WO1998004212A1 - Two-piece, bifurcated intraluminal graft for repair of aneurysm - Google Patents
Two-piece, bifurcated intraluminal graft for repair of aneurysm Download PDFInfo
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- WO1998004212A1 WO1998004212A1 PCT/US1997/013187 US9713187W WO9804212A1 WO 1998004212 A1 WO1998004212 A1 WO 1998004212A1 US 9713187 W US9713187 W US 9713187W WO 9804212 A1 WO9804212 A1 WO 9804212A1
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- graft
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- opening
- aneurysm
- side wall
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- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/852—Two or more distinct overlapping stents
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/856—Single tubular stent with a side portal passage
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
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- 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
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
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- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8483—Barbs
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0095—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof radioactive
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- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
Definitions
- the present invention relates to an intraluminal graft and method and apparatus for installing an intraluminal graft in relation to a bifurcation in a body vessel that is damaged, and more particularly in relation to an aneurysm, defect or injury that affects a main body vessel, e.g., the abdominal aorta, and branching body vessels, e.g. the iliac arteries, wherein the intraluminally implanted graft is formed of two cooperating graft prostheses having a wide range of expansion when placed in position.
- a main body vessel e.g., the abdominal aorta
- branching body vessels e.g. the iliac arteries
- a wide variety of tubular body, artificial grafts, stents or stent-grafts have been proposed for introduction through a percutaneous access site and advancement through the vascular system to the aneurysm site and for deployment to bridge the opening and thereby close off the aneurysm. Once deployed in situ, the graft must be stabilized mechanically until neointimal growth occurs over the graft ends and interior surface.
- Such grafts, stents and stent-grafts have been formed of a wide variety of materials and shapes to accommodate particular vascular sites and to encourage neointimal growth.
- deployment mechanisms and techniques have been proposed to position the structure and stabilize it in place including "active" fixation mechanisms designed to penetrate the vessel wall and "passive" fixation mechanisms that press against and expand the diameter of the vessel lumen.
- expandable metal stents have been accepted in clinical use for insertion into a cardiac artery after a balloon angioplas y procedure has been employed to expand a stenosed site in order to assist in preventing re-stenosis.
- These stents are relatively structurally stiff, and when expanded at the site, enlarge the vessel and are passively retained in place by friction with the vessel wall.
- stents are formed of wire mesh or wire looped to form a tubular member such that the inner diameter may be expanded by a balloon catheter or the like. Blood flow through the openings between wire turns is not an issue, since the wire and openings bear against the vessel wall.
- Vascular grafts on the other hand, classically have been designed to have less porous side walls, since they originally were used to bypass a diseased or enlarged blood vessel site.
- artificial graft typically implies a biocompatible tubular member mimicking the flexibility of the natural blood vessel it is intended to replace.
- suturing in a procedure referred to as anastomosis.
- vascular grafts employ passive stent-like structures that are expanded to enlarge and frictionally engage patent vessel wall on either side of the aneurysm opening or include active barbs or hooks that are manipulated to invade the patent vessel wall and retain the graft in position.
- Such combinations of stent and graft structures are at times referred to as "stent-grafts”.
- graft is used to encompass any such graft, stent or stent-graft intended to be implanted intraluminally to bridge an aneurysm.
- stent is used in the following with respect to active and/or passive expansion and retention mechanisms for attaching ends of certain artificial intraluminal grafts, unless otherwise indicated in the drawings or description.
- the simplest artificial intraluminal graft is formed as a tubular member having a continuous side wall and a single lumen that can be percutaneously advanced in a collapsed configuration and expanded to bridge the aneurysm opening.
- Examples of such intraluminal grafts and introduction systems are shown in U.S. Patent Nos. 4,577,631 to Kreamer, 5,306,294 to Winston et al., 5,360,443 to Barone et al., and is described in "Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms", by J. C. Parodi M.D., et al. in Annals of Vascular Surgery, vol. 5, no. 6, 1991, pp.491-499.
- one focus of investigation and application of intraluminal grafts is to bridge abdominal aortic aneurysms that appear superiorly to the branching of abdominal aorta into the right and left iliac arteries and may extend into one or both of the iliac arteries.
- the simple "trunk" graft may be deployed in the manner shown in the above- referenced Parodi article.
- Bifurcated grafts having one or more "legs" attached to a simple tubular graft have been proposed to bridge an aneurysm that extends into one or more of the iliac arteries as shown in certain figures of the 4 443 patent and in U.S. Patent Nos. 4,994,071, 5,366,473 and 5,489,295, for example.
