RU2736279C1 - Device for collection and storage of biological substances for subsequent analyses - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to prevention of various diseases by conducting a mass examination of people living in remote areas of rural areas, by means of telemedicine on the basis of preliminary conducted analyses of non-invasive biological substances, such as urine, faeces, saliva, seminal fluid and others. Device comprises a body with a patient identification unit and a receiving unit for sampling for storage with a biological substance. Biological material sample used is a sterile laboratory container for analysis. Receiving unit is made in the form of a rectangular parallelepiped, the front face of which is closed with a protective shutter opened when a signal from the patient identification unit arrives. Cell for container installation itself is one of cartridge boxes used as storage container with samples, which is made in form of linear cartridge in form of horizontally lying parallelepiped, inside which are successively installed closed cells, or in form of cartridge in form of cylinder, inside which radially installed closed cells, wherein each of series-connected or radially installed closed cells is connected through air channels to air conditioning and air disinfection systems.

EFFECT: simple maintenance and operation, as well as information value of analyses.

1 cl, 10 dwg

Description

The invention relates to medicine, namely to the field of prevention of various diseases by conducting a mass examination of people living in remote areas of rural areas, by telemedicine based on preliminary analyzes of non-invasive biological substances, such as urine, feces, saliva, seminal fluid and others that can get a non-injection method.

It is known that the further a person lives from a city or even from an urban-type settlement with a clinic and a laboratory suitable for carrying out various standard tests, the more difficult it is for him to monitor his current state of health, because before the doctor's appointment, it is necessary to pass a number of tests, on the basis of which the patient's complaints, the doctor will be able to put forward several possible versions of the diseases, successively excluding which, he will be able to make the correct final diagnosis.

Currently, in connection with the massive spread of the Internet, including satellite, it is possible to use telemedicine for the diagnosis and treatment of patients even in the most remote settlements that are not equipped not only with polyclinics, but also with feldsher-obstetric centers (FAPs) that carry out pre-medical primary medical care in the countryside.

Many medical professionals consider it possible to organize pre-medical and medical care through telemedicine, but on condition that patients are provided with access to high-quality medical tests. If there is a FAP in the settlement, this option is quite workable, because modern automated laboratories make it possible to carry out analyzes according to accepted standards and protocols. In the absence of a FAP, the option of sampling and carrying out analyzes in remote settlements is practically impossible.

One of the real options for solving this problem is the possibility of periodically collecting analyzes in a remote settlement, for example, at a school, shop and other public places, with their subsequent delivery to the nearest FAP equipped with a modern automated analytical laboratory.

Thus, the specified mobile device for receiving analyzes in a remote settlement must meet a number of stringent requirements.

First, the patient must be able to pass the maximum number of the most informative analyzes, using non-invasive biological substances for their conduct.

Secondly, a mobile device for receiving analyzes must guarantee the safety of each submitted analysis throughout the entire period of storage and transportation (from several days to a week or even more), because from an economic point of view, it seems inexpedient to ensure the delivery of each analysis for several tens of kilometers.

Thirdly, the procedure for preparing and passing the analysis should be as simple as possible (otherwise it will be incomprehensible to the majority of the population, who are not health workers) and financially accessible. Currently, the cost of most tests is included in the list of compulsory health insurance (MHI) services and is paid by insurance companies, which means that the patient will have the opportunity to return the money spent on tests in a certified laboratory.

Fourthly, each accepted analysis must be identified in some way, for example, tied to the patient's phone, and must be marked to keep his personal data and medical secrets.

Fifth, there should be a feedback from a patient who has been tested with a FAP, for example, by sending information to his mobile phone or e-mail about the need for certain tests, as well as messages about the results of studies of his biologically substances.

Various technical solutions are known in the art for collecting, storing and transporting patient analyzes.

So, for example, a device is known for obtaining, storing and transporting dry samples of liquid objects intended for subsequent laboratory analysis, comprising a protective container in which at least one adsorption element is placed, configured to apply an aliquot of a liquid object to it, containing the analyzed components, and its subsequent drying (see, RF patent for invention No. 2519030, class A61J 1/05, 2014). The adsorption element is made of a moisture-absorbing porous material capable of reversible desorption of dry components into a solvent when the working zone of the adsorption element with a dried sample is immersed in it. The known device makes it possible to obtain, store and transport samples of liquid objects, but it has its own significant disadvantages.

