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

• US 8,128,692 B2
• Filed: 02/25/2005
• Issued: 03/06/2012
• Est. Priority Date: 02/27/2004
• Status: Expired due to Fees

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: AorTx, Inc. (Johnson & Johnson)
• Inventors: Forster, David C., Heneveld, Scott, Walsh, Brandon, Ginn, Richard
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/067,330
• Publication Number:
  US 20050203615A1
• Time in Patent Office: 2,566 Days
• Field of Search: 623 211- 242
• US Class Current: 623/2.41
• 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 method for implanting a prosthetic heart valve, comprising:

inserting a prosthetic heart valve in a contracted state into the body of a patient, said prosthetic heart valve having a plurality of valve leaflets and a support structure, the support structure comprising a plurality of self-expandable metallic panels being different from and configured to support the plurality of valve leaflets and said contracted state including at least one of said panels of the prosthetic heart valve being in an inverted state,

introducing the prosthetic heart valve to a treatment site of a body lumen having a tissue wall, and

expanding the cross-sectional profile of the prosthetic heart valve into direct contact with the tissue wall of the body lumen, wherein expanding the cross-sectional profile comprises transitioning the at least one panel out of the inverted state.

2. The method of claim 1, wherein all of said plurality of panels are formed into a generally tubular shape when the prosthetic heart valve is in its contracted state.

3. The method of claim 1, wherein said prosthetic heart valve further comprises at least one foldable junction member connecting two adjacent panels, and wherein at least one of said plurality of panels is inverted when the prosthetic heart valve is in its contracted state, whereby at least one foldable junction member forms an elongated vertex.

4. The method of claim 3, wherein each pair of adjacent panels forms a lobe when the prosthetic heart valve is in its contracted state.

5. The method of claim 1, further comprising the step of installing the prosthetic heart valve in a delivery device having a tubular valve restraining member.

6. The method of claim 5, wherein said installing step includes causing relative rotation between the tubular valve restraining member and the entire prosthetic heart valve to cause said prosthetic heart valve to assume the contracted state.

7. The method of claim 1, wherein said expanding step includes releasing the prosthetic heart valve from a delivery device.

8. The method of claim 1, wherein said expanding step includes expanding an expandable member located within at least a portion of the prosthetic heart valve.

9. The method of claim 1, further comprising:

repositioning said prosthetic heart valve.

10. The method of claim 9, wherein said repositioning step comprises:

at least partially contracting the prosthetic heart valve,

moving the contracted prosthetic heart valve to another location, and

expanding the prosthetic heart valve.

11. The method of claim 1, wherein said treatment site is in or around a patient'"'"'s heart.

12. The method of claim 11, wherein said treatment site is in or around a patient'"'"'s aortic valve root.

13. The method of claim 11, wherein said treatment site is in or around a patient'"'"'s ascending aorta.

14. The method of claim 11, wherein said treatment site is in or around a patient'"'"'s descending aorta.

15. The method of claim 1, wherein each inverted panel has a concave shape.

16. The method of claim 15, wherein expanding the cross-sectional profile of the prosthetic heart valve comprises transitioning the inverted panels from the concave shape into a convex shape.

17. The method of claim 1, wherein each of the panels is inverted in the contracted state.

18. The method of claim 1, wherein each of the panels comprises nitinol.

19. The method of claim 1, wherein expanding the cross-sectional profile comprises expanding the cross-sectional profile into a generally tubular shape having a fixed diameter.

20. The method of claim 1, wherein the prosthetic heart valve has only three invertible panels.

21. The method of claim 20, wherein the prosthetic heart valve comprises only three valve leaflets, each valve leaflet being coupled to only one of the invertible panels.

22. The method of claim 1, wherein the support member consists essentially of the plurality of panels and a foldable junction member between each adjacent panel, wherein each panel is invertible.

23. The method of claim 1, wherein each panel is configured to self-expand immediately upon removal of a restraining member, and wherein expanding the cross-sectional profile of the prosthetic heart valve comprises removing the restraining member from restraining contact with the inverted panel.

24. The method of claim 1, wherein the prosthetic heart valve has a longitudinal axis and the at least one inverted panel of the prosthetic heart valve is curled towards the longitudinal axis when in the contracted state.

25. The method of claim 24, wherein expanding the cross-sectional profile of the prosthetic heart valve comprises uncurling the at least one inverted panel prior to transitioning the at least one panel out of the inverted state.

26. A method for implanting a prosthetic heart valve, comprising:

inserting a prosthetic heart valve in a contracted state into the body of a patient, said prosthetic heart valve having a plurality of valve leaflets and a support structure, the support structure comprising only three self-expandable metallic panels different from and configured to support the plurality of valve leaflets, wherein, in the contracted state, the prosthetic heart valve has a longitudinal axis and each panel of the prosthetic heart valve is inverted in a concave shape and curled towards the longitudinal axis,

introducing the prosthetic heart valve to a treatment site in a body lumen having a tissue wall, and

expanding the cross-sectional profile of the prosthetic heart valve into direct contact with the tissue wall of the body lumen, wherein expanding the cross-sectional profile comprises uncurling each of the panels away from the longitudinal axis and then transitioning each of the panels from the concave shape into a convex shape.

27. The method of claim 26, wherein said prosthetic heart valve further comprises at least one foldable junction member connecting two adjacent panels, and wherein the at least one foldable junction member forms an elongated vertex when the prosthetic heart valve is in the contracted state.

28. The method of claim 27, wherein each pair of adjacent panels forms a lobe when the prosthetic heart valve is in the contracted state.

29. The method of claim 26, further comprising causing relative rotation between a tubular valve restraining member and the entire prosthetic heart valve, prior to inserting the prosthetic heart valve, to cause said prosthetic heart valve to assume the contracted state.

30. The method of claim 26, wherein expanding the cross-sectional profile of the prosthetic heart valve comprises releasing the prosthetic heart valve from a delivery device.

31. The method of claim 26, wherein expanding the cross-sectional profile of the prosthetic heart valve comprises expanding an expandable member located within at least a portion of the prosthetic heart valve.

32. The method of claim 26, further comprising:

at least partially contracting the prosthetic heart valve,

moving the contracted prosthetic heart valve to another location, and

expanding the prosthetic heart valve.

33. The method of claim 26, wherein said treatment site is in or around a patient'"'"'s heart.

34. The method of claim 26, wherein said treatment site is in or around a patient'"'"'s aortic valve root.

35. The method of claim 26, wherein said treatment site is in or around a patient'"'"'s ascending aorta.

36. The method of claim 26, wherein said treatment site is in or around a patient'"'"'s descending aorta.

37. The method of claim 26, wherein each panel is configured to self-expand immediately upon removal of a restraining member, and wherein expanding the cross-sectional profile of the prosthetic heart valve comprises removing restraining members from restraining contact with the inverted panels after uncurling each of the panels.

38. The method of claim 26, wherein each of the panels comprises nitinol.

39. The method of claim 26, wherein expanding the cross-sectional profile comprises expanding the cross-sectional profile into a generally tubular shape having a fixed diameter.

40. The method of claim 26, wherein the prosthetic heart valve comprises only three valve leaflets, each valve leaflet being coupled to only one of the invertible panels.