A diabetic foot protection device

Abstract

The present invention relates to a diabetic foot protection device. The device comprises: a computer unit; and a force sensor for monitoring the ground reaction force of the patient's foot and a temperature sensor for monitoring the temperature of the patient's foot connected to the computer unit; the computer unit judges the patient's behavior type based on the ground reaction force of the patient's foot monitored by the force sensor and controls the temperature sensor; the computer unit judges the patient's temperature change based on the patient's foot temperature monitored by the temperature sensor and controls the force sensor. The present invention sets the protective socks into two layers to form a sandwich space, which is used to store the knitting thread ends of the protective socks to prevent the feet of diabetic patients from being scratched by the thread ends, and is used to embed force sensors and temperature sensors to monitor the patient's vital signs in a way that best fits the patient's skin. The present invention continuously monitors the temperature and shear force of the patient's feet to detect abnormal conditions at an early stage, thereby preventing ulcers on the feet of diabetic patients.

Description

Technical Field

[0001] The present invention relates to the technical field of foot protection, and in particular to a diabetic foot protection device. Background Art

[0002] As modern society continues to develop, it has been recognized that the main causes of foot ulcers are diabetic neuropathy and vascular disease. Uncontrolled diabetes can lead to various complications that affect the diabetic foot, among other conditions. Foot complications are one of the most common conditions caused by diabetes and are an important cause of medical problems in most diabetic hospitalizations.

[0003] The two main causes of complications from diabetes are: (a) decreased blood supply and (b) loss of sensation in the diabetic foot (neuropathy). During active walking, the temperature of the foot increases due to the GRF (vertical, horizontal, and lateral forces) as well as the loss of sensation in the foot. This temperature change is not noticeable to the diabetic with neuropathy and therefore often leads to ulcers and even amputation of the affected foot. The change in foot temperature that leads to an ulcerative condition can occur rapidly over a period of time. Therefore, monitoring foot temperature with a thermometer is impractical and difficult to quantify. The difference between a healthy temperature and a temperature that causes an ulcer can be as little as 1 to 2 degrees Celsius, and when the foot temperature rises to 42 degrees Celsius (108 degrees Fahrenheit), skin cells die. Obviously, the range of foot temperature depends on the individual and the type of exercise being performed.

[0004] Regular monitoring of the foot temperature of diabetic patients can reduce the occurrence of disabling diseases such as foot ulcers and lower limb amputations, but only a few methods (such as simple observation or regular measurement of the patient's foot temperature) use thermometers or thermal imaging to scan the foot temperature. Although this method is inconvenient, it can also provide timely information. However, its multiple execution times are still inconvenient and require bulky and expensive scanners. In the prior art, there is an urgent need for a protective device for diabetic patients with neuropathy to monitor their foot temperature. One of the most advanced monitoring methods is to use thermal imaging. However, thermal imaging is usually embedded in an infrared scanner in a scale used to measure the patient's weight. Although this method provides a thermal map of the foot temperature, it is difficult for people without relevant medical knowledge to understand the meaning of the thermal map. In addition, even if this device generates data in the form of a chart for patients to watch, and even if the diabetic patient has this device, the frequency of measurement using the device does not meet the required standards, and is likely to be limited to once a day, and cannot effectively monitor changes in the patient's foot temperature.

[0005] Chinese patent CN106821332A discloses a multifunctional diabetic foot detector, including a multifunctional measuring plate, which is used as a sole, and is connected to a boot upper with an inflatable sleeve and a boot shaft with an inflatable sleeve to form a long boot structure. A central processor is provided on the lower surface of the multifunctional measuring plate; it also includes a large toe sleeve, a small toe sleeve, an inflatable brachial artery sleeve, and a transcutaneous oxygen partial pressure electrode. The peripheral circulation state of diabetic foot patients is evaluated by measuring the dorsalis pedis artery, ankle-brachial index, toe-brachial index, transcutaneous oxygen partial pressure, and foot temperature. The degree of peripheral neuropathy of patients is evaluated by analyzing touch (pain), perspiration function, and vibration sense. The basal metabolic rate and plantar pressure distribution of diabetic patients are output as an objective basis for the degree of lesions in diabetic foot patients. It can guide the precise treatment of diabetic foot patients, and can also play a huge role in the formulation of diabetic foot treatment plans through cloud-based data analysis. However, the defect of this patent is that although the device can monitor multiple vital signs of the patient, the monitoring frequency is too low and cannot be carried out in real time. The temperature of the patient's feet changes at any time, and the resulting ulcers may be delayed for several days. The monitoring cycle cannot meet the requirement of 5-10 minutes, and it is impossible to provide real-time and comprehensive protection for the patient.

[0006] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the inventor studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention

[0007] In view of the deficiencies of the prior art, the technical solution of the present invention is to provide a diabetic foot protection device. The device includes: a computer unit; and a force sensor for monitoring the ground reaction force of the patient's foot and a temperature sensor for monitoring the temperature of the patient's foot connected to the computer unit; the computer unit judges the patient's behavior type based on the ground reaction force of the patient's foot monitored by the force sensor and controls the temperature sensor; the computer unit judges the patient's temperature change based on the patient's foot temperature monitored by the temperature sensor and controls the force sensor. The force sensor uses the patient's behavior type as the key control condition of the temperature sensor, and the temperature sensor uses the patient's temperature change as the key control condition of the force sensor to provide feedback and early warning of abnormal conditions of the patient's foot.

[0008] According to a preferred embodiment, at least three force sensors are provided, wherein the first force sensor is provided on the side of the sole of the patient's foot close to the big toe, the second force sensor is provided on the side of the sole of the patient's foot away from the big toe, and the third sensor is provided on the heel of the patient. The force sensor determines the patient's behavior type based on the ground reaction force of the patient's foot monitored by the force sensor, and the first force sensor sends the monitored ground reaction force to the computer unit, and the computer unit processes and controls the temperature sensor.

[0009] According to a preferred embodiment, there are at least six temperature sensors, wherein the first temperature sensor is arranged at the big toe of the patient's foot, the second temperature sensor is arranged at the arch of the patient's foot, the third temperature sensor is arranged at the heel of the patient, and the fourth temperature sensor, the fifth temperature sensor and the sixth temperature sensor are arranged at the sole of the patient's foot, and the fifth temperature sensor sends the monitored temperature of the patient's foot to the computer unit, and the computer unit processes and controls the force sensor.

