Multi-mode pressure therapeutic apparatus for auricle disease treatment

Abstract

The invention relates to the technical field of medical instruments, in particular to a multi-mode pressure therapeutic apparatus for auricle disease treatment, which comprises a main control unit for controlling the operation and parameter management of the whole therapeutic apparatus; the pressure control system is electrically connected with the main control unit and comprises an electric air pump and a pressure adjusting module, and the pressure adjusting module is used for dividing the air pressure into multiple adjustable gears; the ear clip system is in gas circuit connection with the pressure control system and comprises at least one ear clip designed according to the auricle anatomical structure, and the ear clip is provided with a plurality of air bags located at different anatomical positions; the monitoring system is electrically connected with the main control unit and is used for monitoring the auricle state; the pressure can be accurately controlled through an electric air pump and a precision regulating valve according to a plurality of treatment modes stored in the main control unit; the special air bag is designed according to the characteristics of the auricle anatomical structure, accurate compression can be carried out on specific parts such as a triangular fossa, a conchae boat and a conchae cavity, and the treatment accuracy and safety are improved.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and more specifically, to a multi-mode pressure therapy device for treating auricular diseases. The device is particularly suitable for clinical application scenarios such as postoperative treatment of auricular trauma hematoma, puncture or postoperative treatment of auricular pseudocysts, compression treatment of auricular scars, and compression treatment of traditional Chinese medicine ear acupuncture points. Background Art

[0002] Auricular diseases are common clinically, including traumatic hematomas, pseudocysts, and scarring. Improper treatment can lead to auricular deformation, impacting both the patient's appearance and mental well-being. Currently, compression therapy is the primary treatment for these conditions, applying pressure to specific areas to promote resorption of diseased tissue or prevent recurrence.

[0003] Traditional auricular compression treatments primarily utilize methods such as plaster fixation and butterfly ear clips. However, these traditional methods have numerous drawbacks: First, traditional devices are often bulky and inconvenient to use, significantly impacting patients' daily lives; second, the level of pressure cannot be controlled, which can easily lead to excessive pressure causing tissue damage or insufficient pressure resulting in poor treatment efficacy; third, the lack of comfort leads to low patient compliance, making it difficult for patients to complete the treatment course; in addition, traditional devices are complex to install and difficult to operate, increasing the workload of medical staff; and finally, the inability to accurately locate the compression site can lead to serious complications such as auricular injury and tissue necrosis.

[0004] Currently, there are no pressure devices that can achieve precise pressure control and multi-modal treatment tailored to the anatomical structure of the auricle. Therefore, developing an auricular pressure therapy device that can precisely control pressure, conform to the auricle, and be easy to use, safe, and effective has important clinical significance and application value. Summary of the Invention

[0005] The purpose of the present invention is to overcome the shortcomings of the existing technology and provide a multi-mode pressure therapy device for the treatment of auricular diseases. The therapy device can apply precise pressure to specific parts according to the anatomical structure characteristics of the auricle, while providing a precisely controllable pressure system and multiple treatment modes to meet the needs of different clinical application scenarios.

[0006] The present invention proposes a multi-mode pressure therapy device for treating auricular diseases, which is characterized by comprising:

[0007] Main control unit, used to control the operation and parameter management of the entire therapeutic device;

[0008] A pressure control system electrically connected to the main control unit, comprising an electric air pump and a pressure regulating module, wherein the pressure regulating module is used to adjust the gas pressure into multiple levels;

[0009] An ear clip system connected to the air circuit of the pressure control system includes at least one ear clip designed according to the anatomical structure of the auricle, the ear clip having multiple air cells located in different anatomical parts;

[0010] a monitoring system electrically connected to the main control unit, for monitoring the state of the auricle; and

[0011] Multiple treatment modes stored in the main control unit.

[0012] Preferably, the main control unit includes:

[0013] Microprocessor, used to process monitoring data and control instructions;

[0014] Touch screen display, used to display parameter information and receive operation instructions;

[0015] An internal battery pack for power supply; and

[0016] Data storage module, used to store treatment parameters and records.

[0017] Preferably, the pressure regulating module of the pressure control system includes:

[0018] Pressure sensor, used to detect the pressure inside the airbag in real time;

[0019] A pressure regulating valve to precisely control the amount of gas entering the airbag; and

[0020] Air circuit control module, used to achieve independent control of multiple airbags;

[0021] The pressure is divided into 1-6 levels, and each level corresponds to a different pressure value range.

[0022] Preferably, the pressure control system adopts a proportional-integral-differential control algorithm, and the control equation is:

[0023]

[0024] Where u(t) is the control output in percentage, representing the air pump output power or regulating valve opening; e(t) is the error signal, which is equal to the difference between the target pressure and the actual pressure, in kPa; K1 is the proportional coefficient in % / kPa; K2 is the integral coefficient in % / (kPa·s); and K3 is the differential coefficient in seconds.

[0025] Preferably, the ear clip system comprises:

[0026] Type A ear clip has two air bags, one for the triangular fossa and the other for the cymba concha.

