Percutaneously deliverable heart valve and methods associated therewith

• US 8,361,144 B2
• Filed: 03/01/2011
• Issued: 01/29/2013
• Est. Priority Date: 03/01/2010
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Fish, R. David, Paniagua, David
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/038,361
• Publication Number:
  US 20110301700A1
• Time in Patent Office: 700 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.1, 623/2.11, 623/2.42, 623/900, 623/901, 623/904, 623/910, 623/915, 623/916, 623/917, 623/918, 623/925, 435/1.1
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2/2415 Manufacturing methods
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 29/49908 Joining by deforming

Abstract

A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.

Claims

1. A method, comprising:

partially compressing and mounting a prosthetic heart valve upon a delivery catheter, the prosthetic heart valve comprising a tissue;

allowing the tissue to at least partially dry;

further compressing and mounting the prosthetic heart valve upon the delivery catheter; and

sterilizing and packaging the prosthetic heart valve and delivery catheter.

2. The method of claim 1, further comprising transporting the sterilized and packaged prosthetic heart valve and delivery catheter.

3. The method of claim 1, wherein the tissue comprises a treated pericardium tissue.

4. The method of claim 1, wherein prior to partially compressing and mounting the prosthetic heart valve upon the delivery catheter, the tissue is at least one of (a) not substantially dry, and (b) at least partially hydrated.

5. A method, comprising:

attaching a tissue to a frame;

partially compressing and mounting the frame, with the tissue attached thereto, upon a delivery catheter;

allowing the tissue to at least partially dry;

further compressing and mounting the frame, with the tissue attached thereto, upon the delivery catheter; and

sterilizing and packaging the frame and delivery catheter, with the tissue attached thereto.

6. The method of claim 5, wherein prior to partially compressing and mounting the frame, the tissue is at least one of (a) not substantially dry, and (b) at least partially hydrated.

7. The method of claim 5, further comprising transporting the sterilized and packaged frame, with the tissue attached thereto, mounted upon the delivery catheter, to a surgical or medical procedure facility.

8. The method of claim 5, wherein prior to attaching the tissue to the frame the tissue is folded to form a tissue leaflet assembly.

9. The method of claim 8, wherein the tissue leaflet assembly comprises at least one cuff and at least one pleat.

10. The method of claim 5, wherein the tissue comprises a treated pericardium tissue.

11. A method of preparing a percutaneous, trans-catheter prosthetic heart valve, comprising:

obtaining a membrane tissue from an organism;

treating the membrane tissue with at least one chemical to produce a treated membrane tissue;

drying the treated membrane tissue until it is a substantially dry tissue;

attaching the substantially dry tissue to a frame;

rehydrating the substantially dry tissue that is attached to the frame to form a rehydrated tissue;

collapsing the frame with the rehydrated tissue attached thereto; and

drying the rehydrated tissue attached to the collapsed frame until it is an again substantially dry tissue.

12. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, further comprising compressing and mounting the frame, with the again substantially dry tissue attached thereto, upon a delivery catheter.

13. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 12, further comprising sterilizing and packaging the frame, with the again substantially dry tissue attached thereto, mounted upon the delivery catheter.

14. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 13, further comprising at least one of transporting and shipping the sterilized and packaged frame with the again substantially dry tissue attached thereto, mounted upon the delivery catheter, to a surgical or medical procedure facility.

15. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 14, further comprising implanting the frame with the again substantially dry tissue attached thereto into a patient.

16. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein the frame comprises a stent.

17. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein prior to the attaching step the substantially dry tissue is not folded with a cuff and a pleat.

18. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein prior to the attaching step the substantially dry tissue is folded to form a tissue leaflet assembly.

19. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 18, wherein the tissue leaflet assembly comprises at least one cuff and at least one pleat.

20. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 18, further comprising mounting the frame and the tissue leaflet assembly attached thereto upon a 12 to 14 French balloon catheter.

21. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 18, further comprising mounting the frame and the tissue leaflet assembly attached thereto upon a balloon catheter having a size of less than about 12 French.

22. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 18, further comprising mounting the frame and the tissue leaflet assembly attached thereto upon a balloon catheter having a size of between about 5 to 12 French.

23. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 18, further comprising mounting the frame and the tissue leaflet assembly attached thereto on a mandrel.

24. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, further comprising sterilizing the frame with the again substantially dry tissue attached thereto with exposure to at least one of ethylene oxide, a proton beam, and gamma radiation.

25. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a buffered or unbuffered 1-37.5% formalin solution for between about 3 days to 3 weeks.

26. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a buffered or unbuffered 1-37.5% formalin solution for between about 3 days to 5 weeks.

27. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a buffered or unbuffered 1-37.5% formalin solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 3 weeks.

28. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a buffered or unbuffered 1-37.5% formalin solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 5 weeks.

29. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in 100% glycerol for greater than about 3 weeks.

30. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a 0.1-25% glutaraldehyde solution for between about 3 days to 3 weeks.

31. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a 0.1-25% glutaraldehyde solution for between about 3 days to 5 weeks.

32. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a 0.1-25% glutaraldehyde solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 3 weeks.

33. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in a 0.1-25% glutaraldehyde solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 5 weeks.

34. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in an oligomeric filtered 0.1-25% glutaraldehyde solution for between about 3 days to 3 weeks.

35. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in an oligomeric filtered 0.1-25% glutaraldehyde solution for between about 3 days to 5 weeks.

36. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in an oligomeric filtered 0.1-25% glutaraldehyde solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 3 weeks.

37. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein said treating comprises immersion of the membrane tissue in an oligomeric filtered 0.1-25% glutaraldehyde solution containing at least one of free amino acids (a) lysine and (b) histidine, for between about 3 days to 5 weeks.

38. The method of preparing a percutaneous, trans-catheter prosthetic heart valve of claim 11, wherein the membrane tissue comprises a pericardium tissue.