SYSTEM FOR DETECTING BIOLOGICAL VIRAL PARTICLES EMITTED INTO THE AIR BY A LIVING BEING

Abstract

The present invention relates to a system for detecting biological viral particles emitted into the air by a living being by means of an expiratory air volume, comprising at least one detecting and processing device of said expiratory air volume, capable of detecting a sample of said expiratory air volume and of condensing it into a condensed sample to be analyzed, and at least one analyzing device, connected to said detecting and processing device, capable of receiving said condensed sample, of detecting electrical signals associated with said condensed sample and of processing said electrical signals, so as to detect the viral biological particles contained therein.

Claims

1-11. (canceled)

12. A system for detecting biological viral particles emitted into the air by a living being by an expiratory air volume, comprising: at least one detecting and processing device configured for detecting a sample of the expiratory air volume and condensing the sample into a condensed sample to be analyzed; and at least one analyzing device connected to the detecting and processing device, configured for receiving the condensed sample, detecting electrical signals associated with the condensed sample and processing the electrical signals so as to detect viral biological particles contained within the condensed sample.

13. The system according to claim 12, wherein the detecting and processing device further comprises; a conveying element configured to be put on a head of the living being, the conveying element comprising an entry configured for receiving the expiratory air volume, and an exit capable of sending the expiratory air volume, and a condensing element connected to the conveying element, wherein the condensing element is configured for receiving the expiratory air volume and of condensing the expiratory air volume into the condensed sample.

14. The system according to claim 13, wherein the condensing element is single-use and/or unidirectional.

15. The system according to claim 13, wherein the detecting and processing device further comprises a measuring member configured for timing the detection of the expiratory air volume or measuring the breaths of the living being.

16. The system according to claim 15, wherein the measuring member is arranged internally or externally to the conveying element.

17. The system according to claim 12, wherein the detecting and processing device further comprises an acoustic and/or visual signaling element configured for signaling when the minimum expiratory air volume to be sampled is reached, or the minimum time or the minimum number of breaths to reach the minimum expiratory air volume.

18. The system according to claim 13, wherein the detecting and processing device further comprises a processing cell of the condensed sample.

19. The system according to claim 13, wherein the conveying element is an airtight mask configured to be placed on the face or head of the living being.

20. The system according to claim 13, wherein the conveying element is a mouthpiece configured to be put in a mouth of the living being.

21. The system according to claim 13, wherein the conveying element is a suction element comprising; an entry opening into which the expiratory air volume enters, an exit opening from which the expiratory air volume comes out, and an internal air moving device, configured for facilitating the entry of the expiratory air volume through the entry opening.

22. The system according to claim 12, wherein the analyzing device further comprises: a detecting module, comprising a support on which the condensed sample can be placed and including a plurality of sensors, wherein the sensors are biosensors, nano-sensors, or nano-pores sensors, and a processing module connected to the detecting module, the processing module comprising a plurality of processing channels and a processor, wherein the plurality of processing channels are connected to the plurality of sensors and are configured for detecting electrical signals and of sending electrical signals to the processor, wherein the electrical signals detect biological viral particles.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0043] The present invention will be now described, for illustrative but not limitative purposes, according to its preferred embodiments, with particular reference to the figures of the enclosed drawings, wherein:

[0044] FIG. 1 illustrates a schematic view of a system for detecting viral biological particles emitted into the air by a living being, object of the present invention;

[0045] FIG. 2 illustrates a side schematic view of a component of the system shown in FIG. 1;

[0046] FIG. 3 illustrates a side schematic view of a second embodiment of the component shown in FIG. 2; and

[0047] FIG. 4 illustrates a schematic front view of a third embodiment of the component shown in FIG. 2.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0048] In the various figures similar parts will be indicated with the same numerical references.

[0049] With reference to the attached figures, the system S for detecting viral biological particles emitted into the air by a living being E, object of the present invention, essentially comprises a device for detecting and treating the sample of air or air volume F to be analyzed, emitted during the exhalation of a living being E, and an analysis device 2 of the detected air sample.

[0050] Said detection and treatment device 1 is capable of sampling a quantity of the air volume F exhaled by a living being E.

[0051] Said device 1 comprises an element 11 for conveying the air volume F, a member 12 for measuring said air volume F, a condensing element 13 for the liquid content dispersed in said volume of sampled air F, and a processing cell 14 of the condensed.

[0052] In particular, with reference to FIG. 2, said conveying element 11 is a hermetically sealed mask, capable of being placed on the face or head of a living being E, so as to hermetically isolate it from the external environment.

[0053] Said mask 11 can be used both for a living being E of human and animal type, suitably adapting the external structure to the physical conformation of the living being E.

[0054] Said conveying element 11 comprises within a one-way valve, not shown in the figure, for conveying said air volume F from the mouth of the living entity E towards the subsequent elements of the detection and treatment device 1.

[0055] Said conveying element 11 can preferably be of the disposable type, to avoid the contagion risk of living beings E tested in succession with each other.

