Close-attached temperature-controllable body temperature regulator and control method thereof

Abstract

The invention relates to the technical field of medical equipment, and discloses a clinging type controllable temperature and body temperature regulator which comprises a flexible patch module, a flexible base body capable of being attached to a body, a heat conduction layer in contact with the body is arranged in the flexible base body, a body fixing device is arranged on the edge of the flexible base body, and the flexible patch module is connected with the flexible base body. A temperature sensor used for monitoring the temperature of the contact surface and a pressure sensor used for monitoring the attaching state are embedded in the flexible base body. The temperature control execution module comprises a heating unit and a refrigeration unit which are arranged on the heat conduction layer, and a safety protection circuit which is electrically connected with the heating unit and the refrigeration unit; and the intelligent control module comprises a main controller which is electrically connected with the temperature sensor, the pressure sensor, the heating unit, the refrigeration unit and the safety protection circuit. The clinging type temperature-controllable body temperature regulator aims to solve the problems of visual field interference, slow temperature control and body position adaptation of traditional operation body temperature equipment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a close-fitting temperature-controllable body temperature regulator and a control method thereof. Background Art

[0002] In the medical field, when patients are at risk of hypothermia due to surgical trauma, disease exhaustion or environmental factors, passive temperature regulation builds a line of defense to protect body temperature by using various types of thermal insulation materials. Taking the surgical scenario as an example, the patient's body heat production is reduced under anesthesia, and they are prone to hypothermia when exposed to the low temperature environment of the operating room. After being covered with a high-efficiency thermal insulation blanket, the heat loss rate can be greatly reduced, so that the patient's core body temperature can be maintained in the normal range, providing reliable protection for the patient's body temperature stability and medical safety.

[0003] Traditional surgical temperature management equipment has many limitations in actual application. Take warming blankets and heaters as an example. Because of their large coverage area, warming blankets often need to be spread over a large area on the operating table or wrapped around the patient's body. This not only occupies the effective space in the operating area, but also easily blocks the doctor's surgical field of view, hindering the doctor's delicate operations, and may even affect the flexible use of surgical instruments, increasing the difficulty and risk of the operation. In terms of temperature control, the problem of slow response speed of heating or cooling of traditional equipment is more prominent. During the operation, the patient's body temperature changes rapidly and needs to be adjusted in time and accurately, but this type of equipment cannot adapt quickly Fluctuations in body temperature make it difficult to achieve precise local temperature control of the surgical site, especially in some temperature-sensitive surgeries. The inability to quickly and accurately adjust the temperature may affect the surgical effect and the patient's postoperative recovery. In addition, special body position surgeries, such as lithotomy position and lateral position, place higher requirements on the fit and applicability of body temperature management equipment. However, due to the limitations of structure and usage, traditional equipment is difficult to closely fit the body contours of patients in special positions, and is prone to incomplete coverage and displacement, resulting in a significant reduction in the temperature management effect and being unable to meet the needs of maintaining a stable body temperature in patients during special body position surgeries. Summary of the Invention

[0004] The purpose of the present invention is to solve the problems of visual field interference, slow temperature control and body position adaptation of traditional surgical temperature equipment, and to propose a close-fitting controllable temperature thermostat and its control method.

[0005] The technical solution of the present invention to solve the above technical problems is as follows:

[0006] A close-fitting temperature-controllable body temperature regulator, comprising:

[0007] The flexible patch module comprises a flexible substrate that can be attached to the body, a heat-conducting layer that contacts the body is provided within the flexible substrate, a body fixing device is provided at the edge of the flexible substrate, and a temperature sensor for monitoring the contact surface temperature and a pressure sensor for monitoring the attachment state are embedded within the flexible substrate;

[0008] a temperature control execution module, comprising a heating unit and a cooling unit provided on the heat-conducting layer, and a safety protection circuit electrically connected to the heating unit and the cooling unit;

[0009] The intelligent control module includes a main controller electrically connected to the temperature sensor, pressure sensor, heating unit, refrigeration unit and safety protection circuit, and a wireless communication unit and a power supply unit electrically connected to the main controller.

[0010] On the basis of the above technical solution, the present invention can also be improved as follows.

[0011] Furthermore, the heat-conducting layer includes an outer flexible antibacterial layer, at least one intermediate heat-conducting functional layer and an inner bearing layer stacked in sequence; the outer flexible antibacterial layer is made of antibacterial silicone material, which is used to fit the body surface and provide antibacterial protection, the intermediate heat-conducting functional layer is composed of one or more graphene, metal foil or other highly thermally conductive flexible materials, which is used to achieve efficient heat conduction, and the inner bearing layer is a flexible substrate, which is used to provide structural support to the heating unit and the cooling unit.

[0012] Furthermore, the body fixing device is one of a medical adhesive component or an adsorption fixing component.

[0013] Furthermore, the medical adhesive component includes:

[0014] A first annular connecting portion, coaxially fixedly mounted on the outside of the flexible base, for supporting the adhesive structure;

[0015] a double-sided adhesive layer, one side of which is adhered to the surface of the first annular connecting portion close to the body, for achieving adhesion to the body;

[0016] The protective covering layer is attached to the other side surface of the double-sided adhesive layer to protect the adhesive surface of the double-sided adhesive layer in contact with the body before use.

[0017] Furthermore, the adsorption and fixing component includes:

[0018] A second annular connecting portion is coaxially fixedly mounted on the outside of the flexible base, and an end portion of the second annular connecting portion close to the body is provided with an accommodating notch;

[0019] an annular plug-in portion, detachably plugged into the receiving notch of the second annular connecting portion;

[0020] A suction cup is fixedly mounted on the outer side of the annular plug-in portion and is used for adsorbing the body surface to achieve fixation;

[0021] a limiting collar fixedly mounted on the outer side of the annular plug-in portion, wherein when the annular plug-in portion is plugged into the accommodating notch, the limiting collar is tightly attached to the outer side of the second annular connecting portion;

[0022] The limiting component is embedded in the second annular connecting portion and contacts the annular plug-in portion and the limiting ring, and is used to connect and fix the second annular connecting portion and the limiting ring when the annular plug-in portion is plugged into the accommodating notch.

