CN115644849A - A diabetic foot ulcer risk monitoring and intelligent protection system and its application method - Google Patents

Abstract

The invention discloses a diabetic foot ulcer risk monitoring and intelligent protection system and a use method thereof, wherein the protection system comprises an intelligent shoe (1), and the intelligent shoe (1) is connected with an intelligent terminal device (2) in a wireless connection mode; the intelligent shoe is characterized in that a main control board module (3), a foot ulcer risk monitoring module (4) or a temperature control protection module (5), a pneumatic pressure protection module (6), a vibration protection module (7) and a power supply module (8) are arranged in the intelligent shoe (1). The using method comprises the following steps: the foot ulcer risk monitoring module is used for measuring the foot condition of the diabetic in real time or periodically, and the intelligent terminal selects a corresponding protection means according to the collected actual condition of the diabetic. The invention has the characteristics of monitoring the foot ulcer state of the diabetic and carrying out protection intervention.

Description

A diabetic foot ulcer risk monitoring and intelligent protection system and its application method

technical field

The invention relates to a diabetic foot ulcer device, in particular to a diabetic foot ulcer risk monitoring and intelligent protection system and its use method.

Background technique

Diabetic foot ulcer is one of the most serious complications of diabetes, which has the characteristics of refractory, easy to relapse, high disability rate, and high treatment cost. Therefore, risk prediction and protective intervention on the feet of diabetic patients with high risk of foot ulcers can help reduce the risk of foot ulcers.

Abnormal pressure distribution or stress concentration on the sole of the foot will further cause damage to the foot tissue of diabetic patients and worsen ulcers; there will be potential inflammation before skin damage and ulceration, which may appear as an increase in the temperature difference between the skin of the foot; at the same time, skin temperature is also used for Reflects the level of blood flow in the skin. Therefore, it is necessary to monitor and evaluate the daily plantar pressure and plantar skin temperature of diabetic patients.

Diabetic foot microcirculation dysfunction will affect the blood supply of foot tissue and the protective response ability of blood flow to external adverse stimuli. Therefore, it is necessary to improve the blood supply level of microcirculation in the feet of diabetic patients and enhance the protective response ability of the microcirculation of the foot soft tissue under external mechanical stimulation.

Pneumatic positive and negative pressure stimulation is a physical intervention that improves blood circulation in limbs by applying uniform and regular mechanical force to the limbs. Positive pressure mechanical stimulation mainly increases blood flow through mechanisms such as increasing the arteriovenous pressure difference, increasing the production of endothelial relaxation substances in blood vessels, and promoting the suspension of venule-arteriole reflexes. Negative pressure mechanical stimulation mainly promotes microcirculation in local tissues by promoting vasodilation, increasing metabolism, increasing tissue nutrient absorption and waste discharge.

Vibration stimulation can induce the production and expression of tissue endothelial relaxation substances through the vertical and horizontal forces on the skin tissue, and induce the multisensory receptors on the skin surface to generate nerve impulses, promote the release of neuropeptides, and induce microvascular dilation, thereby increase blood flow. Furthermore, vibration has been shown to alleviate muscle tissue damage and oxidative damage from accumulated mechanical forces.

At the same time, increasing tissue temperature can help promote peripheral circulation, thereby increasing tissue nutrition and reducing infection sensitivity; reducing tissue temperature can help alleviate the increase in oxidative stress adverse reactions in the tissue caused by plantar pressure load, and reduce tissue occurrence. Chance of pressure congestive injury.

However, there is no such device currently used in high-risk diabetic foot patients, and it is urgent to develop a device that can monitor the status of diabetic foot ulcers and perform protective interventions.

Contents of the invention

The purpose of the present invention is to provide a diabetic foot ulcer risk monitoring and intelligent protection system and its use method. The invention has the characteristics of being able to monitor the state of diabetic patients' foot ulcers and perform preventive intervention.

