Perfusate suspension device with dual-redundancy pressure protection

Abstract

The invention discloses a perfusate suspension device with dual-redundancy pressure protection, relates to the technical field of lavage after tibial osteomyelitis in the children orthopedics department, and aims to solve the problem that an existing perfusate suspension device is difficult to operate in lavage after tibial osteomyelitis in children. The technical problems that in the prior art, a dynamic pressure protection mechanism matched with child bone growth is lacked, interference of temperature on pressure monitoring is not eliminated, redundant protection is not achieved, and bone wall damage or incomplete lavage is likely to happen are solved, and the device comprises a hanging assembly used for bearing a perfusate container; the perfusion assembly comprises a perfusion pipeline and a lavage needle, and the two ends of the perfusion pipeline are connected with an outlet of the perfusate container and the lavage needle respectively; and the dual-redundancy pressure monitoring module comprises two independent pressure acquisition paths which are used for respectively acquiring the pressure in the marrow cavity and the pressure in the perfusion pipeline, and the two acquisition paths are synchronously connected to the temperature compensation unit. The device has the advantages that accurate pressure monitoring and dynamic threshold adjustment are achieved, and the child lavage safety and effect are guaranteed.

Description

Technical Field

[0001] This invention relates to the field of irrigation technology after pediatric orthopedic tibial osteomyelitis surgery, and more specifically, to an irrigation fluid suspension device with dual redundancy pressure protection. Background Technology

[0002] In pediatric orthopedic clinical practice, children with tibial osteomyelitis require continuous irrigation for 7-14 days after surgery. This is to remove residual pus and necrotic tissue from the medullary cavity through the circulation of the irrigation fluid, while inhibiting bacterial growth and creating a clean environment for bone tissue repair. Children's tibias are in a rapid growth phase, and the diameter of the medullary cavity can increase by 0.3-0.8 mm during the irrigation period. Moreover, the bone wall thickness is only 1 / 3-1 / 2 that of adults, making it extremely vulnerable to pressure. At the same time, fluctuations in the temperature of the irrigation fluid and the ambient temperature of the operating room directly affect the accuracy of the pressure sensor, further increasing the difficulty of pressure control.

[0003] Existing irrigation fluid suspension devices generally follow the design logic of adult orthopedic irrigation, which has significant adaptation defects: First, they use a fixed pressure protection threshold, which cannot be dynamically adjusted according to the growth of the tibia in children. In the early stages of irrigation, the threshold is too high, causing the pressure to exceed the tolerance limit of the bone wall and triggering microcracks. In the later stages, the threshold is too low, resulting in insufficient irrigation fluid flow rate and incomplete cleaning of lesions. Second, they lack a temperature compensation mechanism, and the data collected by the pressure sensor is easily affected by temperature fluctuations. For example, for every 1°C drop in the irrigation fluid temperature, the pressure monitoring value deviation can reach 3%-5%, which can lead to malfunction of the pressure relief valve. Third, relying solely on a non-redundant design of "single sensor + single pressure relief valve" means that if the sensor fails or the pressure relief valve becomes stuck, there is no backup protection path, which can easily lead to a sudden increase in pressure that damages the bone wall or a sudden drop in pressure that interrupts irrigation. In view of this, we propose an irrigation fluid suspension device with dual redundancy pressure protection. Summary of the Invention

[0004] The purpose of this invention is to provide a double-redundant pressure-protected perfusion fluid suspension device to solve the technical problems of existing perfusion fluid suspension devices in the postoperative irrigation of children with tibial osteomyelitis, which lack a dynamic pressure protection mechanism adapted to children's bone growth, do not eliminate the interference of temperature on pressure monitoring, and have no redundancy protection, which easily leads to bone wall damage or incomplete irrigation.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a perfusion fluid suspension device with dual redundancy pressure protection, comprising:

[0006] Suspension assembly for supporting the filling fluid container;

[0007] The infusion assembly includes an infusion line and an infusion needle, with the infusion line connected to the outlet of the infusion fluid container and the infusion needle at both ends, respectively.

[0008] The dual-redundant pressure monitoring module includes two independent pressure acquisition paths, which acquire pressure in the bone marrow cavity and pressure in the perfusion tubing, respectively. Both acquisition paths are simultaneously connected to a temperature compensation unit to correct for interference from ambient temperature and perfusion fluid temperature on pressure acquisition.

[0009] The dual-redundant pressure protection actuator module includes an electric pressure relief valve and a mechanical pressure relief valve, which can work together according to the degree of pressure abnormality.

[0010] The adaptive control unit is electrically connected to the dual-redundant pressure monitoring module, the dual-redundant pressure protection execution module, the body position linkage component, and the temperature compensation unit, respectively. It has a built-in dynamic adaptation module for children's bone growth and a pipeline deformation recognition module. The dynamic adaptation module for children's bone growth updates the pressure protection threshold according to the tibial growth stage, and the pipeline deformation recognition module can identify the pressure loss caused by the deformation of the infusion pipeline and trigger compensation.

[0011] The body position linkage component is located between the irrigation needle and the suspension component. When the body position of the irrigation needle is detected to be offset, in addition to the linkage suspension component to adjust the container height and pre-start the dual redundant pressure protection execution module, the pressure deviation is also corrected through the pipeline deformation compensation logic.

[0012] The temperature compensation unit, independent of the dual redundant pressure monitoring module, collects the temperature of the perfusion fluid and the ambient temperature in real time, providing dynamic calibration for the pressure acquisition data.

[0013] Preferably, the dual-redundant pressure monitoring module includes an intracavity pressure sensor and a pipeline pressure sensor, and works in conjunction with a temperature compensation unit;

[0014] The intracavitary pressure sensor is integrated into the end of the irrigation needle and is inserted into the tibial medullary cavity along with the irrigation needle.

[0015] The pipeline pressure sensor is located near the outlet of the injection fluid container in the injection pipeline. It uses a different signal transmission protocol than the intracavity pressure sensor to achieve independent transmission of the two pressure data.

