Insertable medical devices with low profile composite coverings

Abstract

A heart valve replacement includes a substrate and a low profile composite covering in conformal contact with the substrate and suturelessly attached to the substrate. The low profile composite covering includes a textile base layer and a thermoplastic polymer coating integrated with the textile base layer. The thermoplastic polymer coating or select portions thereof are substantially fluid impermeable.

What is claimed is: 
     
         1 . A heart valve replacement comprising:
 a substrate; and   a low profile composite covering in conformal contact with the substrate and suturelessly attached to the substrate, the low profile composite covering comprising:
 a textile base layer; and 
 a thermoplastic polymer coating integrated with the textile base layer, the thermoplastic polymer coating or select portions thereof being substantially fluid impermeable. 
   
     
     
         2 . The heart valve replacement of  claim 1 , wherein the composite covering has a thickness of between about 15 μm and about 250 μm. 
     
     
         3 . The heart valve replacement of  claim 1 , wherein the textile base layer and polymer coating form a single laminate around the entire substrate or select portions of less than the entire substrate. 
     
     
         4 . The heart valve replacement of  claim 1 , wherein the composite covering comprises an anti-thrombogenic surface. 
     
     
         5 . The heart valve replacement of  claim 1 , wherein the textile base layer comprises a knit, woven or braided layer. 
     
     
         6 . The heart valve replacement of  claim 1 , wherein the textile base layer has a tenacity of between about 3 and about 10 gram denier. 
     
     
         7 . A method of manufacturing a heart valve replacement comprising:
 obtaining a substrate of an artificial heart valve;   heat stabilizing a textile material;   coating the textile material with a thermoplastic polymer;   attaching the polymer coated textile material to the substrate to form a composite covering on the substrate; and   laminating the composite covering to the substrate.   
     
     
         8 . The method of  claim 7 , further comprising condensing the textile material prior to coating the textile material with a thermoplastic polymer. 
     
     
         9 . The method of  claim 7 , wherein laminating the composite covering to the substrate comprises:
 obtaining a compression tool comprising:
 a compression tool body defining a receptacle, the receptacle including a three-dimensional compliant mold shaped to conform to the shape of the substrate; and 
 a lid removably disposed on a top surface of the compression tool body; 
   placing the substrate having the composite covering disposed thereon into the three-dimensional compliant mold; and   applying compressive force and heat to the lid via a heated press that translates to the substrate and the composite covering to laminate the composite covering to the substrate.   
     
     
         10 . The method of  claim 9 , wherein the three-dimensional mold comprises silicone. 
     
     
         11 . The method of  claim 7 , wherein laminating the composite covering to the substrate comprises heating the polymer coating above its glass transition temperature. 
     
     
         12 . The method of  claim 7 , wherein laminating the composite covering to the substrate comprises:
 obtaining a compression tool comprising:
 a compression tool body defining a receptacle, the receptacle including a granular, inert, water-soluble medium; 
 a top piston slidably coupled to the compression tool body; and 
 a bottom piston slidably coupled to the compression tool body; 
   placing the substrate having the composite covering disposed thereon into the receptacle; and   applying compressive force and heat to the top and bottom pistons via a heat press that translates to the substrate and the composite covering to laminate the composite covering to the substrate.