# US 12,005,222 B2 · Universal single-use cap for male and female connectors

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- Number: US 12,005,222 B2
- Document ID: US12005222B2
- Status: Granted
- Kind: B2
- Application number: 17/045,837
- Filed: 2019-04-09
- Published: 2021-05-13
- Granted: 2024-06-11
- Earliest claimed: 2018-04-10
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Chang Jiang; Nichola Charles
- Web page: https://patentgrep.com/patent/US12005222B2

## CPC

- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 39/20: Closure caps or plugs for connectors or open ends of tubes
- A61M 39/229: {Single-way cut-off valves}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A device for connection to a medical connector, the device includes a cap, a container and a peelable seal. The cap configured to define a chamber to contain an absorbent material and disinfectant or antimicrobial agent. The cap includes one or more threads adapted to engage with a female luer connector. The cap is adapted to engage a male luer connector in a press-fit connection. The peelable seal prevents the disinfectant or the antimicrobial agent from exiting the chamber.

## Claims

### Claim 1

A device for connection to a medical connector, the device comprising:
a cap comprising a closed end, an annular wall having a length extending from the closed end to an open end and defining a chamber containing an absorbent material and disinfectant or antimicrobial agent, the open end having a peripheral ledge extending radially from the open end defining an engagement surface;
the annular wall having a frustoconical shape and further having an exterior wall surface and an interior wall surface;
the interior wall surface defining an opening adjacent to the open end, the opening sized and adapted to receive a male luer connector, a female luer connector and a hemodialysis connector, the interior wall surface extending from the open end to the peripheral edge having a smooth interior wall surface leading to the peripheral ledge, wherein the male luer connector frictionally engages the interior wall surface via a press-fit connection upon insertion into the chamber and the wherein the male luer connector rests on the peripheral ledge upon being fully inserted into the chamber;
the interior wall surface of the peripheral ledge leading to a portion of the interior wall surface comprising internal threads adjacent the closed end partially extending along a length of the interior wall surface, the internal threads adapted and sized to engage a female luer connector, the absorbent material and the disinfectant or the antimicrobial agent capable of contacting the male luer connector, the female luer connector and the hemodialysis connector;
the exterior wall surface comprising a plurality of radial protrusions;
a container comprising an annular container wall having a container wall length extending from a container closed end to a container open end face, the container having an interior container surface and an exterior container surface, the container housing the cap, the container having a complementary plurality of depressions that engage the plurality of radial protrusions; and
a peelable seal on the container open end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

### Claim 2 (depends on 1)

The device of claim 1, wherein the female luer connector comprises a needle-free connector, stopcocks, or hemodialysis connector.

### Claim 3 (depends on 1)

The device of claim 1, wherein the male connector comprises an intravenous tubing end or stopcock.

### Claim 4 (depends on 1)

The device of claim 1, wherein the opening adjacent to the open end of the interior wall surface is sized and adapted to receive a male luer connector in a press-fit connection.

### Claim 5 (depends on 1)

The device of claim 1, wherein the cap comprises an elastomeric material.

### Claim 6 (depends on 5)

The device of claim 5, wherein the elastomeric material comprises a thermoplastic elastomer.

### Claim 7 (depends on 1)

The device of claim 1, wherein the exterior container surface includes a plurality of grip members.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

The device of claim 1, wherein the annular container wall is frusto-conically shaped.

### Claim 10 (depends on 1)

The device of claim 1, wherein the absorbent material is a foam.

### Claim 11 (depends on 10)

The device of claim 10, wherein the foam is a polyurethane foam.

### Claim 12 (depends on 1)

The device of claim 1, wherein the absorbent material is a sponge.

### Claim 13 (depends on 1)

The device of claim 1, wherein the absorbent material is compressible.

### Claim 14 (depends on 13)

The device of claim 13, wherein compression of the absorbent material disinfects the female luer connector or the male luer connector.

### Claim 15 (depends on 1)

The device of claim 1, wherein the absorbent material is under radial compression by the internal threads to retain the absorbent material in the chamber.

### Claim 16 (depends on 1)

The device of claim 1, wherein 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, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof.

### Claim 17 (depends on 16)

The device of claim 16, wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

### Claim 18 (depends on 1)

The device of claim 1, wherein the disinfectant or antimicrobial agent is a fluid or a gel.

### Claim 19 (depends on 1)

The device of claim 1, wherein the peelable seal comprises an aluminum or multi-layer polymer film peel back top.

### Claim 20 (depends on 1)

The device of claim 1, wherein the peelable seal is heat-sealed or induction sealed to the container open end face to retain the cap within the container.

### Claim 21 (depends on 1)

The device of claim 1, wherein the cap is selectively coupled to the container via a keyed connection.

### Claim 22 (depends on 21)

The device of claim 21, wherein the keyed connection comprises one or more depressions of the container configured to be selectively coupled to a plurality of radial protrusions on the cap.

### Claim 23 (depends on 1)

The device of claim 1, wherein the cap is selectively coupled to the container via a slip-fit connection.

### Claim 24 (depends on 23)

The device of claim 23, wherein the plurality of depressions of the container selectively coupled the plurality of radial protrusions of the cap via a slip-fit connection.

### Claim 25 (depends on 1)

The device of claim 1, wherein the plurality of radial protrusions extend along an entire length of the exterior wall surface of the cap and the plurality of depressions extend along an entire length of the interior container surface.

### Claim 26 (depends on 1)

The device of claim 1, wherein the plurality of radial protrusions partially extend along the length of the exterior wall surface of the cap and the plurality of depressions partially extend along the length of the interior container surface.

### Claim 27 (depends on 1)

The device of claim 1, wherein the plurality of radial protrusions and the plurality of depressions are elongate.

### Claim 28 (depends on 1)

The device of claim 1, wherein the plurality of radial protrusions and the plurality of depressions are tapered.

### Claim 29 (depends on 1)

A method of disinfecting a medical connector, the method comprising: connecting the device of claim 1 to a medical connector, wherein connecting includes frictionally engaging the interior wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

### Claim 30 (depends on 1)

An assembly comprising:
a connector of claim 1 connected with one of a male luer connector, a female luer connector, a needleless connector.