Antimicrobial housing and cover for a medical device

• US 9,125,973 B2
• Filed: 04/13/2010
• Issued: 09/08/2015
• Est. Priority Date: 07/20/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Bui, Tuan, Hai, Ton That, Nordhaus, Mark, Sanders, Paul, Jiang, Cong, Lamb, David, Yardimci, Ozlem
• Primary Examiner(s): Basquill, Sean
• Assistant Examiner(s): Rosenthal, Andrew S
• Application Number:
  US12/759,437
• Publication Number:
  US 20100197817A1
• Time in Patent Office: 1,974 Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/442 Colorants, dyes
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: C07D 213/30 Oxygen atoms
• CPC Class Codes: C08J 2207/10 Medical applications, e.g. biocompatible scaffolds
• CPC Class Codes: C08J 2309/06 Copolymers with styrene
• CPC Class Codes: C08J 2345/00 Characterised by the use of homopolymers or copolymers of compounds having no unsaturated aliphatic radicals in side chain, and having one or more carbon-to-carbon double bonds in a carbocyclic or in a heterocyclic ring system; Derivatives of such polymers of cyclic anhydrides or imides C08J2335/00; of cyclic esters of polyfunctional acids C08J2331/00
• CPC Class Codes: C08J 2367/00 Characterised by the use of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08J2377/12; of polyester-imides C08J2379/08; Derivatives of such polymers
• CPC Class Codes: C08J 2369/00 : Characterised by the use of polycarbonates; Derivatives of polycarbonates
• CPC Class Codes: C08J 2375/04 : Polyurethanes
• CPC Class Codes: C08J 2377/00 : Characterised by the use of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08J2379/06; of polyamide-imides or polyamide acids C08J2379/08; Derivatives of such polymers
• CPC Class Codes: C08J 9/36 : After-treatment C08J9/22 takes precedence

Abstract

A method for immobilizing dyes and antimicrobial agents on a polymeric cover or housing for a medical device is disclosed and described. The surface may be that of a catheter, a connector, a drug vial spike, a bag spike, a prosthetic device, an endoscope, a surface of an infusion pump, a key pad, a touch screen or a handle. The surfaces may also be one or more of those associated with a infusion of a medicament or dialysis treatment, such as peritoneal dialysis or hemodialysis, where it is important that the working surface for the dialysis fluid be sterile. These surfaces include connectors for peritoneal dialysis sets or for hemodialysis sets, bag spikes, dialysis catheters, and so forth. A method for determining whether a surface has been sterilized, and a dye useful in so indicating, is also disclosed.

Claims

1. A method of treating a medical device, the method comprising:

providing a plurality of functional groups on a surface or porous surface of a polymeric cover or a polymeric housing for a medical device;

reacting the functional groups with a linking agent to form attachment sites, the linking agent comprising polymers with an aldehyde functional group; and

attaching a solvatochromic dye to the aldehyde functional groups.

2. The method of claim 1, wherein the polymeric cover or housing has an index of refraction from about 1.25 to about 1.6.

3. The method of claim 1, further comprising treating the surface or porous surface to induce amine functional groups.

4. The method of claim 1, wherein the solvatochromatic dye is selected from the group consisting of 4,6-dichloro-2-[2-(6-aminohexyl-4-pyridinio)-vinyl]phenolate and derivatives, Reichardt'"'"'s dye, its salts and derivatives, merocyanine dyes and their derivatives, and tetrazolium compounds and their derivatives.

5. The method of claim 1, further comprising stabilizing the surface or porous surface by converting unreacted carboxyl attachment sites to a salt.

6. The method of claim 1, wherein the surface or porous surface comprises a membrane or a coating for attachment to the medical device.

7. The method of claim 1, wherein the surface or porous surface is selected from the group consisting of nylon, polycarbonate, and polyester and wherein treating the nylon surface with a strong acid results in amino functional groups, treating the polycarbonate surface with chlorosulfonic acid results in sulfonyl chloride functional groups, and treating the polyester surface or polycarbonate surface with an acrylic or methacrylic acid results in carboxyl functional groups.

8. The method of claim 1, wherein the surface or porous surface is treated with a strong acid to provide the plurality of functional groups.