Ventricular restoration shaping apparatus

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 . A surgical device comprising: 
 a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted is adapted to be temporarily placed into the enlarged left ventricle through a myocardium wall during the surgical procedure.    
     
     
         2 . The device of  claim 1  wherein the shaper comprises an expandable balloon, such that when the balloon is in a substantially inflated condition, the balloon is a size and shape substantially equal to the size and shape of an appropriate left ventricle such that the balloon supports a myocardium of the heart during the surgical procedure.  
     
     
         3 . The device of  claim 2  wherein when the balloon is in an inflated condition, the balloon cannot be substantially expanded.  
     
     
         4 . The device of  claim 2  wherein the balloon is in an inflated condition, the balloon maintains the shape of an appropriate left ventricle while being further inflated.  
     
     
         5 . The device of  claim 2  wherein the balloon is filled with fluid.  
     
     
         6 . The device of  claim 2  further comprising: 
 a tube in fluid communication with an interior of the balloon,  
 a pressurized fluid reservoir in fluid communication with the tube, and  
 a valve coupled to the tube for maintaining a pressure of the pressurized fluid,.  
 
     
     
         7 . The device of  claim 6  further comprising a means to monitor the pressure of the pressurized fluid.  
     
     
         8 . The device of  claim 6  wherein the pressurized fluid reservoir is a syringe.  
     
     
         9 . The device of  claim 6  further comprising a means to withdraw the pressurized fluid from the tube.  
     
     
         10 . The device of  claim 9  wherein the means to withdraw the pressurized fluid is a syringe.  
     
     
         11 . The device of  claim 1  wherein the shaper is a wire mesh of a predetermined shape.  
     
     
         12 . The device of  claim 11  wherein the wire mesh is made of nitnol.  
     
     
         13 . The device of  claim 1  wherein the shaper has a short and a long axis.  
     
     
         14 . The device of  claim 13  wherein the ratio of short to long axis is about 0.5.  
     
     
         15 . The device of  claim 1  wherein the shaper is pear shaped.  
     
     
         16 . The device of  claim 1  wherein the shaper is tear drop shaped.