Wrist-worn device for non-invasively checking a person's blood glucose concentration

Abstract

The invention relates to medicine and technology, and more particularly to non-invasively detecting a change in a person's blood glucose concentration, and can be used in the creation of wrist-worn devices for this purpose, as well as in the creation of socially-oriented systems for the early diagnosis of diabetes and associated diseases in the form of wrist-worn devices. The aim of the invention is to improve the operational efficiency of a wrist-worn device for non-invasively checking a person's blood glucose concentration by reducing the preparation and configuration time required. The technical result of the invention is that of reducing preparation and configuration time and, in general, reducing the time taken to perform a non-invasive check of a person's blood glucose concentration by preventing a mobile unit from moving with or along a wrist strap in relation to the radial artery of a person's arm when the person is walking or using the arm on which the device is worn.

Description

[0001] WRIST-WEARING DEVICE FOR NON-INVASIVE MONITORING OF HUMAN BLOOD GLUCOSE CONTENT

[0002] DESCRIPTION

[0003] The invention relates to medicine and technology, specifically to non-invasive determination of changes in glucose levels in human blood and can find application in the creation of wrist devices for this purpose, as well as in the creation of socially oriented systems for the early diagnosis of diabetes and related diseases in the form of wrist devices.

[0004] Prior art.

[0005] For patients with diabetes, constant monitoring of the amount of glucose in the blood is a vital necessity. For this purpose, new developments are currently being used, based on non-invasive methods that determine health parameters without taking blood.

[0006] There are many developed methods and devices. For example, electrical transfer functions are controlled by means of two pairs of four-electrode sensors fixed to the surface of the human body (Patent of the Russian Federation 2342071, published 2007). The disadvantage of the method is low sensitivity to determining the concentration of glucose, since glucose is electrically neutral.

[0007] A non-invasive method for determining the concentration of glucose in human blood is also known (Patent of the Russian Federation 2295915, published 2005). The method is carried out by irradiating the zone of maximum accumulation of blood vessels on the mucous membrane with a laser beam, receiving information and converting it into blood glucose concentration values ​​using hardware. The disadvantage of the method is its low accuracy.

[0008] A non-invasive method for determining glucose concentration is known, which includes measuring systolic and diastolic blood pressure sequentially on the patient's left and right arms, while the glucose content in the blood is calculated using mathematical formulas (Patent of the Russian Federation 2368303, published 2007). This method is complex and not very accurate.

[0009] There is even a known method for non-invasively determining the glucose content in the blood by a person’s voice, which includes recording the sound vibrations of a person’s voice and converting them using hardware to obtain a parameter corresponding to the glucose content in the blood (RU Patent 2506893, published 20.02.2014).

[0010] The best of the modern non-invasive glucometers is a device in the form of a wristwatch - a "smart watch" - for monitoring the pulse wave signal, determining the blood sugar content and other blood parameters with the function of manually determining the location of the radial artery and pointing the sensor at the artery. The change in the pulse wave parameters determines the change in sugar in a person's blood and other parameters.

[0011] Such a device contains a control module with a microprocessor, a monitor, a power supply, a strap with a mobile unit - a sensor that can move along the strap or together with the strap and contains an infrared sensor.

[0012] The case with the control and display module resembles a wristwatch in appearance.

[0013] The mobile unit contains a radiation emitter and receiver and is located above the radial artery on the human arm and is connected to the control and display module via a communication channel.

[0014] The mobile remote unit is so named because, when configured, it has the ability to move relative to a person’s hand, either along the strap or together with the strap.

[0015] The mobile remote unit can also be called a sensor, a mobile unit or a mobile unit - a sensor, or a mobile unit with an infrared sensor, or an infrared sensor. An analogue of the invention is a device for determining the blood glucose level by means of a non-invasive sensor based on infrared light with a television broadcasting function (CN205031270U, ​​published 17.02.2016). The analogue discloses the design of a non-invasive blood glucose sensor. The sensor includes an emitter and a receiver of radiation reflected from human tissues, and an STM32 microprocessor, a pressure control module with a pressure sensor and a drive module.

[0016] Features of the analogue that coincide with the features of the invention: a wrist device for non-invasive monitoring of glucose levels in human blood, a housing with strap fastening devices; a strap for fastening the wrist device on a person's hand; a control and display module located in the housing; an emitter and receiver of radiation reflected from human tissues, located in a mobile remote unit, which, when adjusting the wrist device, is designed with the ability to move relative to the person's hand.

[0017] The disadvantage of the analogue is the relatively long time required for preparation and implementation of non-invasive monitoring of glucose levels in human blood.

[0018] The analog can also be a device for a non-invasive reflective blood glucose level detector (CN104771181A, published on 15.07.2015). The non-invasive reflective blood glucose detector refers to a detector for determining the concentration of glucose in the blood based on an optical method, various physiological parameters, including oxygen saturation in the human body, pulse rate, etc.

[0019] The features of the analogue that coincide with the features of the invention: a device for non-invasive monitoring of glucose levels in human blood, a housing, an emitter and a receiver of radiation reflected from human tissue.

