the connection module 12 after the cutter assembly 10 creates an opening in the wall of the target vessel.
- the interaction between each projection 66 and the corresponding first groove 68 may also act to minimize or prevent motion of the cutter assembly 10 in the lateral or vertical directions.
- the frame 14 has one or more rails, projections or ribs extending therefrom, and the holder 20 includes one or more grooves corresponding to those projections.
- any other or additional appropriate structure or mechanism may be used to guide the motion of the cutter assembly 10 relative to the frame 14 .
- the cutter assembly 10 is rotatable out of the way of the connection module 12 after the cutter assembly 10 creates an opening in the wall of the target vessel.
- the cutter assembly 10 is retracted proximally to a suitable location, then moved off-axis by rotation.
- Such rotation may result from a passive mechanism such as a spring, an active mechanism such as a device that engages the cutter cable 46 or other cable, or a combination of active and passive mechanisms.
- the first grooves 68 optionally may be omitted.
- One or more clips 72 may be connected to the frame 14 , such as by screws 74 .
- the clip or clips 72 may be formed into the frame 14 or otherwise connected to the frame 14 .
- Each clip 72 is shaped and positioned to hold at least one projection 66 of the holder 20 , and substantially to restrain that projection 66 against longitudinal motion in the proximal and/or distal direction, both before actuation of the cutter assembly 10 and while the cutter assembly 10 creates an opening in the wall of the target vessel.
- Each clip 72 may be shaped in the same manner as or in a different manner from any other clip 72 .
- each clip 72 is a leaf spring extending proximally from its connection to the frame 14 , with an upwardly-extending stop 76 formed into its proximal end.
- the stop 76 is located proximal to the corresponding projection 66 , and substantially restrains the corresponding projection 66 and thereby the holder 20 and the cutter assembly 10 against proximal motion.
- the clip or clips 72 are constructed such that the clip or clips 72 , taken together, resist an amount of force in the proximal direction that is greater than the amount exerted on the cutter assembly 10 during forward travel of the cutter member 18 and less than the amount exerted on the cutter assembly 10 by the cutter cable 46 after the forward travel of the cutter member 18 is complete.
- the clip or clips 72 allow motion of the cutter cable 46 to move the cutter member 18 distally, rather than move the cutter assembly 10 as a whole proximally, and thereby allow the cutter assembly 10 to create an opening in the target vessel. Actuation of the cutter assembly 10 and the forces acting upon the cutter assembly 10 are described in greater detail below.
- At least one bracket 78 may be connected to the frame 14 in any suitable manner, or formed into the frame 14 .
- Each bracket 78 is positioned in proximity to a corresponding clip 72 .
- at least one bracket 78 is not associated with a clip 72 , or is spaced apart from a corresponding clip 72 .
- Each bracket 78 includes an indentation 80 defined therein, where that indentation 80 is located distal to the stop 76 of the corresponding clip 72 .
- the indentation 80 may be positioned relative to the corresponding stop 76 such that the distance between the distal surface of the stop 76 and the most-distal portion of the indentation 80 is substantially equal to or slightly greater than the length of the projection 66 held therebetween. In this way, the projection 66 is held securely.
- each bracket 78 and one or more corresponding projections 66 substantially restrains distal motion of the holder 20 during actuation of the cutter assembly 10 .
- the bracket or brackets 78 restrain the holder 20 substantially in place in the longitudinal direction during actuation of the cutter assembly 10 .
- contact between the projection or projections 66 and the corresponding groove or first grooves 68 restrains the holder 20 substantially in place in the lateral and vertical directions.
- vertical refers to the direction that is substantially perpendicular to both the longitudinal direction and to the lateral direction, and is independent of the orientation of the integrated anastomosis tool 2 relative to a patient or to an operating room.
- contact between the sides of the holder 20 and the inner surface 82 of each side wall 70 of the frame 14 also may restrain the holder 20 substantially in place in the lateral direction.
- the holder 20 is substantially restrained in all three dimensions as the cutter member 18 is actuated to create an opening in the target vessel.
- Such restraint allows the cutter assembly 10 to produce an opening of the desired quality in and in a desired location on the target vessel.
- the holder 20 may be free to move at least partially in at least one direction during actuation of the cutter assembly 10 .
- the term “impulse” means a force that acts on a body for a short time but produces a large change in its linear or angular momentum.
- the cutter assembly 10 is configured to be actuated impulsively. That is, an impulse is applied to the cutter assembly 10 to cause it to make an opening in the target vessel and to move off-axis out of the way of the connection module 12 . Alternately, the cutter assembly 10 is configured to be actuated non-impulsively. Further detail regarding the impulsive actuation of the cutter assembly 10 is provided below.
- the effector 4 includes a connection module 12 , which may be any mechanism that is configured to connect a graft vessel to a target vessel.
- the connection module 12 may deploy one or more staples, clips, connectors or other mechanisms to connect the graft vessel to the target vessel.
- the connection module 12 may be configured to suture the graft vessel to the target vessel, such as by moving one or more needles that are connected to suture in order to suture the vessels together.
- the connection module 12 may be configured to adhere the graft vessel to the target vessel, such as by placing adhesive such as fibrin glue therebetween.
- the connection module 12 may be configured to apply RF energy to the graft vessel and/or the target vessel to connect the two together.
- the connection module 12 may be configured in any other suitable manner for connecting the graft vessel to the target vessel.
- an exemplary connection module 12 connects an end of a graft vessel to the side of a target vessel by deploying a plurality of connectors 90 .
- the connectors 90 may be substantially the same as one another, or one or more connectors 90 may be configured differently than one or more of the others.
- the connectors 90 may be staples, clips or other structures or mechanisms configured to connect tissue of the graft vessel to tissue of the target vessel.
- at least one of the connectors 90 is a staple 90 .
- an exemplary staple 90 includes a first tine 92 and a second tine 94 , each connected to a base 96 .
- each tine 92 , 94 is connected to the base 96 .
- a different part of the first tine 92 and/or the second tine 94 is connected to the base.
- the tines 92 , 94 are substantially parallel to one another. Alternately, the tines 92 , 94 are oriented differently relative to one another.
- the first tine 92 is shorter than the second tine 94 . Alternately, the first tine 92 is the same length as or longer than the second tine 94 .
- Each tine 92 , 94 may have a sharp point at its distal end.
- At least one of the tines 92 , 94 may not be sharp at its distal end, instead relying on its diameter being small enough to pierce tissue.
- the base 96 of the staple 90 may be stepped, where a first step 98 is substantially parallel to and distal to a second step 100 .
- the steps 98 , 100 or oriented differently relative to one another.
- the steps 98 , 100 are connected at a transition 102 that may be curved, angled or otherwise configured.
- the first step 98 is connected to the first tine 92
- the second step 100 is connected to the second tine 94 .
- each step 98 , 100 may be substantially perpendicular to the corresponding tine 92 , 94 to which it is attached; however, at least one step 98 , 100 may be oriented differently.
- the base 96 and the tines 92 , 94 are positioned relative to one another such that the staple 90 is substantially bilaterally symmetrical about an imaginary plane that extends through the base 96 and the tines 92 , 94 .
- the base 96 and the tines 92 , 94 are positioned differently relative to one another.
- the staple 90 is configured differently, and may include additional tines, tines that are shaped differently, a base that is shaped differently, and/or other properties different from the exemplary staple 90 described above.
- the staple 90 is a wire staple formed from a single wire, such that the staple 90 is integral.
- the staple 90 may be made from a single piece of material having a different form, such as a sheet of metal.
- the staple 90 is formed from two or more separate components that are connected together in any suitable matter.
- the staple 90 is metallic, and advantageously is made from stainless steel.
- the staple 90 may be made from nickel-titanium alloy or other metal.
- the staple 90 is made from a nonmetallic material.
- the staple 90 includes a non-metallic coating over a metallic or nonmetallic core or substrate.
- a therapeutic amount of at least one substance is associated with the surface of the staple 90 .
- the staples 90 are oriented in the connection module 12 such that their tines 92 , 94 extend substantially distally.
- the staples 90 may be spaced substantially radially symmetrically relative to the connection module 12 . Alternately, the staples 90 are oriented differently relative to the connection module 12 .
- the connection module 12 includes at least one anvil plate 104 .
- Each anvil plate 104 supports one or more staples 90 .
- Each anvil plate 104 includes at least one aperture 106 defined therein, and at least one anvil 108 that extends into a corresponding aperture 106 .
- at least one anvil 108 may be positioned at a different location on the anvil plate 104 .
- Each anvil 108 may be characterized as an external anvil, because it is positioned outside of the tissue to be stapled.
- the anvil plate 104 may be configured to move between a first position in which it supports at least one staple 90 and a second position in which it frees at least one staple 90 .
- each anvil 108 In the first position, each anvil 108 is located distal to and substantially in contact with the first step 98 of a corresponding staple 90 .
- the connection module includes a proximal surface (not shown) located proximal to the first step 98 of each staple 90 , such that the first step 98 of each staple 90 is held between the proximal surface and the anvil 108 .
- each anvil 108 In the second position, each anvil 108 is no longer located distal to or in contact with the first step 98 of the corresponding staple 90 .
- the anvil plate 104 has freed the corresponding staple 90 to exit the connection module 12 .
- the anvil plate 104 may move from the first position to the second position by rotation, where that rotation is provided by any suitable mechanism.
- the anvil plate 104 may be actively rotated such as by a shaft or other mechanism.
- the anvil plate 104 may be passively rotated such as by a spring.
- the spring may bias the anvil plate 104 in a particular direction of rotation, where a structure or mechanism restrains the anvil plate 104 against motion in that direction of rotation until after the staple or staples 90 have been formed.
- Each anvil plate 104 may include at least one rotation aperture 110 , into which a post 112 extends from the connection module.
- Each rotation aperture 110 acts to limit the rotation of the corresponding anvil plate 104 , because contact between each post 112 and an end of the corresponding rotation aperture 110 stops the rotational motion of the anvil plate 104 .
- at least one anvil plate 104 is movable between the first position and the second position in a motion other than rotation.
- At least one post 112 may include a head having a diameter larger than the remainder of the post 112 , in order to prevent the anvil plate 104 from moving substantially distally.
- the connection module 12 may include a first segment 114 and a second segment 116 movable relative to one another.
- the connection module 12 includes three or more members relative to one another; the connection module 12 is not limited to having two segments 114 , 116 .
- Each segment 114 segment 114 , 116 includes at least one anvil plate 104 at or near its distal end, and one or more connectors 90 , and is configured to deploy those connectors 90 .
- at least one segment 114 segment 114 , 116 does not include an anvil plate 104 .
- the segments 114 , 116 may be configured similarly, symmetrically or identically to one another for ease of manufacture and/or assembly.
- the connection module 12 is a unitary structure that does not includes separate segments 114 , 116 .
- the segments 114 , 116 may be movable relative to one another in any suitable manner.
- an axle 118 may connect the segments 114 , 116 to one another, and at least one of the segments 114 , 116 may be rotatable about the axle 118 .
- the axle 118 is oriented substantially transverse to the longitudinal axis of the connection module 12 , such as at an angle substantially perpendicular to that longitudinal axis or at a different angle relative to that longitudinal axis. Alternately, the axle 118 may be oriented differently relative to the longitudinal axis of the connection module 12 .
- one or more hinges may be substituted for the axle 118 in order to allow relative rotation of the segments 114 , 116 .
- a living hinge connects the segments 114 , 116 .
- the segments 114 , 116 may be slidable relative to one another.
- the segments 114 , 116 are connected by one or more frangible elements, where application of force to at least one segment 114 segment 114 , 116 causes at least one of the frangible elements to break and thereby allows the segments 114 , 116 to move relative to one another.
- the segments 114 , 116 may be connected by one or more mechanical linkages.
- connection module 12 may be configured to allow side loading of a graft vessel 120 into the connection module 12 . That is, the connection module 12 may be configured to allow one end of the graft vessel 120 to extend out of the connection module 12 at a location lateral to the longitudinal centerline of the connection module 12 , rather than through the proximal end of the connection module 12 . As one example, at least part of the first segment 114 is spaced apart from part of the second segment 116 when the connection module 12 is in the closed position in order to form the passage 122 in a side of the connection module 12 .
- connection module 12 is not configured to allow side loading of a graft vessel 120 .
- Each segment 114 segment 114 , 116 may include a depression 124 at and/or near its distal end.
- the depressions 124 may be substantially semicircular in cross section, or may be shaped in a different manner.
- the depressions 124 may be substantially linear and coaxial with the longitudinal centerline of the connection module 12 .
- the depressions 124 may be nonlinear and/or oriented other than coaxially with the longitudinal centerline of the connection module 12 .
- each depression 124 in the segments 114 , 116 are substantially aligned with one another to form a channel 125 for receiving at least a portion of the graft vessel 120 .
- the distal end of each depression 124 may coincide with the distal end of the connection module 12 , such that the distal ends of the depressions 124 collectively form an aperture 126 at the distal end of the connection module 12 .
- Each segment 114 segment 114 , 116 includes at least one driver 128 .
- Each driver 128 is movable relative to the corresponding segment 114 segment 114 , 116 from a first position to a second position, such as by sliding, or by any other suitable manner.
- Each driver 128 occupies the first position before deploying one or more corresponding connectors 90 , and occupies the second position after deploying one or more corresponding connectors 90 .
- the motion of each driver 128 between the first position and the second position deploys at least one corresponding connector 90 , as described in greater detail below.
- the distal end of at least one driver 128 is the end that contacts one or more corresponding connectors 16 , and that distal end is contoured to facilitate deployment of those one or more connectors 16 .
- Each driver 128 may be shaped in any suitable manner.
- at least one driver 128 may be an elongated member with a substantially planar proximal end oriented perpendicular to the longitudinal axis of the driver.
- a plunger (not shown) may be positioned between at least one driver 128 and a corresponding one or more connectors 90 , such that the driver 128 urges the plunger distally, and in turn the plunger contacts at least one connector 90 .
- connection module 12 may be biased to the open position, such as by at least one spring 130 located at the proximal end of the connection module 12 and connected to both of the segments 114 , 116 .
- at least one holding member 132 releasably holds the segments 114 , 116 in the closed position.
- at least one holding member 132 is a leaf spring extending from one of the segments 114 , 116 that includes a catch 134 oriented to engage a depression 136 or other feature on the other segment 114 , 116 .
- connection module 12 is biased at least partially toward the longitudinal axis connection module 12 with sufficient force to hold the catch 134 in the corresponding depression 136 such that the connection module 12 is held in the closed position.
- connection module 12 is biased to the closed position, and a different structure or mechanism is provided to move the connection module 12 to the open position after it connects the graft vessel to the target vessel.
- connection module 12 is not biased to the open position or to the closed position.
- At least one holding member 132 may include an engagement element 138 extending from it.
- the engagement element 138 is positioned at the distal end of the corresponding holding member 132 , and extends at least partly in a direction outward from the connection module 12 .
- the frame 14 may be connected to or include at least one stub 140 positioned at or near its distal end, or at a different suitable location.
- At least one engagement element 138 is pressed into contact with a corresponding stub 140 during the deployment process. This contact, when performed with sufficient force, overcomes the bias of the holding member 132 and moves the holding member 132 outward, thereby moving the catch 134 out of the corresponding depression 136 .
- connection module 12 can move to the open position, such as under the influence of the spring 130 .
- One or more different or additional structures and/or mechanisms may be provided to provide for the motion of the connection module 12 from the closed position to the open position at the appropriate time in the deployment process.
- At least one projection 142 extends from the connection module 12 .
- two or more projections 142 extend laterally from each side of the connection module 12 to provide added stability.
- the projection or projections 142 may be flanges, pins or any other suitable structures.
- the projection or projections 142 may extend substantially perpendicular to the longitudinal axis of the connection module 12 . Alternately, the projection or projections 142 may extend at a different angle relative to the longitudinal axis of the connection module 12 .
- the frame 14 includes one or more second grooves 144 defined therein in any suitable manner, such as by molding or machining.
- the second groove or grooves 144 may extend on the frame 14 at least partially in a different direction than the first grooves 68 .
- Each second groove 144 is configured to receive, and guide the motion of, at least one projection 142 .
- the second groove or grooves 144 form a path along which the projections 142 , and thus the connection module 12 , travel.
- the second groove or grooves 144 may extend along any path or paths that allow for motion of the connection module 12 in a desired manner.
- connection module 12 includes one or more grooves corresponding to those projections, and the frame 14 has one or more rails, projections or ribs extending therefrom. Alternately, any other or additional appropriate structure or mechanism may be used to guide the motion of the connection module 12 .
- the second groove or grooves 144 may also be used as cable guides.
- the traveler cable 154 may extend along at least part of the second groove or grooves 144 , and may be held in the second groove or grooves 144 by a screw, clip or other mechanism at or near the distal end of the frame 14 .
- a separate cable guide may be formed in or connected to the frame 14 .
- a traveler 146 may be located proximal to the connection module 12 .
- the traveler 146 acts to impel the connection module 12 distally during the actuation of the integrated anastomosis tool 2 .
- the traveler 146 includes a plate 148 that may be sized, shaped and configured in any manner that allows distal motion of the plate 148 to impel the connection module 12 distally.
- the plate 148 may directly contact the connection module 12 , such that force applied to the plate 148 in a distal direction impels the connection module 12 distally.
- At least one leg 150 may extend from the plate 148 , such as in the distal direction.
- At least one leg 150 may extend into, or include a projection that extends into, one of the second grooves 144 , such that the traveler 146 follows the same path as the connection module 12 relative to the frame 14 .
- at least one leg 150 extends into, or includes a projection that extends into, a groove other than one of the second grooves 144 .
- the frame 14 has one or more projections or ribs extending therefrom, and the traveler 146 includes one or more grooves corresponding to those projections.
- any other or additional appropriate structure or mechanism may be used to guide the motion of the traveler 146 .
- the traveler 146 includes a channel 152 defined therein.
- the channel 152 may be entirely within the body of the traveler 146 , or may be defined entirely or partially on the surface of the traveler 146 .
- the channel 152 is sized and finished to allow a transmission member such as a traveler cable 154 to pass through it.
- the traveler cable 154 is not fixed to the traveler 146 . Rather, the traveler cable 154 enters one end of the channel 152 and extends completely through the channel 152 to exit the other end of the channel 152 .
- the traveler cable 154 is thus free to slide relative to the channel 152 .
- the traveler cable 154 or other transmission member is fixed to the traveler 146 .
- a second traveler cable 155 may be attached to the proximal end of the traveler 146 or other part of the traveler 146 in any appropriate manner.
- At least one end of the traveler cable 154 extends to the actuator 6 .
- the traveler cable 154 is connected to the actuator 6 such that the application of tension to the traveler cable 154 causes the traveler 146 to move distally and cause the connection module 12 to move distally and deploy connectors to connect the graft vessel to the target vessel.
- at least one end of the cutter cable 46 extends to the actuator 6 .
- the cutter cable 46 may be connected to the actuator 6 such that the application of tension to the cutter cable 46 causes the cutter assembly 10 to move distally, create an opening in the wall of the target vessel, and move out of the way of the connection module 12 .
- the cutter cable 46 , the traveler cable 154 and the second traveler cable 155 are collectively one example of a standard interface between the effector 4 and the actuator 6 . That is, any actuator 6 configured to apply specific forces to the cables 46 , 154 , 155 at specific times, as described below, may be utilized, regardless of its structural or mechanical configuration. A different or additional standard interface may be utilized, if desired.
- connection module 12 is configured to suture the graft vessel 120 to the target vessel 166 , rather than deploy staples 90 or clips.
- the connection module 12 may include one or more projections 142 each configured to engage a second groove 144 in the frame 14 .
- the connection module 12 may include a first segment 114 and a second segment 116 movable relative to one another.
- the distal end of the connection module 12 may be curved or otherwise shaped in a manner suitable for contacting the outer surface of the target vessel 166 .
- connection module 12 includes two segments 114 , 116 . Alternately, the connection module 12 includes three or more separate segments. Alternately, the connection module 12 is unitary, and includes only a single segment. At least one segment 114 segment 114 , 116 of the connection module 12 may include a housing that encloses at least some of the components of that segment 114 , 116 . Referring also to FIG. 21 , the second segment is not shown, for clarity. Unless otherwise indicated, the components, characteristics and operation of the first segment 114 described below are equally applicable to the second segment 116 . The first segment 114 may include a housing 180 that extends to the distal end of the first segment 114 .
- the housing 180 may include a number of apertures 182 defined in its distal end.
- the housing 180 may also, or instead, include a number of needle apertures 184 defined on a lateral surface thereof and/or on its distal end.
- the first segment 114 may include a depression 124 defined therein, substantially as described with regard to the previous example of the connection module 12 .
- the depressions in the segments 114 , 116 together form a channel 125 in the connection module that receives the graft vessel 120 .
- the first segment 114 may include a latch 186 .
- the latch 186 may extend substantially laterally, or may extend in a different direction.
- the latch 186 is attached to the first segment 114 at one end, and may be curved, hooked, or otherwise shaped at its free end 188 .
- a notch 190 or other feature corresponding to the free end 188 of the latch 186 is defined in or connected to the second segment 116 .
- the free end 188 of the latch 186 engages the notch 190 to hold the two segments 114 , 116 together during the deployment process.
- the feature 190 in the second segment 116 is a rod or other mechanism that is movable or otherwise actuable relative to the free end 188 of the latch 186 .
- a number of needles 192 are rotatably connected to the inner surface of the distal end of the housing 180 .
- the needles 192 are connected to an end plate or other structure or mechanism that in turn is connected to the inner surface of the distal end of the housing 180 , or to another or a different structure or mechanism in the first segment 114 .
- the needles 192 are connected to the inner surface of the distal end of the housing 180 or to an end plate or other structure in a way that allows for motion in a manner other than rotation, such as sliding motion or compound motion.
- each needle 192 includes an arcuate body 194 .
- the arcuate body 194 may follow a substantially continuous curve, or may follow a more complex curvature. Alternately, the body 194 is angled in a simple or complex manner, rather than being arcuate.
- One end of the arcuate body 194 is connected to one end of a leg 196 .
- the curvature of the arcuate body 194 may have a radius that is substantially equal to the length of the leg 196 . Alternately, the curvature of the arcuate body 194 may have a radius that is different from the length of the leg 196 .
- the opposite end of the leg 196 is connected to one end of an axle 198 .
- the other end of the axle 198 is connected to a retention member 199 .
- the arcuate body 194 may be substantially parallel to an arbitrary plane, and the leg 196 may be substantially parallel to that same arbitrary plane.
- the leg 196 may be substantially linear, and may be oriented in a direction toward the free end 195 of the leg 196 .
- the leg 196 may be shaped and/or oriented in any other suitable manner.
- the free end 195 of the leg 196 may be substantially blunt.
- the free end 195 may be sharp.
- the free end 195 may have a suture retention feature (not shown) capable of holding the suture, and the needle tip 200 described below is not used.
- the axle 198 may be substantially perpendicular to the leg 196 . Alternately, the axle 198 is oriented in a different direction relative to the leg 196 .
- the axle 198 is substantially linear, although it may be shaped differently if desired.
- the retention member 199 is substantially L-shaped. However, the retention member 199 may be shaped differently, if desired.
- the retention member 199 is oriented such that a first part of its L-shaped body is substantially parallel to the leg 196 , and the second part of its L-shaped body is substantially parallel to the axle 198 . However, the retention member 199 may be oriented differently, particularly if it does not take a substantially “L” shape. Alternately, the retention member 199 may be omitted altogether, as described in greater detail below.
- the arcuate body 194 and/or the other components of the needle 192 may be substantially rigid.
- the needle 192 may be constructed from any suitable material, such as stainless steel.
- At least one cable aperture 197 may be defined in the retention member 199 , or other suitable component of the needle 192 .
- the cable aperture 197 is sized to receive a needle actuation cable (not shown) or a portion of a needle actuation cable.
- a needle actuation cable may extend from both sides of the cable aperture 197 , and be fixed to the cable aperture 197 such as by adhesive, crimping, welding, the use of one or more connectors, or any other suitable method, structure or mechanism.
- Each needle 192 may be associated with a separate needle actuation cable.
- one or more needle actuation cables may be provided for each segment 114 segment 114 , 116 of the connection module, and at least one of those cables is split to engage two or more needles 192 .
- the needle actuation cable may include a number of individual strands that are wrapped together at a location proximal to the needles 192 , but that are unwrapped from one another to individually connect to the corresponding cable apertures 197 of the needles 192 .
- the needle actuation cable or cables are physically and/or operationally connected to the actuator 6 , which may be mechanically configured in any manner that provides for motion of the needle actuation cable or cables.
- the needle actuation cable is not used, and a different transmission member or members connects the retention member 199 of the needle 192 and/or other appropriate part of the needle 192 to the actuator 6 .
- the transmission member may be a rack and pinion system, a rod, a belt, a chain, a tube or other structure for transmitting fluid or hydraulic pressure, one or more electrical wires and/or motors, or any other suitable structure or mechanism or combination thereof.
- the cable aperture 197 in the retention member 199 optionally may be omitted.
- a needle tip 200 is detachably connected to at least one needle 192 .
- each needle tip 200 is detachably connected to the free end 195 of the arcuate body 194 of the corresponding needle 192 .
- the needle tip 200 may be curved with a radius of curvature substantially matching the radius of curvature of the arcuate body 194 . Alternately, the needle tip 200 may be curved differently, may be straight, or may be shaped in a different manner.
- Each needle tip 200 includes a spike 202 , a body 204 connected to one end of the spike 202 , and a base 206 connected to the opposite end of the body 204 .
- the spike 202 may be substantially conical, with a tip 208 capable of penetrating tissue.
- the tip 208 may be sharp, or may be otherwise configured to allow it to penetrate tissue.
- the spike 202 is blunt rather than sharp, and/or is not configured to penetrate tissue.
- the spike 202 may be shaped differently.
- An aperture 210 is defined in the body 204 .
- the aperture 210 may be defined completely through the body 204 , or may extend only partially into the body 204 .
- the aperture 210 may have a circular cross-section, or may be shaped differently.
- the aperture 210 may have a constant cross-section along its length, or that cross-section may vary along the length of the aperture 210 . Referring also to FIG. 26 , the diameter and/or cross-section of the aperture 210 is selected to facilitate the connection of suture 212 to the needle tip 200 .
- the suture 212 may be connected to the needle tip 200 in any suitable manner, such as by adhesive, by crimping, by swaging, by co-molding, by passing the suture 212 through the aperture 210 and tying a knot on the opposite side, by welding, or by one or more separate fasteners.
- the body 204 may be shaped as a curved cylinder having a frustum at the end closest to the spike 202 , or may be shaped in any other suitable manner.
- the diameter of the spike 202 is greater than the diameter of the body 204 at the connection between the spike 202 and the body 204 .
- the spike 202 and/or body 204 are shaped such that either or both does not have a diameter, the spike 202 extends further laterally than the body 204 , at least in part, at the connection between the spike 202 and the body 204 .
- the width of the spike 202 at the connection between the spike 202 and the body 204 may be used to capture the needle tip 200 and may assist in retaining graft tissue after poke-through, as described in greater detail below.
- the base 206 is configured to be detachably connected to the free end 195 of the arcuate body 194 of the corresponding needle 192 .
- the base 206 of the needle tip 200 may be a curved cylinder. Alternately, the base 206 may be shaped in any other suitable manner.
- the needle 192 has a lumen defined at least partially therethrough, that lumen extending to the free end 195 of the arcuate body 194
- the outer diameter of the base 206 may be substantially equal to the inner diameter of the arcuate body 194 .
- At least part of the base 206 can be placed into the lumen of the arcuate body 194 at its free end 195 , and then the free end 195 can be crimped to create a detachable connection therebetween.
- the base 206 of the needle tip 200 has a lumen defined therein, and the outer diameter of the free end 195 of the arcuate body 194 is sized to allow entry into the lumen defined in the base 206 .
- at least part of the free end 195 of the arcuate body 194 can be placed into the lumen of the base 206 of the needle tip 200 , and then the base 206 can be crimped to create a detachable connection therebetween.
- the base 206 may be connected to the arcuate body 194 in an other manner that results in a detachable connection therebetween.
- the base 206 is connected to the needle 192 in any other suitable manner that allows for the base 206 to be detached from the needle 192 .
- the base 206 may be connected to the free end 195 of the arcuate body 194 of the corresponding needle 192 by a frangible member.
- the needle tip 200 may be fabricated as a unitary structure with the needle 192 .
- the base 206 may be crimped or swaged to the free end 195 of the arcuate body 194 .
- each needle 192 is movably connected to the proximal surface 213 of the distal end of the housing 180 .
- at least one separate member (not shown) is connected to the proximal surface of the distal end of the housing, and each needle 192 is connected to a proximal surface of at least one of the separate members.
- Each needle 192 is connected to the proximal surface 213 by at least one corresponding bushing 214 .
- the bushing 214 is connected to the proximal surface 213 , or is fabricated integrally with the proximal surface 213 .
- At least one bushing 214 may be semicircular, with a semicircular opening 216 adjacent to the proximal surface 213 .
- the opening 216 is fully circular, or is shaped differently.
- the axle 198 of each needle 192 extends through the corresponding opening 216 or is otherwise held by the corresponding bushing 214 .
- the axle 198 is free to rotate relative to the bushing 214 , and the opening 216 of the bushing 214 constrains the rotation of the axle substantially in the desired direction.
- the retention member 199 holds the needle 194 in place and retains it in the bushing 214 .
- the retention member 199 may be omitted, and the axle 198 may be retained in a different manner.
- the end of the axle 198 that is not attached to the leg 196 may include or be connected to a structure that is larger than the opening 216 in the bushing 214 , such that the axle 198 is retained in the bushing 214 .
- the portion of that retention member 199 that is substantially parallel to the axle 198 may slide along the outer surface of the bushing 214 when the needle 192 rotates. This sliding contact between the retention member 199 additionally constrains the rotation of the needle 192 and enhances the stability of its rotation.
- the bushings 214 are positioned on the proximal surface 213 of the distal end of the housing 180 in an orientation such that the free ends 195 of the needles 192 can move to a position in which they extend through the aperture 126 in the distal end of the connection module 12 .
- each segment 114 segment 114 , 116 includes at least one support 217 .
- each segment 114 segment 114 , 116 includes a single support 217 .
- Each support 217 may include a number of arms 218 at or near its distal end. The arms 218 extend substantially radially from the longitudinal centerline of the connection module 12 . Alternately, the arms 218 extend in a different direction relative to the longitudinal centerline of the connection module 12 .
- Each arm 218 corresponds to at least one needle 192 . Where at least one arm 218 corresponds to a single needle 192 , that arm 218 may be skewed relative to that needle 192 . Alternately, the arm 218 is substantially aligned with the corresponding needle 192 . Alternately, the support 217 and/or the arm or arms 218 may be omitted altogether.
- each segment 114 segment 114 , 116 includes a grate 220 .
- the grate 220 may be connected to the distal end of a slider 222 . Alternately, the grate 220 may be connected to a different part of the slider 222 , or to a different mechanism or structure.
- the grate 220 is a structure or mechanism that is configured to capture at least one of the needle tips 200 .
- the grate 220 may be a thin piece of material that includes at least one aperture 224 defined therein to capture at least one corresponding spike 202 .
- the width of each aperture 224 is less than the widest part of at least one corresponding spike 202 .
- the grate 220 may be shaped in any suitable manner. As one example, at least one grate 220 is curved. As another example, at least one grate 220 forms part of an annulus, and may be described as semi-annular. The grate 220 may be configured in any other suitable manner, and may be any other suitable structure or mechanism. As one example, the grate 220 may be a ring composed at least in part of plastic material, such as polypropylene. The apertures 224 may be omitted from such a grate 220 . The needle tips 200 push into the grate 220 and are held securely by the plastic material. As another example, the grate 220 may be fabricated at least in part from a gel or gel-like material, such as silicone.
