Cell therapy injection constant temperature control integrated machine and control method thereof

Abstract

The application discloses a kind of cell therapy injection constant temperature control integrated machine and its control method, belong to the technical field of therapeutic injection.The cell therapy injection constant temperature control integrated machine includes turnover box, oscillation and shaking mechanism, temperature regulation module and cell therapy injection flow control module.Oscillation and shaking mechanism is arranged in turnover box, can be stabilized clamped injection and oscillate and shake evenly when using, avoid injection breakage pollution, guarantee stem cell suspension state;Temperature regulation module can be accurately adjusted according to the requirement of transportation preservation, back to the inside temperature of turnover box, maintain stem cell activity and avoid cold stimulus;Flow control module can accurately control the flow rate of injection in output pipeline, adapt to different patient treatment needs.Four modules work together, realize cell therapy injection whole process safe and accurate control, simplify operation process, reduce medical work intensity, be convenient for multi-scene adaptation, provide strong guarantee for standardization of cell therapy.

Description

Technical Field

[0001] This invention relates to the field of therapeutic injection technology, and in particular to an integrated machine for constant temperature control of cell therapy injections and its control method. Background Technology

[0002] Cell therapy injections are specialized biological agents with active stem cells as their core active ingredient, used in clinical cell therapy. They can replenish patients with functional cells through intravenous infusion or local injection, repairing bodily damage and regulating immune function. They are widely used in the treatment of various diseases, including tumors, autoimmune diseases, nervous system diseases, and hematological disorders. The core characteristic of these injections is their reliance on the activity of stem cells and precise dosage. The entire process, including storage, transportation, and reinfusion, requires extremely high standards regarding environmental temperature, vibration conditions, and flow control. Improper control at any stage can lead to decreased stem cell activity, dosage deviations, and consequently, affect treatment efficacy and even pose safety risks.

[0003] Currently, in the clinical application of cell therapy injectables, related control measures largely rely on manual operation. The entire process lacks coordination and involves high levels of human intervention. Storage, transportation, temperature regulation, agitation, and flow control of the injectables often rely on separate equipment for step-by-step operation, with each step requiring manual intervention. The lack of coordination between equipment leads to low efficiency and cumbersome operation. Furthermore, manual agitation lacks stable clamping and is prone to affecting stem cell activity due to improper force. Flow regulation also relies on manual control, making it difficult to adapt to the personalized treatment needs of different patients, potentially leading to impaired stem cell activity, dosage deviations, or the risk of reinfusion. Moreover, improper operation during manual handling can easily cause injectable breakage and contamination, failing to meet the requirements for standardized cell therapy implementation. Summary of the Invention

[0004] This invention provides a machine control method for an integrated temperature control system for cell therapy injections, in order to overcome the above-mentioned problems.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows:

[0006] The present invention provides an integrated temperature control machine for cell therapy injections, including a turnover box, an oscillation and mixing mechanism, a temperature adjustment module, and a cell therapy injection flow control module;

[0007] The oscillation and mixing mechanism is located inside the turnover box. The oscillation and mixing mechanism is used to clamp and fix the cell therapy injection in the turnover box, and to oscillate and mix the cell therapy injection when using it.

[0008] The temperature regulation module is used to regulate the internal temperature of the turnover box so that the temperature is suitable for the transportation, resuscitation and reinfusion stages of cell therapy injections.

[0009] The cell therapy injection flow control module is located at the bottom of the turnover box. The cell therapy injection flow control module is used to control the flow rate of the injection in the output pipeline connected to the cell therapy injection.

[0010] Furthermore, the oscillation and shaking mechanism includes a split clamping plate, a driving assembly, and a linkage structure;

[0011] The connecting rod structure is arranged in the transverse direction inside the turnover box, and the driving component is arranged on one side inside the turnover box. The output end of the driving component is fixedly connected to the connecting rod structure and can drive the connecting rod structure to swing back and forth.

[0012] The split clamping plate includes a first plate and a second plate. The first plate is fixed to the connecting rod structure. One end of the second plate is hinged to one end of the first plate. The other ends of the first plate and the second plate are both free ends. The sides of the second plate and the first plate are provided with a fixing plate assembly that can lock the second plate and the first plate into an open or clamped state.

[0013] The first plate is equipped with a fixing column for suspending cell therapy injections.

[0014] Furthermore, the fixing plate assembly includes a fixing plate and a fixing member. One end of the fixing plate is fixedly connected to the second plate. The fixing plate is provided with a main slide and a plurality of fixing grooves that are connected to the main slide and arranged in order from low to high.

[0015] One end of the fixing member passes through the main slide and is fixed to the side of the first plate. When the fixing member is not locked, the free end of the first plate can be driven to move away from or closer to the free end of the second plate by external force. When the fixing member enters the fixing groove and is tightened, the first plate and the second plate are clamped. At this time, the cell therapy injection is fixed on the split clamping plate. After the fixing member is loosened, the external force can drive the first plate to move and drive the fixing member into the main slide. At this time, the first plate and the second plate are open. After the fixing member is tightened again, it can cooperate with the fixing plate to fix the opening angle between the first plate and the second plate.

