Self-molding annuloplasty ring

Abstract

A resilient self molding annuloplasty ring which may be enlarged prior to implantation to facilitate implantation within a dilated or otherwise incompetent valve annulus having sufficient contractive force to render a valve competent. The self-molding annuloplasty ring may further comprise integral attachment devices to aid in the implantation process. The resilient self-molding annuloplasty ring may be stretched to an expanded diameter and attached to a heart valve annulus, then permitted to contract to reduce the diameter of the annulus. The ring may be positioned on an insertion device that maintains the ring in its expanded diameter while attaching to the annulus.

1 . A self-molding annuloplasty ring for implantation in a dilated heart valve annulus having a dilated size, comprising: 
 a resilient inner sizing member positioned within an outer attachment sheath, the annuloplasty ring defining a shape having a first diameter in the absence of an external force, the resilient inner sizing member having sufficient elasticity to permit pre-stretching such that the annuloplasty ring attains an expanded diameter larger than the first diameter and equivalent to the dilated size of the dilated valve annulus, the resilient inner sizing member being biased toward its relaxed diameter and having sufficient contractive force to decrease the dilated size of the dilated valve annulus when the expanded diameter annuloplasty ring is attached thereto.    
   
   
       2 . The device of  claim 1 , further comprising support structure on the annuloplasty ring that limits inward contraction of the inner sizing member to a contracted diameter that is larger than its relaxed diameter.  
   
   
       3 . The device of  claim 2 , wherein the support structure includes a series of support members positioned along the inner sizing member which engage one another to limit inward contraction of the inner sizing member.  
   
   
       4 . The device of  claim 3 , wherein each support member comprises a body member having a lumen formed therein, the lumen being sized to receive the inner sizing member.  
   
   
       5 . The device of  claim 1 , wherein the annuloplasty ring further comprises a plurality of attachment devices positioned thereon and extending outward from the outer attachment sheath.  
   
   
       6 . The device of  claim 5 , wherein the plurality of attachment devices is selected from the group consisting of: 
 needles;    barbs; and    hooks.    
   
   
       7 . The device of  claim 5 , wherein the material of the plurality of attachment devices is selected from the group consisting of: 
 stainless steel;    titanium; and    a nickel-titanium alloy.    
   
   
       8 . The device of  claim 1  wherein the inner sizing member comprises a biologically compatible elastomer.  
   
   
       9 . The device of  claim 1 , wherein the outer attachment sheath comprises a medicament to induce tissue growth.  
   
   
       10 . The device of  claim 1 , wherein the annuloplasty ring has a closed shape selected from the group consisting of: 
 a “D” shape;    a generally round shape; and    an oval shape.    
   
   
       11 . An annuloplasty device for implantation in a dilated heart valve annulus, comprising: 
 an insertion device; and    an annuloplasty ring having a resilient inner sizing member positioned within an outer attachment sheath, the annuloplasty ring being expandable from a first diameter to a larger expanded diameter, the annuloplasty ring being positioned on the insertion device and maintained at its expanded diameter;    wherein, on the insertion device the resilient inner sizing member is biased so as to urge the annuloplasty ring toward its first diameter such that if the insertion device is removed the annuloplasty ring contracts.    
   
   
       12 . The device of  claim 11 , wherein the insertion device has a size commensurate with the diameter of the dilated valve annulus.  
   
   
       13 . The device of  claim 11 , further comprising support structure on the annuloplasty ring that limits inward contraction of the inner sizing member to a contracted diameter that is larger than its relaxed diameter.  
   
   
       14 . The device of  claim 13 , wherein the support structure includes a series of support members positioned along the inner sizing member which engage one another to limit inward contraction of the inner sizing member.  
   
   
       15 . The device of  claim 11 , wherein the annuloplasty ring further comprises a plurality of attachment devices positioned thereon and extending outward from the outer attachment sheath.  
   
   
       16 . The device of  claim 15 , wherein the plurality of attachment devices is selected from the group consisting of: 
 needles;    barbs; and    hooks.    
   
   
       17 . The device of  claim 15 , wherein the material of the plurality of attachment devices is selected from the group consisting of: 
 stainless steel;    titanium; and    a nickel-titanium alloy.    
   
   
       18 . The device of  claim 11  wherein the inner sizing member comprises a biologically compatible elastomer.  
   
   
       19 . The device of  claim 11 , wherein the outer attachment sheath comprises a medicament to induce tissue growth.  
   
   
       20 . The device of  claim 11 , wherein the annuloplasty ring has a closed shape selected from the group consisting of: 
 a “D” shape;    a generally round shape; and    an oval shape.