Techniques for percutaneous mitral valve replacement and sealing

• US 10,376,361 B2
• Filed: 07/25/2018
• Issued: 08/13/2019
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US16/045,059
• Publication Number:
  US 20180344457A1
• Time in Patent Office: 384 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 2/2412 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 2/2433 using balloon catheter
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 : breakable or frangible

Abstract

Apparatus is provided for use with a native valve of a heart of a subject. The apparatus includes: (1) an annular upstream support portion, comprising an expandable first frame, the upstream support portion configured to be placed against an upstream surface of the native valve; (2) a flexible polyester connector; and (3) an anchoring element, flexibly coupled to the upstream support portion by the connector, and configured to anchor the upstream support portion to the native valve by engaging tissue of the native valve.

Claims

1. Apparatus, for use with a native valve of a heart of a subject, the native valve defining an area, the apparatus comprising:

an annular upstream support portion, comprising an expandable first frame, the upstream support portion configured to be placed against an upstream surface of the native valve;

a flexible polyester connector;

an anchoring element, flexibly coupled to the upstream support portion by the connector, and configured to anchor the upstream support portion to the native valve by engaging tissue of the native valve; and

a prosthetic valve,

wherein;

the upstream support portion is configured to support the prosthetic valve at the native valve, and

the prosthetic valve;

comprises (i) an expandable second frame that defines a lumen therethrough, and (ii) a plurality of prosthetic leaflets disposed within the lumen and coupled to the second frame,

is configured to be positioned inward from the upstream support portion, and

has a cross-sectional area that is less than 90 percent of the area defined by the native valve.

2. The apparatus according to claim 1, wherein the first frame has a lattice structure that defines a plurality of struts in a repeating arrangement, and a plurality of voids between the struts.

3. The apparatus according to claim 1, wherein the upstream support portion is flat.

4. The apparatus according to claim 1, wherein the upstream support portion is frustoconical.

5. The apparatus according to claim 1, wherein the upstream support portion has a thickness of less than 2 mm.

6. The apparatus according to claim 1, wherein the upstream support portion is shaped to define (i) an outer edge that defines a diameter of the upstream support portion, and (ii) an inner edge, and the connector flexibly couples the anchoring element to the inner perimeter of the upstream support portion.

7. The apparatus according to claim 1, wherein the upstream support portion further comprises a covering that covers at least part of the first frame.

8. The apparatus according to claim 7, wherein the covering comprises a fabric.

9. The apparatus according to claim 7, wherein the covering comprises polyester.

10. The apparatus according to claim 7, wherein the upstream support portion is configured to be placed against the upstream surface of the native valve with the covering in contact with the native valve.

11. The apparatus according to claim 7, wherein the covering is configured to encourage tissue growth.

12. The apparatus according to claim 1, wherein the prosthetic valve has a cross-sectional area that is less than 80 percent of the area defined by the native valve.

13. The apparatus according to claim 12, wherein the prosthetic valve has a cross-sectional area that is less than 60 percent of the area defined by the native valve.

14. The apparatus according to claim 1, wherein:

the connector comprises a covering, and

the covering at least partly covers the first frame and the second frame, and is configured to facilitate coupling between the upstream support portion and the prosthetic valve.

15. The apparatus according to claim 14, wherein the covering is configured to prevent blood leakage between the prosthetic valve and the upstream support portion.

16. The apparatus according to claim 14, wherein the covering is configured to encourage tissue growth.

17. The apparatus according to claim 1, wherein a height of the prosthetic valve is at least 3 times greater than a height of the upstream support portion.

18. The apparatus according to claim 17, wherein a height of the prosthetic valve is at least 5 times greater than a height of the upstream support portion.

19. The apparatus according to claim 1, wherein the second frame comprises Nitinol.

20. The apparatus according to claim 1, wherein the first frame has a compressed state in which the first frame is cylindrical, and an expanded state in which the first frame is annular.

21. The apparatus according to claim 20, wherein the second frame has a compressed state in which the second frame is cylindrical, and an expanded state in which the second frame is cylindrical.

22. The apparatus according to claim 1, wherein the first frame comprises Nitinol.

23. Apparatus, for use with a native valve of a heart of a subject, the apparatus comprising:

an annular upstream support portion, comprising an expandable first frame, the upstream support portion configured to be placed against an upstream surface of the native valve;

a flexible polyester connector;

an anchoring element, flexibly coupled to the upstream support portion by the connector, and configured to anchor the upstream support portion to the native valve by engaging tissue of the native valve; and

a prosthetic valve,

wherein;

the upstream support portion is configured to support the prosthetic valve at the native valve,

the prosthetic valve;

comprises (i) an expandable second frame that defines a lumen therethrough, and (ii) a plurality of prosthetic leaflets disposed within the lumen and coupled to the second frame, and

is configured to be positioned inward from the upstream support portion,

the connector comprises a covering, and

the covering at least partly covers the first frame and the second frame, and is configured to facilitate coupling between the upstream support portion and the prosthetic valve.

24. The apparatus according to claim 23, wherein the covering is configured to prevent blood leakage between the prosthetic valve and the upstream support portion.

25. The apparatus according to claim 23, wherein the covering is configured to encourage tissue growth.

26. The apparatus according to claim 23, wherein the native valve defines an area, and the prosthetic valve has a cross-sectional area that is less than 90 percent of the area defined by the native valve.

27. The apparatus according to claim 23, wherein a height of the prosthetic valve is at least 3 times greater than a height of the upstream support portion.

28. Apparatus, for use with a native valve of a heart of a subject, the apparatus comprising:

an annular upstream support portion, comprising an expandable first frame, the upstream support portion configured to be placed against an upstream surface of the native valve;

a flexible polyester connector;

an anchoring element, flexibly coupled to the upstream support portion by the connector, and configured to anchor the upstream support portion to the native valve by engaging tissue of the native valve; and

a prosthetic valve,

wherein;

the upstream support portion is configured to support the prosthetic valve at the native valve,

the prosthetic valve;

comprises (i) an expandable second frame that defines a lumen therethrough, and (ii) a plurality of prosthetic leaflets disposed within the lumen and coupled to the second frame, and

is configured to be positioned inward from the upstream support portion, and

a height of the prosthetic valve is at least 3 times greater than a height of the upstream support portion.

29. The apparatus according to claim 28, wherein a height of the prosthetic valve is at least 5 times greater than a height of the upstream support portion.

30. The apparatus according to claim 28, wherein the native valve defines an area, and the prosthetic valve has a cross-sectional area that is less than 90 percent of the area defined by the native valve.

31. The apparatus according to claim 28, wherein:

the connector comprises a covering, and

the covering at least partly covers the first frame and the second frame, and is configured to facilitate coupling between the upstream support portion and the prosthetic valve.