Surgically implanted devices having reduced scar tissue formation

Abstract

This invention is an anti-proliferative drug placed onto or within a sterile sheet or mesh that is designed to be placed between internal body tissues to prevent the formation of post-operative adhesions, which adhesions are really scar tissue formation. This mesh or gauze onto or into which the drug is placed may be either a permanent implant or it may be biodegradable. By impregnating an existing product such as the Johnson & Johnson SURGICEL™ absorbable hemostat gauze-like sheet with an anti-proliferative drug such as Rapamycin or Taxol, the biodegradable, drug impregnated mesh would act as a barrier to cell proliferation and hence be a deterrent to the formation of adhesions. Another embodiment of this invention is an anti-proliferative drug attached to a bandage that is placed onto a cut in the skin to decrease scar tissue formation. Still another embodiment of the invention is an anti-proliferative drug that is attached to a surgical suture or coated onto a surgical staple both of which are used for connecting human tissues. The suture or staple then being more capable for decreasing cellular proliferation where the suture or staple material passes through the human tissue.

We claim:  
     
         1 . A composition, comprising a compound attached to surgical material, said compound selected from the group consisting of sirolimus and analogs of sirolimus.  
     
     
         2 . The composition of  claim 1 , wherein said surgical material comprises a biodegradable sheet of material.  
     
     
         3 . The composition of  claim 1 , wherein said surgical material comprises mesh.  
     
     
         4 . The composition of  claim 1 , wherein said surgical material comprises an implantable device.  
     
     
         5 . The composition of  claim 1 , wherein said analogs of sirolimus comprise: SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin.  
     
     
         6 . A composition, comprising a compound attached to a bandage, said compound selected from the group consisting of sirolimus and analogs of sirolimus.  
     
     
         7 . The composition of  claim 5 , wherein said analogs of sirolimus comprise: SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin.  
     
     
         8 . A composition, comprising a compound attached to a surgical suture, said compound selected from the group consisting of sirolimus and analogs of sirolimus.  
     
     
         9 . The composition of  claim 7 , wherein said analogs of sirolimus comprise: SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin.  
     
     
         10 . A method, comprising: 
 a) providing; 
 i) a subject on whom a surgical procedure is performed;  
 ii) a compound selected from the group consisting of sirolimus and analogs of sirolimus;  
 iii) a surgical material, to which said compound is attached;  
   b) introducing said surgical material into said subject under conditions such that the surgical outcome is improved.    
     
     
         11 . The method of  claim 10 , wherein said surgical material further comprises at least one second compound selected from the group consisting of antiseptic agents, antibiotic agents and analgesic agents.  
     
     
         12 . The method of  claim 10 , wherein said analogs of sirolimus are selected from the group consisting of SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin.  
     
     
         13 . The method of  claim 10 , wherein said surgical material comprises a biodegradable sheet of material.  
     
     
         14 . The method of  claim 10 , wherein said surgical material comprises a mesh.  
     
     
         15 . The method of  claim 10 , wherein said surgical material comprises a suture.  
     
     
         16 . The method of  claim 10 , wherein said surgical material comprises an implantable device.  
     
     
         17 . The method of  claim 10 , wherein said second compound is released systemically.  
     
     
         18 . The method of  claim 10 , wherein said compound is administered at least one day prior to said surgical procedure.  
     
     
         19 . The method of  claim 10 , wherein said compound is administered at least one day following said surgical procedure.  
     
     
         20 . The method of  claim 17 , wherein said second compound is administered by a route selected from the group consisting of oral, transdermal, topical, inhalation and by suppository.  
     
     
         21 . A method, comprising: 
 a) providing; 
 i) a subject on whom a surgical procedure has been performed;  
 ii) a compound selected from the group consisting of sirolimus and analogs of sirolimus;  
 iii) a surgical material, to which said compound is attached;  
   b) introducing said surgical material into said subject under conditions such that scarring is reduced.    
     
     
         22 . The method of  claim 21 , wherein said surgical material further comprises at least one second compound selected from the group consisting of antiseptic agents, antibiotic agents and analgesic agents.  
     
     
         23 . The method of  claim 21 , wherein said analogs of sirolimus are selected from the group consisting of SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin.  
     
     
         24 . The method of  claim 21 , wherein said surgical material comprises a biodegradable sheet of material.  
     
     
         25 . The method of  claim 21 , wherein said surgical material comprises a mesh.  
     
     
         26 . The method of  claim 21 , wherein said surgical material comprises a suture.  
     
     
         27 . The method of  claim 21 , wherein said surgical material comprises an implantable device.  
     
     
         28 . The method of  claim 22 , wherein said second compound is administered systemically.  
     
     
         29 . The method of  claim 21 , wherein,said compound is administered at least one day prior to said surgical procedure.  
     
     
         30 . The method of  claim 21 , wherein said compound is administered at least one day following said surgical procedure.  
     
     
         31 . The method of  claim 28 , wherein said second compound is administered by a route selected from the group consisting of oral, transdermal, topical, inhalation and by suppository.