Device for diagnosing heat and cold urticaria

Abstract

The invention relates to medical technology. A device for controlled provocation testing to diagnose cold and / or heat urticaria by exposing the patient's skin to a temperature effect comprises a metallic thermally conductive element mounted inside a housing (10) and connected to heating and cooling means and to temperature sensors. The heating and cooling means are configured in the form of Peltier temperature control elements (31-33). A lid (11) of the housing is made of a dielectric and has a straight slot (12) for an applicator (20) that provides thermal contact with the patient's skin. The applicator is configured in the form of a metallic strip or an angular or T-shaped aluminium profile with a first vertical leg and a second horizontal leg. The end face of the vertical leg is disposed in the slot in the lid of the housing. The underside of the second leg is connected by its ends in areas free of the first leg to contact surfaces of the Peltier elements. The opposite contact surfaces of the Peltier elements are mounted on the outer side of the wall of a heat sinking base. The temperature sensors (40) are disposed on the underside of the second leg, equidistantly along the length of the first leg. The result is an increase in the accuracy with which the temperature profile of the applicator is set at the point of contact with the skin.

Description

[0001] DEVICE FOR DIAGNOSIS OF TEMPERATURE URTICARIA

[0002] Field of technology to which the invention relates

[0003] The invention relates to medical instrument making and can be used for controlled provocative testing by applying temperature to the skin of patients with cold or heat forms of temperature urticaria and determining the threshold temperature for the onset of urticaria symptoms.

[0004] State of the art

[0005] Thermal urticaria is a variant of physical urticaria in which itching, erythema, wheals, angioedema, or a combination of both occur as a result of general or localized exposure to cold or heat, i.e., external cooling or heating, respectively. Diagnostic testing for both conditions involves skin provocation testing and precise determination of the critical temperature thresholds (CTTs) that trigger urticaria symptoms. Provocative testing is a method for the specific diagnosis of allergic diseases by exposing the patient to a suspected trigger of an allergic reaction under conditions similar to natural conditions. The goal of provocative testing is to induce as controlled, mild, yet clearly defined symptoms as possible to establish the clinical relevance of the investigated trigger.This allows us to assess the potential risk faced by each individual patient and how it can be reduced with appropriate therapy (https: / / www.uptodate.com / contents / cold- urti sap a? source=hi story _wi dget).

[0006] Various devices and approaches for diagnosing thermal urticaria are known in the art. One of these is a thermal test using cold and / or warm / hot objects, such as metal or glass cylinders filled with water at the appropriate temperature (the contact area is the clenched palm, forearm, etc.). The test for diagnosing thermal urticaria is performed by immersing the hands in warm / hot water (40-48°C) for 2-5 minutes, while for diagnosing cold urticaria, the hands are immersed in cold water (0-20°C). The test is considered positive if a skin reaction in the form of a rash appears in the area of ​​skin contact with the water 10 minutes after the end of the provocation.

[0007] In addition, in practical medicine, the following tests are known for provocative testing of suspected cold urticaria: physical exercise performed at a temperature of +4°C for 15-20 minutes; staying in a cold room (+4°C) naked for 10-20 minutes; using cool compresses, cold baths, etc. However, with this approach, an allergist must be able to distinguish the effects of temperature allergy from other possible effects of hypothermia or overheating. Moreover, the use of cold compresses, local immersion in cold water, staying in a cold room naked, etc., requires special attention to the patient's well-being, as these actions are associated with the risk of severe hypothermia, provoking the onset or exacerbation of a number of diseases, and / or the occurrence of dangerous systemic reactions.

[0008] In allergy practice, the classic ice cube test, which uses a protective shell, and a similar thermal test are widely used. These tests are qualitative and, when performed correctly, provide an answer to the question of the presence or absence of a predisposition (hypersensitivity) to this form of thermal urticaria. However, this approach does not allow for the determination of the external temperature threshold with any satisfactory accuracy.

[0009] This problem is addressed by devices based on the use of applicators that provide thermal contact with the target area of ​​the patient's skin, where heating and cooling of the applicator are achieved using Peltier elements. However, existing devices are characterized by insufficient accuracy in determining the external temperature threshold, which is directly related to the accuracy of determining the threshold temperature for the onset of urticaria symptoms.

[0010] In particular, a device for standardized temperature exposure to the skin of patients with cold or heat urticaria (DE10147563 A1) is known from the prior art. The device utilizes the Peltier effect and comprises one or more temperature applicators (A) and a control unit for exposure parameters (B). The device has a metal, preferably aluminum, housing with a temperature sensor, Peltier elements, cooling fins, and a microfan. The device operates at temperatures from 0 to 60°C for approximately 10 minutes and can be positioned in several locations on the patient's forearm, enabling the study of allergic skin reactions. However, the proposed design is unable to restore the external exposure temperature threshold with sufficient accuracy for monitoring (no worse than ±1°C).In addition, at external temperatures above +45°C, the risk of burns and the development of dangerous complications and systemic reactions increases sharply.

