Loading and release of water-insoluble drugs
AssigneeBoston Scientific Scimed, Inc.
InventorsJames J. Barry, Maria Palasis
Life of this patent
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Abstract
A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.
Claims29
A method of preparing an angioplasty balloon catheter having a balloon with an exterior surface, the method comprising:
- mixing at least one drug with a volatile solvent to create a drug solution, the at least one drug comprising paclitaxel and the volatile solvent comprising at least one volatile organic solvent optionally in mixture with water;
- applying said drug solution to said exterior surface of the balloon and
- evaporating the volatile solvent.
The method of claim 13, wherein the modulating layer comprises a silicone.
A method of preparing an angioplasty balloon catheter having a balloon with an exterior surface, the method comprising:
- mixing at least one drug with a volatile solvent to create a drug solution, the at least one drug selected from the group consisting of paclitaxel dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, thymidine kinase inhibitors, lidocaine, bupivacaine, ropivacaine, and mixtures thereof, and the volatile solvent comprising at least one volatile organic solvent optionally in mixture with water;
- applying said drug solution to said exterior surface of the balloon and
- evaporating the volatile solvent.
A method of delivering paclitaxel, to an inner wall of a blood vessel of a patient from an angioplasty catheter having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising:
- providing a balloon of a balloon catheter having a layer consisting of dried paclitaxel on the outer surface of the balloon;
- and
- employing the catheter for vessel dilatation.
A method of delivering paclitaxel to an inner wall of a blood vessel the method comprising:
- providing a balloon catheter having a balloon with an outer surface and a dried layer containing the paclitaxel on the outer surface of the balloon;
- advancing the balloon within the blood vessel to a treatment site within the blood vessel;
- inflating the balloon at the treatment site to contact the balloon with an inner wall of the blood vessel;
- and
- maintaining the inflated balloon in contact with the inner wall of the blood vessel so as to transfer paclitaxel to the inner wall of the blood vessel.
A method of delivering paclitaxel to an inner wall of a blood vessel of a patient from an implantable medical device having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising the steps of:
- providing an angioplasty balloon having a dried layer of coating material containing paclitaxel on the outer surface of the balloon, wherein the dried layer of coating material is the outermost layer on the balloon, wherein the balloon has folds, and wherein portions of the dried layer are positioned in the folds;
- advancing the balloon within the blood vessel to a treatment site within the blood vessel;
- inflating the balloon at the treatment site so as to cause the folds to open so that portions of the balloon come into contact with the inner wall of the blood vessel during which amounts of the coating material containing paclitaxel are transferred to the inner wall of the blood vessel;
- maintaining the inflated balloon in contact with the inner wall of the blood vessel;
- deflating the balloon after said maintaining;
- and
- removing the deflated balloon from the blood vessel.
A method of delivering paclitaxel to an inner wall of a blood vessel from a balloon catheter having an expandable balloon with a coating on an outer surface of the balloon, the method comprising:
- providing a balloon catheter including a balloon with a dried coating consisting of paclitaxel or a mixture of paclitaxel with another bioactive agent, the dried coating being free of any additional coating atop the dried coating;
- advancing the balloon within the blood vessel to a treatment site;
- inflating the balloon to directly contact the paclitaxel or mixture of paclitaxel with another bioactive agent with an inner wall of the blood vessel;
- and
- delivering the paclitaxel or mixture of paclitaxel with another bioactive agent to the inner wall of the blood vessel while maintaining the paclitaxel or mixture of paclitaxel with another bioactive agent in direct contact with the inner wall of the blood vessel while the balloon is inflated.
A method of delivering paclitaxel to an inner wall of a blood vessel of a patient from an implantable medical device having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising the steps of:
- providing an angioplasty balloon having a dried layer of coating material consisting essentially of paclitaxel on the outer surface of the balloon, wherein the dried layer of coating material is the outermost layer on the balloon, wherein the balloon has folds, and wherein portions of the dried layer are positioned in the folds;
- advancing the balloon within the blood vessel to a treatment site within the blood vessel;
- inflating the balloon at the treatment site so as to cause the folds to open so that portions of the balloon come into contact with the inner wall of the blood vessel during which amounts of the coating material containing paclitaxel are transferred to the inner wall of the blood vessel;
- maintaining the inflated balloon in contact with the inner wall of the blood vessel;
- deflating the balloon after said maintaining;
- and
- removing the deflated balloon from the blood vessel.
Dependencies are inferred from the claim text.