- these bifurcated grafts are formed of a single piece having a single body lumen branching into the two leg lumens to mimic the natural trunk and branch structure at the bifurcation site.
- the intraluminal introduction and positioning of the body and legs of the one piece graft into the proper position at the site is complicated, requiring a number of advancements and withdrawals of guide wires and catheters.
- the legs and attendant leg opening stents must be folded over one another or the body, and the resulting folded graft assembled over a deployment catheter and/or within an introduction catheter is bulky and may be difficult to percutaneously introduce and advance to the site.
- a further, three tubular piece, assembly is provided by the Corvita Corporation bifurcated graft.
- the larger tubular trunk member is implanted in the aorta first.
- the lower branch graft members are implanted one at a time in the iliac arteries.
- the two superior ends of the branch graft members are inserted into fittings in the lumen of the trunk member to prevent leakage of blood, and the other ends of the branch graft members are lodged in the iliac vessels so that the assembly does not slip apart.
- the trunk and branch graft members In order to insert the trunk and branch graft members, it is necessary to percutaneously advance the branch members through separate access sites through the right and left femoral arteries and the respective right and left iliac arteries. Moreover, the resulting joint between the trunk and the branch graft members is prone to leak because of the negative seal created by placing the branch graft components inside the trunk where they oppose the flow of blood rather than outside the trunk. In addition, this negative joint may increase the amount of turbulence by creating an excessive ridge or dam over which the blood must flow. This turbulence can lead to the creation of clots which can cause emboli downstream.
- Providing an effective and easily installed, bifurcated intraluminal graft for bridging an aneurysm at the branching of an iliac arteries from the abdominal aortic artery requires a graft structure that may be collapsed to a diameter of less than 15 French (5 mm) for percutaneous insertion into the femoral arteries and easy passage through the iliac arteries to the site. There, the graft must expand to the full lumen diameters of the patent arterial walls outside the length of the aneurysm to seal off and bridge the full length of the aneurysm from the infrarenal neck of the aorta to and including both iliac arteries, which typically is about 22-28 mm.
- the seal must be sufficiently tight to reduce blood pressure within the sealed off aneurysm.
- a self securing attachment mechanism with the patent arterial walls is also desirable to avoid arterial wall damage.
- the graft must be easily seen under fluoroscopy so that it may be located with a high degree of precision. Finally, the graft must, of course, fit a wide variety of anatomical variation, be reasonably biocompatible, and preserve normal blood flow through it.
- branching blood vessels e.g., the abdominal aorta and/or iliac bifurcation
- a two piece prosthetic graft for intraluminally bypassing an aneurysm, defect or injury in a vessel wall close to or involving a bifurcation of a trunk vessel having a trunk vessel wall and lumen into first and second branch vessels having first and second branch vessel walls and lumens comprises: a first graft prosthesis having a continuous side wall extending a length between a first leg opening stent adapted to be expanded into contact with the first branch vessel wall and to define a first leg opening and a second leg opening stent adapted to be expanded into contact with the second branch vessel wall and to define a second leg opening, means for defining a waist opening formed in the fabric side wall along the length of the first graft prosthesis, the continuous side wall and first and second leg opening stents being expandable to an expanded state bridging the bifur
- continuous side wall and the first and second leg opening stents of the first prosthetic graft are collapsible when restrained in a collapsed state and expandable when unrestrained to an expanded state defining the first graft lumen and the expanded first leg opening, second leg opening and waist opening.
- the tubular member of the second graft prosthesis is preferably formed of a flexible sheet material rolled into a tubular member of at least one partially overlapping turn, the tubular member being collapsible in diameter under restraint into a collapsed state for advancement through one of the first and second leg openings, the first graft lumen and out the waist opening and self-expandable in diameter upon removal of the restraint to the expanded state, such that the tubular member self-expands until the expanded distal end bears against and is restrained by the trunk vessel wall beyond the area of the aneurysm, defect or injury and the proximal end bears against and is restrained by the attachment seat.
- the first graft prosthesis is implanted in the collapsed state over a deployment catheter across the bifurcation and the restraint is released to allow the first and second leg opening stents and the waist stent to self-expand and form the first graft lumen.
- the second graft prosthesis is advanced in its collapsed state over a deployment catheter through the first graft lumen and positioned to extend between the waist opening and patent vessel wall outside the area of the aneurysm, defect or injury.
