Temperature control nerve block system and application thereof

Abstract

The invention relates to the technical field of nerve conduction function blocking, and discloses a temperature control nerve blocking system and application thereof.The temperature control nerve blocking system comprises a control unit and further comprises a refrigeration unit and a temperature monitoring unit, the refrigeration unit comprises a blocking semiconductor refrigeration piece and a low-temperature cold dissipation part, and the low-temperature cold dissipation part makes contact with a low-temperature acting body surface target area; the temperature monitoring unit comprises a temperature monitor connected to the low-temperature cold dissipation part, and the temperature monitor transmits a temperature signal to the control unit; and the control unit is used for receiving a temperature signal of the temperature monitor and controlling the output power of the retardation semiconductor chilling plate and the temperature of the low-temperature cold dissipation part. According to the invention, the problems of low temperature control precision and slow control speed during low-temperature retardation of nerves in the prior art are solved.

Description

Technical Field

[0001] The present invention relates to the technical field of intelligent monitoring devices for low-temperature nerve blocks, and in particular to a temperature-controlled nerve block system and applications thereof. Background Art

[0002] Currently, in the process of medical treatment, physical therapy methods that inhibit pain signal transmission, reduce inflammatory responses and tissue damage mainly include pharmacological nerve block technology and non-drug nerve block technology. Among them, pharmacological nerve block technology uses invasive puncture to inject drugs, using drugs to act around nerves to relieve inflammation and pain, incise and suture nerves, and cause conduction block by causing limited damage to nerves. During application, there are risks such as temporary or permanent nerve damage and infection. Local anesthetics and intravenous anesthetics have drug poisoning side effects after use, and the duration of drug action is usually only a few hours, which cannot meet the long-term treatment needs of patients with acute and chronic pain. Cold therapy is a non-drug nerve block technology. Compared with other methods, it has the advantages of fewer side effects, easy operation and low cost, and is widely used.

[0003] Cryotherapy or Local Hypothermic Analgesia refers to a physical therapy method that uses local application of low temperature to inhibit pain signal transmission, reduce inflammatory responses and tissue damage. Its main principles include: reducing the sodium ion channel activity of pain afferent fibers (Aδ, C fibers) through low temperature, reducing action potential generation, blocking pain signal transmission and achieving nerve conduction inhibition; or contracting local blood vessels through low temperature, reducing the release of inflammatory mediators (such as prostaglandins and bradykinin), reducing tissue edema and pain sensitization; or reducing cellular metabolic rate and oxygen consumption through low temperature, reducing ischemia-reperfusion injury and free radical generation. Currently, the core goal of cold therapy or local hypothermia analgesia is to achieve non-drug pain relief through temperature regulation. It is widely used in medical fields such as acute injury scenarios such as soft tissue contusion, ligament sprain, and muscle strain, postoperative management scenarios for local swelling and pain control after joint replacement and fracture reduction, and metabolic relief of delayed onset muscle soreness (DOMS) after high-intensity exercise.

[0004] The means of achieving hypothermia currently mainly include non-invasive methods such as ice packs, ice water immersion, cryogenic wet compresses, and cold sprays, as well as invasive methods such as cryoprobes (used for deep nerve blocks or lesion ablation below -20°C). Different hypothermia methods have different targets, depth of action, hypothermia range, duration, and operational risks. For example, ice packs are usually used to apply ice to wounds or painful areas. When used, the ice pack is in direct contact with the skin to avoid frostbite. A thin towel needs to be wrapped around the outer layer of the ice pack. Although it can achieve a certain analgesic effect, there are the following limitations when using ice packs: 1. The temperature is uncontrollable and the effect time is short when using ice packs. The temperature of the ice pack may change during use, and the low temperature effect is unstable, resulting in unstable analgesic effect; 2. A large amount of condensed water is generated during ice packs, which may cause problems such as wound infection; 3. Ordinary ice packs (0℃~-10℃) can only penetrate 1~2cm under the skin and cannot effectively reach deep nerve trunks or nerve plexuses (such as the lumbar plexus, sciatic nerve, etc.), and the skin surface temperature is difficult to conduct to deep nerves (such as the sciatic nerve is located 5-8cm below the buttocks muscle, and it needs to be below -20℃ to effectively inhibit conduction). Another example is the cryoprobe, which is expensive and has limited use in ordinary cold therapy.

[0005] In order to avoid the drawbacks of various methods in existing low-temperature cold therapy, new heating or cooling devices for medical or human treatment have emerged in the prior art. Among them, a typical one is to use a semiconductor component cooling device (such as Peltier) to reduce the temperature of a cooling medium such as water, and then contact the low-temperature cooling medium with the target object, ultimately achieving low-temperature nerve conduction function blockade at the target location. For example, the invention patent with publication number CN119523722A discloses a dynamic body temperature regulation device and regulation method, which is provided with a semiconductor refrigeration plate and an application portion in contact with the cold end of the semiconductor refrigeration plate. When used, the cold end of the semiconductor refrigeration plate is used to cool the application portion, and the application portion has a cooling effect on the contact part. For another example, the invention patent with publication number CN115634095A discloses a portable cold therapy device, in which the cooling module is composed of a semiconductor Peltier device and a cold transfer medium. The semiconductor Peltier cools the cold transfer medium, and the cold transfer medium is in direct contact with the target part such as the human body to achieve cold compress.

[0006] Although the existing technology of using semiconductor cooling chips to achieve low-temperature cold therapy can control the low temperature value compared to ice packs and other cold compresses, and is less expensive than methods such as cryoprobes, when it is actually used for low-temperature nerve conduction function blockade, such as when performing low-temperature blockade on a nerve during surgery, the following problems still exist:

[0007] 1. For example, the invention patent with publication number CN115634095A lacks temperature feedback on the object of action of the semiconductor refrigeration plate, and can only use the control module to theoretically control the refrigeration temperature, but the actual refrigeration accuracy on the object of action is poor; although the invention patent with publication number CN119523722A is provided with a temperature sensor, the temperature sensor is provided in the electronic control cavity, and is affected by the external ambient temperature during detection, and cannot detect body temperature in a timely and accurate manner, so it is impossible to accurately control the low-temperature process.

[0008] 2. During use, since the hot end of the semiconductor refrigeration chip will generate a large amount of heat, the refrigeration equipment in the existing technology will set a heat dissipation structure or heat dissipation device at the hot end of the semiconductor refrigeration chip to avoid the hot end temperature being too high and affecting the low-temperature blocking effect. For example, the invention patents with publication numbers CN115634095A and CN119523722A both have fan structures for dissipating heat from the hot end of the semiconductor refrigeration chip. However, the use of fans for heat dissipation has significant disadvantages: on the one hand, the low-temperature nerve conduction function blockade process may be accompanied by surgery, and several layers of dressings must be provided during surgery, making it difficult to transfer heat from the hot end of the semiconductor refrigeration chip, thereby preventing the cooling surface from cooling. In addition, a sterile environment is strictly required during surgery, and the use of fans for heat dissipation is prone to bacterial contamination, which is obviously not suitable for surgical environments. On the other hand, for cold compress devices with low cooling effects in the prior art, the cooling power requirements of the semiconductor refrigeration chip are not high, and the heat dissipation requirements of the hot end of the semiconductor refrigeration chip are not large. However, for low-temperature nerve conduction function blockade, since low-temperature nerve conduction function blockade has very high requirements for the accuracy and timeliness of temperature control, the existing semiconductor component cooling devices lack intelligent monitoring devices such as intelligent sensors to intelligently monitor and control signals such as temperature, making it impossible for the refrigeration devices in the prior art to accurately control the effect of low-temperature nerve blockade.

[0009] Therefore, for the refrigeration equipment used for low-temperature nerve block in the existing technology, it is necessary to set up a more accurate and fast temperature control system to achieve better low-temperature nerve block effect; in addition, the application scope of the refrigeration equipment in the existing technology is limited, and it can be applied to more scenarios by improving the refrigeration control accuracy of the refrigeration equipment. Summary of the Invention

[0010] The present invention aims to provide a temperature-controlled nerve block system and its application to solve the problem of low temperature control accuracy when performing low-temperature block on nerves in the prior art.

[0011] To solve the above problems, the present invention adopts the following technical solution: a temperature-controlled nerve block system, comprising a control unit, a refrigeration unit, and a temperature monitoring unit.

[0012] The refrigeration unit includes a blocking semiconductor refrigeration sheet and a low-temperature cooling portion fixedly connected to the cold end of the blocking semiconductor refrigeration sheet, wherein the low-temperature cooling portion contacts the target area on the body surface to which the low temperature is applied;

[0013] The temperature monitoring unit includes a temperature monitor connected to the low-temperature cooling part, and the temperature monitor transmits a temperature signal to the control unit.

