Annuloplasty with enhanced anchoring to the annulus based on tissue healing

Abstract

Methods, delivery systems and engaging apparatuses for the placement and treatment of an insufficient or stenotic cardiac valve, such as the mitral valve are disclosed. One such method is based on a two step procedure, where during the first step the engaging apparatus is brought to the valve annulus using a delivery system which permits continued normal blood flow. In some preferred embodiments, this is implemented with a balloon and other preferred embodiments it is implemented using a multi-pronged structure that is collapsible like an umbrella frame. The second step is performed after the engaging apparatus has been integrated into the annular wall by natural processes of tissue healing and remodeling. In the second step the engaging apparatus is tightened leading to tightening of the valve annulus and correction of existing valvular insufficiency. Optionally, an artificial valve may be anchored to the engaging apparatus during the same or subsequent procedure to correct either valvular insufficiency or stenosis.

1 . An apparatus for repairing an annulus comprising:
 an annulus contact portion having an outer boundary that is configured for pressing outwards against the annulus, wherein the annulus contact portion is substantially arc-shaped and has an inner core; and   a wire that runs through the inner core and is arranged with respect to the annulus contact portion so that pulling on the wire causes the outer boundary to contract.   
   
   
       2 . The apparatus of  claim 1 , wherein the annulus contact portion has a plurality of barbs configured to promote attachment of the annulus contact portion to the annulus. 
   
   
       3 . The apparatus of  claim 1 , wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 180°. 
   
   
       4 . The apparatus of  claim 1 , wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 270°. 
   
   
       5 . The apparatus of  claim 1 , wherein annulus contact portion comprises a helical spring that has been formed into an arc. 
   
   
       6 . The apparatus of  claim 5 , wherein the helical spring has an outer diameter between about 25 and about 60 mm, a helix diameter between about 1 and about 3 mm, and a helix pitch between about 1 and about 3 mm. 
   
   
       7 . The apparatus of  claim 5 , wherein the annulus contact portion has a plurality of barbs configured to promote attachment of the annulus contact portion to the annulus. 
   
   
       8 . The apparatus of  claim 5 , wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 180°. 
   
   
       9 . The apparatus of  claim 5 , wherein the substantially arc-shaped annulus contact portion subtends an angle of at least 270°. 
   
   
       10 . An apparatus for repairing an annulus comprising:
 an annulus contact portion having an outer boundary that is configured for pressing outwards against the annulus, wherein the annulus contact portion is substantially arc-shaped and has an inner core;   a wire that runs through the inner core and is arranged with respect to the annulus contact portion so that pulling on the wire causes the outer boundary to contract; and   a pressing member configured to press the annulus contact portion against the annulus while simultaneously permitting blood to flow therethrough.   
   
   
       11 . The apparatus of  claim 10 , wherein the pressing member comprises an inflatable balloon configured to be positioned within the annulus contact portion so that inflation of the balloon cause the annulus contact portion to press against the annulus, and wherein the balloon has a channel that permits blood to flow therethrough when the balloon is inflated. 
   
   
       12 . The apparatus of  claim 11 , wherein annulus contact portion comprises a helical spring that has been formed into an arc. 
   
   
       13 . The apparatus of  claim 10 , wherein the pressing member comprises a multi-pronged structure adapted to press the annulus contact portion against the inner surface of the annulus when actuated, without blocking off the flow of blood. 
   
   
       14 . The apparatus of  claim 13 , wherein annulus contact portion comprises a helical spring that has been formed into an arc.