Pen-based 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 devices for this purpose, as well as in the creation of socially-oriented systems for the early diagnosis of diabetes and associated diseases, in the form of a pen. The aim of the invention is to improve the operational efficiency 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 a device for non-invasively checking a person's blood glucose concentration is based on a pen and has a sensor disposed on one end of a housing, opposite an end containing a device for applying ink to a surface. The technical results of the invention include: obviating the need for the device to be worn on an arm; simplifying the device by the absence of a strap and by incorporation of the device into a pen; and making it possible to visually check the correct positioning of the sensor of the device on a pulse point.

Description

[0001] A pen-based device for non-invasive monitoring of glucose levels 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 devices for this purpose, as well as in the creation of socially oriented systems for the early diagnosis of diabetes and related diseases in the form of a pen.

[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. Such devices are described in references / 2-5 / .

[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 / 7 / .

[0008] The best modern non-invasive glucometer is a wristwatch-style device—a "smartwatch"—that measures glucose, heart rate, blood pressure, and other parameters. / 1 / 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 targeting. Changes in pulse wave parameters are used to determine changes in a person's blood sugar and other parameters. This device comprises a housing, a control and display module located within the housing, a sensor, a radiation emitter, and a receiver of radiation reflected from human tissue, all located within the sensor.

[0009] The control and display module contains a power source, a control and data processing unit, and a data display panel designed as a screen.

[0010] The case with the control and display module resembles a wristwatch in appearance.

[0011] For simplicity, the control and display module may be referred to as the control module.

[0012] 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.

[0013] An analog of the invention is a wrist-worn device for non-invasive monitoring of human blood glucose levels using infrared light with a teletransmission function for determining blood glucose levels. (CN 110236487 A, published 2019.09.17).

[0014] The publication reveals the device's design. The sensor included in the device includes an emitter and a receiver for radiation reflected from human tissue.

[0015] The features of the analogue that coincide with the features of the invention: a housing, a control and display module located in the housing, a sensor, a radiation emitter and a receiver of radiation reflected from human tissue, located in the sensor.

[0016] The control and display module contains a power source, a control and data processing unit, and a data display panel.

[0017] A disadvantage of the analog is the need to wear the device constantly, which many people find uncomfortable. Furthermore, there's no visual verification of proper placement of the sensor at the pulse measurement site. The sensor is located at the end of one of the strap sections. When placing the sensor at the pulse measurement site, the wearer can't see the sensor or the area on the arm where it needs to be pressed. The watch case and the wearer's arm obscure the sensor, resulting in poor accuracy in applying the sensor to the pulse measurement site.

[0018] The prototype of the invention is a device for non-invasive monitoring of glucose content in human blood, comprising a housing, a control and display module located in the housing, a sensor, a radiation emitter and a receiver of radiation reflected from human tissues, located in the sensor, and light is used as radiation, and on the working surface of the sensor there is a rim surrounding the light receiver and separating it from the light emitter, and the control and display module contains a power source, a control and data processing unit, a data display panel made in the form of a screen, and the screen is made with the possibility of displaying information on it, in addition, the control and display module contains a control button for controlling the operation of the device, wherein the radiation emitter and the receiver of radiation reflected from human tissues are connected to the control and display module located in the housing via a wired communication line.

[0019] These features of the prototype coincide with the features of the invention.

[0020] In addition, the prototype side is made in a rectangular longitudinal section.

[0021] The prototype design is described in the article: New Developments in the Field of Wrist Devices for Non-Invasive Monitoring of Human Blood Glucose Content, as well as for Monitoring Other Human Health Parameters. Terms and Definitions. Tikhonenko D. O., Tikhonenko O. O., Lobko V. P., published in the collection: Higher School: Scientific Research. Proceedings of the Interuniversity International Congress (Moscow, October 13, 2023). Volume 1. - Moscow: Infinity Publishing House, 2023. - 170 p. / 1 / .

[0022] Also information about the prototype is posted in the source / 9 / .

[0023] The prototype works in conjunction with a smartphone. It contains a device for wireless data transmission. It connects to the smartphone via WiFi or Bluetooth when taking measurements. All data collected during measurements is transmitted to the smartphone. A drawback of the prototype is its low operational efficiency for non-invasive blood glucose monitoring due to the long setup and configuration time.

[0024] Another drawback of the prototype is the need to constantly wear the device on the wrist (it is secured with a strap), which many people find uncomfortable. Furthermore, there is no visual verification of the sensor's correct placement at the pulse measurement site. The sensor is located at the end of one of the strap sections on the inner side. When placing the sensor at the pulse measurement site, the user cannot see the sensor or the area on the wrist where it is placed. The sensor is obscured by the device body and the user's arm. This results in low accuracy of sensor placement at the pulse measurement site, as well as high power consumption for noninvasive blood glucose monitoring due to the prototype's long preparation time.

[0025] The essence of the invention.

[0026] The purpose of the invention is to increase the efficiency of operation of a device for non-invasive monitoring of glucose levels in human blood by reducing the time required for preparation for operation and for setup.

[0027] Efficiency is understood as speed of operation, the ability to quickly bring a device into working order, in particular, without frequent preliminary configuration.

[0028] The objective is achieved in that a device for non-invasively monitoring the glucose content in human blood comprises a housing, a control and display module located in the housing, a sensor, a radiation emitter and a receiver of radiation reflected from human tissues, located in the sensor, and light is used as radiation, and on the working surface of the sensor there is a rim surrounding the light receiver and separating it from the light emitter, and the control and display module contains a power source, a control and data processing unit, a data display panel made in the form of a screen, and the screen is made with the possibility of displaying information on it, in addition, the control and display module contains a control button for controlling the operation of the device, wherein the radiation emitter and the receiver of radiation reflected from human tissues are connected to the control and display module located in the housing via a wired communication line, and from the prototype, characterized in that,that the device for non-invasive monitoring of glucose content in human blood is based on a pen, and the sensor is located on the end side of the housing, - the opposite side containing the device for applying ink to the surface, wherein the light emitter and the light receiver are located on the working side of the sensor and are directed outward in the direction of the longitudinal axis of the device; and when preparing for operation and during operation, the device is configured to press the sensor with the emitter and receiver to the place of palpation of the pulse on the radial artery of the hand; and, in addition, while the sensor is in the working position, - pressed to the hand, - the device is configured to visually observe the sensor pressed to the place of palpation of the pulse; wherein the light emitter and the light receiver are made in such a way that when the sensor is pressed to the hand in the working position, 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, in addition, the device for non-invasive monitoring of glucose levels in human blood is configured to be held in working condition by one hand of the person and to be able to input and output information by pressing the control button with a finger of the same hand.

