# US 12,109,365 B2 · Antimicrobial device comprising a cap with ring and insert

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- Number: US 12,109,365 B2
- Document ID: US12109365B2
- Status: Granted
- Kind: B2
- Application number: 17/891,990
- Filed: 2022-08-19
- Published: 2023-03-02
- Granted: 2024-10-08
- Earliest claimed: 2018-11-21
- Assignees: ICU Medical, Inc.
- Applicants: ICU Medical, Inc.
- Inventors: Robert J. Ziebol
- Web page: https://patentgrep.com/patent/US12109365B2

## CPC

- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 1/3661: {for haemodialysis}
- A61M 39/20: Closure caps or plugs for connectors or open ends of tubes
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 39/1033: {Swivel nut connectors, e.g. threaded connectors or bayonet-connectors}
- A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement}
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2209/06: Packaging for specific medical equipment
- 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

Systems, methods, and devices for providing an antimicrobial composition to the proximal elements of a transdermal catheter and into the lumen of the transdermal catheter are disclosed. In an embodiment, the device includes a cap configured to be removably secured to the hub, the cap comprising a ring member comprising first threads for engaging second threads on the hub of the transdermal catheter, the ring member having an opening through its interior; and an insert member secured within the opening of the ring member; wherein the insert member comprises an antimicrobial composition and the ring and insert member do not readily rotate with regard to one another.

## Claims

### Claim 1

A device for insertion into a hub on a proximal end of a transdermal catheter, the device comprising:
a cap configured to be removably secured to the hub, the cap comprising:
a ring member comprising:
first threads configured to engage second threads on the hub of the transdermal catheter;
an opening through an interior of the ring member; and
at least one recess formed in the ring member;
an insert member positioned within the opening of the ring member, comprising:
a central protrusion extending axially along the insert member, the central protrusion having an outside surface; and
a fin projecting away from the outside surface of the central protrusion, the fin positioned within the at least one recess of the ring member in an assembled state of the device to prevent the ring member from rotating relative to the insert member when the cap is rotated and threaded onto the hub of the transdermal catheter;
wherein:
in the assembled state, the insert member is axially secured to the ring member so that the insert member is prevented from moving in any axial direction relative to the ring member; and
the insert member comprises an antimicrobial composition on at least a portion of the insert member.

### Claim 2 (depends on 1)

The device according to claim 1, wherein the fin has a tapered shape such that a width of the fin is greater at a proximal end of the fin than at a distal end of the fin.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the ring member and the insert member are joined by an interference fit.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the ring member has a sharp edge on a proximal edge of one or more tabs to deform into a surface of the insert member.

### Claim 5 (depends on 1)

The device according to claim 1, wherein the insert member further comprises a flange at a proximal end of the insert member and the central protrusion extends axially from the flange, wherein the outside surface of the central protrusion is tapered, and wherein an elongate member extends axially from a distal end of the central protrusion.

### Claim 6 (depends on 1)

The device according to claim 1, wherein the fin is sized and configured to provide an interference fit with the at least one recess of the ring member when the cap is in the assembled state.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the ring member comprises a plurality of recesses between a plurality of tabs and the insert member comprises a plurality of fins located around a circumference of the insert member at or adjacent to the proximal end of the insert member, the plurality of fins being sized and configured to be received by the plurality of recesses of the ring member.

### Claim 8 (depends on 1)

The device according to claim 1, wherein the ring member comprises an antimicrobial on at least a portion of the first threads.

### Claim 9 (depends on 1)

The device according to claim 1, wherein the insert member further comprises an elongate member, the elongate member configured for insertion into the hub of the transdermal catheter.

### Claim 10 (depends on 1)

The device according to claim 1, wherein the insert member has a solid cross-section.

### Claim 11 (depends on 1)

The device according to claim 1, wherein the antimicrobial composition is a layer of dry antimicrobial on at least the outside surface of the insert member.

