IT202100001103A1 - DEVICE FOR THE ANALYSIS OF A BIOLOGICAL FLUID - Google Patents

Description

DESCRIPTION

Attached to a patent application for INDUSTRIAL INVENTION having the title

?Device for the analysis of a biological fluid?

The present invention relates to the technical sector of devices for medical use.

In particular, the present invention relates to a device for identifying at least one marker within a biological fluid. The detection of specific elements contained within a biological fluid and defined as markers is particularly useful for the diagnosis, monitoring and prognosis of numerous pathologies such as: viral, bacterial, autoimmune pathologies.

Although the techniques known in the sector are actually able to detect in an optimal way and with high levels of sensitivity? the presence of the markers of interest remains also? It is true that in order to be carried out correctly, they need trained personnel, laboratories with automated equipment and expensive reagents.

Furthermore, the known techniques require long times to be able to obtain results, since they provide for the collection of biological samples, their transfer to a laboratory, the analysis of the samples and the processing of the data resulting from an optical reading.

These characteristics make known tests relatively complex, expensive and unable to provide immediate and easily interpretable results.

? therefore strongly felt in the sector the necessity? to develop new devices capable of providing clear and precise results in a short time.

In this context, the technical task underlying the present invention ? propose a device for analyzing a biological fluid which overcomes at least some of the drawbacks of the prior art mentioned above.

In particular, ? The object of the present invention is to provide a biological fluid analysis device capable of providing a rapid and accurate analysis of a biological fluid based on the identification of one or more biological fluids. markers inside it.

The technical task specified and the aims specified are substantially achieved by a device for analyzing a biological fluid, comprising the technical characteristics set forth in one or more of the joint claims.

According to the present invention a device for analyzing a biological fluid is shown.

The device comprises a sample holder, a test module and an analysis module.

The champion holder? configured to receive the biological fluid.

Furthermore, the champion holder ? functionalized in such a way as to interact with at least one marker of the biological fluid generating a reaction uniquely associated with this marker.

The test module has a measuring chamber suitable for receiving the sample holder when inserted.

Preferably the test chamber ? shaped in such a way as to fully accommodate the sample holder inside.

The test module comprises a measurement sensor facing the measurement chamber and configured to detect at least one reaction by generating a measurement signal which represents and identifies it.

The analysis module ? configured to process and memorize the measurement signal, determining at least one concentration of the marker in the biological fluid.

Advantageously, the device presented allows information concerning the biological fluid to be acquired in a simple, rapid and efficient manner, in particular with regard to the presence/concentration of specific markers present therein.

The dependent claims, incorporated herein by reference, correspond to different embodiments of the invention.

Further characteristics and advantages of the present invention will appear more clearly from the indicative, and therefore non-limiting, description of a preferred but not exclusive embodiment of a device for analyzing a biological fluid, as illustrated in the accompanying drawings in which: - the figure 1 shows a schematic representation of the components of the device according to the present invention in accordance with a possible embodiment;

- figure 2 ? a detail of a possible embodiment concerning in detail some specific elements of the device of figure 1.

In the attached figures, reference number 1 generally indicates a device for analyzing a biological fluid, to which reference is made in the following description simply as device 1.

In detail, the device 1 presented here? designed to perform an analysis on a biological fluid in order to determine the presence and concentration of at least one marker inside the biological fluid. A marker should be understood in particular as any element, for example a molecule, an enzyme, a biological compound, present inside the fluid and whose identification can be used to determine the presence of a pathology or to carry out an assessment of the state of health of the user from whom the fluid? been picked up. The term biological fluid therefore means, in a non-limiting manner, any fluid taken/which can be taken from an individual, such as in particular blood or saliva.

From a structural point of view, how can you? observed in figure 1, the device 1 comprises a sample holder 2, a test module 3 and an analysis module 4.

The champion holder? configured to accommodate and retain the biological fluid and ? functionalized in such a way as to interact with at least one marker of the biological fluid generating a reaction uniquely associated with this marker.

In other words, the use of the device 1 foresees that the biological fluid is deposited on the sample holder 2 where it interacts with it (or with at least one part/component) generating a reaction, for example a chemical or physical reaction according to the type of functionalization defining the sample holder.