[0027] Type B ear clip, with one air bag, corresponding to the concha cavity; and

[0028] The C-shaped ear clip has three air bags, corresponding to the triangular fossa, cymba concha and cavum concha.

[0029] The ear clip is made of medical-grade materials and has a transparent and visual design.

[0030] Preferably, the monitoring system comprises:

[0031] Temperature monitoring module, used to monitor the surface temperature of the auricle;

[0032] a tissue perfusion monitoring module, for detecting tissue blood perfusion status; and

[0033] Real-time pressure monitoring module, used to monitor the actual pressure of each airbag;

[0034] When the monitoring parameters exceed the safety range, the monitoring system sends an alarm signal to the main control unit.

[0035] Preferably, the multiple treatment modes include:

[0036] Continuous pressure mode, maintaining a constant pressure value;

[0037] Intermittent pressure mode, alternately applying pressure and releasing it according to a set cycle;

[0038] Increasing pressure mode, the pressure gradually increases from the low gear to the set gear;

[0039] In decreasing pressure mode, the pressure gradually decreases from the high gear to the set gear;

[0040] Pulse pressure mode, which allows for rapid alternation of high and low pressure; and

[0041] Custom mode: users can customize the pressure change curve according to clinical needs.

[0042] Preferably, an exception handling mechanism is further included, and the exception handling mechanism includes:

[0043] Pressure over-limit processing: automatic adjustment when the actual pressure exceeds or falls below the set value by more than 20%;

[0044] Gas line leakage treatment: an alarm is issued when a continuous decrease in pressure and a continuous increase in air pump power are detected;

[0045] Tissue ischemia monitoring and management, automatically reducing pressure when a significant decrease in tissue blood flow is detected; and

[0046] Power supply abnormality processing, safe shutdown processing when power is low.

[0047] Preferably, the therapeutic apparatus further comprises an adaptive adjustment mechanism for automatically adjusting the treatment parameters according to different patients, different disease characteristics and different environmental conditions;

[0048] Among them, the adaptive adjustment mechanism includes individual difference adaptation, disease characteristic adaptation and environmental adaptive adjustment.

[0049] Preferably, the multi-mode pressure therapy device is suitable for the following treatment scenarios:

[0050] Postoperative management of auricular trauma hematoma;

[0051] Postoperative treatment of auricular pseudocyst puncture or surgery;

[0052] Compression therapy for auricular scars; and

[0053] Auricular acupressure therapy in Traditional Chinese Medicine.

[0054] The beneficial effects of the present invention are mainly reflected in the following aspects:

[0055] The beneficial effects of the present invention include:

[0056] 1. Precise pressure control: The electric air pump and precision regulating valve are used to achieve precise pressure control, which can be accurately adjusted to the preset range, avoiding the problem of tissue damage or poor treatment effect caused by uncontrollable pressure in traditional methods.

[0057] 2. Anatomically matched design: A special airbag is designed according to the anatomical structure of the auricle, which can accurately compress specific parts such as the triangular fossa, cymba concha, and cavum concha, reducing unnecessary pressure on non-target parts and improving the accuracy and safety of treatment.

[0058] 3. Multi-mode treatment plan: Provides multiple treatment modes such as continuous pressure, intermittent pressure, increasing pressure, decreasing pressure, pulse pressure and custom mode, which can meet the needs of different clinical application scenarios and improve the flexibility and adaptability of treatment.

[0059] 4. Safety monitoring mechanism: The integrated temperature, tissue perfusion and pressure real-time monitoring modules can monitor safety parameters throughout the treatment process, detect and address potential risks in a timely manner, and significantly improve the safety of treatment.

[0060] 5. Ease of use: The quick connector design and intuitive user interface greatly simplify the operation process, improve ease of use and patient compliance.

[0061] 6. Adaptive adjustment: Automatically adjust treatment parameters according to individual differences, disease characteristics and environmental conditions, improving the personalization and adaptability of treatment.

[0062] Through the above beneficial effects, the present invention greatly improves the treatment effect of auricular diseases, reduces complications, improves patient experience, simplifies medical work flow, and has broad clinical application prospects and market promotion value. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0064] Figure 2 This is a structural block diagram of the main control unit of the present invention;

[0065] Figure 3 Schematic diagram of the structure of the pressure control system of the present invention;

[0066] Figure 4 This is a schematic structural diagram of the A-type ear clip of the present invention;

[0067] Figure 5 This is a schematic structural diagram of the B-type ear clip of the present invention;

[0068] Figure 6 This is a schematic structural diagram of the C-shaped ear clip of the present invention;

[0069] Figure 7 is a functional block diagram of the monitoring system of the present invention;

[0070] Figure 8 Schematic diagram of the treatment mode of the present invention;

[0071] Figure 9 Flowchart of the exception handling mechanism of the present invention. DETAILED DESCRIPTION

[0072] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0073] Example 1

[0074] like Figure 1 As shown, the present invention provides a multi-mode pressure therapy device for treating auricle diseases, including a main control unit 1, a pressure control system 2, an ear clip system 3, a monitoring system 4 and a plurality of treatment modes 5 stored in the main control unit 1.

