Sensor for wrist-worn device for checking 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, as well as in the creation of socially-oriented systems for the early diagnosis of diabetes and associated diseases. 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 operational energy consumption of the sensor by virtue of the shape of the inner surface of a rim. The technical result of the invention is that of reducing the operational energy consumption of the sensor. This reduction is achieved by virtue of the shape of the inner surface of a rim, which results in an increase in the amount of light reflected from the arm, and specifically from an artery and other vessels in the arm, and impinging on a light receiver.

Description

[0001] WRIST DEVICE SENSOR FOR BLOOD GLUCOSE MONITORING

[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,

[0008] - “smart watches” that determine glucose, as well as pulse, pressure and other parameters (see source: https: / / gelikonline.ru / fitnes brasleti s izmereniem davleniya i pulsa / umnie-chasy-s-izmereniem-sahara-v-krovi / ?yclid=5227952676836737023).

[0009] This glucometer has an effective battery capacity of 210 mAh. The effective battery capacity is the battery capacity that can be used to operate the device.

[0010] 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. 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. Terms and definitions.

[0011] 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 https: / / studylib.net / doc / 27163933 / kongress-13-oktyabrya-2023-tom-1).

[0012] This glucometer has an effective battery capacity of 510 mAh, which is 2.4 times larger than the smartwatch described above.

[0013] 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.

[0014] 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.

[0015] The control and display module may be called the control and data processing module or the control module.

[0016] The case with the control and display module resembles a wristwatch in appearance.

[0017] The sensor contains a light emitter and a light receiver and is located above the radial artery on a person's hand and is connected to the control and display module via a communication channel. The sensor is also called a mobile remote unit because it has the ability, when configured, to move relative to a person's hand or along a strap, or together with the strap.

[0018] The sensor of a 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.

[0019] For simplicity, the light emitter is simply called an emitter.

[0020] For simplicity, the light receiver is simply called a receiver.

[0021] 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 TV broadcasting function for determining blood glucose levels. The sensor is part of the wrist device (CN 110236487 A, published 2019.09.17).

[0022] 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.

[0023] Features of the analogue that coincide with the features of the invention: a sensor of 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 inside of the sensor housing.

[0024] The disadvantage of the analogue is the absence of a rim on the sensor body separating the emitter from the receiver.

[0025] The prototype of the invention is a wrist device sensor for non-invasive monitoring of glucose levels in human blood (see 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.

[0026] 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 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 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.

[0027] These features of the prototype coincide with the features of the invention.

[0028] In addition, the side is made in a rectangular cross-section.

[0029] The disadvantage of the prototype is the relatively high energy consumption of the light emitter.

[0030] The essence of the invention.

[0031] The purpose of the invention is to increase the operating efficiency of a wrist device sensor for non-invasive monitoring of glucose levels in human blood by reducing energy consumption during its operation due to profiling the inner surface of the rim.

[0032] The objective is achieved in that the sensor of a 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 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, and differs from the prototype in that the inner surface of the rim is convex along its entire length or a part of the inner surface of the rim is convex along the entire length of the rim;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.;

[0033] 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.

[0034] In a particular embodiment of the invention, the sensor can be made in such a way that when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is moistened with water, or when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is wiped dry.

[0035] In a particular embodiment of the invention, the sensor can be made in such a way that the inner surface of the rim is coated with nickel. Nickel plating increases the reflectivity of the surface.

[0036] 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).

[0037] In this case, the emitter and receiver of light reflected from the hand, located in the sensor, are connected by a wired or wireless communication line to the control and display module, located in the housing of the control and display module. Light is electromagnetic radiation perceived by the human eye.

[0038] The technical result of the invention is a reduction in energy consumption during sensor operation. The reduction is achieved by profiling the inner surface of the rim, which leads to an increase in the amount of light reflected from the hand, namely, reflected from the artery and other vessels in the hand, and falling on the light receiver. The increase in incident light occurs due to the convexity of the inner surface of the rim. On the convex surface there is always an area oriented toward the light falling on it, so that the rays reflected from it fall on the light receiver. Thus, the amount of light falling on the receiver increases.