- the apertures 224 may be omitted from such a grate 220 .
- the needle tips 200 push into the grate 220 and are held securely by the gel or gel-like material.
- the grate 200 is fabricated at least in part from fabric which may or may not be impregnated or otherwise associated with a clotting agent.
- the apertures 224 may be omitted from such a grate 220 .
- the needle tips 200 push into and/or through the fabric and are held in place by the fabric.
- the fabric may be coarsely woven from any suitable fiber or materials; for example, the fabric may be fabricated from cotton, polyester or metallic fibers, or any combination thereof.
- the needle tips 200 may be able to pass through the mesh formed by the weave, but unable to pass back through the mesh as a result of interference between the base of the spike 202 and the fabric of the grate 220 .
- the grate 220 may include adhesive on at least one surface of a ring or other structure suitable for carrying the adhesive.
- the apertures 224 may be omitted from such a grate 220 .
- the needle tips 200 contact the adhesive and are held securely by the adhesive.
- any other structure or mechanism may be used instead of or in addition to the grate 200 to capture one or more of the needle tips 200 .
- the slider 222 is a structure connected to and positioned proximal to the grate 220 .
- the slider 222 may be shaped in any suitable manner.
- the slider 222 is actuable to translate proximally after the grate 220 has captured at least one needle tip 200 , as described in greater detail below. Alternately, the slider 222 is movable in a manner other than or in addition to translation.
- At least one registration member 156 may extend from the effector 4 , such as from the distal end of the effector 4 .
- the distal end of the effector 4 may be substantially coincident with the distal end of the frame 14 .
- the registration member or members 156 may be spikes 156 that are configured to penetrate the wall of the target vessel at least partially.
- one or more registration members 156 may push down the wall of the target vessel, pull up the wall of the target vessel or otherwise engage the wall of the target vessel without penetrating it while still achieving registration.
- the cross-sectional area of each spike 156 is selected to be small enough such that the tissue of the target vessel self-closes the aperture created therein by the spike 156 after the spike 156 is removed.
- one or more of the registration members are configured differently.
- the registration member or members 156 act to hold the effector 4 in a substantially fixed position relative to the opening in the target vessel made by the cutter assembly 10 during actuation of the effector 4 . That is, the registration member or members 156 register the distal end of the effector 4 to a particular location on the surface of the target vessel.
- the connection module 12 is able to connect the end of the graft vessel 120 to the proper location on the target vessel relative to the opening created by the cutter assembly 10 .
- At least one registration member 156 may extend from an open support 157 , which may be crescent-shaped or take any other appropriate shape.
- the support 157 is open to allow the graft vessel to exit through the open portion after the effector 4 is removed from the anastomosis site, as described below.
- the support 157 may act as a stop to stop the distal motion of the cutter assembly 10 and/or the connection module 12 during actuation of the effector 4 .
- a stop may be provided as a separate structure connected to the support 157 .
- an introducer such as a sleeve, cage or other mechanism may be used to guide the connection module 12 to the opening created by the cutter assembly 10 , thereby registering the connection module 12 to the target vessel.
- the introducer may be used instead of or in addition to the registration members 156 .
- a separate registration mechanism may be mounted to or around the target vessel, and the distal end of the effector 4 couples to that registration mechanism to register the effector 4 to the target vessel.
- the registration mechanism may be any mechanism that can be mounted to the target vessel, such as the aorta, in any manner.
- the registration mechanism may be the access port system of commonly-assigned U.S. patent application Ser. No. 09/967,684, which is hereby incorporated by reference in its entirety.
- Mounting of the registration mechanism to the target vessel may be performed by applying suction, holding the registration mechanism against the target vessel mechanically or by hand, or in any other appropriate manner. Further, coupling between the effector 4 and the registration mechanism may be accomplished in any suitable manner.
- the effector 4 may lock to the registration mechanism such that the two items are removed together from the target vessel after anastomosis is complete.
- one of the effector 4 and the registration mechanism may include a keyway, and the other may include a mating key, such that the effector 4 and the registration mechanism may be registered to one another in a known and preselected orientation.
- At least one registration member 156 is configured to test the thickness and/or tissue quality of the wall of the target vessel.
- at least one registration member 156 is a hypotube having a sharpened distal end, having at least one orifice near its proximal end that extends to the lumen of the tube. Alternately, the distal end of the hypotube is not sharpened. Alternately, the proximal end of that registration member 156 is open, and no orifice is provided.
- Such a registration member 156 may be substantially the length of the thickest tissue with which the integrated anastomosis tool 2 may be used.
- a number of registration members 156 may be provided, each having a different length, such that the thickness of the wall of the target vessel may be determined by viewing the registration members 156 to determine which ones are contacting fluid within the target vessel.
- the effector 4 includes at least one thickness sensor (not shown) that is separate from the registration member or members 156 .
- an ultrasonic transceiver may be mounted on the effector, where that transceiver is configured to transmit ultrasonic energy to and receive ultrasonic energy from the tissue of the target vessel wall in order to determine its thickness.
- the effector 4 begins in an initial configuration as shown in FIG. 11 .
- the cutter assembly 10 is positioned at or near the distal end of the effector 4
- the connector module 12 is positioned proximal to and spaced apart from the cutter assembly 10 .
- the longitudinal axis of the cutter member 18 is substantially coaxial with the longitudinal axis of the connection module 12 .
- the cutter member 18 and the connection module 12 may have a different spatial relationship relative to one another in the initial configuration.
- the cutter assembly 10 and the connector module 12 may be initially side by side.
- the cutter assembly 10 and the connector module 12 may be angled relative to one another such that their longitudinal axes approach one another or intersect at the location on the target vessel where the cutter assembly 10 creates an opening therein.
- the graft vessel is loaded into the connection module 12 while the connection module 12 is in the open position.
- the graft vessel is placed in the channel 125 of the connection module 12 , with a proximal portion of the graft vessel extending through the side of the connection module 12 at the location that will form the passage 122 and a distal portion of the graft vessel extending distal to the distal end of the connection module 12 .
- the connection module 12 is then moved to the closed position, such that a proximal portion of the graft vessel extends out of the passage 122 .
- a catch 134 on one segment 114 segment 114 , 116 may be oriented to engage a depression 136 or other feature on the other segment 114 segment 114 , 116 .
- the catch 134 may be connected to a leaf spring 132 that is biased at least partially toward the longitudinal axis of the connection module 12 with sufficient force to hold the catch 134 in the corresponding depression 136 such that the connection module 12 is held in the closed position.
- the connection module 12 may be outside the effector 4 during the loading process. If so, the connection module 12 is placed into the effector 4 after the graft vessel is loaded, each projections 142 is placed into a second groove 144 as the connector module 12 . Alternately, the connection module 12 is connected to the effector 4 in a different manner, such as described above.
- the graft vessel is loaded into the connection module 12 while the connection module 12 is in the initial, closed configuration. To do so, the graft vessel is pulled through the passage 122 in the side of the connection module 12 and through the channel 125 of the connection module 12 .
- a pull-through tool (not shown) may be utilized to pull the graft vessel through the passage 122 and the channel 125 .
- Such a pull-through tool may be configured in any suitable manner.
- the pull-through tool may be substantially as disclosed in co-pending and commonly-assigned U.S. patent application Ser. No. 10/055,179, which is hereby incorporated by reference herein in its entirety.
- the pull-through tool is flexible enough to be able to extend through the aperture 126 in the distal end of the connection module 12 and bend sufficiently to extend to the edge of or beyond the passage 122 . In this way, an end of the pull-through tool engages an end of the graft vessel. Alternately, a surgical forceps or other suitable tool may be used.
- the operator then moves the pull-through tool to pull the end of the graft vessel through the passage 122 and through the aperture 126 , such that the end of the graft vessel extends distal to the distal ends of the second tines 94 of the connectors 90 .
- the second tines 94 are positioned closer to the longitudinal axis of the connection module 12 than the first tines 92 .
- the end of the graft vessel is then everted over the second tines 94 . This eversion may be accomplished in any suitable manner. Alternately, if the first tines 92 are positioned closer to the longitudinal centerline of the connection module 12 , the end of the graft vessel is everted over the distal ends of the first tines 92 .
- the end of the graft vessel may be flapped. That is, at least one incision may be made in the end of the graft vessel, creating one or more flaps at the end thereof. If so, the flap or flaps may be placed over the distal ends of the first tines 92 .
- At least one substantially longitudinal incision may be made in the end of the graft vessel that is pulled through the connection module 12 . This incision may be made before or after pull-through. In order to achieve take-off of the graft vessel at an angle to the target vessel, the graft vessel is angled relative to the connection module 12 . To facilitate this, a small substantially-longitudinal incision may be made in the distal end of the graft vessel. Further, by providing one incision, a single flap is created at the end of the graft vessel, facilitating the formation of a standard cobrahead anastomosis as shown in FIG. 11B .
- the graft vessel is oriented relative to the connection module 12 in a manner such that the operator can ensure the cobrahead shape of the finished anastomosis is oriented in a desired manner relative to the target vessel 166 .
- More than one incision may be made, in order to create more than one flap in the end of the graft vessel.
- the connection module 12 may be used with graft vessels having a variety of widths, while the size of the opening in the target vessel created by the cutter assembly 10 remains the same across graft vessels having different widths.
- a greater cross-section of the graft vessel is placed adjacent to the opening in the target vessel.
- small graft vessels may be angled a greater amount relative to the longitudinal axis of the connection module 12 .
- the graft vessel 158 In proximity to the apex of this incision, such as above the apex or to the side of the apex, the graft vessel 158 is pierced onto the second tine 94 of a single connector 90 . The end of the graft vessel 158 is then everted over the remaining second tines 94 of the remaining connectors 94 . Alternately, where the end of the graft vessel 158 is flapped, the flap or flaps are placed onto the remaining second tines 94 of the remaining connectors 94 . Referring also to FIG. 11 , the graft vessel 158 is then pushed onto the second tines 94 such that the second tines 94 penetrate the graft vessel 158 .
- the action of pushing the graft vessel 158 onto the second tines 94 may be referred to as “poke-through,” and may be performed with a poke-through tool 160 such as shown in FIG. 11A , or a different graft preparation tool.
- the poke-through tool 160 includes a poke-through tip 162 connected to a handle 164 in any suitable manner.
- the poke-through tip 162 is composed of a soft material such as rubber or silicone. Alternately, the poke-through tip 162 is substantially rigid and tubular. Alternately, the poke-through tip 162 may be configured in any other suitable manner.
- the poke-through tip 162 pushes the tissue of the graft vessel 158 onto the second tine 94 , while allowing the distal end of the second tines 94 to penetrate into the soft material of the poke-through tip 162 .
- the poke-through tip 162 is then pulled off of the distal ends of the second tine 94 , leaving the end of the graft vessel 158 pushed down onto the second tine 94 .
- the material of the poke-through tip 162 is selected and/or treated such that the poke-through tip 162 does not tear, crumble or otherwise substantially degrade as it is pulled off of the second tine or tines 92 .
- the poke-through tip 162 may be sized such that the graft vessel 158 can be pushed onto all of the second tines 94 at one time, or such that the second tines 94 are poked through the graft vessel 158 individually or in separate groups. Alternately, a forceps or other tool or tools is used to poke the second tines 94 through the graft vessel 158 , and a separate poke-through tool 160 is not utilized.
- one or more thin pieces of polyester film standing alone or connected to a mechanism, may be used to poke the second tines 94 through the graft vessel 158 .
- the width of the spike 202 at the connection between the spike 202 and the body 204 assists in retaining the tissue of the graft vessel; that width acts to prevent the tissue of the graft vessel from sliding off of the needle tip 200 .
- the operator places the effector 4 on a potential anastomosis site on the target vessel 166 .
- the interface member 8 may be bent, manipulated or otherwise moved relative to the actuator 6 to facilitate the connection of a graft vessel to a target vessel without the need to hold the actuator 6 in an awkward position. That is, the actuator 6 may be held or otherwise positioned in a desired position, and the effector 4 may then be placed at a potential anastomosis site on the target vessel 166 , with the interface member 8 flexing or otherwise moving to accommodate that placement.
- the interface member 8 may be rigidified after the effector 4 has been placed in the desired position. Such rigidification of a flexible member of a surgical tool is standard. Alternately, where the interface member 8 is substantially rigid, or where the effector 4 is directly connected to the actuator 6 , the effector 4 may be placed at a potential anastomosis site on the target vessel 166 by moving the actuator 6 .
- the auger 30 extends distally from the effector 4 , and penetrates the wall of the target vessel 166 as the effector 4 is moved in proximity to the target vessel 166 . This penetration occurs prior to and separately from the later creation of the opening in the target vessel 166 that allows fluid to pass through the anastomosis.
- the auger 30 may penetrate the wall of the target vessel 166 partially or completely. After the auger 30 has been inserted through the wall of the target vessel 166 , it remains there until the effector 4 is actuated; its presence in the wall of the target vessel 166 maintains hemostasis. As the effector 4 moves into closer proximity with the target vessel 166 , the registration member or members 156 then engage the wall of the target vessel 166 , penetrating it partially or completely.
- the registration member or members 156 do not penetrate the target vessel wall at all, and instead engage the target vessel wall in a different manner. Motion of the effector 4 toward the target vessel 166 stops when the support 157 or other suitable portion of the effector 4 contacts the wall of the target vessel 166 . At this time, the auger 30 has pierced at least the outer surface of the wall of the target vessel 166 , and the effector 4 is registered to the potential anastomosis site.
- the thickness and/or tissue quality of the wall of the target vessel 166 is tested.
- that registration member 156 is substantially the length of the thickest tissue with which the integrated anastomosis tool 2 may be used.
- the distal end of the registration member 156 contacts the fluid such as blood that is within the target vessel 166 . That fluid enters the hollow interior of the registration member 156 and exits the orifice in the registration member 156 or exits the proximal end of the registration member 156 .
- the registration member 156 When the registration member 156 is inserted into the wall of the target vessel 166 , and the thickness of the wall is greater than the length of the registration member 156 or the interior surface of the wall is calcified, the distal end of the registration member 156 does not contact fluid within the target vessel 166 . No fluid exits the orifice or other part of the registration member 156 . This allows the operator to observe the lack of outflow and visually confirm that the thickness or quality of the wall of the target vessel 166 is not appropriate, and the operator can then select a different potential location for anastomosis.
- the auger 30 will be unable to penetrate completely through the wall due to the presence of the hard calcification, and it will be apparent to the operator that the potential anastomosis site is not suitable even without the use of a thickness-sensing registration member or members 156 .
- an ultrasonic transceiver or other mechanism optionally may be used to determine the thickness and/or tissue quality of a candidate anastomosis site.
- the user After a suitable anastomosis site has been selected on the target vessel 166 , and the effector 4 has been registered to that anastomosis site, the user provides any suitable user input to the actuator 6 to actuate it.
- the actuator includes a switch, trigger or other mechanism that can be operated by the user with one hand or both hands.
- the user input is applied indirectly, such as through an information handling system.
- the user input may be mechanical, electrical, analog or digital, or any other suitable type of input.
- the actuator 6 may be mechanically configured in any manner that provides for motion of the cables 46 , 154 , 155 in the manner described below.
- the actuator 6 may include a pressurized gas reservoir, or may be connected to a source of pressurized gas.
- the pressurized gas may be allowed to escape its reservoir into, or otherwise enter, a chamber having a piston (not shown) and exert force on the piston.
- the piston may be connected directly or indirectly to the cutter cable 46 , the traveler cable 154 and/or the second traveler cable 155 , which may travel around one or more pulleys (not shown) within the actuator 6 .
- the cutter assembly 10 is actuated before the connection module 12 , to create an opening in the wall of the target vessel 166 before connecting the graft vessel 120 to the target vessel 166 .
- the actuator 6 applies tension to the cutter cable 46 , retracting the cutter cable 46 in the proximal direction.
- the actuator 6 applies an impulse to the cutter cable 46 , thereby actuating the cutter assembly 10 impulsively. As the impulse tensions the cutter cable 46 , the cutter cable 46 begins to move proximally.
- the cutter cable 46 is wound around at least a portion of the cutter transport 28 proximal to the holder 20 , as described above.
- the cutter cable 46 is thereby offset from the longitudinal centerline of the cutter transport 28 , and at least a component of its orientation relative to the cutter transport 28 is substantially tangent to the cutter transport 28 .
- the tangential component of the force applied by the cutter cable 46 at a location spaced apart from the centerline of the cutter transport 28 causes the cutter transport 28 to rotate.
- the angle of the threads 48 on the cutter transport 28 causes the cutter transport 28 to advance distally as it rotates.
- the cutter transport 28 is threaded in a direction such that the proximal motion of the cutter cable 46 causes the cutter transport 28 to advance distally as it rotates. Rotation begins at substantially the same time as translation. However, rotation or translation may begin first. As the cutter cable 46 continues to be pulled proximally, it is progressively unwound from the cutter transport. The portion of the cutter cable 46 that is wound around at least a portion of the cutter transport 28 proximal to the holder 20 and outside of the bore 22 may remain proximal to the holder 20 and outside of the bore 22 during actuation. Advancement and rotation of the cutter transport causes advancement and rotation of the cutter 24 .
- the cutter 24 advances distally into the wall of the target vessel and cuts the tissue of the wall of the target vessel with both a rotational and translational cutting action.
- the auger 30 is substantially translationally fixed relative to the cutter 24 , such that the auger 30 and the cutter 24 advance distally at substantially the same rate.
- the rotary motion of these structures creates a substantially smooth and clean hole through the wall of the target vessel 166 .
- the tissue of the target vessel 166 may be strain rate sensitive, such as the tissue of the aorta. Strain rate sensitive tissue is easier to cut when the cutting is performed rapidly than when it is performed slowly. By actuating the auger 30 and the cutter 24 impulsively, they move rapidly such that the cutter 24 can better cut strain rate sensitive tissue.
- the auger 30 and cutter 24 are advanced into the wall of the target vessel 166 fast enough such that the blood or other fluid in the target vessel 166 acts as a solid and supports the wall of the target vessel 166 against the advance of the piercing member 36 and cutter 24 . That is, the auger 30 and cutter 24 advance into the wall of the target vessel 166 fast enough that the fluid within substantially does not have time to move in response to the motion of the auger 30 and cutter 24 , such that the fluid acts as if it were a solid.
- the rate at which the auger 30 and cutter 24 should advance to accomplish this effect is at least substantially 0.25 msec.
- the duration over which the cutter transport 28 is advanced is advantageously less than one second; and may be substantially 0.05 seconds.
- the rotary speed of the cutter 24 is not as critical as the linear speed of the cutter 24 when aortic tissue is to be cut.
- the bore 22 in the holder 20 stabilizes the cutter transport 28 while it advances.
- the length of the bore 22 and its surface finish are selected to provide for such stabilization.
- the bore 22 also reduces or substantially eliminates precession of the cutter member 18 as it is actuated.
- Each clip 72 of the effector 4 may hold at least one projection 66 of the holder 20 and substantially restrain that projection 66 against longitudinal motion as the cutter member 18 advances into the wall of the target vessel 166 . In this way, the proximal motion of the cutter cable 46 does not simply move the cutter assembly 10 in the proximal direction.
- the tooth 29 associated with the bore 22 also stabilizes the cutter transport 28 while it advances. By riding between threads 48 of the cutter transport 28 as the cutter transport 28 rotates and advances, the tooth 29 substantially prevents the cutter transport 28 from sliding axially.
- the cutter 24 After the cutter 24 has penetrated completely through the wall of the target vessel 166 , it has cut a tissue plug from that vessel wall to form an opening therein.
- the cutter 24 cuts a substantially cylindrical tissue plug from the vessel wall due to its tubular shape, thereby leaving a substantially cylindrical opening in the wall of the target vessel 166 .
- the spike 36 is positioned relative to the cutter 24 such that the tissue plug is held within the cutter 24 due to engagement with the ledge 40 of the spike 36 after the tissue plug has been cut. That is, the ledge 40 advances completely through the wall of the target vessel 166 before the cutter 24 has done so, such that the tissue plug cut from the target vessel 166 wall is located proximally to the ledge 40 upon creation of the tissue plug.
- the ledge 40 is wide enough to reliably hold the tissue plug within the cutter 24 .
- the shaft 38 extends axially through the tissue plug, such that contact between the shaft 38 and the tissue plug acts substantially to prevent radial motion of the tissue plug in the cutter 24 .
- a capture feature or features are provided on the cutter 24 itself, they may engage the tissue plug instead of or in addition to the ledge 40 .
- the ledge 40 is omitted, and friction holds the tissue plug in the cutter 24 .
- the distal translation of the cutter 24 and auger 30 continues through a fixed distance greater than the thickness of the vessel wall, to ensure that the cutter 24 has completely penetrated the wall of the target vessel 166 . That fixed distance is selected to be greater than the maximum tissue thickness with which the effector 4 is to be used, but lesser than the interior diameter of the target vessel 166 .
- the rotation of the cutter transport 28 , and hence the cutter member 18 as a whole, substantially stops when the cutter cable 46 has been pulled proximally far enough such that no cutter cable 46 remains on the cutter transport 28 to be unwound.
- a clutch or other mechanism may be provided to allow the cutter transport 28 to continue rotating for a short time after creating an opening in the target vessel 166 , thereby dissipating at least some energy associated with its angular momentum. That is, the cutter transport 28 may be allowed to idle rotationally after it has completed its distal translation. Alternately, the cutter transport 28 encounters a stop (not shown) that substantially stops distal motion of the cutter transport 28 while allowing the cutter cable 46 to move proximally. The stop may extend from or be connected to the frame 14 . Alternately, the stop is the tooth 29 in the holder 20 . When the holder 20 has moved to its most distal location and has stopped its motion, and the cutter transport 28 has rotated such that the tooth 29 encounters the most proximal thread 48 , the tooth 29 acts as a stop.
- the cutter transport 28 and the length of the cutter cable 46 are selected such that the opening in the wall of the target vessel 166 has been created before the time at which no more cutter cable 46 remains to be unwound from the cutter transport 28 .
- the distal end of the cutter cable 46 is fixed to the cutter transport 28 , such as at the anchor feature 50 .
- further proximal motion of the cutter cable 46 no longer acts substantially tangentially to the cutter transport 28 , but substantially longitudinally to the cutter transport 28 .
- a single cable 46 can be utilized to actuate the cutter assembly 10 , move it out of the opening in the target vessel 166 , and move the cutter assembly 10 out of the way of the connection module 12 .
- one or more additional cables may be provided.
- the cutter 24 moves proximally.
- the shoulder 43 of the cutter 24 encounters the holder 20 as the cutter member 18 moves proximally.
- the shoulder 43 extends beyond the diameter of the bore 22 such that it does not pass through the bore 22 , but rather engages the distal surface of the holder 20 .
- This engagement exerts a proximal force on the holder 20 .
- the cutter cable 46 exerts a retraction force on the cutter assembly 10 in the proximal direction.
- the retraction force is larger than the proximal force experienced by the cutter assembly 10 during rotation of the cutter transport 28 .
- the clip or clips 72 are constructed such that the clip or clips 72 , taken together, resist an amount of force in the proximal direction that is less than that amount of retraction force but greater than the proximal force experienced by the cutter assembly 10 during rotation of the cutter transport 28 .
- the force exerted by the cutter cable 46 thereby overcomes the force exerted by each clip 72 on the corresponding projection 66 , causing the clip or clips 72 to flex out of the way of the projection or projections 66 and allowing the cutter assembly 10 to move proximally past the clip or clips 72 .
- the cutter 24 moves out of the opening 167 that it created in the wall of the target vessel 166 , and removes the tissue plug from the opening 167 .
- the tissue plug is held within the cutter 24 by friction with the inner surface of the cutter 24 and/or by contact with the ledge 40 of the auger 30 .
- the cutter assembly 10 thus has created an opening through the wall of the target vessel 166 at a location that had been previously substantially intact. In this way, where the target vessel 166 carries blood, the cutter assembly 10 disrupts the hemostasis of the target vessel 166 at the location where the cutter assembly 10 enters tissue.
- the cutter assembly 10 may be used to make a larger opening in the wall of the target vessel 166 at a location where an opening already exists.
- Each projection 66 extending from the holder 20 is received and guided by at least one first groove 68 .
- the first grooves 68 extend substantially longitudinally at the distal end of the frame 14 , such that the cutter assembly 10 is moved substantially in the proximal direction after it has created an opening 167 in the wall of the target vessel 166 .
- the first groove or grooves 68 extend along the frame 14 in such a manner as to move the cutter assembly 10 off-axis as it is moved proximally.
- the first groove or grooves 68 extend along a path that provides for motion of the cutter assembly 10 away from the line defined by the original position of the longitudinal centerline of the cutter member 18 .
- the first groove or grooves 68 extend substantially longitudinally, then angle partially away from the longitudinal direction, then continue to extend substantially longitudinally before stopping.
- the cutter assembly 10 moves off-axis along the path defined by the first groove or grooves 68 , then moves longitudinally again.
- tension on the cutter cable 46 is released at least in part, and a catch or other mechanism engages at least one projection 66 or a different part of the cutter assembly 10 and holds the cutter assembly 10 in the final position. Alternately, the proximal motion of the cutter assembly 10 is stopped in a different manner.
- connection module 12 may begin its distal travel before or after the cutter assembly 10 has moved off-axis, as long as the timing of their relative motion is such that they do not collide with one another. Referring also to FIG. 10 , the connection module 12 may be moved distally by applying tension to the traveler cable 154 . Both proximal ends of the traveler cable 154 are retracted proximally to do so.
- the portion of the traveler cable 154 proximal to the cable guide 84 is pulled distally, because the cable guide 84 reverses the direction of the traveler cable 154 .
- the portion of the traveler cable 154 within the channel 152 in the traveler 146 is pulled distally, which in turn causes the traveler 146 to move distally.
- the traveler 146 moves distally, it pushes the connection module 12 distally.
- one proximal end of the traveler cable 154 is substantially fixed, and only the other proximal end is moved proximally. Referring also to FIG.
- each projection 142 extending from the connection module 12 is received and guided by at least one second groove 144 .
- each leg 150 of the traveler 146 is received and guided by at least one second groove 144 or other groove substantially parallel to the second groove 144 .
- the second groove or grooves 144 are substantially longitudinal, and are oriented on the frame 14 to translate the connection module 12 substantially longitudinally to the distal end of the effector 4 .
- the second groove or grooves are curved or otherwise shaped, and convey the connection module 12 to the distal end of the effector 4 .
- the cutter assembly 10 and the connection module 12 can be moved in any manner and in any direction that allows each of them to perform its function.
- connection module 12 As the connection module 12 is pushed distally by the traveler 146 , the connection module 12 approaches the stop 170 at the distal end of the effector 4 .
- the longer second tine 94 of each staple moves past the distal end of the effector 4 and enters the opening 167 in the target vessel 166 wall created by the cutter assembly 10 .
- any suitable portion of one or more connectors 90 may enter the opening 167 in the wall of the target vessel 166 as the connection module 12 approaches the stop 170 .
- an end of the graft vessel 120 was previously pushed down onto the second tines 94 , as described above.
- the first tine 92 of each staple 90 penetrates the wall of the target vessel 166 , partially or completely. This penetration occurs in proximity to the opening 167 in the target vessel 166 , such that the first tines 92 are spaced apart from one another in tissue around the opening 167 .
- the traveler 146 continues to push the connection module 12 distally until the connection module 12 encounters the stop 170 .
- the stop 170 is sized and shaped to prevent the connection module 12 from moving substantially further in the distal direction after the connection module 12 encounters it.
- the connection module 12 stops the everted or flapped end of the graft vessel 120 is in contact with, or close to contact with, the outer surface of the wall of the target vessel 166 .
- connection module 12 After the connection module 12 has stopped, tension is still applied to the traveler cable 154 .
- the traveler 146 cannot urge the connection module 12 any further distally due to interference by the stop 170 .
- the traveler 146 applies force in the distal direction to the drivers 128 .
- the drivers 128 are initially biased away from the connectors 90 with a force less than is applied by the traveler 146 after the connection module 12 has encountered the stop 170 .
- the distal force applied by the traveler 146 to the drivers 128 overcomes that bias and urges the drivers 128 distally toward the connectors 90 . Referring also to FIG.
- each driver 128 moves distally toward at least one corresponding connector 90 or a plunger interposed between the driver 128 and the connector 90 .
- the first step 98 of each staple 90 is positioned proximal to a corresponding anvil 108 on one of the anvil plates 104 .
- the first step 98 is closer to the first tine 92 of each staple 90 .
- each driver 128 moves distally, it contacts the second step 100 of at least one corresponding staple 90 .
- This motion of the driver 128 exerts a force on the second step 100 , and thereby a moment about the anvil 108 .
- each staple 90 begins to bend.
- the bending may be concentrated at the transition 102 between the steps 98 , 100 of each staple 90 . Alternately, the bending may be distributed across a greater portion of at least one staple 90 , or may be concentrated in a different part of at least one staple 90 .
- each staple 90 deforms such that its second tine 94 bends outward and proximally, coming to rest against the inner surface of the wall of the target vessel 166 without substantially penetrating it.
- the first tine 92 of each staple 90 penetrates at least the outer surface of the wall of the target vessel 166
- the second tine 94 of each staple 90 does not substantially penetrate the inner surface of the wall of the target vessel 166 .
- the first tine 92 and/or second tine 94 of at least one staple 90 may have a different relationship with the wall of the target vessel 166 after deployment.
- the tissue at the distal end of the graft vessel 120 that had been placed over the second tines 94 shifts such that the inner surface of the end of the graft vessel 120 is placed in contact with the outer surface of the wall of the target vessel 166 .
- Such a connection may be referred to as a cobrahead.
- the topology of the anastomosis may be different, if desired.
- the staples 90 hold and control the edge of the opening 167 in the target vessel 166 , and hold the end of the graft vessel 120 against the outer surface of the target vessel 166 . The anastomosis between the end of the graft vessel 120 and the side of the target vessel 166 is thus complete.
- the cutter assembly 10 advantageously is moved off-axis rapidly after creating the opening 167 in the target vessel 166 . Further, the actuation of the traveler 146 to move the connection module 12 distally and deploy the connectors 90 advantageously is performed rapidly. An impulsive force may be applied to the cutter assembly 10 and to the traveler 146 to cause such rapid motion. Such rapid motion of the cutter assembly 10 and the connection module 12 provides virtual hemostasis. As used in this document, “virtual hemostasis” refers to limiting blood loss through the opening 167 in the target vessel 166 by minimizing the period of time between the cutting and connecting operations.
- the time between the creation of the opening 167 in the wall of the target vessel 166 and the deployment of the connectors 90 to connect the graft vessel 120 to the target vessel 166 is less than one second, such that a minimal amount of blood escapes through the opening 167 .
- the term “quick shuttle” may be used to refer to motion of the cutter assembly 10 and the connection module 12 within a short period of time to provide virtual hemostasis.
- each anvil plate 104 is rotated relative to the corresponding segment 114 segment 114 , 116 of the connection module 12 .
- the anvil plate or plates 104 may be rotated by any suitable structure, mechanism or method. The rotation of each anvil plate 104 moves each anvil 108 laterally relative to the corresponding staple 90 , such that each anvil 108 is no longer distal to the base 96 of the corresponding staple 90 .
- the staples 90 are freed from the anvils 108 and free to move out of the connection module 12 via the corresponding aperture 106 in the anvil plate 104 , and the connection module 12 is free to move proximally away from the deployed connectors 90 and the target vessel 166 .