[0011] The closest to the claimed invention is the TempTest 4.0 device for diagnosing temperature urticaria (M. Magerl et al., An improved Peltier effect-based instrument for critical temperature threshold measurement in cold- and heat-induced urticaria / J Eur Acad Dermatol Venereo 1, 2015 Oct; 29(10):2043-5.doi: 10.11 ll / jdv,12739.Epub 2014 Sep 30. https: / / pubmed.ncbi.nlm.nih.gov / 25266078 / ; Khazaka electronic GmbH [Electronic resource] / / URL: https: / / www.courage-khazaka.com / en / scientific-products / temptest-r , accessed 14.04.2025). The device contains a metal heat-conducting element installed in the housing - an applicator, having a U-shaped configuration, characterized by a width of the heat-conducting element (application zone) of 2 mm and a total length of the applicator from 230 mm to 350 mm, the distance between the parallel axes of the heat-conducting element is 30 mm.The U-shaped applicator maintains a temperature distribution along its entire length, ranging from +4°C at the "cold" end to +44°C at the "hot" end, and approximately +27°C in its central portion. Heating and cooling of the applicator are accomplished using a single temperature-controlled Peltier element located between the ends of the applicator. One surface of the Peltier element is dedicated to heating, while the other is dedicated to cooling. The device's housing ensures thermal contact between the applicator and the patient's skin. Heat-dissipating elements and temperature sensors are installed within the housing to monitor the temperature of the device's operating circuit. The housing is equipped with ventilation slots. The device is equipped with transparent templates depicting the U-shaped applicator and a temperature scale. After performing a temperature test on the patient's skin using the applicator, the template is applied to the skin, and the TTP values ​​are determined.

[0012] One of the identified drawbacks of this device is that it simultaneously increases or decreases "heat and cold" in the application area, moving in the same direction along parallel, closely spaced arms of the applicator from its central portion (approximately +27°C) to the heated (approximately +44°C) and cooled (approximately +4°C) ends. Furthermore, applying the "cold" and "hot" arms to the forearm at a distance of just 2-3 cm results in a significant difference in contact temperatures (up to 40°C!), which in some cases leads to ambiguous interpretation of the obtained data. Furthermore, experience has shown that it is the presence of this temperature gradient, rather than the actual cooling or heating, that causes significant discomfort in some patients, especially women and children.To ensure that the temperature distribution obtained on the applicator is as close as possible to the single declared value, presented as a transparent graphic template, a limitation is imposed on the device's use within an ambient temperature range of +10°C to +27°C. Despite this, the actual threshold value determination accuracy is estimated by the developers to be no better than ±2°C, making it difficult to monitor treatment effectiveness. Furthermore, TempTest 4.0 lacks the ability to independently measure (control) the applicator's current temperature profile at the contact points, which ultimately depends on both the ambient temperature and the patient's skin parameters under the specific test conditions. These shortcomings reduce the accuracy and reliability of diagnostic results.The use of a single Peltier element for heating and cooling the U-shaped applicator limits the thermal distribution created on the applicator to a single temperature range (from +4°C to +44°C). The device's inability to change the temperature profile on the U-shaped applicator, for example, by implementing a "cooling only" or "heating only" mode, which may be recommended for a specific patient, reduces the device's functionality and limits its scope of application.

[0013] The technical problem solved by the claimed invention is the development of a device with expanded functionality that eliminates the shortcomings of prior art solutions.

[0014] Disclosure of invention

[0015] The technical result of the invention is to increase the accuracy of determining the threshold temperature of external exposure that causes the onset of symptoms of induced urticaria, while expanding the range of thermal exposure—from 0°C to +45°C—enabling the ability to vary the thermal exposure regime within the specified temperature range, while eliminating noticeable discomfort in patients associated with simultaneous thermal exposure to minimum (Tmin) and maximum (Tmax) temperatures. The claimed device is characterized by the following functional capabilities:

[0016] - formation and maintenance during the application process of a variant of monotonically changing temperature distribution [from Tmin to Tmax] along a rectilinear applicator, chosen by the diagnostician;

[0017] - selection of any mode of external thermal influence (distribution) that satisfies the inequality 0°C <Tmin < Тшах < +45°С; где Tmin и Тшах - минимальная и максимальная температуры воздействия, определенные для конкретного пациента, при этом помимо режима одновременного нагрева и охлаждения общего аппликатора возможно использование режимов “только охлаждение” или “только нагрев” с повышенной детализацией данных;

[0018] - implementation during the exposure process of the procedure of independent measurement of the actual temperature profile of the applicator at the points of contact with the skin and storing the obtained data in the computer memory;

[0019] - minimizing the thermal impact on the patient’s body while ensuring an unambiguous interpretation of the obtained data with an accuracy of measuring the temperature threshold value of no worse than ±0.5°C.

[0020] The technical result is achieved by using a thermal module of a device for provocative testing of temperature urticaria, which contains a metal heat-conducting element - an applicator having a rectilinear configuration, designed with the ability to form thermal contact with the patient's skin; at least two means for heating and cooling the applicator, designed in the form of temperature-controlled Peltier elements, located at opposite ends of the applicator; temperature sensors installed in contact with the applicator with the ability to measure temperature along its length.

[0021] The thermal module may additionally contain a third Peltier element, installed in the area where one of the first two Peltier elements is located, designed to cool the applicator. Temperature sensors are installed along the length of the applicator, preferably at equal distances from each other. The applicator has a length of 120 to 180 mm, a thickness of 1.5 to 3 mm, and a width of 10 to 20 mm.

[0022] In one embodiment, the applicator may be a metal strip containing an extended edge capable of thermal contact with the patient's skin. In another embodiment, the applicator is an aluminum part with an angular or T-shaped cross-section, having a first vertical shelf and a second horizontal shelf, wherein the vertical shelf contains an extended edge capable of thermal contact with the patient's skin. The length of the vertical shelf is typically shorter than the length of the horizontal shelf, and the vertical shelf is centered on the horizontal shelf, creating platforms at the ends of the horizontal shelf for accommodating Peltier elements.

[0023] Temperature sensors are preferably digital integrated circuits and are placed evenly along the underside of the horizontal shelf, at the corner joint between the two vertical shelves. The horizontal shelf can be perforated with holes or slots to reduce heat transfer along the applicator.

