Therapeutic device based on electrical stimulation and mild hypothermia

Abstract

The invention provides treatment equipment based on electrical stimulation and mild hypothermia. The treatment equipment can be applied to the technical field of medical equipment. The treatment equipment comprises a wearable module which comprises a plurality of stimulation electrodes used for performing electrical stimulation on a preset area of the head; the plurality of temperature sensors are used for collecting the area temperature of a preset area of the head; the cooling water pipeline is used for conducting heat dissipation on the preset area of the head based on circulating cooling water flowing through the cooling water pipeline; the plurality of stimulating electrodes are arranged on the first side of the waterproof layer, and the cooling water pipeline is arranged on the second side of the waterproof layer; the electric excitation control module is electrically connected with the plurality of stimulating electrodes respectively, and the electric excitation control module is used for adjusting the electric stimulation intensity of the plurality of stimulating electrodes; and the heat exchange module is connected between the water inlet and the water outlet of the cooling water pipeline, is electrically connected with the plurality of temperature sensors at the same time, and is used for adjusting the temperature and the flow velocity of the circulating cooling water according to the regional temperature.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical equipment, and more specifically, to a therapeutic device based on electrical stimulation and mild hypothermia. Background Art

[0002] Acute ischemic stroke and brain injury after cardiac arrest are the two main types of ischemic brain injuries and are also the main causes of death and disability.

[0003] In the related art, the treatment of the acute phase of ischemic brain injury mainly relies on drug intervention. However, although many drugs have shown good effects in animal models, they have not achieved consistent success in clinical trials. And the use of these drugs is limited by time and is not suitable for all patients. In addition, the effect of drug treatment is also limited by the blood-brain barrier and drug side effects. Therefore, it is particularly important to explore new treatment strategies for the treatment of the acute phase of ischemic brain injury. Summary of the invention

[0004] In view of this, the present disclosure provides a therapeutic device based on electrical stimulation and mild hypothermia.

[0005] The present disclosure provides a therapeutic device based on electrical stimulation and hypothermia, comprising: a wearable module, comprising: a plurality of stimulation electrodes, for electrically stimulating a predetermined area of ​​the head; a plurality of temperature sensors, for collecting the regional temperature of the predetermined area of ​​the head; a cooling water pipeline, for dissipating heat to the predetermined area of ​​the head based on circulating cooling water flowing through the cooling water pipeline; a waterproof layer, wherein the plurality of stimulation electrodes are arranged on a first side of the waterproof layer, and the cooling water pipeline is arranged on a second side of the waterproof layer; an electrical stimulation control module, electrically connected to the plurality of stimulation electrodes, respectively, and the electrical stimulation control module is used to adjust the electrical stimulation intensity of the plurality of stimulation electrodes; a heat exchange module, connected between the water inlet and the water outlet of the cooling water pipeline, and electrically connected to the plurality of temperature sensors at the same time, and the heat exchange module is used to adjust the temperature and flow rate of the circulating cooling water according to the regional temperature.

[0006] According to an embodiment of the present disclosure, the above-mentioned electric stimulation control module includes: a voltage source; a control unit, the input end of the above-mentioned control unit is electrically connected to the above-mentioned voltage source, and the multiple first control ends of the above-mentioned control unit are respectively electrically connected to the above-mentioned multiple stimulation electrodes, for converting the voltage output by the above-mentioned voltage source according to the first treatment requirement information to obtain a first conversion voltage, and supplying power to the above-mentioned multiple stimulation electrodes according to the above-mentioned first conversion voltage.

[0007] According to an embodiment of the present disclosure, the above-mentioned electric stimulation control module also includes: a patch electrode, wherein the above-mentioned patch electrode is electrically connected to the second control terminal of the above-mentioned control unit, and the polarity of the above-mentioned multiple stimulation electrodes is opposite to the polarity of the above-mentioned patch electrode; the above-mentioned control unit is also used to convert the voltage output by the above-mentioned voltage source according to the second treatment requirement information to obtain a second conversion voltage, and power the above-mentioned multiple stimulation electrodes and the above-mentioned patch electrode according to the above-mentioned second conversion voltage.

