Sensor of a 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 of a device for non-invasively checking a person's blood glucose concentration by reducing the set-up and configuration time required. This aim is achieved in that the claimed sensor of a device for non-invasively checking a person's blood glucose concentration comprises a housing, a light emitter and a light receiver, the inner side of the housing having a rim disposed thereon which surrounds the light receiver and separates it from the light emitter, wherein the crest of said rim has alternating projections and depressions along its length, and during the set-up and operation of the sensor, the emitter and the receiver are pressed against the pulse point on the radial artery of the arm. The technical results of the invention include: increasing the adhesive force between the rim and a person's arm by increasing the contact area between said rim and the surface of the arm; reducing the energy spent on non-invasively checking a person's blood glucose concentration; and increasing heat transfer from 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] SENSOR DEVICE FOR NON-INVASIVE MONITORING OF GLUCOSE CONTENT IN HUMAN BLOOD.

[0002] DESCRIPTION.

[0003] The invention relates to medicine and technology, specifically to the 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 the early diagnosis of diabetes and related diseases.

[0004] Prior art.

[0005] For diabetics, constant blood glucose monitoring is vital. New developments based on non-invasive methods that measure health parameters without drawing blood are currently being used for this purpose.

[0006] Numerous methods and devices have been developed for noninvasively determining changes in human blood glucose levels. References / 2-5 / describe the sensors used in these devices.

[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 of the I / .

[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 / 1 / .

[0009] This glucometer has a battery capacity of 510 mAh, which is 2.4 times larger than that of the smartwatches described above.

[0010] The device contains a sensor for monitoring the pulse wave signal, determining blood sugar levels, and other blood parameters. It also features manual radial artery location and sensor targeting. Changes in pulse wave parameters are used to determine changes in a person's blood sugar and other parameters.

[0011] 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.

[0012] The control and display module may be called the control and data processing module or the control module.

[0013] The case with the control and display module resembles a wristwatch in appearance.

[0014] 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.

[0015] The sensor is also called a mobile remote unit because, when configured, it can move relative to a person's hand, either along the strap or together with the strap.

[0016] The sensor of the 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.

[0017] For simplicity, a light emitter is simply called an emitter.

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

[0019] An analog of the invention is a device sensor for non-invasively monitoring human blood glucose levels using infrared light with a telemetry function for determining blood glucose levels. The sensor is part of the device (CN 110236487 A, published September 17, 2019).

[0020] The publication describes the design of a noninvasive blood glucose sensor. The sensor includes an emitter and a receiver for radiation reflected from human tissue.

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

[0022] A sensor for a device for non-invasive monitoring of glucose levels in human blood, comprising a housing, 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 inner surface of the sensor is also called the working surface of the sensor / 6 / . A disadvantage of the analog is the lack of a rim on the sensor body separating the emitter from the receiver.

[0024] The prototype of the invention is a sensor device for non-invasive monitoring of glucose content in human blood / 1 / , comprising a housing, a light emitter, a light receiver, wherein the light emitter and the light receiver are located on the inside of the sensor housing; both during preparation for operation and during operation, the sensor is designed with the possibility of being pressed against the place of palpation of the pulse on the radial artery of the hand, wherein the light emitter is designed with the possibility of emitting light into the hand on the radial artery, and the light receiver is designed with the possibility of receiving 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.

[0025] These features of the prototype coincide with the features of the invention.

[0026] In addition, the side is made in a rectangular cross-section.

[0027] In the prototype, the longitudinal axis of the light emitter beam is directed at an angle of 90 degrees to the inner side of the sensor housing.

[0028] A drawback of the prototype is the constant height of the edge along its length. The edge lacks protrusions, recesses, and grooves. This results in relatively weak adhesion of the edge to the human hand and, therefore, does not prevent the sensor from shifting from its original installation location.

[0029] The essence of the invention.

[0030] The purpose of the invention is to increase the efficiency of the sensor device for non-invasive monitoring of glucose levels in human blood by reducing the time for preparation and setup.

[0031] Efficiency refers to speed of operation and the ability to quickly bring a device into working order, in particular, without prior configuration.The objective is achieved in that the sensor of the device for non-invasive monitoring of glucose content in human blood comprises a housing, a light emitter, a light receiver, wherein the light emitter and the light receiver are located on the inner side of the sensor housing; both during preparation for operation and during operation, the sensor is configured to be pressed against the place of palpation of the pulse on the radial artery of the hand, wherein 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 differs from the prototype in that 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.

[0032] In a particular embodiment of the invention, the sensor can be designed 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 at the base of the thumb of a 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 a human hand, or from the radial artery of the wrist, or from the radial artery of the forearm.

[0033] 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, or when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is wiped dry.

[0034] In a specific embodiment of the invention, the sensor may be designed such that the rim ridge is formed with alternating projections and depressions along its length, and grooves are formed on the rim ridge projections and depressions. In a specific embodiment, the sensor may be designed such that when the emitter emits light, the longitudinal axis of its light beam is tilted toward the light receiver.

