Disinfection device for female connectors
12521456 ยท 2026-01-13
Assignee
Inventors
Cpc classification
A61L2202/121
HUMAN NECESSITIES
A61L2103/15
HUMAN NECESSITIES
A61M39/20
HUMAN NECESSITIES
A61M2205/0216
HUMAN NECESSITIES
International classification
A61M39/16
HUMAN NECESSITIES
Abstract
A device for connection to a female medical connector is disclosed, the device includes a cap, a scrubbing foam, an elastic sealing lip, and an absorbent material. The cap is configured to define a chamber to contain an absorbent material and disinfectant or antimicrobial agent. The cap may include one or more threads adapted to engage with a female luer connector. The device may also include a peelable seal to maintain sterility prior to use and to prevent the disinfectant or the antimicrobial agent from exiting the chamber prior to use. Also described are methods of disinfecting a medical connector.
Claims
1. A disinfection device for connection to a female medical connector, the disinfection device comprising: a cap comprising an integral body, a closed end, open proximal end, an annular wall having an exterior wall surface and an interior wall surface extending from the closed end to the open proximal end and defining a chamber, extending radially outward from the open proximal end defining an end face and an engagement surface, and a peripheral ledge disposed at the open proximal end, the peripheral ledge including a recessed cavity disposed within the interior wall surface near the open proximal end; a scrubbing foam housed in the recessed cavity of the peripheral ledge near the open proximal end, the scrubbing foam comprising a plurality of bristle-type precut projections; an elastic sealing lip disposed on the scrubbing foam, the sealing lip having a dilatable opening therethrough sized and adapted to receive a female medical connector, the recessed cavity securing the elastic sealing lip to the open proximal end; an absorbent material disposed in the chamber, the absorbent material having a lower portion disposed toward the closed end and an upper portion disposed adjacent the recessed cavity, the upper portion of the absorbent material surrounded by the scrubbing foam; and a disinfectant or antimicrobial agent disposed in the chamber.
2. The disinfection device of claim 1, wherein the female medical connector is selected from a group consisting essentially of needle-free connectors, catheters, luer connectors, stopcocks, and hemodialysis connectors.
3. The disinfection device of claim 1, wherein the dilatable opening sized to frictionally engage a female luer connector.
4. The disinfection device of claim 1, wherein the elastic sealing lip is in contact with the peripheral ledge.
5. The disinfection device of claim 1, wherein the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 6-7 mm to a dilated diameter of about 7-8 mm.
6. The disinfection device of claim 1, further comprising internal threads adjacent the closed end that partially extend along a length of the interior wall surface of the annular wall.
7. The disinfection device of claim 1, wherein the elastic sealing lip comprises an elastomeric material.
8. The device of claim 1, wherein the exterior wall surface includes a plurality of grip members.
9. The disinfection device of claim 1, wherein the absorbent material is a foam.
10. The disinfection device of claim 9, wherein the foam is a polyurethane foam.
11. The disinfection device of claim 1, wherein the absorbent material is a sponge.
12. The disinfection device of claim 1, wherein a compression of the absorbent material toward the closed end of the chamber occurs upon connection to the female luer connector.
13. The disinfection device of claim 12, wherein compression of the absorbent material disinfects a face and threads of the female medical connector.
14. The disinfection device of claim 13, wherein the absorbent material is under radial compression by the internal threads to retain the absorbent material in the chamber.
15. The disinfection device of claim 1, wherein the disinfectant or antimicrobial agent is selected from a group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof.
16. The disinfection device of claim 15, wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.
17. The disinfection device of claim 16, wherein the disinfectant or antimicrobial agent is a fluid or a gel.
18. The disinfection device of claim 1, further comprising a peelable seal on the end face of the open proximal end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.
19. The disinfection device of claim 18, wherein the peelable seal comprises an aluminum or multi-layer polymer film peel back top.
20. The disinfection device of claim 18, wherein the peelable seal is heat-sealed or induction sealed to the engagement surface.
21. A method of disinfecting a medical connector, the method comprising: connecting the disinfection device of claim 1 to a medical connector, wherein connecting includes engaging the interior wall surface upon insertion into the chamber such that the medical connector contacts the scrubbing foam, absorbent material and the disinfectant or antimicrobial agent; performing clockwise and counter-clockwise rotation of the bristle-type precut projections on the incoming female connector to actively remove the contaminants by loosening them with mechanical scrubbing action and further disinfect and kill the microbes by chemical disinfection due to disinfectant.
22. The disinfection device of claim 1, wherein the plurality of bristle-type precut projections extend radially inward from the interior wall surface toward the upper portion of the absorbent material.
23. The disinfection device of claim 1, wherein the scrubbing foam is ring shaped and encircles the upper portion of the absorbent material.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(7) Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways.
(8) Embodiments of the disclosure pertain to a sterile, single-use female luer scrubbing disinfecting device for connection to and disinfection of a female medical connector, specifically injection ports and female luer hubs, in which the device comprises a disinfecting cap, a scrubber foam, an elastic sealing lip, absorbent material, and a disinfectant or the antimicrobial agent. A peelable seal may be attached to an open proximal end to preserve sterility of the disinfecting cap prior to use. The disinfecting device of the present disclosure provides a mechanical barrier for female connectors and contains a disinfectant or an antimicrobial agent for disinfection. The device of the present disclosure allows the practitioner to streamline the disinfecting process.