[0023] Furthermore, the limiting component includes:

[0024] A through hole is formed on the surface of the second annular connecting portion and communicates with the accommodating notch, wherein the through holes are at least three and are equidistantly distributed in a circular pattern around the center of the second annular connecting portion;

[0025] A mounting plate, fixedly disposed inside the through hole;

[0026] a telescopic rod, passing through the mounting plate, and having a connecting ring provided on the outer side thereof;

[0027] an elastic member, one end of which is fixed to the surface of the mounting plate and sleeved on the outside of the telescopic rod, and the other end of which is connected to the connecting ring;

[0028] A limiting ball is fixed to the telescopic end of the telescopic rod;

[0029] Connecting holes are provided on the surface of the limiting ring, and the number and distribution positions of the connecting holes correspond to those of the through holes;

[0030] The elastic arc-shaped spring piece is fixed inside the connecting hole.

[0031] Furthermore, an annular flange is fixedly installed on the outer side of the annular plug-in portion. When the annular plug-in portion is inserted into the accommodating notch, the annular flange contacts the end of the telescopic rod away from the limiting ball. The telescopic rod includes an outer tube, which passes through the mounting plate and is fixedly connected to the connecting ring. An inner rod is provided through the outer tube, and one end of the inner rod located outside the outer tube is fixedly connected to the limiting ball. A spring is fixedly installed on the inner side of the outer tube, and the other end of the spring is fixedly connected to the end of the inner rod located inside the outer tube.

[0032] Furthermore, in the temperature control execution module, the heating unit has a power density of 10-50W / m 2The carbon fiber resistance wire is a semiconductor refrigeration sheet. The inner bearing layer is provided with two installation areas on the surface of the side away from the intermediate heat conductive functional layer. The heating unit and the refrigeration unit are respectively arranged in different installation areas. The safety protection circuit is a temperature control switch. The main controller adopts an ARMCortex-M4 chip. The wireless communication unit is a Bluetooth module for data interaction with the central monitoring system. The power supply unit is a 3.7V / 2000mAh rechargeable lithium battery.

[0033] A control method for a close-fitting temperature-controllable body temperature regulator, characterized by comprising the following steps:

[0034] S1: Data Collection

[0035] The temperature sensor collects temperature data of the contact surface between the flexible substrate and the body in real time, and the pressure sensor monitors the fitting state data of the flexible substrate in real time, and the fitting state data includes but is not limited to pressure value;

[0036] S2: Data processing and parameter calculation

[0037] The main controller receives temperature data and bonding status data, and calculates the operating parameters of the heating unit and cooling unit based on the preset temperature threshold and PID algorithm. The operating parameters include heating or cooling power and start and stop time.

[0038] S3: Temperature control execution

[0039] The main controller sends control instructions to the heating unit and the cooling unit based on the calculated working parameters, starts the corresponding unit or adjusts its power, and realizes the temperature regulation of the body through the heat conduction layer;

[0040] S4: Security Monitoring and Protection

[0041] The safety protection circuit continuously monitors the operating temperature and current of the heating unit and the cooling unit. When the temperature exceeds the set threshold or the current is abnormal, the power supply is automatically cut off to stop heating or cooling.

[0042] S5: Data Transfer

[0043] The wireless communication unit transmits temperature data, fitting status data and equipment working status to the central monitoring system in real time for remote monitoring by medical staff.

[0044] Furthermore, the following steps are included:

[0045] S6: Adaptive adjustment parameter correction

[0046] The main controller dynamically modifies the PID control parameters through an adaptive algorithm based on historical temperature data and fitting status data. The specific formula is:

[0047]

[0048] Where: K′ p , ′K′ i , K′ d are the corrected proportional, integral and differential coefficients respectively;

[0049] K p , K i , K d is the initial control parameter;

[0050] e(t)=T set -T real (t) is the real-time temperature error, T set is the preset temperature, T real (t) is the real-time temperature collected by the temperature sensor;

[0051] α, β, γ, and δ are adaptive adjustment coefficients, which are preset according to the thermal conductivity characteristics of different body parts;

[0052] Integral Item Used to accumulate historical errors to eliminate steady-state deviations, differential terms Used to suppress temperature fluctuations;

[0053] S7: Fitting state compensation control

[0054] When the pressure sensor detects that the fitting pressure F is lower than the preset threshold F min When , the main controller triggers the fitting state compensation mechanism:

[0055] If medical adhesive components are used, an alarm is sent to the central monitoring system via the wireless communication unit, prompting the need to check the adhesive fit;

[0056] If the component is fixed by adsorption, the secondary adsorption process of the suction cup will be automatically started;

[0057] S8: Energy consumption optimization strategy

[0058] The main controller dynamically switches the working mode according to the remaining power Q of the power supply unit and the temperature regulation requirements:

[0059] When Q>70%, full power mode is used to quickly reach the preset temperature;

[0060] When 30%≤Q≤70%, the PID algorithm is used to maintain the temperature and reduce the average power consumption;

[0061] When Q<30%, the core temperature control function is prioritized, the high-frequency transmission mode of the wireless communication unit is turned off, and only periodic data reporting in the low-power state is retained.