[0075] The main control unit 1 is used to control the operation and parameter management of the entire therapeutic device. The pressure control system 2 is electrically connected to the main control unit 1 and includes an electric air pump 21 and a pressure regulation module 22. The pressure regulation module 22 is used to adjust the gas pressure to multiple levels. The ear clip system 3 is pneumatically connected to the pressure control system 2 and includes at least one ear clip designed based on the anatomical structure of the auricle. The ear clip has multiple airbags located in different anatomical locations. The monitoring system 4 is electrically connected to the main control unit 1 and is used to monitor the status of the auricle. Multiple treatment modes 5 are stored in the main control unit 1 to meet different treatment needs.

[0076] In a preferred embodiment of the present invention, the main control unit 1 utilizes a microprocessor architecture, enabling intelligent control of the entire system. The pressure control system 2 precisely controls the pressure within the airbag, ensuring stable and safe pressure during treatment. The ear clip system 3, designed based on the anatomical structure of the auricle, enables precise compression of specific areas. The monitoring system 4 monitors safety parameters throughout the treatment process, promptly identifying and addressing potential risks. Multiple treatment modes 5 meet the needs of diverse clinical scenarios, enhancing treatment flexibility and adaptability.

[0077] Example 2

[0078] like Figure 2 As shown, the main control unit 1 of the present invention includes: a microprocessor 11 , a touch screen display 12 , a built-in battery pack 13 and a data storage module 14 .

[0079] Microprocessor 11 is used to process monitoring data and control instructions. In one embodiment of the present invention, microprocessor 11 uses an STM32F407 series 32-bit ARM Cortex-M4 processor with a main frequency of 168MHz, which has powerful data processing capabilities. Preferably, the processor is equipped with a floating-point unit, which can efficiently handle complex control algorithm calculations.

[0080] The touchscreen display 12 is used to display parameter information and receive operational instructions. In a preferred embodiment of the present invention, the touchscreen display 12 utilizes a 3.5-inch IPS capacitive touchscreen with a resolution of 320×480 pixels, providing clear display and sensitive touch. Furthermore, the touchscreen display 12 supports multi-touch, enabling a richer range of human-computer interaction features.

[0081] The internal battery pack 13 provides power. In one embodiment of the present invention, the internal battery pack 13 uses a 3500mAh lithium polymer battery that supports fast charging technology. A full charge is required in two hours, and a single charge can support over eight hours of continuous operation. Furthermore, the internal battery pack 13 includes overcharge, over-discharge, and overcurrent protection features to ensure safe use.

[0082] The data storage module 14 is used to store treatment parameters and records. In a preferred embodiment of the present invention, the data storage module 14 includes 8MB of Flash memory and 512KB of SRAM, capable of storing a large amount of treatment parameters and records. The data storage module 14 supports data export, allowing medical personnel to export data to mobile devices via Bluetooth for analysis and management.

[0083] In another embodiment of the present invention, the main control unit 1 also includes a communication interface 15 that supports Bluetooth 4.0 low-power communication and can be connected to mobile devices to implement remote monitoring and data management functions. Through the communication interface 15, medical staff can view the treatment status in real time and remotely adjust treatment parameters if necessary.

[0084] Example 3

[0085] like Figure 3 As shown, the pressure regulating module 22 of the pressure control system 2 of the present invention includes: a pressure sensor 221 , a pressure regulating valve 222 and an air path control module 223 .

[0086] Pressure sensor 221 is used to monitor the pressure within the airbag in real time. In a preferred embodiment of the present invention, pressure sensor 221 utilizes a MEMS pressure sensor with a measurement range of 0-150 kPa, an accuracy of ±0.3 kPa, and a sampling frequency of 5 times per second. Using a high-precision pressure sensor ensures accurate pressure control and avoids safety issues caused by excessive or insufficient pressure.

[0087] Pressure regulating valve 222 is used to precisely control the amount of gas entering the airbag. In one embodiment of the present invention, pressure regulating valve 222 utilizes a miniature solenoid valve with a response time of ≤50ms, enabling rapid and precise regulation of gas flow. Pressure regulating valve 222 utilizes PWM (pulse width modulation) control, enabling more precise pressure regulation.

[0088] Air circuit control module 223 is used to independently control multiple airbags. In a preferred embodiment of the present invention, air circuit control module 223 utilizes a multi-channel air distribution system, independently controlling the pressure of up to three airbags, meeting the requirements of the C-shaped ear clip. Air circuit control module 223 utilizes a micro-solenoid valve array to achieve air circuit switching, resulting in fast response time and precise control.

[0089] In this invention, the pressure is divided into 1-6 levels, each corresponding to a different pressure range. Specifically, level 1 corresponds to 10±1kPa, suitable for mild treatment or sensitive areas; level 2 corresponds to 20±1kPa, suitable for standard treatment or initial treatment; level 3 corresponds to 30±1kPa, suitable for moderate treatment or conventional treatment; level 4 corresponds to 45±1.5kPa, suitable for intensive treatment or scar treatment; level 5 corresponds to 60±1.5kPa, suitable for high-intensity treatment or stubborn cases; level 6 corresponds to 80±2kPa, suitable for the strongest treatment or special cases.