[0039] At the same time, it is possible to reduce the energy consumption for non-invasive monitoring of glucose levels in human blood. And, therefore, it is possible to perform more measurements from one battery charge.

[0040] Let us explain the achievement of technical results.

[0041] 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.

[0042] 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 at the radial artery.

[0043] 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.

[0044] 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.

[0045] As stated above, the location of the sensor on the hand should match the location where it was located during testing.

[0046] Testing is carried out as follows.

[0047] 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 / ).

[0048] Non-invasive measurement of blood glucose levels is performed using a 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 use.

[0051] During the tests 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. The disadvantage of the prototype is as follows. During the day, while the person is walking and working with his hands, the sensor shifts from the initial position. In this case, to perform the measurement, it is necessary to repeat the operations to set 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] A large amount of energy is consumed to configure the sensor and take measurements.

[0054] The purpose of the invention is precisely to reduce the amount of energy spent on setting up and taking measurements.

[0055] 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 rim is made with a convex inner surface. Or part of the inner surface of the rim is made convex.

[0056] The reduction of the energy consumption is achieved by profiling the inner surface of the rim, which leads to an increase in the amount of light reflected from the hand, namely, reflected from the artery and other vessels in the hand, and falling on the light receiver. The increase in incident light occurs due to the convexity of the inner surface of the rim. On the convex surface there is always an area oriented towards the light falling on it, so that the rays reflected from it fall on the light receiver. Thus, the amount of light falling on the receiver increases.

[0057] At the same time, it is possible to reduce the energy consumed for non-invasive monitoring of glucose levels in human blood. When testing several sensor variants with different rim designs, it was shown that making the inner rim surface convex allows reducing the energy consumed by the emitter by 25% - 30%. Nickel plating of the inner rim surface allows energy savings to be increased to 35%.

[0058] The tests are described in detail below.

[0059] 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 (see Fig. 17).

[0060] If the sensor testing was carried out on a wet hand (on a wet surface of the hand), then subsequent measurements, until the next sensor testing, are also carried out on a wet hand (see Fig. 8).

[0061] List of figures.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] Fig. 5 shows a longitudinal section of the rim located on the inner surface of the prototype sensor.

[0067] Fig. 6 shows a longitudinal section of the rim located on the inner surface of the sensor. The inner surface of the rim is convex.

[0068] Fig. 7 shows a diagram of the rim indicating its geometric characteristics, as well as the geometric characteristics of the convex inner surface of the rim.

[0069] Fig. 8 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.

[0070] Fig. 9 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.

[0071] Fig. 10 shows a device for non-invasive monitoring of glucose content in human blood as a whole with a control and processing module (control and display module) of data in the housing. At the end of one of the strap sections, a sensor of the wrist device for non-invasive monitoring of glucose content in human blood is located. Inside the strap section, a communication cable is located, connecting the sensor with the control and data processing module, and the power source. Across the strap, a section A - A is designated.

[0072] Fig. 11 shows a section A - A of the strap and cable.

[0073] Fig. 12 shows a longitudinal section of the prototype side. The section shows the inner, upper and outer surfaces of the side.

[0074] Fig. 13 shows a longitudinal section of a rim with a convex inner surface. The section shows the inner, upper and outer surfaces of the rim. Fig. 14 shows a sensor with a rim with their geometric dimensions indicated.

[0075] Fig. 15 shows a prototype sensor with a rim. The radiation (light) from the emitter and the reflected radiation arriving at the receiver are shown schematically.

[0076] Fig. 16 shows a sensor with a rim. The inner surface of the rim is convex. The radiation (light) from the emitter and the reflected radiation arriving at the receiver are shown schematically. Including the radiation reflected from the inner surface of the rim and arriving at the receiver are shown.

[0077] Fig. 17 shows a sensor pressed against the pulse palpation site on a person's arm. When preparing the sensor for operation, the pulse palpation site on the radial artery of the arm was wiped dry.

