US20140005651A1 - Apparatus and method for positioning an implantable device - Google Patents

Apparatus and method for positioning an implantable device Download PDF

Info

Publication number
US20140005651A1
US20140005651A1 US14/013,983 US201314013983A US2014005651A1 US 20140005651 A1 US20140005651 A1 US 20140005651A1 US 201314013983 A US201314013983 A US 201314013983A US 2014005651 A1 US2014005651 A1 US 2014005651A1
Authority
US
United States
Prior art keywords
wire
aneurysm
medical device
attachment point
lumen
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
Application number
US14/013,983
Inventor
Joe Michael Eskridge
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US14/013,983 priority Critical patent/US20140005651A1/en
Publication of US20140005651A1 publication Critical patent/US20140005651A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/048Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • A61B2017/00318Steering mechanisms
    • A61B2017/00323Cables or rods
    • A61B2017/00327Cables or rods with actuating members moving in opposite directions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477Coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/0084Material properties low friction
    • A61B2017/00849Material properties low friction with respect to tissue, e.g. hollow organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00853Material properties low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00942Material properties hydrophilic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966Radiopaque markers visible in an X-ray image
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/16Materials with shape-memory or superelastic properties
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor

Definitions

  • the present disclosure is directed to repairing blood vessel defects, such as aneurysms, and other physiological defects or cavities formed in lumens, tissue, and the like, and, more particularly, to an endovascular implantable device and related endoluminal delivery procedure and deployment techniques.
  • Cranial aneurysms occur when a weakened cerebral blood vessel (root vessel) locally expands to form a bulge or balloon-like enlargement in the vessel wall. These aneurysms can occur along a vessel wall or at locations of vessel branches, such as a T-intersection or V-intersection.
  • the cranium is opened and a clip is placed at the aneurysm neck to cut off blood flow from the root vessel, thereby reducing swelling and stopping expansion.
  • the interior of the aneurysm is accessed by way of a cranial artery, which in turn is reached with a device inserted into the femoral artery.
  • coiling material is inserted into the aneurysm, thereby causing clotting which closes off the aneurysm.
  • Both techniques have drawbacks. Opening the cranium always entails some risk. Some locations in the cranium are difficult or impossible to access from the outside. On the other hand, causing clotting in the aneurysm can increase the mass and size of the aneurysm, causing it to press against delicate and critical tissue, and causing further damage.
  • FIGS. 1A and 1B which are reproduced from U.S. Patent Publication No. 2007/0191884, shown therein is a device 130 having a patch or closure structure 131 mounted to or associated with two anchoring structures 132 , 133 .
  • the closure structure 131 is supported by a framework structure 134 that is provided at least in a perimeter portion and is attached to the closure structure 131 by means of bonding, suturing, or the like.
  • the framework structure 134 is mounted to or associated with the wing-like anchoring structures 132 , 133 .
  • These anchoring structures 132 , 133 in a deployed condition are designed so that at least a portion thereof contacts an inner wall of an aneurysm or an internal wall of an associated blood vessel following deployment.
  • the anchoring structures 132 , 133 are generally formed to curve outwardly from an attachment joint 135 to the framework structure 134 and then back inwardly toward one another at the end remote from the attachment point 135 .
  • the anchoring loops 132 , 133 are generally of the same configuration and same dimension and are located opposite one another as shown in FIG. 1A .
  • FIG. 1B illustrates a similar device having a closure structure 136 with anchoring structures 137 , 138 that attach to or project from a framework structure 139 along opposed, lateral edges of the framework structure.
  • the anchoring structures 137 , 138 as illustrated in FIG. 1B are gently curved and, at their terminal sections, extend beyond corresponding terminal sections of the framework structure and the closure structure.
  • the closure and framework structures in this embodiment are generally provided having a surface area that exceeds the surface area of the aneurysm neck, and the anchoring structures generally reside inside the aneurysm following placement of the device.
  • the anchoring structures exert lateral and downward force on the closure structure so that it generally conforms to the profile of the vessel wall at the site of the aneurysm, thereby sealing the neck of the aneurysm from flow in the vessel and providing reconstruction of the vessel wall at the site of the aneurysm.
  • framework structure 139 and structures 137 and 138 are mismatched in length and are too stiff to apply the mutually opposing forces on interposed tissue, necessary to form an effective clip.
  • this structure is too stiff and expanded to be able to collapse into a configuration that can be fit into the space available in a placement device, small enough to be introduced into the smaller cranial blood vessels.
  • its boxy shape makes it difficult to maneuver as is necessary to effect placement into an aneurysm.
  • FIGS. 1C-1F schematically illustrate the devices of FIGS. 1A and 1B deployed at the site of an aneurysm.
  • a bulge in the blood vessel B forms an aneurysm A.
  • FIGS. 1C and 1D when the device 130 is deployed across the neck of and within the aneurysm A, the closure structure 131 is positioned to cover the opening of the aneurysm and the anchoring structures 132 and 133 are retained inside and contact an inner aneurysm wall along at least a portion of their surface area. In this fashion, the closure structure 131 and the framework portion 134 are supported across the aneurysm opening and are biased against the neck of the aneurysm from outside the aneurysm.
  • closure structure 131 and the framework portion 134 are deployed outside the internal space of the aneurysm.
  • closure structure 131 and the framework portion 134 are supported across the aneurysm opening and biased against the neck of the aneurysm from inside the aneurysm.
  • FIG. 1F illustrates an alternative deployment system and methodology, wherein a device having at least two anchoring structures is deployed such that the closure structure 131 is positioned to cover the opening of the aneurysm, and the anchoring structures 132 , 133 are positioned outside the aneurysm and contact an inner blood vessel wall B in proximity to the aneurysm.
  • the anchoring structures 132 , 133 may be generally sized and configured to match the inner diameter of the vessel in proximity to the neck of the aneurysm so that following deployment the anchoring structures contact the vessel wall in a substantially continuous manner without straining or enlarging the vessel wall in the area of the aneurysm.
  • the closure structure following placement of the device, substantially covers the aneurysm neck to effectively repair the vessel defect.
  • the anchoring structures do not substantially interfere with flow of blood in the vessel.
  • the structures may be difficult to place, particularly in the circuitous blood vessel network of the brain.
  • the typical aneurysm extending in a perpendicular manner from its root blood vessel, it may be a challenge to insert the structure into the aneurysm.
  • the anchoring structures must mutually press against the aneurysm sides. If one side wall of an aneurysm is not well suited for supporting an anchoring structure, the anchor for the opposite side will not be well supported to provide sufficient pressure on this opposite side wall. This problem drives the design of anchor structures 132 and 133 to be larger, to facilitate receiving sufficient support from the aneurysm interior surface.
  • FIG. 1G illustrates a saccular bifurcation aneurysm 150 appearing at the intersection of two vessels 152 , 154 , branching from a stem vessel 156 .
  • Cerebral bifurcation aneurysms are commonly found at the middle cerebral artery, internal carotid artery, anterior communicating artery, basilar artery, posterior communicating artery, and other locations.
  • a sheath is introduced, extending approximately to the aorta.
  • a first guide catheter is inserted through the sheath and extended up into the carotid artery.
  • a second guide catheter is coaxially introduced through the first guide catheter and extended up into the target aneurysm.
  • Both guide catheters are introduced using a guide wire having a steerable tip of either stainless steel or nitinol.
  • microcatheter introducer is inserted through the guide catheter, to the aneurysm, and device 130 is placed at the aneurysm site.
  • a device that would require a definite orientation, at least partially inside the aneurysm presents particular challenges in positioning during implantation
  • Another difficulty in delivering a complex implant into an aneurysm is the lack of space to pack such an implant in a lumen at the end of a microcatheter. Any such device must fold into a cylinder having an internal diameter on the order of 1 mm and a length of about 10 mm. Upon delivery it must expand to anchor itself in place and to seal an area that could be as large as 10 mm 2 . The seal over the neck of the aneurysm although thinner than 1 mm, must be strong enough to affirmatively occlude the aneurysm, with a very high degree of certainty.
  • the present invention may take the form of a method of implanting a medical device that utilizes an implantation catheter including a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively.
  • the first wire defines a first region susceptible to electrolytic disintegration, contiguous to a the first attachment point
  • the second wire defines a second region, also susceptible to electrolytic disintegration, contiguous to the second attachment point.
  • the medical device is positioned at a first desired positioning and electricity is passed through the first wire, sufficient to heat and disintegrate the first region susceptible to electrolytic disintegration, thereby freeing the medical device from the first wire.
  • the medical device is manipulated with the second wire to achieve a second desired positioning.
  • electricity is passed through the second wire, sufficient to heat and disintegrate the second region susceptible to electrolytic disintegration, thereby freeing the medical device from the second wire.
  • the present invention may take the form of a catheter assembly for implanting a medical device, comprising a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively.
  • the first wire defines a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a the first attachment point.
  • the second wire defines a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to the second attachment point.
  • there is a separately controllable electric supply for the first and the second wire so that the first wire may be disconnected from the medical device, without disconnecting the second wire.
  • FIG. 1A illustrates an enlarged schematic front isometric view of a known implantable device in a deployed condition
  • FIG. 1B illustrates an enlarged schematic front isometric view of another known implantable device in a deployed condition
  • FIGS. 1C , 1 D, 1 E, and 1 F schematically illustrate the devices of FIGS. 1A and 1B deployed at the site of an aneurysm
  • FIG. 1G illustrates a saccular bifurcation aneurysm
