Antithrombotic coating for drug eluting medical devices

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

1 . An intraluminal medical device comprising: 
 a scaffold structure having a luminal surface and an abluminal surface;    a first layer affixed to the luminal and abluminal surfaces, the first layer including at least one first therapeutic agent; and    a second layer affixed to the first layer, the second layer including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.    
     
     
         2 . The intraluminal medical device according to  claim 1 , wherein the scaffold structure comprises a stent.  
     
     
         3 . The intraluminal medical device according to  claim 2 , wherein the stent is balloon expandable.  
     
     
         4 . The intraluminal medical device according to  claim 2 , wherein the stent is self-expanding.  
     
     
         5 . The intraluminal medical device according to  claim 1 , wherein the first layer further includes a water insoluble polymeric coating.  
     
     
         6 . The intraluminal medical device according to  claim 5 , wherein the water insoluble polymeric coating comprises poly(ethylene-co-vinylacetate) and poly(n-butylmethacrylate).  
     
     
         7 . The intraluminal medical device according to  claim 6 , wherein the at least one first therapeutic agent comprises a rapamycin.  
     
     
         8 . The intraluminal medical device according to  claim 1 , wherein the at least one second therapeutic agent comprises an antithrombogenic agent.  
     
     
         9 . The intraluminal medical device according to  claim 8 , wherein the antithrombogenic agent comprises heparin.  
     
     
         10 . The intraluminal medical device according to  claim 9 , wherein the water soluble polymeric material comprises polyvinylpyrrolidone.  
     
     
         11 . The intraluminal medical device according to  claim 10 , wherein the water insoluble polymeric material comprises poly(n-butylmethacrylate).  
     
     
         12 . An intraluminal medical device comprising: 
 a scaffold structure having a luminal surface and an abluminal surface;    a first layer affixed to the luminal and abluminal surfaces, the first layer including at least one first therapeutic agent;    a diffusion layer affixed to the first layer; and    a second layer affixed to the diffusion layer, the second layer including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.    
     
     
         13 . The intraluminal medical device according to  claim 12 , wherein the first layer further includes a water insoluble polymeric coating.  
     
     
         14 . The intraluminal medical device according to  claim 13 , wherein the water insoluble polymeric coating comprises poly(ethylene-co-vinylacetate) and poly(n-butylmethacrylate).  
     
     
         15 . The intraluminal medical device according to  claim 14 , wherein the at least one first therapeutic agent comprises a rapamycin.  
     
     
         16 . The intraluminal medical device according to  claim 12 , wherein the diffusion layer comprises poly(n-butylmethacrylate).  
     
     
         17 . The intraluminal medical device according to  claim 12 , wherein the at least one second therapeutic agent comprises an antithrombogenic agent.  
     
     
         18 . The intraluminal medical device according to  claim 17 , wherein the antithrombogenic agent comprises heparin.  
     
     
         19 . The intraluminal medical device according to  claim 18 , wherein the water soluble polymeric material comprises polyvinylpyrrolidone.  
     
     
         20 . The intraluminal medical device according to  claim 19 , wherein the water insoluble polymeric material comprises poly(n-butylmethacrylate).  
     
     
         21 . A medical device comprising: 
 an implantable structure having luminal and abluminal surfaces;    a first layer affixed to the luminal and abluminal surfaces, the first layer having a thickness in the range from about five to about ten microns and including at least one first therapeutic agent; and    a second layer affixed to the first layer, the second layer having a thickness of about one micron and including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.    
     
     
         22 . A medical device comprising: 
 an implantable structure having luminal and abluminal surfaces;    a first layer affixed to the luminal and abluminal surfaces, the first layer having a thickness in the range from about five to about ten microns and including at least one first therapeutic agent; and;    a diffusion layer affixed to the first layer, the diffusion layer having a thickness of about one micron; and    a second layer affixed to the diffusion layer, the second layer having a thickness of about one micron and including at least one second therapeutic agent in combination with a water soluble polymeric material and a water insoluble polymeric material.