METHODS AND APPARATUS FOR ENGAGING A VALVE PROSTHESIS WITH TISSUE

• US 20140052237A1
• Filed: 02/08/2013
• Published: 02/20/2014
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Incorporated
• Inventors: Lane, Randy Matthew, Nyuli, Colin A., Marko, Alexei J.
• Granted Patent: US 9,554,897 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2436 Deployment by retracting a sheath
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.

Claims

1. A prosthetic valve comprising:

a self-expanding frame having a superior end, an inferior end, and a midsection therebetween, wherein the frame has an expanded configuration and a collapsed configuration, the collapsed configuration adapted to be delivered to a patient'"'"'s heart, and the expanded configuration adapted to anchor the self-expanding frame in the patient'"'"'s heart, wherein the frame comprises;

a self-expanding atrial skirt adjacent the superior end, wherein the atrial skirt forms a flanged region after self-expansion thereof, the flanged region configured to anchor the self-expanding frame to an atrial surface of the heart, and wherein the flanged region comprises an edge of the flange;

a self-expanding ventricular skirt adjacent the inferior end, wherein the ventricular skirt anchors the self-expanding frame to a ventricular surface of the heart after self-expansion thereof; and

a first self-expanding tab adjacent the inferior end and coupled with the ventricular skirt, the first self-expanding tab having tip,

wherein the first self-expanding tab radially self-expands when a constraint is removed therefrom, and

wherein a receptacle adapted for receiving a valve leaflet is formed by an area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab, and

wherein a window adapted for receiving the valve leaflet is defined by a gap between the edge of the flange and the tip of the first tab, and

wherein the gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained, and

wherein the gap is minimized when tip of the first tab is unconstrained and the base of the first tab is also unconstrained.

2. The prosthetic valve of claim 1, wherein when the gap is maximized, the window is adapted to receive the valve leaflet in the receptacle.

3. The prosthetic valve of claim 1, wherein when the gap is minimized, the receptacle is adapted to engage the valve leaflet and anchor the prosthetic vale thereto.

4. The prosthetic valve of claim 1, wherein the tip of the first tab moves toward the edge of the flange when the base of the first tab is released from a constraint.

5. The prosthetic valve of claim 1, wherein angle α

is defined by an inner surface of the first tab and an outer surface of the ventricular skirt, and wherein a decreases when the base of the first tab is released from a constraint and the tip of the first tab is unconstrained.

6. The prosthetic valve of claim 1, wherein angle α

is defined by an inner surface of the first tab and an outer surface of the ventricular skirt, and wherein α

is maximized when the tip of the first tab is unconstrained and the base of the first tab is at least partially constrained.

7. The prosthesis of claim 1, further comprising a commissure post coupled with the self-expanding frame and having an end extending radially inward, and wherein an angle β

is defined by an outer surface of the commissure post and an inner surface of the ventricular skirt, and wherein β

is minimized when the base of the first tab is at least partially constrained and the tip of the first tab is unconstrained.

8. The prosthesis of claim 1, further comprising a commissure post coupled with the self-expanding frame and having an end extending radially inward, and wherein an angle β

is defined by an outer surface of the commissure post and an inner surface of the ventricular skirt, and wherein β

is maximized when the base of the first tab is unconstrained and the tip of the first tab is unconstrained.

9. The prosthesis of claim 1, further comprising a commissure post coupled with the self-expanding frame and having an end extending radially inward, wherein the commissure post is adapted to remain coupled to a delivery catheter after the base of the first tab and the tip of the first tab are unconstrained.

10. The prosthesis of claim 1, further comprising a cover disposed at least partially over the self-expanding frame, the cover facilitating tissue ingrowth.

11. The prosthesis of claim 10, wherein the cover comprises fabric, tissue or a polymer.

12. The prosthesis of claim 1, wherein the tip of the tab is adapted to engage a fibrous trigone.

13. The prosthesis of claim 1, wherein the tab is adapted to engage an anterior or a posterior mitral valve leaflet.

14. The prosthesis of claim 1, wherein the atrial skirt expands before the first tab.

15. The prosthesis of claim 1, wherein the atrial skirt anchors the prosthesis to the atrium before the first tab anchors the prosthesis to the valve leaflet.