The technical solution of the present invention: a diabetic foot ulcer risk monitoring and intelligent protection system, including smart shoes, which are connected to smart terminal equipment through wireless connection; the smart shoes are equipped with a main control board module, foot ulcer risk monitoring Module or temperature control protection module, pneumatic pressure protection module, vibration protection module and power supply module.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the smart shoe includes a shoe body, an external box is provided at the back of the shoe body, a bottom box is provided at the heel of the bottom of the shoe body, and a bottom box is installed inside the bottom box. There is a main control board module.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the shoe body is also provided with a switch and an indicator light.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the foot ulcer risk monitoring module includes a plantar pressure and temperature monitoring insole; the plantar pressure and temperature monitoring insole includes a monitoring insole body, and the monitoring insole body internal device There is a group of pressure sensors and temperature sensors. The upper surface of the monitoring insole body is provided with insole surface material; the bottom heel of the monitoring insole body is provided with an interface.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the pressure sensor and temperature sensor are respectively arranged on the big toe, the inner side of the metatarsal bone, the middle side of the metatarsal bone, the outer side of the metatarsal bone, the inner side of the arch of the foot, the outer side of the arch of the foot, Heel medial and heel lateral positions.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the microstructure of the monitoring insole body is a honeycomb structure, a cross-spaced beam structure or a cross-slanted column structure.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the pneumatic pressure protection module includes a pneumatic positive pressure protection unit, a pneumatic negative pressure protection unit and an air pump control unit, and the air pump control unit is located in the external box;

The pneumatic positive pressure protection unit includes shoe body positive pressure airbags located in the rear 1/2 upper area and the tongue area of the shoe body;

The pneumatic negative pressure protection unit includes a foot fitting airbag located at the ankle of the shoe body;

The air pump control unit includes a control valve, an air pump, an air pressure sensor and an air guide tube.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the vibration protection module includes two micro-vibrators respectively located in the inner metatarsal area and the outer metatarsal area of the shoe sole.

In the aforementioned diabetic foot ulcer risk monitoring and intelligent protection system, the temperature control protection module includes a temperature control insole, the middle layer of the temperature control insole is provided with interlaced resistance wires and semiconductor cooling chips, and the surface of the temperature control insole is provided with temperature monitoring. A temperature-controlled surface material is provided above the temperature-controlled insole; a temperature-controlled interface is provided at the heel of the temperature-controlled insole.

A method for using a diabetic foot ulcer risk monitoring and intelligent protection system, in which the smart shoes communicate with the intelligent terminal equipment through the main control board module through the bluetooth connection mode;

The foot ulcer risk monitoring module measures the plantar pressure distribution, peak value and average value of the plantar pressure, and the cumulative pressure load of the plantar in multiple regions of the diabetic patient's foot in real time or periodically to measure the level of external mechanical stimulation of the patient's foot; and Measure the skin temperature level of the foot of diabetic patients, the temperature difference between different areas of the same foot and the same area of different feet, to evaluate the skin blood flow level of the patient's foot and the inflammation inside the tissue;

Based on the data monitored by the foot ulcer risk monitoring module, the smart terminal device evaluates the risk of diabetic foot ulcers;

Then, the mobile smart terminal selects the corresponding protective measures and parameters according to the results of the risk assessment of diabetic foot ulcers;

The selection process of protective means is as follows:

1) Pneumatic pressure protection: When the patient's posterior tibial artery and dorsalis pedis artery have poor blood supply and the temperature of the entire foot is lower than the set threshold, positive pressure protection is selected; when the patient's entire foot blood supply is poor and the metabolism level is low, Choose negative pressure protection.

2) Vibration protection: When the blood supply in the plantar metatarsal area is poor, and the peak pressure and average pressure are higher than the set threshold, select vibration protection;

3) Temperature control protection: When the blood supply to the patient's foot is poor, the temperature of the entire sole of the foot is lower than the set threshold, and there is no inflammatory reaction in the foot, select the heating function in the temperature control protection; when the patient's plantar pressure peak and When the average value is higher than the set threshold, and the sole temperature difference is higher than the set threshold, select the cooling function in the temperature control protection.

