Prosthetic heart valve devices and associated systems and methods

• US 9,572,662 B2
• Filed: 05/04/2016
• Issued: 02/21/2017
• 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:
  US15/146,773
• Publication Number:
  US 20160242902A1
• Time in Patent Office: 293 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 method of treating a native mitral valve having a native annulus and leaflets, the method comprising:

positioning a downstream end of a support of a prosthetic treatment apparatus toward a left ventricle, wherein the prosthetic treatment apparatus comprises—

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

a skirt coupled to a downstream portion of the support and flaring outward in an upstream direction, wherein the skirt extends around the entire circumference of the support;

positioning an upstream end of the support of the prosthetic treatment apparatus toward a left atrium;

positioning elongated members that extend from a downstream portion of the support inward of an inner surface of the native leaflets, wherein the elongated members extend outwardly from the support in an upstream direction; and

expanding the prosthetic treatment apparatus from a low-profile configuration to an expanded configuration at the native mitral annulus such that (a) the elongated members are biased outwardly to exert force against the inner surface of the native leaflets and inhibit movement of the support toward the left atrium, and (b) an upstream end of the skirt is spaced outwardly from the support and inhibits blood flow between the prosthetic treatment device and the native mitral valve, wherein the prosthetic valve and the downstream portion of the support from which the elongated members extend remain fixed relative to each other along a longitudinal dimension of the support as the prosthetic treatment apparatus expands,

wherein, following expansion, the elongated members have sufficient flexibility to deflect inwardly or outwardly relative to the support to accommodate expansion or distortion of the native annulus.

2. The method of claim 1 wherein, when the prosthetic treatment apparatus is expanded, the skirt extends in an upstream direction on an inner side of the elongated members.

3. The method of claim 1 wherein the elongated members are configured to engage the annulus so as to inhibit movement of the support toward the atrium.

4. The method of claim 1 wherein, when expanded, one or more wires coupled to the skirt maintain the shape of the skirt.

5. A method of treating a native mitral valve having a native annulus and leaflets, the method comprising:

positioning a downstream end of a skeleton of a support of a prosthetic treatment apparatus toward a left ventricle;

positioning an upstream end of the skeleton toward a left atrium, wherein the prosthetic treatment apparatus includes—

a plurality of elongated members extending from a downstream portion of the skeleton and extending outwardly from the skeleton in an upstream direction, and

a skirt coupled to the downstream portion of the skeleton and flaring outward in an upstream direction such that an upstream end of the flared portion is spaced outwardly from the skeleton, wherein the skirt extends around the entire circumference of the support; and

expanding the skeleton from a low-profile configuration to an expanded configuration at the native mitral annulus such that (a) the downstream end and the upstream end of the skeleton are spaced apart by a fixed distance in the low-profile configuration and the expanded configuration, (b) the plurality of elongated members are biased outwardly to exert force against an inner surface of the native leaflets to inhibit movement of the skeleton toward the left atrium, and (c) the skirt inhibits blood flow between the prosthetic treatment device and the native mitral valve,

wherein, after expansion, (a) a prosthetic valve having a tri-leaflet assembly mounted directly to the skeleton allows blood flow in the downstream direction and to block blood flow in the upstream direction, and (b) the elongated members have sufficient flexibility to deflect inwardly or outwardly relative to the skeleton to accommodate expansion or distortion of the native annulus.

6. The method of claim 5 wherein the skirt is on an inner surface of the elongated members.

7. A method of treating a native mitral valve having a native annulus and leaflets, the method comprising:

positioning a downstream end of a support of a prosthetic treatment apparatus toward a left ventricle, wherein the prosthetic treatment apparatus comprises—

elongated members extending outwardly from a downstream portion of the support in an upstream direction, and

a skirt coupled to the downstream portion of the support and flaring outward in an upstream direction such that an upstream end of the skirt is spaced outwardly from the support, wherein the skirt extends around a circumference of the support;

positioning an upstream end of the support of the prosthetic treatment apparatus toward a left atrium;

positioning the elongated members inward of an inner surface of the native leaflets; and

expanding the prosthetic treatment apparatus from a low-profile configuration to an expanded configuration at the native mitral annulus such that (a) the elongated members exert force against the inner surface of the native leaflets and inhibit movement of the support toward the left atrium, and (b) the skirt inhibits blood flow between the prosthetic treatment device and the native mitral valve,

wherein, following expansion, the elongated members have sufficient flexibility to deflect inwardly or outwardly relative to the support to accommodate expansion or distortion of the native annulus.