Endoluminal prosthetic bifurcation shunt

• US 6,102,938 A
• Filed: 06/17/1997
• Issued: 08/15/2000
• Est. Priority Date: 06/17/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: De Cicco, Dino, Tolomeo, Deborah, Kinney, Edward V., Evans, Michael A., Coombs, Craig J.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/877,151
• Time in Patent Office: 1,155 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/90 characterised by a net-like or mesh-like structure
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Methods, systems, and devices seal off the branch port of a bifurcated endoluminal prosthesis to transform the bifurcated prosthesis to a single-lumen prosthesis. These methods and devices are available for fallback procedures when the deployment of a bifurcated endoluminal prosthesis is found to be impracticable. By effectively sealing off the second branch port, the attending physician is able to completely isolate an aneurysm or other disease of the vasculature. Where it is necessary and/or desirable to provide fluid communication between the trunk lumen and the second branch lumen, a separate passage may be provided between the first and second branches of the body lumen system.

Claims

1. A shunt for use with a bifurcated tubular endoluminal prosthesis, the bifurcated prosthesis having a branch lumen in fluid communication with a trunk lumen and a branch port disposed therebetween, the shunt comprising:

a substantially impermeable membrane; and

a support structure capable of affixing the impermeable membrane within the bifurcated prosthesis so that the impermeable membrane blocks fluid communication between the trunk lumen and the branch port of the bifurcated prosthesis, wherein the shunt will not substantially occlude fluid communication between the trunk lumen and the branch lumen when the membrane is affixed within the prosthesis by the support structure.

2. A shunt as claimed in claim 1, wherein the support structure comprises a radially expandable tubular body.

3. A shunt as claimed in claim 2, wherein the tubular body comprises a perforate frame, and wherein the membrane comprises a liner supported by the frame.

4. A shunt as claimed in claim 3, wherein the membrane is formed integrally with the tubular body.

5. A shunt as claimed in claim 3, wherein a trunk end of the shunt seals radially against the trunk lumen of the bifurcated prosthesis when expanded therein.

6. A shunt as claimed in claim 5, wherein a branch end of the shunt opposite the trunk end seals radially against the branch lumen of the bifurcated prosthesis when expanded therein.

7. A shunt as claimed in claim 3, wherein a branch end of the shunt is capable of sealing radially against a surrounding lumen having a branch cross-section, and wherein a trunk end of the shunt opposite the branch end is capable of sealing radially against a surrounding lumen having a trunk cross-section which is at least twice as large as the branch cross-section.

8. A shunt as claimed in claim 7, wherein a length of the shunt between the branch end and the trunk end is longer than the bifurcated prosthesis, and wherein the ends of the prosthesis are adapted to seal atraumatically against a surrounding body lumen.

9. A shunt as claimed in claim 2, wherein the shunt has a shunt lumen which tapers between a trunk cross-section within the trunk lumen and a branch cross-section within the branch lumen when the shunt is deployed within the bifurcated prosthesis.

10. A system for repairing a diseased body lumen system, the repair system comprising:

a bifurcated tubular endoluminal prosthesis having a trunk portion with a trunk lumen, a first branch portion having a first branch lumen, and a second branch port in fluid communication with the trunk lumen; and

a shunt including a substantially impermeable membrane and a support structure capable of affixing the impermeable membrane to the bifurcated prosthesis so that the impermeable membrane blocks fluid communication between the trunk lumen and the second branch port of the bifurcated prosthesis.

11. A repair system as claimed in claim 10, wherein the support structure comprises a tubular, radially expandable body.

12. A repair system as claimed in claim 11, wherein the tubular body comprises a perforate frame, and wherein the membrane comprises a liner supported by the frame.

13. A repair system as claimed in claim 11, wherein the membrane is formed integrally with the tubular body.

14. A repair system as claimed in claim 11, wherein a trunk end of the shunt is adapted to seal radially against at least one of the trunk lumen of the bifurcated prosthesis and the trunk lumen of the body lumen system when expanded therein.

15. A repair system as claimed in claim 14, wherein a branch end of the shunt opposite the trunk end is adapted to seal radially against at least one of the branch lumen of the bifurcated prosthesis and the trunk lumen of the body lumen system when expanded therein.

16. A repair system as claimed in claim 15, wherein the branch end of the shunt is capable of sealing radially against a surrounding lumen having a branch cross-section, and wherein the trunk end of the shunt is capable of sealing radially against a surrounding lumen having a trunk cross-section which is at least twice as large as the branch cross-section.