[0062] Compared with the prior art, the technical solution of this application has the following beneficial technical effects:

[0063] The flexible patch module of the present invention can fit the patient's body tightly by virtue of its flexible base and body fixing device, without taking up too much surgical space, blocking the doctor's line of sight, or interfering with the operation of surgical instruments. The temperature sensor and pressure sensor monitor the contact surface temperature and fitting status in real time. Combined with the main controller in the intelligent control module, it can respond quickly according to changes in the patient's body temperature, accurately control the heating unit and the cooling unit, and meet the temperature control requirements of temperature-sensitive operations; the flexible and conformable characteristics enable it to adapt to special body positions such as lithotomy position and lateral position, avoiding incomplete coverage and displacement, and ensuring that the patient's body temperature can be effectively maintained stable in all kinds of special body position operations; in addition, the setting of the safety protection circuit and the wireless communication unit not only ensures the safe operation of the equipment, but also facilitates remote monitoring and regulation by medical staff, and comprehensively improves the safety, accuracy and convenience of surgical temperature management. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 This is a schematic diagram of the overall connection structure of the first embodiment of the present invention;

[0065] Figure 2 This is a schematic diagram of the explosive connection structure between the flexible substrate and the heat-conducting layer of the present invention;

[0066] Figure 3 This is a schematic diagram of the explosive connection structure of the body fixing device of the present invention;

[0067] Figure 4 This is a schematic diagram of the connection structure of the inner bearing layer, the heating unit and the refrigeration unit of the present invention;

[0068] Figure 5 This is a schematic diagram of the connection structure between the flexible substrate and the main controller of the present invention;

[0069] Figure 6 This is a schematic diagram of the overall connection structure of the second embodiment of the present invention;

[0070] Figure 7 This is a schematic diagram of the overall connection structure of the adsorption and fixing assembly of the present invention;

[0071] Figure 8 For the present invention Figure 7 Enlarged view of point A in the middle;

[0072] Figure 9 Schematic diagram of the overall connection structure of the telescopic rod of the present invention.

[0073] In the figure: 1. Flexible substrate; 2. Heat-conducting layer; 21. Outer flexible antibacterial layer; 22. Intermediate heat-conducting functional layer; 23. Inner bearing layer; 3. Body fixation device; 31. Medical adhesive component; 311. First annular connecting portion; 312. Double-sided adhesive layer; 313. Protective covering layer; 32. Adsorption and fixation component; 321. Second annular connecting portion; 322. Accommodating notch; 323. Annular plug-in portion; 324. Suction cup; 325. Limiting ring; 326. Limiting member; 3261. Through hole; 3262. Mounting plate; 3263. Telescopic rod; 32631. Outer tube; 32632. Inner rod; 32633. Spring; 3264. Elastic member; 3265. Limiting ball; 3266. Connecting hole; 3267. Elastic arc spring; 4. Temperature sensor; 5. Pressure sensor; 6. Heating unit; 7. Refrigeration unit; 8. Safety protection circuit; 9. Main controller; 10. Wireless communication unit; 11. Power supply unit; 12. Annular flange. DETAILED DESCRIPTION

[0074] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0075] Embodiment 1: A close-fitting temperature-controllable body temperature regulator of the present invention comprises:

[0076] The flexible patch module comprises a flexible substrate 1 that can be attached to the body, a heat-conducting layer 2 that contacts the body is provided within the flexible substrate 1, a body fixing device 3 is provided at the edge of the flexible substrate 1, and a temperature sensor 4 for monitoring the contact surface temperature and a pressure sensor 5 for monitoring the attachment state are embedded in the flexible substrate 1;

[0077] The temperature control execution module includes a heating unit 6 and a cooling unit 7 provided on the heat-conducting layer 2, and a safety protection circuit 8 electrically connected to the heating unit 6 and the cooling unit 7;

[0078] The intelligent control module includes a main controller 9 electrically connected to the temperature sensor 4, the pressure sensor 5, the heating unit 6, the cooling unit 7 and the safety protection circuit 8, as well as a wireless communication unit 10 and a power supply unit 11 electrically connected to the main controller 9.

[0079] When the close-fitting controllable temperature thermostat is working, the flexible patch module is first tightly fitted to the patient's body through the flexible base 1 and the body fixing device 3 on its edge. The heat conductive layer 2 is in full contact with the body to create conditions for temperature conduction. At the same time, the pressure sensor 5 monitors the fitting state in real time to ensure that the device is firmly fitted. During the operation, the temperature sensor 4 continuously monitors the temperature of the contact surface between the patient and the regulator, and transmits the data to the main controller 9 in real time. The main controller 9 analyzes and judges according to the preset body temperature standard and the received temperature data. When it is detected that the body temperature is lower than the standard value, the main controller 9 sends a The heating unit 6 sends instructions to heat the patient through the heat-conducting layer 2; if the body temperature is higher than the standard value, the refrigeration unit 7 is controlled to start to achieve cooling. During this process, the safety protection circuit 8 monitors the heating unit 6 and the refrigeration unit 7 for safety to prevent abnormal overheating or overcooling. In addition, the main controller 9 can also be connected to external devices through the wireless communication unit 10. Medical staff can remotely obtain body temperature data and equipment working status and adjust parameters. The power supply unit 11 provides stable power support for the operation of the entire regulator to ensure that the body temperature regulation work is continuous and accurate.

