Implantable or insertable medical devices for controlled delivery of a therapeutic agent
First Claim
1. A therapeutic-agent-releasing medical device comprising:
- (a) an implantable or insortable medical device;
(b) a release layer disposed over at least a portion of the implantable or insertable medical device, said release layer comprising (i) a styrene copolymer selected from an alternating styrene copolymer and a random styrene copolymer and (ii) an additional polymer; and
(c) a therapeutic agent selected from one or more of the group consisting of an anti-thrombotic agent, an anti-proliferative agent, an anti-inflammuatory agent, an anti-migratory agent, an agent affecting extracellular matrix production and organization, an antineoplastic agent, an anti-mitotic agent, an anesthetic agent, an anti-coagulant, a vascular cell growth promoter, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, and an agent that interferes with endogenous vasoactive mechanisms, said release layer regulating the rate of release of the therapeutic agent from the medical device such that said medical device exhibits a sustained release profile upon implantation or insertion of the device into a patient and said release layer being formed by a solvent-based technique in which said styrene copolymer and said additional polymer are dissolved or dispersed in a solvent which is applied to all or a portion of said implantable or insertable medical device, wherein less than 20% of the total release from the medical device occurs over the course of implanation/insertion in the body occurs within the first 1–
3 days of administration.
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Accused Products
Abstract
The present invention is directed to novel implantable or insertable medical devices that provide controlled release of a therapeutic agent. According to an embodiment of the present invention, a therapeutic-agent-releasing medical device is provided, which comprises: (a) an implantable or insertable medical device; (b) a release layer disposed over at least a portion of the implantable or insertable medical device; and (c) a therapeutic agent. The release layer comprises a styrene copolymer and at least one additional polymer. The release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient. The present invention is also directed to methods of forming the above implantable or insertable medical devices, methods of administering a therapeutic agent to a patient using such devices, and methods of modulating the release of therapeutic agent from such devices.
110 Citations
39 Claims
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1. A therapeutic-agent-releasing medical device comprising:
- (a) an implantable or insortable medical device;
(b) a release layer disposed over at least a portion of the implantable or insertable medical device, said release layer comprising (i) a styrene copolymer selected from an alternating styrene copolymer and a random styrene copolymer and (ii) an additional polymer; and
(c) a therapeutic agent selected from one or more of the group consisting of an anti-thrombotic agent, an anti-proliferative agent, an anti-inflammuatory agent, an anti-migratory agent, an agent affecting extracellular matrix production and organization, an antineoplastic agent, an anti-mitotic agent, an anesthetic agent, an anti-coagulant, a vascular cell growth promoter, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, and an agent that interferes with endogenous vasoactive mechanisms, said release layer regulating the rate of release of the therapeutic agent from the medical device such that said medical device exhibits a sustained release profile upon implantation or insertion of the device into a patient and said release layer being formed by a solvent-based technique in which said styrene copolymer and said additional polymer are dissolved or dispersed in a solvent which is applied to all or a portion of said implantable or insertable medical device, wherein less than 20% of the total release from the medical device occurs over the course of implanation/insertion in the body occurs within the first 1–
3 days of administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 37, 38, 39)
- (a) an implantable or insortable medical device;
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32. A method of modulating a rate of release of a therapeutic agent by a release layer that (a) is disposed over at least a portion of an implantable or insertable medical device, and (b) comprises (i) a styrene copolymer selected from an alternating styrene copolymer and a random styrene copolymer and (ii) an additional polymer, said method comprising changing the composition of said release layer by a modification step selected from changing the amount of styrene copolymer relative to the amount of the additional polymer, changing the molecular weight of the styrene copolymer, changing the amount of the styrene monomer relative to the total amount of monomer within the styrene copolymer, and combinations thereof, wherein said release layer and (c) is formed by a solvent-based technique in which said styrene copolymer and said additional polymer are dissolved or dispersed in a solvent which is applied to all or a portion of said implantable or insertable medical device, wherein said therapeutic agent is selected from one or more of the group consisting of an anti-thrombotic agent, an anti-proliferative agent, an anti-inflammatory agent, an anti-migratory agent, an agent affecting extracellular matrix production and organization, an antineoplastic agent, an anti-mitotic agent, an anesthetic agent, an anti-coagulant, a vascular cell growth promoter, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, and an agent that interferes with endogenous vasoactive mechanisms, and wherein said medical device exhibits a sustained released profile after said modification step, and wherein said sustained release profile is a release profile in which less than 25% of the total release from the medical device that occurs over the course of implantation/insertion in the body occurs within the first 1–
- 3 days of administration.
- View Dependent Claims (33, 34, 35, 36)
Specification