- the second graft prosthesis is released and allowed to self-expand to an expanded diameter restrained by the expanded diameter of the waist stent and the blood vessel lumen.
- the apparatus for repairing or bypassing an aneurysm, defect or injury of the type described includes the two-piece prosthetic graft and the deployment system for deploying the first and second graft prostheses in accordance with the method.
- the present invention is particularly advantageously employed to repair or bypass aneurysms involving the abdominal artery at or near the bifurcation of the right and left iliac arteries. However, it may be employed to repair or bypass aneurysms, defects or injuries at bifurcations of other blood vessels.
- the ease of insertion into position is enhanced by the single point of percutaneous introduction and advancement allowed by the use of the two separate trunk and limb graft prostheses.
- the trunk and limb graft prostheses may be selected and sized by the physician to fit the particular patient's anatomy.
- the resulting prosthetic graft provides a relatively unobstructed graft lumen with a positive joint relative to the blood flow. This type of joint minimizes the opportunity for leaks and streamlines the flow of blood to reduce the potential for forming clots.
- FIG. 1 is a view of an aneurysm of the abdominal aorta at the bifurcation with the right and left iliac arteries and illustrating the first step of the method of the invention wherein a guidewire is advanced from one iliac artery across the bifurcation and into the other iliac artery;
- FIG. 2 is a perspective view of a first graft prosthesis in accordance with the invention for bridging the bifurcation of aortic artery and providing an attachment seat for a second graft prosthesis of the invention;
- FIG. 3 is a perspective view of the second graft prosthesis in accordance with the invention for engaging the attachment seat of the first prosthesis and the patent aortic side wall for bridging the aneurysm in the aortic artery;
- FIG. 4 is a flattened out, plan view of the second graft prosthesis of FIG. 3;
- FIG. 5 is an end view of the second graft prosthesis of FIG. 3 when released to form a tubular member of multiple overlapping turns;
- FIG. 6 is a view as in FIG. 1 illustrating the second step of the method of the invention of assembling a first graft prosthesis collapsed about a first deployment catheter and advancing the assembly over the guidewire;
- FIG. 7 is a view as in FIG. 1 illustrating the next step of the method of the invention of advancing the assembly of the first graft prosthesis collapsed about a first deployment catheter over the guidewire across the bifurcation and orienting the waist opening toward the lumen of the aorta;
- FIG. 8 is a view as in FIG. 1 illustrating the next step of the method of the invention of releasing the self-expanding right and left leg stents and waist stent in the orientation of FIG. 7, retraction of the first deployment catheter, and repositioning of the guidewire;
- FIG. 9 is a view as in FIG. 1 illustrating the next step of the method of the invention of advancing the assembly of the second graft prosthesis collapsed about a second deployment catheter over the guidewire, through the lumen of the first graft prosthesis and orienting the distal end of the graft prosthesis within the waist opening;
- FIG. 10 is a view as in FIG. 9 illustrating the final step of the method of the invention of releasing the self-expanding second graft prosthesis to expand until its distal end is restrained by patent aortic vessel wall superior to the area of the aneurysm and its distal end is restrained within the waist stent of the first graft prosthesis;
- FIG. 11 is a perspective view of a first embodiment of an arrangement for restraining the waist stent of the first graft prosthesis when collapsed over the first deployment catheter;
- FIG. 12 is a detail view of the release mechanism of the arrangement of FIG. 11 for releasing the waist stent when positioned in the fourth step;
- FIG. 13 is a perspective view of a first embodiment of an arrangement for restraining the waist stent of the first graft prosthesis when collapsed over the first deployment catheter;
- FIG. 14 is a exploded, detail of the perspective view of FIG. 13.
- the present invention is described in the context of intraluminally bypassing an aneurysm, defect or injury at the bifurcation of the abdominal aorta and the right and left iliac arteries, where the two piece intraluminal graft and method and apparatus for installing it are especially advantageous. It will be understood that the invention has application in intraluminally bypassing aneurysms, defects or injuries formed at other bifurcations of blood vessels in the body, e.g. bifurcations along the carotid and coronary arteries.
- FIG. 1 depicts an aneurysm (or a defect or other injury) 10 of the abdominal aorta 12 at the bifurcation 14 with the right and left iliac arteries 16, 18 and illustrating the first step of the method of the invention wherein a guidewire 100 is advanced from the right iliac artery 16 across the bifurcation 14 and into the left iliac artery 18, for example.
