Ventricular restoration shaping apparatus and method of use

Abstract

Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

1 - 28 . (canceled)  
     
     
         29 . A method for reshaping an enlarged left ventricle of a human heart, comprising: 
 positioning a shaper in the left ventricle, wherein the left ventricle has a first shape;    using the shaper as a model to reshape at least a portion of the left ventricle such that the reshaped left ventricle has a second shape; and    removing the shaper from the left ventricle.    
     
     
         30 . The method of  claim 29 , wherein the second shape of the left ventricle displays an increased efficiency relative to the first shape of the left ventricle.  
     
     
         31 . The method of  claim 29 , wherein at least a portion of the second shape substantially corresponds to at least a portion of a size of the shaper, and wherein at least a portion of the second shape substantially corresponds to at least a portion of a shape of the shaper.  
     
     
         32 . The method of  claim 29 , wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.  
     
     
         33 . The method of  claim 29 , wherein the shaper is substantially ellipsoid in shape.  
     
     
         34 . The method of  claim 29 , wherein the shaper is substantially pear shaped.  
     
     
         35 . The method of  claim 29 , wherein the shaper is substantially tear drop shaped.  
     
     
         36 . The method of  claim 29 , further comprising demarking between non-viable tissue and viable tissue of the left ventricle.  
     
     
         37 . The method of  claim 29 , further comprising: 
 engaging a wall of the left ventricle of a beating heart to sense tactile feedback; and    determining a demarcation line between non-viable tissue and viable tissue of the left ventricle.    
     
     
         38 . The method of  claim 29 , further comprising excluding at least some of the non-viable tissue of the left ventricle.  
     
     
         39 . The method of  claim 29 , further comprising: 
 determining a demarcation line between non-viable tissue and viable tissue of the left ventricle; and    excluding at least some of the non-viable tissue;    placing at least one suture along at least a portion of the demarcation line; and    pulling the suture such that the left ventricle is pulled around the shaper.    
     
     
         40 . The method of  claim 39 , further comprising attaching a patch along at least a portion of one of the demarcation lines.  
     
     
         41 . The method of  claim 29 , further comprising attaching a patch to an interior of the left ventricle.  
     
     
         42 . The method of  claim 29 , further comprising excluding at least some scar tissue from viable tissue of the left ventricle.  
     
     
         43 . A method for reshaping a left ventricle of a human heart, comprising: 
 positioning a shaper in the left ventricle; and    reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to a predetermined shape of the shaper.    
     
     
         44 . The method of  claim 43 , further comprising: 
 determining a demarcation line between non-viable tissue and viable tissue;    excluding at least some of the non-viable tissue;    placing at least one suture along at least a portion of the demarcation line; and    pulling the suture such that the left ventricle is pulled around the shaper.    
     
     
         45 . The method of  claim 44 , wherein the determining of the demarcation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.  
     
     
         46 . The method of  claim 44 , further comprising attaching a patch along at least a portion of one of the demarcation lines.  
     
     
         47 . The method of  claim 43 , further comprising attaching a patch to an interior of the left ventricle.  
     
     
         48 . The method of  claim 43 , further comprising excluding scar tissue from viable tissue.