Method of in situ formation of translumenally deployable heart valve support

• US 7,445,630 B2
• Filed: 05/05/2005
• Issued: 11/04/2008
• Est. Priority Date: 05/05/2004
• Status: Expired due to Fees

• Current Assignee: DFM, LLC (PDL BioPharma, Inc.)
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Primary Examiner(s): Matthews; William H.
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/122,978
• Publication Number:
  US 20060020333A1
• Time in Patent Office: 1,279 Days
• Field of Search: 623/2, 623 238- 24, 623/12, 623/900, 606/195, 606/151, 606191-194
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• 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 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

A method of implanting a prosthetic valve within the heart comprises translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart. A first chamber of the inflatable structure is inflated and then, independently, a second chamber of the inflatable structure is inflated.

Claims

1. A method of implanting a prosthetic heart valve, the method comprising the steps of:

translumenally advancing a catheter carrying a prosthetic valve that comprises an inflatable cuff to a position proximate a native valve of a patient;

inflating a first chamber of the inflatable cuff within the left ventricle of the patient;

independently inflating a second chamber of the inflatable cuff within the aorta of the patient; and

removing the catheter from the patient, leaving the prosthetic valve and the inflated inflatable cuff within the patient;

wherein the prosthetic valve is functional prior to full inflation of the inflatable cuff.

2. The method of claim 1, wherein inflating a first chamber of the inflatable cuff comprises inflating a distal end of the cuff.

3. The method of claim 2, further comprising proximally retracting the valve after the first chamber is at least partially inflated.

4. The method of claim 1, wherein inflating a second chamber of the inflatable cuff comprises inflating a proximal end of the cuff.

5. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of removing the native valve prior to the removing the catheter step.

6. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of debulking the native valve prior to the removing the catheter step.

7. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of performing a balloon valvuloplasty on the native valve prior to the removing the catheter step.

8. A method of implanting a prosthetic valve as in claim 1, wherein the translumenally advancing step comprises advancing the catheter over the aortic arch.

9. A method of implanting a prosthetic valve as in claim 1, wherein the inflating a first chamber step comprises inflating the first chamber with a hardenable media.

10. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of manipulating the position of the prosthetic valve using at least one control wire.

11. A method of implanting a prosthetic valve as in claim 10, additionally comprising the step of releasing the prosthetic valve from the control wire following the independently inflating the second chamber step.

12. A method of implanting a prosthetic valve as in claim 11, wherein the control wire comprises a tubular sheath and a core wire, wherein the step of releasing the prosthetic valve from the control wire comprises axially retracting the core wire with respect to the sheath.

13. A method of implanting a prosthetic valve as in claim 11, wherein the prosthetic valve is functional prior to the releasing step.

14. A method of implanting a prosthetic valve as in claim 10, wherein the step of manipulating the position of the prosthetic valve comprises using three control wires.

15. A method of implanting a prosthetic valve as in claim 10, additionally comprising the step of permitting perfusion through the valve during the manipulating the position step.

16. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of permitting perfusion through the valve during the inflating a first chamber step.

17. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of placing a temporary valve downstream from the native valve.

18. A method of implanting a prosthetic valve as in claim 1, additionally comprising the step of placing an embolic filter downstream from the native valve.

19. A method of implanting a prosthetic heart valve, the method comprising the steps of:

translumenally advancing a catheter carrying a prosthetic valve that comprises an inflatable cuff permanently attached to a valve mechanism to a position proximate a native valve;

inflating a first chamber of the inflatable cuff within the left ventricle;

manipulating the position of the prosthetic valve using at least one control wire;

independently inflating a second chamber of the inflatable cuff within the aorta;

releasing the prosthetic valve from the control wire following the independently inflating the second chamber step; and

removing the catheter, leaving the prosthetic valve;

wherein the control wire comprises a tubular sheath and a core wire, and the step of releasing the prosthetic valve from the control wire comprises axially retracting the core wire with respect to the sheath.