### Claim 12 (depends on 1)

The device according to claim 1, wherein the cap comprises a dry antimicrobial composition coated at least on an inside surface of the ring member and on the outside surface of the insert member.

### Claim 13

A device for sealing a lumen of a transdermal catheter, the device comprising:
a cap configured to seal the lumen at a hub at a proximal end of the transdermal catheter, the cap comprising:
a ring member comprising:
first threads configured to engage second threads on the hub;
an opening through an interior of the ring member;
at least one recess;
an insert member comprising:
a tapered outer surface configured to engage a tapered inner surface in the hub to seal a fluid inside a lumen of the hub; and
one or more fins projecting away from the tapered outer surface;
wherein:
in an assembled state, the insert member is secured within the opening of the ring member; and
in the assembled state, the one or more fins of the insert member project into the at least one recess of the ring member so that the ring member is rotationally locked to the insert member at least when the device is rotated and threaded onto the hub at the proximal end of the transdermal catheter.

### Claim 14 (depends on 13)

The device according to claim 13, wherein an outer surface on the one or more fins is configured to engage an inner surface on the ring member, with the outer surface of the one or more fins having a greater diameter than the engaged inner surface on the ring member.

### Claim 15 (depends on 13)

The device according to claim 13, wherein the insert member comprises an antimicrobial composition on at least a portion of the insert member.

### Claim 16 (depends on 13)

The device according to claim 13, wherein the ring member comprises an antimicrobial on at least a portion of threads located on an interior of the ring member.

### Claim 17 (depends on 13)

The device according to claim 13, wherein the insert member comprises a central protrusion and an elongate member extending from the central protrusion, wherein the elongate member has an outer size that is less than an outer size of the central protrusion at a distal end of the central protrusion, and wherein the elongate member comprises an antimicrobial composition on at least a portion of the elongate member.

### Claim 18 (depends on 13)

The device according to claim 13, wherein the ring member and the insert member are joined by an interference fit.

### Claim 19 (depends on 13)

The device according to claim 13, wherein, in the assembled state, the insert member is axially fixed to the ring member such that the insert member is prevented from moving in any axial direction relative to the ring member.

### Claim 20

A device for sealing a lumen of a transdermal catheter, the device comprising:
a cap configured to seal the lumen at a hub at a proximal end of the transdermal catheter, the cap comprising:
a ring member comprising:
first threads configured to engage second threads on the hub;
an opening through an interior of the ring member;
at least one recess;
an insert member comprising:
a tapered outer surface configured to engage a tapered inner surface
in the hub to seal a fluid inside a lumen of the hub; and
one or more fins projecting away from the tapered outer surface;
wherein:
in an assembled state, before the device is threaded onto the hub at the proximal end of the transdermal catheter, the insert member is axially secured to the ring member so that the insert member is at least inhibited from moving in any axial direction relative to the ring member; and
in the assembled state, the one or more fins are configured to project into the at least one recess to rotationally lock the insert member to the ring member.

### Claim 21 (depends on 20)

The device according to claim 20, wherein an outer surface on the one or more fins is configured to engage an inner surface on the ring member, with the outer surface of the one or more fins having a greater diameter than the engaged inner surface on the ring member.

### Claim 22 (depends on 20)

The device according to claim 20, wherein the insert member has a solid cross-section.

### Claim 23 (depends on 20)

The device according to claim 20, wherein the ring member comprises an antimicrobial on at least a portion of threads located on an interior of the ring member.

### Claim 24 (depends on 20)

The device according to claim 20, wherein the insert member comprises a central protrusion and an elongate member extending from the central protrusion, wherein the elongate member has an outer size that is less than an outer size of the central protrusion at a distal end of the central protrusion, and wherein the elongate member comprises an antimicrobial composition on at least a portion of the elongate member.

### Claim 25 (depends on 20)

The device according to claim 20, wherein, in the assembled state, before the device is threaded onto the hub at the proximal end of the transdermal catheter, the insert member is axially secured to the ring member so that the insert member is prevented from moving in any axial direction relative to the ring member.
