Sensor for 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 sensors for non-invasively checking a person's blood glucose concentration. The aim of the invention is to improve the operational efficiency of a sensor for a wrist-worn device for non-invasively checking a person's blood glucose concentration by reducing the preparation and configuration time required. The technical results of the invention include: increasing the adhesive force between a rim and the arm of a person by increasing the contact area between said rim and a wet or dry surface of the arm; reducing the energy spent on non-invasively checking a person's blood glucose concentration; and increasing the heat transfer of the sensor via the crest of the rim to the person's arm by increasing the contact area between the rim and the arm.

Description

[0001] WRIST-WEARING DEVICE SENSOR 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 sensors for non-invasive monitoring of glucose levels in human blood, as well as for the creation of socially oriented systems for early diagnosis of diabetes and related diseases.

[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] Many methods and devices have been developed for non-invasive determination of changes in glucose levels in human blood. Thus, glucose is monitored through electrical transfer functions (RU Patent 2342071, published 2007), through laser beam irradiation of areas of maximum blood vessel concentration on the mucous membrane (RU Patent 2295915, published 2005), through measuring systolic and diastolic blood pressure sequentially on the left and right hands (RU Patent 2368303, published 2007), and even through a person's voice (RU Patent 2506893, published 20.02.2014).

[0007] A good non-invasive glucometer is a device in the form of a wristwatch - a "smart watch" that determines glucose, as well as pulse, pressure and other parameters (see source: https: / / gelikonline.ru / fitnes brasleti s izmereniem dayleniya i pulsa / umnie-chasy-s- izmereniem-sahara-v-krovi / ?yclid : 5227952676836737023).

[0008] The best of the modern non-invasive glucometers is a device in the form of a wristwatch - a "smart watch" that determines glucose, as well as pulse, pressure and other parameters (see source: Tikhonenko D.O., Tikhonenko O.O., Lobko V.P.

[0009] New developments in the field of wrist devices for non-invasive monitoring of glucose content in human blood, as well as for monitoring other parameters of human health. Terms and definitions. Higher school: 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, htps: / / studylib.net / doc / 27163933 / kongress-13-oktyabrya-2023-tom-1).

[0010] This glucometer has a battery capacity of 510 mAh, which is 2.4 times larger than the smartwatch described above.

[0011] The device contains a sensor 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 human blood sugar and other parameters.

[0012] Such a device contains a control and display module with a microprocessor, a monitor, a power supply, a strap with a sensor (mobile unit) that can move along the strap or together with the strap.

[0013] The control and display module may be called the control and data processing module or the control module.

[0014] The case with the control and display module resembles a wristwatch in appearance.

[0015] The sensor contains a light emitter and a light receiver and is positioned above the radial artery on a person's arm and is connected to a control and display module via a communication channel.

[0016] The sensor is also called a mobile remote unit, because it has the ability, when configured, to move relative to a person’s hand, either along the strap or together with the strap.

[0017] The sensor of the wrist device for non-invasive monitoring of glucose levels in human blood can be called simply a sensor, or a mobile remote unit, or a mobile unit - sensor, or a mobile unit with an infrared sensor, or an infrared sensor. For simplicity, the light emitter is simply called an emitter.

[0018] For simplicity, the light receiver is simply called a receiver.

[0019] An analogue of the invention is a wrist device sensor for non-invasive monitoring of glucose levels in human blood based on infrared light with a telecasting function for determining blood glucose levels. The sensor is part of the wrist device (CN110236487A, published 2019.09.17).

[0020] The publication discloses the design of a non-invasive blood glucose sensor. The sensor includes an emitter and a receiver of radiation reflected from human tissue.

[0021] Features of the analogue that coincide with the features of the invention:

[0022] A wrist device sensor for non-invasive monitoring of glucose content in human blood, comprising a housing secured to a strap, a light emitter, and a light receiver; wherein the light emitter and the light receiver are located on the inside of the sensor housing.

[0023] The disadvantage of the analogue is the absence of a rim on the sensor body separating the emitter from the receiver.

[0024] The prototype of the invention is a wrist device sensor for non-invasive monitoring of glucose levels in human blood (see the article by 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: Infinity Publishing House, 2023, 61-98 pp., BBK 65, ISBN 978-5-905695-53-7, DOI 10.34660 / INF.2023.68.11.381, https: / / studylib.net / doc / 27163933 / kongress-13-oktyabrya-2023-tom- 1).comprising a housing secured to a strap, a light emitter, a light receiver; wherein the light emitter and the light receiver are located on the inside of the sensor housing in such a way that when the sensor is on the hand, the light emitter is configured to emit light into the hand onto the radial artery, and the light receiver is configured to receive reflected light from the radial artery of the human hand; and on the inside of the sensor housing there is a rim surrounding the light receiver and separating it from the light emitter. These features of the prototype coincide with the features of the invention.

