Techniques for percutaneous mitral valve replacement and sealing

• US 10,695,173 B2
• Filed: 07/02/2019
• Issued: 06/30/2020
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Reich, Tal
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US16/460,313
• Publication Number:
  US 20190321172A1
• Time in Patent Office: 364 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

An apparatus for use with a prosthetic heart valve at a native heart valve comprises an adjustable-lumen prosthetic valve support. In a delivery state, the prosthetic valve support is transluminally deliverable to the heart. The prosthetic valve support is transitionable, within the heart, into an implantation state for implantation at the native valve. In the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter. After the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen has a second diameter that is greater than the first diameter. In the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.

Claims

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

an adjustable-lumen prosthetic valve support, the prosthetic valve support having;

a delivery state, in which the prosthetic valve support is transluminally deliverable to the heart; and

an implantation state, into which the prosthetic valve support is transitionable within the heart, for implantation at the native valve,

wherein;

in the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter,

the prosthetic valve support comprises;

a frame that has a lattice structure;

a weak zone circumscribing the lumen; and

a stretchable reinforcing wire disposed near an inner edge of the prosthetic valve support,

after the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which (i) the frame defines a generally annular shape, and (ii) the lumen has a second diameter that is greater than the first diameter, and

in the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.

2. The apparatus according to claim 1, wherein the prosthetic valve support further comprises a plurality of tissue-engaging elements, the tissue-engaging elements being configured to engage tissue of the heart.

3. The apparatus according to claim 2, wherein the tissue-engaging elements comprise support-anchoring elements, the support-anchoring elements being configured to anchor the prosthetic valve support to the native valve.

4. The apparatus according to claim 3, wherein the support-anchoring elements are configured to anchor the prosthetic valve support to the native valve by coupling the prosthetic valve support to leaflets of the native valve.

5. The apparatus according to claim 4, wherein the support-anchoring elements are configured such that, while coupling the prosthetic valve support to leaflets of the native valve, the support-anchoring elements allow the leaflets to continue to function at least in part.

6. The apparatus according to claim 1, wherein:

the prosthetic valve support further comprises a covering that covers at least a portion of the frame, and

the covering is configured such that, while the prosthetic valve support supports the prosthetic heart valve at the native valve, the covering directs blood to flow through the prosthetic valve.

7. The apparatus according to claim 6, wherein the covering is configured to facilitate coupling of the prosthetic valve support to the native valve.

8. The apparatus according to claim 1, wherein the lattice structure does not extend into the weak zone.

9. The apparatus according to claim 1, wherein the lattice structure of the frame outside the weak zone differs from the lattice structure of the frame within the weak zone.

10. The apparatus according to claim 1, further comprising an expanding device, deliverable to the prosthetic valve support at the native valve, and configured to transition the prosthetic valve support from the implantation state to the enlarged state by expanding while disposed within the lumen of the prosthetic valve support, such that the expanding device applies a radially-expansive force from within the prosthetic valve support.

11. The apparatus according to claim 10 wherein the expanding device comprises a balloon, the balloon being inflatable.

12. The apparatus according to claim 10, wherein the expanding device is shaped to define a lumen.

13. The apparatus according to claim 12, wherein the expanding device:

comprises one or more temporary prosthetic valve leaflets disposed within the lumen of the expanding device, and

is configured to facilitate continued blood flow through the prosthetic valve support via the lumen of the expanding device while the expanding device is expanded within the lumen of the prosthetic valve support.