  • FIG. 2A is a sectional side view of an aneurysm closure device, according to the present invention, installed in the neck of an aneurysm that has developed at the side of a blood vessel.
  • FIG. 2B is a sectional side view of the aneurysm closure device of FIG. 2A , according to the present invention, installed in the neck of an aneurysm that has developed at a Y-intersection of blood vessels.
  • FIG. 3 is an isometric view of the aneurysm closure device of FIG. 2A .
  • FIG. 4 is an isometric view of an implantation catheter, according to the present invention, with the closure device of FIG. 2A retracted.
  • FIG. 5 is an isometric view of the catheter of FIG. 4 , with the closure device of FIG. 2A exposed.
  • FIG. 6 is an isometric exploded view of the user control portion of the catheter of FIG. 4 .
  • FIG. 7 is a sectional side view of the distal end of the catheter of FIG. 4 , with the closure device of FIG. 2A retracted.
  • FIG. 8 is an isometric view of the distal portion of the positioning assembly of FIG. 4 , with the closure device of FIG. 2A extended.
  • FIG. 9 is a cross-sectional view of the distal portion of FIG. 8 , taken at view line 9 - 9 .
  • FIG. 10 is a cross-sectional view of the distal portion of FIG. 8 , taken at view line 10 - 10 .
  • FIG. 11 is a cross-sectional view of the distal portion of FIG. 8 , taken at view line 11 - 11 .
  • FIG. 12A is a side view of the user control of FIG. 6 , set in a neutral position.
  • FIG. 12B is a side view of the user control of the distal end of FIG. 7 , corresponding to the user control setting of FIG. 12A .
  • FIG. 13A is a side view of the user control of FIG. 6 , set in a skewed position.
  • FIG. 13B is a side view of the user control of the distal end of FIG. 7 , corresponding to the user control setting of FIG. 13A .
  • FIG. 14A is a side view of the user control of FIG. 6 , set in a position skewed opposite to that of FIG. 13A .
  • FIG. 14B is a side view of the user control of the distal end of FIG. 7 , corresponding to the user control setting of FIG. 12A .
  • FIG. 15A is an isometric view of a work piece shown connected to the distal end of FIG. 7 for ease of presentation and representing a stage in the manufacturing of the closure device of FIG. 3 .
  • FIG. 15B is a detail view of a portion of FIG. 15A , as indicated by circle 15 B, in FIG. 15A .
  • FIG. 15C is an isometric view of a work piece shown connected to the distal end of FIG. 7 for ease of presentation and representing a further stage in the manufacturing of the closure device of FIG. 3 .
  • the present disclosure is directed to closing a bulge or aneurysm formed in blood vessel, such as an artery or vein (referred to more generally herein as “vessel”), in a manner that does not suffer from some of the drawbacks of prior art methods.
  • a bulge or aneurysm formed in blood vessel such as an artery or vein (referred to more generally herein as “vessel”)
  • the resultant blood clot can create problems through its mass and the possibility of pressing against nearby nerves.
  • the wire coil can have the effect of keeping the neck open, possibly causing another aneurysm to form.
  • the embodiments of the present disclosure combine the closure structure and the anchoring structure into a single unit to improve compactness, allow delivery into the tortuous intracranial circulation system via a microcatheter, and to improve the aneurysm neck closure.
  • the embodiments of the present disclosure provide enhanced rotation control and placement of the device within the aneurysm via two attachment points for a microcatheter.
  • markers can be used at the junctions of the device structure to aid in tracking the movement of the closure device during insertion and placement.
  • FIG. 2A a preferred embodiment of an aneurysm closure device 10 is shown in its implanted environment of an aneurysm 12 attached to a root vessel 14 .
  • FIG. 2B shows the device 10 , implanted environment, on an aneurysm that has developed at a Y-intersection of blood vessels.
  • FIG. 3 shows a more detailed perspective view of closure device 10 .
  • FIG. 1 a preferred embodiment of an aneurysm closure device 10 is shown in its implanted environment of an aneurysm 12 attached to a root vessel 14 .
  • FIG. 2B shows the device 10 , implanted environment, on an aneurysm that has developed at a Y-intersection of blood vessels.
  • FIG. 3 shows a more detailed perspective view of closure device 10 .
  • aneurysm closure device 10 is held in place by four anchors: A first aneurysm anchor 16 A and a first root vessel anchor 18 A mutually anchor closure device 10 to a distal side of the aneurysm 12 , while a second aneurysm anchor 16 B and a second root vessel anchor 18 B, mutually anchor closure device 10 on a proximal side of the aneurysm 12 .
  • FIG. 3 it is seen that in the installed state of FIG. 2A , a seal 20 is placed over the neck of aneurysm 12 , thereby preventing further blood flow into aneurysm 12 and causing it to atrophy over time.
  • First anchors 16 A and 18 A act as a first clip, mutually applying gentle pressure toward each other, thereby clipping about the interposed tissue.
  • second anchors 16 B and 18 B act as a second clip. Working together, anchors 16 A, 18 A, 16 B and 18 B hold the seal 20 in place, thereby blocking the flow of blood into aneurysm 12 .
  • Closure device 10 includes a wire frame 22 , which is made of nitinol, or some other shape-memory material. Prior to use, closure device 10 is maintained at a temperature below human body temperature, thereby causing wire frame to assume the shape shown in FIG. 3 , when first pushed out of terminal lumen 56 . In one preferred embodiment, after warming to 37 C, however, anchors 16 A and 18 A, are urged together, as are anchors 16 B and 18 B, thereby more securely clipping to the interposed tissue. In another preferred embodiment, however, the natural spring force of the nitinol causes device 10 to expand when it is pushed out of fossa 56 , and it retains this shape during positioning and use.
  • a set of eyeholes 24 are defined by frame 22 and expanded poly tetrafluoroethylene (ePTFE) thread or fiber 26 is threaded into these eyeholes 24 to form a lattice.
  • the eyeholes 24 are filled with gold solder ( FIG. 15B ), thereby anchoring thread 26 and closing eyeholes 24 .
  • gold solder FIG. 15B
  • the ePTFE lattice work 26 is then coated with silicone 28 , which in one preferred embodiment is cured in situ to form the seal 20 . In another preferred embodiment, sheets of silicone are cut to the correct dimensions and adhered together about the ePTFE lattice 26 .
  • silicone 28 is placed on the aneurysm anchors 16 A and 16 B, but in an alternative embodiment, the ePTFE portion on anchors 16 A and 16 B are there to complete the threading arrangement, but are not coated with silicone. In another alternative preferred embodiment more, and smaller, eyeholes 24 are defined. In a preferred embodiment, two spots of radiopaque material 30 are placed at the tip of each aneurysm anchor 16 A and 16 B and one spot of radiopaque material 30 is placed at the tip of each root vessel anchor 18 A and 18 B.
  • a surgeon placing closure device 10 can determine the position of closure device 10 , through a sequence of X-ray images, relative to the contours of the aneurysm 12 , which is shown by the use of a radiopaque dye, placed into the bloodstream.
  • At least some of the anchors, serving the function of anchors 16 A- 18 B are made of a thin sheet of nitinol, or a thin sheet of nitinol covered with a biocompatible silicone, or polymeric material, for forming a good grip on the tissue it contacts.
  • at least some of the anchors are made entirely of polymeric material.
  • ePTFE thread 26 lattice is replaced with metal filigree, made of a metal such as gold, having a high melting point.
  • anchors, serving the function of anchors 16 A- 18 B are made of wire loops or arcs, some of which support an ePTFE reinforced silicone barrier, thereby providing a closure mechanism for an aneurysm.
  • closure device 10 forms a part of a micro-catheter closure device installation assembly 40 , which although specifically adapted to install closure device 10 at an aneurysm also embodies mechanisms that could be used for other tasks, particularly in accessing tissue through a blood vessel.
  • Assembly 40 comprises a micro-catheter subassembly 42 , and a user-control subassembly 44 .
  • a first wire-head handle 46 A and a second wire-head handle 46 B are attached to a first wire 48 A and a second wire 48 B, respectively.
  • wires 48 A and 48 B pass through a flexible tube 50 , which has an exterior diameter of about 1 . 5 mm, and which has a hydrophilic exterior surface, to aid in progressing toward a blood vessel destination.
  • Tube 50 is divided into a proximal single lumen extent 52 , near-distal dual lumen extent 54 , and a distal fossa or wide-lumen extent 56 . This construction permits for the control of the shape and orientation of distal portion of tube 50 , and for the positioning of closure device 10 , after it has been pushed out of fossa 56 . As shown in FIG.
  • closure device 10 After closure device 10 is pushed out of fossa 56 , it responds in like manner, bending toward wire-head handle 46 A, when handle 46 A is retracted, and toward handle 46 B, when handle 46 B is retracted. It can be rotated, and the direction that it bends when wire 46 A or 46 B is pulled can be determined, by rotating the handles 46 A and 46 B, together.
  • This freedom in positioning is important during the implantation process, when as shown in FIGS. 2A and 2B anchors 16 A and 16 B must be maneuvered through the neck of the aneurysm 12 , and positioned so that they extend along the same dimension as root vessel 14 .
  • the radiopaque markings 30 ( FIG. 3 ) are invaluable during this process.
  • subassembly 42 is threaded through an end cap 60 , and passes into a transparent chamber 62 , where wires 48 A and 48 B, emerge from tube 50 , pass through a slider 64 and are separately anchored in handles 46 A and 46 B, respectively.
  • the travel extent of slider 64 is limited by a stop pin 66 and a slot 68 .
  • wires 48 A and 48 B are electrically isolated from each other, either by a thin layer of insulating material or simply by the layout of device 10 and the conductive characteristics of wires 48 A and 48 B. Each include a region 70 ( FIGS. 7 and 8 ) that is susceptible to electrolytic disintegration.
  • an electric current is passed through wire 48 A, causing region 70 of wire 48 A to electrolytically disintegrate.
  • wire 48 B may be used to further orient aneurysm device 10 .
  • handles 46 A and 46 B each includes an electrical contact connected to wire 48 A and 48 B, respectively, for attaching to a source of electricity for performing the above-described step.
  • Subassembly 42 is introduced into the femoral artery and guided through the carotid artery into the brain's arterial system, and further guided to the aneurysm 12 .
  • closure device 10 is pushed out of fossa 56 , anchors 16 A and 16 B are guided into aneurysm 12 , and anchors 18 A and 18 B are positioned in root artery 14 .
  • a pulse of electricity severs closure device 10 from wires 48 A and 48 B and closure device 10 is installed in place.
  • Wires 48 A and 48 B are made of stainless steel alloy 304 , which may also be referred to as alloy 18 - 8 . This material is coated with poly tetrafluoroethylene, except for at detachment points 70 and the points where they are connected to a source of electricity.
  • the nitinol alloy that frame 22 ( FIG. 3 ) is made of is 54.5% to 57% nickel, with the remainder titanium, which forms a super-elastic alloy.
  • the introducer tube 50 is made of high density polyethylene, coated at the distal tip with a hydrophilic coating.
  • silicone 28 of the closure device 10 is silicone MED 4820 or MED-6640, which is a high tear strength liquid silicone elastomer, having a Shore A durometer reading of 20 - 40 .
  • a MED6-161 Silicone Primer is used to attach silicone 28 to Nitinol frame 22 .