Compared with the prior art, the present invention is composed of wirelessly connected smart shoes and smart terminal equipment, and a main control board module, a foot ulcer risk monitoring module/temperature control protection module, a pneumatic pressure protection module, and a vibration protection module are set in the smart shoes. Module and power supply module, the foot ulcer risk monitoring module can be used to measure the plantar pressure distribution, peak and average value of plantar pressure, and cumulative pressure load of the plantar in multiple areas of the diabetic patient's foot in real time or periodically, which can reflect the external pressure on the patient's foot The level of mechanical stimulation; and the measurement of the skin temperature level of the foot of diabetic patients, the temperature difference between different areas of the same foot and the same area of different feet can reflect the blood flow level of the skin of the patient's foot and the inflammation inside the tissue. According to the foot ulcer status collected by the foot ulcer risk monitoring module, the staff can control the temperature control protection module, pneumatic pressure protection module and vibration module to perform corresponding actions. The specific process is as follows:

1) Pneumatic pressure protection: Positive pressure protection mainly targets the posterior tibial artery, dorsalis pedis artery and microcirculation of the entire foot, improving its blood supply level; negative pressure protection mainly targets the microcirculation and metabolism level of the entire foot.

2) Vibration protection: Since the metatarsal area is the main stress-bearing area of the foot and there are many skin receptors, the vibration protection is mainly aimed at the low level of microcirculation blood supply and pressure tissue damage in the metatarsal area; when the blood supply of the plantar metatarsal area is poor It can be used when the pressure peak value and mean value are above a certain threshold.

3) Temperature control protection: heating protection is mainly aimed at the entire plantar artery and microcirculation to improve its blood supply level; when the patient's foot blood supply is poor, the entire plantar temperature is lower than a certain threshold, and at the same time the temperature difference between the two feet is used to analyze the foot It is recommended when no inflammatory reaction occurs. Refrigeration protection is mainly aimed at alleviating the adverse effects of plantar pressure load on foot tissue microcirculation during exercise; it is recommended to use when the accumulated pressure load on the sole of the foot exceeds a certain fixed threshold and the temperature difference of the sole of the foot is higher than the set threshold. If plantar inflammation is present, cooling protection is recommended over vibration protection.

In summary, the present invention has the characteristics of being able to monitor the state of foot ulcers in diabetic patients and perform preventive intervention.

Description of drawings

Fig. 1 is a functional module block diagram of the present invention;

Fig. 2 is a structural view of smart shoes;

Fig. 3 is a structural view of the foot ulcer risk monitoring module;

Fig. 4 is the distribution diagram of monitoring pressure sensor and temperature sensor on the insole body;

Fig. 5 is a structural view of the shoe body positive pressure airbag;

Fig. 6 is a structural view of the foot fitting airbag;

Fig. 7 is a structural view of a micro vibrator;

Fig. 8 is a structural view of the temperature control protection module;

Fig. 9 is a structural view in which the microstructure of the shoe body is honeycomb;

Fig. 10 is a structural view that the microstructure of the shoe body is a cross beam structure;

Fig. 11 is a structural view of the microstructure of the shoe body as a cross slanted column structure.

The marks in the drawings are: 1-smart shoes, 2-intelligent terminal equipment, 3-main control board module, 4-foot ulcer risk monitoring module, 5-temperature control protection module, 6-pneumatic pressure protection module, 7-vibration Protection module, 8-power module, 101-shoe body, 102-external box, 103-bottom box, 9-switch, 10-indicator, 401-monitoring insole body, 402-pressure sensor, 403-temperature sensor, 404- Insole surface material, 405-interface, 601-shoe body positive pressure airbag, 602-foot fitting airbag, 701-miniature vibrator, 501-temperature control insole, 502-resistance wire, 503-semiconductor cooling chip, 504-temperature monitoring Sensor, 505-temperature control surface material, 506-temperature control interface.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings and embodiments, but not as a basis for limiting the present invention.

Example. A diabetic foot ulcer risk monitoring and intelligent protection system is composed as shown in Figure 1 to Figure 11, including smart shoes and smart terminal devices connected by wireless connection, and the smart terminal devices can be mobile terminals.

The smart shoes are equipped with a foot ulcer risk monitoring module, a pneumatic pressure protection module, a vibration protection module, a temperature control protection module, a main control board module, a power supply module, a switch module and an indicator light.

The foot ulcer risk monitoring module and the temperature control protection module are carried out separately and are not placed in the shoe body at the same time.

