Antimicrobial housing and cover for a medical device

• US 9,574,060 B2
• Filed: 07/17/2015
• Issued: 02/21/2017
• 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, Lurvey, Kent L., Krongauz, Vadim V.
• Primary Examiner(s): Thomas, Timothy
• Assistant Examiner(s): Rosenthal, Andrew S
• Application Number:
  US14/802,528
• Publication Number:
  US 20150322229A1
• Time in Patent Office: 585 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
• CPC Class Codes: C08J 2367/00 Characterised by the use of polyesters obtained by reactions forming a carboxylic ester link in the main chain; 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; 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 polymeric housing for a medical device comprising:

a polymer;

a plurality of attachment sites on at least an outer surface of the polymer;

a plurality of functional groups attached to the attachment sites; and

a solvatochromic dye attached to the functional groups, wherein the solvatochromic dye comprises 4,6-dichloro-2-[2-(6-aminohexyl-4-pyridinio)-vinyl]phenolate, and wherein the outer surface is configured to reversibly change from a first appearance to a second appearance when the outer surface is swabbed with a disinfecting solution.

2. The polymeric housing for the medical device according to claim 1, wherein the medical device is selected from the group consisting of a catheter, a drug vial spike, a connector, a vascular access device, a luer access device, an access port, a medication port, a pigtail connector, a prosthetic, an endoscope, a bronchoscope, a stethoscope, an infusion pump.

3. The polymeric housing for the medical device according to claim 1, wherein the polymer is porous and has an index of refraction from about 1.25 to about 1.6.

4. The polymeric housing for the medical device according to claim 1, wherein the polymer is selected from the group consisting of a discrete membrane, a foamed article, a thin film, a casting, a molding, and a coating.

5. The polymeric housing for the medical device according to claim 1 comprising an effective amount of a compound selected from the group consisting of chlorhexidine and its salts, an antimicrobial agent bearing an aminoalkyl group, chloroxyphenol, triclosan, triclocarban, chitosan, and a quaternary ammonium compound.

6. The polymeric housing for the medical device according to claim 1 comprising an effective amount of a material selected from the group consisting of an oligodynamic compound and an antimicrobial compound.

7. A polymeric housing for a medical device comprising:

a porous polymeric surface;

a plurality of attachment sites on the porous polymeric surface;

a plurality of functional groups attached to the attachment sites;

a solvatochromic dye directly attached to the functional groups, wherein the solvatochromic dye comprises 4,6-dichloro-2-[2-(6-aminohexyl-4-pyridinio)-vinyl]phenolate, and wherein the porous polymeric surface is configured to reversibly change from a first appearance to a second appearance when the porous polymeric surface is swabbed with a disinfecting solution; and

an antimicrobial compound directly attached to the functional groups, wherein the antimicrobial compound is configured to be cidal to, or to resist growth of, microorganisms on the porous polymeric surface.

8. The polymeric housing for the medical device according to claim 7, wherein the medical device is selected from the group consisting of a catheter, a drug vial spike, a connector, a vascular access device, a luer access device, an access port, a medication port, a pigtail connector, a prosthetic, an endoscope, a bronchoscope, a stethoscope, an infusion pump.

9. The polymeric housing for the medical device according to claim 7, wherein the porous polymeric surface has an index of refraction from about 1.25 to about 1.6.

10. The polymeric housing for the medical device of claim 7, wherein the polymer is selected from the group consisting of elastomers, acrylic, COC, nylon, methacrylic, polycarbonate, ABS, polyurethane, polyester, and vinylester.

11. The polymeric housing for the medical device according to claim 7, wherein the attachment sites comprise at least one of carboxyl groups, amine groups, and amide groups.

12. The polymeric housing for the medical device according to claim 7, wherein the polymer is selected from a group consisting of a discrete membrane cut from a sheet, a foamed article, a film, a casting, a molding, and a coating.

13. The polymeric housing for the medical device according to claim 7, wherein the antimicrobial compound comprises an effective amount of a compound selected from the group consisting of chlorhexidine and its salts, an antimicrobial agent bearing an aminoalkyl group, chloroxyphenol, triclosan, triclocarban, chitosan, and a quaternary ammonium compound.

14. The polymeric housing for the medical device according to claim 7, wherein the porous polymeric surface further comprises an effective amount of a material selected from the group consisting of an oligodynamic compound and an antimicrobial compound.

15. A polymeric housing for a medical device comprising:

a polymer comprising a porous surface;

a plurality of attachment sites on a surface of the polymer;

a plurality of functional groups attached to the attachment sites;

a solvatochromic dye directly attached to the functional groups, wherein the solvatochromic dye comprises 4,6-dichloro-2-[2-(6-aminohexyl-4-pyridinio)-vinyl]phenolate, and wherein the porous surface is configured to reversibly change from a first appearance to a second appearance when the porous surface is swabbed with a disinfecting solution; and

an amino-alkyl containing compound selected from the group consisting of peptides, proteins, Factor VIII or other anti-clotting Factor, polysaccharides, polymyxins, hyaluronic acid, heparin, condroitin sulfate, and chitosan directly attached to the attachment sites.

16. The polymeric housing for the medical device according to claim 15, further comprising an antimicrobial compound, attached to the attachment sites or to the functional groups, wherein the antimicrobial compound is configured to be cidal to, or to resist growth of, microorganisms on the porous surface.

17. The polymeric housing for the medical device according to claim 15, wherein the medical device is selected from the group consisting of a catheter, a drug vial spike, a connector, a vascular access device, a luer access device, an access port, a medication port, a pigtail connector, a prosthetic, an endoscope, a bronchoscope, a stethoscope, an infusion pump.