Stented prosthetic heart valve having wrap and methods of delivery and deployment

• US 10,179,045 B2
• Filed: 04/18/2018
• Issued: 01/15/2019
• Est. Priority Date: 03/24/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Racchini, Joel, Garde, Kshitija, Rothstein, Paul, Sandstrom, Jeffrey, Clague, Cynthia
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US15/956,165
• Publication Number:
  US 20180228603A1
• Time in Patent Office: 272 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2250/0069 Sealing means

Abstract

Systems and methods of delivering and deploying a stented prosthetic heart valve having a wrap that is automatically deployed to prevent or mitigate paravalvular leakage. In various embodiments, during transcatheter delivery of the stented prosthetic heart valve, the wrap is extends beyond a stent frame of the stented prosthetic heart valve so that the profile of the stented prosthetic heart valve is not increased during delivery. The disclosed embodiments are arranged and configured so that upon expansion of a stent frame of the stented prosthetic heart valve, a plurality of elongated members automatically pull the wrap distally into a deployed arrangement.

Claims

1. A stented prosthetic heart valve comprising:

a stent frame;

a plurality of valve leaflets positioned within the stent frame; and

a wrap connected to the stent frame with an elongated member, the wrap including first and second ends, the elongated member including first and second ends, wherein the first end of the elongated member is secured to the stent frame, wherein the first end of the wrap is secured to the stent frame, wherein the second end of the wrap is connected to the elongated member such that the second end of the wrap is movably connected to the stent frame, wherein the elongate member is threaded at least once through the wrap, wherein the wrap has a delivery configuration and a deployed configuration that is actuated by expansion of the stent frame.

2. The prosthetic heart valve of claim 1, wherein the stent frame includes a plurality of cells formed by segments adjoined at a plurality of nodes, wherein the elongated member extends from the wrap in a first direction, wraps around one respective node and then extends in a second direction that is different than the first direction.

3. The prosthetic heart valve of claim 1, wherein the stent frame defines a length and the wrap covers a greater portion of the length of the stent frame in the deployment configuration as compared to the delivery configuration.

4. The prosthetic heart valve of claim 1, wherein the stent frame includes first and second ends, the second end of the wrap extending beyond the first end of the frame in the delivery configuration and the second end of the wrap extends over the stent frame in the deployed configuration.

5. The prosthetic heart valve of claim 1, further comprising a plurality of elongated members connecting the stent frame and the wrap, wherein each elongate member is threaded at least once through the wrap.

6. The prosthetic heart valve of claim 5, wherein the plurality of elongated members are arranged and configured so that they do not cross one another.

7. The prosthetic heart valve of claim 5, wherein the plurality of elongated members are arranged and configured to be offset such that in the deployed configuration, a plurality of ridges are formed in an outwardly facing surface of the wrap.

8. The prosthetic heart valve of claim 1, wherein the stent frame includes a plurality of cells formed by segments adjoined at a plurality of nodes, wherein the elongated member is threaded around a single respective one of the plurality of cells.

9. The prosthetic heart valve of claim 1, wherein the stent frame includes a plurality of cells formed by segments adjoined at a plurality of nodes, wherein the elongated member is threaded around two respective cells of the plurality of cells.

10. The prosthetic heart valve of claim 9, further comprising a plurality of elongated members connecting the stent frame and the wrap, wherein each of the plurality of elongated members are each threaded around two respective cells of the plurality of cells, wherein each of the plurality of elongated members are not threaded around any of the respective cells around which another of the plurality of elongated members is threaded.

11. The prosthetic heart valve of claim 1, wherein the wrap is folded at least once in the deployed configuration.

12. The prosthetic heart valve of claim 1, wherein the elongate member is threaded a plurality of times through the wrap.