CN115644849A - Diabetes foot ulcer risk monitoring and intelligent protection system and use method - Google Patents
Diabetes foot ulcer risk monitoring and intelligent protection system and use method Download PDFInfo
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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
Technical Field
The invention relates to equipment for diabetic foot ulcer, in particular to a diabetic foot ulcer risk monitoring and intelligent protection system and a using method thereof.
Background
Diabetic foot ulcer is one of the most serious complications of diabetes, and has the characteristics of difficult treatment, easy relapse, high disability rate, high treatment cost and the like. Therefore, risk prediction and protection intervention are carried out on the foot of the diabetic with high-risk foot ulcer, and the risk of foot ulcer occurrence is favorably reduced.
Abnormal plantar pressure distribution or stress concentration can further cause damage and ulcer deterioration of foot tissues of diabetics; potential inflammation occurs before the skin is broken and ulcerated, which may be manifested as an increase in the temperature difference of the foot skin; at the same time, skin temperature is also used to reflect skin blood flow levels. Therefore, it is necessary to monitor and evaluate the daily plantar pressure and plantar skin temperature of diabetic patients.
The microcirculation dysfunction of the foot of a diabetic can affect the blood supply of foot tissues and the protective response capability of the blood flow to external adverse stimuli. Therefore, the microcirculation blood supply level of the feet of the diabetic is improved, and the protective response capability of the foot microcirculation under the external mechanical force stimulation is enhanced.
Pneumatic positive and negative pressure stimulation is a physical intervention that improves limb blood circulation by applying uniform, regular mechanical forces to the limb. The positive pressure mechanical stimulation increases blood flow mainly by increasing arteriovenous pressure difference, increasing blood vessel production of endothelium relaxing substances, and promoting arteriovenous-arteriolar reflex pause. Negative pressure mechanical stimulation promotes local tissue microcirculation mainly by promoting vasodilation, increasing metabolic level, increasing tissue nutrient absorption and waste discharge.
The vibration stimulation can induce the generation and expression of tissue endothelium relaxation substances through vertical and horizontal forces generated on skin tissues, and induce the multi-sensory receptors on the skin surface to generate nerve pulses, so as to promote the release of neuropeptides and induce the expansion of microvessels, thereby increasing blood flow. Moreover, vibration has been shown to alleviate muscle tissue damage and oxidative damage caused by accumulated mechanical forces.
Meanwhile, the temperature of the tissue is increased, which is beneficial to promoting peripheral circulation, thereby increasing the nutrition of the tissue and reducing the infection sensitivity; the temperature of the tissues is reduced, which is helpful for relieving the increase of oxidative stress adverse reactions in the tissues caused by plantar pressure load and reducing the probability of pressure congestive injury of the tissues.
However, no such device is currently applied to patients with high risk of diabetic foot, and the development of a device capable of monitoring the ulcer state of diabetic foot and performing protective intervention is urgently needed.
Disclosure of Invention
The invention aims to provide a diabetic foot ulcer risk monitoring and intelligent protection system and a using method thereof. The invention has the characteristics of monitoring the foot ulcer state of the diabetic and carrying out protection intervention.
The technical scheme of the invention is as follows: a diabetic foot ulcer risk monitoring and intelligent protection system comprises intelligent shoes, wherein the intelligent shoes are connected with intelligent terminal equipment in a wireless connection mode; the intelligent shoe is internally provided with a main control board module, a foot ulcer risk monitoring module or a temperature control protection module, a pneumatic pressure protection module, a vibration protection module and a power supply module.
In the diabetes foot ulcer risk monitoring and intelligent protection system, the intelligent shoe comprises a shoe body, an outer hanging box is arranged at the back upper outside the shoe body, a bottom box is arranged at the heel of the bottom of the shoe body, and a main control board module is arranged in the bottom box.
In the risk monitoring and intelligent protection system for diabetic foot ulcer, the shoe body is further provided with a switch and an indicator light.
In the system for monitoring risk of diabetic foot ulcer and intelligently protecting diabetic foot ulcer, the module for monitoring risk of diabetic foot ulcer comprises a sole pressure monitoring insole and a sole temperature monitoring insole; the sole pressure and temperature monitoring insole comprises a monitoring insole body, a group of pressure sensors and temperature sensors are arranged in the monitoring insole body, and an insole surface layer material is arranged on the upper surface of the monitoring insole body; the bottom heel of the monitoring insole body is provided with a connector.