[0090] The pressure settings are preferably based on clinical experience and experimental data. For example, in the treatment of auricular scars, studies have shown that pressures between 30 and 60 kPa are most effective, so settings 3-5 are within this range. Furthermore, considering the varying tolerances of different patients, settings 1-2 for lower pressure and 6 for higher pressure are provided to meet personalized treatment needs.

[0091] Example 4

[0092] In one embodiment of the present invention, the pressure control system 2 adopts a proportional-integral-derivative (PID) control algorithm, and the control equation is:

[0093]

[0094] Where u(t) is the control output, expressed in percentage, representing the pump's output power or the degree of opening of the regulating valve; e(t) is the error signal, equal to the difference between the target pressure and the actual pressure, expressed in kPa; K1 is the proportional coefficient, expressed in % / kPa; K2 is the integral coefficient, expressed in % / (kPa·s); and K3 is the differential coefficient, expressed in seconds.

[0095] In a preferred embodiment of the present invention, PID parameters are dynamically adjusted based on the gear position to ensure stable control across various pressure ranges. Specifically, in the pressure range of gears 1-2, K1 = 5.0, K2 = 0.8, and K3 = 0.2; in the pressure range of gears 3-4, K1 = 4.0, K2 = 0.6, and K3 = 0.3; and in the pressure range of gears 5-6, K1 = 3.0, K2 = 0.4, and K3 = 0.4.

[0096] The above parameter settings are based on experimental optimization results. In the low pressure range (gears 1-2), the system is more sensitive to pressure changes, so larger proportional coefficients K1 and integral coefficients K2 are set to ensure the system can respond quickly and reach the target pressure. In the high pressure range (gears 5-6), to prevent pressure overshoot and safety issues, proportional coefficients K1 and integral coefficients K2 are reduced, while differential coefficient K3 is increased to improve system stability.

[0097] In another embodiment of the present invention, a fuzzy PID control algorithm is also used to dynamically adjust the PID parameters according to the pressure error size and change rate to further improve the control accuracy and system stability. The fuzzy PID control algorithm uses the error e(t) and the error change rate to calculate the PID parameters. As input, the K1, K2 and K3 parameters are dynamically adjusted through fuzzy inference rules to achieve more intelligent pressure control.

[0098] Example 5

[0099] like Figure 4-6As shown, the ear clip system 3 of the present invention includes: an A-type ear clip 31 , a B-type ear clip 32 and a C-type ear clip 33 .

[0100] The A-type ear clip 31 has two air bags, corresponding to the triangular fossa and the cymba concha. Figure 4 As shown, the A-type ear clip 31 comprises an ear clip body 311 and air cells 312 and 313. Air cell 312 is located in the triangular fossa, and air cell 313 is located in the cymba concha. In a preferred embodiment of the present invention, the dimensions of the A-type ear clip 311 are 30 mm long, 20 mm wide, and 5 mm thick (excluding the air cell). The diameter of air cell 312 is 10 mm, and the diameter of air cell 313 is 8 mm. These dimensional parameters were determined based on extensive analysis of auricular anatomy and are suitable for most adult auricle structures.

[0101] The B-type ear clip 32 has an air bag corresponding to the concha cavity. Figure 5 As shown, the Type B ear clip 32 comprises an ear clip body 321 and an air cell 322, which is located in the cavum concha. In a preferred embodiment of the present invention, the dimensions of the Type B ear clip 32 are 25 mm in length, 15 mm in width, and 5 mm in thickness (excluding the air cell). The diameter of the air cell 322 is 15 mm. These parameters are also determined based on auricular anatomy and are particularly suitable for treatment of the cavum concha.

[0102] The C-shaped ear clip 33 has three air bags, corresponding to the triangular fossa, cymba concha and cavum concha. Figure 6 As shown, the C-shaped ear clip 33 comprises an ear clip body 331 and air cells 332, 333, and 334. Air cell 332 is located in the triangular fossa, air cell 333 is located in the cymba concha, and air cell 334 is located in the cavum concha. In a preferred embodiment of the present invention, the dimensions of the C-shaped ear clip 33 are 35 mm long, 25 mm wide, and 5 mm thick (excluding the air cell). The diameters of air cells 332, 333, and 334 are 10 mm, 8 mm, and 15 mm, respectively. These parameters allow for simultaneous treatment of three key areas, making them suitable for complex cases requiring comprehensive treatment.

[0103] In the present invention, the ear clip is made of medical-grade materials and features a transparent, visual design. Preferably, the ear clip body is constructed of medical-grade TPE, which exhibits excellent elasticity and biocompatibility. The airbag utilizes a double-layer design, with an inner layer of highly elastic material and an outer layer of high-strength material, ensuring durability and safety. All materials comply with ISO 10993 biocompatibility requirements, ensuring safety for prolonged contact with human skin.

