Intraluminal device with a coating containing a therapeutic agent

Abstract

The invention relates to an intraluminal device, in particular an intraluminal prosthesis, shunt, catheter or local drug delivery device. In order to increase the bio-compatibility of this device, it is provided with at least one coating. The coating contains a therapeutic agent which is comprised in a matrix that sticks to the intraluminal device. Instead of being formed by a little bio-compatible polymer, the matrix is formed by a bio-compatible oil or fat, such as cod-liver oil or olive oil. Preferably, the bio-compatible oil or fat further comprises alfa-tocopherol.

What is claimed is: 
     
         1 . A medical device coating material, wherein the coating material comprises:
 a vehicle, wherein the vehicle comprises a synthetic oil or fat which has not been subjected to an aggressive polymerization step, and wherein the vehicle comprises one or more omega-3 fatty acids selected from a group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA); and   at least one therapeutic agent.   
     
     
         2 . The coating material of  claim 1 , wherein the coating material is configured to deliver the therapeutic agent to tissue of a patient upon implantation in the patient. 
     
     
         3 . The coating material of  claim 1 , wherein the therapeutic agent is dispersed in the vehicle to form the coating material. 
     
     
         4 . The coating material of  claim 1 , wherein the therapeutic agent is dissolved in the vehicle to form the coating material. 
     
     
         5 . The coating material of  claim 1 , wherein the coating material further comprises alpha-tocopherol. 
     
     
         6 . The coating material of  claim 5 , wherein the alpha-tocopherol is alpha-tocopherol acetate. 
     
     
         7 . The coating material of  claim 5 , wherein the alpha-tocopherol comprises at least 30% by weight to at least 70% by weight of the coating material. 
     
     
         8 . The coating material  claim 1 , wherein the coating material further comprises one or more triglycerides. 
     
     
         9 . The coating material of  claim 1 , wherein the oil or fat is an oil selected from a group consisting of fish oil, olive oil, linseed oil, sunflower oil, corn oil, palm oil and palmnut oil. 
     
     
         10 . The coating material of  claim 1 , wherein the oil or fat comprises fish oil. 
     
     
         11 . The coating material of  claim 10 , wherein the fish oil comprises one or more fatty acid esters selected from a group consisting of methyl esters of fatty acids and ethyl esters of fatty acids. 
     
     
         12 . The coating material of  claim 1 , wherein the therapeutic agent is selected from the group consisting of immunosuppressants, anti-inflammatories, anti-proliferatives, anti-migratory agents, anti-fibrotic agents, proapoptotics, calcium channel blockers, anti-neoplastics, antibodies, anti-thrombotics, anti-platelet agents, IIb/IIIa blockers, antiviral agents, anti-cancer agents, chemotherapeutics, thrombolytics, vasodilators, antibiotics, growth factor antagonists, free radical scavengers, radiopaque agents, anti-angiogenesis agents, angiogenesis drugs, cyclooxygenase inhibitors, phosphodiesterase inhibitors, cytokine inhibitors, nitrogen oxide donors, cytokine activators, anti-oxidants, radioactive compounds, steroids, and non-steroidal anti-inflammatory drugs and derivatives and analogues thereof. 
     
     
         13 . The coating material of  claim 1 , wherein the therapeutic agent comprises at least one gene component selected from a group of gene components consisting of a polynucleotide, an oligonucleotide, a recombinant nucleic acid, gene/vector system, and a nucleic acid. 
     
     
         14 . The coating material of  claim 1 , wherein the coating material further comprises at least one stabilizing agent selected from a group of stabilizing agents comprising a polymeric substance, a binder, and a thickening agent to stabilize the therapeutic mixture. 
     
     
         15 . The coating material of  claim 2 , wherein the melting point of the coating material is at most about 37° C., such that the coating material is in a liquid state after implantation in the patient. 
     
     
         16 . The coating material of  claim 2 , wherein the coating material is configured to provide prolonged release of the therapeutic agent after implantation in the patient. 
     
     
         17 . The coating material of  claim 1 , wherein the oil or fat is biocompatible. 
     
     
         18 . A biocompatible medical device coating material, wherein the coating material comprises:
 a vehicle, wherein the vehicle comprises a synthetic fish oil which has not been subjected to an aggressive polymerization step, and wherein the vehicle comprises one or more omega-3 fatty acids selected from a group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA); and   at least one therapeutic agent.   
     
     
         19 . The coating material of  claim 18 , wherein the coating material is configured to deliver the therapeutic agent to tissue of a patient upon implantation in the patient. 
     
     
         20 . The coating material of  claim 18 , wherein the synthetic fish oil comprises one or more fatty acid esters selected from a group consisting of methyl esters of fatty acids and ethyl esters of fatty acids. 
     
     
         21 . The coating material of  claim 18 , wherein the coating material further comprises alpha-tocopherol. 
     
     
         22 . The coating material of  claim 18 , wherein the therapeutic agent is dispersed in the vehicle to form the coating material.