US20090090766A1 - Intravascular Stapling Tool - Google Patents
Intravascular Stapling Tool Download PDFInfo
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- US20090090766A1 US20090090766A1 US12/267,350 US26735008A US2009090766A1 US 20090090766 A1 US20090090766 A1 US 20090090766A1 US 26735008 A US26735008 A US 26735008A US 2009090766 A1 US2009090766 A1 US 2009090766A1
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- intravascular
- stapler head
- stapling tool
- holder
- staple
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- 230000005540 biological transmission Effects 0.000 claims description 39
- 230000033001 locomotion Effects 0.000 claims description 30
- 239000003381 stabilizer Substances 0.000 claims description 30
- 208000002223 abdominal aortic aneurysm Diseases 0.000 description 31
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
- A61B17/0684—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
-
- 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
- A61B2017/00238—Type of minimally invasive operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
An intravascular stapler may include a handle; a catheter attached to the handle; a stapler head attached to the catheter; and a staples held by the stapler head, wherein the stapler head is configured to sequentially deploy staples. An intravascular stapler may include a reciprocating driver within the stapler head, wherein the driver reciprocates back and forth substantially along a first axis, and wherein the staples are advanceable substantially along a second axis that is substantially perpendicular to the first axis. An intravascular stapler may include internal anvils held by and movable within the stapler head, each internal anvil positioned in proximity to and movable in tandem with a corresponding staple.
Description
- This application is a divisional of U.S. patent application Ser. No. 11/022,551, filed on Dec. 23, 2004, which is hereby incorporated by reference in its entirety.
- The present invention relates generally to medical devices, and more particularly to an intravascular stapler.
- Abdominal aortic aneurysm (AAA) is an abnormal ballooning of the abdominal portion of the aorta, which is the major artery routing blood from the heart to all organs. Abdominal aortic aneurysm involves a dilation, stretching, or ballooning of the abdominal aorta, which is the section of the aorta residing in the abdominal cavity. Causes of abdominal aortic aneurysm include infection, tissue disease (such as atherosclerosis) resulting in weakening of the connective tissue component of the arterial wall, trauma, and Marfan's syndrome. Abdominal aortic aneurysm can affect anyone, but it is most often seen in men aged 40 to 70. Most commonly, abdominal aortic aneurysms occur in the portion of the vessel below the renal artery origins, and may extend into the vessels supplying the hips and pelvis.
- A common complication of AAA is rupture. This is a medical emergency where the aneurysm breaks open, resulting in profuse bleeding. Aortic rupture is life-threatening; the likelihood of death after rupture is generally considered to be 80-90%. Once an aneurysm reaches 5 cm in diameter, it is usually considered necessary to treat it to prevent rupture.
- Surgical repair or replacement of the section of aorta that includes the aneurysm is recommended for patients with symptoms and for patients with aneurysms greater than 5 cm in diameter, as they are at high risk of fatal rupture. Because surgery for abdominal aortic aneurysm is risky, the surgeon may wait for the aneurysm to expand to a size at which the risk of complications exceeds the risk of surgery. Below 5 cm, the risk of the aneurysm rupturing is lower than the risk of conventional surgery in patients with normal surgical risks. However, it is undesirable to wait for a known AAA to get worse in order to treat it.
- Placement of an AAA graft is also a treatment option. An AAA graft is a tube or tubelike structure placed inside the aorta. Its placement can be performed without an abdominal incision, with specialized catheters that are introduced through arteries at the groin. However, not all patients with abdominal aortic aneurysms are candidates for grafts, however. Further, some AAA grafts in the past have had difficulties that have resulted in their removal from the marketplace, such as breakage of the hooks that hold the AAA graft in place in the aorta, and difficulties with the tools for deploying the AAA grafts.
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FIG. 1 is a perspective view of an intravascular stapling tool having a stapler head connected to a handle by a catheter. -
FIG. 2 is a perspective cutaway view of the stapler head ofFIG. 1 . -
FIG. 3 is a side view of a slider of the stapler head in a first position. -
FIG. 4 is a perspective cutaway view of the stapler head ofFIG. 1 , with the slider omitted for clarity. -
FIG. 5 is a detail perspective cutaway view of the stapler head ofFIG. 1 , with the slider and the distal end of the stapler head omitted for clarity. -
FIG. 6 is a schematic view of an exemplary stapler head. -
FIG. 7 is a side view of a slider of the stapler head in a second position. -
FIG. 8 is a schematic view of the placement of an AAA graft in the abdominal aorta utilizing the intravascular stapling tool. - The use of the same reference symbols in different figures indicates similar or identical items.
