NL2026016B1

NL2026016B1 - A device for a sample collector, the device comprises a mouth piece having an exterior inlet opening configured for receiving mouth exhaled respiratory air and a sample collector

Info

Publication number: NL2026016B1
Application number: NL2026016A
Authority: NL
Inventors: Hendrik Walter Van Tol Remmelt
Original assignee: Medco B V
Priority date: 2020-07-08
Filing date: 2020-07-08
Publication date: 2022-03-11

Abstract

The invention relates to a device for a sample collector, the device comprises a mouth piece having an exterior inlet opening configured for receiving mouth exhaled respiratory air, and an exhale flow channel configured for transporting the mouth exhaled respiratory air received by means of the exterior inlet opening into the sample collector. The invention further relates to a sample collector and to its use.

Description

Title: A device for a sample collector, the device comprises a mouth piece having an exterior inlet opening configured for receiving mouth exhaled respiratory air and a sample collector Description The invention relates to a device for a sample collector, the device comprises a mouth piece having an exterior inlet opening configured for receiving mouth exhaled respiratory air, and an exhale flow channel configured for transporting the mouth exhaled respiratory air received by means of the exterior inlet opening into the sample collector.

The invention further relates to a sample collector and to its use.

WO 2019/081263 discloses a device for a sample collection device for obtaining samples from exhaled respiratory air.

The device has an inlet tube, an outlet tube for discharging the respiratory air from the sample collection device, and at least a portion of a spiral path running into an outlet opening which is designed to transport the respiratory air to the sample collection device.

A drawback of the device known from WO 2019/081263 is that the device has a relatively complex configuration.

In addition, it is not a user friendly device as it will not be evident for an unexperienced user from the appearance of the device whether to use the inlet tube or the outlet tube for a correct use of the device.

It is an object of the present invention to provide a device which has a relatively simple configuration, such that the device is to be used in a relatively user- friendly way in assisting to collect a sample from mouth exhaled respiratory air of a user.

In a further aspect, the device is relatively easily to manufacture.

This object is achieved by a device as defined in claim 1. The device comprises a mouth piece having an exterior inlet opening configured for receiving mouth exhaled respiratory air.

The device also comprises an exhale flow channel configured for transporting the mouth exhaled respiratory air received by means of the exterior inlet opening into the sample collector.

The device is connected or connectable to a top of the sample collector, wherein the exhale flow channel is configured to be positioned at least mainly inside the sample collector such that an outlet opening of the exhale flow channel is positionable in the sample collector closer to a bottom than to the top of the sample collector. A virtual center line of the device extends through a center of the exterior inlet opening and through a center of the outlet opening. By providing such a device having a relatively simple configuration, the device is relatively easy to manufacture in a cost effective manner. In addition, as a result of the mouth piece and its exterior inlet opening which is arranged in such a manner with respect to the outlet opening that a virtual center line of the device extends through a center of the exterior inlet opening and through a center of the outlet opening, the device is user-friendly even for an unexperienced user, because only from the appearance of the device a user knows intuitional how to use the device. Incorrect use of the device is prevented or even excluded as the device has no other projecting parts which can be incorrectly identified or incorrectly used by an user to introduce exhaled respirator air in the sample collector when the device is connected to the sample collector.

In one aspect of the device, a travel path of the mouth exhaled respiratory air provided by the exhale flow channel is relatively long, i.e. a total length of the device extending in the direction of the virtual center line of the device is mainly determined by the exhale flow channel. This length of the exhale flow channel ensures that the exhale flow channel can be positioned or is positioned at least mainly inside the sample collector, wherein an outlet opening of the exhale flow channel is positioned or positionable in the sample collector closer to a bottom than to the top of the sample collector. The sample collector comprises a sample collector material on or close to the bottom of the sample collector to obtain samples from the mouth exhaled respiratory air. Seen in the direction of the virtual center line of the device a length of the mouthpiece may be smaller than a length of the exhale flow channel, preferably at least two times smaller, more preferred at least three times smaller, still more preferred at least four times smaller. Without being bound by theory, the inventor has found out that a relatively long exhale flow channel contributes in an effective way to take samples by means of the sample collector material from the mouth exhaled respiratory air. The relatively long exhale flow channel may for example facilitate to produce more condensate of the exhaled air in the exhale flow channel to be mixed with the sample collector material. In the mouth exhaled respiratory air, exhaled breath condensate (EBC) and associated exhaled breath aerosols (EBA) are valuable non- invasive biological media used for the quantification of biomarkers to identify for example diseases.

