Apparatus and Methods for Preventing or Treating Failure of Hemodialysis Vascular Access and Other Vascular Grafts

Abstract

This invention is a prosthetic device generally placed on the outside surface of the vessel or graft which then elutes antiproliferative drugs or agents from a drug-eluting matrix material. Methods of perivascular antiproliferative drug administration also are disclosed.

1 . A method of preventing or treating vasculoproliferative disease in vascular structures, which comprises the step of:
 administering extravascularly and locally an antiproliferative effective amount of an antiproliferative agent to the vascular structure.   
     
     
         2 . A method according to  claim 1  wherein the agent comprises rapamycin. 
     
     
         3 . A method according to  claim 1  wherein the antiproliferative agent is administered perivascularly. 
     
     
         4 . A method according to  claim 1  wherein extravascular, local administration is accomplished by means of an implantable, antiproliferative agent eluting, perivascular vascular sleeve, the sleeve comprising a matrix material imbibed with the agent. 
     
     
         5 . A method according to  claim 4  wherein the sleeve is substantially circumvascular. 
     
     
         6 . A method according to  claim 4  wherein the matrix material comprises fibrin. 
     
     
         7 . A method according to  claim 4  wherein the agent comprises rapamycin and heparin 
     
     
         8 . A method according to  claim 4  wherein the matrix material comprises collagen. 
     
     
         9 . A method according to  claim 4  wherein the matrix material comprises chitosan. 
     
     
         10 . An implantable, antiproliferative agent-administering perivascular sleeve adapted to be placed in contact with the exterior of a vascular structure comprising:
 a) A flexible, bioabsorbing, agent-eluting matrix material, the material having a vascular-sized lumen passing substantially through said matrix material, the matrix material having dispersed therein:   b) an antiproliferative agent.