PROSTHETIC VALVE FOR REPLACING MITRAL VALVE

• US 20170209264A1
• Filed: 03/10/2017
• Published: 07/27/2017
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Yi, Seung-Beom, Geist, Stephen C., Oba, Travis Zenyo
• Granted Patent: US 10,111,748 B2
• Time in Patent Office: 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 2/2409 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A prosthetic apparatus for implantation in a native mitral valve includes a main body for placement within the native mitral annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. An atrial sealing member is disposed along an atrial portion of the main body and ventricular anchors are coupled to a ventricular portion of the main body. The atrial sealing member impedes the flow of blood between the main body and the native annulus. The ventricular anchors are positioned outside the main body for capturing native mitral valve leaflets between the main body and the ventricular anchors.

Claims

1. A method for implanting a prosthetic valve at a mitral valve region of a heart, the mitral valve region having a native mitral annulus, the method comprising:

delivering to the native mitral annulus a prosthetic valve comprising;

a frame having an expanded and a collapsed state, the frame having a longitudinal axis and comprising;

a main body having an atrial end and a ventricular end, the main body defining inner and outer surfaces;

a lower anchoring portion at the ventricular end of the main body that comprises a plurality of anchors, each of the anchors having a first end that is attached to the main body and a second end that is spaced from the first end; and

an upper anchoring portion at the atrial end of the main body that comprises an atrial portion configured to be positioned on an atrial side of the native mitral annulus, the atrial portion comprising a plurality of struts, the atrial portion having a first end that is attached to the main body and a second end that is spaced from the first end; and

a valve structure attached to the inner surface of the main body of the frame;

wherein when the frame is in the collapsed state, the upper and lower anchoring portions are oriented substantially along the longitudinal axis of the frame;

wherein when the frame transitions from the collapsed state to the expanded state, the lower anchoring portion transitions to a configuration that is no longer oriented substantially along the longitudinal axis of the frame; and

wherein the lower anchoring portion is configured to capture tissue at the ventricular side of the native mitral annulus between the lower anchoring portion and the outer surface of the main body as the frame transitions from the collapsed state to the expanded state; and

expanding the frame to anchor the prosthetic valve at the native mitral annulus.

2. The method according to claim 1, wherein:

the plurality of anchors comprise curling anchors; and

when the frame is in the collapsed state, the curling anchors are oriented substantially along the longitudinal axis of the frame; and

when the frame transitions from the collapsed state to the expanded state, the curling anchors transition to a configuration that is no longer oriented substantially along the longitudinal axis of the frame.

3. The method according to claim 2, wherein the curling anchors are finger-like.

4. The method according to claim 3, wherein curling anchors each extend from one attachment point on the main body.

5. The method according to claim 2, wherein the curling anchors each extend from two or more attachment points on the main body.

6. The method according to claim 1, wherein

the plurality of anchors comprise curling anchors;

and

when the frame is in the collapsed state, the curling anchors extend in a ventricular direction and are substantially straightened; and

when the frame transitions from the collapsed state to the expanded state, the curling anchors transition to a shape in which the curling anchor is curled.

7. The method according to claim 1, wherein the prosthetic valve is delivered to the native mitral annulus via a delivery sheath.

8. The method according to claim 1, wherein the prosthetic valve is delivered to the implantation site transatrially, transapically, or via the patient'"'"'s vasculature.

9. The method according to claim 1, further comprising positioning the prosthetic valve at the native mitral annulus after the delivering step.

10. The method according to claim 9, comprising positioning the prosthetic valve so that the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue at a ventricular side of the native mitral annulus when the frame is expanded.

11. The method according to claim 10, comprising positioning the prosthetic valve so that the upper anchoring portion anchors the frame within the native mitral annulus by contacting tissue at the atrial side of the native mitral annulus when the frame is expanded.

12. The method according to claim 10, wherein the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue of a subvalvular portion of the native mitral valve on the ventricular side of the native mitral annulus.

13. The method according to claim 10, wherein the lower anchoring portion anchors the frame within the mitral annulus by capturing native leaflets of the native mitral valve.

14. The method according to claim 1, wherein the atrial portion extends radially outward from an atrial end of the main body.

36. The method according to claim 1, wherein each strut has a first end that is attached to the main body and a second end that is spaced from the first end.

15. A method for implanting a prosthetic valve at a mitral valve region of a heart, the mitral valve region having a native mitral annulus, the method comprising:

delivering to the native mitral annulus a prosthetic valve comprising;

a frame having an expanded and a collapsed state, the frame having a longitudinal axis and comprising;

a main body having an atrial end and a ventricular end, the main body defining inner and outer surfaces;

a lower anchoring portion at the ventricular end of the main body that comprises a plurality of anchors, each of the anchors having a first end that is attached to the main body and a second end that is spaced from the first end; and

an upper anchoring portion at the atrial end of the main body that comprises an atrial portion configured to be positioned on an atrial side of the native mitral annulus, the atrial portion comprising a plurality of struts, the atrial portion having a first end that is attached to the main body and a second end that is spaced from the first end; and

a valve structure attached to the inner surface of the main body of the frame;

wherein when the frame is in the collapsed state, the upper and lower anchoring portions are oriented substantially along the longitudinal axis of the frame;

wherein when the frame transitions from the collapsed state to the expanded state, the lower anchoring portion transitions to a configuration having a different orientation than when the frame is in the collapsed state; and

wherein the lower anchoring portion is configured to capture tissue at the ventricular side of the native mitral annulus between the lower anchoring portion and the outer surface of the main body as the frame transitions from the collapsed state to the expanded state; and

expanding the frame to anchor the prosthetic valve at the native mitral annulus.

