A rehabilitation therapy device and control method thereof

Abstract

The present invention discloses a rehabilitation therapy instrument and a control method thereof, wherein the rehabilitation therapy instrument comprises an air pump, a signal acquisition unit, a controller and a wearable component; the wearable component can cover the pelvic area, buttocks and thighs; a bag sleeve is provided on the inner side of the wearable component; the air pump is connected to the bag sleeve, and the air pump is used to intermittently pump gas into or out of the bag sleeve; the signal acquisition unit is used to detect an electrocardiogram signal; the air pump and the signal acquisition unit are both electrically connected to the controller, and the controller is used to control the working state of the air pump according to the electrocardiogram signal to control the bag sleeve to intermittently compress the femoral artery and / or gluteus maximus. The present invention can improve the local circulation of the pelvic area without using drugs and surgery, and perform rehabilitation therapy on ED diseases.

Description

Technical Field

[0001] The present invention relates to the technical field of male sexual dysfunction rehabilitation therapy, and in particular to a rehabilitation therapy apparatus and a control method thereof. Background Art

[0002] Erectile dysfunction (ED) refers to the inability of men to obtain or maintain an erection sufficient for a satisfactory sexual life during sexual intercourse. It seriously affects the quality of men's sexual life, mental health, interpersonal relationships and self-confidence. With the accelerated pace of work and life in modern society, the increase in survival pressure and the prevalence of unhealthy lifestyles, the incidence of ED is showing a significant upward trend and a younger trend.

[0003] For ischemic ED disease, currently, drugs and surgery are generally used in clinical treatment. The main principle of drugs (such as vardenafil and sildenafil, etc.) is to dilate blood vessels to increase penile blood flow. They work by dilating blood vessels to allow more blood to enter and stay in the penis, which increases the frequency of erections and lasts longer. The physiological mechanism of normal penile erection involves the release of nitric oxide in the body during sexual stimulation. Nitric oxide relaxes the smooth muscles in the corpus cavernosum, expands the corpus cavernosum, and blood flows in, causing the penis to erect. Patients with erectile dysfunction are mainly due to disorders in the relaxation of the corpus cavernosum smooth muscles. ED treatment drugs relax the corpus cavernosum or enhance the use of nitric oxide mediators, thereby promoting blood flow into the corpus cavernosum.

[0004] For ED patients who have not responded to conservative treatments such as medication, penile prosthesis implantation can be performed. The surgery requires the implantation of two hollow cylinders into the penis, a reservoir in front of the bladder, and a small pump into the penis, all of which are connected by a catheter. Normally, the liquid is stored in the capsule, and the penis is not erect. During sexual intercourse, the filling valve on the pneumatic pump squeezes the liquid in the capsule into the hollow circle surrounded by the cavernous body to promote penile erection. After sexual intercourse, the release valve on the pump is pressed to allow the liquid to flow back into the reservoir.

[0005] Drugs are often not very effective in improving local hemodynamics, and this type of drug involves many contraindications, such as patients with cardiovascular diseases and liver dysfunction, especially those with hypotension, recent stroke or myocardial infarction, unstable angina, family degenerative eye diseases, etc. In addition, this type of drug currently has many side effects, such as indigestion, dizziness, headache, drowsiness and other nervous system reactions and dyspnea. Surgical treatment not only has high medical costs, but also has a high risk of complications such as infection, mechanical failure and pain. It requires long-term monitoring and regular examinations after surgery, which significantly affects the quality of postoperative sexual life and places a huge psychological burden on patients.

[0006] In summary, how to provide a non-invasive, non-drug, non-surgical ED disease rehabilitation therapy device is one of the important issues that need to be urgently resolved in this field. Summary of the invention

[0007] The purpose of the present invention is to provide a rehabilitation therapy instrument and a control method thereof to solve the deficiencies in the prior art. The present invention adopts mechanical stimulation based on air pressure drive, and according to the local vascular distribution characteristics and blood flow pulsation pattern of the pelvic cavity, implements sequential intervention controlled by electrocardiogram signals to promote local blood flow velocity, and guides more blood to flow into the penis through the iliac artery through two different circulation pathways during the diastole and systole of the heart. At the same time, by increasing the diastolic pressure of the pelvis and thigh during the cardiac cycle and extending the pressure holding time, the outflow of penile venous blood flow is reduced, and the efficiency of the cavernous body in retaining blood volume is further improved. It is possible to perform rehabilitation therapy for ED disease without the use of drugs and surgery.

[0008] The present invention provides a rehabilitation therapy apparatus, which includes an air pump, a signal acquisition unit, a controller and a wearable component;

[0009] The wearable component can cover the pelvic area, buttocks and thighs; a bag cover is provided on the inner side of the wearable component;

[0010] The air pump is in communication with the bag sleeve, and is used to intermittently pump gas into or out of the bag sleeve;

[0011] The signal acquisition unit is used to detect ECG signals; the air pump and the signal acquisition unit are both electrically connected to the controller, and the controller is used to control the working state of the air pump according to the ECG signals to control the cuff to intermittently compress the femoral artery and / or gluteus maximus.