[0025] In addition, the side is made in a rectangular cross-section.

[0026] The disadvantage of the prototype is the implementation of the side of a constant height along its length. There are no protrusions and recesses on the side, as well as grooves. This ensures a relatively small force of adhesion of the side to the human hand and, thus, does not prevent the displacement of the sensor from the place of its initial installation.

[0027] The essence of the invention.

[0028] The purpose of the invention is to increase the efficiency of the operation of a wrist device sensor for non-invasive monitoring of glucose levels in human blood by reducing the time for preparation and setup.

[0029] By efficiency we mean speed of action, the ability to quickly bring a device into working condition, in particular, without preliminary configuration.

[0030] The objective is achieved in that the sensor of the wrist device for non-invasive monitoring of glucose content in human blood comprises a housing secured to a strap, a light emitter, a light receiver; wherein the light emitter and the light receiver are located on the inner side of the sensor housing in such a way that when the sensor is on the hand, the light emitter is configured to emit light into the hand on the radial artery, and the light receiver is configured to receive reflected light from the radial artery of the human hand; and on the inner side of the sensor housing there is a rim surrounding the light receiver and separating it from the light emitter, and from the prototype, characterized in that the ridge of the rim is made with alternating projections and depressions along its length or grooves are made on the ridge of the rim; and, in addition, when preparing for work and during work, the sensor is configured to press the emitter and the receiver to the place of palpating the pulse on the radial artery of the hand.

[0031] In a particular embodiment of the invention, the sensor can be made in such a way that when the sensor is on the hand, the light emitter is made with the ability to emit light into the hand onto the radial artery at the base of the thumb of the human hand, or onto the radial artery of the wrist, or onto the radial artery of the forearm, and the receiver is made with the ability to receive reflected light 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.

[0032] In a particular embodiment of the invention, the sensor can be made in such a way that when preparing it for work, the place for palpating the pulse on the radial artery of the hand is moistened with water or when preparing it for work, the place for palpating the pulse on the radial artery of the hand is wiped dry.

[0033] In a particular embodiment of the invention, the sensor can be made in such a way that the ridge of the side is made with protrusions and depressions alternating along its length, and grooves are made on the protrusions and depressions of the ridge of the side.

[0034] As stated earlier, the sensor contains an emitter and a receiver of light reflected from the hand (human tissue) and is part of a wrist device for non-invasive monitoring of glucose levels in human blood. In turn, the wrist device, in addition to the sensor, contains a control and display module located in its own housing (the housing of the control and display module).

[0035] In this case, the emitter and receiver of light reflected from the hand, located in the sensor, are connected via a wired or wireless communication line to the control and display module, located in the housing of the control and display module.

[0036] Light is electromagnetic radiation perceived by the human eye. The technical results of the invention are:

[0037] 1. Making the side with alternating projections and depressions (and / or with ribs) along its length will increase the adhesion force of the side to the human hand by increasing the contact area of ​​the side surface with the hand surface and, thus, preventing the sensor from shifting from its initial installation location, which in turn will reduce the time for preparing and setting up the sensor during multiple measurements during the day and will increase the efficiency of the sensor.

[0038] 2. A particular technical result is an increase in the area of ​​contact between the surface of the side and the dry-wiped surface of the hand at the location of the sensor.

[0039] 3. Another particular technical result is an increase in the area of ​​contact of the side surface with the water-moistened surface of the hand at the location of the sensor.

[0040] 4. Reduction of energy consumption for non-invasive monitoring of glucose levels in human blood due to precise orientation of the emitter and receiver to the artery and reduction of the sensor preparation time for operation.

[0041] 5. Increasing the heat exchange of the sensor through the comb to the human hand by increasing the contact surface area of ​​the rim with the hand. This will increase the reliability of the sensor.

[0042] Let us explain the achievement of technical results.

[0043] Since the sensor of the wrist device for non-invasive monitoring of glucose content in human blood, as claimed in the invention, operates as part of a device for non-invasive monitoring of glucose content in human blood, we will describe the operation of the sensor as part of the device.

[0044] The sensor of the wrist device for non-invasive monitoring of glucose content in human blood and the device as a whole are tightly fastened by means of a strap, for example, on the wrist of the left (or right) hand so that the sensor is opposite the radial artery in this place of the hand. Then the emitter and receiver of reflected light, located in the sensor (in the mobile unit), are directed to the radial artery. For precise guidance of the emitter and receiver during 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 palpation of the pulse on the person's hand.