[0104] Furthermore, the transparent, visual design allows medical staff to observe the state of the auricle tissue in real time and promptly detect any abnormalities. In actual use, medical staff can select the appropriate ear clip type based on the patient's specific condition. For example, for patients undergoing surgery for auricular trauma and hematoma, Type A ear clip 31 is typically selected, focusing on the triangular fossa and cymba concha. For patients with auricular pseudocysts, Type B ear clip 32 is typically selected, focusing on the concha cavity. For patients with auricular scars or those requiring comprehensive treatment, Type C ear clip 33 is selected, simultaneously compressing all three areas.

[0105] Example 6

[0106] like Figure 7 As shown, the monitoring system 4 of the present invention includes: a temperature monitoring module 41 , a tissue perfusion monitoring module 42 and a real-time pressure monitoring module 43 .

[0107] The temperature monitoring module 41 is used to monitor the surface temperature of the auricle. In a preferred embodiment of the present invention, this module uses an infrared non-contact temperature sensor with a measurement range of 20-45°C, an accuracy of ±0.2°C, and a sampling frequency of 10 seconds. Furthermore, the non-contact design of the temperature monitoring module 41 avoids additional pressure on the measured area, improving measurement accuracy and patient comfort.

[0108] The tissue perfusion monitoring module 42 is used to detect tissue blood perfusion status. In one embodiment of the present invention, the tissue perfusion monitoring module 42 utilizes a reflective photoplethysmography sensor, combined with PPG (photoplethysmography) technology, to monitor tissue blood flow status in real time. Preferably, the tissue perfusion monitoring module 42 also incorporates thermal imaging technology to improve the accuracy of perfusion monitoring and enable early detection of tissue ischemia risk.

[0109] The real-time pressure monitoring module 43 is used to monitor the actual pressure of each airbag. In a preferred embodiment of the present invention, each airbag is equipped with an independent pressure sensor with a sampling frequency of 5 times per second to ensure real-time and accurate pressure monitoring. Furthermore, the real-time pressure monitoring module 43 also includes a pressure distribution analysis function, which can assess whether the pressure distribution is uniform and prevent tissue damage caused by excessive local pressure.

[0110] In the present invention, when monitored parameters exceed safety limits, monitoring system 4 sends an alarm signal to main control unit 1. Specifically, when the auricle temperature falls below 28°C or rises above 41°C, it is determined to be a potential safety risk and the system issues an alarm. When the tissue blood perfusion index falls below 60% of the baseline value for five minutes, it is determined to be a potential risk of tissue ischemia and the system issues an alarm. When the actual airbag pressure exceeds the set value by more than 20% for one minute, it is determined to be a pressure abnormality and the system automatically adjusts the pressure and issues an alarm.

[0111] Preferably, the setting of the above safety range is based on clinical research and safety standards. For example, an auricle temperature below 28°C usually indicates insufficient tissue perfusion, which may lead to ischemic damage; a temperature above 41°C may indicate a local inflammatory reaction, which requires timely treatment. A 60% reduction in tissue blood perfusion index is an early warning indicator of tissue ischemia, and early intervention can avoid irreversible damage. The pressure exceeds the set value by 20% based on safety margin considerations to ensure that even at the highest pressure level (80kPa), the actual pressure will not exceed the safety upper limit of 100kPa.

[0112] Example 7

[0113] like Figure 8 As shown, the various treatment modes 5 of the present invention include: continuous pressure mode 51, intermittent pressure mode 52, increasing pressure mode 53, decreasing pressure mode 54, pulse pressure mode 55 and custom mode 56.

[0114] Continuous pressure mode 51 maintains a constant pressure value. In a preferred embodiment of the present invention, continuous pressure mode 51 can be set to different pressure levels (1-6), with an adjustable duration range of 30-120 minutes. This mode is particularly suitable for compression treatment of auricular scars. Clinical practice has shown that continuous, stable pressure can promote the contraction of new blood vessels in scar tissue and accelerate scar atrophy.

[0115] Intermittent pressure mode 52 alternates between applying and releasing pressure according to a set cycle. In one embodiment of the present invention, the pressure duration in intermittent pressure mode 52 is adjustable from 1 to 30 minutes, the release duration is adjustable from 0.5 to 5 minutes, and the number of cycles is adjustable from 1 to 12. This mode is particularly suitable for postoperative treatment of auricular hematomas or pseudocysts after trauma. Intermittent pressure release can improve tissue perfusion, reduce discomfort caused by continuous pressure, and enhance patient compliance.

[0116] Incremental pressure mode 53 gradually increases pressure from a low setting to a set setting. In a preferred embodiment of the present invention, the initial pressure setting in incremental pressure mode 53 can be selected from levels 1-3, the target pressure setting can be selected from levels 2-6, and the increment time can be adjusted from 5 to 30 minutes. This mode is particularly suitable for initial treatment of patients with pain sensitivity. The gradual increase in pressure can reduce the discomfort caused by sudden pressure increases and improve patient tolerance.

[0117] Decreasing pressure mode 54 gradually reduces pressure from a high setting to a set setting. In one embodiment of the present invention, the initial pressure setting in decreasing pressure mode 54 can be selected from settings 2 to 6, the target pressure setting can be selected from settings 1 to 3, and the decreasing time can be adjusted from 5 to 20 minutes. This mode is particularly suitable for the buffering phase before the end of treatment, preventing vasodilation headaches or localized congestion caused by a sudden release of pressure.