[0029] In a particular embodiment of the invention, the device can be made in such a way that when the sensor is in the working position, pressed to 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.

[0030] In a particular embodiment of the invention, the device can be designed in such a way that the ridge of the side is made with projections and depressions alternating along its length, or riffles are made on the ridge of the side.

[0031] In a particular embodiment of the invention, the device can be designed in such a way that the ridge of the side is made with projections and depressions alternating along its length and grooves are made on the ridge of the side.

[0032] Furthermore, in a particular embodiment of the invention, the device can be designed so that, when preparing it for use, the pulse palpation site on the radial artery of the hand is moistened with water. This is accomplished by moistening the pulse palpation site on the radial artery of the hand during testing.

[0033] Also, in a specific embodiment of the invention, the device can be designed so that when preparing it for use, the pulse palpation site on the radial artery of the hand is wiped dry. This is done when testing the device, the pulse palpation site on the radial artery of the hand is wiped dry.

[0034] In a particular embodiment of the invention, the device can be designed in such a way that a touch screen is used as a screen.

[0035] In a particular embodiment of the invention, the device can be designed in such a way that a button on the touch screen is used as a control button.

[0036] In a particular embodiment of the invention, the device can be designed in such a way that a button under the surface of the screen is used as a control button.

[0037] In a specific embodiment of the invention, the device may be designed such that a button located on the housing serves as the control button. In a specific embodiment, the device may be designed such that a ballpoint pen or tip, in particular a pen, is used to apply ink to the surface.

[0038] When developing the invention, the authors established the preferred dimensions for a pen-based device. The device's body is longitudinally elongated, ranging in length from 40 mm to 200 mm, with a maximum diameter of 7 mm to 45 mm. Additionally, the screen length ranges from 20 mm to 150 mm, the screen width ranges from 7 mm to 45 mm, and the sensor diameter ranges from 7 mm to 20 mm.

[0039] For simplicity of presentation, we will call the device for non-invasive monitoring of glucose levels in human blood based on a pen the device.

[0040] For simplicity of presentation, we will simply refer to the sensor of the device for non-invasive monitoring of glucose levels in human blood based on a pen as a sensor.

[0041] For simplicity of presentation of the material, we will call the emitter of radiation and the receiver of radiation reflected from human tissue the emitter and receiver.

[0042] The device is used with the function of manually determining the location of the radial artery based on the pulse palpation site and aiming the emitter and receiver at it.

[0043] Technical results of the invention:

[0044] 1. There's no need to wear a noninvasive blood glucose monitoring device on your arm. For many people, wearing a device on your arm is inconvenient. This drawback is eliminated in the proposed device. The device can be carried, for example, in a pocket or briefcase.

[0045] 2. Compared to the prototype, the design of the device has been simplified by reducing the weight of the device due to the absence of a strap and its implementation as part of a pen.

[0046] 3. Visual verification of the correct placement of the noninvasive blood glucose monitoring device sensor at the pulse site is provided. When placing the sensor at the pulse site, the user can see the sensor and the location on the arm where it should be pressed. This improves the accuracy of sensor placement at the pulse site, minimizing the risk of misplacing the sensor.

[0047] 4. It is possible to hold the device for non-invasive monitoring of human blood glucose levels in a working state when preparing it for operation and during operation using one hand and to simultaneously operate the control button using a finger of the same hand.

[0048] 5. Reduction of energy consumption for non-invasive monitoring of human blood glucose levels due to precise orientation of the emitter and receiver to the artery and reduction of the preparation time of the device for non-invasive monitoring of human blood glucose levels for operation.

[0049] A particular technical result of making the ridge of the edge with alternating protrusions and depressions or with ribs is an increase in the contact area of ​​the edge surface with the surface of the hand (for example, with a dry or wet one) at the location of the sensor.

[0050] This increases the device's grip on the hand surface and helps to hold the device for non-invasive monitoring of human blood glucose levels with the sensor at the pulse measurement site.

[0051] Let us explain the achievement of technical results.

[0052] To simplify the presentation of the material, we will describe the operation of a device containing a touch screen.

[0053] The configuration of the declared device is similar to the configuration of the prototype.

[0054] To perform noninvasive blood glucose monitoring, a person sits still for 3 minutes. The hand is relaxed and placed, for example, on a table in front of the person. The pulse point on the hand should be level with the heart.

[0055] After which, the person determines the place on the arm where the pulse is felt above the radial artery.

[0056] After this, the device is pressed firmly against the pulse site, for example, on the left wrist, using the sensor of the right hand, so that the sensor is aligned with the radial artery at that location. Alternatively, the device can be pressed firmly against the pulse site, such as the right wrist, using the sensor of the left hand, so that the sensor is aligned with the radial artery at that location.

[0057] Next, we will describe the operation of the device when a person holds it with the fingers of the right hand.

[0058] In this case, the emitter and receiver of reflected radiation, located in the sensor, are directed towards the radial artery.

[0059] The accuracy of the sensor's placement on the pulse site is visually verified. Both the sensor and the pulse site can be visually inspected.

[0060] The device's design allows for easy visual observation of the process of applying the sensor to the pulse site. The user can see both the sensor and the pulse site.

[0061] After this, the person sits still for 3 minutes, pressing the device's sensor against their hand. Then, they turn on the device. To do this, they turn on the power and control and data processing unit by pressing the "On" button on the device's body. (It's convenient if the power button is located on the side of the device.) The screen lights up.

[0062] The control unit checks the correct position of the sensor relative to the radial artery (see Fig. 5). The check takes up to 3 minutes.

[0063] When the sensor is correctly located, a person scrolls through the “pages” with their finger on the screen until they reach the page that says: “Take a measurement.”

[0064] After this, the person presses the "Take Measurement" button with their finger. The "Start" button lights up.

[0065] After which, the person presses the “Start” button with his finger.