[0045] After that, the person sits still for 3 minutes. The hand with the sensor is relaxed and is on the person's lap or, for example, on the table in front of the person. After that, the person 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 sensor (emitter and receiver) relative to the radial artery. The check time is up to 3 minutes. If the sensor location is incorrect (i.e. its location on the hand does not match the location on the hand when testing the sensor), then a message about the need to re-install the sensor appears on the display. The device is turned off. The strap is loosened, the sensor is re-positioned above the radial artery (above the place where the pulse is felt), then the strap is tightened, pressing the sensor tightly to the wrist. The person sits still for 3 minutes, after which he turns on the device.Work on installing the sensor continues until a message appears on the display indicating that the device is ready for operation.

[0046] As stated above, the location of the sensor on the hand should match the location where it was located during testing.

[0047] Testing is carried out as follows.

[0048] The sensor is placed on the radial artery at the base of the thumb of the human hand, at the site of palpation of the pulse (see Fig. 27 in the source / 1 / ). Non-invasive measurement of glucose content in the blood is performed using the device (as described above).

[0049] After that, an invasive determination of the glucose content in the blood is immediately carried out. To do this, a finger is pricked and the glucose content in the blood is measured using an invasive glucometer. After that, the invasive control data is entered into the device. After that, the pressure is measured with a tonometer and body temperature with a thermometer, and the data is entered into the device (into the mobile application on the device). All this is done according to the instructions for the device.

[0050] After this, the device is considered tested and ready for operation. 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.

[0051] The disadvantage of the prototype is as follows. During the day, when a person walks and works with his hands, the sensor moves from the initial position. In this case, to perform a measurement, it is necessary to repeat the operations of setting the sensor to the initial position for measurements.

[0052] As a rule, a person works intensively with his hands during the day. The device, in this case, shifts from its original place. During the day, a diabetic has to measure the sugar content in the blood many times - up to 10 times or more (and sometimes up to 20 times). At the same time, it is necessary to set the sensor 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 shift, in particular the rotation, of the sensor with the strap relative to the radial artery.

[0053] In the invention, the sensor of the non-invasive glucometer on its inner side of the housing contains a rim surrounding the light receiver and separating it from the light emitter. In this case, the ridge of the rim is made with projections and depressions alternating along its length, or grooves are made on the ridge of the rim.

[0054] In other words, the side is made with a variable height along its length. Moreover, along the length of the side, the height of the side increases and decreases.

[0055] In other words, along the length of the side, areas with a greater height alternate with areas with a lower side height.

[0056] This allows to increase the adhesion force of the side to the person’s hand and, thus, prevent the sensor from shifting from its original installation location.

[0057] In addition, when preparing it for operation and when the sensor is operating, the emitter and receiver are pressed to the place where the pulse is felt on the radial artery of the wrist. This ensures increased operational efficiency of the wrist device sensor.

[0058] When testing several sensor variants with different rim designs, it was shown that making the rim ridge with alternating projections and depressions along its length or making the rim ridge with ribs allows reducing the time for measuring blood glucose levels, compared to the prototype, by 30% - 40% with ten measurements per day. The tests are described in detail below.

[0059] When implementing the invention, an increase in the area of ​​contact of the surface of the side with the dry-wiped surface of the hand at the location of the sensor is ensured.

[0060] Also, when implementing the invention, an increase in the area of ​​contact of the surface of the side with the water-moistened surface of the hand at the location of the sensor is ensured.

[0061] The method of measurements on a dry hand or on a wet hand depends on which hand the sensor was tested on. If the sensor was tested on a dry hand (on a hand surface wiped dry), then subsequent measurements, until the next sensor test, are also performed on a dry hand.

[0062] If the sensor testing was carried out on a wet hand (on a moistened surface of the hand), then subsequent measurements, until the next sensor testing, are carried out on a wet hand.

[0063] Since the implementation of the invention reduces the time for preparing and setting up the sensor during multiple measurements during the day, and, accordingly, less energy is spent on the operation of the sensor.

[0064] In addition, when implementing the invention, an increase in heat exchange of the sensor through the comb to the human hand is ensured by increasing the contact surface area of ​​the rim with the hand. This will increase the reliability of the sensor.

[0065] List of figures.

[0066] Fig. 1 shows a sensor of a wrist device for non-invasive monitoring of glucose content in human blood. The sensor contains one emitter and one receiver of light reflected from the hand. Fig. 2 shows a sensor of a wrist device for non-invasive monitoring of glucose content in human blood. The sensor contains two emitters and one receiver of light reflected from the hand.

[0067] Fig. 3 shows a wrist device for non-invasive monitoring of glucose levels in human blood. At the end of one of the strap sections is a sensor of the wrist device for non-invasive monitoring of glucose levels in human blood.

[0068] Fig. 4 shows a wrist device for noninvasive monitoring of glucose levels in human blood. At the end of one of the strap sections, there is a sensor of the wrist device for noninvasive monitoring of glucose levels in human blood. The strap sections are fastened. The wire communication line connecting the sensor and the control and display module located in the housing is located inside the strap.