[0078] Disclosure of invention.

[0079] Definitions of terms are given in the source / 1 / .

[0080] 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.

[0081] 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.

[0082] The sensor contains a rim separating the emitter from the receiver. In this case, the inner surface of the rim is convex along its entire length or part of the inner surface of the rim is convex along the entire length of the rim. And, in addition, when preparing for work and when working with the sensor, the emitter and receiver are pressed to the place of palpation of the pulse on the radial artery of the hand. In the figures, the following positions are designated:

[0083] 1 - sensor housing (see Fig. 1);

[0084] 2 - strap;

[0085] 3 - light emitter;

[0086] 4 - light receiver;

[0087] 5 - side;

[0088] 6 - cable (wire communication line) connecting the receiver and emitter with the control and display module;

[0089] 7 - emitter (see Fig. 2);

[0090] 8 - housing with control and display module (see Fig. 3);

[0091] 9 and 10 - strap sections;

[0092] 11 - sensor fixed to the end of section 10 of the strap;

[0093] 12, 13 and 14 elements of the lock with devices for attaching them to the strap sections;

[0094] 15 - housing with control and display module (see Fig. 4);

[0095] 16 - sensor;

[0096] 17 - a lock with devices for attaching it to the strap sections;

[0097] 18 - strap section;

[0098] 19 - cable (wire communication line) connecting the housing (with the control and display module) to the sensor;

[0099] 20 - prototype side (see Fig. 5);

[0100] 21 - sensor body;

[0101] 22 - light receiver;

[0102] 23 - light receiver (see Fig. 6);

[0103] 24 - left, from the observer, section of the longitudinal section of the side (element of the longitudinal section of the side), passing through the center of gravity of the section of the side;

[0104] 25 - right, from the observer, section of the longitudinal section of the side (element of the longitudinal section of the side), passing through the center of gravity of the section of the side;

[0105] 26 - convex inner surface of the side;

[0106] 27 - sensor body;

[0107] 28 - side;

[0108] 29 - light receiver (see Fig. 7);

[0109] 30 - sensor housing; 31 - light emitter;

[0110] 32 - side height;

[0111] 33 - width of the convex part of the side;

[0112] 34 - width of the part of the side adjacent to the outer side of the side;

[0113] 35 - side;

[0114] 36 - radius of the convex part of the side;

[0115] 37 - angle;

[0116] 38 - the center of the circle. Part of the border of this circle forms the convexity of the inner part of the rim;

[0117] 39 - surface of the human hand (see Fig. 8);

[0118] 40 - human hand;

[0119] 41 - moisture on the surface of a person's hand. Moisture is located between the surface of the hand and the sensor;

[0120] 42 - cable connecting the receiver and emitter with the control and display module;

[0121] 43, 44 - light emitter;

[0122] 45 - side;

[0123] 46 - light receiver;

[0124] 47, 48 - rays of light from the emitter into the human hand (see Fig. 9);

[0125] 49 - light reflected from a person's hand, in particular, from an artery;

[0126] 50 - artery;

[0127] 51 - strap (see Fig. 10);

[0128] 52, 53 - light emitter;

[0129] 54 light receiver;

[0130] 55 - side;

[0131] 56 - cable located in the sensor, in the strap and in the control and data processing module;

[0132] 57 - data control and processing module (data control and display module) of a device for non-invasive monitoring of glucose content in human blood;

[0133] 58 - data control and processing module;

[0134] A - A - section of the strap with cable (see Fig. 11); 59 - power source - battery or chemical current source;

[0135] 60 - longitudinal section of the prototype side (see Fig. 12);

[0136] 61 - inner surface of the side (border of the inner surface of the longitudinal section of the side);

[0137] 62 - perpendicular to the inner surface of the side;

[0138] 63 - upper surface of the side (boundary of the upper surface of the longitudinal section of the side);

[0139] 64 - perpendicular to the upper surface of the side;

[0140] 65 - outer surface of the side (border of the outer surface of the longitudinal section of the side);

[0141] 66 - longitudinal section of the side with a convex inner surface (see Fig.

