Valve replacement using rotational anchors

• US 9,848,983 B2
• Filed: 02/12/2016
• Issued: 12/26/2017
• Est. Priority Date: 02/13/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Millipede, Inc. (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Rust, Matthew, Macaulay, Patrick, Glenn, Richard
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/043,301
• Publication Number:
  US 20160235526A1
• Time in Patent Office: 683 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

Claims

1. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors rotatably carried by the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width.

2. The implantable heart valve device of claim 1, further comprising an annular seal carried by the frame, for inhibiting perivalvular leaks.

3. The implantable heart valve device of claim 2, wherein the annular seal comprises a barrier located on an interior of the frame.

4. The implantable heart valve device of claim 2, wherein the annular seal comprises a barrier located on an exterior of the frame.

5. The implantable heart valve device of claim 2, wherein the annular seal comprises a cuff.

6. The implantable heart valve device of claim 5, wherein the cuff is inflatable.

7. The implantable heart valve device of claim 2, wherein the annular seal comprises an axially extending barrier and an outwardly radially extending ring.

8. The implantable heart valve device of claim 1, wherein the valve comprises pericardial tissue.

9. The implantable heart valve device of claim 1, further comprising a plurality of connectors, for connecting the valve to the tubular body.

10. The implantable heart valve device of claim 1, wherein the restraint comprises an aperture for receiving the first pair of adjacent struts.

11. The implantable heart valve device of claim 10, wherein the restraint comprises a collar.

12. The implantable heart valve device of claim 11, wherein the collar comprises a threaded surface.

13. The implantable heart valve device of claim 11, wherein the first pair of adjacent struts comprises a threaded surface.

14. The implantable heart valve device of claim 1, wherein the restraint comprises a loop carried by the tubular body and surrounding the central lumen.

15. The implantable heart valve device of claim 1, wherein the restraint is configured to reversibly adjust the implant body radially within a working range.

16. The implantable heart valve device of claim 11, wherein advancing the collar in an axial direction reduces an angle between the first pair of struts thereby reshaping the frame.

17. The implantable heart valve device of claim 1, wherein the anchors are configured to be retractable.

18. The implantable heart valve device of claim 1, wherein the frame is configured to be reshaped such that a diameter at the proximal end is different from a diameter at the distal end.

19. The implantable heart valve device of claim 1, wherein the restraint is slidable axially along the first pair of struts.

20. The implantable heart valve device of claim 1, wherein at least one anchor of the plurality of anchors has a helical shape and rotating the at least one anchor causes the at least one anchor to extend into the tissue.

21. The implantable heart valve device of claim 1, comprising at least four pairs of adjacent struts and at least four apexes.

22. The implantable heart valve device of claim 21, comprising at least four restraints.

23. The implantable heart valve device of claim 21, comprising at least four anchors.

24. The implantable heart valve device of claim 1, wherein rotation of the anchors axially displaces the anchors with respect to the body.

25. The implantable heart valve device of claim 1, wherein each strut in an adjacent pair of struts comprises a threaded surface.

26. The implantable heart valve device of claim 1, wherein the valve comprises at least a first leaflet and a second leaflet.

27. The implantable heart valve device of claim 26, wherein the first and second leaflets are different sizes to selectively direct the direction of blood flow exiting the valve.

28. The implantable heart valve device of claim 26, further comprising a third leaflet, wherein the first leaflet is larger than both the second and third leaflets.

29. The implantable heart valve device of claim 28, wherein the first leaflet is located on the anterior side of the valve.

30. The implantable heart valve device of claim 1, wherein the distal end of the body comprises a skirt that flares outward away from the lumen.

31. The implantable heart valve device of claim 30, wherein the skirt flares outward and distally.

32. The implantable heart valve device of claim 1, wherein the distal end of the body comprises a skirt that flares outward and proximally.

33. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen;

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width; and

an annular seal carried by the frame, for inhibiting perivalvular leaks, wherein the annular seal comprises an inflatable cuff.

34. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width, wherein the restraint comprises a collar having an aperture for receiving the first pair of adjacent struts.

35. The implantable heart valve device of claim 34, wherein the restraint comprises a threaded surface.

36. The implantable heart valve device of claim 34, wherein advancing the restraint in an axial direction reduces an angle between the first pair of struts thereby reshaping the frame.

37. The implantable heart valve device of claim 34, wherein the plurality of distally facing anchors are rotatably carried by the frame.

38. The implantable heart valve device of claim 34, wherein at least one anchor of the plurality of anchors has a helical shape and rotating the at least one anchor causes the at least one anchor to extend into the tissue.

39. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width, wherein the restraint comprises a loop carried by the tubular body and surrounding the central lumen.

40. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve, wherein the anchors are configured to be retractable;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width.

41. The implantable heart valve device of claim 40, wherein the restraint comprises a threaded surface.

42. The implantable heart valve device of claim 40, wherein advancing the restraint in an axial direction reduces an angle between the first pair of struts thereby reshaping the frame.

43. The implantable heart valve device of claim 40, wherein the plurality of distally facing anchors are rotatably carried by the frame.

44. The implantable heart valve device of claim 40, wherein at least one anchor of the plurality of anchors has a helical shape and rotating the at least one anchor causes the at least one anchor to extend into the tissue.

45. The implantable heart valve device of claim 40, wherein the restraint comprises a collar having an aperture for receiving the first pair of adjacent struts.

46. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve, wherein at least one anchor of the plurality of anchors has a helical shape and rotating the at least one anchor causes the at least one anchor to extend into the tissue;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width.

47. The implantable heart valve device of claim 46, wherein the restraint comprises a threaded surface.

48. The implantable heart valve device of claim 46, wherein advancing the restraint in an axial direction reduces an angle between the first pair of struts thereby reshaping the frame.

49. The implantable heart valve device of claim 46, wherein the plurality of distally facing anchors are rotatably carried by the frame.

50. The implantable heart valve device of claim 46, wherein the restraint comprises a collar having an aperture for receiving the first pair of adjacent struts.

51. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least four pairs of adjacent struts with each pair joined at a proximally facing apex, and at least four pairs of adjacent struts with each pair joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen; and

at least four moveable restraints coupled with the frame and configured to restrain the frame at a desired width.

52. The implantable heart valve device of claim 51, wherein one or more of the least four moveable restraints comprises a threaded surface.

53. The implantable heart valve device of claim 51, wherein advancing the at least four moveable restraints in an axial direction reduces a respective angle between a respective pair of the struts joined at a proximally facing apex, thereby reshaping the frame.

54. The implantable heart valve device of claim 51, wherein the plurality of distally facing anchors are rotatably carried by the frame.

55. The implantable heart valve device of claim 51, wherein at least one anchor of the plurality of anchors has a helical shape and rotating the at least one anchor causes the at least one anchor to extend into the tissue.

56. The implantable heart valve device of claim 51, wherein one or more of the at least four moveable restraints comprises a collar having an aperture for receiving a respective pair of the at least four pairs of adjacent struts.

57. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex, wherein each strut in an adjacent pair of struts comprises a threaded surface;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width.

58. An implantable heart valve device, comprising:

a tubular frame having a proximal end, a distal end and a central lumen extending therethrough;

the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve;

a valve coupled with the frame to regulate blood flow through the central lumen, wherein the valve comprises at least a first leaflet and a second leaflet, wherein the first and second leaflets are different sizes to selectively direct the direction of blood flow exiting the valve; and

a moveable restraint coupled with the frame and configured to restrain the frame at a desired width.