[0056] In the case of living beings E already ill, subjected to ventilation by means of closed circuits, the withdrawal of said volume of exhaled air F is carried out directly in the circuit where the exhaled air of these living beings E is collected.

[0057] Therefore, the measurement of the quantity of viral particles emitted with the exhaled breath, at a certain moment, or in the exhaled air collected, in case of the living beings E are connected to closed circuits, and the variations, presumably in crescendo-decrescendo of this quantity, can also constitute a criterion for following the evolution of the disease.

[0058] Said member 12 for measuring the air volume F receives at its inlet said air volume F exiting from said conveying element 11.

[0059] Without departing from the scope of protection of the present invention, said measuring member 12 can also be inserted inside said conveying element 11.

[0060] Said measuring member 12 can be a flow meter, or a timer, or a number of breaths meter.

[0061] Said measuring member 12 is provided with an acoustic and/or visual signaling element 121, so as to signal to the operator responsible for the use of said system S, that the minimum quantity of air volume F to be sampled has been reached, necessary or, alternatively, the minimum time or, alternatively, the minimum number of breaths to reach this air volume F.

[0062] Said measuring member 12 is preferably disposable to ensure medical safety.

[0063] Or, alternatively, said measuring member 12 is unidirectional, so as to ensure the impossibility of inversion of the air volume F, from the outside towards the living entity E.

[0064] Said condensing element 13 is connected to said measuring member 12.

[0065] In the embodiment wherein said measuring member 12 is comprised within said air conveying element 11, said condensing element 13 is connected directly to said conveying element 11.

[0066] Said condensing element 13 is capable of receiving the volume of exhaled air F and to condense in the liquid phase the water vapor naturally contained in said volume of exhaled air F, which therefore becomes a condensed sample L.

[0067] Said condensed sample L is then transmitted to the subsequent analysis stages.

[0068] Said condensing element 13 carries out the condensation of the water vapor by means of known methods.

[0069] In particular, the condensation takes place either through a direct cooling of the exhaled volume of air F, or through the contact of the exhaled volume of air F with a material, which allows its condensation, such as, for example, a metal sheet, possibly cooled.

[0070] Said condensing element 13 is of the disposable type or, alternatively, it must guarantee the impossibility of inversion of the air volume F to further reduce the possibility of contagion of the next tested living being E.

[0071] Said condensate processing cell 14 is connected to said condensation element 13, and it is capable of receiving the condensed sample L at the inlet and carrying out treatments on it.

[0072] In particular, a chemical and/or physical and/or microbiological treatment can be carried out on said condensate L in order to make it easier to analyze in the subsequent phases.

[0073] By way of example, the treatment could consist of filtering and/or treating with antibodies to identify and then make the microbial particles more visible.

[0074] However, the presence of said processing cell 14 in said detection and treatment device 1 is optional.

[0075] With reference to FIG. 3, in a second embodiment, said conveying element is a mouthpiece 11′ to be inserted in contact with the, or in the mouth of a human being E.

[0076] The above description for said conveying element 11 is also applied unchanged to said mouthpiece 11′.

[0077] With reference to FIG. 4, in a third embodiment, said conveying element is a suction 11″.

[0078] Said suction 11″ is a hollow container, preferably having a cylindrical shape, but which can nevertheless have different shapes and sizes.

[0079] Said suction 11″ is provided with an inlet opening 111 and an outlet opening 112.

[0080] Said air volume F flows into said inlet opening 111, while said air volume F comes out from said outlet opening.

[0081] Each of said inlet opening 111 and outlet opening 112 can be hermetically sealed.

[0082] Furthermore, each of said inlet opening 111 and outlet opening 112 can be closable manually or automatically.

[0083] A humidifier 113 is arranged within said suction device 11″, which is capable of humidifying said volume of incoming air F with a known concentration of water vapor per volume of air, so as to achieve the formation of a minimum condensed quantity for the analysis of the particle density per volume of ambient air.

[0084] Inside said suction 11″ there is also an air handling device 114, in particular a fan 114, capable of facilitating the entry of the air volume F through said inlet opening 111.

[0085] Said air movement device 114, as well as the opening of said suction 11″, can be operated manually or by means of a timer, or on the basis of certain factors such as: the number of living beings E present in a given environment, the achievement of certain concentrations of gas, which is an indirect measure of the air exhaled by living beings E present in the environment, and/or the type of physical activities carried out in the environment.

[0086] All these factors are potentially connected with a greater or lesser presence of potentially harmful biological particles emitted with the breath of living beings and sick and therefore contagious.

[0087] The description of said conveying element 11 remains unchanged also for the third embodiment of said suction 11″, and differs only in the following characteristics.

[0088] Said measuring member 12, if internally arranged, can be arranged in proximity of said inlet opening 111 or in proximity of said outlet opening 112, so as to measure the volume of air transited per unit of time.

[0089] Furthermore, said conveying element 11″ can be directly connected to said signaling element 121, as shown in FIG. 4.

