Devices, systems and methods for heart valve replacement

• US 9,763,780 B2
• Filed: 10/19/2012
• Issued: 09/19/2017
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, III, Hanson, Fann, James I., Dueri, Jean-Pierre, Gittings, Darin, Luna, Michael, Deem, Mark, Sutton, Douglas
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/352,964
• Publication Number:
  US 20150351903A1
• Time in Patent Office: 1,796 Days
• Field of Search: 623 124, 623 126, 623 21, 623 211, 623 217, 623 218, 623 223, 623 237, 623 238
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/006 modular

Abstract

A prosthetic heart valve device (100) for percutaneous replacement of a native heart valve includes an expandable retainer (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to the valve support. The retainer forms a donut-shaped flange (190) having an arcuate outer surface (142) for engaging tissue and an inner lumen defining a passage for blood to flow through the valve support. The retainer can include a plurality of circumferentially positioned, resiliency deformable and flexible ribs (114) which are coupled at their downstream ends 116 to the valve support 120. The flexible ribs, in one embodiment, can have a general C-shape configuration with the tips (117) of the flexible ribs and an opening (119) of the C-shape configuration oriented toward a longitudinal axis (101) of the device.

Claims

1. A device for repair or replacement of a native heart valve, the native heart valve having an annulus and native leaflets associated with the annulus, comprising:

a valve support having an inflow end and an outflow end extending along a longitudinal axis, the valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the valve support has a cross-sectional shape;

an expandable ring-shaped retainer positioned at the inflow end of the valve support, the retainer configured to engage and seal with tissue on or near the annulus on an inner or inflow side of the native leaflets;

wherein the inflow end of the valve support is radially inward from and longitudinally overlapping a portion of the retainer when the device is in a deployed configuration; and

wherein the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains substantially cylindrical such that the prosthetic valve remains competent when the retainer is deformed into a non-circular shape by engagement with the tissue.

2. The device of claim 1 wherein the retainer extends upstream and radially outward of the valve support.

3. The device of claim 1 wherein the retainer is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets downstream of the annulus.

4. The device of claim 1 wherein the device is moveable into a plurality of configurations including:

a first configuration in which the valve support and the retainer are radially contracted, and wherein the valve support has a first cross-sectional shape;

a second configuration in which the valve support and the retainer are radially expanded, and wherein the valve support has a second cross-sectional shape greater than the first cross-sectional shape; and

a third configuration in which the retainer is engaged with and at least partially deformed by tissue on or near the annulus while the valve support remains in the second cross-sectional shape.

5. The device of claim 4 wherein the retainer has an outer circumference, the outer circumference being generally circular in the second configuration and generally non-circular in the third configuration.

6. The device of claim 1 wherein at least a portion of the valve support is generally circular and the retainer is deformable to be generally non-circular when engaging the tissue.

7. The device of claim 1 wherein the valve support includes a plurality of posts connected circumferentially by a plurality of struts, and wherein the retainer includes a plurality of arcuate ribs extending outward from the valve support and in an upstream direction, the ribs being distributed about a perimeter of the valve support.

8. The device of claim 1 wherein the retainer includes a plurality of flexible ribs distributed around a perimeter of the valve support, and wherein one or more ribs bends or rotates in the deployed configuration.

9. The device of claim 1, further comprising a plurality of arms coupled to the valve support and configured to engage an inward-facing surface of the leaflets downstream of the annulus.

10. The device of claim 9 wherein the arms include one or more tissue engaging elements for penetrating the inward-facing surface of the leaflets.

11. The device of claim 9 wherein the plurality of arms are configured to inhibit movement of the device toward an atrium by engagement of the annulus or the leaflets downstream of the annulus.

12. The device of claim 9 wherein the plurality of arms are moveable from an inward configuration for delivery of the device through vasculature of a patient to an outward configuration for engagement of the tissue on or near the annulus.

13. The device of claim 1, further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

14. The device of claim 13 wherein the valve is a tri-leaflet valve.

15. The device of claim 1, further comprising a sealing membrane covering the expandable retainer.

16. The device of claim 1, further comprising tissue engaging elements extending from the expandable retainer.

17. A device for repair or replacement of a native heart valve, the native heart valve having an annulus and native leaflets associated with the annulus, comprising:

a valve support having an inflow end and an outflow end extending along a longitudinal axis, the valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the valve support has a cross-sectional shape;

an expandable ring-shaped retainer coupled to the inflow end of the valve support, the retainer coupled to the inflow end of the valve support, the retainer configured to engage and seal with tissue on or near the annulus on an inner or inflow side of the native leaflets, wherein the retainer includes a plurality of flexible C-shaped ribs circumferentially positioned around an upper portion of the device, and wherein the retainer is a donut-shaped flange coupled to the inflow end of the valve support; and

wherein the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains substantially cylindrical such that the prosthetic valve remains competent when the retainer is deformed into a non-circular shape by engagement with the tissue.

18. The device of claim 17 wherein the C-shaped ribs have a first radius of curvature in an unbiased state, and wherein the C-shaped ribs are configured to be deformed in a deployed configuration such that the C-shaped ribs have a second radius of curvature, the second radius of curvature being smaller or greater than the first radius of curvature.