In the risk monitoring and intelligent protection system for diabetic foot ulcer, the pressure sensor and the temperature sensor are respectively arranged at the big toe, the inner side of the metatarsal, the middle side of the metatarsal, the outer side of the metatarsal, the inner side of the arch of foot, the outer side of the arch of foot, the inner side of the heel and the outer side of the heel of the monitoring insole body.
In the risk monitoring and intelligent protection system for diabetic foot ulcer, the microstructure of the monitoring insole body is a bee hole structure, a cross spacing beam structure or a cross inclined column structure.
In the above diabetes 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 hanging box;
the pneumatic positive pressure protection unit comprises shoe body positive pressure air bags positioned in a rear 1/2 upper area and a shoe tongue area of the shoe body;
the pneumatic negative pressure protection unit comprises a foot fit air bag positioned at the ankle of the shoe body;
the air pump control unit comprises a control valve, an air pump, an air pressure sensor and an air guide pipe.
In the risk monitoring and intelligent protection system for diabetic foot ulcer, the vibration protection module comprises 2 micro vibrators which are respectively positioned in the metatarsal inner area and the metatarsal outer area of the sole of the shoe body.
In the above diabetes foot ulcer risk monitoring and intelligent protection system, the temperature control protection module includes a temperature control insole, a middle layer of the temperature control insole is provided with resistance wires and semiconductor refrigeration sheets which are distributed in a staggered manner, a temperature monitoring sensor is arranged on the surface of the temperature control insole, and a temperature control surface layer material is arranged above the temperature control insole; the heel of the foot of the temperature control insole is provided with a temperature control interface.
A method for using a diabetic foot ulcer risk monitoring and intelligent protection system is characterized in that an intelligent shoe is in data intercommunication with intelligent terminal equipment through a main control board module by using a Bluetooth connection mode;
the foot ulcer risk monitoring module measures the plantar pressure distribution, the plantar pressure peak value and mean value and the plantar accumulated pressure load condition of a plurality of areas of the foot of a diabetic in real time or periodically so as to be used for measuring the level of the foot of the diabetic stimulated by external mechanical force; measuring the temperature level of the skin of the foot of the diabetic, the temperature difference conditions of different areas of the ipsilateral foot and the same area of different feet so as to evaluate the skin blood flow level and the tissue internal inflammation condition of the foot of the diabetic;
the intelligent terminal equipment evaluates the risk of the foot of the diabetic suffering from ulcer according to the data monitored by the foot ulcer risk monitoring module;
then, the mobile intelligent terminal selects corresponding protection means and parameters according to the evaluation result of the risk of foot ulcer of the diabetic;
the selection process of the protection means comprises the following steps:
1) Pneumatic pressure protection: when blood supply of a posterior tibial artery and an dorsal foot artery of a patient is poor and the temperature of the whole sole is lower than a set threshold value, positive pressure protection is selected; when the patient has poor blood supply to the entire foot and low metabolism levels, the negative pressure protection is selected.
2) Vibration protection: when the blood supply difference, the pressure peak value and the mean value of the metatarsal region of the sole are higher than a set threshold value, vibration protection is selected;
3) Temperature control protection: when the blood supply of the feet of a patient is poor, the temperature of the whole sole is lower than a set threshold value, and meanwhile, the feet do not have inflammatory reaction, the heating function in temperature control protection is selected; when the peak value and the mean value of the sole pressure of a patient are higher than a set threshold value and the sole temperature difference is higher than the set threshold value, the refrigeration function in the temperature control protection is selected.