The relatively long travel path of the mouth exhaled respiratory air in the device before contacting the sample collector material further transports the exhaled air towards the sample collector material with minimal mixing risks, or even no mixing risks if a liquid sample collector material is used, with other (external) gases inside the sample collector, which may be beneficial for isolating the required material from the exhaled air in the sample collector material.

The relatively long exhale flow channel has the additional advantage that a relatively low amount of the sample collector material has to be used in the sample collector, because the outlet opening can be positioned relatively close to the bottom of the sample collector.

The device used in combination with the sample collector may be particularly useful for an user- friendly isolation of genetic material for diagnosis machines for diagnosing respiratory viruses such as coronavirus diseases, for example COVID-19. The user-friendly device for the sample collector facilitates taking a sample from the user by the user himself, i.e. without participation or supervision of a medical practitioner.

Hence, it is possible to take the sample at home, wherein the sample collector, for example a portable transport tube sealed by a cap, can be sent by courier/post to a laboratory facility or the like for analysis/diagnosis.

As a result, a potentially infected user does not have to make minimal or no travel movements, which reduces the risk of infecting others.

Further, as the device for the sample collector and the sample collector can be manufactured relatively easily on a large scale, the sample collector and the device can be widely used for testing relatively large groups of people in a relatively fast and user-friendly manner.

In this way it is possible to map out an infection spread and infection pressure on a large scale during an epidemic / pandemic or as an preventive measure in a certain area, such as for example a city, to help map out how many people are infected in the certain area.

Exhaled breath condensate (EBC) and associated exhaled breath aerosols (EBA) may contain exhaled water vapor, soluble gas-phase (polar) organic compounds, ionic species, plus other species including semi- and non-volatile organic compounds, proteins, cell fragments, genetic material (RNA/DNA), dissolved inorganic compounds, ions, and micro-biota (bacteria and viruses) dissolved in the co-collected

EBA.

The device may be fixed to the sample collector in a manner that it is difficult or even impossible to remove the device from the sample collector. Typically, the device is configured to be releasably connectable to the sample collector, for example by a click mechanism or by screwing the device on the sample collector.

In one aspect, a distance extending traverse to the virtual center line of the device between two diametrically opposing outer side portions of the mouth piece varies seen in the direction of the virtual center line of the device. Such a varying distance provides an improved design freedom in obtaining an user-friendly mouthpiece. A distance extending traverse to the virtual center line of the device between two diametrically opposing outer side portions of a first end of the mouth piece including the exterior inlet opening may be smaller than a distance extending traverse to the virtual center line of the device between two diametrically opposing outer side portions of a second end of the mouth piece opposite to the first end seen in the direction of the virtual center line of the device. Such a mouth piece is configured to obtain the exhaled air from the lungs from a user in a relatively user-friendly manner with minimal or even no risk that ambient air or other external gasses is/are introduced in the sample collector during blowing out the exhaled air, which is beneficial in obtaining the required material for diagnosis by the sample collector material in the sample collector. The mouthpiece may have an outer surface of hyperboloidal shape around the virtual center line of the device for an optimal positioning of the mouth piece in a mouth of a user to introduce in the sample collector mouth exhaled respiratory air as pure as possible with minimal or no external components.

The invention also relates to a sample collector comprising the device as described in this disclosure, wherein the sample collector further comprises sample collecting material near the outlet opening of the exhale flow channel. The above- described advantages of the device also apply to the sample collector and these are therefore not repeated here. The sample collecting material may be a liquid medium for isolating viral particles from the mouth exhaled respiratory air. A liquid is in particularly advantageous if the outlet opening of the exhale flow channel is submerged in the liquid medium such that during transport of the mouth exhaled respiratory air to the liquid medium undesired mixing with external fluids is reduced or even excluded. In such a manner, the likelihood of improved or more pure test results from the mouth exhaled respiratory air based on the samples obtained by the sample collector is increased.

5 The invention also relates to use of a sample collector, wherein a user by using the mouthpiece of the device exhales at least once full lung capacity, preferably a user exhales at least two times full lung capacity. The above-described advantages also apply to the use of the sample collector.