This reaction can be detected according to the modalities? which will be further explored in order to identify the presence of the marker and also its concentration.

In detail, the sample holder 2 comprises a substrate 2a, preferably made of paper material, on which applied a coating 2b suitable for interacting with the biological fluid to generate the reaction.

In other words, the coating 2b defines the portion of the sample holder 2 functionalized to react when interacting with the respective marker present in the biological fluid.

Coating 2b can? otherwise? present a plurality of distinct portions, partially overlapping or completely overlapping each of which? individually functionalized to interact with the biological fluid in such a way as to generate a reaction uniquely associated with a respective marker.

In this context, the single sample holder 2 allows to identify more? distinct markers within the biological fluid providing more information? complete in a particularly rapid and efficient way as it is necessary to carry out a single inspection process and a single procedure for sampling the biological fluid.

Preferably, each portion defines a distinct layer of the coating 2b and the layers are superimposed in successive layers.

Alternatively, the individual portions can define adjacent areas of the surface of the coating 2b.

In greater detail, the functionalization of the coating 2b ? obtained by making it using techniques and materials capable of interacting with the marker that one wishes to detect in particular in such a way as to bind to this marker and/or change one or more? property? chemical/physical characteristics of the marker or of the 2b coating itself.

In the first case the coating 2b pu? comprising or being obtained by applying to the substrate 2a at least one antibody of the marker to be detected or an antimarker or with any other substance or combination of substances configured to bind with the marker of interest and suitable for defining interaction sites.

In this context, the investigation aimed at identifying the presence of the marker can also be performed in a passive way going to detect the quantity? of interaction sites occupied and therefore retaining the marker.

Alternatively or additionally the substrate 2b comprises or ? obtained through materials able to interact with the marker by changing one or more? property? selectable for example among: color, shape, chemical composition, activation of biochemiluminescence phenomena or by means of materials in turn able to manifest such changes of properties? following the interaction with the marker.

In this context, the investigation aimed at identifying the presence of the marker can be performed by measuring the change of ownership? functionalizing in terms of intensity? signal and/or speed? with which the change or the activation of this property is manifested.

In accordance with a possible embodiment, described by way of non-limiting example, the coating 2b comprises at least a plurality of of nanofibers defining a filter element that has a density? of mesh such as to interact with a respective marker by holding him.

In other words, the plurality of nanofibers ? applied to the substrate 2a defining a filter capable of blocking the passage of specific components of the biological fluid in particular according to their dimensions.

It is noted that for the purposes of this description with the term density? mesh refers specifically to the density? of nanofibers present in the surface of the layer they compose and consequently much greater? the density? mesh the greater sar? also the capacity? of retention of the layer as it will be? less space exists between adjacent nanofibers or groups of nanofibers.

The plurality? of nanofibers can? otherwise? be applied to the substrate 2a in such a way as to realize a plurality? of distinct overlapping layers or distinct adjacent areas each characterized by a specific density? of mesh such as to make it able to interact and retain a different marker.

The plurality? of nanofibers can? be advantageously made by means of an electrospinning process.

Electrospinning ? a production process that allows to obtain continuous filaments of synthetic material with an extraordinarily small diameter. Operationally via an electrospinning process ? It is possible to stretch a polymer jet within a high electric field.

Nanofibers what? produced can reach reduced diameters much smaller than those obtainable using traditional techniques.

In particular, the plurality of nanofibers can? be deposited on the substrate 2a by aligning them along at least one prevailing deposition direction, preferably along two distinct prevailing deposition directions.

Alternatively or additionally, the coating 2b comprises a plurality of of magnetic nanoparticles capable of interacting and binding with specific markers.

In particular, the magnetic nanoparticles are linked with respective antibodies capable of identifying and binding in turn with antigens present on the cell surface, giving these antigens properties magnetic. By way of example, the magnetic nanoparticles (or the coating 2b in general) are configured to interact with enzymes belonging to the family of metalloproteases.

Such an interaction? of particular importance why? metallo-proteins govern the penetration of tumor cells into tissues by generating new binding sites for tumor cell receptors that stimulate their migration.

