Patient fluid line access valve antimicrobial cap/cleaner

• US 10,406,343 B2
• Filed: 09/06/2017
• Issued: 09/10/2019
• Est. Priority Date: 11/17/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hoang, Minh Quang, Burkholz, Jonathan Karl
• Primary Examiner(s): Gilbert, Andrew
• Application Number:
  US15/697,060
• Publication Number:
  US 20180043148A1
• Time in Patent Office: 734 Days
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• 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
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: Y10T 137/4259 With separate material addition

Abstract

Cap and cleaning devices antiseptically maintain patient fluid line access valves to minimize the risk of infection via catheters. The devices have a cap that may contain a dry pad impregnated with an antimicrobial agent. The cap covers the access portion of the access valve when not in use. The devices have a hood that contains a wet pad impregnated with a cleaning solution and, optionally, an antimicrobial agent. The wet pad cleans the access portion of the access valve prior to and optionally, after the access valve is utilized to access the patient fluid line.

Claims

1. A device for cleaning a patient fluid line access valve having an access portion with a distalmost end face and an external thread on at least a portion of an outer surface of a sidewall, the device comprising:

a housing having an opening with an inner circumference and a maximum inner cross-sectional area greater than a maximum cross-sectional area of the access portion including the external thread, and an inner cavity for receiving the access portion of the patient fluid line access valve via the opening;

a pad including a cleaning solution;

an internal threading configured within the inner cavity of the housing to accommodate the external thread of the access portion of the patient fluid line access valve, the access portion providing an access to a fluid line via the access valve when connected to the fluid line, such that a gap providing an air cavity is formed at least between the inner circumference of the opening and the outer surface of the sidewall including the external thread of the access portion of the patient fluid line access valve when the internal threading provides a secured attachment of the cap to the access valve,

wherein a threading action comprising rotating the housing relative to the patient fluid line access valve causes the external thread and the internal threading to cooperate compressing the pad by the distalmost end face of the access portion of the patient fluid line access valve, thereby allowing the cleaning solution to disinfect at least the distalmost end face of the access portion of the patient fluid line access valve; and

a removable lid enclosing the inner cavity, the pad and the cleaning solution being in the inner cavity, prior to receiving the access portion of the patient fluid line access valve.

2. The device of claim 1, wherein the threading action between the internal threading and the external thread provides adjustable positioning of the distalmost end face within the inner cavity.

3. The device of claim 2, wherein the adjustable positioning of the distalmost end face within the inner cavity allows at least the distalmost end face to contact and compress the pad at least between the distalmost end face and the inner cavity.

4. The device of claim 1, wherein the pad comprises a sponge.

5. The device of claim 1, wherein the housing comprises a polyethylene or polypropylene material.

6. The device of claim 1, wherein the cleaning solution comprises an antimicrobial agent.

7. The device of claim 6, wherein the antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

8. The device of claim 6, wherein the cleaning solution is an alcohol-based cleaning solution.

9. The device of claim 1, wherein a thread length of the internal threading is less than an inner circumference of the opening of the housing.

10. The device of claim 9, wherein the gap comprises a void formed by the circumferentially absent thread length of the internal threading.

11. The device of claim 1, wherein the gap extends towards a proximal end of the opening.

12. The device of claim 11, wherein the gap extends to an abutting interface of the patient fluid line access valve and the housing.

13. The device of claim 1, wherein the compressing of the pad by the distalmost end face of the access portion of the patient fluid line access valve allows the cleaning solution to disinfect the outer surface of the sidewall including the external thread of the access portion of the patient fluid line access valve.

14. A method for cleaning a patient fluid line access valve having an access portion with a distalmost end face and an external thread on at least a portion of an outer surface of a sidewall, the method comprising:

providing a cap having a housing having an opening with an inner circumference and a maximum inner cross-sectional area greater than a maximum cross-sectional area of the access portion including the external thread, an inner cavity for receiving the access portion of the patient fluid line access valve via the opening, the access portion providing an access to a fluid line via the access valve when connected to the fluid line, and an internal threading configured within the opening of the housing;

removing a removable lid enclosing the inner cavity thereby exposing a pad including a cleaning solution disposed in the inner cavity prior to receiving the access portion of the patient fluid line access valve;

rotating said cap onto the patient fluid line access valve, wherein the internal threading of the cap accommodates the external thread of the access portion of the patient fluid line access valve such that a gap providing an air cavity is formed at least between the inner circumference of the opening and the outer surface of the sidewall including the external thread of the access portion of the patient fluid line access valve when the internal threading provides a secured attachment of the cap to the access valve; and

seating said cap onto the patient fluid access valve by a threaded engagement between the internal threading and the external thread thereby forcing the pad to be compressed by the distalmost end face of the access portion of the patient fluid line access valve, thereby allowing the cleaning solution to disinfect at least the distalmost end face of the access portion of the patient fluid line access valve.

15. The method of claim 14, wherein the rotating step further comprises adjusting position of the distalmost end face within the inner cavity by a threaded interaction between the internal threading and the external thread.

16. The method of claim 15, wherein the step of adjusting the position of the distalmost end face within the inner cavity by the threaded interaction comprises the distalmost end face contacting and compressing the pad at least between the distalmost end face and the inner cavity.

17. The method of claim 14, wherein the pad comprises a wetted sponge.

18. The method of claim 14, wherein the cleaning solution comprises an antimicrobial agent.

19. The method of claim 18, wherein the antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

20. The method of claim 19, wherein the cleaning solution is an alcohol-based cleaning solution.

21. The method of claim 14, wherein the forcing of the pad to be compressed by the distalmost end face of the access portion of the patient fluid line access valve allows the cleaning solution to disinfect the outer surface of the sidewall including the external thread of the access portion of the patient fluid line access valve.