[0016] Furthermore, the cell therapy injection flow control module includes a clamping block and a clamping drive motor;

[0017] The bottom panel of the turnover box is provided with a through hole for connecting the output tube of the cell therapy injection;

[0018] The clamping block is located on the lower side of the bottom box plate and on one side of the through hole;

[0019] The clamping drive motor can move the clamping block closer to or further away from the through hole, and cooperate with the side wall of the through hole to clamp or release the output tube, thereby controlling the interception and flow of the cell therapy injection in the output tube to achieve control of the output flow rate of the cell therapy injection.

[0020] Furthermore, the temperature regulation module includes a housing and a semiconductor chip assembly, a main air duct, a cold air duct, a heat dissipation duct, and an intake fan disposed within the housing;

[0021] The housing is located on top of the turnover box, and has an air inlet and an air outlet. The air inlet is connected to the input end of the main air duct, and the air outlet is connected to the cold air duct and the turnover box respectively. The cooling end of the semiconductor chip assembly is opposite to the input end of the cold air duct, and the heating end of the semiconductor chip assembly is facing the heat dissipation air duct. The main air duct is equipped with an air intake fan, the output end of the air intake fan is opposite to the input end of the cold air duct, and the output end of the heat dissipation air duct is equipped with a heat dissipation fan.

[0022] The cell therapy injection container further includes an outer shell and a door mounted on the outer shell;

[0023] The outer shell is a double-layer hollow structure. A vacuum insulation cavity is formed between the inner layer of the double-layer hollow structure and the outer layer of the double-layer hollow structure. The vacuum insulation cavity is filled with a heat insulation structure.

[0024] One side of the box door is hinged to the side of the outer shell with an opening. After the box door is closed, it is locked and fixed to the outer shell by a locking assembly.

[0025] Furthermore, the turnover box is equipped with an ultraviolet sterilization device.

[0026] Furthermore, it also includes several shock-absorbing structures installed at the bottom of the turnover box, which can provide shock-absorbing buffer support for the turnover box.

[0027] Furthermore, it also includes a display screen and an operation panel located on the outside of the turnover box.

[0028] In another aspect, the present invention provides a control method for the integrated temperature control device for cell therapy injection, the control method comprising the following steps:

[0029] S1: Place the cell therapy injection into the turnover box and clamp and fix the injection using a shaking and mixing mechanism;

[0030] S2: Based on the needs of the usage stage, activate the temperature regulation module to adjust the internal temperature of the turnover box to the corresponding temperature suitable for transportation, recovery or return.

[0031] S3: Activate the oscillation and mixing mechanism to oscillate and mix the cell therapy injection in the turnover box to maintain the suspension of stem cells in the injection.

[0032] S4: When entering the reinfusion stage, activate the temperature regulation module to adjust the internal temperature of the turnover box to the temperature required for reinfusion; then activate the cell therapy injection flow control module to adjust the flow rate of the injection in the output tubing to the set value.

[0033] S5: During operation, keep the temperature regulation module and the oscillation and shaking mechanism working continuously, and keep the flow control module outputting a stable flow rate until the use or transportation of the injection is completed, then shut down all modules.

[0034] The beneficial effects of this invention are:

[0035] This invention discloses an integrated thermostatic control system for cell therapy injections. Through the coordinated operation of a transfer box, a shaking and mixing mechanism, a temperature regulation module, and a cell therapy injection flow control module, it achieves safe and precise control over the entire process of cell therapy injections. The transfer box provides a stable platform for each component, ensuring the orderly operation of the entire device. The shaking and mixing mechanism stably holds the injection, preventing damage and contamination during transportation and operation, while ensuring that stem cells remain in suspension, guaranteeing accurate dosage and improving treatment efficacy. The temperature regulation module precisely adjusts the internal temperature of the transfer box according to the needs of different stages of transportation, preservation, and reinfusion / recovery. During transportation and preservation, it is adjusted to a low temperature to induce a "dormant" state for stem cells to maintain activity; during reinfusion, it is adjusted to room temperature or the temperature required by the human body to avoid cold stimulation, stabilize cell function, and balance cell quality and treatment safety. The cell therapy injection flow control module precisely controls the injection flow rate of the output tubing, adapting to the treatment needs of different patients and avoiding risks caused by improper flow. The combination of these four components achieves integrated control, simplifying the operation process, reducing the workload of medical staff, and reducing the size of the device for easy adaptation to multiple scenarios, providing strong support for the standardized implementation of cell therapy. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0037] Figure 1 This is a schematic diagram of the structure of a cell therapy injection constant temperature control integrated machine disclosed in an embodiment of the present invention. Figure 1 ;

[0038] Figure 2This is a schematic diagram of the structure of a cell therapy injection constant temperature control integrated machine disclosed in an embodiment of the present invention. Figure 2 ;

[0039] Figure 3 This is a schematic diagram of the structure of a cell therapy injection constant temperature control integrated machine disclosed in an embodiment of the present invention. Figure 3 ;

[0040] Figure 4 This is a schematic diagram of the structure of a cell therapy injection constant temperature control integrated machine disclosed in an embodiment of the present invention. Figure 4 .

