PROSTHETIC VALVE WITH ANTI-PIVOTING MECHANISM

• US 20140257467A1
• Filed: 03/03/2014
• Published: 09/11/2014
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A., Marko, Alexei J., Neale, Krista L.
• Granted Patent: US 10,583,002 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 2220/0016 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

Abstract

A prosthetic valve for implanting in a patient'"'"'s native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.

Claims

1. A prosthetic valve for implanting in a native valve of a patient, said prosthetic valve comprising:

a self-expanding frame having a first end, a second end opposite the first end, an atrial region near the second end, a ventricular region near the first end, an anterior portion, and a posterior portion,

wherein the self-expanding frame has an expanded configuration and a collapsed configuration, the expanded configuration adapted to engage tissue at a treatment site, and the collapsed configuration adapted to be delivered to the treatment site, and wherein the expandable frame comprises;

a self-expanding atrial skirt disposed in the atrial region;

a self-expanding ventricular skirt disposed in the ventricular region;

a self-expanding annular region disposed between the atrial region and the ventricular region;

a first self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region; and

a self-expanding foot coupled to the ventricular region, wherein the foot is disposed in the posterior portion and extends radially outward from the self-expanding frame and has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.

2. The prosthetic valve of claim 1, wherein the prosthetic valve is a prosthetic mitral valve.

3. The prosthetic valve of claim 1, wherein the atrial skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to lie over a superior surface of the patient'"'"'s native valve, thereby anchoring the atrial skirt against a superior portion of the native valve.

4. The prosthetic valve of claim 1, wherein the atrial skirt comprises a plurality of axially oriented struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

5. The prosthetic valve of claim 1, wherein after self-expansion of the atrial skirt, the atrial skirt forms a flanged region adjacent the second end of the self-expanding frame.

6. The prosthetic valve of claim 5, wherein after self-expanding, the atrial skirt has an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

7. The prosthetic valve of claim 1, further comprising an alignment element coupled to an anterior portion of the atrial skirt, wherein the alignment element is adapted to be aligned with an aortic root of a patient'"'"'s heart and adapted to be disposed between two fibrous trigones of an anterior leaflet of the patient'"'"'s mitral valve.

8. The prosthetic valve of claim 1, wherein at least a portion of the ventricular skirt is covered with tissue or a synthetic material.

9. The prosthetic valve of claim 1, wherein after self-expanding, the ventricular skirt comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

10. The prosthetic valve of claim 1, wherein the ventricular skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to displace native mitral valve leaflets radially outward.

11. The prosthetic valve of claim 1, wherein the ventricular skirt further comprises a plurality of barbs coupled thereto, the plurality of barbs adapted to anchor the ventricular skirt into the tissue.

12. The prosthetic valve of claim 1, wherein the ventricular skirt comprises a plurality of struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

13. The prosthetic valve of claim 12, wherein one or more of the struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

14. The prosthetic valve of claim 1, wherein the annular region has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to conform with and adapted to engage an annulus of the native valve.

15. The prosthetic valve of claim 1, wherein after self-expanding, the annular region has an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

16. The prosthetic valve of claim 1, wherein the annular region comprises a plurality of axially oriented struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys.

17. The prosthetic valve of claim 16, wherein one or more of the plurality of axially oriented struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

18. The prosthetic valve of claim 1, wherein the first anterior tab has a tip portion adapted to engage a first fibrous trigone on a first side of an anterior leaflet of the patient'"'"'s mitral valve, and wherein the first anterior tab is adapted to capture the anterior leaflet and adjacent chordae tendineae between the first anterior tab and an outer anterior surface of the ventricular skirt.

19. The prosthetic valve of claim 18, further comprising a second self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region, and wherein the second anterior tab has a tip portion adapted to engage a second fibrous trigone on a second side of the anterior leaflet of the patient'"'"'s mitral valve opposite the first side of the anterior leaflet, and wherein the second anterior tab is adapted to capture the anterior leaflet and adjacent chordae tendineae between the second anterior tab and the outer surface of the ventricular skirt.

20. The prosthetic valve of claim 19, further comprising a covering disposed over the first or the second anterior tab, the covering increasing contact surface area of the respective first or second anterior tab with the heart tissue.

21. The prosthetic valve of claim 20, wherein the covering comprises a fabric material disposed over a polymer tab that is coupled to the first or the second anterior tab.

22. The prosthetic valve of claim 1, wherein rotation of the posterior portion is minimized or prevented relative to the anterior portion of the prosthetic valve.

23. The prosthetic valve of claim 1, wherein rotation is minimized or prevented in a direction toward the left atrium of the patient'"'"'s heart.

24. The prosthetic valve of claim 1, wherein the foot is covered with a synthetic material or with tissue.

25. The prosthetic valve of claim 1, wherein the foot comprises a wedged shaped element extending radially outward from the self-expanding frame.

