Prosthetic heart valve devices and associated systems and methods

• US 10,028,827 B2
• Filed: 01/25/2017
• Issued: 07/24/2018
• 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, III, Hanson
• Primary Examiner(s): Dukert, Brian
• Application Number:
  US15/415,197
• Publication Number:
  US 20170143481A1
• Time in Patent Office: 545 Days
• 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 heart valve device for treating a native heart valve having a native annulus and native leaflets, comprising:

an expandable frame comprising a first portion having a downstream region and an upstream region and a second portion extending outwardly from the downstream region of the first portion in an upstream direction when the frame is in an expanded configuration;

a valve member attached to an interior of the first portion;

and a skirt coupled to the downstream region of the first portion and flaring outwardly in the upstream direction separate from the second portion such that an upstream region of the skirt is spaced outwardly from the first portion and inwardly from the second portion, wherein the skirt extends around the entire circumference of the first portion.

2. The device claim 1, wherein the valve member comprises a tri-leaflet assembly configured to allow blood flow in the downstream direction and to block blood flow in the upstream direction.

3. The device of claim 1, wherein the valve member comprises a bi-leaflet assembly configured to allow blood flow in the downstream direction and to block blood flow in the upstream direction.

4. The device of claim 1, wherein the first portion of the frame is cylindrical.

5. The device of claim 1, wherein the second portion of the frame comprises elongated members extending outwardly from the downstream region of the first portion of the frame in an upstream direction when the frame is in an expanded configuration.

6. The device of claim 5, wherein the elongated members have a covering.

7. The device claim 1, wherein the frame is configured to receive native heart valve leaflets between the first and second portions of the frame when the frame is in an expanded configuration.

8. The device claim 1, wherein the frame further comprise a third portion extending outwardly from the upstream region of the first portion in a downstream direction when the frame is in an expanded configuration.

9. The device claim 1, wherein the frame further comprises elongated members extending outwardly from the upstream region of the first portion in a downstream direction when the frame is in an expanded configuration.

10. The device of claim 1, wherein the second portion of the frame is biased outwardly from the first portion of the frame.

11. The device of claim 1, wherein the frame is expandable from a low-profile configuration for delivery to an expanded configuration for implantation at the native heart valve.

12. The device of claim 1, wherein the skirt is configured to inhibit blood flow between the prosthetic heart valve device and the native heart valve upon implantation of the prosthetic heart valve device at the native heart valve.

13. The device of claim 1, wherein at least a portion of the frame comprises a covering.

14. The device of claim 1, wherein the first portion of the frame has a circular cross-section.

15. The device of claim 1, wherein the frame is self-expandable.

16. A prosthetic heart valve device for treating a native heart valve having a native annulus and native leaflets, comprising:

an expandable frame comprising a first portion having a downstream region, an upstream region and a circular cross-section, a second portion extending outwardly from the downstream region of the first portion in an upstream direction when the frame is in an expanded configuration, and a third portion extending outwardly from the upstream region of the first portion in a downstream direction when the frame is in an expanded configuration;

a valve member attached to the first portion;

and a skirt coupled to the downstream region of the first portion and flaring outwardly in the upstream direction separate from the second portion such that an upstream region of the skirt is spaced outwardly from the first portion and inwardly from the second portion, wherein the skirt extends around the entire circumference of the first portion, and wherein the frame is configured to receive native heart valve leaflets between the first and second portions of the frame when the frame is in an expanded configuration.

17. A prosthetic heart valve device for treating a native heart valve having a native annulus and native leaflets, comprising:

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

a valve member attached to the valve support; and

a skirt coupled to the downstream portion of the valve support and extending outwardly in the upstream direction separate from the arms such that an upstream portion of the skirt is spaced outwardly from the valve support and inwardly from the arms, wherein the skirt extends around the entire circumference of the valve support, and wherein the frame is configured to receive native heart valve leaflets between the valve support and the arms when the frame is in an expanded configuration.

18. The device of claim 17, wherein the arms comprise a covering.

19. The device of claim 17, wherein the frame further comprises a plurality of elongated members extending outwardly from the upstream portion of the valve support in a downstream direction when the frame is in an expanded configuration.

20. The device of claim 17, wherein the skirt is configured to inhibit blood flow between the valve support and the native heart valve upon implantation of the prosthetic heart valve device at the native heart valve.