Prosthetic heart valve devices and associated systems and methods

• US 9,579,196 B2
• Filed: 07/23/2015
• Issued: 02/28/2017
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, Hanson III
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US14/807,788
• Publication Number:
  US 20150327994A1
• Time in Patent Office: 586 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• 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 2250/0037 differing in height or in length
• 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 expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

Claims

1. A prosthetic treatment apparatus for treating a native mitral valve having a native annulus and native leaflets, the prosthetic treatment apparatus comprising:

a support having a downstream portion configured to be positioned toward a left ventricle and an upstream portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for delivery to an expanded configuration for implantation at the native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow in a downstream direction and to block blood flow in an upstream direction;

a plurality of arms coupled to the downstream portion of the support, wherein the arms extend outwardly from the support in an upstream direction when the support is in the expanded configuration; and

a skirt having an upstream end coupled to the support and a downstream end, wherein—

at least a portion of the skirt downstream of the upstream end extends radially outwardly from the valve support separate from the arms such that the upstream end has a first diameter and the downstream end has a second diameter greater than the first diameter,

the skirt extends around an entire circumference of the support, and

the skirt is configured to fill gaps between the support and native tissue to inhibit blood flow therethrough.

2. The prosthetic treatment apparatus of claim 1 wherein the skirt is attached to the support to limit radial expansion of the skirt.

3. The prosthetic treatment apparatus of claim 1 wherein the downstream end of the skirt is disposed between the arms and the support when the support is in the expanded configuration.

4. The prosthetic treatment apparatus of claim 1 wherein the arms are biased outwardly.

5. The prosthetic treatment apparatus of claim 1 wherein the arms are configured to move relative to the support to compress native tissue as the support expands.

6. The prosthetic treatment apparatus of claim 1 wherein the skirt is configured to be inflated with blood to urge the skirt against the native tissue at or below the native annulus.

7. The prosthetic treatment apparatus of claim 1 wherein the arms are configured to engage native tissue downstream of the native annulus.

8. The prosthetic treatment apparatus of claim 1, further comprising a cover and/or a coating disposed on at least a portion of the arms, wherein the cover and/or coating is configured to distribute forces applied by the arms on native tissue.

9. A prosthetic treatment apparatus for treating a native mitral valve having a native annulus and native leaflets, the prosthetic treatment apparatus comprising:

a support having a distal portion configured to be positioned toward a left ventricle and a proximal portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for implantation to an expanded configuration at a native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow from the proximal portion of the support to the distal portion of the support and to block blood flow travelling proximally from the left ventricle to the left atrium;

a plurality of anchoring arms connected to the distal portion of the support, wherein the arms extend proximally and radially outwardly from the support when the support is in the expanded configuration; and

a sealing member extending around a circumference of the support and having a first end coupled to the support and a second end, wherein the sealing member has a portion between the first and second ends that extends radially outwardly from the support separate from the anchoring arms when the support is in the expanded configuration, and wherein the sealing member is configured to be inflated by blood disposed between the sealing member and the support to urge the sealing member against native tissue at or below the annulus.

10. The prosthetic treatment apparatus of claim 9 wherein the anchoring arms are configured to engage native tissue on or downstream of the native annulus, and wherein at least one of the anchoring arms includes a covering and/or a coating to distribute force applied to the native tissue.

11. A prosthetic device configured for transcatheter replacement of a native mitral valve, the prosthetic device comprising:

a support having a downstream portion configured to be positioned toward a left ventricle and an upstream portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for delivery to an expanded configuration for implantation at a the native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow in a downstream direction and to block blood flow in an upstream direction;

a plurality of anchoring arms coupled to the downstream portion of the support, wherein the anchoring arms extend outwardly from the support in an upstream direction to engage a subannular surface of the native mitral valve when the support is in the expanded configuration; and

a sealing member extending around a perimeter of the support, the sealing member having a first portion mounted to the support between the upstream and downstream portions, and a second portion downstream of the first portion, the second portion extending radially outwardly from the support and separate from the anchoring arms, wherein—

the sealing member is configured to engage the annulus, leaflets, and/or commissures of the native mitral valve to minimize perivalvular leaks.

12. The prosthetic device of claim 11 wherein the anchoring arms comprise distal tips configured to atraumatically engage the annulus of the native mitral valve.

13. The prosthetic device of claim 11 wherein the anchoring arms are configured to push against leaflets and/or chordae of the native mitral valve.

14. The prosthetic device of claim 11 wherein the anchoring arms are distributed circumferentially along the support to distribute the load across the subannular surface of the native mitral valve.

15. The prosthetic device of claim 11 wherein the anchoring arms comprise curved elbow portions, and wherein the curved elbow portions of the anchoring arms comprise arcuate portions that extend from a downstream end of the downstream portion of the support.

16. The prosthetic device of claim 15 wherein the arcuate portions extend radially inward relative to an outer surface of the support.

17. The prosthetic device of claim 11 wherein the support comprises a frame having a plurality of struts.