[0069] Fig. 5 shows a longitudinal section of the rim located on the inner surface of the prototype sensor.

[0070] Fig. 6 shows a longitudinal section of the flange located on the inner surface of the sensor. The flange ridge is made with protrusions and depressions alternating along its length.

[0071] Fig. 7 shows the development of the rim. The ridge of the rim is made with projections and depressions alternating along its length. The ridge is marked with a remote element "A", which is shown in Fig. 8.

[0072] Fig. 8 shows the extension element “A” with ribs on the surface of the side projection.

[0073] Fig. 9 shows the development of the side. The ridge of the side is made with ribs along its length. That is, ribs are made on the ridge of the side.

[0074] Fig. 10 shows a sensor of a wrist device for non-invasive monitoring of glucose content in human blood, located on a human hand. The sensor contains two emitters and one receiver of light reflected from the hand. The surface of the hand in contact with the sensor is moistened with water.

[0075] Fig. 11 shows a sensor of a wrist device for non-invasive monitoring of glucose content in human blood, located on a human hand. The operation of the sensor is shown. Emitters emit light into a human hand, and a receiver receives reflected light from a human hand. The surface of the hand in contact with the sensor is moistened with water.

[0076] Fig. 12 shows the device for non-invasive monitoring of glucose content in human blood as a whole with a control and data processing module in the housing. At the end of one of the strap sections there is a sensor of the wrist device for non-invasive monitoring of glucose content in human blood. Inside the strap section there is a communication cable connecting the sensor with the control and data processing unit and the power source. Across the strap there is a section B - B.

[0077] Fig. 13 shows a section B - B of the strap and cable.

[0078] Fig. 14 shows the development of the rim. The ridge of the rim is made with projections and depressions alternating along its length. The figure shows the changes, in particular, the sizes of the projections and depressions.

[0079] Fig. 15 shows a longitudinal section of the side.

[0080] Fig. 16 shows the development of the rim. The ridge of the rim is made with projections and depressions alternating along its length. The figure shows the dimensions, in particular, the dimensions of the projections and depressions.

[0081] Fig. 17 shows a longitudinal section of the side.

[0082] Fig. 18 shows a sensor with a rim indicating their geometric dimensions.

[0083] Fig. 19 shows a sensor with grooves applied to the ridge of the side.

[0084] Fig. 20 shows the extension element D - a view of the ridge of the side with riffles.

[0085] Disclosure of invention.

[0086] Definitions of terms are given in the source / 1 / .

[0087] The sensor of the wrist device for non-invasive monitoring of glucose content in human blood is part of the wrist device for non-invasive monitoring of glucose in human blood. In fact, the wrist device contains a housing with a control and display module (in other words, with electronics and a power supply), a sensor in which an emitter and a receiver of radiation reflected from human tissues are located, a strap for attaching the control module and the sensor to the human hand. The sensor is designed with the ability to move relative to the human hand (along the strap or together with the strap) during its adjustment.

[0088] Light, radiation visible to the human eye, is used as radiation. Thus, a control and display module, as well as a sensor, are attached to the hand via a strap.

[0089] The sensor contains a rim separating the emitter from the receiver. The rim ridge is made with alternating projections and depressions along its length or grooves are made on the rim ridge. And, in addition, when preparing for work and when the sensor is working, the emitter and receiver are pressed to the place of palpation of the pulse on the radial artery of the hand.

[0090] Riffles are grooves on a surface, particularly on the surface of a side.

[0091] The figures indicate the following positions:

[0092] 1 - sensor housing (see Fig. 1);

[0093] 2 - strap;

[0094] 3 - light emitter;

[0095] 4 - light receiver;

[0096] 5 - side;

[0097] 6 - cable (wire communication line) connecting the receiver and emitter with the control and display module;

[0098] 7 - emitter (see Fig. 2);

[0099] 8 - housing with control and display module (see Fig. 3);

[0100] 9 and 10 - strap sections;

[0101] 11 - sensor fixed to the end of section 10 of the strap;

[0102] 12, 13 and 14 elements of the lock with devices for attaching them to the strap sections;

[0103] 15 - housing with control and display module (see Fig. 4);

[0104] 16 - sensor;

[0105] 17 - a lock with devices for attaching it to the strap sections;

[0106] 18 - strap section;

[0107] 19 - cable (wire communication line) connecting the body (with the control and display module) with the sensor; 20 - prototype side (see Fig. 5);

[0108] 21 - sensor body;

[0109] 22 - light receiver;

[0110] 23 - sensor housing (see Fig. 6);

[0111] 24 - light receiver;

[0112] 25 - a sideboard, the ridge of which is made with protrusions and depressions alternating along its length;

