Prosthetic valve for transluminal delivery

• US 7,018,406 B2
• Filed: 04/10/2003
• Issued: 03/28/2006
• Est. Priority Date: 11/17/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Corevalve Incorporated (Medtronic Plc)
• Inventors: Seguin, Jacques, Börtlein, Georg
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/412,634
• Publication Number:
  US 20040093060A1
• Time in Patent Office: 1,083 Days
• Field of Search: 623 21- 219, 623/1.11, 623/1.19, 606/104
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

Claims

1. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:

a valve having a plurality of resilient leaflets;

a valve support comprising a central band comprising a plurality of expandable cells, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said valve support supporting the base and the commissure points of the valve; and

an anchor for engaging the lumen wall when expanded in place for preventing substantial migration of the valve assembly after deployment;

wherein the anchor is itself configured to be expandable.

2. The valve assembly of claim 1, wherein the leaflets are made of natural tissue.

3. The valve assembly of claim 1, wherein the leaflets are made of synthetic material.

4. The valve assembly of claim 1, wherein the valve support is self-expanding.

5. The valve assembly of claim 4, wherein the configuration and radial force of the valve support substantially preclude any portion of the native valve that remains from obstructing effective placement of said assembly.

6. The valve assembly of claim 1, wherein the valve support comprises wire.

7. The valve assembly of claim 1, wherein the anchor is configured to exert sufficient radial forces against the lumen wall to prevent substantial migration.

8. The valve assembly of claim 1, further comprising a second anchor.

9. The valve assembly of claim 1, wherein the anchor is configured to flare if necessary to conform to the local anatomy.

10. The valve assembly of claim 1 further comprising a delivery catheter having a distally positioned sheath to house the valve assembly in a collapsed position for transluminal delivery and deployment of the valve assembly where desired.

11. The valve assembly of claim 10, further comprising at least one hook for engaging a portion of the valve support for controlled release of said support.

12. The valve assembly of claim 1, wherein the anchor is spaced from the valve support.

13. The valve assembly of claim 1, wherein the anchor is configured to flare if necessary to conform to the local anatomy while still maintaining sufficient radial forces against the lumen wall to prevent substantial migration.

14. A method of replacing a deficient native valve comprising the steps of:

providing a prosthetic valve assembly, the assembly comprising a valve, a valve support comprising a central band comprising a plurality of expandable cells and permitting attachment thereto of the base and the commissures of the valve, and an anchor for engaging the lumen wall when expanded for preventing substantial migration of the valve assembly when positioned in place, wherein the anchor is itself configured to be self-expandable;

collapsing the valve support and anchor to fit within a distally positioned sheath on a catheter;

advancing the catheter to the deficient native valve;

deploying the valve assembly; and

withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve.

15. The method of claim 14, wherein the valve support is self-expanding.

16. The method of claim 14, further comprising the step of hooking a portion of the valve support to the catheter.

17. The method of claim 14, further comprising the step of excising the native valve.

18. The method of claim 14, wherein the excising step comprises using the same catheter used to deploy the valve assembly.

19. The method of claim 14, wherein the anchor is spaced from the valve support.

20. A prosthetic valve assembly configured for endoluminal delivery to replace a deficient native valve, the valve assembly comprising an axial valve support portion configured to support a prosthetic valve having at least one leaflet and configured to expand in situ to push the residual native valve components against the native annulus and surrounding tissue so as to prevent substantial interference with the positioning and/or operation of the prosthetic valve by any residual components of the native valve, including calcified native components, said support portion comprising a first section selectively dimensioned to expand when deployed in situ substantially no greater than a preset diameter to maximize coaptivity of the prosthetic valve leaflets and to prevent significant regurgitation, and a second section expandable to a diameter greater than the first section.

21. The valve assembly of claim 20, wherein the valve has a plurality of leaflets each with corresponding commissures.

22. The valve assembly of claim 21, wherein the first section is selectively dimensioned to expand when deployed in situ substantially no greater than a preset diameter constrained at the commissures of the prosthetic valve to maximize coaptivity.

23. The valve assembly of claim 21, wherein the first section supports the commissures of the valve leaflets.

24. The valve assembly of claim 22, further comprising a second anchor.

25. The valve assembly of claim 22, wherein the anchor is spaced from the valve support portion but linked thereto to permit mutual deployment.

26. The valve assembly of claim 20, wherein the support portion further comprises a third section that is configured to expand in situ to push the residual native valve components against the native annulus and surrounding tissue.

27. The valve assembly of claim 26, wherein the third section has a diameter different from that of the first section when in situ.

