Mannitol injection field temperature control storage system based on phase change material

Abstract

The invention discloses a mannitol injection field temperature control storage system based on a phase change material. The mannitol injection field temperature control storage system comprises a box body, a packaging unit, a temperature control unit, a monitoring unit and a power supply unit. The injection bottle body is coated with a microencapsulated phase-change material layer in the packaging unit, and the phase-change material has specific phase-change temperature, specific heat capacity and phase-change heat. The box body is made of high-strength plastic or light alloy materials, so that impact resistance and durability are enhanced. The temperature control unit at least comprises a heating element, namely a heating patch, which is tightly attached to an injection bottle body. The packaging unit is composed of a packaging frame of a rigid structure, and the space between the packaging frame and the bottle body is filled with the phase change material layer. The monitoring unit at least comprises a thermocouple or a thermistor and is connected to the microcontroller. And the box body is provided with a control screen which is connected with the microcontroller, so that operation and monitoring are facilitated. The box body is further provided with simple wheels, so that moving and carrying are convenient. The design of the system considers the variability of the field environment, and ensures the safety and effectiveness of the injection.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preservation, and in particular to a temperature-controlled preservation system for mannitol injection used in the field environment. Background Art

[0002] Mannitol injection is a commonly used hypertonic dehydrating agent, widely used in medical first aid and treatment, especially for reducing intracranial pressure, intraocular pressure, and as an osmotic diuretic in kidney diseases. However, mannitol injection is prone to crystallization in an environment below 15°C, which will seriously affect its efficacy and safety. Under field conditions, especially in an environment without stable power supply and suitable temperature control equipment, how to ensure the temperature stability of mannitol injection and prevent crystallization has become a technical problem.

[0003] Especially in war or natural disaster relief operations, the efficiency of medical rescue and the quality stability of drugs are crucial for treating the wounded. Mannitol injection plays an important role in treating cerebral edema and reducing intracranial pressure due to its rapid dehydration effect.

[0004] Under field medical conditions, especially in wartime environments, stable heat preservation and power supply facilities are often difficult to guarantee, making the heat preservation of mannitol injection a major challenge. In addition, extreme battlefield environments, such as high temperature, high humidity, vibration, and air pressure changes, also pose a threat to the stability of drugs.

[0005] Traditional heat preservation methods, such as incubators or water baths, may not be applicable under field conditions because they rely on a stable power supply. In addition, if mannitol injection encounters temperature fluctuations during storage and transportation, it may also cause crystallization, affecting the quality of the drug. Under field conditions, the lack of suitable heat preservation and heating equipment makes the heat preservation of mannitol injection more difficult.

[0006] To solve this problem, researchers and engineers have designed various heat preservation devices and methods. For example, a field-portable mannitol heat preservation device (CN218506434U) developed by the 989th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, which includes a heat preservation bag, a flexible backboard, a shoulder strap, and an integrated temperature sensor and heating wire, can generate electricity through a piezoelectric component to heat the heat preservation bag without an external power supply, ensuring the temperature stability of mannitol injection.

[0007] In addition, research has also explored the method of using an incubator combined with an electric blanket to dissolve the crystallized mannitol injection.

[0008] Although these technologies have solved the problems to a certain extent, there are still some challenges, such as the portability and durability of the device, as well as the performance stability in extreme environments. Additionally, the applicable conditions for airdropping in field operations or disaster relief situations need to be considered. Therefore, developing an efficient and reliable temperature - maintaining technology for mannitol injection under field conditions is of great significance for ensuring the quality of drugs and the smooth progress of first - aid work. Summary of the Invention

[0009] The object of the present invention is to provide a field temperature - controlled storage system for mannitol injection based on phase - change materials, aiming to ensure the temperature stability of the injection, especially under field conditions such as field operations.

[0010] The solution of the present invention is as follows:

[0011] Based on the first main aspect of the present invention, a field temperature - controlled storage system for mannitol injection based on phase - change materials is provided, including:

[0012] A box;

[0013] An encapsulation unit, stored in an array inside the box, and the inside of the encapsulation unit is coated with an injection bottle body by a phase - change material layer;

[0014] A temperature control unit for controlling the temperature of the injection bottle body;

[0015] A monitoring unit for monitoring the state of the injection bottle body in the encapsulation unit;

[0016] A power supply unit for providing power.

[0017] In the above solution, the system integrates a box, an encapsulation unit, a temperature control unit, a monitoring unit and a power supply unit to provide a temperature control and storage solution for mannitol injection in the field environment. This design ensures that even in the field environment with large temperature fluctuations, the injection can be maintained within an appropriate temperature range, preventing crystallization and deterioration, thus ensuring the stability and safety of the drug.

[0018] In some embodiments, as a further preferred solution, the phase - change material layer inside the encapsulation unit coats the injection bottle body through micro - encapsulation technology; and

[0019] The phase - change temperature of the phase - change material is 15°C, the specific heat capacity is 2.1 J / g°C, and the phase - change heat is 120 J / g.

[0020] The above solution refines the design of the encapsulation unit. The phase change material layer is coated around the injection liquid bottle body through microencapsulation technology. This microencapsulated phase change material has specific phase change temperature, specific heat capacity, and phase change heat, and can absorb and release heat through the phase change of the material without consuming external energy, effectively maintaining the temperature stability of the injection liquid. This design not only improves the energy efficiency of the system but also enhances the adaptability and reliability of the system.