[0024] In one of the implementation variants of the thermal module, Peltier elements are used with a power of at least 25 W to ensure operation in the “heating” mode, and at least 50 W to operate in the “cooling” mode.

[0025] The technical result is also achieved by a device for provocative testing of temperature urticaria (temperature exposure to the skin of patients for the diagnosis of cold or heat forms of temperature urticaria), comprising, located in a housing: a thermal module, the design solution of which is presented above; at least two radiators installed with the ability to remove heat from the Peltier elements; air supply fans installed with the ability to direct air flows to the radiators; a control unit and control of the device parameters; wherein the housing is provided with ventilation holes, has a flat section on the upper surface in the area of ​​​​the applicator placement, provided with a slit for the protruding part of the applicator to ensure a temperature effect on the skin of the patient, and is made of a material with low thermal conductivity (for example, a dielectric).

[0026] As noted above, the applicator in the claimed device may be formed as a metal strip, or an angular or T-shaped aluminum profile, with a first vertical shelf and a second horizontal shelf. The applicator comprises an extended edge (the "working" edge) capable of providing thermal contact with the patient's skin. The configuration of the slit formed in the housing for the applicator's "working" edge corresponds to the configuration of this edge. In a specific embodiment, the applicator's "working" edge and the slit have a rectilinear configuration. The slit for the applicator may be formed on the upper side of the device's housing (e.g., in a monoblock design). To ensure thermal contact between the applicator and the patient's skin, the applicator protrudes from the slit above the housing surface, for example, by 1-2 mm.

[0027] The device housing may be composite, for example, composed of two or more parts. In one embodiment, the housing comprises a lid and a tray made of a dielectric, between which is a ventilated base made of an aluminum channel. In this embodiment, a slot for the applicator is provided in the housing lid, and the first and second Peltier elements in the device housing are mounted on the outer surface of the upper wall of the ventilated base, ensuring contact with the applicator.

[0028] The device preferably utilizes two plate radiators, located on opposite sides of the housing. The housing walls, where the radiators are located, are provided with openings shaped to match the cross-sectional configuration of the plate radiators. Air intake fans are positioned between the radiators. The device may include a third Peltier element installed between the inner surface of the ventilated base wall and the plate radiator in the area where the first Peltier element is located—on the "cold" end of the applicator.

[0029] The device in a particular embodiment may comprise a partition for separately directing air flows from each fan to the corresponding plate radiator.

[0030] The device typically contains heat-dissipating metal elements, which may be part of the housing itself.

[0031] The device comprises a control and monitoring unit, which is based on a microcontroller with the ability to exchange information and control the operation of Peltier elements, temperature sensors and fans. The control and monitoring unit comprises a module for receiving data from temperature sensors, a module for generating control signals for Peltier elements and a module for generating control commands for fans. In one specific embodiment of the invention, the device housing is made in the form of a rectangular parallelepiped and has a dielectric cover with a rectilinear slit for an applicator, ensuring thermal contact with the patient's skin, and a dielectric tray, between which a ventilated base is installed, made of an aluminum channel, with plate radiators and shelves for mounting the control and monitoring unit boards, while on the first wide side surface of the housing there are ventilation openings for air supply fans,and on both narrow side surfaces there are openings for plate radiators, while a partition is installed in the base for separately directing air flows from each fan to the corresponding plate radiator; the applicator is made of an angular unequal-sided aluminum profile having a first vertical and a second horizontal shelf; the height of the vertical shelf is less than the width of the horizontal shelf, and the length of the vertical shelf is less than the length of the horizontal shelf, and the vertical shelf with its edge is placed in the said rectilinear slot for the applicator on the cover of the housing; the lower side of the second shelf of the said aluminum profile with its ends in areas free from the presence of the first shelf is connected to the contact surfaces of the first and second Peltier elements,The opposite contact surfaces of which are mounted on the outer side of the ventilated base wall; temperature sensors in the form of digital integrated sensors in plastic housings are placed on the underside of the second shelf uniformly along the length of the first shelf and are installed at the corner joint of the said shelves. The housing has the following dimensions: length 210, width 80, and height 72 mm, while the applicator is 140 mm long, 2 mm thick, 15 mm high, and protrudes from a straight slot above the housing cover by a height of 1-2 mm. Connectors for the power source and USB cable are located on the second wide side surface of the housing.

[0032] The technical result is also achieved by using a system for provocative testing of temperature urticaria, which is based on a device connected to a computer with a thermal module, the design solution of which is presented above. In certain embodiments, the system may be configured to generate various temperature profiles / modes on the contact surface of the applicator, selected from a temperature range from 0°C to +45°C; with the ability to graphically represent the results of provocative testing of the patient and independently measure the actual temperature profile of the applicator at the points of contact with the skin during the testing process, with the obtained data stored in the computer memory; with the ability to monitor the thermal state of the device with the thermal module; and may also additionally contain a timer configured to select the time parameters of the effect.

[0033] The key features of the claimed invention, distinguishing it from its closest analogue, are the applicator's configuration—linear or nearly so—the number of Peltier elements—at least two at opposite ends of the applicator, and the presence of a set of temperature sensors for continuous monitoring of the applicator's thermal profile. The claimed device contains metal elements (which, in some embodiments, are part of the housing) that serve as a heat sink and simultaneously act as an inertial temperature damper. Furthermore, the device is capable of controlling the Peltier elements to maintain the applicator's ends at the maximum temperature for a selected range, preset for each specific treatment session.