Compared with the prior art, the intelligent shoe consists of an intelligent shoe and an intelligent terminal device which are in wireless connection, a main control board module, a foot ulcer risk monitoring module/temperature control protection module, a pneumatic pressure protection module, a vibration protection module and a power supply module are arranged in the intelligent shoe, the foot ulcer risk monitoring module can be used for measuring the foot sole pressure distribution, the foot sole pressure peak value and mean value and the foot sole accumulated pressure load condition of a plurality of areas of the foot of a diabetic patient in real time or at regular intervals, and the level of stimulation of the foot of the diabetic patient by external mechanical force can be reflected; and measuring the temperature level of the foot skin of the diabetic, the temperature difference conditions of different areas of the ipsilateral foot and the same area of different feet, and reflecting the skin blood flow level and the tissue internal inflammation condition of the foot of the diabetic. The staff can control temperature control protection module, pneumatic pressure protection module and vibration module according to the foot ulcer state that foot ulcer risk monitoring module gathered and carry out corresponding action, and concrete process is as follows:
1) Pneumatic pressure protection: the positive pressure protection mainly aims at the whole posterior tibial artery, dorsal foot artery and microcirculation of the foot, and improves the blood supply level of the foot; negative pressure protection is primarily directed to the microcirculation and metabolic levels throughout the foot.
2) Vibration protection: because the metatarsal region is the main stress area of the sole of the foot and the skin receptors are more distributed, the vibration protection mainly aims at the low microcirculation blood supply level and the pressure tissue damage of the metatarsal region; it may be used when the plantar metatarsal region blood supply difference, the pressure peak and the mean are above a certain threshold.
3) Temperature control protection: the heating protection mainly aims at the whole plantar artery and microcirculation to improve the blood supply level; when the blood supply of the feet of a patient is poor, the temperature of the whole sole is lower than a certain threshold value, and the feet are analyzed to have no inflammatory reaction through the temperature difference of the feet, the use is recommended. The refrigeration protection mainly aims at relieving the adverse effect of plantar pressure load on foot tissue microcirculation in the exercise process; when the sole accumulated pressure load exceeds a certain fixed threshold value and the sole temperature difference is higher than a set threshold value, the sole accumulated pressure load is recommended to be used. If plantar inflammation is involved, refrigeration protection is more recommended than vibration protection.
In conclusion, the invention has the characteristics of monitoring the foot ulcer state of the diabetic and carrying out protective intervention.
Drawings
FIG. 1 is a functional block diagram of the present invention;
FIG. 2 is a structural view of a smart shoe;
FIG. 3 is a structural view of a foot ulcer risk monitoring module;
FIG. 4 is a distribution diagram of pressure sensors and temperature sensors on the monitoring insole body;
FIG. 5 is a structural view of the shoe positive pressure air bag;
FIG. 6 is a structural view of a foot-engaging bladder;
fig. 7 is a structural view of a micro-vibrator;
FIG. 8 is a structural view of a temperature controlled protective module;
FIG. 9 is a structural view of the shoe body microstructure as bee holes;
FIG. 10 is a structural view of a shoe body microstructure as a cross-spaced beam structure;
FIG. 11 is a structural view of a shoe body microstructure in a cross-diagonal configuration.
The symbols in the drawings are: 1-intelligent shoe, 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 supply module, 101-shoe body, 102-hanging box, 103-bottom box, 9-switch, 10-indicator light, 401-monitoring shoe pad body, 402-pressure sensor, 403-temperature sensor, 404-shoe pad surface layer material, 405-interface, 601-shoe body positive pressure air bag, 602-foot fitting air bag, 701-micro vibrator, 501-temperature control shoe pad, 502-resistance wire, 503-semiconductor refrigeration sheet, 504-temperature monitoring sensor, 505-temperature control surface layer material and 506-temperature control interface.
Detailed Description
The invention is further described with reference to the following figures and examples, which are not to be construed as limiting the invention.
Examples are given. The utility model provides a diabetes foot ulcer risk monitoring and intelligent protection system, constitutes as shown in fig. 1 to 11, includes intelligent shoes and intelligent terminal equipment that link to each other through the wireless connection mode, and intelligent terminal equipment can adopt cell-phone terminal.
Be equipped with foot ulcer risk monitoring module, pneumatic pressure protection module, vibration protection module, control by temperature change protection module, main control panel module, power module, switch module and pilot lamp in the intelligence shoes.
The foot ulcer risk monitoring module and the temperature control protection module are separately carried out and are not placed in the shoe body at the same time.
And data intercommunication is carried out between the intelligent shoes and the mobile phone terminal through the main control board module by utilizing a Bluetooth transmission technology.
The external hanging box is hung at the back upper outside the shoe body, and the bottom box is placed at the heel of the bottom of the special shoe body.
