# US 12,594,410 B2 · Device for delivering an antimicrobial composition into a medical device

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- Number: US 12,594,410 B2
- Document ID: US12594410B2
- Status: Granted
- Kind: B2
- Application number: 18/061,385
- Filed: 2022-12-02
- Published: 2023-04-20
- Granted: 2026-04-07
- Earliest claimed: 2018-11-07
- Assignees: ICU Medical, Inc.
- Applicants: ICU Medical, Inc.
- Inventors: Robert J. Ziebol; Matthew David Beilke
- Web page: https://patentgrep.com/patent/US12594410B2

## CPC

- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 5/178: Syringes
- A61M 5/3134: {characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula}
- A61M 39/20: Closure caps or plugs for connectors or open ends of tubes
- A61M 39/1033: {Swivel nut connectors, e.g. threaded connectors or bayonet-connectors}
- A61M 2039/1083: {having a plurality of female connectors, e.g. Luer connectors}
- A61M 2039/1088: {having a plurality of male connectors, e.g. Luer connectors}
- A61M 2205/0205: Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
- A61M 2205/19: Constructional features of carpules, syringes or blisters
- 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

The present disclosure is directed to a device for delivering an antimicrobial composition into a medical device. Some embodiments disclosed herein provide a method for preventing infection and microbial ingress in medical device connections. The device includes a male connector with a distal tip and a recess at the distal tip. The surface of the recess includes an antimicrobial composition. In certain implementations a male luer comprises a tapered sealing member further comprising a recess containing chlorhexidine acetate.

## Claims

### Claim 1

A male connector device for coupling with a female connector, the male connector device comprising:
a male luer comprising a male tapered surface extending axially away from a wall of the male connector device;
a shroud extending axially away from the wall of the male connector device, the shroud configured to surround at least a portion of a length of the male luer;
an inner thread of the shroud configured to engage with corresponding threads of the female connector;
a fluid flow channel through the male connector device;
a plurality of recesses formed in a distal portion of the male luer, each recess of the plurality of recesses extends proximally from a distal end of the male luer, wherein the plurality of recesses are configured to create a space between a surface of each of the plurality of recesses and a female tapered surface of the female connector that can receive a liquid when the male connector device is coupled with the female connector; and
a water-soluble antimicrobial composition positioned on the surface of each of the plurality of recesses.

### Claim 2 (depends on 1)

The connector device of claim 1, wherein the plurality of recesses extend along a length of the male luer in the distal portion of the male luer.

### Claim 3 (depends on 1)

The connector device of claim 1, wherein the plurality of recesses are circumferentially arranged about the male tapered surface in the distal portion of the male luer.

### Claim 4 (depends on 1)

The connector device of claim 1, wherein the plurality of recesses are formed only in a portion of the male luer that extends past a distal surface of the shroud.

### Claim 5 (depends on 1)

The connector device of claim 1, wherein the male connector device comprises a tapered surface distal edge proximal to a distal tip of the male connector device, the tapered surface distal edge being at a distalmost end of the male tapered surface.

### Claim 6 (depends on 5)

The connector device of claim 5, wherein the tapered surface distal edge is coincident with a proximal edge of the plurality of recesses.

### Claim 7 (depends on 1)

The connector device of claim 1, wherein an axial length of the plurality of recesses is approximately 0.020 inches to 0.040 inches.

### Claim 8 (depends on 1)

The connector device of claim 1, wherein the water-soluble antimicrobial composition comprises chlorhexidine.

### Claim 9 (depends on 1)

The connector device of claim 1, wherein the plurality of recesses are separated by a plurality of blades that extend radially outward.

### Claim 10 (depends on 9)

The connector device of claim 9, wherein the plurality of blades are arranged substantially parallel to a central longitudinal axis.

### Claim 11 (depends on 1)

The connector device of claim 1, wherein the male connector device further comprises a proximal trap comprising a cavity.

### Claim 12 (depends on 11)

The connector device of claim 11, wherein at least a portion of the water-soluble antimicrobial composition is contained within the proximal trap.

### Claim 13 (depends on 1)

The connector device of claim 1, wherein upon insertion of the male connector device into the female connector, an annular cavity is formed between the surface of each of the plurality of recesses and the female tapered surface of the female connector.

### Claim 14 (depends on 1)

The connector device of claim 1, wherein the male luer, including the distal portion thereof, is monolithically formed.

### Claim 15 (depends on 1)

The connector device of claim 1, wherein a distal edge is proximal to the distal end of the male luer, wherein the distal edge is at a distalmost end of the male tapered surface, wherein each recess of the plurality of recesses is entirely distal to the distal edge.

### Claim 16

A connector device for delivering an antimicrobial composition into a medical device, the connector device comprising:
a male connector comprising a male tapered surface configured to engage a female connector of the medical device, the female connector having a female tapered surface, such that the male tapered surface engages the female tapered surface to form a fluid-tight seal, the male connector further comprising:
a conical taper defined in part by the male tapered surface;
a distal tip having a distal end;
a plurality of recesses each comprising a recess surface, each recess of the plurality of recesses extends proximally from the distal end of the male connector, the recess surface of each of the plurality of recesses are configured to extend radially inward of the male tapered surface;
a fluid flow channel through the male connector; and
a water-soluble antimicrobial composition positioned on the recess surface of the plurality of recesses;
wherein:
the connector device is configured such that, upon insertion of the male connector into the female connector, at least one cavity is formed between the recess surface of the plurality of recesses and the female tapered surface of the female connector.

### Claim 17 (depends on 16)

The connector device of claim 16, wherein the connector device is configured such that the at least one cavity defines a volume between the male connector and the female connector that is configured to receive a fluid therein, and wherein a portion of the antimicrobial composition is dissolvable into a fluid to form a chlorhexidine precipitate on a portion of the female tapered surface.

### Claim 18 (depends on 16)

The connector device of claim 16, wherein the recess surface of the plurality of recesses are recessed 0.001″ to 0.015″ radially inwardly from a line of taper extending along the male tapered surface.

### Claim 19 (depends on 16)

The connector device of claim 16, wherein the plurality of recesses are formed in the male connector.

### Claim 20 (depends on 16)

The connector device of claim 16, wherein when the distal end of the male connector is inserted into the medical device, a fluid inside the medical device at least partially fills the at least one cavity and at least a portion of the antimicrobial composition is dispersed within the fluid in the at least one cavity.