- Intravascular Stapling Tool
- Referring to
FIG. 1 , an exemplaryintravascular stapling tool 2 is shown. Theintravascular stapling tool 2 includes ahandle 4, acatheter 6 connected to thehandle 4, and astapler head 8 connected to both thehandle 4 and thecatheter 6. Theintravascular stapling tool 2 may be configured differently, if desired. Thehandle 4 and thestapler head 8 are both fixed to thecatheter 6. Alternately, thehandle 4 and/or thestapler head 8 may be detachable from thecatheter 6 to allow for interchangeability of these components. At least part of thehandle 4 and/or thestapler head 8 may be constructed from materials that can be sterilized, such as by an autoclave, and reused. Thehandle 4 may assume any appropriate configuration; the shape and configuration of thehandle 4 described herein is exemplary and not limiting. Thehandle 4 may include atrigger 10 that provides for actuation of theintravascular stapling tool 2 based solely on a single input from the user to that trigger 10, as described in greater detail below. Alternately, one or more other or additional inputs may be utilized to actuate theintravascular stapling tool 2. For example, actuation of theintravascular stapling tool 2 may be based on an input to one or more buttons in addition to thetrigger 10. - The
catheter 6 is a standard catheter such as used in coronary or peripheral vascular procedures. As such, thecatheter 6 is stiff enough to push thestapler head 8 to the desired position in the vasculature through an opening in the femoral artery or other arty, and flexible enough to move through the vasculature without damaging the tissue thereof. Thecatheter 6 is non-rigid. Thecatheter 6 is a tubular structure having one or more lumens therethrough. Alternately, thecatheter 6 may be configured in any other suitable manner. Referring also toFIG. 2 , one or moreforce transmission members 12 extend through at least one lumen of thecatheter 6. Advantageously, a singleforce transmission member 12 is utilized. Where multipleforce transmission member 12 are utilized, eachforce transmission member 12 may extend through a separate lumen of thecatheter 6, or multipleforce transmission members 12 may extend through one lumen of thecatheter 6. At least oneforce transmission member 12 may be acable 12, such as a braided stainless steel wire cable. Thecatheter 6 may be configured to accommodate a standard guidewire that may be used to guide thecatheter 6 and staplerhead 8 to a treatment site. As one example, thecatheter 6 may include a lumen therein that is configured to receive and travel along the guidewire. As another example, a tube or tubes may be attached to the outer surface of thecatheter 6, where such a tube or tubes receive the guidewire. - Referring also to
FIG. 2 , thestapler head 8 may be attached to the distal end of thecatheter 6. Thestapler head 8 may be attached to thestapler head 8 in any suitable manner. Alternately, thestapler head 8 may be attached to thecatheter 6 at a location other than the distal end of thecatheter 6. Thestapler head 8 includes ahousing 14. A portion of thehousing 14 is cut away to better illustrate the interior of thestapler head 8. Thehousing 14 may have any suitable shape. As one example, thehousing 14 is shaped as the shell of a substantially rectangular solid, with smoothed or curved vertices to protect tissue. At least oneforce transmission member 12 may extend out of the distal end of thecatheter 6 into the interior of thehousing 14. - Referring also to
FIG. 3 , aslider 16 is movable within thehousing 14, and may be connected to at least oneforce transmission member 12. Theslider 16 may be substantially U-shaped as viewed longitudinally, with anupper surface 18 and twowalls 20 extending downward from theupper surface 18, one from either edge of theupper surface 18. The terms “upper,” “lower,” “downward,” “upward,” “vertical,” “horizontal” and the like are used for convenience only, in reference to the position of various components in the Figures. The use of these terms does not limit the orientation of thestapler head 8 in use. Alternately, theslider 16 may be shaped differently. At least onewall 20 of theslider 16 includes at least oneslot 22 defined therein. Aproximal wall 24 may extend downward from theupper surface 18 at or near the proximal end of theslider 16. Theproximal wall 24 may be connected to at least oneforce transmission member 12 in any suitable manner. As one example, theforce transmission member 12 may be acable 12 that extends through an opening (not shown) in theproximal wall 24 and is crimped to theproximal wall 24. As another example, an end of thecable 12 is connected to antermination element 26. Thetermination element 26 is wider than the opening in theproximal wall 24 through which thecable 12 extends. Thus, thetermination element 26 prevents thecable 12 from slipping out of the opening in theproximal wall 24. As another example, the end of thecable 23 may be knotted, forming a knot having a diameter larger than that of the opening in theproximal wall 24. As another example, thecable 12 is connected to the proximal wall by welding or by adhesive. Thecable 12 is routed into thestapler head 8 in such a way that tension exerted on thecable 12 causes theslider 16 to move proximally. Alternately, at least oneforce transmission member 12 is connected to a different location on theslider 16, directly or indirectly. - Referring also to