[0012] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, the controller is used to control the air pump to pump high-pressure gas into the cuff when the T wave of the electrocardiogram signal is detected, and to keep the cuff in a state of compressing the femoral artery and / or the gluteus maximus;

[0013] The controller is also used to control the air pump to pump out gas from the cuff when a P wave of an electrocardiogram signal is detected.

[0014] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, the bag sleeve comprises a first bag sleeve and a second bag sleeve;

[0015] The first bag cover is located at the position where the wearable component covers the thigh, and is used to compress the thigh after being filled with high-pressure gas;

[0016] The second bag cover is located at the position where the wearable component covers the gluteus maximus, and is used to compress the gluteus maximus after being filled with high-pressure gas.

[0017] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, further comprises an air storage cylinder and a solenoid valve; the air storage cylinder is connected in series between the air pump and the solenoid valve;

[0018] The controller is used to control the air pump, the air storage cylinder, and the solenoid valve to fill the first bag with high-pressure gas when a T wave is detected, and to fill the first bag with no less than 3000 ml of high-pressure gas within 25-30 milliseconds; and after 50-60 milliseconds, control the air pump, the air storage cylinder, and the solenoid valve to fill the second bag with gas, and to fill the second bag with no less than 2000 ml of high-pressure gas within 25-30 milliseconds.

[0019] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, the wearable component is in the shape of shorts, and a waist opening and two trouser legs are formed on the wearable component;

[0020] The wearable component also has a first adjustment strap and a second adjustment strap;

[0021] The first adjustment belt is located at the waist opening and is used to adjust the tightness of the waist opening;

[0022] The second adjustment belt is located at the trouser leg and is used for adjusting the tightness of the trouser leg.

[0023] As described above, in the rehabilitation therapy apparatus, optionally, a hollow portion is formed on the wearable component, and the hollow portion is formed at the connection between the two trouser legs of the wearable component.

[0024] As described above, in the rehabilitation therapy apparatus, optionally, the wearable component is further provided with a first metal electrode sheet, and the first metal electrode sheet is used to output electronic pulses in the form of low-frequency modulation waves to stimulate the blood vessels in the pelvic region.

[0025] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, the first metal electrode sheet is electrically connected to the controller;

[0026] The controller is also used to control the first metal electrode sheet to perform low-temperature heating by near-infrared means to apply heat to the blood vessels in the pelvic region.

[0027] The rehabilitation therapy device as described above, optionally, further includes a second metal electrode sheet, which is located in the wearable component and is used for applying heat to the inner thigh.

[0028] The rehabilitation physiotherapy apparatus as described above, wherein, optionally, the wearable component comprises an outer layer and an inner layer, the outer layer is a cortical shell, and the inner layer is made of nylon fabric combined with latex material;

[0029] The bag cover is made of airtight nylon fabric material.

[0030] The present invention also provides a method for controlling a rehabilitation therapy apparatus, wherein the method is used to control the rehabilitation therapy apparatus as described in any one of the above items, and comprises the following steps:

[0031] Obtain ECG signals in real time;

[0032] Real-time detection of T waves and P waves in ECG signals;

[0033] When a T wave is detected, high-pressure gas is filled into the cuff to compress the femoral artery and gluteus maximus in turn and keep the cuff filled; blood from the thigh and buttocks is guided to flow into the penis through the circulation pathway of the femoral artery-iliac artery-internal iliac artery-penile artery during diastole;

[0034] When a P wave is detected, the cuff is controlled to be deflated quickly, and the gas inside the cuff is completely discharged within 20-30 milliseconds, so as to quickly reduce the impedance of the pelvic region and thigh blood vessels, thereby guiding the blood ejected by the heart during the cardiac contraction period to better enter the penis through the circulation pathway of the abdominal aorta-iliac artery-internal iliac artery-penile artery;

[0035] The increase in diastolic pressure in the pelvic region during the cardiac cycle helps to reduce the outflow of blood from the corpus cavernosum through the veins, keeping more blood stored in the corpus cavernosum;

[0036] Repeat the above steps until the set time is reached.