[0113] 26, 28 - protrusions on the ridge of the side;

[0114] 27, 29 - recesses on the ridge of the side;

[0115] 30, 32, 33 - protrusions on the ridge of the side (see Fig. 7);

[0116] 34 - side development;

[0117] 31, 35 - recesses on the ridge of the side;

[0118] A - remote element;

[0119] 36, 37, 38 - riffles (see Fig. 8);

[0120] 39 - surface of the human hand (see Fig. 10);

[0121] 40 - human hand;

[0122] 41 - moisture on the surface of a person's hand. Moisture is located between the surface of the hand and the sensor;

[0123] 42 - cable connecting the receiver and emitter with the control and display module;

[0124] 43, 44 - light emitter;

[0125] 45 - side;

[0126] 46 - light receiver;

[0127] 47, 48 - rays of light from the emitter into the human hand (see Fig. 11);

[0128] 49 - light reflected from a person's hand, in particular, from an artery;

[0129] 50 - sensor housing (see Fig. 12). The position 50 can also designate the sensor itself;

[0130] 51 - strap;

[0131] 52, 53 - light emitter;

[0132] 54 - light receiver;

[0133] 55 - side;

[0134] 56 - a cable located in the sensor, in the strap and in the control and data processing module; 57 - a control and data processing module of the device for non-invasive monitoring of glucose content in human blood;

[0135] 58 - control and data processing unit;

[0136] B - B - section of the strap with cable;

[0137] 59 - riffles on the ridge of the side (see Fig. 9);

[0138] 60 - development of the side with ribs;

[0139] 61 - power source;

[0140] 62 - artery (see Fig. 10 and 11);

[0141] 63 - the length of the side (see Fig. 14);

[0142] 64 - side height;

[0143] 65 - width of the projection;

[0144] 66 - height of the projection;

[0145] 67 - recess width;

[0146] B - B - longitudinal section of the side;

[0147] 68 - length of the side (see Fig. 16);

[0148] 69 - side height;

[0149] 70 - width of the protrusion at the top of the ridge;

[0150] 71 - width of the recess in the upper part of the ridge;

[0151] G - G - longitudinal section of the side;

[0152] 72 - sensor housing (see Fig. 18);

[0153] 73 - the outer dimension of the sensor housing, in particular, the outer diameter of the sensor housing or the outer diameter of the sensor;

[0154] 74 - thickness of the sensor body;

[0155] 75, 76 - light emitters;

[0156] 77 - light receiver;

[0157] 78 - side;

[0158] 79 - side width;

[0159] 80 - inner diameter of the rim;

[0160] 81 - side height;

[0161] 82 - rim with ribs. Fig. 19 shows a sensor with a rim on which ribs 83, 84, 85 are located;

[0162] D - view of the ribbing of the side (see Figs. 19 and 20); 86, 87, 88 - ribbing on the ridge of the side.

[0163] According to the invention, the sensor of the wrist device for non-invasive monitoring of glucose content in human blood comprises a housing 1 (see Fig. 1), secured to a strap 2, a light emitter 3, a light receiver 4. There may be more than one light emitter in the sensor, for example, two - see positions 3 and 7 in Fig. 2. There may also be more than two emitters.

[0164] Moreover, the light emitter 3 and the light receiver 4 are located on the inside of the sensor housing in such a way that when the sensor is on the hand, the light emitter is designed with the ability to emit light into the hand 40 (see Fig. 11) on the radial artery 62. And the light receiver is designed with the ability to receive reflected light from the radial artery of the human hand. On the inside of the sensor housing, there is a rim 5 surrounding the light receiver 4 and separating it from the light emitter 3.

[0165] In this case, the ridge of the side is made with projections 26 (see Fig. 6) and depressions 29 alternating along its length, or grooves 59 (see Fig. 9) are made on the ridge of the side.

[0166] When preparing for work and when the sensor is in operation, the emitter and receiver are pressed to the place where the pulse is felt on the radial artery of the hand.

[0167] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the light emitter is designed with the ability to emit light into the hand onto the radial artery at the base of the thumb of the human hand.

[0168] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the light emitter is designed with the ability to emit light into the hand onto the radial artery of the wrist.

[0169] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the light emitter is designed with the ability to emit light into the hand onto the radial artery of the forearm.

[0170] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the receiver is designed with the ability to receive reflected light from the hand, namely, from the radial artery at the base of the thumb of a person's hand.

[0171] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the receiver is designed with the ability to receive reflected light from the hand, namely, from the radial artery of the wrist.

[0172] In a particular embodiment of the invention, the sensor can be designed in such a way that while the sensor is on the hand, the receiver is designed with the ability to receive reflected light from the hand, namely, from the radial artery of the forearm.