- each leaf spring 132 on the connector module 12 is forced against the corresponding stub 140 at the distal end of the frame 14 .
- the distal end of each leaf spring 132 is pushed away from the longitudinal axis of the connection module 12 .
- this motion causes the catch 134 on each leaf spring 132 to move out of the corresponding depression 136 in the other segment 114 segment 114 , 116 of the connection module 12 .
- the catch 134 no longer holds the connection module 12 in the closed position.
- the second traveler cable 155 is then moved proximally, pulling the traveler 146 away from the connection module 12 .
- the spring 130 then biases at least the distal ends of the segments 114 , 116 apart from one another, opening the connection module 12 to the open position shown in FIGS. 6 and 19 . Because the traveler 146 has moved away from the connection module 12 , the segments 114 , 116 are free to move to the open position.
- the second traveler cable 155 is not provided, and the traveler 146 is otherwise configured to allow the connection module 12 to open while the traveler 146 is in contact with it.
- the traveler 146 includes a shelf 172 defined in the distal surface of the plate 148 .
- the proximal end of at least one driver 128 engages the distal surface of the plate 148
- the shelf 172 is positioned adjacent to a portion of that driver 128 near its proximal end.
- the shelf 172 prevents the connection module 12 from moving to an open position, because the shelf 172 would interfere with at least one driver 128 if the connection module 12 were to attempt to open.
- the drivers 128 after the drivers 128 have been driven distally to deploy the connectors 90 , they are positioned distal to the shelf 172 , such that interference with the shelf 172 no longer prevents the connection module 12 from moving to the open position.
- the shelf 172 acts as a safety to ensure that the connection module 12 opens at the appropriate time.
- the shelf 172 is used instead of the leaf spring or springs 134 to hold the connection module 12 in the closed position until the appropriate time for it to open.
- the effector 4 is then moved away from the target vessel 166 , such that the registration member or members 156 move away from the target vessel 166 .
- the registration member or members 156 are a spike or spikes
- the cross-sectional area of each spike is small enough that the aperture created by each spike in the wall of the target vessel 166 closes as that spike is removed. In this way, substantially no leakage from the target vessel 166 results from the removal of the registration member or members 156 .
- the effector 4 is then moved laterally relative to the graft vessel 120 .
- the graft vessel 120 may exit the connection module 12 through the side thereof.
- the support 157 at the distal end of the effector 4 is open as well, to allow the graft vessel 120 to exit from the side of the connection module 12 and through the open portion of the support 157 . Providing for the side exit of the graft vessel 120 from the effector 4 allows for flexibility in the performance of surgical procedures such as CABG.
- the proximal anastomosis can be performed before or after the distal anastomosis between the graft vessel 120 and a coronary artery.
- This flexibility may be particularly useful where the integrated anastomosis tool 2 is used in the performance of an endoscopic or minimally-invasive CABG procedure, and/or where a mammary artery or other artery is used for anastomosis such that no proximal anastomosis is necessary.
- the actuation of the connection module 12 is similar. For brevity, only the significant differences between actuation of the clip-based connection module 12 and the suture-based connection module 12 are described here.
- the graft vessel 120 may be placed in the depression 124 of either segment 114 segment 114 , 116 of the connection module 12 , after which the segments 114 , 116 are moved together. The segments 114 , 116 of the connection module 12 are held together by engagement between the latch 186 and the notch 190 .
- connection module 12 is moved and held together first, and the graft vessel 120 is pulled through the connection module 12 with a pull-through tool such as described in commonly-owned U.S. patent application Ser. No. 10/055,179, which is hereby incorporated by reference in its entirety.
- connection module 12 is not segmented, such that it is a unitary structure, and the graft vessel 120 is pulled through the connection module with such a pull-through tool.
- the distal end of the graft vessel 120 extends distally from the connection module 12 , through the aperture 126 .
- the needles 192 are positioned such that the needle tips 200 also extend distally from the connection module 12 , through the aperture 126 .
- the needle tips 200 are positioned around the outer surface of the graft vessel 120 .
- the distal end of the graft vessel 120 is then everted, at least partially, over the needle tips 200 .
- at least one incision is made at the end of the graft vessel 120 in the longitudinal direction or other suitable direction, creating at least one flap in the end of the graft vessel 120 .
- the flap or flaps may be everted onto or otherwise positioned relative to the needle tips 200 .
- the distal end of the graft vessel 120 is then pushed down onto the spikes 202 of the needle tips 200 , using any suitable structure, mechanism or method.
- the graft vessel 120 is pushed down onto the needle tips 200 far enough that the spikes 202 penetrate completely through the wall of the graft vessel 120 .
- the width of each spike 202 at its intersection with the body 204 as compared with the smaller width of the body 204 at that intersection acts to hold the graft vessel 120 in place on the needle tips 200 after eversion or partial eversion.
- connection module 12 may be moved distally substantially as described above with regard to the other exemplary connection module 12 .
- Applying tension to the traveler cable 154 causes the traveler 146 to move distally.
- the traveler 146 may contact the proximal end of at least one support 217 , or may contact any other portion of the proximal end of the connection module 12 , to urge the connection module 12 distally.
- drivers 128 are not present because there are no clips or staples to actuate, and thus the traveler 146 contacts a portion of the connection module 12 other than a driver 128 .
- the needle tips 200 may extend partially into the opening 167 in the target vessel 166 . However, the needle tips 200 may be outside the opening 167 .
- the end of the graft vessel 120 is outside the target vessel 166 , positioned against or in close proximity to the outer wall of the target vessel 166 . Alternately, at least part of the end of the graft vessel 120 may extend at least partially into the opening 167 .
- the needle actuation cables are moved by the actuator 6 .
- This motion of the needle actuation cables is in a direction that begins to pull each retention member 199 of each needle 192 along the outer surface of the corresponding bushing 214 .
- This motion of each retention member 199 causes each corresponding axle 198 to begin to rotate relative to the corresponding bushing 214 .
- This rotary motion moves each needle tip 200 through the opening 167 in the target vessel 166 , distally into the lumen of the target vessel 166 , outward from the opening 167 , then proximally back through the wall of the target vessel 166 from the inside out. In this way, suture 212 connected to the needle tip 200 is moved distally and radially outward, then proximally and radially outward.
- the arcuate body 194 of at least one needle 192 may contact the corresponding arm 218 of the support 197 during this rotary motion. Such contact may assist in directing the motion of the needle 192 . Further, such contact reduces the cantilever length of the free end 195 of the needle 192 , which may be helpful if the tissue of the wall of the target vessel 166 is tough or otherwise difficult to penetrate.
- the suture loop 226 is a portion of the same length of suture 212 that is connected to the body 204 of the needle tip 200 through the aperture 210 in the body 204 .
- the suture loop 226 is part of a partially-tied knot, such as the partially-tied knot disclosed in U.S. patent application Ser. No. 10/977,061, filed on Oct. 29, 2004, which is hereby incorporated by reference in its entirety.
- the suture loop 226 may correspond to the noose of the knot described in U.S. patent application Ser. No.
- connection module 12 may utilize one or more mechanisms or structures connected to or associated with suture to connect the graft vessel to the target vessel.
- a separate length of suture 212 is associated with each needle tip 200 , such that a plurality of independent knots can be formed. Alternately, a single length of suture 212 may be associated with two or more separate needle tips 200 . Alternately, for each needle tip 200 and length of suture 212 , a second length of suture (not shown) can be integrated into the knot to assist in its tightening and holding strength.
- each spike 202 moves through the corresponding suture loop 226 and into an aperture 224 in the grate 220 .
- the width of each aperture 224 is less than the widest part of at least one corresponding spike 202 .
- the material of the grate 220 is thin enough to flex as at least one spike 202 is urged into the corresponding aperture 224 , such that the spike 202 can move completely through the aperture 224 .
- At least the portion of the body 204 at the connection between the spike 202 and the body 204 is narrower than the aperture 224 , such that the grate 220 can flex back into its relaxed position and hold the spike 202 on the opposite site of the grate 220 from where it started.
- the slider 222 is then retracted proximally.
- a slider retraction cable (not shown) may be connected to the slider 222 and physically and/or operationally connected to the actuator 6 .
- the slider retraction cable When the slider retraction cable is moved proximally, it moves the slider 222 proximally.
- the slider 222 retracts the grate 220 proximally as well.
- the apertures 224 of the grate 220 each hold at least one needle tip 200 , such that the retraction of the grate 220 proximally pulls the needle tips 200 proximally.
- This proximal force exerted on the needle tips 200 causes them to disconnect from the corresponding arcuate bodies 194 of the needles 192 .
- the proximal force exerted on the needle tip 200 overcomes the crimp between the needle tip 200 and the arcuate body 194 and frees the base 206 from the corresponding arcuate body 194 .
- the proximal force exerted on the needle tip 200 causes the needle tip 200 to break apart from the corresponding arcuate body 194 .
- the needle tips 200 move proximally, and each needle tip 200 pulls a corresponding suture 212 proximally.
- This motion of the suture 212 causes the partially-tied knots to tighten.
- the suture 212 is then cut at a location proximal to the tightened knot. This cutting may be performed by the surgeon, or by a suture cutter (not shown) in the connection module 12 . Alternately, the suture 212 is released from the completed knot in a different manner. As one example, the suture 212 continues to be pulled proximally after the knot is completed, increasing the tension in the suture 212 .
- the suture 212 is crimped to the needle tip 200 in such a manner that it releases from the needle tip 200 under a tension force that is greater than the tension to tighten the knot, but less than the tension to break the suture 212 .
- a crimp may be referred to as a controlled-release crimp.
- the opposite end of the suture 212 from that connected to the needle tip 200 may be separable from the connection module 12 .
- the breaking strength of the suture 212 is preselected such that the increased tension therein after the completion of the knot causes the suture 212 to break, thereby releasing the suture 212 from the completed knots.
- each needle actuation cable may be moved in a direction substantially opposite from the direction in which it was previously moved.
- the effector 4 is then moved away from the target vessel 166 , leaving behind a completed sutured anastomosis.
- the suture 212 may be passed through tissue to connect the graft vessel 120 to the target vessel 166 .
- the connection module 12 may be configured differently.
- at least one needle tip 200 is not connected to suture 212 .
- a corresponding trap 230 is provided, where that trap 230 is connected to suture 212 .
- the trap 230 receives and catches at least the spike 202 of the corresponding needle tip 200 , and may be configured in any manner that allows it to do so.
- the trap 230 may be substantially tubular at least in proximity to a first end 234 , with at least one tab 232 bent inward into the lumen of the trap 230 .
- the tab or tabs 232 flex outward from a neutral position to allow the spike 202 of the needle tip 200 to pass beyond them into the lumen of the trap 230 , then flex back substantially into the neutral position. In the neutral position, the tab or tabs 232 do not allow the spike 202 to pass back out of the trap 230 . That is, the width of the spike 202 at its junction with the body 204 of the needle tip 200 is greater than the distance between the free end 236 of a single tab 232 and an inner wall of the trap 230 , or between two free ends 236 of different tabs 232 . Contact between the free end 236 of at least one tab 232 and the spike 202 thus prevents the spike 202 from moving back out of the trap 230 .
- any other structure or mechanism may be used to hold the spike 202 in or otherwise by the trap 230
- Such structures and mechanisms may include, for example, any of the structures and mechanisms described with regard to the grate 220 above.
- An end of the suture 212 may be crimped, swaged or otherwise attached to the second end 238 of the trap 230 .
- a part of the suture 212 other than an end thereof may be attached to the second end 238 of the trap 230 .
- at least one needle tip 200 may be fixed to the corresponding arcuate body 194 , or may be an integral part of the arcuate body 194 .
- the trap 230 is detachably connected to the connection module 12 in any suitable manner.
- the trap 230 may be held in a ring 240 that is fixed to the connection module 12 .
- the ring 240 may be at least partially flexible, and may be composed of an elastomer or similar substance.
- the inner diameter of the ring 240 is substantially equal to the outer diameter of the crimped area 242 . In this way, the ring 240 holds the trap 230 substantially in place.
- the trap 230 may be detachably connected to the connection module 12 by any other suitable structure and/or mechanism.
- the suture 212 extends out of the second end 238 of the trap 230 .
- the trap 230 and the needle tip 200 are reversed. That is, the needle tip 200 is held by the ring 240 or other structure, rather than by the needle 192 , and the trap 230 is connected to the needle 192 , rather than being held by the ring 240 or other structure.
- the suture 212 may be connected to the trap 230 , as described above. Thus, after the trap 230 engages the needle tip 200 , the needle 192 pulls the suture 212 in substantially the same manner as described above.
- connection module 12 As the connection module 12 is actuated, at least one needle tip 200 is moved toward the first end 234 of the corresponding trap 230 .
- the actuation of the connection module 12 , and the movement of the needle tip or tips 200 may be accomplished in substantially the same manner as described above, or in any other suitable manner.
- the spike 202 of that needle tip 200 enters the first end 234 of the corresponding trap 230 .
- the spike 202 may contact an inner wall of the trap 230 . This may result from the use of a substantially linear trap 230 in conjunction with the curved path of the needle tip 200 .
- the trap 230 may be movable to allow the spike 202 to enter the trap 230 smoothly.
- the trap 230 may be allowed to rotate at its junction with the ring 240 , as shown in FIG. 31 , thereby allowing the needle tip 200 to enter the trap 230 smoothly.
- the trap 230 may be curved to substantially correspond to the path of the needle tip 200 . If so, the trap 230 need not be movable to allow the needle tip 200 to enter, although it may be movable if desired.
- the spike 202 deflects the free end 236 of each tab 232 defined in the trap 230 .
- the free end 236 of each tab 232 is increasingly deflected as the cross-section of the spike 202 moved into contact with the tab 232 increases.
- the free end 236 of that tab moves back toward its initial position.
- the spike 202 extends further laterally than the body 204 of the needle tip 200 , at least in part, at the connection between the spike 202 and the body 204 .
- the free end 236 of each tab 232 moves back toward its initial position, it moves into the space behind the spike 202 .
- the spike 202 is then prevented from moving back out of the trap 230 .
- the needle tip 200 is consequently connected to the trap 230 .
- the trap 230 does not have tabs 232 .
- the spike 202 has one or more flexible arms that bend upon entering the trap 230 .
- the trap 230 may include one or more cutouts, ledges or other features configured to engage the one or more flexible arms of the spike 202 .
- the needle tip 200 is controlled to reverse its direction after it becomes connected to the corresponding trap 230 .
- contact between the needle tip 200 and the tabs 232 in the trap 230 causes the needle tip 200 to exert a force on the trap 230 .
- This force pulls the trap 230 out of the ring 240 , freeing the trap 230 .
- the ring 240 may be configured in any manner that allows the trap 230 to disconnect from it.
- the ring 240 may be composed of a pliable material such as elastomer, such that the ring 240 flexes when force is applied to the trap 230 and allows the trap 230 to disconnect from it.
- the ring 240 may be configured in any other suitable manner. As the needle tips 200 move, each needle tip 200 pulls a corresponding suture 212 through tissue to connect the end of the graft vessel 120 to the side of the target vessel 166 . This motion of the suture 212 causes the partially-tied knots to tighten, forming completely-tied knots. Alternately, the motion of the suture completes a knot instead of or in addition to tightening a partially-tied knot. The tied knots are then separated from a remainder of the suture 212 in any suitable manner, such as described above.
- the effector 4 can be utilized to perform an anastomosis between the end of any tubular tissue structure and the side of any tubular tissue structure.
- the effector 4 may be used to perform a proximal anastomosis between a graft vessel and the aorta in a CABG procedure.
- the effector 4 may be used to perform a distal anastomosis between a graft vessel and a coronary artery in a CABG procedure.
- the effector 4 is particularly well suited to distal anastomosis in a beating-heart CABG procedure, due to its ability to provide virtual hemostasis; the heart does not substantially move in the very short duration between making an opening in the coronary artery and deploying connectors to connect the graft vessel to the coronary artery.
- the cutter assembly 10 may be configured differently.
- the cutter assembly 10 may simply be a sharp edge that is actuated to move out of the distal end of the effector 4 , create a substantially linear slit in the coronary artery, then retract back into the effector 4 and move off-axis.
- the sharp edge may move solely in the longitudinal direction relative to the effector 4 , or may move along at least part of the length of the coronary artery.
- the cutter assembly 10 may be modified in any other suitable manner to facilitate its use with for distal anastomosis.
- the connectors 90 may be scaled down in size relative to the connectors 90 utilized for proximal anastomosis, or different connectors 90 may be used for distal anastomosis than for proximal anastomosis.
Abstract
An integrated anastomosis tool may include an effector that both makes an opening in the wall of a target vessel and connects a graft vessel to the target vessel. The effector may include a cutter assembly and a connection module that are independently actuatable. The connection between the graft vessel and the target vessel may be compliant, and may be achieved by suturing an end of the graft vessel to the side of the target vessel with the connection module.
Description
- This patent application is a divisional of U.S. patent application Ser. No. 11/004,777 (attorney docket no. 157), filed Dec. 3, 2004, which, in turn, is a continuation-in-part of U.S. patent application Ser. No. 10/877,971 (attorney docket no. 150), filed on Jun. 25, 2004, now U.S. Pat. No. 7,794,471, issued Sep. 14, 2010, which, in turn, claims priority of U.S. Provisional Patent Application Ser. No. 60/483,079 (attorney docket no. 141), filed Jun. 26, 2003, all of which are hereby incorporated by reference in their entireties.
- The present invention relates generally to anastomosis, and more particularly to a system for performing a compliant anastomosis.
- Anastomosis is a procedure where two separate tubular or hollow organs are surgically grafted together to form a continuous fluid channel between them. Vascular anastomosis involves creating an anastomosis between blood vessels to create or restore blood flow. When a patient suffers from coronary artery disease (CAD), an occlusion or stenosis in a coronary artery restricts blood flow to the heart muscle. In order to treat CAD, the area where the occlusion occurs is bypassed to reroute blood flow by grafting a vessel in the form of a harvested artery or vein, or a prosthesis. Anastomosis is performed between a graft vessel and two target vessels in order to bypass the blocked coronary artery, circumvent the occlusion and restore adequate blood flow to the heart muscle. This treatment is known as a coronary artery bypass graft procedure (CABG).
- An anastomosis may be compliant or noncompliant. A noncompliant anastomosis is one in which the anastomosis opening in the target vessel is not substantially free to expand or contract radially. A noncompliant anastomosis may be formed with a one-piece or multiple-piece anastomosis device that compresses or otherwise controls tissue in the vicinity of the anastomosis to hold the graft vessel in place relative to the target vessel. Noncompliant anastomoses have been successful, such as when utilizing anastomosis devices deployed by Cardica's PAS-Port™ anastomosis system. A compliant anastomosis is one in which the target vessel is substantially free to expand or contract circumferentially and longitudinally in proximity to the anastomosis site. A traditional sutured anastomosis is compliant, and for this reason some surgeons would prefer to utilize an anastomosis system that provides a compliant anastomosis, particularly between a graft vessel and the aorta or other source of arterial blood.
- In one aspect of the invention, an integrated anastomosis tool includes an effector that both creates an opening in the wall of a target vessel and deploys a plurality of independent connectors to connect a graft vessel to the target vessel to form a compliant anastomosis. The effector includes a cutter assembly for creating the opening and a connection module for deploying the connectors. The connectors may be staples, clips or any other suitable structures or mechanisms.
- In another aspect of the invention, the effector is connected to an actuator directly or indirectly. The actuator transmits energy to the effector to actuate the cutter assembly and the connection module. The actuator may store energy for transmission to the effector in any suitable form and in any suitable structure and/or mechanism. Alternately, the actuator may be connected to an external source of energy, such as compressed gas or electric power, without substantially storing energy within itself. The particular energy source used and/or the structure or mechanism for energy storage may be independent from the configuration of the effector. The actuator may be part of or connected to a handle graspable by a user.
- In another aspect of the invention, the effector is connected to the actuator via an interface member. The interface member may be hinged, flexible, articulated or otherwise configured to allow the effector to be positioned at two or more different positions relative to the actuator. In this way, the effector can be oriented to facilitate the connection of the graft vessel to that target vessel, without the need to hold the actuator in an awkward position. Further, in this way the use of the effector in minimally-invasive surgery through a small incision in the patient is facilitated.
- In another aspect of the invention, the cutter assembly and the connection module each may be attached to or otherwise associated with at least one transmission member such as a cable. Alternately, at least one transmission member may be a flexible shaft, a gear or gear assembly, a belt, or any other suitable mechanism. Each transmission member is in turn connected to the actuator. The cutter assembly may be actuated by motion of at least one transmission member connected to or otherwise associated with it, and the connection module may be actuated by motion of at least one transmission member connected to or otherwise associated with it. For example, a transmission member may be attached to and cause motion of a traveler, which in turn causes motion of the connection module. The transmission member or members connected to the cutter assembly may be independent from the transmission member or members connected to the connection module, to allow the cutter assembly to be actuated independently from the connection module. The cutter assembly and the connection module may be actuated sequentially by sequentially moving different transmission members.
- In another aspect of the invention, the cutter assembly includes a cutter member that includes a cutter, and a holder that receives at least a portion of the cutter. The cutter may be at least partially cylindrical, and the holder may include a corresponding tubular bore therethrough. The distal end of the cutter is a cutting edge that is sharpened as by beveling, and may be circular or otherwise shaped. Further, the distal end of the cutter is tubular or otherwise substantially hollow in order to receive tissue cut from the wall of the target vessel. An auger extends from the distal end of the cutter, such as along the longitudinal axis of the tube. The auger may be threaded or fluted, or may be unthreaded and configured like a spike or spear. The auger may be fixed translationally and/or rotationally relative to the cutter. A transmission member is connected to the cutter member, and may extend through a lateral passage in the holder. Motion of at least one transmission member associated with the cutter assembly may both rotate and advance the cutter. As one example, a portion of the outer surface of the cutter member is threaded, and the transmission member is a cable wound along the threads, such that motion of the cable rotates and advances the cutter.
- In another aspect of the invention, the effector includes at least one registration element that is configured to maintain the effector in substantially the same location relative to the target vessel throughout actuation of the effector. As one example, a number of registration elements extend distally from the effector and are configured to engage the tissue of the target vessel. Optionally, at least one registration element is configured to test the thickness and/or tissue quality of the wall of the target vessel. Each registration element has a cross-section area small enough that its separation from the target vessel causes at most minimal leakage through the wall of the target vessel. Optionally, one or more thickness sensors may be provided independent from the registration element or elements.
- In another aspect of the invention, a graft vessel is loaded onto the connection module. The connection module is moved to the closed position if it is not already in the closed position, and a graft vessel is pulled through a passage in the connection module such as by a pull-through tool or tools. Advantageously, the connection module allows side loading and release of the graft vessel to provide greater surgical flexibility. An end of the graft vessel is placed onto at least a part of each connector.
- In another aspect of the invention, after the graft vessel has been loaded onto the connection module, the connection module is loaded into the effector if it is not already in the effector. The distal end of the effector may be placed on the target vessel at a potential anastomosis site. The effector may include a port or other opening therein to allow the operator to better visualize the intended anastomosis site. At least one registration element engages the target vessel as the effector is placed against it.
- In another aspect of the invention, optionally at least one registration element is configured to measure the thickness of the wall of the target vessel. Where the wall of the target vessel is the proper thickness for anastomosis, fluid enters the hollow interior of the registration element through its distal end and exits through the aperture, providing visual confirmation that the tissue of the wall of the target vessel is of suitable thickness and is not calcified. Where the wall of the target vessel is too thick, or is calcified, no fluid exits the aperture because the end of the registration element has not penetrated the wall of the target vessel completely, and the potential anastomosis site is not suitable. The operator then removes the effector from the target vessel and places it at a different potential anastomosis site on the target vessel. In this way, an operator can easily determine whether the selected anastomosis site on the target vessel is appropriate.
- In another aspect of the invention, after the effector is registered to the target vessel, the cutter assembly is actuated by the corresponding transmission member to create an opening in the wall of the target vessel. Where the transmission member is a cable wound about at least a portion of the cutter member, the proximal motion of the cable causes the cutter to advance as well as rotate about its longitudinal axis. The bore in the holder guides and stabilizes the cutter as it advances. As the cutter advances and spins, it enters the tissue of the target vessel through the aperture in the stop at the distal end of the effector, and creates an opening therein. The auger may be fixed longitudinally relative to the cutter, such that it advances longitudinally at the same rate as the cutter.
- In another aspect of the invention, after the cutter creates an opening in the wall of the target vessel, it is moved out of the way of the connection module. For example, where the transmission member attached to the cutter is a cable, it becomes taut when no more cable remains to pull through the passage in the holder, and then exerts a proximal tensile force on the cutter assembly. In response to that proximal force, the cutter assembly moves proximally, out of and then away from the opening in the target vessel. The cutter assembly then moves in a direction that has a component substantially perpendicular to the direction of its previous longitudinal motion. Alternately, the cutter assembly moves in a different direction relative to the direction of its previous longitudinal motion, such as by rotating on an axis away from that direction. The cutter assembly and the connection module initially may be arranged substantially along an axis, where the cutter assembly is movable away from that axis before the connection module is shuttled distally. In this way, the cutter assembly is moved out of the way of the connection module.
- In another aspect of the invention, the connection module is actuated by a corresponding transmission member, and translates distally toward the opening. Distal motion of the connection module may cease when it contacts a stop. At that time, where the connectors are staples, a tine of each staple may extend through the opening in the wall of the target vessel created by the cutter assembly, and another tine of each staple may penetrate completely through the wall of the target vessel. The connection module may include at least one plate that has a number of apertures defined in it and an anvil extending into each aperture. A staple is positioned adjacent to each anvil, and may be held in place by that anvil. Each plate may rotate, such as about the longitudinal centerline of the connection member. One or more drivers are located proximal to the staples, and are movable distally to push each staple distally against the corresponding anvil.
- In another aspect of the invention, the connection module quickly shuttles distally and deploys the connectors after the cutter assembly has been moved out of the way. Advantageously, the connection module shuttles distally and deploys the connectors in one second or less. Because of the short duration between creation of the opening in the wall of the target vessel and completion of the anastomosis, hemostasis need not be maintained, as only a small amount of fluid escapes through the opening in the target vessel. In this way, construction of the effector is simplified.
- In another aspect of the invention, after the connection module substantially stops its distal motion, force is still exerted on the connection module in the distal direction. This force pushes on the driver or drivers, which in turn exert a force on the connectors in a distal direction that deploys them, anastomosing the graft vessel to the target vessel. The motion of the driver or drivers exerts a force against each connector, which deforms upon contact with the corresponding anvil. Alternately, the connectors are self-deforming, and the force exerted by the driver or drivers is applied to the connection module in a manner that releases the connectors for self-deformation. After the connectors have been deployed, the anastomosis is complete. Each plate is rotated or otherwise moved to clear the anvils out of the way and release the connectors from the connection module through the apertures in the plate.
- In another aspect of the invention, where staples are used as connectors, one tine of each staple may extend through and bends substantially radially outward from the opening in the wall of the target vessel, thereby contacting the inner surface of the wall of the target vessel without penetrating it in response to the force exerted by the driver or drivers. That tine penetrates the wall of the graft vessel, either as part of the prior preparation of the graft, or in response to the force exerted by the driver or drivers. Further, in response to that force another tine of each staple may penetrate, partially or completely, the wall of the target vessel from the outside. Optionally, that tine may penetrate the wall of the graft vessel.
- In another aspect of the invention, the connection module may be configured to suture the graft vessel to the target vessel, rather than deploy connectors such as staples or clips to connect the vessels. Such a connection module utilizes a plurality of partially-tied knots that are tightened to form fully-tied knots to connect the graft vessel to the target vessel. Rather than or in addition to partially-tied knots, the connection module may utilize one or more other mechanisms or structures connected to or otherwise associated with suture in order to connect the graft vessel to the target vessel.
- In another aspect of the invention, where the connection module is configured to suture the graft vessel to the target vessel, the connection module includes a plurality of needles, each movable through the opening in the target vessel created by the cutter. At least one needle may include a detachable tip.
- In another aspect of the invention, the needles penetrate the wall of the graft vessel in proximity to its distal end, which may be everted or flapped. The connection module further includes a plurality of suture loops, each corresponding to a different needle. After the needles pass through the opening in the target vessel created by the cutter, they penetrate the wall of the target vessel from the inside out. After that penetration, each needle passes through the corresponding suture loop.
- In another aspect of the invention, where at least one needle includes a detachable tip, that detachable tip engages a grate at or near the distal end of the connection module. The grate is movable proximally, thereby detaching the detachable tips that it has engaged from the corresponding needles. In this way, a single motion of the grate can tighten all of the suture loops, even if the loops capture different amounts of tissue, and/or tissue of variable compliance. The proximal motion of the grate also tensions the suture, converting the partially-tied knots to fully-tied knots. The connection module may include a slicer that cuts the suture after the knots have been fully tied. Alternately, the suture may be disconnected from the needle tip and the anastomosis tool by a controlled release crimp that is configured to release the suture under a tension force that is greater than the tension to tighten the knot, but less than the tension to break the suture.
- In another aspect of the invention, after the graft vessel has been connected to the target vessel, the connection module moves to the open position, releasing the graft vessel. For example, the connection module may be biased to the open position, and distal force exerted against the connection module may release a catch that previously had overcome that bias to hold the connection module closed. The effector is then removed from the target vessel.
-
FIG. 1 is a schematic view of an integrated anastomosis tool having an actuator and an effector. -
FIG. 2 is a perspective view of an exemplary effector. -
FIG. 3 is a perspective view of an exemplary cutter assembly of an effector. -
FIG. 3A is a perspective view of an exemplary holder that may be used in the cutter assembly. -
FIG. 4 is a cross-section view of a cutter member of the cutter assembly. -
FIG. 5 is a cross-section view of the cutter member showing a cutter cable wrapped around a portion thereof. -
FIG. 6 is a perspective view of one example of a connection module of an effector of an integrated anastomosis tool, where the connection module is in an open position. -
FIG. 7 is a perspective view of the connection module ofFIG. 6 in a closed position. -
FIG. 8 is a front view of an exemplary connector that may be used in conjunction with the connection module. -
FIG. 9 is a top view of an anvil plate that may be used in conjunction with the connection module, showing the relationship between the anvil plate and connectors. -
FIG. 10 is a top cross-section view of a traveler. -
FIG. 11 is a side cutaway view of the effector in an initial configuration. -
FIG. 11A is a perspective view of an exemplary poke-through tool. -
FIG. 11B is a perspective view of an end-to-side anastomosis having a cobrahead configuration. -
FIG. 12 is a side cutaway view of the effector in a second configuration after the cutter member of the cutter assembly has moved distally. -
FIG. 13 is a side cutaway view of the effector in a third configuration after the cutter assembly has moved proximally after creating an opening in the target vessel. -
FIG. 14 is a side cutaway view of the effector in a fourth configuration after the cutter assembly has moved off-axis. -
FIG. 15 is a side cutaway view of the effector in a fifth configuration after the connection module has shuttled distally. -
FIG. 16 is a side cross-section view of tines of connectors entering the opening in the target vessel with the graft vessel everted over those tines, as the connection module moves distally to the position ofFIG. 15 . -
FIG. 17 is a side cross-section view of a connector positioned in the target vessel after the connection module has moved to the position ofFIG. 15 , prior to deployment. -
FIG. 18 is a side cross-section view of a connector positioned in the target vessel after the connection module has moved to the position ofFIG. 15 , after deployment. -
FIG. 19 is a side cutaway view of the effector in a sixth configuration after the connection module has deployed connectors to connect the graft vessel to the target vessel and has opened to release the graft vessel. -
FIG. 20 is a perspective view of a second exemplary connection module placed against the target vessel. -
FIG. 21 is a perspective view of a segment of the connection module ofFIG. 20 , showing the distal end of that segment and the graft vessel. -
FIG. 22 is a side view of the connection module ofFIG. 20 placed against the target vessel. -
FIG. 23 is a perspective view of an inner surface of the distal end of a housing that encloses at least part of a segment of the connection module ofFIG. 21 . -
FIG. 24 is a perspective view of an exemplary needle movable relative to the inner surface of the distal end of the housing ofFIG. 23 . -
FIG. 25 is a perspective view of a needle tip detachably connectable to the needle ofFIG. 24 . -
FIG. 26 is a perspective view of the needle tip ofFIG. 26 connected to a length of suture. -
FIG. 27 is a perspective view of a portion of the connection module including the grate, after at least one needle tip has been captured by the grate. -
FIG. 28 is a perspective view of another exemplary needle tip utilized in conjunction with a trap. -
FIG. 29 is a cross-section view of the trap ofFIG. 28 . -
FIG. 30 is a detail view of a portion of the connection module utilizing the needle tip and trap ofFIG. 28 , showing a first step in actuation. -
FIG. 31 is a detail view of a portion of the connection module utilizing the needle tip and trap ofFIG. 28 , showing a second step in actuation. -
FIG. 32 is a detail view of a portion of the connection module utilizing the needle tip and trap ofFIG. 28 , showing a third step in actuation. -
FIG. 33 is a detail view of a portion of the connection module utilizing the needle tip and trap ofFIG. 28 , showing a fourth step in actuation. - The use of the same reference symbols in different figures indicates similar or identical items.