[0037] Compared with the prior art, the present invention provides a cuff, and repeatedly inflates and deflates the cuff according to the detected electrocardiogram signal, repeatedly and intermittently compresses the femoral artery and / or gluteus maximus. During the process of inflating the cuff, the femoral artery is compressed, which is conducive to more blood flowing into the penile artery through the femoral artery, the external iliac artery, and the internal iliac artery, so as to increase the blood flowing into the cavernous body. In the process of maintaining the compression of the thigh and / or gluteus maximus, the diastolic pressure of the pelvic artery can be increased during the cardiac cycle. During the cardiac cycle, the increase in the diastolic pressure of the pelvic artery helps to reduce the outflow of blood from the cavernous body of the penis through the veins, and keeps more blood stored in the cavernous body. In this way, the local circulation of the penis is promoted and the vascular function of the penis is improved without using drugs or performing surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a schematic diagram of the structure of the wearable component proposed by the present invention;

[0039] Figure 2 This is the first structural block diagram of the rehabilitation physiotherapy apparatus proposed by the present invention;

[0040] Figure 3 This is a second structural block diagram of the rehabilitation physiotherapy apparatus proposed by the present invention;

[0041] Figure 4This is a third structural block diagram of the rehabilitation physiotherapy apparatus proposed by the present invention;

[0042] Figure 5 It is a schematic diagram of the cardiac cycle and intervention effect of the rehabilitation therapy device proposed by the present invention;

[0043] Figure 6 It is a flow chart of the steps of the control method of the rehabilitation physiotherapy apparatus proposed by the present invention;

[0044] Figure 7 This is a schematic diagram of the changes in blood flow in the common femoral artery of healthy volunteers;

[0045] Figure 8 It is a schematic diagram of the changes in blood flow in the common femoral artery in patients with vascular diseases;

[0046] Fig. 9 It is a schematic diagram of the changes in pressure pulse waves collected from the ulnar artery of the upper limb of patients with vascular diseases before and during intervention.

[0047] Description of reference numerals:

[0048] 1-air pump, 2-signal acquisition unit, 3-controller, 4-wearable component, 5-bag sleeve, 6-solenoid valve, 7-air storage cylinder, 8-valve body;

[0049] 41 - first adjustment belt, 42 - second adjustment belt, 43 - hollow portion, 44 - first metal electrode sheet, 45 - second metal electrode sheet, 51 - first bag sleeve, 52 - second bag sleeve. DETAILED DESCRIPTION

[0050] The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, but should not be construed as limiting the present invention.

[0051] For the questions raised in the background technology, please refer to Figures 1 to 9 The present invention proposes a rehabilitation therapy device, which includes an air pump 1, a signal acquisition unit 2, a controller 3 and a wearable component 4.

[0052] Specifically, the wearable component 4 can cover the pelvic area, buttocks and thighs; a bag cover 5 is provided on the inner side of the wearable component 4; in a specific implementation, the wearable component 4 can be in the shape of shorts or other shapes that can cover the pelvic area, buttocks and thighs of the human body.

[0053] Please refer to Figure 1 and Figure 2The air pump 1 is connected to the bag sleeve 5, and the air pump 1 is used to intermittently pump fluid into or out of the bag sleeve 5; in specific implementation, the fluid used can be gas or liquid, wherein gas is preferred. When the fluid is gas, air can be used. In this embodiment, the fluid is air as an example for explanation. When the fluid is liquid, 30-40°C water can be used. In specific implementation, the air pump 1 is connected to the bag sleeve 5 through the solenoid valve 6.

[0054] exist Figures 2 to 4 The present invention proposes three structural block diagrams. Figure 2 The first structural block diagram is disclosed in the figure, wherein the signal acquisition unit 2 is used to detect ECG signals; the air pump 1 and the signal acquisition unit 2 are both electrically connected to the controller 3, and the controller 3 is used to control the working state of the air pump 1 according to the ECG signals, so as to control the cuff 5 to intermittently compress the femoral artery and / or gluteus maximus. In the specific implementation, the cuff 5 is controlled to intermittently compress the femoral artery and / or gluteus maximus according to the detection result of the ECG signal, so that more blood can flow to the corpus cavernosum of the penis, and more blood can be retained in the corpus cavernosum, promoting local circulation of the penis and thus improving the vascular function of the penis, thereby achieving the effect of treating ischemic ED. The signal acquisition unit 2 can adopt a single-lead ECG acquisition module combined with a Bluetooth wireless communication module. The collector is directly attached to the skin above the patient's heart to collect ECG, and then transmitted to the controller 3 via Bluetooth technology.

