# US 12,268,372 B2 · Oral fluids collection device and method

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- Number: US 12,268,372 B2
- Document ID: US12268372B2
- Status: Granted
- Kind: B2
- Application number: 17/448,904
- Filed: 2021-09-27
- Published: 2022-04-07
- Granted: 2025-04-08
- Earliest claimed: 2020-10-07
- Assignees: Kenvue Brands LLC
- Applicants: Johnson & Johnson Consumer Inc.
- Inventors: Curt Binner; Alexandru Paunescu
- Web page: https://patentgrep.com/patent/US12268372B2

## CPC

- A61B 10/0051: {for taking saliva or sputum samples (devices for receiving spittle A61J9/00)}
- A61J 11/0005: {having additional ports, e.g. for connecting syringes or straws (devices for administering medicines orally A61J7/00)}
- A61J 17/001: {Baby-comforters}
- A61J 17/10: {Details; Accessories therefor}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

An oral fluids sample collection method and apparatus includes a shield having a first face and a second face; an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; and a reservoir component extending from the second face of the shield comprising a reservoir having a reservoir interior. These elements are interconnected by a plurality of fluid conduit/valve combinations, including a first combination permitting flow from the nipple interior to an atmospheric vent port disposed on an exterior surface of the oral fluids collection device; a second combination permitting flow from the reservoir interior to the nipple interior; and a third combination permitting flow from a collection port disposed on the outer surface of the nipple to an exit port in the reservoir interior.

## Claims

### Claim 1

An oral fluids collection device comprising:
(a) a shield having a first face and a second face;
(b) an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield;
(c) a reservoir component extending from the second face of the shield comprising a reservoir having a reservoir interior;
(d) a first fluid conduit having a first one-way valve operatively connecting and permitting flow from the nipple interior to an atmospheric vent port disposed on an exterior surface of the oral fluids collection device;
(e) a second fluid conduit having a second one-way valve operatively connecting and permitting flow from the reservoir interior to the nipple interior; and
(f) a third fluid conduit having a third one-way valve operatively connecting and permitting flow from a collection port disposed on the outer surface of the nipple to an exit port in the reservoir interior.

### Claim 2 (depends on 1)

The oral fluids collection device of claim 1 wherein the reservoir component is arranged and configured for demountable engagement to the shield.

### Claim 3 (depends on 1)

The oral fluids collection device of claim 1 wherein the reservoir component further comprises at least one deformable zone.

### Claim 4 (depends on 1)

The oral fluids collection device of claim 1 wherein the reservoir component further comprises a housing to enclose the reservoir.

### Claim 5 (depends on 1)

The oral fluids collection device of claim 1 wherein the reservoir component has disposed within the reservoir interior a buffer solution.

### Claim 6 (depends on 1)

The oral fluids collection device of claim 1 wherein the exit port is arranged and configured to provide an air gap between liquids in the exit port and liquids in the reservoir interior.

### Claim 7 (depends on 1)

A method of collecting oral fluids comprising:
(a) removing the oral fluids collection device of claim 1 from packaging;
(b) inserting the nipple having an initial rest volume into a subject's oral cavity;
(c) deforming the nipple to force fluid from the nipple interior to the atmospheric vent port;
(d) allowing the nipple to expand toward the initial rest volume thereby drawing fluid from the reservoir interior and decreasing fluid pressure in the reservoir component; and
(e) drawing the oral fluids from the subject's oral cavity through the collection port to the reservoir interior.

### Claim 8 (depends on 7)

The method of claim 7 wherein the oral fluids comprise saliva.

### Claim 9 (depends on 7)

The method of claim 7 further comprising demounting the reservoir component from the shield.

### Claim 10 (depends on 9)

The method of claim 9 further comprising adding a buffer solution to the reservoir interior.

### Claim 11 (depends on 10)

The method of claim 10 further comprising analyzing the oral fluids.

### Claim 12 (depends on 7)

The method of claim 7 wherein the reservoir component has disposed within the reservoir interior a buffer solution.

### Claim 13 (depends on 12)

The method claim 12 further comprising analyzing the oral fluids.

### Claim 14

An oral fluids collection kit comprising:
(a) a durable component comprising:
(i) a shield having a first face and a second face; and
(ii) an elastomeric nipple having an outer surface and defining a nipple interior extending from the first face of the shield; and
(b) a plurality of attachable reservoir components arranged and configured for demountable engagement to the shield, each attachable reservoir component comprising a reservoir having a reservoir interior;
wherein an assembly of one of the plurality of attachable reservoir components to the durable component defines an oral fluids collection device having (1) a first fluid conduit having a first one-way valve operatively connecting and permitting flow from the nipple interior to an atmospheric vent port disposed on an exterior surface of the oral fluids collection device; (2) a second fluid conduit having a second one-way valve operatively connecting and permitting flow from the reservoir interior to the nipple interior; and (3) a third fluid conduit having a third one-way valve operatively connecting and permitting flow from a collection port disposed on the outer surface of the nipple to the reservoir interior.

### Claim 15 (depends on 14)

The oral fluids collection kit of claim 14 wherein each of the plurality of attachable reservoir components is individually packaged.

### Claim 16 (depends on 14)

The oral fluids collection kit of claim 14 wherein each of the plurality of attachable reservoir components further comprises at least one deformable zone.

### Claim 17 (depends on 14)

The oral fluids collection kit of claim 14 wherein each of the plurality of attachable reservoir components further comprises a housing to enclose the reservoir.

### Claim 18 (depends on 14)

The oral fluids collection kit of claim 14 wherein the reservoir component each of the plurality of attachable reservoir components has disposed within the reservoir interior a buffer solution.

### Claim 19 (depends on 14)

The oral fluids collection kit of claim 14 wherein the exit port is disposed in a central portion of the reservoir interior of each of the plurality of attachable reservoir components.

### Claim 20 (depends on 14)

The oral fluids collection kit of claim 14 further comprising directions to transport a used reservoir portion of the plurality of reservoir components to a test facility.

### Claim 21 (depends on 14)

A method of collecting oral fluids using the oral fluids collection kit of claim 14 comprising:
(a) removing one of the plurality of attachable reservoir components of the oral fluids collection kit of claim 14 from packaging;
(b) attaching the attachable reservoir component of step (a) to the durable component to form the oral fluids collection device;
(c) inserting the nipple having an initial rest volume into a subject's oral cavity;
(d) deforming the nipple to force fluid from the nipple interior to the atmospheric vent port;
(e) allowing the nipple to expand toward the initial rest volume thereby drawing fluid from the reservoir interior and decreasing fluid pressure in the reservoir component; and
(f) drawing the oral fluids from the subject's oral cavity through the collection port to the reservoir interior.

### Claim 22 (depends on 21)

The method of claim 21 wherein the oral fluids comprise saliva.

### Claim 23 (depends on 21)

The method of claim 21 further comprising demounting the reservoir component from the shield.

### Claim 24 (depends on 23)

The method of claim 23 further comprising adding a buffer solution to the reservoir interior.

### Claim 25 (depends on 24)

The method of claim 24 further comprising analyzing the oral fluids.

### Claim 26 (depends on 21)

The method of claim 21 wherein the one reservoir component of the plurality of attachable reservoir components has disposed within the reservoir interior a buffer solution.

### Claim 27 (depends on 26)

The method of claim 26 further comprising analyzing the oral fluids.