Methods including medical devices having a surface including a biologically active agent therein

Abstract

The present invention provides a medical device, and methods of preparing and using a medical device. The medical device has a surface including a biologically active agent therein. The methods are particularly useful for preparing, for example, coated stents having a biologically active agent within the coating.

1 - 64 . (canceled) 
   
   
       65 . A method for delivering a biologically active agent, the method comprising:
 providing a medical device comprising a partially collapsed polymeric coating on a surface of the device, wherein the polymeric coating comprises a biologically active agent encapsulated therein;   positioning the polymeric coating of the device proximate a tissue to provide an interface between the polymeric coating and the tissue; and   allowing the polymeric coating to deliver the encapsulated biologically active agent to the interface between the polymeric coating and the tissue.   
   
   
       66 . The method of  claim 65  wherein allowing comprises allowing a fluid to at least partially fill the interface between the polymeric coating and the tissue. 
   
   
       67 . The method of  claim 66  wherein the fluid is a body fluid selected from the group consisting of blood, serum, plasma, cerebral fluid, spinal fluid, pericardial fluid, intracellular fluid, extracellular fluid, and combinations thereof. 
   
   
       68 . The method of  claim 65  wherein the biologically active agent is a drug. 
   
   
       69 . The method of  claim 68  wherein the drug is selected from the group consisting of Plasmid DNA, genes, antisense oligonucleotides and other antisense agents, peptides, proteins, protein analogs, siRNA, shRNA, miRNA, ribozymes, DNAzymes and other DNA based agents, viral and non-viral vectors, lyposomes, cells, stem cells, antineoplastic agents, antiproliferative agents, antithrombogenic agents, anticoagulant agents, antiplatelet agents, antibiotics, anti-inflammatory agents, antimitotic agents, immunosuppressants, growth factors, cytokines, hormones, and combinations thereof. 
   
   
       70 . A method for delivering a biologically active agent to the interior of a body lumen, the method comprising:
 providing a radially expandable stent comprising a partially collapsed polymeric coating on a surface of the device, wherein the polymeric coating comprises a biologically active agent encapsulated therein;   introducing the stent transluminally into a selected portion of the body lumen; and   radially expanding at least a portion of the stent into contact with the body lumen.   
   
   
       71 . The method of  claim 70  wherein the biologically active agent is a drug. 
   
   
       72 . The method of  claim 71  wherein the drug is selected from the group consisting of Plasmid DNA, genes, antisense oligonucleotides and other antisense agents, peptides, proteins, protein analogs, siRNA, shRNA, miRNA, ribozymes, DNAzymes and other DNA based agents, viral and non-viral vectors, lyposomes, cells, stem cells, antineoplastic agents, antiproliferative agents, antithrombogenic agents, anticoagulant agents, antiplatelet agents, antibiotics, anti-inflammatory agents, antimitotic agents, immunosuppressants, growth factors, cytokines, hormones, and combinations thereof. 
   
   
       73 . A method of modifying a cellular response of a tissue to a disease, injury, or foreign body, the method comprising:
 providing a medical device comprising a partially collapsed polymeric coating on a surface of the device, wherein the polymeric coating comprises a biologically active agent encapsulated therein;   positioning the polymeric coating of the device proximate a tissue to provide an interface between the polymeric coating and the tissue; and   allowing the polymeric coating to release the encapsulated biologically active agent to the interface between the polymeric coating and the tissue.   
   
   
       74 . The method of  claim 73  wherein allowing comprises allowing a fluid to at least partially fill the interface between the polymeric coating and the tissue. 
   
   
       75 . The method of  claim 74  wherein the fluid is a body fluid selected from the group consisting of blood, serum, plasma, cerebral fluid, spinal fluid, pericardial fluid, intracellular fluid, extracellular fluid, and combinations thereof. 
   
   
       76 . The method of  claim 73  wherein the biologically active agent is a drug. 
   
   
       77 . The method of  claim 76  wherein the drug is selected from the group consisting of Plasmid DNA, genes, antisense oligonucleotides and other antisense agents, peptides, proteins, protein analogs, siRNA, shRNA, miRNA, ribozymes, DNAzymes and other DNA based agents, viral and non-viral vectors, lyposomes, cells, stem cells, antineoplastic agents, antiproliferative agents, antithrombogenic agents, anticoagulant agenth, antiplatelet agents, antibiotics, anti-inflammatory agents, antimitotic agents, immunosuppressants, growth factors, cytokines, hormones, and combinations thereof. 
   
