Pressure device and control system for preventing paclitaxel CIPN by cooling limbs

Abstract

The invention discloses a pressure device for preventing paclitaxel CIPN through limb cooling and a control system, relates to the technical field of medical treatment, and aims to solve the problem that the CIPN prevention effect is affected due to lack of a dynamic regulation mechanism in the prior art. Comprising an attaching protective layer, a temperature control functional layer, a pressure adjusting layer and a wearable main body layer which are sequentially connected in a composite mode from the skin contact side to the outer side. The attaching protective layer is the innermost layer in direct contact with the skin and is composed of medical absorbent cotton and breathable mesh cloth, and a temperature buffer film is arranged on the inner side of the attaching protective layer; the wearable main body layer is an outermost layer and is made of a medical elastic chinlon material; the temperature control functional layer is located between the attaching protective layer and the pressure adjusting layer and comprises a temperature control medium layer and a miniature temperature control module, the temperature control medium layer is filled with a fluid medium, and the miniature temperature control module comprises a semiconductor chilling plate and a heating resistor. The method has the advantage of improving the prevention effect of paclitaxel CIPN.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and more specifically, to a pressure device and control system for limb cooling to prevent paclitaxel CIPN. Background Technology

[0002] Paclitaxel is a first-line chemotherapy drug for the clinical treatment of malignant tumors such as breast cancer and ovarian cancer, and its efficacy has been widely confirmed. However, chemotherapy-induced peripheral neuropathy (CIPN) is a common and troublesome adverse reaction caused during chemotherapy.

[0003] CIPN mainly manifests as numbness, pain, and paresthesia in the extremities, with an incidence rate as high as 60%-80%. It not only reduces the patient's quality of life, but in severe cases, it may also require a reduction in chemotherapy dosage or interruption of treatment, affecting the anti-tumor effect.

[0004] Current clinical studies have confirmed that applying a specific range of low temperature (11–15°C) and pressure (20–30 mmHg) to the patient's hands and feet during chemotherapy can induce local vasoconstriction, reduce drug exposure to peripheral nerves, and thus reduce the incidence and severity of CIPN.

[0005] However, existing technologies have limitations in long-term chemotherapy scenarios.

[0006] Existing pressure devices often use pre-inflated airbags or elastic bandages, lacking a dynamic adjustment mechanism. During prolonged use (up to 90 minutes per session), airbags are prone to pressure decay due to micro-leakage, while elastic bandages experience tension relaxation due to material fatigue, making it difficult to maintain pressure from fingertips / toes to wrists / ankles. This affects the effectiveness of CIPN prevention. Insufficient pressure weakens vasoconstriction, while excessive pressure may hinder limb blood circulation, leading to new ischemic injuries. Therefore, we propose a pressure device and control system for limb cooling to prevent paclitaxel CIPN. Summary of the Invention

[0007] The purpose of this invention is to provide a pressure device and control system for limb cooling to prevent paclitaxel CIPN, aiming to solve the problem that the lack of a dynamic adjustment mechanism in the prior art affects the CIPN prevention effect.

[0008] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a control system for limb cooling to prevent paclitaxel CIPN, the control system comprising a sensing layer and a control layer;

[0009] The sensing layer is used to acquire the temperature data of the fluid medium in the temperature control function layer and the pressure data of the airbag group in the pressure regulation layer in real time, and to store the temperature and pressure data collected in the last 2 minutes as historical data.

[0010] The control layer includes a controller and a data processing module;

[0011] The data processing module is used to calculate the rate of change and predicted values ​​of temperature and pressure based on the historical data collected in the sensing layer;

[0012] The controller has pre-stored target pressure and target temperature values, and compares the predicted values ​​of temperature and pressure calculated by the data processing module with the target pressure and target temperature values. Based on the comparison results, it controls the operation of the semiconductor cooling chip, heating resistor, micro air pump, and solenoid valve in advance, thereby controlling the temperature of the fluid medium in the temperature control functional layer and the pressure of the airbag assembly in the pressure regulation layer in advance.