[0008] According to an embodiment of the present disclosure, the heat exchange module includes: a temperature control unit, which is electrically connected to the multiple temperature sensors, and the temperature control unit is used to determine the first operating frequency of the evaporator and the second operating frequency of the circulation device according to the regional temperature; a water tank, wherein the water inlet of the water tank is connected to the water outlet of the cooling water pipeline, and the water tank is used to store the circulating cooling water; the circulation device, wherein the water inlet of the circulation device is connected to the water outlet of the water tank, and the water outlet of the circulation device is connected to the water inlet of the cooling water pipeline, and the circulation device is used to adjust the flow rate of the circulating cooling water according to the second operating frequency; the evaporator is arranged at the bottom or side of the water tank, and is used to adjust the temperature of the circulating cooling water according to the first operating frequency.

[0009] According to an embodiment of the present disclosure, the wearable module further includes: a fixing layer, wherein the cooling water pipeline is fixed in an area corresponding to the predetermined area of ​​the head on the first side of the fixing layer; a repeating adhesive material is arranged around the bottom of the first side of the fixing layer, and a repeating adhesive material is arranged around the bottom of the second side of the waterproof layer, and the fixing layer and the waterproof layer are connected based on the repeating adhesive material.

[0010] According to an embodiment of the present disclosure, an orthogonal auxiliary line is drawn on the top of the second side of the fixed layer.

[0011] According to an embodiment of the present disclosure, the number of the plurality of stimulation electrodes is between 10 and 30, and the number of the plurality of temperature sensors is between 1 and 6.

[0012] According to an embodiment of the present disclosure, the material of the plurality of stimulation electrodes includes one of the following: silver and silver chloride; the material of the fixing layer is: chloroprene rubber; the material of the waterproof layer is: chloroprene rubber.

[0013] According to an embodiment of the present disclosure, the patch electrode is a sponge electrode.

[0014] According to an embodiment of the present disclosure, the cooling water pipeline includes a water pipe that surrounds the fixed layer in a zigzag shape, wherein the material of the water pipe is silica gel, and the silica gel includes at least one of the following materials: aluminum oxide, magnesium oxide and boron nitride.

[0015] According to the embodiments of the present disclosure, by using multiple stimulation electrodes to electrically stimulate the predetermined area of ​​the head, it is possible to adjust the excitability of neurons in the predetermined area of ​​the head based on electrical stimulation, and promote the recovery and remodeling of the neural network. By using the cooling water pipeline to dissipate heat from the predetermined area of ​​the head based on the circulating cooling water flowing through the cooling water pipeline, it is possible to perform hypothermia treatment on the predetermined area of ​​the head, reduce the temperature of brain tissue, reduce metabolic demand and alleviate secondary damage. The two physical intervention methods have different mechanisms of action, and can perform multi-mechanism comprehensive treatment on the predetermined area of ​​the head without relying on systemic circulation. In addition, since the electric stimulation control module is electrically connected to the multiple stimulation electrodes respectively, the electric stimulation control module is used to adjust the electric stimulation intensity of the multiple stimulation electrodes, and the multiple temperature sensors are used to collect the regional temperature of the predetermined area of ​​the head, the heat exchange module is connected between the water inlet and the water outlet of the cooling water pipeline, and is electrically connected to the multiple temperature sensors at the same time. The heat exchange module is used to adjust the temperature and flow rate of the circulating cooling water according to the regional temperature, so that the treatment device has the function of customized treatment parameters, which can be accurately adjusted according to the specific conditions of individual diseases, thereby optimizing the treatment effect. This comprehensive treatment method not only improves the efficiency and effectiveness of treatment, but also provides an innovative solution for clinical intervention in the acute phase of cerebral ischemia. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The above and other objects, features and advantages of the present disclosure will become more apparent through the following description of the embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0017] Figure 1 The schematic diagram of the structure of the treatment device based on electrical stimulation and mild hypothermia according to the embodiment of the present disclosure is shown;

