Implantable or insertable medical device resistant to microbial growth and biofilm formation
First Claim
1. A stent comprising(A) a polymeric tubular shaft having more than one layer, said polymeric tubular shaft comprising a first annular layer comprising an extruded homogenous mixture of a matrix polymer, an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor that form a single distinct matrix polymer region;
- (B) a first polymeric barrier layer at least partially covering an interior surface of said first annular layer; and
(C) a second polymer barrier layer at least partially covering an exterior surface of said first annular layer.
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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/or 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.
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Citations
32 Claims
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1. A stent comprising
(A) a polymeric tubular shaft having more than one layer, said polymeric tubular shaft comprising a first annular layer comprising an extruded homogenous mixture of a matrix polymer, an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor that form a single distinct matrix polymer region; -
(B) a first polymeric barrier layer at least partially covering an interior surface of said first annular layer; and (C) a second polymer barrier layer at least partially covering an exterior surface of said first annular layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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15. A ureteral stent comprising
(A) a polymeric tubular shaft that is between 0.2 mm and 0.8 mm in wall thickness, said polymeric tubular shaft having more than one layer and comprising a first annular layer comprising an extruded homogenous mixture of a matrix polymer and a bioactive agent that form a single distinct matrix polymer region wherein: -
(a) polymeric species of the matrix polymer consists essentially of ethylene vinyl acetate copolymer; and (b) the bioactive agent consists essentially of triclosan; (B) a first polymeric barrier layer at least partially covering an interior surface of said first annular layer; and (C) a second polymer barrier layer at least partially covering an exterior surface of said first annular layer. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22)
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Specification