[0021] In some embodiments, as a further preferred solution, the box body is made of high-strength plastic or lightweight alloy material. Made of high-strength plastic or lightweight alloy material, it not only enhances the impact resistance and durability of the box body but also reduces the overall weight, making the box body more portable and convenient to move and carry in the field environment. The selection of this material is crucial for ensuring the stability and practicality of the system in harsh environments.

[0022] In some embodiments, as a further preferred solution, the temperature control unit includes at least one heating element; the heating element includes a heating patch that closely adheres to one side surface of the injection liquid bottle body.

[0023] The above solution includes at least one heating element, especially a heating patch, in the temperature control unit. The system can directly perform precise temperature control on the injection liquid bottle body. This design makes the heating process more efficient because the heating patch closely adheres to the bottle body, can quickly respond to temperature changes, and reduces heat loss. In addition, this direct contact heating method helps to reduce energy waste because only the area that needs to be heated will be heated, thereby improving the energy efficiency of the entire system.

[0024] In some embodiments, as a further preferred solution, the encapsulation unit includes an encapsulation frame with a rigid structure, and the phase change material layer is filled between the encapsulation frame and the injection liquid bottle body; and

[0025] The phase change material layer is formed by heating the phase change material to a molten state, mixing it with a gelatin solution, forming an emulsion through mechanical stirring, and then filling it between the encapsulation frame and the injection liquid bottle body.

[0026] The above solution further refines the structural design of the encapsulation unit, especially the filling method of the phase change material layer and the material preparation process. By heating the phase change material to a molten state and mixing it with a gelatin solution, forming an emulsion and then filling it between the encapsulation frame and the injection liquid bottle body, this method can ensure the uniform distribution of the phase change material, thereby providing more stable temperature control. In addition, this preparation and filling process helps to enhance the thermal stability and durability of the phase change material, enabling the system to maintain efficient and reliable performance during long-term operation.

[0027] In some embodiments, as a further preferred solution, a base is provided below the encapsulation frame, and the lower part of the injection liquid bottle body is seated in the base; and

[0028] The base is provided with two front and rear mounting plates for fixedly installing the encapsulation unit inside the box body through bolts.

[0029] The above solution, by providing a base below the encapsulation frame and designing heat dissipation holes on the base, the system can not only ensure the stability of the encapsulation unit, but also effectively manage heat through the heat dissipation holes to prevent local overheating. At the same time, through the fixing method of the two front and rear mounting plates and bolts, the encapsulation unit can be firmly installed inside the box body, which increases the stability and durability of the system, enabling it to withstand vibrations and impacts during transportation and use. This design is crucial for ensuring the reliability and safety of the system in the field environment.

[0030] In some embodiments, as a further preferred solution, the base is provided with at least one heat dissipation hole. By providing at least one heat dissipation hole on the base, the system can effectively manage the heat generated by the temperature control unit during the heating process. This design not only improves the thermal efficiency of the system, but also helps to prevent equipment damage or performance degradation caused by overheating. The setting of the heat dissipation holes enables the heat to be evenly dispersed, thereby maintaining a suitable temperature inside the box body, which is crucial for ensuring the stability and effectiveness of the medicine during the entire storage process.

[0031] In some embodiments, as a further preferred solution, the monitoring unit includes at least one thermocouple or thermistor, which is connected to a microcontroller. The box body includes an upper box body shell and a lower box body shell, and at least one control screen is provided on the lower box body shell, and the control screen is connected to the microcontroller.

[0032] The above solution, by including at least one thermocouple or thermistor in the monitoring unit and connecting it to the microcontroller, the system can monitor the temperature state of the injection liquid bottle body in real time. This real-time monitoring ability enables the system to quickly respond to temperature changes and automatically adjust the working state of the heating element through the microcontroller to maintain the required temperature range. In addition, the control screen on the box body provides a user interface, enabling the operator to conveniently monitor the system state and make manual adjustments, enhancing the flexibility and user experience of the system.

[0033] In some embodiments, as a further preferred solution, the box body is provided with at least two simple wheels, which are stored in the storage space provided on the upper and lower surfaces of the box body when idle, and the storage space is provided with a rubber limit ring.

[0034] The above solution equips the box with at least two simple wheels. These wheels can be stored in the storage spaces on the upper and lower surfaces of the box when not in use, and the storage spaces are provided with rubber limit rings to ensure the stability of the wheels. This design enables the box to be easily pushed when movement is required, and when movement is not needed, the wheels can be safely fixed to avoid accidental movement. This portability design is particularly important for the drug preservation system in the wild environment, as it allows for the rapid and convenient transfer of drugs between different locations while ensuring the safety and integrity of the drugs.

[0035] Based on the second main aspect of the present invention, an intelligent temperature control method for a field temperature-controlled preservation system of mannitol injection based on phase change materials is provided, including: using a microencapsulated phase change material layer to coat the injection bottle body, wherein the phase change material has a specific phase change temperature, specific heat capacity, and phase change heat;

[0036] Collect data related to temperature control, including historical temperature readings of each encapsulation unit, environmental data, and operation data;

[0037] Normalize the collected data and organize it into a time series format. Each time point contains all relevant input variables, and a label, i.e., the target temperature or temperature adjustment value, is created for each time point;

[0038] Construct an LSTM model, which includes an input layer, one or more LSTM layers, and an output layer. The input layer receives the normalized environmental data, historical temperature data, and operation data. The LSTM layers are used to learn the long-term dependencies in the time series data, and the output layer outputs the predicted temperature adjustment value;

[0039] Train the LSTM model using historical data and optimize the model parameters by minimizing the error between the predicted temperature and the actual temperature;

[0040] According to the output of the LSTM model, adjust the power or state of the heating element to achieve precise temperature control, and at the same time utilize the heat storage and release characteristics of the phase change material to maintain temperature stability.