[0066] The measurement has begun. The measurement lasts from 0.5 to 1.5 minutes.

[0067] The measurement results are then displayed on the screen: sugar content and other parameters, such as blood pressure, depending on the device settings.

[0068] If the sensor's placement is incorrect (i.e., its location on the arm does not match the location on the arm during the sensor testing), a message appears on the touchscreen prompting the sensor to be repositioned. The device is turned off.

[0069] After this, the sensor is repositioned over the radial artery (the site where the pulse is felt). The patient sits still for 3 minutes, then turns on the device. The sensor placement continues until a message appears on the touchscreen indicating the device is ready for use. The user can now scroll through the pages on the screen.

[0070] Testing of the prototype device revealed that initial setup requires at least three to four attempts. Each attempt takes six minutes. Afterward, the device is ready to measure blood sugar levels. Therefore, the prototype takes 18 minutes or more to perform its first measurement.

[0071] The prototype's shortcomings stem from the following. During the day, as a person walks and uses their hands, the sensor (also called the mobile unit in the prototype) shifts from its initial position. In this case, to perform a measurement, the mobile unit (sensor) must be reset to its original position. Typically, a person uses their hands intensively throughout the day, causing the device to shift from its original position. A diabetic must measure their blood sugar levels multiple times a day—up to 10 times 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 requires 3 hours or more of daily measurement time, with 10 measurements taken. This is due to the rotation of the device and strap relative to the arm and radial artery.

[0072] Importantly, using the prototype, a user cannot visually see the sensor or the pulse location. They are hidden from view by a strap.

[0073] The invention eliminates the need to wear the device on the wrist, which many people find inconvenient. Furthermore, statistics show that 3 out of 10 people dislike wearing a watch. Compared to the prototype, the invention simplifies the device by reducing its weight by eliminating the strap and making it pen-like. The device can be carried in a pocket, purse, or briefcase.

[0074] The device provides visual verification of the correct placement of the sensor at the pulse measurement site during setup and operation. When placing the sensor at the pulse measurement site, the user observes the sensor and the location on the arm where it should be pressed. This improves the accuracy of sensor placement. Errors in placing the sensor incorrectly are minimized and virtually eliminated.

[0075] During the development of the invention, a prototype device was manufactured with a clearly visible sensor on the end surface. The prototype allowed for interchangeable sensors and the attachment of sensors of various designs.

[0076] The experiments conducted suggest that the proposed pen-based device design virtually eliminates the need for repeated adjustments to the device and sensor throughout the day. This reduces the time it takes to set up and implement noninvasive blood glucose monitoring by preventing erroneous readings.

[0077] Experiments demonstrated a 2.4-2.7-fold reduction in blood glucose measurement time (with ten measurements) compared to the prototype. Using a sensor with a rim containing protrusions and grooves or ridges on the ridge, the blood glucose measurement time was reduced by a factor of three (with ten measurements) compared to the prototype.

[0078] According to the invention, and this has been confirmed experimentally, it is possible to keep the device in working condition when preparing it for work and during work using one hand and simultaneously work with the touch screen using a finger of the same hand.

[0079] Furthermore, energy consumption for non-invasive blood glucose monitoring is reduced by precisely targeting the emitter and receiver to the artery and reducing the device's preparation time. The pen and device's compact size ensures comfortable holding and operation with the fingers of one hand, for both adults and children capable of using a pen.

[0080] The invention allows the device to be held in place during setup and operation using the fingers of one hand, while simultaneously operating the touchscreen using a finger of the same hand. There is no possibility of the sensor and device slipping from the location where the pulse wave data is collected on the wrist artery.

[0081] In addition, a reduction in energy consumption for non-invasive monitoring of human blood glucose levels is ensured by precise orientation of the emitter and receiver to the artery and a reduction in the time it takes to prepare the device for operation.

[0082] The overall dimensions of the device proposed in the invention ensure ease of holding it and operating it with the fingers of one hand.

[0083] Another important feature is that the wired connection from the sensor to the control and display module is shorter than in the prototype. In the prototype, the connection line runs through the strap and is kinked, reducing its reliability. In the proposed device, the connection line from the sensor to the control and display module runs solely within the pen body.

[0084] List of figures.

[0085] Fig. 1 shows a pen-based device for noninvasively monitoring human blood glucose levels. The device's sensor contains one emitter and one receiver.

[0086] Fig. 2 shows a device for noninvasive monitoring of glucose levels in human blood. The device's sensor contains two emitters and one radiation receiver.

[0087] Fig. 3 shows a general view of a pen-shaped device for noninvasively monitoring human blood glucose levels. The sensor is located on the end face of the housing, opposite the surface containing the ink application device. Fig. 4 shows a schematic cross-section of a human hand, indicating the radial artery, and also shows a portion of the device for noninvasively monitoring human blood glucose levels and a sensor with emitters and a receiver of radiation reflected from human tissue, located above the radial artery at the pulse location.

[0088] Fig. 5 shows a schematic cross-section of a human arm, indicating the radial artery. It also shows a portion of a device for noninvasively monitoring human blood glucose levels, as well as a sensor with emitters and a receiver for reflecting radiation from human tissue, positioned above the radial artery at the site of pulse measurement. The beams emanating from the emitters into the arm, specifically the radial artery, are schematically shown, as are the reflected beams from the arm and the radial artery, toward the receiver.

[0089] Fig. 6 shows the dimensions of the pen-based device for noninvasive blood glucose monitoring and its components. The device is viewed from the screen. The sensor is located on the end face of the housing, opposite the side containing the ink application device.

[0090] Fig. 7 shows the dimensions of the device for noninvasive monitoring of human blood glucose levels and its components. The device is viewed from the side of the screen.

[0091] Fig. 8 shows a diagram of the application of a sensor of a device for non-invasive monitoring of glucose content in human blood to the site of pulse palpation.

[0092] Fig. 9 shows a diagram of holding the sensor of the device for non-invasive monitoring of glucose content in human blood at the site of palpation of the pulse on the left hand using the fingers of the right hand and operating the touch screen with the finger of the right hand.

[0093] Fig. 10 shows the side and part of the sensor with a receiver of the prototype device for non-invasive monitoring of glucose levels in human blood.