[0016] The temperature compensation unit is attached to the cavity pressure sensor and the pipeline pressure sensor respectively, and has a built-in temperature-pressure correction model. When the temperature of the injection fluid or the ambient temperature changes, it automatically corrects the pressure data collected by the two sensors.

[0017] The output signals of the intracavity pressure sensor, pipeline pressure sensor and temperature compensation unit are all connected to the adaptive control unit, forming a three-level monitoring logic of "pressure acquisition-temperature calibration-data cross-verification";

[0018] The temperature-pressure correction model achieves dynamic calibration of pressure data using the following formula:

[0019] ;

[0020] in, This is the pressure value after temperature calibration. The raw pressure value collected by the sensor. The temperature coefficient of the injection fluid. For ambient temperature coefficient, For real-time perfusion fluid temperature, For real-time ambient temperature, This is the standard reference temperature.

[0021] Preferably, the electric pressure relief valve is connected in series in the injection pipeline and electrically connected to the adaptive control unit, and the valve opening is adjusted in stages according to the degree of pressure abnormality;

[0022] The mechanical pressure relief valve is connected in parallel to the electric pressure relief valve and adopts a spring-type structure. Its trigger pressure threshold and the graded adjustment threshold of the electric pressure relief valve form a stepped protection. Moreover, the trigger threshold of the mechanical pressure relief valve is higher than the highest graded adjustment threshold of the electric pressure relief valve. When the electric pressure relief valve fails or the injection pressure rises suddenly beyond the adjustment range of the electric pressure relief valve, the mechanical pressure relief valve automatically opens to release pressure.

[0023] The dual-redundant pressure protection execution module also includes a flow coordination unit, which is linked to the electric pressure relief valve, the mechanical pressure relief valve and the suspension assembly respectively. When any pressure relief valve is activated, the flow coordination unit synchronously sends a flow adjustment command to the suspension assembly to maintain the irrigation flow rate within the preset range by finely adjusting the height of the irrigation fluid container.

[0024] The target opening degree for the graded adjustment of the electric pressure relief valve is calculated using the following formula:

[0025] ;

[0026] in, The target opening degree for the electric pressure relief valve. This is the maximum safe opening degree of the electric pressure relief valve. This is the real-time pressure value after temperature calibration. To ensure the maximum safe pressure for rinsing, The upper limit of the flushing warning pressure is less than the trigger threshold of the mechanical pressure relief valve. This forms a tiered protection system.

[0027] Preferably, the adaptive control unit has a built-in dynamic adaptation module for pediatric bone growth, which can receive tibial imaging data obtained before or during surgery, and dynamically update the action threshold of the dual-redundant pressure protection execution module according to the growth changes of the pediatric tibia during the irrigation cycle.

[0028] The pipeline deformation identification module identifies pressure loss caused by bending and squeezing of the infusion pipeline by comparing the rate of change of the difference between the data collected by the cavity pressure sensor and the pipeline pressure sensor in real time. When the rate of change of the difference exceeds the preset range, the compensation action of the body position linkage component is automatically triggered, and the pressure protection threshold of the dual redundant pressure protection execution module is corrected to eliminate the interference of pipeline deformation on pressure monitoring.

[0029] The adaptive control unit also has a fault self-diagnosis function, which can locate the failed component in the dual redundant pressure monitoring module or dual redundant pressure protection execution module, and give priority to activating the backup monitoring path or backup protection unit.

[0030] The dynamic threshold update for children's bone growth is calculated using the following formula to determine the real-time safe pressure limit:

[0031] ;

[0032] in, The upper limit of safe rinsing pressure for children in real time. For initial safety pressure, For the rinsing cycle, This is the current diameter of the tibial medullary cavity. This represents the initial diameter of the tibial medullary cavity;

[0033] The formula for correcting pressure loss due to pipeline deformation is:

[0034] ;

[0035] ;

[0036] in, Pressure loss due to pipeline deformation The intracavity pressure is calibrated for temperature. For temperature-calibrated pipeline pressure, This is the pressure difference value of a normal pipeline. To correct for the actual intracavity pressure after pipeline deformation.

[0037] Preferably, the body position linkage component includes a body position sensor, an electric lifting mechanism, and a pipeline deformation compensation algorithm;

[0038] The body position sensor is integrated into the tail of the irrigation needle and uses a three-axis gyroscope to monitor the spatial attitude of the irrigation needle in real time. When the irrigation needle is detected to be tilted or displaced, a signal containing complete attitude information is generated.

[0039] The electric lifting mechanism is located on the suspension assembly. After receiving the attitude signal, in addition to adjusting the height of the infusion fluid container, it also calculates the change in the length of the infusion pipeline caused by the displacement of the infusion needle through the pipeline deformation compensation algorithm, and then corrects the container height adjustment amount. When the displacement of the infusion needle exceeds the safe range, the body position linkage component, in addition to triggering the pre-start of the dual redundant pressure protection execution module, also sends a command to the flexible positioning structure on the outer wall of the infusion needle. The micro-deformation of the flexible positioning structure helps to fix the infusion needle and reduce its further displacement.

[0040] The height correction for the filling fluid container is calculated using the following formula:

[0041] ;

[0042] in, For container height correction, To correct for the actual intracavity pressure after pipeline deformation, To achieve the target of rinsing pressure, The density of the perfusion fluid, It is the acceleration due to gravity. The effective length of the injection pipeline. This refers to the offset angle of the irrigation needle.

[0043] Preferably, the dual-redundant pressure monitoring module also has a built-in backup fiber optic pressure sensor, and the adaptive control unit is equipped with sensor active switching logic.

[0044] The backup fiber optic pressure sensor, together with the cavity pressure sensor and the pipeline pressure sensor, forms a "three-path pressure monitoring" system.

[0045] The adaptive control unit monitors the signal stability of the cavity pressure sensor and pipeline pressure sensor in real time. When electromagnetic interference is detected that causes the conventional sensor data to be distorted, the signal transmission of the conventional sensor is automatically cut off and the pressure data is switched to the backup fiber optic pressure sensor. During the switching process, the pressure data continuity is maintained by the temperature compensation unit.