First, the known device makes it possible to store and transport samples of liquid objects, but only in dry form. Since an aliquot is an accurately measured multiple of the sample taken for analysis, which retains the properties of the main sample, it is possible to dry the adsorption element with an aliquot of a liquid object only in a specialized laboratory and only by highly qualified specialists.

Second, dry samples of liquid objects must be subjected to reversible desorption of dry components into a solvent before being analyzed in an automated analytical laboratory. The applicant indicates that the placement of the working area of the adsorption element with the dried sample in a solvent is, in terms of the efficiency of reversible desorption of the sample, not less than 30% after no more than 300 s after contact of the dried sample with the solvent. Thus, with the indicated probabilities of the reversible desorption carried out, it is impossible to speak about the accuracy of the obtained analyzes.

Known portable thermostat for transportation and storage of biological substances, containing a thermally insulated housing with a lid and a working chamber, a thermoelectric module, an automatic control unit with a remote control, a radiator, a fan and a ventilation window in a housing with a safety grill, while the working chamber is made of corrosion-resistant metal , the radiator and the fan are located under the bottom of the working chamber, and the lower part of the thermostat housing is equipped with a device that includes supports for attaching it to the vehicle with the formation of a gap to ensure the passage of air into the ventilation window, and the thermostat cover is equipped with a block including a hatch for connection with drainage means life support of donor organs (see RF patent for invention No. 2054608, cl. F25D 3/14, 1996). The thermostat is designed to maintain a temperature of 4 ± 0.5 ° C at an ambient temperature in the range from -40 to + 40 ° C and a relative humidity of up to 85%. The thermostat housing has a control panel and a power supply connector. In the upper part of the thermostat housing there are handles that are rotatable relative to the horizontal hinges. The handles are used to carry the thermostat.

The known device makes it possible to store and transport samples of liquid objects in a wide range of ambient air, but has several disadvantages.

First, the known device was developed for the transportation and storage of biological substances, such as donor organs, which are a very expensive and valuable object that must be stored in a strictly defined temperature range of 4 ± 0.5 ° C at an ambient temperature in the range from -40 to + 40 ° C. All suspected biological substances must be taken from one donor, because the thermostat has only one chamber. It is known that such organs as the heart, lungs, kidneys, liver, spleen are sensitive to the effects of low temperatures and ischemia, therefore, they need hypothermic conservation and additional protection measures against hypothermia even when cooled to temperatures from +4 to + 5 ° C. That is why the thermostat is equipped with such a complex and reliable system for maintaining the temperature in the working chamber.

Secondly, the well-known device must be serviced by medical specialists: to put biological substances in a certain way in the working chamber, set the required temperature in the working chamber, etc. It is impossible to operate such a device offline without the participation of medical personnel.

Thirdly, there is no need to identify biological substances placed in the working chamber, because there is only one donor and his identity is known.

Known assay device for field analysis of urine (see US patent No. 6497843, MKI: A61B 10/00, 2002). The assay device includes a container having an upper opening for taking a urine sample, a lid for sealing this opening, and a sampling assembly provided in the container for chemical analysis of a urine sample. The device contains a liquid-impermeable substrate, a moisture-wicking material applied to the back surface of the substrate, several test sampling strips applied to the front surface of the substrate and the adjacent upper edge of the substrate in contact with the moisture-wicking material. Each sample strip is capable of fixing one substance The device is intended for use in the field and is capable of detecting the presence of unwanted chemicals (eg drugs) or diseases. Each assay device is necessarily identified with a specific patient.

The main disadvantages of the known device can be considered that, firstly, it was developed for preliminary testing, mainly, athletes participating in competitions in some remote place. After the competition, it is necessary to take urine samples from athletes, primarily from the winners, for the presence of doping, drugs and other substances prohibited by athletes. If a positive sample is found, the assay device for detailed examination can be transported with the athlete to the medical center.

Secondly, the known device can only perform qualitative analysis, i.e. to test urine for several indicators, and to detect a disease in a patient, it is necessary to do a detailed quantitative analysis indicating the limits of the limits of the norm of one or another measured indicator of the sample taken.

