Methods and apparatus for endovascularly replacing a patient's heart valve

• US 9,526,609 B2
• Filed: 07/15/2004
• Issued: 12/27/2016
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Haug, Ulrich R., Valencia, Hans F., Geshlider, Robert A., Saul, Tom, Morejohn, Dwight P.
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US10/893,131
• Publication Number:
  US 20050137692A1
• Time in Patent Office: 4,548 Days
• Field of Search: 623 113- 122, 623/1.24
• US Class Current: 1/1
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes a replacement valve and an anchor having an expandable braid. In some embodiments, the expandable braid is fabricated from a single strand of wire. In some embodiments, the expandable braid comprises at least one turn feature. The anchor and the valve preferably are configured for endovascular delivery and deployment.

Claims

1. Apparatus for replacing a native aortic valve, the apparatus comprising:

a replacement heart valve having a first valve end and a second valve end, the replacement heart valve comprising;

an anchor comprising an expandable braided material that comprises an outer surface and an inner surface, the expandable braided material extending from the first valve end to the second valve end, the inner surface defining a lumen, the braided material comprising a plurality of strand sections that slide with respect to each other as the anchor expands from a delivery configuration to a deployed configuration, the anchor decreasing in longitudinal length as the anchor expands from the delivery configuration to the deployed configuration, the anchor being adapted to be endovascularly delivered to an anchor site within the native aortic valve in the delivery configuration and secured at the anchor site within the native aortic valve in the deployed configuration; and

a replacement valve secured to, and positioned inside the lumen of, the anchor, wherein the replacement valve includes a longitudinally-oriented valve support adapted to support the replacement valve within the anchor, wherein the valve support maintains a uniform longitudinal length before, during, and after the anchor expands from the delivery configuration to the deployed configuration.

2. The apparatus of claim 1 wherein the braided material further comprises a third region having a diameter larger than the first region diameter when the anchor is expanded.

3. The apparatus of claim 2 wherein the first, second and third regions are adapted to center the anchor within the native aortic valve.

4. The apparatus of claim 2 wherein the braided material defines a plurality of cells, at least a first set of the cells in the first region each being of a substantially different configuration than a second set of the cells in the second region and a third set of cells in the third region.

5. The apparatus of claim 1 wherein the anchor is further adapted to avoid interference with coronary ostia.

6. The apparatus of claim 1 wherein the braided material comprises a region adapted to prevent expansion of the anchor into a mitral valve to avoid interference with the mitral valve.

7. The apparatus of claim 1 wherein the braided material is configured to have an expanded shape that is bilaterally symmetrical.

8. The apparatus of claim 1 wherein the braided material is configured to have an expanded shape that is asymmetrical.

9. The apparatus of claim 1 wherein the braided material has a distal fine mesh section with a higher pitch than a proximal section of the braided material.

10. The apparatus of claim 4 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

11. The apparatus of claim 4 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

12. The apparatus of claim 4 wherein each cell in the first set of cells comprises an inward bend to form a W shape along one side of the cell and each cell in the second set of cells does not.

13. The apparatus of claim 12 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

14. The apparatus of claim 4 wherein each cell in the first set of cells comprises a loop and each cell in the second set of cells does not.

15. The apparatus of claim 14 wherein the loop is disposed asymmetrically within each cell of the first set of cells.

16. The apparatus of claim 14 each cell in the first set of cells comprises a plurality of loops and each cell in the second set of cells does not.

17. The apparatus of claim 14 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

18. The apparatus of claim 4 wherein each cell in the first set of cells comprises a FIG. 8 shaped loop and each cell in the second set of cells does not.

19. The apparatus of claim 18 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

20. The apparatus of claim 4 wherein each cell in the first set of cells comprises a heart shaped loop and each cell in the second set of cells does not.

21. The apparatus of claim 20 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

22. The apparatus of claim 4 wherein a wire section of each cell of the first set of cells comprises a reduced cross-sectional diameter in at least one location and each cell in the second set of cells does not.

23. The apparatus of claim 22 wherein the first set of cells comprises substantially all cells at at least a proximal edge or a distal edge of the braided material.

24. The apparatus of claim 4 wherein each cell of the first set of cells comprises a lock adapted to lock the anchor in an expanded configuration.

25. The apparatus of claim 24 wherein the braided material further comprises a third set of cells each being of a substantially different configuration than the second set of cells, each of the third set of cells being adapted to interact with the first set of cells to lock the anchor in the expanded configuration.