[0020] The disadvantage of the analogue is the relatively long time of preparation and implementation of non-invasive monitoring of glucose content in human blood. Another analogue of the invention is a wrist device for non-invasive monitoring of glucose content in human blood (CN104188636A, publ.

[0021] 10.12.2014).

[0022] This analogue resembles a wristwatch in appearance and is designed to monitor the pulse wave signal, determine blood sugar levels and other blood parameters with the function of manually determining the location of the radial artery.

[0023] In addition, the wrist device can perform the functions of an electronic wristwatch, showing the time, date, day of the week, etc.

[0024] The wrist device for monitoring the pulse wave signal contains a control and display module, left and right strap sections. At the tail end of one of the watch strap sections, there is a mounting recess (mounting hole in one of the strap layers), in which a mobile unit - an infrared sensor - is installed and secured.

[0025] The mobile unit with an infrared sensor is connected to the control and display module via a flexible printed circuit board in the form of a cable and laid inside the strap.

[0026] Features of the analogue that coincide with the features of the invention: a wrist device for non-invasive monitoring of glucose content in human blood, comprising a housing with strap fastening devices, a strap for fastening the device on a person's hand, a control and display module located in the housing; an emitter and a receiver of radiation reflected from human tissues, located in a mobile unit that is designed with the ability to move along the strap and, in addition, during the operation of the device, the emitter is directed to the radial artery of the person's hand.

[0027] The disadvantage of the analogue is the relatively long time required for preparation and implementation of non-invasive monitoring of glucose levels in human blood.

[0028] The analog does not prevent the mobile unit with the strap from moving along the wrist relative to the radial artery at the base of the thumb of the person's hand when walking and working with his hands. In particular, the rotational movement of the mobile unit with the strap relative to the wrist of the person is not prevented, which disrupts the initial adjustment of the wrist device and makes it necessary to re-adjust the device.

[0029] The prototype of the invention is a wrist device for non-invasive monitoring of glucose levels in human blood (Tikhonenko D.O., Tikhonenko O.O., Lobko V.P. New developments in the field of wrist devices for non-invasive monitoring of glucose levels in human blood, as well as for monitoring other human health parameters. Terms and definitions. Higher education: scientific research. Proceedings of the Interuniversity International Congress (Moscow, October 13, 2023). Volume 1. - Moscow: Infiniti Publishing House, 2023, 61-98 pp., BBK 65, ISBN 978-5-905695-53-7, DOI 10.34660 / INF.2023.68.11.381, IPC A61B 5 / 00, A61B 5 / 053, https: / / studylib.net / doc / 27163933 / kon ress-13-oktyabrya-2023-tom-l), comprising a housing with strap fastening devices; a strap for fastening the wrist device on a person's hand; a control and display module located in the housing; a radiation emitter and a receiver of radiation reflected from human tissues, located in a mobile remote unit, which, when adjusting the wrist device, is designed with the possibility of moving relative to the person's hand, and the control and display module contains a power source, a control and data processing unit, a data display panel; wherein the radiation emitter and the receiver of radiation reflected from human tissues are connected to the control and display module located in the housing via a wired or wireless communication line.

[0030] The disadvantage of the prototype is the relatively long time required for preparation and implementation of non-invasive monitoring of glucose levels in human blood.

[0031] The long time is due to the movement of the mobile unit together with the strap on the wrist relative to the original place - away from the radial artery of the person's hand when he walks and works with his hands, which disrupts the initial adjustment of the wrist device and makes it necessary to re-adjust the device. The essence of the invention.

[0032] The purpose of the invention: to increase the efficiency of operation of a wrist device for non-invasive monitoring of glucose levels in human blood by reducing the time for preparation and setup.

[0033] By efficiency we mean speed of action, the ability to quickly bring a device into working condition, in particular, without preliminary configuration.

[0034] The objective is achieved in that the wrist device for non-invasive monitoring of glucose content in human blood comprises a housing with strap fastening devices; a strap for fastening the wrist device on a person's hand; a control and display module located in the housing; a radiation emitter and a receiver of radiation reflected from human tissues located in a mobile remote unit, which, when setting up the wrist device, is designed with the ability to move relative to the person's hand, and the control and display module contains a power source, a control and data processing unit, a data display panel;wherein the emitter of radiation and the receiver of radiation reflected from human tissue are connected to the control and display module located in the housing via a wired or wireless communication line, and differs from the prototype in that the strap is made with a variable hardness along the length of the strap of the inner surface of the strap in contact with the hand, wherein the ratio of the maximum hardness Tmax to the minimum hardness Tmin is determined by the relationship:;

[0035] Tmin / Tmax = k, where k is an empirical coefficient that takes a value from 0.35 to 0.95; and, in addition, when preparing for work and during work, the sensor is designed with the possibility of pressing the emitter and receiver to the place of palpation of the pulse on the radial artery of the hand. For simplicity of presentation of the material, the device for non-invasive monitoring of glucose content in human blood will be called the device.

[0036] For simplicity of presentation of the material, we will call the emitter of radiation and the receiver of radiation reflected from human tissue the emitter and receiver.