[0046] Once the electromagnetic interference disappears, the adaptive control unit gradually switches the pressure monitoring path back to the conventional sensor to avoid pressure monitoring fluctuations caused by frequent switching.

[0047] The formula for determining signal distortion in conventional sensors is:

[0048] ;

[0049] when This is determined to be signal distortion.

[0050] in, The standard deviation of the calibration pressure over the past 30 seconds. This refers to the number of pressure samples taken within the last 30 seconds. For the first Secondary calibration pressure value. The average calibration pressure over the past 30 seconds. This is the preset maximum permissible standard deviation of signal fluctuation.

[0051] Compared with the prior art, the beneficial effects of the present invention are:

[0052] 1. This invention utilizes a dual-redundant pressure monitoring module (two independent pressure acquisition paths: intracavitary and tubing) in conjunction with a temperature compensation unit to correct for interference from perfusion fluid temperature and ambient temperature on pressure monitoring in real time. Combined with the pediatric bone growth dynamic adaptation module built into the adaptive control unit, it can dynamically update the pressure protection threshold based on preoperative / intraoperative tibial imaging data and irrigation cycle, accurately matching the changes in medullary cavity volume during tibial growth in children. This completely solves the problems of bone wall damage or incomplete irrigation caused by inaccurate pressure monitoring and fixed thresholds in existing devices, significantly reducing the risk of delayed postoperative recovery.

[0053] 2. The dual-redundant pressure protection execution module of this invention adopts a stepped design of "electric pressure relief valve graded adjustment + mechanical pressure relief valve ultimate protection". In conjunction with the flow coordination unit and the suspension assembly, when the pressure is abnormal, it can accurately adjust the opening of the electric pressure relief valve according to the degree of pressure deviation to avoid excessive pressure relief, and can also ensure pressure safety in extreme situations through the mechanical pressure relief valve. At the same time, the flow coordination unit can synchronously fine-tune the height of the perfusion fluid container to maintain the perfusion flow rate within the preset range, avoiding the problem of reduced perfusion efficiency and insufficient lesion cleaning caused by simple pressure relief.

[0054] 3. The body position linkage component (three-axis gyroscope body position sensor + electric lifting mechanism) of the present invention works in conjunction with the tubing deformation recognition module to monitor the body position deviation of the irrigation needle in real time, and calculate the pressure loss through the tubing deformation compensation algorithm to correct the container height adjustment amount; at the same time, the flexible positioning structure on the outer wall of the irrigation needle can fix the needle with slight deformation when the body position deviation exceeds the limit, ensuring that the dynamic pressure protection can still be effective accurately under sudden clinical operation interference (such as tubing bending, needle displacement), avoiding the problem of pressure protection failure and secondary infection caused by external interference. Attached Figure Description

[0055] Figure 1 This is a schematic diagram of the system framework of the present invention. Detailed Implementation

[0056] To facilitate understanding of the technical solution of the present invention by those skilled in the art, the technical solution of the present invention will now be further described in conjunction with the accompanying drawings.

[0057] Example 1, such as Figure 1As shown, the present invention provides a perfusion fluid suspension device with dual redundancy pressure protection, comprising:

[0058] The suspension assembly is used to support the filling fluid container, has the function of adjusting the container height, and integrates a flushing flow auxiliary adjustment structure.

[0059] The infusion assembly includes an infusion tubing and an infusion needle. The two ends of the infusion tubing are connected to the outlet of the infusion fluid container and the infusion needle, respectively. The outer wall of the infusion needle is provided with a flexible positioning structure adapted to the tibia of children.

[0060] The dual-redundant pressure monitoring module includes two independent pressure acquisition paths, which acquire pressure in the bone marrow cavity and pressure in the perfusion tubing, respectively. Both acquisition paths are simultaneously connected to a temperature compensation unit to correct for interference from ambient temperature and perfusion fluid temperature on pressure acquisition.

[0061] The dual-redundant pressure protection actuator module includes an electric pressure relief valve and a mechanical pressure relief valve, which can work together according to the degree of pressure abnormality, and are also associated with the flushing flow to avoid conflict between pressure regulation and flushing efficiency.

[0062] The adaptive control unit is electrically connected to the dual-redundant pressure monitoring module, the dual-redundant pressure protection execution module, the body position linkage component, and the temperature compensation unit, respectively. It has a built-in dynamic adaptation module for children's bone growth and a pipeline deformation recognition module. The dynamic adaptation module for children's bone growth updates the pressure protection threshold according to the tibial growth stage, and the pipeline deformation recognition module can identify the pressure loss caused by the deformation of the infusion pipeline and trigger compensation.

[0063] The body position linkage component is located between the irrigation needle and the suspension component. When the body position of the irrigation needle is detected to be offset, in addition to the linkage suspension component to adjust the container height and pre-start the dual redundant pressure protection execution module, the pressure deviation is also corrected through the pipeline deformation compensation logic.

[0064] The temperature compensation unit, independent of the dual redundant pressure monitoring module, collects the temperature of the perfusion fluid and the ambient temperature in real time, providing dynamic calibration for the pressure acquisition data.

[0065] In an embodiment of the present invention, the dual-redundant pressure monitoring module includes an intracavity pressure sensor and a pipeline pressure sensor, and works in conjunction with a temperature compensation unit.

[0066] The intracavitary pressure sensor is integrated into the end of the irrigation needle and is inserted into the tibial medullary cavity along with the irrigation needle. Its probe surface is coated with an anti-bioadhesion coating to prevent the medullary cavity tissue from encapsulating the sensor and affecting the accuracy of pressure acquisition.

[0067] The pipeline pressure sensor is located near the outlet of the injection fluid container in the injection pipeline. It uses a different signal transmission protocol than the intracavity pressure sensor to achieve independent transmission of the two pressure data.

[0068] The temperature compensation unit is attached to the cavity pressure sensor and the pipeline pressure sensor respectively. It has a built-in temperature-pressure correction model. When the temperature of the injection fluid or the ambient temperature changes, it automatically corrects the pressure data collected by the two sensors to avoid monitoring errors caused by temperature drift.