[0010] According to a preferred embodiment, the computer unit divides the patient's behavior type into at least four behaviors based on the patient's weight through the ground reaction force sent by the first force sensor and activates the temperature sensor, wherein the computer unit determines the behavior type through the relationship between the ground reaction force and the patient's weight, and the patient can improve the analysis quality of the computer unit by determining the behavior type in which he or she participates in the computer unit.

[0011] According to a preferred embodiment, the computer unit determines the temperature change of the patient's foot through the temperature data sent by the fifth temperature sensor, and when the temperature of the patient's foot has a continuous upward trend, the computer unit starts and determines the patient's current behavior type and the ground reaction force at each position of the patient's foot based on the data sent by the second force sensor and the third force sensor. The computer unit provides corrective measures to the patient based on the patient's current behavior type and the ground reaction force at each position of the patient's foot.

[0012] According to a preferred embodiment, the computer unit determines the patient's current foot information and the warning information corresponding to the current foot information based on at least one of the ground reaction force of the patient's foot monitored by the force sensor and the patient's foot temperature monitored by the temperature sensor; the warning information is prioritized in a differential manner, and the difference can at least be first limited by time; when the computer unit responds to the current foot information to perform a corresponding action, the computer unit prioritizes the warning information corresponding to the current foot information in a linearly increasing manner with time, so that the computer unit can provide corrective measures in a differential manner.

[0013] According to a preferred embodiment, a standardized time corresponding to the at least four behaviors of the patient is established, and the priority of the warning information is increased by using the standardized time as a second limitation for characterizing the patient's foot status.

[0014] According to a preferred embodiment, the device further comprises: a protective sock for protecting the patient's foot; wherein the protective sock is provided with a silicone pad at the bony protrusion and the heel of the patient's foot. The present invention aims to prevent foot ulcers in diabetic patients by early detection of abnormal temperature changes in the patient's foot. The present invention mainly detects abnormal conditions by continuously monitoring the temperature and lateral (shear) ground reaction force of the patient's foot.

[0015] According to a preferred embodiment, the protective socks are provided with two layers, wherein the knitting thread ends of the protective socks are stored in the interlayer space formed by the two layers. The interlayer space is used to store the knitting thread ends of the protective socks to prevent the feet of the diabetic patient from being scratched by the thread ends. The interlayer space is also used to embed force sensors and temperature sensors to monitor the patient's vital signs in a manner that best fits the patient's skin.

[0016] According to a preferred embodiment, the bone protrusions of the patient include the outer bone of the big toe and the outer side of the little toe.

[0017] According to a preferred embodiment, the color of the protective socks is set to be light-colored, so that it is easy for medical staff to observe whether the patient's feet have cracks, ulcers or other diseases.

[0018] According to a preferred embodiment, the force sensor and the temperature sensor are embedded in the interlayer space of the protective socks or in the protective pad of the device, and the tactile actuator is embedded in the protective pad of the device. The protective pad is placed under the patient's foot and is used to monitor the patient's foot activities. The force sensor and the temperature sensor are used to monitor the patient's daily life. Due to their small size, they can be set in the interlayer space or in the protective pad. The tactile actuator needs to provide vibration and is not suitable for being set on the protective socks, so it is set on the protective pad that matches the protective socks. Preferably, the protective pad can be used as the patient's insole, so that the tactile sensor can operate for a long time when the patient is exercising. Both the force sensor and the temperature sensor can be set in the protective pad, that is, in the patient's insole, to provide accurate monitoring and improve the comfort of the patient's feet.

[0019] According to a preferred embodiment, the computer unit compares the change in the patient's foot temperature with a calibrated safety threshold, and if any parameter exceeds the safety threshold, an alarm is issued to the patient and / or a designated medical professional, and when any safety threshold is exceeded, a tactile stimulus is transmitted to the tactile actuator embedded in the protective pad, and the computer unit transmits the alarm to the patient's mobile terminal in the form of an audio and / or text message and is used to explain the nature of the alarm.

[0020] According to a preferred embodiment, before the protective pad monitors the temperature of the patient's feet, the temperature sensor measures the temperature of the left and right feet of the patient in different postures multiple times to obtain the safety threshold. Based on the change in the vibration amplitude of the tactile actuator, the time taken by the patient to respond to the change in the vibration amplitude is used as the patient's neuropathy level, and the temperature safety threshold is adjusted when the patient's neuropathy condition changes based on the neuropathy level. Wherein, if the neuropathy level is higher and the patient's foot temperature rises for a long time, an alarm is issued to the patient and / or designated medical professionals, and if the detected neuropathy level rises above the normal level, the foot temperature safety threshold is proportionally reduced based on the neuropathy level.

[0021] According to a preferred embodiment, the formula for adjusting the safety threshold of the patient's foot temperature based on the difference in the level of neuropathy in the left and right feet of the patient is: Maximum horizontal line difference = (normalized temperature of the left foot × neuropathy level / 100) - (normalized temperature of the right foot * neuropathy level / 100); wherein the normalized temperature of the left foot and the normalized temperature of the right foot are obtained in the process of establishing the safety threshold of the patient's foot temperature, and the maximum horizontal line difference is used to reduce the difference between the patient's left foot and right foot. Since the foot temperature varies with the ambient temperature, patient activity, etc., and the foot temperature of a patient with neuropathy is 3-5 degrees Celsius higher than that of a patient without neuropathy, the foot temperature measured by the temperature sensor cannot be used. In this regard, the present invention calibrates the temperature sensor by measuring the temperature difference between the patient's left and right feet at the same position, and is also used for the safety threshold of the patient's foot in this area. There is a high correlation between the temperatures of the left and right feet of the patient at the same position, and there is also a high correlation between the degree of diabetic foot ulcers and the degree of neuropathy of the patient. Therefore, the safety thresholds of temperature and shear force of the present invention are also affected by the level of neuropathy in the patient's foot.

[0022] According to a preferred embodiment, when the computer unit needs to be remotely alerted, detailed information is sent to a medical professional or medical institution or medical institution, and the medical institution can retrieve the complete data log from the computer unit and transmit professional advice back to the patient's smartphone, and the tactile actuator provides tactile feedback of the appropriate distribution of force within the protective pad to monitor and promote the patient to take corrective measures in response to local or remote advice.