[0037] In a particular embodiment of the invention, the device can be designed in such a way that the strap can be made in one section or two sections.

[0038] In a particular embodiment of the invention, the device can be designed in such a way that a light emitter is used as a radiation emitter, and a light receiver is used as a receiver of radiation reflected from human tissue.

[0039] In a particular embodiment of the invention, the device can be made in such a way that when the device is on the hand, the radiation emitter is made with the ability to emit radiation into the hand to the radial artery at the base of the thumb of the human hand, or to the radial artery of the wrist, or to the radial artery of the forearm, and the receiver of radiation reflected from human tissues is made with the ability to receive reflected radiation from the hand, namely, from the radial artery at the base of the thumb of the human hand, or from the radial artery of the wrist, or from the radial artery of the forearm.

[0040] In a particular embodiment of the invention, the device can be made in such a way that when preparing it for work, the place of palpation of the pulse on the radial artery of the hand is moistened with water or when preparing it for work, the place of palpation of the pulse on the radial artery of the hand is wiped dry. Wetting or wiping dry depends on the condition of the person's hand during testing and adjustment of the sensor and the device as a whole.

[0041] The device is designed with the function of manually determining the location of the radial artery based on the location of the pulse palpation and aiming the emitter and receiver at it.

[0042] The technical result of the invention: reducing the time of preparation and adjustment of the device, and in general reducing the time of non-invasive monitoring of glucose content in human blood by preventing the movement of the mobile unit together with the strap or along the strap along the hand relative to the radial artery of the human hand when the human walks and works with the hand with the device on. In particular, by preventing the rotational and translational movement of the mobile unit with the strap relative to the human hand.

[0043] Let us explain how the technical result was achieved.

[0044] The device is firmly secured by means of a strap, for example, on the wrist of the left (or right) hand so that the mobile unit is opposite the radial artery in this place of the hand. Then the emitter and receiver of reflected radiation, located in the mobile unit, are directed at the radial artery. For precise guidance of the emitter and receiver during the operation of the device, the emitter and receiver are directed at the radial artery, namely, the emitter and receiver are pressed to the place of palpation of the pulse on the person's hand.

[0045] After that, the person sits still for 3 minutes, and then turns on the device. To do this, turn on the power and turn on the control module by pressing the buttons on the touch screen of the display. The control module checks the correct location of the mobile unit (emitter) relative to the radial artery. The check time is up to 3 minutes. If the location of the mobile unit is incorrect, a message about the need to re-install the mobile unit appears on the display. The device is turned off. The strap is loosened, the mobile unit is re-positioned above the radial artery (above the place where the pulse is palpated), then the strap is tightened, tightly pressing the mobile unit to the wrist. The person sits still for 3 minutes, and then turns on the device. Work on installing the mobile unit continues until a message appears on the display that the device is ready for operation.

[0046] During testing of the prototype device, it was found that the initial setup of the device for operation requires at least 3 attempts. Each attempt takes up to 6 minutes. After that, the device is on the person's hand ready to measure the blood sugar level. Thus, the time for the first measurement takes 18 minutes.

[0047] The disadvantage of the prototype is as follows. During the day, when a person walks and works with his hands, the mobile unit moves from the initial installed place. In this case, to perform the measurement, it is necessary to repeat the operations of setting the mobile unit to the initial position for measurements.

[0048] As a rule, a person works intensively with his hands during the day. The device, in this case, moves from its original place. During the day, a diabetic has to measure blood sugar levels many times - up to 10 times or more (and sometimes up to 20 times). At the same time, it is necessary to set the mobile unit to its original position and adjust the device for work the same number of times. This is up to 3 hours per day for measurements with 10 measurements. The reason is the rotation of the device with the strap relative to the wrist and the radial artery.

[0049] According to the invention, it is proposed to make areas of increased and decreased hardness on the strap - on its inner surface. When developing the invention, recesses in the flexible plastic strap were made in the plan having the shape of a circle and a rectangle. Inserts of soft rubber and harder plastic were placed in these recesses. As an option, inserts were made of rubber with different hardness.

[0050] Other options for making the strap are given below in the section on the implementation of the invention.

[0051] When tightening the strap on the hand, in particular, on the wrist, the softer places on the inner surface of the strap adjacent to the wrist are pressed by the wrist (tissues of the human hand). The harder places on the inner surface of the strap adjacent to the wrist press the wrist (tissues of the human hand). This creates a reliable, with increased resistance to rotation relative to the wrist, grip of the wrist with the strap.

[0052] Experiments have shown that this inventive solution completely eliminates the repeated adjustment of the device and the mobile unit during the day. The technical result is achieved - a reduction in the time of preparation and implementation of non-invasive monitoring of glucose content in human blood by preventing the movement of the mobile unit along with the strap along the arm relative to the radial artery of the person when he walks and works with his hands.

[0053] In the experiments, the time for measuring blood glucose levels was reduced by 2.3 times (with ten measurements) and by 2.6 times (with twenty measurements). List of figures.

[0054] Fig. 1 shows a device for non-invasive monitoring of glucose levels in human blood with a strap, on the inner surface of which inserts of varying hardness are located.