[0041] In the picture:

[0042] 1. Turnover box; 11. Bottom panel; 12. Through hole; 13. Outer shell; 14. Box door;

[0043] 2. Vibration and shaking mechanism; 21. First plate; 22. Second plate; 23. Fixed plate assembly; 231. Fixed plate; 232. Fixing component; 233. Main slide; 234. Fixing groove; 24. Fixing column; 25. Linkage structure; 26. Swing motor; 27. Fixing slot; 28. Encoder;

[0044] 3. Temperature control module;

[0045] 4. Cell therapy injection flow control module; 41. Clamping block; 42. Clamping drive motor;

[0046] 5. Earthquake-resistant structure;

[0047] 6. Display screen;

[0048] 7. Control panel;

[0049] 8. Handle;

[0050] 9. Locking assembly. Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0052] like Figure 1-4 The image shown is an integrated temperature control machine for cell therapy injections provided in this embodiment, including a turnover box 1, an oscillation and shaking mechanism 2, a temperature adjustment module 3, and a cell therapy injection flow control module 4;

[0053] The oscillation and mixing mechanism is located inside the turnover box. The oscillation and mixing mechanism is used to clamp and fix the cell therapy injection in the turnover box, and to oscillate and mix the cell therapy injection when using it, so as to ensure that the stem cells in the cell therapy injection are in a suspended state.

[0054] The temperature regulation module is used to regulate the internal temperature of the transfer box, ensuring that the temperature is suitable for the transportation, resuscitation, and reinfusion stages of the cell therapy injection. (For example, during the transportation and storage of cell therapy injections (fresh liquid), the temperature regulation module adjusts the internal temperature of the transfer box to approximately 2-8°C to inhibit cell metabolism, significantly reduce cell metabolism and energy consumption, and induce a dormant state, maintaining vitality during long-distance transportation. When administering treatment to the user, the temperature regulation module adjusts the internal temperature of the transfer box to approximately 37°C, allowing the cell therapy injection to return to room temperature, avoiding adverse reactions caused by cold stimulation, and also allowing the cells to gradually adapt from a dormant or cryogenic state to the in vivo environment, stabilizing cell function.)

[0055] The cell therapy injection flow control module is located at the bottom of the turnover box. The cell therapy injection flow control module is used to control the flow rate of the injection in the output pipeline connected to the cell therapy injection.

[0056] This integrated temperature control system for cell therapy injections achieves safe and precise control of the entire process through the coordinated operation of a turnover box 1, a shaking and agitating mechanism 2, a temperature regulation module 3, and a cell therapy injection flow control module 4. It possesses significant practical value: the turnover box 1 provides a stable platform for all components, ensuring the orderly operation of the entire device; the shaking and agitating mechanism 2 stably holds the injection, preventing damage and contamination during transportation and operation, while simultaneously ensuring that stem cells remain suspended through shaking and agitation, guaranteeing accurate treatment dosage and improving treatment efficacy; the temperature regulation module 3 can adjust the flow according to transportation, storage, and reinfusion needs. To meet the needs of different stages of recovery, the internal temperature of the transfer box 1 is precisely adjusted. During transportation and storage, it is set to 2-8℃ to allow stem cells to enter a "dormant" state and maintain their activity. During reinfusion, it is set to 37℃ to avoid cold stimulation and stabilize cell function, balancing cell quality and treatment safety. The cell therapy injection flow control module 4 precisely controls the injection flow rate of the output tubing to adapt to the treatment needs of different patients and avoid risks caused by improper flow. The four components are organically combined to achieve integrated management, simplify the operation process, reduce the workload of medical staff, and reduce the size of the equipment for easy adaptation to multiple scenarios, providing a strong guarantee for the standardized development of cell therapy.

[0057] In a specific embodiment, the oscillation and shaking mechanism includes a split clamping plate, a driving assembly, and a connecting rod structure 25;

[0058] The connecting rod structure is arranged in the transverse direction inside the turnover box, and the driving component is arranged on one side inside the turnover box. The output end of the driving component is fixedly connected to the connecting rod structure and can drive the connecting rod structure to swing back and forth.

[0059] The split clamping plate includes a first plate 21 and a second plate 22. The first plate is fixed on the connecting rod structure 25. One end of the second plate 22 is hinged to one end of the first plate 21. The other ends of the first plate 21 and the second plate 22 are both free ends. The sides of the second plate 22 and the first plate 21 are provided with a fixing plate assembly 23 that can lock the second plate 22 and the first plate 21 into an open or clamped state.

[0060] The first plate 21 is provided with a fixing post 24 for suspending cell therapy injections and a fixing slot 27 that cooperates with the fixing post 24. When the cell therapy injection is placed on the first plate, its output end is placed in the fixing slot 27. The fixing slot 27 cooperates with the fixing post 24 to improve the initial stability of the position of the cell therapy injection.

[0061] In the clamped state, the first plate and the second plate cooperate with each other and can fix the cell therapy injection under the action of the fixing plate assembly; by external force, the free end of the second plate can be driven to move away from the first plate, changing the split clamping plate from the clamped state to the open and closed state (when the fixing plate assembly 23 is unlocked). In the open and closed state, the cell therapy injection can be removed from the split clamping plate (after use) or placed on the split clamping plate (for subsequent infusion use).

[0062] The hinged arrangement of the first and second plates, along with the locking mechanism of the fixed plate assembly, not only reliably clamps the cell therapy injection during the shaking process, preventing displacement and detachment and ensuring the stability of the shaking operation, but also allows for quick loading and unloading of the cell therapy injection through the opening and closing mechanism. Combined with the fixed column, this enables the positioning and suspension of the injection, improving operational convenience and efficiency.