14. A method for treating a native valve of a heart of a subject, the method comprising:

transluminally advancing, in a delivery state, an adjustable-lumen prosthetic valve support;

delivering the prosthetic valve support to the heart while the prosthetic valve support is in the delivery state;

transitioning, within the heart, the prosthetic valve support from the delivery state to an implantation state in which the prosthetic valve support has an inner edge that defines, through the prosthetic valve support, a lumen that has a first diameter;

subsequently, coupling the prosthetic valve support to the native valve;

subsequently, transitioning the prosthetic valve support from the implantation state to an enlarged state by enlarging the lumen such that the lumen has a second diameter that is greater than the first diameter, the transitioning of the prosthetic valve support from the implantation state to the enlarged state comprising;

advancing an expanding device to the prosthetic valve support at the native valve, the expanding device including a balloon that is shaped to define a lumen and that includes temporary prosthetic valve leaflets disposed within the lumen of the balloon;

inflating the balloon while the balloon is disposed within the lumen of the prosthetic valve support;

applying a radially-expansive force to an interior of the prosthetic valve support from within the prosthetic valve support;

subsequently, providing temporary valve function by function of the temporary prosthetic valve leaflets; and

subsequently, and while the prosthetic valve support remains in the enlarged state, implanting a prosthetic heart valve by coupling the prosthetic heart valve to the prosthetic valve support such that the prosthetic valve support supports the prosthetic heart valve within the lumen of the prosthetic valve support.

15. The method according to claim 14, wherein delivering the prosthetic valve support comprises:

exerting a pushing force upon the prosthetic valve support to advance the prosthetic valve support within an overtube, and

exposing the prosthetic valve support from a distal end of the overtube.

16. The method according to claim 14, wherein the prosthetic valve support further includes:

a tightening wire, the tightening wire forming a loop around a central portion of the prosthetic valve support, and

a spool, the spool coupled to the tightening wire; and

wherein transitioning the prosthetic valve support from the implantation state to the enlarged state comprises interacting with the spool to loosen the tightening wire.

17. The method according to claim 14, wherein coupling the prosthetic valve support to the native valve comprises aligning the lumen of the support with an orifice of the native valve.

18. The method according to claim 14, wherein the prosthetic valve support further includes tissue-engaging elements, the method further comprising engaging tissue of the native valve with the tissue-engaging elements.

19. The method according to claim 18, wherein the tissue-engaging elements include support-anchoring elements, and engaging tissue of the native valve comprises anchoring the prosthetic valve support to the native valve by coupling the prosthetic valve support to leaflets of the native valve.

20. The method according to claim 19, wherein coupling the prosthetic valve support to leaflets of the native valve comprises allowing the leaflets of the native valve to continue to function at least in part.

21. The method according to claim 14, further comprising removing the expanding-device from the subject.

22. The method according to claim 14, wherein the prosthetic valve support further comprises a weak zone that circumscribes the lumen, and expanding the expanding-device comprises deforming the weak zone.

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

an adjustable-lumen prosthetic valve support, the prosthetic valve support having;

a delivery state, in which the prosthetic valve support is transluminally deliverable to the heart; and

an implantation state, into which the prosthetic valve support is transitionable within the heart, for implantation at the native valve; and

an expanding device;

deliverable to the prosthetic valve support at the native valve,

shaped to define a lumen, and

comprising one or more temporary prosthetic valve leaflets disposed within the lumen of the expanding device,

wherein;

in the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter,

after the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen of the prosthetic valve support has a second diameter that is greater than the first diameter,

in the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen of the prosthetic valve support, and

the expanding device is configured;

to transition the prosthetic valve support from the implantation state to the enlarged state by expanding while disposed within the lumen of the prosthetic valve support, such that the expanding device applies a radially-expansive force from within the prosthetic valve support, and

to facilitate continued blood flow through the prosthetic valve support via the lumen of the expanding device while the expanding device is expanded within the lumen of the prosthetic valve support.

24. The apparatus according to claim 23, wherein the prosthetic valve support further comprises a plurality of tissue-engaging elements, the tissue-engaging elements being configured to engage tissue of the heart.

25. The apparatus according to claim 24, wherein the tissue-engaging elements comprise support-anchoring elements, the support-anchoring elements being configured to anchor the prosthetic valve support to the native valve.

26. The apparatus according to claim 25, wherein the support-anchoring elements are configured to anchor the prosthetic valve support to the native valve by coupling the prosthetic valve support to leaflets of the native valve.

27. The apparatus according to claim 26, wherein, the support-anchoring elements are configured such that, while coupling the prosthetic valve support to leaflets of the native valve, the support-anchoring elements allow the leaflets to continue to function at least in part.