[0142] 13);

[0143] 67 - inner surface of the side (border of the inner surface of the longitudinal section of the side);

[0144] 68, 69 - perpendiculars to the inner surface of the side in the longitudinal section of the side;

[0145] 70 - upper surface of the side (boundary of the upper surface of the longitudinal section of the side);

[0146] 71 - perpendicular to the upper surface of the side;

[0147] 72 - outer surface of the side (border of the outer surface of the longitudinal section of the side);

[0148] 73 - sensor surface;

[0149] 74 – thickness of the sensor body (see Fig. 14);

[0150] 75 - outer diameter of the rim;

[0151] 76 - light emitters;

[0152] 77 - light receiver;

[0153] 78 - side;

[0154] 79 - side width;

[0155] 80 - inner diameter of the rim;

[0156] 81 - side height;

[0157] 82 - sensor housing; 83 - outer dimension of the sensor housing, in particular, the outer diameter of the sensor housing or the outer diameter of the sensor;

[0158] 84 - prototype sensor housing (see Fig. 15);

[0159] 85 - side - prototype;

[0160] 86 - emitter;

[0161] 87 - receiver;

[0162] 88 - radiation (light) from the emitter;

[0163] 89 - reflected radiation arriving at the receiver;

[0164] 90 - prototype sensor housing (see Fig. 16);

[0165] 91 - rim with convex inner surface;

[0166] 92 - emitter;

[0167] 93 - receiver;

[0168] 94 - radiation (light) from the emitter;

[0169] 95 - reflected radiation arriving at the receiver;

[0170] 96, 97 - radiation reflected from the inner surface of the side and arriving at the receiver;

[0171] 98 - a section of the inner surface of the rim, made cylindrical. At the boundary of the longitudinal section of the rim, the cylindrical section is located between point 99 and the surface of the sensor;

[0172] 99 - a point on the boundary of the longitudinal section of the side, separating the convex section of the inner surface of the side from the cylindrical section of the inner surface of the side;

[0173] 100 - a point on the boundary of the longitudinal section of the side, separating the convex section of the inner surface of the side from the upper surface of the side;

[0174] 101 - human hand;

[0175] 102 - surface of a human hand, wiped dry;

[0176] 103 - side;

[0177] 104, 105 - emitters;

[0178] 106 - receiver;

[0179] 107 - artery;

[0180] 108 - sensor (sensor housing). See Fig. 10. 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, for example, three, four. Fig. 3 shows the location of the sensor 11 at the end of the strap 10.

[0181] Moreover, the light emitter 3 and the light receiver 4 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 designed with the ability to emit light into the hand 40 (see Fig. 8 and 9) onto the radial artery 50. And the light receiver is designed with the ability to receive reflected light from the radial artery of the human hand. On the inner side of the sensor housing, there is a rim 5 surrounding the light receiver 4 and separating it from the light emitter 3.

[0182] In this case, the inner surface of the rim is made convex along its entire length (see Fig. 1, 2, 6) or part of the inner surface of the rim is made convex along the entire length of the rim (see Fig. 13). The convex section on the boundary of the longitudinal section of the rim between points 99 and 100 on the boundary of the section.

[0183] The sensor design can be described by describing its longitudinal section. Namely, in the longitudinal section of the rim, the inner border of the rim is made in the form of a convex curve. Or the inner border of the rim in the longitudinal section is made convex.

[0184] In a particular embodiment of the invention, the boundary of the inner surface of the longitudinal section of the flange 67 can be made in the form of a circular element, or a parabolic element, or a hyperbolic element.

[0185] Or the boundary of the inner surface of the longitudinal section of the flange 67 can be made in the form of a combination of a circle element and a parabola element, or a circle element and a hyperbola element.

[0186] The shape of the boundary of the inner surface of the longitudinal section of the flange can be an identifier of the manufacturer of the sensor or the device as a whole.

