Method for Obtaining a Breath Sample of a Test Person and Device

Abstract

The disclosure relates to a method and a device for obtaining a breath sample of a test person, wherein the test person inhales a droplet mist which is preferably colder than the ambient temperature. The material exhaled and/or ejected by the test person is collected as a breath sample in one or more collection vessels.

Claims

1. A method for obtaining a breath sample from a test person, comprising: inhaling, by the test person, a droplet mist; at least one of exhaling and coughing up material by the test person after inhaling the droplet mist; and collecting the at least one of the exhaled and the coughed-up material as a breath sample.

2. The method as claimed in claim 1, wherein the droplet mist is colder than the ambient temperature.

3. The method as claimed in claim 1, further comprising: generating the droplet mist with an ultrasonic atomizer.

4. The method as claimed in claim 1, further comprising: cooling the droplet mist using at least one of ice and at least one Peltier element.

5. The method as claimed in claim 1, further comprising: conveying the at least one of the exhaled and the coughed-up material to at least one collecting vessel.

6. The method as claimed in claim 1, further comprising: guiding the at least one of the exhaled and the coughed-up material through a filter; and binding the at least one of the exhaled and the coughed-up material with the filter.

7. An apparatus for obtaining a breath sample from a test person, comprising: a device configured to generate a droplet mist; and a device configured to aspirate the droplet mist by the test person and to collect at least one of exhaled and coughed-up material from the test person.

8. The apparatus as claimed in claim 7, wherein the device configured to generate the droplet mist comprises: a storage vessel configured to store a liquid that is to be atomized; and an ultrasound transmitter.

9. The apparatus as claimed in claim 8, wherein the storage vessel is a disposable article.

10. The apparatus as claimed in claim 7, wherein the device configured to generate the droplet mist comprises: a cooling device.

11. The apparatus as claimed in claim 7, wherein the device configured to aspirate comprises: at least one check valve; and at least one collecting vessel.

12. The apparatus as claimed in claim 11, wherein the at least one collecting vessel comprises; at least one filter configured to bind the at least one of the exhaled and the coughed-up material.

13. The apparatus as claimed in claim 12, wherein the at least one comprises filter an SiO.sub.2 frit.

14. The apparatus as claimed in claim 12, wherein the filter comprises a porous Teflon film.

15. The apparatus as claimed in claim 7, wherein the device configured to aspirate consists of one or more disposable articles.

Description

[0016] Further features and advantages of the invention will become clear from the following description of illustrative embodiments in connection with the drawings. The individual features can be implemented individually or in combination with one another.

[0017] In the drawings:

[0018] FIG. 1 shows a schematic sectional view of an apparatus for obtaining a breath sample from a test person, and

[0019] FIG. 2 shows a view of a device for the aspiration of a droplet mist and for collecting the exhaled and/or coughed-up material, as part of the apparatus according to the invention.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0020] FIG. 1 shows in schematic form the components of an apparatus 10 for obtaining a breath sample. The apparatus 10 comprises a device 114 for generating a droplet mist 100. In this embodiment, the droplet mist is generated by means of an ultrasound transmitter 101. The liquid 102 that is to be atomized, in particular an aqueous liquid or pure water (tap water), is located in a storage vessel 103. By subjecting the storage vessel 103 to ultrasound using the ultrasound transmitter 101, which in this example is operated with a high-frequency alternating current (AC), the droplet mist 100 is generated in the storage vessel 103. The storage vessel 103 comprises an air inflow opening 104 and a droplet mist outlet opening 105. The air enters through the air inflow opening 104, here indicated by an arrow, and the droplet mist 100 leaves the storage vessel 103 through the droplet mist outlet opening 105, again indicated by an arrow. For the method according to the invention, a droplet mist is used whose temperature is preferably below the ambient temperature and which triggers a mild cough stimulus in the test person when the droplet mist is inhaled. The cold droplet mist can be generated in different ways. In this embodiment, a Peltier cooling element 106 is provided which, for example, can be operated with direct current (DC). By means of the cooling element 106, the aqueous solution or the water 102 in the storage vessel 103 is cooled, such that the formed droplet mist 100 is also cold. In another embodiment, it is possible, for example, to place ice or an ice cube in the liquid 102.

[0021] The generation of a cold droplet mist 100 is also possible in this way. On the other hand, the evaporative cold of the droplets, generated by the atomization, may in some cases be sufficient to trigger a subjective sensation of coldness and to elicit a cough in the test person.

[0022] For the purposes of the invention, it is possible to use a customary, commercially available appliance with ultrasound function and, optionally, a cooling function, into which appliance the storage vessel 103, with the liquid 102 that is to be atomized, is inserted for example. The storage vessel 103 can be coupled to the actual ultrasound transmitter/cooler via a further coupling medium, in particular a liquid. The storage vessel 103 can be designed as a disposable article, for example in a cost-effective manner from plastic, which article is formed accordingly. Thus, the storage vessel 103 can be disposed of after use. The ultrasound transmitter 101 and the optional Peltier cooling element 106 can be provided for mains operation or also for mobile battery operation.