26. The apparatus of claim 4 wherein the third set of cells have a substantially different configuration than the second set of the cells.

27. The apparatus of claim 26 wherein the first set of cells is disposed at a distal end of the anchor and the third set of cells is disposed at a proximal end of the anchor.

28. The apparatus of claim 1 wherein the anchor comprises first and second wires, the first wire having a diameter smaller than a diameter of the second wire.

29. The apparatus of claim 1 wherein the anchor comprises first and second wires formed from different materials.

30. The apparatus of claim 1 wherein the anchor has a collapsed delivery configuration, an at-rest configuration and an expanded deployed configuration.

31. The apparatus of claim 30 wherein the braid comprises a shape memory material that is heat set in the at-rest configuration.

32. The apparatus of claim 30 wherein the at-rest configuration is between the collapsed delivery configuration and expanded deployed configuration.

33. The apparatus of claim 1 wherein the braided material is configured for active foreshortening during endovascular deployment.

34. The apparatus of claim 1 further comprising a lock configured to maintain expansion of the braided material, the lock attached to the inner surface of the braided material.

35. The apparatus of claim 34 wherein the lock is further configured to maintain expansion of the braided material at a plurality of amounts of expansion.

36. The apparatus of claim 1 wherein the valve support is secured to the inner surface of the braided material so that a portion of the plurality of strand sections slide along an outer surface of the valve support.

37. The apparatus of claim 36 further comprising buckle members adapted to interlock with the valve support, each buckle member having a first portion extending longitudinally adjacent to and attached to the outer surface of the braided material, a second portion extending radially inward from a proximal end of the first portion through an opening defined by strands forming the braided material, and a third portion extending distally from the second portion adjacent to the inner surface of the braided material.

38. The apparatus of claim 1 wherein the braided material has at least one closed end formed by turns, the turns formed by strands forming the braided material.

39. A replacement valve with a first valve end and a second valve end, the replacement valve comprising:

an expandable braided anchor comprising a plurality of strand sections that slide with respect to each other as the anchor expands from a delivery configuration to a deployed configuration, a first end of the anchor forming the first valve end, a second end of the anchor forming the second valve end, the anchor having an inner surface defining a lumen and an outer surface;

elongated valve supports secured to the inner surface of the anchor and adapted to slide longitudinally over the inner surface of the anchor as the anchor expands from the delivery configuration to the deployed configuration;

leaflets positioned inside the lumen of the anchor, the leaflets secured to the elongated valve supports.

40. The replacement valve of claim 39, wherein each leaflet is secured to two valve supports.

41. The replacement valve of claim 40, wherein each valve support does not collapse or expand.

42. The replacement valve of claim 40, each valve support is configured to interlock with a second element to maintain an expanded state of the braided material.

43. The replacement valve of claim 42, wherein the second element has a radially-extending end portion connecting a first portion of the second element attached to the outer surface of the braided anchor and a second portion of the second element adapted to interlock with one of the elongated valve supports.

44. The replacement valve of claim 43, wherein each valve support is secured to a distal region of the braided anchor and each second element is secured to a proximal region of the braided anchor.

45. The replacement valve of claim 39, the expandable braided anchor comprising a two part lock mechanism for maintaining the braided anchor in an expanded state, wherein the elongated valve supports form one part of the two part lock mechanism.

46. The replacement valve of claim 45, wherein the first part of the lock mechanism is secured to a proximal region of the braided anchor and the second part of the lock mechanism is secured to a distal region of the braided anchor.

47. The replacement valve of claim 40, each leaflet further comprising an annular base, wherein the annular base is secured to the braided anchor.

48. The replacement valve of claim 39, wherein the braided anchor is formed from a single strand of wire, the single strand of wire forming the plurality of strand sections.

49. The replacement valve of claim 39, wherein the braided anchor is formed from a wire, the wire forming the plurality of strand sections, the braided anchor further including at least one closed end formed by turns in the wire, the turns having a continuous cross-sectional profile.

50. The replacement valve of claim 49, wherein the turns include inwardly canted turns and outwardly canted turns.

51. The replacement valve of claim 39, wherein the braided anchor is formed from a wire, the wire having two ends and forming the plurality of strand sections, the two ends of the wire forming a crimped termination with an end cap surrounding the two ends.