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.

1 - 17 . (canceled)  
     
     
         18 . An intracardiac occluder for percutaneous transvascular 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 comprising a bioengineered collagen, and    wherein at least one of the support structures is biodegradable or bioresorbable.    
     
     
         19 . The occluder of  claim 18 , wherein the at least one support structure that is biodegradable or bioresorbable is fabricated from a biodegradable or bioresorbable polymer.  
     
     
         20 . The occluder of  claim 18 , wherein the bioengineered collagen is purified bioengineered type 1 collagen.  
     
     
         21 . The occluder of  claim 18 , wherein the bioengineered collagen is derived from tunica submucosa.  
     
     
         22 . The occluder of  claim 18 , 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.  
     
     
         23 . The occluder of  claim 18 , wherein heparin is ionically or covalently bound to the biological tissue scaffold.  
     
     
         24 . The occluder of  claim 18 , wherein the biological tissue scaffold is laminated to the biodegradable or bioresorbable support structure.  
     
     
         25 . A method for percutaneous transvascular 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 comprising a bioengineered collagen, and wherein at least one of the support structures is biodegradable or bioresorbable;  
   positioning the intracardiac occluder proximate the intracardiac defect; and    engaging the intracardiac defect with the intracardiac occluder to substantially occlude the intracardiac defect, wherein at least one of said support structures is biodegraded or bioresorbed.    
     
     
         26 . The method of  claim 25 , wherein the at least one support structure that is biodegradable is fabricated from a biodegradable or bioresorbable polymer.  
     
     
         27 . The method of  claim 25 , wherein engaging the intracardiac defect comprises positioning the proximal occlusion shell and the distal occlusion shell on different sides of the intracardiac defect.  
     
     
         28 . The method of  claim 25 , wherein the intracardiac defect is a patent foramen ovale.  
     
     
         29 . The method of  claim 25 , wherein the intracardiac defect is an atrial septal defect.  
     
     
         30 . The method of  claim 25 , wherein the intracardiac defect is a ventricular septal defect.  
     
     
         31 . The method of  claim 25 , wherein the intracardiac defect is a left atrial appendage.  
     
     
         32 . The method of  claim 25 , wherein the bioengineered collagen is derived from a tunica submucosa layer of porcine small intestine.  
     
     
         33 . A method for making an intracardiac occluder for percutaneous transluminal treatment of an intracardiac defect, comprising: 
 providing a support structure comprising a proximal support structure and a distal support structure wherein at least one of the proximal or distal support structure is biodegradable or bioresorbable;    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, wherein at least one of the first or second biological tissue scaffolds comprises a bioengineered collagen.    
     
     
         34 . The method of  claim 33 , wherein coupling the biological tissue scaffolds comprises sewing the biological tissue scaffolds to the biodegradable or bioresorbable support structures.  
     
     
         35 . The method of  claim 33 , wherein coupling the biological tissue scaffolds comprises laminating the biological tissue scaffolds to the biodegradable or bioresorbable support structures.  
     
     
         36 . The method of  claim 33 , wherein coupling the biological tissue scaffolds comprises gluing the biological tissue scaffolds to the biodegradable or bioresorbable support structures.  
     
     
         37 . The method of  claim 33 , wherein the at least one support structure that is biodegradable or bioresorbable is fabricated from a biodegradable or bioresorbable polymer.  
     
     
         38 . An intracardiac occluder for percutaneous transvascular treatment of an intracardiac defect, comprising: 
 a proximal support structure comprising a plurality of arms and supporting a proximal occlusion shell, said arms each comprising a biasing point comprising three or more coils;    a distal support structure comprising a plurality of arms, the distal support structure coupled to the proximal support structure and supporting a distal occlusion shell, said arms each comprising a biasing point comprising three or more coils;    wherein at least one of the occlusion shells comprises a biological tissue scaffold comprising a bioengineered collagen, and    wherein at least one of the support structures is biodegradable or bioresorbable.