[0014] The principle of this solution is: a control unit is used to receive the temperature signal of the temperature monitor and control the output power of the blocking semiconductor refrigeration piece and the temperature of the low-temperature heat dissipation part. The control unit accurately controls the low-temperature value of the cold end of the blocking semiconductor refrigeration piece by controlling the power supply size of the blocking semiconductor refrigeration piece. The cold end of the blocking semiconductor refrigeration piece is fixedly connected and in direct contact with the low-temperature heat dissipation part. When in use, the low temperature of the cold end of the blocking semiconductor refrigeration piece is transmitted to the low-temperature heat dissipation part. The cold end of the blocking semiconductor refrigeration piece is used to cool the low-temperature heat dissipation part, and the temperature of the low-temperature heat dissipation part is controlled within the set low-temperature value range. The low-temperature heat dissipation part is used to contact the target area on the body surface affected by low temperature to play a low-temperature nerve conduction function blocking role on subcutaneous nerve fibers.

[0015] In the present application, a temperature monitor connected to the control unit signal is provided. The temperature monitor is directly connected to the low-temperature cooling part. The low-temperature monitor is used to directly monitor the temperature signal of the low-temperature cooling part in real time and transmit the temperature signal to the control unit. The control unit controls the output power of the blocking semiconductor refrigeration piece according to the monitored temperature signal. After the output power of the blocking semiconductor refrigeration piece changes, the low-temperature value of the cold end of the blocking semiconductor refrigeration piece is adjusted, and finally the temperature of the low-temperature cooling part is controlled within a predetermined low-temperature range, which has an accurate and stable low-temperature conduction function blocking effect on the relevant nerve fibers. At the same time, a cooling unit is connected to the hot end of the blocking semiconductor refrigeration piece. The cooling unit adopts a circulating water cooling mechanism to circulate cooling water to circulate heat to the hot end of the blocking semiconductor refrigeration piece, so as to avoid the hot end of the blocking semiconductor refrigeration piece from being too high and affecting the cooling effect of the blocking semiconductor refrigeration piece.

[0016] The beneficial effects of this program are:

[0017] 1. More precise control of low temperature: Compared with the prior art refrigeration equipment, which does not have a temperature monitor or the temperature monitor cannot quickly and accurately monitor the temperature value of the target area on the body surface affected by low temperature. In the present application, the low temperature cooling part is fixedly connected to the cold end of the blocking semiconductor refrigeration plate, and the low temperature cooling part is in close contact with the blocking semiconductor refrigeration plate. During use, the cold end of the blocking semiconductor refrigeration plate can directly and quickly cool the low temperature cooling part, and then the low temperature cooling part directly contacts the target area on the body surface affected by low temperature, quickly achieving low temperature nerve conduction function blockade, and the blockade is more precise and efficient. At the same time, in the present application, a temperature monitor is fixedly connected to the low temperature cooling part, and the temperature monitor can monitor the actual temperature of the low temperature cooling part in real time. When the temperature difference between the monitored temperature of the low temperature cooling part and the preset temperature is too large, the control unit can dynamically adjust the power supply of the blocking semiconductor refrigeration plate after receiving the temperature signal, thereby quickly and accurately adjusting the cooling effect of the blocking semiconductor refrigeration plate on the low temperature cooling part. This is an intelligent monitoring device that ensures that the low temperature cooling part can accurately produce low temperature nerve conduction function blockade through precise monitoring and rapid control.

[0018] 2. It can effectively realize intelligent monitoring and control: In the present application, by fixing the temperature monitor to the low-temperature cooling part, the temperature monitor can directly monitor the temperature of the low-temperature cooling part used for the action part, such as measuring the temperature of some parts of the body. The low-temperature cooling part is in direct contact with the low-temperature action target area on the body surface. The temperature of the low-temperature action target area on the body surface is very close to the temperature of the low-temperature cooling part. Therefore, the temperature monitor detects the temperature of the low-temperature cooling part to accurately monitor the temperature of the low-temperature action target area on the body surface. When the temperature of the low-temperature cooling part is not within the set value range or the temperature fluctuates during use, the temperature monitor can transmit the temperature signal to the control unit in real time. The control unit controls the power supply of the blocking semiconductor refrigeration piece and quickly adjusts the cooling effect of the blocking semiconductor refrigeration piece. The whole process can be completed continuously, accurately and quickly.

[0019] Preferably, as an improvement, the low-temperature cooling portion includes a disc-shaped low-temperature cooling copper piece, one side of the low-temperature cooling copper piece is in contact with the blocking semiconductor refrigeration plate, and the other side is used to contact the target area on the body surface where the low temperature acts.

[0020] In this solution, a low-temperature dissipation copper piece is used as the low-temperature dissipation part. The copper low-temperature dissipation copper piece can conduct low temperature quickly and efficiently, and the disc-shaped low-temperature dissipation copper piece is easy to process. The dissipation process can cool down the target area on the body surface with the center of the low-temperature dissipation copper piece as the center of the circle, making the low temperature more uniform. At the same time, the disc-shaped low-temperature dissipation copper piece can easily and stably install a temperature monitor.

[0021] Preferably, as an improvement, a low-temperature conductive water bag is fixedly connected to one side of the low-temperature heat dissipation copper piece used for the low-temperature action on the target area of ​​the body surface.

[0022] In this solution, a low-temperature conductive water bag is fixedly connected to the side of the low-temperature heat-dissipating copper piece used for the target area on the body surface to be acted upon by low temperature. During use, the low-temperature conductive water bag can play a role in low-temperature conduction. At the same time, since the low-temperature conductive water bag has a flexible structure, it can fit well with the target area on the body surface to be acted upon by low temperature during use, thereby improving the effectiveness of the low-temperature effect. At the same time, the low-temperature conductive water bag is more comfortable to use and is particularly suitable for application scenarios of cold therapy.

[0023] Preferably, as an improvement, it further comprises a cooling unit, the cooling unit comprising a circulating water cooling mechanism connected to the hot end of the blocking semiconductor refrigeration plate;

[0024] The circulating water cooling mechanism includes a cooling copper piece, a circulating cooling medium, a circulating pipeline and a heat exchange system. The cooling copper piece is fixedly connected to the hot end of the blocking semiconductor refrigeration plate. The circulating pipeline is connected between the cooling copper piece and the heat exchange system. The circulating cooling medium circulates between the heat exchange system and the cooling copper piece through the circulating pipeline to dissipate heat to the cooling copper piece.

[0025] The heat exchange system includes a circulating cooling water tank, and a circulating pipeline is connected between the circulating cooling water tank and the cooling copper piece;

[0026] Alternatively, the heat exchange system includes a heat exchange semiconductor refrigeration plate and a heat exchange copper plate. The heat exchange semiconductor refrigeration plate is connected to the control unit signal, the heat exchange copper plate is fixedly connected to the cold end of the heat exchange semiconductor, a heat exchange flow channel is provided in the heat exchange copper plate, a circulation pipeline is connected between the heat exchange copper plate and the cooling copper part, and a circulation pump is connected to the circulation pipeline.

[0027] In this solution, the cooling copper part is fixedly connected to the hot end of the blocking semiconductor refrigeration plate. During use, the cooling copper part can quickly conduct and dissipate the heat from the hot end of the blocking semiconductor refrigeration plate, while avoiding direct contact between the circulating cooling medium and the blocking semiconductor refrigeration plate, thereby improving the working stability of the blocking semiconductor refrigeration plate; in addition, the circulating cooling medium circulates between the heat exchange system and the cooling copper part through the circulating pipeline. The circulating cooling medium increases in temperature at the cooling copper part due to heat exchange with the cooling copper part. The circulating cooling medium in a high-temperature state is cooled when flowing through the heat exchange system, and then the cooled circulating cooling medium flows to the cooling copper part and continues to dissipate heat. At the same time, when a circulating pipeline is set up, the heat exchange system can be away from the blocking semiconductor refrigeration plate, which can effectively reduce the impact of the high-temperature heat exchange system on the blocking semiconductor refrigeration plate, and is particularly suitable for scenarios with high requirements for low-temperature nerve conduction function blocking, such as surgery.

[0028] Compared to the existing method of using fans for heat dissipation, which has limited heat dissipation effects and is not suitable for low-temperature nerve conduction function blockade during surgery, this solution uses cooling water from a circulating water cooling mechanism to circulate heat around the hot end of the blocking semiconductor refrigeration plate, achieving high heat dissipation efficiency and effectively reducing the impact of high temperatures at the hot end of the blocking semiconductor refrigeration plate on low-temperature nerve conduction function blockade. Furthermore, the use of water cooling for heat dissipation is not only highly efficient, but also does not disturb the airflow around the heat dissipation area compared to the existing method of using fans for heat dissipation. This makes it particularly suitable for applications such as low-temperature nerve conduction function blockade during surgery, reducing the risk of bacterial infection.