[0035] In a specific embodiment of the invention, the sensor can be designed such that the longitudinal axis of the emitter beam is inclined toward the light receiver at an angle ranging from 45 degrees to 85 degrees relative to the inside of the sensor housing. In the prototype, the longitudinal axis of the light emitter beam is directed at an angle of 90 degrees relative to the inside of the sensor housing.

[0036] As mentioned earlier, the sensor contains an emitter and receiver of light reflected from the hand (human tissue) and is part of a device for non-invasively monitoring human blood glucose levels. Specifically, the sensor may be part of a wrist-worn device for non-invasively monitoring human blood glucose levels, a key fob-style device, or a device located in a smartphone.

[0037] In turn, the device, in addition to the sensor, contains a control and display module.

[0038] 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.

[0039] The term light refers to electromagnetic radiation perceived by the human eye.

[0040] The technical results of the invention are:

[0041] 1. Designing the edge with alternating protrusions and depressions (and / or ridges) along its length will increase the edge's adhesion to the user's hand by increasing the contact area between the edge and the hand. This will prevent the sensor from shifting from its initial installation location. This, in turn, will reduce the time required for sensor preparation and setup during multiple measurements throughout the day and improve the sensor's operational efficiency. 2. A specific technical result is an increase in the contact area between the edge and the dry, wiped hand surface at the sensor's location.

[0042] 3. Another particular technical result is an increase in the contact area of ​​the side surface with the water-wetted surface of the hand at the location of the sensor.

[0043] 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.

[0044] 5. Increased heat transfer from the sensor through the comb to the user's hand by increasing the contact surface area between the rim and the hand. This will improve the reliability of the sensor.

[0045] Let us explain the achievement of technical results.

[0046] Since the claimed sensor for the noninvasive blood glucose monitoring device operates within a device for noninvasive blood glucose monitoring, we will describe the sensor's operation within the device. For ease of comparison with the prototype, we will describe the sensor and its operation within a wrist-worn device for noninvasive blood glucose monitoring.

[0047] Setting up the claimed device is similar to setting up the prototype. A user configures the device to work with themselves.

[0048] The sensor and device are then ready to perform non-invasive monitoring of blood glucose levels.

[0049] The sensor of the noninvasive blood glucose monitoring device, and the entire device itself, is securely fastened using a strap, for example, to the left (or right) wrist so that the sensor is aligned with the radial artery at that location. The emitter and receiver of reflected light located in the sensor are then directed toward the radial artery.

[0050] To accurately target the emitter and receiver during operation, the emitter and receiver are aimed at the radial artery. Specifically, the emitter and receiver are pressed against the pulse site on the person's arm. To perform noninvasive blood glucose monitoring, the person sits still for 3 minutes. The arm is relaxed and placed, for example, on a table in front of the person. The pulse site is at heart level.

[0051] After which, the person determines the place on the arm where the pulse is felt above the radial artery.

[0052] After this, the device with the sensor is pressed tightly to the place where the pulse is felt, so that the sensor is opposite the radial artery in this place of the arm.

[0053] In this case, the emitter and receiver of reflected radiation, located in the sensor, are directed towards the radial artery.

[0054] After this, the person sits still for 3 minutes. The device with the sensor is placed on the arm. The device is then turned on, and the device checks the sensor's correct position relative to the radial artery. The check lasts up to 3 minutes.

[0055] When the sensor is correctly positioned, the user takes a measurement. The measurement lasts from 0.5 to 1.5 minutes.

[0056] The measurement result, namely sugar content, is then displayed on the screen. Other parameters may also be displayed, such as blood pressure, pulse, temperature, hemoglobin, cholesterol, uric acid, heart / lung / liver / brain function, and others.

[0057] If the sensor placement is incorrect (i.e., its location on the arm does not match the location on the arm when testing the sensor), a message will appear on the touch screen indicating the need to reinstall the sensor.

[0058] Testing of the prototype device revealed that initial setup requires at least three attempts. Each attempt takes up to 6 minutes. Afterward, the device is ready to measure blood sugar levels. Therefore, the prototype takes 18 minutes to perform the first measurement.

[0059] The prototype's shortcomings stem from the following: During the day, as a person walks and uses their hands, the sensor shifts from its initial position. In this case, to perform a measurement, it is necessary to reset the sensor to its original position.

[0060] Typically, people use their hands intensively throughout the day. This causes the device to shift from its original position. A diabetic patient must measure their blood sugar levels multiple times a day—up to 10 or more (and sometimes up to 20 times). This requires resetting the sensor and adjusting the device almost as many times. This can take up to three hours of measurements per day, with 10 measurements. This is due to the rotation of the device and strap relative to the arm and radial artery.

[0061] In the invention, the noninvasive glucometer sensor has a rim on its inner housing that surrounds the light receiver and separates it from the light emitter. The rim's ridge is formed with alternating protrusions and depressions along its length, or the rim's ridge is ribbed.

[0062] In other words, the curb is designed with a variable height along its length. Moreover, as it extends, the curb's height increases and decreases.

[0063] In other words, along the length of the side, sections with a greater height alternate with sections with a lower side height.

