Implantable or insertable medical device resistant to microbial growth and biofilm formation
First Claim
1. An implantable or insertable medical device comprising:
- (a) bioactive agents comprising (i) an antimicrobial agent and (ii) a microbial attachment/biofilm synthesis inhibitor selected from NSAIDs, chelating agents, and mixtures thereof, (b) at least one biocompatible matrix polymer region that comprises (i) one or more polymers and (ii) one or more of said bioactive agents dispersed throughout, wherein said bioactive agents are present in said device in an amount effective to inhibit microbial growth on the device for a period of at least 30 days after implantation or insertion of said device into a subject, and wherein said medical device comprises at least one biocompatible matrix polymer region that is not a coating.
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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.
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Citations
57 Claims
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1. An implantable or insertable medical device comprising:
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(a) bioactive agents comprising (i) an antimicrobial agent and (ii) a microbial attachment/biofilm synthesis inhibitor selected from NSAIDs, chelating agents, and mixtures thereof, (b) at least one biocompatible matrix polymer region that comprises (i) one or more polymers and (ii) one or more of said bioactive agents dispersed throughout, wherein said bioactive agents are present in said device in an amount effective to inhibit microbial growth on the device for a period of at least 30 days after implantation or insertion of said device into a subject, and wherein said medical device comprises at least one biocompatible matrix polymer region that is not a coating. - 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, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 54, 55, 56, 57)
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49. An implantable or insertable medical device comprising:
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(a) bioactive agents comprising (i) an antimicrobial agent selected from the group consisting of triclosan, chlorhexidine and mixtures thereof and (ii) a microbial attachment/biofilm synthesis inhibitor selected from the group consisting of salicylic acid and salts and derivatives thereof; and
(b) at least one biocompatible matrix polymer region comprising (i) one or more polymeric materials selected from the group consisting of ethylene vinyl acetate copolymers, copolymers of ethylene with acrylic acid or methacrylic acid, metallocene catalyzed polyethylenes and polyethylene copolymers, ionomers, vinyl aromatic copolymers, elastomeric polyurethanes and polyurethane copolymers, silicones and mixtures thereof; and
(ii) one or more of said bioactive agents dispersed throughout,wherein said bioactive agents are present in said device in an amount effective to inhibit microbial growth on the device for a period of at least 30 days after implantation or insertion of said device into a subject, wherein said medical device comprises at least one biocompatible matrix polymer region that is not a coating, and wherein the medical device is selected from the group consisting of a stent cover, a biliary stent, a ureteral stent, a pancreatic stent, a urinary catheter, a venous access device, a peritoneal access device, a device connecting or providing drainage between two sterile body environments, and a device connecting or providing drainage between a non-sterile and a sterile body environment. - View Dependent Claims (50, 51, 52, 53)
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Specification