[0034] The threshold temperature measurement accuracy of no worse than ±0.5°C is ensured by the aforementioned distinctive features, which ensure a monotonic temperature distribution (increasing or decreasing) along the linear contact area (the edges / ribs of the applicator). This avoids thermal interaction between surface areas with significantly different temperatures, significantly reducing the risk of ambiguous interpretation of the obtained data and decreasing the error in determining the threshold temperature. The presence of at least two independent Peltier elements of sufficient power—for example, at least 25 W for operation in "heating" mode, and at least 50 W for operation in "cooling" mode—at opposite ends of the applicator allows for the effective formation of the desired temperature profile and flexible response to the need to change the thermal mode.To independently monitor the thermal profile, for example, with a sampling rate of 30 Hz to 120 Hz, a set of temperature sensors distributed along the applicator's contact surface converts the linear (geometric) characteristics of the resulting blister into a threshold temperature for the external stimulus. When the "hot" or "cold" edge of the blister falls between the positions of adjacent temperature sensors, a linear interpolation procedure is used to restore the threshold temperature.

[0035] Brief description of the drawings

[0036] The invention is explained by illustrative material, where Figure 1 shows a 3D image of the design of the device with a thermal module, with a raised lid and a cut-out fragment of the housing for visualization of its individual structural elements; Figure 2 shows a top view of the ventilated base of the device; Figure 3 is an enlarged fragment of Figure 1, demonstrating the placement of Peltier elements; Figure 4 shows a bottom view of the heat-conducting element (applicator) with placed temperature sensors; Figure 5 shows a functional diagram of the device with a control and monitoring unit; Figure 6 is a photograph of the claimed system, demonstrating the external appearance of the manufactured device placed on the doctor's desk and connected to a personal computer; Figure 7 is a photograph of the device at the time of performing a test on the patient's forearm;Figure 8 shows a diagram of the application of a template (ruler) to the application site 10 minutes after the end of the provocative temperature effect on the patient's forearm; Figure 9 shows a block diagram of the control algorithm of the lower level of the control and monitoring unit; Figure 10 shows a block diagram of the control algorithm of the upper level of the control and monitoring unit.

[0037] Implementation of the invention

[0038] The claimed device is intended for controlled provocative testing of thermal urticaria, specifically, for thermal exposure of patients' skin to diagnose cold- or heat-induced thermal urticaria. Skin provocative testing using the claimed device allows for the precise determination of the threshold temperature values ​​(or critical temperature thresholds (CTTs)) that trigger urticaria symptoms, with the ability to subsequently monitor these values.

[0039] In the case of cold urticaria, the threshold temperature of external exposure is defined as the "highest temperature" of external cold exposure (cooling) capable of causing this type of allergic reaction, with its characteristic symptoms (wheals, erythema, itching). In the case of heat urticaria, the threshold temperature separates the warmer temperature range with distinct urticarial manifestations from the cooler range where testing does not yield a positive response. This threshold temperature is the minimum heating temperature at which heat testing is capable of triggering the manifestation of heat urticaria. Measurement during initial testing and subsequent monitoring of this parameter aid in accurate diagnosis and selection of optimal treatment strategies.

[0040] The following description of the invention is for explanatory purposes only, demonstrating the feasibility of achieving the claimed technical result. This technical solution is subject to various changes and modifications, as would be apparent to a person skilled in the art based on this description. Such changes do not limit the scope of the claims. For example, the dimensions of the device and the configuration of the housing, which may be made from various components, the linear dimensions of the applicator, which is tailored to the length of a human forearm (for adults or children), the number of temperature sensors used in the device, the configuration and number of heat-conducting elements and heat-dissipating radiators, and other changes may be varied.

[0041] One of the possible embodiments of the claimed device is shown in Figures 1 - 5, a detailed description of which is presented below.

[0042] A metal heat-conducting element is installed in the housing 10 - an applicator 20, connected to heating and cooling means made in the form of temperature-controlled Peltier elements 31, 32, 33, and to temperature sensors 40, 41, 42, 43, connected to the control and monitoring unit 50.

[0043] In a specific embodiment, housing 10 is designed as a rectangular parallelepiped containing three components: a dielectric tray 13, a ventilated metal base 14, and a dielectric cover 11. The housing may have a non-rectangular configuration and contain a greater or lesser number of components. In all embodiments, the housing features a flat section on the upper surface in the applicator area, allowing the patient's forearm to be positioned thereon for a temperature test. This section of the housing is made of a material with low thermal conductivity to ensure local thermodynamic equilibrium on the forearm in the area of ​​its thermal contact with the applicator. The housing is provided with a straight slit 12 for applicator 20, ensuring thermal contact with the patient's skin.The configuration of the slit 12 corresponds to the configuration of the applicator, which may differ from a straight line, i.e., have a slight curvature that does not affect the results of the measurements. In the embodiment of the invention shown in Figs. 1-5, the slit 12 is formed in the cover 11 of the housing 10. In another embodiment of the invention, the housing may be made as a composite of two parts: a lower part containing a base configured to support the structural elements and components of the device, and an upper part containing the slit 12 (this embodiment is not shown in the drawings).

[0044] The ventilated base 14 is designed to accommodate the applicator with temperature sensors, as well as other device components and parts, including Peltier elements, radiators, fans, control boards, and a power connector. In a specific embodiment, the ventilated base is made of a lightweight, heat-conducting material, such as an aluminum channel 141, with shelves 15 for mounting the boards 51 of the control and monitoring unit 50.

[0045] The device in a specific embodiment also contains a tray 13, which functions as a lower and partially lateral cover of the device with slots for ventilation and a communication connector.