- the aneurysm 10 expands as the weakened aortic vessel wall 20 stretches under arterial blood pressure in an area of the aortic neck 28 extending generally between the branching of the right and left renal arteries 22, 24 and often inferiorly to include one or both of the iliac arteries 16, 18.
- the aortic lumen 30 and the iliac artery lumens 32, 34 are therefore expanded in the area affected by the aneurysm 10.
- the patent vessel wall of the aortic neck 28 superior to the area of the aneurysm 10 retains a healthy diameter of between 20-30 mm, and the aneurysm 10 may double that diameter in the affected area.
- the unaffected diameters of the right and left iliac artery lumens 32, 34 inferior to the area of the aneurysm 10 are typically between 8-14 mm.
- a two piece intraluminal prosthetic graft 100 for repairing such an abdominal aortic aneurysm 10 is deployed intraluminally to bridge the aneurysm 10 between patent aortic vessel wall in the aortic neck 28 and patent arterial walls of the right and left iliac arteries 16, 18 to seal off aneurysm 10 from blood flow and blood pressure.
- the prosthetic graft is formed of a first graft prosthesis 110 and a second graft prosthesis 140 which are depicted in the remaining figures in relation to first and second delivery or deployment catheters 160 and 170 and the guidewire 180.
- the first graft prosthesis 110 has a continuous side wall 112 formed of a woven biocompatible Dacron fabric of a type employed in the above described flexible fabric grafts, e.g. that material disclosed in the above-referenced '473 patent.
- the f st graft prosthesis 110 is formed to resemble trousers without any appreciable seat when expanded to an expanded state in situ having a waist opening 114 and right and left legs 116, 118, terminating in right and left leg openings 120, 122, respectively.
- the waist opening 114 is formed midway along the length of the continuous side wall 112 between the right and left leg openings 120 and 122.
- the continuous side wall 112 may be collapsed upon itself in folds, and the waist opening 114 and right and left leg openings 120, 122 closed or contracted.
- the waist opening 114 is maintained by a waist opening stent 124 for providing a substantially circular attachment seat of a predetermined diameter approximating the diameter of the aortic lumen 30 superior to the area of the aneurysm 10 when it is expanded in the expanded state.
- the right and left leg openings 120, 122 are preferably maintained by respective right and left leg opening stents 126, 128 that expand until they engage patent side walls of the right and left iliac arteries 16, 18.
- the expansion of the leg opening stents 126, 128 applies force outward against the arterial sidewalls that is countered by inward force of the patent arterial side wall.
- a first graft lumen 130 extends within the expanded fabric between the expanded waist opening 114 and the right and left leg openings 120, 122 that substantially conforms to the lumens 30, 32 and 34 without substantially stretching the vessel lumen diameters.
- the leg opening stents 126 and 128 are preferably formed in ring-shaped bands of plural overlapping turns of sheet material of the type described in the above-referenced '294 and '473 patents incorporated herein by reference.
- a thin biocompatible metal e.g. Elgiloy or stainless steel metal foil, having a thickness of about 0.04 mm is preferred to form the ring-shaped bands.
- the ring-shaped bands may be restrained in a collapsed state to a collapsed diameter about a spool of an deployment catheter and which self-expand in the expanded state to an expanded diameter when the restraint is released.
- the leg opening stents 126, 128 are preferably attached to the fabric continuous side wall 112 in the manner disclosed in the '473 patent. In this manner, the continuous side wall 112 and leg opening stents 126, 128 are collapsible when restrained in a collapsed state and expandable when unrestrained to an expanded state that conforms with the blood vessel lumens 32, 34 they bear against thereby defining the first graft lumen 130 in the manner taught by the '473 patent.
- the waist opening 114 provided by waist opening stent 124 is adapted to be oriented to face superiorly from the aortic bifurcation 14 and toward the aortic lumen 30 of to provide an attachment or restraining seat of predetermined diameter approximating the diameter of the aorta lumen 30 beyond the area of the aneurysm 10 when released from restraint. Therefore, in this case, the waist opening stent 124 is not necessarily subjected to any vessel wall restraint when it is expanded. When it is released from the first deployment catheter 160, the waist opening stent 124 expands within the void of the aneurysm 10 to a maximum free diameter of opening 114.
- the maximum free diameter of waist opening 114 may be expanded further by force exerted by the expanded distal end of the second graft prosthesis 140.
- a preferred method of forming, constraining and releasing the waist opening stent 124 is described below with respect to FIGS. 11 and 12.