[0069] The output signals of the intracavity pressure sensor, pipeline pressure sensor and temperature compensation unit are all connected to the adaptive control unit, forming a three-level monitoring logic of "pressure acquisition-temperature calibration-data cross-verification";

[0070] The temperature-pressure correction model achieves dynamic calibration of pressure data using the following formula:

[0071] ;

[0072] in, The pressure value after temperature calibration (unit: mmHg) is the core data used for subsequent pressure judgment and control after correction, and directly determines the action basis of the pressure protection execution module;

[0073] The raw pressure values ​​(unit: mmHg) collected by the sensor have not been corrected for temperature and may contain errors due to temperature changes.

[0074] The temperature coefficient of the injection fluid (unit: °C⁻¹) is determined by the physical properties of the injection fluid (such as the variation of density and viscosity with temperature). Different types of injection fluids correspond to different coefficients.

[0075] The ambient temperature coefficient (unit: °C⁻¹) is determined by the sensor material properties (such as the temperature sensitivity of metal strain gauges) and reflects the influence of ambient temperature on the sensor itself.

[0076] The real-time temperature of the infusion fluid (unit: °C) is collected in real time by the temperature sensor of the temperature compensation unit and is directly related to the physical state of the infusion fluid.

[0077] The real-time ambient temperature (unit: °C) is also collected by the temperature compensation unit, reflecting the temperature of the surgical environment or ward environment.

[0078] The standard reference temperature (default 25℃) is the industry-recognized reference temperature for pressure monitoring and is used as a standard for unified pressure calibration.

[0079] The core of this algorithm is to eliminate the interference of temperature on pressure acquisition. By introducing the temperature coefficient of the infusion fluid and the ambient temperature coefficient, the original pressure value collected by the sensor is corrected to an accurate pressure value that conforms to the standard reference temperature. First, the difference between the infusion fluid temperature, the ambient temperature, and the reference temperature is calculated, and then multiplied by the corresponding temperature coefficient to obtain the temperature influence. Then, the original pressure value is multiplied by "1 + the total temperature influence" to finally obtain the calibrated pressure value, ensuring the accuracy of pressure monitoring under different temperature environments.

[0080] This temperature correction algorithm effectively solves the pressure monitoring error problem caused by changes in irrigation fluid temperature and fluctuations in ambient temperature, ensuring that pressure monitoring data remains accurate regardless of changes in the surgical environment temperature or changes in the temperature of the irrigation fluid during use. This provides a reliable pressure data foundation for the subsequent graded actions of the dual-redundant pressure protection execution module and the precise adjustment of the body position linkage component, avoiding pressure misjudgment due to temperature interference, and thus reducing the clinical risks caused by abnormal irrigation pressure.

[0081] In an embodiment of the present invention, an electric pressure relief valve is connected in series with the infusion pipeline and electrically connected to the adaptive control unit. The valve opening is adjusted in stages according to the degree of pressure abnormality, rather than simply achieving full opening or full closing, so as to avoid the sudden drop in pressure affecting the bone marrow cavity irrigation effect.

[0082] The mechanical pressure relief valve is connected in parallel to the electric pressure relief valve and adopts a spring-type structure. Its trigger pressure threshold and the graded adjustment threshold of the electric pressure relief valve form a stepped protection. Moreover, the trigger threshold of the mechanical pressure relief valve is higher than the highest graded adjustment threshold of the electric pressure relief valve. When the electric pressure relief valve fails or the injection pressure rises suddenly beyond the adjustment range of the electric pressure relief valve, the mechanical pressure relief valve automatically opens to release pressure.

[0083] The dual-redundant pressure protection execution module also includes a flow coordination unit, which is linked to the electric pressure relief valve, the mechanical pressure relief valve and the suspension assembly respectively. When any pressure relief valve is activated, the flow coordination unit synchronously sends a flow adjustment command to the suspension assembly, and maintains the irrigation flow rate within the preset range by finely adjusting the height of the irrigation fluid container.

[0084] The target opening degree for the graded adjustment of the electric pressure relief valve is calculated using the following formula:

[0085] ;

[0086] in, The target opening degree of the electric pressure relief valve (unit: %), where 0% indicates that the valve is completely closed and 100% indicates that it is fully open, directly determining the pressure relief rate and the degree of retention of flushing flow;

[0087] This is the maximum safe opening of the electric pressure relief valve (default 80%), which is the upper limit of opening that balances pressure relief efficiency and rinsing continuity, avoiding excessively low rinsing flow due to full opening;

[0088] The real-time pressure value (unit: mmHg) is calibrated for temperature to ensure the accuracy of the pressure data.

[0089] The upper limit of safe irrigation pressure (unit: mmHg) is the critical value for clinically determining that the irrigation pressure is within the safe range. There is no need to release pressure if it is below this value.

[0090] The upper limit of the flushing warning pressure (unit: mmHg) is the critical value that triggers the electric pressure relief valve, and it must be less than the trigger threshold of the mechanical pressure relief valve. This forms a tiered protection system;

[0091] The trigger threshold for the mechanical pressure relief valve (unit: mmHg) is the final protection threshold after the failure of the electric pressure relief valve, ensuring that the pressure does not exceed the dangerous range.

[0092] This algorithm aims to balance pressure protection and flushing efficiency, avoiding sudden pressure drops or flushing interruptions caused by the traditional "open or close" mode. First, it calculates the difference between the real-time pressure after temperature calibration and the upper limit of the safe pressure. Then, it divides this difference by the difference between the upper limit of the warning pressure and the upper limit of the safe pressure to obtain the pressure deviation ratio. Finally, it multiplies this ratio by the maximum safe opening of the electric pressure relief valve to determine the target valve opening. The smaller the pressure deviation, the smaller the valve opening, which can alleviate pressure anomalies while maintaining a basic flushing flow rate; the larger the pressure deviation, the larger the valve opening, quickly reducing the pressure to a safe range.