[0094] Fig. 11 shows the rim and a portion of the sensor with a receiver of a specific embodiment of the claimed device for noninvasively monitoring glucose levels in human blood. The rim's ridge is formed with alternating projections and depressions along its length.

[0095] Fig. 12 shows a development of the ridge of the rim. The rim is made with projections and depressions alternating along its length.

[0096] Fig. 13 shows a development of the ridge of the side. The projection shows the extension element "A". The projection of the ridge is ribbed.

[0097] Fig. 14 shows the extension element “A” from Fig. 13. The projection of the side is ribbed.

[0098] Fig. 15 shows a scan of the sensor flange with the geometric dimensions of the protrusions and recesses on the ridge (on the edge) of the flange.

[0099] Fig. 16 shows a schematic representation of the sensor with dimensions.

[0100] Disclosure of invention.

[0101] The definition of terms is given in article / 8 / .

[0102] In terms of the sensor and its characteristics, the terms are given in article / 1 / .

[0103] The length of a pen-based noninvasive blood glucose monitoring device is the linear dimension of the device in the longitudinal direction—the direction of its longest axis (the direction of its greatest dimension). In this particular case, it is the distance between its two most distant points.

[0104] To measure the length of a pen-based noninvasive blood glucose monitoring device, place it on a horizontal surface, such as a table. Then, measure the distance between the two outermost points of the device.

[0105] To measure the length of a pen-based noninvasive blood glucose monitoring device, place it on a horizontal surface, such as a table. Then, measure the distance between the two outermost points of the device along its longitudinal axis.

[0106] The longitudinal axis of the device for non-invasive monitoring of glucose content in human blood passes as shown in Fig. 6 (position 68). In a particular case, the longitudinal axis may pass through the center of mass of the device 69 (see Fig. 6), through the sensor, parallel to the plane of the screen. The transverse axis of the device for non-invasive monitoring of glucose content in human blood passes as shown in Fig. 6 (position 70). The transverse axis is perpendicular to the longitudinal axis and parallel to the surface of the screen (or parallel to the tangent plane to the surface of the screen). In a particular case, the transverse axis may pass through the center of mass of the device, perpendicular to the longitudinal axis, parallel to the surface of the screen.

[0107] The longitudinal direction of the device as a whole and the housing in particular is the direction along the longitudinal axis of the device, along the longitudinal axis of the pen. The transverse direction of the device as a whole and the housing in particular is the direction along the transverse axis of the device, along the transverse axis of the pen. The housing width of the device for noninvasive blood glucose monitoring is the maximum dimension (i.e., the distance between the two most distant points), measured across the housing (at a right angle to the longitudinal axis).

[0108] To measure the width of a noninvasive blood glucose monitoring device, place it on a horizontal surface, such as a table. Then, measure the maximum transverse dimension between the two outermost points of the device, along the device's transverse axis.

[0109] The thickness of the housing of a device for non-invasive monitoring of glucose levels in human blood is the distance between the upper and lower horizontal tangent planes to the device, measured when the device is placed on a horizontal surface, such as a table.

[0110] The screen length is the linear dimension of the screen along the longitudinal axis of the device, that is, the distance between its two farthest points along the longitudinal axis of the device. Typically, the longitudinal axis of the screen coincides with the longitudinal axis of the device. In particular cases, it is the direction of the largest screen dimension along the longitudinal axis of the device.

[0111] The screen width is the linear dimension of the screen in the direction perpendicular to the longitudinal axis of the device, that is, the distance between its two most distant points on the transverse axis of the device. The sensor diameter is the maximum distance between two points from a set of points on the outer boundary of the sensor's cross-section.

[0112] The working surface of the sensor is the surface of the sensor where the emitter and receiver are located, as well as the flange separating the emitter from the receiver. The working surface is also called the inner surface of the sensor.

[0113] The inner surface of the sensor or the inner surface of the sensor housing is the surface that faces the human arm during non-invasive blood glucose monitoring.

[0114] The light emitter and light receiver are located on the working surface of the sensor and are directed outward in the direction of the longitudinal axis of the device.

[0115] The lower end of the device for noninvasive blood glucose monitoring is the side that faces the user's hand when the longitudinal axis of the device is vertical. The sensor is located on the lower end of the device.

[0116] The bottom end of the body is the side opposite the side with the ink-dispensing device. The bottom end of the body is the side opposite the side with the ballpoint pen or the nib.

[0117] The top end of the noninvasive blood glucose monitoring device is the side opposite the bottom end of the device. The top end of the noninvasive blood glucose monitoring device is the side with the ink application device, such as a ballpoint pen or stylus.

[0118] A border is a boundary around something, specifically the boundary around the surface of a sensor housing containing a light receiver. In other words, it's the boundary around the light receiver on the sensor's working surface.

[0119] The ridge of the edge is the upper part of the edge, when the sensor is oriented in such a way that its emitter or emitters are directed away from the center of the earth - upwards (see article / 1 / ).

[0120] The front surface 83 of the pen-based noninvasive blood glucose monitoring device housing is the surface of the housing on which the display is located. The front surface may be referred to as the face, front side, or front surface.

[0121] The back surface 84 of the housing of the device for non-invasive monitoring of glucose content in human blood based on a pen is the surface opposite to the front surface.

[0122] The side surface of the body of a device for non-invasive monitoring of glucose content in human blood based on a pen is the surface located between the front and back surfaces.

[0123] A device for non-invasive monitoring of glucose content in human blood based on a pen comprises a housing 1 (see Fig. 1), a control and display module located in the housing 1, a sensor 3, a radiation emitter 4 and a receiver 5 of radiation reflected from human tissues, located in the sensor 3, and on the working surface 6 of the sensor 3 there is a rim 7 surrounding the light receiver 5 and separating it from the light emitter 4, and the control and display module comprises a power source 8, a control and data processing unit 2, a data display panel 9 made in the form of a screen, for example, in the form of a touch screen, made with the possibility of inputting and outputting information by touching it with a human finger. The button on the touch screen is a control button and is intended for controlling the operation of the device.

[0124] If a simple screen rather than a touchscreen is used, a control button is located on the device body to control its operation. In other words, the control and display module contains a control button for controlling the device's operation.