The foot ulcer risk monitoring module comprises a pair of sole pressure and sole temperature monitoring insoles. The sole pressure and sole temperature monitoring insole consists of a monitoring insole body, a pressure sensor, a temperature sensor and an insole surface layer material. The sole pressure and sole temperature monitoring insole can measure the sole pressure and temperature of 8 regions of soles of both feet in real time. The 8 areas include big toe, medial metatarsal, lateral metatarsal, medial arch, lateral arch, medial heel, lateral heel.
The monitoring insole body is a TPU material insole which is manufactured in a personalized and customized mode by utilizing a 3D printing technology. And (3) the 3D printing microstructure of the special insole is individually designed according to the geometrical shape and the pressure distribution characteristics of the sole of the foot of a user. Firstly, according to the foot bottom geometry of the foot of a user, particularly the foot skeleton deformity, the surface layer geometry of a special insole is subjected to foot full-fit design; and then, designing microstructures of different areas of the special insole based on a plantar pressure-microstructure mapping algorithm according to the plantar pressure distribution characteristics of a user.
The plantar pressure-microstructure mapping algorithm is as follows: according to the numerical ranges of the pressure peak value, the pressure mean value and the pressure gradient of the sole, different microstructure unit shapes, the diameter of the tangent circle in the unit hole and the wall thickness among the unit holes are matched.
The microstructure shape includes: bee holes, cross-spaced beam structures, cross-diagonal column structures, as shown in fig. 9-11 below.
The diameters of the tangent circles in the unit holes are respectively set as: bee holes (2.5 mm, 3.0mm, 3.5mm, 4.0mm, 5.0 mm), cross spacing beam structures ((1.5 mm, 2.0mm, 2.5mm, 3.0mm, 3.5mm, 4.0 mm), cross oblique column structures (1.4 mm, 1.6mm, 1.8mm, 2.0 mm).
The wall thicknesses of the unit holes are respectively set as follows: 0.4mm, 0.8mm
When the peak value of the sole pressure and the mean value of the sole pressure are larger, selecting a microstructure unit in the shape of a cross interval beam structure; when the peak value of the sole pressure and the mean value of the sole pressure are equal, the microstructure units with the shapes of crossed oblique columns are selected; when the peak value of the sole pressure and the mean value of the sole pressure are small, the micro-structural units in the shape of the bee holes are selected; the larger the value, the larger the diameter of the tangent circle in the unit hole of the matched microstructure, and the smaller the thickness of the wall between the unit hole.
In the area with larger plantar pressure gradient, gradual transition conversion of different microstructure units is required. Generally, the microstructure units are in the same shape, and the diameter of the microstructure supporting column and the area of the supporting unit are gradually increased or decreased according to the variation trend of the pressure gradient of the sole, so that the pressure distribution is further homogenized, and the pressure gradient is reduced.
The foot ulcer risk monitoring module is connected with the main control board module through an interface at the heel of the bottom of the monitoring insole body. The main control board module controls the foot ulcer risk monitoring module after receiving the monitoring instruction transmitted by the mobile phone terminal, and realizes measurement of sole pressure and sole temperature of 8 regions of the sole. The main control board module transmits the measured sole pressure and sole temperature data to the mobile phone terminal in real time and displays the data on the mobile phone terminal in real time.
The pneumatic pressure protection module comprises a pneumatic positive pressure protection unit, a pneumatic negative pressure protection unit and an air pump control unit; the air pump control unit is arranged in the external hanging box and consists of a control valve, an air pump, an air pressure sensor and an air guide pipe.
The pneumatic positive pressure protection unit comprises a shoe body positive pressure air bag. The shoe body positive pressure air bag is made of TPU materials with special shapes and is internally arranged in the rear 1/2 of an upper area and a tongue area of the shoe body (as shown in figure 5, the left side in the figure is provided with the air bag at the upper, and the right side is provided with the air bag at the tongue). The air pump control unit is connected with the positive pressure air bag of the shoe body through an air bag interface at the inner side of the outer hanging box and is connected with the main control board module in the bottom box through a data line arranged in the outer hanging box. The main control board module controls the air pump control unit after receiving the instruction transmitted by the mobile phone terminal, so that the inflation and deflation functions of the shoe positive pressure air bag in the shoe body are controlled. And 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 the execution parameters on the mobile phone terminal in real time.