Therefore, a precise and accurate measurement of the presence and concentration of these enzymes within the biological fluid provides important information which is useful in the field of oncological diagnostics.

The presence of magnetic nanoparticles in the 2b coating can be used in combination with the presence of a filtering layer, defined by the gi? cited plurality of nanofibers or also obtainable through a semipermeable membrane, which allows the passage of small analytes (for example glucose) while retaining in position the structure generated by the bond between nanoparticles and metalloproteases which has larger dimensions, thus facilitating its identification and measurement as an initial filtering is performed which removes the elements of no interest which therefore do not interfere with the inspection process which can be performed by device 1.

Operationally, the actual inspection of the biological fluid retained on the sample holder 2 is carried out inside the test module 3.

To this end, the test module 3 has and defines a measuring chamber 3a shaped to receive the sample holder 2 when inserted. Preferably the measuring chamber has a shape and dimensions such as to be able to receive the entire sample holder 2 inside it.

Alternatively, the measuring chamber 3a has a shape and dimensions such as to be able to house inside it at least the portion of the sample holder 2 on which it is located. present and interacting with the biological fluid. In general, the test module 3 has a conformation such that when the sample holder 2 ? inserted inside the detection chamber 3a, it is also isolated from an external environment at least in relation to the relevant parameters for the measurement process aimed at detecting the marker of interest.

By way of example, in accordance with a possible embodiment which will be? discussed below, if the measurement ? of the optical type, the test module 3 has a conformation such as to prevent the entry of ambient light into the measuring chamber 3a when the sample holder 2 is? placed inside it.

In greater detail, the text module 3 comprises a measurement sensor 3b facing the measurement chamber 3a and configured to detect at least one reaction between the marker and the sample holder 2, generating a measurement signal representative of this reaction.

In other words, by means of the measuring sensor 3b ? possible to locate, identify and measure the reaction that takes place between the biological fluid and the functionalized portion of the sample holder 2 thus allowing? to determine the presence and concentration of the marker of interest. In detail, the 3b measurement sensor can? be achieved by at least one of: a spectrometer, a chromatograph, a gaussmeter or an optical sensor, preferably an optical sensor capable of acquiring optical signals belonging to the ultraviolet optical range.

The selection of the specific measurement sensor 3b can? be performed according to the marker or the type of marker to be identified and possibly also according to the type of functionalization used to react with the marker or markers of interest in such a way as to optimize the cost/efficiency ratio of measurement.

In accordance with a possible embodiment, the measurement sensor 3b comprises a single photon light source.

This source generates a single photon which is made to interact with the sample holder and the biological fluid it holds in order to inspect it, improving the resolution of the device 1 and the quantity/quality? of obtainable information.

Advantageously, test module 3 can? it further comprises a catalyst element 3c configured to promote the reaction between the sample holder and the biological fluid and/or to assist the detection of this reaction by the measurement sensor 3b.

In other words, the catalyst element 3c interacts with the sample holder and/or with the biological fluid retained by it to improve the measurement process aimed at identifying the marker.

In accordance with one aspect of the present invention, the catalyst element 3c and the measurement sensor 3b are arranged at opposite walls of the measurement chamber 3b and face each other.

Consequently, in a configuration of use, the sample holder 2 is interposed between the catalyst element 3c and the measurement sensor 3b.

In this context, the measurement sensor 3b can? include an optical sensor and the element? catalyst 3c pu? comprising a light source configured to generate a light beam on the sample holder capable of assisting in the detection of the reaction by the optical sensor and/or to activate the reaction representative of the interaction between the sample holder 2 and the biological fluid marker.

For example, the functionalization of sample holder 2 pu? be obtained by means of a compound that when ? linked with the marker of interest manifests the property? of phosphorescence/fluorescence and the catalyst element 3c generates a light beam at a wavelength capable of exciting the compound by activating its phosphorescence/fluorescence which is then detected in the form of intensity? light from the measurement sensor 3b.

As illustrated in figure 2, the catalyst element 3c can? also define a support base for the sample holder 2 inside the measuring chamber 3a.