[0125] In this case, the radiation emitter and the receiver of radiation reflected from human tissue are connected to the control and display module located in the housing via a wired communication line 10.

[0126] The control and data processing unit may be referred to as the control unit. Sensor 3 comprises housing 11. When storing the device, the sensor is covered with cover 12.

[0127] A sensor may contain two or more emitters. Fig. 2 shows a sensor with two emitters, 13 and 14, and one receiver, 15.

[0128] Fig. 3 shows a device for non-invasive monitoring of human blood glucose levels based on a pen (in the shape of a pen). The device comprises a housing 17, a screen 16, and a sensor 18. The sensor 18 is located in the lower end portion of the housing (as shown in Fig. 3).

[0129] 88 - the upper end face of the device housing for noninvasively monitoring human blood glucose levels. The upper end face of the device contains a device for applying ink to a surface, such as paper. The device housing is longitudinally elongated, with a length of 40 mm to 200 mm, a maximum diameter of 7 mm to 45 mm, and a screen length of 20 mm to 150 mm, a screen width of 7 mm to 45 mm, and a sensor diameter of 7 mm to 20 mm.

[0130] In Fig. 6 and 7 the following are indicated:

[0131] 19 - the length of a device for non-invasive monitoring of glucose levels in human blood based on a pen;

[0132] 20 - device width;

[0133] 21 - thickness of the device.

[0134] If the device body is made in the shape of a cylinder, then it is characterized by a diameter;

[0135] 22 - screen length 24;

[0136] 23 - screen width 24;

[0137] 24 - screen, such as a touch screen;

[0138] 25 - sensor diameter 26;

[0139] 27 - body;

[0140] 68 - longitudinal axis of a device for non-invasive monitoring of glucose content in human blood based on a pen;

[0141] 69 - center of mass of a device for non-invasive monitoring of glucose levels in human blood based on a pen;

[0142] 70 - transverse axis of the device for non-invasive monitoring of glucose content in human blood based on a pen; 83 - front side of the housing of the device for non-invasive monitoring of glucose content in human blood, - the side on which the screen is located. The front side of the housing is the front side of the device for non-invasive monitoring of glucose content in human blood. The front side may be called the front surface, the front side;

[0143] 84 - the back surface of the housing of the device for non-invasive monitoring of glucose levels in human blood, - the opposite side of the front surface or front side. The back surface of the housing is the back side of the device for non-invasive monitoring of glucose levels in human blood. The back surface may be called the back side of the housing of the device, the back side, or the back surface of the device);

[0144] 85 - an axis perpendicular to the longitudinal axis of the device for noninvasive monitoring of human blood glucose levels and the transverse axis of the device for noninvasive monitoring of human blood glucose levels. This axis is simply referred to as the axis perpendicular to the longitudinal and transverse axes of the device. Or the axis perpendicular to the longitudinal and transverse axes of the pen-based device for noninvasive monitoring of human blood glucose levels. Or the axis perpendicular to the longitudinal axis of the device and perpendicular to the transverse axis of the device.

[0145] 86 - the lower end side of the housing of the device for non-invasive monitoring of glucose levels in human blood.

[0146] 87 - the upper end side of the housing of the device for non-invasive monitoring of glucose levels in human blood.

[0147] The upper end of the device contains a device for applying ink to a surface, such as paper.

[0148] Fig. 4 shows a schematic cross-section of a human arm with the radial artery indicated, and also shows part of a device for non-invasive monitoring of glucose levels in human blood based on a pen and a sensor with emitters and a receiver.

[0149] Sensor 28 is located on the lower end of the housing. It contains emitters 32 and 33, as well as a radiation receiver 34. The lower end of the housing is the side that, in the operating position, faces the person's hand 29. The sensor is positioned on the surface of the hand 30 above the artery 31.

[0150] In this case, the light emitter 32 and the light emitter 33, as well as the light receiver 34 are located on the working side of the sensor 35 and are directed outward in the direction of the longitudinal axis 36 of the device.

[0151] The light emitter 32, as well as 33 and the light receiver 34 are designed in such a way that when the sensor 28 is pressed against the hand 29 in the working position, the light emitter 32 is designed with the ability to emit light into the hand 29 onto the radial artery 31. The emitter 33 is also designed with the ability to emit light into the hand 29 onto the radial artery 31. And the light receiver 34 is designed with the ability to receive reflected light from the radial artery 31 of the human hand.

[0152] Fig. 5 schematically shows rays 37, 38 emanating from emitters 32 and 33 into the hand of a person 29, in particular, onto the radial artery 31, and shows reflected rays 39 from the hand of a person 29 and from the radial artery 31 towards the radiation receiver 34.

[0153] The device for non-invasive monitoring of glucose content in human blood 40 is designed with the possibility of being held in working condition by one hand of a person, in particular by the hand of an adult, and with the possibility of inputting and outputting information by touching the touch screen with a finger or fingers of the same hand (see Figs. 8 and 9).

[0154] In Fig. 8 and 9, a person presses device 40 with sensor 41 to the pulse palpation site 42 of the left hand 43 (on the left hand). The sensor is held with the right hand. The user presses buttons 46 of the touch screen 45 with the thumb of the right hand 44.

[0155] When preparing for work and during work, the device is designed with the possibility of pressing the sensor 41 with the emitter and receiver to the pulse palpation site 42 on the radial artery of the hand.

[0156] In a particular embodiment of the invention, the device can be designed in such a way that while the sensor is in the working state 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.

[0157] In a particular embodiment of the invention, the device 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.

[0158] Fig. 10 shows a portion of the sensor 47 of the prototype device. The radiation receiver 49 surrounds the edge 48. The emitter is not shown in the figure.

[0159] In a particular embodiment of the claimed invention, a device for non-invasive monitoring of glucose levels in human blood can be made in such a way that the ridge of the edge 51 (see Fig. 11) is made with projections 53, 54 and recesses 55, 56 alternating along its length.

[0160] In Fig. 11 the following are indicated:

[0161] 50 - sensor;

[0162] 51 - side;

[0163] 52 - radiation receiver.

[0164] In addition, grooves 67 can be made on the ridge of the side (see Fig. 12). Fig. 12 shows a development 66 of the side, side view.