The above-described and claimed aspects will be explained below by means of an exemplary embodiment in combination with the figures. However, the invention is not limited to the exemplary embodiment described below. Rather, a number of variants and modifications are possible which also use the inventive idea and therefore fall within the scope of protection. In particular, the possibility of combining the features/aspects which have only been mentioned in the description and/or been shown in the figures with the features of the claims, in so far as they are compatible, is mentioned.

Fig. 1a-e show various views of a device for a sample collector; Fig. 2 shows a side view of a sample collector in combination with the device shown in fig. 1a-d; In the figures, similar components are denoted with the same reference signs.

Fig. 1a-e show various views of a device 1 for a sample collector 100 shown in fig. 2, wherein fig. 1a shows a side view of the device 1, fig. 1b a cross section through the device 1, fig. 1c a perspective view of the device 1, fig. 1d a cross section of the device 1 and fig. 1e a top view of the device 1.

The device 1 is a disposable device 1. The device 1 is disposable from a hygienic and/or public safety perspective, but also because reuse of the device 1 may introduce the risk of pollution which may have a negative influence on an effective isolation of (viral) particles from the mouth exhaled respiratory air by the sample collecting material. It is noted that the configuration of the device 1 is relatively simple, such that it is possible to manufacture the disposable device 1 in a cost- effective way. The device 1 comprises a mouth piece 3 having an exterior inlet opening 5 configured for receiving mouth exhaled respiratory air. The device 1 also comprises an exhale flow channel 7 configured for transporting the mouth exhaled respiratory air received by means of the exterior inlet opening 5 into the sample collector 100. The device 1 is connectable to a top 110 of the sample collector 100. The exhale flow channel 7 is configured to be positioned at least mainly inside the sample collector as is shown in fig. 2 such that an outlet opening 5 of the exhale flow channel 7 is positionable in the sample collector 100 closer to a bottom 120 than to the top 110 of the sample collector 100. A virtual center line 50 of the device 1 extends through a center of the exterior inlet opening 5 and through a center of the outlet opening 9 as shown in figure 1e by a cross 20 shown with dotted lines in fig. 1e, wherein the intersection of the two lines of the cross 20 coincides with the virtual center line 50 and the centres of the exterior inlet opening 5 and the outlet opening 9. The device 1 is relatively user-friendly as mentioned above and has a relatively simple configuration, wherein a relatively long exhale flow channel 7 further contributes in an effective way to take samples by means of the sample collector material from the mouth exhaled respiratory air. As a result of the relatively long exhale flow channel with the outlet end located relatively close to the bottom 120 of the sample collector 100 a minimal volume of sample collector material in the sample collector 100 is required.

A distance, see for example distances D1 and D2 indicated in fig. 2, extending traverse to the virtual center line 50 of the device 1 between two diametrically opposing outer side portions of the mouth piece 3 varies seen in the direction of the virtual center line 50 of the device 1. In particular, a distance D3 extending traverse to the virtual center line 50 of the device 1 between two diametrically opposing outer side portions of a first end of the mouth piece 3 including the exterior inlet opening 5 is smaller than a distance D4 extending traverse to the virtual center line of the device between two diametrically opposing outer side portions of a second end (indicated by dotted line 15 in figure 2} of the mouth piece 3 opposite to the first end seen in the direction of the virtual center line of the device. The mouth piece 3 shown in the figures has around the virtual center line 50 of the device 1 an outer surface of hyperboloidal shape. Seen in the direction of the virtual center line 50 of the device a length L1 (fig. 2) of the mouthpiece 3 is smaller than a length L2 of the exhale flow channel 7, i.e. the length L1 is at least four times smaller than the length L2. As can be seen in figs 1b and 2 (see L2), the exhale flow channel 7 extends between the exterior inlet opening 5 and the outlet opening 9. A cross section of the exhale flow channel 7 traverse to the virtual center line 50 of the device 1 decreases toward the outlet opening 9, in particular the cross section of the exhale flow channel 7 traverse to the virtual center line 50 of the device 1 continuously decreases toward the outlet opening. Such a tapered design of the exhale flow channel 7 facilitates a condensation process of the mouth exhaled respiratory air inside the exhale flow channel 7, which may improve/accelerate an isolation process of particles from the mouth exhaled respiratory air in the sample collector material.