[0013] Preferably, it also includes a terminal layer, which includes a medical monitoring terminal for displaying in real time the temperature data of the fluid medium in the temperature control function layer and the pressure data of the airbag group in the pressure regulation layer acquired in real time by the sensing layer, as well as the rate of change and predicted value of temperature and pressure calculated by the data processing module. The medical monitoring terminal is also used to manually set the pressure target value and temperature target value pre-stored in the controller.

[0014] Preferably, the sensing layer includes a temperature sensor and a pressure sensor, and the temperature sensor and pressure sensor acquire data at a frequency of 1 time per second.

[0015] Preferably, the data processing module calculates the rate of temperature change using the following formula:

[0016] ;

[0017] In the formula, For the rate of temperature change, No. One temperature data point, It is 120. This is the first temperature data point. It is 120, in seconds;

[0018] when When it is a positive number, use the formula Calculate the predicted temperature value;

[0019] when When the value is negative, use the formula. Calculate the predicted temperature value;

[0020] In the formula, This is the current measured temperature value. The predicted duration is in seconds.

[0021] Preferably, the data processing module uses the following formula to calculate the pressure change rate:

[0022] ;

[0023] In the formula, The rate of change of pressure, For the first One stress data point, It is 120. This is the first pressure data point. It is 120, in seconds;

[0024] when When it is a positive number, use the formula Calculate the predicted pressure value;

[0025] when When the value is negative, use the formula. Calculate the predicted pressure value;

[0026] In the formula, This is the current measured pressure value. The predicted duration is in seconds.

[0027] Preferably, when the controller compares the temperature prediction value calculated by the data processing module with the temperature target value, if the temperature prediction value is less than the temperature target value, it controls the heating resistor to heat the fluid medium in the temperature control function layer in advance until the fluid medium temperature reaches the median of the temperature target value.

[0028] If the predicted temperature is greater than the target temperature, the semiconductor refrigeration chip is controlled to cool the fluid medium in the temperature control functional layer in advance until the fluid medium temperature reaches the median of the target temperature.

[0029] Preferably, when the controller compares the pressure prediction value calculated by the data processing module with the pressure target value, if the pressure prediction value is less than the pressure target value, it controls the micro air pump to pressurize the airbag group in the pressure regulating layer in advance until the pressure of the airbag group reaches the median of the pressure target value.

[0030] If the predicted pressure value is greater than the target pressure value, the solenoid valve will be controlled to depressurize the airbag assembly in the pressure regulating layer in advance until the pressure of the airbag assembly reaches the median of the target pressure value.

[0031] Preferably, it also includes a power supply module, which includes a rechargeable lithium battery for supplying power to the sensing layer, control layer, terminal layer, temperature control functional layer and pressure regulation layer respectively.

[0032] Preferably, the power supply module further includes a low battery warning unit, which pushes a charging reminder through the terminal layer when the remaining power of the rechargeable lithium battery is ≤20%.

[0033] The present invention also provides a pressure device for limb cooling to prevent paclitaxel CIPN, comprising a protective layer, a temperature control layer, a pressure regulating layer, and a wearable body layer that are sequentially bonded and connected from the skin contact side to the outside.

[0034] The adhesive protective layer is the innermost layer that directly contacts the skin. It is composed of medical absorbent cotton and breathable mesh fabric, and its inner side is provided with a temperature buffer film.

[0035] The outermost layer of the wearable main body is made of medical elastic nylon material;

[0036] The temperature control functional layer is located between the bonding protective layer and the pressure regulating layer, and includes a temperature control medium layer and a micro temperature control module. The temperature control medium layer is filled with a fluid medium, and the micro temperature control module includes a semiconductor cooling chip and a heating resistor, which are used to actively adjust the temperature deviation of the fluid medium inside the temperature control medium layer.