Abstract

A catheter assembly for implanting a medical device, comprising a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a the first attachment point. Similarly, and the second wire defines a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to the second attachment point. Also, there is a separately controllable electric supply for the first and the second wire, so that the first wire may be disconnected from the medical device, without disconnecting the second wire.

Description

    RELATED APPLICATIONS
  • This application is a continuation-in-part of application serial number PCT/US12/27259, filed on Mar. 1, 2012 which claims priority from provisional application Ser. No. 61/448,459, filed on Mar. 2, 2011 which are incorporated by reference as if fully set forth herein.
  • BACKGROUND
  • The present disclosure is directed to repairing blood vessel defects, such as aneurysms, and other physiological defects or cavities formed in lumens, tissue, and the like, and, more particularly, to an endovascular implantable device and related endoluminal delivery procedure and deployment techniques.
  • Cranial aneurysms occur when a weakened cerebral blood vessel (root vessel) locally expands to form a bulge or balloon-like enlargement in the vessel wall. These aneurysms can occur along a vessel wall or at locations of vessel branches, such as a T-intersection or V-intersection.
  • Currently, options for the treatment of brain aneurysms are limited. In one technique, the cranium is opened and a clip is placed at the aneurysm neck to cut off blood flow from the root vessel, thereby reducing swelling and stopping expansion. In another technique, the interior of the aneurysm is accessed by way of a cranial artery, which in turn is reached with a device inserted into the femoral artery. In this technique, coiling material is inserted into the aneurysm, thereby causing clotting which closes off the aneurysm. Both techniques have drawbacks. Opening the cranium always entails some risk. Some locations in the cranium are difficult or impossible to access from the outside. On the other hand, causing clotting in the aneurysm can increase the mass and size of the aneurysm, causing it to press against delicate and critical tissue, and causing further damage.
  • Devices and techniques have been developed to facilitate treatment of aneurysms. The application herein is a joint inventor on the following U.S. Patent Publication Nos. 2006/0264905 (“Improved Catheters”), 2006/0264907 (“Catheters Having Stiffening Mechanisms”), 2007/0088387 (“Implantable Aneurysm Closure Systems and Methods”), and 2007/0191884 (“Methods and Systems for Endovascularly Clipping and Repairing Lumen and Tissue Defects”). All of these published applications are incorporated by reference herein in their entirety, to the extent legally possible.
  • For example, referring to FIGS. 1A and 1B, which are reproduced from U.S. Patent Publication No. 2007/0191884, shown therein is a device 130 having a patch or closure structure 131 mounted to or associated with two anchoring structures 132, 133. The closure structure 131 is supported by a framework structure 134 that is provided at least in a perimeter portion and is attached to the closure structure 131 by means of bonding, suturing, or the like. The framework structure 134 is mounted to or associated with the wing- like anchoring structures 132, 133. These anchoring structures 132, 133 in a deployed condition are designed so that at least a portion thereof contacts an inner wall of an aneurysm or an internal wall of an associated blood vessel following deployment.
  • As can be seen in FIG. 1A, the anchoring structures 132, 133 are generally formed to curve outwardly from an attachment joint 135 to the framework structure 134 and then back inwardly toward one another at the end remote from the attachment point 135. The anchoring loops 132, 133 are generally of the same configuration and same dimension and are located opposite one another as shown in FIG. 1A.
  • FIG. 1B illustrates a similar device having a closure structure 136 with anchoring structures 137, 138 that attach to or project from a framework structure 139 along opposed, lateral edges of the framework structure. The anchoring structures 137, 138 as illustrated in FIG. 1B are gently curved and, at their terminal sections, extend beyond corresponding terminal sections of the framework structure and the closure structure. The closure and framework structures in this embodiment are generally provided having a surface area that exceeds the surface area of the aneurysm neck, and the anchoring structures generally reside inside the aneurysm following placement of the device. In this configuration, the anchoring structures exert lateral and downward force on the closure structure so that it generally conforms to the profile of the vessel wall at the site of the aneurysm, thereby sealing the neck of the aneurysm from flow in the vessel and providing reconstruction of the vessel wall at the site of the aneurysm. Unfortunately, framework structure 139 and structures 137 and 138 are mismatched in length and are too stiff to apply the mutually opposing forces on interposed tissue, necessary to form an effective clip. In addition this structure is too stiff and expanded to be able to collapse into a configuration that can be fit into the space available in a placement device, small enough to be introduced into the smaller cranial blood vessels. Moreover, its boxy shape makes it difficult to maneuver as is necessary to effect placement into an aneurysm.
  • FIGS. 1C-1F schematically illustrate the devices of FIGS. 1A and 1B deployed at the site of an aneurysm. A bulge in the blood vessel B forms an aneurysm A. As shown in FIGS. 1C and 1D, when the device 130 is deployed across the neck of and within the aneurysm A, the closure structure 131 is positioned to cover the opening of the aneurysm and the anchoring structures 132 and 133 are retained inside and contact an inner aneurysm wall along at least a portion of their surface area. In this fashion, the closure structure 131 and the framework portion 134 are supported across the aneurysm opening and are biased against the neck of the aneurysm from outside the aneurysm.
  • In the embodiment illustrated in FIGS. 1C and 1D, the closure structure 131 and the framework portion 134 are deployed outside the internal space of the aneurysm. In an alternative embodiment illustrated in FIG. 1E, the closure structure 131 and the framework portion 134 are supported across the aneurysm opening and biased against the neck of the aneurysm from inside the aneurysm.
  • FIG. 1F illustrates an alternative deployment system and methodology, wherein a device having at least two anchoring structures is deployed such that the closure structure 131 is positioned to cover the opening of the aneurysm, and the anchoring structures 132, 133 are positioned outside the aneurysm and contact an inner blood vessel wall B in proximity to the aneurysm. In this embodiment, the anchoring structures 132, 133 may be generally sized and configured to match the inner diameter of the vessel in proximity to the neck of the aneurysm so that following deployment the anchoring structures contact the vessel wall in a substantially continuous manner without straining or enlarging the vessel wall in the area of the aneurysm. In all of these embodiments, following placement of the device, the closure structure substantially covers the aneurysm neck to effectively repair the vessel defect. The anchoring structures do not substantially interfere with flow of blood in the vessel.
  • As can be seen in the foregoing, the structures may be difficult to place, particularly in the circuitous blood vessel network of the brain. For the typical aneurysm, extending in a perpendicular manner from its root blood vessel, it may be a challenge to insert the structure into the aneurysm. Moreover, for the device to seal or close the aneurysm, the anchoring structures must mutually press against the aneurysm sides. If one side wall of an aneurysm is not well suited for supporting an anchoring structure, the anchor for the opposite side will not be well supported to provide sufficient pressure on this opposite side wall. This problem drives the design of anchor structures 132 and 133 to be larger, to facilitate receiving sufficient support from the aneurysm interior surface. This, in turn, has the potential to create a mass effect problem, in which the mass of the structures 132 and 133, plus any clotting that occurs around them, causes the aneurysm to become more massive, potentially pressing against delicate nervous system tissue as a result.
  • Moreover, the situation is even more difficult for aneurysms formed at the intersection of vessels, such as a T-intersection or V-intersection. FIG. 1G illustrates a saccular bifurcation aneurysm 150 appearing at the intersection of two vessels 152, 154, branching from a stem vessel 156. Cerebral bifurcation aneurysms are commonly found at the middle cerebral artery, internal carotid artery, anterior communicating artery, basilar artery, posterior communicating artery, and other locations.
