TRANSCATHETER MITRAL VALVE PROSTHESIS

• US 20170348100A1
• Filed: 08/22/2017
• Published: 12/07/2017
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation), Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A.
• Granted Patent: US 10,449,042 B2
• Time in Patent Office: 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2230/0034 D-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 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has 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. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient'"'"'s heart.

Claims

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

providing the prosthetic valve, wherein the prosthetic valve comprises an anchor having an atrial skirt, an annular region, a ventricular skirt, and a plurality of valve leaflets, wherein the anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring with the heart;

positioning the prosthetic valve in the patient'"'"'s heart;

expanding the atrial skirt radially outward so as to lie over a superior surface of the patient'"'"'s native mitral valve, and anchoring the atrial skirt against a portion of the atrium;

radially expanding the annular region of the anchor to conform with and to engage the native mitral valve annulus; and

radially expanding the ventricular skirt thereby displacing the native mitral valve leaflets radially outward.

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

3. The method of claim 1, wherein positioning the prosthetic valve comprises transseptally delivering the prosthetic valve from the right atrium to the left atrium of the heart.

4. The method of claim 1, wherein positioning the prosthetic valve comprises transapically delivering the prosthetic valve from a region outside the heart to the left ventricle of the heart.

5. The method of claim 1, wherein expanding the atrial skirt comprises slidably moving a restraining sheath away from the atrial skirt thereby allowing radial expansion thereof

6. The method of claim 5, wherein the atrial skirt self-expands when the restraining sheath is removed therefrom.

7. The method of claim 1, further comprising applying a force on the prosthetic valve to ensure that the atrial skirt engages the superior surface of the mitral valve.

8. The method of claim 1, wherein the atrial skirt comprises a plurality of barbs, and wherein expanding the atrial skirt comprises anchoring the barbs into the superior surface of the mitral valve.

9. The method of claim 1, wherein expanding the atrial skirt comprises sealing the atrial skirt against the superior surface of the native mitral valve.

10. The method of claim 1, wherein radially expanding the annular region comprises slidably moving a restraining sheath away from the annular region thereby allowing radial expansion thereof.

11. The method of claim 10, wherein the annular region self-expands when the restraining sheath is removed therefrom.

12. The method of claim 1, wherein radially 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.

13. The method of claim 1, wherein the ventricular skirt further comprises a trigonal anchoring tab on an anterior portion of the ventricular skirt, and wherein radially expanding the ventricular skirt comprises anchoring the trigonal anchoring tab against a first fibrous trigon on a first side of the anterior leaflet of the native mitral valve, such that the native anterior leaflet and adjacent chordae tendineae are captured between the trigonal anchoring tab and an anterior surface of the anchor.

14. The method of claim 13, wherein the ventricular skirt further comprises a second trigonal anchoring tab on the anterior portion of the ventricular skirt, and wherein radial expanding the ventricular skirt comprises anchoring the second trigonal anchoring tab against a second fibrous trigon opposite the first fibrous trigon, such that the native anterior leaflet and adjacent chordae tendineae are captured between the second trigonal anchoring tab and an anterior surface of the anchor.

15. The method of claim 1, wherein the ventricular skirt further comprises a posterior ventricular anchoring tab on a posterior portion of the ventricular skirt, and wherein radially expanding the ventricular skirt comprises anchoring the posterior ventricular anchoring tab over a posterior leaflet of the native mitral valve to seat between the posterior leaflet and a ventricular wall of the heart.

16. The method of claim 1, wherein radially expanding the ventricular skirt comprises slidably moving a restraining sheath away from the ventricular skirt thereby allowing radial expansion thereof.

17. The method of claim 16, wherein the ventricular skirt self-expands when the restraining sheath is removed therefrom.

18. The method of claim 1, wherein the ventricular skirt comprises a plurality of barbs, and wherein expanding the ventricular skirt comprises anchoring the barbs into heart tissue.

19. The method of claim 1, wherein the prosthetic valve comprises a plurality of prosthetic valve leaflets, and wherein radially expanding the ventricular skirt comprises displacing the native mitral valve leaflets radially outward thereby preventing interference of the native mitral valve leaflets with the prosthetic valve leaflets.