- This specification describes an exemplary embodiment of an integrated anastomosis tool and an exemplary method for using that tool.
- Integrated Anastomosis Tool
- Referring to
FIG. 1 , anintegrated anastomosis tool 2 includes aneffector 4 connected to anactuator 6, such as by aninterface member 8. Theinterface member 8 may be flexible, articulated, hinged or otherwise configured in any suitable manner to allow theeffector 4 to be positioned at two or more different positions relative to theactuator 6. That is, theinterface member 8 may be bent, manipulated or otherwise moved such that theeffector 4 may be positioned in more than one orientation relative to theactuator 6. Articulation or other motion of theinterface member 8 may be located anywhere along the length of theinterface member 8, or on theeffector 4 oractuator 6. Alternately, control of the articulation may be integrated into the actuation sequence of thetool 2. In this way, theeffector 4 can be oriented by the user to facilitate the connection of a graft vessel to a target vessel without the need to hold theactuator 6 in an awkward position. Alternately, theinterface member 8 may be rigid. Alternately, theeffector 4 may be connected directly to theactuator 6. For example, theeffector 4 andactuator 6 may be fixed mechanically relative to one another, such as by securing both theeffector 4 andactuator 6 to a common frame or housing. - Actuator
- The
actuator 6 may be connected operationally to theeffector 4 by one or more transmission members (not shown). At least one transmission member may be a cable, a rod, a belt, a chain, a tube or other structure for transmitting fluid or hydraulic pressure, one or more electrical wires and/or motors, or any other suitable structure or mechanism. Where more than one transmission member is utilized, one or more of the transmission members may be configured differently from one or more of the others. For example, the transmission members may include a cable used in conjunction with a rod. Theactuator 6 is operationally connected to theeffector 4 by one or more transmission members, and as a result the mechanical configuration of theactuator 6 is independent of the mechanical configuration of theeffector 4. That is, because theactuator 6 interfaces with theeffector 4 via the transmission member or members, theactuator 6 may be any mechanism capable of actuating the transmission members in such a way as to operate theeffector 4. In this way, theeffector 4 presents a standard interface to theactuator 6, such that anyactuator 6 that meets the standard interface may be utilized. The design of a particular configuration of theactuator 6 to achieve desired motion of one or more transmission members is within the capability of one skilled in the art. Alternately, theactuator 6 is directly connected to theeffector 4, and transmission members are not used, such that the mechanical configurations of theactuator 6 and of theeffector 4 are not independent. - The
actuator 6 transmits energy to theeffector 4 to actuate it, such as via the one or more transmission members. Theactuator 6 may store energy for transmission to theeffector 4. Such energy may be stored in any suitable form, and in any suitable structure and/or mechanism. As one example, a reservoir of compressed gas such as carbon dioxide, argon or nitrogen is included within or connected to theactuator 6, in which energy is stored in the form of gas pressure. As another example, a battery or batteries are included within or connected to theactuator 6, such that electrical energy is stored. As another example, a spring or springs are included within or connected to theactuator 6 and deformed, such that energy is stored as a result of the deformation of that spring or springs. Other types of energy may be stored by different or additional mechanisms within or connected to theactuator 6, if desired. Alternately, theactuator 6 may be connectable to an external source of energy used to transmit force to theeffector 4, instead of or in conjunction with an internal energy source within theactuator 6. As one example, theactuator 6 may be connectable to an external electrical outlet that provides AC or DC power. As another example, theactuator 6 may be connectable to an external source of compressed gas, such as carbon dioxide or nitrogen. As another example, theactuator 6 may be connectable to an external vacuum source. Such vacuum may be utilized, for example, to draw ambient air into and/or through theactuator 6 to drive an impeller, thereby generating energy for transmission to theeffector 4. Other types of energy may be received from an external source by theactuator 6. The particular energy source utilized and/or the structure or mechanism for energy storage is independent from the configuration of theeffector 4. Alternately, energy is stored in theeffector 4, or received from a source other than theactuator 6 by theeffector 4, and theactuator 6 controls the application of such energy without substantially storing or transmitting it. - The
actuator 6 may form, be part of or be connected to a handle (not shown) of theintegrated anastomosis tool 2 that is graspable by a user. Alternately, or additionally, theeffector 4 may form, be part of or be connected to a handle (not shown) of theintegrated anastomosis tool 2 that is graspable by a user. The use of two handles may be advantageous where the interface member ormembers 8 are substantially flexible. At least one handle may be configured to facilitate its handling by a robotic end effector or other mechanism. - Effector
- Referring also to
FIG. 2 , theeffector 4 includes aframe 14, and acutter assembly 10 and aconnection module 12 that are both movable relative to theframe 14. Alternately, at least one of thecutter assembly 10 and thecutter deployment array 12 is substantially fixed relative to at least part of theframe 14, where that part of theframe 14 may or may not be movable relative to a remainder of theframe 14. Thecutter assembly 10 creates an opening in the wall of a target vessel, and theconnection module 12 connects a graft vessel to the target vessel, such as by deploying one ormore connectors 90. - Cutter Assembly
- Referring also to
FIGS. 3-4 , theeffector 4 includes acutter assembly 10. Thecutter assembly 10 includes acutter member 18, and aholder 20 with abore 22 defined therein that receives at least a portion of thecutter member 18. Thebore 22 may extend partly into or completely through theholder 20. Thecutter member 18 includes acutter transport 28 connected to acutter 24, where thecutter 20 is distal to thecutter transport 28. Thecutter 24 may be fixed to anauger 30, either of which may be configured as described in U.S. patent application Ser. No. 10/054,745 or U.S. patent application Ser. No. 10/659,057, both of which are incorporated by reference herein in their entirety. - The
cutter 24 is constructed from a metal, such as stainless steel, but a different material may be used if desired. Thecutter 24 may be constructed from biocompatible material, if desired. As one example, thecutter 24 is a hollow tubular structure with an open distal end. The distal end of thecutter 24 has a substantially circular shape, and thecutter 24 has a substantially circular cross-section along its length. However, at least part of thecutter 24 may take another shape, have a different cross section, or vary in cross sectional perimeter or area along its length. For example, thecutter 24 may take the shape of a tube having an open slit along its length. That is, thecutter 24 may form the majority of a cylindrical surface, where thecutter 24 extends along, for example, 350° of the complete 360° perimeter of the cylinder. Alternately, the distal end of thecutter 24 may be angled relative to its longitudinal axis, if desired. That is, the distal end of thecutter 24 may be coincident with a plane angled relative to the longitudinal axis of thecutter 24. - The proximal end of the
cutter 24 has a larger diameter than thecutter transport 28, such that ashoulder 43 results from that difference in diameter. Theshoulder 43 may be circumferential. Alternately, theshoulder 43 may include one or more separate segments. Alternately, thecutter 24 has the same diameter or a smaller diameter than thecutter transport 28, and theshoulder 43 is at least one stub or other structure that extends outward further than the outer surface of thecutter transport 28 adjacent to thecutter 24. - The distal end of the
cutter 24 is sharpened to cut the wall of a tubular vessel, such as the aorta or other blood vessel. For example, the distal end of thecutter 24 may be beveled for sharpness. The distal end of thecutter 24 may be beveled inward, such that aninner surface 32 of thecutter 24 contacts a vessel wall before anouter surface 34 of thecutter 24, or beveled outward, such that theinner surface 32 contacts a vessel wall after theouter surface 34. Alternately, the distal end of thecutter 24 may be beveled both inward and outward, such that a sharp edge is provided at a location between theinner surface 32 andouter surface 34 of thecutter 24. Alternately, less than the entire circumference of the distal end of thecutter 24 is sharpened. Alternately, the distal end of thecutter 24 is at least partially serrated. - The
inner surface 32 may be substantially smooth. Alternately, at least a portion of theinner surface 32 may be rough to facilitate capture of tissue removed from the wall of a target vessel by increasing the coefficient of friction between theinner surface 32 and captured tissue. Alternately, theinner surface 32 may include one or more tissue plug capture features (not shown) defined therein to facilitate capture of tissue removed from the wall of a target vessel. Theouter surface 34 of thecutter 24 may be substantially smooth as well. - The
cutter 24 is connected to anauger 30, which may be constructed from the same biocompatible metal as thecutter 24 or from a different biocompatible material. Theauger 30 may be substantially coaxial with thecutter 24. Theauger 30 may be connected to thecutter 24 indirectly via thecutter transport 28. That is, theauger 30 may be connected to or formed integrally with thecutter transport 28, which in turn is connected to thecutter 24. Theauger 30 is fixed relative to thecutter 24, such that theauger 30 andcutter 24 both translate and rotate together at the same rates. Alternately, theauger 30 is translationally fixed relative to thecutter 24 such that theauger 30 andcutter 24 translate at the same rate, but is at least partially free to rotate relative to thecutter 24. For example, theauger 30 may include a circumferential flange (not shown) held within a corresponding groove (not shown) in thecutter 24. The flange can rotate within the groove, and contact between the flange and the groove causes theauger 30 andcutter 24 to translate together. In such an embodiment, theauger 30 and thecutter 24 are fixed axially, but independent rotationally. Other mechanisms or structures may be used to allow theauger 30 and thecutter 24 to translate together axially while having the capability of rotating at least partially independently. - The
auger 30 includes aspike 36 at its distal end, and ashaft 38 extending proximally from thespike 36. The distal end of thespike 36 extends distally to the distal end of thecutter 24. Theshaft 38 is substantially cylindrical. Alternately, theshaft 38 may be shaped differently. The distal end of thespike 36 is sharp to allow it to readily penetrate tissue. For example, thespike 36 may be tapered from its proximal end toward its distal end, and may be substantially axisymmetric. The proximal end of thespike 36 may be wider than theshaft 38, such that aledge 40 is formed at the proximal end of thespike 36. Further, thespike 36 may be positioned relative to thecutter 24 and is shaped such that theledge 40 is distal to the distal end of thecutter 24. Alternately, theledge 40 is positioned proximal to the distal end of thecutter 24. - The
auger 30 may be configured differently, if desired. As one example, theauger 30 may be threaded, with a sharp distal end to facilitate its entry into the wall of a target vessel. Such anauger 30 may be tapered as well. Alternately, theauger 30 may be a needle that is solid or at least partially hollow. As an example, the needle may be simply a length of hypotube. As another example, the needle is a thin solid rod. The needle may be pointed or sharpened at its distal end. However, the needle may have a diameter small enough that its distal end is sharp enough to readily penetrated tissue as a consequence of its size. Alternately, theauger 30 is a barb, harpoon, lance, corkscrew or other suitable symmetrical or non-symmetrical structure. Alternately, more than oneauger 30 is utilized, or theauger 30 includes a number of individual components. For example, a number ofaugers 30 may be clustered together in proximity to the longitudinal axis of thecutter 24. Alternately, theauger 30 may be omitted altogether. - The
cutter 24 may be attached to thecutter transport 28 and/or theauger 30 by dimpling thecutter 24 against thecutter transport 28 in one or more locations. Thecutter transport 28 may have a groove (not shown) defined at least partially circumferentially around it. Eachdimple 42 is formed by pressing thecutter 24 inward toward the groove, causing that location on thecutter 24 to deform into adimple 42. Thedimple 42 expands into a portion of the groove, trapping at least part of thedimple 42 therein. Thecutter 24 thus is fixed relative to theauger 30, such that they rotate and translate together. Theauger 30 may be connected to thecutter 24 using any other or additional suitable mechanism, structure or method. For example, theauger 30 and thecutter 24 may be molded or otherwise formed together as a single piece. As another example, theauger 30 and thecutter 24 may be fixed together by adhesive. As another example, theauger 30 and thecutter 24 may be fixed together by welding, or may be pinned or screwed together. - Referring also to
FIGS. 4-5 , acenterpiece 56 may extend distally from thecutter transport 28. Thecenterpiece 56 may be formed into thecutter transport 28 as an integral component thereof, or may be a separate piece that is connected to thecutter transport 28 in any suitable manner, such as by welding, soldering, or adhesive. Thecutter 24 may be connected to thecenterpiece 56, and may be connected to thecutter transport 28 indirectly via thecenterpiece 56. - At least one
cutter vent 44 may be defined in thecutter 24, providing a pathway for fluid such as air or blood to escape from thecutter 24 when thecutter 24 andauger 30 are deployed into the target vessel. Thus, the cutter vent or vents 44 prevent fluid from becoming trapped within thecutter 24, because the pressure of that trapped fluid otherwise could potentially prevent thecutter 24 from penetrating the vessel wall or other anatomical structure. The cutter vent or vents 44 are defined in thecutter 24 at or proximal to the proximal end of thecutter 24. Alternately, the cutter vent or vents 44 are located at the proximal end of thecutter 24, at its connection to thecutter transport 28. Eachcutter vent 44 may be shaped in any appropriate manner. For example, acutter vent 44 in thecutter 24 may be substantially straight, extending longitudinally, transversely or diagonally, or may be curved and extend at least partially in the longitudinal direction; for example, it may be helical or sinusoidal. - The
cutter transport 28 may be any structure or mechanism suitable for advancing thecutter 24. As one example, thecutter transport 28 is a rod or other member that is at least partially threaded with a number ofthreads 48. The crests of thethreads 48 may be flat, rounded, angled or shaped in any other appropriate manner. Referring also toFIG. 5 , a transmission member such as acutter cable 46 is wound along at least some of thethreads 48 of thecutter transport 28. The difference between the major diameter and the minor diameter of the threaded area of thecutter transport 28 may be at least twice the diameter of thecutter cable 46. In this way, thecutter cable 46 is held within thethreads 48 and does not extend outward further than the crests of thethreads 48. Alternately, thecutter cable 46 does extend outward further than the crests of thethreads 48; for example, where thecutter cable 46 is wound aroundthreads 48 of thecutter transport 28 proximal to theholder 20. An end of thecutter cable 46 may be fixed to thecutter transport 28 in any suitable manner. The anchor feature 50 may be located proximal to the threaded area of thecutter transport 28. As one example, the anchor feature 50 is a hole or passage extending into or through thecutter transport 28. An end of thecutter cable 46 is inserted into that anchor feature 50, then welded, fastened, clipped, tied or otherwise fixed to the anchor feature 50. As another example, the anchor feature 50 is a slot at the proximal end of thecutter transport 28 to which an end of thecutter 46 is connected. Alternately, the anchor feature 50 receives thecutter cable 46 and allows the end of thecutter cable 46 to move relative to thecutter transport 28. Alternately, the anchor feature 50 is located in or distal to the threaded area of thecutter transport 28. Any suitable structure, mechanism or method may be used to connect thecutter cable 46 to thecutter transport 28 either directly or indirectly. Thecutter transport 28 may include abore 49 or other feature to receive thecenterpiece 56 of thecutter 24. - The
cutter transport 28 is received in thebore 22 of theholder 20. Thebore 22 may be created in theholder 20 in any suitable manner, such as by molding it into theholder 20 or machining it through theholder 20. Thebore 22 may be substantially smooth-walled, with a diameter slightly greater than the major diameter of the threaded area of thecutter transport 28. The fit between the major diameter of the threaded area of thecutter transport 28 and thebore 22 is selected to permit thecutter transport 28 to rotate smoothly within thebore 22 substantially without binding. The diameter of thebore 22 and its length are also selected to reduce or eliminate precession of thecutter transport 28 andcutter 24 during operation of thecutter assembly 10. Alternately, thebore 22 is threaded. Where thecutter cable 46 does not enter thebore 22, the threads of thebore 22 and thethreads 48 of thecutter transport 28 may be closely matched to one another. Alternately, if thecutter cable 46 enters thebore 22, the crests of the threads of thebore 22, and the depth of the roots of thethreads 48 of thecutter transport 28, are sized such that adequate space exists between them to accommodate thecutter cable 46 on thecutter transport 28. - Referring also to
FIG. 3A , atooth 29 may be located in or at the edge of thebore 22. Thetooth 29 is sized to engage thethreads 48 of thecutter transport 28 to provide stability to thecutter transport 28 and substantially prevent axial slide of thecutter transport 28 during its actuation, without substantially impeding motion of thecutter transport 28. - The
cutter cable 46 is wound around at least a portion of thecutter transport 28 proximal to theholder 20, and remains proximal to theholder 20 and outside of thebore 22 during actuation. Optionally, a cable passage (not shown) extends outward from thebore 22 of theholder 20 to an outer surface of theholder 20. Where the cable passage is used, thecutter cable 46 is wound around at least a portion of thecutter transport 28 that is positioned within thebore 22. The cable passage is sized and shaped to receive thecutter cable 46 therethrough. The cable passage has a surface finish along its interior and at each end such that thecutter cable 46 can move smoothly through it when thecutter assembly 10 is actuated, as described in greater detail below. The cable passage is substantially straight, and may be oriented substantially tangent to the surface of thecutter transport 28, or in a different direction relative to thecutter transport 28. Further, the cable passage may be oriented such that its axis, extended outward, intersects thecutter transport 28 at a location between its major diameter and its minor diameter, to facilitate the smooth unwinding of thecutter cable 46 from thecutter transport 28. Alternately, the cable passage is curved, at least in part. Alternately, the cable passage is oriented differently. - The
holder 20 may include at least oneprojection 66 extending therefrom. Advantageously, two ormore projections 66 extend laterally from each side of theholder 20 to provide added stability. The projection orprojections 66 may be flanges, pins or any other suitable structures that are integral with or that are attached to theholder 20. The projection orprojections 66 may extend substantially perpendicular to the longitudinal axis of thecutter member 18. Alternately, the projection orprojections 66 may extend at a different angle relative to the longitudinal centerline of thecutter member 18. The projection orprojections 66 may extend from the base of theholder 20 or from any other portion of theholder 20. - Alternately, instead of a
cutter 24 andauger 30, a knife (not shown) or other structure or mechanism can be provided. The knife or other mechanism may be configured to create a linear, rather than curved, opening in the target vessel. For example, the knife may be movable in a direction substantially parallel to the longitudinal centerline of the target vessel in order to create a substantially linear incision therein. Where the knife or other mechanism is configured to create a linear incision, thecutter transport 28 may be configured to move the knife or other mechanism in a linear rather than rotational manner. - Frame
- Referring also to
FIG. 2 , theframe 14 includes one or morefirst grooves 68 defined therein. Theframe 14 may be formed of any suitable material, such as polycarbonate or stainless steel, and the groove orfirst grooves 68 may be formed in any suitable manner, such as by molding or machining. Eachfirst groove 68 is configured to receive at least oneprojection 66 and guide the motion thereof. The groove orfirst grooves 68 form a path along which theprojections 66, and thus theholder 20 and thecutter assembly 10, can travel, and that path may extend in any direction or combination of directions that allows for motion of thecutter assembly 10 in a desired manner. As one example, at least onefirst groove 68 is defined in eachside wall 70 of the frame, and thefirst grooves 68 guide thecutter assembly 10 proximally relative to its original position and away from the line defined by the original position of the longitudinal axis of thecutter member 18. Motion away from the line defined by the original position of the longitudinal axis of thecutter member 18 may be referred to as off-axis motion. In this way, thecutter assembly 10 is movable out of the way of theconnection module 12 after thecutter assembly 10 creates an opening in the wall of the target vessel. The interaction between eachprojection 66 and the correspondingfirst groove 68 may also act to minimize or prevent motion of thecutter assembly 10 in the lateral or vertical directions. Alternately, theframe 14 has one or more rails, projections or ribs extending therefrom, and theholder 20 includes one or more grooves corresponding to those projections. Alternately, any other or additional appropriate structure or mechanism may be used to guide the motion of thecutter assembly 10 relative to theframe 14. As one example, thecutter assembly 10 is rotatable out of the way of theconnection module 12 after thecutter assembly 10 creates an opening in the wall of the target vessel. Thecutter assembly 10 is retracted proximally to a suitable location, then moved off-axis by rotation. Such rotation may result from a passive mechanism such as a spring, an active mechanism such as a device that engages thecutter cable 46 or other cable, or a combination of active and passive mechanisms. Where such a system is utilized, thefirst grooves 68 optionally may be omitted. - One or
more clips 72 may be connected to theframe 14, such as by screws 74. Alternately, the clip or clips 72 may be formed into theframe 14 or otherwise connected to theframe 14. Eachclip 72 is shaped and positioned to hold at least oneprojection 66 of theholder 20, and substantially to restrain thatprojection 66 against longitudinal motion in the proximal and/or distal direction, both before actuation of thecutter assembly 10 and while thecutter assembly 10 creates an opening in the wall of the target vessel. Eachclip 72 may be shaped in the same manner as or in a different manner from anyother clip 72. As one example, eachclip 72 is a leaf spring extending proximally from its connection to theframe 14, with an upwardly-extendingstop 76 formed into its proximal end. Thestop 76 is located proximal to the correspondingprojection 66, and substantially restrains the correspondingprojection 66 and thereby theholder 20 and thecutter assembly 10 against proximal motion. The clip or clips 72 are constructed such that the clip or clips 72, taken together, resist an amount of force in the proximal direction that is greater than the amount exerted on thecutter assembly 10 during forward travel of thecutter member 18 and less than the amount exerted on thecutter assembly 10 by thecutter cable 46 after the forward travel of thecutter member 18 is complete. In this way, the clip or clips 72 allow motion of thecutter cable 46 to move thecutter member 18 distally, rather than move thecutter assembly 10 as a whole proximally, and thereby allow thecutter assembly 10 to create an opening in the target vessel. Actuation of thecutter assembly 10 and the forces acting upon thecutter assembly 10 are described in greater detail below. - At least one
bracket 78 may be connected to theframe 14 in any suitable manner, or formed into theframe 14. Eachbracket 78 is positioned in proximity to acorresponding clip 72. Alternately, at least onebracket 78 is not associated with aclip 72, or is spaced apart from a correspondingclip 72. Eachbracket 78 includes anindentation 80 defined therein, where thatindentation 80 is located distal to thestop 76 of thecorresponding clip 72. Theindentation 80 may be positioned relative to thecorresponding stop 76 such that the distance between the distal surface of thestop 76 and the most-distal portion of theindentation 80 is substantially equal to or slightly greater than the length of theprojection 66 held therebetween. In this way, theprojection 66 is held securely. Contact between eachbracket 78 and one or morecorresponding projections 66 substantially restrains distal motion of theholder 20 during actuation of thecutter assembly 10. In combination with the corresponding stop or stops 76, the bracket orbrackets 78 restrain theholder 20 substantially in place in the longitudinal direction during actuation of thecutter assembly 10. Further, contact between the projection orprojections 66 and the corresponding groove orfirst grooves 68 restrains theholder 20 substantially in place in the lateral and vertical directions. For convenience, the term “vertical” refers to the direction that is substantially perpendicular to both the longitudinal direction and to the lateral direction, and is independent of the orientation of theintegrated anastomosis tool 2 relative to a patient or to an operating room. In addition, contact between the sides of theholder 20 and theinner surface 82 of eachside wall 70 of theframe 14 also may restrain theholder 20 substantially in place in the lateral direction. Thus, theholder 20 is substantially restrained in all three dimensions as thecutter member 18 is actuated to create an opening in the target vessel. Such restraint allows thecutter assembly 10 to produce an opening of the desired quality in and in a desired location on the target vessel. Alternately, theholder 20 may be free to move at least partially in at least one direction during actuation of thecutter assembly 10. - As used in this document, the term “impulse” means a force that acts on a body for a short time but produces a large change in its linear or angular momentum. The
cutter assembly 10 is configured to be actuated impulsively. That is, an impulse is applied to thecutter assembly 10 to cause it to make an opening in the target vessel and to move off-axis out of the way of theconnection module 12. Alternately, thecutter assembly 10 is configured to be actuated non-impulsively. Further detail regarding the impulsive actuation of thecutter assembly 10 is provided below. - Connection Module
- The
effector 4 includes aconnection module 12, which may be any mechanism that is configured to connect a graft vessel to a target vessel. As one example, theconnection module 12 may deploy one or more staples, clips, connectors or other mechanisms to connect the graft vessel to the target vessel. As another example, theconnection module 12 may be configured to suture the graft vessel to the target vessel, such as by moving one or more needles that are connected to suture in order to suture the vessels together. As another example, theconnection module 12 may be configured to adhere the graft vessel to the target vessel, such as by placing adhesive such as fibrin glue therebetween. As another example, theconnection module 12 may be configured to apply RF energy to the graft vessel and/or the target vessel to connect the two together. Theconnection module 12 may be configured in any other suitable manner for connecting the graft vessel to the target vessel. - Referring to
FIG. 2 and toFIGS. 6-7 , anexemplary connection module 12 connects an end of a graft vessel to the side of a target vessel by deploying a plurality ofconnectors 90. Theconnectors 90 may be substantially the same as one another, or one ormore connectors 90 may be configured differently than one or more of the others. Theconnectors 90 may be staples, clips or other structures or mechanisms configured to connect tissue of the graft vessel to tissue of the target vessel. In one embodiment, at least one of theconnectors 90 is a staple 90. Referring toFIG. 8 , anexemplary staple 90 includes afirst tine 92 and asecond tine 94, each connected to abase 96. The proximal end of eachtine base 96. Alternately, a different part of thefirst tine 92 and/or thesecond tine 94 is connected to the base. Thetines tines first tine 92 is shorter than thesecond tine 94. Alternately, thefirst tine 92 is the same length as or longer than thesecond tine 94. Eachtine tines base 96 of the staple 90 may be stepped, where afirst step 98 is substantially parallel to and distal to asecond step 100. Alternately, thesteps steps transition 102 that may be curved, angled or otherwise configured. Thefirst step 98 is connected to thefirst tine 92, and thesecond step 100 is connected to thesecond tine 94. Before deployment of the staple 90, eachstep corresponding tine step base 96 and thetines base 96 and thetines base 96 and thetines staple 90 is configured differently, and may include additional tines, tines that are shaped differently, a base that is shaped differently, and/or other properties different from theexemplary staple 90 described above. - Advantageously, the
staple 90 is a wire staple formed from a single wire, such that the staple 90 is integral. However, the staple 90 may be made from a single piece of material having a different form, such as a sheet of metal. Alternately, thestaple 90 is formed from two or more separate components that are connected together in any suitable matter. The staple 90 is metallic, and advantageously is made from stainless steel. Alternately, the staple 90 may be made from nickel-titanium alloy or other metal. Alternately, thestaple 90 is made from a nonmetallic material. Alternately, thestaple 90 includes a non-metallic coating over a metallic or nonmetallic core or substrate. Alternately, a therapeutic amount of at least one substance is associated with the surface of thestaple 90. Thestaples 90 are oriented in theconnection module 12 such that theirtines staples 90 may be spaced substantially radially symmetrically relative to theconnection module 12. Alternately, thestaples 90 are oriented differently relative to theconnection module 12. - Referring to
FIGS. 6-7 and 9, theconnection module 12 includes at least oneanvil plate 104. Eachanvil plate 104 supports one ormore staples 90. Eachanvil plate 104 includes at least oneaperture 106 defined therein, and at least oneanvil 108 that extends into acorresponding aperture 106. Alternately, at least oneanvil 108 may be positioned at a different location on theanvil plate 104. Eachanvil 108 may be characterized as an external anvil, because it is positioned outside of the tissue to be stapled. Referring also toFIG. 8 , theanvil plate 104 may be configured to move between a first position in which it supports at least onestaple 90 and a second position in which it frees at least onestaple 90. In the first position, eachanvil 108 is located distal to and substantially in contact with thefirst step 98 of acorresponding staple 90. The connection module includes a proximal surface (not shown) located proximal to thefirst step 98 of each staple 90, such that thefirst step 98 of each staple 90 is held between the proximal surface and theanvil 108. In the second position, eachanvil 108 is no longer located distal to or in contact with thefirst step 98 of thecorresponding staple 90. Thus, in the second position theanvil plate 104 has freed thecorresponding staple 90 to exit theconnection module 12. - The
anvil plate 104 may move from the first position to the second position by rotation, where that rotation is provided by any suitable mechanism. Theanvil plate 104 may be actively rotated such as by a shaft or other mechanism. Alternately, theanvil plate 104 may be passively rotated such as by a spring. For example, the spring may bias theanvil plate 104 in a particular direction of rotation, where a structure or mechanism restrains theanvil plate 104 against motion in that direction of rotation until after the staple orstaples 90 have been formed. Eachanvil plate 104 may include at least onerotation aperture 110, into which apost 112 extends from the connection module. Eachrotation aperture 110 acts to limit the rotation of thecorresponding anvil plate 104, because contact between eachpost 112 and an end of thecorresponding rotation aperture 110 stops the rotational motion of theanvil plate 104. Alternately, at least oneanvil plate 104 is movable between the first position and the second position in a motion other than rotation. At least onepost 112 may include a head having a diameter larger than the remainder of thepost 112, in order to prevent theanvil plate 104 from moving substantially distally. - Referring to FIGS. 2 and 6-7, the