  • Typically, to place device 130 into a blood vessel of the brain requires a number of steps. First, an incision is made into the femoral artery and a sheath is introduced, extending approximately to the aorta. A first guide catheter is inserted through the sheath and extended up into the carotid artery. A second guide catheter is coaxially introduced through the first guide catheter and extended up into the target aneurysm. Both guide catheters are introduced using a guide wire having a steerable tip of either stainless steel or nitinol. Then, microcatheter introducer is inserted through the guide catheter, to the aneurysm, and device 130 is placed at the aneurysm site. Heretofore, however, once reaching the aneurysm there has been no effective method for positioning a device that requires precise positioning. A device that would require a definite orientation, at least partially inside the aneurysm, presents particular challenges in positioning during implantation
  • Another difficulty in delivering a complex implant into an aneurysm is the lack of space to pack such an implant in a lumen at the end of a microcatheter. Any such device must fold into a cylinder having an internal diameter on the order of 1 mm and a length of about 10 mm. Upon delivery it must expand to anchor itself in place and to seal an area that could be as large as 10 mm2. The seal over the neck of the aneurysm although thinner than 1 mm, must be strong enough to affirmatively occlude the aneurysm, with a very high degree of certainty.
  • SUMMARY
  • The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements.
  • In a first separate aspect, the present invention may take the form of a method of implanting a medical device that utilizes an implantation catheter including a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, contiguous to a the first attachment point, and the second wire defines a second region, also susceptible to electrolytic disintegration, contiguous to the second attachment point. The medical device is positioned at a first desired positioning and electricity is passed through the first wire, sufficient to heat and disintegrate the first region susceptible to electrolytic disintegration, thereby freeing the medical device from the first wire. Then, the medical device is manipulated with the second wire to achieve a second desired positioning. Finally, electricity is passed through the second wire, sufficient to heat and disintegrate the second region susceptible to electrolytic disintegration, thereby freeing the medical device from the second wire.
  • In a second separate aspect, the present invention may take the form of a catheter assembly for implanting a medical device, comprising a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a the first attachment point. Similarly, and the second wire defines a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to the second attachment point. Also, there is a separately controllable electric supply for the first and the second wire, so that the first wire may be disconnected from the medical device, without disconnecting the second wire.
  • In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.
  • BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
  • Exemplary embodiments are illustrated in referenced drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.
  • FIG. 1A illustrates an enlarged schematic front isometric view of a known implantable device in a deployed condition;
  • FIG. 1B illustrates an enlarged schematic front isometric view of another known implantable device in a deployed condition;
  • FIGS. 1C, 1D, 1E, and 1F schematically illustrate the devices of FIGS. 1A and 1B deployed at the site of an aneurysm;
  • FIG. 1G illustrates a saccular bifurcation aneurysm;
  • FIG. 2A is a sectional side view of an aneurysm closure device, according to the present invention, installed in the neck of an aneurysm that has developed at the side of a blood vessel.
  • FIG. 2B is a sectional side view of the aneurysm closure device of FIG. 2A, according to the present invention, installed in the neck of an aneurysm that has developed at a Y-intersection of blood vessels.
  • FIG. 3 is an isometric view of the aneurysm closure device of FIG. 2A.
  • FIG. 4 is an isometric view of an implantation catheter, according to the present invention, with the closure device of FIG. 2A retracted.
  • FIG. 5 is an isometric view of the catheter of FIG. 4, with the closure device of FIG. 2A exposed.
  • FIG. 6 is an isometric exploded view of the user control portion of the catheter of FIG. 4.
  • FIG. 7 is a sectional side view of the distal end of the catheter of FIG. 4, with the closure device of FIG. 2A retracted.
  • FIG. 8 is an isometric view of the distal portion of the positioning assembly of FIG. 4, with the closure device of FIG. 2A extended.
  • FIG. 9 is a cross-sectional view of the distal portion of FIG. 8, taken at view line 9-9.
  • FIG. 10 is a cross-sectional view of the distal portion of FIG. 8, taken at view line 10-10.
  • FIG. 11 is a cross-sectional view of the distal portion of FIG. 8, taken at view line 11-11.
  • FIG. 12A is a side view of the user control of FIG. 6, set in a neutral position.
  • FIG. 12B is a side view of the user control of the distal end of FIG. 7, corresponding to the user control setting of FIG. 12A.
  • FIG. 13A is a side view of the user control of FIG. 6, set in a skewed position.
  • FIG. 13B is a side view of the user control of the distal end of FIG. 7, corresponding to the user control setting of FIG. 13A.
  • FIG. 14A is a side view of the user control of FIG. 6, set in a position skewed opposite to that of FIG. 13A.
  • FIG. 14B is a side view of the user control of the distal end of FIG. 7, corresponding to the user control setting of FIG. 12A.
  • FIG. 15A is an isometric view of a work piece shown connected to the distal end of FIG. 7 for ease of presentation and representing a stage in the manufacturing of the closure device of FIG. 3.
  • FIG. 15B is a detail view of a portion of FIG. 15A, as indicated by circle 15B, in FIG. 15A.
  • FIG. 15C is an isometric view of a work piece shown connected to the distal end of FIG. 7 for ease of presentation and representing a further stage in the manufacturing of the closure device of FIG. 3.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures or components or both associated with endovascular coils, including but not limited to deployment mechanisms, have not been shown or described in order to avoid unnecessarily obscuring descriptions of the embodiments.
  • Unless the context requires otherwise, throughout the specification and claims that follow, the word “comprise” and variations thereof, such as “comprises” and “comprising” are to be construed in an open inclusive sense, that is, as “including, but not limited to.” The foregoing applies equally to the words “including” and “having.”
  • Reference throughout this description to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearance of the phrases “in one embodiment” or “in an embodiment” in various places throughout the specification are not necessarily all referring to the same embodiment.
  • Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
  • The present disclosure is directed to closing a bulge or aneurysm formed in blood vessel, such as an artery or vein (referred to more generally herein as “vessel”), in a manner that does not suffer from some of the drawbacks of prior art methods. For example, in the prior art method involving the insertion of a wire coil into the aneurysm, the resultant blood clot can create problems through its mass and the possibility of pressing against nearby nerves. In addition, the wire coil can have the effect of keeping the neck open, possibly causing another aneurysm to form.
  • The embodiments of the present disclosure combine the closure structure and the anchoring structure into a single unit to improve compactness, allow delivery into the tortuous intracranial circulation system via a microcatheter, and to improve the aneurysm neck closure. In addition, the embodiments of the present disclosure provide enhanced rotation control and placement of the device within the aneurysm via two attachment points for a microcatheter. Moreover, markers can be used at the junctions of the device structure to aid in tracking the movement of the closure device during insertion and placement.
  • Referring to FIG. 2A, a preferred embodiment of an aneurysm closure device 10 is shown in its implanted environment of an aneurysm 12 attached to a root vessel 14. FIG. 2B shows the device 10, implanted environment, on an aneurysm that has developed at a Y-intersection of blood vessels. FIG. 3 shows a more detailed perspective view of closure device 10. In FIG. 2A, aneurysm closure device 10 is held in place by four anchors: A first aneurysm anchor 16A and a first root vessel anchor 18A mutually anchor closure device 10 to a distal side of the aneurysm 12, while a second aneurysm anchor 16B and a second root vessel anchor 18B, mutually anchor closure device 10 on a proximal side of the aneurysm 12. Referring to FIG. 3, it is seen that in the installed state of FIG. 2A, a seal 20 is placed over the neck of aneurysm 12, thereby preventing further blood flow into aneurysm 12 and causing it to atrophy over time.
