Prosthetic heart valves, scaffolding structures, and systems and methods for implantation of same

• US 20050203617A1
• Filed: 02/25/2005
• Published: 09/15/2005
• Est. Priority Date: 02/27/2004
• Status: Active Grant

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: AorTx, Inc. (Johnson & Johnson)
• Inventors: Ginn, Richard, Heneveld, Scott, Forster, David C., Walsh, Brandon
• Granted Patent: US 8,430,925 B2
• Time in Patent Office: Days
• US Class Current: 623/2.140
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-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 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Claims

1. A prosthetic heart valve comprising:

a support member having a plurality of segments and at least one foldable junction member connecting two adjacent segments, the support member having an expanded state and a contracted state, and

a valvular body having a plurality of leaflets attached to said support member.

2. The prosthetic heart valve of claim 1, wherein said support member comprises at least three segments.

3. The prosthetic heart valve of claim 1, wherein each segment comprises a panel.

4. The prosthetic heart valve of claim 1, wherein said support member is generally tubular in the expanded state.

5. The prosthetic heart valve of claim 4, wherein said support member is generally cylindrical in the expanded state.

6. The prosthetic heart valve of claim 4, wherein said support member has a generally oval cross-sectional shape when the support member is in the expanded state.

7. The prosthetic heart valve of claim 1, wherein said foldable junction member comprises a hinge.

8. The prosthetic heart valve of claim 7, wherein said hinge comprises one of the following:

a mechanical hinge, a membrane hinge, or a living hinge.

9. The prosthetic heart valve of claim 8, wherein said hinge comprises a mechanical hinge having a removable pin.

10. The prosthetic heart valve of claim 1, wherein said support member further comprises an anchoring member.

11. The prosthetic heart valve of claim 10, wherein said anchoring member has a delivery position and a deployment position, and further comprising an actuator adapted to move said anchoring member from its delivery position to its deployment condition.

12. The prosthetic heart valve of claim 10, wherein said anchoring member has a delivery position and a deployment position, and wherein said anchoring member is self-actuating from its delivery position to its deployment position.

13. The prosthetic heart valve of claim 1, wherein at least one of said plurality of segments is inverted when the support member is in its contracted state.

14. The prosthetic heart valve of claim 13, wherein all of said plurality of segments are formed into a generally tubular shape when the support member is in its contracted state.

15. The prosthetic heart valve of claim 13, wherein each of said plurality of segments is inverted when the support member is in its contracted state, whereby each foldable junction member forms an elongated vertex.

16. The prosthetic heart valve of claim 15, wherein each pair of adjacent segments forms a lobe when the support member is in its contracted state.

17. The prosthetic heart valve of claim 1, wherein said plurality of leaflets of said valvular body are separate.

18. The prosthetic heart valve of claim 1, wherein said valvular body comprises animal tissue.

19. The prosthetic heart valve of claim 1, wherein said valvular body comprises human tissue.

20. The prosthetic heart valve of claim 1, wherein said plurality of leaflets of said valvular body comprise a coated substrate.

21. The prosthetic heart valve of claim 20, wherein said substrate comprises a mesh material.

22. The prosthetic heart valve of claim 20, wherein said valvular body comprises a substrate coated with a polymeric material.

23. The prosthetic heart valve of claim 22, wherein said polymeric material comprises polyurethane.

24. The prosthetic heart valve of claim 1, wherein said valvular body is attached to the interior of said support member.

25. A support member adapted to provide a scaffolding force to the interior of a body lumen comprising:

a plurality of peripheral segments and at least one foldable junction member connecting two adjacent peripheral segments, the support member having an expanded state having a first maximum cross-sectional dimension and a contracted state having a second maximum cross-sectional dimension, with the first maximum cross-sectional dimension being larger than the second maximum cross-sectional dimension.

26. The support member of claim 25, wherein said support member comprises at least three peripheral segments.

27. The support member of claim 25, wherein each peripheral segment comprises a panel.

28. The support member of claim 25, wherein the support member is generally tubular in the expanded state.

29. The support member of claim 28, wherein said support member is generally cylindrical in the expanded state.

30. The support member of claim 28, wherein said support member has a generally oval cross-sectional shape when the support member is in the expanded state.

31. The support member of claim 25, wherein said foldable junction member comprises a hinge.

32. The support member of claim 31, wherein said hinge comprises one of the following:

a mechanical hinge, a membrane hinge, or a living hinge.

33. The support member of claim 32, wherein said hinge comprises a mechanical hinge having a removable pin.

34. The support member of claim 25, further comprising an anchoring member.

35. The support member of claim 34, wherein said anchoring member has a delivery position and a deployment position, and further comprising an actuator adapted to move said anchoring member from its delivery position to its deployment condition.

36. The support member of claim 34, wherein said anchoring member has a delivery position and a deployment position, and wherein said anchoring member is self-actuating from its delivery position to its deployment position.

37. The support member of claim 25, wherein at least one of said plurality of peripheral segments is inverted when the support member is in its contracted state.

38. The support member of claim 37, wherein all of said plurality of peripheral segments are formed into a generally tubular shape when the support member is in its contracted state.

39. The support member of claim 37, wherein each of said plurality of peripheral segments is inverted when the support member is in its contracted state, whereby each foldable junction member forms an elongated vertex.

40. The support member of claim 39, wherein each pair of adjacent peripheral segments forms a lobe when the support member is in its contracted state.