26. The prosthetic valve of claim 1, wherein the foot comprises a central elongate element and a cover, wherein the cover is disposed over the central elongate element and the cover is coupled to a strut on either side thereof.

27. The prosthetic valve of claim 26, wherein the central elongate element comprises a pair of struts coupled together to form a U-shape or a V-shape.

28. The prosthetic valve of claim 1, wherein the foot forms a vestibule on the posterior portion.

29. The prosthetic valve of claim 1, wherein the foot comprises barbs, texturing or other surface features for anchoring the foot to tissue.

30. The prosthetic valve of claim 1, further comprising a plurality of prosthetic valve leaflets, each of the leaflets having a first end and a free end, wherein the first end is coupled with the self-expanding frame and the free end is opposite of the first end, wherein the prosthetic valve leaflets have an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast.

31. The prosthetic valve of claim 30, wherein the plurality of prosthetic valve leaflets form a tricuspid valve.

32. The prosthetic valve of claim 30, wherein at least a portion of one or more prosthetic valve leaflets comprises tissue or a synthetic material.

33. The prosthetic valve of claim 30, wherein one or more of the prosthetic valve leaflets comprise a commissure post having a commissure tab, the commissure tab adapted to be releasably engaged with a delivery device.

34. The prosthetic valve of claim 1, wherein the prosthetic valve carries a therapeutic agent, the therapeutic agent adapted to being eluted therefrom.

35. The prosthetic valve of claim 1, further comprising a posterior ventricular anchoring tab disposed on a posterior portion of the self-expanding frame, wherein the posterior ventricular anchoring tab is adapted to being anchored over a posterior leaflet of the patient'"'"'s mitral valve, such that the posterior ventricular anchoring tab is seated between the posterior leaflet and a ventricular wall of the patient'"'"'s heart.

36. The prosthetic valve of claim 35, further comprising barbs, texturing or other surface features disposed on the posterior ventricular anchoring tab, and adapted to engage tissue and anchor the posterior ventricular tab thereto.

37. A method for anchoring a prosthetic valve in a native valve of a patient'"'"'s heart, said method comprising:

providing a prosthetic valve, wherein the prosthetic valve comprises an expandable frame having a first end, a second end opposite the first end, a first anterior tab on an anterior portion of the expandable frame adjacent the first end, a foot on a posterior portion of the expandable frame adjacent the first end, a ventricular skirt adjacent the first end of the expandable frame, and an annular region disposed between the first and second ends, and wherein the prosthetic valve has an expanded configuration for engaging the native valve, and a collapsed configuration;

advancing the prosthetic valve in the collapsed configuration to the native valve;

expanding the first anterior tab radially outward such that a tip of the first anterior tab engages a first fibrous trigone on a first side of an anterior leaflet of the native valve, and

wherein the anterior leaflet is disposed between the first anterior tab and an outer surface of the ventricular skirt;

expanding the foot radially outward such that the foot engages a posterior portion of the native valve thereby anchoring the prosthetic valve to a posterior portion of the native valve and preventing or minimizing rotation of the prosthetic valve.

38. The method of claim 37, wherein providing the prosthetic valve further comprises providing a delivery device for delivering the prosthetic valve to the native valve, and wherein the prosthetic valve is releasably coupled to the delivery device.

39. The method of claim 37, wherein advancing the prosthetic valve comprises transapically delivering the prosthetic valve from a region outside of the patient to the patient'"'"'s heart.

40. The method of claim 37, wherein advancing the prosthetic valve comprises transseptally delivering the prosthetic valve from the right atrium to the left atrium of the patient'"'"'s heart.

41. The method of claim 37, wherein advancing the prosthetic valve comprises positioning the prosthetic valve across the patient'"'"'s mitral valve so that the first end is inferior to the mitral valve and the second end is superior to the mitral valve.

42. The method of claim 37, wherein expanding the first anterior tab comprises retracting a constraining sheath therefrom and allowing the first anterior tab to self-expand radially outward.

43. The method of claim 37, wherein the prosthetic valve further comprises a second anterior tab on the anterior portion of the expandable frame, and the method further comprises expanding the second anterior tab radially outward such that a tip portion of the second anterior tab engages a second fibrous trigone on a second side of the anterior leaflet opposite the first side of the anterior leaflet.

44. The method of claim 43, wherein the second anterior tab expands radially outward concurrently with expansion of the first anterior tab.

45. The method of claim 43, wherein expanding the second anterior tab comprises retracting a constraining sheath from the second anterior tab so that the second anterior tab is free to self-expand radially outward.

46. The method of claim 37, wherein expanding the foot forms a vestibule adjacent the first end of the prosthetic valve.

47. The method of claim 37, wherein expanding the foot increases the size of the first end of the prosthetic valve so that it cannot pass through the native valve.