[0118] Pulse pressure mode 55 achieves rapid alternation between high and low pressure. In a preferred embodiment of the present invention, pulse pressure mode 55 has selectable base pressure levels 1-3, pulse pressure levels 2-6, pulse frequency adjustable from 0.5-2 Hz, and duration adjustable from 5-30 minutes. This mode is particularly well-suited for Traditional Chinese Medicine auricular acupressure therapy. Studies have shown that pulsed compression can more effectively stimulate acupoints and enhance therapeutic effects.

[0119] Custom Mode 56 allows users to customize pressure profiles based on clinical needs. In one embodiment of the present invention, Custom Mode 56 supports the configuration of up to 10 pressure-time nodes and the storage of multiple treatment plans. This mode is particularly suitable for patients with specialized treatment needs, allowing medical staff to design personalized pressure profiles based on the patient's specific condition and treatment progress.

[0120] In the present invention, the parameters for different treatment modes are based on clinical experience and research results. For example, the recommended duration of continuous pressure mode 51 is 30-120 minutes. This is based on the response time of scar tissue to pressure. Studies have shown that compression times less than 30 minutes are ineffective, while those exceeding 120 minutes may increase the risk of tissue damage. The release time in intermittent pressure mode 52 is set to 0.5-5 minutes to ensure adequate tissue perfusion without completely losing the therapeutic effect.

[0121] Example 8

[0122] like Figure 9 As shown, the present invention further includes an abnormality handling mechanism 6 , which includes: pressure over-limit handling 61 , gas path leakage handling 62 , tissue ischemia monitoring and handling 63 , and power supply abnormality handling 64 .

[0123] The pressure overlimit process 61 automatically adjusts when the actual pressure exceeds or falls below the set value by more than 20%. In a preferred embodiment of the present invention, when the actual pressure exceeds the set value by more than 20%, the system immediately releases some gas to reduce the pressure; when the actual pressure falls below the set value by more than 20%, the system increases the air pump power or adjusts the regulating valve opening. If the expected pressure cannot be reached after three adjustments, the system issues an audible and visual alarm and records the abnormality. This design ensures the stability and safety of treatment pressure and avoids poor treatment results or safety risks caused by abnormal pressure.

[0124] Airway leakage detection 62 issues an alarm when it detects a sustained drop in pressure and a sustained increase in pump power. In one embodiment of the present invention, the system incorporates an airtightness self-check routine that automatically tests airway integrity before treatment. During operation, if a sustained drop in pressure exceeding 5 kPa / minute and a sustained increase in pump power exceeding 30% of the set value are detected, a leak is detected. The system then activates an audible and visual alarm, displays "Airway Leak," and pauses treatment. This design enables timely detection of airway leaks, preventing poor treatment outcomes and energy waste.

[0125] Tissue Ischemia Monitoring and Treatment 63 automatically reduces pressure when a significant decrease in tissue blood flow is detected. In a preferred embodiment of the present invention, the system monitors tissue blood flow using photoplethysmography technology. When a significant decrease in tissue blood flow (less than 60% of the baseline value) is detected for 5 minutes, the system automatically reduces pressure by one level. If blood flow does not improve within 10 minutes of the pressure reduction, the system reduces pressure again by one level and issues an alarm, prompting medical personnel to conduct an inspection. This design enables timely detection and treatment of tissue ischemia risks, avoiding tissue damage caused by compression.

[0126] Power supply exception handling 64 performs a safety shutdown when the battery is low. In one embodiment of the present invention, when the battery level drops below 30%, a low-battery warning is displayed on the screen; when the battery level drops below 15%, the system automatically saves the current parameters and prompts the user to recharge; and when the battery level drops below 5%, the system initiates a safety shutdown sequence, gradually releasing pressure before shutting down. Furthermore, the system is designed with a power outage protection function. A built-in emergency capacitor provides approximately 30 seconds of emergency power. In the event of a power outage, the emergency sequence is automatically activated, controlling the regulating valve to gradually release the airbag pressure, ensuring that no harm will be caused to the patient even in the event of a sudden power outage.

[0127] In the present invention, the various threshold settings for exception handling mechanism 6 are based on safety considerations and experimental verification. For example, the pressure overlimit threshold is set at 20%, which takes into account system errors and safety margins while ensuring therapeutic effectiveness. The 60% reduction in tissue blood flow is used as the ischemia criterion based on histological research results. At this level, tissue damage has not yet occurred, but intervention is required. The power warning levels (30%, 15%, and 5%) are determined based on system power consumption testing and safety margins to ensure sufficient time for necessary operations and safe shutdown.

[0128] Example 9

[0129] The therapeutic device of the present invention also includes an adaptive adjustment mechanism for automatically adjusting treatment parameters according to different patients, different disease characteristics and different environmental conditions. The adaptive adjustment mechanism includes individual difference adaptation, disease characteristic adaptation and environmental adaptability adjustment.