[0165] In a particular embodiment of the invention, a device for non-invasive monitoring of glucose levels in human blood can be made in such a way that the ridge of the edge 57 (see Fig. 13) is made with projections 58, 59, 60 and recesses 61, 62 alternating along its length. And grooves are made on the surface of the projections and recesses.

[0166] Fig. 14 shows the extension element "A". It is shown that grooves 63, 64, 65 are made on the surface of the projection 59.

[0167] Fig. 15 shows a scan of the sensor flange with the geometric dimensions of the protrusions and recesses on the flange edge.

[0168] In Fig. 15 the following are indicated:

[0169] 71 - width of the projection;

[0170] 72 - recess width; 73 - protrusion height;

[0171] 74 - the length of the edge development;

[0172] 75 - side height.

[0173] Fig. 16 shows a diagram of the sensor with dimensions.

[0174] In Fig. 16 the following are indicated:

[0175] 76 - sensor housing;

[0176] 77 - side;

[0177] 78 - sensor diameter;

[0178] 79 - outer diameter of the rim;

[0179] 80 - inner diameter of the rim;

[0180] 81 - side height;

[0181] 82 – thickness of the sensor body.

[0182] In a particular embodiment of the invention, the device can be designed in such a way that, when preparing for work and during work, the device is designed with the possibility of visually monitoring the pressing of the sensor with the emitter and receiver to the place of palpation of the pulse on the radial artery of the hand at the base of the thumb of the human hand, or on the radial artery of the wrist, or on the radial artery of the forearm.

[0183] For simplicity of presentation of the material, we will call the device for non-invasive monitoring of glucose levels in human blood the device.

[0184] For simplicity of presentation of the material, we will call the emitter of radiation and the receiver of radiation reflected from human tissue the emitter and receiver.

[0185] The device is used with the function of manually determining the location of the radial artery based on the pulse palpation site and aiming the emitter and receiver at it.

[0186] Light, a radiation visible to the human eye, is used as radiation. In addition, radiation invisible to the human eye can also be used.

[0187] The device works as follows.

[0188] Using the example of the operation of an experimental device prototype.

[0189] During the development of the invention, an experimental device with a touchscreen was produced. The experimental device resembled a flat prism in shape. The experimental device allowed for interchangeable sensors and allowed for the attachment of sensors of various designs.

[0190] First, the device is configured. The configuration of the proposed device is similar to that of the prototype. A user performs a series of invasive blood sugar measurements and simultaneously takes a series of non-invasive measurements using the device. The control and data processing unit then processes the received data and configures the device for a specific user.

[0191] The device is then ready to perform non-invasive blood glucose monitoring.

[0192] To perform noninvasive blood glucose monitoring, a person sits still for 3 minutes. The arm is relaxed and placed, for example, on a table in front of the person. The pulse is felt at heart level.

[0193] After which, the person determines the place on the arm where the pulse is felt above the radial artery.

[0194] After this, the device is pressed firmly against the place where the pulse is being felt, for example, on the wrist of the left hand, using, for example, the sensor of the right hand, so that the sensor is opposite the radial artery in this place of the hand (see Fig. 8).

[0195] In this case, the emitter and receiver of reflected radiation, located in the sensor, are directed towards the radial artery (see Fig. 4).

[0196] Accuracy of the sensor's placement on the pulse site is visually verified. Both the sensor and the pulse site can be visually inspected (see Figs. 8 and 9).

[0197] The device's design allows for easy visual observation of the process of applying the sensor to the pulse site. The user can see both the sensor and the pulse site.

[0198] After this, the person sits still for 3 minutes, pressing the device's sensor against their hand. Then, they turn on the device. To do this, they turn on the power and control and data processing unit by pressing the "On" button on the device's body (the button is conveniently located on the side of the device). The screen lights up.

[0199] The control unit checks the correct position of the sensor relative to the radial artery (see Fig. 5). The check takes up to 3 minutes.

[0200] When the sensor is correctly located, the person scrolls through the “pages” on the screen with their finger until they reach the page that says: “Take a measurement.”

[0201] After which, the person presses the “Take measurement” button with his finger.

[0202] The "Start" button lights up.

[0203] After which, the person presses the “Start” button with his finger.

[0204] The measurement has begun. The measurement lasts from 0.5 to 1.5 minutes.

[0205] The screen then displays the measurement results: sugar level and other parameters, such as blood pressure. Depending on the device settings, the screen may display: sugar level, blood pressure, pulse, temperature, hemoglobin, cholesterol, uric acid, heart / lung / liver / brain function, etc.

[0206] If the sensor's placement is incorrect (i.e., its location on the arm does not match the location on the arm during the sensor testing), a message appears on the touchscreen prompting the sensor to be repositioned. The device is turned off.

[0207] After this, the sensor is repositioned over the radial artery (the site where the pulse is felt). The patient sits still for 3 minutes, then turns on the device. The sensor placement continues until a message appears on the touchscreen indicating the device is ready for use. The user can now scroll through the pages on the screen.

[0208] Testing of the prototype device revealed that initial setup required at least three attempts. Each attempt took up to 6 minutes or more. Afterward, the device was ready to measure blood sugar levels. Therefore, the prototype's first measurement took 18 minutes or more.

[0209] The prototype's shortcomings stem from the following. During the day, as a person walks and uses their hands, the sensor moves from its initial position. In this case, to perform a measurement, it is necessary to reposition the mobile sensor unit back to its original position / 1 / . The prototype lacks the ability to visually observe the sensor's positioning accuracy at the pulse measurement site. Both the sensor and the pulse measurement site are hidden from the user's view by a strap.

[0210] Typically, people work intensively with their hands 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 for operation the same number of times. This can take up to three hours of measurement time per day, with 10 measurements. This is due to the rotation of the device and strap relative to the arm and radial artery.

[0211] The invention eliminates the need to wear the device on the wrist, which many people find inconvenient. Compared to the prototype, the device has been simplified by reducing weight by eliminating the strap and redesigning it in the shape of a pen. The device can be carried in a pocket or on a necklace.

[0212] The device provides visual verification of the correct placement of the sensor at the pulse measurement site during setup and operation. Experiments with a prototype device are described in source / 6 / . When placing the sensor at the pulse measurement site, the user observes the sensor and the location on the arm where it should be pressed. This improves the accuracy of sensor placement. Errors in placing the sensor incorrectly are minimized and virtually eliminated.