19. A prosthetic heart valve device for treating a mitral valve, comprising:

a valve support configured to support a valve;

a ring-shaped retainer coupled to the valve support and positioned at an inflow end of the device, wherein the retainer is positionable between the native valve leaflets at least partially along a subannular surface of a native mitral valve annulus, and wherein the retainer is configured to form a fluid seal with heart tissue and to inhibit upstream migration of the device;

wherein, when the prosthetic heart valve device is in a deployed configuration, the valve support is positioned radially inward from the retainer and an upstream region of the valve support overlaps a portion of the retainer along a longitudinal axis of the prosthetic heart valve device; and

wherein the retainer is coupled to the valve support so as to mechanically isolate the valve support from distorting force exerted on the retainer by native anatomy and thereby maintain the valve support in a substantially cylindrical shape when the retainer is formed into a non-circular shape by the distorting force applied to the retainer by the native anatomy.

20. The device of claim 19 wherein the retainer is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets downstream of the annulus.

21. The device of claim 19 wherein the device is moveable into a plurality of configurations including:

a first configuration in which the valve support and the retainer are radially contracted, and wherein the valve support has a first cross-sectional shape;

a second configuration in which the valve support and the retainer are radially expanded, and wherein the valve support has a second cross-sectional shape greater than the first cross-sectional shape; and

a third configuration in which the retainer is configured to be engaged with and at least partially deformed by tissue on or near the annulus while the valve support remains in the second cross-sectional shape.

22. The device of claim 21 wherein the retainer has an outer circumference, the outer circumference being generally circular in the second configuration and generally non-circular in the third configuration.

23. The device of claim 19 wherein at least a portion of the valve support is generally circular and the retainer is deformable to be generally non-circular when engaging the tissue.

24. The device of claim 19 wherein the valve support includes a plurality of posts connected circumferentially by a plurality of struts, and wherein the retainer includes a plurality of arcuate ribs extending outward from the valve support and in an upstream direction, the ribs being distributed about a perimeter of the valve support.

25. The device of claim 19, further comprising a plurality of arms coupled to the valve support and configured to engage an inward-facing surface of the leaflets downstream of the annulus.

26. The device of claim 25 wherein the arms include one or more tissue engaging elements for penetrating the inward-facing surface of the leaflets.

27. The device of claim 25 wherein the plurality of arms are configured to inhibit movement of the device toward an atrium by engagement of the annulus or the leaflets downstream of the annulus.

28. The device of claim 25 wherein the plurality of arms are moveable from an inward configuration for delivery of the device through vasculature of a patient to an outward configuration for engagement of the tissue on or near the annulus.

29. The device claim 19, further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

30. The device of claim 29 wherein the valve is a tri-leaflet valve.

31. A prosthetic heart valve device for treating a mitral valve, comprising:

a flexible ring-shaped retainer configured to be positioned between the native valve leaflets and to engage cardiac tissue at or downstream of a native mitral valve annulus so as to inhibit movement of the prosthetic heart valve device and to create a seal with the cardiac tissue; and

an expandable valve support coupled to and extending in an outflow direction with respect to the retainer, wherein the valve support is configured to contain a prosthetic valve having a plurality of leaflets, the valve support having a substantially cylindrical deployed shape in an expanded state in which the leaflets of the prosthetic valve seal with one another;

wherein, in the expanded state, an inflow portion of the valve support is longitudinally overlapping a portion of the retainer and positioned radially inward from the retainer; and

wherein the retainer is configured to flex radially to adapt to a non-circular shape of the native mitral valve annulus and the valve support remains in the substantially cylindrical deployed shape after the retainer has adapted to the non-circular shape.

32. The device of claim 31 wherein the retainer is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets downstream of the annulus.

33. The device of claim 31 wherein the device is moveable into a plurality of configurations including:

a first configuration in which the valve support and the retainer are radially contracted, and wherein the valve support has a first cross-sectional shape;

a second configuration in which the valve support and the retainer are radially expanded, and wherein the valve support has a second cross-sectional shape greater than the first cross-sectional shape; and

a third configuration in which the retainer is configured to be engaged with and at least partially deformed by tissue on or near the annulus while the valve support remains in the second cross-sectional shape.

34. The device of claim 33 wherein the retainer has an outer circumference, the outer circumference being generally circular in the second configuration and generally non-circular in the third configuration.

35. The device of claim 31 wherein the valve support is substantially cylindrical and the retainer is deformable to be generally non-circular when engaging the tissue.

36. The device of claim 31, further comprising a plurality of arms coupled to the valve support and configured to engage an inward-facing surface of the leaflets downstream of the annulus.

37. The device of claim 36 wherein the arms include one or more tissue engaging elements for penetrating the inward-facing surface of the leaflets.

38. The device of claim 36 wherein the plurality of arms are configured to inhibit movement of the device toward an atrium by engagement of the annulus or the leaflets downstream of the annulus.

39. The device of claim 36 wherein the plurality of arms are moveable from an inward configuration for delivery of the device through vasculature of a patient to an outward configuration for engagement of the tissue on or near the annulus.

40. The device claim 31, further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

41. The device of claim 40 wherein the valve is a tri-leaflet valve.

42. A prosthetic heart valve device comprising:

an expandable valve support having an inflow end and an outflow end extending along a longitudinal axis, the valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the valve support has a cross-sectional shape;

an expandable retainer coupled to and encircling the valve support, the retainer configured to engage and seal with tissue on or near a native heart valve annulus on an inner or inflow side of the heart valve annulus or native heart valve leaflets;

wherein the inflow end of the valve support is radially inward from and longitudinally overlapping a portion of the retainer when the device is in a deployed configuration; and

wherein the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains substantially cylindrical such that the prosthetic valve remains competent when the retainer is deformed into a non-circular shape by engagement with the tissue.