[0064] This increases the grip strength of the edge on the user's hand, preventing the sensor from shifting from its original position. Furthermore, during setup and operation, the transmitter and receiver are pressed against the pulse measurement site on the radial artery of the wrist.

[0065] This ensures increased operational efficiency of the device's sensor.

[0066] Testing several sensor variants with different rim designs showed that a rim with alternating protrusions and depressions along its length, or a rim with ridges, reduces blood glucose measurement time by 30% to 40% compared to the prototype, with ten measurements per day. The testing details are described below. The invention increases the contact area between the rim and the dry hand surface at the sensor location.

[0067] Also, when implementing the invention, an increase in the area of ​​contact of the surface of the side with the water-wetted surface of the hand at the location of the sensor is ensured.

[0068] The method for taking measurements on a dry or wet hand depends on which hand was used for sensor testing. If the sensor was tested on a dry hand (using a wiped surface), then subsequent measurements, until the next sensor test, are taken on a dry hand.

[0069] If the sensor was tested on a wet hand (on a moistened surface of the hand), then subsequent measurements, until the next sensor test, are also carried out on a wet hand.

[0070] 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.

[0071] Furthermore, the invention increases heat transfer from the sensor through the ridge to the user's hand by increasing the contact surface area between the rim and the hand. This will improve the reliability of the sensor.

[0072] It should be noted that tilting the longitudinal axis of the light beam toward the light receiver increases the light flux reaching the artery during sensor operation. This, in turn, reduces light intensity and saves energy.

[0073] List of figures.

[0074] Fig. 1 shows a sensor for a device for noninvasively monitoring glucose levels in human blood. The sensor contains one emitter and one receiver of light reflected from the hand.

[0075] Fig. 2 shows a sensor for a device for noninvasively monitoring human blood glucose levels. The sensor contains two emitters and one receiver for reflecting light from the hand. Fig. 3 shows a wrist-worn device for noninvasively monitoring human blood glucose levels. A sensor for the device for noninvasively monitoring human blood glucose levels is located at the end of one of the strap sections.

[0076] Fig. 4 shows a wrist-worn device for noninvasive blood glucose monitoring. A sensor for the device is located at the end of one of the strap sections. The strap sections are fastened. The communication cable connecting the sensor and the control and display module located within the housing is located inside the strap.

[0077] Fig. 5 shows a longitudinal section of the rim located on the inner surface of the prototype sensor.

[0078] Fig. 6 shows a longitudinal section of the flange located on the inner surface of the sensor. The flange's ridge is formed with alternating projections and depressions along its length.

[0079] Fig. 7 shows a development of the rim. The rim's ridge is formed with alternating projections and depressions along its length. The ridge is marked with a projection "A," which is shown in Fig. 8.

[0080] Fig. 8 shows the extension element “A” with ribs on the surface of the side projection.

[0081] Fig. 9 shows a development of the rim. The rim's crest is ribbed along its length. That is, the rim's crest is ribbed.

[0082] Fig. 10 shows a sensor for a device for noninvasively monitoring human blood glucose levels, positioned on a person's hand. The sensor contains two emitters and one receiver for light reflected from the hand. The surface of the hand in contact with the sensor is moistened with water.

[0083] Fig. 11 shows a sensor for a device for noninvasively monitoring human blood glucose levels, positioned on a person's hand. The sensor's operation is demonstrated. Emitters emit light into the person's hand, and a receiver receives the reflected light from the hand. The surface of the hand in contact with the sensor is moistened with water.

[0084] Fig. 12 shows the entire device for noninvasive blood glucose monitoring with a control and data processing module in the housing. A sensor for the device for noninvasive blood glucose monitoring is located at the end of one of the strap sections. A communication cable is located inside the strap section, connecting the sensor to the control and data processing unit and the power source. Section B - B is marked across the strap.

[0085] Fig. 13 shows a section B - B of the strap and cable.

[0086] Fig. 14 shows a development of the rim. The ridge of the rim is formed with alternating projections and depressions along its length. The figure shows the dimensions, in particular, the projections and depressions.

[0087] Fig. 15 shows a longitudinal section of the side.

[0088] Fig. 16 shows a development of the rim. The rim's ridge is formed with alternating projections and depressions along its length. The figure shows the dimensions, in particular, the projections and depressions.

[0089] Fig. 17 shows a longitudinal section of the side.

[0090] Fig. 18 shows a sensor with a flange indicating its geometric dimensions.

[0091] Fig. 19 shows a sensor with grooves applied to the ridge of the side.

[0092] Fig. 20 shows the detail element D - a view of the ridge of the side with riffles.

[0093] Fig. 21 shows a device for noninvasively monitoring human blood glucose levels with a sensor. The device is designed as a key fob, and the sensor is located on the lower end of the device's housing.

[0094] Fig. 22 shows a device for non-invasively monitoring human blood glucose levels with a sensor. The device is designed as a key fob. The sensor is located on the rear surface of the device's housing, near the lower end.

[0095] Fig. 23 shows a device for noninvasively monitoring human blood glucose levels using a sensor. The device is based on a smartphone, with the sensor located on the back of the smartphone's casing near the top edge. Fig. 24 shows the sensor for the device for noninvasively monitoring human blood glucose levels. The sensor's emitter is tilted toward the edge.

