CA2478787A1 - Implantable or insertable medical device resistant to microbial growth and biofilm formation - Google Patents

Implantable or insertable medical device resistant to microbial growth and biofilm formation Download PDF

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Publication number
CA2478787A1
CA2478787A1 CA002478787A CA2478787A CA2478787A1 CA 2478787 A1 CA2478787 A1 CA 2478787A1 CA 002478787 A CA002478787 A CA 002478787A CA 2478787 A CA2478787 A CA 2478787A CA 2478787 A1 CA2478787 A1 CA 2478787A1
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medical device
matrix polymer
polymer region
copolymers
group
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CA002478787A
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French (fr)
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CA2478787C (en
Inventor
Kathleen M. Miller
Gregory T. Sydney
Kurt Geitz
Peter L. Dayton
Ronald A. Sahatjian
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Boston Scientific Ltd Barbados
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/23—Solid substances, e.g. granules, powders, blocks, tablets
    • A61L2/232—Solid substances, e.g. granules, powders, blocks, tablets layered or coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/202—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with halogen atoms, e.g. triclosan, povidone-iodine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
    • A61L2300/206—Biguanides, e.g. chlorohexidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1372—Randomly noninterengaged or randomly contacting fibers, filaments, particles, or flakes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1379—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1386—Natural or synthetic rubber or rubber-like compound containing
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393—Multilayer [continuous layer]

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 device s 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 an d substantially prevent chemical modification of said bioactive agents.</SDOAB >

Claims (72)

