# US 11,433,215 B2 · Antimicrobial device comprising a cap with ring and insert

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- Number: US 11,433,215 B2
- Document ID: US11433215B2
- Status: Granted
- Kind: B2
- Application number: 16/691,242
- Filed: 2019-11-21
- Published: 2020-05-21
- Granted: 2022-09-06
- Earliest claimed: 2018-11-21
- Assignees: ICU Medical, Inc.
- Applicants: ICU Medical, Inc.
- Inventors: Robert J. Ziebol
- Web page: https://patentgrep.com/patent/US11433215B2

## 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;
a plurality of tabs projecting into the opening; and
at least one recess between the plurality of tabs;
an insert member secured 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 being sized and configured to be received by the at least one recess between the plurality of tabs of the ring member;
wherein:
in an 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;
in an assembled state, the fin and the plurality of tabs prevent the ring member from rotating relative to the insert member when the cap is rotated and threaded onto the hub; 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 ring member and the insert member are joined by an interference fit.

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

The device according to claim 1, wherein the ring member and insert member are prevented from any axial movement by an interference fit between the ring member and 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 an assembled state.

### Claim 7 (depends on 1)

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

### Claim 13

A method of forming a device for insertion into a hub on a proximal end of a transdermal catheter, the method comprising:
providing 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;
applying an antimicrobial composition to at least a portion of an insert member, wherein the insert member has at least one fin projecting radially outwardly from an outer surface of the insert member, the at least one fin being configured to be received by the at least one recess of the ring member; and
advancing the insert member through the opening of the ring member so that the at least one fin advances into at least one recess of the ring member so as to secure the insert member to the ring member such that the ring member is at least inhibited from rotating relative to the insert member;
wherein the device is configured such that, in an assembled state, the at least one fin and the recess prevent the ring member from rotating relative to the insert member when the device is rotated and threaded onto the hub on a proximal end of the transdermal catheter.

### Claim 14 (depends on 13)

The method of claim 13, wherein the insert member and the ring member do not readily rotate more than 5 degrees with regard to one another when installed or removed from a hub of a transdermal catheter.

### Claim 15 (depends on 13)

The method of claim 13, comprising applying the antimicrobial composition to at least a portion of the ring member prior to assembling the insert member with the ring member.

### Claim 16 (depends on 13)

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

### Claim 17 (depends on 13)

The method of claim 13, wherein the insert member further comprises an elongate member, the elongate member configured for insertion into the hub of the transdermal catheter.

### Claim 18 (depends on 13)

The method of claim 13, wherein the device is configured such that, in an 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.

### Claim 19

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;
a plurality of tabs extending into the opening;
at least one recess between the plurality of tabs;
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 outer surface;
wherein:
the insert member is secured within the opening of the ring member; and
the one or more fins are configured to engage the tabs to prevent significant rotational movement of the insert member relative to the ring member when the cap is rotated and threaded onto the hub at a proximal end of the transdermal catheter.

### Claim 20 (depends on 19)

The device according to claim 19, 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 21 (depends on 19)

The device according to claim 19, wherein the insert member comprises an antimicrobial composition on at least a portion of the insert member.

### Claim 22 (depends on 19)

The device according to claim 19, wherein the ring member comprises an antimicrobial on at least a portion of threads located on an interior of the ring member.

### Claim 23 (depends on 19)

The device according to claim 19, 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 24 (depends on 19)

The device according to claim 19, wherein the ring member and the insert member are joined by an interference fit.

### Claim 25 (depends on 19)

The device according to claim 19, wherein, in an 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.