20. The method of claim 19, wherein inflating a first chamber of the inflatable cuff comprises inflating a distal end of the cuff.

21. The method of claim 20, further comprising proximally retracting the valve after the first chamber is at least partially inflated.

22. The method of claim 19, wherein inflating a second chamber of the inflatable cuff comprises inflating a proximal end of the cuff.

23. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of removing the native valve prior to the removing the catheter step.

24. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of debulking the native valve prior to the removing the catheter step.

25. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of performing a balloon valvuloplasty on the native valve prior to the removing the catheter step.

26. A method of implanting a prosthetic valve as in claim 19, wherein the translumenally advancing step comprises advancing the catheter over the aortic arch.

27. A method of implanting a prosthetic valve as in claim 19, wherein the inflating a first chamber step comprises inflating the first chamber with a hardenable media.

28. A method of implanting a prosthetic valve as in claim 19, wherein the step of manipulating the position of the prosthetic valve comprises using three control wires.

29. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of permitting perfusion through the valve during the inflating a first chamber step.

30. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of permitting perfusion through the valve during the manipulating the position step.

31. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of placing a temporary valve downstream from the native valve.

32. A method of implanting a prosthetic valve as in claim 19, additionally comprising the step of placing an embolic filter downstream from the native valve.

33. A method of implanting a prosthetic valve as in claim 19, wherein the prosthetic valve is functional prior to full inflation of the inflatable cuff.

34. A method of implanting a prosthetic valve as in claim 19, wherein the prosthetic valve is functional prior to the releasing step.

35. A method of implanting a prosthetic heart valve, the method comprising the steps of:

translumenally advancing a catheter carrying a prosthetic valve that comprises an inflatable cuff to a position proximate a native valve;

inflating a first chamber of the inflatable cuff within the left ventricle;

manipulating the position of the prosthetic valve using at least one control wire;

independently inflating a second chamber of the inflatable cuff within the aorta;

releasing the prosthetic valve from the control wire following the independently inflating the second chamber step; and

removing the catheter from a position proximate the native valve while, leaving the prosthetic valve and the inflated cuff at a position proximate the native valve;

wherein the prosthetic valve is functional prior to the releasing step.

36. The method of claim 35, wherein inflating a first chamber of the inflatable cuff comprises inflating a distal end of the cuff.

37. The method of claim 36, further comprising proximally retracting the valve after the first chamber is at least partially inflated.

38. The method of claim 35, wherein inflating a second chamber of the inflatable cuff comprises inflating a proximal end of the cuff.

39. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of removing the native valve prior to the removing the catheter step.

40. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of debulking the native valve prior to the removing the catheter step.

41. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of performing a balloon valvuloplasty on the native valve prior to the removing the catheter step.

42. A method of implanting a prosthetic valve as in claim 35, wherein the translumenally advancing step comprises advancing the catheter over the aortic arch.

43. A method of implanting a prosthetic valve as in claim 35, wherein the inflating a first chamber step comprises inflating the first chamber with a hardenable media.

44. A method of implanting a prosthetic valve as in claim 35, wherein the control wire comprises a tubular sheath and a core wire, wherein the step of releasing the prosthetic valve from the control wire comprises axially retracting the core wire with respect to the sheath.

45. A method of implanting a prosthetic valve as in claim 35, wherein the step of manipulating the position of the prosthetic valve comprises using three control wires.

46. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of permitting perfusion through the valve during the inflating a first chamber step.

47. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of permitting perfusion through the valve during the manipulating the position step.

48. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of placing a temporary valve downstream from the native valve.

49. A method of implanting a prosthetic valve as in claim 35, additionally comprising the step of placing an embolic filter downstream from the native valve.

50. A method of implanting a prosthetic valve as in claim 35, wherein the prosthetic valve is functional prior to full inflation of the inflatable cuff.