[0090] Said analysis device 2 is connected to said detection and treatment device 1 by means of the processing cell 14, otherwise, in the absence of said processing cell 14, it is connected directly to said condensation element 13.

[0091] In the case of the third embodiment, said analysis device 2 can be connected directly to said outlet opening 112.

[0092] Said analysis device 2 can be of various substantially known types, the preferred ones are described.

[0093] Said analysis device 2 is preferably of the type comprising sensors, biosensors, or nano-sensors, by means of which it is possible to carry out detection and a subsequent analysis of ion channels, which are responsible for the exchange of trans-membrane proteins between intra and extra-cellular environments.

[0094] The ion channels are therefore able to respond to chemical-physical stimulations.

[0095] Said analysis device 2 essentially comprises a detecting module 21 and a processing module 22, connected to said detecting module 21.

[0096] In particular, said detecting module 21 comprises a support or plate of inorganic type material, preferably SiO.sub.2 or SiN.sub.x, on which nano-sensors or biosensors or artificial nano-pores of nano-metric dimensions, from a few nm up to hundreds of nm, for example 10.sup.−9 m, which come into contact with said condensed sample L to be examined.

[0097] Said processing module 22 comprises a plurality of processing channels connected to said detecting module 21, in particular, to said nano-pores support and to a processor.

[0098] When said condensed sample L comes into contact with said support, due to microfluidicity phenomena, said condensed sample L comes into contact with said nano-pores.

[0099] Consequently, suitable electrical signals are detectable by said plurality of processing channels, which send said electrical signals to said processor for processing said electrical signals.

[0100] In particular, said nano-pores detect the nano-metric particles with which they interact.

[0101] An interaction mode can, for example, be the following.

[0102] Said support, having nano-pores of the desired size, can be arranged as a separating element between two compartments containing an electrolytic solution, capable of sustaining an electric current, the flux variations of which can be measured.

[0103] If material containing nano-particles to be detected, such as viral particles or viral particles sensitized with modifications of their characteristics, is introduced into one of the two compartments, their passage through the nano-pores of the specific size can alter the flow of current.

[0104] These alterations, which can be associated with the characteristics of the nano-particles, such as, for example, mass, shape, and size, can be measured by said processing module 22 in real-time.

[0105] Said processing module 22 provides, in a digital and/or analog form and/or when thresholds are crossed, the results of the qualitative and quantitative analysis of the fluid sample L, showing whether the researched particles are present, presumably beyond a certain minimum threshold, and, in the positive case, with which quantitative presence, for example per unit of volume of the sample and, knowing the ratio of the fluid sample to the volume of air, per unit of volume of air subject to sampling.

[0106] The particles can be detected thanks to the nano-pores by various known techniques.

[0107] The two preferred methods are substantially described.

[0108] The first way is of the protein-protein interaction type in the nano-pore.

[0109] The detection principle is based on the interaction between the antibodies attached to the surfaces of the nano-pore, or functionalization, and the proteins present on the particle to be detected, such as, for example, in the case of the Corona Virus 19, the S1-spike on its capsid.

[0110] As the potential of virus particles present in said condensed sample L is intercepted by the antibodies in the nano-pore, the measured current is reduced depending on the number of particles, which remain attached to the nano-pore, contributing to its partial occlusion.

[0111] This technique has the advantage of being able to be used directly on a condensed sample L, without the pretreatment to sensitize them operated by said processing cell 14.

[0112] Furthermore, the presence of specific antibodies able to bind only to the searched particles ensures their selectivity with respect to other possible particles with very similar characteristics present in the sample.

[0113] The second mode is of the Resistive Pulse Sensing type.

[0114] This technique is based on the analysis of the shape of the current signal generated during the passage of the specific particle sought through the nano-pore.

[0115] For example, if the average diameter of a virus, excluding spikes, is between 82 and 94 nm, as in the case of the Corona Virus, using a nano-pore with a size of 300 nm and analyzing the impulses generated by the transit of the virus within it, it is possible to correlate the characteristics of the current pulses with the specific virus.

[0116] The main limitation of this technique is the lower specificity, due to the less exact discrimination of the type of particles, for example the viral ones of a certain virus, if other particles, viral or not, of similar size are present in the sample.

[0117] However, this technique can be used, taking advantage of fewer steps and less complexity and therefore shorter times and lower costs, in a first step of evaluation of the presence of all particles of a certain type, such as, for example, of all viruses of a certain family, in order to eventually be able to discriminate, in subsequent passages, which type it is.

[0118] As is evident from the above description, said detection system S is able to quickly and reliably detect the presence of viral biological particles in a sample of air exhaled by a living being, both by taking the sample directly from the living being, and indirectly from the environment in which several subjects are, or have been present, at a given time.

[0119] The present invention has been described for illustrative but not limitative purposes, according to its preferred embodiments, but it is to be understood that modifications and/or changes can be introduced by those skilled in the art without departing from the relevant scope as defined in the enclosed claims.