[0018] Figure 2 The structure diagram of the wearable module according to the embodiment of the present disclosure is schematically shown;

[0019] Figure 3 The structure diagram of the fixed layer included in the wearable module according to the embodiment of the present disclosure is schematically shown;

[0020] Figure 4 The schematic diagram shows the structure of a therapeutic device based on electrical stimulation and mild hypothermia according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0021] Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings. However, it should be understood that these descriptions are exemplary only and are not intended to limit the scope of the present disclosure. In the following detailed description, for ease of explanation, many specific details are set forth to provide a comprehensive understanding of the embodiments of the present disclosure. However, it is apparent that one or more embodiments may also be implemented without these specific details. In addition, in the following description, descriptions of known structures and technologies are omitted to avoid unnecessary confusion of the concepts of the present disclosure.

[0022] The terms used herein are only for describing specific embodiments and are not intended to limit the present disclosure. The terms "comprise", "include", etc. used herein indicate the existence of the features, steps, operations and / or components, but do not exclude the existence or addition of one or more other features, steps, operations or components.

[0023] All terms (including technical and scientific terms) used herein have the meanings commonly understood by those skilled in the art unless otherwise defined. It should be noted that the terms used herein should be interpreted as having a meaning consistent with the context of this specification and should not be interpreted in an idealized or overly rigid manner.

[0024] When using expressions such as "at least one of A, B, and C, etc.", they should generally be interpreted according to the meaning of the expression commonly understood by those skilled in the art (for example, "a system having at least one of A, B, and C" should include but is not limited to a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, C, etc.).

[0025] Although relevant technologies have significantly improved the early rescue of cardiac arrest and ischemic stroke, brain damage caused by ischemia and reperfusion is still the main factor for long-term disability of patients. Brain tissue is extremely sensitive to ischemia and hypoxia. Therefore, protecting brain function during the critical window period of the acute phase is crucial to improving patient prognosis. Timely and effective intervention of brain tissue during the acute phase of brain ischemia and hypoxia can reduce the death and loss of brain cell function, thereby improving the patient's quality of life and reducing the risk of long-term disability.

[0026] At present, there is still a lack of comprehensive physical interventions that do not rely on systemic circulation. Such interventions can provide a powerful supplement to drug treatment and are expected to provide more direct and effective protection for brain tissue in the acute phase.

[0027] In view of this, an embodiment of the present disclosure provides a therapeutic device based on electrical stimulation and mild hypothermia, which can be applied in the field of medical device technology.

[0028] Figure 1The schematic diagram shows the structure of a therapeutic device based on electrical stimulation and mild hypothermia according to an embodiment of the present disclosure.

[0029] like Figure 1 As shown, the therapeutic device 100 based on electrical stimulation and mild hypothermia may include a wearable module 110 , an electrical stimulation control module 120 and a heat exchange module 130 .

[0030] The wearable module 110 may include a plurality of stimulation electrodes 111, a plurality of temperature sensors 112, a cooling water pipeline 113 and a waterproof layer 114. The plurality of stimulation electrodes 111 and the plurality of temperature sensors 112 may be both disposed on an electrode layer. The electrode layer may be a tDCS (transcranial Direct Current Stimulation) electrode layer.

[0031] For example, the wearable module 110 may include 21 stimulation electrodes 111 and 2 temperature sensors 112 .

[0032] The plurality of stimulation electrodes 111 may be used to electrically stimulate a predetermined area of ​​the head. For example, the plurality of stimulation electrodes 111 may be placed close to the scalp to provide tDCS stimulation.

[0033] The plurality of temperature sensors 112 may be used to collect regional temperatures of predetermined regions of the head.