   
       78 . A method of modifying cellular response in a body lumen to a disease, injury, or foreign body, the method comprising:
 providing a radially expandable stent comprising a partially collapsed polymeric coating on a surface of the device, wherein the polymeric coating comprises a biologically active agent encapsulated therein;   introducing the stent transluminally into a selected portion of the body lumen;   radially expanding at least a portion of the stent into contact with the body lumen; and   controllably releasing the biologically active agent into the body lumen.   
   
   
       79 . The method of  claim 78  wherein the biologically active agent is a drug. 
   
   
       80 . The method of  claim 79  wherein the drug is selected from the group consisting of Plasmid DNA, genes, antisense oligonucleotides and other antisense agents, peptides, proteins, protein analogs, siRNA, shRNA, miRNA, ribozymes, DNAzymes and other DNA based agents, viral and non-viral vectors, lyposomes, cells, stem cells, antineoplastic agents, antiproliferative agents, antithrombogenic agents, anticoagulant agents, antiplatelet agents, antibiotics, anti-inflammatory agents, antimitotic agents, immunosuppressants, growth factors, cytokines, hormones, and combinations thereof. 
   
   
       81 . A method for delivering a biologically active agent, the method comprising:
 providing a coated medical device prepared according to a method comprising:
 applying a coating composition comprising a polymer and a water soluble porogen to at least a portion of a surface of a device; 
 removing at least a portion of the water soluble porogen to form a porous polymeric coating on at least a portion of the surface of the device; 
 at least partially loading the porous polymeric coating with a biologically active agent; and 
 heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent to provide the coated medical device; 
   positioning the polymeric coating of the coated device proximate a tissue to provide an interface between the polymeric coating and the tissue; and   allowing the polymeric coating to deliver the encapsulated biologically active agent to the interface between the polymeric coating and the tissue.   
   
   
       82 . A method for delivering a biologically active agent to the interior of a body lumen, the method comprising:
 providing a coated radially expandable stent prepared according to a method comprising:
 applying a coating composition comprising a polymer and a water soluble porogen to at least a portion of a surface of a radially expandable stent; 
 removing at least a portion of the water soluble porogen to form a porous polymeric coating on at least a portion of the surface of the stent; 
 at least partially loading the porous polymeric coating with a biologically active agent; and 
 heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent to provide the coated radially expandable stent; 
   introducing the coated stent transluminally into a selected portion of the body lumen; and   radially expanding at least a portion of the coated stent into contact with the body lumen.   
   
   
       83 . A method of modifying a cellular response of a tissue to a disease, injury, or foreign body, the method comprising:
 providing a coated medical device prepared according to a method comprising:
 applying a coating composition comprising a polymer and a water soluble porogen to at least a portion of a surface of a device; 
 removing at least a portion of the water soluble porogen to form a porous polymeric coating on at least a portion of the surface of the device; 
 at least partially loading the porous polymeric coating with a biologically active agent; and 
 heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent to provide the coated medical device; 
   positioning the polymeric coating of the coated device proximate a tissue to provide an interface between the polymeric coating and the tissue; and   allowing the polymeric coating to release the encapsulated biologically active agent to the interface between the polymeric coating and the tissue.   
   
   
       84 . A method of modifying cellular response in a body lumen to a disease, injury, or foreign body, the method comprising:
 providing a coated radially expandable stent prepared according to a method comprising:
 applying a coating composition comprising a polymer and a water soluble porogen to at least a portion of a surface of a radially expandable stent; 
 removing at least a portion of the water soluble porogen to form a porous polymeric coating on at least a portion of the surface of the stent; 
 at least partially loading the porous polymeric coating with a biologically active agent; and 
 heating at least the porous polymeric coating to at least partially collapse a surface of the porous polymeric coating and encapsulate the biologically active agent to provide the coated radially expandable stent; 
   introducing the coated stent transluminally into a selected portion of the body lumen;   radially expanding at least a portion of the coated stent into contact with the body lumen; and   controllably releasing the biologically active agent into the body lumen.