[0023] According to a preferred embodiment, the computer unit also warns of the magnitude of the shear force on the patient's foot, and the establishment of the safety threshold of the shear force is performed through a motion processor, wherein, when the ratio between the maximum shear forces is lower than the safety threshold of the shear force, or when the ratio between the maximum shear force and the lateral component is lower than the safety threshold of the shear force, the motion timer is started, and if the start time of the motion timer exceeds the standardized time of the motion, or if the patient's foot temperature continues to rise, a warning message is sent to the patient and / or medical staff. The factor causing the patient's foot temperature to rise is the shear force on the foot. The shear force is the horizontal and lateral component of the GRF. The shear force causes friction between the patient's foot and the shoe, leading to increased foot temperature and related ulcers. In addition, since the change in foot temperature is gradual, the resulting ulcer may be delayed for several days. A reasonable measurement cycle is in the range of 5-10 minutes. The excessive shear force and long-term friction information can provide an early warning of the patient's foot temperature rise.

[0024] Beneficial technical effects of the present invention:

[0025] (1) The present invention controls the start and stop of force sensors and temperature sensors to ensure that the working time of each sensor can cover the patient's treatment cycle. When the patient uses the device, multiple force sensors or multiple temperature sensors are not activated, but force sensors and temperature sensors at key positions of the patient's feet are activated. According to the change of their parameters, multiple force sensors or temperature sensors are activated accordingly, so that the monitoring cycle covers the patient's treatment cycle.

[0026] (2) The present invention provides a protective sock with two layers to form a sandwich space, which is used to store the knitting thread ends of the protective socks to prevent the feet of diabetic patients from being scratched by the thread ends, and is used to embed force sensors and temperature sensors to monitor the patient's vital signs in a manner that best fits the patient's skin;

[0027] (3) The present invention prevents foot ulcers in diabetic patients by continuously monitoring the temperature and lateral (shear) ground reaction force of the patient's foot to detect abnormal conditions at an early stage;

[0028] (4) The present invention measures the temperature difference between the left and right feet of the patient at the same position to calibrate the temperature sensor and use it for the safety threshold of the patient's foot in this area. It also establishes the safety threshold of the patient's foot temperature in proportion to the degree of the patient's foot ulcer based on the vibration perception threshold level. This solves the problem that the foot temperature measured by the temperature sensor cannot be used because the foot temperature varies with the ambient temperature, patient activities, etc., and the foot temperature of a patient with neuropathy is 3-5 degrees Celsius higher than that of a patient without neuropathy. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 1 is a schematic structural diagram of a preferred embodiment of the protective socks of the present invention;

[0030] Figure 2 is a structural schematic diagram of a preferred embodiment of a protection pad of the present invention;

[0031] Figure 3 It is a schematic diagram of parameters for determining the safety threshold of the patient's foot temperature according to the present invention.

[0032] Reference numerals list

[0033] 1: protection socks; 2: silicone pad; 3: protection pad; 4: force sensor; 51: first temperature sensor; 52: second temperature sensor; 53: third temperature sensor; 54: fourth temperature sensor; 55: fifth temperature sensor; 56: sixth temperature sensor; 6: tactile actuator; 7: motion processor; A1: first horizontal line; A2: second horizontal line; A3: third horizontal line; A4: fourth horizontal line; A5: distance line; A6: first maximum horizontal line difference; A7: second maximum horizontal line difference. DETAILED DESCRIPTION

[0034] The following is a detailed description with reference to the accompanying drawings.

[0035] First, the professional terms mentioned in the present invention are explained.

[0036] Application Program: A hardware configuration program that may be stored in a memory and executable by a processor or may be used to configure a programmable hardware element.

[0037] Computer Unit / Server: Any type of computer or processing system, including but not limited to mobile terminals, personal computers (PCs), personal digital assistants (PDAs), mainframe computers, network equipment, systems with databases capable of storing and processing patient information, or other devices or combinations of devices. It is broadly defined to cover any device or combination of devices having at least one processor that executes instructions from a storage medium.

[0038] Mobile terminal: including but not limited to any wireless terminal, such as mobile phones, smart phones, etc.; including but not limited to local wireless communication ports, such as Wi-Fi communication ports, personal wireless communication ports; including but not limited to Bluetooth, ZigBee, etc. In the present invention, the mobile terminal can be configured to operate in a cellular network.

[0039] Smartphone: comprising a computing device including a wireless cellular communication port, a memory, a processor, wherein the processor is configured to execute application instructions, and wherein the smartphone has local and personal area wireless communication ports, a GPS receiver, and a patient interface.

[0040] Storage Media: Any of various types of storage devices or storage devices, including installation media such as CD-ROM, floppy disk, or tape devices; computer system memory or random access memory such as DRAM, DDR RAM, SRAM, EDO RAM, etc.; or non-volatile memory such as a hard drive of magnetic media or optical storage.

[0041] Ground Reaction Force (GRF): The force displaced by the ground on an object in contact with it, as defined by Newton's third law of physics. When a person is standing, the GRF corresponds to the person's weight and increases in proportion to the acceleration of the person as the person moves; when the person is in motion, the GRF has two components, vertical and horizontal. The horizontal (or friction) force may also be called the shear force, and the ratio of the magnitude of the horizontal force to the vertical force produces the static friction / shear coefficient.

[0042] Pronation: The natural side-to-side movement of the foot during walking or running that begins in the first part of the stance phase of gait.

[0043] Neutral pronation: A position where the center of mass acts inward and is medial to the midline of the foot and weight is evenly distributed over the POB of the foot and all toes, slightly pronating the big toe.

[0044] Supination: A position in which the center of mass moves outward and outside the midline of the foot and weight is primarily distributed over the outside of the foot and outer toes.

[0045] Euler angles: Three angles introduced by Leonard Euler for describing the orientation of a rigid object using a sequence of three consecutive rotations.

[0046] Quaternion: A mathematical expression used to calculate the rotational state of a device using an axis of rotation and an angle of rotation.

[0047] VPT (Vibration Perception Threshold): A specific vibration stimulus is applied to the patient's big toe to measure the patient's response and determine the patient's level of sensory loss.