[0187] The rim may be characterized by geometric dimensions, for example, the width of the convex part of the rim 33 and the width of the part of the rim adjacent to the outer side of the rim 34 (see Fig. 7). The sum of the width 33 and the width 34 constitute the width of the rim.

[0188] The ratio of width 33 to width 34 is also a geometric characteristic of the side and is characterized by the coefficient F.

[0189] F = НЗЗ / Н34, where F is an empirical coefficient;

[0190] NZZ - width of the convex part of the side;

[0191] H34 - the width of the part of the side adjacent to the outer side of the side.

[0192] Width H34 is the width of the upper surface of the side or the width of the border of the upper surface of the longitudinal section of the side (see position 70 in Fig. 13).

[0193] The side can be designed in such a way that the coefficient F takes values ​​from 0.1 to 0.9.

[0194] In a particular embodiment, the sidewall can be made in such a way that the coefficient F takes values ​​from 0.1 to 0.3, or in a particular embodiment, the sidewall can be made in such a way that the coefficient F takes values ​​from 0.3 to 0.6, or in a particular embodiment, the sidewall can be made in such a way that the coefficient F takes values ​​from 0.6 to 0.9.

[0195] 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.

[0196] 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.

[0197] 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.

[0198] 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.

[0199] 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.

[0200] 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.

[0201] 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.

[0202] In a particular embodiment of the invention, the sensor can be designed in such a way that when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is moistened with water (see Fig. 8).

[0203] In a particular embodiment of the invention, the sensor can be designed in such a way that when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is wiped dry (see Fig. 17).

[0204] The control and data processing module 57 contains a control and data processing unit 58 and a power source 59 (battery or chemical current source). See Fig. 10.

[0205] Power source 59 supplies energy 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.

[0206] Energy from the power source 59, 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 51 (see.

[0207] Fig. 10 and 11).

[0208] The sensor works as follows.

[0209] 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. Before the sensor operates, the battery is charged (using a charger from the network), which powers the sensor and the device for non-invasive monitoring of glucose content in human blood as a whole. Charging time is up to 1.5 hours.

[0210] Let us describe the operation of the sensor as part of the device. For clarity, we will use Fig. 10. During operation (see Fig. 10), a human hand is located between the sensor 108 and the control and data processing module 57.

[0211] The sensor is oriented on the arm so that the light emitter (or emitters) and the light receiver are located opposite the radial artery (see Figs. 8 and 9).

[0212] The sensor of the wrist device for non-invasive monitoring of glucose content in human blood and the device as a whole are tightly secured 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 50 in this place of the hand (see Fig. 8). Then the emitter and receiver of reflected light, located in the sensor (in the mobile unit), are directed at the radial artery.

[0213] 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.

[0214] After that, the person sits quietly and motionless 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 Fig. 27, 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 (conditionally, 1.5 minutes are spent on measurements using the emitter and receiver and 1.5 minutes are spent on receiving data and processing them). If the location of the sensor is incorrect (i.e. its location on the hand does not match the location on the hand during sensor testing), then the display shows a message about the data error "Data error" and the need to re-install the sensor.

[0215] After this, the device is switched 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 the device is switched on. Work on installing the sensor continues until a message appears on the display that the device is ready for operation.

[0216] As stated above, the location of the sensor on the hand should correspond to the place where it was during testing. We described testing above in the section "Essence of the invention". After this, the device is considered tested and ready for operation.

[0217] 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 (3 minutes of quiet motionless sitting, 3 minutes of checking). 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.

[0218] 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.

[0219] 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.

[0220] The experimental samples of devices (prototypes and declared devices) contain a battery with an effective capacity of 510 mAh.

[0221] During the development of the invention, many experiments were conducted to measure the energy consumption of devices for non-invasive monitoring of glucose levels in human blood, as well as sensors for non-invasive monitoring of glucose levels in human blood.

[0222] It has been established that if measurements are taken during the day, then one measurement takes up to 18 minutes (conditionally, 9 minutes are spent on measurements using a transmitter and receiver, and 9 minutes are spent on receiving data and processing it).

