Articles and methods of treating vascular conditions

Abstract

The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

1 . A method of treating a vascular condition comprising:
 providing a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to treat said vascular condition in said vascular tissue upon release of said bioactive agent from said gel material;   administering said gel material to a vascular treatment site within an interior space of a blood vessel;   allowing said gel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said gel material.   
     
     
         2 . The method of  claim 1  wherein said gel material does not occlude vascular structures upon introduction into flowing blood. 
     
     
         3 . The method of  claim 2  further comprising removing said gel material from within said blood vessel. 
     
     
         4 . The method of  claim 1  wherein said bioactive agent has anti-inflammatory properties. 
     
     
         5 . The method of  claim 1  wherein said bioactive agent has anti-proliferative properties. 
     
     
         6 . The method of  claim 1  wherein said bioactive agent is dexamethasone. 
     
     
         7 . The method of  claim 1  wherein said bioactive agent is selected from the group consisting of dexamethasone, estradiol, carvedilol, and cilostazol. 
     
     
         8 . The method of  claim 1  wherein said vascular disease is intimal hyperplasia. 
     
     
         9 . The method of  claim 1  wherein administrating said gel material includes injection through a needle-containing syringe. 
     
     
         10 . The method of  claim 1  wherein administrating said gel material includes injection through a catheter. 
     
     
         11 . The method of  claim 1  wherein administrating said gel material includes injection through a balloon. 
     
     
         12 . A method of treating a vascular condition comprising:
 providing a thixotropic, turbid gel material containing at least one bioactive agent capable of treating intimal hyperplasia in sufficient amounts to inhibit intimal hyperplasia upon release of said bioactive agent from said gel material;   administering said gel material to a vascular treatment site within an interior space of a blood vessel; and   allowing said gel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said gel material.   
     
     
         13 . The method of  claim 12  wherein said gel material does not occlude vascular structures upon introduction into flowing blood. 
     
     
         14 . The method of  claim 13  further comprising removing said material from within said blood vessel. 
     
     
         15 . The method of  claim 12  wherein said agent has anti-proliferative properties. 
     
     
         16 . The method of  claim 12  wherein said agent has anti-inflammatory properties. 
     
     
         17 . The method of  claim 12  wherein said agent is dexamethasone. 
     
     
         18 . The method of  claim 12  wherein said agent is selected from the group consisting of dexamethasone, estradiol, carvedilol, and cilostazol. 
     
     
         19 . The method of  claim 12  wherein administrating said gel material includes injection through a needle-containing syringe. 
     
     
         20 . The method of  claim 12  wherein administrating said gel material includes injection through a catheter. 
     
     
         21 . The method of  claim 12  wherein administrating said gel material includes injection through a balloon. 
     
     
         22 . A method of treating a vascular condition comprising:
 applying a thixotropic, turbid, gel material containing at least one bioactive agent to at least one surface of an implantable medical device.   
     
     
         23 . The method of  claim 22  further comprising implanting said implantable medical device in an implant recipient. 
     
     
         24 . A method of treating a vascular condition comprising:
 identifying a vascular structure in need of treatment or repair;   surgically isolating said vascular structure;   applying means for stopping any blood flow in said vascular structure;   providing a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to inhibit vascular disease in said vascular tissue upon release of said bioactive agent from said gel material;   administering said gel material to a vascular treatment site within an interior space of the vascular structure;   allowing said gel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said gel material;   removing said means for stopping blood flow;   allowing said gel material to be removed within said vascular structure by flowing blood in the vascular structure; and   closing said vascular structure.   
     
     
         25 . The method of  claim 24  wherein said gel material does not occlude vascular structures upon introduction into flowing blood. 
     
     
         26 . The method of  claim 24  wherein said bioactive agent has anti-inflammatory properties. 
     
     
         27 . The method of  claim 24  wherein said bioactive agent has anti-proliferative properties. 
     
     
         28 . The method of  claim 24  wherein said bioactive agent is dexamethasone. 
     
     
         29 . The method of  claim 24  wherein said bioactive agent is selected from the group consisting of dexamethasone, estradiol, carvedilol, and cilostazol. 
     