  • First anchors 16A and 18A act as a first clip, mutually applying gentle pressure toward each other, thereby clipping about the interposed tissue. In similar manner, second anchors 16B and 18B act as a second clip. Working together, anchors 16A, 18A, 16B and 18B hold the seal 20 in place, thereby blocking the flow of blood into aneurysm 12.
  • Closure device 10 includes a wire frame 22, which is made of nitinol, or some other shape-memory material. Prior to use, closure device 10 is maintained at a temperature below human body temperature, thereby causing wire frame to assume the shape shown in FIG. 3, when first pushed out of terminal lumen 56. In one preferred embodiment, after warming to 37C, however, anchors 16A and 18A, are urged together, as are anchors 16B and 18B, thereby more securely clipping to the interposed tissue. In another preferred embodiment, however, the natural spring force of the nitinol causes device 10 to expand when it is pushed out of fossa 56, and it retains this shape during positioning and use. A set of eyeholes 24 are defined by frame 22 and expanded poly tetrafluoroethylene (ePTFE) thread or fiber 26 is threaded into these eyeholes 24 to form a lattice. The eyeholes 24 are filled with gold solder (FIG. 15B), thereby anchoring thread 26 and closing eyeholes 24. Accordingly, although materials may be useable as thread 26 whatever material is used must be capable of withstanding the temperature of molten gold solder, which is typically 716° C. The ePTFE lattice work 26 is then coated with silicone 28, which in one preferred embodiment is cured in situ to form the seal 20. In another preferred embodiment, sheets of silicone are cut to the correct dimensions and adhered together about the ePTFE lattice 26. In the embodiment shown, silicone 28 is placed on the aneurysm anchors 16A and 16B, but in an alternative embodiment, the ePTFE portion on anchors 16A and 16B are there to complete the threading arrangement, but are not coated with silicone. In another alternative preferred embodiment more, and smaller, eyeholes 24 are defined. In a preferred embodiment, two spots of radiopaque material 30 are placed at the tip of each aneurysm anchor 16A and 16B and one spot of radiopaque material 30 is placed at the tip of each root vessel anchor 18A and 18B. Accordingly, a surgeon placing closure device 10 can determine the position of closure device 10, through a sequence of X-ray images, relative to the contours of the aneurysm 12, which is shown by the use of a radiopaque dye, placed into the bloodstream.
  • In an alternative preferred embodiment at least some of the anchors, serving the function of anchors 16A-18B, are made of a thin sheet of nitinol, or a thin sheet of nitinol covered with a biocompatible silicone, or polymeric material, for forming a good grip on the tissue it contacts. In yet another embodiment, at least some of the anchors are made entirely of polymeric material. In an additional preferred embodiment, ePTFE thread 26 lattice, is replaced with metal filigree, made of a metal such as gold, having a high melting point. In addition, there is a broad range of engineered materials that can be created for this type of purpose. In yet another preferred embodiment, anchors, serving the function of anchors 16A-18B, are made of wire loops or arcs, some of which support an ePTFE reinforced silicone barrier, thereby providing a closure mechanism for an aneurysm.
  • Referring to FIGS. 4-14B, prior to installation, closure device 10 forms a part of a micro-catheter closure device installation assembly 40, which although specifically adapted to install closure device 10 at an aneurysm also embodies mechanisms that could be used for other tasks, particularly in accessing tissue through a blood vessel. Assembly 40 comprises a micro-catheter subassembly 42, and a user-control subassembly 44. A first wire-head handle 46A and a second wire-head handle 46B, are attached to a first wire 48A and a second wire 48B, respectively.
  • Referring to FIGS. 7-14B, in micro-catheter subassembly 42, wires 48A and 48B pass through a flexible tube 50, which has an exterior diameter of about 1.5 mm, and which has a hydrophilic exterior surface, to aid in progressing toward a blood vessel destination. Tube 50 is divided into a proximal single lumen extent 52, near-distal dual lumen extent 54, and a distal fossa or wide-lumen extent 56. This construction permits for the control of the shape and orientation of distal portion of tube 50, and for the positioning of closure device 10, after it has been pushed out of fossa 56. As shown in FIG. 13A and 13B, if the first wire-head handle 46A is retracted relative to second wire-head handle 46B, then distal fossa 56 bends towards handle 46A. Likewise, as shown in FIGS. 14A and 14B, if the second wire-head handle 46B is retracted relative to first wire-head handle 46A, then distal fossa 56 bends towards handle 46B. The orientation of fossa 56, and the direction it turns to when handle 46A or 46B is retracted, can be changed by rotating the wire-head handles 46A and 46B, together. After closure device 10 is pushed out of fossa 56, it responds in like manner, bending toward wire-head handle 46A, when handle 46A is retracted, and toward handle 46B, when handle 46B is retracted. It can be rotated, and the direction that it bends when wire 46A or 46B is pulled can be determined, by rotating the handles 46A and 46B, together. This freedom in positioning is important during the implantation process, when as shown in FIGS. 2A and 2B anchors 16A and 16B must be maneuvered through the neck of the aneurysm 12, and positioned so that they extend along the same dimension as root vessel 14. The radiopaque markings 30 (FIG. 3) are invaluable during this process.
  • Referring now to FIG. 6, subassembly 42 is threaded through an end cap 60, and passes into a transparent chamber 62, where wires 48A and 48B, emerge from tube 50, pass through a slider 64 and are separately anchored in handles 46A and 46B, respectively. The travel extent of slider 64 is limited by a stop pin 66 and a slot 68.
  • In one preferred embodiment, wires 48A and 48B are electrically isolated from each other, either by a thin layer of insulating material or simply by the layout of device 10 and the conductive characteristics of wires 48A and 48B. Each include a region 70 (FIGS. 7 and 8) that is susceptible to electrolytic disintegration. To detach closure device 10, after partial placement and initial orientation, which may be checked by reference to radio opaque markings 30, an electric current is passed through wire 48A, causing region 70 of wire 48A to electrolytically disintegrate. After this, wire 48B may be used to further orient aneurysm device 10.
  • Although after the freeing of seal 20 from wire 48A, control may be less certain, it may in some instances be possible to have a greater freedom of positioning device 10 when a single wire 48B is attached, only. This may be particularly true when a portion of device 10 has contacted body tissue, for example entering aneurysm 12, and it is desired to orient device 10 properly for the setting of anchors 16A and 16B and 18A and 18B so that the extend along the length of blood vessel 14. Again verifying orientation by way of markings 30, when device 10 is properly oriented electricity is passed through wire 48B, causing its region 70 to disintegrate, and freeing closure device 10 from wires 48A and 48B, entirely so that it can be left in place in its target location, sealing aneurysm 12. In a preferred embodiment, handles 46A and 46B each includes an electrical contact connected to wire 48A and 48B, respectively, for attaching to a source of electricity for performing the above-described step.
  • Subassembly 42 is introduced into the femoral artery and guided through the carotid artery into the brain's arterial system, and further guided to the aneurysm 12. At this point closure device 10 is pushed out of fossa 56, anchors 16A and 16B are guided into aneurysm 12, and anchors 18A and 18B are positioned in root artery 14. Then a pulse of electricity severs closure device 10 from wires 48A and 48B and closure device 10 is installed in place.
  • Wires 48A and 48B are made of stainless steel alloy 304, which may also be referred to as alloy 18-8. This material is coated with poly tetrafluoroethylene, except for at detachment points 70 and the points where they are connected to a source of electricity. The nitinol alloy that frame 22 (FIG. 3) is made of is 54.5% to 57% nickel, with the remainder titanium, which forms a super-elastic alloy. The introducer tube 50 is made of high density polyethylene, coated at the distal tip with a hydrophilic coating. Finally, the silicone 28 of the closure device 10 is silicone MED 4820 or MED-6640, which is a high tear strength liquid silicone elastomer, having a Shore A durometer reading of 20-40. A MED6-161 Silicone Primer is used to attach silicone 28 to Nitinol frame 22.
  • While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations, thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims (5)