16. The method according to claim 15, wherein:

the plurality of anchors comprise flip-up anchors; and

when the frame is in the collapsed state, the flip-up anchors are oriented substantially along the longitudinal axis of the frame; and

when the frame transitions from the collapsed state to the expanded state, the flip-up anchors transition to a configuration having a different orientation than when the frame is in the collapsed state.

17. The method according to claim 16, wherein the flip-up anchors are finger-like.

18. The method according to claim 17, wherein the flip-up anchors extend from one attachment point on the main body.

19. The method according to claim 16, wherein the flip-up anchors extend from two or more attachment points on the main body.

20. The method according to claim 15, wherein:

the plurality of anchors comprise flip-up anchors;

when the frame is in the collapsed state, the flip-up anchors extends in a ventricular direction; and

when the frame transitions from the collapsed state to the expanded state, the flip-up anchors extend in an atrial direction.

21. The method according to claim 20, wherein:

when the frame is in the collapsed state, the flip-up anchors are substantially straightened; and

when the frame transitions from the collapsed state to the expanded state, the flip-up anchors spring back to a pre-formed shape.

22. The method according to claim 15, wherein:

the plurality of anchors comprise bend-up anchors having a pre-formed curved shape; and

when the frame is in the collapsed state, the bend-up anchors are oriented substantially along the longitudinal axis of the frame; and

when the frame transitions from the collapsed state to the expanded state, the bend-up anchors transitions to a configuration having a different orientation than when the frame is in the collapsed state.

23. The method according to claim 22, wherein the bend-up anchors are finger-like.

24. The method according to claim 23, wherein the bend-up anchors each extend from one attachment point on the main body.

25. The method according to claim 22, wherein the bend-up anchors extends from two or more attachment points on the main body.

26. The method according to claim 15, wherein:

the plurality of anchors comprise bend-up anchors having a pre-formed curved shape;

when the frame is in the collapsed state, the bend-up anchors extend in a ventricular direction; and

when the frame transitions from the collapsed state to the expanded state, the bend-up anchors extend in an atrial direction.

27. The method according to claim 26, wherein:

when the frame is in the collapsed state, the bend-up anchors are substantially straightened; and

when the frame transitions from the collapsed state to the expanded state, the bend-up anchors spring back to the pre-formed curved shape.

28. The method according to claim 15, wherein the prosthetic valve is delivered to the native mitral annulus via a delivery sheath.

29. The method according to claim 15, wherein the prosthetic valve is delivered to the implantation site transatrially, transapically, or via the patient'"'"'s vasculature.

30. The method according to claim 15, further comprising positioning the prosthetic valve at the native mitral annulus after the delivering step.

31. The method according to claim 30, comprising positioning the prosthetic valve so that the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue at a ventricular side of the native mitral annulus when the frame is expanded.

32. The method according to claim 31, comprising positioning the prosthetic valve so that the upper anchoring portion anchors the frame within the native mitral annulus by contacting tissue at the atrial side of the native mitral annulus when the frame is expanded.

33. The method according to claim 31, wherein the lower anchoring portion anchors the frame within the native mitral annulus by capturing tissue of a subvalvular portion of the native mitral valve on the ventricular side of the native mitral annulus.

34. The method according to claim 31, wherein the lower anchoring portion anchors the frame within the mitral annulus by capturing native leaflets of the native mitral valve.

35. The method according to claim 15, wherein the atrial portion extends radially outward from an atrial end of the main body.

37. The method according to claim 15, wherein each strut has a first end that is attached to the main body and a second end that is spaced from the first end.

38. A method for replacing a damaged or diseased mitral valve in a subject comprising:

delivering to the mitral valve annulus of said subject a valve prosthesis that comprises

a stent having an expanded and an unexpanded state and

that includes

a long axis;

a middle region having first and second ends and comprising a framework that defines inner and outer surfaces;

a lower flange portion at the first end of the middle region that comprises a plurality of flange elements, each of said elements having a first end that is attached to the middle region and an opposed second end that is spaced from the first end;

and,

an upper flange portion at the second end of the middle region that comprises a plurality of flange elements, each of said elements having a first end that is attached to the middle region and an opposed second end that is spaced from the first end;

and,

a valve that is attached to the inner surface of the middle region of the stent,

wherein,

when said stent is in the unexpanded state, the upper and lower flange portions are oriented substantially along the long axis of the stent;

when said stent transitions from the unexpanded state to the expanded state, the lower flange portion transitions in space so that it is no longer oriented substantially along the long axis of the stent; and

,

the lower flange portion grasps tissue at the ventricular side of the annulus by enfolding it between the lower flange portion and the outer surface of the middle region as the stent transitions from the unexpanded state to the expanded state

and,

expanding said stent to anchor the prosthesis at the mitral valve annulus.

39. The method according to claim 38 wherein the valve prosthesis is delivered to the implantation site by a positioning catheter.

40. The method according to claim 38 wherein the valve prosthesis is delivered to the implantation site transatrially, transapically, or percutaneously.

41. The method according to claim 38 further comprising positioning said valve prosthesis at the implantation site after said delivering step.

42. The method according to claim 41 comprising positioning said valve prosthesis so that the lower flange portion anchors the stent within the mitral annulus by grasping tissue at the ventricular side of the annulus when said stent is expanded.

43. The method according to claim 42 comprising positioning said valve prosthesis so that the upper flange portion anchors the stent within the mitral annulus by grasping tissue at the atrial side of the annulus when said stent is expanded.

44. The method according to claim 42 wherein the lower flange portion anchors the stent within the mitral annulus by grasping the subvalvular apparatus at the ventricular side of the annulus.

45. The method according to claim 42 wherein the lower flange portion anchors the stent within the mitral annulus by grasping leaflets of the native mitral valve.