Valve replacement using moveable restrains and angled struts

• US 10,258,466 B2
• Filed: 12/01/2017
• Issued: 04/16/2019
• Est. Priority Date: 02/13/2015
• Status: Expired due to Fees

• 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:
  US15/829,760
• Publication Number:
  US 20180085217A1
• Time in Patent Office: 501 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 defining an angle therebetween;

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

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

a restraint having an aperture receiving therethrough the first pair of adjacent struts, wherein the restraint is moveable in an axial direction along the first pair of adjacent struts to adjust the angle therebetween, and wherein the restraint comprises a threaded surface.

2. The implantable heart valve device of claim 1, wherein the restraint comprises a collar.

3. The implantable heart valve device of claim 1, wherein the restraint is configured to rotate about the axial direction.

4. The implantable heart valve device of claim 1, wherein moving the restraint in an axial distal direction reduces the angle between the first pair of struts thereby reshaping the frame.

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

6. The implantable heart valve device of claim 1, wherein the anchors are each rotatably carried by the frame.

7. The implantable heart valve device of claim 1, wherein the anchors are configured to advance distally to embed into the tissue surrounding the native heart valve.

8. The implantable heart valve device of claim 1, wherein the first pair of adjacent struts are joined at a proximally facing apex, the frame further comprising at least a second pair of adjacent struts joined at a distally facing apex.

9. 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 an apex and defining an angle therebetween;

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

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

a restraint surrounding the first pair of adjacent struts, wherein the restraint is moveable in an axial direction along the first pair of adjacent struts to adjust the angle therebetween.

10. The implantable heart valve device of claim 9, the restraint further comprising an aperture receiving therethrough the first pair of adjacent struts.

11. The implantable heart valve device of claim 9, wherein the restraint comprises a threaded surface.

12. The implantable heart valve device of claim 9, wherein moving the restraint in an axial distal direction reduces the angle between the first pair of struts thereby reshaping the frame.

13. The implantable heart valve device of claim 9, wherein the restraint is slidable axially along the first pair of struts.

14. The implantable heart valve device of claim 9, wherein the anchors are rotatably carried by the frame.

15. The implantable heart valve device of claim 9, wherein the anchors are helical anchors.

16. The implantable heart valve device of claim 9, wherein the leaflets comprise pericardial tissue.

17. A method for implanting a heart valve device, comprising:

positioning the device adjacent tissue surrounding a native heart valve, the device comprising a frame having a pair of adjacent struts joined at an apex and defining an angle therebetween, a valve coupled with the frame, a plurality of anchors coupled with the frame, and a restraint surrounding the pair of adjacent struts;

advancing the anchors to embed into the tissue surrounding the native heart valve; and

advancing the restraint in an axial direction along the pair of adjacent struts to reduce the angle between the pair of adjacent struts thereby reshaping the frame.

18. The method of claim 17, wherein advancing the restraint comprises sliding the restraint in the axial direction along the pair of adjacent struts.

19. The method of claim 17, wherein advancing the anchors comprises rotating the anchors to embed into the tissue surrounding the native heart valve.

20. 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 defining an angle therebetween;

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

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

a restraint having an aperture receiving therethrough the first pair of adjacent struts, wherein the restraint comprises a collar and is moveable in an axial direction along the first pair of adjacent struts to adjust the angle therebetween.

21. The implantable heart valve device of claim 20, wherein the restraint is configured to rotate about the axial direction.

22. The implantable heart valve device of claim 20, wherein moving the restraint in an axial distal direction reduces the angle between the first pair of struts thereby reshaping the frame.

23. The implantable heart valve device of claim 20, wherein the restraint is slidable axially along the first pair of struts.

24. The implantable heart valve device of claim 20, wherein the anchors are each rotatably carried by the frame.

25. The implantable heart valve device of claim 20, wherein the anchors are configured to advance distally to embed into the tissue surrounding the native heart valve.

26. The implantable heart valve device of claim 20, wherein the first pair of adjacent struts are joined at a proximally facing apex, the frame further comprising at least a second pair of adjacent struts joined at a distally facing apex.

27. 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 defining an angle therebetween;

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

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

a restraint having an aperture receiving therethrough the first pair of adjacent struts, wherein the restraint is moveable in an axial direction along the first pair of adjacent struts to adjust the angle therebetween.

28. The implantable heart valve device of claim 27, wherein the restraint comprises a collar.

29. The implantable heart valve device of claim 27, wherein the restraint comprises a threaded surface.

30. The implantable heart valve device of claim 29, wherein the restraint is configured to rotate about the axial direction.

31. The implantable heart valve device of claim 27, wherein moving the restraint in an axial distal direction reduces the angle between the first pair of struts thereby reshaping the frame.

32. The implantable heart valve device of claim 27, wherein the restraint is slidable axially along the first pair of struts.

33. The implantable heart valve device of claim 27, wherein the anchors are configured to advance distally to embed into the tissue surrounding the native heart valve.

34. The implantable heart valve device of claim 27, wherein the first pair of adjacent struts are joined at a proximally facing apex, the frame further comprising at least a second pair of adjacent struts joined at a distally facing apex.

35. 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 defining an angle therebetween;

a plurality of anchors coupled with the frame and configured to advance distally relative to the frame to embed into tissue surrounding a native heart valve;

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

a restraint having an aperture receiving therethrough the first pair of adjacent struts, wherein the restraint is moveable in an axial direction along the first pair of adjacent struts to adjust the angle therebetween.

36. The implantable heart valve device of claim 35, wherein the restraint comprises a collar.

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

38. The implantable heart valve device of claim 37, wherein the restraint is configured to rotate about the axial direction.

39. The implantable heart valve device of claim 35, wherein moving the restraint in an axial distal direction reduces the angle between the first pair of struts thereby reshaping the frame.

40. The implantable heart valve device of claim 35, wherein the restraint is slidable axially along the first pair of struts.

41. The implantable heart valve device of claim 35, wherein the first pair of adjacent struts are joined at a proximally facing apex, the frame further comprising at least a second pair of adjacent struts joined at a distally facing apex.