Regardless of the specific embodiment and the type of measurement implemented, it is necessary to process the measurement signal to make it immediately interpretable and usable by a user.

To this end, the analysis module 4 ? configured to process and memorize the measurement signal, determining at least one concentration of the marker inside the biological fluid.

In other words, the analysis module 4 ? connected with the test module 3, with the measurement sensor 3b in particular, to receive the measurement signal from it and process it by determining the presence and concentration of the marker.

This aspect is particularly relevant when the measurement process performed by the measurement sensor 3b is of the passive type, i.e. aimed at identifying not so much the marker but the element functionalizing the sample holder or a signal generated by it.

Advantageously, the analysis module 4 ? connectable, preferably via a wireless communication protocol (e.g. Wi-Fi?, Bluetooth? or cellular network) with at least one biometric sensor configured to measure at least one biometric parameter of a user in such a way as to receive a representative biometric signal from it of the respective biometric parameter.

Preferably, the device 1 itself comprises the at least one biometric sensor B with which it is connected. connectable, in other words l?at least one biometric sensor B ? a device component 1.

Preferably, each biometric sensor B has the same structure and the same characteristics as the sample holder 2 with the simple addition of an antenna capable of transmitting the biometric signal to the analysis module 4.

In this context, the biometric signal ? a representative and identifying signal of the reaction generated by the interaction between the biological fluid and the biometric sensor B.

In accordance with one aspect of the present invention, the biometric sensors B and the sample holders 2 are provided in the form of a kit comprising a plurality of of biometric sensors B and sample holder 2 each of which ? configured to interact and react with one or more? specific markers.

In detail, each biometric sensor B can? further comprising a biocompatible support which allows the device to be applied in direct contact with a user (for example with one of its mucous membranes) for an immediate and direct acquisition of the biological fluid.

Furthermore, the analysis module 4 ? connectable, still preferably by means of a wireless communication protocol, with a portable terminal capable of displaying at least one graphic representation of the measurement signal.

The portable terminal can include a physical device such as, for example, a smartphone or a computer, or a distributed database such as a cloud computing.

Device 1 can? then communicate externally to a portable/remote terminal the results of the measurement process performed on the biological fluid.

This aspect is particularly advantageous as it allows the user to carry out the sampling and analysis of the biological fluid locally, subsequently transmitting the measurement results remotely, sending them for example to a health facility which can then proceed to evaluate them to determine the state of health of the user. Advantageously, the device 1 comprises a graphic interface 5 configured to receive the measurement signal and to display at least a graphic representation of the measurement signal and/or a result obtained from the processing of this measurement signal by the analysis module 4.

This graphical interface 5 pu? be realized for example by means of a screen arranged in correspondence with an external wall of the test module 3 or of the analysis module 4.

in particular, the screen pu? be a tactile screen or be combined with a push-button panel by which a user can? access features? of the device 1, for example by starting a measurement process, by starting a processing of the measurement signal by the analysis module 4 or by activating a transmission/reception of data and information by the device 1 (in particular by the analysis module 4).

In accordance with one aspect of the present invention, the marker of interest whose presence, concentration and/or composition it is desired to inspect comprises a nucleic acid, preferably comprises DNA (deoxyribonucleic acid) or RNA (ribonucleic acid).

In this context, the measurement signal which is acquired by the measurement sensor 3b ? representative and identification of at least one nitrogenous base of said nucleic acid.

For example, sample holder 2 can? be functionalized in such a way as to interact with the marker by generating a signal of the same type (for example an optical signal) but with a different characteristic (intensity?, frequency?) according to the specific nitrogenous base with which it is interacting.

The analysis module 4 ? then configured to process the measurement signal in such a way as to sequence the nucleic acid.

In detail, the analysis module 4 ? configured to sequence nucleic acid by applying Grover's algorithm to the measurement signal. Grover's algorithm? an example of a quantum algorithm that pu? be exploited to search for data in a non-structured way that can? be applied in a particularly advantageous way when the measurement sensor includes a single photon spectrometer which allows to make the most of the phenomena of quantum physics with which the application of Grover's algorithm is particularly efficient. Advantageously, the present invention achieves the aims proposed by overcoming the drawbacks complained of in the prior art by making available to the user a device for analyzing a biological fluid which allows information concerning the presence and concentration of certain compounds to be obtained in a simple and efficient manner and elements within the biological fluid.