[0080] In a preferred embodiment, the present invention can be further configured as follows: Figure 1 、 Figure 2As shown; the heat-conducting layer 2 includes an outer flexible antibacterial layer 21, at least one intermediate heat-conducting functional layer 22 and an inner bearing layer 23 stacked in sequence; the outer flexible antibacterial layer 21 is made of antibacterial silicone material, which is used to fit the body surface and provide antibacterial protection, and the intermediate heat-conducting functional layer 22 is composed of one or more of graphene, metal foil or other high thermal conductivity flexible materials, which is used to achieve efficient heat conduction, and the inner bearing layer 23 is a flexible substrate, which is used to provide structural support to the heating unit 6 and the refrigeration unit 7. The outer flexible antibacterial layer 21 is made of antibacterial silicone material, which is soft and has strong conformability, and fits closely to the patient's body surface. It can not only ensure full contact between the regulator and the patient's body, which is beneficial to temperature conduction, but also can effectively inhibit bacterial growth with its own antibacterial properties, thereby reducing the patient's risk of contact with the regulator during surgery. The device can reduce the risk of infection caused by the device and provide a safe and hygienic use environment for patients. The intermediate thermal conductive functional layer 22 is made of high thermal conductivity flexible materials such as graphene and metal foil. These materials have excellent thermal conductivity and can quickly and efficiently transfer the heat generated by the heating unit 6 or the cold brought by the refrigeration unit 7 to the patient's body, so that the patient's body temperature can quickly reach and be maintained within an appropriate range. The inner bearing layer 23 serves as a flexible substrate to provide stable structural support for the heating unit 6 and the refrigeration unit 7, ensuring that they remain in a fixed position during operation and will not shift due to changes in the patient's body position or other external forces, thereby ensuring the normal operation of the temperature control execution module. At the same time, it also provides the necessary structural strength for the entire thermal conductive layer 2, so that it is not easy to deform or damage when it fits the patient's body, thereby ensuring that the body temperature regulator can continue to function stably.

[0081] In a preferred embodiment, the present invention can be further configured as follows: Figure 1 、 Figure 6 As shown, the torso fixation device 3 is either a medical adhesive component 31 or an adsorption fixation component 32. If the medical adhesive component 31 is used, before the operation begins, the medical staff will adhere the edge of the flexible base 1 of the regulator to the appropriate part of the patient through the medical adhesive component 31. This adhesive can not only closely adhere to the skin, ensuring full contact between the thermal conductive layer 2 and the torso, but also maintain a good fixation effect even if the patient's body position changes slightly during the operation, preventing the regulator from shifting, interfering with the surgical field of view, or affecting the temperature control effect. The adsorption fixation component 32 utilizes the principle of negative pressure adsorption. Once the adsorption fixation component 32 is attached to the patient's torso, it is tightly adsorbed to the skin. The adsorption force and position can be flexibly adjusted according to the patient's different body positions and body contours, closely conforming to the patient's body contours in special positions such as lithotomy and lateral decubitus positions, ensuring that the regulator can be firmly fixed in various surgical positions and preventing incomplete coverage and displacement. It should also be noted that regardless of which torso fixation device 3 is used, the thermal conductive layer 2 can always be in contact with the torso during fixation.

[0082] In a preferred embodiment, the present invention can be further configured as follows: Figure 1 、 Figure 3 As shown; the medical adhesive component 31 includes:

[0083] The first annular connecting portion 311 is coaxially fixedly mounted on the outside of the flexible base 1 and is used to support the adhesive structure;

[0084] A double-sided adhesive layer 312, one side of which is adhered to the surface of the first annular connecting portion 311 close to the body, for achieving adhesion to the body;

[0085] The protective covering layer 313 is attached to the other side surface of the double-sided adhesive layer 312 to protect the adhesive surface of the double-sided adhesive layer 312 in contact with the body before use. The first annular connecting portion 311 is coaxially fixedly installed on the outside of the flexible base 1, serving as the bearing base of the adhesive structure and providing a reliable adhesion surface for the double-sided adhesive layer 312. Before the regulator is used, the protective covering layer 313 is tightly attached to the side surface of the double-sided adhesive layer 312 that is not attached to the first annular connecting portion 311, forming a protective barrier to effectively isolate dust, impurities, etc., prevent the adhesive surface of the double-sided adhesive layer 312 in contact with the body from being contaminated, and ensure its viscosity is not affected. When the regulator needs to be used, the medical staff peels off the protective covering layer 313, exposing the adhesive surface of the double-sided adhesive layer 312, and presses it tightly on the corresponding part of the patient's body. At this time, the double-sided adhesive layer 312, by virtue of its own viscosity, fits tightly to the patient's skin, so that the thermal conductive layer 2 is in full contact with the body.

[0086] In a preferred embodiment, the present invention can be further configured as follows: Figure 4 、 Figure 5 As shown; in the temperature control execution module, the heating unit 6 has a power density of 10-50W / m 2 The carbon fiber resistance wire, the refrigeration unit 7 is a semiconductor refrigeration sheet, the inner bearing layer 23 is provided with two installation areas on the side surface away from the middle heat conductive functional layer 22, the heating unit 6 and the refrigeration unit 7 are respectively arranged in different installation areas, the safety protection circuit 8 is a temperature control switch, the main controller 9 adopts the ARMCortex-M4 chip, the wireless communication unit 1 is a Bluetooth module for data interaction with the central monitoring system, the power supply unit 11 is a 3.7V / 2000mAh rechargeable lithium battery, and the heating unit 6 adopts a power density of 10-50W / m 2The carbon fiber resistance wire has good flexibility and high-efficiency heating characteristics. When the main controller 9 uses the ARMCortex-M4 chip to determine that the temperature needs to be raised according to the patient's body temperature data monitored by the temperature sensor 4, it sends a command to the heating unit 6. The carbon fiber resistance wire quickly heats up after being energized, and the generated heat is quickly transferred to the patient's body through the intermediate thermal conductive functional layer 22, achieving a fast and gentle warming effect. The refrigeration unit 7 uses a semiconductor refrigeration chip. When the main controller 9 determines that the patient's body temperature is too high, it controls the semiconductor refrigeration chip to start, and uses the Peltier effect to absorb heat. The installation area layout on the other side of the inner bearing layer 23 makes the refrigeration unit 7 and the heating unit 6 not interfere with each other, and the cold is transferred to the patient through the intermediate thermal conductive functional layer 22 to achieve the purpose of cooling. The temperature control in the safety protection circuit 8 The switch monitors the temperature of the heating unit 6 and the cooling unit 7 in real time. Once the temperature exceeds the safety threshold, the circuit is immediately cut off to prevent overheating or overcooling from causing harm to the patient. The power supply unit 11 is a 3.7V / 2000mAh rechargeable lithium battery, which provides stable power for the entire system and ensures the continuous operation of each component. In order to ensure the cooling effect of the entire semiconductor refrigeration plate, corresponding heat dissipation holes are also opened on the flexible substrate 1 to dissipate the heat from the hot end of the semiconductor refrigeration plate. The cold end of the semiconductor refrigeration plate is in contact with the inner bearing layer 23. At the same time, the wireless communication unit 10, as a Bluetooth module, can interact with the central monitoring system for data. Medical staff can obtain the patient's body temperature data and equipment working status in real time, and remotely adjust the parameters of the main controller 9 to achieve intelligent and precise body temperature management.