[0173] In a particular embodiment of the invention, the sensor can be made in such a way that when preparing it for work, the place for palpating the pulse on the radial artery of the hand is moistened with water or when preparing it for work, the place for palpating the pulse on the radial artery of the hand is wiped dry.

[0174] In a particular embodiment of the invention, the sensor can be made in such a way that the ridge of the side is made with protrusions and depressions alternating along its length, and grooves are made on the protrusions and depressions of the ridge of the side.

[0175] The control and data processing module 57 contains a control and data processing unit 58 and a power source 61.

[0176] Power source 61 supplies power to control and data processing unit 58, as well as emitters 52 and 53, and light receiver 54. Control and data processing unit 58 controls the operation of the emitters and receiver.

[0177] Energy from the power source 61, as well as the exchange of information between the emitters 52, 53, the receiver 54, and the control and data processing module 57 is carried out via cable 56. Part of the cable passes inside the strap (see Fig. 13).

[0178] The sensor works as follows.

[0179] The sensor of the wrist device for non-invasive monitoring of glucose content in human blood operates as part of the device for non-invasive monitoring of glucose content in human blood. Let us describe the operation of the sensor as part of the device. For clarity, let us use Fig. 12. During operation, see Fig. 12, a person's hand is located between the sensor 50 and the control and data processing module 57.

[0180] The sensor is oriented on the arm so that the light emitter (or emitters) and light receiver are located opposite the radial artery.

[0181] The sensor of the wrist device for non-invasive monitoring of glucose content in human blood and the device as a whole are tightly fastened by means of a strap, for example, on the wrist of the left (or right) hand in such a way that the sensor (emitters 43, 44 and receiver 46) is opposite the radial artery 62 in this place of the hand (see Figs. 10 and 11). Then the emitter and receiver of reflected light, located in the sensor (in the mobile unit), are directed at the radial artery.

[0182] To accurately aim the emitter and receiver during operation of the device, the emitter and receiver are directed to the radial artery, namely, the emitter and receiver are pressed to the place where the pulse is felt on the person’s arm.

[0183] After that, the person sits still for 3 minutes. The hand with the sensor is relaxed and is on the person's lap or, for example, on the table in front of the person (See Figure 27 of the source / 1 / ). After that, the person 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 sensor (emitter and receiver) relative to the radial artery. The check time is up to 3 minutes. If the sensor location is incorrect (i.e. its location on the hand does not match the location on the hand when testing the sensor), a message about the need to re-install the sensor appears on the display. The device is turned off. The strap is loosened, the sensor is re-positioned above the radial artery (above the place where the pulse is felt), then the strap is tightened, pressing the sensor tightly to the wrist. The person sits still for 3 minutes, after which he turns on the device.Work on installing the sensor continues until a message appears on the display indicating that the device is ready for operation.

[0184] As stated above, the location of the sensor on the hand should match the location where it was located during testing.

[0185] We described the testing above.

[0186] After this, the device is considered tested and ready for operation. 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.

[0187] The disadvantage of the prototype is as follows. During the day, when a person walks and works with his hands, the sensor moves from the initial position. In this case, to perform a measurement, it is necessary to repeat the operations of setting the sensor to the initial position for measurements.

[0188] As a rule, a person works intensively with his hands during the day. The sensor, in this case, shifts from its original place. During the day, a diabetic has to measure the sugar content in the blood many times - up to 10 times or more (and sometimes up to 20 times). At the same time, it is necessary to set the sensor 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 shift, in particular the rotation, of the sensor with the strap relative to the radial artery and its original location.

[0189] The invention partially eliminates this drawback.

[0190] In the invention, the sensor of the non-invasive glucometer on its inner side of the housing contains a rim surrounding the light receiver and separating it from the light emitter. In this case, the ridge of the rim is made with projections and depressions alternating along its length, or grooves are made on the ridge of the rim.

[0191] In other words, the side is made with a variable height along its length. Moreover, along the length of the side, the height of the side increases and decreases.

[0192] In other words, along the length of the side, sections with a greater height alternate with sections with a lower side height.

[0193] This allows increasing the force of adhesion of the side to the human hand and, thus, preventing the sensor from shifting from its initial installation location. When making a side with a constant height along the side, as in the prototype, the term "side height" is defined as follows. Side height is the distance between the inner surface of the sensor and the plane constructed tangent to the edge of the side / 1 / .

[0194] The height of the side may be variable along the length of the side, as in the claimed invention.

[0195] If the sidewall is made with a variable height along the entire length of the sidewall, then the term “average sidewall height” or the term “sidewall height in the longitudinal section of the sidewall” or “sidewall height in the i-th longitudinal section of the sidewall” may be used.

[0196] The term maximum side height can also be used.

[0197] The maximum height of the side is the maximum of the set of side heights obtained by constructing a set of longitudinal sections of the side.

