GB2584846A

GB2584846A - Improved breath sampling device

Info

Publication number: GB2584846A
Application number: GB1908622.2A
Authority: GB
Inventors: Allsworth Max; Gordon Patrick; Smith Robert
Original assignee: Owlstone Medical Ltd
Current assignee: Owlstone Medical Ltd
Priority date: 2019-06-17
Filing date: 2019-06-17
Publication date: 2020-12-23
Anticipated expiration: 2039-06-17
Also published as: GB2584846B; GB201908622D0

Abstract

Breath sampling device (10) comprising a conduit (14) coupled to a sensor region ( 18) in which at least one sensor (20) is disposed, at least one collection container (26) for collecting breath samples, the at least one collection container (26) disposed external to the sensor region (18) and in communication with the conduit ( 14), wherein a VOC filter (50) is disposed between the sensor region (18) and the conduit (14), so as to separate the sensor region (18) from the conduit (14). The VOC filter may be disposed adjacent a bacterial filter (22), or may be combined with the bacterial filter. The collection container may be a tube containing sorbent material and may be orthogonal to the conduit. The device may be used in combination with a scrubbed air supply.

Description

Intellectual Property Office Application No. GII1908622.2 RTM Date:12 November 2019 The following terms are registered trade marks and should be read as such wherever they occur in this document: Page 4 line 1 I: Organosorb Intellectual Property Office is an operating name of the Patent Office www.gov.uk /ipo Title: Improved Breath Sampling Device

Field of the invention

The present invention relates to an improved breath sampling device used for obtaining one or more samples of breath from the subject.

Background of the invention

Apparatus to capture one or more breath samples from a patient is known and disclosed in WO 2017/187120. This apparatus allows samples of breath to be to obtained from the patient for analysis to detect one or more biomarkers or other analytes. Biomarkers are of specific interest in health and disease as they are excreted through breath, urine, faeces and skin, providing non-invasive access. Volatile biomarkers (VBs) consist of both volatile organic compounds (VOCs) and volatile inorganic compounds (VICs). Examples of VBs implicated in health and disease IS include alkanes, alkenes, acetone, isoprene, NO, CO and aldehydes.

Any change in the function of an organism changes cellular metabolism and the resulting changes in VBs may serve as biomarkers for assessment of a wide range of physiological and pathophysiological processes.

Contamination of the breath sample needs to be avoided. To this end, generally the device disclosed in WO 2017/187120 is used with a clean air supply.

Summary of the invention

In accordance with the invention, there is provided a breath sampling device comprising a conduit coupled to a sensor region in which at least one sensor is disposed, at least one collection container for collecting breath samples, the at least one collection container disposed external to the sensor region and in communication with the conduit, wherein a VOC filter is disposed between the sensor region and the conduit, so as to separate the sensor region from the conduit and ensure any air passing from the sensor region to the conduit is filtered to reverse medium-weight VOCs. The VOC filter allows volatile biomarkers to pass through it but volatile medium-weight VOC contaminants are not able to pass through, so ensuring they cannot contaminate samples taken within one or more collection containers. In use, air returning along the conduit from the sensor region, as will happen when a user exhales and inhales, must pass through the VOC filter to reach the at least one collection container.

The VOC filter may be positioned across an end of the sensor region proximal the conduit. Alternatively the VOC filter may be positioned across an end of the conduit proximal the sensor region. Thus the VOC filter may be incorporated either into the sensor region, or with the conduit which is particularly of use where the conduit is 0 disposable, such as for example with a mouthpiece-type conduit rather than a mask acting as a conduit.

The VOC filter may be disposed adjacent a bacterial filter and if desired the bacterial filter and VOC filter may be combined as a single unit.

The at least one collection container preferably partially extends into the conduit.

Preferably the at least one collection container is a tube, and in particular a tube containing sorbent material, for example similar to activated carbon, that is capable of absorbing VBs and then re-emitting them when heated in a detector or other analyser apparatus. Typically a plurality of collection containers, or tubes, will be used so as to collect a plurality of samples.

Where the at least one collection container s a tube, preferably the tube is positioned substantially orthogonal to the conduit.

The device may be used in combination with a scrubbed air supply.