[0037] The pressure regulating layer is located between the temperature control functional layer and the wearable main body layer, and includes an airbag group and a gas control component. The airbag group is distributed on the protective layer corresponding to the patient's fingers and toes, palms and soles, wrists and ankles. The gas control component includes a miniature air pump and a solenoid valve.

[0038] Compared with the prior art, the beneficial effects of the present invention are:

[0039] 1. This invention uses a pressure regulating layer to distribute airbags to different parts of the limb, combined with a pneumatic control component to achieve precise pressurization and depressurization. The temperature control layer actively regulates the temperature of the fluid medium through a semiconductor cooling chip and a heating resistor. Combined with the control system's real-time acquisition and predictive regulation of temperature and pressure, it provides a continuous and stable temperature environment for limb cooling and maintains stable pressure to ensure that the pressure accurately covers key limb areas, thereby improving the preventive effect of paclitaxel CIPN. In addition, both temperature and pressure regulation use the median of the target value as the control endpoint, avoiding discomfort caused by drastic parameter fluctuations to the limb and allowing patients to have a better experience during long-term use.

[0040] 2. The protective layer of this invention is made of a combination of medical degreased cotton and breathable mesh fabric, and a temperature buffer film is added on the inner side. When in direct contact with the skin, it can reduce irritation and enhance breathability. The main body layer is made of medical elastic nylon material, which has both elasticity and stability and can be adapted to the wearing needs of different limb sizes.

[0041] 3. The sensing layer in this invention collects data at a frequency of 1 time / second and stores historical data. The data processing module calculates the rate of change and the predicted value, and the controller actively adjusts the parameters in advance to achieve closed-loop management of "prediction-control". It does not require frequent manual intervention. The medical monitoring terminal can display data in real time and supports manual modification. The low power warning function of the power supply module avoids interruption of treatment due to power failure during use, which not only improves the convenience and efficiency of medical work, but also further ensures the continuity and reliability of treatment. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of the pressure device in this invention;

[0043] Figure 2 This is a schematic diagram of the architecture of the control system in this invention;

[0044] Figure 3 This is a schematic diagram illustrating the principle of the present invention. Detailed Implementation

[0045] Example 1

[0046] In this embodiment, the target pressure value is 20–30 mmHg and the target temperature value is 11–15°C. This is to address the problem that existing pressure devices mostly use pre-inflated airbags or elastic bandages, which lack a dynamic adjustment mechanism. During long-term use, the airbags are prone to pressure decay due to slight air leakage, and the elastic bandages experience tension relaxation due to material fatigue, making it difficult to maintain pressure from the fingertips / toes to the wrist / ankle, thus affecting the CIPN prevention effect.

[0047] This embodiment provides a pressure device for limb cooling to prevent paclitaxel CIPN, comprising a protective layer, a temperature control layer, a pressure regulating layer, and a wearable body layer that are sequentially connected from the skin contact side to the outside.

[0048] The protective layer is the innermost layer that comes into direct contact with the skin. It consists of medical absorbent cotton and breathable mesh fabric, and its inner side is equipped with a temperature buffer film.

[0049] The outermost layer is the main wearable layer, made of medical-grade elastic nylon material;

[0050] The temperature control functional layer is located between the bonding protective layer and the pressure regulating layer. It includes a temperature control medium layer and a micro temperature control module. The temperature control medium layer is filled with a fluid medium (pure water is used in this embodiment). The micro temperature control module includes a semiconductor cooling chip and a heating resistor, which are used to actively adjust the temperature deviation of the fluid medium inside the temperature control medium layer.

[0051] The pressure regulating layer is located between the temperature control functional layer and the wearable main body layer. It includes airbag groups and air control components. The airbag groups are distributed on the protective layer corresponding to the patient's fingers and toes, palms and soles, wrists and ankles. The air control components include a miniature air pump and a solenoid valve.

[0052] In this embodiment, the pressure device adopts a composite structure design of "adhesive protective layer - temperature control functional layer - pressure adjustment layer - wearable body layer". The adhesive protective layer uses medical degreased cotton and breathable mesh fabric with an inner temperature buffer film, which can achieve gentle contact with the skin, avoid discomfort or irritation caused by prolonged wear, and reduce the impact of sudden temperature changes on the skin, thus ensuring the safety and comfort of wearing.