[0046] On the wide side surface 16 of the housing 10 there are ventilation openings 17 for air supply fans 171, 172, and on the narrow side surfaces 18 there are slots 181, adjacent to which plate radiators 191, 192 are installed. The device may contain a partition 151 for independent separate direction of air flows and their regulation from each fan 171, 172 to the corresponding plate radiator 191, 192. That is, the air flow from the fan 171 is pumped through the radiator 191, and from the fan 172 - through the radiator 192. The direction of the air flow is shown by arrows 152. The vertically installed printed circuit board of the control and monitoring unit 50, made taking into account the dimensions of the housing, may serve as a partition 151.

[0047] The heat-conducting element—applicator 20—has a linear configuration. In one embodiment, it may be implemented as an extended metal strip, the length of which is determined by its placement on the patient's forearm. The metal strip is oriented vertically within the housing and positioned so as to ensure contact of its edge (or end surface) with the patient's skin for thermal application. The applicator may be secured to the device housing by any means known in the art. In one embodiment, the applicator is formed from an angular, unequal-sided aluminum profile 21, as shown in Figs. 1, 3, and 4, having a first vertical shelf 211 and a second horizontal shelf 212. The vertical shelf 211 of the profile has a smaller height and a smaller length in relation to the second shelf 212 and its edge 213 is placed in the mentioned rectilinear slot 12 under the applicator on the cover 11 of the housing 10.The lower side 2121 of the shelf 212 of the aluminum profile 21 with its ends 2122 in the zones free from the presence of the first shelf 211 is connected to the contact surfaces of the Peltier elements 31, 32, the opposite contact surfaces of which are installed on the outer wall 142 of the ventilated base 14.

[0048] The device is equipped with 40 temperature sensors, preferably digital integrated sensors housed in plastic housings. These temperature sensors are designed to measure the temperature profile generated directly on the applicator and are distributed along the applicator's length, preferably at equal distances from one another. The number of sensors can vary depending on the applicator's length. For example, in a device designed to diagnose thermal urticaria in children, the applicator's length can be 120 mm with an inner forearm length (from the elbow to the wrist) of approximately 160 mm. The number of sensors can range from four, provided an optimal temperature range is selected to maintain high threshold determination accuracy.In the embodiment of the device for adult patients, the number of sensors can reach 13, uniformly distributed on an applicator up to 180 mm long. For a linear applicator length of 140-150 mm, the optimal solution is to use 8-10 temperature sensors at a fixed distance of 15-20 mm from each other. In an example of a specific implementation of the invention, eight sensors (DS18B20 digital temperature sensors) are used for an applicator 140 mm long, which are uniformly distributed on the lower side 2121 of the second shelf 212 at a distance of 20 mm from each other along the length of shelf 211 at the corner junction of the first and second shelves 211 and 212 (Fig. 4). The second shelf 212 of the heat-conducting applicator element 20 is preferably perforated with through holes 201, which can have different configurations, from the condition of reducing heat transfer along the second shelf 212 of the profile.In the implemented design, the second shelf 212, 2 mm thick and 25 mm wide, contains seven through holes 201 with a diameter of approximately 10 mm. This ensures minimal heat transfer while maintaining sufficient mechanical strength and rigidity.

[0049] The device utilizes at least two Peltier elements 33 mounted at opposite ends of a linear applicator. The configuration of this unit in the application area creates a linear temperature gradient from the "cold" end of the applicator to its "hot" end, spaced apart by a distance corresponding to the applicator's length—from 120 to 180 mm—thus facilitating unambiguous interpretation of the obtained data and reducing patient discomfort from temperature fluctuations during testing, compared to the prototype device. In one embodiment, for additional heat dissipation from the base, Peltier element 33 is installed between the outer wall 142 of the ventilated base 14 and the plate radiator 191 in the area where the first Peltier element 31 is located.The device can be equipped with a third Peltier element, installed between the inner surface of the ventilated base wall and the plate radiator in the area where the first Peltier element is located, mounted at the "cold" end of the applicator. Using only two Peltier elements in the device requires more powerful elements, such as a first Peltier element with a minimum power of 25 W for operation in "heating" mode, and a second Peltier element with a minimum power of 50 W for operation in "cooling" mode. This also requires increasing the dimensions of the air ducts, radiators, and fans. It is possible to use two Peltier elements at the "cold" end of the applicator for operation in "cooling" mode, each with a lower power, but with a total power of at least 50 W.

[0050] The control and monitoring unit 50 is made on the basis of a microcontroller 501 with the ability to exchange information and control with a module 52 for receiving data from digital integrated temperature sensors 40, a module 53 for generating control signals for Peltier elements 31, 32, 33 and a module 54 for generating control commands for fans 171, 172.

[0051] In addition to temperature sensors 40 (401...408), which directly record the temperature profile of the applicator 20, temperature sensors 41, 42, 43 for controlling the profile can be installed in the device at the places where the ends of the second shelf 212 are attached to the radiators 191 and 192. These sensors are connected to the module 54 for generating control commands for each of the fans 171, 172. In Fig. 5, the designations of sensors 401 and 408 are given only for the initial and final points of temperature measurements on the applicator 20. The inputs of module 52 are connected to temperature sensors 40 and 41, 42, 43 via bus 55.

[0052] Modules 52, 53, and 54 of control and monitoring unit 50 are programmed as lower-level control modules. The input / output of unit 50 is connected to upper-level computer 60 via a USB connection. The operating algorithm of unit 50 is shown in Fig. 9.

[0053] Computer 60 implements a high-level program, i.e., performs communication functions with the device, allowing the formation of the required temperature profile by means of Peltier elements 31, 32, 33, receiving and displaying data from sensors 40 (401...408), located on the lower side 2121 of the second shelf 212 of profile 21, housing 10 and radiators 191, 192, and processing (saving) the received data. The operating algorithm of the high-level program is shown in Fig. 10. The device can also be provided with the function of monitoring the thermal state of the housing structure and controlling changes in the characteristics of the cooling system.