1. An implantable medical device comprising (a) at least one biocompatible matrix polymer region and (b) bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor.
2. The medical device of claim 1, wherein both the antimicrobial agent and microbial attachment/biofilm synthesis inhibitor are present in a single distinct matrix polymer region.
3. The medical device of claim 1, wherein the antimicrobial agent and the microbial attachment/biofilm synthesis inhibitor are present in distinct matrix polymer regions.
4. The medical device of claim 1, wherein said antimicrobial agent is present in an amount effective to inhibit the growth of microbes on and around the device and the microbial attachment/biofilm synthesis inhibitor is present in an amount effective to inhibit the attachment of microbes onto and the synthesis and accumulation of biofilm from attached microbes on the surface of the device.
5. The medical device of claim 1, wherein said device is adapted to remain implanted for a period of greater than about 30 days.
6. The medical device of claim 1, wherein said matrix polymer comprises a biocompatible biodegradable polymer.
7. The medical device of claim 1, wherein said matrix polymer comprises a biocompatible non-biodegradable polymer.
8. The medical device of claim 7, wherein said non-biodegradable polymer is selected from the group consisting of ethylene vinyl acetate copolymers, copolymers of ethylene with acrylic acid or methacrylic acid, elastomeric polyurethanes and polyurethane copolymers, metallocene catalyzed polyethylene, ionomers and vinyl aromatic copolymers.
9. The medical device of claim 6, wherein said biodegradable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, copolymers and mixtures thereof.
10. The medical device of claim 8, wherein said non-biodegradable polymer is an ethylene vinyl acetate copolymer.
11. The medical device of claim 10, wherein said ethylene vinyl acetate copolymer has a vinyl acetate content of from about 19% to about 28%.
12. The medical device of claim 10, wherein said ethylene vinyl acetate copolymer has a vinyl acetate content of from about 3% to about 15%.
13. The medical device of claim 1, wherein said antimicrobial agent is selected from the group consisting of triclosan and chlorhexidine and mixtures thereof.
14. The medical device of claim 13, wherein said antimicrobial agent is triclosan.
15. The medical device of claim 14, wherein said microbial attachment/biofilm synthesis inhibitor is selected from the group consisting of NSAIDs, EDTA and EGTA.
16. The medical device of claim 15, wherein said microbial attachment/biofilm synthesis inhibitor is salicylic acid or a salt or derivative thereof.
17. The medical device of claim 16, wherein said microbial attachment/biofilm synthesis inhibitor is salicylic acid.
18. The medical device of claim 4, wherein the amount of said antimicrobial agent present in said matrix polymer is from about 0.5% to about 25% by weight of the matrix polymer.
19. The medical device of claim 4, wherein the amount of said microbial attachment/biofilm synthesis inhibitor present in said matrix polymer is from about 0.5%
to about 25% by weight of the matrix polymer.
20. The medical device of claim 1, wherein said matrix polymer further comprises a radio-opacifying agent.
21. The medical device of claim 20, wherein said radio-opacifying agent comprises bismuth subcarbonate.
22. The medical device of claim 20 wherein the amount of said radio-opacifying agent present in said matrix polymer is from about 0.5% to about 45% by weight of the matrix polymer.
23. The medical device of claim 1, wherein the matrix polymer further comprises at least one therapeutic agent.
24. The medical device of claim 23, wherein the therapeutic agent is selected from the group consisting of chemotherapeutic agents, NSAIDs, steroidal anti-inflammatory agents, and mixtures thereof.
25. The medical device of claim 23, wherein the therapeutic agent is selected from the group consisting of cisplatin, methotrexate, doxonibicin, paclitaxel, docetaxel, dexamethasone, hydrocortisone and prednisone.
26. The medical device of claim 1, further comprising one or more barrier layers at least partially covering said at least one matrix polymer region.
27. The medical device of claim 26, comprising a first matrix polymer region;
a first polymeric barn'er layer at least partially covering an interior surface of said first matrix polymer region; and a second polymeric barrier layer at least partially covering an exterior surface of said first matrix polymer region.
28. The medical device of claim 27, wherein each of said first matrix polymer region, and said first and second polymeric barrier layers is in the form of an annulus.
29. The medical device of claim 28, wherein the first and second polymeric barrier layers comprise the same polymeric materials.
30. The medical device of claim 28, wherein the first and second polymeric barrier layers comprise different polymeric materials.
31. The medical device of claim 27, further comprising a second and, optionally, a third matrix polymer region and a third and, optionally, a fourth polymeric barrier layer;
wherein the second matrix polymer region is disposed on an outside surface of the second polymeric barrier layer and the third polymeric barrier layer at least partially covers an exterior surface of said second matrix polymer region; and, wherein the third matrix polymer region, when present, is disposed on an interior surface of said first polymeric barrier layer and the fourth polymeric barrier layer at least partially covers an interior surface of said third matrix polymer region.
32. The medical device of claim 27, wherein the first matrix polymer region comprises an ethylene vinyl acetate copolymer.
33. The medical device of claim 32, wherein each of the first and second polymeric barrier layers comprises a material selected from the group consisting of metallocene catalyzed polyethylenes and polyethylene copolymers, ionomers, elastomeric polyurethanes and polyurethane copolymers, ethylene vinyl acetate copolymers and copolymers of ethylene with acrylic acid or methacrylic acid.
34. The medical device of claim 33, wherein the antimicrobial agent is selected from the group consisting of triclosan , chlorhexidine and combinations thereof, and the microbial attachment/biofilm synthesis inhibitor is salicylic acid or a salt thereof.
35. The medical device of claim 1, 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.
36. The medical device of claim 35, wherein the device comprises a device connecting or providing drainage between a non-sterile and a sterile body environment.
37. The medical device of claim 36, wherein the device comprises a hollow tubular stricture.
38. The medical device of claim 35, wherein the device comprises a stent cover.
39. The medical device of claim 38, wherein said biocompatible polymeric matrix comprises polyurethane, said antimicrobial agent comprises triclosan, said microbial attachment/biofilm synthesis inhibitor comprises salicylic acid or a salicylic acid derivative and further comprising a bismuth subcarbonate radio-opacifying agent.
40. The medical device of claim 38, wherein the stent cover comprises a hollow tubular structure adapted to be placed over a stent that comprises a woven, knitted or braided open mesh design comprising a biocompatible material.
41. The medical device of claim 40, wherein the stent cover is placed over a biliary stent.
42. The medical device of claim 40, wherein the biocompatible material is selected from the group consisting of stainless steel or a shape memory material.
43. The medical device of claim 35, wherein the medical device comprises a pancreatic stent that provides drainage from the pancreas to the duodenum.
