Device with biological tissue scaffold for percutaneous closure of an intracardiac defect and methods thereof

Abstract

The invention provides an intracardiac occluder, which has biological tissue scaffolds as occlusion shells, for the percutaneous transluminal treatment of an intracardiac defect. The intracardiac occluder includes a proximal support structure supporting the proximal occlusion shell and a distal support structure supporting the distal occlusion shell. In one embodiment, biological tissue derived from the tunica submucosa layer of the porcine small intestine forms the occlusion shells.

What is claimed is:  
     
         1 . An intracardiac occluder for percutaneous transluminal treatment of an intracardiac defect, comprising: 
 a proximal support structure supporting a proximal occlusion shell; and    a distal support structure, coupled to the proximal support structure, supporting a distal occlusion shell,    wherein at least one of the occlusion shells comprises a biological tissue scaffold.    
     
     
         2 . The occluder of  claim 1 , wherein the biological tissue scaffold comprises a purified bioengineered type 1 collagen.  
     
     
         3 . The occluder of  claim 2 , wherein the purified bioengineered type 1 collagen is derived from a tunica submucosa layer of a porcine small intestine.  
     
     
         4 . The occluder of  claim 1 , wherein at least one of the support structures comprises a corrosion resistant metal.  
     
     
         5 . The occluder of  claim 1 , wherein at least one of the support structures comprises a bioresorbable polymer.  
     
     
         6 . The occluder of  claim 1 , wherein at least one of the support structures comprises a biodegradable polymer.  
     
     
         7 . The occluder of  claim 1 , wherein the proximal support structure comprises a plurality of outwardly extending proximal arms and the distal support structure comprises a plurality of outwardly extending distal arms.  
     
     
         8 . A method for percutaneous transluminal treatment of an intracardiac defect in a patient, comprising: 
 providing an intracardiac occluder, comprising: 
 a proximal support structure supporting a proximal occlusion shell; and  
 a distal support structure, coupled to the proximal support structure, supporting a distal occlusion shell,  
 wherein at least one of the occlusion shells comprises a biological tissue scaffold;  
   positioning the intracardiac occluder proximate the intracardiac defect; and    engaging the intracardiac defect with the intracardiac occluder to substantially occlude the intracardiac defect.    
     
     
         9 . The method of  claim 8 , wherein engaging the intracardiac defect comprises positioning the proximal occlusion shell and the distal occlusion shell on different sides of the intracardiac defect.  
     
     
         10 . The method of  claim 8 , wherein the intracardiac defect is a patent foramen ovale.  
     
     
         11 . The method of  claim 8 , wherein the intracardiac defect is an atrial septal defect.  
     
     
         12 . The method of  claim 8 , wherein the intracardiac defect is a ventricular septal defect.  
     
     
         13 . The method of  claim 8 , wherein the intracardiac defect is a left atrial appendage.  
     
     
         14 . A method for making an intracardiac occluder for percutaneous transluminal treatment of an intracardiac defect, comprising: 
 providing an overall support structure comprising a proximal support structure and a distal support structure;    providing first and second biological tissue scaffolds;    coupling the first biological tissue scaffold to the proximal support structure; and    coupling the second biological tissue scaffold to the distal support structure.    
     
     
         15 . The method of  claim 14 , wherein coupling the biological tissue scaffolds comprises sewing the biological tissue scaffolds to the support structures.  
     
     
         16 . The method of  claim 14 , wherein coupling the biological tissue scaffolds comprises laminating the biological tissue scaffolds to the support structures.  
     
     
         17 . The method of  claim 14 , wherein coupling the biological tissue scaffolds comprises gluing the biological tissue scaffolds to the support structures.