Vascular prosthetic assemblies

Abstract

This disclosure includes embodiments of vascular prosthetic assemblies (e.g., heart valves) and methods for using (e.g., percutaneously) and manufacturing (e.g., overmolding) the assemblies. In one embodiment, a vascular prosthetic assembly comprises a frame and a cellulose-based body coupled to the frame, wherein the frame is configured to be altered from an expanded configuration to a collapsed configuration. The frame can be biased toward the expanded configuration, and the assembly can be configured for placement within a catheter when the frame is in the collapsed configuration. In the embodiment shown, the frame can comprise any number of biocompatible materials, including, but not limited to, nitinol. Stainless steel, or cobalt chromium.

1 . A vascular prosthetic assembly comprising:
 a frame; and   a cellulose-based body coupled to the frame, wherein:
 the frame is configured to be altered from an expanded configuration to a collapsed configuration; 
 the frame is biased toward the expanded configuration; and 
 the assembly is configured for placement within a catheter when the frame is in the collapsed configuration. 
   
     
     
         2 . The vascular prosthetic assembly of  claim 1  wherein the cellulose-based body is generally tubular. 
     
     
         3 . The vascular prosthetic assembly of  claim 1  wherein the frame comprises nitinol, stainless steel or cobalt chromium. 
     
     
         4 . The vascular prosthetic assembly of  claim 1  wherein the frame comprises a plurality of wires coupled together. 
     
     
         5 . The vascular prosthetic assembly of  claim 1  wherein the assembly is configured for placement within a catheter having an outer diameter of approximately 7.0 mm when the frame is in the collapsed configuration. 
     
     
         6 . The vascular prosthetic assembly of  claim 1  wherein the assembly is configured for placement within a catheter having an outer diameter of between approximately 5.0 mm and 9.0 mm when the frame is in the collapsed configuration. 
     
     
         7 . The vascular prosthetic assembly of  claim 1  wherein the cellulose-based body comprises a plurality of leaflets. 
     
     
         8 . The vascular prosthetic assembly of  claim 7  wherein the plurality of leaflets are configured to move from an open configuration to a closed configuration. 
     
     
         9 . The vascular prosthetic assembly of  claim 8  wherein the plurality of leaflets are configured to restrict a fluid flow through the assembly in the closed configuration. 
     
     
         10 . The vascular prosthetic assembly of  claim 1  wherein the cellulose-based body is formed from a methylolcellulose solution. 
     
     
         11 . The vascular prosthetic assembly of  claim 1  wherein the frame is configured to remain in the expanded configuration when the assembly is deployed in a native heart valve. 
     
     
         12 . The vascular prosthetic assembly of  claim 1  wherein the cellulose-based body further comprises a mixture of silicone. 
     
     
         13 . The vascular prosthetic assembly of  claim 12  wherein the cellulose-based body is approximately 60 percent cellulose and 40 percent silicone by weight. 
     
     
         14 . The vascular prosthetic assembly of  claim 1  wherein the cellulose-based body comprises a bacterial cellulose material. 
     
     
         15 . A method of inserting a vascular prosthetic assembly, the method comprising:
 inserting an assembly comprising a frame and a cellulose-based body into a catheter;   inserting the catheter into a native heart valve;   deploying the assembly in the native heart valve;   expanding the assembly; and   retracting the catheter from the native heart valve.   
     
     
         16 . The method of  claim 15 , further comprising:
 inserting a guidewire through a vascular entry point to a region proximal to the native heart valve; and   inserting the catheter over the guidewire and into the native heart valve.   
     
     
         17 . The method of  claim 16  wherein the method of deploying the assembly is selected from the group consisting of transcatheter deployment, transapical deployment, retrograde vascular deployment, and antegrade vascular deployment. 
     
     
         18 . The method of  claim 16  wherein inserting the guidewire through the vascular entry point to the region proximal to the native heart valve comprises inserting the guidewire through an aortic valve and into a left ventricle. 
     
     
         19 . A method of manufacturing a vascular prosthetic assembly, the method comprising:
 placing a generally tubular frame around a mandrel having a first diameter configured for deployment in a heart;   heating the generally tubular frame;   quenching the generally tubular frame in liquid;   pouring a cellulose-based mixture over the generally tubular frame to form a body; and   compressing the generally tubular frame such that it can be placed within a catheter.   
     
     
         20 . The method of  claim 19  wherein the generally tubular frame is steel. 
     
     
         21 . The method of  claim 19  wherein the generally tubular frame is nitinol. 
     
     
         22 . A method of manufacturing a vascular prosthetic assembly, the method comprising:
 pouring a cellulose-based mixture over a mandrel to form a first cellulose-based layer;   submerging the first cellulose-based layer in a first liquid;   placing a generally tubular frame around the first cellulose-based layer;   pouring the cellulose-based mixture over the generally tubular frame and the first cellulose-based layer to form a second cellulose-based layer;   submerging the assembly in the first liquid; and   submerging the assembly in a second liquid.   
     
     
         23 . The method of  claim 22  wherein the first liquid is acetone. 
     
     
         24 . The method of  claim 22  wherein the second liquid is water. 
     
     
         25 . A method of assembling a vascular prosthetic assembly, the method comprising:
 providing a generally tubular frame comprising a plurality of apertures;   coupling a cellulose body to the generally tubular frame wherein the cellulose body is disposed within a lumen of the generally tubular frame and wherein the cellulose body extends through the plurality of apertures to form a plurality of loops;   inserting a bar into each loop formed by the cellulose body extending through generally tubular frame; and   securing each bar to the generally tubular frame.   
     
     
         26 . The method of  claim 25  wherein each bar comprises a hook on one end. 
     
     
         27 . The method of  claim 25  wherein the bar is configured as a wire. 
     
     
         28 . The method of  claim 25  wherein the plurality of apertures are configured as elongated gaps spaced around the circumference of the generally tubular frame. 
     
     
         29 . The method of claim wherein each bar is secured to the generally tubular frame with sutures. 
     
     
         30 . The method of  claim 25  further comprising cutting the length of the cellulose body. 
     
     
         31 . The method of  claim 25  further comprising coupling struts to the generally tubular frame to reinforce the plurality of apertures.