[0034] The cooling water pipeline 113 can be used to dissipate heat from a predetermined area of ​​the head based on the circulating cooling water flowing through the cooling water pipeline. That is, the cooling water pipeline 113 can exchange heat with the predetermined area of ​​the head through the circulating cooling water to achieve sub-hypothermic regulation of the cranium and brain.

[0035] The plurality of stimulation electrodes 111 may be disposed on a first side of the waterproof layer 114, and the cooling water pipeline 113 may be disposed on a second side of the waterproof layer 114. The plurality of stimulation electrodes 111 and the plurality of temperature sensors may be disposed on the first side of the waterproof layer 114, that is, the electrode layer where the plurality of stimulation electrodes 111 and the plurality of temperature sensors are located may be disposed on the first side of the waterproof layer 114.

[0036] The locations of the multiple stimulation electrodes 111 in the waterproof layer 114 are determined according to the 10-20 system electrode placement method, which can accurately locate specific brain areas for stimulation. The multiple temperature sensors 112 can be distributed on both sides at the same distance from the midline of the head, and can monitor the temperature changes of the predetermined area of ​​the scalp.

[0037] The stimulation electrode 111 can be individually configured as a cathode or an anode according to treatment requirements, and supports full cathode, full anode or hemispheric competition mode to achieve specific treatment effects.

[0038] The electrical stimulation control module 120 may be electrically connected to the plurality of stimulation electrodes 111 respectively.

[0039] According to an embodiment of the present disclosure, by electrically connecting the electric stimulation control module 120 to the multiple stimulation electrodes 111 respectively, the multiple stimulation electrodes 111 are individually connected to the stimulation controller module 120, ensuring that each stimulation electrode 111 can work independently, thereby improving the reliability and signal quality of the treatment device.

[0040] The electrical stimulation control module 120 may be used to adjust the electrical stimulation intensity of the plurality of stimulation electrodes 111 .

[0041] The heat exchange module 130 can be connected between the water inlet and the water outlet of the cooling water pipeline 113, and electrically connected to the plurality of temperature sensors 112. The heat exchange module 130 can be used to adjust the temperature and flow rate of the circulating cooling water according to the regional temperature.

[0042] According to the embodiments of the present disclosure, by using multiple stimulation electrodes to electrically stimulate the predetermined area of ​​the head, it is possible to adjust the excitability of neurons in the predetermined area of ​​the head based on electrical stimulation, and promote the recovery and remodeling of the neural network. By using the cooling water pipeline to dissipate heat from the predetermined area of ​​the head based on the circulating cooling water flowing through the cooling water pipeline, it is possible to perform hypothermia treatment on the predetermined area of ​​the head, reduce the temperature of brain tissue, reduce metabolic demand and alleviate secondary damage. The two physical intervention methods have different mechanisms of action, and can perform multi-mechanism comprehensive treatment on the predetermined area of ​​the head without relying on systemic circulation. In addition, since the electric stimulation control module is electrically connected to the multiple stimulation electrodes respectively, the electric stimulation control module is used to adjust the electric stimulation intensity of the multiple stimulation electrodes, and the multiple temperature sensors are used to collect the regional temperature of the predetermined area of ​​the head, the heat exchange module is connected between the water inlet and the water outlet of the cooling water pipeline, and is electrically connected to the multiple temperature sensors at the same time. The heat exchange module is used to adjust the temperature and flow rate of the circulating cooling water according to the regional temperature, so that the treatment device has the function of customized treatment parameters, which can be accurately adjusted according to the specific conditions of individual diseases, thereby optimizing the treatment effect. This comprehensive treatment method not only improves the efficiency and effectiveness of treatment, but also provides an innovative solution for clinical intervention in the acute phase of cerebral ischemia.

[0043] According to the treatment device based on electrical stimulation and mild hypothermia provided in the embodiment of the present disclosure, effective treatment of acute cerebral ischemia in different disease states can be achieved through convenient and integrated physical intervention means. The treatment device can provide brain protection for ischemic stroke and cardiac arrest, which are challenging due to the narrow treatment time window, by comprehensively using physical intervention means without relying on systemic circulation.

