Blood control catheter with antimicrobial needle lube

• US 9,789,280 B2
• Filed: 04/26/2016
• Issued: 10/17/2017
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ma, Yiping
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US15/138,864
• Publication Number:
  US 20160235944A1
• Time in Patent Office: 539 Days
• Field of Search: 604500
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• 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: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction coatings A61M2025/0046
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/068 having a seal being made of or coated with a special material
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 : "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/0606 : without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/162 : with antiseptic agent incorporated within the connector
• CPC Class Codes: A61P 31/02 : Local antiseptics

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.

Claims

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 at least a portion of an outer surface of the body of the needle distal to a distal end of the septum when the needle extends beyond the distal end of the catheter, wherein the amount of antimicrobial lubricant is spaced apart from the catheter and catheter adapter when the needle extends beyond the distal end of the catheter, wherein as the needle is withdrawn proximally through the slit of the septum, the septum removes the antimicrobial lubricant from the needle thereby depositing the antimicrobial lubricant on a distal side 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 5, wherein the antimicrobial lubricant further comprises at least one of a fugitive solvent component, an alcohol component, a polymer component, and an antimicrobial agent.

8. The catheter assembly of claim 5, wherein the antimicrobial agent is a non-alcohol based antimicrobial agent.

9. The catheter assembly of claim 7, wherein the antimicrobial lubricant is insoluble in water.

10. The catheter assembly of claim 7, wherein the antimicrobial lubricant 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 antimicrobial lubricant comprises an alcohol component 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 distal surface of a septum of a catheter assembly, the method comprising:

placing a needle within a slit of the septum such that a distal portion of the needle is positioned distally to the septum and a proximal portion of the needle is positioned proximally to the septum;

applying an antimicrobial lubricant to an outer surface of the distal portion of the needle; and

withdrawing the needle from the slit of the septum in a proximal direction such that, as the needle passes through the slit in the septum, the slit removes a portion of the antimicrobial lubricant from the outer surface of the distal portion 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 placing a needle within a slit of the septum such that a distal portion of the needle is positioned distally to the septum and a proximal portion of the needle is positioned proximally to the septum;

applying an antimicrobial lubricant to an outer surface of the distal portion of the needle;

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 outer surface of the distal portion of the needle thereby forming a deposit of the antimicrobial lubricant around the slit of the septum.