[0093] This tiered opening adjustment algorithm breaks away from the traditional "one-size-fits-all" control mode of pressure relief valves, achieving precise adjustment of pressure protection. When the pressure slightly exceeds the limit, a small opening is used to relieve pressure and maintain irrigation efficiency, avoiding the impact of excessive pressure relief on lesion cleaning. When the pressure significantly exceeds the limit, a large opening is used to quickly relieve pressure and ensure safety. This, combined with the stepped protection of the mechanical pressure relief valve, forms a dual pressure protection system of "precise adjustment + ultimate guarantee." This design not only meets the clinical needs for irrigation efficiency but also further improves the reliability of pressure protection, reducing the risks caused by sudden pressure drops or untimely protection.

[0094] In an embodiment of the present invention, the adaptive control unit has a built-in dynamic adaptation module for pediatric bone growth, which can receive tibial imaging data (including medullary cavity volume and bone wall thickness) obtained before or during surgery, and dynamically update the action threshold of the dual-redundant pressure protection execution module according to the growth changes of the child's tibia during the irrigation cycle (such as bone development 1-2 weeks after surgery), so as to avoid the fixed threshold being overprotected or underprotected due to the growth of the child's bones.

[0095] The pipeline deformation identification module identifies pressure loss caused by bending and squeezing of the injection pipeline by comparing the rate of change of the difference between the data collected by the cavity pressure sensor and the pipeline pressure sensor in real time. When the rate of change of the difference exceeds the preset range, the compensation action of the body position linkage component is automatically triggered, and the pressure protection threshold of the dual redundant pressure protection execution module is corrected to eliminate the interference of pipeline deformation on pressure monitoring.

[0096] The adaptive control unit also has a fault self-diagnosis function, which can locate the failed component (such as a pressure sensor or electric pressure relief valve) in the dual redundant pressure monitoring module or dual redundant pressure protection execution module, and give priority to activating the backup monitoring path or backup protection unit.

[0097] The dynamic threshold update for children's bone growth is calculated using the following formula to determine the real-time safe pressure limit:

[0098] ;

[0099] in, The upper limit of safe pressure for real-time irrigation of children (unit: mmHg) is a critical value of safe pressure that is adapted to the current condition of the child's tibia.

[0100] The initial safe pressure (unit: mmHg) is determined based on the preoperative tibial diameter of the child and serves as the benchmark for safe pressure during the initial irrigation phase.

[0101] The irrigation cycle (unit: week) reflects the time span of children's bone growth. The longer the time, the greater the impact of bone growth on the pressure threshold.

[0102] The current diameter of the tibial medullary cavity (unit: mm) is obtained from intraoperative imaging data and reflects the actual cavity diameter after bone growth.

[0103] The initial diameter of the tibial medullary cavity (unit: mm) is obtained from preoperative imaging data and serves as a reference for changes in bone growth.

[0104] This algorithm addresses the issue of mismatched fixed pressure thresholds caused by bone growth during lavage in children with tibial osteomyelitis. Based on an initial safe pressure, it dynamically adjusts the upper limit of the safe pressure by considering the bone growth time and changes in the tibial medullary cavity diameter during the lavage cycle. First, a correction coefficient (1 + 0.05 × t) corresponding to the bone growth time is calculated. Then, the ratio of the current tibial diameter to the initial diameter is calculated. The two are multiplied, and then multiplied by the initial safe pressure to obtain a real-time safe pressure upper limit adapted to the current bone state, ensuring that the pressure threshold is updated synchronously with the child's bone growth.

[0105] This dynamic threshold update algorithm is the first to incorporate children's bone growth characteristics into the irrigation pressure protection system, avoiding the problems of "overprotection" (too low pressure affecting irrigation effect) or "underprotection" (too high pressure damaging bone wall) caused by bone growth during long-term irrigation of children using traditional fixed thresholds. By adapting to the child's bone status in real time, it ensures that the pressure protection is always at the optimal level throughout the entire irrigation cycle, significantly improving the safety and effectiveness of irrigation for tibial osteomyelitis in children and filling the gap in pressure protection solutions specifically for children.

[0106] The formula for correcting pressure loss due to pipeline deformation is:

[0107] ;

[0108] ;

[0109] in, Pressure loss due to pipeline deformation (unit: mmHg), reflecting the degree of influence of pipeline deformation on pressure transmission;

[0110] The intracavitary pressure (unit: mmHg) is temperature-calibrated and collected directly from the bone marrow cavity;

[0111] The pressure is temperature-calibrated inline pressure (unit: mmHg), collected from the proximal end of the injection line;

[0112] The pressure difference in a normal pipeline (unit: mmHg) is determined experimentally and reflects the inherent difference between the pressure inside the cavity and the pipeline when there is no pipeline deformation.

[0113] The actual intracavity pressure (unit: mmHg) after pipeline deformation is corrected; it is the real intracavity pressure data used for pressure judgment and control.

[0114] This algorithm is used to eliminate pressure monitoring errors caused by deformation of the perfusion tubing, such as bending and compression, to ensure accurate acquisition of intramedullary pressure. First, the absolute difference between the temperature-calibrated intramedullary pressure and the tubing pressure is calculated. This difference is then subtracted from the standard pressure difference of a normal tubing line to obtain the pressure loss caused by tubing deformation. Finally, this pressure loss is added to the intramedullary pressure to obtain the corrected actual intramedullary pressure, thus eliminating the interference of tubing deformation on pressure assessment.

[0115] This tubing deformation correction algorithm effectively solves the problem of pressure misjudgment caused by accidental bending or compression of the tubing during clinical irrigation. By accurately calculating the pressure loss caused by tubing deformation, it ensures that the adaptive control unit obtains the true intramedullary pressure, avoiding malfunctions of the protection execution module due to distorted pressure data (such as mistakenly judging the pressure as too low and increasing the irrigation pressure, or mistakenly judging the pressure as normal and failing to release pressure in time). This design further improves the accuracy of pressure monitoring, providing a reliable basis for the compensation actions of subsequent body position linkage components, and ensuring the stability and safety of the irrigation process.