[0087] The overall working principle is as follows: before use, tear off the protective covering layer 313 and stick the double-sided adhesive layer 312 to the corresponding part of the patient's body through the first annular connecting portion 311, ensuring that the edges of the flexible base 1 are tightly fitted;

[0088] During use, the thermally conductive layer 2 within the flexible substrate 1 contacts the patient's skin through the outer flexible antibacterial layer 21. The antibacterial silicone material ensures both conformability and antibacterial protection. The intermediate thermally conductive functional layer 22 rapidly transfers heat or cold from the heating unit 6 or cooling unit 7, while the inner load-bearing layer 23 supports the heating unit 6 and cooling unit 7 to prevent displacement. A temperature sensor 4 collects contact surface temperature data in real time. The main controller 9 calculates the heating / cooling power and start / stop time based on preset temperature thresholds and a PID algorithm. Safety protection circuit 8 monitors the device status to prevent overheating / overcooling. A wireless communication unit 10 transmits data in real time to the central monitoring system, allowing medical staff to adjust parameters remotely.

[0089] The difference between the second embodiment and the first embodiment is that: Figure 6 、 Figure 7 As shown; the adsorption fixing component 32 includes:

[0090] The second annular connecting portion 321 is coaxially fixedly mounted on the outside of the flexible base 1. An accommodating notch 322 is formed at one end of the second annular connecting portion 321 close to the body.

[0091] The annular plug-in portion 323 is detachably plugged into the receiving notch 322 of the second annular connecting portion 321;

[0092] The suction cup 324 is fixedly mounted on the outer side of the annular plug-in portion 323 and is used to absorb the body surface for fixation;

[0093] The limiting ring 325 is fixedly installed on the outer side of the annular plug-in portion 323. When the annular plug-in portion 323 is inserted into the receiving notch 322, the limiting ring 325 is tightly attached to the outer side of the second annular connecting portion 321.

[0094] The limiting member 326 is embedded in the second annular connecting portion 321 and contacts with the annular plug-in portion 323 and the limiting ring 325. It is used to connect and fix the second annular connecting portion 321 to the limiting ring 325 when the annular plug-in portion 323 is plugged into the accommodating notch 322. The second annular connecting portion 321 is coaxially fixedly installed on the outside of the flexible base 1, serving as the basic connection structure of the entire adsorption and fixing component 32. The accommodating notch 322 opened at the end portion on one side of the torso provides an installation space for the annular plug-in portion 323. When in use, the medical staff aligns the annular plug-in portion 323 with the accommodating notch 322 for plugging. At this time, the suction cup 324 fixedly installed on the outside of the annular plug-in portion 323 faces the surface of the patient's torso. When the annular plug-in portion 323 is fully After being fully inserted into the accommodating notch 322, the limiting ring 325 is tightly attached to the outer side of the second annular connecting portion 321, playing a preliminary limiting role. Then, the limiting member 326 embedded in the second annular connecting portion 321 comes into play. It contacts the annular plug-in portion 323 and the limiting ring 325, firmly connecting and fixing the second annular connecting portion 321 and the limiting ring 325 to ensure that the annular plug-in portion 323 will not fall off easily. Press the suction cup 324, and use the negative pressure principle to make the suction cup 324 tightly adsorbed on the patient's body surface. The adsorption position and strength of the suction cup 324 can be flexibly adjusted according to the patient's different body positions and body contours, and closely fit the body contours of patients in special positions such as lithotomy position and lateral position, to avoid incomplete coverage, displacement, etc.

[0095] In a preferred embodiment, the present invention can be further configured as follows: Figure 7 、 Figure 8 As shown; the limiting member 326 includes:

[0096] Through holes 3261 are formed on the surface of the second annular connecting portion 321 and communicate with the receiving notch 322 . There are at least three through holes 3261 equidistantly distributed in a circular pattern around the center of the second annular connecting portion 321 .

[0097] The mounting plate 3262 is fixedly disposed inside the through hole 3261;

[0098] The telescopic rod 3263 passes through the mounting plate 3262 and has a connecting ring on its outer side;

[0099] The elastic member 3264 has one end fixed to the surface of the mounting plate 3262 and sleeved on the outside of the telescopic rod 3263, and the other end connected to the connecting ring;

[0100] The limiting ball 3265 is fixed to the telescopic end of the telescopic rod 3263;

[0101] The connection holes 3266 are formed on the surface of the limiting ring 325 , and their number and distribution positions correspond to those of the through holes 3261 ;

[0102] The elastic arc-shaped spring piece 3267 is fixed inside the connecting hole 3266;

[0103] When the annular plug-in portion 323 is inserted into the accommodating notch 322, the annular plug-in portion 323 pushes the telescopic rod 3263 to compress the elastic part 3264, so that the limiting ball 3265 is stuck in the elastic arc-shaped spring piece 3267, thereby realizing the fixed connection between the second annular connecting portion 321 and the limiting ring 325; pressing the elastic arc-shaped spring piece 3267 to deform it, this deformation can drive the end of the telescopic rod 3263 where the limiting ball 3265 is located to shrink, and the limiting ball 3265 retreats into the through hole 3261 to separate the second annular connecting portion 321 and the limiting ring 325.