1. A method of implanting a medical device, including:
a. providing an implantation catheter including a first wire and a second wire, electrically insulated from each other, attached to said medical device at a first attachment point and a second attachment point, respectively, said first wire defining a first region susceptible to electrolytic disintegration, contiguous to a said first attachment point, and said second wire defining a second region susceptible to electrolytic disintegration, contiguous to said second attachment point;
b. positioning said medical device at a first desired positioning;
c. passing electricity through said first wire, sufficient to heat and disintegrate said first region susceptible to electrolytic disintegration, thereby freeing said medical device from said first wire; and
d. manipulating said medical device with said second wire to achieve a second desired positioning; and
e. passing electricity through said second wire, sufficient to heat and disintegrate said second region susceptible to electrolytic disintegration, thereby freeing said medical device from said second wire.
2. The method of claim 1, wherein said medical device is a aneurysm seal.
3. The method of claim 1, wherein said medical catheter further includes:
a. double lumen section, including a first lumen through which said first wire extends and a second lumen through which said second wire extends; and
b. a control unit, having a first wire control handle affixed to said first wire and a second wire control handle affixed to said second wire, each control handle being capable of pushing its affixed wire distally through said corresponding lumen or retracting its wire proximally through said lumen, and where said first and second wire control handles can be rotated together to any rotational position.
4. A catheter assembly for implanting a medical device, comprising:
a. a first wire and a second wire, electrically insulated from each other, attached to said medical device at a first attachment point and a second attachment point, respectively, said first wire defining a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a said first attachment point, and said second wire defining a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to said second attachment point; and
b. a separately controllable electric supply for said wire and said second wire, so that said first wire may be disconnected from said medical device, without disconnecting said second wire.
5. The catheter assembly of claim 4, wherein said medical catheter further includes:
a. double lumen section, including a first lumen through which said first wire extends and a second lumen through which said second wire extends; and
b. a control unit, having a first wire control handle affixed to said first wire and a second wire control handle affixed to said second wire, each control handle being capable of pushing its affixed wire distally through said corresponding lumen or retracting its wire proximally through said lumen, and where said first and second wire control handles can be rotated together to any rotational position.
US14/013,983 2011-03-02 2013-08-29 Apparatus and method for positioning an implantable device Abandoned US20140005651A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/013,983 US20140005651A1 (en) 2011-03-02 2013-08-29 Apparatus and method for positioning an implantable device