[0116] In an embodiment of the present invention, the body position linkage component includes a body position sensor, an electric lifting mechanism, and a pipeline deformation compensation algorithm;

[0117] The body position sensor is integrated into the tail of the irrigation needle. It uses a three-axis gyroscope to monitor the spatial attitude of the irrigation needle in real time (including the direction of displacement, the angle of displacement, and the magnitude of displacement), rather than just monitoring the angle of displacement. When the tilt or displacement of the irrigation needle is detected, a signal containing complete attitude information is generated.

[0118] The electric lifting mechanism is located on the suspension assembly. After receiving the attitude signal, in addition to adjusting the height of the infusion fluid container, it also calculates the change in the length of the infusion pipeline caused by the displacement of the infusion needle through the pipeline deformation compensation algorithm, and then corrects the container height adjustment amount to ensure the accuracy of the infusion pressure compensation. When the displacement of the infusion needle exceeds the safe range, the body position linkage component, in addition to triggering the pre-start of the dual redundant pressure protection execution module, also sends a command to the flexible positioning structure on the outer wall of the infusion needle. The micro-deformation of the flexible positioning structure helps to fix the infusion needle and reduce its further displacement.

[0119] The height correction for the filling fluid container is calculated using the following formula:

[0120] ;

[0121] in, This is the container height correction amount (unit: mm). A positive value indicates that the container needs to be raised to increase the pressure, while a negative value indicates that the container needs to be lowered to reduce the pressure. It directly determines the magnitude of the pressure compensation.

[0122] To correct for the actual intracavity pressure (unit: mmHg) after pipeline deformation, and to ensure the accuracy of pressure data;

[0123] The target irrigation pressure (unit: mmHg) is the optimal irrigation pressure value set clinically, and also the benchmark for highly adjustable target pressure.

[0124] The density of the injection fluid (unit: kg / m³, default 1000 kg / m³) reflects the influence of the gravity characteristics of the injection fluid on the pressure.

[0125] It is the acceleration due to gravity (unit: m / s², default 9.8 m / s²), which is a key physical quantity relating pressure and liquid column height under the action of gravity;

[0126] The effective length of the infusion tubing (unit: mm) refers to the length of the tubing from the outlet of the infusion fluid container to the end of the infusion needle, and the amount of change in tubing length affected by body position displacement.

[0127] The angle of the irrigation needle offset (unit: rad) is collected by a three-axis gyroscope, reflecting the degree of tilt of the irrigation needle in space, and is directly related to the change in pipeline length;

[0128] This algorithm corrects for pressure changes caused by needle displacement during irrigation by adjusting the height of the irrigation fluid container. First, it calculates the difference between the actual intracavitary pressure after correcting tubing deformation and the target irrigation pressure. Based on the irrigation fluid density and gravitational acceleration, this pressure difference is converted into a corresponding basic adjustment for the container height. Then, it calculates the height compensation for the change in tubing length caused by the needle displacement angle. The two are added together to obtain the final container height correction, ensuring that the height adjustment accurately offsets the pressure effect of the displacement.

[0129] This height correction algorithm decomposes the impact of body position deviation on pressure into "basic adjustment corresponding to the pressure difference" and "compensation adjustment corresponding to changes in tubing length," achieving precise body position-linked compensation. Compared to traditional methods that adjust height solely based on pressure difference, this algorithm further considers changes in tubing length caused by body position deviation, avoiding issues of undercompensation or overcompensation. By precisely adjusting the container height, it ensures that even if the irrigation needle shifts due to pediatric agitation or surgical procedures, the irrigation pressure can quickly return to the target range, maintaining the stability of the irrigation effect. Simultaneously, it reduces clinical risks caused by pressure fluctuations, improving the flexibility and safety of surgical procedures.

[0130] In an embodiment of the present invention, a pressure feedback component is also included. The pressure feedback component is electrically connected to the dual redundant pressure monitoring module and the adaptive control unit, and is respectively located at the operating end of the irrigation needle and the operating panel of the suspension component.

[0131] The pressure feedback component adopts a combination of indicator lights and fault codes. Different colored indicator lights correspond to the pressure safety status, pressure warning status, and pressure fault status collected by the dual redundant pressure monitoring module. When the pressure fault status is in the fault status, the fault code is displayed simultaneously, which makes it easy for operators to quickly locate the failed component.

[0132] Meanwhile, the pressure feedback component can receive compensation action commands (such as temperature calibration commands and pipeline deformation compensation commands) sent by the adaptive control unit, and indicate the progress of the compensation action through the flashing frequency of the indicator lights, so as to avoid operators misjudging the current pressure status.

[0133] The formula relating the flashing frequency of the indicator light on the pressure feedback component to the compensation progress is as follows:

[0134] ;

[0135] in, The indicator light flashes at a real-time frequency (unit: Hz), reflecting the current progress of the compensation action. The frequency change is intuitive and easy to observe.

[0136] The maximum flashing frequency (default 5Hz) is the flashing frequency used to compensate for the completion of the action, serving as a visual signal of progress completion.

[0137] The compensation progress (unit: %) is calculated by the adaptive control unit based on the completion status of the compensation action. 0% indicates that compensation has not started, and 100% indicates that compensation has been completed.

[0138] This algorithm is used to link the pressure feedback component and the adaptive control unit, visually reflecting the progress of compensation actions (such as temperature calibration and pipeline deformation compensation) through the flashing frequency of indicator lights. Based on the maximum flashing frequency, the progress (percentage) of the compensation action is linearly correlated with the flashing frequency; the lower the compensation progress, the lower the flashing frequency; the higher the compensation progress, the higher the flashing frequency. When compensation is complete (progress 100%), the flashing frequency reaches its maximum, allowing operators to monitor the dynamics of the compensation action in real time.