[0055] Fig. 2 shows a cross-section of a human arm with the radial artery indicated, as well as a sensor with an emitter and receiver of radiation reflected from human tissue.

[0056] Fig. 3 shows the operation diagram of the emitter and receiver of radiation reflected from human tissue. The radiation is directed to the radial artery.

[0057] Fig. 4 shows the operation diagram of the emitter and receiver of radiation reflected from human tissue. The radiation is directed past the radial artery.

[0058] Fig. 5 shows a cross-section of a human hand with a device strap. Areas of increased and decreased hardness are shown. Areas of increased hardness are recessed into the human hand. Areas of decreased hardness are pressed into the human hand tissue.

[0059] Fig. 6 shows a cross-section of a human hand with a device strap. The strap is made with variable hardness of the inner surface along the length of the strap. Areas of increased and decreased hardness are shown.

[0060] Fig. 7 shows a device for non-invasive monitoring of glucose levels in human blood with a strap. The strap is made with variable hardness of the inner surface along the length of the strap. Areas of increased and decreased hardness on the strap are shown. A mobile remote unit - a sensor - is also shown.

[0061] Fig. 8 shows a device for noninvasive monitoring of glucose content in human blood with a strap. The mobile unit is located on the left section of the strap. The mobile unit - the sensor is connected to the control and display module located in the housing via a wireless communication line.

[0062] Fig. 9 shows a device for noninvasive monitoring of glucose content in human blood with a strap. The mobile unit is located on the right section of the strap. The mobile unit - the sensor is connected to the control and display module located in the housing via a wireless communication line. Fig. 10 shows the dependence of the change in hardness along the length of the strap. Two areas with increased and decreased hardness are shown.

[0063] Fig. 11 shows the dependence of the change in hardness along the length of the strap. Seven areas with increased and decreased hardness are shown.

[0064] Fig. 12 shows the dependence of the change in hardness along the length of the strap. Four areas with increased and decreased hardness are shown.

[0065] Fig. 13 shows a diagram of the device with a strap on which areas of different hardness are indicated. View of the device from the inside.

[0066] Fig. 14 shows a diagram of the device with a strap on which areas of different hardness are indicated. View of the device from the inside.

[0067] Fig. 15 shows a device for noninvasive monitoring of glucose content in human blood with a strap. A mobile unit - a sensor is attached to the strap, in which an emitter and a receiver of radiation (light) reflected from human tissues are located. The mobile unit - a sensor is connected by a cable to the control and display module. The cable is located in the strap.

[0068] Fig. 16 shows the strap lock. At the end of one of the strap sections (on the right side from the viewer) there is a mobile unit - a sensor.

[0069] Fig. 17 shows a device for non-invasive monitoring of glucose content in human blood with a strap. A mobile unit is attached to the strap - a sensor, stretched along the right (from the viewer) section of the strap in the direction of the control module.

[0070] Fig. 18 shows a diagram of the mobile unit - a sensor attached to the end of a strap. The diagram shows the sensor body, two emitters, a receiver, a cable and a strap.

[0071] Fig. 19 shows a diagram of a mobile unit - a sensor attached to the end of a strap. The diagram shows the sensor body, one emitter, a receiver, a cable and a strap.

[0072] Fig. 20 shows a device for non-invasive monitoring of glucose content in human blood with a strap. On the inner surface of the strap there are inserts of different hardness. The figure explains Fig. 1. View of the device from the inside. Fig. 21 shows a device for non-invasive monitoring of glucose content in human blood with a strap. On the inner surface of which there are inserts of different hardness. The figure explains Fig. 1. View of the device from the outside.

[0073] Disclosure of invention.

[0074] A wrist device for non-invasive monitoring of glucose levels in human blood contains a housing with a control and display module (in other words, with electronics and a power supply), a strap for attaching the wrist device to a person's hand, a mobile remote unit in which an emitter and a receiver of radiation reflected from human tissue are located.

[0075] Light, radiation visible to the human eye, is used as radiation. Radiation invisible to the eye can also be used.

[0076] Thus, the control and display module, as well as the mobile remote unit, are attached to the hand via a strap.

[0077] The control and display module may be referred to as the management module in the literature.

[0078] In turn, a mobile remote unit can be called a sensor or, more precisely, a wrist device sensor for non-invasive monitoring of glucose levels in human blood.

[0079] The mobile remote unit is so named because, when configured, it has the ability to move relative to a person’s hand, either along the strap or together with the strap.

[0080] In literature, a mobile remote unit can also be called a sensor, a mobile unit, or a mobile unit - sensor, or a mobile unit with an infrared sensor, or an infrared sensor. Definitions of terms are given in the source / 1 / .