[0213] Experiments have shown that this inventive solution virtually eliminates the need for repeated device and sensor adjustments throughout the day / 6 / . This reduces the time it takes to prepare and implement noninvasive blood glucose monitoring by preventing erroneous readings.

[0214] Experiments demonstrated a 2.4-2.7-fold reduction in blood glucose measurement time (with ten measurements) compared to the prototype. Using a sensor with a rim containing protrusions and grooves or ridges on the ridge, the blood glucose measurement time was reduced by a factor of three (with ten measurements) compared to the prototype.

[0215] According to the invention, and this has been confirmed experimentally, it is possible to keep the device in working condition when preparing it for work and during work using one hand and simultaneously work with the touch screen using a finger of the same hand.

[0216] In addition, a reduction in energy consumption for non-invasive monitoring of human blood glucose levels is ensured by precise orientation of the emitter and receiver to the artery and a reduction in the time it takes to prepare the device for operation.

[0217] The overall dimensions of the device proposed in the invention ensure that it is easy to hold and operate with the fingers of one hand, both for an adult and for a child capable of operating the device.

[0218] Another important feature is that the wired connection from the sensor to the control and display module is shorter than in the prototype. In the prototype, the connection line runs through the strap and is kinked, reducing its reliability. In the proposed device, the connection line from the sensor to the control and display module runs exclusively within the housing.

[0219] The pen itself is also used to record the device's readings.

[0220] Description of experiments with a device for non-invasive monitoring of glucose levels in human blood.

[0221] The experiments involved 10 volunteer test subjects aged 16 to 65 years.

[0222] Before testing, each tester tested the sensor and the device as a whole, and configured it to work on their hand.

[0223] After testing the device, the tester measured his blood sugar levels 10 times a day for one month.

[0224] The experiments tested whether the device for non-invasive monitoring of human blood glucose levels could be held in working order during preparation for operation and during operation with one hand, and whether it could be operated simultaneously with the touch screen using a finger of the same hand.

[0225] The test results showed that holding the device and operating the touchscreen with the fingers of one hand is possible.

[0226] It was found that the average time for ten measurements over a single day was 65-75 minutes, which is 2.4-2.7 times shorter than that of the prototype. When using a sensor with a rim containing protrusions and indentations (or ridges) on the ridge, the average time for ten measurements over a single day was 60 minutes. This reduced the time required for blood glucose measurements by a factor of three compared to the prototype / 6 / .

[0227] The reduction in measurement time, compared to the prototype, results in reduced energy consumption for noninvasive blood glucose monitoring. This reduction is achieved through precise orientation of the emitter and receiver to the artery and reduced setup time for the noninvasive blood glucose monitoring device.

[0228] Experiments also tested knurling on the side of the device's body to improve grip. Testers noted that the knurling made it easier to hold the pen-based device with the fingers of one hand.

[0229] In a formalized form, the presence of grooves on the device's body can be described as follows: alternating protrusions and depressions or grooves (in particular, transverse grooves) are provided on the side or sides of the body and / or its back surface. This enhances the grip of the body on the hand and helps prevent the device's sensor from moving along the hand relative to the radial artery. This technical solution can be further used to enhance the technical result. Furthermore, this solution simultaneously promotes heat exchange between the body and the hand.

[0230] The experimental device has a longitudinally elongated body measuring 80 mm in length, 43 mm in width, and 12 mm in thickness. This gives the device a diameter of 44.46 mm. The touchscreen is 50 mm long, 43 mm wide, and the sensor has a diameter of 15 mm.

[0231] Figures 8 and 9 show glucose measurements taken using a pen-based noninvasive blood glucose monitoring device. The person performing the measurement can visually observe both the sensor and the previously determined pulse location on the arm.

[0232] The experimental device was designed with interchangeable sensors. The interchangeable sensors had different side designs.

[0233] The ridges of the replaceable sensors were made with projections and depressions alternating along their length, and grooves were also made on the ridges of the sides (see Figs. 11 - 14).

[0234] Table 2 presents the geometric characteristics of the sensors and flanges on the tested sensor housings. The sensor housing and flange material are plastic.

[0235] Table 3 presents the characteristics of the protrusions and recesses on the side of the experimental sensor variants.

[0236] Mock-ups were also made - see Table 1 - to test how comfortable they were to hold in the hand.

[0237] When testing the layouts, it was found that the above-mentioned range of sizes of the device and its elements are the most convenient for use by both adults and children.

[0238] In the invention, the sensor has a rim on its inner housing that surrounds the light receiver and separates it from the light emitter. In a particular embodiment, the rim's ridge is formed with alternating projections and depressions along its length, or the rim's ridge is ribbed.

[0239] 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.

[0240] In other words, along the edge, sections of higher height alternate with sections of lower height. This increases the grip of the edge on the user's hand and, thus, prevents the sensor from shifting from its original location.

[0241] When constructing a flange with a constant height along the flange length, as in the prototype, the term "flange height" is defined as follows. Flange height is the distance between the inner surface of the sensor and a plane constructed tangent to the flange edge / 1 / .

[0242] The height of the side may be variable along the length of the side, as in the claimed invention.

[0243] 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.

[0244] The term maximum side height can also be used.

[0245] 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.

[0246] 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.

[0247] The protrusions on the edge ridge can be of varying heights. In this case, the geometric characteristics of the protrusions and recesses can be characterized by an empirical (experimentally derived) coefficient "K."

[0248] K = H / h, where H is the maximum height of the protrusion on the ridge of the side; h is the minimum height of the protrusion on the ridge of the side.

[0249] Conducted studies have shown that the coefficient K can take values ​​from 1.000001 to 1.1.

[0250] In a particular variant, the coefficient K can take values ​​from 1.000001 to 1.0001, or in a particular variant, the coefficient K can take values ​​from 1.0001 to 1.001, or in a particular variant, the coefficient K can take values ​​from 1.001 to 1.01, or in another particular variant, the coefficient K can take values ​​from 1.01 to 1.1.

[0251] The average height of the side is the arithmetic mean between the smallest and largest heights in the longitudinal sections of the side along its length.

[0252] 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.

[0253] This ensures increased operational efficiency of the device's sensor.