17. A repair system as claimed in claim 10, further comprising a branch tubular prosthesis having an end which sealingly engages the branch port of the bifurcated prosthesis when expanded therein.

18. A repair system as claimed in claim 10, wherein the assembled system provides a prosthetic lumen system which tapers smoothly from the trunk portion to the branch portion so as to minimize stagnation of lumenal flow.

19. A repair system as claimed in claim 10, wherein the shunt comprises a frame which expands within at least one of the trunk portion and the branch port of the bifurcated prosthesis to a cross-section which is larger than a branch cross-section of the branch lumen so as to stabilize the position of the shunt.

20. A method for repairing a bifurcated body lumen system, the method comprising:

inserting a bifurcated prosthesis into the lumen system so that a first lumen of the of the prosthesis sealingly engages a first lumen of the body system, so that a second lumen of the prosthesis sealingly engages a second lumen of the body lumen system, and so that a port of the prosthesis is adjacent a third lumen of the body lumen system, wherein the port is reversibly sealed to substantially prevent flow through the port.

21. A method as claimed in claim 20, further comprising opening the port in situ to provide fluid communication between the first lumen and the third lumen of the body lumen system.

22. A method as claimed in claim 21, further comprising inserting a balloon catheter into the sealed port, plastically expanding the port with the balloon, and deploying a branch prosthesis within the expanded port.

23. A bifurcated endoluminal prosthesis comprising:

a tubular body which is radially expandable from a narrow configuration for endoluminal introduction to a large configuration, the body in the large configuration having a first lumen, a second lumen in fluid communication with the first lumen, and a reversibly sealed port disposed between the first lumen and the second lumen.

24. A bifurcated prosthesis as claimed in claim 23, wherein the port is capable of receiving a branch tubular prosthesis therein so as to provide fluid communication between the first lumen and a branch lumen of the branch prosthesis.

25. A bifurcated prosthesis as claimed in claim 23, wherein the tubular body comprises a resilient structure which radially expands when released in a body lumen, and wherein the port is plastically expandable after the tubular body is deployed in situ.

26. A system for repairing a diseased body lumen, the system comprising:

a bifurcated endoluminal prosthesis having a port disposed between and in fluid communication with first and second lumens, the prosthesis radially expandable from a narrow configuration for introduction into the body lumen to a larger deployed configuration;

an occluder disposable in the port of the deployed prosthesis so as to substantially seal the port.

27. A system as claimed in claim 26, wherein the occluder is adapted to provide a smooth transition from within the prosthesis from the first lumen to the second lumen.

28. An endoluminal prosthetic system comprising:

a first prosthetic module having a first tubular body and a first imageable marker having a first image forming property;

a second prosthetic module having a second tubular body which can expand radially to engage the first tubular body, and a second imageable marker having a second image forming property different from said first image forming property, said second imageable marker adapted to provide an image which is different than an image of the first marker.

29. A system for occluding a body lumen, the system comprising:

a tubular frame having a proximal end, a distal end and a longitudinal axis, the frame resiliently expandable from a narrow configuration to a wide configuration within the body lumen; and

a liner supported by the frame, the liner adapted to occlude the body lumen when the frame is in the wide configuration, the liner extending longitudinally axially beyond the frame when the frame is in the narrow configuration.

30. A system as claimed in claim 29, further comprising:

a sheath having a lumen which receives the frame and liner, the sheath radially restraining the frame in the narrow configuration with the liner extending distally beyond the frame; and

an inner member having a guidewire lumen disposed within the sheath, the inner member extending distally through the frame and liner, the sheath and inner member withdrawable proximally from the liner and frame when the frame is radially expanded within the body lumen, the liner adapted to seal when the inner member is withdrawn.

31. A system for occluding a body lumen, the system comprising:

a tubular frame having a proximal end, a distal end, and an axis, the frame resiliently expandable from a narrow configuration to a wide configuration within the body lumen;

a liner supported by the frame, the liner adapted to occlude the body lumen when the frame is in the wide configuration, the liner extending axially beyond the frame when the frame is in the narrow configuration;

a sheath having a lumen which receives the frame and liner, the sheath radially restraining the frame in the narrow configuration with the liner extending distally beyond the frame;

an inner member having a guidewire lumen disposed within the sheath, the inner member extending distally through the frame and liner, the sheath and inner member withdrawable proximally from the liner and frame when the frame is radially expanded within the body lumen, the liner adapted to seal when the inner member is withdrawn; and

an expandable atraumatic tip at the distal end of the sheath, the tip comprising a plurality of deformable segments which separate radially when the frame moves distally from within the lumen of the sheath.