FIG. 4 , adriver 28 is movable within thehousing 14. Thedriver 28 includes at least onepost 30 extending laterally from acentral body 34. Each post may be substantially cylindrical, or may be shaped differently. At least onegroove 32 is defined in the inner surface of thehousing 14, oriented substantially in the vertical direction. Eachgroove 32 is sized and shaped to receive acorresponding post 30 of thedriver 28. Advantageously, posts 30 extend laterally from thedriver 28 in both directions, and each is received in the correspondinggroove 32 in the housing. Thegroove 32 constrains motion of thecorresponding post 30 along the direction of thegroove 32. Thus, the use of two substantiallyvertical grooves 32 with adriver 28 having twolateral posts 30 extending therefrom constrains the motion of thedriver 28, allowing thedriver 28 to move up and down along thegrooves 32 but substantially restricting the motion of thedriver 28 in the longitudinal or lateral directions. That is, thedriver 28 is constrained to move substantially perpendicular to the longitudinal axis of thestapler head 8. Alternately, thegrooves 32 are oriented differently, and thereby constrain the motion of thedriver 28 differently. - Referring also to
FIG. 3 , thedriver 28 may be positioned within theslider 16. That is, thedriver 28 may be positioned below theupper surface 18 of theslider 16, and between thewalls 20 of theslider 16. Eachpost 30 of thedriver 28 extends through acorresponding slot 22 in thewall 20 of theslider 16, then into the correspondinggroove 32 in thehousing 14. In this way, at least onewall 20 is positioned between thecentral body 34 of thedriver 26 and agroove 32 in the inner surface of thehousing 14. - Referring to
FIGS. 4-5 , at least oneholder 36 is positioned within thehousing 14. Eachholder 36 holds astaple 38. Thestaples 38 may be shaped in any suitable manner, and at least onestaple 38 may be shaped differently than one or moreother staples 38. As one example, at least onestaple 38 has a substantiallyplanar base 40, with atine 42 extending laterally from each side of thebase 40. Eachtine 40 is narrower than the width of thebase 40, as measured in the longitudinal direction. Alternately, at least onestaple 38 is configured differently. - Each
holder 36 may be shaped in any manner that allows it to hold a staple 38, and at least oneholder 36 may be shaped differently than one or moreother holders 36. As one example, aholder 36 may include two substantially upwardly-extendingcolumns 44 connected to a substantially laterally-extendingbase 46. Thecolumns 44 may have a generally U-shaped profile looking downward into them, where atine 42 of the staple 38 is held by acolumn 44 between the arms of the U. The open sides of theU-shaped columns 44 face each other, such that eachcolumn 44 of aholder 36 holds atine 42 of thecorresponding staple 38. Alternately, thecolumns 44 are configured differently to hold thecorresponding staple 38. The inner surface of eachcolumn 44 facing the longitudinal centerline of thehousing 14 may be aramp element 48. Theramp element 48 is smoothly curved inward, moving downward along thecolumn 44. That is, the distance between twoopposed ramp elements 48 in aholder 36 is less at the bottom of theholder 36 than at the top of theholder 36. This curvature assists in deployment of thestaple 38. At the bottom of theholder 36, eachramp element 48 terminates in afoot 50. Taken together, thefeet 50 of eachholder 36, in conjunction with a portion of eachramp element 48 in proximity to eachfoot 50, may be characterized as an internal anvil. Thus, at least oneholder 36 includes an internal anvil for forming the staple 38 deployed therefrom. - The
base 46 of at least oneholder 36 may be two substantially laterally-extending bars on opposite sides of two laterally-spacedcolumns 44. Advantageously, theholder 36 is fabricated from a single piece of material, but thecolumns 44 andbase 46 initially may be separate pieces that are connected in any suitable manner. Thebase 46 of eachholder 36 contacts thebase 46 of at least oneadjacent holder 36. In this manner, force betweenadjacent holders 36 is transmitted between thebases 46 of thoseholders 36. Alternately,adjacent holders 36 contact one another in one or more different or additional locations. Theholders 36 separateadjacent staples 38 from one another such that force is transmitted betweenholders 36, not betweenstaples 38. That is, where a longitudinal force is applied to oneholder 36, that force is transmitted to theadjacent holder 36 without exerting any force on thestaple 38 within eachholder 36. In this way, the design and fabrication of thestaples 38 may be simplified, as thestaples 38 do not transmit forces among one another. That is, eachholder 36 substantially isolates the staple 38 that it holds from force transmitted from anyadjacent holder 36. Thestaples 38 may be spaced apart from one another without touching, as a result of their being held within theholders 36. Alternately, at least onestaple 38 may contact one or moreadjacent staples 38. - Where more than one