[0254] When testing several sensor variants with different rim designs, it was shown that making the rim ridge with alternating projections and depressions along its length or making the rim ridge with ribs allows for a reduction in the time it takes to measure blood glucose levels, compared to the prototype.

[0255] 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.

[0256] It would seem that the problem could be solved by tightening the strap more tightly. But this causes extreme discomfort.

[0257] 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.

[0258] From the above, it follows that the invention achieves its objective. It improves the efficiency of a pen-based device for noninvasive blood glucose monitoring by reducing setup and configuration time.

[0259] The technical results of the invention are also achieved.

[0260] There is no need to wear a device for non-invasive monitoring of blood glucose levels on a person’s arm.

[0261] Compared to the prototype, the device has been simplified by reducing its weight due to the absence of a strap and making it in the form of a pen.

[0262] Visual verification of the correct placement of the noninvasive blood glucose monitoring device's sensor at the pulse site is provided. When placing the sensor at the pulse site, the user can see the sensor and the location on the arm where it should be pressed. This improves the accuracy of sensor placement at the pulse site, minimizing the risk of misplacing the sensor.

[0263] It is possible to hold the device for non-invasive monitoring of human blood glucose levels in a working state when preparing it for operation and during operation using one hand and simultaneously operate the touch screen using a finger of the same hand.

[0264] A reduction in energy consumption for non-invasive monitoring of human blood glucose levels is achieved by precisely orienting the emitter and receiver to the artery and reducing the time it takes to prepare the device for non-invasive monitoring of human blood glucose levels for operation.

[0265] A specific technical result of creating a ridge on the edge with alternating protrusions and depressions or with ribs is an increase in the contact area of ​​the edge surface with the dry or wet hand surface at the sensor location. This helps maintain the noninvasive blood glucose monitoring device with the sensor at the pulse location.

[0266] Table 1

[0267] Dimensions of the device layout for non-invasive monitoring of human blood glucose levels based on a pen and its components

[0268] Table 2

[0269] Geometric characteristics of the sensors and flanges on the sensor housings submitted for testing. The sensor housing and flange material is plastic.

[0270] Table 3

[0271] Characteristics of the protrusions and recesses on the side of the experimental sensor variants Literature.

[0272] 1. Tikhonenko D.O., Tikhonenko O.O., Lobko V.P. NEW DEVELOPMENTS IN THE FIELD OF WRIST-WEARING DEVICES FOR NON-INVASIVE MONITORING OF HUMAN BLOOD GLUCOSE CONTENT, 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 978-5-905695-53-7, DOI 10.34660 / INF.2023.68.11.381 https: / / studylib.net / doc / 27163933 / kongress-13-oktyabrya-2023-tom-1

[0273] 2. Russian Federation Patent 2295915, published 2005.

[0274] 3. Russian Federation Patent 2342071, published 2007.

[0275] 4. Russian Federation Patent 2368303, published 2007.

[0276] 5. Patent of the Russian Federation 2506893, published 2014.

[0277] 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

[0278] 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)

[0279] 8. Tikhonenko D.O., Tikhonenko O.U., Lobko V.P. NEW DEVELOPMENTS IN THE FIELD OF NON-INVASIVE MONITORING OF GLUCOSE CONTENT IN HUMAN BLOOD, AS WELL AS MONITORING OF OTHER HUMAN HEALTH PARAMETERS. A DEVICE FOR NON-INVASIVE MONITORING BASED ON A FOUNTAIN PEN. TERMS AND DEFINITIONS. Collection of scientific articles based on the results of the International Scientific Forum SCIENCE AND INNOVATIONS - MODERN CONCEPTS (Moscow, April 11, 2024). Volume 1. - Moscow: Infinity Publishing House, 2024, 89-116 pp., UDC 330, BBK 65, C56, ISBN 978-5-905695-78-0, DOI 10.34660 / INF.2024.14.29.226 https: / / study lib,net / d / gi9R2

[0280] 9. Accof isk Smartwatch. https: / / accofrisk.com / ru / non-invasive-smartwatch

Claims

Invention formula 1. A device for non-invasive monitoring of glucose levels in human blood, comprising a housing, a control and display module located in the housing, a sensor, a radiation emitter and a receiver of radiation reflected from human tissue, located in the sensor, and light is used as radiation, and on the working surface of the sensor there is a rim surrounding the light receiver and separating it from the light emitter, and the control and display module contains a power source, a control and data processing unit, a data display panel made in the form of a screen, and the screen is designed with the possibility of displaying information on it, in addition, the control and display module contains a control button for controlling the operation of the device, wherein the radiation emitter and the receiver of radiation reflected from human tissue are connected to the control and display module located in the housing by means of a wired communication line, characterized in that,that the device for non-invasive monitoring of glucose content in human blood is based on a pen, and the sensor is located on the end side of the housing, - the opposite side containing the device for applying ink to the surface, wherein the light emitter and the light receiver are located on the working side of the sensor and are directed outward in the direction of the longitudinal axis of the device; and when preparing for operation and during operation, the device is configured to press the sensor with the emitter and receiver to the place of palpation of the pulse on the radial artery of the hand; and, in addition, while the sensor is in the working position, - pressed to the hand, - the device is configured to visually observe the sensor pressed to the place of palpation of the pulse; wherein the light emitter and the light receiver are made in such a way that when the sensor is pressed to the hand in the working position, 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, in addition, the device for non-invasive monitoring of glucose content in human blood is designed with the ability to be held in working condition by one hand of a person and with the ability to input and output information by pressing a control button with a finger of the same hand.

2. The device according to claim 1, characterized in that while the sensor is in the working position, pressed to 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 device according to paragraph 1, characterized in that the ridge of the side is made with projections and depressions alternating along its length, or ribbing is made on the ridge of the side.

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

5. The device according to paragraph 1, characterized in that a touch screen is used as a screen.

6. The device according to paragraphs 1 and 5, characterized in that a button on a touch screen is used as a control button.

7. The device according to paragraph 1, characterized in that a button under the surface of the screen is used as a control button.

8. The device according to paragraph 1, characterized in that a button located on the housing is used as a control button.

9. The device according to paragraph 1, characterized in that a ball or tip, in particular a pen, is used to apply ink to the surface.

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