Thirdly, the known device does not imply any storage at the place of sampling and must be delivered in special sealed boxes to the medical center immediately after the end of the competition.

Closest to the claimed technical solution is taken as a prototype, the device disclosed in the PCT application WO 2010104225, MKI: G01N 33/493, 2010 - "automatic system and device for urine analysis". The device allows people of any age and gender to analyze urine and diagnose diseases of the human body. The device contains a housing with a patient identification unit, a payment terminal, a receiving unit for taking a sample with a biological substance, and a sample analyzer capable of immediately producing a printout of the analysis.

The known device has wide functionality and allows not only to take a urine sample, but also to analyze it, issuing a printout. However, the known device has its own significant disadvantages.

Firstly, a device with the function of a sample analyzer, although it is an automated diagnostic device, cannot function without constant control of the operator, who is carrying out work on setting up the analyzer and checking the accuracy of the results. Such work can only be carried out with the help of a highly qualified specialist and special fluids with a predetermined composition, therefore, such a device is not intended for functioning in a remote rural settlement.

Secondly, the known device uses only urine as a biological substance, which means that many patients will need to additionally donate other biological substances elsewhere, for example, feces, saliva or semen.

Third, it is also worth noting a significant limitation in the measured parameters of the built-in sample analyzer, which uses a urine-soaked sampling strip, which clearly indicates a low sample volume of a biological substance. It is known that for a detailed general analysis of an adult, the optimal volume of a urine sample should be from 75 ml to 100 ml. For children's analyzes, a smaller volume is required - even 15 ml is enough. From these figures it becomes clear that the amount of urine available on the sample strip is clearly insufficient to obtain detailed analyzes.

Fourth, it is worth noting that the built-in sample analyzer is only capable of real-time analysis. These analyzes do not include those associated with culture of the sample. Taking an analysis for microflora is not a difficult, but very informative procedure. The method helps to identify pathologies in the body. On their basis, the doctor objectively evaluates the results of the study, makes a diagnosis or determines the effectiveness of the prescribed treatment, therefore it is so important to do an analysis for microflora. In this case, urine analysis is microbiological or cytological. Using the first one, you can determine the composition of microflora (including pathogenic), and using the second, unnatural (foreign), for example, tumor cells.

The technical result of the claimed device for collecting and storing biological substances for conducting analyzes is to eliminate the indicated drawbacks of the known technical solution, namely, to create an easy-to-maintain device that can be operated in a remote rural settlement, which takes as samples various biological substances that the patient can obtain in a non-invasive way, while these samples are suitable for conducting informative detailed general analyzes, including for bacterial inoculation.

The specified technical result in a device for collecting and storing biological substances for analysis, containing a housing with a patient identification unit and a receiving unit for taking a sample with a biological substance, is achieved by the fact that a sterile laboratory container for analyzes is used as a sample for storing a biological substance, when In this case, the receiving unit is made in the form of a rectangular parallelepiped, the front face of which is closed by a protective shutter that opens when a signal from the patient identification unit is received, and the cell for installing the container itself is one of the boxes of the cartridge used as a storage for containers with samples, which is made in the form of a linear a cartridge in the form of a horizontally lying parallelepiped, inside which closed cells are installed in series, or in the form of a cartridge in the form of a cylinder, inside which closed cells are radially installed, each of which is installed in series or radially closed cells is connected through air ducts to air conditioning and air disinfection systems.

The use of universal sterile containers for analyzes sold through the pharmacy network allows solving several problems at once.

First, to ensure the sterility of the sample for sampling, which makes it possible to exclude the presence of foreign substances or pathogenic microflora in the sample.

Secondly, this container allows you to use it for taking samples of any non-invasive biological substances, including urine, feces, saliva, semen.

Thirdly, the volume of the container allows you to place up to 100 ml of urine in it, which is quite enough for a detailed general analysis of an adult.

Fourthly, each container has a sealed lid, which guarantees its integrity during transportation inside the cartridge.

To expand the functionality of the device, all donated biological substances use the same type of laboratory container - a sterile laboratory container for analyzes with a volume of 100 ml (a container with a volume of up to 120 ml is allowed). The cell of the receiving unit is designed for the volume of such a container, which, after installing the container into it, switches to the mode of sealing the cell and becomes a chamber for long-term storage of the container with the sample. All lockers are housed in a single removable cartridge. After taking the container from the patient, the protective shutter of the receiving unit of the device closes and simultaneously with it the front flap of the cartridge closes, sealing this cell in it. To ensure the required temperature conditions for storing the container, the cartridge is connected through air channels to the air conditioning and disinfection systems in it.