[0198] The minimum height of the side is the minimum of the set of side heights obtained by constructing a set of longitudinal sections of the side.

[0199] The geometric characteristics of protrusions and recesses can be characterized by the empirical (obtained on the basis of experiments) coefficient “K”.

[0200] K = H / h, where H is the maximum height of the side; h is the minimum height of the side.

[0201] The conducted studies have shown that the coefficient K can take values ​​from 0.0001 to 0.5.

[0202] In a particular embodiment, the coefficient K can take values ​​from 0.0001 to 0.01, or in another particular embodiment, the coefficient K can take values ​​from 0.01 to 0.1, or in another particular embodiment, the coefficient K can take values ​​from 0.1 to 0.2, or in another particular embodiment, the coefficient K can take values ​​from 0.2 to 0.3, or in another particular embodiment, the coefficient K can take values ​​from 0.3 to 0.4, or in another particular embodiment, the coefficient K can take values ​​from 0.4 to 0.5.

[0203] The average height of the side is the arithmetic mean between the smallest and largest heights in the longitudinal sections of the side along its length.

[0204] In addition, when preparing it for operation and when the sensor is operating, the emitter and receiver are pressed to the place where the pulse is felt on the radial artery of the wrist.

[0205] This ensures increased operational efficiency of the wrist device sensor.

[0206] When testing several sensor variants with different rim designs, it was shown that making the rim ridge with alternating projections and depressions along its length or making the rim ridge with ribs allows reducing the time for measuring blood glucose levels, compared to the prototype, by 30% - 40% with ten measurements per day. The tests are described in detail below.

[0207] The main reason for the low efficiency of the prototype is the rotation of the sensor with the strap relative to the wrist and artery.

[0208] It would seem that the problem can be solved by tightening the strap more tightly. But in this case, the person feels extremely uncomfortable.

[0209] You can also use glue - stick the sensor 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.

[0210] Description of experiments.

[0211] Ten volunteer test subjects took part in the experiments.

[0212] Wrist-mounted devices for non-invasive monitoring of human blood glucose levels were placed on the test subjects' wrists.

[0213] Before the tests, each tester tested the sensor and the device as a whole, configured it for operation on his hand. Blood glucose (sugar) levels were also measured for each tester. After that, the testers performed successive sets of exercises for hands No. 1 - No. 6 / 1 / .

[0214] Descriptions of the exercise complexes are given below.

[0215] Exercise set #1: feet shoulder-width apart, arms in front of chest, bent at the elbows and touching chest. Arm jerks. On the count of 1, 2 arm jerks in front of you, on the count of 3, 4 arm jerks with arms out to the left. On the count of 1, 2 arm jerks in front of you, on the count of 3, 4 arm jerks with arms out to the right.

[0216] Exercise set #2: feet shoulder-width apart, hands at shoulders. Circular rotations of the arms. On the count of 1, 2, 3, 4, circular movements forward. On the count of 1, 2, 3, 4, circular movements backward.

[0217] Exercise set #3: feet shoulder-width apart, arms down along the body. On the count of 1, 2 swing your arms to the sides - up and down along the body. Repeat 10 times.

[0218] Exercise set #4: feet shoulder-width apart, arms extended forward at chest level. On the count of 1, 2 horizontal arm swings to the sides. Repeat 10 times.

[0219] Exercise set #5: feet shoulder-width apart, arms down along the body. On the count of 1, 2, 3, 4, rotate your arms back. Repeat 10 times.

[0220] Exercise set #6: feet shoulder-width apart, arms down along the body. On the count of 1, 2, 3, 4, rotate your arms forward. Repeat 10 times.

[0221] After completing the exercise sets, each volunteer turned on the device and measured the glucose (sugar) level in the blood. If necessary (the sensor moved from its original location), the device was adjusted for operation.

[0222] During the day, the testers performed Exercise Complexes #1 - #6 ten times. During the tests, the time of preparation and measurement of blood glucose levels was recorded.

[0223] The first month of testing was devoted to working with prototypes. There were 8 prototypes in total with the characteristics listed in Table 1.

[0224] The following months of testing were carried out with sensors of various designs - according to the invention. In total, there were 48 sensors with the declared designs of the sides with the characteristics given in Tables 2 - 9. Tables 1 - 9 present the geometric characteristics of the sensors and the sides on the sensor body.

[0225] Table 1 presents the geometric characteristics of the sensors and the flanges on the sensor body submitted for testing. The sensor body and flange material is plastic. A total of 8 experimental sensor variants were submitted for testing.

[0226] Table 2 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 1.

[0227] Table 3 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 2.

[0228] Table 4 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 3.

[0229] Table 5 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 4.

[0230] Table 6 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 5.

[0231] Table 7 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 6.

[0232] Table 8 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 7.