[0044] Figure 2 The structural diagram of the wearable module according to the embodiment of the present disclosure is schematically shown.

[0045] like Figure 2 As shown, the wearable module 110 may include multiple stimulation electrodes 111, multiple temperature sensors 112, a cooling water pipeline 113, a waterproof layer 114 and a fixing layer 115.

[0046] The waterproof layer 114 is arranged on the outside of the tDCS electrode layer and is made of a chloroprene rubber material with moderate thickness. It is soft, elastic and durable, can effectively prevent water and provide a comfortable wearing experience.

[0047] The number of the plurality of stimulation electrodes 111 is between 10 and 30. The number of the plurality of temperature sensors 112 is between 1 and 6.

[0048] For example, the number of the plurality of stimulation electrodes 111 may be 10, 15, 21, 25 or 30, etc. The number of the plurality of temperature sensors 112 may be 1, 2, 3, 4, 5 or 6, etc.

[0049] For example, when the number of the plurality of stimulation electrodes 111 is 21, adhesive can be used to fix the plurality of stimulation electrodes 111 to the waterproof layer 114 according to the standard electroencephalogram system (i.e., the 10-20 system electrode placement method). The waterproof layer 114 can protect the plurality of stimulation electrodes 111 from external moisture, avoid the risk of leakage caused by liquid leakage in the cooling water pipeline 113, and can serve as a fixing basis for the plurality of stimulation electrodes 111.

[0050] The material of the plurality of stimulation electrodes 111 includes one of the following: silver and silver chloride.

[0051] According to an embodiment of the present disclosure, when the material of the plurality of stimulation electrodes 111 is silver or silver chloride, the stimulation electrodes 111 can have high conductivity, high biocompatibility and stability, can provide stable current transmission, and reduce skin irritation and voltage drift.

[0052] The cooling water pipeline 113 is fixed to a region of the first side of the fixing layer 115 corresponding to a predetermined region of the head.

[0053] The cooling water pipeline 113 includes a water pipe that is zigzag-shaped and surrounds the fixing layer 115. The water pipe included in the cooling water pipeline 113 can be fixed inside the fixing layer 115 by an adhesive to enhance stability. The material of the water pipe is silica gel, and the silica gel includes at least one of the following materials: aluminum oxide, magnesium oxide, and boron nitride.

[0054] For example, the cooling water pipeline 113 may include a zigzag-shaped hose, which may be made of silicone and added with a heat-conductive filler with high biocompatibility such as aluminum oxide (Al2O3), magnesium oxide (MgO), and boron nitride (BN). The hose is connected to the heat exchange module through a water inlet and a water outlet to form a closed circulation system, which can accurately control the flow rate and temperature of the circulating cooling water.

[0055] The fixing layer 115 is designed according to the shape of the head and is made of neoprene material to provide an adjustable fit and is equipped with adjustable straps to adapt to different head sizes, ensuring that the multiple stimulation electrodes 111 and the multiple temperature sensors 112 are in good contact with the scalp and ensuring that the cooling water pipeline 113 is close to the head to achieve cooling.

[0056] Repeatedly-adhesive material 101 is disposed around the bottom of the first side of the fixing layer 115 , and repeatedly-adhesive material 101 is disposed around the bottom of the second side of the waterproof layer 114 . The fixing layer 115 and the waterproof layer 114 are connected based on the repeatedly-adhesive material 101 .

[0057] According to an embodiment of the present disclosure, the waterproof layer 114 and the fixing layer 115 are fixed around the bottom by a circle of repeated adhesive material 101 (such as Velcro), so that the wearable module 110 forms an integrated structure and is easy to disassemble for inspection.

[0058] Figure 3 The schematic diagram shows the structure of the fixing layer included in the wearable module according to the embodiment of the present disclosure.