holder 36 is utilized, they are arranged longitudinally, such that oneholder 36 is the mostproximal holder 36, and that oneholder 36 is the mostdistal holder 36. Alternately, at least one of theholders 36 may be positioned differently relative to at least one of theother holders 36. The holder orholders 36 are positioned within thehousing 14 such that the upper boundary of eachholder 36 is at a lower height than the lower boundary of thedriver 28, when thedriver 28 is in a ready position. In the ready position, thedriver 28 is above thestaple 38, but is not applying a deployment force to thestaple 38. Alternately, the holder orholders 36 may be positioned differently within thehousing 14. Anejection aperture 52 is defined through the bottom surface of thehousing 14. Theejection aperture 52 is directly underneath thedriver 28, such as where the groove orgrooves 32 are substantially vertical. Alternately, the longitudinal position of theejection aperture 52 may be offset from the longitudinal position of thedriver 28. Because thedriver 28 is constrained to move along the groove orgrooves 32, the ejection point of each staple 38 from the correspondingholder 36 is always known, and that ejection point is theejection aperture 52. - Referring to
FIG. 6 , theslider 16 may be biased distally by a biasingelement 56. As one example, the biasingelement 56 may be a compression spring positioned between theproximal wall 24 of theslider 16 and therear wall 54 of the inner surface of thehousing 14. The compression spring may be substantially concentric with theforce transmission member 12, or may be offset from theforce transmission member 12. Alternately, the biasingelement 56 may be any other structure, mechanism or combination thereof that biases theslider 16 distally. Alternately, the biasingelement 56 may be omitted, such that theslider 16 is not biased distally. - The
holders 36 may be indexed in the proximal direction. That is, anindexing mechanism 58 may be configured to move theholders 36 collectively in the proximal direction, oneholder 36 at a time. This discrete motion of theholders 36 may be referred to as indexing. Theindexing mechanism 58 moves theholders 36 sequentially into position over theejection aperture 52, or facilitates this motion. Theindexing mechanism 58 may be any mechanism capable of doing so. As one example, theindexing mechanism 58 may include a ratchet mechanism. A second force transmission member may be connected to theindexing mechanism 58, and may move proximally a distance substantially equal to the width of oneholder 36 in order to index theholders 36. The second force transmission member may be controlled by a piston, spring, stepper motor or other suitable mechanism in thehandle 4 or elsewhere. - The
stapler head 8 may include astabilizer 37. Thestabilizer 37 is movable from a first position to a second position in order to stabilize thestapler head 8 in use, as described in greater detail below. Thestabilizer 37 may be any mechanism that is configured to stabilizer thestapler head 8. As one example, thestabilizer 37 is a paddle or similar device movable relative to thestapler head 8. Thestabilizer 37 may be hinged or otherwise connected to thestapler head 8, and may rotate about any axis or axes, or move in any suitable direction, between the first position and the second position. Optionally, a biasing element such as a spring may bias thestabilizer 37 to the first, stowed position. A force transmission member may connect thestabilizer 37 to thehandle 4 directly or indirectly, such that the force transmission member controls the position of thestabilizer 37. Alternately, thestabilizer 37 may be a balloon or other inflatable structure that is connected to thestapler head 8, such as to the upper surface of thestapler head 8. Theballoon 37 may be inflatable to stabilize thestapler head 8 in a desired location, and deflatable to allow movement of thestapler head 8 to a treatment site. Theballoon 37 may be inflated by a fluid source in thehandle 4, particularly where thehandle 4 includes a fluid-driven actuator for actuating thestapler head 8; fluid such as pressurized gas may be transmitted to and from theballoon 37 via a lumen of thecatheter 6. Alternately, the pressurized gas source or other fluid source may be located substantially within thestapler head 8. Alternately, thestabilizer 37 is not used. Alternately, theintravascular stapling tool 2 includes two opposed stapler heads 8 facing in substantially opposite directions, where neitherstapler head 8 includes astabilizer 37 The stapler heads 8 may be movable apart from and/or biased apart from one another, such that when both stapler heads 8 are in contact with tissue, eachstapler head 8 stabilizes the other. - Operation
- Referring also to
FIG. 8 , to introduce thestapler head 8 into the vasculature of a patient, anincision 65 is made in the patient'sfemoral artery 64 in a standard manner. For the purpose of describing the operation of theintravascular stapling tool 2, the placement of aAAA graft 60 will be described. However, theintravascular stapling tool 2 may be utilized at a different location in the patient's vasculature. Further, theintravascular stapling tool 2 may be introduced into the vasculature via the radial artery or other blood vessel. Before inserting thestapler head 8 into thefemoral artery 64, aAAA graft 60 may be advanced through the opening in the femoral artery into theabdominal aorta 62 and placed in its desired location. Alternately, theAAA graft 60 may be moved into its desired position in theaorta 62 along with thestapler head 8. Alternately, theAAA graft 60 may be moved into its desired position in theaorta 62 after thestapler head 8 has been moved into position. - The