28. The valve assembly of claim 26, wherein the first section is spaced from the third section but linked thereto to permit mutual deployment of the first and third section and permit placement of the prosthetic valve spaced from the location of the native valve.

29. The valve assembly of claim 26, wherein the radial force of the first section is substantially the same as the radial force of the third section.

30. The valve assembly of claim 20, wherein the valve support portion comprises at least one balloon expandable section.

31. The valve assembly of claim 20, wherein the valve support comprises at least one self expanding section and at least one balloon expandable section.

32. The valve assembly of claim 20, wherein the assembly is configured for percutaneous delivery.

33. The valve assembly of claim 20, wherein at least a portion of the support portion is sufficiently resilient to allow in situ expansion and contraction throughout the cardiac cycle while still substantially preventing migration.

34. The valve assembly of claim 20, further comprising at least one anchor configured to exert sufficient radial forces against the lumen wall to prevent substantial migration.

35. The valve assembly of claim 20, further comprising a sealing means for limiting leakage between the valve assembly and the native tissue due in part to surface irregularities in the native lumen.

36. The valve assembly of claim 20, wherein the valve support portion comprises a single length of wire.

37. The valve assembly of claim 20, wherein the valve support portion comprises a metal laser cut tube.

38. The valve assembly of claim 20, wherein the valve support portion comprises reinforced ePTFE.

39. The valve assembly of claim 20, further comprising a catheter having a distally positioned sheath to house the valve assembly in a collapsed position for transluminal deployment of the valve assembly where desired.

40. A prosthetic valve assembly configured for percutaneous delivery to replace a deficient native valve, the valve assembly comprising an axial valve support portion comprising a central band comprising a plurality of expandable cells, the support portion configured to support a prosthetic valve having a plurality of leaflets and to prevent substantial interference with the positioning and/or operation of the prosthetic valve by any residual components of the native valve, including calcified native components, said support portion comprising a first section selectively dimensioned to expand when deployed in situ substantially no greater than a preset diameter to maximize coaptivity of the prosthetic valve leaflets and to prevent significant regurgitation.

41. The valve assembly of claim 40, further comprising a second section that is configured to expand in situ to push the residual native valve components against the native annulus and surrounding tissue.

42. The valve assembly of claim 41, wherein the second section has a diameter different from that of the first section when in situ.

43. The valve assembly of claim 41, wherein the valve support portion comprises at least one balloon expandable section.

44. The valve assembly of claim 40, wherein the first section is selectively dimensioned to expand when deployed in situ substantially no greater than a preset diameter constrained at the commissures of the prosthetic valve to maximize coaptivity.

45. The valve assembly of claim 40, further comprising at least one anchor configured to exert sufficient radial forces against the lumen wall to prevent substantial migration.

46. The valve assembly of claim 45, further comprising a second anchor.

47. The valve assembly of claim 40, further comprising a sealing means for limiting leakage between the valve assembly and the native tissue due in part to surface irregularities in the native lumen.

48. The valve assembly of claim 40, further comprising a catheter having a distally positioned sheath to house the valve assembly in a collapsed position for transluminal deployment of the valve assembly where desired.

49. A prosthetic valve assembly comprising an axial valve support portion configured to support a prosthetic valve having a plurality of leaflets and to prevent substantial interference with the positioning and/or operation of the prosthetic valve by any residual components of the native valve, including calcified native components, said support portion comprising

a first section selectively dimensioned to expand when deployed in situ substantially no greater than a preset diameter to maximize coaptivity of the prosthetic valve leaflets and to prevent significant regurgitation,

a second section having a diameter different from that of the first section and configured to expand in situ to push the residual native valve components against the native annulus and surrounding tissue, and

at least one anchor configured to exert sufficient radial forces against the lumen wall to prevent substantial migration

whereby the valve assembly is configured for percutaneous delivery to replace a deficient native valve.

50. The valve assembly of claim 49, further comprising a sealing means for limiting leakage between the valve assembly and the native tissue due in part to surface irregularities in the native lumen.

51. The valve assembly of claim 49, wherein the valve support portion comprises at least one balloon expandable section.

52. The valve assembly of claim 49, further comprising a second anchor.

53. The valve assembly of claim 49, further comprising a catheter having a distally positioned sheath to house the valve assembly in a collapsed position for transluminal deployment of the valve assembly where desired.

54. The valve assembly of claim 49, wherein the valve support portion comprises a single length of wire.

55. The valve assembly of claim 49, wherein the valve support portion comprises a metal laser cut tube.

56. The valve assembly of claim 49, wherein the valve support portion comprises reinforced ePTFE.