[0081] The figures indicate the following positions:

[0082] 1 - body with strap fastening devices;

[0083] 2 and 3 - right and left sections of the strap for attaching the device to a person's hand; 4 - control module (control and data processing unit) located in the housing;

[0084] 5 - data display panel (display with sensors) is located on the opposite side of the body;

[0085] 6 and 7 - a radiation emitter and a receiver of radiation reflected from human tissues, located in a mobile unit 8, which is designed with the possibility of movement along the left (from the viewer's side) section of the strap (see Figs. 1, 2, 8). Alternatively, the mobile unit can be attached to the right (from the viewer's side) section of the strap (see Figs. 9, 15, 16 and 17). As was said earlier, for simplicity of presentation of the material, we will call the radiation emitter and the receiver of radiation reflected from human tissues - an emitter and a receiver;

[0086] During operation of the device, the emitter 6 (see Fig. 3) is directed at the radial artery 9 at the base of the thumb of the human hand. The receiver 7 receives the radiation reflected from the artery;

[0087] The control and display module 1 contains a power source 10, a control and data processing unit 4 and a data display panel (display) 5 (see Fig. 2);

[0088] The emitter 6 and the receiver 7 of the reflected radiation from human tissue 12 are connected to the control module 4 and display module 5, located in the housing 1 via a wired or wireless communication line.

[0089] Positions 13, 14, 15, 16, 17 and 18 (see Fig. 6) also indicate areas with different hardnesses. These areas are made in the form of inserts in holes made in the strap.

[0090] The strap can be made in one or two sections, as shown in figures 1, 7.

[0091] Position 20 indicates the radius bone.

[0092] Position 21 indicates the ulna.

[0093] Position 19 indicates an area of ​​increased hardness.

[0094] Position 22 indicates an area of ​​reduced hardness. Position 23 indicates an area of ​​increased hardness.

[0095] Position 24 denotes the hardness axis on the graph of hardness versus strap length. Position 25 denotes the strap length axis on the graph of hardness versus strap length.

[0096] Positions 26, 28, 30, 32, 34 indicate increased hardness values. These hardnesses are maximum.

[0097] Positions 27, 29, 31, 33 indicate reduced hardness values. These hardnesses are minimal.

[0098] Positions 35, 36 and 38 indicate increased hardness values. Hardness 35 is the maximum hardness.

[0099] Position 37 indicates reduced hardness. Moreover, hardness 37 is the minimum hardness.

[0100] Positions 39 - 70 indicate areas on the inner surface of the strap. The areas differ in hardness values.

[0101] Structurally, the strap can be made in one or two sections.

[0102] The figures show the preferred strap design, namely the two-piece strap design.

[0103] Position 11 indicates the device with a wireless communication line between the control and data processing unit 4 and the mobile unit 8.

[0104] In figures 15-18, position 71 denotes the strap, position 72 denotes the mobile unit - sensor, fixed at the end of the strap, position 73 denotes the cable, positions 74 and 75 denote the emitters, position 76 denotes the radiation (light) receiver, position 77 denotes the rim on the mobile unit - sensor, enclosing the receiver.

[0105] Positions 78 and 79, 80 and 81 indicate the devices for attaching the strap to the case.

[0106] The remote unit (see Fig. 18 and 19) is also called a sensor. The remote unit is fixed to the end of one of the strap sections. Together with the strap, the remote unit can move relative to the person's hand when adjusting the device. Fig. 15 and 16 show the remote unit 72 located at the end of the strap 71 in the immediate vicinity of the lock. Fig. 7 shows a device in which the remote unit 8 is also located at the end of the strap in the immediate vicinity of the lock. Fig. 17 shows the remote unit 72 located at the end of the strap 71 at a fairly large distance from the lock.

[0107] In addition, the device can be designed in such a way that the remote unit is secured to the strap by means of a moving device. And the remote unit is moved along the strap during adjustment. Such an embodiment of the invention is shown in Figs. 2 - 6, 8 and 9.

[0108] According to the invention, a wrist device for non-invasive monitoring of glucose content in human blood (hereinafter referred to in the text for simplicity of presentation as simply the device) comprises a housing 1 with strap fastening devices 80 and 81 (see Fig. 1); a strap for fastening the wrist device on a person's hand, consisting of two sections 2 and 3; a control and display module located in the housing; an emitter and a receiver of radiation reflected from human tissues, located in a mobile remote unit 8, which, when adjusting the wrist device, is designed with the possibility of moving relative to the person's hand, and the control and display module comprises a power source, a control and data processing unit, a data display panel; wherein the emitter and receiver of radiation reflected from human tissues are connected to the control and display module located in the housing by means of a wired or wireless communication line.

[0109] The strap is made with a variable hardness along the length of the strap on the inner surface of the strap that is in contact with the hand (on the inner surface of the strap there are inserts 13 - 18 with different hardnesses, see Fig. 1), and the ratio of the maximum hardness Tmax to the minimum hardness Tmin is determined by the relationship:

[0110] Tmin / Tmax = k, where k is an empirical coefficient that takes a value from 0.35 to 0.95.

[0111] In addition, when preparing for work and when working, the sensor is designed with the possibility of pressing the emitter and receiver to the place of palpating the pulse on the radial artery of the hand. In other words, during the operation of the device, the emitter and receiver are directed to the radial artery, namely, the emitter and receiver are pressed to the place of palpating the pulse on the person's hand. Thus, the mobile unit 8 (see Fig. 2) is located above the artery 9.