(9) With respect to terms used in this disclosure, the following definitions are provided.
(10) As used herein, the use of a, an, and the includes the singular and plural.
(11) As used herein, the term catheter related bloodstream infection or CRBSI refers to any infection resulting from the presence of a catheter or IV line.
(12) As used herein, the term Luer connector refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a vascular access device (VAD). A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.
(13) An exploded view of the disinfection device of the present disclosure, along with a female connector 10 according to the prior art is shown in
(14)
(15) Referring to
(16) Cap 110 houses the absorbent material 130, a disinfectant or an antimicrobial agent 140, a scrubbing foam 150, and elastic sealing lip 160 within it. The cap 110 connects to an incoming female connector. In one or more embodiments, the cap is composed of a plastic material. Scrubbing foam 150 is retained within the recessed cavity 122 interior wall surface 123 near the open end 114 of cap 110.
(17) Referring to
(18) Referring to
(19) Referring to
(20) Referring to
(21) Retention of chemical disinfectant 140 or antimicrobial agent, such as isopropyl alcohol (IPA) in the plurality of bristle-type precut projections 151 of scrubbing foam 150 occurs due to surface tension which wet the threaded region of the needle-free female luer connector 10 and disinfects it. Clockwise and counter-clockwise rotation of the integral body 111 of the disinfection cap 110 results in a scrubbing action of the plurality of bristle-type precut projections 151 of scrubbing foam 150 on the incoming female connector to actively remove the contaminants by loosening them with mechanical scrubbing action and further disinfect and kill the microbes by chemical disinfection due to disinfectant 140 or antimicrobial agent present in the chamber of the cap and wetted within the pores of the scrubbing foam 150. The plurality of grip members 121 allows the user to better grip the cap 110 to perform the clockwise and counter-clockwise rotation of the integral body 111 of the disinfection cap 110. In one or more specific embodiments, the disinfectant 140 is IPA.
(22) Therefore, the cap of the present disclosure provides both active disinfection of the luer portion of the connector hub via the plurality of bristle-type precut projections 151 of scrubbing foam 150 and passive disinfection of the female connector face via chemical contact with the absorbent material 130 which is wetted with liquid disinfectant or antimicrobial agent 140, such as isopropyl alcohol (IPA).
(23) Sealing lip 160 provides a sealing between internal chamber 115 of disinfecting cap 110 and the external environment to reduce or eliminate microbial and physical debris ingress into the cap 110. Referring to
(24) Referring to
(25) Referring to
(26) Referring to
(27) Referring to
(28) In one or more embodiments, the female luer connector frictionally engages the scrubber foam upon insertion into the chamber 115.
(29) Referring to
(30) Subsequent to the initial contact with the scrubber foam after insertion of the connector into the open end 114 of the cap 110, the female luer connector contacts the absorbent material 130 disposed in the chamber 115 which is also wetted with the disinfectant or the antimicrobial agent.
(31) The cap 110 is made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices. In one or more embodiments, the cap 110 comprises a polypropylene or polyethylene material.
(32) Referring to
(33) Referring to
(34) The device 100 can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent 140 in the chamber 115 of the cap 110. The disinfectant or antimicrobial agent can be directly included in the chamber 115 or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of cap 110. The device is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel. In one or more specific embodiments, the disinfectant or antimicrobial agent is 70% isopropyl alcohol (IPA).
(35) Referring to
(36) Referring to
(37) In one or more embodiments, the peelable seal 170 comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the peelable seal 170 is heat-sealed or induction sealed to the end face of the cap to seal the open proximal end. In one or more embodiments, the peelable seal 170 comprises a moisture barrier.
(38) Referring to
(39) Other aspects of the present disclosure are directed to methods of disinfecting medical connectors and assemblies. As shown in
(40) Referring to
(41) The disinfection device 100 herein can achieve disinfection when used on female Luer connectors by active disinfection when the female luer connector is rotated back and forth (clockwise and counterclockwise) in a twisting motion while maintaining contact with the plurality of bristle-type precut projections 151 of scrubbing foam 150 to dislodge the contaminants and debris in combination with passive disinfection of the threads and luer surface when the female luer connector is inserted into cap and makes contact with the liquid disinfectant 140 which is wetted in the absorbent material 130. As shown in
(42) The female connector 10 is further advanced into the cap 110 and screwed onto the cap 110 due to threads 180 present inside the cap 110. This allows the cap 110 to stay connected onto the connector 10 until the connector 10 is accessed again for medication delivery to a patient. The connection of disinfection device 100 can keep the connector 10 disinfected for up to 7 days.
(43) When the connection between the female connector 10 and cap 110 is complete, the sealing lip 160 in the scrubbing foam 150 is pressed against the outer body of connector 10 through interference fit thus creating a seal acting as a mechanical barrier to prevent entry of contaminants and microbes into the inner chamber 115 of cap 110. In one or more embodiments, the cap 110 will remain connected to the vascular access ports until next access.
(44) In one or more embodiments, an assembly comprises the disinfection device 100 of one or more embodiments connected to a medical connector 10. In one or more embodiments, the medical connector 10 is a female luer connector.
(45) Reference throughout this specification to one embodiment, certain embodiments, one or more embodiments or an embodiment means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as in one or more embodiments, in certain embodiments, in one embodiment or in an embodiment in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
(46) Although the disclosure herein has provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.