The smart shoes and the mobile terminal communicate with each other through the main control board module using bluetooth transmission technology.

The external box is hung on the heel outside the shoe body, and the bottom box is placed at the bottom heel of the special shoe body.

The Foot Ulcer Risk Monitoring Module includes a pair of plantar pressure and plantar temperature monitoring insoles. The plantar pressure and plantar temperature monitoring insole is composed of a monitoring insole body, a pressure sensor, a temperature sensor, and an insole surface material. The plantar pressure and plantar temperature monitoring insole can measure the plantar pressure and temperature of 8 areas on the soles of both feet in real time. The 8 regions include the big toe, medial metatarsal, medial metatarsal, lateral metatarsal, medial arch, lateral arch, medial heel, lateral heel.

The body of the monitoring insole is a customized TPU material insole manufactured by 3D printing technology. According to the user's plantar geometry and plantar pressure distribution characteristics, the 3D printed microstructure of the special insole is personalized. First, according to the plantar geometry of the user's foot, especially the deformity of the foot bones, the surface geometry of the special insole is designed for full fit of the foot; then, according to the user's plantar pressure distribution characteristics, based on the plantar pressure-micro The structure mapping algorithm is used to design the microstructure of different regions of the special insole.

The plantar pressure-microstructure mapping algorithm is: according to the peak value of the plantar pressure, the average value of the pressure, and the value range of the pressure gradient, different microstructure unit shapes, the diameter of the inscribed circle of the unit hole, and the wall thickness between the unit holes are matched.

Microstructure shapes include: honeycomb hole, cross-spaced beam structure, and cross-slanted column structure, as shown in Figure 9-11 below.

The diameter of the inscribed circle of the unit hole is respectively set as: honeycomb hole (2.5mm, 3.0mm, 3.5mm, 4.0mm, 5.0mm), cross beam structure (1.5mm, 2.0mm, 2.5mm, 3.0mm, 3.5mm, 4.0mm), crossed oblique column structure (1.4mm, 1.6mm, 1.8mm, 2.0mm).

The wall thickness between the unit holes is respectively set as: 0.4mm, 0.8mm

When the peak value of plantar pressure and the average value of plantar pressure are large, the microstructure unit with the structural shape of cross-spaced beam should be selected; When the peak value of the bottom pressure and the average value of the plantar pressure are small, the honeycomb-shaped microstructure unit should be selected; the larger the value, the larger the diameter of the inscribed circle of the matched microstructure unit hole, and the smaller the wall thickness between the unit pores.

In areas with large plantar pressure gradients, a gradual transition of different microstructural units should be performed. Usually the shape of the microstructure unit is the same. According to the changing trend of the plantar pressure gradient, the diameter of the microstructure support column and the area of the support unit are gradually increased or decreased to further homogenize the pressure distribution and reduce the pressure gradient.

The foot ulcer risk monitoring module is connected to the main control board module by monitoring the interface at the bottom heel of the insole body. After receiving the monitoring instruction transmitted by the mobile phone terminal, the main control board module controls the foot ulcer risk monitoring module to measure the plantar pressure and plantar temperature of 8 areas on the sole of the foot. The main control board module transmits the measured plantar pressure and plantar temperature data to the mobile phone terminal in real time, and displays them in real time on the mobile terminal.

The pneumatic pressure protection module includes a pneumatic positive pressure protection unit, a pneumatic negative pressure protection unit, and an air pump control unit; the air pump control unit is built in an external box and consists of a control valve, an air pump, an air pressure sensor, and an air guide tube.

Pneumatic positive pressure protection unit, including shoe body positive pressure airbags. The positive pressure airbag of the shoe body is a TPU material with a special shape, and is built in the rear 1/2 upper area and the tongue area of the shoe body (as shown in Figure 5, the left side of the figure is the airbag at the upper, and the right side is the airbag at the tongue ). The air pump control unit is connected to the positive pressure airbag of the shoe body through the airbag interface inside the external box, and connected to the main control board module in the bottom box through the data cable built in the external box. The main control board module controls the air pump control unit after receiving the instruction transmitted by the mobile phone terminal, so as to control the inflation and deflation functions of the shoe body positive pressure airbag in the shoe body. The main control board module transmits the execution parameters of the air pump control unit to the mobile phone terminal in real time, and displays them in real time on the mobile phone terminal.