[0139] This flashing frequency correlation algorithm transforms the abstract progress of compensation actions into intuitive visual signals, solving the problem of operators struggling to monitor compensation dynamics in real time. During compensation, frequency changes allow operators to clearly understand whether compensation is progressing normally, avoiding misoperations due to information asymmetry (such as mistakenly believing pressure has stabilized before compensation is complete). Once compensation is complete, the flashing signal at the highest frequency quickly alerts the operator that the pressure has returned to normal, eliminating the need for continuous monitoring. This design improves the device's user-friendliness, reduces operational risks caused by information asymmetry, lightens the monitoring burden on operators, and increases clinical work efficiency.

[0140] In an embodiment of the present invention, the infusion pipeline is made of anti-bend silicone material, and a one-way flow restriction structure is provided at the inlet of the pressure buffer bladder in the middle section of the infusion pipeline.

[0141] The pressure buffer bladder is an elastic bladder structure. When the local pressure rises suddenly due to an accidental bend in the infusion tubing, the elastic bladder expands to temporarily store some of the infusion fluid, so as to alleviate the pressure fluctuation amplitude and prevent the instantaneous high pressure from being directly transmitted to the tibial medullary cavity. At the same time, it provides a buffer time for the action triggering of the dual redundant pressure protection execution module.

[0142] The unidirectional flow-limiting structure only allows the perfusion fluid to flow from the perfusion fluid container to the pressure buffer bladder, preventing the perfusion fluid temporarily stored in the pressure buffer bladder from flowing back to the perfusion fluid container and ensuring the continuity of the perfusion process. The outer wall of the pressure buffer bladder is equipped with a pressure sensing strip, which is electrically connected to the adaptive control unit. When the pressure buffer bladder expands to a preset volume (corresponding to the degree of bending of the perfusion pipeline exceeding the safe range), the pressure sensing strip sends a pipeline maintenance signal to the adaptive control unit, prompting the operator to handle the bent perfusion pipeline and avoid pipeline damage caused by long-term deformation.

[0143] The formula relating the pressure buffer bladder volume to the degree of pipe bend is:

[0144] ;

[0145] in, The real-time volume of the pressure buffer bladder (unit: mL) reflects the current degree of expansion of the buffer bladder and indirectly reflects the sudden pressure rise caused by pipeline bends.

[0146] The initial volume of the buffer bladder (unit: mL) is the volume of the buffer bladder when there are no tubing bends and the pressure is normal, and it serves as a benchmark for judging the degree of expansion.

[0147] The buffer bladder volume coefficient (unit: mL / mmHg) is determined by the bladder material (such as elastic modulus) and reflects the degree of influence of a sudden increase in pressure on volume expansion.

[0148] This represents the instantaneous pressure surge in the pipeline (unit: mmHg). The difference between the temperature-calibrated pipeline pressure and the upper limit of the safe pressure directly reflects the degree of pressure abnormality caused by pipeline bends.

[0149] For temperature-calibrated pipeline pressure (unit: mmHg), ensure accurate pressure data;

[0150] The upper limit of safe pressure (unit: mmHg) is the critical value for determining whether the pressure is normal. Below this value, there is no sudden pressure rise.

[0151] This algorithm quantifies the correlation between the pressure buffer bladder volume and the degree of pipe bend, indirectly determining the extent of pipe bends through changes in the buffer bladder volume. Based on the initial volume of the buffer bladder, and combined with the instantaneous pressure surge and the buffer bladder volume coefficient, the real-time buffer bladder volume is calculated. The more severe the pipe bend, the greater the instantaneous pressure surge, and the more significant the buffer bladder expansion. When the volume exceeds a preset safety range, a pipe maintenance signal is triggered, prompting operators to address the bend in the pipe.

[0152] This volume correlation algorithm indirectly monitors pipeline bends by changing the volume of the buffer bladder, solving the problem of traditional methods that struggle to detect hidden bends in real time. When a slight bend occurs, the buffer bladder expands to alleviate the sudden pressure surge, providing a buffer time for the dual-redundant pressure protection execution module to trigger its actions. When a severe bend causes the volume to exceed the safe range, a maintenance signal is triggered promptly, preventing persistent pressure anomalies or pipeline damage due to prolonged bends. This design leverages the pressure-relieving function of the buffer bladder while enabling real-time monitoring of the pipeline status, further enhancing the reliability and safety of the irrigation system and reducing the risk of pressure runaway caused by pipeline bends.

[0153] In an embodiment of the present invention, the outer wall of the irrigation needle and the inner wall of the irrigation tubing are provided with an antibacterial coating, and an insulating isolation layer is provided between the intracavitary pressure sensor and the antibacterial coating.

[0154] The antibacterial coating uses a biocompatible material containing silver ions to inhibit the growth of bacteria on the outer wall of the irrigation needle and the inner wall of the irrigation tubing during the irrigation process, thereby reducing the risk of secondary infection of the tibial medullary cavity caused by the irrigation operation.

[0155] The insulating layer is made of medical ceramic material and is attached to the probe surface of the intracavitary pressure sensor. This avoids interference from metal ions in the antibacterial coating with the signal acquisition of the intracavitary pressure sensor and does not affect the transmission efficiency of the pressure signal to the sensor probe.

[0156] Meanwhile, the antibacterial coating is thickened at the connection between the infusion tubing and the irrigation needle to form a sealed antibacterial ring, preventing bacteria from growing in the gaps between the infusion tubing and the irrigation needle.

[0157] In embodiments of the present invention, a remote monitoring module is also included. The remote monitoring module is connected to the adaptive control unit via dual-path wireless communication (WiFi + Bluetooth) and supports multi-terminal collaborative alarm.

[0158] The remote monitoring module receives dual-channel pressure data, irrigation needle position status data, action status data of dual redundant pressure protection execution module, and temperature compensation data transmitted by the adaptive control unit in real time, and generates a pressure trend chart of the irrigation process based on the received data.

[0159] When the system triggers a pressure fault, the remote monitoring module not only pushes an audible and visual alarm to the nurse station terminal, but also sends fault details (including fault type, current pressure value, and suggested handling solution) to the surgeon's mobile terminal, so that the doctor can remotely guide the on-site operators to handle the fault.

[0160] Meanwhile, the remote monitoring module has a data backtracking function, which can export the monitoring data and action records of the entire irrigation process for postoperative efficacy analysis and complication tracing.