[0104] In a preferred embodiment, the present invention can be further configured as follows: Figure 8 、 Figure 9As shown; an annular flange 12 is fixedly installed on the outer side of the annular plug portion 323. When the annular plug portion 323 is inserted into the accommodating notch 322, the annular flange 12 and the end of the telescopic rod 3263 away from the limiting ball 3265 contact each other. The telescopic rod 3263 includes an outer cylinder 32631, the outer cylinder 32631 passes through the mounting plate 3262, and the outer cylinder 32631 is fixedly connected to the connecting ring. An inner rod 32632 is provided through the outer cylinder 32631. The end of the inner rod 32632 located outside the outer cylinder 32631 is fixedly connected to the limiting ball 3265. The outer cylinder 32631 A spring 32633 is fixedly installed on the inner side of 631, and the other end of the spring 32633 is fixedly connected to the end of the inner rod 32632 located in the outer tube 32631. When the annular plug-in portion 323 is inserted into the accommodating notch 322 of the second annular connecting portion 321, the annular flange 12 fixedly installed on the outer side first contacts the end of the telescopic rod 3263 away from the limiting ball 3265. As the annular plug-in portion 323 continues to penetrate deeper, the annular flange 12 pushes the telescopic rod 3263 to move, and the thrust exerted by the annular flange 12 causes the outer tube 32631 to drive the connecting portion The ring moves, compressing the elastic member 3264 on the outside of the telescopic rod 3263, so that the limiting ball 3265 is stuck in the elastic arc spring piece 3267 on the inside of the connecting hole 3266, so as to achieve a firm fixation of the second annular connecting portion 321 and the limiting ring 325, ensuring that the suction cup 324 stably adsorbs the patient's body, maintaining good contact between the thermal conductive layer 2 and the body and normal body temperature regulation function. When disassembling, press the elastic arc spring piece 3267, the inner rod 32632 retreats to the outer cylinder 32631, the limiting ball 3265 retracts to the through hole 3261, and the annular plug part 32 3, it can be easily pulled out. It should be noted that the elastic arc spring piece 3267 is initially in a "(" shape, that is, when the annular plug-in portion 323 is not inserted into the accommodating notch 322 of the second annular connecting portion 321, the outer contour of the limiting ball 3265 is adapted to the state of the elastic arc spring piece 3267 when limiting, and is snapped into the recessed area of the elastic arc spring piece 3267. When releasing the fixation, the elastic arc spring piece 3267 is pressed, and the elastic arc spring piece 3267 is in a ")" shape, so that the limiting ball 3265 can be pushed back into the through hole 3261.

[0105] A control method for a close-fitting temperature-controllable body temperature regulator comprises the following steps:

[0106] S1: Data Collection

[0107] The temperature sensor collects temperature data of the contact surface between the flexible substrate and the body in real time, and the pressure sensor monitors the fitting state data of the flexible substrate in real time, and the fitting state data includes but is not limited to pressure value;

[0108] S2: Data processing and parameter calculation

[0109] The main controller receives temperature data and bonding status data, and calculates the operating parameters of the heating unit and cooling unit based on the preset temperature threshold and PID algorithm. The operating parameters include heating or cooling power and start and stop time.

[0110] S3: Temperature control execution

[0111] The main controller sends control instructions to the heating unit and the cooling unit based on the calculated working parameters, starts the corresponding unit or adjusts its power, and realizes the temperature regulation of the body through the heat conduction layer;

[0112] S4: Security Monitoring and Protection

[0113] The safety protection circuit continuously monitors the operating temperature and current of the heating unit and the cooling unit. When the temperature exceeds the set threshold or the current is abnormal, the power supply is automatically cut off to stop heating or cooling.

[0114] S5: Data Transfer

[0115] The wireless communication unit transmits temperature data, fitting status data and equipment working status to the central monitoring system in real time for remote monitoring by medical staff.

[0116] During the data collection stage, pressure value monitoring can promptly detect displacement problems caused by changes in the patient's body position. The PID algorithm is introduced in the data processing and parameter calculation links, which can dynamically adjust the heating / cooling power according to the real-time temperature, control the temperature fluctuation within a smaller dial range, and achieve precise local temperature control. In the temperature control execution link, the independent partition layout of the heating unit and the cooling unit, combined with the efficient conduction of the heat conductive layer, meet the needs of rapid temperature regulation during surgery. The safety monitoring and protection mechanism reduces the risk of equipment failure through temperature control switches and current monitoring. The data transmission link uses the remote monitoring function realized by the Bluetooth module, so that medical staff can intervene in the adjustment parameters in real time. Especially when dealing with special body position surgeries (such as lateral position), the fixation plan can be dynamically adjusted through pressure data to ensure the fit effect.

[0117] In a preferred embodiment, the present invention can be further configured to include the following steps:

[0118] S6: Adaptive adjustment parameter correction

[0119] The main controller dynamically modifies the PID control parameters through an adaptive algorithm based on historical temperature data and fitting status data. The specific formula is:

[0120]

[0121] Where: K′ p , K′ i , K′ d are the corrected proportional, integral and differential coefficients respectively;

[0122] K p , K i , K d is the initial control parameter;

[0123] e(t)=T set -T real (t) is the real-time temperature error, T set is the preset temperature, T real (t) is the real-time temperature collected by the temperature sensor (4);

[0124] α, β, γ, and δ are adaptive adjustment coefficients, which are preset according to the thermal conductivity characteristics of different body parts;

[0125] Integral Item Used to accumulate historical errors to eliminate steady-state deviations, differential terms Used to suppress temperature fluctuations;

[0126] S7: Compensation control of fitting state

[0127] When the pressure sensor detects that the fitting pressure F is lower than the preset threshold F min When , the main controller triggers the fitting state compensation mechanism:

[0128] If medical adhesive components are used, an alarm is sent to the central monitoring system via the wireless communication unit, prompting the need to check the adhesive fit;

[0129] If the adsorption fixing component is used, the secondary adsorption process of the suction cup will be automatically started to increase the contact pressure between the suction cup and the body surface until F≥F min During the operation, if the pressure sensor detects that the fitting pressure F is lower than the threshold, an alarm is triggered to prompt the user to check the fit and adjust the body fixation device.