[0048] Example 1

[0049] The technical solution of the present invention is to provide a diabetic foot protection device for early detection of foot diseases in diabetic patients. The purpose of the present invention is to prevent foot ulcers in diabetic patients by early detection of abnormal temperature changes in the patient's feet. The present invention mainly detects abnormal conditions by continuously monitoring the temperature and lateral (shear) ground reaction force of the patient's feet.

[0050] According to a preferred embodiment, the present invention achieves this function by embedding several temperature sensors and force sensors, motion processors and tactile actuators into one or more protective pads. The above-mentioned temperature sensor can adopt thin film platinum or nickel, titanium carbide and other sensors, which measure the temperature by the change of sensor resistance. The force sensor can adopt a thin film sensor (resistive, capacitive, etc.) to measure the pressure (in Newtons) applied by the patient's foot on the protective pad. The motion processor is configured to perform complex motion fusion algorithms by combining data from accelerometers, gyroscopes and magnetometers to provide accurate direction representation in 3D space and compensate for drift in the sensor. It should be noted that the above-mentioned temperature sensors, force sensors, motion processors and tactile actuators are all prior art, and the present invention is only aimed at its practical application, not targeted design.

[0051] According to a preferred embodiment, the protective socks are used to protect the patient's feet, and the protective socks are provided with silicone pads at the bone protrusions and heels of the patient's feet. The protective socks are provided with two layers, and the braided thread ends of the protective socks are collected in the interlayer space formed by the two layers. The interlayer space is used to store the braided thread ends of the protective socks to prevent the feet of diabetic patients from being scratched by the thread ends. The interlayer space is also used to embed force sensors and temperature sensors to monitor the patient's vital signs in a way that best fits the patient's skin. The above-mentioned silicone pad can be adaptively formulated using silicone original glue with a hardness of 40 degrees, color glue and color-changing powder. Among them, the color-changing powder is prepared using styrene maleic anhydride, dodecyl alcohol, polyoxymethylene melamine and dichlorofluorescein. The prepared silicone pad can change color in a short time when it reaches the critical temperature.

[0052] According to a preferred embodiment, the bone protrusions of the patient include the outer bone of the big toe and the outer side of the little toe.

[0053] According to a preferred embodiment, the color of the protective socks is set to be light-colored, so that it is easy for medical staff to observe whether the patient's feet have cracks, ulcers or other diseases.

[0054] According to a preferred embodiment, the device includes: a force sensor for monitoring the ground reaction force of the patient's foot; a temperature sensor for monitoring the temperature of the patient's foot. The force sensor uses the patient's behavior type as the key control condition of the temperature sensor, and the temperature sensor uses the patient's temperature change as the key control condition of the force sensor to provide feedback and early warning of abnormal conditions of the patient's foot. The force sensor and the temperature sensor are in a state of mutual control. In order to ensure that the working time of each sensor can cover the patient's treatment cycle, when the patient uses the device, multiple force sensors or multiple temperature sensors will not be enabled, but force sensors and temperature sensors at key positions of the patient's foot will be enabled, and multiple force sensors or temperature sensors will be started accordingly based on the changes in their parameters, so as to achieve the effect of the monitoring cycle covering the patient's treatment cycle.

[0055] According to a preferred embodiment, at least three force sensors are provided, wherein the first force sensor is arranged on the side of the patient's sole close to the big toe, the second force sensor is arranged on the side of the patient's sole away from the big toe, and the third sensor is arranged on the patient's heel. The force sensor determines the patient's behavior type based on the ground reaction force of the patient's foot monitored by it, and the first force sensor sends the monitored ground reaction force to the computer unit, and the computer unit processes and controls the temperature sensor. When the patient's ground reaction force monitored by the first force sensor is at a high level for a long time, multiple temperature sensors are activated to judge the temperature change of the patient's foot to prevent the patient's foot from rubbing rapidly under the action of the high ground reaction force, causing the temperature to rise too quickly. The prevention method is to remind through a tactile actuator, a smart phone or a medical institution.

[0056] According to a preferred embodiment, at least six temperature sensors are provided, wherein the first temperature sensor is arranged at the big toe of the patient's foot, the second temperature sensor is arranged at the arch of the patient's foot, the third temperature sensor is arranged at the heel of the patient, and the fourth temperature sensor, the fifth temperature sensor and the sixth temperature sensor are arranged at the sole of the patient's foot, and the fifth temperature sensor sends the monitored temperature of the patient's foot to the computer unit, and the computer unit processes and controls the force sensor. When the fifth temperature sensor detects that the temperature of the patient's foot is at a high level, multiple force sensors are activated to determine the patient's exercise state. If the patient is in intense exercise, a message is sent to a smartphone or a medical institution to remind family members or medical staff to pay attention to the patient's current state and take appropriate measures.

[0057] According to a preferred embodiment, the computer unit divides the patient's behavior type into at least four behaviors based on the patient's weight through the ground reaction force sent by the first force sensor and activates the temperature sensor, wherein the computer unit determines the behavior type with high confidence through the relationship between the ground reaction force and the patient's weight, and the patient can improve the analysis quality of the computer unit by determining the behavior type in which he / she participates in the computer unit. The above-mentioned analysis quality refers to the judgment of the computer unit on the patient's state, that is, the quality of the early warning.

[0058] According to a preferred embodiment, the computer unit determines the temperature change of the patient's foot through the temperature data sent by the fifth temperature sensor, and when the temperature of the patient's foot has a continuous upward trend, the computer unit starts and determines the patient's current behavior type and the ground reaction force at each position of the patient's foot based on the data sent by the second force sensor and the third force sensor. The computer unit provides corrective measures to the patient based on the patient's current behavior type and the ground reaction force at each position of the patient's foot.

[0059] According to a preferred embodiment, the patient's current foot information and the warning information corresponding to the current foot information are determined based on at least one of the ground reaction force of the patient's foot monitored by the force sensor and the patient's foot temperature monitored by the temperature sensor; the warning information is prioritized in a differential manner, and the differential can at least be limited by time; when the computer unit responds to the current foot information to perform a corresponding action, the warning information corresponding to the current foot information is prioritized according to the linear growth of time, so that the computer unit can provide corrective measures in a differential manner. Specifically, the patient's foot information is judged by the ground reaction force and temperature. When judging from the ground reaction force, the patient's current foot information is the patient's motion state. The longer the patient is in the motion state, the greater the possibility that the foot may ulcerate. In this regard, the priority of the warning information is increased in sequence until the patient exits the motion state. And when the priority of the warning information increases along the linear time, the computer unit gives the corrective measures of the corresponding priority. For example, at the zero moment of entering the motion state, the computer unit does not act, and starts recording time; when the motion state reaches the first priority, the tactile actuator starts to remind the patient to stop the current motion; when the motion state reaches the second priority, the computer unit sends a message or pops up a reminder to the patient's mobile phone to stop the motion state; when the motion state reaches the third priority, the computer unit sends a reminder to the family or medical staff to stop the patient's current motion. The temperature sensor gives a reminder of the corresponding priority based on the temperature change.