[0096] Fig. 25 shows a sensor for a device for noninvasively monitoring human blood glucose levels, positioned on a person's hand. The sensor's emitter is tilted toward the edge. The sensor's operation is shown. The emitter emits light into the person's hand, and the receiver receives the reflected light from the hand.

[0097] Disclosure of invention.

[0098] Definitions of terms are given in the source / 1 / .

[0099] The definition of terms for the sensor device, made in the form of a key fob, is given in the source / 6 / .

[0100] A sensor for a noninvasive blood glucose monitoring device is part of a device for noninvasive blood glucose monitoring. The device (e.g., a wrist device) comprises a housing with a control and display module (in other words, electronics and a power supply), a sensor housing an emitter and receiver for reflecting radiation from human tissue, and a strap for attaching the control module and sensor to the user's hand. The sensor is designed to move relative to the user's hand (along the strap or together with the strap) during adjustment.

[0101] The radiation used is light, which is visible to the human eye. Thus, a control and display module, as well as a sensor, are attached to the hand via a strap.

[0102] The sensor contains a flange separating the transmitter from the receiver. The flange's ridge is either ribbed or ridged, with alternating projections and depressions along its length. Furthermore, during setup and operation of the sensor, the transmitter and receiver are pressed against the pulse location on the radial artery of the arm.

[0103] Riffles are grooves on a surface, particularly on the surface of a rim. The rim ridge is the upper part of the rim when the sensor is oriented so that the outer surface of the sensor housing is parallel to the local horizon and points toward the center of the earth.

[0104] The outer surface of the sensor housing or the outer surface of the sensor is the surface that faces away from the person's hand during non-invasive blood glucose monitoring.

[0105] The inner surface of the sensor housing, or the inner surface of the sensor, or the working surface of the sensor is the surface that faces the human hand during non-invasive blood glucose monitoring.

[0106] The figures indicate the following positions:

[0107] 1 - sensor housing (see Fig. 1);

[0108] 2 - strap;

[0109] 3 - light emitter;

[0110] 4 - light receiver;

[0111] 5 - side;

[0112] 6 - cable (wire communication line) connecting the receiver and emitter with the control and display module;

[0113] 7 - emitter (see Fig. 2);

[0114] 8 - housing with control and display module (see Fig. 3);

[0115] 9 and 10 - strap sections;

[0116] 11 - a sensor fixed to the end of section 10 of the strap;

[0117] 12, 13 and 14 elements of the lock with devices for attaching them to the strap sections;

[0118] 15 - housing with control and display module (see Fig. 4);

[0119] 16 - sensor;

[0120] 17 - a lock with devices for attaching it to the strap sections;

[0121] 18 - strap section;

[0122] 19 - cable (wire communication line) connecting the housing (with the control and display module) to the sensor;

[0123] 20 - prototype side (see Fig. 5);

[0124] 21 - sensor housing;

[0125] 22 - light receiver; 23 - sensor housing (see Fig. 6);

[0126] 24 - light receiver;

[0127] 25 - a sideboard, the ridge of which is made with projections and depressions alternating along its length;

[0128] 26, 28 - protrusions on the ridge of the side;

[0129] 27, 29 - recesses on the ridge of the side;

[0130] 30, 32, 33 - protrusions on the ridge of the side (see Fig. 7);

[0131] 34 - side development;

[0132] 31, 35 - recesses on the ridge of the side;

[0133] A - remote element;

[0134] 36, 37, 38 - riffles (see Fig. 8);

[0135] 39 - surface of the human hand (see Fig. 10);

[0136] 40 - human hand;

[0137] 41 - moisture on the surface of a human hand. Moisture is located between the surface of the hand and the sensor;

[0138] 42 - cable connecting the receiver and emitter with the control and display module;

[0139] 43, 44 - light emitter;

[0140] 45 - side;

[0141] 46 - light receiver;

[0142] 47, 48 - rays of light from the emitter into the human hand (see Fig. 11);

[0143] 49 - light reflected from a person’s hand, in particular, from an artery;

[0144] 50 - sensor housing (see Fig. 12). The position 50 can also designate the sensor itself;

[0145] 51 - strap;

[0146] 52, 53 - light emitter;

[0147] 54 - light receiver;

[0148] 55 - side;

[0149] 56 - cable located in the sensor, in the strap and in the control and data processing module;

[0150] 57 - control and data processing module of a device for non-invasive monitoring of glucose content in human blood;

[0151] 58 - control and data processing unit; B - B - section of the strap with cable;

[0152] 59 - riffles on the ridge of the side (see Fig. 9);

[0153] 60 - development of the side with ribs;

[0154] 61 - power source;

[0155] 62 - artery (see Figs. 10 and 11);

[0156] 63 - the length of the side (see Fig. 14);

[0157] 64 - side height;

[0158] 65 - width of the projection;

[0159] 66 - height of the projection;

[0160] 67 - recess width;

[0161] B - B - longitudinal section of the side;

[0162] 68 - the length of the side (see Fig. 16);