16. The prosthesis of claim 1, wherein the first tab expands to a position transverse to a longitudinal axis of the prosthesis followed by expansion to a position substantially parallel to the longitudinal axis of the prosthesis.

17. A method for anchoring a prosthetic valve to a cardiac valve having a valve leaflet, said method comprising:

providing a delivery system having an outer sheath;

providing a prosthetic valve, wherein the prosthetic valve is carried by the delivery system, and wherein the prosthetic valve comprises an atrial skirt, a ventricular skirt and a first tab coupled to the ventricular skirt, and

wherein an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab forms a leaflet receptacle, the leaflet receptacle having a window for receiving the valve leaflet defined by a gap between an edge of the atrial skirt and a tip of the first tab;

positioning the prosthetic valve adjacent the cardiac valve;

self-expanding the atrial skirt into engagement with an atrial surface of the cardiac valve;

self-expanding the ventricular skirt into engagement with a ventricular surface of the cardiac valve;

removing a constraint from a portion of the first tab thereby allowing a tip of the first tab to expand radially outward;

receiving the valve leaflet through the window and into the leaflet receptacle; and

at least partially closing the window thereby engaging the valve leaflet with the leaflet receptacle and anchoring the prosthetic valve to the valve leaflet.

18. The method of claim 17, wherein positioning the prosthetic valve adjacent the cardiac valve comprises transseptally delivering the prosthetic valve to the cardiac valve.

19. The method of claim 17, wherein positioning the prosthetic valve adjacent the cardiac valve comprises transapically delivering the prosthetic valve to the cardiac valve.

20. The method of claim 17, wherein self-expanding the atrial skirt comprises retracting the outer sheath thereby removing a constraint therefrom.

21. The method of claim 17, wherein self-expanding the atrial skirt comprises forming a flange which engages an atrial surface of the cardiac valve thereby anchoring the prosthetic valve thereagainst.

22. The method of claim 17, wherein self-expanding the ventricular skirt comprises retracting the outer sheath thereby removing a constraint therefrom.

23. The method of claim 17, wherein self-expanding the ventricular skirt comprises expanding the ventricular skirt into engagement with a ventricular surface of the cardiac valve thereby anchoring the prosthetic valve thereagainst.

24. The method of claim 17, wherein removing a constraint from a portion of the first tab comprises retracting the outer sheath therefrom.

25. The method of claim 17, wherein at least partially closing the window comprises further retracting the outer sheath to remove a constraint from a base of the first tab thereby allowing the base to radially expand outward and such that the tip of the first tab moves toward the edge of the atrial skirt.

26. The method of claim 17, wherein the valve leaflet comprises an anterior mitral valve leaflet, the method further comprising engaging the tip of the first tab with a fibrous trigone of the mitral valve.

27. The method of claim 17, wherein the valve leaflet comprises a posterior mitral valve leaflet, and wherein engaging the valve leaflet comprises engaging the posterior mitral valve leaflet.

28. The method of claim 17, wherein the atrial skirt expands before the first tab.

29. The method of claim 17, wherein the atrial skirt anchors the prosthetic valve to the atrium before the first tab anchors the prosthetic valve to the valve leaflet.

30. The method of claim 17, wherein the first tab expands to a position transverse to a longitudinal axis of the prosthetic valve followed by expansion to a position substantially parallel to the longitudinal axis of the prosthetic valve.

31. A system for deploying a prosthetic valve, said system comprising:

a prosthetic cardiac valve comprising an atrial skirt, a ventricular skirt, and a tab coupled to the ventricular skirt; and

a delivery system comprising an outer sheath, wherein the prosthetic cardiac valve is carried by the delivery system, and wherein the outer sheath comprises a cam on the outer sheath adjacent a distal end thereof,

wherein partial retraction of the outer sheath releases a constraint from the atrial skirt and the ventricular skirt thereby allowing self-expansion thereof, and

wherein further retraction of the outer sheath releases a constraint from the tab thereby allowing a tip of the tab to radially self-expand outward forming a window between an edge of the atrial skirt and the tip of the tab while the cam remains engaged with a base portion of the tab such that the tip self-expands to open the window to its maximum size, and

wherein further retraction of the outer sheath disengages the cam from the base portion of the tab thereby releasing a constraint therefrom such that the base of the tab radially expands outward and the tip of the tab moves toward the edge of the atrial skirt, at least partially closing the window.