[0060] According to a preferred embodiment, a standardized time corresponding to the behavior is established based on at least four behaviors of the patient, and the standardized time is used as the second limit for characterizing the patient's foot state to prioritize the warning information. Preferably, the four behaviors of the patient include standing, walking, jogging and running. It should be noted that the present invention only lists four important states, which does not mean that the remaining behaviors cannot be designed, for example, basketball, badminton, high jump and other behaviors. Each behavior has a different standardized time to prevent the patient from being in the behavior for a long time. Standardized time refers to the best time that the patient can bear for the exercise, and the time can be adaptively adjusted according to the different physical qualities of the patient. Taking jogging as an example, the peak amplitude of the vertical component of GRF during jogging accounts for 180% of the patient's body weight, and the threshold is 170% of the body weight. Its standardized time is designed to be 10 minutes. When the patient's jogging time exceeds the standardized time, the warning information is upgraded to a first-level priority, that is, from the first priority to the second priority or from the second priority to the third priority. More intense exercise behavior will lead to faster priority increase, so that the patient's body is always in a healthy state.

[0061] According to a preferred embodiment, the force sensor and the temperature sensor are embedded in the interlayer space of the protective socks or in the protective pad of the device, and the tactile actuator is embedded in the protective pad of the device. The protective pad is placed under the patient's foot and is used to monitor the patient's foot activities. The force sensor and the temperature sensor are used to monitor the patient's daily life. Due to their small size, they can be set in the interlayer space or in the protective pad. The tactile actuator needs to provide vibration and is not suitable for being set on the protective socks, so it is set on the protective pad that matches the protective socks. Preferably, the protective pad can be used as the patient's insole, so that the tactile sensor can operate for a long time when the patient is exercising. Both the force sensor and the temperature sensor can be set in the protective pad, that is, in the patient's insole, to provide accurate monitoring and improve the comfort of the patient's feet.

[0062] According to a preferred embodiment, the computer unit compares the change in the patient's foot temperature with calibrated safety thresholds, and if any parameter exceeds the safety threshold, an alarm is issued to the patient and / or a designated medical professional, and when any safety threshold is exceeded, a tactile stimulus is transmitted to the tactile actuator embedded in the protective pad and an audio and / or text message is transmitted to explain the nature of the alarm.

[0063] According to a preferred embodiment, before the protective pad monitors the temperature of the patient's feet, the temperature sensor measures the temperature of the left and right feet of the patient in different postures multiple times to obtain the safety threshold. Based on the change in the vibration amplitude of the tactile actuator, the time taken by the patient to respond to the change in the vibration amplitude is used as the patient's neuropathy level, and the temperature safety threshold is adjusted when the patient's neuropathy condition changes based on the neuropathy level, wherein, if the neuropathy level is higher and the patient's foot temperature rises for a long time, an alarm is issued to the patient and / or a designated medical professional, and if the detected neuropathy level rises above the normal level, the foot temperature safety threshold is proportionally reduced based on the neuropathy level.

[0064] Example 2

[0065] This embodiment is a further improvement on Embodiment 1, and the repeated contents will not be repeated here.

[0066] According to a preferred embodiment, the motion vector and the vertical component of the GRF vector are used to calculate the lateral component of the GRF (shear force), while also monitoring the temperature changes of the selected area of ​​the patient's foot. The computer unit and / or server and / or mobile terminal compare the changes in foot temperature and shear force with calibrated safety thresholds, and if any parameter exceeds such safety threshold, an alarm is issued to the patient and / or a designated medical professional. If any parameter exceeds the safety threshold, the computer unit will issue an alarm to the patient and / or the designated medical professional, and when any parameter exceeds the safety threshold, a tactile stimulus is transmitted to the tactile actuator embedded in the protective pad, and the computer unit transmits the alarm to the patient's mobile terminal in the form of an audio and / or text message and is used to explain the nature of the alarm. When the computer unit and / or server and / or mobile terminal needs to be remotely alarmed, detailed information is sent to the medical professional or medical institution or medical institution. The medical institution can retrieve the complete data log from the computer unit and / or server and / or mobile terminal and in turn transmit professional advice to the patient's smartphone. The present invention monitors and encourages the patient to take corrective actions in response to local or remote suggestions by providing tactile feedback indicating the proper distribution of forces within the protective pad. The correct distribution of forces within the protective pad can include the correct location of pressure, or the correct orientation of the protective pad in three-dimensional space. In addition, the tactile actuator can also be used to confirm the degree of neuropathy in the patient's foot.

[0067] Since the temperature of the patient's feet is not constant, it depends on the activity of the patient's feet, which is largely determined by the patient's walking pattern. The gait of the patient when walking, the type of exercise performed, such as walking, running, hiking, sports, etc., will affect the change of the patient's foot temperature. In addition to the change in foot temperature caused by the different activities performed by the patient, the range of GRF affecting the patient's feet also changes.

[0068] For people who do not suffer from related diseases, controlling the vertical component of GRF can control the foot temperature within a suitable range, which is mainly controlled by the type and quality of shoes. Diabetic patients must control other components of GRF. Specifically, the vertical and horizontal components (sometimes called shear forces) are crucial for diabetic patients because these components cause the patient's feet to rub against the soles of shoes. The present invention is simple and easy to use by continuously monitoring the patient's foot temperature and lateral shear force to provide real-time feedback and early warning. Specifically, the embedded setting of the protective pad of the present invention includes: an accelerometer sensor, a gyroscope sensor and a magnetometer sensor; a motion processor that executes a motion processing algorithm; multiple force sensors; multiple temperature sensors, and a microprocessor embedded in the protective pad. The system is configured to: analyze the lateral component of the GRF ground reaction force present at the patient's foot / protective pad; monitor temperature changes in specific areas of the patient's foot, and alert the patient and / or medical staff when the foot temperature exceeds a predetermined standard. The temperature sensor, force sensor and motion processor can transmit the data of the temperature sensor, force sensor and motion processor to the analysis application based on the computer unit and / or server and / or mobile terminal, and the transmission mode can be a wireless personal area network transceiver (including Bluetooth, ANT, etc.). The computer unit and / or server and / or mobile terminal transmits the calibration and analysis data, the patient's GPS coordinates and alarm messages to the remote server through the cellular radio interface.