[0163] 69 - side height;

[0164] 70 - width of the protrusion at the top of the ridge;

[0165] 71 - width of the recess in the upper part of the ridge;

[0166] G - G - longitudinal section of the side;

[0167] 72 - sensor housing (see Fig. 18);

[0168] 73 - the outer dimension of the sensor housing, in particular the outer diameter of the sensor housing or the outer diameter of the sensor;

[0169] 74 – thickness of the sensor body;

[0170] 75, 76 - light emitters;

[0171] 77 - light receiver;

[0172] 78 - side;

[0173] 79 - width of the side;

[0174] 80 - inner diameter of the rim;

[0175] 81 - side height;

[0176] 82 - rim with grooves. Fig. 19 shows a sensor with a rim on which grooves 83, 84, 85 are located;

[0177] D - view of the ribbing of the side (see Figs. 19 and 20);

[0178] 86, 87, 88 - grooves on the ridge of the side. According to the invention, the sensor of the device for non-invasive monitoring of glucose content in human blood contains a housing 1 (see Fig. 1), 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, five, six.

[0179] Moreover, light emitter 3 and light receiver 4 are located on the inside of the sensor housing such that, when the sensor is on the hand, the light emitter is configured to emit light into hand 40 (see Fig. 11) onto radial artery 62. And the light receiver is configured to receive reflected light from the radial artery of the human hand. A rim 5 is located on the inside of the sensor housing, surrounding light receiver 4 and separating it from light emitter 3.

[0180] In this case, the ridge of the side is made with projections 26 (see Fig. 6) and depressions 29 alternating along its length, or riffles 59 are made on the ridge of the side (see Fig. 9).

[0181] When preparing for work and during operation of the sensor, the emitter and receiver are pressed to the place where the pulse is felt on the radial artery of the hand.

[0182] 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 to emit light into the hand onto the radial artery at the base of the thumb of the human hand.

[0183] 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 to emit light into the hand onto the radial artery of the wrist.

[0184] 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 to emit light into the hand onto the radial artery of the forearm.

[0185] In a particular embodiment of the invention, the sensor can be designed such that, while the sensor is on the hand, the receiver is configured to receive reflected light from the hand, specifically, from the radial artery at the base of the thumb. In a particular embodiment of the invention, the sensor can be designed such that, while the sensor is on the hand, the receiver is configured to receive reflected light from the hand, specifically, from the radial artery of the wrist.

[0186] 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 to receive reflected light from the hand, namely, from the radial artery of the forearm.

[0187] 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, or when preparing it for operation, the place where the pulse is felt on the radial artery of the hand is wiped dry.

[0188] In a particular embodiment of the invention, the sensor can be designed in such a way that the ridge of the side is made with projections and recesses alternating along its length, and grooves are made on the projections and recesses of the ridge of the side.

[0189] The control and data processing module 57 contains a control and data processing unit 58 and a power source 61.

[0190] 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.

[0191] 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 runs inside the strap (see Fig. 13).

[0192] In general, the sensor can be part of a device made in the form of a key fob.

[0193] Fig. 21 shows a device for non-invasive monitoring of glucose levels in human blood with a sensor. And sensor 91 (see Fig. 21) is located on the lower end side of device housing 90. In the figure, reference numeral 89 denotes a touch screen / 6 / . Fig. 22 shows a device for non-invasive monitoring of glucose levels in human blood with a sensor. And sensor 92 is located on the rear surface of device housing 93 at the lower end side of the device housing. In the figure, reference numeral 94 denotes a connector for recharging the battery and communicating with an external device, such as a smartphone or computer.

[0194] The sensor can also be part of a device located in a smartphone.

[0195] Fig. 23 shows a device for noninvasively monitoring human blood glucose levels using a sensor. The device is based on a smartphone, with sensor 95 located on the rear surface of the smartphone's housing near the top edge.

[0196] Fig. 24 shows a sensor 116 of a device for non-invasively monitoring glucose levels in human blood. The emitter 99 of the sensor 116 is tilted toward the edge 97. In other words, the emitter is designed such that when emitting light, the longitudinal axis of the light beam is tilted toward the light receiver.

[0197] The figure shows:

[0198] 96 - sensor housing;

[0199] 97 - side;

[0200] 98 - light receiver;

[0201] 99 - light emitter;

[0202] 100 - longitudinal axis of the light beam;

[0203] 101 - perpendicular to the inner side of the sensor housing;

[0204] 102 – the angle between the longitudinal axis of the beam and the inner side of the sensor housing (in the longitudinal section of the sensor passing through the longitudinal axis of the beam);

[0205] 103 - cable (wire communication line) connecting the receiver and emitter with the control and display module;

[0206] 104 - strap;

[0207] 105 - recess on the ridge of the side;

[0208] 106 - protrusion on the ridge of the side;

[0209] 116 - a sensor of a device for non-invasive monitoring of glucose levels in human blood; In Fig. 24, the ridge of the edge is made with protrusions and depressions alternating along its length.

