Leaflet-restraining techniques

Abstract

Methods are described for use with a valve of a heart of a subject, the valve having an annulus, a first leaflet and an opposing leaflet, the heart having an atrium upstream of the valve, and a ventricle downstream of the valve. A tissue anchor, and an implant that includes a flexible frame, are transluminally advanced to the atrium. The implant is deployed within the atrium. Via anchoring of the tissue anchor to the annulus of the valve, the implant is secured within the heart by a first part of the frame being secured to the annulus, such that the frame extends over the first leaflet toward the opposing leaflet with a first side of the frame facing the first leaflet. Part of the frame can be disposed between the first leaflet and the opposing leaflet. Other embodiments are also described.

1 . A method for use with a valve of a heart of a subject, the valve having an annulus, a first leaflet and an opposing leaflet, the heart having an atrium upstream of the valve, and a ventricle downstream of the valve, the method comprising:
 transluminally advancing to the atrium:
 an implant that includes a flexible frame, the frame having a first part, a first side, and an opposing side opposite the first side, and 
 a tissue anchor; 
   deploying the frame within the atrium of the heart; and   via anchoring of the tissue anchor to the annulus, securing the implant within the heart by securing the first part of the frame to the annulus such that:
 the frame is cantilevered, extending from the first part, over the first leaflet toward the opposing leaflet, with the first side facing the first leaflet, and 
 a second part of the frame is disposed between the first leaflet and the opposing leaflet. 
   
     
     
         2 . The method according to  claim 1 , wherein:
 the method further comprises transluminally advancing a catheter to the atrium,   transluminally advancing the implant to the atrium comprises transluminally advancing the implant to the atrium via the catheter, and   the method further comprises withdrawing the catheter from the subject without having anchored the implant to the ventricle.   
     
     
         3 . The method according to  claim 1 , wherein securing the implant within the heart comprises securing the implant within the heart without anchoring the implant in the ventricle. 
     
     
         4 . The method according to  claim 1 , wherein advancing the implant to the atrium comprises advancing the implant to the atrium while the frame is constrained within a catheter. 
     
     
         5 . The method according to  claim 1 , wherein:
 the implant further includes a force-distribution portion,   deploying the implant comprises deploying the implant such that the force-distribution portion extends away from the frame, and   securing the first part of the frame comprises securing the first part of the frame such that the force-distribution portion lies against a wall of the atrium.   
     
     
         6 . The method according to  claim 5 , wherein the force-distribution portion includes a wire arc, and wherein securing the first part of the frame comprises securing the first part of the frame such that the wire arc lies against the wall of the atrium. 
     
     
         7 . The method according to  claim 6 , wherein the implant includes a unitary structure that defines the frame and the force-distribution portion, and wherein transluminally advancing the implant to the atrium comprises transluminally advancing the unitary structure to the atrium. 
     
     
         8 . The method according to  claim 5 , wherein securing the first part to the annulus comprises securing the first part to the annulus such that:
 the first part defines a fulcrum site for the implant, and   an atrially-directed force applied by the first leaflet to the frame is transferred via the fulcrum site to press the force-distribution portion against the wall of the atrium.   
     
     
         9 . The method according to  claim 1 , wherein securing the first part of the frame to the annulus comprises securing the frame to the annulus such that the frame defines an arc that extends, from the first part, towards the opposing leaflet, and back towards the first part. 
     
     
         10 . The method according to  claim 9 , wherein:
 the first leaflet has a lip, and   securing the first part of the frame to the annulus comprises securing the first part of the frame to the annulus such that a segment of the arc is disposed beyond of the lip of the first leaflet, within the ventricle.   
     
     
         11 . The method according to  claim 1 , wherein the valve is a mitral valve of the heart, the atrium is a left atrium of the heart, and transluminally advancing the implant to the atrium comprises transluminally advancing the implant to the left atrium. 
     
     
         12 . The method according to  claim 1 , wherein the implant includes a sheet spread over the frame, and wherein transluminally advancing the implant comprises transluminally advancing the implant with the sheet spread over the frame. 
     
     
         13 . The method according to  claim 1 , wherein the frame includes a shape-memory material, and wherein advancing the implant comprises advancing the implant that includes the frame including the shape-memory material. 
     
     
         14 . The method according to  claim 1 , wherein the implant further includes a support structure, and wherein securing the first part of the frame to the annulus comprises:
 securing the support structure to the annulus using the tissue anchor, and   securing the first part to the support structure.   
     
     
         15 . The method according to  claim 14 , wherein securing the first part to the support structure comprises securing the first part to the support structure subsequently to securing the support structure to the annulus. 
     
     
         16 . The method according to  claim 14 , wherein the tissue anchor is a first tissue anchor, and wherein:
 the method further comprises transluminally advancing a second tissue anchor to the atrium of the heart, and   securing the support structure to the annulus comprises securing the support structure to the annulus using both the first tissue anchor and the second tissue anchor.   
     
     
         17 . A method for use with a valve of a heart of a subject, the valve having an annulus, a first leaflet and an opposing leaflet, the first leaflet having a lip, and the heart having an atrium upstream of the valve, and a ventricle downstream of the valve, the method comprising:
 transluminally advancing to the atrium:
 an implant that includes a flexible frame, and 
 a tissue anchor; 
   deploying the frame within the atrium of the heart; and   securing the implant to the annulus via anchoring of the tissue anchor to the annulus, the securing being such that the frame extends, from the tissue anchor and over the first leaflet such that a free end of the implant overhangs beyond the lip.   
     
     
         18 . The method according to  claim 17 , wherein securing the implant to the annulus comprises securing the implant to the annulus such that the frame extends, from the tissue anchor, over the first leaflet towards the opposing leaflet in a direction generally perpendicular to the lip of the first leaflet. 
     
     
         19 . The method according to  claim 17 , wherein securing the implant to the annulus comprises securing the implant to the annulus without anchoring the implant in the ventricle. 
     
     
         20 . The method according to  claim 17 , wherein:
 the method further comprises transluminally advancing a catheter to the atrium,   transluminally advancing the implant to the atrium comprises transluminally advancing the implant to the atrium via the catheter, and   the method further comprises withdrawing the catheter from the subject without having anchored the implant to the ventricle.   
     
     
         21 . The method according to  claim 17 , wherein:
 the method further comprises driving the tissue anchor through a fabric of the implant and into tissue of the annulus, and   securing the implant to the annulus comprises securing the implant to the annulus via coupling between the frame and the tissue anchor via the fabric.   
     
     
         22 . The method according to  claim 17 , wherein securing the frame to the annulus comprises securing a first part of the frame to the annulus, such that the frame defines an arc, that extends, from the first part, to the free end, and back towards the first part.