- the second graft prosthesis 140 is shown in FIG. 3 in an unrestrained side perspective view, in FIG. 4 rolled out in a plan view, and in FIG. 5 in an end view.
- the second graft prosthesis 140 is preferably formed in a rectangular, flexible, thin sheet 142 having a length L and width W.
- a thin biocompatible metal e.g. Elgiloy or stainless steel metal foil, having a thickness of about 0.04 mm is preferred to form the sheet 142, although other materials may be used.
- the sheet 142 is biased to oil up in its width dimension W into a roll or tubular member 148 of at least one partially overlapping layer or turn, but preferably a number of overlapping turns as shown in FIG. 5, when unrestrained.
- the tubular member 148 therefore forms a continuous side wall of length L extending between distal and proximal ends and defining a graft lumen 150 extending between distal and proximal ends 152, 154, respectively.
- the flexibility of the biocompatible sheet material 142 allows the overall diameter of the tubular member 148 to be collapsed under restraint into a collapsed state and to self- expand upon removal of the restraint to an expanded state. A high expansion ratio of the expanded diameter to the contracted diameter can be attained, and the adjacent turns remain close together in the expanded state to define as great a lumen 150 diameter as possible.
- the reduced diameter allows the second stent prosthesis 140 to be advanced through the femoral artery and iliac artery 16 or 18 and be readily advanced through the leg opening 120 or 122 and waist opening 114 of the previously placed first graft prosthesis 110.
- the multiple metal foil turns of the tubular member 148 when in the collapsed state are highly visible under fluoroscopy, aiding in attaining the desired position.
- the second graft prosthesis 140 is introduced superior to the aortic bifurcation 14 with the proximal end thereof located within the attachment seat formed by said waist opening stent 124.
- the tubular member 148 expands until the expanded distal end bears against and is restrained by the aortic wall beyond the area of the aneurysm 10, and the proximal end bears against and is restrained by the attachment seat to seal the first and second graft lumens with the aorta lumen 30 and the iliac artery lumens 32, 34 and from the aneurysm 10.
- the sheet 142 is preferably formed with very small perforations to encourage the growth of neointimal tissue over the surface of the tubular member 148.
- Rows of larger perforations or circular holes 144 and 146 are arranged along opposite edges of the sheet 142.
- the circular holes 144 and 146 contain small spring flaps 145 and 147, respectively, in the outer one third of each of the holes.
- the flaps 145 and 147 protrude slightly outward from the center axis of the second graft prosthesis 140, and the rows of flaps 145, 147 project toward one another.
- first and second introduction and deployment mechanisms for restraining the first and second graft prostheses 110, 140 in the collapsed state are provided.
- the introduction mechanisms are deployment catheters 160 and 170 of the type disclosed in the above-incorporated '294 and '473 patents.
- deployment catheters 160 and 170 preferably have guidewire lumens 162 and 172 so that they may be percutaneously introduced and advanced over a guidewire 180 that has been introduced and advanced to the site.
- deployment catheters 160, 170 may be introduced through introducer catheters (not shown for convenience of illustration except in FIG. 7) that are first introduced over the guidewire 180 to the site or are advanced with the deployment catheters 160, 170 having the first and second graft prostheses 110, 140 collapsed over respective distal portions thereof in the manner shown in the above-incorporated '294 and 473 patents.
- the outer introducer catheter may act as the restraining mechanism for maintaining the first and second graft prostheses 110, 140 in the collapsed state such that expansion to the expanded state takes place upon retraction of the introducer catheter from the distal portion of the deployment catheter 160, 170 as shown in the above-incorporated '473 patent.
- control cords extending through lumens of the deployment catheters 160, 170 from the proximal ends thereof to the distal portions and terminating in slip knots at distal spool flanges may be employed in the manner described in the above-incorporated '294 patent.
- looped control cords extending through lumens of the deployment catheters 160, 170 from the proximal ends thereof to the distal portions and terminating in recesses in the deployment catheter and held in place by stainless steel pins which extend through lumens from the distal end of the deployment catheter to the recesses may be employed to secure the stents and graft material in a collapsed state.
- the stent is released by pulling the stainless steel pin from the distal end of the delivery catheter thereby releasing the loop in the recess and allowing the stent and graft material to expand to their limits.
- the looped control cord is withdrawn into the deployment catheter following deployment of the stent.
- control cords extend over the collapsed outer turns of the respective stents 124, 126, 128 of the first graft prosthesis 110 or over the outer surface of tubular member 148 of the second graft prostheses surface 148 to maintain the collapsed state until they are pulled on at the proximal ends to untie the slip knots and allow the expansions to the expanded states to take place.
- these details for releasing the restraints on the stents 126, 128 and the tubular member 148 are incorporated from the '294 and '473 patents and not illustrated.
- One form of a suitable restraint and release mechanism for the waist opening stent 124 is described below in reference to FIGS. 11 and 12.
- the method of repairing the abdominal aortic aneurysm 10 close to or involving the aortic bifurcation 14 in accordance with a preferred embodiment of the invention comprises the steps illustrated in FIGS. 1 and 6-10.
- the first graft prosthesis 110 is advanced to bridge the bifurcation 14 with the left leg 118 extending into the left iliac artery 18 and the right leg 116 extending into the right iliac artery 16 and expanded so that the waist opening 114 is facing the aortic lumen 30 to provide a retention mechanism for receiving the proximal end of the second graft prosthesis 140 when it is expanded distally to it.
- the second graft prosthesis 140 is advanced in a collapsed state through the himen of the first graft prosthesis 110 and positioned in relation to engage with the waist opening 114 when it is expanded to its expanded state. Then, the second graft prosthesis is expanded 140 so that the side wall adjacent the distal end opening engages patent aortic side wall and the proximal end opening expands within the waist opening 114 of the first graft prosthesis and is restrained there from expanding further.
- FIG. 1 the first step of advancing the distal end of the guidewire 180 across the bifurcation 14 is shown.
- the guidewire 180 has been percutaneously introduced and advanced into the right femoral artery, into the respective right iliac artery coupled thereto, and then across the aortic bifurcation 14 and into the left iliac artery.
- the direction of introduction is selected by the physician taking asymmetry of the bifurcation 14 and die state of the blood vessels to be traversed into account.
- it is not necessary to approach the bifurcation 14 from cut downs made in both femoral arteries, etc. and with duplicate guidewires, etc.
- aortic lumen 30 and the iliac arterial lumens 32, 34 and the length of the aneurysm 10 is mapped out using a contrast agent and fluoroscopic observation, and the physician selects the best sized set from among different sized first and second graft prostheses 110, 140 to bridge the aneurysm 10 when the procedure is completed.
- FIG. 6 illustrates the step of assembhng the first graft prosthesis 110 collapsed about the distal portion of the first deployment catheter 110.
- the guidewire lumen 162 in the distal end of the deployment catheter 160 is fitted over the guidewire 180, and the assembly is advanced over the guidewire 180 toward the bifurcation 14.
- the fabric continuous side wall 112 is folded against the distal portion of the first deployment catheter 160 and to extend between the collapsed right leg opening stent 126 and left leg opening stent 128 with the a waist opening stent 124 elongated in a purse opening shape.
- This collapsed state allows the first graft stent to take on an elongated tubular shape with maximum longitudinal shape and rninimal cross-section so that the assembly can be maintained within a diameter of 10-12 French (3.3-4.0 mm).
- a four fold expansion of the graft lumen diameter in the expanded state to the 8-14 mm diameters of lumens 32 and 34 can be realized.
- FIG. 7 illustrates the next step of advancing the assembly of the first graft prosthesis 110 collapsed about the first deployment catheter 160 over the guidewire 180 across the bifurcation 14 and orienting the waist opening 114 toward the lumen 30 of the aorta.
- the right and left leg opening stents 126, 128 are then located in the right and left iliac artery lumens 32, 34.
- the introducer catheter 200 is depicted in phantom lines over the first deployment catheter and the first graft prosthesis 110.
- FIG. 8 illustrates the next step of releasing the self-expanding right and left leg opening stents 126, 128 and waist opening stent 124 in the orientation attained in the step of FIG. 7, resulting in expansion of the continuous side wall 112, and the repositioning of the guidewire 180.
- the left opening stent 128 is first released, then the waist opening stent 124 is released and finally the right opening stent 126 is released.
- the restraint and release mechanisms for the left and right opening stents are described above. The manner of restraining and releasing the waist opening stent is described in greater detail below.
- the right and left leg opening stents 126, 128 bear against arterial walls of the right and left iliac arteries 16, 18 to seal the first graft lumen 130 and iliac artery lumens 32, 34 from the aneurysm 10.
- the waist opening 114 is oriented to face the aortic lumen 30 to provide an attachment seat of predetermined diameter approximating the diameter of the aortic lumen 30 beyond the area of the aneurysm 10.
- the positioning of the right and left legs 116, 118 and the expansion of the waist opening stent 124 to the waist opening diameter for receiving the second graft prosthesis 140 is sufficient to inhibit dislodgement of the first graft prosthesis 110 without the need for any active fixation mechanism.
- the guidewire 180 is then retracted from the left iliac artery lumen 34 and repositioned to extend distally from the right iliac artery lumen 32 into the aortic lumen 30 beyond the area of the aneurysm 10.
- FIG. 9 illustrates the next step of advancing the assembly of the second graft prosthesis 140 collapsed about a second deployment catheter 170 over the guidewire 180, through the right leg opening 120, the lumen of the first graft prosthesis 110, and out of the waist opening 114, to orient the proximal end 154 of the second graft prosthesis 140 within the waist opening 114.
- the second graft prosthesis 140 is first assembled in a collapsed state about a distal end segment of the second deployment catheter 170 and maintained there by one of the mechanisms described above.
- the second deployment catheter has a guidewire lumen 172 formed therein that is fitted over the guidewire 180 to percutaneously advance the assembly to the depicted position.
- the assembly may be advanced easily through the right leg opening 120 and out the waist opening 114.
- the advancement may be monitored under fluoroscopy because of the radiopacity of the turns of the metal foil 142.
- FIG. 10 illustrates the final steps of releasing the self-expanding second graft prosthesis to expand until its distal end 152 is restrained by patent aortic vessel wall superior to the area of the aneurysm 10 in the aorta 12 and its distal end is seated and restrained within the waist opening stent 124 of the first graft prosthesis 110.
- the waist opening stent 124 defines the waist opening 114 maximal diameter and acts as an attachment ring or seat for restraining further expansion of the proximal end 154 of the second graft prosthesis.
- the second graft prosthesis 140 expands so that the continuous side wall 148 adjacent the expanded distal end 152 bears against the aortic arterial wall beyond the area of the aneurysm 10, and the continuous side wall 148 adjacent to the expanded proximal end 154 bears against the attachment seat to seal the second graft lumen 150 and the aortic lumen 30 from the aneurysm 10.
- the rows of flaps 145, 147 increase the frictional holding power of the second graft prosthesis 140 against the vessel wall and in the waist band attachment seat.
- the waist opening 114 and lumen of the first graft prosthesis 110 are thereby pressure sealed from the aneurysm 10. The higher blood pressure within the lumen 150 and the growth of neointimal tissue also helps maintain the seal.
- tubular member 148 During the placement, as the tubular member 148 expands, it exhibits considerable stiffness and no foreshortening thereby reducing the chance of incorrect placement due to the influence of blood pressure or changes in length as can occur with other self-expanding fabric, foil and wire stents introduced into this site.
- the second deployment catheter 170 and the guidewire 180 are withdrawn, completing the procedure for positioning the two piece intraluminal graft prosthesis of the invention.
- the self expansion of the second graft prosthesis 140 simplifies the withdrawal of these components from the graft lumen 150 and the smaller leg lumen and leg opening 120.
- FIG. 11 it is a perspective view of a first arrangement for restraining the waist opening stent 124 in an elongated manner when the first graft prosthesis 110 is collapsed over the first deployment catheter 160.
- FIG. 12 is a detail view of the release mechanism of the first arrangement of FIG. 11 for releasing the waist opening stent 124 when positioned in the fourth step of FIG. 7.
- the waist opening stent 124 is formed of a single wire coil spring that is flexible enough to be compressed or collapsed into an elongated oval and restrained by a suture or thread 182.
- the thread 182 is wrapped around the collapsed coil spring and the outer surface of the fabric continuous side wall 112 in double strands and looped over the end 184 of an elongated release pin 186 extending down a lumen of the first deployment catheter 160.
- the waist opening stent 124 formed of the closely wound coil spring is enclosed in a draw string type loop or channel created in the graft material at the waist opening border. As shown in FIG.
- the release pin distal end 184 is accessible through a recess 190 in the release pin lumen 192 of the first deployment catheter 160, and the end loop 188 of the thread 182 is fitted over it.
- the double strands of the thread 182 extend proximally through a further lumen (or the guide wire lumen) of deployment catheter 160 and out the proximal end thereof.