[0055] Specifically, the controller 3 is used to control the air pump 1 to pump fluid into the cuff 5 when the T wave of the electrocardiogram signal is detected, and to keep the cuff 5 in a state of compressing the femoral artery and / or the gluteus maximus. Specifically, it can be to compress only the femoral artery, or only the gluteus maximus, or not only the femoral artery but also the gluteus maximus. The following is an example of compressing both the femoral artery and the gluteus maximus: please refer to Figure 5When the T wave is detected, in the middle and late stages of the ventricular systolic phase in the cardiac cycle, the air pump 1 is controlled to pump fluid into the cuff 5 to compress the femoral artery, which is conducive to more blood flowing into the penile artery through the femoral artery, the external iliac artery, and the internal iliac artery to increase the blood flowing into the corpus cavernosum. From the detection of the T wave to the detection of the P wave, during this period of time, the cuff 5 keeps compressing the thigh and / or gluteus maximus; during the time period between the detection of the T wave and the next detection of the P wave, the increase in the diastolic pressure of the pelvic artery in the cardiac cycle helps to reduce the outflow of blood from the corpus cavernosum through the veins, keeping more blood stored in the corpus cavernosum. The controller 3 is also used to control the air pump 1 to quickly pump fluid out of the cuff 5 when the P wave of the electrocardiogram signal is detected. The P wave is in the late diastolic phase, ready to enter the systolic phase, and the heart is ready to eject blood. At this time, the cuff 5 quickly exhausts air, reduces the resistance of the lower blood vessels, guides the blood flow to flow rapidly downward, and increases the blood supply to the abdomen and pelvis, thereby further improving the local hemodynamics of the penis through the passage of the abdominal aorta, the common iliac artery, the internal iliac artery, and the penile artery. Its long-term effects help improve pelvic arterial function, increase nitric oxide release, etc.

[0056] Please refer to Figure 1 In a specific implementation, in order to better allow more blood to flow into the corpus cavernosum after the T wave is detected, in this embodiment, the cuff 5 includes a first cuff 51 and a second cuff 52; the first cuff 51 is located at the position where the wearable component 4 covers the thigh, and is used to compress the thigh after the fluid is filled; the second cuff 52 is located at the position where the wearable component 4 covers the gluteus maximus, and is used to compress the gluteus maximus after the fluid is filled. The first cuff 51 and the second cuff 52 are made of the same material, but have different positions and shapes. By controlling the inflation timing of the first cuff 51 and the second cuff 52, it is possible to better increase the amount of blood flowing into the corpus cavernosum and increase the residence time of the blood in the corpus cavernosum.

[0057] In a specific implementation, when the T wave is detected, the controller 3 controls the air pump 1 and the electromagnetic valve 6 to fill the first bag cuff 51 with gas; and after 5-10 milliseconds, controls the air pump 1 and the electromagnetic valve 6 to fill the second bag cuff 52 with high-pressure gas. By filling the first bag cuff 51 and the second bag cuff 52 with gas in succession, the blood flow from the thigh and buttocks can be guided to flow into the penis through the circulation pathway of the femoral artery-iliac artery-internal iliac artery-penile artery during the diastole period, thereby increasing the blood congestion of the corpus cavernosum. During the time period between the detection of the T wave and the next detection of the P wave, the pressure in the first bag cuff 51 and the second bag cuff 52 is maintained, which is conducive to increasing the diastolic pressure of the pelvic artery during the cardiac cycle. The increase in the diastolic pressure of the pelvic artery during the cardiac cycle helps to reduce the outflow of blood from the corpus cavernosum through the veins, and keeps more blood stored in the corpus cavernosum. After the P wave is detected, the cuff 5 is quickly deflated to reduce the resistance of the lower blood vessels, guide the blood flow to flow rapidly downward, increase the blood supply to the abdomen and pelvis, and further improve the local blood flow to the penis through the abdominal aorta, common iliac artery, internal iliac artery, and penile artery.

[0058] exist Figure 3 , discloses a second structural block diagram of a rehabilitation physiotherapy apparatus. In order to facilitate rapid and accurate inflation of the bag sleeve 5, it also includes an air storage cylinder 7 and an electromagnetic valve 6. The air inlet of the air storage cylinder 7 is connected to the air pump 1, and the air outlet of the air storage cylinder 7 is connected to the electromagnetic valve 6. The air storage cylinder 7 is used to store high-pressure air. When it is necessary to fill the first bag sleeve 51 with high-pressure gas, the air storage cylinder 7 is connected to the first bag sleeve 51; when it is necessary to fill the second bag sleeve 52 with high-pressure gas, the air storage cylinder 7 is connected to the second bag sleeve 52. When it is necessary to discharge the gas in the first bag sleeve 51 and / or the second bag sleeve 52, the gas in the first bag sleeve 51 and / or the second bag sleeve 52 is filled into the air storage cylinder 7 through the air pump 1. In actual application, a pressure sensor can be set in the air storage cylinder 7. When the pressure in the air storage cylinder 7 is too low, the air storage cylinder 7 is filled with gas through the air pump 1.

[0059] exist Figure 4 , discloses a third structural block diagram of a rehabilitation physiotherapy apparatus, in which the air pump 1 is configured to pump gas into the air storage cylinder 7, or directly pump high-pressure gas into the first bag sleeve 51 or the second bag sleeve 52 through the solenoid valve 6. That is, when pumping gas into the bag sleeve 5, the gas may be pumped into the air storage cylinder 7 alone, the gas may be pumped into the air pump 1 alone, or the gas may be supplied by both the air storage cylinder 7 and the air pump 1. In this implementation, the gas in the air storage cylinder 7 is supplied by the air pump 1.