[0041] The present invention improves the efficiency and accuracy of the field temperature-controlled preservation system of mannitol injection by combining advanced data processing technologies and artificial intelligence algorithms. By using a microencapsulated phase change material layer to coat the injection bottle body and combining a phase change material with a specific phase change temperature, specific heat capacity, and phase change heat, the system can effectively maintain the temperature stability of the injection by absorbing and releasing heat through the phase change of the material without consuming external energy.

[0042] In addition, by collecting and normalizing data related to temperature control and organizing it in a time series format, rich input data is provided for the LSTM model. This data-driven approach enables the system to learn and predict temperature change trends, thereby achieving more precise temperature control. The introduction of the LSTM model, especially its ability to learn long-term dependencies in time series data, provides the system with powerful prediction capabilities, enabling it to adapt to different environmental conditions and operating requirements.

[0043] Finally, by training the LSTM model and adjusting the power or state of the heating element according to the model output, precise temperature control is achieved. This method not only improves energy utilization efficiency but also ensures the temperature stability of the medicine in the field environment, thus guaranteeing the quality and safety of the medicine. Through the intelligent control strategy, the system can automatically respond to temperature changes, reducing the need for manual intervention, improving the operational convenience and the reliability of the system.

[0044] Advantages and beneficial effects of the present invention:

[0045] Generally speaking, compared with the prior art, by combining microencapsulated phase change materials and an intelligent temperature control method, the system can maintain the appropriate temperature of the injection solution in a changing field environment, prevent drug crystallization and deterioration caused by temperature fluctuations, and ensure the stability and effectiveness of the drug. This design not only improves the safety of the drug during transportation and storage but also reduces drug waste caused by improper temperature control.

[0046] In addition, through the intelligent temperature control strategy of the present invention, precise control of the heating element is achieved, optimizing the energy usage efficiency. By using the LSTM model to learn and predict temperature data, the system can automatically adjust the power or state of the heating element to respond to real-time temperature changes, reducing energy consumption while improving the response speed and accuracy of temperature control. The application of this intelligent control method enables the system to adapt to different environmental conditions, improving the reliability and practicality of the system.

[0047] The cabinet design of the present invention also takes into account durability and portability. The use of high-strength plastic or lightweight alloy materials, as well as the design of simple wheels and storage space, makes the cabinet both sturdy and durable and easy to carry and move. These design details not only improve the applicability of the system but also make rapid deployment and use in the field environment possible, which is particularly important for emergency situations such as wartime medical rescue and disaster relief.

[0048] Finally, through real-time monitoring and the design of the user interface, the present invention improves the user-friendliness of the system. The monitoring unit can monitor the temperature status of the injection bottle body in real time, while the control screen provides an intuitive user interface, enabling the operator to conveniently monitor the system status and make necessary adjustments. This design not only improves the flexibility of the system but also enhances the user experience, making the system more convenient and efficient in practical applications. Description of the Drawings

[0049] Figure 1 Shows a schematic diagram of the overall appearance of the storage box in an embodiment of the present invention;

[0050] Figure 2 Shows a schematic diagram of the use of the simple wheels and the pull rope of the storage box in an embodiment of the present invention;

[0051] Figure 3 Shows a schematic diagram of the layout of the internal encapsulation unit of the storage box in an embodiment of the present invention;

[0052] Figure 4 Shows the overall structure diagram of the encapsulation unit in an embodiment of the present invention;

[0053] Figure 5 Shows the internal structure diagram of the encapsulation unit in an embodiment of the present invention;

[0054] Figure 6 Shows the working flow chart of the intelligent temperature control method of the mannitol injection field temperature control preservation system based on phase change materials in an embodiment of the present invention.

[0055] Description of the Reference Numerals: 1 - box body, 1a - upper box body shell, 1b - lower box body shell, 2 - rubber limit ring, 3 - simple wheel, 4 - anti-collision pier, 5 - lock, 6 - buffer block, 7 - arc surface, 8 - control screen, 9 - pull rope storage cover, 10 - simple wheel mounting hole, 11 - reinforcing rib, 12 - pull rope, 13 - encapsulation unit, 14 - structural layer, 15 - shockproof layer, 16 - sealing groove, 17 - observation window, 18 - pressing plate, 19 - encapsulation frame, 20 - heating patch, 21 - heat dissipation hole, 22 - mounting plate, 23 - temperature control unit, 24 - monitoring unit, 25 - support frame, 26 - base, 27 - injection bottle body, 28 - phase change material layer. Detailed Description of the Embodiment

[0056] The following will elaborate on the preferred embodiments of the present invention to more clearly understand the purpose, features, and advantages of the present invention. It should be understood that the following embodiments are not limitations on the scope of the present invention but only to illustrate the essential spirit of the technical solution of the present invention.

