Surgically implanted devices having reduced scar tissue formation

Abstract

An anti-proliferative drug, such as rapamycin or taxol, is placed onto or within a sheet of material or mesh. The strands onto or into which the drug is placed may be either a permanent implant or it may be biodegradable. Surgical sutures or staples may also be coated and used for connecting human tissues (i.e., for example, an anastomosis).

1 . A method of prophylactically treating vasculoproliferative disease, in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamnycin to the vascular structure.  
     
     
         2 . A method of treating established vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.  
     
     
         3 . A method of treating or preventing vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or aterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.  
     
     
         4 . A method according to claims  1 - 3  wherein the sleeve is substantially circumvascular.  
     
     
         5 . A method according to claims  1 - 3  wherein a combination of rapamycin and heparin is administered to the vascular structure.  
     
     
         6 . A method according to  claim 5  wherein the amounts of rapamycin and heparin are sufficient to exhibit a synergistic effect in treating vasculoproliferative disease.  
     
     
         7 . A method according to claims  1 - 3  wherein the amount of rapamycin is about 2 micrograms/cm 2  to about 10.0 mgs/cm 2  and the amount of heparin is about 70 units/cm 2  to about 20,000 units/cm 2  before contacting the sleeve to the vascular structure.  
     
     
         8 . A method according to claims  12  wherein a combination of rapamycin analogue(s) and heparin is administered to the vascular structure.  
     
     
         9 . A method according to claim  18  wherein the amounts of rapamycin analogues and heparin are sufficient to exhibit a synergistic effect in treating vasculoproliferative disease.  
     
     
         10 . A method according to claim  12  wherein the biocompatabile matrix is biodegradable.