[0223] It was found that, in fact, 3.2 mAh of battery energy is spent on one measurement (for 9 minutes of operation) (the average value for all experiments). During 1 minute of operation, approximately 0.36 mAh is spent.

[0224] It has also been established that in the sleep monitoring mode, the sensor with the device for non-invasive monitoring of glucose levels in human blood is on the person's hand for, for example, 8 hours. The device operates for 480 minutes (the average value for all experiments). During this time, measurements, data acquisition and processing are performed every ten minutes, and there is a break in operation. (1.5 minutes are spent on measurements using the emitter and receiver, 1.5 minutes are spent on data acquisition and processing, and 7 minutes are a break in operation). At the same time, during 8-hour monitoring, the sensor and the wrist device for non-invasive monitoring of glucose levels in human blood consume 153 mAh of battery power in total (the average value for all experiments). This is 30% of the battery power.

[0225] 0.32 mAh is consumed per minute of monitoring (153 mAh / 480 min = 0.32 mAh / min).

[0226] The invention partially eliminates this drawback. The invention is aimed at reducing the energy consumption of the sensor, and, consequently, the device as a whole. In the invention, the sensor (see Fig. 1) of the non-invasive glucometer on its inner side of the housing 1 contains a rim 5 surrounding the light receiver 4 and separating it from the light emitter 3. In this case, the rim is made with a convex inner surface 26 (see Fig. 6).

[0227] The reduction of the energy expended is achieved by profiling this inner surface of the rim (see Fig. 16), which leads to an increase in the amount of light reflected from the hand, namely, reflected from the artery and other vessels in the hand, and falling on the light receiver. The increase in incident light occurs due to the convexity of the inner surface of the rim 91. On the convex surface there is always an area oriented toward the light 95 falling on it, so that the rays 96, 97 reflected from it fall on the light receiver. Thus, the amount of light falling on the receiver increases.

[0228] At the same time, it is possible to reduce the energy consumed to power the emitter(s), as well as in general for non-invasive monitoring of glucose levels in human blood.

[0229] Testing five sensor variants (see Tables 1 and 2) with different rim designs showed that making the inner rim surface convex allows for a reduction in the energy consumed by the emitter by 25%-30%. Nickel plating the inner rim surface allows for energy savings of up to 35%.

[0230] The tests are described in detail below.

[0231] Description of experiments.

[0232] Ten volunteer test subjects took part in the experiments.

[0233] Wrist-mounted devices and sensors for non-invasive monitoring of human blood glucose levels were placed on the test subjects' hands.

[0234] Before the tests, each tester tested the sensor and the device as a whole, configured it to work on his hand. The glucose (sugar) level in the blood of each tester was also measured.

[0235] After which the testers sequentially performed sets of exercises for the arms No. 1 - No. 6 (see source / 1 / , pp. 95 - 96).

[0236] Descriptions of the exercise complexes are given below.

[0237] 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.

[0238] Exercise set #2: feet shoulder-width apart, hands at shoulders. Circular arm movements. On the count of 1, 2, 3, 4, make circular movements forward. On the count of 1, 2, 3, 4, make circular movements backward. Exercise set #3: feet shoulder-width apart, hands 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.

[0239] 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.

[0240] 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.

[0241] 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.

[0242] 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.

[0243] 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.

[0244] In addition, a sleep monitoring mode was implemented at night. A sensor with a device for non-invasive monitoring of glucose levels in human blood was on the person's hand for 8 hours in working condition.

[0245] Work with experimental devices containing prototype sensors. Before the experiments, the batteries of all experimental wrist devices for noninvasive monitoring of glucose levels in human blood were charged. The charge was carried out until the message about the full charge of the battery and the deactivation of the charging mode appeared on the monitor. During the charge, the amount of energy consumed from the network, as well as the % of the battery charge were monitored on the monitor of the wrist device. After that, a graph was constructed of the dependence of the amount of energy received by the battery during charging on the amount of energy consumed from the network by the charger. After that, 10 measurements were made during the day using each experimental prototype. The device consumed 32 mAh of battery energy (the average value for all experiments). See Table 3.