The device 1 is further provided with three ventilation holes 17a-c (fig. 1d) configured for discharging gas from the interior of the sample collector 100 during use, wherein the ventilation holes 17a-c are located at an equidistant spacing with respect to the virtual center line 50 of the device and located in one virtual plane extending traverse to the virtual center line 50 of the device 1. In this manner, the pressure inside the sample collector 100 can be controlled effectively. The ventilation holes 17a-c are provided in or partially provided in the mouthpiece 3, i.e. in the device 1 shown the ventilation holes 17a-c are provided on the transition between mouthpiece 3 and base body 23 of the device such that in a connected state of the device 1 on the sample collector 100 gas may escape from the interior of the sample collector 100 by means of the ventilation holes 17a-c. An inner side of the base body 23 is provided with a screw thread to provide the connection between the device 1 and the sample collector 100 which on an outer side close to top 110 is also provide with a cooperating screw thread. Seen in the direction of the virtual center line 50 the base body 23 lies between the exterior inlet opening 5 and the outlet opening 9, i.e. seen in the direction of the virtual center line the base body 23 lies between the mouthpiece 3 and the outlet opening 9, wherein around the virtual center line 50 a portion of the exhale flow channel 7 extends in the interior of the base body 23 and the mouthpiece 3. A distance D5 extending traverse to the virtual center line 50 between two diametrically opposing outer side portions of the base body 23 is larger than a distance D1-D4 extending traverse to the virtual center line 50 between two diametrically opposing outer side portions of the mouth piece 3. The outer side of the base body 23 has a substantially cylindrical shape. The distance D5 between the two diametrically opposing outer side portions of the base body 23 is at least two times larger than a distance D3 extending traverse to the virtual center line 50 between two diametrically opposing outer side portions of a first end of the mouth piece 3 including the exterior inlet opening 5. The base body has a cap-like design, wherein the outer side of the base body 23 is ribbed or textured (see figure 1a and 1c) to facilitate grip for a hand for twisting the device 1 to accomplish the releasable connection between the device 1 and the sample collector 100 by means of the screw threads.

The sample collector 100 is a portable transport tube. The sample collector 100 further comprises sample collecting material 150 (figure 2) near the outlet opening 9 of the exhale flow channel 7. The sample collecting material 150 may be a liquid medium for isolating (viral) particles from the mouth exhaled respiratory air. A liquid is in particularly advantageous if the outlet opening 9 of the exhale flow channel 7 is submerged in the liquid medium 150 such that during transport of the mouth exhaled respiratory air to the liquid medium undesired mixing with external fluids is reduced or even excluded to improve test results from the mouth exhaled respiratory air in a subsequent step (not shown). The sample collector 100 is operated by a user by using the mouthpiece 3 of the device 1 to exhale at least once full lung capacity. Normally, a user exhales at least two times full lung capacity. Hence, taking samples using the device 1 and the sample collector 100 can be done in relatively small time window such that the device 1 and the sample collector 100 are extremely suitable for taking samples on a large scale.

The sample collector 100 further comprises a releasably connectable cap (not shown) for hermetically sealing the interior of the sample collector 100, wherein the cap has to be removed for connecting the device 1 to the sample collector 100 such that after using the device 1 and after taking the sample, the cap is (re)connectable to the sample collector 100 for transport of the sample in the sample collector 100 to a laboratory facility or the like. In other words, after an user has used the mouthpiece 3 of the device 1 for obtaining the required exhaled respiratory air in the sample collector 100, the device 1 is removed from the sample collector and the cap is used to hermetically seal the interior of the sample collector 100. A device (not shown) having more or less the same configuration as the device 1 may be fixed to the sample collector in a manner that it is difficult or even impossible to remove the device from the sample collector. For example, the device (not shown) may be one-piece structure with the sample collector 100, in that that the device constitutes an integral part of the sample collector 100.

The device 1 may further comprises a device cap (not shown) for hermetically sealing the interior of the sample collector such that the device cap can be used instead of the cap for sealing the sample collector only. Such a device cap seals the exterior inlet opening 5 and the ventilation holes 17a-c, wherein an outer side of the device may be configured to provide the releasable connection between the device and the device cap.

Claims

CONCLUSIONS

A sample collector apparatus, the apparatus comprising a mouthpiece having an external entrance opening configured to receive exhaled air through the mouth, and an exhalation flow channel configured to convey the air received through the mouth exhaled through the external entrance opening into the mouthpiece collector, the device being connected or connectable to a top of the sample collector, the exhalation flow channel configured to be positioned at least partially within the sample collector such that an exit opening of the exhalation flow channel is positionable in the sample collector closer to a bottom than to the top of the sample collector, a virtual centerline of the device extending through a center of the external entrance opening and through a center of the exit opening.