44. The medical device of claim 43, wherein the pancreatic stent comprises a buffering agent.
45. The medical device of claim 44, wherein said buffering agent, upon exposure to physiological fluids, creates a pancreas-compatible pH level in an environment in which the pancreatic stent is implanted.
46. The medical device of claim 45, wherein said buffering agent is a bicarbonate salt.
47. The medical device of claim 46, wherein said bicarbonate salt is selected from the group consisting of sodium and potassium bicarbonate.
48. A method of manufacturing an implantable or insertable medical device comprising: providing a combination of (a) one or more biocompatible matrix polymers and (b) bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor; 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 modification of said bioactive agents.
49. The method of claim 48, further comprising controlling either or both of the temperature and moisture content during said processing.
50 50. The method of claim 48, wherein said processing comprises mixing said one or more biocompatible matrix polymers with one or more of said bioactive agents to a form a homogeneous mixture of said one or more matrix polymers and said one or more bioactive agents.
51. The method of claim 50, wherein said homogeneous mixture comprises both bioactive agents.
52. The method of claim 50, wherein said mixing comprises applying mechanical shear to said one or more biocompatible matrix polymers and said one or more bioactive agents with a device selected from the group consisting of a single screw extruder, a twin screw extruder, a banbury mixer, a high-speed mixer and a ross kettle.
53. The method of claim 50, where said mixing comprises forming a solvent solution or a liquid dispersion of said one or more bioactive agents and said one or more biocompatible matrix polymers.
54. The method of claim 50, further comprising shaping said homogenous mixture into a matrix polymer region of an implantable or insertable medical device.
55. The method of claim 54, wherein said shaping comprises a process selected from molding, calendaring, casting and solvent coating.
56. The method of claim 54, wherein said shaping comprises extrusion.
57. The method of claim 56, wherein said extrusion comprises forming at least one annular matrix polymer region.
58. The method of claim 57, further comprising forming at least one polymeric barrier layer at least partially covering a surface of said annular matrix polymer region.
59. The method of claim 58, wherein said method comprises a process selected from extrusion coating said polymeric barrier layer onto said annular matrix polymer region and solvent coating said polymeric barrier layer onto said annular matrix polymer region.
60. The method of claim 58, wherein said covering comprises coextruding said polymeric barrier layer and said annular matrix polymer region.
61. The method of claim 58, forming a first polymeric barrier layer at least partially covering an interior surface of said annular matrix polymer region and forming a second polymeric barrier layer at least partially covering an exterior surface of said annular matrix polymer region.
62. The method of claim 61, wherein said covering comprises coextruding said first and second polymer barrier layers with said annular matrix polymer region.
63. The method of claim 50, wherein said processing comprises forming homogeneous first and second mixtures of first and second biocompatible matrix polymers and one or more of said bioactive agents and, optionally, forming a homogenous third mixture of a third biocompatible matrix polymer and one or more of said bioactive agents.
64. The method of claim 63, comprising coextruding said homogenous first and second mixtures to form first and second annular matrix polymer regions and, optionally, coextruding therewith said homogeneous third mixture to form a third annular matrix polymer region.
65. The method of claim 64, further comprising forming at least first and second polymeric barrier layers at least partially covering interior and exterior surfaces of said first annular matrix polymer region; forming a third polymer barrier layer at least partially covering an exterior surface of said second annular matrix polymer region and, optionally, forming a fourth polymeric barrier layer at least partially covering an interior surface of third annular matrix polymer region.
66. The method of claim 65, wherein said covering comprises coextruding said first, second and third polymeric barrier layers with said first and second annular matrix polymer regions and, optionally, coextruding therewith said fourth polymeric barrier layer and said third annular matrix polymer region.
67. The method of claim 62, wherein said first annular matrix polymer region and said first and second barrier layers comprise a material selected from the group consisting of ethylene vinyl acetate copolymers, copolymers of ethylene with acrylic acid or methacrylic acid, elastomeric polyurethanes and polyurethane copolymers, metallocene catalyzed polyethylene and polyethylene copolymers, ionomers, vinyl aromatic copolymers, silicones and mixtures thereof.
68. The method of claim 67, wherein said first 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.
69. The method of claim 68, wherein said first annular matrix polymer region comprises salicylic acid or a salt thereof as said microbial attachment/biofilm synthesis inhibitor, triclosan as said antimicrobial agent and bismuth subcarbonate as a radio-opacifying agent; and, said coextrusion is performed under conditions such that said salicylic acid or salt thereof does not preferentially partition to a surface of said first annular matrix polymer region or to a surface of said first or second polymeric barrier layers.
70. The medical device of claim 26, wherein at least one of said one or more barrier layers comprises a biodegradable polymer.
71. The medical device of claim 70, where said biodegradable polymer is selected from the group consisting of polylactic acid, polyglycolic acid and copolymers and mixtures thereof.
72. An implantable or insertable medical device comprising at least one biocompatible matrix polymer region comprising a material 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; bioactive agents comprising an antimicrobial agent selected from the group consisting of triclosan, chlorhexidine and mixtures thereof;
a microbial attachment/biofilm synthesis inhibitor selected from the group consisting of salicylic acid and salts and derivatives thereof; and, a radio-opacifying agent selected from the group consisting of bismuth subcarbonate, bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten and mixtures thereof.
CA2478787A 2002-02-08 2003-02-07 Implantable or insertable medical device resistant to microbial growth and biofilm formation Expired - Fee Related CA2478787C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/071,840 2002-02-08
US10/071,840 US6887270B2 (en) 2002-02-08 2002-02-08 Implantable or insertable medical device resistant to microbial growth and biofilm formation
PCT/US2003/003624 WO2003066119A1 (en) 2002-02-08 2003-02-07 Implantable or insertable medical device resistant to microbial-growth and biofilm formation

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CA2478787A1 true CA2478787A1 (en) 2003-08-14
CA2478787C CA2478787C (en) 2012-07-10

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US (4) US6887270B2 (en)
EP (1) EP1476205B1 (en)
JP (1) JP4846980B2 (en)
AU (2) AU2003215079A1 (en)
CA (1) CA2478787C (en)
WO (1) WO2003066119A1 (en)

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