[0054] The claimed device is equipped with 6 connectors for connecting a power source and a USB cable, which can be placed on the second wide side surface of the case.

[0055] In a specific embodiment of the invention, housing 10 has dimensions of 210 mm in length, 80 mm in width, and 72 mm in height. Applicator 20 is 140 mm in length, 2 mm in thickness, and 15 mm in height, protruding from a straight slot 12 above cover 11 of housing 10 by 1-2 mm. The size of the cover, which serves as a support, is selected to accommodate the forearms of subjects of varying ages.

[0056] The device works as follows.

[0057] The claimed device, containing a thermal module, is connected to a computer with pre-installed software, for example, “VTERM” (Certificate of State Registration of a Computer Program, certificate number: RU 2025611708) implementing the top-level algorithm, using a mini USB - USB 2.0 cable, then the device is connected to a power source.The device functionality using the top-level algorithm allows: 1) visualization of temperature data obtained from the temperature sensors installed on the applicator and the device body; 2) switching the display of digital data from the applicator temperature sensors in integer or fractional values; 3) entering patient data; 4) setting a countdown timer for the application time; 5) setting the required temperature at the ends of the applicator; 6) starting temperature control; 7) continuously recording temperature values ​​for a set time; 8) creating a file and recording temperature, time, and entered patient data in it, generating a protocol of the completed session. OS: Windows XP and higher with NET software installed.

[0058] The microcontroller can also utilize software such as "URTERM" (Certificate of State Registration of Computer Program, Certificate Number: RU 2025611387), which implements a lower-level algorithm for measuring the object's temperature threshold while monitoring the applicator's actual temperature profile at the point of contact with the skin. Specifically, the device can receive control commands from the upper-level program; record temperature data from the body and applicator temperature sensors; transmit data to the upper-level program; start and stop the blower fans; and set the duty cycle of the Peltier elements.

[0059] When the control and monitoring unit 50 is first connected to the computer 60, the device is automatically initialized, followed by the configuration of the corresponding COM port with the user interface elements and the current temperature values ​​for the temperature sensors 40 (401...408), which are evenly distributed on the second shelf 212 of the aluminum profile 21 of the applicator 20. When first turned on, the readings from the sensors 40 will be approximately equal and close in value to the ambient temperature (room temperature).

[0060] Next, set specific maximum and minimum temperatures for applicator 20 for the current session, along with the application time. A custom temperature profile can be created for a specific patient on the applicator's contact surface by setting maximum and minimum values ​​at the applicator's ends, determined by the physician diagnosing the patient within a temperature range from 0°C to +45°C. When the temperature distribution curve reaches the specified profile (e.g., +10 / +30°C), the patient places the back of their forearm on applicator 20 (Fig. 7), and the physician starts the application timer countdown (e.g., 5 minutes) while simultaneously recording the current readings in a thermometric monitoring file.Moreover, the application time can also be varied depending on the diagnostic needs of a particular patient. A timer function has been added to the device, assisting the diagnostician in selecting the time parameters of the treatment and in sequentially passing through the checkpoints of the process.

[0061] After the application time set on the timer (usually 5 minutes) has elapsed, a beep will sound and the patient should remove their forearm from the applicator 20. At this point, the control and monitoring unit 50 will automatically stop maintaining the set temperature distribution (profile) and switch to a mode of forced reduction of the operating temperature to the set threshold value, switching to standby mode.

[0062] To monitor the actual temperature distribution along the applicator during application, a procedure is used for continuous parallel measurement using a set of temperature sensors and archiving the obtained data in a computer file in the appropriate format. Measurement results from the temperature sensors are recorded at a specified interval, for example, every 1 second, throughout the application. The device allows for displaying the modified data on a computer screen as graphs, using data processing tools such as MS Excel, OpenOffice, LibreOffice, and others. Because the device measures the actual temperature distribution on the applicator, there is no need to use algorithms to account for / compensate for ambient temperature during testing, nor is it necessary to calibrate the device before use.

[0063] The test result is determined later, after a control period (usually 10 minutes). The threshold temperature is determined by measuring the length of the blister formed on the patient's forearm and correlating it with the temperature readings from the 40 sensors. If the blister is located between points in the projection of the temperature sensors, the accuracy of the threshold temperature measurement is increased by using linear interpolation procedures for data obtained from adjacent sensors. The results represent objective monitoring of the patient's condition, free from subjective assessment and the qualifications of medical personnel.

[0064] For example, after stopping the application and a 10-minute relaxation pause, not all patients will have a clear trace from the applicator, and the wheal (and / or erythema) will spread in all directions from the corresponding pole (end) of the applicator, masking the area of ​​direct thermal contact. Therefore, immediately after the application, at least one end of the residual trace on the skin is marked (a zero reference point is created) - for example, with a felt-tip pen (see line 0- in Fig. 8). Next, at the end of the relaxation interval, a template or ruler is applied to the reference point and it is determined between which adjacent sensors (number n and n + 1) the desired boundary of the formation of visible elements of urticaria falls (in the case shown in Fig. 8, this is n = 5 and n + 1 = 6); then the distance L is measured in millimeters. x from the reference point to the opposite boundary of the blister (the effective length of the blister) and then determine the temperature values ​​T п and T п+^ for sensors with numbers n and n+1 according to the thermometric control file data (in Fig. 8 these are 7 and T, respectively); after which the temperature T is calculated х according to the formula: where L n and L n+1 - distances to sensor n and n+1, respectively. For the case in Fig. 8, the formula has the following form:

