Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

• US 9,901,443 B2
• Filed: 08/07/2015
• Issued: 02/27/2018
• 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, McLean, Matt, Gittings, Darin, Luna, Michael, Deem, Mark, Sutton, Douglas, Grainger, Jeffry J.
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US14/820,830
• Publication Number:
  US 20150335429A1
• Time in Patent Office: 935 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 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2220/0041 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• 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 a first 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 valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

Claims

1. A device for treatment of a native valve of a heart, the device comprising:

an anchoring member having an annular portion at an upstream region, wherein the annular portion of the anchoring member comprises a first frame configured to press outwardly against an inner surface of a native annulus in an expanded state;

a flange coupled to the annular portion of the anchoring member, wherein the flange extends radially outward with respect to the annular portion of the anchoring member and is configured to engage a supra-annular surface of an atrial side of the native annulus in the expanded state;

an inner valve support disposed in the anchoring member, wherein the inner valve support comprises a second frame having an inflow portion spaced radially inward apart from the annular portion of the anchoring member in the expanded state; and

a prosthetic valve carried by the inner valve support.

2. The device of claim 1 wherein the anchoring member comprises a plurality of ribs, and wherein each rib comprises:

a lower rib segment; and

an upper rib segment extending from the lower rib segment, wherein the upper rib segment is angled radially outward from a longitudinal axis of the device.

3. The device of claim 2, further comprising a sealing member having a first portion disposed on the upper rib segments of the anchoring member and a second portion disposed on the lower rib segments of the anchoring member.

4. The device of claim 2 wherein:

the lower rib segment is angled radially outwardly from a downstream portion of the inner valve support in an upstream direction;

the lower rib segment is angled radially outward at a first angle from the longitudinal axis; and

the upper rib segment is angled radially outward from the longitudinal axis at a second angle greater than the first angle.

6. The device of claim 1 wherein the anchoring member and the inner valve support are spaced apart by a gap, and wherein the sealing member is disposed across the gap between the anchoring member to the inner valve support.

8. The device of claim 1, further comprising a sealing member on an inner surface of the anchoring member and on the flange.

9. The device of claim 1, further comprising a sealing member defined by a continuous sleeve of material extending around the anchoring member.

10. The device of claim 1 wherein the anchoring member and the inner valve support are coupled together at a downstream portion of the device via a filament.

11. The device of claim 1 wherein the anchoring member and the inner valve support are coupled together at a downstream portion of the device via a fastener.

12. The device of claim 1 wherein:

the anchoring member comprises circumferential connectors at a downstream portion of the device;

the inner valve support comprises struts at the downstream portion; and

the circumferential connectors and the struts couple together to attach the anchoring member to the inner valve support at the downstream portion.

13. The device of claim 1 wherein:

the valve support comprises a tubular member made of fabric polymer, or pericardium with no metallic structural support; and

the prosthetic valve comprises leaflets attached to the tubular member.

14. The device of claim 13, further comprising a sleeve that extends around the anchoring member, and wherein the tubular member is attached to the sleeve.

15. The device of claim 13 wherein the tubular member comprises a plurality of struts embedded within a wall of the tubular member.

5. A device for treatment of a native valve of a heart, the device comprising:

an anchoring member having an upstream portion and an atrial retainer configured to extend radially outward from the upstream portion to engage a supra-annular surface, wherein the anchoring member comprises a first frame;

a sealing member extending around and radially outward from the upstream portion of the anchoring member, wherein the sealing member is configured to extend over an atrial side of a native annulus, and wherein the anchoring member and the sealing member are configured to prevent paravalvular leaks between the device and native tissue;

an inner valve support disposed in the anchoring member, wherein the inner valve support comprises a second frame; and

a prosthetic valve carried by the inner valve support.

7. A device for treatment of a native valve of a heart, the device comprising:

an anchoring member having an upstream portion, wherein the anchoring member comprises a first frame;

a flange extending around the upstream portion of the anchoring member, wherein the flange extends radially outward with respect to the upstream portion of the anchoring member and is configured to extend over an atrial side of a native annulus, and wherein the anchoring member and the flange are configured to prevent paravalvular leaks between the device and native tissue;

an inner valve support disposed in the anchoring member, wherein the inner valve support comprises a second frame; and

a prosthetic valve carried by the inner valve support;

wherein the anchoring member has a first diameter at the upstream portion and a second diameter smaller than the first diameter at a downstream portion of the anchoring member.

16. A device for treatment of a native valve of a heart, the device comprising:

an anchoring member having an annular portion at an upstream region, wherein annular portion of the anchoring member comprises a first frame configured to press outwardly against an inner surface of a native annulus in an expanded state;

a flange extending around and radially outward from the upstream portion of the anchoring member, wherein the flange is configured to extend over an atrial side of a native annulus, and wherein the anchoring member and the sealing member are configured to prevent paravalvular leaks between the device and native tissue;

an inner valve support disposed in the anchoring member, wherein the inner valve support comprises a second frame having an inflow portion spaced radially inward apart from the annular portion of the anchoring member in the expanded state; and

a prosthetic valve carried by the inner valve support.

17. The device of claim 16 wherein the anchoring member has a first diameter at the upstream portion and a second diameter smaller than the first diameter at a downstream portion of the anchoring member.

18. The device of claim 16 wherein the anchoring member further comprises an atrial retainer configured to extend radially outward to engage a supra-annular surface.