[0060] In the above three structural block diagrams, a valve body 8 is also included which is arranged at the air inlet of the air pump 1, and the valve body 8 is electrically connected to the controller 3. Figure 2As shown, the valve body 8 can be opened when the first bag 51 and / or the second bag 52 are inflated to achieve rapid inflation. When the gas in the first bag 51 and / or the second bag 52 is extracted, the valve body 8 is controlled to be closed to achieve rapid deflation. For the second and third structural block diagrams, the valve body 8 is used to be opened only when pumping gas into the gas storage cylinder 7.

[0061] Please refer to Figures 1 to 4 In a specific implementation, in order to facilitate the arrangement of the first bag cover 51 and the second bag cover 52, the wearable component 4 is in the shape of shorts, and a waist opening and two trouser legs are formed on the wearable component 4. Specifically, the waist opening refers to the position of the wearable component facing the waist. When in use, the waist opening is tightly wrapped around the waist of the user, and the two trouser legs are respectively wrapped around the legs of the user, and specifically can be located above the knees of the user.

[0062] In a specific implementation, the first bag sleeve 51 may be annular and can be wrapped around the thigh of the user when in use, and the second bag sleeve 52 may be distributed on the gluteus maximus. Figure 2 In the specific implementation, the first bag 51 and the second bag 52 are connected to the air pump 1 through the electromagnetic valve 6. Specifically, the electromagnetic valve 6 is a three-position four-way electromagnetic valve with four ports, namely, port A, port B, port T and port P. Port A and port B are connected to the inlet and outlet of the air pump 1 respectively, port T is connected to the filling and exhaust port of the first bag 51 or the filling and exhaust port of the second bag 52, and port P is freely open. The valve core of the electromagnetic valve 6 has three position states. In the first position state, port A is connected to port T, and port B is connected to port P. At this time, the first bag 51 or the second bag 52 is inflated. In the second position state, port A, port B, port T and port P are all cut off. At this time, the first bag 51 or the second bag 52 is in a pressure-maintaining state. In the third position state, port A is connected to port P, and port B is connected to port T. At this time, it is in a fast exhaust state.

[0063] In the specific implementation, in order to ensure that the wearable component 4 can provide sufficient tension to achieve intermittent pressurization using the first bag 51 and the second bag 52, the wearable component 4 includes an outer layer and an inner layer, the outer layer is a leather shell, specifically a hard leather shell, and the inner layer is made of nylon fabric combined with latex material or nylon fabric combined with cotton material; the bag 5 is made of airtight nylon fabric. The hard leather shell has a certain elasticity and can be adjusted appropriately to meet the needs of patients of different body shapes. At the same time, it can effectively restrict the expansion of the internal bag 5 when inflated, thereby saving air source, reducing power consumption and noise. There are two first bags 51 and two second bags 52, a total of four. Among them, the first bag 51 is annular and surrounds the thigh. It is made of high-strength and airtight nylon fabric material. The single capacity is not less than 3000ml in the fully loaded inflated state. The second bag 52 is wrapped around the gluteus maximus. When the patient lies flat, the second bag 52 is naturally compressed. The second bag cover 52 is made of high-strength and airtight nylon fabric material, and the single capacity is not less than 2000ml when fully inflated. In some embodiments, the inner side of the wearable component 4 is made of nylon fabric combined with cotton material, which not only ensures tensile and shear strength, reduces ductility, and ensures patient comfort and reduces the risk of adverse events.

[0064] In the specific implementation, the air pump 1 and the controller 3 can be integrated in the external host, and an electromagnetic control valve is also provided for the convenience of controlling the external host. The external host receives the ECG signal collected by the signal acquisition unit 2, and performs data processing and feature extraction, and then triggers a series of actions of the air pump 1 and the electromagnetic valve according to the blood flow characteristics of the pelvic blood vessels, so as to inflate, maintain pressure and exhaust the first bag 51 and the second bag 52 in the wearable component 4 with an accuracy of 10 milliseconds, thereby achieving the regulation and enhancement of local perfusion pressure and blood flow. Among them, the air pump 1 can use a small air pump 1, which can generate a maximum working pressure of 25kPa and a maximum output flow of not less than 45m 3 / h. The solenoid valve has a diameter of 20mm and a response time of no more than 50ms. The controller 3 includes a microprocessor, a Bluetooth communication module, an ECG signal processing and analysis module, an inflation and exhaust control module, an electronic pulse output control module and a far-infrared temperature control module. The microprocessor includes a data analysis and processing module, a data storage module, a display module, a control module and an A / D conversion module, wherein the control module adopts a microcontroller unit, for example, an ATmega8 chip, which has multiple 16-bit timers and 8-bit timers, and can realize multi-channel, sequential and distributed intervention modes, and can accurately calculate the time nodes and time intervals of the electric pulses and issue instructions to the waveform generator of the pulse component. The A / D conversion module is used to perform A / D conversion on the ECG signal obtained by the ECG signal monitoring unit. In order to power the main control unit, the microprocessor is also connected to a power module, and the power module is preferably a rechargeable lithium battery.