[0112] In a particular embodiment of the invention, the device can be designed in such a way that the strap can be made in one section or two sections.

[0113] In a particular embodiment of the invention, the device can be designed in such a way that it additionally contains a lock for fastening a strap to a person’s hand, wherein the lock has a device for fastening to the strap.

[0114] In a particular embodiment of the invention, the device can be designed in such a way that a light emitter is used as an emitter, and a light receiver is used as a receiver.

[0115] In a particular embodiment of the invention, the device can be made in such a way that when the device is on the hand, the emitter is made with the ability to emit radiation into the hand to the radial artery at the base of the thumb of the human hand, or to the radial artery of the wrist, or to the radial artery of the forearm, and the receiver is made with the ability to receive reflected radiation from the hand, namely, from the radial artery at the base of the thumb of the human hand, or from the radial artery of the wrist, or from the radial artery of the forearm.

[0116] In a particular embodiment of the invention, the device can be made in such a way that when preparing it for work, the place of palpation of the pulse on the radial artery of the hand is moistened with water or when preparing it for work, the place of palpation of the pulse on the radial artery of the hand is wiped dry. Wetting or wiping dry depends on the condition of the person's hand during testing and adjustment of the sensor and the device as a whole.

[0117] The claimed device is designed with the function of manually determining the location of the radial artery by the place of palpation of the pulse and aiming the emitter and receiver at it.

[0118] The production of a strap with variable hardness of the inner surface is carried out by creating areas of increased and decreased hardness on the inner surface of the strap.

[0119] In general, the device of the strap can be described as follows: the strap is made in such a way that on the inner surface it contains at least two regions 13 and 14 along the length of the strap with different hardnesses, and the ratio of the maximum hardness Tmax to the minimum hardness Train is determined by the relationship:

[0120] Train / Тгаах = k, where k is an empirical coefficient, taking a value from 0.35 to 0.95. In special cases of the invention implementation, the empirical coefficient takes a value from 0.35 to 0.4.

[0121] In particular cases of implementation of the invention, the empirical coefficient takes a value from 0.401 to 0.5.

[0122] In particular cases of implementation of the invention, the empirical coefficient takes a value from 0.501 to 0.6.

[0123] In particular cases of implementation of the invention, the empirical coefficient takes a value from 0.601 to 0.7.

[0124] In particular cases of implementation of the invention, the empirical coefficient takes a value from 0.701 to 0.8.

[0125] In particular cases of implementation of the invention, the empirical coefficient takes a value from 0.801 to 0.95.

[0126] The following formalized description of the invention is possible: the strap is made with a variable hardness of the inner surface of the strap, which is in contact with the hand, along the length of the strap. This is realized due to the fact that the strap on its inner surface, which is in contact with the human hand during operation, contains areas along the length (or along the length) of the strap, which have different hardness values, and areas with lower hardness alternate with areas with higher hardness.

[0127] It should be noted that the holes located in the strap do not belong to its inner surface. The longitudinal direction of the device as a whole and the case in particular is the direction parallel to the cross-section passing through the hand and through the device with the strap worn on the hand.

[0128] The transverse direction of the device as a whole and the body in particular is the direction perpendicular to the cross-section passing through the hand and through the device with the strap worn on the hand.

[0129] The device works as follows.

[0130] The device is tightly secured to the arm using a strap, for example, to the wrist of the person’s left (or right) hand, so that the mobile unit is opposite the radial artery in that area of ​​the arm.

[0131] In general, when the device is on the hand, the emitter and receiver of the radiation are directed at the radial artery at the base of the thumb of the human hand, or at the radial artery of the wrist, or at the radial artery of the forearm.

[0132] In order to correctly orient the mobile unit, it is necessary to feel the pulse of the artery and press the mobile unit to this place, and then tighten the strap. In this case, the emitter and receiver located in the mobile unit are directed to the radial artery.

[0133] Further actions. The person sits motionless for 3 minutes (or 5 minutes if he / she has worked intensively before), the hand is relaxed and placed on the table or on the knees. After that, the person turns on the device: turns on the power and turns on the control module by pressing the buttons on the touch screen of the display.

[0134] After this, the control module checks the correct location of the mobile unit (emitter and receiver) relative to the radial artery. The check time is up to 3 minutes. If the location of the mobile unit is incorrect, a message about the need to re-install the mobile unit appears on the display.

[0135] To reinstall the mobile unit, the device is switched off. The strap is loosened, the mobile unit is repositioned above the radial artery, then the strap is tightened, pressing the mobile unit tightly to the hand. The person sits still for 3 minutes, after which the device is switched on. Work on installing the mobile unit continues until a message appears on the display that the device is ready for operation. During testing of the prototype device, it was found that the initial setup of the device for operation requires up to 3 attempts. Each attempt takes up to 6 minutes - this is the arithmetic mean of the time out of 100 attempts made by 10 testers. After that, the device is on the person's hand ready to measure the blood sugar level. Thus, the time for the first measurement takes up to 18 minutes (this is also the arithmetic mean of the time out of 100 attempts).