The pneumatic positive pressure protection unit regulates positive pressure compression on the instep artery and the posterior tibial artery of the foot by controlling the inflation pressure and the inflation and deflation frequency of the air pump, so that the aims of periodically emptying the venous blood of the foot, improving the pressure difference of the artery and the vein, increasing the shearing force on endothelial cells of the arterial endothelial cells of the foot and enhancing the release of vasodilation substances are fulfilled.
The specific control method of the pneumatic positive pressure protection unit comprises the following steps:
the staff controls the pneumatic positive pressure protection unit to adjust the inflation pressure and the inflation and deflation frequency of the air pump according to the physiological and pathological characteristics of the lower limbs of the user.
The inflation pressure (P) of the air pump is determined by the vascular mechanical characteristics and the soft tissue force transmission efficiency of the foot of the user. The vascular mechanical characteristics include arterial pressure (P) a ) And venous pressure (P) v ) Two parameters. The soft tissue force transmission efficiency comprises two parameters of the thickness (T) of the soft tissue of the foot and the elastic modulus (e) of the soft tissue. The pressure of the inflation pressure of the air pump transmitted to the vessel wall through the limb is set to be P p Need to satisfy P v <P p <P a . The inflation pressure (P) of the air pump and the stress (P) on the vessel wall p ) Is shown by the following formula:
P×&=P p ;
wherein, & is the force transmission coefficient of the limb. The relationship between the force transmission coefficient of the limb and the soft tissue thickness and the soft tissue elastic modulus is shown as follows:
&=k×(e÷T);
where k is a coefficient. The smaller the thickness of the soft tissue of the foot is, the larger the elastic modulus of the soft tissue is, the smaller the conduction coefficient of the limb is, the less the force loss of the inflation pressure of the air pump is transmitted to the vascular wall through the limb, and finally the larger the effective pressure borne by the vascular wall is.
The frequency of inflation and deflation of the air pump is determined by the blood circulation period (T) of the foot 1 ) And venous drainage time (T) 2 ) And (6) determining. Single set of air pump inflation (T) i ) And discharge (T) d ) The time (reciprocal of the inflation and deflation frequency) of (f) is related to the blood circulation period and the venous emptying time of the foot as follows:
T 1 <T i +T d ;
T d >T 2 。
the pneumatic negative pressure protection unit comprises a foot fitting air bag, the foot fitting air bag is made of TPU materials in a foot sleeve shape, the shape and the size of the foot fitting air bag are customized according to the shape and the size of the foot of a user, and a closed opening is designed at the ankle.
The air pump control unit is connected with the foot fitting air bag through an air bag interface on the inner side of the outer hanging box, and the main control board module controls the air pump control unit after receiving an instruction transmitted by the mobile phone terminal, so that the air suction and air discharge functions of the foot fitting air bag are controlled. 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 the execution parameters on the mobile phone terminal in real time.
The pneumatic negative pressure protection unit adjusts the negative pressure suction force to the foot tissue by controlling the air suction pressure and the air suction time of the air pump, thereby achieving the purposes of improving the local microcirculation of the foot tissue, changing the physiological regulation and control activity, enhancing the permeability of the vessel wall and improving the local metabolism level.
The specific control method of the pneumatic negative pressure protection unit comprises the following steps:
the air suction pressure and the air suction duration of the air pump are determined by the micro-circulation mechanical response and physiological regulation and control characteristics of the feet of the user. The inspiratory pressure is typically between-375 and-150 mmHg and the inspiratory time period is typically between 5 and 20 minutes. The higher the mechanical response capability and physiological regulation level of foot microcirculation of a user, the higher the applicable inhalation pressure and the longer the inhalation duration. Generally, the higher the mechanical response capability and the physiological regulation level of the foot microcirculation of the user are divided into three ranges, namely a high range, a middle range and a low range, which correspond to the values of the inspiratory pressure and the inspiratory time from large to small.