[0057] In the following description, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other instances, well-known technologies associated with this application may not be shown or described in detail so as to avoid unnecessarily obscuring the description of the embodiments.

[0058] References to "one embodiment" or "an embodiment" throughout the specification mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout the specification are not necessarily all referring to the same embodiment. Additionally, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0059] First, as Figure 1 shown, in one embodiment of the present invention, a field temperature-controlled preservation system for mannitol injection based on phase change materials includes a box body 1. Considering the working conditions of rapid transportation or airdrop under field conditions, the box body 1 is made of high-strength plastic or lightweight alloy materials.

[0060] The following traditional materials can be used for the production of the box body 1.

[0061] Polypropylene (PP): A common high-strength plastic with good chemical resistance and heat resistance, suitable for manufacturing box bodies.

[0062] Polyethylene (PE): Including high-density polyethylene (HDPE) and low-density polyethylene (LDPE), having good impact resistance and flexibility, suitable for manufacturing durable box bodies.

[0063] ABS plastic: Acrylonitrile-butadiene-styrene copolymer, having high strength, impact resistance, and heat resistance, suitable for manufacturing box bodies with complex structures.

[0064] Aluminum alloy: Such as 6061 or 7075 aluminum alloy, lightweight and having high strength, a common choice for manufacturing box bodies.

[0065] Magnesium alloy: Such as AZ31B magnesium alloy, having a lower density than aluminum alloy and good strength, another choice of lightweight alloy material.

[0066] The following new materials can also be used for the production of the box body 1. For example:

[0067] Carbon fiber reinforced plastic (CFRP): Carbon fiber reinforced plastic has extremely high strength and rigidity while maintaining a low weight, and is an ideal material for manufacturing high-performance box bodies.

[0068] Nanocomposites: By adding nanoscale reinforcements to a plastic or metal matrix, the strength and durability of the material can be significantly improved.

[0069] Bio-based plastics: such as polylactic acid (PLA), which are derived from renewable resources and have good biodegradability, are an environmentally friendly choice.

[0070] Smart materials: such as shape memory alloys (SMA) or piezoelectric materials, which are able to change shape or generate electrical signals under external stimuli (such as temperature or electric field) and can be used for the intelligent response design of the cabinet.

[0071] Aerogels: While aerogels are often used as thermal insulation, they can also be used to create lightweight enclosures with excellent thermal insulation properties, especially in environments where the internal temperature needs to remain stable.

[0072] Of course, the above-mentioned materials mainly refer to the shell used to make the box body 1, wherein the box body 1 includes an upper box body shell 1a and a lower box body shell 1b, and the upper box body shell 1a and the lower box body shell 1b are locked by a lock 5 or a similar device.

[0073] from Figure 1 As can be seen in the figure, in this embodiment, the box body 1 is a rectangular parallelepiped structure as a whole, and anti-collision piers 4 are provided at the four corners of the upper and lower surfaces, mainly considering that the impact force of the box body 1 falling to the ground can be effectively offset in the airdrop scenario, and the packaging unit 13 inside can be protected. In addition, the four sides are designed with curved surfaces 7, which is also conducive to reducing impact in field scenes such as airdrop.

[0074] In addition, buffer blocks 6 are designed on the upper and lower surfaces of the box body 1 to further strengthen the impact that the upper and lower surfaces may receive. A large number of densely distributed reinforcing ribs 11 are also designed on the side of the box body 1, which play an important role in strengthening the structure of the box body 1.

[0075] The box body 1 is provided with at least two simple wheels 3, which are stored in the storage space provided on the upper and lower surfaces of the box body 1 when idle, and the storage space is provided with a rubber stop ring 2. The simple wheel 3 is installed at the simple wheel installation hole 10 on the side of the lower box shell 1b, and is connected to the simple wheel after the wheel axle passes through the simple wheel installation hole 10. The wheel axle runs through the lower part of the box body 1. The wheel axle can be placed inside the box body 1, or can be stored in the storage space together with the simple wheel 3 after being disassembled.

[0076] The storage space is provided with a rubber limiting ring 2 as an outer covering component. The rubber limiting ring 2 has high elasticity. After being stretched outward, the simple wheel 3 is inserted. After rebounding, the simple wheel 3 is pulled out to prevent it from escaping from the storage space. Figure 2 The scene in which the simple wheel 3 is installed on the box 1 is shown.

[0077] From Figure 1 It can also be seen that at least one control panel 8 is provided on the outer shell 1b of the lower box body, and the control panel 8 is connected to the microcontroller inside the box body 1. The control panel 8 can set the temperature control strategy for one or more encapsulation units 13 by means of touch operation, or start the pre-set intelligent temperature control method with one key.

[0078] As Figure 2 shown, a drawstring 12 is also provided at the upper part on the same side of the control panel 8, which can be pulled out from the box body 1 during use and cooperate with the simple pulley 3 to quickly transfer in the field environment.

[0079] The drawstring 12 can be retracted into the box body 1 when not in use and covered from the outside by the drawstring storage cover 9.

[0080] As Figure 3 shown, the internal setting method of the box body 1 can be seen. From Figure 3 It can be seen that the encapsulation units 13 are stored in an array inside the box body 1, and the inside of the box body 1 is divided into an outer structural layer 14 and an inner shock-proof layer 15. A sealing groove 16 is provided at the top of the structural layer 14, and the sealing groove 16 can be used in cooperation with the raised sealing rubber strip provided on the upper box body outer shell 1a to play a sealing role.

