STENTED PROSTHETIC HEART VALVE HAVING A WRAP AND DELIVERY DEVICES

• US 20170258586A1
• Filed: 03/14/2017
• Published: 09/14/2017
• Est. Priority Date: 03/14/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bateman, Michael, Clague, Cynthia, Sandstrom, Jeffrey, Racchini, Joel, Keogh, James R.
• Granted Patent: US 10,888,420 B2
• Time in Patent Office: Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient'"'"'s vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Claims

1. A stented prosthetic heart valve comprising:

a stent frame having a compressed arrangement for delivery within a vasculature and an expanded arrangement for deployment within a native heart valve;

valve leaflets disposed within and secured to the stent frame; and

a wrap encircling the stent frame and formed of a flexible material;

the wrap having a delivery position and a deployed position;

wherein the wrap can be actuated from the delivery position to the deployed position independently of the arrangement of the stent frame.

2. The stented prosthetic heart valve of claim 1, wherein the wrap can be maintained in the deployed position with a coupling element.

3. The stented prosthetic heart valve of claim 1, the wrap having a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein a diameter of the wrap can selectively be enlarged via movement of the second end.

4. The stented prosthetic heart valve of claim 1, wherein the wrap is biased in the deployed position.

5. The stented prosthetic heart valve of claim 4, wherein the wrap includes a plurality of spines that bias the wrap in the deployed position.

6. A stented prosthetic heart valve comprising:

a stent frame having a compressed arrangement for delivery within a vasculature and an expanded arrangement upon deployment within a native heart valve;

valve leaflets disposed within and secured to the stent frame; and

a wrap encircling the stent frame and formed of a flexible material having a variable diameter defined by a greatest distance between any two opposing points on the wrap;

wherein the wrap is configured to have a deployed position in which a diameter of the wrap can selectively be enlarged in situ.

7. The stented prosthetic heart valve of claim 6, wherein the wrap can be maintained in the deployed position with a coupling element.

8. The stented prosthetic heart valve of claim 6, the wrap having a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the diameter of the wrap can selectively be enlarged via movement of the second end.

9. The stented prosthetic heart valve of claim 6, wherein the wrap has a delivery position;

wherein the diameter of the wrap is greater in the deployed position than in the delivery position;

wherein the deployed position of the wrap can be actuated independently of the compressed or expanded arrangement of the stent frame.

10. The stented prosthetic heart valve of claim 6, wherein the wrap is biased to the deployed position.

11. The stented prosthetic heart valve of claim 10, wherein the wrap includes a plurality of spines that bias the wrap to the deployed position.

12. A method of delivering and deploying a stented prosthetic heart valve at a native heart valve, the method comprising the steps of:

providing a stented prosthetic heart valve including;

a stent frame having a compressed arrangement for delivery within a vasculature and an expanded arrangement for deployment within a native heart valve,

valve leaflets disposed within and secured to the stent frame, and

a wrap encircling the stent frame in a delivery position, the wrap formed of a flexible material having a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame;

providing a delivery device comprising a shaft assembly on which the stented prosthetic heart valve is releasably connected in the compressed arrangement;

guiding the stented prosthetic heart valve to a native valve with the delivery device;

assessing whether paravalvular leakage is occurring proximate the native aortic valve; and

only if paravalvular leakage is detected, deploying the wrap to a deployed position in which a diameter of the wrap, defined by a greatest distance between the wrap and the stent frame, is enlarged.

13. The method of claim 12, further comprising the step of maintaining the wrap in the deployed position with a coupling element.

14. The method of claim 12, the wrap having a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap is deployed via movement of the second end.

15. The method of claim 12, wherein the wrap is biased in to the deployed position.

16. The method of claim 15, wherein the wrap includes a plurality of spines that bias the wrap to the deployed position.

17. The method of claim 12, wherein the delivery device further comprises a plurality of tethers, each tether connected to both the delivery device and the second end of the wrap.

18. The method of claim 17, wherein, when positioned to the deployed position, the second end of the wrap is retained in the deployed position with at least one coupling element.

19. The method of claim 17, wherein the shaft assembly includes a tip and the plurality of tethers are secured to the tip.

20. The method of claim 17, wherein the shaft assembly includes a tip and the step of positioning the wrap in the deployed position includes either:

1) moving the tip distally past the stented prosthetic heart valve;

or

     2) drawing the tip proximally past the second end of the wrap.