[0136] However, the prototype has a drawback - during the day, when a person walks and works with his hands, the mobile unit moves from the initial installed place. In this case, to carry out the measurement, it is necessary to carry out operations to set the mobile unit to the initial position for measurements.

[0137] As a rule, a person works intensively with his hands during the day. The device, in this case, shifts from its original place - rotates on the hand. During the day, a diabetic has to repeatedly - up to 10 times or more - measure the sugar content in the blood. At the same time, it is necessary to set the mobile unit to its original position and adjust the device for work the same number of times. And this is up to 3 hours per day for measurements. These data were obtained from the results of experiments during the development of the present invention. The main reason is the rotation of the device with the strap relative to the wrist and artery.

[0138] It would seem that the problem can be solved by tightening the strap more tightly. But in this case, the person feels extremely uncomfortable.

[0139] You can also use glue - stick the device with a strap to your wrist every day, for example. However, this solution to the problem causes discomfort during the day and has a negative effect on human skin.

[0140] During the development of the present invention, the above-described methods of fastening the device were tested in practice.

[0141] According to the invention, it is proposed to make areas of increased and decreased hardness on the strap - on its inner surface in contact with the hand, i.e. to make a strap with variable hardness of the inner surface in contact with the hand, along the length of the strap or strap section. When developing the invention, areas of variable hardness were made in two ways - by inserting materials with different hardness and by heat treatment of areas on the inner surface of the strap.

[0142] For example, in a flexible plastic or rubber strap, recesses were made in the plane having the shape of a circle or rectangle. Inserts of soft rubber, hard rubber or harder plastic were placed in these recesses. Inserts of rubber with different hardness were also made.

[0143] When tightening the strap on the hand, the softer areas on the inner surface of the strap adjacent to the hand are pressed by the tissues of the hand. The harder areas on the inner surface of the strap adjacent to the hand press through the tissues of the hand. This creates a reliable (with increased resistance to movement along the hand, in particular, to rotation relative to the hand) grip of the strap with the hand.

[0144] During the development of the invention, plastic, rubber and leather straps were made. In the straps, recesses for inserts were made with a milling cutter. It is preferable to make rubber and plastic straps.

[0145] Inserts with reduced hardness were made from various grades of rubber. Inserts with increased hardness were made from various plastics or hard rubber. In addition, a variant of manufacturing plastic and rubber straps by heat treatment of areas on their internal surfaces was tested. Heat treatment of plastic and rubber products or their elements is widely used nowadays.

[0146] Thus, when developing the invention, known methods of hardening plastics were used to create areas with minimal hardness. The required hardness characteristics of the areas were achieved by the level of heating temperature, heating rate, holding time and cooling time (cooling rate).

[0147] During the research, we achieved a local increase in the strap hardness by 30 - 200% of the initial hardness of the inner surface of the strap. To create areas with maximum hardness, we used known methods of annealing plastics. The required hardness characteristics of the areas were achieved by the level of heating temperature, heating rate and cooling time (very slow cooling).

[0148] Experiments have shown that this solution completely eliminates the need to reconfigure the device and mobile unit during the day.

[0149] The technical result achieved is a reduction in the time of preparation and adjustment of the device, and in general a reduction in the time of non-invasive monitoring of glucose content in human blood by preventing the movement of the mobile unit together with the strap or along the strap along the wrist relative to the radial artery of the human hand when the human walks and works with the hand with the device on. In particular, by preventing the rotational and translational movement of the mobile unit with the strap relative to the human hand.

[0150] In the experiments (involving 10 test subjects), the time for measuring blood glucose levels was reduced by 2.3 times (with ten measurements per day) and 2.6 times (with twenty measurements per day).

[0151] Table 1 presents the hardness values ​​in Shore units of the areas located on the inner surface of the strap along the length of the strap. Experimental straps Nos. 1 - 5 are presented. See Fig. 13.

[0152] Strap #1 is a traditional strap with a constant hardness of the inner surface of the strap along the length of the strap. Its hardness is 54 Shore units.

[0153] The strap material is rubber.

[0154] In straps No. 2 - 3 the maximum hardness value is 91 Shore units. The minimum value is 32 Shore units. The coefficient "k" is 0.35.

[0155] In strap #4 the maximum hardness value is 91 Shore units. The minimum value is 62 Shore units. The coefficient "k" is 0.68.

[0156] In strap #5 the maximum hardness value is 88 Shore units. The minimum value is 32 Shore units. The coefficient "k" is 0.36.

[0157] Table 2 presents the hardness values ​​in Shore units of the areas located on the inner surface of the strap along the length of the strap. Experimental straps Nos. 6 - 10 are presented. See Fig. 14. Strap No. 6 is a traditional strap with a constant hardness of the inner surface of the strap along the length of the strap. Its hardness is 68 Shore units. The strap material is plastic.

[0158] In strap #7 the maximum hardness value is 146 Shore units. The minimum value is 51 Shore units. The coefficient "k" is 0.35.

[0159] In strap #8 the maximum hardness value is 146 Shore units. The minimum value is 68 Shore units. The coefficient "k" is 0.46.