[0053] The temperature control layer, with the active adjustment capability of the semiconductor cooling chip and heating resistor, can accurately control the temperature of the internal fluid medium to remain stable within the target range of 11-15℃, providing a continuous and stable temperature environment for limb cooling and meeting the temperature control requirements for CIPN prevention.

[0054] The pressure regulating layer is divided into airbag groups according to "fingers and toes, palms and soles, wrists and ankles", and is equipped with a pneumatic control component consisting of a micro air pump and a solenoid valve. This effectively avoids the pressure decay caused by micro-leakage of traditional pre-inflated airbags and the tension relaxation caused by fatigue of elastic bandage materials. It stably maintains a pressure target value of 20-30 mmHg, ensuring that the pressure accurately covers key limb areas and improves the preventive effect of paclitaxel CIPN.

[0055] The outermost layer, made of medical-grade elastic nylon, combines elasticity and stability, ensuring a snug and secure fit after wearing the device and preventing displacement during use that could affect its effectiveness.

[0056] This embodiment also provides a control system for a pressure device for limb cooling to prevent paclitaxel CIPN, the control system including a sensing layer, a control layer, a terminal layer and a power supply module.

[0057] in:

[0058] The sensing layer is used to acquire temperature data of the fluid medium in the temperature control function layer and pressure data of the airbag group in the pressure regulation layer in real time, and to store 120 temperature and pressure data collected in the last 2 minutes as historical data. It includes temperature sensors and pressure sensors, and the acquisition frequency of temperature sensors and pressure sensors is 1 time / second.

[0059] The control layer includes controllers and data processing modules;

[0060] The data processing module is used to calculate the rate of change and predicted values ​​of temperature and pressure based on the historical data collected in the sensing layer;

[0061] The controller has pre-stored target pressure and temperature values ​​(i.e., target pressure 20–30 mmHg, target temperature 11–15℃), and compares the predicted temperature and pressure values ​​calculated by the data processing module with the target pressure and temperature values:

[0062] If the predicted temperature is less than the target temperature, the heating resistor is controlled to preheat the fluid medium in the temperature control function layer until the fluid medium temperature reaches the median of the target temperature.

[0063] If the predicted temperature value is greater than the target temperature value, the operation of the semiconductor refrigeration chip is controlled to cool the fluid medium in the temperature control functional layer in advance until the fluid medium temperature reaches the median of the target temperature value.

[0064] If the predicted pressure value is less than the target pressure value, the micro air pump is controlled to pressurize the airbag group in the pressure regulating layer in advance until the pressure of the airbag group reaches the median of the target pressure value.

[0065] If the predicted pressure value is greater than the target pressure value, the solenoid valve will be controlled to depressurize the airbag assembly in the pressure regulating layer in advance until the pressure of the airbag assembly reaches the median of the target pressure value.

[0066] in:

[0067] The following formula is used to calculate the rate of temperature change:

[0068] ;

[0069] In the formula, For the rate of temperature change, No. One temperature data point, It is 120. This is the first temperature data point. It is 120, in seconds;

[0070] when When it is a positive number, use the formula Calculate the predicted temperature value;

[0071] when When the value is negative, use the formula. Calculate the predicted temperature value;

[0072] In the formula, This is the current measured temperature value. The prediction duration is in seconds; in this embodiment, it is 60 seconds, which means predicting the temperature for the next minute.

[0073] The following formula is used to calculate the rate of change of pressure:

[0074] ;

[0075] In the formula, The rate of change of pressure, For the first One stress data point, It is 120. This is the first pressure data point. It is 120, in seconds;

[0076] when When it is a positive number, use the formula Calculate the predicted pressure value;

[0077] when When the value is negative, use the formula. Calculate the predicted pressure value;

[0078] In the formula, This is the current measured pressure value. The prediction duration is in seconds; in this embodiment, it is 60 seconds, which means predicting the pressure for the next minute.