[0246] At night (in sleep monitoring mode), each experimental prototype worked for 480 minutes and consumed 153 mAh of battery energy (average value for all experiments). In total, each prototype consumed 185 mAh of battery energy per day. This is 36% of the battery energy. Over two days, 370 mAh of battery energy (average value for all experiments) was consumed. This is 72.6% of the initial battery energy.

[0247] During the following third day, the remaining energy equal to 140 mAh was spent on work in monitoring mode (average value for all experiments). After 140 mAh of energy was generated, the device was switched off and the monitor indicated the operating time and the reason for the stop.

[0248] The battery's 140 mAh of energy was generated in 439 minutes. After all the battery's energy was used up, a message appeared on the monitor about the need to charge the battery.

[0249] The battery was put on charge. The battery was charged and the charging process was monitored as described earlier - until the monitor displayed a message about the battery being fully charged and the charge being turned off.

[0250] Thus, as a result of the experiment, which lasted two days and 439 minutes on the third day, 510 mAh of battery energy was consumed.

[0251] Work with experimental devices containing the declared sensors. The declared experimental wrist devices for non-invasive monitoring of glucose levels in human blood were improved. The energy consumption of the light emitter was reduced (the experimental samples had two emitters) by reducing the voltage supplied to it. At the same time, the total energy consumption of the wrist device was reduced. The energy consumption of two emitters was approximately 97% of the total energy consumption of the wrist device. A graph of the dependence of the energy consumption of the wrist device on the voltage supplied to the light emitters was also plotted.

[0252] Before the experiments, the batteries of all experimental wrist devices for non-invasive monitoring of glucose levels in human blood with the declared sensors were charged.

[0253] The charge was carried out until the monitor showed a message about the battery being fully charged and the charging mode being turned off. During the charge, the amount of energy consumed from the network was monitored, as well as the battery charge percentage on the wrist device monitor. After that, a graph was constructed showing the dependence of the amount of energy received by the battery during charging on the amount of energy consumed from the network by the charger.

[0254] After which, using each declared experimental sample, 10 measurements were taken during the day.

[0255] The device consumed 22.4 - 24 mAh of battery power (range of values ​​across all experiments). See Table 3.

[0256] At night (in sleep monitoring mode), each experimental sample worked for 480 minutes and consumed 107 - 114.8 mAh of battery energy (range of values ​​for all experiments). In total, each device with the declared sensor consumed 129.4 - 138.8 mAh of battery energy per day. This is 25 - 27% of the battery energy.

[0257] Over two days, 259 - 277 mAh of battery energy was consumed (range of values ​​for all experiments). This is 50 - 54% of the initial battery energy.

[0258] After two days of operation, 232.4 - 251 mAh of energy remained.

[0259] During the subsequent third day, the remaining energy of 232.4 - 251 mAh was spent on operation in monitoring mode (range of values ​​for all experiments).

[0260] After 232.4 - 251 mAh of energy was generated, the device turned off and the operating time and the reason for the stop were indicated on the monitor.

[0261] The battery's energy output of 232.4 - 251 mAh was carried out within 968 - 1141 minutes. After all the battery's energy was used up, a message about the need to charge the battery appeared on the monitor.

[0262] The battery was put on charge. The battery was charged and the charging process was monitored as described earlier - until the monitor displayed a message about the battery being fully charged and the charge being turned off.

[0263] Thus, as a result of the experiment, which lasted two days and 968 - 1141 minutes on the third day, 510 mAh of battery energy was consumed.

[0264] After that, the battery was put on charge. The battery was charged and the charging process was monitored as described earlier - until the monitor showed a message about the battery being fully charged and the charge being turned off.

[0265] During the experiments, the amount of energy remaining in the battery was recorded after 439 minutes of operation in the monitoring mode on the third day. The value of the remainder was recorded (see Table 3). It was found that the amount of energy remaining in the battery is 25 - 30% of the initial energy in the battery.

