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

• US 9,974,649 B2
• Filed: 03/24/2016
• Issued: 05/22/2018
• 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
• Application Number:
  US15/079,090
• Publication Number:
  US 20170273784A1
• Time in Patent Office: 789 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 including a plurality of cells formed by segments adjoined at a plurality of nodes;

the stent frame further including a first frame end and a second frame end;

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

a wrap connected to the stent frame with at least one elongated member;

each elongated member having two ends;

wherein at least one end of the elongated member is secured to the stent frame;

wherein the wrap has a delivery arrangement and a deployed arrangement that is actuated by expansion of the stent frame;

wherein each 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.

2. The stented 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 arrangement as compared to the delivery arrangement.

3. The stented prosthetic heart valve of claim 1, wherein the wrap has first and second ends;

wherein the second end of the wrap extends beyond the first frame end in the delivery arrangement and the second end of the wrap extends over the stent frame in the deployed arrangement.

4. The stented prosthetic heart valve of claim 3, wherein the first end of the wrap extends beyond the first frame end in the delivery arrangement the first end of the wrap extends over the stent frame in the deployed arrangement.

5. The stented prosthetic heart valve of claim 1, further comprising a plurality of elongated members connecting the stent frame and the wrap.

6. The stented 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 stented prosthetic heart valve of claim 5, wherein the wrap has first and second ends;

wherein six or more individual elongated members connect one of the first and second ends to the stent frame.

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

9. The stented prosthetic heart valve of claim 5, wherein each elongated member is threaded around a single respective one of the plurality of cells.

10. The stented prosthetic heart valve of claim 1, wherein the two ends of the elongated member are connected to the stent frame.

11. The stented prosthetic heart valve of claim 1, further comprising a plurality of eyelets at the first frame end, wherein at least one of the plurality of elongated members is threaded through one of the eyelets.

12. The stented prosthetic heart valve of claim 1, wherein the wrap is folded over itself in the delivery arrangement.

13. The stented prosthetic heart valve of claim 12, wherein the wrap is not folded over itself in the deployed arrangement.

14. The stented prosthetic heart valve of claim 1, wherein in the deployed arrangement, each elongated member is oriented tangential to the stent frame.

15. The stented prosthetic heart valve of claim 1, wherein a longitudinal position of the wrap with respect to the stent frame varies in the delivery arrangement as compared to the deployment arrangement.

16. A stented prosthetic heart valve comprising:

a stent frame including a plurality of cells formed by segments adjoined at a plurality of nodes;

the stent frame further including a first frame end and a second frame end;

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

a wrap connected to the stent frame with a plurality of elongated members;

each elongated member having two ends;

wherein at least one end of the elongated member is secured to the stent frame;

wherein the wrap has a delivery frame;

wherein each elongated member is 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.

17. A stented prosthetic heart valve comprising:

a stent frame including a plurality of cells formed by segments adjoined at a plurality of nodes;

the stent frame further including a first frame end and a second frame end;

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

a wrap connected to the stent frame with a plurality of elongated members;

each elongated member having two ends;

wherein at least one end of the elongated member is secured to the stent frame;

wherein the wrap has a delivery arrangement and a deployed arrangement that is actuated by expansion of the stent frame;

wherein the wrap has first and seconds ends;

wherein the first end of the wrap is secured to the stent frame and the second end of the wrap is movably connected to the stent frame with the plurality of elongated members;

wherein each of the plurality of elongate members are threaded through the wrap approximately halfway between the first and second ends of the wrap.

18. The stented prosthetic heart valve of claim 17, wherein, in the deployed arrangement, the first and second ends are adjacent one another.

19. A stented prosthetic heart valve comprising:

a stent frame including a plurality of cells formed by segments adjoined at a plurality of nodes;

the stent frame further including a first frame end and a second frame end;

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

a wrap connected to the stent frame with a plurality of elongated members;

each elongated member having two ends;

wherein at least one end of the elongated member is secured to the stent frame;

wherein the wrap has a delivery arrangement and a deployed arrangement that is actuated by expansion of the stent frame;

wherein at least one elongated member extends between two adjacent nodes twice.

20. A stented prosthetic heart valve comprising:

a stent frame including a plurality of cells formed by segments adjoined at a plurality of nodes;

the stent frame further including a first frame end and a second frame end;

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

a wrap connected to the stent frame with at least one elongated member;

each elongated member having two ends;

wherein at least one end of the elongated member is secured to the stent frame;

wherein the wrap has a delivery arrangement and a deployed arrangement that is actuated by expansion of the stent frame;

wherein the wrap has first and second ends;

wherein the wrap has a midsection between the first end of the wrap and the second end of the wrap;

wherein, in the deployed arrangement, the wrap is folded at the midsection.

21. The stented prosthetic heart valve of claim 20, wherein the midsection of the wrap is closer to the first frame end when in the deployed arrangement as compared to the delivery arrangement.

22. The stented prosthetic heart valve of claim 20, wherein the midsection of the wrap is connected to the stent frame such that each elongated member slidably wraps around one node and then horizontally across a width of at least one cell.