[0059] like Figure 3 As shown, orthogonal auxiliary lines may be drawn on the top of the second side of the fixing layer 115. The orthogonal auxiliary lines may include a first orthogonal line 1151 and a second orthogonal line 1152. The orthogonal auxiliary lines on the fixing layer 115 can provide a clear visual reference for the user to ensure the correct positioning of the wearable module 110.

[0060] like Figure 1 As shown, the electric excitation control module 120 may include a voltage source 121 and a control unit 122. The voltage source 121 may be a direct current power source with an output voltage range of ±5V and an output current intensity range of ±4500μA.

[0061] The input end of the control unit 122 can be electrically connected to the voltage source 121, and the multiple first control ends of the control unit 122 can be electrically connected to the multiple stimulation electrodes 111. The control unit 122 can be used to convert the voltage output by the voltage source 121 according to the first treatment requirement information to obtain a first conversion voltage, and power the multiple stimulation electrodes 111 according to the first conversion voltage.

[0062] The electrostimulation control module 120 may further include a patch electrode 123 .

[0063] The patch electrode 123 may be electrically connected to the second control terminal of the control unit 122. The polarity of the plurality of stimulation electrodes 111 may be opposite to the polarity of the patch electrode 123. The patch electrode 123 may be a sponge electrode.

[0064] The control unit 122 can also be used to convert the voltage output by the voltage source 121 according to the second treatment requirement information to obtain a second converted voltage, and power the multiple stimulation electrodes 111 and the patch electrodes 123 according to the second converted voltage.

[0065] For example, the control unit 122 may embed a stimulation mode, selected by disease classification, mainly including stroke and cardiac arrest. The control unit 122 may automatically generate stimulation parameters corresponding to each of the plurality of stimulation electrodes 111 for the stimulation mode specified by the user, i.e. based on the treatment requirement information.

[0066] For example, after the control unit 122 determines that the user has selected the stroke mode based on the treatment demand information, it can determine the location of the head lesion selected by the user, and output a first conversion voltage to power the multiple stimulation electrodes 111, so as to achieve cathode stimulation on the half of the brain where the lesion is located based on the multiple stimulation electrodes 111, and achieve anodal stimulation on the other half of the brain. When the control unit 122 determines that the user has selected the cardiac arrest mode based on the treatment demand information, it outputs a second conversion voltage to power the multiple stimulation electrodes 111 and the patch electrodes 123, at which time, the multiple stimulation electrodes 111 are cathodes and the patch electrodes 123 are anodes. Thus, the control unit 122 can be used to control the polarity and current intensity of the electrodes, wherein the electrodes include the stimulation electrodes 111 and the patch electrodes 123.

[0067] Figure 4 The schematic diagram shows the structure of a therapeutic device based on electrical stimulation and mild hypothermia according to another embodiment of the present disclosure.

[0068] like Figure 4 As shown, the patch electrode 123 can be a 25 square centimeter sponge electrode. In a specific mode, the patch electrode 123 can be attached to the patient's shoulder as an anode.

[0069] The heat exchange module 130 may include a temperature control unit 131 , a water tank 132 , a circulation device 133 and an evaporator 134 .

[0070] like Figure 1 As shown, the temperature control unit 131 may be electrically connected to the plurality of temperature sensors 112. The temperature control unit 131 may be used to determine a first operating frequency of the evaporator 134 and a second operating frequency of the circulation device 133 according to the regional temperature.

[0071] According to the embodiment of the present disclosure, the temperature sensor 112 can monitor the change of scalp temperature in real time and obtain the real-time regional temperature of the predetermined area of ​​the head. The temperature control unit 131 can calculate the temperature deviation between the real-time regional temperature and the set temperature, and use the built-in adaptive PID (Proportion Integration Differentiation) controller to dynamically adjust the first operating frequency of the evaporator 134 and the second operating frequency of the circulation device 133 according to the size, duration and change rate of the temperature deviation, so as to dynamically adjust the cooling strength of the evaporator 134 and the flow rate of the circulating cooling water in the water tank 132, and realize stable body surface temperature control.