[0210] Fig. 25 shows a diagram of a sensor 116 of a device for noninvasively monitoring glucose levels in human blood, located on a person's hand 107. The emitter 108 of the sensor 117 is tilted toward the side. The operation of the sensor is shown. The emitter emits light into the person's hand, and the receiver receives the reflected light from the person's hand.

[0211] The figure shows:

[0212] 107 - human hand;

[0213] 108 - emitter;

[0214] 109 - schematic of a beam of light;

[0215] 110 - schematic of a beam of light;

[0216] 111 - schematic of a beam of light;

[0217] 112 - longitudinal axis of the beam;

[0218] 113 - artery;

[0219] 114 - reflected light;

[0220] 115 - reflected light;

[0221] 117 - sensor.

[0222] The longitudinal axis of the beam is inclined toward the light receiver at an angle ranging from 45 degrees to 85 degrees relative to the inside of the sensor housing. This angle is based on a longitudinal cross-section of the sensor passing through the longitudinal axis of the beam.

[0223] The angle is selected based on the sensor design. Key factors include the inner diameter of the flange, the flange width, the flange height, and the distance from the emitter to the flange.

[0224] The sensor works as follows.

[0225] The sensor of the device for noninvasive monitoring of human blood glucose levels operates as part of the device for noninvasive monitoring of human blood glucose levels. We will describe the operation of the sensor as part of the device. For clarity, we will use Fig. 12. During operation (see Fig. 12), a person's hand is positioned between the sensor 50 and the control and data processing module 57. The sensor is oriented on the hand so that the light emitter (or emitters) and light receiver are positioned opposite the radial artery.

[0226] The sensor of the device for noninvasive monitoring of glucose levels in human blood and the device as a whole are firmly secured by a strap, for example, to 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 area 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 toward the radial artery.

[0227] To accurately aim the emitter and receiver during operation of the device, the emitter and receiver are directed towards the radial artery, namely, the emitter and receiver are pressed to the place where the pulse is felt on the person's arm.

[0228] After this, the person sits still for 3 minutes. The arm with the sensor is relaxed and placed, for example, on a table in front of the person (See Figure 27 of source / 1 / ). The person then turns on the device. To do this, turn on the power and activate the control module by pressing buttons on the display touchscreen. The control module checks the correct position of the sensor (emitter and receiver) relative to the radial artery. The check time is up to 3 minutes. If the sensor position is incorrect (i.e., its location on the arm does not match the location on the arm during sensor testing), a message appears on the display indicating the need to re-install the sensor. The device is turned off. The strap is loosened, the sensor is re-positioned over the radial artery (above the pulse palpation site), then the strap is tightened, pressing the sensor firmly to the wrist. The person sits still for 3 minutes, after which the device is turned on.Work on installing the sensor continues until a message appears on the display indicating that the device is ready for operation.

[0229] As mentioned above, the location of the sensor on the hand should correspond to the place where it was located during testing.

[0230] We described the testing above.

[0231] After this, the device is considered tested and ready for use.

[0232] Testing of the prototype device revealed that initial setup required at least three attempts. Each attempt took up to 6 minutes. Afterward, the device was ready to measure blood sugar levels. Therefore, the first measurement took 18 minutes.

[0233] The prototype's drawback is as follows. During the day, while a person walks and uses their hands, the sensor shifts from its initial position. In this case, to perform a measurement, it is necessary to reset the sensor to its original position.

[0234] Typically, a person works intensively with their hands throughout the day. This causes the sensor to shift from its original position. A diabetic patient must measure their blood sugar levels multiple times a day—up to 10 or more (and sometimes up to 20 times). This requires resetting the sensor and adjusting the device for operation the same number of times. This amounts to up to three hours of measurement time per day, with 10 measurements taken. This is caused by displacement, specifically rotation, of the sensor and strap relative to the radial artery and its original location.

[0235] The invention partially eliminates this drawback.

[0236] In the invention, the noninvasive glucometer sensor has a rim on its inner housing that surrounds the light receiver and separates it from the light emitter. The rim's ridge is formed with alternating protrusions and depressions along its length, or the rim's ridge is ribbed.

[0237] In other words, the curb is designed with a variable height along its length. Moreover, as it extends, the curb's height increases and decreases.

[0238] In other words, along the length of the side, sections with a greater height alternate with sections with a lower side height.

[0239] This increases the adhesion force of the edge to the user's hand, thereby preventing the sensor from shifting from its original installation location. When implementing a edge with a constant height along the edge, as in the prototype, the term "edge height" is defined as follows. Edge height is the distance between the inner surface of the sensor and a plane tangent to the edge of the edge / 1 / .

[0240] The height of the side may be variable along the length of the side, as in the claimed invention.

[0241] 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” can be used.

[0242] The term maximum side height can also be used.

[0243] 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.

[0244] 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.

[0245] The geometric characteristics of protrusions and recesses can be characterized by the empirical (obtained on the basis of experiments) coefficient “K”.

[0246] K = H / h, where H is the maximum height of the side; h is the minimum height of the side.

[0247] Conducted studies have shown that the coefficient K can take values ​​from 0.0001 to 0.5.

