PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATED SYSTEMS AND METHODS

• US 20190321171A1
• Filed: 05/02/2019
• Published: 10/24/2019
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, McLean, Matt, Bensing, Maureen, Dueri, Jean-Pierre, Gifford, III, Hanson, Miyashiro, Katie, Scott, David Jerry, Trask, David, Valley, Kirsten
• Granted Patent: US 11,202,704 B2
• Time in Patent Office: Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.

Claims

1. A prosthetic heart valve device comprising:

a valve support;

a prosthetic valve having a plurality of leaflets disposed within the valve support;

an anchoring member having an upstream portion, a downstream portion, and a frame spaced radially outward from and encircling at least a portion of the valve support, the frame having an engagement surface facing laterally outward when the prosthetic heart valve device is in an expanded state, wherein the engagement surface is configured to exert a radially outward force against an inner surface of a native annulus facing the valve support to secure the heart valve device against ventricular systole forces, and wherein the upstream and downstream portion are defined relative to a direction of blood flow through the native annulus; and

an extension member extending radially outward from the upstream portion of the anchoring member.

2. The prosthetic heart valve device of claim 1 wherein the extension member comprises a sheet of flexible material coupled to upstream portion of the anchoring member.

3. The prosthetic heart valve device of claim 1 wherein the extension member comprises a flexible brim and a support structure, wherein the support structure is configured to impart rigidity to the brim.

4. The prosthetic heart valve device of claim 3 wherein the support structure comprises shape memory material secured to or positioned within the brim.

5. The prosthetic heart valve device of claim 3 wherein the support structure comprises a plurality of struts extending around a circumference of the extension member.

6. The prosthetic heart valve device of claim 3 wherein the brim is coupled to the anchoring member and the support structure is spaced apart from and mechanically isolated from the anchoring member.

7. The prosthetic heart valve device of claim 3 wherein the support structure is integral with the frame.

8. The prosthetic heart valve device of claim 7 wherein:

the frame comprises structural elements; and

the support structure comprises integral wires extending from the structural elements into the brim, the integral wires together being substantially more flexible than the structural elements such that the extension member is easier to deflect than the frame.

9. The prosthetic heart valve device of claim 1, further comprising a connection structure extending between and connecting the downstream portion of the frame to the valve support, wherein the connection structure is configured to allow movement of the frame relative to the valve support.

10. A prosthetic heart valve device comprising:

a valve support configured to carry a prosthetic valve;

an anchoring member having an upstream portion, a downstream portion, and a frame, the frame comprising a generally tubular body having a plurality of interconnected closed cells extending circumferentially around the valve support, wherein an inner surface of the frame is spaced apart from the valve support, wherein an outer surface of the frame is configured to press against an inward-facing surface of ta native annulus; and

an extension member extending laterally outward from the upstream portion of the anchoring member and configured to engage tissue upstream of the native annulus.

11. The prosthetic heart valve device of claim 10 wherein the upstream portion of the anchoring member is mechanically isolated from the valve support such that the valve support is configured to maintain a cross-sectional shape while the upstream portion of the anchoring member deforms from a first cross-sectional shape into a second cross-sectional shape.

12. The prosthetic heart valve device of claim 10 wherein the extension member is deflectable relative to the frame about an axis transverse to an axis extending through the upstream portion and downstream portion of the anchoring member.

13. The prosthetic heart valve device of claim 10 wherein, when the prosthetic heart valve device is in an expanded state, the extension member has a transverse dimension of 40-80 mm.

14. The prosthetic heart valve device of claim 10 wherein the extension member has a non-circular shape.

15. The prosthetic heart valve device of claim 10 wherein the extension member comprises a brim and a resilient support structure coupled to the brim, wherein the brim comprises a flexible material.

16. The prosthetic heart valve device of claim 15 wherein the support structure is structurally independent of the frame.

17. The prosthetic heart valve device of claim 15 wherein the support structure comprises struts that extend from the frame.

18. The prosthetic heart valve device of claim 10 wherein, in the expanded state, the extension member is radially deformable without substantial deformation of the anchoring member.

19. The prosthetic heart valve device of claim 10, further comprising a connection structure coupling the downstream portion of the anchoring member to the valve support, wherein the connection structure flares outwardly from the valve support to the frame.

20. The prosthetic heart valve device of claim 19 wherein the connection structure comprises a plurality of struts each having an inner end connected to the valve support and an outer end connected to the frame.