Blood control catheter with antimicrobial needle lube

Patent metadata

Field	Value
Publication number	US-9327095-B2
Application number	US-201313793569-A
Country	US
Kind code	B2
Filing date	Mar 11, 2013
Priority date	Mar 11, 2013
Publication date	May 3, 2016
Grant date	May 3, 2016

Abstract

An antimicrobial lubricant applied to an outer surface of an introducer needle as part of a catheter assembly device. The catheter assembly device further includes a blood control septum having a slit through which the introducer needle is threaded. The antimicrobial lubricant is squeegeed, or removed from the outer surface of the introducer needle as the needle is removed from the slit following catheterization. The removed antimicrobial lubricant forms a deposit on the septum at a location proximate to the slit, thereby preventing colonization and growth of pathogens on the septum and other adjacent components and surfaces of the catheter assembly device.

First claim

The invention claimed is:

1. A catheter assembly, comprising:
a catheter adapter having a proximal end, a distal end, and a fluid pathway extending therebetween;
a catheter having a distal end and a proximal end, the proximal end of the catheter being coupled to the distal end of the catheter adapter, the catheter having a lumen in fluid communication with the fluid pathway;
a septum disposed within the fluid pathway thereby dividing the fluid pathway into a forward chamber and a rearward chamber, the septum having a slit;
a needle having a base, a tip, and a body extending therebetween;
an amount of an antimicrobial lubricant applied to an outer surface of the body of the needle; and
a threader for forming a temporary pathway through the septum during assembly of the catheter assembly, the temporary pathway formed by the threader allowing the body of the needle to be inserted through the slit of the septum without substantially removing the amount of antimicrobial lubricant from the outer surface of the body of the needle, wherein after the needle is inserted through the slit of the septum and the threader is removed from the septum, the outer surface of the body of the needle is positioned distal to the septum such that, as the needle is withdrawn proximally through the septum, the septum removes the antimicrobial lubricant from the needle thereby depositing the antimicrobial lubricant on a distal side of the septum;
wherein the threader is configured to be removed from the catheter assembly after the needle is inserted through the slit of the septum.

2. The catheter assembly of claim 1 , wherein the slit comprises a tri-slit configuration.

3. The catheter assembly of claim 1 , wherein the antimicrobial lubricant comprises at least one of a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, or a solid lubricant.

4. The catheter assembly of claim 1 , wherein the antimicrobial lubricant comprises an oil lubricant such as polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane.

5. The catheter assembly of claim 1 , wherein the antimicrobial lubricant comprises an antimicrobial agent.

6. The catheter assembly of claim 5 , wherein the antimicrobial agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, and benzalkonium chloride.

7. The catheter assembly of claim 4 , wherein the antimicrobial lubricant further comprises at least one of a fugitive solvent component, an alcohol component, and an antimicrobial agent.

8. The catheter assembly of claim 4 , wherein the antimicrobial agent is a non-alcohol based antimicrobial agent.

9. The catheter assembly of claim 7 , wherein the polymer component is insoluble in water.

10. The catheter assembly of claim 7 , wherein the polymer component is water soluble.

11. The catheter assembly of claim 7 , wherein the antimicrobial agent is present in an amount from approximately 0.001% (w/v) to approximately 10.0% (w/v).

12. The catheter assembly of claim 7 , wherein the antimicrobial agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, and benzalkonium chloride.

13. The catheter assembly of claim 7 , wherein the alcohol component comprises a lower alcohol having between one and six carbon atoms.

14. The catheter assembly of claim 7 , wherein the alcohol component is present within the antimicrobial lubricant in an amount approximately equal to 20% (w/v).

15. The catheter assembly of claim 7 , wherein the alcohol component comprises a mixture of isopropyl alcohol and ethanol, and is present within the antimicrobial lubricant in an amount from approximately 40% (w/v) to approximately 95% (w/v).

16. The catheter assembly of claim 7 , wherein the fugitive solvent comprises an organic solvent that is present within the antimicrobial lubricant in an amount from approximately 20% (w/v) to approximately 95% (w/v).

17. A method for applying an antimicrobial lubricant to a septum of a catheter assembly, the method comprising:
applying an antimicrobial lubricant to an outer surface of a needle;
inserting a threader into a slit of the septum, the threader forming an enlarged opening through the septum;
inserting the coated needle through the enlarged opening, the coated needle having a diameter less than the diameter of the enlarged opening such that the lubricant is not removed from the needle during insertion through the septum; and
removing the threader from within the slit to allow the slit to seal around the needle such that, upon withdrawing the needle from the slit of the septum, the slit will remove a portion of the antimicrobial lubricant from the outer surface of the needle to form a deposit of the antimicrobial lubricant on the septum at a location proximate to the slit.

18. The method of claim 17 , wherein the slit comprises a tri-slit configuration.

19. The method of claim 17 , wherein the antimicrobial agent comprises at least one of a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, and a solid lubricant.

20. A method for depositing an antimicrobial agent on a septum of a catheter adapter after insertion of a catheter into a patient's vasculature, the method comprising:
providing a catheter assembly comprising a catheter connected to a catheter adapter containing a septum positioned to divide the catheter adapter into a distal and proximal chamber;
preparing the catheter assembly by inserting a threader into a slit of the septum to form an enlarged opening and inserting an antimicrobial lubricant coated needle through the enlarged opening, positioning the needle within the catheter, and removing the threader;
inserting the needle and the catheter positioned around the needle into a patient's vasculature; and
withdrawing the needle from the catheter such that, as the needle passes through the slit in the septum, the slit removes the antimicrobial lubricant from the needle thereby forming a deposit of the antimicrobial lubricant around the slit of the septum.

Assignees

• Becton Dickinson Co

Inventors

• Ma Yiping

Classifications

• A61P31/02

  Local antiseptics · CPC title

• A61M2205/0222

  Materials for reducing friction · CPC title

• A61M2039/068

  having a seal being made of or coated with a special material · CPC title

• A61L2300/404

  Biocides, antimicrobial agents, antiseptic agents · CPC title

• A61M2039/062

  used with a catheter · CPC title