Application Of Antimicrobial Agents To Medical Devices

Patent metadata

Field	Value
Publication number	US-2016287758-A1
Application number	US-201615085463-A
Country	US
Kind code	A1
Filing date	Mar 30, 2016
Priority date	Mar 30, 2015
Publication date	Oct 6, 2016
Grant date	—

Abstract

Invasive medical devices including a substantially non-eluting antimicrobial treatment are disclosed. One or more external and/or internal surfaces of the medical device include a substantially non-eluting copper-coated surface that assists in preventing microbial colonization of the coated surface. This in turn reduces the incidence of infection to the patient originating from the medical device. In one embodiment, a catheter assembly is disclosed and comprises an elongate catheter tube that defines at least one lumen, at least one extension leg including a luer connector, and a bifurcation hub including at least one fluid passageway that provides fluid communication between the extension leg and the lumen. A substantially non-eluting copper coating is disposed on a surface of at least one of the lumen, the extension leg, the luer connector, and the fluid passageway. The coating is applied via an electroless deposition process. A water-shed coating is disposed on the copper coating.

First claim

What is claimed is:

1 . An medical device, comprising:
a body defining at least a portion of a fluid path, the fluid path including a surface; a substantially non-eluting copper coating disposed on at least a portion of the surface, the coating having been applied via an electroless deposition process; and a water-shed layer disposed on the copper coating.

2 . The medical device as defined in claim 1 , wherein the copper coating includes a thickness that is from about 0.8 to about 2.6 micrometers.

3 . The medical device as defined in claim 1 , wherein the medical device provides access to a venous system of the patient.

4 . The medical device as defined in claim 3 , wherein the medical device is an invasive medical device and includes one of a catheter assembly and an implantable vascular access port.

5 . The medical device as defined in claim 1 , wherein the water-shed layer includes at least one of butoxyethanol and butoxyethoxyethanol.

6 . The medical device as defined in claim 1 , wherein the medical device includes one of a needleless connector and an end cap, and wherein the surface is disposed on at least one of an interior portion and an exterior portion of the needleless connector or end cap.

7 . A catheter assembly, comprising:
an elongate catheter tube defining at least one lumen; at least one extension leg including a luer connector; a bifurcation hub including at least one fluid passageway that provides fluid communication between the at least one extension leg and the at least one lumen; a substantially non-eluting copper coating disposed on a surface of at least one of the at least one lumen, at least one extension leg, luer connector, and at least one fluid passageway, the coating having been applied via an electroless deposition process; and a water-shed coating disposed on the copper coating.

8 . The catheter assembly as defined in claim 7 , wherein at least an interior surface of the luer connector and an interior surface of the at least one fluid passageway of the bifurcation hub includes the copper coating thereon.

9 . The catheter assembly as defined in claim 8 , wherein another antimicrobial agent is included on a surface of at least one of the catheter tube and the extension leg.

10 . The catheter assembly as defined in claim 7 , wherein the copper coating elutes less than about 0.01% of a total copper content of the copper coating after about 24 hours of fluid contact with the copper coating.

11 . The catheter assembly as defined in claim 7 , wherein at least one of an interior surface and an exterior surface of the luer connector includes the copper coating thereon, the luer connector including a valve.

12 . The catheter assembly as defined in claim 11 , wherein at least a portion of the valve includes the copper coating.

13 . A luer connector for a medical device, comprising:
a body defining a fluid passageway; and a substantially non-eluting copper coating disposed on a surface of the body of the luer connector, the copper coating having been applied via an electroless deposition process, the copper coating including a water-shed coating thereon.

14 . The luer connector as defined in claim 13 , wherein at least an outer surface of the luer connector body includes the copper coating.

15 . The luer connector as defined in claim 13 , wherein at least one of an interior surface and an exterior surface of the luer connector includes the copper coating thereon, the luer connector including a valve.

16 . The luer connector as defined in claim 15 , wherein at least a portion of the valve includes the copper coating.

17 . The luer connector as defined in claim 13 , wherein the water-shed layer includes at least one of butoxyethanol and butoxyethoxyethanol.

18 . The luer connector as defined in claim 13 , wherein the luer connector is included with a catheter assembly.

19 . A method of making a medical device, the method comprising:
forming a body, the body defining at least a portion of a fluid path; and applying via electroless deposition a substantially non-eluting copper coating on at least a portion of the body.

20 . The method of making as defined in claim 19 , further comprising disposing a water-shed layer disposed on the copper coating.

21 . The method of making as defined in claim 19 , wherein applying the substantially non-eluting copper coating further includes applying the copper coating on a surface defining at least a portion of the fluid path.

22 . The method of making as defined in claim 19 , wherein the copper coating is applied to a thermoplastic polyurethane portion of the body.

23 . The method of making as defined in claim 19 , wherein forming the body includes at least one of extruding, molding, casting, and machining the body.

24 . A method of making a medical device, the method comprising:
compounding a forming material with copper; and forming at least a portion of a fluid path of the medical device with the forming material, the compounded copper of the forming material being substantially non-eluting.

25 . The method of making as defined in claim 24 , wherein forming the at least a portion of the fluid path includes at least one of extruding, molding, casting, and machining.

26 . The method of making as defined in claim 24 , wherein compounding the forming material includes compounding the forming material with a copper-containing powder.

27 . The method of making as defined in claim 24 , wherein the forming material includes a polymer and wherein the medical device includes one of a catheter assembly and an implantable access port.

28 . The method of making as defined in claim 24 , wherein the forming material is compounded with at least one of cuprous chloride, cupric chloride, cupric oxide, copper hydroxide, copper oxalate, copper citrate, copper gluconate, copper acetate, copper carbonate, copper sulfate, copper phosphate, another copper salt, and divided metallic copper.

29 . A method of making a medical device, the method comprising:
forming a copper-containing component; and insert-molding the copper-containing component with the medical device such that the copper-containing component defines at least a portion of a fluid path of the medical device, wherein the copper-containing component is substantially non-eluting.

30 . The method of making as defined in claim 29 , wherein the medical device is a luer connector and wherein the copper containing component defines at least a portion of an interior surface of the luer connector.

Assignees

• Bard Inc C R

Inventors

• Thiagarajan Giridhar
• Amin Murtaza Yusuf
• Matson Jerrid

Classifications

• A61M2025/0056

  provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir · CPC title

• A61M39/162

  with antiseptic agent incorporated within the connector · CPC title

• A61M25/0045

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61M25/0009

  Making of catheters or other medical or surgical tubes · CPC title

• A61M39/0247

  Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body (peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053) · CPC title