[0063] In a specific embodiment, the fixing plate assembly 23 includes a fixing plate 231 and a fixing member 232. One end of the fixing plate 231 is fixedly connected to the second plate by bolts. The fixing plate is provided with a main slide 233 and a plurality of fixing grooves 234 that are connected to the main slide and arranged in order from low to high.

[0064] One end of the fixing member passes through the main slide and is fixed to the side of the first plate. When the fixing member is not locked (not tightened), external force can drive the free end of the first plate to move away from or towards the free end of the second plate. When the fixing member moves downward into the fixing groove and is tightened, the first plate and the second plate are clamped. At this time, the cell therapy injection is fixed on the split clamping plate. After the fixing member is loosened, external force can drive the first plate to move and drive the fixing member into the main slide. At this time, the first plate and the second plate are open. After the fixing member is tightened again, it can cooperate with the fixing plate to fix the opening angle between the first plate and the second plate.

[0065] Through the gradient design of the main slide of the fixed plate and the multi-level fixed grooves, combined with the sliding and locking actions of the fixing parts, the opening and closing state and clamping degree of the split clamping plates can be precisely controlled in a step-like manner. The smooth sliding of the fixing parts along the main slide and the locking positioning embedded in the fixing grooves not only ensures the connection strength when the first plate and the second plate are clamped, preventing the fixing parts from loosening during the vibration and shaking process, but also allows for flexible adjustment of the clamping distance according to the specifications of cell therapy injections, adapting to the clamping requirements of injections of different sizes. At the same time, the tightening and loosening operation method, combined with the guide and limit of the slide and groove, simplifies the adjustment process of the clamping plates and improves the adaptability and ease of operation of the mechanism.

[0066] In this embodiment, the fixing component is a threaded knob, and the second plate has a threaded hole on its side wall. The threaded rod of the threaded knob is set in the threaded hole through the main slide. The fixing component cooperates with the threaded hole on the side wall of the second plate and the main slide. After loosening the threaded knob, the fixing plate can move under the action of external force, so that the fixing component leaves one fixing groove and enters the main slide. Then, under the action of external force from the operator, the fixing component enters another fixing groove. After tightening the threaded knob, the first plate and the second plate are used to fix and clamp the injection via the fixing plate. This structure is convenient to operate, locks firmly, and can flexibly adjust the clamping position of the clamping plate to adapt to different specifications of injection bottles, avoiding damage to the bottle due to excessive clamping, further improving the stability and adaptability of clamping. Together with the clamping plate, fixing column, and fixing slot, it ensures the smooth progress of oscillation and mixing.

[0067] The drive assembly includes a swing motor 26, a reducer, and an encoder 28. The output end of the swing motor is connected to the input end of the reducer. The encoder is mounted on the output end of the reducer to collect speed and stroke signals. One end of the linkage structure is fixedly connected to the output end of the reducer. The swing motor can drive the linkage structure to reciprocate, thereby driving the first plate and the second plate to reciprocate synchronously, so as to realize the oscillation and mixing of the cell therapy injection between the first plate and the second plate.

[0068] The oscillating motor provides oscillation power, while the reducer amplifies torque and ensures stable speed output, guaranteeing that the linkage structure drives the first and second plates to perform low-vibration, high-stability reciprocating motion. The encoder collects the speed and stroke signals from the reducer output in real time, enabling precise control of the oscillation frequency and amplitude. This allows the cell therapy injection to be fully mixed under controllable and gentle motion, avoiding damage to cell activity caused by violent oscillation. At the same time, the overall drive structure is reliable and stable, improving the oscillation mixing effect and consistency, and extending the service life of the mechanism, meeting the high-precision and high-safety mixing requirements of cell therapy injections.

[0069] In a specific embodiment, the cell therapy injection flow control module 4 includes a clamping block 41 and a clamping drive motor 42;

[0070] The bottom panel 11 of the turnover box is provided with a through hole 12 for connecting the output tube of the cell therapy injection;

[0071] The clamping block is located on the lower side of the bottom box plate and on one side of the through hole 12;

[0072] The clamping drive motor 42 can move the clamping block 41 toward the side closer to or away from the through hole 12, and cooperate with the side wall of the through hole to clamp or release the output tube, thereby controlling the interception and flow of the cell therapy injection in the output tube to achieve control of the output flow rate of the cell therapy injection.

[0073] In this embodiment, the output end of the clamping drive motor 42 is connected to a lead screw, and the clamping block 41 is mounted on the lead screw via a nut.

[0074] In use, the output tube of the cell therapy injection is connected and fixed through the through hole 12. When the injection needs to flow, the clamping drive motor 42 drives the clamping block 41 to move away from the through hole 12, the clamping block 41 separates from the side wall of the through hole 12, the output tube is in a relaxed and conductive state, and the injection flows normally. When the flow rate needs to be reduced, the clamping drive motor 42 drives the clamping block 41 to move closer to the through hole 12 through the lead screw and lead nut. By squeezing the clamping block 41 against the side wall of the through hole 12, the conductive cross section of the output tube is reduced, and the flow rate is finely adjusted. When complete closure is required, the clamping drive motor 42 continuously drives the clamping block 41 to squeeze the output tube until the output tube is completely closed, stopping the injection delivery. Reversing the drive of the clamping block 41 will restore the flow.