[0130] S8: Energy consumption optimization strategy

[0131] The main controller dynamically switches the working mode according to the remaining power Q of the power supply unit and the temperature regulation requirements:

[0132] When Q>70%, full power mode is used to quickly reach the preset temperature;

[0133] When 30%≤Q≤70%, the PID algorithm is used to maintain the temperature and reduce the average power consumption;

[0134] When Q<30%, the core temperature control function is prioritized, the high-frequency transmission mode of the wireless communication unit is turned off, and only periodic data reporting in the low-power state is retained. The power supply unit dynamically switches modes according to the power: full-power rapid temperature control when the power is >70%, PID energy-saving temperature control when 30%≤power≤70%, and priority is given to core functions and reducing communication power consumption when the power is <30%. The main controller also corrects the PID parameters through an adaptive algorithm, combines historical data and the thermal conductivity characteristics of the body parts, improves the temperature control accuracy, and ensures the stability of the patient's body temperature throughout the operation. In terms of adaptive adjustment, the main controller dynamically corrects the PID parameters based on historical data and the adaptive algorithm, and eliminates historical errors accumulated through the integral term. Steady-state deviation and differential terms suppress temperature fluctuations. Combined with the preset adjustment coefficients based on the thermal conductivity characteristics of different body parts, the temperature control accuracy is improved, which completely solves the problem of slow response and inability to accurately adapt to individual differences in traditional equipment. The fit state compensation control targets the common fixation failure problem in special body position surgery. When the pressure sensor detects insufficient fit pressure, the body fixation device is adjusted to ensure that the fit pressure is stably maintained above the preset threshold in scenarios such as lithotomy position and lateral position. The energy consumption optimization strategy dynamically switches the working mode. When the battery is sufficient, it uses full-power mode for rapid temperature control. When the battery is insufficient, it prioritizes core functions and reduces unnecessary power consumption, thereby extending the continuous working time of the equipment.

[0135] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0136] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A close-fitting temperature-controllable body temperature regulator, characterized in that: include: A flexible patch module comprises a flexible substrate (1) that can be attached to a body, a heat-conducting layer (2) in contact with the body is provided in the flexible substrate (1), a body fixing device (3) is provided at the edge of the flexible substrate (1), and a temperature sensor (4) for monitoring the temperature of the contact surface and a pressure sensor (5) for monitoring the attachment state are embedded in the flexible substrate (1); A temperature control execution module comprises a heating unit (6) and a cooling unit (7) provided on the heat-conducting layer (2), and a safety protection circuit (8) electrically connected to the heating unit (6) and the cooling unit (7); The intelligent control module comprises a main controller (9) electrically connected to the temperature sensor (4), the pressure sensor (5), the heating unit (6), the refrigeration unit (7) and the safety protection circuit (8), and a wireless communication unit (10) and a power supply unit (11) electrically connected to the main controller (9).

2. A close-fitting temperature-controllable body temperature regulator according to claim 1, characterized in that: The heat-conducting layer (2) comprises an outer flexible antibacterial layer (21), at least one intermediate heat-conducting functional layer (22), and an inner bearing layer (23) which are stacked in sequence; the outer flexible antibacterial layer (21) is made of an antibacterial silicone material and is used to fit the body surface and provide antibacterial protection; the intermediate heat-conducting functional layer (22) is made of one or more of graphene, metal foil, or other highly heat-conductive flexible materials and is used to achieve efficient heat conduction; the inner bearing layer (23) is a flexible substrate and is used to provide structural support for the heating unit (6) and the refrigeration unit (7).

3. The close-fitting temperature-controllable body temperature regulator according to claim 1, characterized in that: The body fixing device (3) is one of a medical adhesive component (31) and an adsorption fixing component (32).

4. The close-fitting temperature-controllable body temperature regulator according to claim 3, characterized in that: The medical adhesive component (31) comprises: A first annular connecting portion (311) is coaxially fixedly mounted on the outside of the flexible base (1) and is used to support the adhesive structure; a double-sided adhesive layer (312), one side of which is adhered to the surface of the first annular connecting portion (311) close to the body, for achieving adhesion to the body; The protective covering layer (313) is attached to the other side surface of the double-sided adhesive layer (312) to protect the adhesive surface of the double-sided adhesive layer (312) in contact with the body before use.

5. The close-fitting temperature-controllable body temperature regulator according to claim 3, characterized in that: The adsorption and fixing component (32) comprises: A second annular connecting portion (321) is coaxially fixedly mounted on the outside of the flexible base (1), and an end portion of the second annular connecting portion (321) close to the body is provided with an accommodating notch (322); An annular plug-in portion (323) is detachably plugged into the receiving notch (322) of the second annular connecting portion (321); A suction cup (324) is fixedly mounted on the outside of the annular plug-in portion (323) and is used to absorb the body surface for fixation; A limiting ring (325) is fixedly mounted on the outer side of the annular plug-in portion (323). When the annular plug-in portion (323) is plugged into the accommodating notch (322), the limiting ring (325) is tightly attached to the outer side of the second annular connecting portion (321). The limiting member (326) is embedded in the second annular connecting portion (321) and contacts the annular plug-in portion (323) and the limiting ring (325), and is used to connect and fix the second annular connecting portion (321) and the limiting ring (325) when the annular plug-in portion (323) is plugged into the accommodating notch (322).

