Repositionable endoluminal support structure and its applications

• US 8,226,707 B2
• Filed: 04/15/2010
• Issued: 07/24/2012
• 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, William H.
• Application Number:
  US12/761,295
• Publication Number:
  US 20110066224A1
• Time in Patent Office: 831 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 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An endoluminal support structure includes strut members interconnected by swivel 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. A medical device configured for passage through a biological lumen of a patient, comprising:

a plurality of strut members, comprising;

discrete elongated inner strut members; and

discrete elongated outer strut members interlinked to the plurality of elongated inner strut members by a plurality of swivel joints to form a shaped structure comprising a compressed orientation and an expanded orientation;

wherein each inner strut member is interlinked with at least three outer strut members and none of the inner strut members are interlinked to another inner strut member; and

wherein each outer strut member is interlinked with at least three inner strut members and none of the outer strut members is interlinked to another outer strut member, and wherein at each swivel joint, the inner strut members are located closer to a central axis of the apparatus than the outer strut members.

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

3. The apparatus of claim 1, wherein a swivel joint forms a scissor mechanism with an inner strut member and an outer strut member.

4. The apparatus of claim 3, wherein the inner strut members and the outer strut members are arranged as a series of linked scissor mechanisms.

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

6. The apparatus of claim 5, wherein the prosthetic valve comprises:

a first structural member coupled to the plurality of strut members;

a second structural member rotatable relative to the first structural member; and

a plurality of pliable valve members connecting the first structural member with the second structural member such that rotation of the second structural member relative to the first structural member urges the valve members between an open and a closed state.

7. The apparatus of claim 6, wherein the rotation of the second structural member is responsive to the natural flow of a biological fluid.

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

9. The apparatus of claim 8, wherein the prosthetic valve includes a skirt material coupled to the strut members.

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

11. A medical stent, comprising:

a plurality of elongated strut members, including inner strut members and outer strut members; and

articulations connecting the inner strut members and the outer strut members such that;

each inner strut member comprises articulations with three outer strut members;

none of the inner strut members comprises articulations with another inner strut member;

each outer strut member comprises articulations with three inner strut members; and

none of the outer strut members comprises articulations with another outer strut member, and wherein at each articulation, when the stent is at a maximally expanded orientation, the inner strut members are located closer to a central axis of the stent than the outer strut members.

12. The stent of claim 11, wherein the articulation form scissor mechanisms with the inner strut members and the outer strut members.

13. The stent of claim 12, wherein at least one articulation bisects an inner strut member and an outer strut member.

14. The stent of claim 12, wherein the plurality of strut members are arranged as a series of linked scissor mechanisms.

15. The stent of claim 11, wherein at least one articulation interconnects a first end of an inner strut member with a first end of an outer strut member.

16. The stent of claim 11, further comprising an adjustment mechanism to exerting a force to urge the plurality of strut members about the articulations within a range of motion.

17. The stent of claim 11, wherein the inner and outer strut members are non-linear.

18. The stent of claim 11, further comprising a prosthetic valve coupled to the plurality of strut members.

19. The stent of claim 18, wherein the prosthetic valve comprises:

a first structural member coupled to the plurality of strut members;

a second structural member rotatable relative to the first structural member; and

a plurality of pliable valve members connecting the first structural member with the second structural member such that rotation of the second structural member relative to the first structural member urges the valve members between an open and a closed state.

20. The stent of claim 19, wherein the rotation of the second structural member is responsive to the natural flow of a biological fluid.

21. The stent of claim 18, wherein the prosthetic valve includes a plurality of pliable valve leaflets having commissures at the intersection of two strut members.

22. The stent of claim 21, wherein the prosthetic valve includes a skirt material coupled to the plurality of strut members.

23. The stent of claim 11, wherein the plurality of strut members are arranged to form one of a cylindrical, a conical, or an hourglass shape.

24. The stent of claim 16, wherein the adjustment mechanism is a screw mechanism.

25. The stent of claim 24, wherein the screw mechanism is permanently attached to the plurality of strut members.

26. The stent of claim 11, wherein the stent is coupled to a catheter.