A membrane that reduces the rate at which a therapeutic substance is released from an implantable medical device, such as a stent, is disclosed.
대표청구항▼
What is claimed is: 1. A stent having a therapeutic agent, comprising: (a) a first coating or layer over a surface of a stent; (b) a second coating or layer comprising a polymer and an agent over the first coating or layer; and (c) a third coating or layer comprising a polymer over the second coat
What is claimed is: 1. A stent having a therapeutic agent, comprising: (a) a first coating or layer over a surface of a stent; (b) a second coating or layer comprising a polymer and an agent over the first coating or layer; and (c) a third coating or layer comprising a polymer over the second coating or layer, the polymer having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2 , wherein the third coating or layer reduces the rate of release of the agent. 2. The stent of claim 1, wherein the agent comprises rapamycin. 3. The stent of claim 1, wherein the agent comprises docetaxel or paclitaxel. 4. The stent of claim 1, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 5. The stent of claim 4, wherein the agent comprises rapamycin. 6. The stent of claim 4, wherein the agent comprises docetaxel or paclitaxel. 7. The stent of claim 1, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 8. The stent of claim 7, wherein the agent comprises rapamycin. 9. The stent of claim 7, wherein the agent comprises docetaxel or paclitaxel. 10. The stent of claim 1, wherein the polymer of the third coating or layer has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 11. The stent of claim 10, wherein the agent comprises rapamycin. 12. The stent of claim 10, wherein the agent comprises docetaxel or paclitaxel. 13. A stent having a therapeutic agent, comprising: (a) a first coating or layer comprising a polymer and an agent for a stent; and (b) a second coating or layer comprising a polymer over the first coating or layer, the polymer having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2, wherein the second coating or layer reduces the rate of release of the agent. 14. The stent of claim 13, wherein the agent comprises rapamycin. 15. The stent of claim 13, wherein the agent comprises docetaxel or paclitaxel. 16. The stent of claim 13, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 17. The stent of claim 16, wherein the agent comprises rapamycin. 18. The stent of claim 16, wherein the agent comprises docetaxel or paclitaxel. 19. The stent of claim 13, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 20. The stent of claim 19, wherein the agent comprises rapamycin. 21. The stent of claim 19, wherein the agent comprises docetaxel or paclitaxel. 22. The stent of claim 13, wherein the polymer of the second coating or layer has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 23. The stent of claim 22, wherein the agent comprises rapamycin. 24. The stent of claim 22, wherein the agent comprises docetaxel or paclitaxel. 25. The stent of claim 13, wherein the stent is a balloon expandable or self-expandable metallic stent. 26. The stent of claim 13, additionally comprising a primer beneath the first coating or layer. 27. A stent having a therapeutic agent, comprising: (a) a first coating comprising a polymer and an agent for the stent; and (b) a second coating comprising a polymer over the first coating, the second coating having a solubility parameter not greater than a parameter selected from the group consisting of about 11.5 (cal/cm3)1/2, about 10 (cal/cm3)1/2, and about 8.5 (cal/cm3)1/2. 28. The stent of claim 27, wherein the agent is rapamycin. 29. The stent of claim 27, wherein the agent is docetaxel or paclitaxel. 30. The stent of claim 27, wherein the second coating has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 31. The stent of claim 30, wherein the agent is rapamycin. 32. The stent of claim 30, wherein the agent is docetaxel or paclitaxel. 33. A stent comprising a coating having a first region including rapamycin and a second region above the first region, the second region including a polymer having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2. 34. The stent of claim 33, wherein the polymer has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 35. The stent of claim 33, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 36. The stent of claim 33, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 37. A stent comprising a coating having a first region including docetaxel or paclitaxel and a second region above the first region, the second region including a polymer having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2 . 38. The stent of claim 37, wherein the polymer has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 39. The stent of claim 37, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 40. The stent of claim 37, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 41. A stent comprising a radially expandable metallic body and a coating on the body, the coating having a first region including rapamycin and a second region above the first region, the second region having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2. 42. The stent of claim 41, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 43. The stent of claim 41, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 44. The stent of claim 41, wherein the second region has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 45. A stent comprising a radially expandable metallic body and a coating on the body, the coating having a first region including docetaxel or paclitaxel and a second region above the first region, the second region having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2. 46. The stent of claim 45, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 47. The stent of claim 45, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 48. The stent of claim 45, wherein the second region has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 49. A method of forming a coating for a stent, comprising: (a) forming a first coating or layer including an agent on the stent; (b) forming a second coating or layer including a polymer over the first coating or layer, the polymer of the second coating or layer having a solubility parameter not greater than approximately 11.5 (cal/cm3)1/2, wherein the second coating reduces the rate of release of the agent. 50. The method of claim 49, additionally including forming a primer on the surface of the stent, beneath the first coating or layer. 51. The method of claim 49, wherein the agent comprises rapamycin. 52. The method of claim 49, wherein the agent comprises docetaxel or paclitaxel. 53. The method of claim 49, wherein the solubility parameter is not greater than approximately 10 (cal/cm3)1/2. 54. The method of claim 53, wherein the agent comprises rapamycin. 55. The method of claim 53, wherein the agent comprises docetaxel or paclitaxel. 56. The method of claim 49, wherein the solubility parameter is not greater than approximately 8.5 (cal/cm3)1/2. 57. The method of claim 56, wherein the agent comprises rapamycin. 58. The method of claim 56, wherein the agent comprises docetaxel or paclitaxel. 59. The method of claim 49, wherein the polymer of the second coating has an equilibrium water absorption factor of less than about 5% by weight under physiologic conditions. 60. The method of claim 59, wherein the agent comprises rapamycin. 61. The method of claim 59, wherein the agent comprises docetaxel or paclitaxel. 62. The method of claim 49, wherein the forming the second coating or layer comprises applying a composition including the polymer and a non-polar solvent on the first coating or layer. 63. The method of claim 62, wherein the agent is polar. 64. The method of claim 49, wherein the forming the second coating or layer comprises applying a composition including the polymer and a solvent over the first coating or layer, wherein the agent doesn't dissolve in the solvent. 65. The method of claim 49, wherein the forming the second coating or layer comprises applying a composition including the polymer and a solvent over the first coating or layer, wherein the composition does not cause a leaching out of the agent out from the first coating or layer.
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