The pneumatic positive pressure protection unit adjusts the positive pressure compression on the dorsalis pedis artery and posterior tibial artery by controlling the air pump inflation pressure and inflation and deflation frequency, so as to achieve periodic emptying of foot venous blood and increase arteriovenous pressure difference , Increase the shear force on the foot artery endothelial cells, and enhance the release of vasodilation substances.

The specific control method of the pneumatic positive pressure protection unit is as follows:

According to the physiological and pathological characteristics of the user's lower limbs, the staff controls the pneumatic positive pressure protection unit to adjust the inflation pressure and inflation and deflation frequency of the air pump.

The inflation pressure (P) of the air pump is determined by the vascular mechanical characteristics of the user's foot and the force conduction efficiency of the soft tissue. Vascular mechanical characteristics include arterial pressure (P _a ) and venous pressure (P _v ). Soft tissue force conduction efficiency includes two parameters: soft tissue thickness (T) and soft tissue elastic modulus (e). Set the inflation pressure of the air pump to be transmitted to the blood vessel wall through the limbs as P _p , which must satisfy P _v <P _p <P _a . The relationship between the air pump inflation pressure (P) and the force on the vessel wall (P _p ) is shown in the following formula:

P×&=P _p ;

Among them, & is the force conduction coefficient of the limb. The relationship between the force conduction coefficient of the limb and the soft tissue thickness and soft tissue elastic modulus is shown in the following formula:

&=k×(e÷T);

Among them, k is a coefficient. The smaller the soft tissue thickness of the foot, the greater the elastic modulus of the soft tissue, and the smaller the conduction coefficient of the limbs, the less force loss the air pump inflation pressure passes through the limbs to the vessel wall, and the greater the effective pressure on the vessel wall.

The inflation and deflation frequency of the air pump is determined by the foot blood circulation period (T ₁ ) and the venous emptying time (T ₂ ). The relationship between the inflation (T _i ) and deflation (T _d ) time (the reciprocal of the inflation and deflation frequency) of a single group of air pumps and the foot blood circulation cycle and venous emptying time is as follows:

T ₁ <T _i +T _d ;

T _d >T ₂ .

The pneumatic negative pressure protection unit includes a foot fitting airbag, which is made of TPU material in the shape of a foot cover. Its shape and size are customized according to the shape and size of the user's foot, and there is a closed opening design at the ankle.

The air pump control unit is connected to the foot-fitting airbag through the airbag interface inside the external box, and the main control board module controls the air pump control unit after receiving the instruction transmitted by the mobile phone terminal, thereby controlling the inhalation of the foot-fitting airbag , deflation function. The main control board module transmits the execution parameters of the air pump control module to the mobile phone terminal in real time, and displays them in real time on the mobile phone terminal.

The pneumatic negative pressure protection unit adjusts the negative pressure suction to the foot tissue by controlling the air pump suction pressure and suction time, so as to improve the local microcirculation of the foot tissue, change the physiological regulation activities, and strengthen the blood vessel wall. The permeability, the purpose of improving the level of local metabolism.

The specific control method of the pneumatic negative pressure protection unit:

The inspiratory pressure and inhalation time of the air pump are determined by the microcirculation mechanical response and physiological regulation characteristics of the user's foot. The inspiratory pressure is usually between -375 and -150mmHg, and the inspiratory time is usually between 5-20 minutes. The higher the mechanical response ability and physiological regulation level of the user's foot microcirculation, the greater the applicable inhalation pressure and the longer the inhalation time. Normally, the higher the mechanical response ability and physiological regulation level of the user's foot microcirculation, they are divided into three ranges: high, medium, and low, respectively, corresponding to the inspiratory pressure and inspiratory pressure in the three ranges from large to small. time value.