[0079] The terminal layer includes a medical monitoring terminal, which is used to display in real time the temperature data of the fluid medium in the temperature control function layer and the pressure data of the airbag group in the pressure regulation layer, which are obtained in real time by the sensing layer, as well as the rate of change and predicted value of temperature and pressure calculated by the data processing module. The medical monitoring terminal is also used to manually set the pressure target value and temperature target value pre-stored in the controller.

[0080] The power supply module includes a rechargeable lithium battery, which supplies power to the sensing layer, control layer, terminal layer, temperature control function layer and pressure regulation layer respectively. The power supply module also includes a low battery warning unit, which pushes a charging reminder through the terminal layer when the remaining power of the rechargeable lithium battery is ≤20%.

[0081] In this embodiment, the control system provides functional support for the stable operation and efficient prevention of pressure devices;

[0082] in:

[0083] The sensing layer collects temperature and pressure data at a high frequency of 1 time per second and stores 120 sets of historical data from the last 2 minutes, providing a real-time and complete data source for subsequent regulation and avoiding regulation deviations caused by data lag.

[0084] The control layer calculates the rate of change of temperature / pressure and the predicted value through the data processing module. Based on the prediction results, the controller starts heating, cooling, pressurizing or depressurizing operations in advance (such as heating to the median of the target value in advance when the predicted temperature value is lower than the target value), so as to achieve "predictive" dynamic regulation and ensure that the temperature and pressure are always stable within the target range.

[0085] The terminal-level medical monitoring terminal can display temperature, pressure, rate of change and predicted values ​​in real time. It also supports manual modification of target parameters, which not only makes it convenient for medical staff to keep track of the device's operating status in real time, but also allows for flexible adjustments based on individual patient conditions, improving the adaptability for clinical applications.

[0086] The rechargeable lithium battery of the power supply module powers the entire system. With the warning push function when the remaining power is ≤20%, it can avoid the device from shutting down due to sudden power failure, ensure the continuity and reliability of the CIPN prevention process, and further reduce the risk of the prevention effect being affected by equipment failure.

[0087] The embodiments disclosed in this invention are preferred embodiments, but are not limited thereto. Those skilled in the art can easily understand the spirit of this invention based on the above embodiments and make different extensions and variations, but as long as they do not depart from the spirit of this invention, they are all within the protection scope of this invention.

Claims

1. A control system for limb cooling to prevent paclitaxel CIPN, characterized in that, The control system includes a sensing layer and a control layer; The sensing layer is used to acquire the temperature data of the fluid medium in the temperature control function layer and the pressure data of the airbag group in the pressure regulation layer in real time, and to store the temperature and pressure data collected in the last 2 minutes as historical data. The control layer includes a controller and a data processing module; The data processing module is used to calculate the rate of change and predicted values ​​of temperature and pressure based on the historical data collected in the sensing layer; The controller has pre-stored target pressure and target temperature values, and compares the predicted values ​​of temperature and pressure calculated by the data processing module with the target pressure and target temperature values. Based on the comparison results, it controls the operation of the semiconductor cooling chip, heating resistor, micro air pump, and solenoid valve in advance, thereby controlling the temperature of the fluid medium in the temperature control functional layer and the pressure of the airbag assembly in the pressure regulation layer in advance.

2. The control system for limb cooling to prevent paclitaxel CIPN according to claim 1, characterized in that, It also includes a terminal layer, which includes a medical monitoring terminal for displaying in real time the temperature data of the fluid medium in the temperature control function layer and the pressure data of the airbag group in the pressure regulation layer, which are obtained in real time by the sensing layer, as well as the rate of change and predicted value of temperature and pressure calculated by the data processing module. The medical monitoring terminal is also used to manually set the pressure target value and temperature target value pre-stored in the controller.