[0075] The clamping drive motor 42 precisely drives the clamping block 41 to reciprocate, which, in conjunction with the sidewall of the through hole 12 on the bottom box plate 11, forms a simple and easy-to-operate flow control structure. This eliminates the need for additional complex flow valves, reducing the complexity of the equipment structure and manufacturing costs. The corresponding fit between the clamping block 41 and the sidewall of the through hole 12 provides uniform and stable clamping of the output tube, preventing excessive local force that could cause damage or leakage, thus preventing contamination or loss of the cell therapy injection and ensuring delivery safety. Simultaneously, by controlling the stroke of the clamping drive motor 42, the squeezing degree of the clamping block 41 can be precisely adjusted, thereby flexibly achieving precise control of the injection's interception, flow, and flow rate. This adapts to the flow requirements of different administration stages in cell therapy, and the control process is stable, without affecting the cell activity in the injection, further improving the equipment's reliability, practicality, and safety, meeting the high-precision requirements of cell therapy.

[0076] In a specific embodiment, the temperature regulation module includes a housing and a semiconductor chip assembly, a main air duct, a cold air duct, a heat dissipation duct, and an intake fan disposed within the housing;

[0077] The housing is located on top of the turnover box, and has an air inlet and an air outlet. The air inlet is connected to the input end of the main air duct, and the air outlet is connected to both the cold air duct and the turnover box. The cooling end of the semiconductor chip assembly is positioned opposite the input end of the cold air duct, and the heating end of the semiconductor chip assembly faces the heat dissipation duct. An air intake fan is installed inside the main air duct, with its output end (outlet side) opposite the input end of the cold air duct. A heat dissipation fan is installed at the output end of the heat dissipation duct. The fan draws air from outside the turnover box into the main air duct through the air inlet, then, after temperature control by the semiconductor chip assembly, it is introduced into the cold air duct and finally enters the chamber of the turnover box through the air outlet, thus achieving temperature regulation (reduction).

[0078] The housing has heat dissipation holes on the side away from the turnover box chamber that communicate with the heat dissipation duct to dissipate the heat generated during the operation of the semiconductor chip assembly. A gas filtration device can be installed at the air outlet of the cold air duct to filter the air entering the turnover box chamber and prevent impurities from contaminating the cell therapy injection.

[0079] During operation, a fan draws outside air into the main air duct through the air inlet. After being temperature-controlled by the cooling end of the semiconductor chip assembly, the air is guided into the cold air duct and finally enters the turnover box chamber through the air outlet, thus lowering and regulating the internal temperature of the turnover box. During return operation, the control system changes the power supply direction of the semiconductor chip assembly, switching the original cooling end to the heating end and vice versa. The semiconductor chip assembly generates heat, which, along with the air inlet fan continuing to draw outside air into the main air duct, heats the airflow as it passes through the heating end of the semiconductor chip assembly before being sent into the turnover box chamber through the cold air duct and air outlet, thus raising and regulating the internal temperature of the turnover box. Simultaneously, the cooling energy generated by the original heating end (now the cooling end) of the semiconductor chip assembly is discharged to the outside of the casing through the heat dissipation duct and the cooling fan via the heat dissipation holes, ensuring stable operation of the semiconductor chip assembly.

[0080] In this embodiment, to ensure pressure balance within the turnover box, avoid airflow interference, and guarantee temperature control and safety, an exhaust vent for pressure regulation is provided on the turnover box body. A pressure regulating valve is installed at the exhaust vent to adjust the exhaust rate according to the real-time pressure within the turnover box, maintaining stable pressure within the chamber and preventing structural damage from positive pressure and contamination from negative pressure, thus balancing temperature control and safety. Simultaneously, a cold-conducting plate / heat-conducting plate can be attached between the cooling end and the inner wall of the cold air duct, and a heat-conducting plate / cold-conducting plate can be attached between the heating end and the inner wall of the heat dissipation duct to improve the heat / cold transfer effect and uniformity.

[0081] As a core temperature control component, the semiconductor chip assembly can rapidly conduct cold and heat, evenly transferring cold energy from the cooling end to the cold air duct, ensuring uniform airflow temperature entering the turnover box, and quickly dissipating heat from the heating end to prevent heat buildup from affecting temperature control. The intake fan provides stable power for the temperature-controlled airflow, realizing air intake and temperature control, while the cooling fan accelerates heat dissipation from the cooling duct, ensuring long-term stable operation of the semiconductor chip assembly and extending its service life. The semiconductor chip assembly is a commonly used structure in existing technology; its more specific structural composition and temperature control principle will not be elaborated here.

[0082] In a specific embodiment, the cell therapy injection container includes an outer shell 13 and a door 14 installed on the outer shell;

[0083] The outer shell is a double-layer hollow structure, with a vacuum insulation cavity formed between the inner and outer layers of the double-layer hollow structure. The vacuum insulation cavity is filled with a heat insulation structure, which is heat insulation cotton. This effectively blocks the heat transfer between the inside and outside of the box, greatly improves the heat insulation performance of the turnover box, and can stably maintain a constant temperature environment inside the box. This prevents cell therapy injections from being damaged by temperature fluctuations, ensures the cell activity of the injections, and is suitable for the low-temperature or constant-temperature storage and transportation needs of cell therapy injections.