[0029] In addition, in this solution, based on actual costs and application requirements, a circulating cooling water tank or a structure composed of a heat exchange semiconductor refrigeration plate and a heat exchange copper plate is used as a heat exchange system, both of which can provide efficient and continuous heat dissipation for the hot end of the organization semiconductor refrigeration plate. The circulating cooling water tank has a low purchase cost and can be used directly after purchase, which is very convenient; the structure composed of the heat exchange semiconductor refrigeration plate and the heat exchange copper plate can be controlled by a control unit to achieve a cooling effect. The cooling effect of the heat exchange semiconductor refrigeration plate can be adjusted accordingly according to the cooling power of the blocking semiconductor refrigeration plate, making the cooling more precise and reducing unnecessary energy consumption. This can not only effectively save costs, but also provide efficient heat dissipation when the blocking semiconductor refrigeration plate has high output power, effectively ensuring the cooling effect.

[0030] Preferably, as an improvement, the temperature monitor includes an internal temperature sensor and an external temperature sensor, the internal temperature sensor is fixedly connected to the side of the low-temperature heat dissipation copper piece away from the blocking semiconductor refrigeration piece, the number of internal temperature sensors is at least two, and the internal temperature sensors are arranged on the bottom surface of the low-temperature heat dissipation copper piece along the radial direction of the low-temperature heat dissipation copper piece; the external temperature sensor is connected to the outside of the low-temperature heat dissipation copper piece and its radial position along the low-temperature heat dissipation copper piece is adjustable, the distance between the external temperature sensor and the outer wall of the low-temperature heat dissipation copper piece is Z, the nerve fibers of the target area on the surface of the body affected by low temperature are located at a subcutaneous depth of d, Z=d, and the control unit dynamically adjusts the output power of the blocking semiconductor refrigeration piece according to the temperature signals monitored by the internal temperature sensor and the external temperature sensor.

[0031] In this solution, the internal temperature sensor is fixedly connected to the side of the low-temperature heat dissipation copper piece that is away from the blocking semiconductor refrigeration plate. The internal temperature sensor is used to monitor the temperature of the contact surface between the low-temperature heat dissipation copper piece and the target area on the body surface where the low temperature is applied. There are at least two internal temperature sensors and all the internal temperature sensors are arranged on the bottom surface of the low-temperature heat dissipation copper piece. When the control unit receives the temperature monitoring signal from the internal temperature sensor, only when the temperature signals monitored by all the internal temperature sensors are equal (or within the allowable difference range, such as 0.5°C), does it indicate that the low-temperature heat dissipation copper piece uniformly cools the target area on the body surface where the low temperature is applied, thereby effectively ensuring the effect of low-temperature nerve conduction function blocking.

[0032] In addition, in this solution, an external temperature sensor is provided on the outside of the low-temperature heat dissipation copper component. The external temperature sensor is used to monitor the temperature signal at a position Z distance from the outer wall of the low-temperature heat dissipation copper component, and Z=d. The heat conduction of the subcutaneous tissue is radially symmetrical. The temperature signal at the monitoring position Z is used to map the temperature signal at a depth of d under the skin, so as to realize dynamic monitoring and dynamically adjust the output power of the blocking semiconductor refrigeration plate according to the monitored temperature signal, so as to control the target tissue temperature at a depth of d under the skin within the set range, so as to stabilize the low-temperature nerve conduction function blocking effect.

[0033] Preferably, as an improvement, the power calculation formula of the blocking semiconductor refrigeration plate is:

[0034] q cool The calculation formula is:

[0035] Among them A Cu The area of ​​contact between the low-temperature heat dissipation copper component and the target area on the surface of the low-temperature action body, in m 2 ;q cool is the heat flow and metabolic heat production from the cooling center area to the subcutaneous depth d; η is the safety factor, ranging from 1.5 to 2; COP is the cooling efficiency of the blocking semiconductor refrigeration chip, ranging from 0.5 to 0.7;

[0036] where k eff is the equivalent thermal conductivity of the tissue, ranging from 0.35 to 0.49 W / m·K; T core is the core temperature of the human body, which is 37°C; T target is the target tissue temperature at subcutaneous depth d; q met is the metabolic heat production rate, ranging from 500 to 1000 W / m 3 ; d is the subcutaneous target depth, ranging from 1 to 10 cm.

[0037] In this solution, the power of the blocking semiconductor refrigeration chip is determined based on the heat flow and metabolic heat production from the cooling center area to the subcutaneous depth d and the contact area of ​​the low-temperature heat dissipation copper piece. In actual application, it is ensured that the power of the blocking semiconductor refrigeration chip is sufficient. Under the control of the control unit, the blocking semiconductor refrigeration chip can reach the predetermined output power and cool the low-temperature heat dissipation copper piece to the predetermined temperature range, thereby controlling the target tissue temperature at the subcutaneous depth d to T target The target tissue temperature value can effectively achieve low-temperature nerve conduction function blockade.

[0038] Preferably, as an improvement, there are multiple blocking semiconductor refrigeration plates, all of which are connected to the control unit signal, and each blocking semiconductor refrigeration plate is connected to the cooling mechanism, low-temperature cooling part and temperature monitor.

[0039] In this solution, multiple blocking semiconductor cooling sheets are set up. When in use, they can act on different parts of the body through multiple blocking semiconductor cooling sheets to block nerves in different parts, meeting more usage scenarios. For example, in cold therapy applications, multiple parts can be treated simultaneously (for example, the hand and shoulder can be treated at the same time). Another example is during surgery, during low-temperature nerve conduction function blockade, multiple nerves can be cryogenically blocked, coordinating with perioperative analgesia.

[0040] An application of a temperature-controlled nerve block system, wherein the temperature-controlled nerve block system is applied to pain sensitivity detection.

[0041] In this solution, since the control unit can accurately control the temperature of the refrigeration unit, the temperature-controlled nerve blocking system can be used for pain sensitivity detection, specifically to detect the temperature pain range.

[0042] For example, when measuring pain sensitivity, the control unit can be used to adjust the output power of the blocking semiconductor refrigeration piece so that the temperature of the low-temperature cooling part drops to 4°C (or 8°C, etc.), and the low-temperature cooling part is brought into contact with the subject, and then the time when the subject feels pain and the time when the pain becomes unbearable are detected and recorded. For another example, when testing the cold pain threshold, the low-temperature cooling part can be brought into contact with the subject, and then the control unit controls the temperature of the blocking semiconductor refrigeration piece to decrease in a step-by-step manner (for example, by lowering the temperature by 1°C / S) until the subject feels pain. The temperature monitoring unit is used to detect the temperature value at which the subject feels pain, and the cold pain threshold (CPT) of the subject can be accurately measured; at the same time, a timer is started to record the time from when the subject starts to feel pain to when he can no longer tolerate the cold pain (pain tolerance time CPT-T), to evaluate the subject's tolerance to continuous cold stimulation, which can be used to guide the optimization of cold therapy parameters.

[0043] Preferably, as an improvement, a temperature-controlled nerve block system is used for analgesia, wherein the refrigeration unit acts on a target area on the body surface affected by low temperature, and the target area on the body surface affected by low temperature is located at the proximal nerve trunk or nerve plexus of the nerve fibers corresponding to the analgesic treatment area.

[0044] In this solution, the refrigeration unit does not act directly on the analgesic treatment area, but acts on the proximal nerve trunk or nerve plexus of the nerve fibers corresponding to the analgesic treatment area. The low-temperature cooling part in the refrigeration unit is used to block the low-temperature nerve conduction function of the nerve fibers corresponding to the analgesic treatment area. The refrigeration unit is at a certain distance from the analgesic treatment area, and the same low-temperature nerve conduction function blocking effect is achieved while avoiding direct contact between the refrigeration unit and the analgesic treatment area. Compared with the existing technology of directly using low-temperature equipment to act on the treatment area, it has better technical effects.

[0045] In cold therapy applications, prior art cryogenic devices may cause discomfort when applied directly to an injured area, and condensation may form on the surface of the device during use, which can contaminate wounds (especially open wounds or infected areas). This solution prevents discomfort caused by direct contact between the refrigeration unit and the injured area. Furthermore, even if condensation forms on the surface of the cryogenic cooling unit during use, the condensation will not affect the treatment area because the unit acts on nerve trunks or plexuses far from the treatment area, resulting in a better cold therapy effect.

[0046] An application of a temperature-controlled nerve block system, applying the temperature-controlled nerve block system to pain sensitivity detection and analgesia, integrating cold pain measurement and cold therapy analgesia into a closed-loop system.

[0047] In this solution, a temperature-controlled nerve block system in this application is used for both pain sensitivity detection and cold analgesia. The same system is used to implement closed-loop management of "assessment-treatment", integrating cold pain measurement and cold analgesia into a closed-loop system, thus realizing a highly potential personalized intervention strategy in pain medicine.