[0266] The tests were conducted over a period of 2 months. In parallel, they worked with the prototype sensors and with the sensors declared in the invention.

[0267] There were 5 experimental prototypes in total with the characteristics given in Tables 1 and 2. There were also 5 declared experimental devices with the characteristics given in Tables 1 and 2.

[0268] Table 1 presents the geometric characteristics of the sensors and the flanges on the sensor housing submitted for testing. The sensor housing and flange material is plastic. These geometric characteristics are present in 5 prototype sensors and 5 sensors declared in the invention.

[0269] Table 2 presents the geometric characteristics of the inner surfaces of the sides of the experimental versions of sensors and prototypes. The presented geometric characteristics have 5 sensors - prototypes and 5 sensors declared in the invention.

[0270] Table 3 shows the energy expended by the batteries for noninvasive monitoring of glucose levels in human blood during 3 days of experiments with the prototype and the claimed sensor. In the experiments, we additionally tested a sensor whose outer surface of the case (including the rim with a convex inner surface) was coated with nickel. The sensor case and rim were made of plastic.

[0271] Nickel plating of the outer surface of the plastic case was carried out in a traditional way. The surface was degreased, etched, and activated.

[0272] After activation, the sensor body was placed in a solution for nickel plating. An aqueous solution was used: nickel sulfate - 30 g, sodium hypophosphite - 10 g, sodium acetate - 10 g, water - 1 liter. The time the body was in the solution was 20 minutes. The thickness of the nickel film was 5 μm.

[0273] In experiments, the reduction in energy consumption during sensor operation increased to 35%.

[0274] In addition, when working on the invention, the authors came to the conclusion that in addition to making the inner surface of the rim convex, it is advisable that the ridge of the rim be made with alternating projections and depressions along its length or that grooves be made on the ridge of the rim. This will increase the adhesion force of the rim to the human hand by increasing the contact area of ​​the rim surface with the hand surface and, thereby, prevent the sensor from shifting from the place of its initial installation, which in turn will reduce the time for preparing and adjusting the sensor during multiple measurements during the day, increase the efficiency of the sensor, and, as a result, save battery power. At the same time, it will increase the efficiency of the sensor of the wrist device for non-invasive monitoring of glucose content in human blood by reducing energy consumption during its operation.

[0275] In a formalized form, this can be written as follows: in a particular embodiment of the invention, the sensor can be made in such a way 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. Thus, the objective of the invention is achieved. It is ensured: an increase in the efficiency of the sensor of the wrist device for non-invasive monitoring of glucose content in human blood by reducing energy consumption during its operation due to profiling the inner surface of the rim.

[0276] The technical result is also achieved.

[0277] Reduced energy consumption during sensor operation. The reduction is achieved by profiling the inner surface of the rim, which increases the amount of light reflected from the hand, namely, reflected from the artery and other vessels in the hand, and falling on the light receiver. The increase in incident light occurs due to the convexity of the inner surface of the rim. The rays reflected from the convex surface fall on the light receiver. Thus, the amount of light falling on the receiver increases.

[0278] At the same time, it is possible to reduce the energy consumption for non-invasive monitoring of glucose levels in human blood. And, therefore, it is possible to perform more measurements from one battery charge.

[0279] Table 1

[0280] Geometrical characteristics of sensors and flanges on the sensor body submitted for testing. Sensor body and flange material - plastic

[0281] Table 2

[0282] Characteristics of the inner surfaces of the sides of the experimental sensor variants

[0283] Table 3

[0284] Energy expended by batteries for non-invasive monitoring of glucose content in human blood during 3 days of experiments Literature.

[0285] 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.

[0286] 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.2023.68.1 1.381

Claims

Invention formula 1. A wrist device sensor 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 inner surface of the rim is convex along its entire length or a part of the inner surface of the rim is convex along the entire length 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 inner surface of the rim is coated with nickel.

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