[0084] One side of the cabinet door 14 is hinged to the side of the outer casing 13 with an opening. After the cabinet door 14 is closed, it is locked and fixed to the outer casing 13 by the locking assembly 9. The cabinet door is hinged and locked in place by the push-button locking assembly, which is convenient to operate. It can realize the quick opening and closing of the cabinet door and ensure the firmness of the cabinet door after it is closed. At the same time, the push-button locking assembly uses conventional components, which reduces the equipment manufacturing cost and the difficulty of later maintenance.

[0085] A sealing strip is provided on the inner perimeter of the door. After the door is closed, the sealing strip fits tightly against the opening of the outer shell, which can reduce the loss of temperature inside the box and further improve the insulation effect.

[0086] The handle 8 on the top of the outer shell makes it easy for operators to move and transfer the turnover box, improving the portability of the equipment and adapting to the transportation needs of multiple scenarios in clinical treatment.

[0087] In use, press the push-button locking assembly on the outer shell to unlock it, allowing the door to be rotated around the hinges to open the outer shell and facilitate the placement of cell therapy injections into the transfer box. After placement, rotate the door until it is flush with the opening of the outer shell. At this point, the sealing strip on the inside of the door will be in close contact with the opening of the outer shell. Press the locking assembly to lock it in place, ensuring a secure fixation between the door and the outer shell and a sealed chamber. When the transfer box needs to be moved, simply hold the handle on the top of the outer shell for easy and stable handling. During operation, the vacuum insulation chamber formed by the double-layer hollow structure of the outer shell, combined with the internal insulation cotton, continuously provides insulation and maintains a constant temperature environment inside the box. Through the outer shell, door, hinges, push-button locking assembly, and handle, the design balances insulation, portability, and ease of operation. The overall structural design is simple and reasonable, effectively ensuring the safety and stability of cell therapy injections during storage and transportation, further enhancing the practicality and reliability of the equipment.

[0088] In a specific embodiment, the turnover box is equipped with an ultraviolet sterilization device, which is used to sterilize and disinfect the internal chamber of the turnover box and the outer surface of the cell therapy injection, effectively killing harmful microorganisms such as bacteria and mold in the turnover box, removing contaminants attached to the outer surface of the cell therapy injection, avoiding damage to the cell therapy injection due to external contamination, ensuring the cleanliness and safety of the injection, and meeting the strict hygiene requirements of cell therapy.

[0089] In a specific embodiment, it also includes several shock-absorbing structures 5 arranged at the bottom of the turnover box, which can provide shock-absorbing buffer support for the turnover box.

[0090] In this embodiment, the shock-absorbing structure is a spring shock absorber, with four spring shock absorbers installed at the bottom of the turnover box. The four spring shock absorbers correspond to the four corners of the bottom of the turnover box, achieving balanced support for the turnover box, ensuring uniform buffering force, and effectively absorbing the vibration and impact force generated during the handling, transfer, and operation of the turnover box. It plays a good role in shock absorption, buffering, and vibration reduction. With its own elasticity and expansion characteristics, the spring shock absorber can accurately attenuate vibrations of different frequencies, preventing vibrations from being transmitted to the inside of the turnover box when the oscillating and shaking mechanism is running. This prevents the cell therapy injections inside the box from being damaged by vibration and affecting cell activity, meeting the stringent requirements of cell therapy injections for storage and transportation environments. As a conventional and common component in the industry, the spring shock absorber has a mature structure, stable performance, wear resistance, and durability. Its buffering effect is better than that of ordinary rubber pads, and it requires no complicated maintenance. It can play a stable shock-absorbing role for a long time. At the same time, it is convenient to purchase and the cost is controllable, reducing the equipment manufacturing cost and the difficulty of later maintenance, and is suitable for the shock absorption requirements of cell therapy injection turnover boxes.

[0091] In a specific embodiment, the system also includes a display screen 6 and an operation panel 7 disposed on the outer surface of the turnover box. The display screen and operation panel display and control various parameters of the equipment.

[0092] This equipment also includes conventional components such as temperature sensors, flow sensors, and a main control system. The temperature sensor, flow sensor, display screen, and operation panel are all electrically connected to the main control system. The temperature sensor is installed inside the turnover box to collect real-time temperature data. The flow sensor is installed on the cell therapy injection outlet tube to collect real-time flow data of the injection within the outlet tube. The main control system receives real-time data collected by the temperature and flow sensors and transmits the data to the display screen for real-time display. Simultaneously, it receives operator commands through the operation panel to precisely control functions such as temperature control, oscillation and mixing, flow regulation, and ultraviolet sterilization, achieving automated and intelligent operation of all equipment functions. Furthermore, the main control system integrates a status monitoring and early warning module, enabling real-time monitoring and intelligent analysis of the equipment's operating status and triggering warnings when data anomalies occur to avoid unexpected problems during operation. The system also supports remote access and visual monitoring, achieving remote, real-time, and visual management of the entire equipment's operating status. Since the aforementioned sensors and main control system are conventional components, their specific data transmission, processing, and control logic will not be elaborated here.