The method for testing the foot microcirculation mechanical response capability comprises the following steps: measuring the blood flow baseline value of the abdominal part of the big toe of the sole in the supine position of the user for 5 minutes in a constant room temperature environment; keeping the body and foot posture unchanged, and applying 300mmHg pressure to the abdomen of the big toes and the toes of the sole of the user for 3 minutes; after the pressure is removed, standNamely, the blood flow value of the big toe and the abdomen of the sole of the supine position of the user is measured for 5 minutes. Calculating the SBF of the plantar big toe, toe and abdomen baseline blood flow of the user by taking the mean value b Calculating the peak SBF of the ventral blood flow of the big toe of the sole after the pressure is removed p Foot microcirculation mechanical response (SBF) r ) The capability is set as follows:
SBF r =k×(SBF p ÷SBF b ) (ii) a Where k is a coefficient.
The physiological regulation level of the foot microcirculation is that a wavelet transform algorithm is utilized to carry out frequency domain calculation on the oscillation waveform of the plantar big toe belly baseline blood flow, and the absolute value of the frequency domain amplitude is used for representing the physiological regulation level of the microcirculation.
The vibration protection module comprises 2 micro vibrators. The 2 miniature vibrators are respectively arranged in the metatarsal inner area and the metatarsal outer area of 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 line. And 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. And the main control board module transmits the execution parameters of the vibration control module to the mobile phone terminal in real time and displays the execution parameters on the mobile phone terminal in real time.
The vibration protection module regulates the nerve regulation and control activity of the foot skin receptor and the relaxation regulation and control activity of the microvessels by controlling the vibration amplitude and the frequency of the vibrator, so that the aims of promoting the vasodilatation of the microvessels and improving the local microcirculation level are fulfilled.
The specific control method of the vibration protection module comprises the following steps:
vibration amplitude: the amplitude of the applied vibrations is determined by the thickness of the skin tissue at the user's foot soles, and is typically 0.5mm,1mm,2mm. The thicker the skin tissue, the greater the amplitude of vibration that is applicable.
Vibration frequency: the sensitivity of the sensorial bodies to the vibration of the skin of the user's foot determines the applicable vibration frequency.
The temperature control protection module comprises two functions of heating protection and refrigerating protection. The shoe pad comprises a temperature control shoe pad body, wherein resistance wires and semiconductor refrigerating pieces which are distributed in a staggered mode are arranged in a middle layer of the temperature control shoe pad body, 2 temperature monitoring sensors are embedded in the surface layer of the temperature control shoe pad body, and a shoe pad surface layer material is arranged above the temperature control shoe pad body.
The embedded temperature monitoring sensor can monitor the temperature of the heating resistance wire and the semiconductor refrigerating sheet, so that the function of the heating module can be controlled and fed back. The temperature monitoring sensor is used for monitoring the heating or refrigerating temperature of the insole, and the temperature of the insole is accurately fed back by comparing the measured values of the two temperature sensors.
The temperature control protection module is connected with the main control board module through a temperature control interface at the heel of the bottom of the temperature control insole. And the main control board module controls the temperature control protection module after receiving the instruction transmitted by the mobile phone terminal, so as to control the heating and refrigerating functions of the insole. And the main control board module transmits the execution parameters of the heating control module to the mobile phone terminal in real time and displays the execution parameters on the mobile phone terminal in real time.
The heating function of the temperature control protection module is to control the heating temperature and the heating rate of the special insole through a heating resistance wire, thereby achieving the purpose of promoting blood circulation; the refrigeration function of the temperature control protection module is to control the refrigeration temperature and the cooling rate of the special insole through the semiconductor refrigeration sheet, thereby achieving the purpose of relieving tissue ischemia, pressure injury and inflammatory reaction caused by sole pressure load to soft tissues in the exercise process.
The specific control method of the temperature control protection module comprises the following steps:
a heating module:
the heating temperature is set according to the foot basic temperature. The foot basic temperature is divided into three ranges of low, middle and high, and the corresponding heating temperature ranges are low, middle and high (the lowest temperature and the highest temperature of the low, middle and high heating temperature ranges are respectively 25/30 ℃,30/35 ℃ and 35/40 ℃).
Heating rate: the high, middle and low gears are divided to represent the amplitude of the heating rate. The amplitude of which heating rate is adopted is determined by the degree of foot neuropathy of the user, and the degree of neuropathy is divided into three levels of none, mild, moderate and above, which correspond to three levels of high, medium and low heating rates respectively.