[0081] The main function of the shock-proof layer 15 inside the box body 1 is to absorb and reduce the vibration and impact during transportation or movement, so as to protect the internal encapsulation units 13 and the injection vial body 27. In terms of material selection, foam plastics can be selected: such as polystyrene (EPS), polyurethane (PU) and polyethylene (PE) foams. Such materials are light and low-cost and have good cushioning performance. Materials such as silica gel can also be selected. Such materials have good elasticity and heat resistance and are suitable for occasions that require heat resistance or chemical resistance. Some new materials such as shape memory foam, nano foam, etc. are also excellent options.

[0082] The thickness of the shock-proof layer 15 is considered according to the size of the box body 1, the usage conditions (such as whether air drop is required), etc. and verified through impact tests to ensure that the encapsulation units 13 are not damaged under certain impact conditions.

[0083] As Figure 4 and Figure 5 shown, the inside of the encapsulation unit 13 is coated with an injection vial body 27 by a phase change material layer 28; a temperature control unit 23 is used to control the temperature of the injection vial body 27; a monitoring unit 24 is used to monitor the state of the injection vial body 27 in the encapsulation unit 13; in addition, a power supply unit is provided to provide power.

[0084] The phase change material layer 28 inside the encapsulation unit 13 coats the injection vial body 27 through microencapsulation technology; and the phase change temperature of the phase change material is 15 °C, the specific heat capacity is 2.1 J / g°C, and the phase change heat is 120 J / g.

[0085] The temperature control unit 23 includes at least one heating element; the heating element includes a heating patch 20 closely attached to one side surface of the injection vial body 27.

[0086] In specific implementation, the preparation and coating steps of the phase change material layer 28 are as follows: Select a phase change material with a phase change temperature of 15 °C. Such materials can absorb or release a large amount of heat energy during the phase change process (the phase change heat is 120 J / g). The following are some optional material types:

[0087] Such as palmitic acid (C 16 H 31 COOH) and stearic acid (C 18 H 35 COOH). These saturated fatty acids can change their melting points by adjusting the chain length. In addition, certain salts such as sodium acetate (CH3COONa) and sodium citrate (C6H5O7·3Na) can have a phase change temperature close to 15 °C in a specific hydrated state. In addition, such as glycerol caprate (C 10 H 20 O2) and glyceryl stearate (C 21 H 42 O4). Such ester compounds can adjust the melting point by adjusting the ratio of acid and alcohol.

[0088] In this embodiment, an ester compound with a customized melting point is adopted, and its chemical formula is C 13 H 26 O4, and the synthesis steps are as follows:

[0089] Raw material preparation: Capric acid (C 10 H 20 O2): A saturated fatty acid with a melting point close to the required 15 °C.

[0090] Glycerol (C3H8O3): A triol used as the alcohol part in the esterification reaction.

[0091] Esterification reaction: In the presence of an acidic catalyst (such as sulfuric acid), mix capric acid and glycerol in a molar ratio of 1:3. Heat the mixture above the melting point of capric acid, usually between 160 °C and 180 °C, to promote the reaction.

[0092] Reaction control: Maintain the reaction temperature and pressure until the expected degree of esterification is reached, usually determined by monitoring the acid value or infrared spectrum of the reaction mixture. Remove unreacted acids and alcohols, as well as by-product water, through vacuum distillation or extraction.

[0093] Product purification: Further purify the product by column chromatography or crystallization to ensure obtaining high-purity ester compounds.

[0094] Melting point adjustment: By adjusting the ratio of capric acid to glycerol, or introducing other saturated fatty acids or alcohols, the melting point of the resulting ester compounds can be fine-tuned until it is close to 15 °C.

[0095] Performance testing: Conduct thermal performance tests on the synthesized ester compounds, including phase change temperature, specific heat capacity, and latent heat of phase change, to ensure they meet the design requirements.

[0096] Microencapsulation: Microencapsulate the synthesized ester compounds for use in temperature control systems.

[0097] This customized melting point ester compound provides a flexible method for designing phase change materials with specific phase change temperatures, enabling them to more precisely meet the requirements of specific applications. By adjusting the raw material ratio and synthesis conditions, the performance of the material can be further optimized to adapt to different thermal management applications.

[0098] After determining the phase change material, microencapsulate the phase change material, that is, wrap the PCM in tiny capsules to prevent leakage and direct contact with the injection solution. Microcapsules are usually made of gelatin or other polymer materials. The following is a microencapsulation process for the phase change material layer 28:

[0099] First, select a suitable wall material (i.e., the material of the capsule). Commonly used wall materials include gelatin, proteins, polymers (such as poly(lactic-co-glycolic acid) PLGA), etc. The wall material needs to have good biocompatibility, chemical stability, and film-forming properties.

[0100] Heat the phase change material above its melting point to make it completely melt. Mix the molten PCM with the wall material solution (usually an aqueous solution) and form an emulsion by mechanical stirring or ultrasonic treatment. This step is crucial in the microencapsulation process and requires controlling the particle size and distribution of the emulsion.

[0101] Further process the formed emulsion to solidify the wall material around the PCM particles. This can be achieved by methods such as cooling, chemical cross-linking, or physical drying. For example, if gelatin is used as the wall material, gelatin can be solidified by cooling.