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161448459P 2011-03-02 2011-03-02
PCT/US2012/027259 WO2012118957A2 (en) 2011-03-02 2012-03-01 Endovascular closure system
US14/013,983 US20140005651A1 (en) 2011-03-02 2013-08-29 Apparatus and method for positioning an implantable device

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/027259 Continuation-In-Part WO2012118957A2 (en) 2011-03-02 2012-03-01 Endovascular closure system

Publications (1)

Publication Number Publication Date
US20140005651A1 true US20140005651A1 (en) 2014-01-02

Family

ID=46758490

Family Applications (3)

Application Number Title Priority Date Filing Date
US14/013,949 Abandoned US20140005698A1 (en) 2011-03-02 2013-08-29 Endovascular Closure System
US14/013,983 Abandoned US20140005651A1 (en) 2011-03-02 2013-08-29 Apparatus and method for positioning an implantable device
US14/013,964 Active US8876863B2 (en) 2011-03-02 2013-08-29 Endovascular closure device

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US14/013,949 Abandoned US20140005698A1 (en) 2011-03-02 2013-08-29 Endovascular Closure System

Family Applications After (1)

Application Number Title Priority Date Filing Date
US14/013,964 Active US8876863B2 (en) 2011-03-02 2013-08-29 Endovascular closure device

Country Status (4)

Country Link
US (3) US20140005698A1 (en)
EP (1) EP2680765A4 (en)
CA (1) CA2828960A1 (en)
WO (1) WO2012118957A2 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9326774B2 (en) 2012-08-03 2016-05-03 Covidien Lp Device for implantation of medical devices
US9717503B2 (en) 2015-05-11 2017-08-01 Covidien Lp Electrolytic detachment for implant delivery systems
US9808256B2 (en) 2014-08-08 2017-11-07 Covidien Lp Electrolytic detachment elements for implant delivery systems
US9814466B2 (en) 2014-08-08 2017-11-14 Covidien Lp Electrolytic and mechanical detachment for implant delivery systems
US9848906B1 (en) 2017-06-20 2017-12-26 Joe Michael Eskridge Stent retriever having an expandable fragment guard
US10828037B2 (en) 2016-06-27 2020-11-10 Covidien Lp Electrolytic detachment with fluid electrical connection
US10828039B2 (en) 2016-06-27 2020-11-10 Covidien Lp Electrolytic detachment for implantable devices
US11051822B2 (en) 2016-06-28 2021-07-06 Covidien Lp Implant detachment with thermal activation

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10028747B2 (en) 2008-05-01 2018-07-24 Aneuclose Llc Coils with a series of proximally-and-distally-connected loops for occluding a cerebral aneurysm
US10716573B2 (en) 2008-05-01 2020-07-21 Aneuclose Janjua aneurysm net with a resilient neck-bridging portion for occluding a cerebral aneurysm
US9358140B1 (en) 2009-11-18 2016-06-07 Aneuclose Llc Stent with outer member to embolize an aneurysm
US20150080945A1 (en) * 2013-09-18 2015-03-19 W. L. Gore Associates, Inc. Partial Circumferential Stent with Non-Radial Apposition
GB2520482B (en) 2013-11-15 2015-12-23 Cook Medical Technologies Llc Aneurysm closure device
US11154302B2 (en) 2014-03-31 2021-10-26 DePuy Synthes Products, Inc. Aneurysm occlusion device
US11076860B2 (en) 2014-03-31 2021-08-03 DePuy Synthes Products, Inc. Aneurysm occlusion device
WO2016041077A1 (en) * 2014-09-16 2016-03-24 Smilesonica Inc. Silicone and polymer substrate composite materials, methods, and uses of the same
US20170367710A1 (en) * 2016-06-24 2017-12-28 Cook Medical Technologies Llc Double sided occlusive device
WO2018156833A1 (en) 2017-02-23 2018-08-30 DePuy Synthes Products, Inc. Aneurysm device and delivery system
US10905430B2 (en) 2018-01-24 2021-02-02 DePuy Synthes Products, Inc. Aneurysm device and delivery system
US11596412B2 (en) 2018-05-25 2023-03-07 DePuy Synthes Products, Inc. Aneurysm device and delivery system
US11058430B2 (en) 2018-05-25 2021-07-13 DePuy Synthes Products, Inc. Aneurysm device and delivery system
US10939915B2 (en) 2018-05-31 2021-03-09 DePuy Synthes Products, Inc. Aneurysm device and delivery system
US11051825B2 (en) 2018-08-08 2021-07-06 DePuy Synthes Products, Inc. Delivery system for embolic braid
US11123077B2 (en) 2018-09-25 2021-09-21 DePuy Synthes Products, Inc. Intrasaccular device positioning and deployment system
US11076861B2 (en) 2018-10-12 2021-08-03 DePuy Synthes Products, Inc. Folded aneurysm treatment device and delivery method
US11406392B2 (en) 2018-12-12 2022-08-09 DePuy Synthes Products, Inc. Aneurysm occluding device for use with coagulating agents
US11272939B2 (en) * 2018-12-18 2022-03-15 DePuy Synthes Products, Inc. Intrasaccular flow diverter for treating cerebral aneurysms
US11134953B2 (en) 2019-02-06 2021-10-05 DePuy Synthes Products, Inc. Adhesive cover occluding device for aneurysm treatment
US11337706B2 (en) 2019-03-27 2022-05-24 DePuy Synthes Products, Inc. Aneurysm treatment device
US10653425B1 (en) 2019-05-21 2020-05-19 DePuy Synthes Products, Inc. Layered braided aneurysm treatment device
US11413046B2 (en) 2019-05-21 2022-08-16 DePuy Synthes Products, Inc. Layered braided aneurysm treatment device
US11278292B2 (en) 2019-05-21 2022-03-22 DePuy Synthes Products, Inc. Inverting braided aneurysm treatment system and method
US11672542B2 (en) 2019-05-21 2023-06-13 DePuy Synthes Products, Inc. Aneurysm treatment with pushable ball segment
US11497504B2 (en) 2019-05-21 2022-11-15 DePuy Synthes Products, Inc. Aneurysm treatment with pushable implanted braid
US11607226B2 (en) 2019-05-21 2023-03-21 DePuy Synthes Products, Inc. Layered braided aneurysm treatment device with corrugations
US11602350B2 (en) 2019-12-05 2023-03-14 DePuy Synthes Products, Inc. Intrasaccular inverting braid with highly flexible fill material
US11457926B2 (en) 2019-12-18 2022-10-04 DePuy Synthes Products, Inc. Implant having an intrasaccular section and intravascular section
CN117694940A (en) * 2022-09-06 2024-03-15 深圳市先健纬康科技有限公司 Vascular closure device and vascular closure system