32. The system of claim 31, wherein the cam comprises an annular flange disposed on an inside surface of the outer sheath.

33. The system of claim 31, wherein the outer sheath comprises a lumen and the prosthetic cardiac valve is disposed therein.

34. The system of claim 31, wherein the window is adapted to receive a valve leaflet while open.

35. The system of claim 34, wherein the prosthetic valve is anchored to the valve leaflet after the window is at least partially closed

36. The system of claim 31, further comprising a cover disposed at least partially over the prosthetic cardiac valve, the cover facilitating tissue ingrowth.

37. The system of claim 36, wherein the cover comprises fabric, tissue, or a polymer.

38. The system of claim 31, wherein the tip of the tab is adapted to engage a fibrous trigone.

39. The system of claim 31, wherein the tab is adapted to engage an anterior or a posterior mitral valve leaflet.

40. The system of claim 31, wherein the atrial skirt expands before the tab.

41. The system of claim 31, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic valve to a valve leaflet

42. The system of claim 31, wherein the tab expands to a position transverse to a longitudinal axis of the prosthetic valve followed by expansion to a position substantially parallel to the longitudinal axis of the prosthetic valve.

43. A method for anchoring a prosthetic valve to a cardiac valve having a valve leaflet, said method comprising:

providing a prosthetic cardiac valve, the cardiac valve comprising an atrial skirt, a ventricular skirt, and a tab coupled to the ventricular skirt;

providing a delivery system with an outer sheath, the outer sheath having a cam adjacent a distal end thereof, and wherein the prosthetic cardiac valve is carried by the delivery system;

self-expanding the atrial skirt and the ventricular skirt;

self-expanding the tab such that a tip of the tab expands radially outward and whereby a window is formed between an edge of the atrial skirt and the tip of the tab;

opening the window to its maximum size;

receiving the valve leaflet in the window;

self-expanding the base portion radially outward; and

at least partially closing the window, wherein the tip of the tab moves toward the edge of the atrial skirt.

44. The method of claim 43, wherein self-expanding the atrial skirt and the ventricular skirt comprises retracting the outer sheath thereby releasing a constraint therefrom.

45. The method of claim 43, wherein self-expanding the atrial skirt allows the atrial skirt to self-expand into engagement with an atrial surface of the cardiac valve.

46. The method of claim 43, wherein self-expanding the ventricular skirt allows the ventricular skirt to self-expand into engagement with a ventricular surface of the cardiac valve.

47. The method of claim 43, wherein self-expanding the tab comprises retracting the outer sheath thereby releasing a constraint therefrom.

48. The method of claim 43, wherein opening the window comprises maintaining engagement of the cam with a base portion of the tab such that the tip self-expands independently of the base of the tab.

49. The method of claim 43, wherein self-expanding the base portion comprises disengaging the cam from the base portion of the tab thereby releasing a constraint therefrom.

50. The method of claim 43, wherein the valve leaflet comprises an anterior mitral valve leaflet, the method further comprising engaging the tip of the tab with a fibrous trigone of the mitral valve.

51. The method of claim 43, wherein the valve leaflet comprises a posterior mitral valve leaflet, the method further comprising engaging the tab with the posterior mitral valve leaflet.

52. The method of claim 43, wherein the atrial skirt expands before the tab.

53. The method of claim 43, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic cardiac valve to the valve leaflet.

54. The method of claim 43, wherein the tab expands to a position transverse to a longitudinal axis of the prosthetic cardiac valve followed by expansion to a position substantially parallel to the longitudinal axis of the prosthetic cardiac valve.