connection module 12 may include afirst segment 114 and asecond segment 116 movable relative to one another. Alternately, theconnection module 12 includes three or more members relative to one another; theconnection module 12 is not limited to having twosegments segment 114segment anvil plate 104 at or near its distal end, and one ormore connectors 90, and is configured to deploy thoseconnectors 90. Alternately, at least onesegment 114segment anvil plate 104. Thesegments connection module 12 is a unitary structure that does not includesseparate segments - The
segments axle 118 may connect thesegments segments axle 118. Theaxle 118 is oriented substantially transverse to the longitudinal axis of theconnection module 12, such as at an angle substantially perpendicular to that longitudinal axis or at a different angle relative to that longitudinal axis. Alternately, theaxle 118 may be oriented differently relative to the longitudinal axis of theconnection module 12. As another example, one or more hinges may be substituted for theaxle 118 in order to allow relative rotation of thesegments segments segments segments segment 114segment segments segments - The
segments FIGS. 7 and 11 , theconnection module 12 may be configured to allow side loading of agraft vessel 120 into theconnection module 12. That is, theconnection module 12 may be configured to allow one end of thegraft vessel 120 to extend out of theconnection module 12 at a location lateral to the longitudinal centerline of theconnection module 12, rather than through the proximal end of theconnection module 12. As one example, at least part of thefirst segment 114 is spaced apart from part of thesecond segment 116 when theconnection module 12 is in the closed position in order to form thepassage 122 in a side of theconnection module 12. Alternately, theconnection module 12 is not configured to allow side loading of agraft vessel 120. Eachsegment 114segment depression 124 at and/or near its distal end. Thedepressions 124 may be substantially semicircular in cross section, or may be shaped in a different manner. Thedepressions 124 may be substantially linear and coaxial with the longitudinal centerline of theconnection module 12. Alternately, thedepressions 124 may be nonlinear and/or oriented other than coaxially with the longitudinal centerline of theconnection module 12. When theconnection mechanism 12 is in the closed position, thedepressions 124 in thesegments graft vessel 120. The distal end of eachdepression 124 may coincide with the distal end of theconnection module 12, such that the distal ends of thedepressions 124 collectively form anaperture 126 at the distal end of theconnection module 12. - Each
segment 114segment driver 128. Eachdriver 128 is movable relative to the correspondingsegment 114segment driver 128 occupies the first position before deploying one or morecorresponding connectors 90, and occupies the second position after deploying one or morecorresponding connectors 90. The motion of eachdriver 128 between the first position and the second position deploys at least one correspondingconnector 90, as described in greater detail below. The distal end of at least onedriver 128 is the end that contacts one or more corresponding connectors 16, and that distal end is contoured to facilitate deployment of those one or more connectors 16. Eachdriver 128 may be shaped in any suitable manner. As one example, at least onedriver 128 may be an elongated member with a substantially planar proximal end oriented perpendicular to the longitudinal axis of the driver. A plunger (not shown) may be positioned between at least onedriver 128 and a corresponding one ormore connectors 90, such that thedriver 128 urges the plunger distally, and in turn the plunger contacts at least oneconnector 90. - Referring to FIGS. 2 and 6-7, the
connection module 12 may be biased to the open position, such as by at least onespring 130 located at the proximal end of theconnection module 12 and connected to both of thesegments connection module 12 is biased to the open position, at least one holdingmember 132 releasably holds thesegments member 132 is a leaf spring extending from one of thesegments catch 134 oriented to engage adepression 136 or other feature on theother segment leaf spring 132 is biased at least partially toward the longitudinalaxis connection module 12 with sufficient force to hold thecatch 134 in thecorresponding depression 136 such that theconnection module 12 is held in the closed position. Alternately, theconnection module 12 is biased to the closed position, and a different structure or mechanism is provided to move theconnection module 12 to the open position after it connects the graft vessel to the target vessel. Alternately, theconnection module 12 is not biased to the open position or to the closed position. - At least one holding
member 132 may include anengagement element 138 extending from it. As one example, theengagement element 138 is positioned at the distal end of the corresponding holdingmember 132, and extends at least partly in a direction outward from theconnection module 12. Theframe 14 may be connected to or include at least onestub 140 positioned at or near its distal end, or at a different suitable location. At least oneengagement element 138 is pressed into contact with acorresponding stub 140 during the deployment process. This contact, when performed with sufficient force, overcomes the bias of the holdingmember 132 and moves the holdingmember 132 outward, thereby moving thecatch 134 out of thecorresponding depression 136. After thecatch 134 has been disengaged from the correspondingdepression 136, theconnection module 12 can move to the open position, such as under the influence of thespring 130. One or more different or additional structures and/or mechanisms may be provided to provide for the motion of theconnection module 12 from the closed position to the open position at the appropriate time in the deployment process. - At least one
projection 142 extends from theconnection module 12. Advantageously, two ormore projections 142 extend laterally from each side of theconnection module 12 to provide added stability. The projection orprojections 142 may be flanges, pins or any other suitable structures. The projection orprojections 142 may extend substantially perpendicular to the longitudinal axis of theconnection module 12. Alternately, the projection orprojections 142 may extend at a different angle relative to the longitudinal axis of theconnection module 12. - The
frame 14 includes one or moresecond grooves 144 defined therein in any suitable manner, such as by molding or machining. The second groove orgrooves 144 may extend on theframe 14 at least partially in a different direction than thefirst grooves 68. Eachsecond groove 144 is configured to receive, and guide the motion of, at least oneprojection 142. The second groove orgrooves 144 form a path along which theprojections 142, and thus theconnection module 12, travel. Thus, the second groove orgrooves 144 may extend along any path or paths that allow for motion of theconnection module 12 in a desired manner. As one example, at least onesecond groove 144 is defined in eachside wall 70 of the frame, and the second groove orgrooves 144 guide theconnection module 12 substantially distally in the direction defined by the original position of the longitudinal axis of theconnection module 12. The interaction between eachprojection 142 and the correspondingsecond groove 144 may also act to minimize or prevent motion of theconnection module 12 in the lateral or vertical directions. Alternately, theconnection module 12 includes one or more grooves corresponding to those projections, and theframe 14 has one or more rails, projections or ribs extending therefrom. Alternately, any other or additional appropriate structure or mechanism may be used to guide the motion of theconnection module 12. - Optionally, the second groove or
grooves 144 may also be used as cable guides. Thetraveler cable 154 may extend along at least part of the second groove orgrooves 144, and may be held in the second groove orgrooves 144 by a screw, clip or other mechanism at or near the distal end of theframe 14. Alternately, a separate cable guide may be formed in or connected to theframe 14. - Referring to
FIGS. 2 and 10 , atraveler 146 may be located proximal to theconnection module 12. Thetraveler 146 acts to impel theconnection module 12 distally during the actuation of theintegrated anastomosis tool 2. Thetraveler 146 includes aplate 148 that may be sized, shaped and configured in any manner that allows distal motion of theplate 148 to impel theconnection module 12 distally. For example, theplate 148 may directly contact theconnection module 12, such that force applied to theplate 148 in a distal direction impels theconnection module 12 distally. At least oneleg 150 may extend from theplate 148, such as in the distal direction. At least oneleg 150 may extend into, or include a projection that extends into, one of thesecond grooves 144, such that thetraveler 146 follows the same path as theconnection module 12 relative to theframe 14. Alternately, at least oneleg 150 extends into, or includes a projection that extends into, a groove other than one of thesecond grooves 144. Alternately, theframe 14 has one or more projections or ribs extending therefrom, and thetraveler 146 includes one or more grooves corresponding to those projections. Alternately, any other or additional appropriate structure or mechanism may be used to guide the motion of thetraveler 146. - The
traveler 146 includes achannel 152 defined therein. Thechannel 152 may be entirely within the body of thetraveler 146, or may be defined entirely or partially on the surface of thetraveler 146. Thechannel 152 is sized and finished to allow a transmission member such as atraveler cable 154 to pass through it. Thetraveler cable 154 is not fixed to thetraveler 146. Rather, thetraveler cable 154 enters one end of thechannel 152 and extends completely through thechannel 152 to exit the other end of thechannel 152. Thetraveler cable 154 is thus free to slide relative to thechannel 152. Alternately, thetraveler cable 154 or other transmission member is fixed to thetraveler 146. Asecond traveler cable 155 may be attached to the proximal end of thetraveler 146 or other part of thetraveler 146 in any appropriate manner. - At least one end of the
traveler cable 154 extends to theactuator 6. Thetraveler cable 154 is connected to theactuator 6 such that the application of tension to thetraveler cable 154 causes thetraveler 146 to move distally and cause theconnection module 12 to move distally and deploy connectors to connect the graft vessel to the target vessel. Similarly, at least one end of thecutter cable 46 extends to theactuator 6. Thecutter cable 46 may be connected to theactuator 6 such that the application of tension to thecutter cable 46 causes thecutter assembly 10 to move distally, create an opening in the wall of the target vessel, and move out of the way of theconnection module 12. Thecutter cable 46, thetraveler cable 154 and thesecond traveler cable 155 are collectively one example of a standard interface between theeffector 4 and theactuator 6. That is, anyactuator 6 configured to apply specific forces to thecables - Referring to
FIG. 20 , another embodiment of aconnection module 12 is configured to suture thegraft vessel 120 to thetarget vessel 166, rather than deploystaples 90 or clips. As in the previous embodiment, theconnection module 12 may include one ormore projections 142 each configured to engage asecond groove 144 in theframe 14. Also, as in the previous embodiment, theconnection module 12 may include afirst segment 114 and asecond segment 116 movable relative to one another. Referring also toFIG. 22 , the distal end of theconnection module 12 may be curved or otherwise shaped in a manner suitable for contacting the outer surface of thetarget vessel 166. - The
connection module 12 includes twosegments connection module 12 includes three or more separate segments. Alternately, theconnection module 12 is unitary, and includes only a single segment. At least onesegment 114segment connection module 12 may include a housing that encloses at least some of the components of thatsegment FIG. 21 , the second segment is not shown, for clarity. Unless otherwise indicated, the components, characteristics and operation of thefirst segment 114 described below are equally applicable to thesecond segment 116. Thefirst segment 114 may include ahousing 180 that extends to the distal end of thefirst segment 114. Thehousing 180 may include a number ofapertures 182 defined in its distal end. Thehousing 180 may also, or instead, include a number ofneedle apertures 184 defined on a lateral surface thereof and/or on its distal end. Further, thefirst segment 114 may include adepression 124 defined therein, substantially as described with regard to the previous example of theconnection module 12. The depressions in thesegments graft vessel 120. - The
first segment 114 may include alatch 186. Thelatch 186 may extend substantially laterally, or may extend in a different direction. Thelatch 186 is attached to thefirst segment 114 at one end, and may be curved, hooked, or otherwise shaped at itsfree end 188. Referring also toFIG. 22 , anotch 190 or other feature corresponding to thefree end 188 of thelatch 186 is defined in or connected to thesecond segment 116. Thefree end 188 of thelatch 186 engages thenotch 190 to hold the twosegments feature 190 in thesecond segment 116 is a rod or other mechanism that is movable or otherwise actuable relative to thefree end 188 of thelatch 186. - Referring also to
FIG. 23 , a number ofneedles 192 are rotatably connected to the inner surface of the distal end of thehousing 180. Alternately, theneedles 192 are connected to an end plate or other structure or mechanism that in turn is connected to the inner surface of the distal end of thehousing 180, or to another or a different structure or mechanism in thefirst segment 114. Alternately, theneedles 192 are connected to the inner surface of the distal end of thehousing 180 or to an end plate or other structure in a way that allows for motion in a manner other than rotation, such as sliding motion or compound motion. - Referring also to
FIG. 24 , eachneedle 192 includes anarcuate body 194. Thearcuate body 194 may follow a substantially continuous curve, or may follow a more complex curvature. Alternately, thebody 194 is angled in a simple or complex manner, rather than being arcuate. One end of thearcuate body 194 is connected to one end of aleg 196. The curvature of thearcuate body 194 may have a radius that is substantially equal to the length of theleg 196. Alternately, the curvature of thearcuate body 194 may have a radius that is different from the length of theleg 196. The opposite end of theleg 196 is connected to one end of anaxle 198. The other end of theaxle 198 is connected to aretention member 199. Thearcuate body 194 may be substantially parallel to an arbitrary plane, and theleg 196 may be substantially parallel to that same arbitrary plane. Theleg 196 may be substantially linear, and may be oriented in a direction toward thefree end 195 of theleg 196. Alternately, theleg 196 may be shaped and/or oriented in any other suitable manner. Thefree end 195 of theleg 196 may be substantially blunt. Alternately, thefree end 195 may be sharp. Alternately, thefree end 195 may have a suture retention feature (not shown) capable of holding the suture, and theneedle tip 200 described below is not used. Theaxle 198 may be substantially perpendicular to theleg 196. Alternately, theaxle 198 is oriented in a different direction relative to theleg 196. Theaxle 198 is substantially linear, although it may be shaped differently if desired. Theretention member 199 is substantially L-shaped. However, theretention member 199 may be shaped differently, if desired. Theretention member 199 is oriented such that a first part of its L-shaped body is substantially parallel to theleg 196, and the second part of its L-shaped body is substantially parallel to theaxle 198. However, theretention member 199 may be oriented differently, particularly if it does not take a substantially “L” shape. Alternately, theretention member 199 may be omitted altogether, as described in greater detail below. Thearcuate body 194 and/or the other components of theneedle 192 may be substantially rigid. Theneedle 192 may be constructed from any suitable material, such as stainless steel. - At least one
cable aperture 197 may be defined in theretention member 199, or other suitable component of theneedle 192. Thecable aperture 197 is sized to receive a needle actuation cable (not shown) or a portion of a needle actuation cable. For example, a needle actuation cable may extend from both sides of thecable aperture 197, and be fixed to thecable aperture 197 such as by adhesive, crimping, welding, the use of one or more connectors, or any other suitable method, structure or mechanism. Eachneedle 192 may be associated with a separate needle actuation cable. Alternately, one or more needle actuation cables may be provided for eachsegment 114segment needles 192, but that are unwrapped from one another to individually connect to thecorresponding cable apertures 197 of theneedles 192. The needle actuation cable or cables are physically and/or operationally connected to theactuator 6, which may be mechanically configured in any manner that provides for motion of the needle actuation cable or cables. Alternately, the needle actuation cable is not used, and a different transmission member or members connects theretention member 199 of theneedle 192 and/or other appropriate part of theneedle 192 to theactuator 6. For example, the transmission member may be a rack and pinion system, a rod, a belt, a chain, a tube or other structure for transmitting fluid or hydraulic pressure, one or more electrical wires and/or motors, or any other suitable structure or mechanism or combination thereof. Where the needle actuation cable is not used, thecable aperture 197 in theretention member 199 optionally may be omitted. - Referring also to
FIG. 25 , aneedle tip 200 is detachably connected to at least oneneedle 192. Advantageously, eachneedle tip 200 is detachably connected to thefree end 195 of thearcuate body 194 of thecorresponding needle 192. Theneedle tip 200 may be curved with a radius of curvature substantially matching the radius of curvature of thearcuate body 194. Alternately, theneedle tip 200 may be curved differently, may be straight, or may be shaped in a different manner. Eachneedle tip 200 includes aspike 202, abody 204 connected to one end of thespike 202, and a base 206 connected to the opposite end of thebody 204. Thespike 202 may be substantially conical, with atip 208 capable of penetrating tissue. Thetip 208 may be sharp, or may be otherwise configured to allow it to penetrate tissue. Alternately, thespike 202 is blunt rather than sharp, and/or is not configured to penetrate tissue. Alternately, thespike 202 may be shaped differently. - An
aperture 210 is defined in thebody 204. Theaperture 210 may be defined completely through thebody 204, or may extend only partially into thebody 204. Theaperture 210 may have a circular cross-section, or may be shaped differently. Theaperture 210 may have a constant cross-section along its length, or that cross-section may vary along the length of theaperture 210. Referring also toFIG. 26 , the diameter and/or cross-section of theaperture 210 is selected to facilitate the connection ofsuture 212 to theneedle tip 200. Thesuture 212 may be connected to theneedle tip 200 in any suitable manner, such as by adhesive, by crimping, by swaging, by co-molding, by passing thesuture 212 through theaperture 210 and tying a knot on the opposite side, by welding, or by one or more separate fasteners. - The
body 204 may be shaped as a curved cylinder having a frustum at the end closest to thespike 202, or may be shaped in any other suitable manner. The diameter of thespike 202 is greater than the diameter of thebody 204 at the connection between thespike 202 and thebody 204. Alternately, where thespike 202 and/orbody 204 are shaped such that either or both does not have a diameter, thespike 202 extends further laterally than thebody 204, at least in part, at the connection between thespike 202 and thebody 204. The width of thespike 202 at the connection between thespike 202 and thebody 204 may be used to capture theneedle tip 200 and may assist in retaining graft tissue after poke-through, as described in greater detail below. - The
base 206 is configured to be detachably connected to thefree end 195 of thearcuate body 194 of thecorresponding needle 192. Thebase 206 of theneedle tip 200 may be a curved cylinder. Alternately, thebase 206 may be shaped in any other suitable manner. Where theneedle 192 has a lumen defined at least partially therethrough, that lumen extending to thefree end 195 of thearcuate body 194, the outer diameter of the base 206 may be substantially equal to the inner diameter of thearcuate body 194. At least part of the base 206 can be placed into the lumen of thearcuate body 194 at itsfree end 195, and then thefree end 195 can be crimped to create a detachable connection therebetween. Alternately, thebase 206 of theneedle tip 200 has a lumen defined therein, and the outer diameter of thefree end 195 of thearcuate body 194 is sized to allow entry into the lumen defined in thebase 206. In such an example, at least part of thefree end 195 of thearcuate body 194 can be placed into the lumen of thebase 206 of theneedle tip 200, and then the base 206 can be crimped to create a detachable connection therebetween. Alternately, thebase 206 may be connected to thearcuate body 194 in an other manner that results in a detachable connection therebetween. Alternately, thebase 206 is connected to theneedle 192 in any other suitable manner that allows for the base 206 to be detached from theneedle 192. For example, thebase 206 may be connected to thefree end 195 of thearcuate body 194 of thecorresponding needle 192 by a frangible member. In such an example, theneedle tip 200 may be fabricated as a unitary structure with theneedle 192. As other examples, thebase 206 may be crimped or swaged to thefree end 195 of thearcuate body 194. - Referring also to
FIG. 23 , eachneedle 192 is movably connected to theproximal surface 213 of the distal end of thehousing 180. Alternately, at least one separate member (not shown) is connected to the proximal surface of the distal end of the housing, and eachneedle 192 is connected to a proximal surface of at least one of the separate members. Eachneedle 192 is connected to theproximal surface 213 by at least one correspondingbushing 214. Thebushing 214 is connected to theproximal surface 213, or is fabricated integrally with theproximal surface 213. At least onebushing 214 may be semicircular, with asemicircular opening 216 adjacent to theproximal surface 213. Alternately, theopening 216 is fully circular, or is shaped differently. Theaxle 198 of eachneedle 192 extends through thecorresponding opening 216 or is otherwise held by the correspondingbushing 214. Theaxle 198 is free to rotate relative to thebushing 214, and theopening 216 of thebushing 214 constrains the rotation of the axle substantially in the desired direction. - The
retention member 199 holds theneedle 194 in place and retains it in thebushing 214. Optionally, theretention member 199 may be omitted, and theaxle 198 may be retained in a different manner. For example, the end of theaxle 198 that is not attached to theleg 196 may include or be connected to a structure that is larger than theopening 216 in thebushing 214, such that theaxle 198 is retained in thebushing 214. Where theretention member 199 is used, the portion of thatretention member 199 that is substantially parallel to theaxle 198 may slide along the outer surface of thebushing 214 when theneedle 192 rotates. This sliding contact between theretention member 199 additionally constrains the rotation of theneedle 192 and enhances the stability of its rotation. Thebushings 214 are positioned on theproximal surface 213 of the distal end of thehousing 180 in an orientation such that the free ends 195 of theneedles 192 can move to a position in which they extend through theaperture 126 in the distal end of theconnection module 12. - Referring also to
FIG. 21 , as in the previous example of aconnection module 12, eachsegment 114segment support 217. Advantageously, eachsegment 114segment single support 217. Eachsupport 217 may include a number ofarms 218 at or near its distal end. Thearms 218 extend substantially radially from the longitudinal centerline of theconnection module 12. Alternately, thearms 218 extend in a different direction relative to the longitudinal centerline of theconnection module 12. Eacharm 218 corresponds to at least oneneedle 192. Where at least onearm 218 corresponds to asingle needle 192, thatarm 218 may be skewed relative to thatneedle 192. Alternately, thearm 218 is substantially aligned with thecorresponding needle 192. Alternately, thesupport 217 and/or the arm orarms 218 may be omitted altogether. - Referring also to
FIG. 27 , eachsegment 114segment grate 220. Thegrate 220 may be connected to the distal end of aslider 222. Alternately, thegrate 220 may be connected to a different part of theslider 222, or to a different mechanism or structure. Thegrate 220 is a structure or mechanism that is configured to capture at least one of theneedle tips 200. For example, thegrate 220 may be a thin piece of material that includes at least oneaperture 224 defined therein to capture at least onecorresponding spike 202. The width of eachaperture 224 is less than the widest part of at least onecorresponding spike 202. Thegrate 220 may be shaped in any suitable manner. As one example, at least onegrate 220 is curved. As another example, at least onegrate 220 forms part of an annulus, and may be described as semi-annular. Thegrate 220 may be configured in any other suitable manner, and may be any other suitable structure or mechanism. As one example, thegrate 220 may be a ring composed at least in part of plastic material, such as polypropylene. Theapertures 224 may be omitted from such agrate 220. Theneedle tips 200 push into thegrate 220 and are held securely by the plastic material. As another example, thegrate 220 may be fabricated at least in part from a gel or gel-like material, such as silicone. Theapertures 224 may be omitted from such agrate 220. Theneedle tips 200 push into thegrate 220 and are held securely by the gel or gel-like material. As another example, thegrate 200 is fabricated at least in part from fabric which may or may not be impregnated or otherwise associated with a clotting agent. Theapertures 224 may be omitted from such agrate 220. Theneedle tips 200 push into and/or through the fabric and are held in place by the fabric. The fabric may be coarsely woven from any suitable fiber or materials; for example, the fabric may be fabricated from cotton, polyester or metallic fibers, or any combination thereof. If the fabric is coarsely woven, theneedle tips 200 may be able to pass through the mesh formed by the weave, but unable to pass back through the mesh as a result of interference between the base of thespike 202 and the fabric of thegrate 220. As another example, thegrate 220 may include adhesive on at least one surface of a ring or other structure suitable for carrying the adhesive. Theapertures 224 may be omitted from such agrate 220. Theneedle tips 200 contact the adhesive and are held securely by the adhesive. Alternately, any other structure or mechanism may be used instead of or in addition to thegrate 200 to capture one or more of theneedle tips 200. - The
slider 222 is a structure connected to and positioned proximal to thegrate 220. Theslider 222 may be shaped in any suitable manner. Theslider 222 is actuable to translate proximally after thegrate 220 has captured at least oneneedle tip 200, as described in greater detail below. Alternately, theslider 222 is movable in a manner other than or in addition to translation. - Registration Member
- Referring to
FIG. 2 , at least oneregistration member 156 may extend from theeffector 4, such as from the distal end of theeffector 4. The distal end of theeffector 4 may be substantially coincident with the distal end of theframe 14. The registration member ormembers 156 may bespikes 156 that are configured to penetrate the wall of the target vessel at least partially. Alternately, one ormore registration members 156 may push down the wall of the target vessel, pull up the wall of the target vessel or otherwise engage the wall of the target vessel without penetrating it while still achieving registration. The cross-sectional area of eachspike 156 is selected to be small enough such that the tissue of the target vessel self-closes the aperture created therein by thespike 156 after thespike 156 is removed. Alternately, one or more of the registration members are configured differently. The registration member ormembers 156 act to hold theeffector 4 in a substantially fixed position relative to the opening in the target vessel made by thecutter assembly 10 during actuation of theeffector 4. That is, the registration member ormembers 156 register the distal end of theeffector 4 to a particular location on the surface of the target vessel. By registering theeffector 4 to the target vessel, theconnection module 12 is able to connect the end of thegraft vessel 120 to the proper location on the target vessel relative to the opening created by thecutter assembly 10. At least oneregistration member 156 may extend from anopen support 157, which may be crescent-shaped or take any other appropriate shape. Thesupport 157 is open to allow the graft vessel to exit through the open portion after theeffector 4 is removed from the anastomosis site, as described below. Thesupport 157 may act as a stop to stop the distal motion of thecutter assembly 10 and/or theconnection module 12 during actuation of theeffector 4. Alternately, a stop may be provided as a separate structure connected to thesupport 157. Alternately, an introducer (not shown) such as a sleeve, cage or other mechanism may be used to guide theconnection module 12 to the opening created by thecutter assembly 10, thereby registering theconnection module 12 to the target vessel. The introducer may be used instead of or in addition to theregistration members 156. Alternately, a separate registration mechanism (not shown) may be mounted to or around the target vessel, and the distal end of theeffector 4 couples to that registration mechanism to register theeffector 4 to the target vessel. The registration mechanism may be any mechanism that can be mounted to the target vessel, such as the aorta, in any manner. For example, the registration mechanism may be the access port system of commonly-assigned U.S. patent application Ser. No. 09/967,684, which is hereby incorporated by reference in its entirety. Mounting of the registration mechanism to the target vessel may be performed by applying suction, holding the registration mechanism against the target vessel mechanically or by hand, or in any other appropriate manner. Further, coupling between theeffector 4 and the registration mechanism may be accomplished in any suitable manner. As one example, theeffector 4 may lock to the registration mechanism such that the two items are removed together from the target vessel after anastomosis is complete. As another example, one of theeffector 4 and the registration mechanism may include a keyway, and the other may include a mating key, such that theeffector 4 and the registration mechanism may be registered to one another in a known and preselected orientation. - Optionally, at least one
registration member 156 is configured to test the thickness and/or tissue quality of the wall of the target vessel. As one example, at least oneregistration member 156 is a hypotube having a sharpened distal end, having at least one orifice near its proximal end that extends to the lumen of the tube. Alternately, the distal end of the hypotube is not sharpened. Alternately, the proximal end of thatregistration member 156 is open, and no orifice is provided. Such aregistration member 156 may be substantially the length of the thickest tissue with which theintegrated anastomosis tool 2 may be used. A number ofregistration members 156 may be provided, each having a different length, such that the thickness of the wall of the target vessel may be determined by viewing theregistration members 156 to determine which ones are contacting fluid within the target vessel. - Optionally, the
effector 4 includes at least one thickness sensor (not shown) that is separate from the registration member ormembers 156. For example, an ultrasonic transceiver may be mounted on the effector, where that transceiver is configured to transmit ultrasonic energy to and receive ultrasonic energy from the tissue of the target vessel wall in order to determine its thickness. - Operation
- The
effector 4 begins in an initial configuration as shown inFIG. 11 . In the initial configuration, thecutter assembly 10 is positioned at or near the distal end of theeffector 4, and theconnector module 12 is positioned proximal to and spaced apart from thecutter assembly 10. When theeffector 4 is in the initial configuration, the longitudinal axis of thecutter member 18 is substantially coaxial with the longitudinal axis of theconnection module 12. However, thecutter member 18 and theconnection module 12 may have a different spatial relationship relative to one another in the initial configuration. For example, thecutter assembly 10 and theconnector module 12 may be initially side by side. As another example, thecutter assembly 10 and theconnector module 12 may be angled relative to one another such that their longitudinal axes approach one another or intersect at the location on the target vessel where thecutter assembly 10 creates an opening therein. - Graft Vessel Preparation