[0065] Please refer to Figure 1 The wearable component 4 also has a first adjustment belt 41 and a second adjustment belt 42; the first adjustment belt 41 and the second adjustment belt 42 are used to adjust the tightness, so that when the first bag 51 and the second bag 52 are inflated, sufficient tension can be provided, so that the first bag 51 and the second bag 52 press the corresponding position. Specifically, the first adjustment belt 41 is located at the waist opening, and is used to adjust the tightness at the waist opening; in some preferred implementations, the first adjustment belt 41 can be set by Velcro to achieve the adjustment of the tightness. How to set Velcro to achieve the adjustment of the tightness is common knowledge for those skilled in the art, and will not be repeated here. The second adjustment belt 42 is located at the trouser leg, and is used to adjust the tightness at the trouser leg. The second adjustment belt 42 can also be set by Velcro to achieve the adjustment of the tightness. How to set Velcro to achieve the adjustment of the tightness is common knowledge for those skilled in the art, and will not be repeated here. In a specific implementation, a hollow portion 43 is further formed on the wearable component 4, and the hollow portion 43 is formed at the connection between the two trouser legs of the wearable component 4. The hollow portion 43 corresponds to the penis of the wearer, so that the penis is exposed from the hollow portion 43.

[0066] In the specific implementation, in order to further improve the physiotherapy effect, in the present invention, the wearable component 4 is also provided with a first metal electrode sheet 44, which is used to output electronic pulses in the form of low-frequency modulated waves to stimulate the blood vessels in the pelvic area. In the specific implementation, the function of the first metal electrode sheet 44 is mainly to perform hot compress intervention on the blood vessels in the pelvic area, through the junction of the lower end of the bladder and the pubic bone in the pelvic area. The first metal electrode sheet 44 stimulates the blood vessels in the pelvic area by outputting electronic pulses, reducing blood flow impedance and increasing local nerve sensitivity. At the same time, the first metal electrode sheet 44 performs low-temperature heating by near-infrared means, which produces a hot compress effect on the blood vessels in the pelvic area, further reducing microcirculation resistance. In the specific implementation, the low-temperature heating referred to here refers to heating at a temperature not higher than 50°C, and preferably, the heating temperature range is 30°C to 50°C.

[0067] In a specific implementation, the first metal electrode sheet 44 is electrically connected to the controller 3; the controller 3 is also used to control the first metal electrode sheet 44 to perform low-temperature heating by near-infrared means to perform heat compress on the blood vessels in the pelvic region.

[0068] In a specific implementation, in order to improve the stimulation effect, a second metal electrode sheet 45 is also included. The second metal electrode sheet 45 is located in the wearable component 4 and is used for applying heat to the inner thigh, which can further improve the local nerve sensitivity.

[0069] Specifically, the first metal electrode sheet 44 is arranged on the inner side of the wearable component 4 corresponding to the junction of the lower end of the bladder and the pubic bone in the pelvic area. Two groups of second metal electrode sheets 45 are arranged in the left groin area and the right groin area respectively. The first metal electrode sheet 44 and the second metal electrode sheet 45 output low-frequency electronic pulses with a frequency of 100-1000Hz; for example, a variety of adjustable modulation wave output modes such as triangular wave, rectangular wave, and sine wave can be used. The pulse width range is 50-500us, the maximum output energy is not more than 200 mJ, and the single pulse power is not less than 5μC when the output amplitude is maximum; the maximum output amplitude effective value: the voltage is not more than 20V, and the current is 35mA. The first metal electrode sheet 44 and the second metal electrode sheet 45 are both built-in infrared heating modules, which can raise the metal electrode to a maximum temperature of 50 degrees Celsius, thereby providing a hot compress effect for the pelvic area.

[0070] On the other hand, please refer to Figure 6 The present invention also proposes a control method for a rehabilitation therapy apparatus, which is used to control the rehabilitation therapy apparatus as described above, and comprises the following steps:

[0071] S1, real-time acquisition of ECG signals; in specific implementation, the ECG signals are acquired in real time through the signal acquisition unit 2. In specific implementation, the acquisition and transmission of ECG signals can be achieved by combining a single-lead ECG acquisition module with a Bluetooth wireless communication module. The collector is directly attached to the skin above the patient's heart to collect ECG signals, which are then transmitted to the controller 3 via Bluetooth technology.

