Method and device for treatment of valve regurgitation

Abstract

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 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 leaflet so that after implantation a significant overlap of the device body occurs.

1 .- 35 . (canceled) 
     
     
         36 . A method for assisting coaptation of a native cardiac valve, the method comprising:
 identifying that the native cardiac valve suffers from valve insufficiency; and   implanting only one valve assist leaflet such that:   a fixed end of the valve assist leaflet is fixed with respect to a first portion of a native valve annulus of the native cardiac valve, and the valve assist leaflet lies over a superior surface of a first native valve leaflet of the native cardiac valve, and   an open space is formed between (a) a ventricular end of the valve assist leaflet opposite the fixed end of the valve assist leaflet and (b) a second portion of the native valve annulus opposite the first portion of the native valve annulus, the open space accommodating movement of a second native valve leaflet of the cardiac valve in response to blood flow through the native cardiac valve,   wherein the valve assist leaflet is sufficiently flexible and the ventricular end of the valve assist leaflet is freely moveable such that the valve assist leaflet moves in unison with the first native valve leaflet and coapts with the second native valve leaflet in response to the blood flow through the native cardiac valve.   
     
     
         37 . The method according to  claim 36 , wherein implanting the valve assist leaflet comprises implanting the valve assist leaflet such that first and second curved lateral edges of the valve assist leaflet face in generally opposite directions from each other and extend between the ventricular end and the fixed end. 
     
     
         38 . The method according to  claim 37 , wherein the open space is a first open space, and wherein implanting the valve assist leaflet comprises implanting the valve assist leaflet such that second and third open spaces are formed in a radial direction between the native valve annulus and the first and the second curved lateral edges, respectively. 
     
     
         39 . The method according to  claim 37 , wherein the first and the second curved lateral edges are shaped so as to define respective first and second concave portions. 
     
     
         40 . The method according to  claim 36 , wherein implanting the valve assist leaflet comprises implanting the valve assist leaflet such that the valve assist leaflet entirely covers the superior surface of the first native leaflet. 
     
     
         41 . The method according to  claim 36 , wherein a length of the valve assist leaflet in an atrioventricular direction is greater than a greatest width of the valve assist leaflet. 
     
     
         42 . The method according to  claim 36 , wherein implanting the valve assist leaflet comprises anchoring the valve assist leaflet to cardiac tissue using an anchor, and wherein the valve assist leaflet is coupled to the anchor only at the fixed end of the valve assist leaflet. 
     
     
         43 . The method according to  claim 42 , wherein anchoring the valve assist leaflet to the cardiac tissue comprises attaching the anchor to the native valve annulus. 
     
     
         44 . The method according to  claim 43 , wherein attaching the anchor to the native valve annulus comprises self-expanding the anchor within the native valve annulus. 
     
     
         45 . The method according to  claim 44 , wherein self-expanding the anchor within the native valve annulus comprises self-expanding the anchor within the native valve annulus to fully circumscribe the native valve annulus. 
     
     
         46 . The method according to  claim 45 , wherein the anchor includes a ring. 
     
     
         47 . The method according to  claim 44 , wherein self-expanding the anchor within the native valve annulus comprises self-expanding the anchor within the native valve annulus to partially circumscribe the valve annulus. 
     
     
         48 . The method according to  claim 44 , wherein anchor includes one or more barbs, and wherein self-expanding the anchor within the native valve annulus comprises self-expanding the anchor within the native valve annulus such that the one or more barbs penetrate the native valve annulus as the anchor self-expands. 
     
     
         49 . The method according to  claim 43 , wherein attaching the anchor to the native valve annulus comprises suturing the anchor to the native valve annulus. 
     
     
         50 . The method according to  claim 42 , wherein anchoring the valve assist leaflet to the cardiac tissue comprises attaching the anchor to myocardial tissue of a cardiac wall above the native valve annulus. 
     
     
         51 . The method according to  claim 42 , wherein a length of the anchor is greater than a greatest length of the valve assist leaflet in an atrioventricular direction. 
     
     
         52 . The method according to  claim 36 , wherein the native cardiac valve is a mitral valve or an aortic valve. 
     
     
         53 . The method according to  claim 36 , wherein the native cardiac valve is a venous valve. 
     
     
         54 . The method according to  claim 36 , wherein implanting comprises implanting the valve assist leaflet in an open surgical procedure. 
     
     
         55 . The method according to  claim 36 , wherein implanting comprises advancing the valve assist leaflet endovascularly. 
     
     
         56 . The method according to  claim 36 , wherein implanting comprises advancing the valve assist leaflet transseptally. 
     
     
         57 . The method according to  claim 36 , wherein implanting comprises advancing the valve assist leaflet transapically. 
     
     
         58 . The method according to  claim 36 , wherein the valve assist leaflet defines an atrioventricular-oriented axis between the fixed and the ventricular ends, and has:
 a first width at the fixed end and a first location along the atrioventricular-oriented axis,   a second width at a second location along the atrioventricular-oriented axis between the fixed and ventricular ends greater than the first width, and   a third width less than the second width at a third location along the atrioventricular-oriented axis, the third location being between the second location and the ventricular end along the atrioventricular-oriented axis.   
     
     
         59 . The method according to  claim 36 , wherein the ventricular end is entirely convex. 
     
     
         60 . The method according to  claim 36 , wherein the valve assist leaflet defines an atrioventricular-oriented axis between the fixed and the ventricular ends, and has:
 a first width at the fixed end and a first location along the atrioventricular-oriented axis,   a second width at a second location along the atrioventricular-oriented axis between the fixed and the ventricular ends less than the first width, and   a third width greater than the second width at a third location along the atrioventricular-oriented axis, the third location being between the second location and the ventricular end along the atrioventricular-oriented axis.   
     
     
         61 . The method according to  claim 60 , wherein the valve assist leaflet has a fourth width less than the third width at a fourth location along the atrioventricular-oriented axis, the fourth location being between the third location and the ventricular end along the atrioventricular-oriented axis. 
     
     
         62 . A method for assisting coaptation of a cardiac valve, the method comprising:
 identifying that the cardiac valve suffers from valve insufficiency; and   implanting only one valve assist leaflet such that:   a fixed end of the valve assist leaflet is fixed with respect to a first portion of a valve annulus of the cardiac valve, and the valve assist leaflet lies over a superior surface of a first valve leaflet of the cardiac valve, and   an open space is formed between (a) a ventricular end of the valve assist leaflet opposite the fixed end of the valve assist leaflet and (b) a second portion of the valve annulus opposite the first portion of the valve annulus, the open space accommodating movement of a second valve leaflet of the cardiac valve in response to blood flow through the cardiac valve,   wherein the valve assist leaflet is sufficiently flexible and the ventricular end of the valve assist leaflet is freely moveable such that the valve assist leaflet moves in unison with the first valve leaflet and coapts with the second valve leaflet in response to the blood flow through the cardiac valve.   
     
     
         63 . The method according to  claim 62 , wherein the ventricular end is entirely convex. 
     
     
         64 . The method according to  claim 62 ,
 wherein implanting the valve assist leaflet comprises implanting the valve assist leaflet such that first and second curved lateral edges of the valve assist leaflet face in generally opposite directions from each other and extend between the ventricular end and the fixed end, and   wherein the open space is a first open space, and wherein implanting the valve assist leaflet comprises implanting the valve assist leaflet such that second and third open spaces are formed in a radial direction between the valve annulus and the first and the second curved lateral edges, respectively.   
     
     
         65 . The method according to  claim 62 , wherein a length of the valve assist leaflet in an atrioventricular direction is greater than a greatest width of the only one valve assist leaflet.