20. The method of claim 1, wherein radially expanding the ventricular skirt comprises displacing the native mitral valve leaflets radially outward without contacting a ventricular wall, and without obstructing a left ventricular outflow tract.

21. The method of claim 1, wherein radially expanding the ventricular skirt comprises asymmetrically expanding the ventricular skirt such that an anterior portion of the ventricular skirt is substantially flat, and a posterior portion of the ventricular skirt is cylindrically shaped.

22. The method of claim 1, wherein the atrial skirt comprises an alignment element, the method further comprising aligning the alignment element relative to the patient'"'"'s valve.

23. The method of claim 22, wherein the valve comprises a mitral valve, and wherein aligning comprises aligning the alignment element with an aortic root and disposing the alignment between two fibrous trigones of an anterior leaflet of the mitral valve.

24. The method of claim 22, wherein aligning comprises rotating the prosthetic valve.

25. The method of claim 1, wherein the prosthetic valve comprises a plurality of prosthetic leaflets coupled to commissures, the method further comprising releasing the commissures from a delivery catheter.

26. The method of claim 25, wherein the prosthetic valve comprises a tricuspid leaflet configuration.

27. The method of claim 1, wherein the prosthetic valve has an open configuration in which the prosthetic valve leaflets are disposed away from one another, and the prosthetic valve has a closed configuration in which the prosthetic valve leaflets engage one another, and wherein blood flows freely through the prosthetic valve in the open configuration, and wherein retrograde blood flow across the prosthetic valve is substantially prevented in the closed configuration.

28. The method of claim 1, further comprising reducing or eliminating mitral regurgitation.

29. The method of claim 1, wherein the prosthetic valve comprises a therapeutic agent, the method further comprising eluting the therapeutic agent from the prosthetic valve into adjacent tissue.

30. A prosthetic cardiac valve, said valve comprising:

an anchor having an atrial skirt, an annular region, and a ventricular skirt, wherein the anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient'"'"'s heart; and

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 anchor and the free end is opposite of the first end,

wherein the prosthetic cardiac valve has 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 cardiac valve of claim 30, wherein at least a portion of the atrial skirt is covered with tissue or a synthetic material.

32. The prosthetic cardiac valve of claim 30, wherein the atrial skirt further comprises a plurality of barbs coupled thereto, the plurality of barbs adapted to anchor the atrial skirt into a superior surface of the patient'"'"'s mitral valve.

33. The prosthetic cardiac valve of claim 30, wherein the atrial skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to lie over a superior surface of the patient'"'"'s native mitral valve, thereby anchoring the atrial skirt against a portion of the atrium.

34. The prosthetic cardiac valve of claim 33, wherein the atrial skirt self-expands from the collapsed configuration to the radially expanded configuration when unconstrained.

35. The prosthetic cardiac valve of claim 30, wherein the atrial skirt comprises one or more radiopaque markers.

36. The prosthetic cardiac valve of claim 30, 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.

37. The prosthetic cardiac valve of claim 30, wherein at least a portion of the annular region is covered with tissue or a synthetic material.

38. The prosthetic cardiac valve of claim 30, wherein the annular region has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to conform with and to engage the native mitral valve annulus.

39. The prosthetic cardiac valve of claim 38, wherein the annular region self-expands from the collapsed configuration to the expanded configuration when unconstrained.

40. The prosthetic cardiac valve of claim 30, wherein the annular region comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

41. The prosthetic cardiac valve of claim 30, 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.

42. The prosthetic cardiac valve of claim 41, wherein one or more of the axially oriented struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

43. The prosthetic cardiac valve of claim 30, wherein at least a portion of the ventricular skirt is covered with tissue or a synthetic material.

44. The prosthetic cardiac valve of claim 30, wherein the ventricular skirt comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

45. The prosthetic cardiac valve of claim 30, wherein the ventricular skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the patient'"'"'s heart, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to displace the native mitral valve leaflets radially outward.

46. The prosthetic cardiac valve of claim 45, wherein the ventricular skirt self-expands from the collapsed configuration to the expanded configuration when unconstrained.