28. The apparatus according to claim 23, wherein the prosthetic valve support comprises a frame, the frame:

having a lattice structure, and

defining, in the enlarged state, a generally annular shape.

29. The apparatus according to claim 28, wherein:

the prosthetic valve support further comprises a covering that covers at least a portion of the frame, and

the covering is configured such that, while the prosthetic valve support supports the prosthetic heart valve at the native valve, the covering directs blood to flow through the prosthetic valve.

30. The apparatus according to claim 29, wherein the covering is configured to facilitate coupling of the prosthetic valve support to the native valve.

31. The apparatus according to claim 28, wherein the prosthetic valve support comprises a weak zone, the weak zone circumscribing the lumen defined by the prosthetic valve support.

32. The apparatus according to claim 31, wherein the prosthetic valve support comprises a stretchable reinforcing-wire disposed near an inner edge of the prosthetic valve support.

33. The apparatus according to claim 31, further comprising a breakable reinforcing-wire that is disposed near an inner edge of the prosthetic valve support.

34. The apparatus according to claim 31, wherein the lattice structure does not extend into the weak zone.

35. The apparatus according to claim 31, wherein the lattice structure of the frame outside the weak zone differs from the lattice structure of the frame within the weak zone.

36. The apparatus according to claim 23, wherein the expanding device comprises a balloon, the balloon being inflatable.

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

an adjustable-lumen prosthetic valve support, the prosthetic valve support having;

a delivery state, in which the prosthetic valve support is transluminally deliverable to the heart; and

an implantation state, into which the prosthetic valve support is transitionable within the heart, for implantation at the native valve;

a tightening wire forming a loop around a central portion of the prosthetic valve support; and

a spool, the spool coupled to the tightening wire,

wherein;

in the implantation state, the prosthetic valve support has an inner edge that defines a lumen through the prosthetic valve support, the lumen having a first diameter,

after the prosthetic valve support is implanted at the native valve, the prosthetic valve support is transitionable into an enlarged state in which the lumen has a second diameter that is greater than the first diameter,

the spool is configured to transition the lumen between the first and second diameters by adjusting the tightening wire, and

in the enlarged state, the prosthetic valve support is configured to support, at the native valve, the prosthetic heart valve within the lumen.

38. The apparatus according to claim 37, wherein the prosthetic valve support further comprises a plurality of tissue-engaging elements, the tissue-engaging elements being configured to engage tissue of the heart.

39. The apparatus according to claim 38, wherein the tissue-engaging elements comprise support-anchoring elements, the support-anchoring elements being configured to anchor the prosthetic valve support to the native valve.

40. The apparatus according to claim 39, wherein the support-anchoring elements are configured to anchor the prosthetic valve support to the native valve by coupling the prosthetic valve support to leaflets of the native valve.

41. The apparatus according to claim 40, wherein, the support-anchoring elements are configured such that, while coupling the prosthetic valve support to leaflets of the native valve, the support-anchoring elements allow the leaflets to continue to function at least in part.

42. The apparatus according to claim 37, wherein the prosthetic valve support comprises a frame, the frame:

having a lattice structure, and

defining, in the enlarged state, a generally annular shape.

43. The apparatus according to claim 42, wherein:

the prosthetic valve support further comprises a covering that covers at least a portion of the frame, and

the covering is configured such that, while the prosthetic valve support supports the prosthetic heart valve at the native valve, the covering directs blood to flow through the prosthetic valve.

44. The apparatus according to claim 43, wherein the covering is configured to facilitate coupling of the prosthetic valve support to the native valve.

45. The apparatus according to claim 42, wherein the prosthetic valve support comprises a weak zone, the weak zone circumscribing the lumen defined by the prosthetic valve support.

46. The apparatus according to claim 45, wherein the lattice structure does not extend into the weak zone.

47. The apparatus according to claim 45, wherein the lattice structure of the frame outside the weak zone differs from the lattice structure of the frame within the weak zone.