Claims (16)

1. Device for the analysis of a biological fluid including: - a sample holder (2) configured to receive said biological fluid, said sample holder (2) being functionalized to interact with at least one marker of said biological fluid generating a reaction uniquely associated with said marker; - a test module (3) having a measurement chamber (3a) suitable for receiving the sample holder (2) when inserted and comprising a measurement sensor (3b) facing said measurement chamber (3a), said measurement sensor ( 3b) being configured to detect the at least one reaction by generating a measurement signal representative of said reaction; - an analysis module (4) configured to process and memorize the measurement signal, determining at least one concentration of said marker in the biological fluid. 2. Device according to claim 1, wherein the analysis module (4) is connectable, preferably by means of a wireless communication protocol, with at least one biometric sensor (B) configured to measure at least one biometric parameter of a user in such a way as to receive from said biometric sensor (B) a biometric signal representative of the respective biometric parameter. 3. Device according to claim 2, comprising one or more? biometric sensors. 4. Device according to any one of the preceding claims, comprising a graphical interface (5) configured to receive the measurement signal from the analysis module (4) and to display at least one graphical representation of said measurement signal. 5. Device according to any one of the preceding claims, wherein the analysis module (4) is connectable, preferably by means of a wireless communication protocol, with a portable terminal capable of displaying at least one graphic representation of the measurement signal. 6. Device according to any one of the preceding claims, wherein the measurement sensor (3b) comprises at least one of: a spectrometer, a chromatograph, a gaussmeter or an optical sensor, preferably an optical sensor capable of acquiring optical signals belonging to the optical range of the ?ultraviolet. 7. Device according to any one of the preceding claims, wherein the test module (3) comprises a catalyst element (3c) configured to promote the reaction between the sample holder (2) and the biological fluid and/or to assist the detection of said reaction from the measurement sensor (3b). 8. Device according to claim 7, wherein in a configuration of use the sample holder (2) is? interposed between the measurement sensor (3b) and the catalyst element (3c) and wherein the measurement sensor (3b) comprises an optical sensor and the catalyst element (3c) comprises a light source configured to generate a light beam on the sample holder ( 2) to assist the detection of the reaction by the optical sensor and/or to activate said reaction. 9. Device according to one or more? of the preceding characteristics, wherein the sample holder (2) comprises a substrate (2a), preferably a paper substrate (2a), and a coating (2b) capable of interacting with the biological fluid to generate the reaction. 10. Device according to claim 9, wherein the coating (2b) has a plurality of? of portions in which each portion ? functionalized in such a way as to interact with said biological fluid generating a reaction uniquely associated with a respective marker, preferably each portion defining a distinct layer of said coating (2b). 11. Device according to claim 9 or 10, wherein the covering (2b) comprises at least a plurality of of nanofibers defining a filter element presenting a density? of mesh such as to interact with a respective marker by holding him. 12. Device according to claim 11, wherein the plurality? of nanofibers ? made by means of an electrospinning process, preferably by depositing said plurality? of nanofibers by aligning them along at least one prevailing deposition direction, preferably by aligning them along two distinct prevailing deposition directions. 13. Device according to any one of the preceding claims from 9 to 12, wherein the covering (2b) comprises a plurality of of magnetic nanoparticles capable of interacting and binding with enzymes belonging to the family of metalloproteases. The device according to any one of the preceding claims, wherein the measurement sensor (3b) comprises a single photon light source. 15. Device according to any one of the preceding claims, wherein the marker comprises a nucleic acid, preferably DNA or RNA, the measurement signal ? representative of at least one nitrogenous base of said nucleic acid and the analysis module (4) ? configured to process the measurement signal in such a way as to sequence said nucleic acid. 16. Device according to claim 15, wherein the analysis module (4) is configured to sequence the nucleic acid by applying the Grover algorithm to the measurement signal.