[0023] The apparatus 10 further comprises a device 126 by which the droplet mist 100 can be aspirated by the test person and into which the test person exhales again or coughs, such that the device 126 is further provided for collecting the exhaled and/or coughed-up material. The device 126 is preferably designed as a disposable article, such that it can be disposed of after use in order to rule out the possibility of a further test person being infected by infectious material. The device 126 comprises a suction opening or a suction pipe 107 through which the droplet mist 100 is aspirated by the test person (arrow 115). The suction pipe 107 can be designed as a mouthpiece. In other designs, a mouthpiece can be plugged or screwed, for example, onto the suction pipe 107. The suction pipe 107 also serves to blow in the exhaled and/or coughed-up air flow after the droplet mist has been inhaled. To direct this air flow, here indicated by the arrow 116, a check valve 108 is provided between the suction pipe 107 and that end of the device 126 via which the generated droplet mist 100 flows into the device 126. With this check valve 108, the exhaled flow of air is diverted into a collecting vessel 109. This collecting vessel 109 can be in the form of, for example, a commercially available Eppendorf® filter vessel, which can be plugged onto a corresponding lateral opening or a lateral port 110 of the suction pipe 107. In this preferred embodiment, the collecting vessel 109 comprises a filter 111, in particular a filter frit, for example made of silicon oxide, on which the exhaled and/or coughed-up material is collected. So as not to generate any significant counterpressure during the blowing of the exhaled air into the device 126, the collecting vessel is provided with an outflow opening 112 through which the blown-in exhaled air can flow out in the arrow direction. After the test person has inhaled the droplet mist and the exhaled and/or coughed-up material has been blown back into the device 126, the collecting vessel 109 with the filter 111 contained therein can be removed in a simple manner and, in particular, the filter 111 can be removed for further analysis of the material and processed further.

[0024] The device 126 is connected to the device 114 (mist generator) in such a way that the droplet mist 100 generated can flow through the device 126. For this purpose, the device 126 can be plugged or screwed into the droplet mist outlet opening 105 via a connector piece 113 for example. For this purpose, a suitable seal or a thread can be provided in the region of the connection.

[0025] The connector piece 113 to the rear of the check valve 108 can, for example, be plugged directly into the droplet mist outlet opening 105, wherein further sealing means can be provided here to ensure a tight closure.

[0026] The check valve 108 is expediently realized as a simple mechanical check valve, such that the droplet mist 100 or the water droplet/air mixture can only be aspirated from the mist generator 114, which is formed in particular of the storage vessel 103, the ultrasound transmitter 101 and optionally the Peltier cooling element 106, and can no longer flow back. Such check valves 108 can be made of plastic, for example, and are available at low cost.

[0027] To prepare for taking a sample, the device 126 can first of all be connected to the device 114 or the storage vessel 103, before the coupling of the ultrasound and optionally the Peltier cooling means takes place, for example via an additional water reservoir as coupling medium. Commercially available atomizers can be used here. The process of inhaling the droplet mist 100 and blowing the exhaled flow of air into the device 126 can be repeated one or more times. Once the sampling is complete, the whole device 126 can be separated from the mist generator 114. The one or more collecting vessels 109 can, for example, be broken off or unscrewed, and the biological material contained therein, which may be bound to the filter 111, can undergo molecular biological analysis, for example with the aid of lab-on-a-chip analyses.

[0028] If the device 126 and optionally the storage vessel 103 are designed as disposable articles, then, after removal of the collecting vessels 109, the whole device 26 and optionally the storage vessel 103 can be discarded, since these parts may possibly be contaminated with pathogens.

[0029] These parts may also be stored on a temporary basis, for example with disinfectant solution, and later disposed of, for example by burning them.

[0030] If the storage vessel 103 is also designed as a disposable article, the check valve 108 does not have to be impermeable to microbes, since contamination by the disposable article is ruled out in any case. Therefore, the whole device 126 and also the storage vessel 103 can be manufactured as one or more inexpensive plastic parts that do not represent a significant cost factor. For example, the suction pipe 107, with the port 110 and the check valve 108 and also the connector part 113, can be manufactured as a one-piece article. It is also possible to combine these elements as a one-piece article with the storage vessel 103. This makes the use particularly easy since, in order to prepare to take a sample, all that needs to be done is to plug one or more collecting vessels 109 onto the one or more ports 110 and to insert the storage vessel 103 into the corresponding ultrasound/cooling appliance.

[0031] FIG. 2 shows a device 206 for the aspiration of the droplet mist and for collecting the exhaled/coughed-up material, the device 206 being provided for two collecting vessels 209. These collecting vessels 209, each with a filter 211, are plugged on via ports 210 located on opposite sides of the suction pipe 207. In other embodiments, a predetermined breaking point 210 can be provided instead of a port, such that the collecting vessels 209 can be broken off or twisted off after use, in order to be taken for further analysis. In other respects, the device 206 is comparable to the device 126 from FIG. 1, with a check valve 208 being provided in the interior of the device 206. With the region 213, the device 206 can be plugged or screwed into a droplet mist outlet opening of a storage vessel of a mist generator for the liquid that is to be atomized, wherein a corresponding thread can be provided.

[0032] The apparatuses described here serve to obtain a breath sample from a test person, wherein the droplet mist generated in the apparatuses, which preferably has a temperature below the ambient temperature, is inhaled and interacts with the surface of the test person's airways, wherein biological material located there is absorbed and at the same time a cough stimulus is generated, which has the effect that the water droplets charged with sample material are coughed up. By providing the substantially disposable apparatus with a check valve, the exhaled aerosol is forced through the preferably provided filters of the collecting vessels, such that the biological sample material is held back on the filters. The collecting vessels, with the filters thus charged, can be separated and, for example, taken for a molecular biological analysis and diagnosis process, preferably in lab-on-a-chip systems. These apparatuses and methods are particularly suitable for screening bacterial infections of the lungs, for example for tuberculosis screening. However, other diseases of the lungs, for example systemic diseases caused by bacteria, fungi or viruses or tumor diseases, can also be diagnosed and/or monitored using this method and the apparatuses described.