[0233] Table 9 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 8.

[0234] As stated above, when testing sensors with different designs of the rim, it was found that making the rim ridge with alternating projections and depressions along its length or making the rim ridge with ribs allows to reduce the time of measuring the blood glucose level, compared to the prototype, by 30% - 40% with ten measurements per day. It was found that the more the area of ​​contact of the person's hand with the rim increases, the more the time of measuring the blood glucose level decreases, compared to the prototype. Moreover, such a result is achieved both when the sensor is operating on a dry hand and when the sensor is operating on a wet hand - on a hand moistened with water.

[0235] The value of 40% is a percentage reduction in the time it takes to measure blood glucose levels, compared to the prototype. So, if the prototype takes 180 minutes during the day with ten measurements, the declared device takes 108 minutes.

[0236] In the experiments, the corrugation of the rim surface was additionally tested to enhance the effect in order to strengthen the technical result. Corrugation was carried out on the rims of prototypes.

[0237] The depth of the groove along the edge of the rim comb is 1 mm, the width of the groove along the edge of the rim comb is 1 mm, the distance between the grooves along the edge of the rim comb is 1 mm (see Fig. 9).

[0238] In tests of sensors with different designs of the rim, it was found that the implementation of the rim ridge with ribs allows to reduce the time of measuring the blood glucose level, compared to the prototype, by 30% with ten measurements per day.

[0239] It follows from the above that the aim of the invention is achieved. Increased operational efficiency of the sensor of the wrist device for non-invasive monitoring of glucose content in human blood is ensured by reducing the time for preparation and adjustment.

[0240] The technical result of the invention is also achieved.

[0241] The implementation of the side with alternating projections and depressions (and / or with ribs) along its length will increase the adhesion force of the side to the human hand by increasing the contact area of ​​the side surface with the surface of the hand and, thus, preventing the displacement of the sensor from the place of its initial installation, which in turn, as experiments have shown, will reduce the time for preparing and adjusting the sensor during multiple measurements during the day, and will increase the efficiency of the sensor.

[0242] In particular embodiments, when implementing the invention, an increase in the contact area of ​​the rim surface with the hand surface wiped dry at the location of the sensor is ensured. Also, when implementing the invention, an increase in the contact area of ​​the rim surface with the hand surface moistened with water at the location of the sensor is ensured.

[0243] The method of measurements on a dry hand or on a wet hand depends on which hand the sensor was tested on. If the sensor was tested on a dry hand (on a hand surface wiped dry), then subsequent measurements, until the next sensor test, are also performed on a dry hand.

[0244] If the sensor testing was carried out on a wet hand (on a moistened surface of the hand), then subsequent measurements, until the next sensor testing, are carried out on a wet hand.

[0245] Since the implementation of the invention reduces the time for preparing and setting up the sensor during multiple measurements during the day, and, accordingly, less energy is spent on the operation of the sensor.

[0246] In addition, when implementing the invention, an increase in heat exchange of the sensor through the comb to the human hand is ensured by increasing the contact surface area of ​​the rim with the hand. This will increase the reliability of the sensor.

[0247] Table 1

[0248] Geometrical characteristics of sensors and flanges on the sensor body submitted for testing. Sensor body and flange material - plastic

[0249] Table 2

[0250] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 1

[0251] Table 3

[0252] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 2 Table 4

[0253] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 3

[0254] Table 5

[0255] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 4 Table 6

[0256] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 5

[0257] Table 7

[0258] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 6 Table 8

[0259] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 7

[0260] Table 9

[0261] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 8 Literature.

[0262] 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.

[0263] 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 sensor for a wrist device for non-invasive monitoring of glucose content in human blood, comprising a housing secured to a strap, a light emitter, a light receiver; wherein the light emitter and the light receiver are located on the inner side of the sensor housing in such a way that when the sensor is on the hand, the light emitter is configured to emit light into the hand onto the radial artery, and the light receiver is configured to receive reflected light from the radial artery of the human hand; and on the inner side of the sensor housing there is a rim surrounding the light receiver and separating it from the light emitter, characterized in that the ridge of the rim is made with alternating projections and depressions along its length or grooves are made on the ridge of the rim; and, in addition, when preparing for operation and during operation, the sensor is configured to press the emitter and receiver to the place of palpating the pulse on the radial artery of the hand.

2. The sensor according to claim 1, characterized in that when the sensor is on the hand, the light emitter is configured to emit light into the hand onto the radial artery at the base of the thumb of the human hand, or onto the radial artery of the wrist, or onto the radial artery of the forearm, and the receiver is configured to receive reflected light 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.

3. The sensor 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.

4. The sensor according to item 1, characterized in that the ridge of the side is made with projections and depressions alternating along its length, and grooves are made on the projections and depressions of the ridge of the side.

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