Implantable or insertable medical device resistant to microbial growth and biofilm formation
First Claim
1. A method of manufacturing an implantable or insertable medical device comprising:
- providing a combination comprising;
(a) one or more biocompatible matrix polymers comprising an ethylene vinyl acetate copolymer and (b) bioactive agents comprising (i) triclosan as an antimicrobial agent and (ii) a microbial attachment/biofilm synthesis inhibitor selected from NSAIDS, chelating agents, and mixtures thereof;
processing said combination by mixing a polymer melt that comprises said combination under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of any of said biocompatible matrix polymers and that substantially prevent chemical reaction of said bioactive agents; and
shaping said combination into a matrix polymer region of an implantable or insertable medical device.
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Accused Products
Abstract
Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents.
101 Citations
27 Claims
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1. A method of manufacturing an implantable or insertable medical device comprising:
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providing a combination comprising;
(a) one or more biocompatible matrix polymers comprising an ethylene vinyl acetate copolymer and (b) bioactive agents comprising (i) triclosan as an antimicrobial agent and (ii) a microbial attachment/biofilm synthesis inhibitor selected from NSAIDS, chelating agents, and mixtures thereof;processing said combination by mixing a polymer melt that comprises said combination under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of any of said biocompatible matrix polymers and that substantially prevent chemical reaction of said bioactive agents; and shaping said combination into a matrix polymer region of an implantable or insertable medical device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 21, 22, 23, 24, 25, 26, 27)
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11. A method of manufacturing an implantable or insertable medical device comprising:
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providing a combination of (a) one or more biocompatible matrix polymers and (b) bioactive agents comprising (i) an antimicrobial agent and (ii) a microbial attachment/biofilm synthesis inhibitor; mixing said one or more biocompatible matrix polymers with said bioactive agents to a form a homogeneous mixture of said one or more matrix polymers and said bioactive agents under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of any of said biocompatible matrix polymers and that substantially prevent chemical reaction of said bioactive agents; and shaping said homogeneous mixture into an annular matrix polymer region of said implantable or insertable medical device, wherein said shaping comprises co-extruding said annular matrix polymer region, a first polymeric barrier layer at least partially covering an interior surface of said annular matrix polymer region, and a second polymeric barrier layer at least partially covering an exterior surface of said annular matrix polymer region, wherein said annular matrix polymer region comprises an ethylene vinyl acetate copolymer having a vinyl acetate content of from about 19% to about 28% and said first and second polymeric barrier layers comprise a metallocene catalyzed polyethylene or polyethylene copolymer, or an ionomer. - View Dependent Claims (12)
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13. A method of manufacturing an implantable or insertable medical device comprising:
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mixing a combination comprising (a) one or more biocompatible matrix polymers comprising an ethylene-vinyl acetate copolymer (b) additives comprising (i) an antimicrobial agent and (ii) salicylic acid by a process that comprises applying mechanical shear to said combination, and (c) bismuth subcarbonate as a radio-opacifying agent ; and processing said combination under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of any of said biocompatible matrix polymers and that substantially prevent chemical reaction of said bioactive agents; and shaping said mixture into a matrix polymer region of an implantable or insertable medical device. - View Dependent Claims (14, 15, 16, 17, 18, 19)
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Specification