Needleless connector and access port disinfection cleaner and antimicrobial protection cap

Patent metadata

Field	Value
Publication number	US-12296137-B2
Application number	US-202217941811-A
Country	US
Kind code	B2
Filing date	Sep 9, 2022
Priority date	Feb 13, 2013
Publication date	May 13, 2025
Grant date	May 13, 2025

Abstract

A protective cap having a first cap and a second cap that are removably coupled together for use in short-term and long-term antimicrobial treatment of needleless connectors and access ports of an infusion system. The instant invention further provides a protective cap having a first cap and a second cap that each coupled to a different surface of a component of an infusion system, such as a syringe. The instant invention further provides a strip containing a plurality of disposable protective caps.

First claim

The invention claimed is:

1. A method for antiseptically maintaining a patient fluid line access valve, the method comprising:
providing a syringe having a volume filled with a fluid for injection, the syringe having a nozzle coupled to a cap, the cap having a first end and a second end, the first end comprising a first opening having a pad disposed therein, wherein the first opening comprises a cylindrical shape configured to receive a patient fluid line access valve, wherein a cross-section of the first end comprises a first side wall and a second side wall opposite the first side wall, wherein the pad comprises a planar surface having a diameter equal to a distance between the first side wall and the second side wall, wherein the second end is engaged to the syringe by a threaded engagement, wherein a lid covers the first opening to seal the first end;
removing the lid covering thereby exposing the first opening;
engaging the first opening to the patient fluid line access valve, thereby contacting the planar surface of the pad to at least a portion of the patient fluid line access valve;
disinfecting at least the portion of the patient fluid line access valve;
disengaging the cap from the nozzle by unthreading the cap from the syringe;
connecting the nozzle of the syringe to the patient fluid line access valve; and
injecting the fluid for injection through the patient fluid line access valve.

2. The method of claim 1 , wherein the lid comprises at least one of a foil lidding material and a polymer lidding material.

3. The method of claim 1 , wherein the first opening is configured to receive an access portion of a patient fluid line access valve, wherein the pad further comprises a cylindrical cut extending into the pad to divide the pad into a central, cylindrical cutout and a surrounding portion, wherein when the central, cylindrical cutout is uncompressed, the pad at the central, cylindrical cutout and the surrounding portion forms the planar surface, and wherein when the access portion is inserted into the first opening, the central, cylindrical cutout compresses to displace the pad at the central, cylindrical cutout from the planar surface at the surrounding portion thereby forming a central cavity within the pad.

4. The method of claim 3 , wherein the first opening includes a set of threads that is configured to receive a compatible set of threads on the access portion of the patient fluid line access valve.

5. The method of claim 1 , wherein the pad contains an antimicrobial solution and the disinfecting step includes contacting the antimicrobial solution to the portion of the patient fluid line access valve.

6. The method of claim 5 , wherein the antimicrobial solution comprises a wet solution selected from at least one of an antimicrobial agent from approximately 0.01% to approximately 10.0% (v/v) and an alcohol from approximately 50% to approximately 99.99% (v/v).

7. The method of claim 6 , wherein the antimicrobial agent is selected from the group consisting of chlorhexidine acetate, chlorhexidine gluconate, PVP-I, Triclosan, PCMX, BEC, BAC, antibiotic, Octinidine, and suitable salts thereof.

8. The method of claim 5 , wherein the antimicrobial solution comprises a wet, water-based solution, comprising:
an antimicrobial agent from approximately 0.01% to approximately 10.0% (v/v);
an alcohol solvent from approximately 1% to approximately 10% (v/v); and
water from approximately 90% to approximately 99% (v/v).

9. The method of claim 1 , wherein the disengaging step occurs prior to the removing step.

10. The method of claim 1 , wherein the steps occur in the order stated.

11. The method of claim 1 , wherein the injection step comprises injecting an entire volume of fluid for injection contained within the syringe through the patient fluid line access valve.

12. The method of claim 1 , wherein injection step comprises injecting a portion of the volume of fluid for injection contained within the syringe through the patient fluid line access valve.

13. The method of claim 12 , further comprising providing a second cap for engagement to the nozzle of the syringe, wherein the second cap is configured to sealingly engage the nozzle thereby containing an un-injected volume of fluid for injection.

14. The method of claim 13 , further comprising removing the second cap from a plunger of the syringe.

15. A method for antiseptically maintaining a patient fluid line access valve, the method comprising:
providing a syringe having a volume filled with a fluid for injection, the syringe having a nozzle coupled to a cap, the cap having a first end and a second end, the first end comprising a first opening having a pad disposed therein, wherein the first opening comprises a cylindrical shape configured to receive a patient fluid line access valve, wherein a cross-section of the first end comprises a first side wall and a second side wall opposite the first side wall, wherein the pad comprises a planar surface having a diameter equal to a distance between the first side wall and the second side wall, wherein the second end is coupled to the nozzle, wherein a lid covers the first opening to seal the first end;
removing the lid covering thereby exposing the first opening;
engaging the first opening to the patient fluid line access valve, thereby contacting the planar surface of the pad to at least a portion of the patient fluid line access valve;
disinfecting the portion of the patient fluid line access valve with the pad in the first receptacle;
disengaging the cap from the syringe nozzle by uncoupling the cap from the syringe;
connecting the nozzle of the syringe to the patient fluid line access valve; and
injecting the fluid for injection through the patient fluid line access valve.

16. The method of claim 15 , wherein the pad further comprises a cylindrical cut extending into the pad to divide the pad into a central, cylindrical cutout and a surrounding portion, wherein when the central, cylindrical cutout is uncompressed, the pad at the central, cylindrical cutout and the surrounding portion forms the planar surface, and wherein when a device is inserted into the first opening, the central, cylindrical cutout compresses to displace the pad at the central, cylindrical cutout from the planar surface at the surrounding portion thereby forming a central cavity within the pad.

Assignees

• Becton Dickinson Co

Inventors

• Burkholz Jonathan Karl

Classifications

• A61M5/31

  Details · CPC title

• A61M39/20

  Closure caps or plugs for connectors or open ends of tubes · CPC title

• A61M39/16

  having provision for disinfection or sterilisation {(A61M39/143 takes precedence)} · CPC title

• A61M5/001

  Apparatus specially adapted for cleaning or sterilising syringes or needles · CPC title

• A61M39/162 Primary

  with antiseptic agent incorporated within the connector · CPC title