     
         30 . The method of  claim 24  wherein administrating said gel material includes injection through a needle-containing syringe. 
     
     
         31 . The method of  claim 24  wherein administrating said gel material includes injection through a catheter. 
     
     
         32 . The method of  claim 24  wherein administrating said gel material includes injection through a balloon. 
     
     
         33 . A method of treating a vascular condition comprising:
 providing a cyclodextrin polymer-based composition comprising cyclodextrin, a polymer, and a pharmacologically effective amount of at least one drug; wherein the polymer comprises ethylene glycol units that can form a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic and injectable into the body of a person through a needle, and wherein the hydrogel forms a matrix for the drug such that when the composition is injected into the body of the person, the drug is released from the hydrogel in a sustained manner,   administering said hydrogel material to a vascular treatment site within an interior space of a blood vessel; and   allowing said hydrogel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said hydrogel material.   
     
     
         34 . An implantable medical device comprising at least one thixotropic, turbid, gel material applied to at least a portion of said medical device. 
     
     
         35 . The implantable medical device of  claim 34  further comprising at least one bioactive agent combined with said gel material. 
     
     
         36 . The implantable medical device of  claim 34  wherein said medical device is a nitinol wire reinforced expanded polytetrafluoroethylene-based vascular prosthesis. 
     
     
         37 . The implantable medical device of  claim 34  wherein said medical device is an endovascular angioplasty balloon. 
     
     
         38 . An implantable medical device comprising a cyclodextrin polymer-based composition comprising cyclodextrin, a polymer, and a pharmacologically effective amount of at least one drug, wherein the polymer comprises ethylene glycol units that can form a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic, and wherein said hydrogel is attached to at least a portion of a medical device. 
     
     
         39 . The implantable medical device of  claim 38 , further comprising at least one bioactive agent in said hydrogel capable of treating vascular tissue in sufficient amounts to treat a vascular condition upon release of said bioactive agent from said hydrogel. 
     
     
         40 . An implantable medical device comprising a surface having at least one thixotropic, turbid, gel material impregnated therein. 
     
     
         41 . The implantable medical device of  claim 40  further comprising at least one bioactive agent combined with said gel material. 
     
     
         42 . An implantable medical device comprising a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to treat said vascular condition in said vascular tissue upon release of said bioactive agent from said gel material on at least a portion of said medical device. 
     
     
         43 . An implantable medical device comprising a cyclodextrin polymer-based injectable composition applied to at least a portion of said implantable medical device, said composition comprising cyclodextrin, a polymer, and a pharmacologically effective amount of at least one drug, wherein the polymer comprises ethylene glycol units that can form a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic and injectable into the body of a person through a needle, and wherein the hydrogel forms a matrix for the drug such that, when the composition is injected into the body of the person, the drug is released from the hydrogel in a sustained manner. 
     
     
         44 . A drug delivery vehicle comprising a substrate material and a turbid thixotropic gel material for drug delivery applied thereto. 
     
     
         45 . The drug delivery vehicle of  claim 44  further comprising at least one bioactive agent combined with said gel material. 
     
     
         46 . A drug delivery vehicle comprising a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to treat said vascular condition in said vascular tissue upon release of said bioactive agent from said gel material. 
     
     
         47 . A drug delivery vehicle comprising a cyclodextrin polymer-based composition applied to at least a portion of said implantable medical device, said composition comprising cyclodextrin, a polymer, and a pharmacologically effective amount of at least one drug, wherein the polymer comprises ethylene glycol units that can form a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic, and wherein the hydrogel forms a matrix for the drug such that, when the composition is placed into the body of the person, the drug is released from the hydrogel in a sustained manner. 
     
     
         48 . A combination comprising a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to treat said vascular condition in said vascular tissue upon release of said bioactive agent from said gel material; and
 means for administering the gel material into a vascular structure.   
     
     
         49 . A combination comprising a thixotropic, turbid gel material containing at least one bioactive agent capable of treating intimal hyperplasia in sufficient amounts to inhibit intimal hyperplasia upon release of said bioactive agent from said gel material; and
 means for administering the gel material into a vascular structure.