[0048] In practical applications, the system can first accurately detect pain sensitivity, such as completing CPT and CPT-T tests, and then adjust individualized cold therapy parameter settings based on CPT. For example, the cold therapy temperature can be adjusted based on CPT, and the duration of a single cold therapy session can be determined based on CPT-T to avoid cold pain discomfort and decreased tolerance, or the target tissue temperature T can be dynamically set based on individual sensitivity. target In addition, this system can also be used for dynamic efficacy monitoring, that is, repeating CPT evaluation before and after cold therapy, and the modulation effect of cold therapy on the pain pathway can be evaluated by repeating CPT. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 This is a schematic diagram of embodiment 1 of the invention.

[0050] Figure 2 for Figure 1 Exploded diagram of the medium-blocking semiconductor refrigeration chip, temperature monitor, low-temperature heat dissipation copper parts, and cooling copper parts.

[0051] Figure 3 This is a schematic diagram of the low-temperature cooling copper component acting on nerve fibers in Example 1 of the present invention.

[0052] Figure 4 Schematic diagram of the test position in Example 3 of the present invention.

[0053] Figure 5 These are the test results of the pain threshold detection test of the subjects under 8°C low temperature intervention in Example 3 of the present invention.

[0054] Figure 6 These are the test results of the pain tolerance threshold of the subjects under 8°C low temperature intervention in Example 3 of the present invention.

[0055] Figure 7 This is a schematic diagram of embodiment 6 of the present invention.

[0056] Figure 8 This is a schematic diagram of embodiment 7 of the present invention.

[0057] Figure 9 This is a partial cross-sectional view of the connection between the low-temperature heat dissipation copper component and the low-temperature conductive water bag in Example 8 of the present invention. DETAILED DESCRIPTION

[0058] The following is further described in detail through specific implementation methods:

[0059] The figure marks in the drawings of the specification include: control unit 1, blocking semiconductor refrigeration plate 2, temperature monitor 3, internal temperature sensor 301, external temperature sensor 302, low-temperature heat dissipation copper part 4, cooling copper part 5, cooling channel 501, liquid inlet port 502, liquid outlet port 503, plugging head 504, circulating cooling water tank 6, heat circulation pipe 7, cold circulation pipe 8, heat exchange semiconductor refrigeration plate 9, heat exchange copper plate 10, circulating pump 11, heat sink 12, heat sink 1201, low-temperature conductive water bag 13.

[0060] Example 1

[0061] This embodiment is as shown in the attached Figure 1 and Figure 2As shown: A temperature-controlled nerve block system includes a control unit 1, a refrigeration unit, and a temperature monitoring unit. The refrigeration unit includes a blocking semiconductor refrigeration plate 2 and a low-temperature cooling part fixedly connected to the cold end 2 of the blocking semiconductor refrigeration plate. The low-temperature cooling part is in contact with the target area on the body surface where the low temperature acts. The blocking semiconductor refrigeration plate 2 is signal-connected to the control unit 1. The blocking semiconductor refrigeration plate 2 has a Peltier effect. The control unit 1 can adopt a single-chip microcomputer, a PLC controller, etc. In this embodiment, the control unit 1 is connected to the blocking semiconductor refrigeration plate 2 through an electric wire. The control unit 1 controls the power supply size of the blocking semiconductor refrigeration plate 2 (in this embodiment, the cooling intensity of the blocking semiconductor refrigeration plate 2 is controlled by controlling the current size of the blocking semiconductor refrigeration plate 2). Therefore, the temperature of the cold end and the hot end of the blocking semiconductor refrigeration plate 2 can be controlled.

[0062] Combine Figure 1 and Figure 2 The temperature monitoring unit includes a temperature monitor 3 connected to the low-temperature cooling part, the temperature monitor 3 transmits the temperature signal to the control unit 1, and the low-temperature cooling part is fixedly connected to the cold end of the blocking semiconductor refrigeration plate 2 (i.e. Figure 2 The bottom end of the low-temperature heat dissipation part is fixedly connected to the temperature monitor 3, and the temperature monitor 3 is signal-connected to the control unit 1. Specifically, the blocking semiconductor refrigeration sheet 2 is a square sheet structure, and the low-temperature heat dissipation part is a disc-shaped copper low-temperature heat dissipation copper member 4. The blocking semiconductor refrigeration sheet 2 is located in the middle of the top of the low-temperature heat dissipation copper member 4. The diameter of the low-temperature heat dissipation copper member 4 is larger than the side length of the blocking semiconductor refrigeration sheet 2, so that the bottom surface of the blocking semiconductor refrigeration sheet 2 can completely contact the low-temperature heat dissipation copper member 4. The bottom surface of the low-temperature heat dissipation copper member 4 is used to contact the target area on the surface of the body to be affected by the low temperature, so that the nerve fibers under the skin of the target area on the surface of the body to be affected by the low temperature are affected by the low temperature, thereby achieving low-temperature nerve conduction function blockade.

[0063] When the disc-shaped low-temperature heat dissipation copper piece 4 is conducting at low temperature, the area of ​​the low-temperature heat dissipation copper piece 4 is:

[0064] Among them A Cu The area of ​​low temperature heat dissipation copper parts 4, unit is m 2 ;k eff k is the equivalent thermal conductivity of the tissue, ranging from 0.35 to 0.49 W / m·K (layer-weighted mean); CU is the thermal conductivity of copper, ranging from 386 to 413 W / m·K, with a preferred value of 400 W / m·K; d is the subcutaneous target depth, ranging from 1 to 10 cm.

[0065] The heat flow and metabolic heat production from the cooling center area to the subcutaneous depth d are:

[0066] where q coolis the heat flow and metabolic heat production from the cooling center area to the subcutaneous depth d; T core is the core temperature of the human body, which is 37°C; T target is the target tissue temperature at subcutaneous depth d; q met is the metabolic heat production rate, ranging from 500 to 1000 W / m 3 ;

[0067] The power of blocking semiconductor refrigeration plate 2 is:

[0068] Among them, P input is the input power of the Peltier; η is the safety factor, ranging from 1.5 to 2; COP is the cooling efficiency of the semiconductor refrigeration piece 2, ranging from 0.5 to 0.7.

[0069] In summary, the power of the blocking semiconductor refrigeration plate 2 is:

[0070] P input =(k eff ·(T core -T target ) / d+q met ·d)(η·π·k eff d / k Cu ) / COP.

[0071] like Figure 1 As shown, it also includes a cooling unit, which includes a circulating water cooling mechanism connected to the hot end of the blocking semiconductor refrigeration plate. The circulating water cooling mechanism is connected to the hot end surface of the top of the blocking semiconductor refrigeration plate 2. The circulating water cooling mechanism is used to circulate heat to the hot end surface of the top of the blocking semiconductor refrigeration plate 2 to avoid the temperature of the hot end of the blocking semiconductor refrigeration plate 2 being too high and affecting the cooling effect or causing combustion. Specifically, the circulating water cooling mechanism includes a cooling copper part 5, a circulating cooling medium, a circulating pipeline and a heat exchange system, wherein the cooling copper part 5 is a square block structure, and the side length of the cooling copper part 5 is greater than the side length of the blocking semiconductor refrigeration plate 2 to ensure that the hot end of the top surface of the blocking semiconductor refrigeration plate 2 is in full contact with the bottom end of the cooling copper part 5. At the same time, combined with Figure 2In this embodiment, a cooling channel 501 is opened in the cooling copper part 5 (to facilitate the processing of the cooling channel 501, multiple blind holes are first drilled on the side of the cooling copper part 5, and the multiple blind holes are interconnected to form the cooling channel 501, and then the sealing head 504 is welded to seal the redundant blind holes, leaving only two holes for connecting the circulation pipeline). The side wall of the cooling copper part 5 is connected to the liquid inlet port 502 and the liquid outlet port 503 connected to the cooling channel 501 by threaded fixing, which is convenient for connecting the circulation pipeline. The heat exchange system includes a circulating cooling water tank 6. In this embodiment, in order to make the system more regular, the control unit 1 can be installed and fixed in the circulating cooling water tank 6 to achieve integration; the circulating pipeline includes a hot circulation pipe 7 and a cold circulation pipe 8. The hot circulation pipe 7 is connected between the liquid outlet port 503 and the circulating cooling water tank 6, and the cold circulation pipe 8 is connected between the liquid inlet port 502 and the circulating cooling water tank 6. The circulating cooling water tank 6 is used to cool down hot water. The cold water formed after cooling flows through the cold circulation pipe 8 to the cooling copper part 5. After heat exchange with the cooling copper part 5, the temperature increases to form hot water. The cooling copper part 5 is cooled during heat exchange. The hot water with the increased temperature flows back to the circulating cooling water tank 6 through the hot circulation pipe 7 and is cooled again. In this way, the continuous cooling and cooling of the cooling copper part 5 can be completed, and heat dissipation can be achieved efficiently and stably. The circulating cooling water tank 6 can adopt an intelligent constant temperature circulator with internal pumping function and cooling fan, etc., which can achieve a stable cooling cycle. It will not be repeated here.