[0160] In strap #9 the maximum hardness value is 154 Shore units. The minimum value is 68 Shore units. The coefficient "k" is 0.44.

[0161] In strap #10 the maximum hardness value is 105 Shore units. The minimum value is 55 Shore units. The coefficient "k" is 0.52.

[0162] In the experiments, the ribbing of the surface of the device body was additionally tested to enhance the effect in order to strengthen the technical result. On the surface of the body adjacent to the surface of the hand in the transverse direction, alternating protrusions and depressions or ribs are made (transverse ribs, see pos. 82 in Fig. 20), and / or on the surface of the body adjacent to the surface of the hand in the longitudinal direction, alternating protrusions and depressions or ribs are made (longitudinal ribs, see pos. 83 in Fig. 20).

[0163] This enhances the grip of the body with the hand, helps prevent the movement of the device body, the mobile unit together with the strap along the hand relative to the radial artery on the human hand. At the same time, the time of preparation and implementation of non-invasive control of glucose content in human blood is reduced. This technical solution can be additionally used to enhance the technical result. In addition, this solution simultaneously promotes heat exchange between the body and the hand.

[0164] It follows from the above that the objective of the invention is achieved. Increased efficiency of operation of the wrist device for non-invasive monitoring of glucose content in human blood is ensured by reducing the time for preparation and adjustment. The technical result of the invention is also achieved. Reduction of the time for preparation and adjustment of the device is achieved, and in general, a reduction in the time for non-invasive monitoring of glucose content in human blood is achieved by preventing movement of the mobile unit together with the strap or along the strap along the wrist relative to the radial artery of the human hand when the person walks and works with the hand with the device on. In particular, by preventing rotational and translational movement of the mobile unit with the strap relative to the human hand.

[0165] Table 1

[0166] Hardness values ​​in Shore units of areas located on the inner surface of the strap along the length of the strap. Straps numbered 1-5 are presented. Strap No. 1 is a traditional strap with a constant hardness of the inner surface of the strap along the length of the strap.

[0167] The strap material is rubber.

[0168] Table 2

[0169] Hardness values ​​in Shore units of areas located on the inner surface of the strap along the length of the strap. Straps numbered 6-10 are presented.

[0170] Strap No. 6 is a traditional strap with a constant hardness of the inner surface of the strap along the length of the strap. The material of the strap is plastic. Literature.

[0171] 1. Tikhonenko D.O., Tikhonenko O.O., Lobko V.P. New developments in the field of wrist devices for non-invasive monitoring of glucose levels in human blood, as well as for monitoring other parameters of human health.

[0172] Terms and definitions. Higher school: scientific research. Proceedings of the Interuniversity International Congress (Moscow, October 13, 2023). Volume 1. - Moscow: Infinity Publishing House, 2023, 61-98 pp., BBK 65, ISBN 978-5-905695-53-7, DOI 10.34660 / INF.2023.68.11.381, MIK A61B 5 / 00, A61B 5 / 053, https: / / studylib.net / doc / 27163933 / kongress-13-oktyabrya-2023-tom-1

Claims

Invention formula.

1. A wrist device for non-invasive monitoring of glucose levels in human blood, comprising a housing with strap fastening devices; a strap for fastening the wrist device to a person's hand; a control and display module located in the housing; a radiation emitter and a receiver of radiation reflected from human tissues, located in a mobile remote unit, which, when setting up the wrist device, is designed with the ability to move relative to the person's hand, and the control and display module contains a power source, a control and data processing unit, a data display panel;wherein the emitter of radiation and the receiver of radiation reflected from human tissue are connected to the control and display module located in the housing via a wired or wireless communication line, characterized in that the strap is made with a variable hardness along the length of the strap of the inner surface of the strap in contact with the hand, wherein the ratio of the maximum hardness Tmax to the minimum hardness Tmin is determined by the relationship:; Tmin / Tmax k, where k is an empirical coefficient that takes a value from 0.35 to 0.95; and, in addition, when preparing for work and during work, the sensor is designed with the possibility of pressing the emitter and receiver to the place of palpation of the pulse on the radial artery of the hand.

2. The device according to item 1, characterized in that the strap can be made in one section or two sections.

3. The device according to item 1, characterized in that it additionally contains a lock for fastening the strap to a person’s hand, wherein the lock has a device for fastening to the strap.

4. The device according to paragraph 1, characterized in that a light emitter is used as the radiation emitter, and a light receiver is used as the receiver of radiation reflected from human tissue.

5. The device according to claim 1, characterized in that when the device is on the hand, the radiation emitter is designed with the ability to emit radiation into the hand to the radial artery at the base of the thumb of the human hand, or to the radial artery of the wrist, or to the radial artery of the forearm, and the receiver of radiation reflected from human tissues is designed with the ability to receive reflected radiation from the hand, namely, from the radial artery at the base of the thumb of the human hand, or from the radial artery of the wrist, or from the radial artery of the forearm.

6. The device according to item 1, characterized in that when preparing it for operation, the place for palpating the pulse on the radial artery of the hand is moistened with water or when preparing it for operation, the place for palpating the pulse on the radial artery of the hand is wiped dry.

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