A refrigeration module:
the refrigeration temperature is set according to the foot base temperature. The foot basic temperature is divided into three ranges of low, middle and high, the corresponding refrigeration temperature ranges are low, middle and high (the lowest temperature and the highest temperature of the refrigeration degree ranges of the low, middle and high are respectively 20/25 ℃,25/30 ℃ and 30/35 ℃)
Cooling rate: the three grades of high, middle and low represent the amplitude of the cooling rate. The degree of neuropathy of the foot of the user determines which grade of the amplitude of the cooling rate is adopted, the degree of neuropathy is divided into three grades of none, mild, moderate and above, and the three grades respectively correspond to high, medium and low heating rates.
The temperature control surface layer material and the insole surface layer material are special materials with air permeability and sweat absorption functions, and the surface layers are coated with nano antibacterial materials so as to maintain the healthy external microenvironment of the diabetic foot and reduce the probability of foot tissue ulcer deterioration.
The mobile phone terminal can display data measured by the intelligent shoe foot ulcer risk monitoring module, and can control and display the protection process of the intelligent shoe pneumatic pressure protection module, the vibration protection module and the temperature control protection module.
The specific use method of the invention is as follows: measuring the plantar pressure distribution, the plantar pressure peak value and the mean value, and the plantar accumulated pressure load condition of a plurality of areas of the foot of a diabetic patient in real time or periodically by using a foot ulcer risk monitoring module so as to evaluate the level of the foot of the diabetic patient stimulated by external mechanical force; measuring the temperature level of the skin of the foot of the diabetic patient, the temperature difference conditions of different areas of the ipsilateral foot and the same area of different feet so as to evaluate the skin blood flow level and the tissue internal inflammation condition of the foot of the diabetic patient; and (3) integrating the data analysis results, evaluating the risk of foot ulcer of the diabetic, and providing data basis for the foot protection means and personalized parameter formulation.
And recommending protection means and parameters by a mobile phone terminal intelligent algorithm according to the foot ulcer risk evaluation result.
The recommended principle of the protection means is as follows:
1) Pneumatic pressure protection: the positive pressure protection mainly aims at the whole posterior tibial artery, dorsal plantar artery and microcirculation of the foot, and improves the blood supply level of the foot; when blood supply of the posterior tibial artery and the dorsal foot artery of a patient is poor and the whole sole temperature is lower than a certain threshold value, the use is recommended. The negative pressure protection is mainly aimed at the microcirculation and metabolism level of the whole foot; use is recommended when the patient has poor blood supply to the entire foot and low levels of metabolism.
2) Vibration protection: because the metatarsal region is the main stress area of the sole and the skin receptors are more distributed, the vibration protection mainly aims at the microcirculation low blood supply level and the pressure tissue damage of the metatarsal region; use is recommended when the plantar metatarsal area poor blood supply, pressure peaks and means are above a certain threshold.
3) Temperature control protection: the heating protection mainly aims at the whole plantar artery and microcirculation to improve the blood supply level; when the blood supply of the feet of a patient is poor, the temperature of the whole sole is lower than a certain threshold value, and the feet are analyzed to have no inflammatory reaction through the temperature difference of the feet, the use is recommended. The refrigeration protection mainly aims at relieving the adverse effect of plantar pressure load on foot tissue microcirculation in the exercise process; when the pressure load accumulated on the sole exceeds a certain fixed threshold value and the temperature difference of the sole is higher than a set threshold value, the use is recommended. If plantar inflammation is involved, refrigeration protection is more recommended than vibration protection. The protection parameters comprise high-level, middle-level and low-level protection, and respectively correspond to different types and degrees of diabetic foot ulcer risk assessment results.
Claims (10)
1. The utility model provides a diabetes foot ulcer risk monitoring and intelligent protection system which characterized in that: the intelligent shoe comprises an intelligent shoe (1), wherein 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).
2. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 1, characterized in that: the intelligent shoe (1) comprises a shoe body (101), an outer hanging box (102) is arranged at the back upper part outside the shoe body (101), a bottom box (103) is arranged at the back upper part at the bottom of the shoe body (101), and a main control board module (3) is arranged in the bottom box (103).