[0093] A control method for an integrated temperature control system for cell therapy injections includes the following steps:

[0094] S1: After the operator unlocks the pressure-locking assembly, they open the box door 14, opening the outer shell 13. The cell therapy injection is placed into the turnover box, and suspended on the fixed column 24 on the split clamping plate of the oscillation and mixing mechanism. The second plate 22 is rotated to fit against the first plate 21, and the two plates are locked in a clamped state by the fixing plate assembly 23, achieving stable clamping of the injection. Then, the box door 14 is closed, and the locking assembly is pressed to lock it. The ultraviolet sterilization device can be activated simultaneously to sterilize and disinfect the internal chamber of the turnover box and the outer surface of the injection. At this time, the spring shock absorber at the bottom of the turnover box provides balanced support for the turnover box, ensuring overall stability.

[0095] S2: The operator issues a temperature adjustment command through the operation panel 7 on the outer surface of the turnover box. After receiving the command, the control system starts the temperature adjustment module. At the same time, the temperature sensor inside the turnover box collects the temperature data inside the box in real time and transmits the data to the control system. The control system analyzes and processes the collected data, compares it with the preset temperature corresponding to transportation, recovery or return, and automatically adjusts the operating status of the temperature adjustment module until the temperature inside the box reaches the set value. The vacuum insulation cavity formed by the double-layer hollow structure of the outer shell 13 and the internal heat insulation cotton reduce the temperature loss inside the box and maintain temperature stability. The temperature data is displayed in real time on the display screen 6 for easy viewing by the operator.

[0096] S3: The operator starts the oscillation and shaking mechanism through the operation panel 7. The control system controls the swing motor 26 to start. The output end of the swing motor 26 drives the reducer to run. The reducer realizes torque amplification and stable speed output. At the same time, the encoder 28 collects the speed and stroke signals of the reducer output end and feeds them back to the control system to achieve precise control of oscillation frequency and swing amplitude. The output end of the reducer drives the connecting rod structure 25 to reciprocate, which in turn drives the first plate 21, the second plate 22 and the cell therapy injection held by the first plate 21 and the second plate 22 to reciprocate synchronously, realizing the oscillation and shaking of the injection and maintaining the suspension of stem cells in the injection. During the oscillation, the spring shock absorber absorbs the vibration and impact force generated by the oscillation to prevent the turnover box from shaking or shifting. At the same time, the ultraviolet sterilization device can work continuously as needed. The display screen 6 displays the oscillation parameters, the temperature inside the box and the sterilization status in real time.

[0097] S4: When entering the reinfusion stage, the operator first sets the target temperature (e.g., 37°C) and the preset injection flow rate through the operation panel 7, and sends a start command to the control system;

[0098] The control system then activates the temperature regulation module: controlling the semiconductor cooling chip to reverse its operation mode, switching it to heating mode, and monitoring the ambient temperature inside the turnover box 1 in real time via a temperature sensor. Simultaneously, the oscillation and shaking mechanism 2 maintains a low speed to ensure uniform heating of the injection containers during the heating process. The control system dynamically adjusts the power of the semiconductor cooling chip based on temperature feedback, causing the temperature inside the box to rise rapidly and stably and be maintained at the set return temperature.

[0099] Once the temperature reaches the set value and stabilizes, the control system automatically (or upon operator confirmation) activates the cell therapy injection flow control module, controlling the clamping drive motor 42 to move the clamping block 41 away from the through hole 12, thus restoring the injection output tube to its conductive state. At this time, the flow sensor installed on the output tube collects flow data in real time and feeds it back to the control system. The control system compares this flow rate with the preset flow rate and dynamically adjusts the stroke of the clamping drive motor 42 to precisely control the degree of clamping of the clamping block 41 on the output tube, thereby adjusting the tube's conductive cross-section and accurately stabilizing the output flow at the set value.

[0100] Key data throughout the process, including real-time temperature inside the chamber and injection flow rate, are clearly displayed on screen 6, facilitating operator monitoring throughout the process and ensuring the safety and accuracy of the reinfusion operation.

[0101] S5: During equipment operation, the control system continuously receives real-time data collected by temperature and flow sensors, and adjusts the operating status of the temperature regulation module and flow control module in real time to ensure stable temperature and constant output flow within the chamber. The oscillation and shaking mechanism continues to work to maintain the suspension of stem cells in the injection, the spring shock absorber continuously absorbs vibrations to ensure the stability of the turnover box, and the ultraviolet sterilization device continuously sterilizes as needed. All operating parameters are displayed in real time on the display screen 6 for easy monitoring by operators. Until the use or transportation of the injection is completed, the operator issues a shutdown command through the operation panel 7, and the control system controls the temperature regulation module, oscillation and shaking mechanism, flow control module, and ultraviolet sterilization device to shut down sequentially, completing the entire operation process.