6. The close-fitting temperature-controllable body temperature regulator according to claim 5, characterized in that: The limiting member (326) includes: A through hole (3261) is formed on the surface of the second annular connecting portion (321) and communicates with the accommodating notch (322), wherein the through holes (3261) are not less than three and are equidistantly distributed in an annular manner with the center of the second annular connecting portion (321) as the axis; A mounting plate (3262) is fixedly disposed inside the through hole (3261); A telescopic rod (3263) passes through the mounting plate (3262) and has a connecting ring on its outer side; an elastic member (3264), one end of which is fixed to the surface of the mounting plate (3262) and sleeved on the outside of the telescopic rod (3263), and the other end of which is connected to the connecting ring; A limiting ball (3265) is fixed to the telescopic end of the telescopic rod (3263); The connection holes (3266) are formed on the surface of the limiting ring (325), and the number and distribution positions of the connection holes (3266) correspond to those of the through holes (3261); The elastic arc-shaped spring piece (3267) is fixed inside the connecting hole (3266).

7. The close-fitting temperature-controllable body temperature regulator according to claim 6, characterized in that: An annular flange (12) is fixedly mounted on the outer side of the annular plug-in portion (323). When the annular plug-in portion (323) is inserted into the accommodating notch (322), the annular flange (12) and the end of the telescopic rod (3263) away from the limiting ball (3265) contact each other. The telescopic rod (3263) includes an outer cylinder (32631), which passes through the mounting plate (3262). The outer cylinder (32631) is fixedly mounted on the outer side of the annular plug-in portion (323). When the annular plug-in portion (323) is inserted into the accommodating notch (322), the annular flange (12) and the end of the telescopic rod (3263) away from the limiting ball (3265) contact each other. 631) is fixedly connected to the connecting ring, an inner rod (32632) is provided through the outer cylinder (32631), one end of the inner rod (32632) located outside the outer cylinder (32631) is fixedly connected to the limiting ball (3265), a spring (32633) is fixedly installed on the inner side of the outer cylinder (32631), and the other end of the spring (32633) is fixedly connected to the end of the inner rod (32632) located inside the outer cylinder (32631).

8. The close-fitting temperature-controllable body temperature regulator according to claim 2, characterized in that: In the temperature control execution module, the heating unit (6) has a power density of 10-50W / m 2 The carbon fiber resistance wire is provided, the refrigeration unit (7) is a semiconductor refrigeration sheet, the inner bearing layer (23) is provided with two installation areas on a side surface away from the intermediate heat conductive functional layer (22), the heating unit (6) and the refrigeration unit (7) are respectively provided in different installation areas, the safety protection circuit (8) is a temperature control switch, the main controller (9) adopts an ARM Cortex-M4 chip, the wireless communication unit (10) is a Bluetooth module for data exchange with a central monitoring system, and the power supply unit (11) is a 3.7V / 2000mAh rechargeable lithium battery.

9. The control method of a close-fitting temperature-controllable body temperature regulator according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1: Data Collection The temperature sensor (4) collects temperature data of the contact surface between the flexible substrate (1) and the body in real time, and the pressure sensor (5) monitors the fitting state data of the flexible substrate (1) in real time, and the fitting state data includes but is not limited to pressure value; S2: Data processing and parameter calculation The main controller (9) receives the temperature data and the bonding state data, and calculates the operating parameters of the heating unit (6) and the cooling unit (7) based on a preset temperature threshold and a PID algorithm. The operating parameters include heating or cooling power and start and stop time. S3: Temperature control execution The main controller (9) sends control instructions to the heating unit (6) and the cooling unit (7) based on the calculated working parameters, starts the corresponding units or adjusts their power, and realizes temperature regulation of the body through the heat conductive layer (2); S4: Security Monitoring and Protection The safety protection circuit (8) continuously monitors the operating temperature and current of the heating unit (6) and the cooling unit (7), and automatically cuts off the power supply to stop heating or cooling when the temperature exceeds a set threshold or the current is abnormal; S5: Data Transfer The wireless communication unit (10) transmits temperature data, fitting status data and equipment working status to the central monitoring system in real time for remote monitoring by medical staff.

10. The method for controlling a close-fitting temperature-controllable body temperature regulator according to claim 9, characterized in that: The following steps are also included: S6: Adaptive adjustment parameter correction The main controller (9) dynamically modifies the PID control parameters through an adaptive algorithm based on historical temperature data and fitting state data. The specific formula is: Where: K′ p , K′ i , K′ d are the corrected proportional, integral and differential coefficients respectively; K p , K i , K d is the initial control parameter; e(t)=T set -T real (t) is the real-time temperature error, T set is the preset temperature, T real (t) is the real-time temperature collected by the temperature sensor (4); α, β, γ, and δ are adaptive adjustment coefficients, which are preset according to the thermal conductivity characteristics of different body parts; Integral Item Used to accumulate historical errors to eliminate steady-state deviations, differential terms Used to suppress temperature fluctuations; S7: Fitting state compensation control When the pressure sensor (5) detects that the fitting pressure F is lower than the preset threshold F min When , the main controller (9) triggers the fitting state compensation mechanism: If a medical adhesive component (31) is used, an alarm is sent to a central monitoring system via a wireless communication unit (10), prompting the need to check the adhesive fit; If the adsorption fixing component (32) is used, the secondary adsorption process of the suction cup (324) is automatically started to increase the contact pressure between the suction cup (324) and the body surface until F≥F min ; S8: Energy consumption optimization strategy The main controller (9) dynamically switches the working mode according to the remaining power Q of the power supply unit (11) and the temperature regulation requirement: When Q>70%, full power mode is used to quickly reach the preset temperature; When 30%≤Q≤70%, the PID algorithm is used to maintain the temperature and reduce the average power consumption; When Q is less than 30%, the core temperature control function is prioritized, the high-frequency transmission mode of the wireless communication unit (10) is turned off, and only periodic data reporting in a low power consumption state is retained.

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