[0069] Figure 2 The installation positions of various sensors and components are shown. It should be noted that the position of the silicone pad is equivalent to Figure 2 The device embedded in the protective pad includes: a motion processing element for obtaining samples from an accelerometer, a gyroscope, and a magnetometer; a plurality of force sensors located on both sides of the heel and the sole; a plurality of temperature sensors, namely: a first temperature sensor located at the big toe of the foot, a second temperature sensor located at the arch of the foot, a third temperature sensor located at the heel, and a fourth, fifth, and sixth sensors located at the sole; and tactile actuators, namely: a first tactile actuator and a second tactile actuator for the big toes of the left and right feet.

[0070] The magnitude of the GRF value is monitored and recorded by a force sensor, and the temperature of the patient's foot is monitored and recorded by a temperature sensor. The first tactile actuator and the second tactile actuator are respectively located under the big toes of the left and right feet of the patient. The first tactile actuator and the second tactile actuator are used to determine the level of neuropathy by providing specific vibration stimulation to the big toe of the patient and measuring the response thereto. In addition to the actuator, an eccentric wheel can also be used for vibration stimulation. The above settings determine the level of sensory loss of the patient, and thus obtain the foot vibration perception threshold (VPT), ​​and provide feedback when the set safety parameters are exceeded.

[0071] The motion processing element obtains samples from the accelerometer, gyroscope, magnetometer, force temperature sensor and temperature sensor at a specified rate, and then calculates the Euler angles and quaternions through the computer unit and / or server and / or mobile terminal and assembles them into a data packet. The data packet includes the x, y and z samples from the accelerometer and the x of the Euler angle samples. o and o .

[0072] The computer unit and / or server and / or mobile terminal uses a Bluetooth radio interface or other communication interface to transmit an assembled data packet containing data on the size of the GRF value and the temperature of the patient's foot to an analysis application based on the computer unit and / or server and / or mobile terminal. The present invention can calculate the GRF based on the horizontal and lateral components of the received GRF by using Cartesian arithmetic. Cartesian arithmetic calculation of the GRF belongs to the prior art and will not be described in detail. Since the size of the GRF depends on the type of physical activity performed by the patient. For example, when the patient is running on a flat surface, a larger vertical component will appear in the sole of the foot, and when running downhill, a larger vertical component will appear in the heel. In addition, when performing sports that require lateral movement (such as badminton, table tennis, etc.), the patient's foot has a larger lateral component.

[0073] The computer unit and / or server and / or mobile terminal of the present invention determines the activity type with a higher confidence by observing the velocity and acceleration vectors. The patient can also improve the quality of the analysis by inputting the type of activity participated in in the application.

[0074] From the above-mentioned changes in the types of patient physical activities, it can be seen that since the foot temperature changes with the ambient temperature, patient activity, etc., and the foot temperature of patients with neuropathy is 3-5 degrees Celsius higher than the foot temperature of patients without neuropathy, the foot temperature measured by the temperature sensor cannot be used. In this regard, the present invention calibrates the temperature sensor by measuring the temperature difference between the left and right feet of the patient at the same position, and at the same time uses it for the safety threshold of the patient's foot in this area. There is a high correlation between the temperature of the left and right feet of the patient at the same position, and there is also a high correlation between the degree of diabetic foot ulcers and the degree of neuropathy of the patient, so the safety threshold of the temperature and GRF horizontal force of the present invention is also affected by the level of neuropathy in the patient's foot (obtained by the tactile actuator).

[0075] The prior art often uses a bioelectrophysiological instrument to measure the level of neuropathy, but the bioelectrophysiological instrument is a high-precision laboratory device and cannot be used in the daily life of patients. In this regard, the present invention measures through a tactile actuator located under the big toe of the patient's foot. The tactile actuator periodically changes its own vibration frequency, and then records its response through the patient's smartphone to measure the level of neuropathy. The VPT measured by the tactile actuator is used to determine the coefficient of the safety threshold of the patient's foot temperature, thereby effectively narrowing the range of safe temperatures. When any area of ​​the patient's foot exceeds the safety threshold of temperature, or when the horizontal force of the GRF exceeds the safety threshold of force, the computer unit and / or server and / or mobile terminal application will send an alarm message to the patient and / or medical staff to notify the patient or medical staff that an abnormal condition has occurred in the foot.

[0076] When the protective pad is monitoring the temperature of the patient's feet, the temperature sensor needs to be calibrated and the safety threshold is determined. Specifically, the calibration of the temperature sensor is performed according to the following steps:

[0077] S1: The patient wears protective gear and stands in a relaxed position (feet side by side and apart) so that the patient's weight pressure is evenly distributed on both feet;

[0078] S2: For the left and right feet of the patient, each temperature sensor embedded therein is used to perform 16 consecutive measurements, and the average temperature of the patient is obtained by taking the average value of all the data;

[0079] S3: If the temperature value recorded by the temperature sensor is greater than the average temperature of the patient, the result is stored in the storage medium and used as a negative offset; if the temperature value recorded by the temperature sensor is less than the average temperature of the patient, the result is stored in the storage medium and used as a positive offset;

[0080] S4: The patient remained in a prone position (lying on a flat surface) for 5 minutes, followed by a relaxed position for 5–20 minutes, and then the average temperature of 16 consecutive measurements of the patient's left and right feet was measured 64 times;

[0081] S5: storing the temperature in the storage medium in step S2 as the normalized foot temperature;

[0082] S6: calculating the average foot temperature by averaging all normalized foot temperatures;

[0083] S7: By comparing the normalized foot temperatures of each temperature sensor area of ​​the patient's foot, and storing the difference in a storage medium as a normalized threshold, the temperature difference between the patient's left and right feet in the same area (or the same temperature sensor) is calculated.