stapler head 8 is inserted through the opening in the femoral artery and advanced upward by pushing on thecatheter 6. Thecatheter 6 may be configured to follow a guidewire that has been previously placed in the patient according to standard interventional cardiology practice, or may be configured to be advanced regardless of the presence of a guidewire. Thestapler head 8 is thus advanced through the femoral artery into the abdominal aorta. Any suitable technique may be utilized to place thestapler head 8 in the desired position in the abdominal aorta. For example, at least part of thestapler head 8 may be radiopaque, such that an x-ray machine or the like in the operating room may be used to determine when thestapler head 8 has reached its final position. - When the
stapler head 8 reaches its desired position, thestabilizer 37 is deployed, moving from a first (stowed) position to a second (stabilizing) position. Such deployment may be performed in any suitable manner. As one example, where thestabilizer 37 is a paddle or similar device movable relative to thestapler head 8, a force transmission member that connects thestabilizer 37 to thehandle 4 directly or indirectly may be moved. As a result of motion of that force transmission member, thestabilizer 37 may rotate, expand or otherwise move into contact with an inner surface of the wall of theaorta 62, thus moving from the first position to the second position. This contact between thestabilizer 37 and the wall of theaorta 62 pushes thestapler head 8 into contact with a different part of the wall of theaorta 62 and/or with theAAA graft 60, such that theejection aperture 52 is substantially adjacent to the wall of the aorta and/or theAAA graft 60. Alternately, where thestabilizer 37 is a balloon, the stabilizer is inflated from the first position to the second position. Alternately, where thestabilizer 37 is a different mechanism, thestabilizer 37 is actuated in any suitable manner. Alternately, where thestabilizer 37 is omitted, and two opposed stapler heads 8 are provided, the stapler heads 8 are moved apart from one another, such that eachstapler head 8 contacts the wall of theaorta 62 and stabilizes the other. Optionally, thestapler head 8 and/or thehandle 4 may include a safety mechanism that prevents deployment of a staple 38 until thestabilizer 37 is deployed. - Initially, the
slider 16 is in an initial position, as shown inFIGS. 2-3 . In the initial position of theslider 16, each post 30 of thedriver 28 is positioned at the proximal end of thecorresponding slot 22 in thewall 20 of theslider 16. Theslot 22 is shaped to facilitate deployment ofstaples 38, as described in greater detail below. When theslider 16 is in the initial position, aholder 36 is positioned directly below thedriver 28, and may be said to be in firing position. When theholder 36 is in firing position, it is above theejection aperture 52 in the lower surface of thehousing 14. Further, thedriver 28 is initially in a ready position above theholder 36. The ready position may be the uppermost position that thedriver 28 can occupy, or may be a different vertical position relative to thehousing 14. - The user depresses the
trigger 10, manipulates a different control, or otherwise actuates theintravascular stapling tool 2 after thestapler head 8 has reached the desired position. In this way, theintravascular stapling tool 2 may be actuated with a single input from a user. In response, thehandle 4 moves theforce transmission member 12 proximally. For example, where theforce transmission member 12 is a cable, thehandle 4 applies tension to that cable, moving it proximally. This proximal motion of theforce transmission member 12 moves theslider 16 proximally. Eachpost 30 of thedriver 28 is constrained against horizontal motion and restricted to vertical motion by the correspondinggroove 32. Thus, as theslider 16 moves proximally, eachslot 22 in thewall 20 of theslider 16 acts to move thecorresponding post 30 vertically. That is, the shape of theslot 22 controls the vertical motion of thecorresponding post 30, and thus the vertical motion of thedriver 28. - The
exemplary slot 22 is substantially horizontal for a short distance extending distally from its proximal end, such that proximal motion of theslider 16 initially does not move thecorresponding post 30 and thus thedriver 28 vertically. This horizontal portion of theslot 22 provides extra safety, such that negligible motion of theforce transmission member 20 does not cause vertical motion of thedriver 28. - Looking distally along the
slider 16, afirst portion 23 of theslot 22 extends downward at a first angle from horizontal. As thefirst portion 23 of theslot 22 is pulled proximally, thefirst portion 23 urges thecorresponding post 30 downward in the correspondinggroove 32, thus urging thedriver 28 downward. Thedriver 28 contacts thebase 40 of the staple 38 that is located in theholder 36 in firing position. Advantageously, the shape of thedriver 28 and the shape of the base 40 facilitate contact and force transmission therebetween. For example, where thebase 40 of the staple is substantially rectangular, thedriver 28 may include a substantially rectangular surface that is similar in size to thebase 40 of the staple 40 to spread the contact force therebetween over a larger area. - As the