[0102] The solidified microcapsules may need further drying and sieving to remove excess moisture and wall material solution, and classify the microcapsules according to size. Conduct quality control on the microcapsules, including checking the integrity, particle size distribution, wall thickness, and encapsulation efficiency of the PCM. This may involve techniques such as microscopy, particle size analysis, and thermal analysis.

[0103] The microencapsulated PCM is filled into the encapsulation unit 13 to form a phase change material layer 28 around the injection vial body 27. This can be accomplished by pouring, spraying, or other suitable methods.

[0104] As a preferred solution or a future improvement direction, during the microencapsulation process, some steps can be introduced to improve the performance of the microcapsules. For example, using nanoscale wall materials to enhance the strength and stability of the microcapsules. Developing intelligent microcapsules that can automatically adjust the release characteristics according to environmental temperature changes. Designing a multi-layer wall material structure to provide better protection and control the release of PCM.

[0105] The present invention adopts the application of the microencapsulated phase change material layer 28 in the encapsulation unit 13, providing an effective thermal management solution that can maintain the temperature stability of the injection vial body 27 in the field environment and prevent drug quality problems caused by temperature fluctuations.

[0106] Implementation of the temperature control unit 23: Select one or more heating elements, such as the heating patch 20, which can generate heat when powered on. Press the heating patch 20 tightly against one side surface of the injection vial body 27 to ensure good heat conduction. Monitor the vial temperature in real time through the monitoring unit 24. When the temperature is lower than the set value, start the heating patch 20 for heating; when the temperature reaches or exceeds the set value, stop heating.

[0107] Implementation of the monitoring unit 24: Install at least one thermocouple or thermistor inside the encapsulation unit 13 for real-time monitoring of the temperature of the injection vial body 27. Connect the sensor to the microcontroller and transmit the monitored temperature data to the microcontroller for processing. The microcontroller calculates the required heating power based on the received temperature data and then controls the working state of the heating patch 20.

[0108] In addition, a power supply unit needs to be designed, which can be a battery, a solar panel, or a combination of both, to ensure the continuous operation of the system in the field environment. The power supply unit needs to have sufficient capacity to support the operation of the temperature control unit and the monitoring unit, and may also require a power management system to monitor the power and optimize energy use.

[0109] In terms of the structure of the present invention, the encapsulation unit 13 includes a rigid encapsulation frame 19, and the phase change material layer 28 is filled between the encapsulation frame 19 and the injection vial body 28; wherein, the phase change material layer 28 is formed by heating the phase change material to a molten state, mixing it with a gelatin solution, and forming an emulsion through mechanical stirring, and then filling it between the encapsulation frame 19 and the injection vial body 28.

[0110] Such as Figure 4 and Figure 5As shown, a base 26 is provided below the encapsulation frame 19, and the lower part of the injection liquid bottle body 27 is seated in the base 26; and the base 26 is provided with two front and rear mounting plates 22 for fixedly installing the encapsulation unit 13 inside the box body 1 by bolts. Ensure that the bolts are tightened to prevent the movement or vibration of the encapsulation unit during transportation or use.

[0111] The monitoring unit 24 includes at least one thermocouple or thermistor and is connected to a microcontroller.

[0112] The encapsulation frame 19 is a rigid structure for fixing the injection liquid bottle body and the phase change material layer. It can be made by methods such as injection molding, welding or bonding. The base 26 is designed with two front and rear mounting plates 22 for fixing the encapsulation unit 13. The base 26 can be made by injection molding or machining to ensure its stable structure.

[0113] At least one heat dissipation hole 21 is designed on the base 26 to improve the heat dissipation efficiency and prevent local overheating. The size and distribution of the heat dissipation holes need to be determined according to thermodynamic calculations and experimental verification.

[0114] In this embodiment, at least one thermocouple or thermistor is selected as the temperature sensor. Such sensors need to have high precision and fast response time. The sensor is installed inside the encapsulation unit 13, close to the injection liquid bottle body 28, to accurately monitor the temperature. The temperature sensor is connected to the microcontroller. The microcontroller is responsible for collecting sensor data and processing it according to the preset temperature control logic. The microcontroller periodically collects temperature data and adjusts the working state of the heating element according to the data to maintain the temperature of the injection liquid bottle body within the set range.

[0115] Integrate all the above components into the box body 1, including the encapsulation unit 13, the temperature control unit 23, the monitoring unit 24 and the power supply unit. Before actual operation, test the entire system, including the accuracy of temperature control, the stability and safety of the system.

[0116] Overall implementation process:

[0117] First, manufacture or procure a box body 1 made of high-strength plastic or lightweight alloy material. Assemble the encapsulation unit 13 inside the box body 1, including installing the injection liquid bottle body 27 and filling a microencapsulated phase change material layer 28 around it. Install a heating patch 20 on one side of the injection liquid bottle body 27 and ensure its connection to the microcontroller. Install a thermocouple or thermistor inside the encapsulation unit 13 and connect it to the microcontroller. Integrate the power supply unit and ensure that all electronic components can obtain stable power supply from the power supply unit. Before actual operation, test and calibrate the entire system to ensure that the temperature control unit and the monitoring unit can accurately respond and maintain the temperature of the injection liquid bottle body 27 within a safe range. During daily use, regularly check the system performance to ensure that all components are working properly and perform necessary maintenance.