[0072] Combine Figure 1 and Figure 2 In this embodiment, the temperature monitor 3 includes an internal temperature sensor 301 and an external temperature sensor 302. The internal temperature sensor 301 is fixedly connected to the side of the low-temperature heat dissipation copper member 4 away from the blocking semiconductor refrigeration plate 2 by screw thread. The number of internal temperature sensors 301 is at least two, and the multiple internal temperature sensors 301 are arranged on the same circumference along the bottom surface of the low-temperature heat dissipation copper member 4 ( Figure 2 In other embodiments other than this embodiment, the number and arrangement of the internal temperature sensors 302 can be set according to the size of the bottom surface of the low-temperature heat dissipation copper member 4, and other settings are not described here; the external temperature sensor 302 is connected to the outside of the low-temperature heat dissipation copper member 4 and is adjustable along the radial position of the low-temperature heat dissipation copper member 4, combined with Figure 3 The distance between the external temperature sensor 302 and the outer wall of the low-temperature heat dissipation copper member 4 is Z, and the nerve fibers in the target area of ​​the body surface affected by low temperature are located at a subcutaneous depth of d, where Z=d. The control unit 1 dynamically adjusts the output power of the blocking semiconductor refrigeration plate 2 according to the temperature signals monitored by the internal temperature sensor 301 and the external temperature sensor 302 to ensure that the low-temperature heat dissipation copper member 4 can exert a stable low-temperature effect on the nerve fibers at a depth of d under the skin, so that the nerve fibers can stably achieve the low-temperature nerve conduction function blocking effect.

[0073] During specific adjustment, multiple internal temperature sensors 301 are set at different positions on the bottom surface of the low-temperature heat dissipation copper piece 4. When the tissue semiconductor refrigeration piece 2 is powered on and the temperature of the low-temperature heat dissipation copper piece 4 gradually decreases. Only when the temperatures of all internal temperature sensors 301 are equal (or the temperature difference is not large, for example, less than or equal to 0.3°C), indicating that the temperature of the bottom surface of the low-temperature heat dissipation copper piece 4 is uniform, the temperature signal of the external temperature sensor 302 is received. When the temperatures of all internal temperature sensors 301 are equal, the distance Z between the external temperature sensor 302 and the outer wall of the low-temperature heat dissipation copper piece 4 is adjusted to make Z=d, and then the external temperature sensor 302 is used to monitor the temperature value of the target area on the body surface where the low temperature is applied. After receiving the temperature signal monitored by the external temperature sensor 302, the control unit 1 adjusts the temperature according to the set target tissue temperature T target and the monitored temperature T of the external temperature sensor 302 test , use PID algorithm to control the output power of the semiconductor refrigeration piece 2, so that the temperature value of the monitoring position of the external temperature sensor 302 is at T target Within the setting range, for example, the temperature range is ±0.3°C. Since the combination of PID algorithm and temperature control belongs to the existing technology, the specific control process will not be described here.

[0074] In addition, in this embodiment, the internal temperature sensor 301 is fixed on the low-temperature heat dissipation copper part 4. To facilitate the installation and use of the internal temperature sensor 301, the internal temperature sensor 301 in this embodiment can adopt a flat-top screw head temperature sensor (NTC temperature sensor, temperature monitoring range -20 to 105°C) of the brand SST Shensitai and model CWF-S26. At the same time, since the external temperature sensor 302 is located on the outside of the low-temperature heat dissipation copper part 4, it is necessary to set different Z values ​​according to the different values ​​of the subcutaneous depth d of the nerve fibers in the target area of ​​the body surface affected by the low temperature. Therefore, the position of the external temperature sensor 302 needs to be adjusted during use. In order to conveniently and accurately adjust the position of the external temperature sensor 302, a guide plate can be fixed on the top surface of the low-temperature heat dissipation copper part 4, and a guide groove or multiple fixing holes ( Figure 2The figure shows a form of setting multiple fixing holes), and the multiple fixing holes are arranged along the radial direction of the low-temperature heat dissipation copper piece 4, and the spacing can be set to 0.3 cm, 0.5 cm, etc., or when the guide groove is set, the guide groove is set along the radial direction of the low-temperature heat dissipation copper piece 4, and then the external temperature sensor 302 is fixed to different fixing holes or located at different positions in the guide groove to achieve position adjustment of the external temperature sensor 302. This embodiment is only described in terms of setting fixing holes or guide grooves. In other embodiments other than this embodiment, the external temperature sensor 302 can be set in other ways, as long as the distance between the external temperature sensor 302 and the outer wall of the low-temperature heat dissipation copper piece 4 can be adjusted, and after adjustment, the external temperature sensor 302 can detect the temperature signal corresponding to the location of the low-temperature action target area on the body surface. At the same time, in order to facilitate the accurate monitoring of the external temperature sensor 302, the external temperature sensor 302 can adopt an infrared temperature sensor, or a PT100 temperature sensor. When in use, a spring or other components are used to apply pressure to the temperature sensor to ensure that the temperature sensor is in close contact with the low-temperature action target area on the body surface and accurately monitors the temperature. No further details are given here.

[0075] The specific implementation process is as follows:

[0076] It should be noted that the cryogenic nerve conduction block in this protocol uses cryogenic equipment to act on nerve fibers at the target location to achieve a reversible blockade. According to the classification of nerve function, the nerves with conduction block can be divided into sensory nerves (such as pain fibers (Aδ, C fibers), temperature fibers, touch / pressure fibers (Aβ fibers), etc.), motor nerves (such as α motor fibers (Aα fibers)), autonomic nerves (such as sympathetic nerves (B fibers), parasympathetic nerves (some C fibers)), etc.; according to the classification of anatomical location, the nerves with conduction block can be divided into peripheral nerves (common targets include the upper limbs, lower limbs, trunk, etc.), ganglia and plexuses (common targets include dorsal root ganglia, stellate ganglia, celiac plexus, etc.), and cranial nerves (common targets include trigeminal nerve branches (such as infraorbital nerve, mandibular nerve), facial nerve, etc.). Table 1 shows the diameter and functional classification of common nerve blocks, as well as the differences in the effects of cold therapy on nerve conduction blockade. Table 2 shows common wound areas and corresponding nerve targets / target fibers / target areas.

[0077] Table 1 Diameter and functional classification of blocked nerves, and differences in their blocking effects by cold therapy

[0078]

[0079]

[0080] Table 2 Common wound areas and corresponding neural targets / target fibers / target areas

[0081]

[0082] In actual application, the number of nerve fibers blocked by cold therapy depends on the nerve distribution density and the depth of cryogenic penetration in the affected area:

[0083] 1. For skin and superficial tissues with high nerve density (especially pain endings and autonomic nerve endings): Superficial cold compresses (0℃~-10℃) can simultaneously inhibit a large number of Aδ and C fiber endings, blocking 80%~90% of local pain signals; when acting on touch (Aβ fibers), partial retention is achieved, with a retention rate of about 50%~70% (due to insufficient temperature for complete blockade).

[0084] 2. For deep muscles and nerve trunks with low nerve density: Large nerve trunks are concentrated, such as the sciatic nerve and median nerve, which require low temperatures (below -20°C) and longer time to penetrate the deep nerves. It may selectively block the fine fibers (pain, autonomic nerves) in the nerve trunks, while the coarse motor fibers (Aα) retain their function.

[0085] 3. Indications for nerve block in clinical applications:

[0086] (1) Acute injury (such as ankle sprain): For target fibers of Aδ and C fibers (pain) and some autonomic nerves (vasoconstriction), after 15 minutes of local cold compress, the pain signal is reduced by 60% to 80%, and the touch (Aβ fibers) is only reduced by 20% to 30%, retaining the protective sensation.

[0087] (2) Postoperative analgesia (such as knee replacement): For the target areas of nerve endings and superficial nerve branches around the surgical incision, cold compresses with ice packs can reduce the amount of opioids used in the 24 hours after surgery by 30% to 40%. Deep joint capsule nerves (Aδ fibers) require invasive cold therapy (such as intra-articular hypothermic perfusion).

[0088] (3) Chronic pain (such as osteoarthritis): For the targets of Aδ / C fibers and inflammatory mediator-releasing nerve endings around the joints, incomplete blockade of thick fibers (Aβ) may lead to residual mechanical allodynia (such as tactile allodynia).