The invention will now be described, by way of example with reference to the accompanying drawings in which: Figure 1 shows a perspective view from the front of a breath sampler device being one embodiment of the present invention; Figure 2 shows a perspective view from the rear of the breath sampler device; and Figure 3 shows a cross-sectional view of the breath sampler device.

Description

Referring to Figure 1, breath sampling device 10 comprises body 12 to which mask portion 14 is attached, mask portion 14 acting as a conduit into inlet 16 which leads to an enclosed region 18 in which sensor 20 is located. If required, a mouthpiece may be used instead of a mask, the mouthpiece connecting to inlet 16. Mask portion 14 is generally preferred as it is positionable over a user's mouth and nose allowing the user to breathe through either their nose or mouth, with typically the mask portion o being attached to the user's face by an elasticated band or the like. The mask portion is formed of a soft, resiliently deformable plastics material and forms an airtight seal with the facial skin.

Region 18 is separated from mask portion 14 by a bacterial filter 22 which extends is across inlet 16 so that all air passes through this filter.

Sensor 20 is typically a CO2 and pressure sensor and is monitored by microprocessor control board 24. When sensor 20 detects the correct points in a breathing cycle to collect a sample of breath from a human user for capture in collection tubes 26, collection pump 28 is operated in response to signals from control board 24 so as to draw air away from the conduit defined by mask portion 14 and down into tubes 26.

Collection tubes 26 are typically filled with sorbent material, such as activated carbon, capable of absorbing VBs and to then re-emitting the VBs when tube 26 is heated in a detector or analyser. Collection tubes 26 are held within a clamp element 30 and protrude through apertures 32 in mask portion 14 such that air exhaled/ inhaled from a human user passes over the tops of tubes 26.

When undertaking sampling, generally clean air is input through port 34. An outlet 40 from region 18 includes a one-way valve 42 permitting the human user to breathe out to the room while inhaling (scrubbed) clean air from port 34. One-way valve 42 is typically a mechanical unit consisting of a plastic membrane that permits air out of device 10 but does not permit air in.

Device 10 is designed to be re-useable, although bacterial filler 22, mask portion 14 and tubes 26 are replaceable. When undertaking sampling, with or without clean air being input through port 26, it has been observed that contaminating VOCs are being collected in sorbent tubes 26 even when a clean air supply is used where these contaminant VOCs have in theory been removed. The contaminating VOCs can obscure important volatile biomarkers that require detection. It was determined that these contaminants were coming from the human user's breath, which is a particular problem when the equipment is used by successive users as residual air exhaled from io the previous user can be retained in region 18. By positioning a VOC filter 50, for example made from charcoal granules, or activated carbon cloth, or Organosorb (coconut-based) carbon, to extend over inlet 16 so that all air passes through filter 50, it was found that contaminants in the form of medium-weight compounds did not return from sensor region 18 to reach sorbent tubes 26 although volatile biomarkers of Is interest could still reach sorbent tubes 26, leading to improved detection of volatile biomarkers as they are no longer obscured from detection by medium-weight contaminants.

VOC filter 50 can be combined with bacterial filter 22 or placed proximal or adjacent bacterial filter 22. VOC filter 50 is thus disposed within body 12 between sensor 20 and inlet 16 and extends over the entirety of inlet 16, ensuring unwanted contaminants in residual air in region 18 are removed before they reach sample tubes 26.

Claims

Claims 1. A breath sampling device comprising a conduit coupled to a sensor region in which at least one sensor is disposed, at least one collection container for collecting breath samples, the at least one collection container disposed external to the sensor region and in communication with the conduit, wherein a VOC filter is disposed between the sensor region and the conduit.
2. A device according to claim 1, wherein the VOC filter s positioned across an end of the sensor region proximal the conduit.
3. A device according to claim 1, wherein the VOC filter is positioned across an end of the conduit proximal the sensor region.
4. A device according to any of the preceding claims, wherein the VOC filter s is disposed adjacent a bacterial filter.
5. A device according to claim 4, wherein the bacterial filter and VOC filter are combined as a single unit.
6. A device according to any of the preceding claims, wherein the at least one collection container partially extends into the conduit.
7. A device according to any of the preceding claims, wherein the at least one collection container is a tube containing sorbent material.
8. A device according to claim 7, wherein the tube is positioned substantially orthogonal to the conduit.
9. A device according to any of the preceding claims used in combination with a scrubbed air supply.