55. A system for deploying a prosthetic valve, said system comprising:

a prosthetic cardiac valve comprising an atrial skirt, a ventricular skirt, and a tab coupled to the ventricular skirt; and

a delivery system comprising an outer sheath and pusher element, wherein the prosthetic cardiac valve is carried by the delivery system and the pusher element is slidably disposed under the outer sheath,

wherein partial retraction of the outer sheath releases a constraint from the atrial skirt and the ventricular skirt thereby allowing self-expansion thereof, and

wherein further retraction of the outer sheath releases a constraint from the tab thereby allowing a tip of the tab to radially self-expand outward forming a window between an edge of the atrial skirt and the tip of the tab, and

wherein a base portion of the tab remains constrained by the outer sheath and actuation of the pusher element into engagement with the base portion actuates the tip of the tab to open the window to its maximum size, and

wherein further retraction of the outer sheath or further actuation of the pusher element removes the constraint from the base portion of the tab, thereby at least partially closing the window.

56. The system of claim 55, wherein the base portion self-expands radially outward when the constraint is released therefrom, and wherein the tip of the tab moves toward the edge of the atrial skirt to close the window.

57. The system of claim 55, further comprising a cover disposed at least partially over the prosthetic cardiac valve, thereby facilitating tissue ingrowth.

58. The system of claim 55, wherein the cover comprises fabric, tissue, or a polymer.

59. The system of claim 55, wherein the tip of the tab is adapted to engage a fibrous trigone.

60. The system of claim 55, wherein the tab is adapted to engage an anterior or a posterior mitral valve leaflet.

61. The system of claim 55, wherein the atrial skirt expands before the tab.

62. The system of claim 55, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic cardiac valve to a valve leaflet.

63. The system of claim 55, wherein the tab expands to a position transverse to a longitudinal axis of the prosthetic cardiac valve followed by expansion to a position substantially parallel to the longitudinal axis of the prosthetic cardiac valve.

64. A method for anchoring a prosthetic valve to a cardiac valve having a valve leaflet, said method comprising:

providing a prosthetic cardiac valve, the cardiac valve comprising an atrial skirt, a ventricular skirt, and a tab coupled to the ventricular skirt;

providing a delivery system, the delivery system comprising an outer sheath and a pusher element, wherein the cardiac valve is carried by the delivery system and the pusher element is slidably disposed under the outer sheath;

self-expanding the atrial skirt into engagement with an atrial surface of the cardiac valve;

self-expanding the ventricular skirt into engagement with a ventricular surface of the cardiac valve;

self-expanding the tab such that a tip of the tab expands radially outward to form a window between an edge of the atrial skirt and the tip of the tab;

while a base portion of the tab remains constrained by the outer sheath, opening the window to its maximum size;

receiving a valve leaflet into the window; and

closing the window.

65. The method of claim 64, wherein self-expanding the atrial skirt comprises retracting the outer sheath to remove a constraint therefrom.

66. The method of claim 64, wherein self-expanding the ventricular skirt comprises retracting the outer sheath to remove a constraint therefrom.

67. The method of claim 64, wherein self-expanding the tab comprises retracting the outer sheath to remove a constraint therefrom.

68. The method of claim 64, wherein opening the window comprises actuating the pusher element into engagement with the base portion thereby moving the tip away from edge of the atrial skirt.

69. The method of claim 64, wherein closing the window comprises further retraction of the outer sheath to remove a constraint from the base portion, thereby allowing the base portion to radially expand outward and the tip to move toward the edge of the atrial skirt.

70. The method of claim 64, wherein closing the window comprises disengaging the pusher element from the base portion, thereby allowing the base portion to return to an unbiased position.

71. The method of claim 64, wherein closing the window comprises pushing the base portion out of the outer sheath with the pusher element, thereby allowing the base portion to expand radially outward and the tip to move toward the edge of the atrial skirt.

72. The method of claim 64, wherein the valve leaflet comprises an anterior mitral valve leaflet, the method further comprising engaging the tip of the tab with a fibrous trigone of the mitral valve.

73. The method of claim 64, wherein the valve leaflet comprises a posterior mitral valve leaflet, the method further comprising engaging the tab with the posterior mitral valve leaflet.

74. The method of claim 64, wherein the atrial skirt expands before the tab.

75. The method of claim 64, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic cardiac valve to the valve leaflet.

76. The method of claim 64, wherein the tab expands to a position transverse to a longitudinal axis of the prosthetic cardiac valve followed by expansion to a position substantially parallel to the longitudinal axis of the prosthetic cardiac valve.