[0084] Figure 3 The relationship between the parameters obtained during the above-described calibration and monitoring method is shown.

[0085] The normalized temperature between the first horizontal line A1 of the left foot of the patient and the second horizontal line A2 of the right foot, the normalized temperature between the third horizontal line A3 of the left foot of the patient and the fourth horizontal line A4 of the right foot, and the normalized threshold of the patient between the distance lines A5, the three differences represent the maximum temperature difference between the five temperature sensors of the left and right feet of the patient. The horizontal line difference between the third horizontal line A3 of the left foot of the patient and the fourth horizontal line A4 of the right foot is defined as the first maximum horizontal line difference A6, and the maximum range of the normalized temperature between the left and right feet of the patient is determined thereby. If the value of the temperature sensor exceeds any of the above thresholds, the application of the computer unit and / or the server and / or the mobile terminal will send an alarm message to the patient's smartphone and / or medical personnel.

[0086] In addition to the above-mentioned temperature sensor calibration and determination of the safety threshold, the vibration perception threshold level VPT of the patient's left and right feet neuropathy also requires confirmation of the safety threshold to confirm whether the neuropathy levels of the patient's left and right feet are the same or different. It has been explained in the above content that VPT is obtained by stimulating a tactile actuator (or eccentric wheel) embedded in a protective pad and located under the patient's big toe. Specifically, the stimulation frequency of the tactile actuator (or eccentric wheel) is 60Hz, and the amplitude gradually increases. When the patient responds to the stimulation of the tactile actuator (or eccentric wheel) through a smartphone, the current vibration amplitude is used as the threshold of the neuropathy level, and the VPT threshold detection is repeated multiple times to obtain the average VPT threshold. More specifically, the steps for measuring foot VPT are as follows:

[0087] a. The patient puts on protective equipment and enters the neuropathy level calibration;

[0088] b. Apply the lowest amplitude to the tactile actuator of the left or right foot, wait for the patient to confirm the response and record the time taken;

[0089] c. Repeat step b N times to obtain the patient's neuropathy level and the time it takes for the patient to respond, where N is a preset integer;

[0090] d. If no patient response confirmation is received, increase the amplitude and repeat step b until the patient response confirms that the tactile actuator has produced a stimulus;

[0091] e. Store the neuropathy level to a storage medium.

[0092] The safety threshold of the temperature can be adjusted based on the neuropathy level when the patient's neuropathy condition changes. The higher the neuropathy level, the lower the sensitivity level of the patient's foot temperature changes. The long-term increase in the patient's foot temperature will increase the possibility of foot ulcers. If the detected neuropathy level increases above the normal level, the safety threshold of the foot temperature is reduced in proportion to the neuropathy level.

[0093] Figure 3 It means that the normalized temperature of the first horizontal line A1 of the five temperature sensors on the patient's left foot is slightly higher than the normalized temperature of the second horizontal line A2 of the five temperature sensors on the patient's right foot. However, if the neuropathy level of the patient's left foot is 20, and the neuropathy level of the right foot is 25. Since a neuropathy level above 20 is moderate neuropathy and above 25 is severe neuropathy, the neuropathy level of the patient's right foot is used as a coefficient to calculate the maximum horizontal line difference. The neuropathy level / 100 is used as a coefficient and added to the normalized temperatures of the left and right feet to obtain the second maximum horizontal line difference A7 under the neuropathy level, thereby effectively reducing the difference between the patient's left and right feet. The formula is:

[0094] Maximum horizontal line difference = (normalized temperature of left foot x neuropathy level / 100) - (normalized temperature of right foot * neuropathy level / 100)

[0095] The above illustrates that elevated patient foot temperature is the main cause of foot ulcers in diabetic patients. The factor that causes elevated patient foot temperature is the shear force of the foot. Shear force is the horizontal and lateral component of GRF. Shear force causes friction between the patient's foot and the shoe, leading to elevated foot temperature and associated ulcers. In addition, since the change in foot temperature is gradual, the resulting ulcer may be delayed for several days, and a reasonable measurement cycle is in the range of 5-10 minutes. Excessive shear force and long-term friction information can provide an early warning of elevated patient foot temperature. GRF consists of three components: vertical Fx; horizontal Fy; and lateral Fy, with the vertical component being the largest. The horizontal and lateral components are referred to as shear force in the present invention. The peak amplitude of the vertical component of GRF is about 120% during walking, about 180% during jogging, and up to 275% of the patient's body weight during running. The shear force during walking and jogging is similar, about 30% to 35% of the patient's body weight, and up to 45% of the patient's body weight during running.

[0096] The safety threshold of the vertical component is set to 120% of the patient's body weight when walking normally, 170% of the patient's body weight when jogging, and 250% of the patient's normal body weight during running. The vertical component Fx is not the focus of the present invention, and is only briefly described. The processing of the GRF vertical component and the threshold definition are not described in detail.

[0097] The magnitude of shear force is particularly important for diabetic patients, especially if the patient also suffers from neuropathy. The motion processor can analyze GRF in 3D space, and remind the patient to avoid foot injury when the shear force exceeds a predetermined safety threshold or when the shear force may cause increased pressure in a specific foot area. The present invention monitors changes in foot temperature and takes into account temporary increases in foot temperature caused by specific patient activities, providing a long-term, safe and comfortable protection device for diabetic patients' normal life activities.

[0098] The steps to establish the safety threshold of shear force are:

[0099] The safety thresholds for shear force are determined by subtracting the patient's normalized weight from the values ​​obtained from the accelerometer x- and y-axis values, which are 25% for walking, 35% for jogging, and 45% for running. The thresholds can be adaptively modified based on several criteria, such as: increased foot temperature or the patient's level of neuropathy.

[0100] The direction and magnitude of the horizontal and lateral components of the GRF are obtained by observing the magnitude and sign of the accelerometer x and y axes, respectively, while the directions of these vectors are provided by the Euler angles to the motion processing algorithm, generating the shear force vector. Here, patients with supination or those with neutral pronation but showing side-to-side motion during badminton or sports exert most of the forces and moments on the lateral portion of the foot.

[0101] The Euler angles provide the direction and rotation angle, the accelerometer x-axis and y-axis provide the magnitude of the horizontal and lateral forces, and the magnitude of the shear force can be calculated using the Pythagorean principle. The normalized body weight (obtained by subtracting the patient-provided weight from the perpendicular GRF vector, which is prior art and will not be described in detail) is compared to the shear component of the GRF.