[0065] To conduct studies using the claimed device, a prototype with the following dimensions and characteristics was manufactured. The device measured 210 mm in length, 80 mm in width, and 72 mm in height. Applicator 20 measured 140 mm in length, 2 mm in thickness, and 15 mm in width, protruding 1-2 mm from a straight slot 12 above cover 11 of housing 10. The size of the cover, which served as a support, was chosen to accommodate the forearms of subjects of varying ages. The device utilized eight DS18B20 digital temperature sensors, which were evenly spaced 20 mm apart on the underside 2121 of second shelf 212. The device was tested on 50 patients with various allergies to detect cases of temperature urticaria in both its cold and heat forms.The studies were also conducted on a control group of healthy patients (20 people), in whom traces of such exposure practically disappeared after 10 minutes. The diagnosis made in the studied patients was subsequently confirmed by an allergist based on the totality of all diagnostic features. In a specific example of implementation, during the diagnosis of temperature urticaria in Patient A, the form of cold urticaria was determined using the claimed device, which contains a 14 cm long applicator and 8 temperature sensors evenly distributed along the length of the applicator. Exposure with the applicator was carried out for 5 minutes in a mode from +5... to +25.... The exposure resulted in the formation of a blister, the border of which was located at a distance of 112 mm from the "cold" end of the applicator (TO sensor). The test results are presented in the form of a template in Fig. 8. Based on the sensor readings collected in the thermometric control file, the following values ​​were obtained: = + 14.4°C and T ( =+19.5°С, geometric measurements showed the following results = 12 mm, while the distance between adjacent sensors was ~ L n ) = 20 mm. In this case: 14.4 = +17.46 (°C) « +17.5 (°C)

[0066] The presented calculations demonstrate that due to the presence of 8 measuring sensors uniformly placed at intervals of 20 mm on the applicator and the smooth nature of the dependence of T on L, the final error in determining T х does not exceed ±0.5°C.

[0067] Thus, the tests demonstrated that the device provides a threshold temperature measurement accuracy of no worse than ±0.5°C while monitoring the applicator's actual temperature profile at the point of contact with the skin. This is achieved through the optimal design of the linear applicator with temperature sensors and, additionally, the separate regulation of the heat and air flows that shape its temperature profile. This device implementation allows for the consideration of ambient temperature through independent temperature control of the thermal distribution along the applicator (the sampling rate from the eight temperature sensors in this particular implementation was 1 Hz), further enhancing the measurement accuracy and reliability of diagnostic results.

[0068] Highly accurate determination of the external temperature threshold, beyond which signs of thermal (cold or heat) urticaria begin to appear, is necessary for identifying and subsequently monitoring the evolution of this parameter, which is key to quantitative diagnosis and regular monitoring of thermal urticaria during treatment or remission. Data measured using the proposed device significantly improves the accuracy of threshold temperature restoration compared to current diagnostic and monitoring methods for thermal urticaria.Knowing the threshold temperature trigger value in cases of cold and / or heat-induced urticaria allows us to move from a simple statement of the presence or absence of signs of these diseases (for example, with a classic test with an ice cube or a heated object) to a quantitative assessment of the severity of this disease, the choice of appropriate treatment tactics and monitoring of its effectiveness.

[0069] Thus, the claimed device with a thermal module and system allow for provocative testing with simultaneous high-precision determination of threshold values ​​in cases of heat and cold urticaria.

[0070] Although specific embodiments have been described and illustrated, such embodiments are to be considered merely as illustrative and not limiting of the invention as interpreted in accordance with the appended claims.

Claims

CLAUSES OF THE INVENTION 1. A thermal module of a device for provocative testing of temperature urticaria, characterized in that it contains a metal heat-conducting element - an applicator having a rectilinear configuration, made with the ability to form thermal contact with the skin of a patient; at least two means for heating and cooling the applicator, made in the form of temperature-controlled Peltier elements, located at opposite ends of the applicator; temperature sensors installed in contact with the applicator with the ability to measure temperature along its length.

2. The thermal module according to item 1, characterized in that it includes a third Peltier element installed in the area where the first Peltier element is located, where the first Peltier element is installed at one end of the applicator with the possibility of implementing the “cooling” mode, and the second Peltier element is installed at the opposite end of the applicator with the possibility of implementing the “heating” mode.

3. A thermal module according to paragraph 1, characterized in that the temperature sensors are installed along the length of the applicator at an equal distance from each other.

4. The thermal module according to item 1, characterized in that the applicator has a length from 120 to 180 mm, a thickness from 1.5 to 3 mm, and a width from 10 to 20 mm.

5. A thermal module according to paragraph 1, characterized in that the applicator is made in the form of a metal strip, one of the edges of which is intended to provide thermal contact with the patient’s skin.

6. A thermal module according to claim 1, characterized in that the applicator is a part made of aluminum, with an angular or T-shaped cross-sectional profile having a first vertical shelf and a second horizontal shelf, wherein the vertical shelf contains an extended edge designed to enable thermal contact with the patient’s skin.

7. A thermal module according to paragraph 4, characterized in that the length of the vertical shelf is less than the length of the horizontal shelf, wherein the vertical shelf is placed in the center of the horizontal shelf with the formation of platforms at the ends of the horizontal shelf for placing Peltier elements.

8. A thermal module according to paragraph 4, characterized in that the temperature sensors are made in the form of digital integrated sensors and are located on the bottom side. the second shelf evenly along the length of the first shelf at the corner joint of the said shelves.

9. A thermal module according to paragraph 4, characterized in that the second shelf of the heat-conducting element is perforated with through holes or slots.

10. A thermal module according to paragraph 1, characterized in that the Peltier elements are used with a power of at least 25 W to ensure operation in the “heating” mode, and at least 50 W to ensure operation in the “cooling” mode.