[0130] Individual adaptation primarily considers individual factors such as the patient's ear size and pain tolerance. In a preferred embodiment of this invention, the system offers ear clips in different sizes (S / M / L) to accommodate the ear sizes of patients of different ages. The airbag design features a certain degree of elastic deformation, accommodating ±15% dimensional variations to ensure a secure fit. Furthermore, the system offers an automatic adaptation mode, automatically adjusting pressure based on patient feedback. It supports a progressive treatment approach, starting with a low intensity and gradually increasing the pressure, making it particularly suitable for patients with pain sensitivity.

[0131] Adaptation to disease characteristics primarily considers the acute and chronic nature of the disease and the stage of treatment. In one embodiment of the present invention, for acute trauma cases, the system provides an "acute phase mode" that prioritizes tissue safety, automatically limits the maximum pressure to no more than level 4, and doubles the tissue monitoring frequency. For chronic scar cases, the system provides a "chronic phase mode" that prioritizes treatment effectiveness, allowing for higher pressures (levels 5-6) but increasing the pressure buffer time to reduce discomfort. This adaptive adjustment optimizes treatment plans based on disease characteristics, improving both efficacy and safety.

[0132] Environmental adaptability adjustment mainly considers environmental factors such as temperature, humidity and altitude. In a preferred embodiment of the present invention, in a low temperature environment (<18°C), the system automatically increases the frequency of tissue temperature monitoring to 2 times to prevent the risk of ischemia; in a high temperature environment (>30°C), the system automatically reduces the initial pressure by 1 level to reduce the risk of tissue damage. In addition, in a high humidity environment, the system enhances moisture-proof protection and increases the thickness of the circuit board coating; in an extremely dry environment, the system optimizes the air path sealing design to reduce the risk of gas leakage. For high altitude areas (>2000 meters), the system detects the ambient air pressure through a built-in air pressure sensor and automatically calibrates the pressure parameters to ensure consistent treatment effects.

[0133] In this invention, the parameters of the adaptive adjustment mechanism are set based on clinical experience and scientific research. For example, the acute phase mode limits the maximum pressure to no more than 45kPa because tissues are more fragile during the acute phase and high pressure can easily cause tissue damage. The frequency of tissue temperature monitoring is increased in low-temperature environments because low temperatures can affect peripheral blood circulation and increase the risk of ischemia. High-altitude calibration takes into account that atmospheric pressure decreases with increasing altitude, and the same relative pressure may produce a stronger absolute pressure effect at high altitudes.

[0134] Example 10

[0135] In one embodiment of the present invention, the multi-mode pressure therapy device is suitable for the following treatment scenarios: postoperative treatment of auricular trauma hematoma, postoperative treatment of auricular pseudocyst puncture or surgery, compression therapy of auricular scars, and traditional Chinese medicine ear acupuncture point compression therapy.

[0136] For the postoperative treatment of auricular trauma hematoma, the present invention provides precise pressure control and continuous monitoring functions, which can effectively prevent the hematoma from forming again. In a preferred embodiment of the present invention, it is recommended to use a type A ear clip 31, adopt an intermittent pressure mode 52, initially set 3 gears of pressure (30kPa), a pressure time of 15 minutes, a release time of 2 minutes, and continue for 6-8 cycles. Clinical practice has shown that this solution can prevent the hematoma from forming again without affecting the blood supply of the auricular tissue, greatly reducing the risk of tissue necrosis. Compared with traditional methods, the cure rate is increased by about 35% and the complication rate is reduced by about 85%.

[0137] For postoperative treatment of auricular pseudocysts after puncture or surgery, the present invention can precisely compress specific areas to prevent the cyst from forming again. In one embodiment of the present invention, it is recommended to use a type B ear clip 32, adopt a continuous pressure mode 51, set a 4-level pressure (45kPa), and last for 60-90 minutes, 2-3 times a day. This treatment regimen can effectively compress the cyst cavity, promote tissue adhesion, and prevent fluid from accumulating again. Clinical data show that the recurrence rate of auricular pseudocysts treated with the present invention is reduced by about 60%, and the treatment cycle is shortened by about 25%.

[0138] For the compression treatment of auricular scars, the present invention provides long-term and stable pressure control, which can promote the atrophy of scar tissue. In a preferred embodiment of the present invention, it is recommended to use a C-type ear clip 33, adopt an incremental pressure mode 53, initially set the pressure level 2 (20kPa), the target pressure level 5 (60kPa), increase the time for 20 minutes, and then maintain the target pressure for 60 minutes. This treatment plan can gradually adapt to the pressure tolerance of scar tissue and eventually reach the ideal treatment pressure. Long-term adherence to treatment can cause scar blood vessels to contract, and scar tissue to gradually atrophy and soften. Clinical follow-up shows that the scar treatment effect is improved by about 40%, and patient satisfaction is improved by about 75%.

[0139] For the ear acupuncture point compression treatment of traditional Chinese medicine, the present invention provides precise positioning and diversified pressure modes, which can enhance the acupuncture point stimulation effect. In one embodiment of the present invention, it is recommended to select a suitable ear clip according to the specific acupuncture point, adopt pulse pressure mode 55, basic pressure setting 1 gear (10kPa), pulse pressure setting 3 gear (30kPa), pulse frequency 1Hz, and duration 15-20 minutes. This treatment scheme simulates the rhythmic changes of traditional pressing techniques, but provides more stable and controllable pressure. Clinical applications have shown that compared with traditional ear acupuncture point pressure beans, the treatment effect is improved by about 30% and patient compliance is improved by about 65%.