driver 28 continues to move downward, it pushes the staple 38 within theholder 36 toward theejection aperture 52. The end of eachtine 42 of the staple 38 contacts thecorresponding ramp element 48 of theholder 36. This contact causes eachtine 42 to begin to bend as the staple 38 moves toward theejection aperture 52. Referring also toFIG. 8 , as thetines 42 move out of theejection aperture 52, they penetrate theAAA graft 60, and then the tissue of theaorta 62. The angle of eachslot 22 immediately distal to the horizontal portion of theslot 22 assists in the penetration of theAAA graft 60 and the tissue of theaorta 62 by causing substantial vertical motion in a short period of time. That is, because theslider 16 may be moved horizontally by theforce transmission member 12 at substantially a constant rate, the angle of theslot 22 relative to the horizontal at any given point controls the rate of vertical motion of thedriver 28. The greater the angle from horizontal, the more rapid the vertical motion. - Moving further distally along the
slider 16, asecond portion 25 of theslot 22 extends downward at a second angle from horizontal. As thesecond portion 25 of theslot 22 is pulled proximally, thesecond portion 25 urges thecorresponding post 30 downward in the correspondinggroove 32, thus continuing to urge thedriver 28 downward. The second angle is less than the first angle, relative to the horizontal. The second portion of eachslot 22 immediately distal to the first portion of thatslot 22 spreads vertical motion of thedriver 28 over a longer time than the first portion of thatslot 22, because the force required for forming the staple 38 is less than the potential force required to urge thetines 42 of the staple 38 through the AAA graft and the tissue of the aorta. Alternately, the second angle is the same as the first angle, or is greater than the first angle. As thedriver 28 continues to move downward, it continues to push toward theejection aperture 52 thestaple 38 that is within theholder 36 underneath thedriver 28. The end of eachtine 42 of the staple 38 continues to contact thecorresponding ramp element 48 of theholder 36 as thedriver 28 continues to move downward. This contact causes eachtine 42 to continue to bend as the staple 38 moves toward theejection aperture 52. The curvature of eachramp element 48 in proximity to thecorresponding foot 50 determines the path along which eachtine 42 travels as it moves through the AAA graft and the tissue of the aorta. Advantageously, the curvature of eachramp element 48 in proximity to thecorresponding foot 50 directs thecorresponding tine 42 along a path that does not snag tissue outside of the aorta. - Each
foot 50 controls the entry point of thecorresponding tine 42 into tissue, and controls the path of eachtine 42 into tissue during staple forming. In this way, thefeet 50 prevent bunching of the tissue as thestaple 38 is formed. Bunching refers to the undesirable effect on tissue of the tines of a traditional surgical staple when the staple is closed and the tines are brought closer together. With a traditional staple and stapler, this motion pushes tissue between the tines together, thereby bunching the tissue, and also may create holes in tissue as the tines stretch tissue that is not trapped between the tines. Eachfoot 50 provides a known location at which thetine 42 is controlled to exit the correspondingholder 36. That is, eachfoot 50 guides thecorresponding tine 42 through tissue substantially along a path determined by thatfoot 50. As a result, during staple forming, the location of eachtine 42 relative to its penetration of tissue is substantially constant. That is, the location on the tissue that is penetrated by thetine 42 of a staple 38, which may be referred to as the tine entry point, is substantially constant throughout the process of deploying thestaple 38. The tine entry point is not substantially enlarged or moved during deployment. Because the location at which eachtine 42 penetrates the tissue of theaorta 62 is substantially the same throughout the staple forming process, bunching is substantially prevented. - Referring also to
FIG. 7 , as thestaple 38 is formed, thetines 42 swipe past each other. In this way, thetines 42 do not substantially interfere with one another, substantially preventing uncontrolled deflections that may result from such interference. Thetines 42 may be configured to swipe past one another in any suitable manner. As one example, theramp elements 48 are angled differently from one another and/or thefeet 50 are slightly offset from one another, such that thetines 42 are controlled to swipe past one another. As another example, thestaple 38 is fabricated to result in thetines 42 swiping past one another. The staple 38 may be fabricated such that thetines 42 are offset from one another before deployment; cutouts or weakened areas in one or bothtines 42 of the staple 38 may provide for preferential bending of thetines 42 in directions that result in thetines 42 swiping past each other, or the staple 38 may have other properties that result in itstines 42 swiping past each other. - Referring also to