48. The method of claim 37, wherein expanding the foot comprises retracting a constraint therefrom so that the foot self-expands radially outward.

49. The method of claim 37, wherein posterior chordae tendineae engage the expanded foot.

50. The method of claim 37, wherein the foot comprises barbs, texturing, or other surface features, and wherein expanding the foot engages the barbs, texturing or other surface features with tissue, thereby anchoring the foot with the tissue.

51. The method of claim 37, further comprising expanding the ventricular skirt radially outward into engagement with the anterior and posterior leaflets of the native valve.

52. The method of claim 51, wherein anterior chordae tendineae are disposed between the first anterior tab and the outer surface of the ventricular skirt.

53. The method of claim 51, wherein expanding the ventricular skirt comprises retracting a constraining sheath from the ventricular skirt so that the ventricular skirt is free to self-expand radially outward.

54. The method of claim 51, wherein the ventricular skirt comprises a plurality of barbs, and wherein expanding the ventricular skirt comprises anchoring the plurality of barbs into heart tissue.

55. The method of claim 37, wherein the prosthetic valve further comprises a plurality of commissures, and wherein expanding the ventricular skirt displaces anterior and posterior leaflets of the native valve radially outward thereby preventing interference between the commissures and the leaflets.

56. The method of claim 37, wherein expanding the ventricular skirt displaces anterior and posterior leaflets of the native valve radially outward without contacting an inner wall of the left ventricle, and without obstructing a left ventricular outflow tract.

57. The method of claim 37, wherein radially expanding the ventricular skirt expands the ventricular skirt asymmetrically such that an anterior portion of the ventricular skirt is substantially flat, and a posterior portion of the ventricular skirt is cylindrically shaped.

58. The method of claim 37, further comprising expanding the annular region radially outward so as to engage an annulus of the native valve.

59. The method of claim 58, wherein expanding the annular region comprises retracting a constraining sheath therefrom so that the annular region is free to self-expand radially outward.

60. The method of claim 58, wherein expanding the annular region comprises asymmetrically expanding the annular region such that an anterior portion of the annular region is substantially flat, and a posterior portion of the annular region is cylindrically shaped.

61. The method of claim 37, wherein the native valve is a mitral valve, the method further comprising reducing or eliminating mitral regurgitation.

62. The method of claim 37, wherein the prosthetic valve carries a therapeutic agent, and the method further comprises eluting the therapeutic agent from the prosthetic valve into adjacent tissue.

63. The method of claim 37, wherein the prosthetic valve comprises an alignment element, and wherein a second fibrous trigone is disposed on a second side of the anterior leaflet opposite the first side of the anterior leaflet, the method further comprising aligning the alignment element with an aortic root and disposing the alignment element between the first and second fibrous trigones.

64. The method of claim 63, wherein aligning the alignment element comprises rotating the prosthetic valve.

65. The method of claim 37, wherein the prosthetic valve further comprises a plurality of commissures with a covering disposed thereover whereby a plurality of prosthetic valve leaflets are formed, the method further comprising releasing the plurality of prosthetic valve leaflets from a delivery catheter.

66. The method of claim 65, wherein the plurality of prosthetic valve leaflets form a tricuspid valve, the tricuspid valve having an open configuration and a closed configuration, wherein the plurality of prosthetic valve leaflets are disposed away from one another in the open configuration thereby permitting antegrade blood flow therethrough, and wherein the plurality of prosthetic valve leaflets engage one another in the closed configuration thereby substantially preventing retrograde blood flow therethrough.

67. The method of claim 37, wherein the prosthetic valve further comprises an atrial skirt adjacent the second end, the method further comprising:

expanding the atrial skirt radially outward so as to lie over a superior surface of the native valve; and

engaging the atrial skirt against the superior surface of the native valve.

68. The method of claim 67, wherein expanding the atrial skirt comprises retracting a constraining sheath from the atrial skirt so that the atrial skirt is free to self-expand radially outward.

69. The method of claim 67, further comprising moving the prosthetic valve upstream or downstream relative to the native valve to ensure that the atrial skirt engages the superior surface of the native valve.

70. The method of claim 67, wherein engaging the atrial skirt against the superior surface seals the atrial skirt against the superior surface of the native valve to prevent or substantially prevent blood flow therebetween.

71. The method of claim 37, wherein the prosthetic valve further comprises a posterior ventricular anchoring tab disposed on a posterior portion of the self-expanding frame, the method further comprising anchoring the posterior ventricular anchoring tab over a posterior leaflet of the patient'"'"'s mitral valve, such that the posterior ventricular anchoring tab is seated between the posterior leaflet and a ventricular wall of the patient'"'"'s heart.

72. The method of claim 71, wherein the posterior ventricular tab comprises barbs, texturing or other surface features, and wherein anchoring the posterior ventricular tab comprises engaging the barbs, texturing or other surface features with tissue.