3. The control system for limb cooling to prevent paclitaxel CIPN according to claim 1, characterized in that, The sensing layer includes a temperature sensor and a pressure sensor, and the temperature sensor and pressure sensor acquire data at a frequency of 1 time per second.

4. The control system for limb cooling to prevent paclitaxel CIPN according to claim 1, characterized in that, The data processing module uses the following formula to calculate the rate of temperature change: ； In the formula, For the rate of temperature change, No. One temperature data point, It is 120. This is the first temperature data point. It is 120, in seconds; when When it is a positive number, use the formula Calculate the predicted temperature value; when When the value is negative, use the formula. Calculate the predicted temperature value; In the formula, This is the current measured temperature value. The predicted duration is in seconds.

5. The control system for preventing paclitaxel CIPN by limb cooling according to claim 4, characterized in that, The data processing module uses the following formula to calculate the pressure change rate: ； In the formula, The rate of change of pressure, For the first One stress data point, It is 120. This is the first pressure data point. It is 120, in seconds; when When it is a positive number, use the formula Calculate the predicted pressure value; when When the value is negative, use the formula. Calculate the predicted pressure value; In the formula, This is the current measured pressure value. The predicted duration is in seconds.

6. The control system for limb cooling to prevent paclitaxel CIPN according to claim 4, characterized in that, When the controller compares the temperature prediction value calculated by the data processing module with the temperature target value, if the temperature prediction value is less than the temperature target value, it controls the heating resistor to heat the fluid medium in the temperature control function layer in advance until the fluid medium temperature reaches the median of the temperature target value. If the predicted temperature is greater than the target temperature, the semiconductor refrigeration chip is controlled to cool the fluid medium in the temperature control functional layer in advance until the fluid medium temperature reaches the median of the target temperature.

7. A control system for preventing paclitaxel CIPN by limb cooling according to claim 5, characterized in that, When the controller compares the pressure prediction value calculated by the data processing module with the pressure target value, if the pressure prediction value is less than the pressure target value, it controls the micro air pump to pressurize the airbag group in the pressure regulating layer in advance until the pressure of the airbag group reaches the median of the pressure target value. If the predicted pressure value is greater than the target pressure value, the solenoid valve will be controlled to depressurize the airbag assembly in the pressure regulating layer in advance until the pressure of the airbag assembly reaches the median of the target pressure value.

8. The control system for limb cooling to prevent paclitaxel CIPN according to claim 1, characterized in that, It also includes a power supply module, which includes a rechargeable lithium battery for supplying power to the sensing layer, control layer, terminal layer, temperature control function layer and pressure regulation layer respectively.

9. A control system for preventing paclitaxel CIPN by limb cooling according to claim 8, characterized in that, The power supply module also includes a low battery warning unit, which pushes a charging reminder through the terminal layer when the remaining power of the rechargeable lithium battery is ≤20%.

10. A pressure device for limb cooling to prevent paclitaxel CIPN, wherein the pressure device is controlled by a control system for limb cooling to prevent paclitaxel CIPN as described in any one of claims 1-9, characterized in that, It includes a protective layer, a temperature control layer, a pressure regulating layer, and a wearable body layer that are sequentially bonded together from the side that contacts the skin to the outside. The adhesive protective layer is the innermost layer that directly contacts the skin. It is composed of medical absorbent cotton and breathable mesh fabric, and its inner side is provided with a temperature buffer film. The outermost layer of the wearable main body is made of medical elastic nylon material; The temperature control functional layer is located between the bonding protective layer and the pressure regulating layer, and includes a temperature control medium layer and a micro temperature control module. The temperature control medium layer is filled with a fluid medium, and the micro temperature control module includes a semiconductor cooling chip and a heating resistor, which are used to actively adjust the temperature deviation of the fluid medium inside the temperature control medium layer. The pressure regulating layer is located between the temperature control functional layer and the wearable main body layer, and includes an airbag group and a gas control component. The airbag group is distributed on the protective layer corresponding to the patient's fingers and toes, palms and soles, wrists and ankles. The gas control component includes a miniature air pump and a solenoid valve.

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