[0248] In a particular embodiment, the coefficient K may take values ​​from 0.0001 to 0.01, or in another particular embodiment, the coefficient K may take values ​​from 0.01 to 0.1, or in another particular embodiment, the coefficient K may take values ​​from 0.1 to 0.2, or in another particular embodiment, the coefficient K may take values ​​from 0.2 to 0.3, or in another particular embodiment, the coefficient K may take values ​​from 0.3 to 0.4, or in another particular embodiment, the coefficient K may take values ​​from 0.4 to 0.5. The average height of the curb is the arithmetic mean between the smallest and largest heights in the longitudinal sections of the curb along its length.

[0249] 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.

[0250] This ensures improved sensor performance. Testing several sensor variants with different rim designs showed that a rim ridge with alternating protrusions and indentations along its length, or a rim ridge with ribs, reduces blood glucose measurement time by 30% to 40% compared to the prototype, with ten measurements per day. The testing details are provided below.

[0251] 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.

[0252] It would seem that the problem could be solved by tightening the strap more tightly. But this causes extreme discomfort.

[0253] Another option is to use adhesive—sticking the sensor and strap daily, for example, to your wrist. However, this solution causes discomfort throughout the day and is harmful to your skin.

[0254] Description of experiments.

[0255] Ten volunteer test subjects took part in the experiments.

[0256] Devices for non-invasive monitoring of human blood glucose levels were placed on the test subjects' arms.

[0257] Before testing, each test subject tested the sensor and the device as a whole, configuring it for use on their arm. Blood glucose (sugar) levels were also measured for each test subject.

[0258] After which the testers sequentially performed sets of exercises for the arms No. 1 - No. 6 / 1 / .

[0259] Descriptions of the exercise routines are provided below. Exercise routine #1: Stand with your feet shoulder-width apart and your arms bent at the elbows, touching your chest. Arm jerks. On the count of 1, 2, jerk your arms forward; on the count of 3, 4, jerk your arms out to the left. On the count of 1, 2, jerk your arms forward; on the count of 3, 4, jerk your arms out to the right.

[0260] Exercise set #2: Stand with your feet shoulder-width apart and your hands at your sides. Rotate your arms. Count 1, 2, 3, 4 and rotate forward. Count 1, 2, 3, 4 and rotate backward.

[0261] Exercise set #3: Stand with your feet shoulder-width apart and your arms at your sides. On the count of 1, 2, swing your arms out to the sides, up and down along your torso. Repeat 10 times.

[0262] Exercise set #4: Stand with your feet shoulder-width apart and your arms extended forward at chest level. On the count of 1, 2, swing your arms horizontally out to the sides. Repeat 10 times.

[0263] Exercise set #5: Stand with your feet shoulder-width apart and your arms at your sides. On the count of 1, 2, 3, 4, rotate your arms backward. Repeat 10 times.

[0264] Exercise set #6: Stand with your feet shoulder-width apart and your arms at your sides. On the count of 1, 2, 3, 4, rotate your arms forward. Repeat 10 times.

[0265] After completing the exercise routine, each volunteer turned on the device and measured their blood glucose (sugar) levels. If necessary (the sensor moved from its original position), the device was adjusted for operation.

[0266] Over the course of the day, the test subjects performed Exercise Sets #1–#6 ten times. Preparation time and blood glucose measurements were recorded during the tests.

[0267] The first month of testing was devoted to working with prototypes. There were eight prototypes in total, with the characteristics listed in Table 1.

[0268] The following months of testing involved working with sensors of various designs—based on the invention. A total of 48 sensors with the stated curb designs were tested, with the characteristics listed in Tables 2–9.

[0269] Tables 1–9 present the geometric characteristics of the sensors and the flanges on the sensor housings. Table 1 presents the geometric characteristics of the sensors and flanges on the sensor housings submitted for testing. The sensor housing and flange material are plastic. A total of eight experimental sensor variants were submitted for testing.

[0270] Table 2 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 1.

[0271] Table 3 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 2.

[0272] Table 4 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 3.

[0273] Table 5 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 4.

[0274] Table 6 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 5.

[0275] Table 7 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 6.

[0276] Table 8 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 7.

[0277] Table 9 shows the characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 8.

[0278] As noted above, testing of sensors with various rim designs revealed that a rim with alternating protrusions and depressions along its length, or a rim with ribs, reduces blood glucose measurement time by 30% to 40% compared to the prototype, with ten measurements per day. It was found that the greater the area of ​​contact between the user's hand and the rim, the more the blood glucose measurement time is reduced compared to the prototype.

[0279] Moreover, this 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.

[0280] The 40% value represents a percentage reduction in blood glucose measurement time compared to the prototype. So, while the prototype takes 180 minutes to perform ten measurements per day, the claimed device takes 108 minutes.

[0281] In experiments, we additionally tested ribbing on the edge surface to enhance the effect and improve the technical results. The ribbing was applied to the edges of prototypes.

[0282] 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).

[0283] Testing of sensors with different rim designs revealed that the rim ridge with grooves reduces the time it takes to measure blood glucose levels by 30% compared to the prototype, with ten measurements per day.