- Referring also to FIGS. 2 and 6-7, the graft vessel is loaded into the
connection module 12 while theconnection module 12 is in the open position. The graft vessel is placed in the channel 125 of theconnection module 12, with a proximal portion of the graft vessel extending through the side of theconnection module 12 at the location that will form thepassage 122 and a distal portion of the graft vessel extending distal to the distal end of theconnection module 12. Theconnection module 12 is then moved to the closed position, such that a proximal portion of the graft vessel extends out of thepassage 122. As described above, acatch 134 on onesegment 114segment depression 136 or other feature on theother segment 114segment catch 134 may be connected to aleaf spring 132 that is biased at least partially toward the longitudinal axis of theconnection module 12 with sufficient force to hold thecatch 134 in thecorresponding depression 136 such that theconnection module 12 is held in the closed position. Theconnection module 12 may be outside theeffector 4 during the loading process. If so, theconnection module 12 is placed into theeffector 4 after the graft vessel is loaded, eachprojections 142 is placed into asecond groove 144 as theconnector module 12. Alternately, theconnection module 12 is connected to theeffector 4 in a different manner, such as described above. - Alternately, the graft vessel is loaded into the
connection module 12 while theconnection module 12 is in the initial, closed configuration. To do so, the graft vessel is pulled through thepassage 122 in the side of theconnection module 12 and through the channel 125 of theconnection module 12. A pull-through tool (not shown) may be utilized to pull the graft vessel through thepassage 122 and the channel 125. Such a pull-through tool may be configured in any suitable manner. As one example, the pull-through tool may be substantially as disclosed in co-pending and commonly-assigned U.S. patent application Ser. No. 10/055,179, which is hereby incorporated by reference herein in its entirety. The pull-through tool is flexible enough to be able to extend through theaperture 126 in the distal end of theconnection module 12 and bend sufficiently to extend to the edge of or beyond thepassage 122. In this way, an end of the pull-through tool engages an end of the graft vessel. Alternately, a surgical forceps or other suitable tool may be used. - The operator then moves the pull-through tool to pull the end of the graft vessel through the
passage 122 and through theaperture 126, such that the end of the graft vessel extends distal to the distal ends of thesecond tines 94 of theconnectors 90. Thesecond tines 94 are positioned closer to the longitudinal axis of theconnection module 12 than thefirst tines 92. The end of the graft vessel is then everted over thesecond tines 94. This eversion may be accomplished in any suitable manner. Alternately, if thefirst tines 92 are positioned closer to the longitudinal centerline of theconnection module 12, the end of the graft vessel is everted over the distal ends of thefirst tines 92. Alternately, the end of the graft vessel may be flapped. That is, at least one incision may be made in the end of the graft vessel, creating one or more flaps at the end thereof. If so, the flap or flaps may be placed over the distal ends of thefirst tines 92. - At least one substantially longitudinal incision may be made in the end of the graft vessel that is pulled through the
connection module 12. This incision may be made before or after pull-through. In order to achieve take-off of the graft vessel at an angle to the target vessel, the graft vessel is angled relative to theconnection module 12. To facilitate this, a small substantially-longitudinal incision may be made in the distal end of the graft vessel. Further, by providing one incision, a single flap is created at the end of the graft vessel, facilitating the formation of a standard cobrahead anastomosis as shown inFIG. 11B . If so, the graft vessel is oriented relative to theconnection module 12 in a manner such that the operator can ensure the cobrahead shape of the finished anastomosis is oriented in a desired manner relative to thetarget vessel 166. More than one incision may be made, in order to create more than one flap in the end of the graft vessel. By placing the flapped end of the graft vessel at an angle to the end of theconnection module 12, where that angle varies based on the width of the graft vessel, theconnection module 12 may be used with graft vessels having a variety of widths, while the size of the opening in the target vessel created by thecutter assembly 10 remains the same across graft vessels having different widths. That is, by angling the graft vessel a larger amount relative to the longitudinal axis of theconnection module 12, a greater cross-section of the graft vessel is placed adjacent to the opening in the target vessel. Thus, small graft vessels may be angled a greater amount relative to the longitudinal axis of theconnection module 12. - In proximity to the apex of this incision, such as above the apex or to the side of the apex, the
graft vessel 158 is pierced onto thesecond tine 94 of asingle connector 90. The end of thegraft vessel 158 is then everted over the remainingsecond tines 94 of the remainingconnectors 94. Alternately, where the end of thegraft vessel 158 is flapped, the flap or flaps are placed onto the remainingsecond tines 94 of the remainingconnectors 94. Referring also toFIG. 11 , thegraft vessel 158 is then pushed onto thesecond tines 94 such that thesecond tines 94 penetrate thegraft vessel 158. The action of pushing thegraft vessel 158 onto thesecond tines 94 may be referred to as “poke-through,” and may be performed with a poke-throughtool 160 such as shown inFIG. 11A , or a different graft preparation tool. The poke-throughtool 160 includes a poke-throughtip 162 connected to ahandle 164 in any suitable manner. The poke-throughtip 162 is composed of a soft material such as rubber or silicone. Alternately, the poke-throughtip 162 is substantially rigid and tubular. Alternately, the poke-throughtip 162 may be configured in any other suitable manner. The user grasps thehandle 164, places the poke-throughtip 162 against the end of thegraft vessel 158, and applies force against thegraft vessel 158 toward the distal end of at least onesecond tine 94. The poke-throughtip 162 pushes the tissue of thegraft vessel 158 onto thesecond tine 94, while allowing the distal end of thesecond tines 94 to penetrate into the soft material of the poke-throughtip 162. The poke-throughtip 162 is then pulled off of the distal ends of thesecond tine 94, leaving the end of thegraft vessel 158 pushed down onto thesecond tine 94. Advantageously, the material of the poke-throughtip 162 is selected and/or treated such that the poke-throughtip 162 does not tear, crumble or otherwise substantially degrade as it is pulled off of the second tine ortines 92. The poke-throughtip 162 may be sized such that thegraft vessel 158 can be pushed onto all of thesecond tines 94 at one time, or such that thesecond tines 94 are poked through thegraft vessel 158 individually or in separate groups. Alternately, a forceps or other tool or tools is used to poke thesecond tines 94 through thegraft vessel 158, and a separate poke-throughtool 160 is not utilized. Alternately, one or more thin pieces of polyester film, standing alone or connected to a mechanism, may be used to poke thesecond tines 94 through thegraft vessel 158. After poke-through, the width of thespike 202 at the connection between thespike 202 and thebody 204 assists in retaining the tissue of the graft vessel; that width acts to prevent the tissue of the graft vessel from sliding off of theneedle tip 200. - Selecting an Anastomosis Site
- Referring to
FIGS. 2 and 11 , after thegraft vessel 158 has been loaded onto theconnection module 12, the operator places theeffector 4 on a potential anastomosis site on thetarget vessel 166. As described above, theinterface member 8 may be bent, manipulated or otherwise moved relative to theactuator 6 to facilitate the connection of a graft vessel to a target vessel without the need to hold theactuator 6 in an awkward position. That is, theactuator 6 may be held or otherwise positioned in a desired position, and theeffector 4 may then be placed at a potential anastomosis site on thetarget vessel 166, with theinterface member 8 flexing or otherwise moving to accommodate that placement. Where theinterface member 8 is flexible, it may be rigidified after theeffector 4 has been placed in the desired position. Such rigidification of a flexible member of a surgical tool is standard. Alternately, where theinterface member 8 is substantially rigid, or where theeffector 4 is directly connected to theactuator 6, theeffector 4 may be placed at a potential anastomosis site on thetarget vessel 166 by moving theactuator 6. - The
auger 30 extends distally from theeffector 4, and penetrates the wall of thetarget vessel 166 as theeffector 4 is moved in proximity to thetarget vessel 166. This penetration occurs prior to and separately from the later creation of the opening in thetarget vessel 166 that allows fluid to pass through the anastomosis. Theauger 30 may penetrate the wall of thetarget vessel 166 partially or completely. After theauger 30 has been inserted through the wall of thetarget vessel 166, it remains there until theeffector 4 is actuated; its presence in the wall of thetarget vessel 166 maintains hemostasis. As theeffector 4 moves into closer proximity with thetarget vessel 166, the registration member ormembers 156 then engage the wall of thetarget vessel 166, penetrating it partially or completely. Alternately, the registration member ormembers 156 do not penetrate the target vessel wall at all, and instead engage the target vessel wall in a different manner. Motion of theeffector 4 toward thetarget vessel 166 stops when thesupport 157 or other suitable portion of theeffector 4 contacts the wall of thetarget vessel 166. At this time, theauger 30 has pierced at least the outer surface of the wall of thetarget vessel 166, and theeffector 4 is registered to the potential anastomosis site. - Optionally, the thickness and/or tissue quality of the wall of the
target vessel 166 is tested. Where at least one of theregistration members 156 is at least partially hollow, thatregistration member 156 is substantially the length of the thickest tissue with which theintegrated anastomosis tool 2 may be used. When theregistration member 156 is inserted into the wall of thetarget vessel 166, and the thickness of the wall is less than the length of theregistration member 156, the distal end of theregistration member 156 contacts the fluid such as blood that is within thetarget vessel 166. That fluid enters the hollow interior of theregistration member 156 and exits the orifice in theregistration member 156 or exits the proximal end of theregistration member 156. This allows the operator to observe the outflow and visually confirm that the thickness and quality of the wall of thetarget vessel 166 is sufficient to proceed. When theregistration member 156 is inserted into the wall of thetarget vessel 166, and the thickness of the wall is greater than the length of theregistration member 156 or the interior surface of the wall is calcified, the distal end of theregistration member 156 does not contact fluid within thetarget vessel 166. No fluid exits the orifice or other part of theregistration member 156. This allows the operator to observe the lack of outflow and visually confirm that the thickness or quality of the wall of thetarget vessel 166 is not appropriate, and the operator can then select a different potential location for anastomosis. Where the wall of thetarget vessel 166 is calcified, theauger 30 will be unable to penetrate completely through the wall due to the presence of the hard calcification, and it will be apparent to the operator that the potential anastomosis site is not suitable even without the use of a thickness-sensing registration member ormembers 156. Alternately, an ultrasonic transceiver or other mechanism optionally may be used to determine the thickness and/or tissue quality of a candidate anastomosis site. - Creating an Opening in the Target Vessel
- After a suitable anastomosis site has been selected on the
target vessel 166, and theeffector 4 has been registered to that anastomosis site, the user provides any suitable user input to theactuator 6 to actuate it. As one example, the actuator includes a switch, trigger or other mechanism that can be operated by the user with one hand or both hands. As another example, the user input is applied indirectly, such as through an information handling system. The user input may be mechanical, electrical, analog or digital, or any other suitable type of input. Theactuator 6 may be mechanically configured in any manner that provides for motion of thecables actuator 6 may include a pressurized gas reservoir, or may be connected to a source of pressurized gas. Upon depressing a trigger or otherwise actuating one or more controls, the pressurized gas may be allowed to escape its reservoir into, or otherwise enter, a chamber having a piston (not shown) and exert force on the piston. The piston may be connected directly or indirectly to thecutter cable 46, thetraveler cable 154 and/or thesecond traveler cable 155, which may travel around one or more pulleys (not shown) within theactuator 6. - The
cutter assembly 10 is actuated before theconnection module 12, to create an opening in the wall of thetarget vessel 166 before connecting thegraft vessel 120 to thetarget vessel 166. Theactuator 6 applies tension to thecutter cable 46, retracting thecutter cable 46 in the proximal direction. Advantageously, theactuator 6 applies an impulse to thecutter cable 46, thereby actuating thecutter assembly 10 impulsively. As the impulse tensions thecutter cable 46, thecutter cable 46 begins to move proximally. - The
cutter cable 46 is wound around at least a portion of thecutter transport 28 proximal to theholder 20, as described above. Thecutter cable 46 is thereby offset from the longitudinal centerline of thecutter transport 28, and at least a component of its orientation relative to thecutter transport 28 is substantially tangent to thecutter transport 28. As thecutter cable 46 is tensioned and moved proximally, the tangential component of the force applied by thecutter cable 46 at a location spaced apart from the centerline of thecutter transport 28 causes thecutter transport 28 to rotate. As thecutter cable 46 rotates thecutter transport 28, the angle of thethreads 48 on thecutter transport 28 causes thecutter transport 28 to advance distally as it rotates. That is, thecutter transport 28 is threaded in a direction such that the proximal motion of thecutter cable 46 causes thecutter transport 28 to advance distally as it rotates. Rotation begins at substantially the same time as translation. However, rotation or translation may begin first. As thecutter cable 46 continues to be pulled proximally, it is progressively unwound from the cutter transport. The portion of thecutter cable 46 that is wound around at least a portion of thecutter transport 28 proximal to theholder 20 and outside of thebore 22 may remain proximal to theholder 20 and outside of thebore 22 during actuation. Advancement and rotation of the cutter transport causes advancement and rotation of thecutter 24. - Referring also to
FIG. 12 , thecutter 24 advances distally into the wall of the target vessel and cuts the tissue of the wall of the target vessel with both a rotational and translational cutting action. Theauger 30 is substantially translationally fixed relative to thecutter 24, such that theauger 30 and thecutter 24 advance distally at substantially the same rate. By constructing theauger 30 and thecutter 24 to be substantially smooth and radially symmetrical, the rotary motion of these structures creates a substantially smooth and clean hole through the wall of thetarget vessel 166. The tissue of thetarget vessel 166 may be strain rate sensitive, such as the tissue of the aorta. Strain rate sensitive tissue is easier to cut when the cutting is performed rapidly than when it is performed slowly. By actuating theauger 30 and thecutter 24 impulsively, they move rapidly such that thecutter 24 can better cut strain rate sensitive tissue. - The
auger 30 andcutter 24 are advanced into the wall of thetarget vessel 166 fast enough such that the blood or other fluid in thetarget vessel 166 acts as a solid and supports the wall of thetarget vessel 166 against the advance of the piercingmember 36 andcutter 24. That is, theauger 30 andcutter 24 advance into the wall of thetarget vessel 166 fast enough that the fluid within substantially does not have time to move in response to the motion of theauger 30 andcutter 24, such that the fluid acts as if it were a solid. Experiments have shown that the rate at which theauger 30 andcutter 24 should advance to accomplish this effect is at least substantially 0.25 msec. Similarly, the duration over which thecutter transport 28 is advanced is advantageously less than one second; and may be substantially 0.05 seconds. The rotary speed of thecutter 24 is not as critical as the linear speed of thecutter 24 when aortic tissue is to be cut. - The
bore 22 in theholder 20 stabilizes thecutter transport 28 while it advances. The length of thebore 22 and its surface finish are selected to provide for such stabilization. Thebore 22 also reduces or substantially eliminates precession of thecutter member 18 as it is actuated. Eachclip 72 of theeffector 4 may hold at least oneprojection 66 of theholder 20 and substantially restrain thatprojection 66 against longitudinal motion as thecutter member 18 advances into the wall of thetarget vessel 166. In this way, the proximal motion of thecutter cable 46 does not simply move thecutter assembly 10 in the proximal direction. Thetooth 29 associated with thebore 22 also stabilizes thecutter transport 28 while it advances. By riding betweenthreads 48 of thecutter transport 28 as thecutter transport 28 rotates and advances, thetooth 29 substantially prevents thecutter transport 28 from sliding axially. - After the
cutter 24 has penetrated completely through the wall of thetarget vessel 166, it has cut a tissue plug from that vessel wall to form an opening therein. Thecutter 24 cuts a substantially cylindrical tissue plug from the vessel wall due to its tubular shape, thereby leaving a substantially cylindrical opening in the wall of thetarget vessel 166. Thespike 36 is positioned relative to thecutter 24 such that the tissue plug is held within thecutter 24 due to engagement with theledge 40 of thespike 36 after the tissue plug has been cut. That is, theledge 40 advances completely through the wall of thetarget vessel 166 before thecutter 24 has done so, such that the tissue plug cut from thetarget vessel 166 wall is located proximally to theledge 40 upon creation of the tissue plug. Theledge 40 is wide enough to reliably hold the tissue plug within thecutter 24. Theshaft 38 extends axially through the tissue plug, such that contact between theshaft 38 and the tissue plug acts substantially to prevent radial motion of the tissue plug in thecutter 24. Where a capture feature or features are provided on thecutter 24 itself, they may engage the tissue plug instead of or in addition to theledge 40. Alternately, theledge 40 is omitted, and friction holds the tissue plug in thecutter 24. - The distal translation of the
cutter 24 andauger 30 continues through a fixed distance greater than the thickness of the vessel wall, to ensure that thecutter 24 has completely penetrated the wall of thetarget vessel 166. That fixed distance is selected to be greater than the maximum tissue thickness with which theeffector 4 is to be used, but lesser than the interior diameter of thetarget vessel 166. The rotation of thecutter transport 28, and hence thecutter member 18 as a whole, substantially stops when thecutter cable 46 has been pulled proximally far enough such that nocutter cable 46 remains on thecutter transport 28 to be unwound. Alternately, a clutch or other mechanism may be provided to allow thecutter transport 28 to continue rotating for a short time after creating an opening in thetarget vessel 166, thereby dissipating at least some energy associated with its angular momentum. That is, thecutter transport 28 may be allowed to idle rotationally after it has completed its distal translation. Alternately, thecutter transport 28 encounters a stop (not shown) that substantially stops distal motion of thecutter transport 28 while allowing thecutter cable 46 to move proximally. The stop may extend from or be connected to theframe 14. Alternately, the stop is thetooth 29 in theholder 20. When theholder 20 has moved to its most distal location and has stopped its motion, and thecutter transport 28 has rotated such that thetooth 29 encounters the mostproximal thread 48, thetooth 29 acts as a stop. - The
cutter transport 28 and the length of thecutter cable 46 are selected such that the opening in the wall of thetarget vessel 166 has been created before the time at which nomore cutter cable 46 remains to be unwound from thecutter transport 28. The distal end of thecutter cable 46 is fixed to thecutter transport 28, such as at the anchor feature 50. Thus, when nomore cutter cable 46 remains to be unwound from thecutter transport 28, further proximal motion of thecutter cable 46 no longer acts substantially tangentially to thecutter transport 28, but substantially longitudinally to thecutter transport 28. In this way, asingle cable 46 can be utilized to actuate thecutter assembly 10, move it out of the opening in thetarget vessel 166, and move thecutter assembly 10 out of the way of theconnection module 12. Optionally, one or more additional cables may be provided. - As the
cutter member 18 moves proximally, thecutter 24 moves proximally. Theshoulder 43 of thecutter 24 encounters theholder 20 as thecutter member 18 moves proximally. Theshoulder 43 extends beyond the diameter of thebore 22 such that it does not pass through thebore 22, but rather engages the distal surface of theholder 20. This engagement exerts a proximal force on theholder 20. In this way, thecutter cable 46 exerts a retraction force on thecutter assembly 10 in the proximal direction. The retraction force is larger than the proximal force experienced by thecutter assembly 10 during rotation of thecutter transport 28. The clip or clips 72 are constructed such that the clip or clips 72, taken together, resist an amount of force in the proximal direction that is less than that amount of retraction force but greater than the proximal force experienced by thecutter assembly 10 during rotation of thecutter transport 28. The force exerted by thecutter cable 46 thereby overcomes the force exerted by eachclip 72 on the correspondingprojection 66, causing the clip or clips 72 to flex out of the way of the projection orprojections 66 and allowing thecutter assembly 10 to move proximally past the clip or clips 72. - Referring also to
FIG. 13 , as thecutter assembly 10 moves proximally, thecutter 24 moves out of theopening 167 that it created in the wall of thetarget vessel 166, and removes the tissue plug from theopening 167. The tissue plug is held within thecutter 24 by friction with the inner surface of thecutter 24 and/or by contact with theledge 40 of theauger 30. Thecutter assembly 10 thus has created an opening through the wall of thetarget vessel 166 at a location that had been previously substantially intact. In this way, where thetarget vessel 166 carries blood, thecutter assembly 10 disrupts the hemostasis of thetarget vessel 166 at the location where thecutter assembly 10 enters tissue. Alternately, thecutter assembly 10 may be used to make a larger opening in the wall of thetarget vessel 166 at a location where an opening already exists. - Each
projection 66 extending from theholder 20 is received and guided by at least onefirst groove 68. As thecutter assembly 10 moves proximally, it follows the path of the first groove orgrooves 68 in theframe 14. Referring also toFIG. 2 , thefirst grooves 68 extend substantially longitudinally at the distal end of theframe 14, such that thecutter assembly 10 is moved substantially in the proximal direction after it has created anopening 167 in the wall of thetarget vessel 166. The first groove orgrooves 68 extend along theframe 14 in such a manner as to move thecutter assembly 10 off-axis as it is moved proximally. That is, the first groove orgrooves 68 extend along a path that provides for motion of thecutter assembly 10 away from the line defined by the original position of the longitudinal centerline of thecutter member 18. As an example, starting at the distal end of theframe 14, the first groove orgrooves 68 extend substantially longitudinally, then angle partially away from the longitudinal direction, then continue to extend substantially longitudinally before stopping. Referring also toFIG. 14 , as thecutter assembly 10 continues to move proximally under the influence of thecutter cable 46, thecutter assembly 10 moves off-axis along the path defined by the first groove orgrooves 68, then moves longitudinally again. When the most-proximal projection 66 of theholder 20 encounters theproximal end 168 of the correspondingfirst groove 68, that contact stops the proximal motion of thecutter assembly 10 in a final position. Continued tension in thecutter cable 46 maintains thecutter assembly 10 in that final position during the remainder of the operation of theeffector 4. Alternately, tension on thecutter cable 46 is released at least in part, and friction or interference between at least one of theprojections 66 and theproximal end 168 of the correspondingfirst groove 68 holds thecutter assembly 10 in the final position. Alternately, tension on thecutter cable 46 is released at least in part, and a catch or other mechanism engages at least oneprojection 66 or a different part of thecutter assembly 10 and holds thecutter assembly 10 in the final position. Alternately, the proximal motion of thecutter assembly 10 is stopped in a different manner. - Connecting the Graft Vessel to the Target Vessel
- With the
cutter assembly 10 moved off-axis, the path is clear for theconnection module 12 to advance distally. Theconnection module 12 may begin its distal travel before or after thecutter assembly 10 has moved off-axis, as long as the timing of their relative motion is such that they do not collide with one another. Referring also toFIG. 10 , theconnection module 12 may be moved distally by applying tension to thetraveler cable 154. Both proximal ends of thetraveler cable 154 are retracted proximally to do so. As both proximal ends of thetraveler cable 154 are retracted proximally, the portion of thetraveler cable 154 proximal to thecable guide 84 is pulled distally, because thecable guide 84 reverses the direction of thetraveler cable 154. As a result, the portion of thetraveler cable 154 within thechannel 152 in thetraveler 146 is pulled distally, which in turn causes thetraveler 146 to move distally. As thetraveler 146 moves distally, it pushes theconnection module 12 distally. Alternately, one proximal end of thetraveler cable 154 is substantially fixed, and only the other proximal end is moved proximally. Referring also toFIG. 6 , eachprojection 142 extending from theconnection module 12 is received and guided by at least onesecond groove 144. Further, eachleg 150 of thetraveler 146 is received and guided by at least onesecond groove 144 or other groove substantially parallel to thesecond groove 144. The second groove orgrooves 144 are substantially longitudinal, and are oriented on theframe 14 to translate theconnection module 12 substantially longitudinally to the distal end of theeffector 4. Alternately, the second groove or grooves are curved or otherwise shaped, and convey theconnection module 12 to the distal end of theeffector 4. Alternately, thecutter assembly 10 and theconnection module 12 can be moved in any manner and in any direction that allows each of them to perform its function. - Referring also to
FIG. 15 , as theconnection module 12 is pushed distally by thetraveler 146, theconnection module 12 approaches the stop 170 at the distal end of theeffector 4. Where theconnectors 90 arestaples 90, the longersecond tine 94 of each staple moves past the distal end of theeffector 4 and enters theopening 167 in thetarget vessel 166 wall created by thecutter assembly 10. Alternately, where theconnectors 90 are not staples, any suitable portion of one ormore connectors 90 may enter theopening 167 in the wall of thetarget vessel 166 as theconnection module 12 approaches the stop 170. Referring also toFIG. 16 , an end of thegraft vessel 120 was previously pushed down onto thesecond tines 94, as described above. As theconnection module 12 approaches the stop, where theconnector 90 is a staple 90, thefirst tine 92 of each staple 90 penetrates the wall of thetarget vessel 166, partially or completely. This penetration occurs in proximity to theopening 167 in thetarget vessel 166, such that thefirst tines 92 are spaced apart from one another in tissue around theopening 167. - The
traveler 146 continues to push theconnection module 12 distally until theconnection module 12 encounters the stop 170. The stop 170 is sized and shaped to prevent theconnection module 12 from moving substantially further in the distal direction after theconnection module 12 encounters it. When theconnection module 12 stops, the everted or flapped end of thegraft vessel 120 is in contact with, or close to contact with, the outer surface of the wall of thetarget vessel 166. - After the
connection module 12 has stopped, tension is still applied to thetraveler cable 154. Thetraveler 146 cannot urge theconnection module 12 any further distally due to interference by the stop 170. As a result, referring also toFIGS. 6-7 , thetraveler 146 applies force in the distal direction to thedrivers 128. Thedrivers 128 are initially biased away from theconnectors 90 with a force less than is applied by thetraveler 146 after theconnection module 12 has encountered the stop 170. After theconnection module 12 encounters the stop 170, the distal force applied by thetraveler 146 to thedrivers 128 overcomes that bias and urges thedrivers 128 distally toward theconnectors 90. Referring also toFIG. 17 , eachdriver 128 moves distally toward at least one correspondingconnector 90 or a plunger interposed between thedriver 128 and theconnector 90. Referring also toFIG. 9 , where theconnectors 90 are steppedstaples 90 as described above, thefirst step 98 of each staple 90 is positioned proximal to acorresponding anvil 108 on one of theanvil plates 104. Thefirst step 98 is closer to thefirst tine 92 of each staple 90. As eachdriver 128 moves distally, it contacts thesecond step 100 of at least onecorresponding staple 90. This motion of thedriver 128 exerts a force on thesecond step 100, and thereby a moment about theanvil 108. As a result, each staple 90 begins to bend. The bending may be concentrated at thetransition 102 between thesteps staple 90, or may be concentrated in a different part of at least onestaple 90. - Referring also to
FIG. 18 , as eachdriver 128 moves distally against thesecond step 100 of one ormore staples 90, each staple 90 deforms such that itssecond tine 94 bends outward and proximally, coming to rest against the inner surface of the wall of thetarget vessel 166 without substantially penetrating it. Thus, thefirst tine 92 of each staple 90 penetrates at least the outer surface of the wall of thetarget vessel 166, and thesecond tine 94 of each staple 90 does not substantially penetrate the inner surface of the wall of thetarget vessel 166. Alternately, thefirst tine 92 and/orsecond tine 94 of at least onestaple 90 may have a different relationship with the wall of thetarget vessel 166 after deployment. After thestaples 90 have been deployed, the tissue at the distal end of thegraft vessel 120 that had been placed over thesecond tines 94 shifts such that the inner surface of the end of thegraft vessel 120 is placed in contact with the outer surface of the wall of thetarget vessel 166. Such a connection may be referred to as a cobrahead. However, the topology of the anastomosis may be different, if desired. In the deployed configuration, thestaples 90 hold and control the edge of theopening 167 in thetarget vessel 166, and hold the end of thegraft vessel 120 against the outer surface of thetarget vessel 166. The anastomosis between the end of thegraft vessel 120 and the side of thetarget vessel 166 is thus complete. - The
cutter assembly 10 advantageously is moved off-axis rapidly after creating theopening 167 in thetarget vessel 166. Further, the actuation of thetraveler 146 to move theconnection module 12 distally and deploy theconnectors 90 advantageously is performed rapidly. An impulsive force may be applied to thecutter assembly 10 and to thetraveler 146 to cause such rapid motion. Such rapid motion of thecutter assembly 10 and theconnection module 12 provides virtual hemostasis. As used in this document, “virtual hemostasis” refers to limiting blood loss through theopening 167 in thetarget vessel 166 by minimizing the period of time between the cutting and connecting operations. As one example of virtual hemostasis, where thetarget vessel 166 is the aorta and the heart is beating, the time between the creation of theopening 167 in the wall of thetarget vessel 166 and the deployment of theconnectors 90 to connect thegraft vessel 120 to thetarget vessel 166 is less than one second, such that a minimal amount of blood escapes through theopening 167. Further, the term “quick shuttle” may be used to refer to motion of thecutter assembly 10 and theconnection module 12 within a short period of time to provide virtual hemostasis. - After the
connectors 90 have been deployed and the anastomosis has been completed, eachanvil plate 104 is rotated relative to the correspondingsegment 114segment connection module 12. The anvil plate orplates 104 may be rotated by any suitable structure, mechanism or method. The rotation of eachanvil plate 104 moves eachanvil 108 laterally relative to thecorresponding staple 90, such that eachanvil 108 is no longer distal to thebase 96 of thecorresponding staple 90. In this way, thestaples 90 are freed from theanvils 108 and free to move out of theconnection module 12 via the correspondingaperture 106 in theanvil plate 104, and theconnection module 12 is free to move proximally away from the deployedconnectors 90 and thetarget vessel 166. - As the
