Repositionable endoluminal support structure and its applications

• US 9,039,756 B2
• Filed: 03/22/2011
• Issued: 05/26/2015
• Est. Priority Date: 07/21/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Jenesis Surgical LLC
• Inventors: White, Jennifer K.
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/069,037
• Publication Number:
  US 20110230956A1
• Time in Patent Office: 1,526 Days
• Field of Search: 623/1.11, 623 115- 116, 623 124- 126, 623 21- 219, 623/2.38
• US Class Current: 623/1.24
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Claims

1. An implantable medical apparatus, comprising:

a plurality of pivot joints; and

a plurality of elongated strut members comprising a first set of strut members and a second set of strut members, each set comprising a plurality of inner strut members and a plurality of outer strut members, wherein the first set is interlinked by a subset of the plurality of pivot joints to form a chain of alternating inner and outer strut members, and the second set is interlinked by a subset of the plurality of pivot joints to form a chain of alternating inner and outer strut members,

wherein at least one of the inner strut members of the first set is interlinked by one of the plurality of pivot joints to at least one of the outer strut members of the second set,

wherein the plurality of pivot joints cooperate with the plurality of elongated strut members to adjustably define a tubular shaped structure between a compressed orientation and an expanded orientation,

and wherein the tubular shaped structure has a longitudinal axis, and wherein all of the inner strut members are located closer to the longitudinal axis of the shaped structure than all of the outer strut members.

2. The apparatus of claim 1, further comprising an actuation mechanism to urge the plurality of pivot joints within a range of motion.

3. The apparatus of claim 1, wherein a pivot joint of the plurality of pivot joints forms a scissor mechanism with a first strut member of the plurality of elongated strut members and a second strut member of the plurality of elongated strut members.

4. The apparatus of claim 1, further comprising a prosthetic valve coupled to the shaped structure.

5. The apparatus of claim 4, wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures at the intersection of two of the plurality of elongated strut members.

6. The apparatus of claim 5, wherein the prosthetic valve includes a skirt material coupled to the shaped structure.

7. The apparatus of claim 1, wherein the shaped structure is one of a cylindrical, a conical, or an hourglass shape.

8. A tubular medical stent having a longitudinal axis and implantable within a biological lumen, comprising:

a plurality of elongated strut members, comprising a first set of strut members and a second set of strut members, each set comprising a plurality of inner strut members and a plurality of outer strut members, wherein all of the inner strut members are located closer to the longitudinal axis of the stent than all of the outer strut members;

a plurality of pivot joints, wherein a subset of the plurality of pivot joints connects the first set of strut members to form a chain of alternating inner and outer strut members, and a subset of the plurality of pivot joints connects the second set of strut members to form a chain of alternating inner and outer strut members; and

at least one pivot joint of the plurality of pivot joints connecting a strut member of the first set of strut members to a strut member of the second set of strut members.

9. The stent of claim 8, wherein the at least one pivot joint of the plurality of pivot joints connecting a strut member of the first set of strut members to a strut member of the second set of strut members bisects the strut member of the first set of strut members and the strut member of the second set of strut members.

10. The stent of claim 8, wherein each of the plurality of pivot joints connecting the first set of strut members to form a chain of alternating inner and outer strut members connects a first end of an inner strut member with a first end of an outer strut member.

11. The stent of claim 8, further comprising an adjustment mechanism to exert a force to urge the plurality of elongated strut members about the plurality of pivot joints within a range of motion.

12. The stent of claim 8, wherein the plurality of elongated strut members are curved.

13. The stent of claim 8, further comprising a prosthetic valve coupled to the shaped structure.

14. The stent of claim 13, wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures, wherein each commissure is at the intersection of two strut members of the plurality of elongated strut members.

15. The stent of claim 14, wherein the prosthetic valve includes a skirt material coupled to the shaped structure.

16. The stent of claim 8, wherein the plurality of elongated strut members are arranged to form one of a cylindrical, a conical, or an hourglass shape.

17. A prosthetic valve assembly implantable within a biological lumen, comprising:

a tubular support structure having a longitudinal axis, comprising a plurality of pivot joints and a plurality of elongated strut members comprising a first set of strut members and a second set of strut members, each set comprising a plurality of inner strut members and a plurality of outer strut members, wherein the first set is interlinked by a subset of the plurality of pivot joints to form a chain of alternating inner and outer strut members, and the second set is interlinked by a subset of the plurality of pivot joints to form a chain of alternating inner and outer strut members,

wherein all of the inner strut members are located closer to the longitudinal axis of the support structure than all of the outer strut members,

wherein at least one of the inner strut members of the first set of strut members is interlinked by one of the plurality of pivot joints to at least one of the outer strut members of the second set of strut members,

and wherein the plurality of pivot joints cooperate with the plurality of elongated strut members to adjustably define a shaped structure between a compressed orientation and an expanded orientation; and

a prosthetic valve connected to the support structure.

18. The assembly of claim 17, further comprising an actuation mechanism to urge the plurality of pivot joints within a range of motion.

19. The assembly of claim 17, wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures, wherein each commissure is at the intersection of two strut members of the plurality of elongated strut members.

20. The assembly of claim 19, wherein the prosthetic valve includes a skirt material coupled to the support structure.

21. The assembly of claim 17, wherein the shaped structure is one of a cylindrical, a conical, or an hourglass shape.

22. A prosthetic valve assembly implantable within a biological lumen, comprising:

a tubular medical stent having a longitudinal axis, comprising;

a plurality of elongated strut members, comprising a first set of strut members and a second set of strut members, each set comprising a plurality of inner strut members and a plurality of outer strut members, wherein all of the inner strut members are located closer to the longitudinal axis of the stent than all of the outer strut members;

a plurality of pivot joints, wherein a subset of the plurality of pivot joints connects the first set of strut members to form a chain of alternating inner and outer strut members, and a subset of the plurality of pivot joints connects the second set of strut members to form a chain of alternating inner and outer strut members, and

wherein at least one pivot joint of the plurality of pivot joints connects a strut member of the first set of strut members to a strut member of the second set of strut members; and

a prosthetic valve connected to the medical stent.

23. The assembly of claim 22, wherein the at least one pivot joint of the plurality of pivot joints connecting a strut member of the first set of strut members to a strut member of the second set of strut members bisects the strut member of the first set of strut members and bisects the strut member of the second set of strut members.

24. The assembly of claim 22, wherein each pivot joint of the subset of the plurality of pivot joints connecting the first set of strut members to form a chain of alternating inner and outer strut members connects a first end of an inner strut member with a first end of an outer strut member.

25. The assembly of claim 22, further comprising an adjustment mechanism to exert a force to urge the plurality of elongated strut members about the plurality of pivot joints within a range of motion.

26. The assembly of claim 22, wherein the plurality of elongated strut members are curved.

27. The assembly of claim 22, wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures, wherein each commissure is at the intersection of two strut members of the plurality of elongated strut members.

28. The assembly of claim 27, wherein the prosthetic valve includes a skirt material coupled to the medical stent.

29. The assembly of claim 22, wherein the plurality of elongated strut members are arranged to form one of a cylindrical, a conical, or an hourglass shape.