TRANSCATHETER MITRAL VALVE PROSTHESIS

• US 20140039611A1
• Filed: 10/04/2013
• Published: 02/06/2014
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Incorporated
• Inventors: Lane, Randy Matthew, Nyuli, Colin A.
• Granted Patent: US 9,770,329 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 prosthetic cardiac valve, said valve comprising:

an anchor having an atrial skirt, an annular region, and a ventricular skirt, wherein the ventricular skirt comprises first and second trigonal anchoring tabs, both tabs disposed on an anterior portion of the ventricular skirt, the first trigonal anchoring tab adapted to be anchored against a first fibrous trigone on a first side of an anterior leaflet of the patient'"'"'s mitral valve, the second trigonal anchoring tab adapted to be anchored against a second fibrous trigone on a second side of the anterior leaflet, and wherein the anterior leaflet and adjacent chordae tendineae are captured between the trigonal anchoring tabs and an anterior surface of the anchor, and

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.

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

3. The prosthetic cardiac valve of claim 1, 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.

4. The prosthetic cardiac valve of claim 1, 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.

5. The prosthetic cardiac valve of claim 4, wherein the atrial skirt self-expands from the collapsed configuration to the radially expanded configuration when unconstrained.

6. The prosthetic cardiac valve of claim 1, wherein the atrial skirt comprises one or more radiopaque markers.

7. The prosthetic cardiac 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.

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

9. The prosthetic cardiac valve of claim 1, 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.

10. The prosthetic cardiac valve of claim 1, wherein the annular region self-expands from the collapsed configuration to the expanded configuration when unconstrained.

11. The prosthetic cardiac valve of claim 1, wherein the annular region comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a cylindrically shaped posterior portion.

12. The prosthetic cardiac 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.

13. The prosthetic cardiac valve of claim 12, 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.

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

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

16. The prosthetic cardiac valve of claim 1, 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.

17. The prosthetic cardiac valve of claim 16, wherein the ventricular skirt self-expands from the collapsed configuration to the expanded configuration when unconstrained.

18. The prosthetic cardiac valve of claim 1, 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 fibruous trigone and a first side of an anterior leaflet of the patient'"'"'s mitral valve, such that the anterior leaflet and adjacent chordate tendineae are captured between the trigonal anchoring tab and an anterior surface of the anchor.

19. The prosthetic cardiac valve of claim 18, 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 trigone opposite the first fibrous trigone, such that the anterior leaflet and adjacent chordate tendineae are captured between the second trigonal anchoring tab and the anterior surface of the anchor.

20. The prosthetic cardiac valve of claim 1, 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.

21. The prosthetic cardiac 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 heart tissue.

22. The prosthetic cardiac 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.

23. The prosthetic cardiac valve of claim 22, wherein one or more of the struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

24. The prosthetic cardiac valve of claim 1, wherein the plurality of prosthetic valve leaflets comprise a tricuspid leaflet configuration.

25. The prosthetic cardiac valve of claim 1, wherein at least a portion of one or more prosthetic valve leaflets comprises tissue or a synthetic material.

26. The prosthetic cardiac valve of claim 1, 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.

27. The prosthetic cardiac valve of claim 26, wherein the one or more struts comprise one or more suture holes extending therethrough, the suture holes sized to receive a suture.

28. The prosthetic cardiac valve of claim 1, 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.

29. The prosthetic cardiac valve of claim 1, 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.

30. The prosthetic cardiac valve of claim 29, wherein the alignment element is coupled with the atrial skirt.

31. The prosthetic cardiac valve of claim 1, wherein the prosthetic cardiac valve further comprises a therapeutic agent coupled thereto, wherein the therapeutic agent is adapted to being eluted therefrom.

33. The prosthetic cardiac valve of claim 1, wherein the first or the second trigonal anchoring tabs comprise a plurality of substantially parallel struts in the collapsed configuration.

34. The prosthetic cardiac valve of claim 1, wherein the first or the second trigonal anchoring tabs comprise a plurality of struts, and wherein the struts are angled inward toward one another in the expanded configuration.

32. 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.

35. The system of claim 32, further comprising the prosthetic cardiac valve, wherein the prosthetic cardiac valve is housed in the sheath in a radially collapsed configuration.

36. The delivery system of claim 32, 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.

37. The system of claim 35, 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.

38. The system of claim 35, 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.

39. The system of claim 32, wherein the actuator mechanism comprises a rotatable wheel.

40. The system of claim 32, 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.

41. The system of claim 32, further comprising a pin lock mechanism releasably coupled with the handle, wherein the pin lock mechanism limits proximal retraction of the sheath.

42. The system of claim 36, 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 trigone 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.

43. The system of claim 42, 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 trigone opposite the first fibrous trigone, such that the anterior leaflet and adjacent chordae tendineae are captured between the second trigonal anchoring tab and the anterior surface of the anchor.

44. The system of claim 36, 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.