It is advisable to make the cartridge in the form of a horizontally lying parallelepiped, inside which closed cells are sequentially installed, each of which is connected through air channels to air conditioning and air disinfection systems, or (to increase the volume of the cartridge) in the form of a cylinder, inside which radially (in the form of cylinder sectors) closed cells are installed, each of which is connected through air ducts to air conditioning and air disinfection systems.

The air conditioning system allows maintaining the required temperature in each chamber in the range from -5 ° C to 5 ° C through the system of internal channels of the cartridge, which allows the samples to be stored for up to 10 days. To exclude pathogenic contamination of the cartridge, for example, due to accidental depressurization of one of the containers with the sample, the cartridge is equipped with a system for air disinfection, which is involved in cooling the cells with containers. After the cartridge is fully loaded, it is easily removed, and then transported to the laboratory by a machine equipped with a similar air conditioning and air disinfection system.

Thus, the claimed device for collecting and storing biological substances, placed in sterile containers, allows you to take samples of any taken non-invasive biological substances, including urine, feces, saliva, semen, and store them in the cells of a special cartridge connected through air channels. to air conditioning and disinfection systems, and then transport them together with a cartridge to a medical laboratory closest to a remote settlement, for further use for telemedicine tasks, which has no analogues among known devices for collecting and storing analyzes, which means that it meets the criterion “ inventive step ".

The essence of the proposed technical solution is illustrated in FIG. 1-10 figures.

FIG. 1 shows a general view of the inventive device for collecting and storing analyzes, with a linear cartridge, where: 1 - device case with control panel 2; 3 - touch screen; 4 - numeric keypad; 5 - bill acceptor; 6 - card collector; 7 - device for issuing checks and identification tags; 8 - voice prompt; 9 - protective shutter of the inlet chamber of the receiving device; 10 - door for installing a new and removing the filled cartridge.

FIG. 2 shows a fragment of the front panel of the inventive device with a container 11 installed in the receiving device chamber, closed by a protective shutter 9.

FIG. 3 shows a front view of a linear cartridge of the inventive device with a conditionally removed front panel (to simplify the figure, it is made of four cells), where: 12a-12n - cells of storage chambers for containers 11; 13 - entrance movable panel; 14 - inlet channel for supplying cooled air; 15 - outlet channel for air suction; 16 - channel for disinfection of used air; 17 - substrates made of double-sided tape for containers.

FIG. 4 shows a linear cartridge for the inventive device with containers in cells, prepared for transportation.

FIG. 5 shows a linear cartridge in open view (rear view) with a front panel drive and channels for air conditioning and air decontamination, where panel 13 shows a fixing projection 18 and a toothed comb 19, and also shows a gear motor 20 interacting with a toothed comb 19 by gears 21.

FIG. 6 shows a general view of the claimed device for collecting and storing analyzes, with a drum cartridge, where: 22 - receiving device chamber; 23 - door for installing a new and removing the filled drum cartridge.

FIG. 7 shows a simplified drawing of a drum-type cartridge for the inventive device, where: 24a-24n - cells of storage chambers for containers 25; 26 - movable cell door; 27 - persistent fixed finger.

FIG. 8 shows a simplified drawing (bottom view) of a drum-type cartridge with a cartridge rotation mechanism, where: 28 is a gear motor of the cartridge rotation mechanism drive; 29 - drive gear of the cartridge mechanism drive; 30 - driven gear wheel of the cartridge mechanism; 31 - guide bush, which ensures accurate installation of the cartridge in a given seat; 32 - channel for supplying clean air; 33 - channel for suction of air from the cartridge (decontamination of the exhaust air is carried out outside the cartridge).

FIG. 9 shows a simplified drawing explaining the principle of closing the door of the cell 24b using a fixed finger 27.

FIG. 10 is a simplified cross-sectional drawing of a drum-type cartridge explaining the location of the air supply and suction ducts from the cartridge.