Among them, the test method for the mechanical response ability of foot microcirculation is: in a constant room temperature environment, measure the blood flow baseline value of the big toe of the user's supine position for 5 minutes; keep the body and foot posture unchanged, the user's foot Apply a pressure of 300mmHg on the belly of the big toe for 3 minutes; after removing the pressure, immediately measure the blood flow of the big toe in the supine position for 5 minutes. The mean value is used to calculate the baseline blood flow of the big toe of the user's foot as SBF _b , and the peak blood flow SBF _p of the big toe of the plantar big toe after the pressure is removed is calculated. The mechanical response capability of the foot microcirculation (SBF _r ) is set as follows:

SBF _r =k×(SBF _p ÷ SBF _b ); wherein, k is a coefficient.

The physiological regulation level of the microcirculation of the foot is calculated in the frequency domain by using the wavelet transform algorithm to calculate the oscillation waveform of the baseline blood flow in the abdomen of the big toe, and the absolute value of the amplitude in the frequency domain is used to characterize the physiological regulation level of the microcirculation .

Vibration protection module, including 2 miniature vibrators. The two miniature vibrators are respectively placed on the inside area of the metatarsal bone and the outside area of the metatarsal bone on the sole of the shoe body.

The vibration protection module is connected with the main control board module in the bottom box through a data cable. The main control board module controls the vibration control module after receiving the instruction transmitted by the mobile phone terminal, so as to control the vibration function of the sole micro-vibrator. The main control board module transmits the execution parameters of the vibration control module to the mobile phone terminal in real time, and displays them in real time on the mobile phone terminal.

The vibration protection module adjusts the nerve regulation activity of the foot skin receptors and the dilation regulation activity of microvessels by controlling the vibration amplitude and frequency of the vibrator, so as to achieve the purpose of promoting microvascular relaxation and improving the level of local microcirculation.

The specific control method of the vibration protection module:

Vibration amplitude: The applicable vibration amplitude is determined by the thickness of the user's plantar skin tissue, usually 0.5mm, 1mm, 2mm. The thicker the skin tissue, the greater the applicable vibration amplitude.

Vibration frequency: The applicable vibration frequency is determined by the sensitive characteristics of the vibration sensory body of the user's foot skin.

The temperature control protection module includes two functions of heating protection and cooling protection. It specifically includes temperature-controlled insoles. The middle layer of the temperature-controlled insoles has built-in staggered distribution of resistance wires and semiconductor cooling chips. Two temperature monitoring sensors are embedded in the surface of the temperature-controlled insoles. There is an insole surface material on the top of the temperature-controlled insoles.

The embedded temperature monitoring sensor can monitor the temperature of the heating resistance wire and the semiconductor cooling chip, so as to realize the control and feedback of the heating module function. The temperature monitoring sensor is used to monitor the heating or cooling temperature of the insole, and accurately feedback the temperature of the insole by comparing the measured values of the two temperature sensors.

The temperature control protection module is connected to the main control board module through the temperature control interface at the bottom heel of the temperature control insole. The main control board module controls the temperature control and protection module after receiving the instruction transmitted by the mobile phone terminal, thereby controlling the heating and cooling functions of the insole. The main control board module transmits the execution parameters of the heating control module to the mobile phone terminal in real time, and displays them in real time on the mobile phone terminal.

The heating function of the temperature control protection module is to control the heating temperature and heating rate of the special insole through the heating resistance wire, so as to achieve the purpose of promoting blood circulation; the cooling function of the temperature control protection module is to control the cooling of the special insole through the semiconductor refrigeration chip. Temperature, cooling rate, so as to achieve the purpose of relieving tissue ischemia, pressure injury and inflammatory response caused by plantar pressure load on soft tissue during exercise.

The specific control method of the temperature control protection module:

Heating module:

The heating temperature is set according to the basic temperature of the foot. The basic temperature of the foot is divided into three ranges of low, medium and high, and the corresponding heating temperature ranges are low, medium and high (the minimum and maximum temperatures of the low, medium and high heating temperature ranges are respectively: 25/30°C, 30/35°C, 35/40°C).

Heating rate: divided into high, medium and low levels, indicating the amplitude of the heating rate. The amplitude of the heating rate is determined by the user's foot neuropathy degree. The degree of neuropathy is divided into three levels: none, mild, moderate and above, corresponding to high, medium and low heating rates respectively.

