METHODS AND APPARATUS FOR ENGAGING A VALVE PROSTHESIS WITH TISSUE

• US 20170231760A1
• Filed: 12/14/2016
• Published: 08/17/2017
• Est. Priority Date: 02/14/2012
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Marko, Alexei J., Lane, Randy Matthew, Nyuli, Colin A.
• Granted Patent: US 10,363,133 B2
• Time in Patent Office: Days
• 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 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.

2. The system of claim 1, wherein the cam comprises an annular flange disposed on an inside surface of the outer sheath.

3. The system of claim 1, wherein the outer sheath comprises a lumen and the prosthetic cardiac valve is disposed therein.

4. The system of claim 1, wherein the window is adapted to receive a valve leaflet while open.

5. The system of claim 4, wherein the prosthetic valve is anchored to the valve leaflet after the window is at least partially closed

6. The system of claim 1, further comprising a cover disposed at least partially over the prosthetic cardiac valve, the cover facilitating tissue ingrowth.

7. The system of claim 6, wherein the cover comprises fabric, tissue, or a polymer.

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

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

10. The system of claim 1, wherein the atrial skirt expands before the tab.

11. The system of claim 1, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic valve to a valve leaflet

12. The system of claim 1, 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.

13. 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.

14. The system of claim 13, 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.

15. The system of claim 13, further comprising a cover disposed at least partially over the prosthetic cardiac valve, thereby facilitating tissue ingrowth.

16. The system of claim 13, wherein the cover comprises fabric, tissue, or a polymer.

17. The system of claim 13, wherein the tip of the tab is adapted to engage a fibrous trigone.

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

19. The system of claim 13, wherein the atrial skirt expands before the tab.

20. The system of claim 13, wherein the atrial skirt anchors the prosthetic cardiac valve to the atrium before the tab anchors the prosthetic cardiac valve to a valve leaflet.

21. The system of claim 13, 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.