3. The system of claim 2, wherein the system comprises: the shoe body (101) is also provided with a switch (9) and an indicator light (10).
4. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 1, characterized in that: the foot ulcer risk monitoring module (4) comprises a sole pressure and temperature monitoring insole; the sole pressure and temperature monitoring insole comprises a monitoring insole body (401), a group of pressure sensors (402) and temperature sensors (403) are arranged in the monitoring insole body (401), and an insole surface layer material (404) is arranged on the upper surface of the monitoring insole body (401); an interface (405) is arranged at the heel part of the bottom of the monitoring insole body (401).
5. The system of claim 4, wherein the system comprises: the pressure sensor (402) and the temperature sensor (403) are respectively arranged at the big toe, the inner side of the metatarsal, the middle side of the metatarsal, the outer side of the metatarsal, the inner side of the arch, the outer side of the arch, the inner side of the heel and the outer side of the heel of the monitoring insole body (401).
6. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 5, characterized in that: the microstructure of the monitoring insole body (401) is a bee hole structure, a cross spacing beam structure or a cross inclined column structure.
7. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 2, characterized in that: the pneumatic pressure protection module (6) comprises 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 positioned in the outer hanging box (102);
the pneumatic positive pressure protection unit comprises a shoe body positive pressure air bag (601) positioned in the rear 1/2 upper area and the tongue area of the shoe body;
the pneumatic negative pressure protection unit comprises a foot fitting air bag (602) positioned at the ankle of the shoe body;
the air pump control unit comprises a control valve, an air pump, an air pressure sensor and an air guide pipe.
8. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 2, characterized in that: the vibration protection module (7) comprises 2 micro vibrators (701) which are respectively positioned in the metatarsal inner area and the metatarsal outer area of the sole of the shoe body (101).
9. The system for risk monitoring and intelligent protection of diabetic foot ulcers according to claim 1, characterized in that: the temperature control protection module (5) comprises a temperature control insole (501), a resistance wire (502) and a semiconductor refrigerating sheet (503) which are distributed in a mutually staggered manner are arranged in the middle layer of the temperature control insole (501), a temperature monitoring sensor (504) is arranged on the surface of the temperature control insole (501), and a temperature control surface layer material (505) is arranged above the temperature control insole (501); the heel of the foot of the temperature control insole (501) is provided with a temperature control interface (506).
10. A method of using the diabetic foot ulcer risk monitoring and intelligent protection system of any of claims 1-9, wherein: the intelligent shoe is in data intercommunication with the intelligent terminal equipment through the main control board module by using a Bluetooth connection mode;
the foot ulcer risk monitoring module measures the plantar pressure distribution, the plantar pressure peak value and mean value and the plantar accumulated pressure load condition of a plurality of areas of the foot of the diabetic patient in real time or periodically so as to judge the level of the foot of the diabetic patient stimulated by external mechanical force; measuring the temperature level of the foot skin of the diabetic, the temperature difference conditions of different areas of the ipsilateral foot and the same area of the different feet so as to judge the skin blood flow level of the foot of the diabetic and the inflammation condition inside the tissue;
the intelligent terminal equipment judges the risk of the foot of the diabetic suffering from the ulcer according to the data monitored by the foot ulcer risk monitoring module;
then, the mobile intelligent terminal selects corresponding protection means and parameters according to the judgment result of the diabetic foot ulcer risk;
the selection process of the protection means comprises the following steps:
1) Pneumatic pressure protection: when the blood supply of the posterior tibial artery and the dorsal foot artery of a patient is poor and the temperature of the whole sole is lower than a set threshold value, positive pressure protection is selected; when the blood supply of the whole foot of the patient is poor and the metabolism level is low, negative pressure protection is selected;
2) Vibration protection: when the blood supply difference, the pressure peak value and the mean value of the metatarsal region of the sole are higher than a set threshold value, vibration protection is selected;
3) Temperature control protection: when the blood supply of the feet of a patient is poor, the temperature of the whole sole is lower than a set threshold value, and meanwhile, the feet do not have inflammatory reaction, the heating function in temperature control protection is selected; when the peak value and the mean value of the sole pressure of a patient are higher than a set threshold value and the sole temperature difference is higher than the set threshold value, the refrigeration function in the temperature control protection is selected.
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