47. The prosthetic cardiac valve of claim 30, wherein the ventricular skirt further comprises a trigonal anchoring tab disposed on an anterior portion of the ventricular skirt, the trigonal anchoring tab adapted to being anchored against a first fibrous trigon on a first side of an anterior leaflet of the patient'"'"'s mitral valve, such that the anterior leaflet and adjacent chordae tendineae are captured between the trigonal anchoring tab and an anterior surface of the anchor.

48. The prosthetic cardiac valve of claim 47, wherein the ventricular skirt further comprises a second trigonal anchoring tab disposed on the anterior portion of the ventricular skirt, the second trigonal anchoring tab adapted to being anchored against a second fibrous trigon opposite the first fibrous trigon, such that the anterior leaflet and adjacent chordae tendineae are captured between the second trigonal anchoring tab and the anterior surface of the anchor.

49. The prosthetic cardiac valve of claim 30, wherein the ventricular skirt further comprises a posterior ventricular anchoring tab disposed on a posterior portion of the ventricular skirt, and 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.

50. The prosthetic cardiac valve of claim 30, wherein the ventricular skirt further comprises a plurality of barbs coupled thereto, the plurality of barbs adapted to anchor the ventricular skirt into heart tissue.

51. The prosthetic cardiac valve of claim 30, 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.

52. The prosthetic cardiac valve of claim 51, wherein one or more of the struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

53. The prosthetic cardiac valve of claim 30, wherein the plurality of prosthetic valve leaflets comprise a tricuspid leaflet configuration.

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

55. The prosthetic cardiac valve of claim 30, wherein one or more of the plurality of prosthetic valve leaflets are coupled to one or more struts radially biased inward relative to the ventricular skirt.

56. The prosthetic cardiac valve of claim 55, wherein the one or more struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

57. The prosthetic cardiac valve of claim 30, wherein one or more of the prosthetic valve leaflets are coupled to a commissure post having a commissure tab adapted to releasably engage the commissure post with a delivery device.

58. The prosthetic cardiac valve of claim 30, further comprising an alignment element coupled to an anterior portion of the anchor, wherein the alignment element is adapted to be aligned with an aortic root of the patient'"'"'s heart and disposed between two fibrous trigones of an anterior leaflet of the patient'"'"'s mitral valve.

59. The prosthetic cardiac valve of claim 58, wherein the alignment element is coupled with the atrial skirt.

60. The prosthetic cardiac valve of claim 30, wherein the prosthetic cardiac valve further comprises a therapeutic agent coupled thereto, wherein the therapeutic agent is adapted to being eluted therefrom.

61. A delivery system for delivering a prosthetic cardiac valve to a patient'"'"'s heart, said system comprising:

an inner guidewire shaft having a lumen extending therethrough, the lumen adapted to slidably receive a guidewire;

a hub shaft concentrically disposed over the inner guidewire shaft;

a bell shaft slidably and concentrically disposed over the hub shaft;

a sheath slidably and concentrically disposed over the bell shaft; and

a handle near a proximal end of the delivery system, the handle comprising an actuator mechanism adapted to advance and retract the bell shaft and the sheath.

62. The system of claim 61, further comprising the prosthetic cardiac valve, wherein the prosthetic cardiac valve is housed in the sheath in a radially collapsed configuration.

63. The delivery system of claim 62, wherein the prosthetic cardiac valve comprises:

an anchor having an atrial skirt, an annular region, and a ventricular skirt; and

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 anchor and the free end is opposite of the first end, and wherein the prosthetic cardiac valve has 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.

64. The system of claim 62, wherein proximal retraction of the sheath relative to the bell shaft removes a constraint from the prosthetic cardiac valve thereby allowing the prosthetic cardiac valve to self-expand into engagement with the patient'"'"'s native heart tissue.

65. The system of claim 62, wherein the prosthetic cardiac valve is releasably coupled with the hub shaft, and wherein proximal retraction of the bell shaft relative to the hub shaft releases the prosthetic cardiac valve therefrom.

66. The system of claim 61, wherein the actuator mechanism comprises a rotatable wheel.

67. The system of claim 61, further comprising a tissue penetrating distal tip coupled to the hub shaft, wherein the tissue penetrating distal tip is adapted to pass through and expand an incision in the patient'"'"'s heart.

68. The system of claim 61, further comprising a pin lock mechanism releasably coupled with the handle, wherein the pin lock mechanism limits proximal retraction of the sheath.