[0284] If the sensor's emitter is tilted toward the edge and toward the light receiver, or, in other words, the emitter is designed such that when emitting light, the longitudinal axis of its beam is tilted toward the light receiver. The invention proposes that the longitudinal axis of the beam be positioned at an angle of 45 to 85 degrees to the inside of the sensor housing.

[0285] This design of the emitter ensures a reduction in the energy consumption for non-invasive monitoring of glucose levels in human blood due to more precise orientation of the emitter to the artery.

[0286] From the above, it follows that the invention achieves its objective. It improves the operational efficiency of the device's sensor for noninvasively monitoring human blood glucose levels by reducing setup and configuration time.

[0287] The technical results of the invention are also achieved.

[0288] Providing a rim with alternating protrusions and depressions (and / or ridges) along its length will increase the rim's grip on the user's hand by increasing the contact area between the rim and the hand, thereby preventing the sensor from shifting from its initial installation location. Experiments have shown that this, in turn, will reduce the time required to prepare and configure the sensor during multiple measurements throughout the day and improve the sensor's performance. In specific embodiments, the invention increases the contact area between the rim and the dry hand surface at the sensor location. Furthermore, the invention increases the contact area between the rim and the wet hand surface at the sensor location.

[0289] The method for taking measurements on a dry or wet hand depends on which hand was used for sensor testing. If the sensor was tested on a dry hand (using a wiped surface), then subsequent measurements, until the next sensor test, are taken on a dry hand.

[0290] If the sensor was tested on a wet hand (on a moistened surface of the hand), then subsequent measurements, until the next sensor test, are also carried out on a wet hand.

[0291] 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.

[0292] Furthermore, the invention increases heat transfer from the sensor through the ridge to the user's hand by increasing the contact surface area between the rim and the hand. This will improve the reliability of the sensor.

[0293] Table 1

[0294] Geometric characteristics of the sensors and flanges on the sensor housings submitted for testing. The sensor housing and flange material is plastic.

[0295] Table 2

[0296] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 1

[0297] Table 3

[0298] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 2

[0299] Table 4

[0300] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 3 Table 5

[0301] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 4

[0302] Table 6

[0303] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 5

[0304] Table 7

[0305] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 6

[0306] Table 8

[0307] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 7

[0308] Table 9

[0309] Characteristics of the protrusions and recesses on the side of the experimental version of sensor No. 8

[0310] Literature.

[0311] 1. Tikhonenko D.O., Tikhonenko O.O., Lobko V.P. NEW DEVELOPMENTS IN THE FIELD OF WRIST DEVICES FOR NON-INVASIVE MONITORING OF GLUCOSE CONTENT IN HUMAN BLOOD, AS WELL AS FOR MONITORING OTHER HUMAN HEALTH PARAMETERS. 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-

[0312] 7, DOI 10.34660 / INF.2023.68.11.381 https: / / studylib.net / doc / 27163933 / kongress- 13-oktyabrya-2023-tom- 1

[0313] 2. Russian Federation Patent 2295915, published 2005.

[0314] 3. Russian Federation Patent 2342071, published 2007.

[0315] 4. Russian Federation Patent 2368303, published 2007.

[0316] 5. Patent of the Russian Federation 2506893, published 2014.

[0317] 6. Tikhonenko D.O., Tikhonenko O.O., Lobko V.P. New developments in the field of non-invasive monitoring of glucose content in human blood, as well as monitoring of other parameters of human health. Control devices in the form of a key fob. Terms and definitions. Higher school: scientific research. Proceedings of the Interuniversity International Congress (Moscow, March 21, 2024). - Moscow: Infinity Publishing House, 2024, 77-126 pp., BBK 65, B42, ISBN 978-5-905695-53-7, DOI 10.34660 / INF.2024.46.11.006 htt s: / / studylib.net / d / JW3R2

[0318] 7. GLE-04 (2024) watch with ECG, blood pressure, pulse, temperature, oxygen, and blood sugar measurement. (https: / / gelikonline.ru / fitnes brasleti s izmereniem dayleniya i pulsa / umnie-chasy-s-izmereniem-sahara-v-krovi / ?yclid=5227952676836737023)

Claims

Invention formula 1. A sensor for a device for non-invasively monitoring the glucose content in human blood, comprising a housing, a light emitter, and a light receiver, wherein the light emitter and the light receiver are located on the inside of the sensor housing; both during preparation for operation and during operation, the sensor is configured to be pressed against the place where the pulse is palpated on the radial artery of the arm, wherein the light emitter is configured to emit light into the arm onto the radial artery, and the light receiver is configured to receive reflected light from the radial artery of the human arm; and on the inside 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 projections and depressions alternating along its length, or that grooves are made on the ridge of the rim.

2. The sensor according to claim 1, characterized in that while 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 paragraph 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 paragraph 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.

5. The sensor according to claim 1, characterized in that the emitter is designed in such a way that when emitting light, the longitudinal axis of the light beam is inclined towards the light receiver.

6. The sensor according to paragraph 5, characterized in that the longitudinal axis of the beam is inclined towards the light receiver at an angle of 45 - 85 degrees to the inner side of the sensor housing.

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