11. A device for provocative testing of temperature urticaria, characterized in that it contains a thermal module located in a housing, made according to claim 1, containing a metal heat-conducting element - an applicator having a rectilinear configuration, made with the possibility of forming thermal contact with the skin of a patient; at least two means for heating and cooling the applicator, made in the form of temperature-controlled Peltier elements, placed at opposite ends of the applicator; temperature sensors installed in contact with the applicator with the possibility of measuring the temperature along its length; as well as at least two radiators located in the housing, installed with the possibility of removing heat from the Peltier elements; air supply fans installed with the possibility of directing air flows to the radiators; a control unit and monitoring the parameters of the device;the body is equipped with ventilation holes, has a flat section on the upper surface in the area where the applicator is located, equipped with a slot for the protruding part of the applicator to ensure a temperature effect on the patient’s skin, and is made of a material with low thermal conductivity.

12. The device according to item P, characterized in that the applicator is made in the form of a metal strip, or an angular or T-shaped aluminum profile, has a first vertical shelf and a second horizontal shelf, wherein the vertical shelf contains an extended “working” edge, made with the possibility of making thermal contact with the patient’s skin.

13. The device according to item 12, characterized in that the configuration of the slit corresponds to the configuration of the “working” edge of the applicator.

14. The device according to paragraph P, characterized in that the housing is made composite - it contains a lid and a tray made of a dielectric, between which a ventilated base made of an aluminum channel is installed.

15. The device according to item P, characterized in that the radiators are made plate-shaped and are located in the housing on opposite sides, while the walls The housings in which the radiators are located are provided with openings having a configuration corresponding to the cross-sectional configuration of the plate radiators, while the air supply fans are located between the said radiators.

16. The device according to item 11, characterized in that it contains a partition for separate direction of air flows from each fan to the corresponding plate radiator.

17. The device according to item 12, characterized in that the applicator is placed with its “working” edge in the said rectilinear slot for the applicator, made on the upper side of the device body or its cover.

18. The device according to item 14, characterized in that the first and second Peltier elements are installed on the outer surface of the upper wall of the ventilated base, ensuring contact with the applicator.

19. The device according to item 14, characterized in that it contains a third Peltier element installed between the inner surface of the wall of the ventilated base and the plate radiator in the area where the first Peltier element is located.

20. The device according to item 11, characterized in that the applicator is located protruding from the gap above the surface of the housing to a height of 1-2 mm.

21. The device according to paragraph 11, characterized in that it is equipped with heat-dissipating metal elements.

22. The device according to paragraph 11, characterized in that the control and monitoring unit is based on a microcontroller with the ability to exchange information and control the operation of Peltier elements, temperature sensors, and fans.

23. The device according to item 22, characterized in that the control and monitoring unit contains a module for receiving data from temperature sensors, a module for generating control signals for Peltier elements, and a module for generating control commands for fans.

24. The device according to item 11, characterized in that the housing is made in the form of a rectangular parallelepiped and has a dielectric cover with a rectilinear slot for the applicator, providing thermal contact with the patient's skin, and a dielectric tray, between which a ventilated base is installed, made of an aluminum channel, with plate radiators and shelves for fastening the control and monitoring unit boards, while on the first wide side surface of the housing there are ventilation openings for air supply fans, and on both narrow side surfaces there are openings for plate radiators, wherein a partition is installed in the base for separately directing air flows from each fan to the corresponding plate radiator; the applicator is made of an angular unequal-sided aluminum profile, having a first vertical and a second horizontal shelf; the height of the vertical shelf is less than the width of the horizontal shelf, and the length of the vertical shelf is less than the length of the horizontal shelf, wherein the vertical shelf with its edge is placed in the said rectilinear slot for the applicator on the cover of the housing; the lower side of the second shelf of the said aluminum profile with its ends in areas free from the presence of the first shelf is connected to the contact surfaces of the first and second Peltier elements, the opposite contact surfaces of which are installed on the outer side of the wall of the ventilated base;temperature sensors in the form of digital integrated sensors in plastic housings are placed on the bottom side of the second shelf evenly along the length of the first shelf and are installed at the corner joint of the said shelves.

25. The device according to item 24, characterized in that the housing has the following dimensions: length 210, width 80 and height 72 mm, while the applicator has a length of 140 mm, a thickness of 2 mm, a height of 15 mm and protrudes from a straight slot above the housing cover to a height of 1-2 mm.

26. The device according to item 24, characterized in that the connectors for connecting the power source and the USB cable are located on the second wide side surface of the housing.

27. A system for provocative testing of temperature urticaria, characterized in that it contains a device according to claim 11, connected to a computer, with a thermal module containing a metal heat-conducting element - an applicator having a rectilinear configuration, made with the possibility of forming thermal contact with the skin of a patient; at least two means for heating and cooling the applicator, made in the form of temperature-controlled Peltier elements, located at opposite ends of the applicator; temperature sensors installed in contact with the applicator with the possibility of measuring the temperature along its length.

28. The system according to item 27, characterized in that it contains a timer configured to select the time parameters of the effect.

29. The system according to Art. 27, characterized in that it is designed with the possibility of forming various temperature profiles or modes on the contact surface of the applicator, selected from a temperature range from 0°C to +45°C.

30. The system according to I.27, characterized in that it is designed with the ability to graphically represent the results of provocative testing of the patient and independently measure during the testing process the actual temperature profile of the applicator at the points of contact with the skin, with the storage of the obtained data in the computer memory.

31. The system according to item 27, characterized in that it is designed with the ability to monitor the thermal state of the device according to item 11.

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