[0140] In this invention, the above treatment plans are based on clinical research and expert consensus. However, in practice, medical staff should make individual adjustments based on the patient's specific situation. For example, for children, a smaller ear clip is usually selected, and the pressure setting is reduced by 1-2 levels. For elderly patients, considering the fragility of the skin, a gradual treatment plan and increased tissue monitoring frequency are recommended.

[0141] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformation made by using the contents of the present invention description and drawings under the concept of the present invention, or directly / indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A multi-mode pressure therapy device for treating auricular diseases, characterized in that: include: Main control unit, used to control the operation and parameter management of the entire therapeutic device; A pressure control system electrically connected to the main control unit, comprising an electric air pump and a pressure regulating module, wherein the pressure regulating module is used to adjust the gas pressure into multiple levels; An ear clip system connected to the air circuit of the pressure control system includes at least one ear clip designed according to the anatomical structure of the auricle, the ear clip having multiple air cells located in different anatomical parts; a monitoring system electrically connected to the main control unit, for monitoring the state of the auricle; and Multiple treatment modes stored in the main control unit.

2. The multi-mode pressure therapy device according to claim 1, characterized in that: The main control unit includes: Microprocessor, used to process monitoring data and control instructions; Touch screen display, used to display parameter information and receive operation instructions; An internal battery pack for power supply; and Data storage module, used to store treatment parameters and records.

3. The multi-mode pressure therapy device according to claim 1, characterized in that: The pressure regulating module of the pressure control system includes: Pressure sensor, used to detect the pressure inside the airbag in real time; A pressure regulating valve to precisely control the amount of gas entering the airbag; and Air circuit control module, used to achieve independent control of multiple airbags; The pressure is divided into 1-6 levels, and each level corresponds to a different pressure value range.

4. The multi-mode pressure therapy device according to claim 3, characterized in that: The pressure control system adopts the proportional-integral-differential control algorithm, and the control equation is: Where u(t) is the control output in percentage, representing the air pump output power or regulating valve opening; e(t) is the error signal, which is equal to the difference between the target pressure and the actual pressure, in kPa; K1 is the proportional coefficient in % / kPa; K2 is the integral coefficient in % / (kPa·s); and K3 is the differential coefficient in seconds.

5. The multi-mode pressure therapy device according to claim 1, characterized in that: The ear clip system comprises: Type A ear clip has two air bags, one for the triangular fossa and the other for the cymba concha. Type B ear clip, with one air bag, corresponding to the concha cavity; and The C-shaped ear clip has three air bags, corresponding to the triangular fossa, cymba concha and cavum concha. The ear clip is made of medical-grade materials and has a transparent and visual design.

6. The multi-mode pressure therapy device according to claim 1, characterized in that: The monitoring system comprises: Temperature monitoring module, used to monitor the surface temperature of the auricle; a tissue perfusion monitoring module, for detecting tissue blood perfusion status; and Real-time pressure monitoring module, used to monitor the actual pressure of each airbag; When the monitoring parameters exceed the safety range, the monitoring system sends an alarm signal to the main control unit.

7. The multi-mode pressure therapy device according to claim 1, characterized in that: The various treatment modalities include: Continuous pressure mode, maintaining a constant pressure value; Intermittent pressure mode, alternately applying pressure and releasing it according to a set cycle; Increasing pressure mode, the pressure gradually increases from the low gear to the set gear; In decreasing pressure mode, the pressure gradually decreases from the high gear to the set gear; Pulse pressure mode, which allows for rapid alternation of high and low pressure; and Custom mode: users can customize the pressure change curve according to clinical needs.

8. The multi-mode pressure therapy device according to claim 1, characterized in that: It also includes an exception handling mechanism, which includes: Pressure over-limit processing: automatic adjustment when the actual pressure exceeds or falls below the set value by more than 20%; Gas line leakage treatment: an alarm is issued when a continuous decrease in pressure and a continuous increase in air pump power are detected; Tissue ischemia monitoring and management, automatically reducing pressure when a significant decrease in tissue blood flow is detected; and Power supply abnormality processing, safe shutdown processing when power is low.

9. The multi-mode pressure therapy device according to claim 1, characterized in that: The therapeutic apparatus also includes an adaptive adjustment mechanism for automatically adjusting treatment parameters according to different patients, different disease characteristics and different environmental conditions; Among them, the adaptive adjustment mechanism includes individual difference adaptation, disease characteristic adaptation and environmental adaptive adjustment.

10. The multi-mode pressure therapy device according to claim 1, characterized in that: The multi-mode pressure therapy device is suitable for the following treatment scenarios: Postoperative management of auricular trauma hematoma; Postoperative treatment of auricular pseudocyst puncture or surgery; Compression therapy for auricular scars; and Auricular acupressure therapy in Traditional Chinese Medicine.

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