Methods and systems for assisting or repairing prosthetic cardiac valves
A prosthetic valve coaptation assist device includes an anchor and a single valve assist leaflet. The anchor may be a supporting ring frame, brace or arc structure and will usually be radially self-expandable so that it can expand against surrounding natural or prosthetic tissue. The valve assist leaflet may be made of pericardium or other biological or artificial material and is shaped like the native target valve leaflet. The valve assist leaflet is typically sized larger than the target natural or prosthetic leaflet so that after implantation a significant overlap of the device body occurs.
1. A method comprising:
advancing, to within a heart, a leaflet assist device comprising two prosthetic leaflets; and
attaching the leaflet assist device to a native valve annulus of a native cardiac or venous valve of the heart or to an annuloplasty ring previously placed in the heart, so that the two prosthetic leaflets are adjacent each other and lie over a superior surface of (a) a first native valve leaflet of the native cardiac or venous valve or (b) a first defective prosthetic leaflet coupled to the annuloplasty ring at a first side of the native valve annulus, leaving at least (a) a second native valve leaflet of the native cardiac or venous valve or (b) a second prosthetic leaflet coupled to the annuloplasty ring at a second side of the native valve annulus uncovered by any prosthetic leaflet of the leaflet assist device,
wherein the attaching of the leaflet assist device to the native valve annulus or the annuloplasty ring comprises attaching, to the native valve annulus or the annuloplasty ring, an anchor coupled to the two prosthetic leaflets of the leaflet assist device, such that the anchor fully or partially circumscribes the native valve annulus or the annuloplasty ring, and
wherein the two prosthetic leaflets of the leaflet assist device comprise respective fixed ends and free ventricular ends, the fixed ends being sealingly and continuously coupled to the anchor along respective entire lengths of the fixed ends.
2. The method according to claim 1 , wherein the attaching of the leaflet assist device to the native valve annulus or to the annuloplasty ring comprises attaching the leaflet assist device to a mitral valve.
3. The method according to claim 1 , wherein the attaching comprises attaching the leaflet assist device to the native cardiac or venous valve, the native cardiac or venous valve previously treated with a leaflet fixation device.
4. The method according to claim 1 , wherein each prosthetic leaflet of the leaflet assist device is sufficiently flexible so that the free ventricular end is freely moveable and will move in unison with (a) the first native valve leaflet of the native cardiac or venous valve or (b) the first defective prosthetic leaflet coupled to the annuloplasty ring to coapt with (a) the second native valve leaflet or (b) the second prosthetic leaflet coupled to the annuloplasty ring in response to blood flow through the native cardiac or venous valve.
5. The method according to claim 1 , wherein at least one of the two prosthetic leaflets of the leaflet assist device comprises a body formed from tissue or a synthetic polymer.
6. The method according to claim 1 , wherein at least one of the two leaflets of the leaflet assist device comprises a stiffening element.
7. The method according to claim 6 , wherein the stiffening element is directionally sensitive.
8. The method according to claim 6 , wherein the stiffening element comprises a plurality of slices or spaces between multiple raised sections.
9. The method according to claim 6 , wherein the stiffening element is provided at an inner side of each of the two prosthetic leaflets of the leaflet assist device.
10. The method according to claim 1 ,
wherein the attaching of the leaflet assist device to the native valve annulus or to the annuloplasty ring comprises attaching the leaflet assist device to a mitral valve, and
wherein the attaching of the leaflet assist device to the native valve annulus or to the annuloplasty ring further comprises placing a barrier of the leaflet assist device at or near a flexural level of the mitral valve, such that the barrier limits a movement of the first native valve leaflet or the first defective a leaflet to a level at or less that the flexural level.
11. The method according to claim 10 , wherein the placing of the barrier comprises placing a rectangular sheet of the barrier below the flexural level of the mitral valve.
12. The method according to claim 1 , wherein the respective free ventricular ends of the prosthetic leaflets of the leaflet assist device are spaced apart from each other such that the two prosthetic leaflets of the leaflet assist device do not coapt with each other when coapting with (a) the second native valve leaflet of the native cardiac or venous valve or (b) the second prosthetic leaflet coupled to the annuloplasty ring.
13. The method according to claim 1 , wherein the second side of the native valve annulus is located opposite to the first side of the native valve annulus.
14. The method according to claim 1 , wherein the attaching of the leaflet assist device to the native valve annulus or to the annuloplasty ring comprises attaching the leaflet assist device to an aortic valve.
15. The method according to claim 1 , wherein the attaching of the leaflet assist device to the native valve annulus or to the annuloplasty ring comprises attaching the leaflet assist device to a tricuspid valve.
16. The method according to claim 1 , wherein the native cardiac or venous valve of the heart further comprises a third native valve leaflet, and wherein the attaching of the leaflet assist device to the native valve annulus or the venous valve of the heart leaves both the second native valve leaflet and the third native valve leaflet uncovered by any prosthetic leaflet of the leaflet assist device.
17. The method according to claim 1 , wherein a third prosthetic valve leaflet is coupled to the annuloplasty ring at a third side of the native valve annulus, and wherein the attaching of the leaflet assist device to the annuloplasty ring leaves both the first prosthetic valve leaflet coupled to the annuloplasty ring and the second prosthetic valve leaflet coupled to the annuloplasty ring uncovered by any prosthetic leaflet of the leaflet assist device.
18. The method according to claim 1 , wherein the fixed ends of the two prosthetic leaflets of the leaflet assist device are contiguous.
19. The method according to claim 1 , wherein the two prosthetic leaflets of the leaflet assist device are continuous.
20. The method according to claim 1 , wherein the two prosthetic leaflets of the leaflet assist device are comprised of a single fabric, polymer sheet, or tissue.