Seeding Implantable Medical Devices with Cells

Abstract

The invention is directed to apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device, and the device is subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient.

1 . A method for seeding cells comprising:
 introducing cells into a lumen of an implantable medical device adapted to be implanted in a living body, wherein the lumen comprises a luminal surface comprising expanded polytetrafluoroethylene and wherein the lumen defines a longitudinal axis; and   applying centrifugation to the implantable medical device to rotate the implantable medical device around the axis.   
     
     
         2 . The method of  claim 1 , further comprising placing the implantable medical device in a protective sleeve prior to introducing the cells. 
     
     
         3 . The method of  claim 1 , further comprising delivering the implantable medical device for implantation in the living body after centrifugation. 
     
     
         4 . The method of  claim 3 , further comprising incubating the implantable medical device after centrifugation and before delivering the implantable medical device for implantation in the living body. 
     
     
         5 . The method of  claim 4 , wherein the incubating occurs for about five minutes to about two hours. 
     
     
         6 . The method of  claim 1 , further comprising:
 wetting the luminal surface with a wetting agent;   placing a growth medium on the luminal surface, the growth medium supplanting the wetting agent; and   introducing the cells after the growth medium is placed on the luminal surface.   
     
     
         7 . The method of  claim 1 , wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 250 g to about 500 g to the luminal surface for about one to about ten minutes. 
     
     
         8 . The method of  claim 1 , wherein applying centrifugation to the implantable medical device comprises applying between about 1 g and about 10,000 g. 
     
     
         9 . The method of  claim 1 , wherein the cells are endothelial cells. 
     
     
         10 . The method of  claim 1 , further comprising:
 placing the implantable medical device in a tube prior to introducing the cells, the tube comprising at least one open end;   introducing the cells into the lumen through the open end of the tube; and   sealing the open end of the tube with a plug.   
     
     
         11 . The method of  claim 10 , further comprising loading the sealed tube into a centrifuge. 
     
     
         12 . The method of  claim 1 , wherein the implantable medical device comprises a vascular prosthesis. 
     
     
         13 . The method of  claim 1 , wherein the implantable medical device comprises a mechanical heart valve, a bioprosthetic heart valve, a coronary stent, a stent graft or an AAA graft. 
     
     
         14 . The method of  claim 1 , wherein the surface comprising expanded polytetrafluoroethylene comprises nodes formed of polytetrafluoroethylene, and wherein the surface includes recesses defined by nodes lifted from the surface. 
     
     
         15 . A method for seeding cells comprising:
 introducing cells into a lumen of an implantable medical device adapted to be implanted in a living body, wherein the lumen includes a luminal surface having recesses defined by nodes lifted from the surface, and wherein the lumen defines a longitudinal axis; and   applying centrifugation to the implantable medical device to rotate the implantable medical device around the axis.   
     
     
         16 . The method of  claim 15 , wherein the luminal surface comprises expanded polytetrafluoroethylene. 
     
     
         17 . The method of  claim 16 , wherein the surface comprising expanded polytetrafluoroethylene comprises nodes formed of polytetrafluoroethylene, and wherein the surface includes recesses defined by nodes lifted from the surface. 
     
     
         18 . The method of  claim 15 , further comprising placing the implantable medical device in a protective sleeve prior to introducing the cells. 
     
     
         19 . The method of  claim 15 , wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 250 g to about 500 g to the luminal surface for about one to about ten minutes. 
     
     
         20 . The method of  claim 15 , wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 1 g to about 10,000 g. 
     
     
         21 . The method of  claim 15 , further comprising:
 incubating the implantable medical device after centrifugation; and delivering the implantable medical device for implantation in the living body.   
     
     
         22 . The method of  claim 15 , wherein the implantable medical device comprises a vascular prosthesis. 
     
     
         23 . The method of  claim 15 , wherein the implantable medical device comprises a mechanical heart valve, a bioprosthetic heart valve, a coronary stent, a stent graft or an AAA graft.