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204290A1 (en) * 2009-09-04 2013-08-08 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6083220A (en) * 1990-03-13 2000-07-04 The Regents Of The University Of California Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas
US5866217A (en) * 1991-11-04 1999-02-02 Possis Medical, Inc. Silicone composite vascular graft
US7569066B2 (en) * 1997-07-10 2009-08-04 Boston Scientific Scimed, Inc. Methods and devices for the treatment of aneurysms
ES2272007T3 (en) * 1997-08-04 2007-04-16 Boston Scientific Limited OCLUSION SYSTEM FOR PREPARATION OF AN ANEURISM.
EP1211983B1 (en) 1999-09-13 2007-03-07 Rex Medical, LP Vascular closure
US6689150B1 (en) * 1999-10-27 2004-02-10 Atritech, Inc. Filter apparatus for ostium of left atrial appendage
US6551344B2 (en) * 2000-04-26 2003-04-22 Ev3 Inc. Septal defect occluder
JP2003190175A (en) * 2001-11-15 2003-07-08 Cordis Neurovascular Inc Aneurysm neck cover for sealing aneurysm
US20050060017A1 (en) * 2003-09-15 2005-03-17 Fischell Robert E. Means and method for the treatment of cerebral aneurysms
US7722666B2 (en) * 2005-04-15 2010-05-25 Boston Scientific Scimed, Inc. Valve apparatus, system and method
AU2006304660B2 (en) * 2005-10-19 2013-10-24 Pulsar Vascular, Inc. Methods and systems for endovascularly clipping and repairing lumen and tissue defects
US8545530B2 (en) * 2005-10-19 2013-10-01 Pulsar Vascular, Inc. Implantable aneurysm closure systems and methods
US20070299461A1 (en) * 2006-06-21 2007-12-27 Boston Scientific Scimed, Inc. Embolic coils and related components, systems, and methods
US9220487B2 (en) * 2006-08-09 2015-12-29 Coherex Medical, Inc. Devices for reducing the size of an internal tissue opening
BRPI0907787B8 (en) * 2008-02-21 2021-06-22 Angiotech Pharm Inc method for forming a self-retaining suture and apparatus for raising the retainers in a suture to a desired angle
US8262692B2 (en) * 2008-09-05 2012-09-11 Merlin Md Pte Ltd Endovascular device
JP5791048B2 (en) * 2008-09-05 2015-10-07 パルサー バスキュラー インコーポレイテッド System and method for supporting or occluding a physiological opening or cavity
US8029534B2 (en) * 2009-03-16 2011-10-04 Cook Medical Technologies Llc Closure device with string retractable umbrella
US8852204B2 (en) * 2010-09-01 2014-10-07 Merit Medical Systems, Inc. Medical snare device

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130204290A1 (en) * 2009-09-04 2013-08-08 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9326774B2 (en) 2012-08-03 2016-05-03 Covidien Lp Device for implantation of medical devices
US9808256B2 (en) 2014-08-08 2017-11-07 Covidien Lp Electrolytic detachment elements for implant delivery systems
US9814466B2 (en) 2014-08-08 2017-11-14 Covidien Lp Electrolytic and mechanical detachment for implant delivery systems
US10874401B2 (en) 2014-08-08 2020-12-29 Covidien Lp Electrolytic and mechanical detachment for implant delivery systems
US11839380B2 (en) 2014-08-08 2023-12-12 Covidien Lp Electrolytic and mechanical detachment for implant delivery systems
US9717503B2 (en) 2015-05-11 2017-08-01 Covidien Lp Electrolytic detachment for implant delivery systems
US10828037B2 (en) 2016-06-27 2020-11-10 Covidien Lp Electrolytic detachment with fluid electrical connection
US10828039B2 (en) 2016-06-27 2020-11-10 Covidien Lp Electrolytic detachment for implantable devices
US11051822B2 (en) 2016-06-28 2021-07-06 Covidien Lp Implant detachment with thermal activation
US9848906B1 (en) 2017-06-20 2017-12-26 Joe Michael Eskridge Stent retriever having an expandable fragment guard
US11266435B2 (en) 2017-06-20 2022-03-08 Joe Michael Eskridge Stent retriever having an expandable fragment guard

Also Published As

Publication number Publication date
US20130345738A1 (en) 2013-12-26
EP2680765A2 (en) 2014-01-08
WO2012118957A2 (en) 2012-09-07
CA2828960A1 (en) 2012-09-07
US8876863B2 (en) 2014-11-04
US20140005698A1 (en) 2014-01-02
EP2680765A4 (en) 2015-11-18
WO2012118957A3 (en) 2012-11-01

Similar Documents

Publication Publication Date Title
US8876863B2 (en) Endovascular closure device
JP6622367B2 (en) Intravascular prosthesis and method for delivery of an endovascular prosthesis
US10335155B2 (en) Positioning and detaching implants
US10856880B1 (en) Systems and methods for treating aneurysms
US8545530B2 (en) Implantable aneurysm closure systems and methods
ES2676661T3 (en) Sphere Stent Device
US8747430B2 (en) Device for closure of a vascular defect and method for treating the same
EP2757957B1 (en) Medical implantable occlusion device
US9259229B2 (en) Systems and methods for enclosing an anatomical opening, including coil-tipped aneurysm devices
JP2019524342A (en) Intravascular diverter
EP3300674A1 (en) Systems for enclosing an anatomical opening
JP2015523121A (en) Aneurysm occlusion system and method
EP3030158B1 (en) Transvascular and transcameral device access and closure
WO2011072053A1 (en) Aneurysm shield
US20230263649A1 (en) Endovascular prosthesis delivery system
EP2750614B1 (en) Aneurysm closure clip

Legal Events

Date Code Title Description
STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION