Bifurcated multicapsule intraluminal grafting system and method

• US 5,628,783 A
• Filed: 05/12/1994
• Issued: 05/13/1997
• Est. Priority Date: 04/11/1991
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Baker, Steve G., Williams, Richard S., Johansson, Peter K., Piplani, Alec A., Quiachon, Dinah B.
• Primary Examiner(s): Clarke, Robert A.
• Application Number:
  US08/241,476
• Time in Patent Office: 1,097 Days
• Field of Search: 606/194, 606/195, 606/150, 623/1, 623/2
• US Class Current: 623/1.35
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An intraluminal grafting system having a balloon catheter assembly, a capsule catheter assembly and capsule jacket assembly is used for deploying in the vessel of an animal body a bifurcated graft having a plurality of attachment systems. The deployment catheters contain an ipsilateral capsule assembly, a contralateral capsule assembly and a distal capsule assembly, wherein the attachment systems of the bifurcated graft are disposed within the three capsule assemblies. A removable sheath of the capsule jacket assembly covers the bifurcated graft and capsule assemblies to provide a smooth transition along the length of the deployment catheters. The bifurcated graft is comprised of a main tubular member and two tubular legs, having attachment systems with wall engaging members secured to the superior end of the main tubular member and the inferior ends of the tubular legs. An inflatable membrane configured on the balloon catheter is used to firmly implant the attachment systems within the vessel. The bifurcated graft and attachment systems are configured to remain in the vessel after the deployment catheters are withdrawn. The method of use of the present intraluminal grafting system is also disclosed, for example, for deploying a bifurcated graft proximate the abdominal aortic bifurcation.

Claims

1. A prosthesis having a bifurcation for repairing an aortic aneurysm close to or involving the aortic bifurcation having an arterial wall and comprising the aorta and the first and second iliac arteries extending therefrom and in fluid communication therewith in a patient, the prosthesis comprising:

a main tubular body;

first and second tubular legs joined to said main tubular body in a bifurcation, said main tubular body and said first and second tubular legs being formed of a flexible surgically implantable material, said main tubular body and said first and second tubular legs having respectively first, second and third openings therein in fluid communication with each other;

first expandable attachment means for anchoring said main tubular body, said first attachment means being secured to said main tubular body adjacent the first opening;

second expandable attachment means for anchoring said first tubular leg, said second attachment means being secured to said first tubular leg adjacent the second opening; and

third expandable attachment means for anchoring said second tubular leg, said third attachment means being secured to said second tubular leg adjacent the third opening,

wherein said prosthesis is configured with said first, second, and third attachment means prior to insertion into the patient'"'"'s vasculature and is capable of intraluminal implantation by a catheter into the aortic bifurcation through the first iliac artery such that said main tubular body can be anchored by said first attachment means in the aorta, said first tubular leg can be anchored by said second attachment means in the first iliac artery, and said second tubular leg can be anchored by said third attachment means in the second iliac artery.

2. The prosthesis as in claim 1, wherein said first, second and third attachment means are each in the form of a self-expanding attachment system having outwardly disposed wall engaging members.

3. The prosthesis as in claim 1, wherein said main tubular body includes a plurality of radiopaque markers spaced longitudinally along said main tubular body, such that twisting of the main tubular body may be detected by viewing the radiopaque markers by fluoroscopy.

4. The prosthesis as in claim 1, further comprising a plurality of longitudinally spaced apart radiopaque markers carried by each of said first and second tubular legs, wherein twisting of said tubular legs may be detected by viewing said radiopaque markers by fluoroscopy.

5. An intraluminal graft deployed using a catheter in the vasculature of a patient, the intraluminal graft comprising:

support means for reinforcing a vasculature of a patient, said support means having a main tubular member, a first tubular leg and a second tubular leg in fluid communication with the vasculature;

first, second and third anchoring means for attaching the main tubular member, the first tubular leg and the second tubular leg, respectively, to the vasculature; and

means for resisting kinking in the first tubular leg and in the second tubular leg;

wherein said prosthesis is configured with said first, second, and third anchoring means prior to insertion into the patient'"'"'s vasculature.

6. The intraluminal graft of claim 5, wherein said means for resisting kinking comprises a plurality of crimps configured in the first tubular leg and in the second tubular leg.

7. The intraluminal graft of claim 5, wherein said means for resisting kinking comprises at least one medial attachment system secured within the first tubular leg and at least one medial attachment system secured within the second tubular leg.

8. An intraluminal graft for permanent implantation in a patient'"'"'s vasculature for repairing the vasculature proximate to a bifurcation in the vasculature, the intraluminal graft being intraluminally deployed into the vasculature using a catheter, the intraluminal graft comprising:

a main tubular body having a superior end and configured to reside proximate a bifurcation in a vasculature of a patient, the bifurcation forming a first vessel and a second vessel;

a first tubular member having an inferior end and joined to and in fluid communication with said main tubular body, said first tubular member configured to extend into the first vessel;

a second tubular member having an inferior end and joined to and in fluid communication with said main tubular body, said second tubular member configured to extend distally into the second vessel;

a first attachment system secured to the superior end of said main tubular body;

a second attachment system secured to the inferior end of said first tubular member; and

a third attachment system secured to the inferior end of said second tubular member;

wherein said prosthesis is configured with said first, second, and third attachment systems prior to insertion into the patient'"'"'s vasculature.

9. The intraluminal graft of claim 8, further comprising a plurality of crimps configured in the first tubular member and in the second tubular member.

10. The intraluminal graft of claim 8, wherein said first attachment system, said second attachment system and said third attachment system each include a plurality of support members and a plurality of wall engaging members, each support member having two legs joined to form an apex, each leg being joined to the legs of adjacent support members to form a circular arrangement of support members about a central axis and operable between a first collapsed position and a second expanded position.

11. The intraluminal graft of claim 10, wherein the support members of said attachment systems further include a first helical spring and a second helical spring.

12. The intraluminal graft of claim 8, wherein the support members of said attachment systems are formed from a non-round wire.

13. The intraluminal graft of claim 8, further comprising means for reducing blood leakage near the superior end of the main tubular body.

14. The intraluminal graft of claim 13, wherein said means for reducing blood leakage near the superior end of the main tubular body is formed from a segment of biocompatible fiber.

15. A system for implanting a prosthesis in a corporeal lumen having a wall, said system comprising:

a bifurcated graft having a superior end, an ipsilateral inferior end and a contralateral inferior end, said bifurcated graft having an attachment system located at each of the superior and inferior ends;

a capsule catheter having an elongate tubular member having proximal and distal ends, said capsule catheter having an ipsilateral capsule positioned at the distal end of the elongate tubular member;

a balloon catheter disposed within said capsule catheter, said balloon catheter including a second elongate tubular member having proximal and distal ends, an inflatable member positioned proximal the distal end of the second elongate tubular member, and a distal capsule positioned proximate the distal end of the second elongate tubular member; and

a contralateral capsule assembly positionable proximate the ipsilateral capsule of said capsule catheter, said contralateral capsule assembly including a contralateral capsule,

wherein the superior end of said bifurcated graft is removably retained in the distal capsule, the ipsilateral inferior end is removably retained in the ipsilateral capsule and the contralateral inferior end is removably retained in the contralateral capsule.

16. The system as recited in claim 15, further comprising a capsule jacket slidably positioned coaxially with said capsule catheter and said balloon catheter, wherein the capsule jacket is of sufficient length to cover the ipsilateral capsule, the contralateral capsule and at least a portion of the distal capsule.

17. The system as recited in claim 15, further comprising:

a control wire slidably disposed in a lumen of the second elongate tubular member, the control wire having a proximal end and a distal end secured to the distal capsule; and

control means connected to the proximal end of the control wire for moving the distal capsule relative to the second elongate tubular member.

18. The system as recited in claim 17, wherein said balloon catheter further comprises a proximal cap secured to the second elongate tubular member, wherein the proximal cap is configured and positioned to be slidably retained within the distal capsule.

19. The system as recited in claim 15, wherein said contralateral capsule assembly further includes a guiding tube having a distal end secured to the contralateral capsule and a pull wire disposed within a lumen of the guiding tube, wherein the pull wire has a distal end configured with a locking ball for retaining within the contralateral capsule the attachment system located at the contralateral inferior end of the bifurcated graft.

20. The system of claim 15, wherein said balloon catheter further comprises retaining means for engaging the attachment system located at the ipsilateral inferior end of said bifurcated graft, the retaining means being slidably disposed on the second elongate tubular member proximal the inflatable member.

21. The system of claim 20, wherein said balloon catheter further comprises locking means fixedly positioned on the second elongate tubular member proximal the retaining means for preventing longitudinal movement of the retaining means.

22. A system for implanting a prosthesis proximate an aortic bifurcation having an aneurism, said system comprising:

a bifurcated graft having a superior end, an ipsilateral inferior end and a contralateral inferior end, said bifurcated graft having an attachment system located at each of the superior and inferior ends;

a capsule catheter having an elongate tubular member having proximal and distal ends, said capsule catheter having an ipsilateral capsule positioned at the distal end of the elongate tubular member;

a balloon catheter disposed within said capsule catheter, said balloon catheter including a second elongate tubular member having proximal and distal ends, an inflatable member positioned proximal the distal end of the second elongate tubular member, and a distal capsule positioned proximate the distal end of the second elongate tubular member;

a contralateral capsule assembly positionable proximate the ipsilateral capsule of said capsule catheter, said contralateral capsule assembly including a contralateral capsule; and

a capsule jacket slidably positioned coaxially with said capsule catheter and said balloon catheter and covering at least a portion of said contralateral capsule assembly, wherein said capsule jacket is of sufficient length to cover both the ipsilateral capsule and at least a portion of the distal capsule such that the superior end of said bifurcated graft is removably retained in the distal capsule, the ipsilateral inferior end is removably retained in the ipsilateral capsule and the contralateral inferior end is removably retained in the contralateral capsule.

23. A system for placing a bifurcated graft in a lumen formed by a wall proximate an aortic bifurcation having an aneurism, said system comprising:

a bifurcated graft having a superior extremity, an ipsilateral inferior extremity and a contralateral inferior extremity, said bifurcated graft being deformable between a collapsed condition and an expanded condition;

first anchoring means secured to the superior extremity of said bifurcated graft for attaching the superior extremity of said bifurcated graft to the lumen wall;

second anchoring means secured to the ipsilateral inferior extremity of said bifurcated graft for attaching the ipsilateral inferior extremity of said bifurcated graft to the lumen wall;

third anchoring means secured to the contralateral inferior extremity of said bifurcated graft for attaching the contralateral inferior extremity of said bifurcated graft to the lumen wall;

a distal capsule assembly for covering said first anchoring means;

an ipsilateral capsule assembly for covering said second anchoring means;

a contralateral capsule assembly for covering said third anchoring means, wherein at least a portion of said bifurcated graft between said first, second and third anchoring means remains uncovered by the capsules;

a removable sleeve of a flexible material, said removable sleeve configured to extend over said inferior capsule assembly, said bifurcated graft and at least a portion of said contralateral capsule assembly and said distal capsule assembly, wherein a smooth transition is provided between said ipsilateral capsule assembly, said contralateral capsule assembly and said distal capsule assembly;

a first catheter including a balloon secured to a first flexible elongate shaft having an inflation lumen in fluid communication with the balloon, said first catheter being capable of moving the balloon within said bifurcated graft and into engagement with said first anchoring means and with said second anchoring means;

a control wire having a proximal end and a distal end secured to the distal capsule assembly, the shaft of the first catheter being provided with a control wire lumen for slidably retaining the control wire, wherein the distal capsule assembly moves relative to the shaft by movement of the proximal end of the control wire; and

a second catheter including a second flexible elongate shaft having a proximal end positioned distal the proximal end of the first shaft of said first catheter and having a distal end secured to the ipsilateral capsule assembly, such that movement of said second catheter may move said ipsilateral capsule assembly without moving said distal capsule assembly,

wherein the first shaft of said first catheter is coaxially disposed within the second shaft of said second catheter, said removable sleeve being coaxially disposed over both the first shaft the second shaft.

24. The system as recited in claim 23, wherein said contralateral capsule assembly further includes a contralateral capsule, a guiding tube having a distal end secured to the contralateral capsule and a pull wire disposed within a lumen of the guiding tube, wherein the pull wire has a distal end configured with a locking ball for retaining the third anchoring means within the contralateral capsule.