The claimed device operates as follows. The patient enters the room where the claimed device is installed (see Fig. 1 and 2) and through the payment terminal (in cash or non-cash payment for the analysis). After that, the identification device is connected: on the touch screen 3, information appears on how the patient can identify himself (for example, via the CMC message to the phone with a password), and the voice prompt 8 gives him the necessary current instructions. After identifying the patient, through the device for issuing checks and identification tags 7, he receives an identification self-adhesive number, which he sticks on the container 11, which through the opened protective entrance shutter 9 the patient must install into the chamber of the receiving device. In this case, the voice prompt 8 says: "remove the protective film on the colored circle in the opened window and install the container with the glued identification number on it" (on the touch screen 3, the view of the container with the glued identification number is shown). The patient (see Fig. 3) places the container 11 with the analysis on the circle 17. The circle 17 is made of double-sided tape, which allows you to reliably fix the position of the container inside the chamber, and prevents it from hitting the walls of the chamber during subsequent transportation. After that, the protective entrance shutter 9 of the receiving device chamber is closed and the geared motor 20 (see Fig. 5) is turned on, interacting with the toothed comb 19 by means of the gear 21. Since the cartridge installed in the longitudinal guides (they are not conventionally shown in Fig. 5) , it is able to move only along the panel 13, the edge of which is fixed inside the body of the device by the locking protrusion 18. Therefore, when the geared motor 20 is turned on, the cartridge will begin to move (in the direction of the arrow) towards the protrusion 18 by a step equal to the width of the cell 12a. After that, the geared motor 20 stops, the cell 12a is closed from the outside by the panel 13, and in front of the protective entrance shutter 9 the next free cell 12b is installed, which is ready to receive the next container with the analysis. Inside each closing cell 12a-12n, from the side of channels 14-16 synchronously with the movement of the panel 13, curtains with perforations on the rear wall (they are not shown in the figure) are opened, through which cold air begins to flow only into the closed cells 12a-12n through channel 14, as well as suction of air from channel 15, which is then disinfected with an ultraviolet lamp located in channel 16. FIG. 5 shows that each of the channels 14-16 ends with cylindrical connectors through which it is easy to connect tubes to the cartridge for supplying, sucking, and disinfecting air. After filling all the cells of the cartridge, it is removed from the device through door 10 and a new cartridge is installed. The removed cartridge is connected to the transportation unit, which, during its transportation to the laboratory, is also equipped with tubes for air supply, suction and disinfection.

The operation shown in FIG. 6-10 device with a drum cartridge. A distinctive feature of this embodiment of the device is the large capacity of the drum cartridge compared to the linear one. The rotation of the cartridge is carried out by means of a geared motor 28, and the closing of the doors of the cells 24a-24n is carried out by means of a fixed thrust pin 27 (see Fig. 9). This is achieved due to the difference between the radii of the closed and open movable door of the cell 26. Since the door 26 in the open position is located tangentially to the closest vertical wall of the cell 24b, its radius of rotation exceeds the radius of rotation of the edge of the wall. Thus, the cell door 26 abuts against the stationary thrust pin 27 until the radius of its rotation is equal to the radius of the cartridge drum.

After taking the filled cartridges from the claimed device, they are delivered to the laboratory of the FAP equipped with modern analytical equipment. The cartridges are opened, the containers removed and the analyzes performed. The test results are sent by e-mail to the patients who passed them. Having on hand reliable analyzes that meet modern requirements and methods, obtained on certified equipment, the patient can use modern telemedicine by sending this analysis to a specialist for consultation about the presence of one or another disease or control over the treatment.

Claims (1)

A device for collecting and storing biological substances for analysis, containing a housing with a patient identification unit and a receiving unit for taking a sample for storage with a biological substance, characterized in that a sterile laboratory container for analyzes is used as a sample for storing a biological substance, while a receiving the unit is made in the form of a rectangular parallelepiped, the front face of which is closed with a protective shutter that opens when a signal from the patient identification unit is received, and the cell for installing the container itself is one of the boxes of the cartridge used as a storage for containers with samples, which is made in the form of a linear cartridge in in the form of a horizontally lying parallelepiped, inside which closed cells are sequentially installed, or in the form of a cartridge in the form of a cylinder, inside which closed cells are radially installed, each of the sequentially or radially installed closed cells n Connected through air ducts to air conditioning and air disinfection systems.

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