[0072] S2, real-time detection of T waves and P waves in the ECG signal. Taking the occurrence of T waves and P waves as the control timing, the filling, maintaining and releasing of pressure in the cuff 5 are controlled respectively, so that the cuff 5 can compress the femoral artery in the middle and late stages of the ventricular contraction period, so that more blood can flow into the penile artery through the femoral artery, external iliac artery and internal iliac artery. By maintaining the pressure between the T wave and the P wave, the venous perfusion pressure is kept at a high state, and the resistance of the blood in the cavernous body to the venous return is increased, so that the cavernous body remains in a congested state. When the P wave appears, the cuff 5 releases the pressure to facilitate cardiac ejection. Therefore, by detecting the T wave and the P wave, it can help to make the cavernous body congested for a longer time. In specific implementation, the T wave and the P wave are difficult to be detected directly, and the timing of the occurrence of the T wave and the P wave needs to be obtained by calculation. Specifically, the average cardiac cycle is calculated first. The average cardiac cycle can be taken as the average value of multiple consecutive cardiac cycles, such as, ;in, is the average cardiac cycle, , and It is the last three consecutive cardiac cycles. In specific implementation, the R wave is easier to detect accurately. Therefore, the R wave is used as the benchmark to calculate the timing of the T wave and P wave. The time when the T wave appears is one-third of the average cardiac cycle after the R wave appears, that is, ,in, is the moment when the T wave appears. is the moment when the R wave appears, and the P wave appears three quarters of the average cardiac cycle after the R wave appears, that is, ;in, is the moment when the P wave appears.

[0073] S3, when a T wave is detected, fluid is filled into the cuff 5 to compress the femoral artery and gluteus maximus successively, and the pressure is maintained. In a specific implementation, in one implementation, air can be filled into the cuff 5 at the thigh when a T wave is detected, and within 5-10 milliseconds after the T wave is detected, air is filled into the cuff 5 corresponding to the gluteus maximus. In this way, the blood can be driven through the femoral artery-external iliac artery-internal iliac artery-penile artery pathway to improve the local hemodynamics of the penis.

[0074] S4, when the P wave is detected, the bag cuff 5 is controlled to discharge the fluid; in this step, by controlling the rapid exhaust of the whole set, it can promote cardiac ejection and guide blood flow to the distal lower limbs, thereby further improving the local hemodynamics of the penis through the abdominal aorta, common iliac artery, internal iliac artery, and penile artery. Its long-term effect helps to improve the arterial function of the pelvic region and increase the release of nitric oxide.

[0075] S5, repeat the above steps until the set time. In specific implementation, the set time can be, for example, 30 minutes. When 30 minutes are reached, the physical therapy process is ended.

[0076] Penile erection refers to the congestion of the corpora cavernosa. When a man is sexually excited, the arteries and veins inside the corpora cavernosa are simultaneously congested, causing the penis to become erect and maintain an erection. If there is insufficient blood supply to the penile arteries or too fast venous return, symptoms of erectile dysfunction will occur. To ensure the normal erectile function of the penis, it is necessary to ensure smooth local blood circulation and sufficient blood supply. The blood supply to the penis mainly comes from the arteries, including the dorsal artery of the penis and the deep artery of the penis. The blood of the penis returns from the veins, including the superficial dorsal vein of the penis and the deep dorsal vein of the penis. The external iliac artery is the artery that supplies blood to the lower limbs, while the internal iliac artery is the artery that supplies blood to the pelvic cavity. An important branch of the internal iliac artery is the internal pudendal artery, which is the main source of arterial blood supply to the male penis. Normal erection requires blood flow from the internal iliac artery to the specific erectile chamber of the penis, that is, the corpora cavernosa. At the same time, when the blood flow accelerates, the pressure in the cavity of the corpora cavernosa increases significantly, thereby preventing the venous blood flow of the penis from flowing out of the veins. The present invention can improve the blood circulation pathway of the iliac artery-internal iliac artery-penile artery, increase the blood flow velocity and blood perfusion volume; reduce the outflow of penile vein blood, and ensure that more blood remains in the corpus cavernosum for a longer time, thereby achieving the purpose of improving the blood supply to the pelvic area, especially the penile area, of ED patients.

[0077] In actual application, in order to ensure the treatment effect, electric pulses and hot compresses can be applied to the pelvic area and inner thighs of the person being treated before the above steps are performed.

[0078] In actual application, the effect on the blood flow of the common femoral artery and the superficial femoral artery was tested on 5 healthy male volunteers and 5 patients with obvious vascular diseases, and statistical analysis was performed. The obtained data are shown in Table 1.

[0079] Table 1 Hemodynamic statistics

[0080]

[0081] From the table and Figures 7 to 9 It can be seen that the present invention can significantly improve the femoral artery blood flow level of healthy volunteers and patients with vascular diseases. It is speculated that the blood flow of the iliac artery and the internal pudendal artery will also be effectively improved, thereby providing a richer blood source for the penis. Fig. 9 The middle is a continuous blood pressure curve, collected at the ulnar artery of the upper limb, and it can be seen that the diastolic pressure increased significantly during the intervention. The present invention can significantly increase the diastolic pressure pulse wave level, which not only drives the blood flow into the penis through the arterial system and improves blood perfusion, but also helps to reduce the outflow of penile venous blood from the vein, thereby ensuring that it remains at a high level for a longer time.