traveler cable 154 continues to force thetraveler 146 distally, theengagement element 138 of eachleaf spring 132 on theconnector module 12 is forced against thecorresponding stub 140 at the distal end of theframe 14. As a result, the distal end of eachleaf spring 132 is pushed away from the longitudinal axis of theconnection module 12. As eachleaf spring 132 is forced away from the longitudinal centerline of theconnection module 12, this motion causes thecatch 134 on eachleaf spring 132 to move out of thecorresponding depression 136 in theother segment 114segment connection module 12. As a result, thecatch 134 no longer holds theconnection module 12 in the closed position. Thesecond traveler cable 155 is then moved proximally, pulling thetraveler 146 away from theconnection module 12. Thespring 130 then biases at least the distal ends of thesegments connection module 12 to the open position shown inFIGS. 6 and 19 . Because thetraveler 146 has moved away from theconnection module 12, thesegments second traveler cable 155 is not provided, and thetraveler 146 is otherwise configured to allow theconnection module 12 to open while thetraveler 146 is in contact with it. - Optionally, the
traveler 146 includes ashelf 172 defined in the distal surface of theplate 148. As thetraveler 146 moves distally, the proximal end of at least onedriver 128 engages the distal surface of theplate 148, and theshelf 172 is positioned adjacent to a portion of thatdriver 128 near its proximal end. Theshelf 172 prevents theconnection module 12 from moving to an open position, because theshelf 172 would interfere with at least onedriver 128 if theconnection module 12 were to attempt to open. However, after thedrivers 128 have been driven distally to deploy theconnectors 90, they are positioned distal to theshelf 172, such that interference with theshelf 172 no longer prevents theconnection module 12 from moving to the open position. Thus, theshelf 172 acts as a safety to ensure that theconnection module 12 opens at the appropriate time. Alternately, theshelf 172 is used instead of the leaf spring or springs 134 to hold theconnection module 12 in the closed position until the appropriate time for it to open. - The
effector 4 is then moved away from thetarget vessel 166, such that the registration member ormembers 156 move away from thetarget vessel 166. Where the registration member ormembers 156 are a spike or spikes, the cross-sectional area of each spike is small enough that the aperture created by each spike in the wall of thetarget vessel 166 closes as that spike is removed. In this way, substantially no leakage from thetarget vessel 166 results from the removal of the registration member ormembers 156. - The
effector 4 is then moved laterally relative to thegraft vessel 120. With theconnection module 12 open, thegraft vessel 120 may exit theconnection module 12 through the side thereof. Thesupport 157 at the distal end of theeffector 4 is open as well, to allow thegraft vessel 120 to exit from the side of theconnection module 12 and through the open portion of thesupport 157. Providing for the side exit of thegraft vessel 120 from theeffector 4 allows for flexibility in the performance of surgical procedures such as CABG. For example, where thegraft vessel 120 is side-loaded into theconnection module 12 and is capable of exiting from the side of theconnection module 12, and theintegrated anastomosis tool 2 is used to perform a proximal anastomosis between agraft vessel 120 and the aorta, the proximal anastomosis can be performed before or after the distal anastomosis between thegraft vessel 120 and a coronary artery. This flexibility may be particularly useful where theintegrated anastomosis tool 2 is used in the performance of an endoscopic or minimally-invasive CABG procedure, and/or where a mammary artery or other artery is used for anastomosis such that no proximal anastomosis is necessary. - Where the suture-based
connection module 12 described above and inFIGS. 21-27 is utilized, the actuation of theconnection module 12 is similar. For brevity, only the significant differences between actuation of the clip-basedconnection module 12 and the suture-basedconnection module 12 are described here. Referring toFIG. 21 , thegraft vessel 120 may be placed in thedepression 124 of eithersegment 114segment connection module 12, after which thesegments segments connection module 12 are held together by engagement between thelatch 186 and thenotch 190. Alternately, thesegments connection module 12 are moved and held together first, and thegraft vessel 120 is pulled through theconnection module 12 with a pull-through tool such as described in commonly-owned U.S. patent application Ser. No. 10/055,179, which is hereby incorporated by reference in its entirety. Alternately, theconnection module 12 is not segmented, such that it is a unitary structure, and thegraft vessel 120 is pulled through the connection module with such a pull-through tool. - The distal end of the
graft vessel 120 extends distally from theconnection module 12, through theaperture 126. In the initial configuration of theconnection module 12, theneedles 192 are positioned such that theneedle tips 200 also extend distally from theconnection module 12, through theaperture 126. Initially, theneedle tips 200 are positioned around the outer surface of thegraft vessel 120. The distal end of thegraft vessel 120 is then everted, at least partially, over theneedle tips 200. Alternately, at least one incision is made at the end of thegraft vessel 120 in the longitudinal direction or other suitable direction, creating at least one flap in the end of thegraft vessel 120. The flap or flaps may be everted onto or otherwise positioned relative to theneedle tips 200. The distal end of thegraft vessel 120 is then pushed down onto thespikes 202 of theneedle tips 200, using any suitable structure, mechanism or method. Advantageously, thegraft vessel 120 is pushed down onto theneedle tips 200 far enough that thespikes 202 penetrate completely through the wall of thegraft vessel 120. In this way, the width of each spike 202 at its intersection with thebody 204 as compared with the smaller width of thebody 204 at that intersection acts to hold thegraft vessel 120 in place on theneedle tips 200 after eversion or partial eversion. - Next, referring also to
FIG. 10 , theconnection module 12 may be moved distally substantially as described above with regard to the otherexemplary connection module 12. Applying tension to thetraveler cable 154 causes thetraveler 146 to move distally. As thetraveler 146 moves distally, it pushes theconnection module 12 distally. Thetraveler 146 may contact the proximal end of at least onesupport 217, or may contact any other portion of the proximal end of theconnection module 12, to urge theconnection module 12 distally. In this example of theconnection module 12,drivers 128 are not present because there are no clips or staples to actuate, and thus thetraveler 146 contacts a portion of theconnection module 12 other than adriver 128. - When the
connection module 12 encounters the stop 170, its distal motion stops. At this time, theneedle tips 200 may extend partially into theopening 167 in thetarget vessel 166. However, theneedle tips 200 may be outside theopening 167. The end of thegraft vessel 120 is outside thetarget vessel 166, positioned against or in close proximity to the outer wall of thetarget vessel 166. Alternately, at least part of the end of thegraft vessel 120 may extend at least partially into theopening 167. - Next, the needle actuation cables are moved by the
actuator 6. This motion of the needle actuation cables is in a direction that begins to pull eachretention member 199 of eachneedle 192 along the outer surface of thecorresponding bushing 214. This motion of eachretention member 199 causes eachcorresponding axle 198 to begin to rotate relative to thecorresponding bushing 214. This rotary motion moves eachneedle tip 200 through theopening 167 in thetarget vessel 166, distally into the lumen of thetarget vessel 166, outward from theopening 167, then proximally back through the wall of thetarget vessel 166 from the inside out. In this way,suture 212 connected to theneedle tip 200 is moved distally and radially outward, then proximally and radially outward. Thearcuate body 194 of at least oneneedle 192 may contact thecorresponding arm 218 of thesupport 197 during this rotary motion. Such contact may assist in directing the motion of theneedle 192. Further, such contact reduces the cantilever length of thefree end 195 of theneedle 192, which may be helpful if the tissue of the wall of thetarget vessel 166 is tough or otherwise difficult to penetrate. - After each
needle tip 200 penetrates the wall of thetarget vessel 166, at least thespike 202 of thatneedle tip 200 passes through asuture loop 226 held in anaperture 182 in the distal end of thehousing 180. Thesuture loop 226 is a portion of the same length ofsuture 212 that is connected to thebody 204 of theneedle tip 200 through theaperture 210 in thebody 204. Thesuture loop 226 is part of a partially-tied knot, such as the partially-tied knot disclosed in U.S. patent application Ser. No. 10/977,061, filed on Oct. 29, 2004, which is hereby incorporated by reference in its entirety. Thesuture loop 226 may correspond to the noose of the knot described in U.S. patent application Ser. No. 10/977,061. Alternately, a different partially-tied knot is utilized. Alternately, rather than or in addition to partially-tied knots, theconnection module 12 may utilize one or more mechanisms or structures connected to or associated with suture to connect the graft vessel to the target vessel. - After the
aperture 210 of thebody 204 of theneedle tip 200 has passed through the correspondingsuture loop 226, at least part of thesuture 212 connected to thatneedle tip 200 has also passed through the correspondingsuture loop 226, which is a step in the formation of a fully-tied knot. A separate length ofsuture 212 is associated with eachneedle tip 200, such that a plurality of independent knots can be formed. Alternately, a single length ofsuture 212 may be associated with two or moreseparate needle tips 200. Alternately, for eachneedle tip 200 and length ofsuture 212, a second length of suture (not shown) can be integrated into the knot to assist in its tightening and holding strength. - At this point, a length of suture extends through the end of the
graft vessel 120, into theaperture 167 of thetarget vessel 166, and back out of the wall of thetarget vessel 166. Referring also toFIG. 27 , as theneedle 192 continues to move, each spike 202 moves through the correspondingsuture loop 226 and into anaperture 224 in thegrate 220. The width of eachaperture 224 is less than the widest part of at least onecorresponding spike 202. The material of thegrate 220 is thin enough to flex as at least onespike 202 is urged into the correspondingaperture 224, such that thespike 202 can move completely through theaperture 224. At least the portion of thebody 204 at the connection between thespike 202 and thebody 204 is narrower than theaperture 224, such that thegrate 220 can flex back into its relaxed position and hold thespike 202 on the opposite site of thegrate 220 from where it started. - The
slider 222 is then retracted proximally. Such retraction may be accomplished by any suitable mechanism or structure. For example, a slider retraction cable (not shown) may be connected to theslider 222 and physically and/or operationally connected to theactuator 6. When the slider retraction cable is moved proximally, it moves theslider 222 proximally. As theslider 222 is retracted proximally, it retracts thegrate 220 proximally as well. Theapertures 224 of thegrate 220 each hold at least oneneedle tip 200, such that the retraction of thegrate 220 proximally pulls theneedle tips 200 proximally. This proximal force exerted on theneedle tips 200 causes them to disconnect from the correspondingarcuate bodies 194 of theneedles 192. For example, where thebase 206 of aneedle tip 200 is crimped to thefree end 195 of the correspondingarcuate body 194, the proximal force exerted on theneedle tip 200 overcomes the crimp between theneedle tip 200 and thearcuate body 194 and frees the base 206 from the correspondingarcuate body 194. As another example, if theneedle tip 200 is frangibly connected to the correspondingarcuate body 194, the proximal force exerted on theneedle tip 200 causes theneedle tip 200 to break apart from the correspondingarcuate body 194. - As the
grate 220 moves proximally, theneedle tips 200 move proximally, and eachneedle tip 200 pulls acorresponding suture 212 proximally. This motion of thesuture 212 causes the partially-tied knots to tighten. Thesuture 212 is then cut at a location proximal to the tightened knot. This cutting may be performed by the surgeon, or by a suture cutter (not shown) in theconnection module 12. Alternately, thesuture 212 is released from the completed knot in a different manner. As one example, thesuture 212 continues to be pulled proximally after the knot is completed, increasing the tension in thesuture 212. Thesuture 212 is crimped to theneedle tip 200 in such a manner that it releases from theneedle tip 200 under a tension force that is greater than the tension to tighten the knot, but less than the tension to break thesuture 212. Such a crimp may be referred to as a controlled-release crimp. Alternately, the opposite end of thesuture 212 from that connected to theneedle tip 200 may be separable from theconnection module 12. Alternately, the breaking strength of thesuture 212 is preselected such that the increased tension therein after the completion of the knot causes thesuture 212 to break, thereby releasing thesuture 212 from the completed knots. In addition, theneedles 192 are moved back to their initial position by moving the needle actuation cables or other transmission members. For example, each needle actuation cable may be moved in a direction substantially opposite from the direction in which it was previously moved. Theeffector 4 is then moved away from thetarget vessel 166, leaving behind a completed sutured anastomosis. - Alternately, the
suture 212 may be passed through tissue to connect thegraft vessel 120 to thetarget vessel 166. If so, theconnection module 12 may be configured differently. As one example, at least oneneedle tip 200 is not connected to suture 212. Instead, referring toFIGS. 28-29 , acorresponding trap 230 is provided, where thattrap 230 is connected to suture 212. Thetrap 230 receives and catches at least thespike 202 of thecorresponding needle tip 200, and may be configured in any manner that allows it to do so. As one example, thetrap 230 may be substantially tubular at least in proximity to afirst end 234, with at least onetab 232 bent inward into the lumen of thetrap 230. The tab ortabs 232 flex outward from a neutral position to allow thespike 202 of theneedle tip 200 to pass beyond them into the lumen of thetrap 230, then flex back substantially into the neutral position. In the neutral position, the tab ortabs 232 do not allow thespike 202 to pass back out of thetrap 230. That is, the width of thespike 202 at its junction with thebody 204 of theneedle tip 200 is greater than the distance between thefree end 236 of asingle tab 232 and an inner wall of thetrap 230, or between twofree ends 236 ofdifferent tabs 232. Contact between thefree end 236 of at least onetab 232 and thespike 202 thus prevents thespike 202 from moving back out of thetrap 230. Alternately, any other structure or mechanism may be used to hold thespike 202 in or otherwise by thetrap 230 Such structures and mechanisms may include, for example, any of the structures and mechanisms described with regard to thegrate 220 above. An end of thesuture 212 may be crimped, swaged or otherwise attached to thesecond end 238 of thetrap 230. Alternately, a part of thesuture 212 other than an end thereof may be attached to thesecond end 238 of thetrap 230. In this embodiment, at least oneneedle tip 200 may be fixed to the correspondingarcuate body 194, or may be an integral part of thearcuate body 194. - The
trap 230 is detachably connected to theconnection module 12 in any suitable manner. Referring also toFIG. 30 , as one example, thetrap 230 may be held in aring 240 that is fixed to theconnection module 12. Thering 240 may be at least partially flexible, and may be composed of an elastomer or similar substance. Where thetrap 230 is crimped onto thesuture 212, such that the crimpedarea 242 has a smaller outer diameter than the outer diameter of an adjacent part of thetrap 230, the inner diameter of thering 240 is substantially equal to the outer diameter of the crimpedarea 242. In this way, thering 240 holds thetrap 230 substantially in place. Alternately, thetrap 230 may be detachably connected to theconnection module 12 by any other suitable structure and/or mechanism. Thesuture 212 extends out of thesecond end 238 of thetrap 230. Alternately, thetrap 230 and theneedle tip 200 are reversed. That is, theneedle tip 200 is held by thering 240 or other structure, rather than by theneedle 192, and thetrap 230 is connected to theneedle 192, rather than being held by thering 240 or other structure. Thesuture 212 may be connected to thetrap 230, as described above. Thus, after thetrap 230 engages theneedle tip 200, theneedle 192 pulls thesuture 212 in substantially the same manner as described above. - As the
connection module 12 is actuated, at least oneneedle tip 200 is moved toward thefirst end 234 of thecorresponding trap 230. The actuation of theconnection module 12, and the movement of the needle tip ortips 200, may be accomplished in substantially the same manner as described above, or in any other suitable manner. Referring also toFIG. 31 , as theneedle tip 200 continues to move, thespike 202 of thatneedle tip 200 enters thefirst end 234 of thecorresponding trap 230. As theneedle tip 200 enters thetrap 230, thespike 202 may contact an inner wall of thetrap 230. This may result from the use of a substantiallylinear trap 230 in conjunction with the curved path of theneedle tip 200. If so, thetrap 230 may be movable to allow thespike 202 to enter thetrap 230 smoothly. For example, thetrap 230 may be allowed to rotate at its junction with thering 240, as shown inFIG. 31 , thereby allowing theneedle tip 200 to enter thetrap 230 smoothly. Alternately, thetrap 230 may be curved to substantially correspond to the path of theneedle tip 200. If so, thetrap 230 need not be movable to allow theneedle tip 200 to enter, although it may be movable if desired. - Referring also to
FIGS. 28 and 32 , as thespike 202 continues to move into thecorresponding trap 230, it deflects thefree end 236 of eachtab 232 defined in thetrap 230. Thefree end 236 of eachtab 232 is increasingly deflected as the cross-section of thespike 202 moved into contact with thetab 232 increases. As thespike 202 moves past eachtab 232, thefree end 236 of that tab moves back toward its initial position. Thespike 202 extends further laterally than thebody 204 of theneedle tip 200, at least in part, at the connection between thespike 202 and thebody 204. Thus, when thefree end 236 of eachtab 232 moves back toward its initial position, it moves into the space behind thespike 202. As a result, thespike 202 is then prevented from moving back out of thetrap 230. Theneedle tip 200 is consequently connected to thetrap 230. Alternately, thetrap 230 does not havetabs 232. Instead, thespike 202 has one or more flexible arms that bend upon entering thetrap 230. Thetrap 230 may include one or more cutouts, ledges or other features configured to engage the one or more flexible arms of thespike 202. - Referring also to
FIG. 33 , theneedle tip 200 is controlled to reverse its direction after it becomes connected to thecorresponding trap 230. As theneedle tip 200 moves, contact between theneedle tip 200 and thetabs 232 in thetrap 230 causes theneedle tip 200 to exert a force on thetrap 230. This force pulls thetrap 230 out of thering 240, freeing thetrap 230. As described above, thering 240 may be configured in any manner that allows thetrap 230 to disconnect from it. As one example, thering 240 may be composed of a pliable material such as elastomer, such that thering 240 flexes when force is applied to thetrap 230 and allows thetrap 230 to disconnect from it. However, thering 240 may be configured in any other suitable manner. As theneedle tips 200 move, eachneedle tip 200 pulls acorresponding suture 212 through tissue to connect the end of thegraft vessel 120 to the side of thetarget vessel 166. This motion of thesuture 212 causes the partially-tied knots to tighten, forming completely-tied knots. Alternately, the motion of the suture completes a knot instead of or in addition to tightening a partially-tied knot. The tied knots are then separated from a remainder of thesuture 212 in any suitable manner, such as described above. - Proximal/Distal Anastomoses
- The
effector 4 can be utilized to perform an anastomosis between the end of any tubular tissue structure and the side of any tubular tissue structure. As an example, theeffector 4 may be used to perform a proximal anastomosis between a graft vessel and the aorta in a CABG procedure. As another example, theeffector 4 may be used to perform a distal anastomosis between a graft vessel and a coronary artery in a CABG procedure. Theeffector 4 is particularly well suited to distal anastomosis in a beating-heart CABG procedure, due to its ability to provide virtual hemostasis; the heart does not substantially move in the very short duration between making an opening in the coronary artery and deploying connectors to connect the graft vessel to the coronary artery. - Where the
effector 4 is used for distal anastomosis between a graft vessel and a coronary artery, thecutter assembly 10 may be configured differently. For example, thecutter assembly 10 may simply be a sharp edge that is actuated to move out of the distal end of theeffector 4, create a substantially linear slit in the coronary artery, then retract back into theeffector 4 and move off-axis. The sharp edge may move solely in the longitudinal direction relative to theeffector 4, or may move along at least part of the length of the coronary artery. Alternately, thecutter assembly 10 may be modified in any other suitable manner to facilitate its use with for distal anastomosis. - In addition, where the
effector 4 is used for distal anastomosis, theconnectors 90 may be scaled down in size relative to theconnectors 90 utilized for proximal anastomosis, ordifferent connectors 90 may be used for distal anastomosis than for proximal anastomosis. - While the invention has been described in detail, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention. For example, the system described above may be used for surgical procedures other than CABG procedures, such as peripheral vascular surgery, neurovascular surgery, or transplant surgery. It is to be understood that the invention is not limited to the details of construction, the arrangements of components and/or the details of operation set forth in the above description or illustrated in the drawings. Headings and subheadings are for the convenience of the reader only. They should not and cannot be construed to have any substantive significance, meaning or interpretation, and should not and cannot be deemed to be limiting in any way, or indicate that all of the information relating to any particular topic is to be found under or limited to any particular heading or subheading. Statements in the abstract of this document and in the summary, to the extent that the invention is summarized at any location in this document, are merely exemplary; they do not limit, and cannot be interpreted as limiting, the scope of the claims. The contents of each section of this document are merely exemplary and do not limit the scope of the invention or the interpretation of the claims. Therefore, the invention is not to be restricted or limited except in accordance with the following claims and their legal equivalents.
Claims (27)
1. A surgical apparatus for connecting a graft vessel to a target vessel, comprising:
a cutter; and
a connection module, at least one of said cutter and said connection module movable relative to the other, wherein said connection module includes a plurality of needles.
2. The surgical apparatus of claim 1 , wherein at least one said needle is substantially rigid.
3. The surgical apparatus of claim 1 , wherein at least one needle includes a substantially arcuate body having a free end.
4. The surgical apparatus of claim 3 , wherein said needle includes an axle oriented substantially perpendicular to said arcuate body.
5. The surgical apparatus of claim 4 , wherein said needle includes a retention member connected to said axle.
6. The surgical apparatus of claim 5 , wherein said retention member is substantially L-shaped.
7. The surgical apparatus of claim 1 , further comprising at least one needle tip detachably connected to a corresponding said needle, further comprising suture connected to said needle tip.
8. The surgical apparatus of claim 7 , wherein at least one needle tip is crimped to an end of the corresponding said needle.
9. The surgical apparatus of claim 7 , wherein at least one needle tip is frangibly connected to an end of the corresponding said needle.
10. The surgical apparatus of claim 7 , wherein said connection module further comprises at least one grate, wherein at least one said needle tip is engageable with said grate.
11. The surgical apparatus of claim 10 , wherein at least one said grate is movable from a first position in proximity to the distal end of said connection module to a second position proximal to said first position.
12. The surgical apparatus of claim 10 , wherein at least one said grate includes at least one aperture therethrough.
13. The surgical apparatus of claim 12 , wherein at least one said grate includes a plurality of said apertures spaced apart from one another.
14. The surgical apparatus of claim 12 , wherein each said needle tip includes a spike at its distal end, and wherein the width of each aperture is less than the width of the widest part of said spike.
15. The surgical apparatus of claim 1 , further comprising at least one trap detachably connected to said connection module, each said trap connected to suture and configured to receive a corresponding said needle.
16. The surgical apparatus of claim 15 , wherein at least one said trap includes at least one tab defined therein to capture said corresponding needle.
17. A surgical apparatus for connecting a graft vessel to a target vessel, comprising:
an actuator; and
an effector operationally connected to said actuator, said effector configured to place the graft vessel in fluid communication with the target vessel; wherein said effector includes a connection module having a plurality of needles, a needle tip detachably connected to each said needle, and suture connected to each said needle tip.
18. The surgical apparatus of claim 17 , wherein said actuator and said effector are operationally connected by at least one transmission member extending therebetween.
19. The surgical apparatus of claim 18 , wherein said actuator includes a source of stored energy operationally connected to said transmission member.
20. The surgical apparatus of claim 19 , wherein said source of stored energy is a pressurized gas reservoir.
21. The surgical apparatus of claim 19 , wherein at least one said transmission member is a cable.
22. The surgical apparatus of claim 20 , wherein said connection module includes at least one housing extending to a distal end thereof.
23. The surgical apparatus of claim 22 , further comprising at least one bushing connected to a proximal surface of the distal end of at least one said housing.
24. The surgical apparatus of claim 23 , wherein at least one said bushing includes an opening therein, and wherein each said needle corresponding to each bushing includes a substantially arcuate body and an axle substantially perpendicular to said substantially arcuate body; wherein at least one said axle extends into the corresponding said opening.
25. The surgical apparatus of claim 24 , wherein at least one said axle is rotatable relative to the corresponding said bushing.
26. The surgical apparatus of claim 24 , wherein each said needle includes a retention member connected to said axle, and wherein each said retention member is configured to slide along the outer surface of the corresponding said bushing.
27. The surgical apparatus of claim 18 , wherein said actuator is connectable to an external energy source to receive energy therefrom, said actuator configured to convert energy received from the external energy source into motion of said transmission member.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/930,640 US20130289584A1 (en) | 2003-06-26 | 2013-06-28 | Compliant anastomosis system utilizing suture |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48307903P | 2003-06-26 | 2003-06-26 | |
US10/877,971 US7794471B1 (en) | 2003-06-26 | 2004-06-25 | Compliant anastomosis system |
US11/004,777 US8574246B1 (en) | 2004-06-25 | 2004-12-03 | Compliant anastomosis system utilizing suture |
US13/930,640 US20130289584A1 (en) | 2003-06-26 | 2013-06-28 | Compliant anastomosis system utilizing suture |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/004,777 Division US8574246B1 (en) | 2003-06-26 | 2004-12-03 | Compliant anastomosis system utilizing suture |
Publications (1)
Publication Number | Publication Date |
---|---|
US20130289584A1 true US20130289584A1 (en) | 2013-10-31 |
Family
ID=42710913
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/877,971 Active 2027-12-05 US7794471B1 (en) | 2003-06-26 | 2004-06-25 | Compliant anastomosis system |
US13/930,640 Abandoned US20130289584A1 (en) | 2003-06-26 | 2013-06-28 | Compliant anastomosis system utilizing suture |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/877,971 Active 2027-12-05 US7794471B1 (en) | 2003-06-26 | 2004-06-25 | Compliant anastomosis system |
Country Status (1)
Country | Link |
---|---|
US (2) | US7794471B1 (en) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9282967B2 (en) | 2007-08-02 | 2016-03-15 | Bioconnect Systems, Inc. | Implantable flow connector |
EP2173259A4 (en) | 2007-08-02 | 2015-07-08 | Bio Connect Systems | Implantable flow connector |
US8662369B1 (en) | 2010-05-27 | 2014-03-04 | Cardica, Inc. | Barbed surgical staple |
US8465504B2 (en) | 2011-01-25 | 2013-06-18 | Isuturing, Llc | Devices and methods for continuous surgical suturing |
US9775602B2 (en) | 2011-01-25 | 2017-10-03 | Isuturing, Llc | Devices and methods for continuous surgical suturing |
US9974928B2 (en) * | 2011-05-10 | 2018-05-22 | Safesharp Technologies Corporation | Apparatus for securing a medical clamp to a patient |
US10434293B2 (en) | 2012-04-15 | 2019-10-08 | Tva Medical, Inc. | Implantable flow connector |
US9314600B2 (en) | 2012-04-15 | 2016-04-19 | Bioconnect Systems, Inc. | Delivery system for implantable flow connector |
EP3013395B1 (en) | 2013-06-28 | 2019-10-02 | Duc Hong Le | Catheter anchoring device and method |
US11564728B1 (en) * | 2017-12-14 | 2023-01-31 | Avenu Medical, Inc. | Systems and methods for percutaneous access, formation, and maintenance of arteriovenous fistulas |
JP2022522959A (en) * | 2019-01-11 | 2022-04-21 | ザ リージェンツ オブ ザ ユニバーシティ オブ コロラド,ア ボディー コーポレイト | Systems and methods for attaching fluid conduits to anatomical structures |
CN114081560B (en) * | 2021-12-29 | 2023-07-25 | 苏州法兰克曼医疗器械有限公司 | Gastrointestinal electric cutting anastomat |
Citations (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4557265A (en) * | 1983-02-08 | 1985-12-10 | Innova Ab | Suturing instrument |
US5364408A (en) * | 1992-09-04 | 1994-11-15 | Laurus Medical Corporation | Endoscopic suture system |
US5458609A (en) * | 1992-09-04 | 1995-10-17 | Laurus Medical Corporation | Surgical needle and retainer system |
US5478347A (en) * | 1990-10-05 | 1995-12-26 | United States Surgical Corporation | Endoscopic surgical instrument having curved blades |
US5496332A (en) * | 1994-10-20 | 1996-03-05 | Cordis Corporation | Wound closure apparatus and method for its use |
US5573540A (en) * | 1994-07-18 | 1996-11-12 | Yoon; Inbae | Apparatus and method for suturing an opening in anatomical tissue |
US5578044A (en) * | 1992-09-04 | 1996-11-26 | Laurus Medical Corporation | Endoscopic suture system |
US5695504A (en) * | 1995-02-24 | 1997-12-09 | Heartport, Inc. | Devices and methods for performing a vascular anastomosis |
US5713910A (en) * | 1992-09-04 | 1998-02-03 | Laurus Medical Corporation | Needle guidance system for endoscopic suture device |
US5836956A (en) * | 1995-07-14 | 1998-11-17 | C.R. Bard, Inc. | Wound closure apparatus and method |
US5893369A (en) * | 1997-02-24 | 1999-04-13 | Lemole; Gerald M. | Procedure for bypassing an occlusion in a blood vessel |
US5951576A (en) * | 1998-03-02 | 1999-09-14 | Wakabayashi; Akio | End-to-side vascular anastomosing stapling device |
US5972024A (en) * | 1996-12-24 | 1999-10-26 | Metacardia, Inc. | Suture-staple apparatus and method |
US5993468A (en) * | 1995-10-31 | 1999-11-30 | Oticon A/S | Method and anastomotic instrument for use when performing an end-to-side anastomosis |
US6030392A (en) * | 1995-01-18 | 2000-02-29 | Motorola, Inc. | Connector for hollow anatomical structures and methods of use |
US6036699A (en) * | 1992-12-10 | 2000-03-14 | Perclose, Inc. | Device and method for suturing tissue |
US6036702A (en) * | 1997-04-23 | 2000-03-14 | Vascular Science Inc. | Medical grafting connectors and fasteners |
US6066148A (en) * | 1996-04-30 | 2000-05-23 | Oticon A/S | Method and anastomotic instrument for use when performing an end-to-side anastomosis |
US20010007069A1 (en) * | 1999-07-28 | 2001-07-05 | David Bombard | Tissue bonding system and method for controlling a tissue site during anastomosis |
US6280460B1 (en) * | 1998-02-13 | 2001-08-28 | Heartport, Inc. | Devices and methods for performing vascular anastomosis |
US6358258B1 (en) * | 1999-09-14 | 2002-03-19 | Abbott Laboratories | Device and method for performing end-to-side anastomosis |