[0118] To achieve more intelligent control, the present invention also provides an intelligent temperature control method for the field temperature-controlled preservation system of mannitol injection based on phase change materials, as Figure 6 shown, including:

[0119] The specific implementation process is as follows:

[0120] Select a phase change material with specific phase change temperature, specific heat capacity, and latent heat of phase change. Heat the phase change material to the molten state and mix it with the gelatin solution. Form an emulsion through mechanical stirring, and then fill the emulsion between the encapsulation frame and the injection liquid bottle body to form a microencapsulated phase change material layer. This structure can utilize the characteristic that the phase change material absorbs and releases a large amount of heat during the phase change process to provide a stable temperature environment for mannitol injection.

[0121] Collect data related to temperature control, including historical temperature readings of each encapsulation unit, environmental data (such as environmental temperature, humidity, light intensity, etc.), and operation data (such as working time of the heating element, power adjustment records, etc.). These data will be used as the basis for subsequent temperature prediction and control.

[0122] Normalize the collected data so that its numerical range is within a specific interval for the convenience of model training and processing. For example, the maximum-minimum normalization method can be used to map the data to the [0,1] interval.

[0123] Organize it into a time series format, with each time point containing all relevant input variables, and create a label for each time point, that is, the target temperature or temperature adjustment value. This allows the model to learn the variation law of temperature over time and the influence of different factors on temperature.

[0124] Build an LSTM model. LSTM (Long Short-Term Memory) is a special type of recurrent neural network suitable for processing time series data. The built LSTM model includes an input layer, one or more LSTM layers, and an output layer.

[0125] The input layer receives the normalized environmental data, historical temperature data, and operation data. After being processed by different features, these data serve as the input vectors of the model.

[0126] The LSTM layer is used to learn the long-term dependencies in time series data. The LSTM cells can effectively remember and forget information through the gating mechanism, thus better capturing the trends and patterns of temperature changes.

[0127] The output layer outputs the predicted temperature adjustment value. This value can be used to adjust the power or state of the heating element to achieve precise temperature control.

[0128] Train the LSTM model using historical data. Divide the organized time series data into a training set and a test set. Use the training set to train the model and optimize the model parameters by minimizing the error between the predicted temperature and the actual temperature. Mean Squared Error (MSE) can be used as the loss function, and the weights and biases of the model are continuously adjusted through optimization algorithms such as gradient descent to make the prediction results of the model gradually approach the actual temperature.

[0129] Adjust the power or state of the heating element according to the output of the LSTM model. If the predicted temperature adjustment value of the model is positive, indicating that the temperature needs to be increased, the power of the heating element can be increased or the working time can be extended; if the predicted value is negative, indicating that the temperature needs to be decreased, the power of the heating element can be decreased or the operation can be paused.

[0130] At the same time, utilize the heat storage and release characteristics of the phase change material to maintain temperature stability. When the environmental temperature rises, the phase change material absorbs heat to prevent the temperature of the injection vial from being too high; when the environmental temperature drops, the phase change material releases heat to keep the temperature of the injection vial within an appropriate range. The specific calculation process is as follows:

[0131] Suppose the following data is collected:

[0132] (1) Environmental temperature data: The environmental temperature is recorded every hour for a period of time, obtaining a time series data T env ={T env,1 , T env,2 , …, T env,n}, where n represents the number of records. Assume the environmental temperature ranges from 0°C to 40°C.

[0133] (2) Encapsulation unit historical temperature readings: Similarly, record the temperature of the injection vial in each encapsulation unit 13 every hour to obtain a matrix-form data T hist ={T hist,1 , T hist,2 ,..., T hist,m}, where m represents the number of encapsulation units. Assume the temperature range is between 5°C and 30°C.

[0134] (3) Operating data: Record the working state of the heating element, such as the heating power P heat ={P heat,1 , P heat,2 ,..., P heat,n}, with a range between 0 W and 100 W.

[0135] For the ambient temperature, use the maximum-minimum normalization method. The normalized ambient temperature:

[0136]

[0137] where, T env_min = 0°C, T env_max = 40°C.

[0138] For the historical temperature readings, perform the maximum-minimum normalization as well. The normalized historical temperature is

[0139]

[0140] where, T hist_min = 5°C, T hist_max = 30°C,.

[0141] For the heating power, the normalized heating power is

[0142]

[0143] where, P heat_max = 100 W.

[0144] Assume a model is constructed with two LSTM layers and a fully connected output layer. The input layer receives the normalized ambient temperature, historical temperature readings, and heating power data. Assume the dimension of the input vector is d input .

[0145] The first LSTM layer contains h1 hidden units, and the second LSTM layer contains h2 hidden units. The output layer is a fully connected layer that outputs the predicted temperature adjustment value, with a dimension of d output = 1.

[0146] Randomly initialize the weight matrix and bias vector of the LSTM layer, as well as the weight matrix and bias vector of the output layer. Then, perform model training, and the training steps are as follows:

[0147] (1) Define the loss function: Use the mean squared error (MSE) as the loss function, that is

[0148]

[0149] where y true,i is the actual temperature adjustment value, y pred,i is the temperature adjustment value predicted by the model, and n is the number of training samples.

[0150] (2) The training process is as follows: Divide the organized time series data into a training set and a validation set. Use the training set data to train the model, and adopt an optimization algorithm (such as the Adam optimizer) to minimize the loss function. In each iteration, calculate the predicted value of the model, calculate the loss function, and update the model parameters according to the gradient of the loss function. Regularly evaluate the performance of the model using the validation set data. When the performance of the model on the validation set no longer improves, stop training.