Refrigeration module:

The cooling temperature is set according to the base temperature of the foot. The basic temperature of the foot is divided into three ranges of low, medium and high, and the corresponding cooling temperature ranges are low, medium and high (the minimum and maximum temperatures of the low, medium and high cooling ranges are respectively: 20/25°C, 25/30℃, 30/35℃)

Cooling rate: It is divided into high, medium and low levels, indicating the amplitude of the cooling rate. The magnitude of the cooling rate is determined by the degree of neuropathy in the user's foot. The degree of neuropathy is divided into three levels: none, mild, moderate and above, corresponding to high, medium and low heating rates.

The temperature-controlled surface material and the insole surface material are special materials with breathable and sweat-absorbing functions, and the surface layer is coated with nano-bacteriostatic materials to maintain a healthy external microenvironment for diabetic feet and reduce the chance of foot tissue ulcers getting worse.

The mobile terminal can display the data measured by the smart shoe foot ulcer risk monitoring module, control the smart shoe pneumatic pressure protection module, vibration protection module, and temperature control protection module and display the protection process.

The specific application method of the present invention is: using the foot ulcer risk monitoring module to measure the plantar pressure distribution, peak value and average value of plantar pressure, and cumulative pressure load of the plantar of diabetic patients in real time or regularly in multiple areas of the foot, so as to evaluate the patient's foot The level of external mechanical stimulation; as well as measuring the skin temperature level of diabetic patients' feet, the temperature difference between different areas of the same side of the foot and the same area of different feet, so as to evaluate the skin blood flow level of the patient's foot and the inflammation inside the tissue; comprehensive The above data analysis results evaluate the risk of foot ulcers in diabetic patients, and provide a data basis for the formulation of foot protection measures and personalized parameters.

According to the risk assessment results of foot ulcers, the intelligent algorithm of the mobile terminal recommends protective measures and parameters.

The recommended principles of protective measures are:

1) Pneumatic pressure protection: Positive pressure protection is mainly aimed at the entire posterior tibial artery, dorsalis pedis artery and microcirculation to improve the blood supply level; threshold is recommended. Negative pressure protection is mainly aimed at the microcirculation and metabolism level of the whole foot; it is recommended to be used when the blood supply to the whole foot of the patient is poor and the metabolism level is low.

2) Vibration protection: Since the metatarsal area is the main stress-bearing area of the foot and there are many skin receptors, the vibration protection is mainly aimed at the low level of microcirculation blood supply and pressure tissue damage in the metatarsal area; when the blood supply of the plantar metatarsal area is poor Recommended when , peak and mean pressures are above a certain threshold.

3) Temperature control protection: heating protection is mainly aimed at the entire plantar artery and microcirculation to improve its blood supply level; when the patient's foot blood supply is poor, the entire plantar temperature is lower than a certain threshold, and at the same time the temperature difference between the two feet is used to analyze the foot It is recommended when no inflammatory reaction occurs. Refrigeration protection is mainly aimed at alleviating the adverse effects of plantar pressure load on foot tissue microcirculation during exercise; it is recommended to use when the accumulated pressure load on the sole of the foot exceeds a certain fixed threshold and the temperature difference of the sole of the foot is higher than the set threshold. If plantar inflammation is present, cooling protection is recommended over vibration protection. Protection parameters include high-level, medium-level, and low-level protection, corresponding to different types and degrees of diabetic foot ulcer risk assessment results.

Claims (10)