[0089] During the process of hypothermic nerve conduction blockade, key influencing factors include temperature gradient, cold compress duration, and individual differences. For the temperature gradient, for every 1°C drop in skin surface temperature, the temperature 1 cm below the skin drops by approximately 0.5°C, and deep nerves require a lower surface temperature. For cold compress duration, it can be divided into short-term treatment of less than 10 minutes (for example, inhibiting surface C fibers) and long-term treatment (for example, penetrating deep Aδ fibers but potentially causing rebound congestion). For individual differences, the subcutaneous fat of obese people has a significant insulating effect, and the cold compress time needs to be extended or the cold source intensity needs to be increased.

[0090] When the temperature-controlled nerve block system in this embodiment is actually applied, highly sensitive blocking nerves are preferably selected according to the functional classification of the blocked nerves. First, the nerve innervation relationship is clarified. For example, according to the location of the wound (such as the hand, foot and trunk), the nerve sources of its sensory and motor innervation are determined (such as the hand is innervated by the brachial plexus branch). Then, the proximal nerve trunk or nerve plexus is selected as the blocking target / target fiber / target area, and the target tissue depth d is measured using the ultrasonic positioning technology in the prior art. Then, the temperature-controlled nerve block system in this embodiment is fixed to the selected target / target fiber / target area. When fixing, the device can be fixed with the help of a strap in the prior art, so that the low-temperature heat dissipating copper part 4 contacts the skin surface of the blocking target / target fiber / target area. Then, the control unit controls the target depth d of the target / target fiber / target area and the target tissue temperature T target The cooling power of the blocking semiconductor refrigeration plate 2 is calculated, and the control unit 1 controls the power supply of the blocking semiconductor refrigeration plate 2 according to the calculated power. When the blocking semiconductor refrigeration plate 2 is powered on, the temperature of the cold end decreases, and the temperature of the low-temperature heat dissipation copper part 4 decreases accordingly and acts on the target position. At the same time, the circulating cooling water tank 6 is started to continuously dissipate heat from the hot end of the blocking semiconductor refrigeration plate 2, ensuring that the entire device can stably and continuously complete temperature control, and the low temperature of the low-temperature heat dissipation copper part 4 is conducted to the target point / target fiber / target area, achieving a stable low-temperature nerve conduction function blocking effect.

[0091] In this embodiment, during the low-temperature conduction process of the low-temperature heat dissipation copper piece 4, the external temperature sensor 302 can monitor the temperature of the low-temperature heat dissipation copper piece 4 in real time (the detection cycle can be set to 1s), ensuring that the measured temperature value at the position Z distance from the outer wall of the low-temperature heat dissipation copper piece 4 is within T target The temperature of the target area under the skin at a depth of d under the action of hypothermia is within a predetermined range, so that the temperature of the target area under the action of hypothermia is equal to the target tissue temperature, and the nerve fibers at the corresponding position are affected by hypothermia, thereby producing a hypothermia nerve conduction function blocking effect; when the external temperature sensor 302 detects that the temperature is higher or lower than the allowable range value, the control unit 1 adjusts the Peltier current through the PID algorithm to ensure that the temperature of the blocking target point / target fiber / target area is always within the target tissue temperature range.

[0092] In this embodiment, d=2cm, T target =15℃,q met =1000W / m 3 , k eff =0.4W / m·K,k CU =400W / m·K, η safety factor is 1.5, COP is 0.6, and the area of ​​the low-temperature heat dissipation copper piece 4 is 1.26cm 2 (Including safety factor η = 1.5) for routine calculation:

[0093]

[0094] Therefore, the Peltier model used is TEC1-12706 (cooling power 0.8W), the Peltier input power is 0.097W (50% margin is required in practice), and the PID (sampling period 1 second). The technical parameters of this solution can ensure T target The temperature range is within 15℃, which can effectively achieve low-temperature nerve conduction function blockade.

[0095] Table 3 shows the comparison between the nerve block achieved by the temperature-controlled nerve block system in this embodiment and other nerve block technologies.

[0096]

[0097] Table 4 Core differences between cryotherapy and conventional ice packs

[0098]

[0099] It can be seen from Tables 3 and 4 that when the temperature-controlled nerve block system in this embodiment is used to achieve nerve conduction function blockade, not only is the blockade ratio very high, but it also lasts longer than conventional ice compress cold therapy and local anesthetic technology. In addition, compared with conventional ice compress cold therapy, the low-temperature nerve block in this embodiment has a wider temperature range and a greater depth of action, which has obvious technical advantages.

[0100] Example 2

[0101] An application of a temperature-controlled nerve block system is described. The above-mentioned temperature-controlled nerve block system is applied to pain sensitivity detection. In this embodiment, the measurement of cold pain threshold and cold pain tolerance time is used as an example for illustration. The specific measurement method is as follows:

[0102] Step 1. Set the initial temperature of the low-temperature heat dissipation part (i.e., the low-temperature heat dissipation copper part 4): Initially, the low-temperature heat dissipation part (i.e., the low-temperature heat dissipation copper part 4) is placed against the skin of the test area (such as the subject's forearm, hand, back, etc.), and then the control unit 1 controls the output power of the blocking semiconductor refrigeration plate 2 to control the temperature of the low-temperature heat dissipation copper part 4 to the initial temperature. In this embodiment, the initial temperature of the low-temperature heat dissipation copper part 4 is set to 32°C (it can also be 25°C, 37°C, etc.).

[0103] Step 2: Testing the Cold Pain Threshold (CPT) and Cold Pain Tolerance Time (CPT-T): Control unit 1 controls the output power of the blocking semiconductor refrigeration element 2, causing the low-temperature cooling portion (i.e., the low-temperature cooling copper element 4) to cool at a rate of 1°C / s. When the subject first reports pain and records the temperature T1, the subject's cold pain threshold (CPT) can be accurately measured. Simultaneously, a timer is started when the subject experiences pain, and the time from the onset of pain to the subject becoming unable to tolerate the cold pain (CPT-T) is recorded. When testing CPT and CPT-T, the patient's subjective pain sensation (visual analog scale (VAS) or numerical rating scale (NRS)) and physiological signals (such as changes in skin impedance, heart rate, and blood pressure) can be recorded to more accurately determine the subject's perceived pain. Therefore, in practical applications, a timer and voice button can be connected to the temperature-controlled nerve block system, allowing the subject to express their perception of pain by pressing a button, etc., and the timer to measure the time. Detailed descriptions of how to use other equipment to assist in testing and recording CPT and CPT-T are not provided here.

[0104] Step 3: Temperature return verification: After the temperature reaches T1 in step 2, it is raised to T1+2°C, and then cooled at the same rate of 1°C / s as in step 2. When the subject feels pain again, the temperature is recorded as T2. The control unit 1 calculates the average value of the two trigger temperatures, T threshold =(T1+T2) / 2, the subject's cold pain threshold T can be measured threshold Of course, the number of temperature return verifications can be multiple, such as three times, five times, etc., to improve the accuracy of the detection; in addition, the minimum temperature limit of the low-temperature heat dissipation copper part 4 during the cooling process is 5°C to 10°C to prevent tissue frostbite; at the same time, in order to improve the accuracy of the detection, medical-grade silicone is coated on the side of the low-temperature heat dissipation copper part 4 that contacts the subject during the detection process.

[0105] Example 3

[0106] An application of a temperature-controlled nerve blocking system, wherein the above-mentioned temperature-controlled nerve blocking system is applied to pain sensitivity detection, and the specific measurement method is as follows: using the control unit 1 to control the output power of the blocking semiconductor refrigeration plate 2, so that the temperature of the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) drops to 4°C (or 8°C, etc.), and the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) is brought into contact with the skin of the test area of ​​the subject, and then the time when the subject feels pain and the time when the pain is unbearable are detected and recorded, thereby completing the detection of the subject's temperature pain range.

[0107] In this embodiment, after completing pain sensitivity detection (specifically, temperature pain domain) using a temperature-controlled nerve block system, the detection results can be used in application scenarios such as rehabilitation management, development of personalized temperature control products, and auxiliary diagnosis. For example, the temperature-controlled nerve block system in this solution is used to detect differences in temperature sensitivity of different parts of an individual, and temperature control functions corresponding to different areas are set according to the detection results (such as flexible wearable settings, furniture with heating and cooling functions, etc.), so as to improve the comfort during the application of personalized products.

[0108] The following experiments were conducted using a temperature-controlled nerve block system in this protocol to complete pain sensitivity testing:

[0109] Test location and method: 8℃ hypothermia intervention was performed in the superficial area of ​​the radial nerve groove segment located by ultrasound, i.e., the proximal end of the nerve course. At the same time, mechanical pressure analgesia instrument was used to test the pain threshold and pain tolerance threshold of the subjects' forearms before intervention and 5 minutes, 10 minutes, and 15 minutes after intervention. When selecting the test location, if Figure 4 As shown in the figure, two groups of locations were symmetrically selected on both forearms for tenderness-evoked pain testing. The researchers applied the algesiometer to the two groups of locations in the following order: pain point 1 was the midpoint of the radius and ulna at the wrist joint (as a bony pain point), and pain point 2 was the brachioradialis muscle on the lateral side of the forearm (as a muscle pain point). "X" was used as a mark to ensure that the pressure pain threshold (PPT) and pain tolerance threshold (PTO) were measured at the same pain point each time.