[0102] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A cell therapy injection constant temperature control integrated machine, characterized in that, It includes a turnover box (1), an oscillation and shaking mechanism (2), a temperature regulation module (3), and a cell therapy injection flow control module (4); The oscillation and shaking mechanism (2) is located inside the turnover box. The oscillation and shaking mechanism is used to clamp and fix the cell therapy injection in the turnover box, and to oscillate and shake the cell therapy injection when using it. The temperature regulation module (3) is used to regulate the internal temperature of the turnover box so that the temperature is suitable for the transportation, recovery and reinfusion stages of cell therapy injections; The cell therapy injection flow control module (4) is used to control the flow rate of the injection in the output pipeline connected to the cell therapy injection. During the operation of the cell therapy injection constant temperature control integrated machine, the temperature regulation module (3) and the oscillation and shaking mechanism (2) are kept working continuously, and the cell therapy injection flow control module (4) outputs a stable flow. The oscillation and shaking mechanism includes a split clamping plate, a drive assembly, and a linkage structure (25). The connecting rod structure is arranged in the transverse direction inside the turnover box, and the driving component is arranged on one side inside the turnover box. The output end of the driving component is fixedly connected to the connecting rod structure and can drive the connecting rod structure to swing back and forth. The split clamping plate includes a first plate (21) and a second plate (22). The first plate is fixed on the connecting rod structure (25). One end of the second plate (22) is hinged to one end of the first plate (21). The other ends of the first plate (21) and the second plate (22) are both free ends. The sides of the second plate (22) and the first plate (21) are provided with a fixing plate assembly (23) that can lock the second plate (22) and the first plate (21) into an open or clamped state. The first plate (21) is provided with a fixing column (24) for suspending cell therapy injections. The fixing plate assembly (23) includes a fixing plate (231) and a fixing member (232). One end of the fixing plate (231) is fixedly connected to the second plate (22). The fixing plate (231) is provided with a main slide (233) and a plurality of fixing grooves (234) that are connected to the main slide and arranged in order from low to high. One end of the fixing member (232) passes through the main slide (233) and is fixed to the side of the first plate (21). When the fixing member is not locked, the free end of the first plate (21) can be driven by external force to move away from or closer to the free end of the second plate (22). When the fixing member (232) enters the fixing groove (234) and is tightened, the first plate and the second plate are clamped. At this time, the cell therapy injection is fixed on the split clamping plate. After the fixing member is loosened, the external force can drive the first plate to move and drive the fixing member into the main slide. At this time, the first plate and the second plate are open. After the fixing member is tightened again, it can cooperate with the fixing plate to fix the opening angle between the first plate and the second plate.

2. The cell therapy injection constant temperature control integrated machine according to claim 1, characterized in that, The cell therapy injection flow control module (4) includes a clamping block (41) and a clamping drive motor (42). The bottom panel (11) of the turnover box (1) is provided with a through hole (12) for connecting the output tube of the cell therapy injection. The clamping block (41) is located on the lower side of the bottom box plate and on one side of the through hole (12); The clamping drive motor (42) can move the clamping block (41) to the side closer to or away from the through hole (12) and cooperate with the side wall of the through hole (12) to clamp or release the output tube, thereby controlling the interception and flow of the cell therapy injection in the output tube, so as to control the output flow rate of the cell therapy injection.

3. The cell therapy injection constant temperature control integrated machine according to claim 1, characterized in that, The temperature control module includes a housing and a semiconductor chip assembly, a main air duct, a cold air duct, a heat dissipation air duct, and an intake fan disposed within the housing; The housing is located on top of the turnover box, and has an air inlet and an air outlet. The air inlet is connected to the input end of the main air duct, and the air outlet is connected to the cold air duct and the turnover box respectively. The cooling end of the semiconductor chip assembly is opposite to the input end of the cold air duct, and the heating end of the semiconductor chip assembly is facing the heat dissipation air duct. The main air duct is equipped with an air intake fan, the output end of the air intake fan is opposite to the input end of the cold air duct, and the output end of the heat dissipation air duct is equipped with a heat dissipation fan.

4. The cell therapy injection constant temperature control integrated machine according to claim 3, characterized in that, The cell therapy injection container includes an outer shell (13) and a door (14) installed on the outer shell. The outer shell (13) is a double-layer hollow structure. A vacuum insulation cavity is formed between the inner layer of the double-layer hollow structure and the outer layer of the double-layer hollow structure. The vacuum insulation cavity is filled with a heat insulation structure. The door (14) is hinged to the side of the outer shell (13) with an opening. After the door (14) is closed, it is locked and fixed to the outer shell (13) by the locking assembly (9).

5. The cell therapy injection constant temperature control integrated machine according to claim 1, characterized in that, The turnover box is equipped with an ultraviolet sterilization device.

6. The cell therapy injection constant temperature control integrated machine according to claim 1, characterized in that, It also includes several shock-absorbing structures (5) installed at the bottom of the turnover box, which can provide shock-absorbing buffer support for the turnover box.

7. The cell therapy injection constant temperature control integrated machine according to claim 1, characterized in that, It also includes a display screen (6) and an operation panel (7) located on the outside of the turnover box.

8. The control method for the cell therapy injection constant temperature control integrated machine according to any one of claims 1-7, characterized in that, The control method includes the following steps: S1: Place the cell therapy injection into the turnover box and clamp and fix the injection using a shaking and mixing mechanism; S2: Based on the needs of the usage stage, activate the temperature regulation module to adjust the internal temperature of the turnover box to the corresponding temperature suitable for transportation, recovery or return. S3: Activate the oscillation and mixing mechanism to oscillate and mix the cell therapy injection in the turnover box to maintain the suspension of stem cells in the injection. S4: When entering the reinfusion stage, activate the temperature regulation module to adjust the internal temperature of the turnover box to the temperature required for reinfusion; then activate the cell therapy injection flow control module to adjust the flow rate of the injection in the output tubing to the set value. S5: During operation, the temperature regulation module and the oscillation and shaking mechanism are kept working continuously, and the cell therapy injection flow control module outputs a stable flow until the injection is used or transported, at which point all modules are turned off.

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