1. A diabetic foot ulcer risk monitoring and intelligent protection system, characterized in that: comprising smart shoes (1), the smart shoes (1) are connected to the smart terminal equipment (2) via a wireless connection; the smart shoes (1) It is equipped with a main control board module (3), a foot ulcer risk monitoring module (4) or a temperature control protection module (5), a pneumatic pressure protection module (6), a vibration protection module (7) and a power supply module (8). 2. A kind of diabetic foot ulcer risk monitoring and intelligent protection system according to claim 1, characterized in that: the smart shoe (1) includes a shoe body (101), and the rear upper part of the shoe body (101) is provided with There is an external box (102), a bottom box (103) is arranged at the heel of the bottom of the shoe body (101), and a main control board module (3) is arranged in the bottom box (103). 3. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 2, characterized in that: the shoe body (101) is also provided with a switch (9) and an indicator light (10). 4. A kind of diabetic foot ulcer risk monitoring and intelligent protection system according to claim 1, characterized in that: said foot ulcer risk monitoring module (4) includes plantar pressure and temperature monitoring insole; said plantar pressure and The temperature monitoring insole includes a monitoring insole body (401), a group of pressure sensors (402) and a temperature sensor (403) are arranged in the monitoring insole body (401), and an insole surface material (404) is arranged on the upper surface of the monitoring insole body (401); An interface (405) is provided at the bottom heel of the monitoring insole body (401). 5. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 4, characterized in that: the pressure sensor (402) and the temperature sensor (403) are respectively arranged on the big toe of the monitoring insole body (401) , Medial metatarsal, medial metatarsal, lateral metatarsal, medial arch, lateral arch, medial heel, and lateral heel. 6. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 5, characterized in that: the microstructure of the monitoring insole body (401) is honeycomb, intersecting spacer beam structure or intersecting oblique column structure. 7. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 2, characterized in that: the pneumatic pressure protection module (6) includes a pneumatic positive pressure protection unit, a pneumatic negative pressure protection unit and an air pump control unit , and the air pump control unit is located in the external box (102); The pneumatic positive pressure protection unit includes shoe body positive pressure airbags (601) located in the rear 1/2 upper area and the tongue area of the shoe body; The pneumatic negative pressure protection unit includes a foot fitting airbag (602) located at the ankle of the shoe body; The air pump control unit includes a control valve, an air pump, an air pressure sensor and an air guide tube. 8. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 2, characterized in that: the vibration protection module (7) includes two vibration protection modules respectively located in the inner metatarsal area and the outer metatarsal area of the shoe body (101). Micro vibrator (701). 9. A diabetic foot ulcer risk monitoring and intelligent protection system according to claim 1, characterized in that: the temperature control protection module (5) includes a temperature control insole (501), and the middle layer of the temperature control insole (501) is provided with Resistance wires (502) and semiconductor cooling sheets (503) interlaced with each other, a temperature monitoring sensor (504) is provided on the surface of the temperature-controlled insole (501), and a temperature-controlled surface material (505) is provided above the temperature-controlled insole (501) ; The temperature-controlled insole (501) is provided with a temperature-controlled interface (506) at the heel of the foot. 10. The method of using the diabetic foot ulcer risk monitoring and intelligent protection system according to any one of claims 1-9, characterized in that: the smart shoes use the Bluetooth connection method to communicate with the smart terminal equipment through the main control board module; The foot ulcer risk monitoring module measures the plantar pressure distribution, peak value and average value of the plantar pressure, and the cumulative pressure load of the plantar in multiple areas of the diabetic patient's foot in real time or periodically to determine the level of external mechanical stimulation of the patient's foot; And measure the skin temperature level of diabetic patients' feet, the temperature difference between different areas of the same side of the foot and the same area of different feet, so as to judge the blood flow level of the skin of the patient's foot and the inflammation inside the tissue; Based on the data monitored by the foot ulcer risk monitoring module, the intelligent terminal device judges the risk of diabetic foot ulcers; Then, the mobile intelligent terminal selects the corresponding protective measures and parameters according to the results of the judgment of the risk of foot ulcers in diabetic patients; The selection process of protective means is as follows: 1) Pneumatic pressure protection: When the patient's posterior tibial artery and dorsalis pedis artery have poor blood supply and the temperature of the entire foot is lower than the set threshold, positive pressure protection is selected; when the patient's entire foot blood supply is poor and the metabolism level is low, Choose negative pressure protection; 2) Vibration protection: When the blood supply in the plantar metatarsal area is poor, and the peak pressure and average pressure are higher than the set threshold, select vibration protection; 3) Temperature control protection: When the blood supply to the patient's foot is poor, the temperature of the entire sole of the foot is lower than the set threshold, and there is no inflammatory reaction in the foot, select the heating function in the temperature control protection; when the patient's plantar pressure peak and When the average value is higher than the set threshold, and the sole temperature difference is higher than the set threshold, select the cooling function in the temperature control protection.

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