[0110] Experimental equipment and test methods:

[0111] The experimental equipment used was a handheld pain meter (model YISIDA-DS2, Hong Kong, China) with a 0.1 cm 2 The surface area of ​​the probe is small, and the surface is a 2mm thick neoprene pad. During the test, the patient lies in the supine position and places the pain meter probe vertically on the pain point. The tester applies pressure at a uniform speed through the LCD display, increasing the pressure at a rate of 0.3kg / s. To avoid tissue damage, the maximum test value does not exceed 5kg. If this value is reached, the pressure is stopped and the value is recorded according to this cutoff value.

[0112] The study included 7 subjects, who were treated with 8°C hypothermia intervention in the superficial area of ​​the radial nerve groove segment, which is the proximal end of the nerve course, located by ultrasound. At the same time, mechanical pressure analgesia was used to measure the pain threshold and pain tolerance threshold of the subjects' forearms before, 5 minutes, 10 minutes, and 15 minutes after the intervention. Figure 5As shown in the results, the pain threshold increased from the baseline (1.63±0.26) kg to 5 min ((1.80±0.31) kg, p=0.194), 10 min ((2.01±0.41) kg, p=0.027) and 15 min ((2.06±0.48) kg, p=0.036) after intervention, indicating that low temperature intervention can reduce the pain sensitivity of the subjects. Figure 6 As shown in the results, the pain tolerance threshold increased from (2.49±0.72) kg at baseline to 5 min ((2.91±0.50) kg, p=0.036), 10 min ((3.05±0.64) kg, p=0.041) and 15 min ((3.11±0.66) kg, p=0.011) after intervention, indicating that hypothermia intervention can increase the subjects' pain tolerance.

[0113] Example 4

[0114] An application of a temperature-controlled nerve block system, wherein the above-mentioned temperature-controlled nerve block system is applied to analgesia, and the method is as follows: first, the nerve innervation relationship is clarified, for example, according to the location of the wound (such as the hand, foot and trunk), the nerve source of its sensory and motor innervation is determined (such as the hand is innervated by the brachial plexus branch), and then the proximal nerve trunk or nerve plexus is selected as the blocking target point / target fiber / target area, and the corresponding area of ​​the low-temperature surface target area is determined. The target tissue depth d (i.e., the depth value from the corresponding nerve fiber to the corresponding low-temperature surface target area) is measured using the ultrasonic positioning technology in the prior art, and then the low-temperature nerve block device in this embodiment is fixed to the low-temperature surface target area. Specifically, the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) is brought into contact with the low-temperature surface target area of ​​the blocking target point / target fiber / target area. After the low temperature of the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) acts on the low-temperature surface target area, the nerve trunk or nerve plexus at the subcutaneous target depth d is cooled to the target tissue temperature T target The corresponding nerve fibers produce a nerve conduction function blocking effect due to the effect of low temperature. For example, when the local temperature drops to 15-20℃, the conduction velocity of Aδ and C fibers decreases by more than 50% (effective analgesia range), achieving an effective analgesic effect.

[0115] Example 5

[0116] An application of a temperature-controlled nerve block system, applying the above-mentioned temperature-controlled nerve block system to pain sensitivity detection and cold analgesia, integrating cold pain detection and cold analgesia into a closed-loop system, and its application method is as follows:

[0117] Step 1: Baseline measurement. Use the control unit to control the output power of the blocking semiconductor refrigeration piece to drop the temperature of the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) to the initial temperature (e.g., 25°C, 32°C, etc.). Then, bring the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) into contact with the low-temperature action target area of ​​the blocking target point / target fiber / target area, and record the patient's baseline physiological signals (e.g., changes in the patient's skin impedance, heart rate, blood pressure, etc.).

[0118] Step 2: Pain sensitivity detection, including the detection of the cold pain threshold (CPT) and the cold pain tolerance time (CPT-T). The control unit 1 controls the output power of the blocking semiconductor refrigeration plate 2 to cool the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) at a rate of 1°C / S. When the subject feels pain, he reports the pain for the first time and records the temperature T1. This can accurately measure the subject's cold pain threshold (CPT); at the same time, when the subject feels pain, a timer is started to record the time from the beginning of the subject feeling pain to the time when the subject can no longer tolerate the cold pain (cold pain tolerance time CPT-T). The specific test process is the same as that of Example 2 and will not be specifically described here.

[0119] Step 3: Temperature return verification: After the temperature reaches T1 in step 2, it is raised to T1+2°C, and then cooled at the same rate of 1°C / s as in step 2. When the subject feels pain again, the temperature is recorded as T2. The control unit 1 calculates the average value of the two trigger temperatures, T threshold =(T1+T2) / 2, the subject's cold pain threshold T can be measured threshold .

[0120] Step 4: According to the cold pain threshold T threshold Determine the target tissue temperature T for analgesia target And the cooling rate, when T threshold When the temperature is less than 10℃, the patient is sensitive to cold pain. target =T threshold +(1~2)℃, cooling rate is less than or equal to 1℃ / min; when T threshold ≥10℃ is considered normal tolerance, T target =T threshold +2℃, cooling rate is less than or equal to 2℃ / min.

[0121] Step 5: Complete analgesia, when the target tissue temperature T target After the cooling speed is determined, the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) is brought into contact with the target area of ​​the body surface that blocks the low-temperature action of the target point / target fiber / target area, and then the control unit 1 controls the output current of the tissue semiconductor refrigeration sheet 2 to make the low-temperature cooling part (i.e., the low-temperature cooling copper part 4) gradually drop from the initial temperature to the target tissue temperature T at the cooling speed determined by the calculation. targetThe low-temperature cooling part (i.e., the low-temperature cooling copper part 4) causes the low-temperature action on the nerve fibers at the target area of ​​the body surface to produce low-temperature nerve conduction function blockade, thereby achieving analgesic effect; at the same time, the analgesic time is shorter than the cold pain tolerance time CPT-T, thereby avoiding cold pain during the analgesic process.

[0122] During the analgesic process, the temperature monitor 3 monitors the temperature at a position Z outside the outer wall of the cryogenic cooling part (i.e., the cryogenic cooling copper part 4), where Z = d, d is the depth of the nerve fibers in the target area of ​​the hypothermia effect on the body surface under the skin. When the temperature monitored by the temperature monitor 3 drops to the target tissue temperature T target After that, it can play an analgesic role. At the same time, the temperature stability is checked every 10 seconds. If the fluctuation is greater than 0.5℃, the PID parameters are recalculated and the control unit 1 re-controls the current of the semiconductor refrigeration piece 2 to make the target tissue temperature T target Maintain stability; at the same time, use temperature monitoring 3 to monitor the edge temperature value of the low-temperature heat dissipation part (i.e., the low-temperature heat dissipation copper part 4) (an additional edge temperature sensor for detecting the outer wall of the low-temperature heat dissipation part needs to be set). If the surface temperature of the low-temperature heat dissipation copper part 4 is less than 0°C, the control unit 1 forcibly controls the semiconductor refrigeration plate 2 to reduce power to avoid frostbite caused by too low temperature.

[0123] In this embodiment, the temperature-controlled nerve block system can accurately control the output power of the blocking semiconductor refrigeration chip 2, thereby accurately and quickly controlling the temperature value of the heat dissipation copper piece 4, accurately measuring the patient's cold pain threshold, and then determining the patient's target tissue temperature and cooling rate based on the detected cold pain threshold, and dynamically setting the target tissue temperature T based on individual sensitivity. target It can not only effectively guarantee the analgesic effect during the analgesic process, but also reduce the cold pain triggering rate by more than 60% during the treatment process, providing an intelligent tool for postoperative rehabilitation and chronic pain management.

[0124] Example 6

[0125] The difference between the sixth embodiment and the first embodiment is that: Figure 7As shown, the heat exchange system in the first embodiment includes a circulating cooling water tank 6. The heat exchange system in this embodiment includes a heat exchange semiconductor refrigeration plate 9 and a heat exchange copper plate 10. The heat exchange semiconductor refrigeration plate 9 is signal-connected to the control unit 1. The heat exchange copper plate 10 is fixedly connected to the cold end of the heat exchange semiconductor. A heat exchange flow channel is provided in the heat exchange copper plate 10. The circulation pipeline is connected between the heat exchange copper plate 10 and the cooling copper part 5. A circulation pump 11 is connected to the circulation pipeline. Correspondingly, the circulation pipeline includes a hot circulation pipe 7 and a cold circulation pipe 8. The water circulation process is the same as that in the first embodiment and will not be repeated here. In this embodiment, the circulation pump 11 is used as the circulation driving force to circulate water between the heat exchange copper plate 10 and the cooling copper part 5 to continuously dissipate heat to the cooling copper part 5, effectively ensuring the stable operation of the entire device. In this embodiment, the control unit 1 simultaneously controls the blocking semiconductor refrigeration plate 2 and the heat exchange semiconductor refrigeration plate 9, with precise control and low cost.