- FIGs. 13 and 14 show an alternative arrangement for creating the waist opening stent 124 surrounding the waist opening 114 and the manner of restraining the stent 124 in an elongated manner when the first graft prosthesis 110 is collapsed over the first deployment catheter 160.
- the waist opening stent 124 is preferably formed of two lengths of straight, closely wound coil springs 224 and 226 that extend in overlapping manner alongside one another and are folded about their mid-points.
- a first fabric loop or channel 250 is formed in the fabric continuous side wall 112 and extends around the waist opening 114 to receive the coil spring 224.
- FIG. 13 and 14 show an alternative arrangement for creating the waist opening stent 124 surrounding the waist opening 114 and the manner of restraining the stent 124 in an elongated manner when the first graft prosthesis 110 is collapsed over the first deployment catheter 160.
- the waist opening stent 124 is preferably formed of two lengths of straight, closely wound coil springs 224 and 226 that extend in
- each coil spring 224 is secured in end pockets 252 and 254 of the first channel 250 extending away from one end of the elongated waist opening 114 formed in the fabric continuous side wall 112.
- a second fabric loop or channel 260 is formed to extend in parallel with the first channel 250 and terminate in a further pair of end pockets (not shown) extending away from the opposite end of the elongated waist opening 114 as shown in FIG. 13.
- the mid points of each coil spring 224, 226 are exposed at channel end openings, e.g. channel end openings 266 and 268 of the second channel 260 depicted in FIG. 14.
- the ends of the first and second coils 224, 226 are slipped into the respective channel end openings and extended through channels 250, 260 until the coil ends are fitted into the end pockets for each channel.
- the resulting configuration is similar to two partially overlapping horseshoes in which the apex of each shoe opposes the other and lies over the leg ends of the other shoe.
- the two coil springs 224, 226 When released from the collapsed position shown in FIG. 13, the two coil springs 224, 226 assume overlapping circular shapes and draw their respective free ends toward one another, thereby forming the circular seat in the waist opening 114.
- the release pin 186 is retracted proximally so that the release pin distal end 186 releases the end loop 188.
- the coil spring or springs 224, 226 forming the waist opening stent 124 then spring into the circular configuration providing the seat for the second graft prosthesis 140.
- the looped restraining thread 182 is then drawn out through the lumen in the first deployment catheter 160.
- This method may be employed at other bifurcated vessel sites in the body where aneurysms occur.
- Different sized first and second graft prostheses 110, 140 and related deployment catheters may be necessary for specific sites, although the high ratio of expansion may suffice for a wide range of vessel lumens.
- the above described method preferably employs the self-expanding second graft prosthesis 140 and the self-expanding stents 124, 126, 128 of the first graft prosthesis, it will be understood that the method may be employed to position a first graft prosthesis having leg opening stents, for example, that are not self-expanding and are expanded by the deployment catheter and/or employ active fixation mechanisms.
- the deflated balloon would be more difficult to withdraw through the first and second graft prostheses lumens and could catch and dislodge the tubular member 148 or tear, leaving a fragment that could and create an embolism. Consequently, the above-described embodiments are preferred for this reason and for other reasons of size and convenience of installation.
- the described method employs deployment catheters optionally with introducer catheters and restraining mechanisms for placing the first and second graft prostheses in the collapsed state and release mechanisms for allowing the self-expansion thereof of the type described in the above-incorporated '294 and '473 patents
- other mechanisms may be employed to perform these functions.
- simpler introducer catheters may be employed with the collapsed first and second prostheses simply collapsed within the introducer catheter lumens and then expelled from the lumens by a pusher mechanism.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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AU40469/97A AU4046997A (en) | 1996-07-29 | 1997-07-28 | Two-piece, bifurcated intraluminal graft for repair of aneurysm |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/681,906 US5676697A (en) | 1996-07-29 | 1996-07-29 | Two-piece, bifurcated intraluminal graft for repair of aneurysm |
US08/681,906 | 1996-07-29 |
Publications (1)
Publication Number | Publication Date |
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WO1998004212A1 true WO1998004212A1 (en) | 1998-02-05 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/US1997/013187 WO1998004212A1 (en) | 1996-07-29 | 1997-07-28 | Two-piece, bifurcated intraluminal graft for repair of aneurysm |
Country Status (3)
Country | Link |
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US (1) | US5676697A (en) |
AU (1) | AU4046997A (en) |
WO (1) | WO1998004212A1 (en) |
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US5676697A (en) | 1997-10-14 |
AU4046997A (en) | 1998-02-20 |
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