Prosthetic heart valve devices and associated systems and methods

• US 10,729,541 B2
• Filed: 07/06/2017
• Issued: 08/04/2020
• Est. Priority Date: 07/06/2017
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Francis, Richard, Robertson, Scott, Lally, Marian, Hill, Alexander, Miyashiro, Katherine, Frisby, Paraic, Keogh, James R.
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/642,834
• Publication Number:
  US 20190008635A1
• Time in Patent Office: 1,125 Days
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

Claims

1. A prosthetic heart valve device comprising:

an anchoring member comprising a radially expandable frame defining an interior, an upstream portion, and a downstream portion, wherein the upstream portion includes a tissue fixation portion configured to press outwardly against tissue located at and/or downstream of a native annulus of a heart valve, and wherein the tissue fixation portion is at least partially deformable to conform to a shape of the tissue;

a valve comprising at least one leaflet movable from a closed position in which blood flow is blocked through the interior of the anchoring member and an open position in which blood flow is allowed through the interior of the anchoring member in a flow direction from the upstream portion toward the downstream portion, wherein the valve is spaced inwardly apart from the tissue fixation portion of the anchoring member such that the valve remains competent when the tissue fixation portion is deformed to conform to the shape of the tissue; and

an extension member extending laterally away from the upstream portion of the anchoring member in a deployed configuration, wherein the extension member comprises a plurality of discrete fabric segments having a first end at the anchoring member and a second end spaced apart from the anchoring member, wherein the fabric segments are arranged side-by-side around the extension member and adjacent fabric segments are loosely coupled together by corresponding sutures such that the second ends of adjacent fabric segments can be positioned independently of each other in the deployed state.

2. The prosthetic heart valve device of claim 1 wherein the fabric segments do not include a separate structural member.

3. The prosthetic heart valve device of claim 1 wherein the extension member is configured to deform relative to the expandable frame in the deployed configuration.

4. The prosthetic heart valve device of claim 1 wherein the second ends of the fabric segments coincide with an outer circumference of the extension member.

5. The prosthetic heart valve device of claim 1 wherein the fabric segments are spaced apart from the expandable frame such that the fabric segments are only indirectly coupled to the anchoring member.

6. The prosthetic heart valve device of claim 1 wherein the fabric segments are directly connected to the expandable frame.