US20020055752A1 (en) * | 2000-11-09 | 2002-05-09 | Schraft Rolf Dieter | Device and procedure for joining hollow organs |
US6409739B1 (en) * | 1997-05-19 | 2002-06-25 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to side anastomosis |
US20020082626A1 (en) * | 1999-11-15 | 2002-06-27 | Donohoe Brendan M. | Integrated anastomosis tool with graft vessel attachment device and cutting device |
US6428555B1 (en) * | 2000-01-28 | 2002-08-06 | J. Kenneth Koster, Jr. | Anastomosis punch device and method |
US20020173800A1 (en) * | 2001-05-21 | 2002-11-21 | Peter Dreyfuss | Suture passer |
US20030125755A1 (en) * | 1998-06-03 | 2003-07-03 | Laurent Schaller | Tissue connector apparatus and methods |
US6709442B2 (en) * | 2000-09-01 | 2004-03-23 | Onux Medical, Inc. | Vascular bypass grafting instrument and method |
US20040068276A1 (en) * | 2002-10-04 | 2004-04-08 | Steve Golden | Anastomosis apparatus and methods |
US6730102B1 (en) * | 2000-11-06 | 2004-05-04 | Abbott Laboratories | Systems, devices and methods for deploying needles |
US20050070924A1 (en) * | 2003-09-26 | 2005-03-31 | Coalescent Surgical, Inc. | Surgical connection apparatus and methods |
US20050080435A1 (en) * | 2002-09-20 | 2005-04-14 | Kevin Smith | Tissue retractor and method for using the retractor |
US7029481B1 (en) * | 2000-11-06 | 2006-04-18 | Abbott Laboratories | Systems, devices and methods for suturing patient tissue |
US20060200177A1 (en) * | 2003-04-16 | 2006-09-07 | Tyco Healthcare Group Lp | Method and apparatus for radical prostatectomy anastomosis including an anchor for engaging a body vessel and deployable sutures |
US20070010832A1 (en) * | 2003-04-16 | 2007-01-11 | Manzo Scott E | Method and apparatus for radical prostatectomy anastomosis including an anchor for engaging a body vessel and deployable sutures |
Family Cites Families (223)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2012776A (en) | 1931-05-23 | 1935-08-27 | Roeder Hans Albert | Ligator |
US2566625A (en) | 1950-08-24 | 1951-09-04 | Clemens B Nagelmann | Ligating instrument |
US3090386A (en) | 1961-07-20 | 1963-05-21 | Curtis Scott Company | Surgical suturing instrument |
US3254650A (en) | 1962-03-19 | 1966-06-07 | Michael B Collito | Surgical anastomosis methods and devices |
US3254651A (en) | 1962-09-12 | 1966-06-07 | Babies Hospital | Surgical anastomosis methods and devices |
US3177021A (en) | 1962-09-18 | 1965-04-06 | Franklin G Benham | Knot tying device |
US3344790A (en) | 1964-11-02 | 1967-10-03 | Richard L Dorner | Surgical suturing device with auxiliary spool-brake means |
US3519187A (en) | 1966-12-06 | 1970-07-07 | Nickolai Nickolajevich Kapitan | Instrument for suturing vessels |
US3643851A (en) | 1969-08-25 | 1972-02-22 | United States Surgical Corp | Skin stapler |
US3662939A (en) | 1970-02-26 | 1972-05-16 | United States Surgical Corp | Surgical stapler for skin and fascia |
US3647310A (en) * | 1970-04-03 | 1972-03-07 | Mansfield K Morse | Universal hole saw arbor |
US3774615A (en) | 1971-02-08 | 1973-11-27 | Ceskoslovenska Akademie Ved | Device for connecting or joining the ends of interrupted tubular organs in surgical operations without stitching |
US3871379A (en) | 1971-08-26 | 1975-03-18 | Henry C N Clarke | Laparoscopy instruments and method for suturing and ligation |
US3788303A (en) * | 1972-01-24 | 1974-01-29 | American Cystoscope Makers Inc | Orthogonally deflectable endoscope |
US4018228A (en) | 1975-02-24 | 1977-04-19 | Goosen Carl C | Surgical punch apparatus |
US4014492A (en) | 1975-06-11 | 1977-03-29 | Senco Products, Inc. | Surgical staple |
SU571253A1 (en) | 1975-07-11 | 1977-09-05 | Всесоюзный научно-исследовательский и испытательный институт медицинской техники | Apparatus fir suturing vessels with metal clips |
US4127227A (en) | 1976-10-08 | 1978-11-28 | United States Surgical Corporation | Wide fascia staple cartridge |
US4109844A (en) | 1976-11-18 | 1978-08-29 | Senco Products, Inc. | Surgical stapling instrument |
US4603693A (en) | 1977-05-26 | 1986-08-05 | United States Surgical Corporation | Instrument for circular surgical stapling of hollow body organs and disposable cartridge therefor |
US4180196A (en) | 1977-08-05 | 1979-12-25 | Senco Products, Inc. | Anvil attachment for a surgical stapling instrument |
US4256251A (en) | 1978-04-24 | 1981-03-17 | Lawrence M. Smith | Surgical staplers and staple |
US4214587A (en) | 1979-02-12 | 1980-07-29 | Sakura Chester Y Jr | Anastomosis device and method |
SU1088712A1 (en) | 1979-11-14 | 1984-04-30 | Всесоюзный научно-исследовательский и испытательный институт медицинской техники | Apparatus for circular suture of blood vessels |
US4352358A (en) | 1979-12-28 | 1982-10-05 | Angelchik Jean P | Apparatus for effecting anastomotic procedures |
US4317451A (en) | 1980-02-19 | 1982-03-02 | Ethicon, Inc. | Plastic surgical staple |
US4331277A (en) | 1980-05-23 | 1982-05-25 | United States Surgical Corporation | Self-contained gas powered surgical stapler |
US4406392A (en) | 1980-05-27 | 1983-09-27 | American Cyanamid Company | Surgical stapling instrument |
US4368736A (en) | 1980-11-17 | 1983-01-18 | Kaster Robert L | Anastomotic fitting |
US4366819A (en) | 1980-11-17 | 1983-01-04 | Kaster Robert L | Anastomotic fitting |
US4411378A (en) | 1981-01-28 | 1983-10-25 | Senco Products, Inc. | Disposable surgical stapling instrument having an anvil with coextensive lateral flanges |
US4645111A (en) | 1981-07-08 | 1987-02-24 | Howmedica, Inc. | Surgical stapler with retractable anvil |
US4410125A (en) | 1981-10-02 | 1983-10-18 | United States Surgical Corporation | Surgical stapler apparatus with curved staple pusher |
US4503568A (en) | 1981-11-25 | 1985-03-12 | New England Deaconess Hospital | Small diameter vascular bypass and method |
DE3204532C2 (en) | 1982-02-10 | 1983-12-08 | B. Braun Melsungen Ag, 3508 Melsungen | Surgical skin staple |
US4474181A (en) | 1982-02-18 | 1984-10-02 | Schenck Robert R | Method and apparatus for anastomosing small blood vessels |
US4624255A (en) | 1982-02-18 | 1986-11-25 | Schenck Robert R | Apparatus for anastomosing living vessels |
US4523707A (en) | 1982-05-04 | 1985-06-18 | Blake Joseph W Iii | Surgical stapler |
US4917091A (en) | 1982-06-24 | 1990-04-17 | Unilink Ab | Annular fastening means |
SE431609B (en) | 1982-06-24 | 1984-02-20 | Unilink Ab | SURGICAL INSTRUMENT FOR THE ASTAD COMMAND OF ANASTOMOS AND ITS PARTS |
US4493322A (en) | 1982-09-28 | 1985-01-15 | Senco Products, Inc. | Surgical stapling instrument |
US4493323A (en) | 1982-12-13 | 1985-01-15 | University Of Iowa Research Foundation | Suturing device and method for using same |
US4523592A (en) | 1983-04-25 | 1985-06-18 | Rollin K. Daniel P.S.C. | Anastomotic coupling means capable of end-to-end and end-to-side anastomosis |
US4607637A (en) | 1983-07-22 | 1986-08-26 | Anders Berggren | Surgical instrument for performing anastomosis with the aid of ring-like fastening elements and the fastening elements for performing anastomosis |
US5125553A (en) | 1987-03-02 | 1992-06-30 | Stryker Sales Corporation | Surgical suturing instrument and method |
US5220928A (en) | 1983-08-22 | 1993-06-22 | Stryker Sales Corporation | Surgical procedure for joining tissue in an internal body cavity |
US4665906A (en) | 1983-10-14 | 1987-05-19 | Raychem Corporation | Medical devices incorporating sim alloy elements |
US4558810A (en) | 1983-12-09 | 1985-12-17 | Richard-Allan Medical Industries, Inc. | Surgical stapler construction |
US4634035A (en) | 1984-03-12 | 1987-01-06 | American Cyanamid Company | Skin stapler |
US4597390A (en) | 1984-04-02 | 1986-07-01 | Mulhollan James S | Surgical needle manipulator |
US4917087A (en) | 1984-04-10 | 1990-04-17 | Walsh Manufacturing (Mississuaga) Limited | Anastomosis devices, kits and method |
US4657019A (en) | 1984-04-10 | 1987-04-14 | Idea Research Investment Fund, Inc. | Anastomosis devices and kits |
US4671279A (en) | 1984-04-24 | 1987-06-09 | Beta Phase, Inc. | Surgical staple applying method |
EP0185026A1 (en) | 1984-05-07 | 1986-06-25 | PUCHY, David Peter William | Surgical stapler providing variable degree of staple closure |
US4596350A (en) | 1984-05-10 | 1986-06-24 | Senmed, Inc. | Surgical stapler drive apparatus |
GB8417562D0 (en) | 1984-07-10 | 1984-08-15 | Surgical Design Services | Fasteners |
US4741336A (en) | 1984-07-16 | 1988-05-03 | Ethicon, Inc. | Shaped staples and slotted receivers (case VII) |
US4807628A (en) | 1985-04-26 | 1989-02-28 | Edward Weck & Company, Inc. | Method and apparatus for storing, dispensing, and applying surgical staples |
US4593693A (en) | 1985-04-26 | 1986-06-10 | Schenck Robert R | Methods and apparatus for anastomosing living vessels |
CN85106639B (en) | 1985-09-03 | 1988-08-03 | 第三军医大学野战外科研究所 | Instrument for blood vessel anastomosis |
US4691853A (en) | 1985-12-30 | 1987-09-08 | Technalytics, Inc. | Surgical stapler |
US4752024A (en) | 1986-10-17 | 1988-06-21 | Green David T | Surgical fastener and surgical stapling apparatus |
US4760848A (en) | 1986-11-03 | 1988-08-02 | Hasson Harrith M | Rotational surgical instrument |
US4776506A (en) * | 1986-11-13 | 1988-10-11 | United States Surgical Corporation | Surgical stapler apparatus |
US4747531A (en) | 1987-03-23 | 1988-05-31 | Ethicon, Inc. | Anvil and driver assembly for a surgical skin stapling instrument |
US5119983A (en) | 1987-05-26 | 1992-06-09 | United States Surgical Corporation | Surgical stapler apparatus |
US5285944A (en) | 1987-05-26 | 1994-02-15 | United States Surgical Corporation | Surgical stapler apparatus |
US4773420A (en) | 1987-06-22 | 1988-09-27 | U.S. Surgical Corporation | Purse string applicator |
US4951860A (en) | 1987-12-28 | 1990-08-28 | Edward Weck & Co. | Method and apparatus for storing, dispensing and applying surgical staples |
US4811886A (en) | 1988-02-18 | 1989-03-14 | Ethicon, Inc. | Staple positioning tab |
US4945920A (en) | 1988-03-28 | 1990-08-07 | Cordis Corporation | Torqueable and formable biopsy forceps |
US4907591A (en) | 1988-03-29 | 1990-03-13 | Pfizer Hospital Products Group, Inc. | Surgical instrument for establishing compression anastomosis |
US5193731A (en) | 1988-07-01 | 1993-03-16 | United States Surgical Corporation | Anastomosis surgical stapling instrument |
US5005749A (en) | 1988-07-01 | 1991-04-09 | United States Surgical Corp. | Anastomosis surgical stapling instrument |
US5336233A (en) | 1989-01-26 | 1994-08-09 | Chen Fusen H | Anastomotic device |
US4930674A (en) | 1989-02-24 | 1990-06-05 | Abiomed, Inc. | Surgical stapler |
US5178634A (en) | 1989-03-31 | 1993-01-12 | Wilson Ramos Martinez | Aortic valved tubes for human implants |
US5049153A (en) * | 1989-12-26 | 1991-09-17 | Nakao Naomi L | Endoscopic stapling device and method |
US5062842A (en) | 1989-12-21 | 1991-11-05 | Coherent, Inc. | Isotopic co2 laser and method of use for medical treatment |
US5015250A (en) | 1990-01-12 | 1991-05-14 | Vance Products Incorporated | Medical instrument for driving a suture needle |
US5240164A (en) | 1990-02-13 | 1993-08-31 | Ethicon, Inc. | Rotating head skin stapler |
US5037433A (en) | 1990-05-17 | 1991-08-06 | Wilk Peter J | Endoscopic suturing device and related method and suture |
US5105672A (en) * | 1990-05-17 | 1992-04-21 | Carson Donald G | Rotary drive apparatus having one member with smooth outer peripheral surface |
US5156619A (en) | 1990-06-15 | 1992-10-20 | Ehrenfeld William K | Flanged end-to-side vascular graft |
US5366462A (en) | 1990-08-28 | 1994-11-22 | Robert L. Kaster | Method of side-to-end vascular anastomotic stapling |
US5234447A (en) | 1990-08-28 | 1993-08-10 | Robert L. Kaster | Side-to-end vascular anastomotic staple apparatus |
US5176691A (en) | 1990-09-11 | 1993-01-05 | Pierce Instruments, Inc. | Knot pusher |
US5653373A (en) | 1990-09-17 | 1997-08-05 | United States Surgical Corporation | Arcuate apparatus for applying two-part surgical fasteners |
US5104025A (en) | 1990-09-28 | 1992-04-14 | Ethicon, Inc. | Intraluminal anastomotic surgical stapler with detached anvil |
CA2096651A1 (en) | 1990-11-20 | 1992-05-21 | Robert S. Behl | Tension guide and dilator |
US5425489A (en) | 1990-12-20 | 1995-06-20 | United States Surgical Corporation | Fascia clip and instrument |
US5320629B1 (en) | 1991-01-07 | 2000-05-02 | Advanced Surgical Inc | Device and method for applying suture |
US5129912B2 (en) | 1991-01-07 | 2000-01-11 | Urohealth Systems Inc | Device and method for applying suture |
US5250058A (en) | 1991-01-17 | 1993-10-05 | Ethicon, Inc. | Absorbable anastomosic fastener means |
US5405352A (en) | 1991-04-09 | 1995-04-11 | Weston; Peter V. | Suture knot, method for its formation and use, and knot forming apparatus |
US5147373A (en) | 1991-04-29 | 1992-09-15 | Ferzli George S | Laparoscopic instrument |
US5217470A (en) | 1991-04-29 | 1993-06-08 | Weston Peter V | Apparatuses and methods for formation and use of a slipknot as a surgical suture knot |
US5304220A (en) | 1991-07-03 | 1994-04-19 | Maginot Thomas J | Method and apparatus for implanting a graft prosthesis in the body of a patient |
US5211683A (en) | 1991-07-03 | 1993-05-18 | Maginot Thomas J | Method of implanting a graft prosthesis in the body of a patient |
WO1993000868A1 (en) | 1991-07-04 | 1993-01-21 | Earl Ronald Owen | Tubular surgical implant |
US5279067A (en) | 1991-08-01 | 1994-01-18 | Tollison Bruce O | Easy tie fish hook or the like |
US5251801A (en) | 1991-08-05 | 1993-10-12 | Edward Weck Incorporated | Surgical stapler |
US5333773A (en) | 1991-08-23 | 1994-08-02 | Ethicon, Inc. | Sealing means for endoscopic surgical anastomosis stapling instrument |
US5350104A (en) | 1991-08-23 | 1994-09-27 | Ethicon, Inc. | Sealing means for endoscopic surgical anastomosis stapling instrument |
GR920100358A (en) | 1991-08-23 | 1993-06-07 | Ethicon Inc | Surgical anastomosis stapling instrument. |
US5273545A (en) | 1991-10-15 | 1993-12-28 | Apple Medical Corporation | Endoscopic cannula with tricuspid leaf valve |
US5443198A (en) | 1991-10-18 | 1995-08-22 | United States Surgical Corporation | Surgical fastener applying apparatus |
US5289963A (en) | 1991-10-18 | 1994-03-01 | United States Surgical Corporation | Apparatus and method for applying surgical staples to attach an object to body tissue |
US5312023A (en) * | 1991-10-18 | 1994-05-17 | United States Surgical Corporation | Self contained gas powered surgical apparatus |
DE4137218C1 (en) | 1991-11-13 | 1993-02-11 | Heidmueller, Harald, 5000 Koeln, De | |
US5271543A (en) | 1992-02-07 | 1993-12-21 | Ethicon, Inc. | Surgical anastomosis stapling instrument with flexible support shaft and anvil adjusting mechanism |
US5707362A (en) | 1992-04-15 | 1998-01-13 | Yoon; Inbae | Penetrating instrument having an expandable anchoring portion for triggering protrusion of a safety member and/or retraction of a penetrating member |
US5368601A (en) | 1992-04-30 | 1994-11-29 | Lasersurge, Inc. | Trocar wound closure device |
US5314435A (en) | 1992-05-19 | 1994-05-24 | United States Surgical Corporation | Anvil delivery system |
US5344059A (en) | 1992-05-19 | 1994-09-06 | United States Surgical Corporation | Surgical apparatus and anvil delivery system therefor |
JPH0647050A (en) | 1992-06-04 | 1994-02-22 | Olympus Optical Co Ltd | Tissue suture and ligature device |
US7060077B2 (en) | 1992-09-04 | 2006-06-13 | Boston Scientific Scimed, Inc. | Suturing instruments and methods of use |
US6048351A (en) | 1992-09-04 | 2000-04-11 | Scimed Life Systems, Inc. | Transvaginal suturing system |
CA2106127A1 (en) | 1992-09-23 | 1994-03-24 | Peter W.J. Hinchliffe | Instrument for closing trocar puncture wounds |
US5292327A (en) | 1992-10-08 | 1994-03-08 | Dodd Joseph T | Surgical knot pusher |
US5522834A (en) | 1992-10-15 | 1996-06-04 | Applied Medical Resources Corporation | Internal mammary artery catheter and method |
US5417699A (en) | 1992-12-10 | 1995-05-23 | Perclose Incorporated | Device and method for the percutaneous suturing of a vascular puncture site |
US20020095164A1 (en) | 1997-06-26 | 2002-07-18 | Andreas Bernard H. | Device and method for suturing tissue |
US6355050B1 (en) | 1992-12-10 | 2002-03-12 | Abbott Laboratories | Device and method for suturing tissue |
US5403327A (en) | 1992-12-31 | 1995-04-04 | Pilling Weck Incorporated | Surgical clip applier |
US5456400A (en) | 1993-04-22 | 1995-10-10 | United States Surgical Corporation | Apparatus and clip for fastening body tissue |
US5364003A (en) | 1993-05-05 | 1994-11-15 | Ethicon Endo-Surgery | Staple cartridge for a surgical stapler |
US5464449A (en) | 1993-07-08 | 1995-11-07 | Thomas J. Fogarty | Internal graft prosthesis and delivery system |
US5454820A (en) | 1993-07-14 | 1995-10-03 | Ethicon, Inc. | Method of tying knots using a tube knot applicator |
US5478354A (en) | 1993-07-14 | 1995-12-26 | United States Surgical Corporation | Wound closing apparatus and method |
US5454825A (en) | 1993-10-01 | 1995-10-03 | United States Surgical Corporation | Circular anastomosis device with seal |
US5447514A (en) | 1993-10-01 | 1995-09-05 | United States Surgical Corporation | Circular anastomosis device |
CA2132917C (en) | 1993-10-07 | 2004-12-14 | John Charles Robertson | Circular anastomosis device |
US5478344A (en) | 1993-10-08 | 1995-12-26 | United States Surgical Corporation | Surgical suturing apparatus with loading mechanism |
WO1995013033A1 (en) | 1993-11-08 | 1995-05-18 | Lazarus Harrison M | Intraluminal vascular graft and method |
US5527322A (en) | 1993-11-08 | 1996-06-18 | Perclose, Inc. | Device and method for suturing of internal puncture sites |
US5443497A (en) | 1993-11-22 | 1995-08-22 | The Johns Hopkins University | Percutaneous prosthetic by-pass graft and method of use |
US5536273A (en) | 1993-12-09 | 1996-07-16 | Lehrer; Theodor | Apparatus and method of extracorporeally applying and locking laparoscopic suture and loop ligatures |
DK145593A (en) | 1993-12-23 | 1995-06-24 | Joergen A Rygaard | Surgical double instrument for performing connection mlm. arteries (end-to-side anastomosis) |
US5643293A (en) | 1993-12-29 | 1997-07-01 | Olympus Optical Co., Ltd. | Suturing instrument |
US5465895A (en) | 1994-02-03 | 1995-11-14 | Ethicon Endo-Surgery, Inc. | Surgical stapler instrument |
US5452836A (en) | 1994-02-07 | 1995-09-26 | Ethicon Endo-Surgery, Inc. | Surgical stapling instrument with improved jaw closure and staple firing actuator mechanism |
US5527320A (en) | 1994-02-10 | 1996-06-18 | Pilling Weck Inc. | Surgical clip applying instrument |
US5431666A (en) | 1994-02-24 | 1995-07-11 | Lasersurge, Inc. | Surgical suture instrument |
CA2145723A1 (en) | 1994-03-30 | 1995-10-01 | Steven W. Hamblin | Surgical stapling instrument with remotely articulated stapling head assembly on rotatable support shaft |
US5489058A (en) | 1994-05-02 | 1996-02-06 | Minnesota Mining And Manufacturing Company | Surgical stapler with mechanisms for reducing the firing force |
WO1995032669A1 (en) | 1994-06-01 | 1995-12-07 | Perclose, Inc. | Apparatus and method for advancing surgical knots |
US5881943A (en) | 1994-06-17 | 1999-03-16 | Heartport, Inc. | Surgical anastomosis apparatus and method thereof |
US5732872A (en) | 1994-06-17 | 1998-03-31 | Heartport, Inc. | Surgical stapling instrument |
US5544802A (en) | 1994-07-27 | 1996-08-13 | Crainich; Lawrence | Surgical staple and stapler device therefor |
US5601576A (en) | 1994-08-10 | 1997-02-11 | Heartport Inc. | Surgical knot pusher and method of use |
US5480406A (en) | 1994-10-07 | 1996-01-02 | United States Surgical Corporation | Method of employing surgical suturing apparatus to tie knots |
US5571090A (en) | 1994-10-07 | 1996-11-05 | United States Surgical Corporation | Vascular suturing apparatus |
CA2157744C (en) | 1994-10-07 | 2005-08-23 | Charles R. Sherts | Endoscopic vascular suturing apparatus |
US5562684A (en) | 1994-10-11 | 1996-10-08 | Ethicon, Inc. | Surgical knot pusher device and improved method of forming knots |
JP2911763B2 (en) | 1994-10-27 | 1999-06-23 | 三桜子 布川 | Artificial blood vessel |
US5554162A (en) | 1994-12-02 | 1996-09-10 | Delange; Gregory S. | Method and device for surgically joining luminal structures |
US5868760A (en) * | 1994-12-07 | 1999-02-09 | Mcguckin, Jr.; James F. | Method and apparatus for endolumenally resectioning tissue |
US5558667A (en) | 1994-12-14 | 1996-09-24 | Coherent, Inc. | Method and apparatus for treating vascular lesions |
US5632432A (en) | 1994-12-19 | 1997-05-27 | Ethicon Endo-Surgery, Inc. | Surgical instrument |
US5976159A (en) | 1995-02-24 | 1999-11-02 | Heartport, Inc. | Surgical clips and methods for tissue approximation |
US6110187A (en) | 1995-02-24 | 2000-08-29 | Heartport, Inc. | Device and method for minimizing heart displacements during a beating heart surgical procedure |
US5573286A (en) | 1995-03-15 | 1996-11-12 | Rogozinski; Chaim | Knot |
DE19509115C2 (en) | 1995-03-16 | 1997-11-27 | Deutsche Forsch Luft Raumfahrt | Surgical device for preparing an anastomosis using minimally invasive surgical techniques |
US5709694A (en) | 1995-03-22 | 1998-01-20 | Human Factors Industrial Design, Inc. | Endoscopic intracorporeal suture tying aid |
US5630540A (en) | 1995-05-24 | 1997-05-20 | United States Surgical Corporation | Surgical staple and staple drive member |
US5902311A (en) | 1995-06-15 | 1999-05-11 | Perclose, Inc. | Low profile intraluminal suturing device and method |
US6562052B2 (en) | 1995-08-24 | 2003-05-13 | Sutura, Inc. | Suturing device and method |
US6117144A (en) | 1995-08-24 | 2000-09-12 | Sutura, Inc. | Suturing device and method for sealing an opening in a blood vessel or other biological structure |
US5653719A (en) | 1995-09-25 | 1997-08-05 | Raiken; Steve | Knot pushing instrument for endoscopic surgery |
US5702412A (en) * | 1995-10-03 | 1997-12-30 | Cedars-Sinai Medical Center | Method and devices for performing vascular anastomosis |
US5746752A (en) | 1995-11-08 | 1998-05-05 | Arthrex, Inc. | Double-diameter knot pusher |
US5709693A (en) | 1996-02-20 | 1998-01-20 | Cardiothoracic System, Inc. | Stitcher |
US5792159A (en) | 1996-04-23 | 1998-08-11 | Amin; Jatin N. | Tongue cleaner |
US6050472A (en) | 1996-04-26 | 2000-04-18 | Olympus Optical Co., Ltd. | Surgical anastomosis stapler |
US5676670A (en) | 1996-06-14 | 1997-10-14 | Beth Israel Deaconess Medical Center | Catheter apparatus and method for creating a vascular bypass in-vivo |
US5797920A (en) | 1996-06-14 | 1998-08-25 | Beth Israel Deaconess Medical Center | Catheter apparatus and method using a shape-memory alloy cuff for creating a bypass graft in-vivo |
US5833698A (en) | 1996-07-23 | 1998-11-10 | United States Surgical Corporation | Anastomosis instrument and method |
US6024748A (en) | 1996-07-23 | 2000-02-15 | United States Surgical Corporation | Singleshot anastomosis instrument with detachable loading unit and method |
US20020019642A1 (en) | 1996-07-23 | 2002-02-14 | Keith Milliman | Anastomosis instrument and method for performing same |
US5707380A (en) * | 1996-07-23 | 1998-01-13 | United States Surgical Corporation | Anastomosis instrument and method |
US6083234A (en) | 1996-07-23 | 2000-07-04 | Surgical Dynamics, Inc. | Anastomosis instrument and method |
US5755778A (en) | 1996-10-16 | 1998-05-26 | Nitinol Medical Technologies, Inc. | Anastomosis device |
US5879371A (en) | 1997-01-09 | 1999-03-09 | Elective Vascular Interventions, Inc. | Ferruled loop surgical fasteners, instruments, and methods for minimally invasive vascular and endoscopic surgery |
US5759189A (en) | 1997-02-25 | 1998-06-02 | Smith & Nephew Inc. | Knot pusher |
US5728109A (en) | 1997-04-08 | 1998-03-17 | Ethicon Endo-Surgery, Inc. | Surgical knot and method for its formation |
US5938101A (en) | 1997-05-14 | 1999-08-17 | Ethicon Endo-Surgery, Inc. | Skin stapler with movable anvil |
US5944730A (en) | 1997-05-19 | 1999-08-31 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to-side anastomosis |
DE19732234A1 (en) | 1997-07-26 | 1999-01-28 | Georg Dr Med Quatchadze | Surgical endoscopic instrument |
US6066144A (en) | 1997-10-07 | 2000-05-23 | Ethicon Endo-Surgery, Inc. | Surgical anastomosis method |
US5993464A (en) | 1998-01-23 | 1999-11-30 | Ethicon Endo-Surgery, Inc. | Surgical stapling instrument |
US5865730A (en) | 1997-10-07 | 1999-02-02 | Ethicon Endo-Surgery, Inc. | Tissue stabilization device for use during surgery having remotely actuated feet |
US5897563A (en) | 1997-10-08 | 1999-04-27 | Ethicon Endo-Surgery, Inc. | Method for using a needle holder to assist in suturing |
US6117148A (en) | 1997-10-17 | 2000-09-12 | Ravo; Biagio | Intraluminal anastomotic device |
US6193734B1 (en) | 1998-01-23 | 2001-02-27 | Heartport, Inc. | System for performing vascular anastomoses |
US6416527B1 (en) * | 1998-01-28 | 2002-07-09 | St. Jude Medical Cardiovascular Group, Inc. | Vessel cutting device |
US6015416A (en) | 1998-02-26 | 2000-01-18 | Ethicon Endo-Surgery, Inc. | Surgical anastomosis instrument |
EP1067872B1 (en) | 1998-03-20 | 2006-03-01 | Boston Scientific Limited | Endoscopic suture system |
US7022131B1 (en) * | 1998-05-29 | 2006-04-04 | By-Pass Inc. | Methods and devices for vascular surgery |
US6036700A (en) | 1998-07-14 | 2000-03-14 | Ethicon Endo-Surgery, Inc. | Surgical anastomosis instrument |
EP0990420B1 (en) | 1998-09-28 | 2005-07-20 | United States Surgical Corporation | Anastomosis instrument |
US6318616B1 (en) | 1998-10-23 | 2001-11-20 | United States Surgical | Surgical fastener applier |
US6132439A (en) | 1999-02-17 | 2000-10-17 | X-Site, L.L.C. | Knot pusher |
US6136010A (en) | 1999-03-04 | 2000-10-24 | Perclose, Inc. | Articulating suturing device and method |
US6071289A (en) | 1999-03-15 | 2000-06-06 | Ethicon Endo-Surgery, Inc. | Surgical device for suturing tissue |
US6695859B1 (en) | 1999-04-05 | 2004-02-24 | Coalescent Surgical, Inc. | Apparatus and methods for anastomosis |
US6248117B1 (en) | 1999-04-16 | 2001-06-19 | Vital Access Corp | Anastomosis apparatus for use in intraluminally directed vascular anastomosis |
US6673088B1 (en) | 1999-05-18 | 2004-01-06 | Cardica, Inc. | Tissue punch |
US6428550B1 (en) * | 1999-05-18 | 2002-08-06 | Cardica, Inc. | Sutureless closure and deployment system for connecting blood vessels |
US6699256B1 (en) | 1999-06-04 | 2004-03-02 | St. Jude Medical Atg, Inc. | Medical grafting apparatus and methods |
US6190396B1 (en) | 1999-09-14 | 2001-02-20 | Perclose, Inc. | Device and method for deploying and organizing sutures for anastomotic and other attachments |
US6171317B1 (en) | 1999-09-14 | 2001-01-09 | Perclose, Inc. | Knot tying device and method |
US6626917B1 (en) | 1999-10-26 | 2003-09-30 | H. Randall Craig | Helical suture instrument |
US6193129B1 (en) | 2000-01-24 | 2001-02-27 | Ethicon Endo-Surgery, Inc. | Cutting blade for a surgical anastomosis stapling instrument |
US6596003B1 (en) * | 2000-06-28 | 2003-07-22 | Genzyme Corporation | Vascular anastomosis device |
US6613058B1 (en) * | 2000-08-30 | 2003-09-02 | Ethicon Endo-Surgery, Inc. | Anastomosis device having needle receiver for capturing the needle |
US6514263B1 (en) | 2000-08-30 | 2003-02-04 | Ethicon Endo-Surgery, Inc. | Helical needle and suture combination having a strain relief element |
US6520973B1 (en) | 2000-08-30 | 2003-02-18 | Ethicon Endo-Surgery, Inc. | Anastomosis device having an improved needle driver |
US6530932B1 (en) | 2000-08-30 | 2003-03-11 | Ethicon Endo-Surgery, Inc. | Anastomosis device having improved tissue presentation |
US6425900B1 (en) | 2000-10-19 | 2002-07-30 | Ethicon Endo-Surgery | Method for attaching hernia mesh |
US6524321B2 (en) | 2001-01-03 | 2003-02-25 | Nozomu Kanesaka | Closure device for puncture in vessel |
US6605098B2 (en) | 2001-09-28 | 2003-08-12 | Ethicon, Inc. | Surgical device for creating an anastomosis between first and second hollow organs |
US7323004B2 (en) | 2002-09-30 | 2008-01-29 | Ethicon, Inc. | Device for providing automatic stitching of an incision |
-
2004
- 2004-06-25 US US10/877,971 patent/US7794471B1/en active Active
-
2013
- 2013-06-28 US US13/930,640 patent/US20130289584A1/en not_active Abandoned
Patent Citations (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4557265A (en) * | 1983-02-08 | 1985-12-10 | Innova Ab | Suturing instrument |
US5478347A (en) * | 1990-10-05 | 1995-12-26 | United States Surgical Corporation | Endoscopic surgical instrument having curved blades |
US5713910A (en) * | 1992-09-04 | 1998-02-03 | Laurus Medical Corporation | Needle guidance system for endoscopic suture device |
US5364408A (en) * | 1992-09-04 | 1994-11-15 | Laurus Medical Corporation | Endoscopic suture system |
US5458609A (en) * | 1992-09-04 | 1995-10-17 | Laurus Medical Corporation | Surgical needle and retainer system |
US5578044A (en) * | 1992-09-04 | 1996-11-26 | Laurus Medical Corporation | Endoscopic suture system |
US6036699A (en) * | 1992-12-10 | 2000-03-14 | Perclose, Inc. | Device and method for suturing tissue |
US5573540A (en) * | 1994-07-18 | 1996-11-12 | Yoon; Inbae | Apparatus and method for suturing an opening in anatomical tissue |
US5496332A (en) * | 1994-10-20 | 1996-03-05 | Cordis Corporation | Wound closure apparatus and method for its use |
US6030392A (en) * | 1995-01-18 | 2000-02-29 | Motorola, Inc. | Connector for hollow anatomical structures and methods of use |
US5695504A (en) * | 1995-02-24 | 1997-12-09 | Heartport, Inc. | Devices and methods for performing a vascular anastomosis |
US5836956A (en) * | 1995-07-14 | 1998-11-17 | C.R. Bard, Inc. | Wound closure apparatus and method |
US5993468A (en) * | 1995-10-31 | 1999-11-30 | Oticon A/S | Method and anastomotic instrument for use when performing an end-to-side anastomosis |
US6066148A (en) * | 1996-04-30 | 2000-05-23 | Oticon A/S | Method and anastomotic instrument for use when performing an end-to-side anastomosis |
US5972024A (en) * | 1996-12-24 | 1999-10-26 | Metacardia, Inc. | Suture-staple apparatus and method |
US5893369A (en) * | 1997-02-24 | 1999-04-13 | Lemole; Gerald M. | Procedure for bypassing an occlusion in a blood vessel |
US6036702A (en) * | 1997-04-23 | 2000-03-14 | Vascular Science Inc. | Medical grafting connectors and fasteners |
US6409739B1 (en) * | 1997-05-19 | 2002-06-25 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to side anastomosis |
US6280460B1 (en) * | 1998-02-13 | 2001-08-28 | Heartport, Inc. | Devices and methods for performing vascular anastomosis |
US5951576A (en) * | 1998-03-02 | 1999-09-14 | Wakabayashi; Akio | End-to-side vascular anastomosing stapling device |
US20030125755A1 (en) * | 1998-06-03 | 2003-07-03 | Laurent Schaller | Tissue connector apparatus and methods |
US20010007069A1 (en) * | 1999-07-28 | 2001-07-05 | David Bombard | Tissue bonding system and method for controlling a tissue site during anastomosis |
US6358258B1 (en) * | 1999-09-14 | 2002-03-19 | Abbott Laboratories | Device and method for performing end-to-side anastomosis |
US20020082626A1 (en) * | 1999-11-15 | 2002-06-27 | Donohoe Brendan M. | Integrated anastomosis tool with graft vessel attachment device and cutting device |
US6428555B1 (en) * | 2000-01-28 | 2002-08-06 | J. Kenneth Koster, Jr. | Anastomosis punch device and method |
US6709442B2 (en) * | 2000-09-01 | 2004-03-23 | Onux Medical, Inc. | Vascular bypass grafting instrument and method |
US6730102B1 (en) * | 2000-11-06 | 2004-05-04 | Abbott Laboratories | Systems, devices and methods for deploying needles |
US7029481B1 (en) * | 2000-11-06 | 2006-04-18 | Abbott Laboratories | Systems, devices and methods for suturing patient tissue |
US20020055752A1 (en) * | 2000-11-09 | 2002-05-09 | Schraft Rolf Dieter | Device and procedure for joining hollow organs |
US20020173800A1 (en) * | 2001-05-21 | 2002-11-21 | Peter Dreyfuss | Suture passer |
US20050080435A1 (en) * | 2002-09-20 | 2005-04-14 | Kevin Smith | Tissue retractor and method for using the retractor |
US20040068276A1 (en) * | 2002-10-04 | 2004-04-08 | Steve Golden | Anastomosis apparatus and methods |
US20060200177A1 (en) * | 2003-04-16 | 2006-09-07 | Tyco Healthcare Group Lp | Method and apparatus for radical prostatectomy anastomosis including an anchor for engaging a body vessel and deployable sutures |
US20070010832A1 (en) * | 2003-04-16 | 2007-01-11 | Manzo Scott E | Method and apparatus for radical prostatectomy anastomosis including an anchor for engaging a body vessel and deployable sutures |
US20050070924A1 (en) * | 2003-09-26 | 2005-03-31 | Coalescent Surgical, Inc. | Surgical connection apparatus and methods |
Also Published As
Publication number | Publication date |
---|---|
US7794471B1 (en) | 2010-09-14 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20130289584A1 (en) | Compliant anastomosis system utilizing suture | |
US10729442B2 (en) | Surgical stapler for aortic anastomosis | |
US7150750B2 (en) | Method and device for endoscopic suturing | |
US8475474B2 (en) | Anastomosis method utilizing tool with fluid-driven actuator | |
US7766924B1 (en) | System for performing anastomosis | |
US6530932B1 (en) | Anastomosis device having improved tissue presentation | |
US9622748B2 (en) | Anastomosis system with flexible shaft | |
US6520973B1 (en) | Anastomosis device having an improved needle driver | |
US7300444B1 (en) | Surgical system and method for connecting hollow tissue structures | |
EP1933720B1 (en) | Vascular opening edge eversion apparatuses | |
US6514263B1 (en) | Helical needle and suture combination having a strain relief element | |
JP6258335B2 (en) | Anastomosis clip tool with half loop clip | |
JP2010506664A (en) | Blood vessel closure | |
US20040122473A1 (en) | Delivery systems and methods for gastric reduction | |
US20060106405A1 (en) | Systems and methods for delivering fastener to opposed tissue structures | |
JP7232858B2 (en) | Tissue closure device and method | |
JP2004500209A (en) | Transfer of grafts and connectors | |
JP2006181375A (en) | Surgical needle | |
WO2001019259A1 (en) | Device and method for performing end-to-side anastomosis | |
WO2003078721A2 (en) | Apparatus for sewing tissue and method of use | |
US6613058B1 (en) | Anastomosis device having needle receiver for capturing the needle | |
JP2010506665A (en) | Leg suspension system for internal suture | |
US7371243B1 (en) | Surgical apparatus and method for anastomosis | |
US20030163143A1 (en) | Apparatus and method for suturing in restricted space | |
US8574246B1 (en) | Compliant anastomosis system utilizing suture |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |
|
AS | Assignment |
Owner name: AESCULAP AG, GERMANY Free format text: ASSET PURCHASE AGREEMENT;ASSIGNOR:AESDEX, LLC;REEL/FRAME:045870/0567 Effective date: 20180220 Owner name: AESDEX, LLC, PENNSYLVANIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:DEXTERA SURGICAL INC.;REEL/FRAME:045870/0478 Effective date: 20180214 |