US2008286332A1PendingUtilityA1

Implantable medical devices with a topcoat layer of phosphoryl choline acrylate polymer for reduced thrombosis, and improved mechanical properties

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Assignee: PACETTI STEPHEN DPriority: May 14, 2007Filed: May 14, 2007Published: Nov 20, 2008
Est. expiryMay 14, 2027(~0.8 yrs left)· nominal 20-yr term from priority
Inventors:Stephen D. Pacetti
A61P 9/10A61L 27/34A61L 2300/416A61L 2300/606A61L 31/16A61L 2420/08A61L 31/10A61L 2300/41A61L 27/54A61L 2300/42A61P 9/00
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Claims

Abstract

The present invention relates to implantable medical devices coated with phosphoryl choline acrylate polymer topcoat layer, an acrylate copolymer layer containing a therapeutic agent, and their use in the treatment of vascular diseases.

Claims

exact text as granted — not AI-modified
1 . An implantable medical device, comprising:
 a device body;   an optional primer layer disposed over the device body;   a drug reservoir layer disposed over the device body or the primer layer, if opted, wherein the drug reservoir layer comprises one or more therapeutic agents; and   a topcoat layer disposed as an outermost layer over the drug reservoir layer, wherein the topcoat layer comprises a phosphoryl choline acrylate polymer.   
   
   
       2 . The implantable medical device of  claim 1 , wherein the device is a stent. 
   
   
       3 . The implantable medical device of  claim 1 , wherein the phosphoryl choline acrylate polymer comprises poly(2-(methacryloyloxyethyl)-2-(trimethylammoniumethyl)-phosphate, inner salt)-co-(n-dodecylmethacrylate)-co-(hydroxypropylmethacrylate)-co-(3-trimethoxysilyl)propylmethacrylate). 
   
   
       4 . The implantable medical device of  claim 1 , wherein the (trimethylammoniumethyl)-phosphate, inner salt)/(n-dodecylmethacrylate)/(hydroxypropylmethacrylate)/(3-trimethoxysilyl)propylmethacrylate) constitutional unit wt/wt ratio is from about 28.8:50.7:15.3:5.3. 
   
   
       5 . The implantable medical device of  claim 1 , wherein the phosphoryl choline acrylate polymer is substantially amorphous. 
   
   
       6 . The implantable medical device of  claim 1 , wherein the drug reservoir layer comprises acrylate or methacrylate polymer. 
   
   
       7 . The implantable medical device of  claim 6 , wherein the acrylate or methacrylate polymer has an average molecular weight of about 20,000 to about 600,000 Daltons. 
   
   
       8 . The implantable medical device of  claim 6 , wherein the acrylate or methacrylate polymer comprises poly(butyl methacrylate). 
   
   
       9 . The implantable medical device of  claim 6 , wherein the drug reservoir layer comprises poly(acrylate) or poly(methacrylate) having the formula: 
     
       
         
         
             
             
         
       
       wherein: 
       m=0.005 to 0.90 
       n=0.10 to 0.995 
       m+n=1 
       x=65 to 6960 
       R 1  and R 2  are independently selected from the group consisting of hydrogen and methyl; and, 
       Hydrocarbon Group is selected from the group consisting of an unsaturated or saturated, branched or straight chain C 1  to C 16  aliphatic, a cycloaliphatic or an aromatic moiety. 
     
   
   
       10 . The implantable medical device of  claim 9 , wherein the Polar Group is selected from the group consisting of an alkyl ether and an amide. 
   
   
       11 . The implantable medical device of  claim 10 , wherein the alkyl ether is selected from the group consisting of: 
     
       
         
         
             
             
         
       
     
   
   
       12 . The implantable medical device of  claim 10 , wherein the amide is selected from the group consisting of: 
     
       
         
         
             
             
         
       
     
   
   
       13 . A method of treating a vascular disease, comprising:
 deploying in the vasculature of a patient in need thereof an implantable medical device, wherein the device comprises:   a device body;   an optional primer layer disposed over the device body;   a drug reservoir layer disposed over the device body or the primer layer, if opted, wherein the drug reservoir layer comprises one or more therapeutic agents; and   a topcoat layer disposed as an outermost layer over the drug reservoir layer, wherein the topcoat layer comprises a phosphoryl choline acrylate polymer.   
   
   
       14 . The method of  claim 13 , wherein the device is a stent. 
   
   
       15 . The method of  claim 13 , wherein the phosphoryl choline acrylate polymer comprises poly(2-(methacryloyloxyethyl)-2-(trimethylammoniumethyl)-phosphate, inner salt)-co-(n-dodecylmethacrylate)-co-(hydroxypropylmethacrylate)-co-(3-trimethoxysilyl)propylmethacrylate). 
   
   
       16 . The method of  claim 13 , wherein the (trimethylammoniumethyl)-phosphate, inner salt)/(n-dodecylmethacrylate)/(hydroxypropylmethacrylate)/(3-trimethoxysilyl)-propylmethacrylate) constitutional unit wt/wt ratio is from about 28.8:50.7:15.3:5.3. 
   
   
       17 . The method of  claim 13 , wherein the phosphoryl choline acrylate polymer is substantially amorphous. 
   
   
       18 . The method of  claim 13 , wherein the drug reservoir layer comprises acrylate or methacrylate polymer. 
   
   
       19 . The method of  claim 18 , wherein the acrylate or methacrylate polymer has an average molecular weight of about 20,000 to about 600,000 Daltons. 
   
   
       20 . The method of  claim 18 , wherein the acrylate or methacrylate polymer comprises poly(butyl methacrylate). 
   
   
       21 . The method of  claim 18 , wherein the drug reservoir layer comprises poly(acrylate) or poly(methacrylate) having the formula: 
     
       
         
         
             
             
         
       
       Wherein: 
       m=0.005 to 0.90 
       n=0.10 to 0.995 
       m+n=1 
       x=65 to 6960 
       R 1  and R 2  are independently selected from the group consisting of hydrogen and methyl; and, 
       Hydrocarbon Group is selected from the group consisting of an unsaturated or saturated, branched or straight chain C 1  to C 16  aliphatic, a cycloaliphatic or an aromatic moiety. 
     
   
   
       22 . The implantable medical device of  claim 21 , wherein the Polar Group is selected from the group consisting of an alkyl ether and an amide. 
   
   
       23 . The implantable medical device of  claim 22 , wherein the alkyl ether is selected from the group consisting of: 
     
       
         
         
             
             
         
       
     
   
   
       24 . The implantable medical device of  claim 22 , wherein the amide is selected from the group consisting of: 
     
       
         
         
             
             
         
       
     
   
   
       25 . The method of  claim 13 , wherein the vascular disease is atherosclerosis. 
   
   
       26 . The method of  claim 13 , wherein the vascular disease is restenosis. 
   
   
       27 . The method of  claim 13 , wherein the vascular disease is vulnerable plaque. 
   
   
       28 . The method of  claim 13 , wherein the vascular disease is peripheral vascular disease. 
   
   
       29 . The method of  claim 13 , wherein the vascular disease is late stent thrombosis.

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