# US 10,245,342 B2 · Antimicrobial devices for use with medical devices and related assemblies and methods

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- Number: US 10,245,342 B2
- Document ID: US10245342B2
- Status: Granted
- Kind: B2
- Application number: 14/559,746
- Filed: 2014-12-03
- Published: 2015-03-26
- Granted: 2019-04-02
- Earliest claimed: 2012-06-22
- Assignees: Health Line International Corp.
- Applicants: Health Line International Corp.
- Inventors: Li Min She; Joel K. Faulkner; Zhao Jie; Aaron Garcia Faulkner
- Web page: https://patentgrep.com/patent/US10245342B2

## CPC

- A61L 2/18: Liquid substances
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Antimicrobial devices for use with at least a portion of a medical device include at least one flexible portion configured to secure the antimicrobial device to the at least a portion of the medical device. Medical device assemblies include an access port and an antimicrobial device adapted to disinfect at least a portion of the access port. Methods of disinfecting a portion of a device include deforming a housing of the antimicrobial device to couple the antimicrobial device to the portion of the device.

## Claims

### Claim 1

An antimicrobial device for use in disinfecting at least a portion of a medical device, the antimicrobial device comprising:
a monolithic, nonporous flexible housing formed from a flexible material, the flexible housing having a first open end forming an access port in the antimicrobial device to a cavity formed in the flexible housing for receiving the at least portion of the medical device within the antimicrobial device, a second closed end opposing the first open end, and a longitudinal axis extending between the first open end and the second closed end, the first open end being defined by a furthest longitudinal extent of the housing at a first longitudinal end of the housing, wherein the cavity in the flexible housing and an outer surface of the flexible housing are both tapered along the longitudinal axis of the flexible housing;
an antimicrobial substance contained within the cavity in an amount sufficient to disinfect at least a portion of the medical device;
a plurality of flexible concentric protrusions, at least one flexible protrusion of the plurality of flexible protrusions positioned at and directly adjacent to the first open end and extending around and into the cavity from an inner surface of the flexible housing in a direction perpendicular to the longitudinal axis of the flexible housing, wherein the at least one flexible protrusion is configured to directly engage with and secure the antimicrobial device to the at least a portion of the medical device in a manner allowing for the antimicrobial substance to make surface contact with the at least a portion of the medical device, wherein each successive concentric protrusion of the plurality of flexible concentric protrusions has a diameter that is less than a diameter of an adjacent concentric protrusion of the plurality of flexible concentric protrusions, wherein the at least one flexible protrusion and the flexible housing comprise a single unitary structure formed by injection molding; and
a nonporous sealing member adhered to the first open end, the sealing member and the nonporous flexible housing configured to entirely contain the antimicrobial substance within the cavity, while only enabling the antimicrobial substance to pass through the access port at the first open end after the nonporous sealing member has been removed from the housing.

### Claim 2 (depends on 1)

The antimicrobial device of claim 1, wherein the at least one flexible protrusion encompasses the cavity.

### Claim 3 (depends on 1)

The antimicrobial device of claim 1, wherein the at least one flexible protrusion is further configured to secure the antimicrobial substance to a threaded portion of a medical device and a non-threaded portion of a medical device.

### Claim 4 (depends on 1)

The antimicrobial device of claim 1, wherein the at least one flexible protrusion comprises a plurality of flexible protrusions positioned along the longitudinal axis of the flexible housing.

### Claim 5 (depends on 1)

The antimicrobial device of claim 1, wherein the cavity in the flexible housing and the outer surface exhibit a non-tapered portion along the longitudinal axis of the flexible housing at a location proximate the first open end.

### Claim 6 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing is configured to engage with both a needle access site and a needleless access site.

### Claim 7 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing does not have threads formed on an inner surface of the flexible housing.

### Claim 8 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing is configured to elastically deform responsive to a force applied to the flexible housing by fingers of a user.

### Claim 9 (depends on 1)

The antimicrobial device of claim 1, wherein at least one of the flexible housing and the at least one flexible protrusion are configured to elastically deform about the at least a portion of the medical device in order to secure the antimicrobial device to the at least a portion of the medical device.

### Claim 10 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing is entirely formed from the flexible material exhibiting at least one of a type A Shore hardness of less than 90 and a Young's modulus of less than 50 MPa.

### Claim 11 (depends on 1)

The antimicrobial device of claim 1, wherein only the at least one flexible protrusion is configured to secure the antimicrobial device to the at least a portion of the medical device.

### Claim 12 (depends on 1)

The antimicrobial device of claim 1, further comprising a plurality of external ribs extending from the outer surface of the flexible housing along the longitudinal axis of the flexible housing.

### Claim 13 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing comprises:
a tapered portion wherein the cavity in the flexible housing and the outer surface of the flexible housing are both tapered along the longitudinal axis of the flexible housing; and
a non-tapered portion adjacent the tapered portion and the first open end wherein the cavity in the flexible housing and the outer surface of the flexible housing exhibit a substantially constant cross section along the longitudinal axis of the flexible housing.

### Claim 14 (depends on 1)

The antimicrobial device of claim 1, wherein the flexible housing further comprises a non-tapered portion adjacent the tapered portion and the first open end wherein the cavity in the flexible housing and the outer surface of the flexible housing exhibit a substantially constant cross section along the longitudinal axis of the flexible housing.

### Claim 15 (depends on 1)

A medical device assembly comprising:
a device access port configured to at least one of sample fluid from a subject and deliver fluid to a subject; and
the antimicrobial device of claim 1 adapted to disinfect at least a portion of the access port.

### Claim 16 (depends on 1)

A method of disinfecting a portion of a device, the method comprising:
deforming the flexible housing of the antimicrobial device of claim 1;
retaining the antimicrobial device on the portion of the device for a selected period of time with the at least one flexible protrusion of the plurality of flexible protrusions so as to disinfect the portion of the device; and
removing the antimicrobial device from the portion of the device.

### Claim 17 (depends on 16)

The method according to claim 16, wherein deforming at least a portion of a housing of the antimicrobial device comprises elastically deforming the housing of the antimicrobial device comprising a flexible material with a force applied to the flexible housing with fingers of a user.

### Claim 18 (depends on 16)

The method according to claim 16, further comprising retaining the antimicrobial device on the portion of the device with only the at least one protrusion of the plurality of protrusions.

### Claim 19 (depends on 16)

The method according to claim 16, further comprising engaging a threaded portion of the device with the housing of the antimicrobial device.

### Claim 20 (depends on 16)

The method according to claim 16, further comprising engaging a non-threaded portion of the device with the housing of the antimicrobial device.
