Blood control catheter with antimicrobial needle lube

• US 9,750,927 B2
• Filed: 11/02/2016
• Issued: 09/05/2017
• 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:
  US15/341,944
• Publication Number:
  US 20170056639A1
• Time in Patent Office: 307 Days
• Field of Search: 604500
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/3437 with means for removing or absorbing fluid, e.g. wicks or absorbent pads
• 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 2420/02 Methods for coating 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
• 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 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• 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 25/065 : Guide needles
• CPC Class Codes: A61M 39/0606 : without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/10 : Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• 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: A61M 39/162 : with antiseptic agent incorporated within the connector

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 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, wherein the catheter adapter comprises a proximal end, a distal end, a lumen extending therebetween, a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to a septum, and a catheter;

wherein a proximal end of the catheter is coupled to the distal end of the catheter adapter;

the septum disposed in the lumen of the catheter adapter, wherein the septum prevents fluid in the fluid pathway from exiting the proximal end of the catheter adapter;

a needle comprising a base, a tip, and a body extending therebetween, wherein the body of the needle is disposed within the lumen of the catheter adapter; and

an antimicrobial lubricant applied to only a portion of an outer surface of the needle, wherein the portion of the outer surface extends from a distal portion of the needle to a distal end of the septum when the needle extends beyond the distal end of the catheter, wherein as the needle is withdrawn proximally through the septum, the septum removes the antimicrobial lubricant from the needle thereby depositing the antimicrobial lubricant on the distal end of the septum.

2. 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, and a solid lubricant.

3. 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.

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

5. The catheter assembly of claim 4, 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.

6. 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.

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

8. The catheter assembly of claim 6, wherein the polymer component is insoluble in water.

9. The catheter assembly of claim 6, wherein the polymer component is water soluble.

10. The catheter assembly of claim 6, wherein the antimicrobial agent is present in an amount from approximately 0.001% (w/v) to approximately 10.0% (w/v).

11. The catheter assembly of claim 6, 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.

12. The catheter assembly of claim 6, wherein the alcohol component comprises a lower alcohol having between one and six carbon atoms.

13. The catheter assembly of claim 6, wherein the alcohol component is present within the antimicrobial lubricant in amount approximately equal to 20% (w/v).

14. The catheter assembly of claim 6, 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).

15. The catheter assembly of claim 6, 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).

16. A method for applying an antimicrobial lubricant to a septum of a catheter assembly, the method comprising:

providing a catheter assembly, the catheter assembly comprising;

a catheter adapter comprising a proximal end, a distal end, and a lumen extending therebetween, wherein the distal end of the catheter adapter comprises a distal opening;

a catheter connected to the distal end of the catheter adapter, wherein the catheter comprises a distal end and a proximal end; and

a septum disposed within the lumen;

applying an antimicrobial lubricant to a portion of an outer surface of a needle, wherein the needle comprises a base, tip, and a body extending therebetween;

preparing the catheter assembly for insertion into vasculature of the patient by inserting the needle proximally through the distal opening of the catheter adapter such that the body of the needle extends through the septum, the tip of the needle extends beyond the distal end of the catheter, and the portion is disposed distal to a distal end of the septum, wherein when the body of the needle extends through the septum, a slit of the septum seals around the body of the needle such that upon withdrawing the needle proximally from the slit of the septum, the slit removes a portion of the antimicrobial lubricant from the portion of the outer surface of the needle to form a deposit of the antimicrobial lubricant on the septum at a location proximate to the slit.

17. The method of claim 16, wherein a fluid pathway extending through the catheter adapter does not extend through the septum.

18. The method of claim 16, wherein the septum is configured to prevent fluid from exiting a proximal end of the catheter adapter, wherein the catheter adapter further comprises a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway that does not extend through the septum, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to the septum, and the catheter.

19. A method of depositing an antimicrobial agent on a septum of a catheter adapter after insertion of a catheter into vasculature of a patient, the method comprising:

applying an antimicrobial lubricant to an outer surface of a needle, wherein the needle comprises a base, a tip, and a body extending therebetween;

preparing a catheter assembly for insertion into vasculature of a patient, wherein the catheter assembly comprises a catheter adapter having a lumen extending therethrough, a catheter connected to the catheter adapter, and septum disposed in the lumen, wherein preparing the catheter assembly for insertion into the vasculature comprises inserting the needle proximally through the distal opening of the catheter adapter such that the lubricant is not removed from the needle during insertion through the distal opening;

inserting the needle and the catheter positioned around the needle into the vasculature of the patient; and

withdrawing the needle from the catheter such that, as the needle passes through a 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.

20. The method of claim 19, wherein the catheter adapter comprises a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway separate from the septum, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to the septum, and the catheter.