FIG. 7 , theslider 16 has reached the end of its travel, with at least onepost 30 of thedriver 28 contacting the distal end of thecorresponding slot 22. At this point, thestaple 38 is fully formed. The process of urging the tines of the staple 38 into tissue and forming the staple 38 may be referred to as deployment. Thefeet 50 andramp elements 48 may control thetines 42 such that their ends are substantially tangent to the outer surface of the wall of the aorta and such that thetines 42 lie against or close to the outer surface of the wall of the aorta. Thus, after the staple 38 has been fully formed, it secures the AAA graft to the wall of the aorta, and is itself secured to tissue. Nothing remains to hold the staple 38 within theholder 36, and thebase 40 of the staple 38 moves out of the bottom of theholder 36 and through theejection aperture 52. The staple 38 is thus released from thestapler head 8. - Next, tension on the
force transmission member 12 is released. As a result, theforce transmission member 12 exerts no force or a reduced force in the distal direction on theslider 16. The biasingelement 56 exerts a distal force on theslider 16, moving it back toward its initial position. Alternately, theforce transmission member 12 is substantially rigid and is moved distally, and the biasingelement 56 is omitted. As theslider 16 moves distally, each post 30 of thedriver 28 moves along the correspondingslot 22 in a manner opposite to its motion during deployment of the staple 38, such that thedriver 28 moves upward to its initial position as a result. Next, theindexing mechanism 58 moves theholders 36 collectively in the proximal direction, by a distance substantially equal to the width of oneholder 36. In this way, anotherholder 36 containing a staple 38 may be moved into the firing position between thedriver 28 and theejection aperture 52. As one example of operation, a second force transmission member is connected to the indexing mechanism, and moves proximally a distance substantially equal to the width of oneholder 36 in order to index theholders 36. The second force transmission member may be controlled by a piston, spring, stepper motor or other suitable mechanism in thehandle 4 or elsewhere. As another example, a biasing element acts in concert with a ratchet mechanism in thestapler head 8 to index theholders 36. Theholders 36 may be indexed in any suitable manner. Thestapler head 8 is thus ready to fire again, utilizing the process described above. - Next, the
stabilizer 37 is moved from the second position to the first position, freeing thestapler head 8 to move relative to theaorta 62. Such movement may be performed in any suitable manner, such as by performing actions that are substantially the opposite of those actions performed to move thestabilizer 37 from the first position to the second position. As one example, thestabilizer 37 may be biased to the first position, and tension may be released on the force transmission member holding thestabilizer 37 in the second position such that the biasing force on thestabilizer 37 returns it to the first position. As another example, thestabilizer 37 may be deflated. A number ofstaples 38 may need to be placed to secure theAAA graft 60 to theaorta 62. Thehandle 4 may be rotated and/or moved longitudinally along theaorta 62 to position thestapler head 8 in a different position for deploying anotherstaple 38. Such motion of thehandle 4 causes motion of thecatheter 6, which in turn causes motion of thestapler head 8. Alternately, a rotary mechanism (not shown) in thehandle 4 is used to rotate thestapler head 8 without having to rotate theentire handle 4. Thestapler head 8 may be moved into eachfemoral artery 64 in proximity to the lower portion of theAAA graft 60 to staple that portion of theAAA graft 60 to the tissue of thefemoral artery 64. Thefemoral artery 64 other than that in which theincision 65 is made may be accessed by steering thestapler head 8 via thecatheter 6 using any standard catheter guidance method. Alternately, an incision is made in the otherfemoral artery 64, and thestapler head 8 is inserted through that incision to staple theAAA graft 60 to thatfemoral artery 64 and complete the procedure. - In the course of operation of the intravascular stapling tool, the
force transmission member 12 and other force transmission members may be manipulated as described above by any suitable mechanism or mechanisms. Thus, the particular configuration of thehandle 4 is not critical, because it may be configured in any manner that controls the force transmission members as described above. As one example, thehandle 4 may include a fluid-driven actuator that utilizes a working fluid such as compressed gas to drive one or more pistons in response to the actuation of thetrigger 10; theforce transmission member 12 may be coupled to one of those pistons, as may one or more other force transmission members. In this way, motion of the pistons causes motion of the correspondingforce transmission member 12. Such a fluid-driven actuator is described in U.S. patent application Ser. No. TBD, Attorney Docket No. 167, entitled “Anastomosis Tool Actuated with Stored Energy,” which is hereby incorporated by reference in its entirety. Alternately, thehandle 4 may include any other mechanism or mechanisms that manipulate theforce transmission members 12 as described above after actuation of thetrigger 10. - 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. 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. 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 (20)
1. An intravascular stapling tool, comprising:
a handle;
a catheter attached to said handle;
a stapler head attached to said catheter; and
a plurality of staples held by said stapler head, wherein said stapler head is configured to sequentially deploy a plurality of said staples.