[0082] The above describes in detail the structure, features and effects of the present invention based on the embodiments shown in the drawings. The above is only a preferred embodiment of the present invention, but the present invention is not limited to the scope of implementation shown in the drawings. Any changes made according to the concept of the present invention, or modifications to equivalent embodiments with equivalent changes, which still do not exceed the spirit covered by the description and drawings, should be within the protection scope of the present invention.

Claims

1. A rehabilitation therapy apparatus for ischemic erectile dysfunction, characterized in that: It comprises an air pump (1), a signal acquisition unit (2), a controller (3) and a wearable component (4); The wearable component (4) is capable of covering the pelvic region, buttocks and thighs; a bag cover (5) is provided on the inner side of the wearable component (4); The air pump (1) is in communication with the bag sleeve (5), and the air pump (1) is used to intermittently pump gas into or out of the bag sleeve (5); The signal acquisition unit (2) is used to detect an electrocardiogram signal; the air pump (1) and the signal acquisition unit (2) are both electrically connected to the controller (3); the controller (3) is used to control the working state of the air pump (1) according to the electrocardiogram signal, so as to control the cuff (5) to intermittently compress the femoral artery and gluteus maximus; When the T wave appears, high-pressure gas is filled into the cuff (5) to successively compress the femoral artery and the gluteus maximus muscle, and to keep the cuff filled; When the P wave appears, the cuff (5) is controlled to be deflated quickly, and the gas inside the cuff (5) is completely discharged within 20-30 milliseconds; The timing of the appearance of the T wave and the P wave is calculated as follows: the R wave is detected, and the timing of the appearance of the T wave and the P wave is calculated based on the R wave; ； ； ； in, is the moment when the T wave appears. is the moment when the R wave appears. is the moment when the P wave appears, is the average cardiac cycle, , and It is the last three consecutive cardiac cycles; The capsule (5) comprises a first capsule (51) and a second capsule (52); The first bag cover (51) is located at a position where the wearable component (4) covers the thigh, and is used to compress the thigh after being filled with high-pressure gas; The second bag sleeve (52) is located at a position of the wearable component (4) covering the gluteus maximus, and is used to compress the gluteus maximus after being filled with high-pressure gas; It also includes an air storage cylinder (7) and a solenoid valve (6); the air storage cylinder (7) is connected in series between the air pump (1) and the solenoid valve (6); The controller (3) is used to control the air pump (1), the air storage cylinder (7), and the electromagnetic valve (6) to fill the first bag (51) with high-pressure gas when the T wave is detected, and fill the first bag (51) with no less than 3000 milliliters of high-pressure gas within 25-30 milliseconds, and after 50-60 milliseconds, control the air pump (1), the air storage cylinder (7), and the electromagnetic valve (6) to fill the second bag (52) with gas, and fill the second bag (52) with no less than 2000 milliliter of high-pressure gas within 25-30 milliseconds.

2. The ischemic erectile dysfunction rehabilitation physiotherapy apparatus according to claim 1, characterized in that: The wearable component (4) is in the shape of shorts, and is provided with a waist opening and two trouser legs; The wearable component (4) also has a first adjustment belt (41) and a second adjustment belt (42); The first adjustment belt (41) is located at the waist opening and is used to adjust the tightness of the waist opening; The second adjustment belt (42) is located at the trouser leg and is used to adjust the tightness of the trouser leg.

3. The ischemic erectile dysfunction rehabilitation physiotherapy apparatus according to claim 2, characterized in that: The wearable component (4) is also provided with a hollow portion (43), and the hollow portion (43) is formed at the connection between the two trouser legs of the wearable component (4).

4. The ischemic erectile dysfunction rehabilitation physiotherapy apparatus according to any one of claims 1 to 3, characterized in that: The wearable component (4) is also provided with a first metal electrode sheet (44), and the first metal electrode sheet (44) is used to output electronic pulses in the form of low-frequency modulation waves to stimulate blood vessels in the pelvic region.

5. The ischemic erectile dysfunction rehabilitation therapy apparatus according to claim 4, characterized in that: The first metal electrode sheet (44) is electrically connected to the controller (3); The controller (3) is also used to control the first metal electrode sheet (44) to be heated to no higher than 50 degrees Celsius by near infrared means, so as to provide heat compress to the blood vessels in the pelvic region.

6. The ischemic erectile dysfunction rehabilitation physiotherapy apparatus according to any one of claims 1 to 3, characterized in that: It also includes a second metal electrode sheet (45), which is located in the wearable component (4) and is used to apply heat to the inner thigh.

7. The ischemic erectile dysfunction rehabilitation physiotherapy apparatus according to any one of claims 1 to 3, characterized in that: The wearable component (4) comprises an outer layer and an inner layer, the outer layer is a leather shell, and the inner layer is made of nylon fabric combined with latex material; The bag cover (5) is made of airtight nylon fabric material.

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