[0151] For new input data, that is, the current ambient temperature, historical temperature readings, and heating power, input it into the trained LSTM model to obtain the temperature adjustment value ΔT predicted .

[0152] Adjust the power of the heating element according to the predicted temperature adjustment value. Assume that the current power of the heating element is P current , the target temperature is T target , and the current temperature is T current .

[0153] The proportional control method can be used to adjust the heating power, that is, P new = P current + k·(ΔT predicted ), where k is the proportionality coefficient and can be adjusted according to the actual situation.

[0154] If ΔT predicted > 0, it means that the temperature needs to be increased and the heating power should be increased; if ΔT predicted < 0, it means that the temperature needs to be decreased and the heating power should be decreased.

[0155] For example, assume that the current ambient temperature is 25°C, which is normalized to 0.625; the historical temperature reading is 20°C, which is normalized to 0.5; the current heating power is 50W, which is normalized to 0.5. Input these data into the trained LSTM model, and assume that the predicted temperature adjustment value of the model is 0.2 (the normalized value). If the proportionality coefficient k = 20, the new heating power is Pnew = 50 + 20 × 0.2 = 54 W.

[0156] The above calculation process is only an example. In actual applications, adjustments and optimizations need to be made according to specific situations, including the frequency of data acquisition, the structure and parameters of the model, the selection of the proportionality coefficient, etc. At the same time, the characteristics of the phase change material and the actual operating conditions of the system also need to be considered to achieve more accurate temperature control.

[0157] Where the present invention is not described in detail are all well-known techniques to those skilled in the art.

[0158] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art of this industry should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A field temperature-controlled preservation system for mannitol injection based on phase change materials, characterized in that, Comprising: A box body (1); An encapsulation unit (13), stored in an array inside the box body (1), and an injection vial (27) is coated by a phase change material layer (28) inside the encapsulation unit (13); A temperature control unit (23) for controlling the temperature of the injection vial (27); A monitoring unit (24) for monitoring the state of the injection vial (27) in the encapsulation unit (13); A power supply unit for providing power.

2. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 1, characterized in that, The phase change material layer (28) inside the encapsulation unit (13) coats the injection vial (27) through microencapsulation technology; and The phase change temperature of the phase change material is 15 °C, the specific heat capacity is 2.1 J / g·°C, and the latent heat of phase change is 120 J / g.

3. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 1, wherein The box body (1) is made of high-strength plastic or lightweight alloy material.

4. The mannitol injection field temperature control preservation system based on phase change materials according to claim 1, characterized in that The temperature control unit (23) includes at least one heating element; the heating element includes a heating patch (20) closely attached to one side surface of the injection vial (27).

5. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 2, wherein, The encapsulation unit (13) includes an encapsulation frame (19) with a rigid structure, and the phase change material layer (28) is filled between the encapsulation frame (19) and the injection vial (28); and The phase change material layer (28) is formed by heating the phase change material to a molten state, mixing it with a gelatin solution, forming an emulsion through mechanical stirring, and then filling it between the encapsulation frame (19) and the injection vial (28).

6. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 5, characterized in that A base (26) is provided below the encapsulation frame (19), and the injection vial (27) is seated in the base (26); and The base (26) is provided with front and rear mounting plates (22) for fixedly installing the encapsulation unit (13) inside the box body (1) through bolts.

7. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 6, characterized in that, The base (26) is provided with at least one heat dissipation hole (21).

8. The mannitol injection field temperature control and preservation system based on phase change materials according to claim 1, wherein The monitoring unit (24) includes at least one thermocouple or thermistor, connected to a microcontroller; and The box body (1) includes an upper box body shell (1a) and a lower box body shell (1b), and at least one control panel (8) is provided on the lower box body shell (1b), and the control panel (8) is connected to the microcontroller.

9. The mannitol injection field temperature control and preservation system based on phase change materials according to any one of claims 1-8, characterized in that, The box body (1) is provided with at least two simple wheels (3), and the simple wheels (3) are stored in a storage space provided on the upper and lower surfaces of the box body (1) when idle, and the storage space is provided with a rubber limit ring (2).

10. An intelligent temperature control method for a field temperature-controlled preservation system of mannitol injection based on phase change materials, characterized in that, Comprising: Coating the injection vial (27) with a microencapsulated phase change material layer, wherein the phase change material has a specific phase change temperature, specific heat capacity, and latent heat of phase change; Collecting temperature control-related data, including historical temperature readings, environmental data, and operation data of each encapsulation unit (13); Normalizing the collected data and organizing it into a time series format, where each time point contains all relevant input variables, and creating a label for each time point, namely the target temperature or temperature adjustment value; Build an LSTM model that includes an input layer, one or more LSTM layers, and an output layer, where the input layer receives normalized environmental data, historical temperature data, and operation data, the LSTM layers are used to learn long-term dependencies in time series data, and the output layer outputs the predicted temperature adjustment value; Train the LSTM model using historical data and optimize the model parameters by minimizing the error between the predicted temperature and the actual temperature; Adjust the power or state of the heating element according to the output of the LSTM model to achieve precise temperature control, and at the same time utilize the heat storage and release characteristics of the phase change material to maintain temperature stability.

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