[0102] When the ratio between the maximum shear forces is below a safety threshold, or when the ratio between the maximum shear force and the lateral component is below a threshold, the motion timer is activated. If the activation time of the motion timer exceeds the standardized time of the motion, or if the patient's foot temperature continues to rise, an early warning message is sent to the patient and / or medical staff.

[0103] Example 3

[0104] In this embodiment, auxiliary equipment of the above system (specifically, a system for analyzing abnormal body temperature of diabetic patients) is supplemented.

[0105] According to a preferred embodiment, the computer unit and / or server and / or mobile terminal communicate with the motion and force processing element embedded in the patient protection pad. The communication is performed using a wireless PAN protocol. The smartphone communicates with a remote service on a remote computing server via a wireless cellular interface. The foot scanner provides a highly accurate scan of the physical characteristics of the patient's foot. The scanner can use a combination of 3D laser scanning, pressure plates, etc. to obtain foot volume, pronation, pressure, and gait patterns, to name just a few types of patient vital signs data that may be obtained. The patient's foot temperature distribution and / or neuropathy level can be stored in a storage medium maintained by the computer server.

[0106] Furthermore, unless the medical staff determines different thresholds after viewing the patient's foot thermal imaging data: distance line A5, second maximum horizontal line difference A7 and VPT level, the thresholds will be determined by the computer unit and / or server and / or mobile terminal through the steps of the present invention.

[0107] Throughout the text, the features referred to as “preferably” are merely optional and should not be understood as having to be set. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.

[0108] It should be noted that the above specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention description and its drawings are illustrative and do not constitute a limitation of the claims. The protection scope of the present invention is defined by the claims and their equivalents.

Claims

1. A diabetic foot protection device, characterized in that: The device comprises: A computer unit; and a force sensor for monitoring the ground reaction force of the patient's foot and a temperature sensor for monitoring the temperature of the patient's foot connected to the computer unit; The computer unit determines the patient's behavior type based on the ground reaction force of the patient's foot monitored by the force sensor and controls the temperature sensor. The force sensor determines the patient's behavior type based on the ground reaction force of the patient's foot monitored by the force sensor. At least three force sensors are provided, wherein the first force sensor is provided on the side of the sole of the patient close to the big toe, the second force sensor is provided on the side of the sole of the patient away from the big toe, and the third sensor is provided on the heel of the patient. The first force sensor sends the monitored ground reaction force to the computer unit, so that the computer unit processes and controls the temperature sensor. The computer unit classifies the patient's behavior type into at least four behaviors based on the patient's weight through the ground reaction force sent by the first force sensor and activates the temperature sensor, wherein the computer unit determines the behavior type through the relationship between the ground reaction force and the patient's weight, and the patient can improve the analysis quality of the computer unit by determining the behavior type in which he / she participates in the computer unit; The computer unit determines the patient's temperature change based on the patient's foot temperature monitored by the temperature sensor and controls the force sensor, The fifth temperature sensor disposed at the sole of the patient's foot sends the monitored temperature of the patient's foot to the computer unit so that the computer unit processes and controls the force sensor. The computer unit determines the temperature change of the patient's foot through the temperature data sent by the fifth temperature sensor, and when the temperature of the patient's foot has a continuous upward trend, the computer unit starts and determines the patient's current behavior type and the ground reaction force at each position of the patient's foot based on the data sent by the second force sensor and the third force sensor. The computer unit provides corrective measures to the patient based on the patient's current activity type and the ground reaction forces at various locations of the patient's foot.

2. The diabetic foot protection device according to claim 1, characterized in that: There are at least six temperature sensors, wherein the first temperature sensor is arranged at the big toe of the patient's foot, the second temperature sensor is arranged at the arch of the patient's foot, the third temperature sensor is arranged at the heel of the patient, and the fourth temperature sensor and the sixth temperature sensor are arranged at the sole of the patient's foot.

3. The diabetic foot protection device according to claim 2, characterized in that: The computer unit determines the patient's current foot information and the warning information corresponding to the current foot information based on at least one of the ground reaction force of the patient's foot monitored by the force sensor and the patient's foot temperature monitored by the temperature sensor; The warning information is prioritized in a differentiated manner, wherein the differentiation can be at least first limited by time; In the case where the computer unit responds to the current foot information to perform a corresponding action, the computer unit increases the priority of the warning information corresponding to the current foot information in a linear growth manner over time, so that the computer unit can provide corrective measures in a manner having the difference.

4. The diabetic foot protection device according to claim 3, characterized in that: Based on at least four behaviors of the patient, a standardized time corresponding to the behaviors is established, and the priority of the warning information is increased by using the standardized time as a second limitation for characterizing the patient's foot status.

5. The diabetic foot protection device according to claim 4, characterized in that: The device also includes: a tactile actuator for providing vibration stimulation to measure the patient's vibration perception threshold level; The temperature sensor is used to measure the temperature difference between the left and right feet of the patient at the same position to calibrate the temperature sensor, and a safety threshold is established on the area at the same position of the left and right feet of the patient. The safety threshold of the patient's foot temperature is proportionally adjusted according to the degree of the patient's foot ulcer based on the vibration perception threshold level measured by the tactile actuator.

6. The diabetic foot protection device according to claim 5, characterized in that: The formula for adjusting the safety threshold of the patient's foot temperature based on the different levels of neuropathy in the patient's left and right feet is: Maximum horizontal line difference = (normalized temperature of left foot × neuropathy level / 100) - (normalized temperature of right foot * neuropathy level / 100); where, The normalized temperature of the left foot and the normalized temperature of the right foot are obtained during the process of establishing the safety threshold of the patient's foot temperature, and the maximum horizontal line difference is used to reduce the difference between the patient's left foot and right foot.

7. The diabetic foot protection device according to claim 6, characterized in that: The computer unit compares the change in the patient's foot temperature to a calibrated safety threshold, If any parameter exceeds the safety threshold, the computer unit will issue an alarm to the patient and / or designated medical professional, and when any parameter exceeds the safety threshold, tactile stimulation is transmitted to the tactile actuator embedded in the protective pad, and the computer unit transmits the alarm to the patient's mobile terminal in the form of an audio and / or text message and is used to explain the nature of the alarm.

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