[0072] The water inlet of the water tank 132 is connected to the water outlet of the cooling water pipeline 113. The water tank 132 is used to store circulating cooling water.

[0073] The water inlet of the circulation device 133 is connected to the water outlet of the water tank 132. The water outlet of the circulation device 133 is connected to the water inlet of the cooling water pipeline 113. The circulation device 133 can be used to adjust the flow rate of the circulating cooling water according to the second operating frequency.

[0074] The evaporator 134 is disposed at the bottom or side of the water tank 132. The evaporator 134 is used to adjust the temperature of the circulating cooling water according to the first operating frequency.

[0075] Based on the above-mentioned treatment device based on electrical stimulation and mild hypothermia, an embodiment of the present disclosure provides a method for using the treatment device based on electrical stimulation and mild hypothermia.

[0076] For example, taking an ischemic stroke patient with a lesion in the left brain as an example, the method of using a therapeutic device based on electrical stimulation and mild hypothermia may include the following steps:

[0077] (1) Equipment wearing: First, gently place the wearable module of the treatment device on the patient's head and adjust the position preliminarily. Then, carefully observe the wearing auxiliary lines on the outside of the wearable module, and slightly adjust the position of the wearable module so that the middle first orthogonal line 1151 is accurately aligned with the center of the patient's brow. At this time, it should be ensured that the second orthogonal lines 1152 on both sides are at the same height in the horizontal direction to maintain overall symmetry and stability. Next, ensure that multiple stimulation electrodes, multiple temperature sensors and cooling water pipelines are close to the patient's head. Finally, confirm that the fixing device of the wearable module is stable and correct to avoid displacement during treatment, and ensure the safety and effectiveness of the treatment device during use.

[0078] (2) Parameter setting: Enter the parameter setting interface of the treatment device through the control unit. According to the patient's specific condition, select the appropriate stimulation mode and cooling parameters. For hypothermia treatment, the hypothermia parameter can be set to 35 degrees. During the treatment, the temperature of the predetermined area of ​​the head will be maintained at 35 degrees to achieve the ideal cooling effect. Next, select the transcranial direct current stimulation (tDCS) mode, select the disease as stroke in the control unit, and select the lesion as the left brain. The control unit prompts that tDCS stimulation will be performed on the left brain. The default stimulation intensity is 5mA. The stimulation electrode used to stimulate the left brain is the cathode, and the stimulation electrode used to stimulate the right brain is the anode. The patch electrode has no output. At this time, the stimulation intensity can be adjusted and confirmed.

[0079] (3) Start treatment and real-time monitoring: Turn on the tDCS stimulation controller and heat exchange module in the control unit to start comprehensive treatment. Through the temperature sensor, control unit and heat exchange module, the current and temperature parameters are monitored and adjusted in real time to ensure the best treatment effect.

[0080] (4) End of treatment: End treatment according to the time and conditions set in the treatment plan and remove the treatment equipment.

[0081] It will be appreciated by those skilled in the art that the features described in the various embodiments and / or claims of the present disclosure may be combined and / or combined in a variety of ways, even if such combinations and / or combinations are not explicitly described in the present disclosure. In particular, the features described in the various embodiments and / or claims of the present disclosure may be combined and / or combined in a variety of ways without departing from the spirit and teachings of the present disclosure. All of these combinations and / or combinations fall within the scope of the present disclosure.

[0082] The embodiments of the present disclosure are described above. However, these embodiments are only for illustrative purposes and are not intended to limit the scope of the present disclosure. Although the embodiments are described above separately, this does not mean that the measures in the various embodiments cannot be used in combination to advantage. The scope of the present disclosure is defined by the attached claims and their equivalents. Without departing from the scope of the present disclosure, those skilled in the art may make a variety of substitutions and modifications, which should all fall within the scope of the present disclosure.