[0126] Example 7

[0127] The difference between the seventh embodiment and the first embodiment is that: the number of the blocking semiconductor refrigeration plate 2 in the first embodiment is one, while the number of the blocking semiconductor refrigeration plate 2 in this embodiment is multiple, for example, 3 or 4. Figure 8 The diagram shows a situation where two blocking semiconductor refrigeration sheets 2 are set up. All the blocking semiconductor refrigeration sheets 2 are connected to the control unit 1 by signal, and each blocking semiconductor refrigeration sheet 2 is connected to a cooling mechanism, a low-temperature heat dissipation copper piece 4 and a temperature monitor 3. On the one hand, multiple blocking semiconductor refrigeration sheets 2 can be combined together to achieve low-temperature nerve conduction function blocking of a larger area, such as low-temperature conduction function blocking of certain nerve fibers with larger diameters to ensure the effect of low-temperature conduction function blocking; on the other hand, in some special cases, multiple blocking semiconductor refrigeration sheets 2 can be used to simultaneously or successively play a role in low-temperature nerve conduction function blocking on multiple nerve fibers to meet the needs of application scenarios such as coordinated perioperative analgesia.

[0128] Example 8

[0129] The difference between the eighth embodiment and the first embodiment is that: Figure 9As shown, in this embodiment, a low-temperature conductive water bag 13 is fixedly connected to the side of the low-temperature heat-dissipating copper member 4 used for low-temperature nerve conduction function blocking. The low-temperature conductive water bag 13 is fixedly connected to the side wall of the low-temperature heat-dissipating copper member 4 by bonding, round steel ring clamping, etc., and the low-temperature conductive water bag 13 is filled with water. In this solution, the water in the low-temperature conductive water bag 13 contacts the bottom surface of the low-temperature heat-dissipating copper piece 4. The low temperature of the low-temperature heat-dissipating copper piece 4 can quickly cool the water in the low-temperature conductive water bag 13. When in use, the low-temperature conductive water bag 13 contacts the skin. Since the low-temperature conductive water bag 13 is flexible, it can form a better fit with the skin when used. For example, for special-shaped tissues such as the upper limbs, the low-temperature conductive water bag 13 can also be used to effectively achieve an effective low-temperature nerve conduction function blocking effect on the target position; and the contact between the skin and the low-temperature conductive water bag 13 is more comfortable than direct contact with the low-temperature heat-dissipating copper piece 4, and the low-temperature conductive water bag 13 is fixedly connected to the side wall of the low-temperature heat-dissipating copper piece 4, which can effectively reduce the lateral ineffective heat exchange of the low-temperature heat-dissipating copper piece 4, thereby making the low-temperature heat-dissipating copper piece 4 have a more precise low-temperature nerve conduction function blocking effect.

[0130] The above is only an embodiment of the present invention, and the common knowledge such as the specific technical solutions and / or characteristics in the solution are not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several variations and improvements can be made, which should also be regarded as the scope of protection of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the description can be used to interpret the content of the claims.

Claims

1. A temperature-controlled nerve block system, comprising a control unit, characterized in that: It also includes refrigeration unit, temperature monitoring unit, The refrigeration unit includes a blocking semiconductor refrigeration sheet and a low-temperature cooling portion fixedly connected to the cold end of the blocking semiconductor refrigeration sheet, wherein the low-temperature cooling portion contacts the target area on the body surface to which the low temperature is applied; The temperature monitoring unit includes a temperature monitor connected to the low-temperature cooling part, and the temperature monitor transmits a temperature signal to the control unit.

2. A temperature-controlled nerve block system according to claim 1, characterized in that: The low-temperature heat dissipation part includes a disc-shaped low-temperature heat dissipation copper piece, one side of the low-temperature heat dissipation copper piece is in contact with the blocking semiconductor refrigeration plate, and the other side is used to contact the target area on the body surface acting on the low temperature.

3. A temperature-controlled nerve block system according to claim 2, characterized in that: The low-temperature heat dissipation copper piece is used for a low temperature effect on the body surface target area. One side thereof is fixedly connected with a low-temperature conductive water bag. The low-temperature conductive water bag is provided with cooling water in contact with the low-temperature heat dissipation copper piece.

4. The temperature-controlled nerve block system according to claim 2, characterized in that: It also includes a cooling unit, which includes a circulating water cooling mechanism connected to the hot end of the blocking semiconductor refrigeration plate; The circulating water cooling mechanism includes a cooling copper piece, a circulating cooling medium, a circulating pipeline and a heat exchange system. The cooling copper piece is fixedly connected to the hot end of the blocking semiconductor refrigeration plate. The circulating pipeline is connected between the cooling copper piece and the heat exchange system. The circulating cooling medium circulates between the heat exchange system and the cooling copper piece through the circulating pipeline to dissipate heat to the cooling copper piece. The heat exchange system includes a circulating cooling water tank, and a circulating pipeline is connected between the circulating cooling water tank and the cooling copper piece; Alternatively, the heat exchange system includes a heat exchange semiconductor refrigeration plate and a heat exchange copper plate. The heat exchange semiconductor refrigeration plate is connected to the control unit signal, the heat exchange copper plate is fixedly connected to the cold end of the heat exchange semiconductor, a heat exchange flow channel is provided in the heat exchange copper plate, a circulation pipeline is connected between the heat exchange copper plate and the cooling copper part, and a circulation pump is connected to the circulation pipeline.

5. The temperature-controlled nerve block system according to claim 4, characterized in that: The temperature monitor includes an internal temperature sensor and an external temperature sensor. The internal temperature sensor is fixedly connected to the side of the low-temperature heat dissipation copper piece that is away from the blocking semiconductor refrigeration piece. There are at least two internal temperature sensors, and the internal temperature sensors are arranged on the bottom surface of the low-temperature heat dissipation copper piece; the external temperature sensor is connected to the outside of the low-temperature heat dissipation copper piece and its radial position along the low-temperature heat dissipation copper piece is adjustable. The distance between the external temperature sensor and the outer wall of the low-temperature heat dissipation copper piece is Z. The nerve fibers in the target area of ​​the body surface affected by low temperature are located at a subcutaneous depth of d, Z=d. The control unit dynamically adjusts the output power of the blocking semiconductor refrigeration piece according to the temperature signals monitored by the internal temperature sensor and the external temperature sensor.

6. The temperature-controlled nerve block system according to claim 2, characterized in that: The power calculation formula of the blocking semiconductor refrigeration plate is: ; Among them A Cu The area of ​​contact between the low-temperature heat dissipation copper and the target area on the surface of the low-temperature action body, in m 2 ; q cool is the heat flow and metabolic heat production from the cooling center area to the subcutaneous depth d; η is the safety factor, ranging from 1.5 to 2; COP is the cooling efficiency of the semiconductor refrigeration chip, ranging from 0.5 to 0.7; q cool The calculation formula is: ; where k eff is the equivalent thermal conductivity of the tissue, ranging from 0.35 to 0.49 W / m·K; T core is the core temperature of the human body, which is 37°C; T target is the target tissue temperature at subcutaneous depth d; q met is the metabolic heat production rate, ranging from 500 to 1000 W / m³; d is the subcutaneous target depth, ranging from 1 to 10 cm.

7. The temperature-controlled nerve block system and its application according to claim 1, characterized in that: There are multiple blocking semiconductor refrigeration pieces, all of which are connected to the control unit signal, and each blocking semiconductor refrigeration piece is connected to the cooling mechanism, low-temperature cooling part and temperature monitor.

8. An application of a temperature-controlled nerve block system, characterized in that: A temperature-controlled nerve block system as described in any one of claims 1 to 7 is applied to pain sensitivity detection.

9. An application of a temperature-controlled nerve block system, characterized in that: A temperature-controlled nerve block system as described in any one of claims 1 to 7 is used for analgesia, wherein the refrigeration unit acts on a target area on the body surface subjected to low temperature, and the target area on the body surface subjected to low temperature is located at a proximal nerve trunk or nerve plexus of the nerve fibers corresponding to the analgesic treatment area.

10. An application of a temperature-controlled nerve block system, characterized in that: The temperature-controlled nerve block system as described in any one of claims 1 to 7 is combined with pain sensitivity detection and analgesia to integrate cold pain measurement and cold therapy analgesia into a closed-loop system.

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