2. The intravascular stapling tool of claim 1 , wherein said stapler head is attached to the distal end of said catheter.
3. The intravascular stapling tool of claim 1 , wherein said stapler head includes a plurality of holders, wherein each said holder holds a staple.
4. The intravascular stapling tool of claim 3 , wherein each said holder is adjacent to at least one other holder.
5. The intravascular stapling tool of claim 3 , wherein each said holder substantially isolates said staple associated with said holder from force transmitted from any adjacent said holder.
6. The intravascular stapling tool of claim 3 , wherein at least one said holder includes an internal anvil.
7. The intravascular stapling tool of claim 6 , wherein said internal anvil includes two spaced-apart feet.
8. The intravascular stapling tool of claim 3 , wherein said stapler head includes a driver constrained to move substantially perpendicular to the longitudinal axis of said stapler head, and an ejection aperture aligned with said driver; and wherein said holders are movable along a path extending between said driver and said ejection aperture.
9. The intravascular stapling tool of claim 8 , wherein said stapler head includes a slider connected to a force transmission member extending between said slider and said handle through said catheter; wherein said slider is movable to control said driver.
10. The intravascular stapling tool of claim 1 , wherein said staples are spaced apart from one another without touching one another.
11. The intravascular stapling tool of claim 1 , further comprising a stabilizer movable relative to said stapler head.
12. The intravascular stapling tool of claim 1 , wherein said handle includes a trigger, wherein said handle and said stapler head are operationally connected such that a single input to said trigger actuates said staple head.
13. An intravascular stapling tool, comprising:
a handle;
a catheter attached to said handle;
a stapler head attached to said catheter;
a plurality of staples held by said stapler head; and
a reciprocating driver within said stapler head, wherein said driver reciprocates back and forth substantially along a first axis, and wherein said plurality of staples are advanceable substantially along a second axis that is substantially perpendicular to said first axis.
14. The intravascular stapling tool of claim 13 , wherein said stapler head includes an aperture defined therein at a deployment position, and wherein said stapler head is configured to index a plurality of said of staples sequentially to said deployment position.
15. The intravascular stapling tool of claim 13 , wherein said stapler head holds each said staple independently and spaced apart from the other said staples.
16. The intravascular stapling tool of claim 13 , further comprising a plurality of holders, wherein each said holder holds a corresponding said staple.
17. The intravascular stapling tool of claim 13 , further comprising a slider within said stapler head, wherein said slider reciprocates substantially along said second axis, and wherein said slider includes a slot defined therein that engages said driver, wherein motion of said slider substantially along said second axis controls motion of said driver substantially along said first axis.
18. An intravascular stapling tool, comprising:
a handle;
a catheter attached to said handle;
a stapler head attached to said catheter;
a plurality of staples held by and movable within said stapler head; and
a plurality of internal anvils held by said stapler head and movable within said stapler head, each said internal anvil positioned in proximity to and movable in tandem with a corresponding said staple.
19. The intravascular stapling tool of claim 18 , further comprising a plurality of holders, wherein each said holder holds a corresponding said staple, and wherein each said internal anvil is defined in a corresponding said holder.
20. The intravascular stapling tool of claim 18 , wherein each said holder includes two generally-parallel columns each connected to a base.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/267,350 US20090090766A1 (en) | 2004-12-23 | 2008-11-07 | Intravascular Stapling Tool |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US11/022,551 US7462185B1 (en) | 2004-12-23 | 2004-12-23 | Intravascular stapling tool |
US12/267,350 US20090090766A1 (en) | 2004-12-23 | 2008-11-07 | Intravascular Stapling Tool |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/022,551 Division US7462185B1 (en) | 2004-12-23 | 2004-12-23 | Intravascular stapling tool |
Publications (1)
Publication Number | Publication Date |
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US20090090766A1 true US20090090766A1 (en) | 2009-04-09 |
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ID=40090552
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Application Number | Title | Priority Date | Filing Date |
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US11/022,551 Expired - Fee Related US7462185B1 (en) | 2004-12-23 | 2004-12-23 | Intravascular stapling tool |
US12/267,350 Abandoned US20090090766A1 (en) | 2004-12-23 | 2008-11-07 | Intravascular Stapling Tool |
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Application Number | Title | Priority Date | Filing Date |
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US11/022,551 Expired - Fee Related US7462185B1 (en) | 2004-12-23 | 2004-12-23 | Intravascular stapling tool |
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US (2) | US7462185B1 (en) |
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