# US 12,178,415 B2 · Airway sampling device and associated methods

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- Number: US 12,178,415 B2
- Document ID: US12178415B2
- Status: Granted
- Kind: B2
- Application number: 16/973,864
- Filed: 2019-06-11
- Published: 2021-06-17
- Granted: 2024-12-31
- Earliest claimed: 2018-06-11
- Assignees: Hunt Developments (UK) Ltd.; Imperial College Innovations Limited
- Applicants: Hunt Developments Ltd.; Imperial College Innovations Limited
- Inventors: Trevor T Hansel; Toby Hunt; Trevor Hunt; Duncan Hunt
- Web page: https://patentgrep.com/patent/US12178415B2

## CPC

- A61B 10/0051: {for taking saliva or sputum samples (devices for receiving spittle A61J9/00)}
- A61B 13/00: Instruments for depressing the tongue (combined with illuminating and viewing instruments A61B1/24; combined with saliva removers A61C17/10)
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61B 10/00: Instruments for taking body samples for diagnostic purposes (for taking samples of blood A61B5/15); Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- G01N 1/4055: {by solubility techniques}
- A61B 2010/0087: {Breath samples}
- A61B 2010/009: {Various features of diagnostic instruments}
- G01N 2001/4061: {Solvent extraction}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present application discloses a variety of airway sampling devices and associated methods. According to an embodiment, an airway sampling device for taking a sample from a subject's airway is provided with a handle to be gripped by a user when taking the sample and a sampling head carried by the handle, the sampling head comprising a cavity with an opening for entry by the sample and a sample collection membrane located within the cavity for receiving the sample.

## Claims

### Claim 1

An airway sampling device for taking a sample from a subject's airway, the device comprising:
a handle to be gripped by a user when taking the sample, and
a sampling head carried by the handle, the sampling head comprising a cavity with an opening for entry by the sample and a sample collection membrane located within the cavity for receiving the sample,
wherein the sampling head is provided with a wrap-around hood which encloses the sample collection membrane on all sides, including on lateral sides of the sampling head and on a leading side of the sampling head opposite to the handle, such that the sample collection membrane is enclosed on all sides other than at the opening to the cavity within the hood to enable the sampling head to push past the tonsils of the subject, to deflect the uvula of the subject, and potentially to also contact the back of the subject's throat, without any fluid contamination of the sample collection membrane.

### Claim 2 (depends on 1)

The airway sampling device according to claim 1, wherein the sample collection membrane comprises absorbent and/or adsorbent material.

### Claim 3 (depends on 1)

The airway sampling device according to claim 1, wherein the sample collection membrane is detachable from the sampling head.

### Claim 4 (depends on 1)

The airway sampling device according to claim 1, wherein the cavity has a gutter provided at least partly around its opening.

### Claim 5 (depends on 1)

The airway sampling device according to claim 1, wherein the cavity is defined within a peripheral wall which creates the wrap-around hood, and wherein an outer surface of the peripheral wall is configured to be perpendicular to the tonsils of the subject when the sampling head is inserted into and/or removed from the subject's pharynx.

### Claim 6 (depends on 5)

The airway sampling device according to claim 5, wherein the outer surface of the peripheral wall is further configured to be perpendicular to the uvula and/or posterior wall of the oropharynx of the subject during capture of the sample from a sampling position in the patient's airway at which the opening of the cavity is located over the vocal cords and within the oropharynx posterior to the uvula of the subject.

### Claim 7 (depends on 6)

The airway sampling device according to claim 6, wherein an outer surface of the peripheral wall is configured to deflect the uvula of the subject, allowing the sampling head to enter the pharynx from the oral cavity.

### Claim 8 (depends on 1)

The airway sampling device according to claim 1, wherein the handle is provided with a chamber, and the sampling head is movable relative to the handle between a first condition in which the sampling head is distal from the handle and a second condition in which the cavity is located over the chamber to define an enclosure which encloses the sample collection membrane between the cavity and the chamber.

### Claim 9 (depends on 8)

The airway sampling device according to claim 8, wherein the enclosure is fluid-tight.

### Claim 10 (depends on 8)

The airway sampling device according to claim 8, wherein a weakened area is provided in one of the chamber or the cavity.

### Claim 11 (depends on 10)

The airway sampling device according to claim 10, wherein the weakened area is configured to rupture when pressure is applied to the enclosure.

### Claim 12 (depends on 11)

The airway sampling device according to claim 11, wherein the weakened area is provided in the chamber, and the chamber is formed from a deformable material to allow a user to apply pressure to the enclosure.

### Claim 13 (depends on 8)

The airway sampling device according to claim 8, wherein the interior of the chamber is provided with one or more protrusions which contact the sample collection membrane when the sampling head is placed into its second condition.

### Claim 14 (depends on 1)

The airway sampling device according to claim 1, wherein the interior of the cavity is provided with one or more protrusions on which the sample collection membrane is located.

### Claim 15 (depends on 1)

The airway sampling device according to claim 1, wherein the sampling device further comprises an illumination module, and the sampling head is configured as a light guide to guide and emit light emitted from the illumination module.

### Claim 16 (depends on 15)

The airway sampling device according claim 15, wherein the illumination module is removably mounted on the sampling device.

### Claim 17 (depends on 1)

The airway sampling device according to claim 1, wherein the sampling head is provided at a first end of the sampling device distal from a second end of the sampling device at which the handle is provided, and the sampling device further comprises a shield mounted between the first and second ends of the sampling device, for shielding the user from sample from the subject.

### Claim 18 (depends on 1)

The airway sampling device according to claim 1, wherein the airway sampling device is shaped and dimensioned so as to locate the opening of the cavity over the vocal cords and within the oropharynx posterior to the uvula of a subject when the sampling head is located at a sampling position in the patient's airway for taking the sample.

### Claim 19 (depends on 1)

The airway sampling device according to claim 1, wherein the sampling head is angled relative to the handle, so as to present a plane of the opening of the cavity at an angle of between 25° to 45° downwardly from horizontal when the sampling head is located at a sampling position in the patient's airway at which the opening of the cavity is located over the vocal cords and within the oropharynx posterior to the uvula of the subject, with the subject upright.

### Claim 20 (depends on 1)

The airway sampling device according to claim 1, wherein a depth of the sampling device, from an uppermost surface of the handle to a lowermost tip of the sampling head, is from 17 mm to 23 mm.

### Claim 21 (depends on 1)

The airway sampling device according to claim 1, wherein a maximum width of the sampling head is between 10 mm to 16 mm.

### Claim 22 (depends on 1)

A method of taking a sample from a subject's airway using the airway sampling device of claim 1, the method comprising:
(i) inserting the airway sampling device of any one of the preceding claims into the subject's airway so as to position the sampling head at a sampling position located above the vocal cords and within the oropharynx and posterior to the uvula of the subject;
(ii) prompting the subject to cough or give a forcible expiration to produce the sample, which sample is collected by the sampling head; and
(iii) removing the sampling device from the subject's airway.

### Claim 23 (depends on 22)

The method of claim 22, further comprising exposing the sample collection membrane to an elution buffer to elute the sample into the elution buffer.