The device of claim 1, wherein a distance extending transverse to the virtual axis of the device between two diametrically opposed outer side portions of the nozzle varies when viewed in the direction of the virtual axis of the device.

The device of claim 1 or 2, wherein a distance extending transverse to the virtual axis of the device between two diametrically opposed outer side portions of a first end of the mouthpiece including the outer entrance opening is less than a distance transversely extending on the virtual axis of the device between two diametrically opposed outer side portions of a second end of the nozzle opposite the first end when viewed in the direction of the virtual axis of the device.

A device according to any one of the preceding claims, wherein about the virtual axis of the device the mouthpiece has an outer surface of hyperboloid shape.

Device according to any one of the preceding claims, wherein viewed in the direction of the virtual axis of the device a length of the mouthpiece is smaller than a length of the exhalation flow channel, preferably at least two times smaller, more preferably at least three times smaller , even more elected at least four times smaller.

The device of any preceding claim, wherein the exhalation flow channel extends between the external entrance opening and the exit opening.

A device according to any one of the preceding claims, wherein a cross section of the exhalation flow channel transverse to the virtual axis of the device decreases towards the exit opening, preferably the cross section of the exhalation flow channel transverse to the virtual axis of the device decreases continuously towards the exit opening.

An apparatus according to any one of the preceding claims, wherein the apparatus comprises at least one ventilation cavity configured to discharge gas from the interior of the sample collector during use, preferably the apparatus comprises a plurality of ventilation cavities located on an equal distance from the virtual axis of the device and located in a virtual plane extending transverse to the virtual axis of the device.

The device of claim 8, wherein the at least one ventilation cavity is provided in or partially provided in the mouthpiece.

A device according to any one of the preceding claims, wherein the device is provided with a basic body for providing the connection between the device and the sample collector, wherein viewed in the direction of the virtual axis of the device, the basic body is located between the outer entrance opening and the exit opening.

Device according to claim 10, wherein viewed in the direction of the virtual axis of the device, the basic body is located between the mouthpiece and the exit opening, a part of the outflow channel extending around the virtual axis of the device into the interior of the device. the basic body and/or of the mouthpiece.

A device according to claim 10 or 11, wherein a distance extending transversely to the virtual axis of the device between two diametrically opposite outer side portions of the basic body is greater than a distance extending transversely to the virtual axis of the device. between two diametrically opposed side portions of the mouthpiece.

13. Device as claimed in any of the foregoing claims 10-12, wherein the outside of the basic body has a substantially cylindrical shape.

A device according to claim 12 or 13, wherein the distance between the two diametrically opposed outer side parts of the basic body is at least twice greater than a distance extending transversely to the virtual centerline of the device between two diametrically opposed outermost parts. side portions of a first end of the mouthpiece including the external entrance opening.

An apparatus according to any one of the preceding claims 10-14, wherein the base body is releasably connectable to the sample collector and the base body has a cap-like design, preferably the outside of the base body is ribbed or textured.

A device according to any one of the preceding claims, wherein the device is a disposable device.

A sample collector comprising the apparatus of any preceding claim, wherein the sample collector further comprises a sample collection material proximate the exit opening of the exhalation flow channel.

The sample collector of claim 17, wherein the sample collector includes a releasably connectable cap for hermetically sealing the interior of the sample collector, the cap being removed before connecting the device to the sample collector such that after use of the device, the cap is (re)connectable to the sample collector.

The sample collector of claim 17 or 18, wherein the sample collector is a portable transport tube.

A sample collector according to any one of claims 17-19, wherein the sample collection material is a liquid medium for isolating virus particles from the air exhaled through the mouth.

A sample collector according to any one of claims 17-19, wherein the device includes a device cap for hermetically sealing the interior of the sample collector.

Use of a sample collector according to any one of the preceding claims, wherein a user exhales full lung capacity at least once using the mouthpiece of the device, preferably a user exhales full lung capacity at least twice.

Use of a sample collector according to claim 18 and 22 or claim 21 and 22, wherein after a user has used the mouthpiece of the device to obtain the required exhaled air into the sample collector, the device is removed from the sample collector and the cap is used to hermetically seal the interior of the sample collector or after a user has used the mouthpiece of the device to obtain the required exhaled air into the sample collector the device cap is used to hermetically seal the interior of the sample collector.