Implantable or insertable medical devices for controlled drug delivery
First Claim
1. An implantable or insertable medical device comprising:
- a single-layer matrix polymer structure formed from a mixture comprising an extruded polymeric matrix region comprising (a) a biocompatible polymer, (b) a radio-opacifying agent, and (c) at least one therapeutic agent, wherein said medical device is adapted for implantation or insertion at a site that is associated with pain or discomfort upon implantation or insertion,wherein said radio-opacifying agent is bismuth subcarbonate,wherein said therapeutic agent is ketorolac and pharmaceutically acceptable salts thereof, andwherein said biocompatible polymer is an ethylene-vinyl acetate (EVA) copolymer.
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Accused Products
Abstract
Implantable or insertable medical devices are provided, which comprises: (a) a biocompatible polymer; and (b) at least one therapeutic agent selected from an anti-inflammatory agent, an analgesic agent, an anesthetic agent, and an antispasmodic agent. The medical devices are adapted for implantation or insertion at a site associated with pain or discomfort upon implantation or insertion. In many embodiments, the therapeutic will be selected from at least one of (i) ketorolac and pharmaceutically acceptable salts thereof (e.g., ketorolac tromethamine) and (ii) 4-diethylamino-2-butynylphenylcyclohexyl glycolate and pharmaceutically acceptable salts thereof (e.g., oxybutynin chloride). Also provided are uses for the implantable or insertable medical devices, which uses comprise reducing pain or discomfort accompanying the implantation or insertion of such devices. Further uses may comprise reducing microbial buildup along the device. Methods for manufacturing implantable or insertable medical devices are also provided.
155 Citations
23 Claims
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1. An implantable or insertable medical device comprising:
- a single-layer matrix polymer structure formed from a mixture comprising an extruded polymeric matrix region comprising (a) a biocompatible polymer, (b) a radio-opacifying agent, and (c) at least one therapeutic agent, wherein said medical device is adapted for implantation or insertion at a site that is associated with pain or discomfort upon implantation or insertion,
wherein said radio-opacifying agent is bismuth subcarbonate, wherein said therapeutic agent is ketorolac and pharmaceutically acceptable salts thereof, and wherein said biocompatible polymer is an ethylene-vinyl acetate (EVA) copolymer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 19, 21, 22, 23)
- a single-layer matrix polymer structure formed from a mixture comprising an extruded polymeric matrix region comprising (a) a biocompatible polymer, (b) a radio-opacifying agent, and (c) at least one therapeutic agent, wherein said medical device is adapted for implantation or insertion at a site that is associated with pain or discomfort upon implantation or insertion,
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11. A method of manufacturing an implantable or insertable medical device that comprises a polymeric matrix region comprising:
- (a) a biocompatible polymer, (b) at least one therapeutic agent selected from ketorolac and pharmaceutically acceptable salts thereof and (c) a radio-opacifying agent, wherein said medical device is adapted for implantation or insertion at a site that is associated with pain or discomfort upon implantation or insertion, said method comprising;
providing a combination comprising said biocompatible polymer, said therapeutic agent and said radio-opacifying agent; extruding said combination; and forming said polymeric matrix from said combination into a single-layer matrix polymer structure, wherein said radio-opacifying agent is bismuth subcarbonate, and wherein said biocompatible polymer is an ethylene-vinyl acetate (EVA) copolymer. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 20)
- (a) a biocompatible polymer, (b) at least one therapeutic agent selected from ketorolac and pharmaceutically acceptable salts thereof and (c) a radio-opacifying agent, wherein said medical device is adapted for implantation or insertion at a site that is associated with pain or discomfort upon implantation or insertion, said method comprising;
Specification