Claims

1. A therapeutic device based on electrical stimulation and mild hypothermia, comprising: Wearable module, including: a plurality of stimulation electrodes for electrically stimulating predetermined areas of the head; A plurality of temperature sensors, used for collecting the regional temperature of a predetermined area of ​​the head; a cooling water pipeline for dissipating heat from a predetermined area of ​​the head based on circulating cooling water flowing through the cooling water pipeline; a waterproof layer, wherein the plurality of stimulation electrodes are disposed on a first side of the waterproof layer, and the cooling water pipeline is disposed on a second side of the waterproof layer; An electrical stimulation control module, electrically connected to the plurality of stimulation electrodes respectively, and configured to adjust the electrical stimulation intensity of the plurality of stimulation electrodes; A heat exchange module is connected between the water inlet and the water outlet of the cooling water pipeline and is electrically connected to the multiple temperature sensors. The heat exchange module is used to adjust the temperature and flow rate of the circulating cooling water according to the regional temperature.

2. The therapeutic device according to claim 1, wherein: The electric excitation control module comprises: Voltage source; A control unit, wherein an input end of the control unit is electrically connected to the voltage source, and a plurality of first control ends of the control unit are electrically connected to the plurality of stimulation electrodes respectively, for converting the voltage output by the voltage source according to first treatment requirement information to obtain a first conversion voltage, and supplying power to the plurality of stimulation electrodes according to the first conversion voltage.

3. The therapeutic device according to claim 2, wherein: The electric excitation control module also includes: a patch electrode, wherein the patch electrode is electrically connected to the second control terminal of the control unit, and the polarity of the plurality of stimulation electrodes is opposite to that of the patch electrode; The control unit is further used to convert the voltage output by the voltage source according to the second treatment requirement information to obtain a second converted voltage, and to supply power to the multiple stimulation electrodes and the patch electrodes according to the second converted voltage.

4. A therapeutic device according to any one of claims 1 to 3, wherein: The heat exchange module comprises: a temperature control unit, electrically connected to the plurality of temperature sensors, the temperature control unit being used to determine a first operating frequency of the evaporator and a second operating frequency of the circulation device according to the regional temperature; A water tank, wherein a water inlet of the water tank is connected to a water outlet of the cooling water pipeline, and the water tank is used to store the circulating cooling water; The circulation device, wherein the water inlet of the circulation device is connected to the water outlet of the water tank, the water outlet of the circulation device is connected to the water inlet of the cooling water pipeline, and the circulation device is used to adjust the flow rate of the circulating cooling water according to the second operating frequency; The evaporator is arranged at the bottom or side of the water tank, and is used to adjust the temperature of the circulating cooling water according to the first operating frequency.

5. The therapeutic device according to claim 4, wherein: The wearable module also includes: a fixing layer, wherein the cooling water pipeline is fixed in an area corresponding to the predetermined area of ​​the head on a first side of the fixing layer; Repeatedly-adhesive materials are arranged around the bottom of the first side of the fixing layer, and repeated-adhesive materials are arranged around the bottom of the second side of the waterproof layer. The fixing layer and the waterproof layer are connected based on the repeated-adhesive materials.

6. The therapeutic device according to claim 5, wherein: An orthogonal auxiliary line is drawn on the top of the second side of the fixed layer.

7. A therapeutic device according to any one of claims 1 to 3, wherein: The number of the plurality of stimulation electrodes is between 10 and 30, and the number of the plurality of temperature sensors is between 1 and 6.

8. The therapeutic device according to claim 5, wherein: The material of the plurality of stimulation electrodes comprises one of the following: silver and silver chloride; The material of the fixing layer is: chloroprene rubber; The material of the waterproof layer is: chloroprene rubber.

9. The therapeutic device according to claim 3, wherein: The patch electrode is a sponge electrode.

10. The therapeutic device according to claim 5, wherein: The cooling water pipeline includes a water pipe that surrounds the fixed layer in a zigzag shape, wherein the water pipe is made of silica gel, and the silica gel includes at least one of the following materials: aluminum oxide, magnesium oxide and boron nitride.

Images