[0161] The pressure trend prediction formula for the remote monitoring module (based on data from the past 5 minutes) is as follows:

[0162] ;

[0163] in, The predicted pressure value (unit: mmHg) for the next minute reflects the future trend of pressure changes and provides a basis for early intervention;

[0164] The current pressure value (unit: mmHg) serves as the baseline data for trend prediction.

[0165] The number of pressure samples taken within the last 5 minutes reflects the density of the sampled data; the more samples taken, the more accurate the prediction results.

[0166] For the first The pressure value sampled (unit: mmHg) is one of the pressure sampling data within the past 5 minutes;

[0167] For the first The pressure value sampled (unit: mmHg) is the first... The previous pressure data from the next sampling is used to calculate the pressure change difference;

[0168] The prediction time interval (default 1 minute) is the length of future time corresponding to the predicted pressure.

[0169] This algorithm is used by the remote monitoring module to predict the trend of irrigation pressure. Based on the pressure sampling data of the past 5 minutes, it predicts the pressure value for the next minute. First, it calculates the difference between the pressure of each sampled pressure in the past 5 minutes and the previous sampled pressure, calculates the average value to obtain the average rate of pressure change, multiplies this rate by the prediction time interval, adds it to the current pressure value, and obtains the predicted pressure value for the next minute, helping medical staff to predict the pressure change trend in advance.

[0170] This pressure trend prediction algorithm upgrades remote monitoring from "real-time monitoring" to "early prediction," solving the problem that traditional remote monitoring can only issue alarms after pressure anomalies, lacking the opportunity for early intervention. By predicting future pressure changes, medical staff can take timely intervention measures (such as remotely adjusting the container height or prompting on-site pipeline checks) before the pressure exceeds safe limits, preventing pressure anomalies from occurring. Simultaneously, the predicted data also provides trend references for postoperative efficacy analysis, helping medical staff summarize pressure change patterns during irrigation and optimize subsequent irrigation protocols. This design enhances the initiative and foresight of remote monitoring, further ensuring the safety and stability of the irrigation process, and is particularly suitable for unattended scenarios involving continuous postoperative irrigation.

[0171] In an embodiment of the present invention, the dual-redundant pressure monitoring module also has a built-in backup fiber optic pressure sensor, and the adaptive control unit is equipped with sensor active switching logic.

[0172] The backup fiber optic pressure sensor, together with the intracavitary pressure sensor and the pipeline pressure sensor, forms a "three-path pressure monitoring" system. It is completely unaffected by electromagnetic radiation and is mainly used for pressure monitoring in strong electromagnetic environments such as when the C-arm machine is started during surgery.

[0173] The adaptive control unit monitors the signal stability of the cavity pressure sensor and the pipeline pressure sensor in real time. When electromagnetic interference is detected that causes data distortion of conventional sensors (cavity pressure sensor and pipeline pressure sensor) (such as signal fluctuation amplitude exceeding the preset value), the signal transmission of conventional sensors is automatically cut off and the pressure data is switched to the backup fiber optic pressure sensor. During the switching process, the continuity of pressure data is maintained by the temperature compensation unit.

[0174] Once the electromagnetic interference disappears, the adaptive control unit gradually switches the pressure monitoring path back to the conventional sensor to avoid pressure monitoring fluctuations caused by frequent switching.

[0175] The formula for determining signal distortion in conventional sensors is:

[0176] ;

[0177] when This is determined to be signal distortion.

[0178] in, The standard deviation of the calibration pressure over the past 30 seconds (unit: mmHg) reflects the degree of fluctuation in the pressure data. The larger the standard deviation, the worse the signal stability and the higher the risk of distortion.

[0179] The number of pressure samples taken within the last 30 seconds determines the sample size for data statistics. The larger the sample size, the better the standard deviation calculation results can reflect the true signal fluctuation.

[0180] For the first The calibration pressure value (unit: mmHg) is the basic data used in the standard deviation calculation, ensuring that the data has been freed from temperature interference;

[0181] The average calibration pressure (unit: mmHg) over the past 30 seconds was calculated by analyzing all data within the past 30 seconds. Sum and divide by the number of samples This is used as a benchmark for judging single pressure value fluctuations;

[0182] The maximum permissible standard deviation of signal fluctuation (unit: mmHg) is preset and set according to the clinical irrigation pressure control accuracy requirements. It is the critical value for determining whether the signal is distorted. Below this value, the signal is stable, and above this value, the signal is distorted.

[0183] This algorithm is used to determine whether conventional sensors (internal pressure sensors, pipeline pressure sensors) are causing data distortion due to electromagnetic interference. It assesses signal stability by calculating the standard deviation of the calibration pressure over the past 30 seconds. First, it calculates the squared difference between each calibration pressure value over the past 30 seconds and the average calibration pressure over that time period. Then, it sums all the squared differences and divides by the number of samples to obtain the variance. Finally, it takes the square root of the variance to obtain the standard deviation. When the standard deviation exceeds the preset maximum allowable fluctuation standard deviation, the conventional sensor signal is considered distorted, and the adaptive control unit automatically switches to the backup fiber optic pressure sensor to ensure the continuity and accuracy of pressure monitoring.

[0184] This signal distortion detection algorithm effectively solves the interference problem of conventional pressure sensors caused by strong electromagnetic environments during surgery (such as C-arm activation). It achieves accurate distortion detection by quantifying the degree of signal fluctuation, avoiding misjudgments of pressure data due to electromagnetic interference. Simultaneously, in conjunction with the automatic switching logic of the backup fiber optic pressure sensor, it ensures that pressure monitoring remains continuous and accurate even when the conventional sensor malfunctions, preventing monitoring interruptions or data loss. This design fills the gap in redundant protection for pressure monitoring in strong electromagnetic medical environments, further improving the reliability of the irrigation system in complex surgical environments and ensuring the continuous effectiveness of pressure protection during surgery.

[0185] The embodiments disclosed in this invention are preferred embodiments, but are not limited thereto. Those skilled in the art can easily understand the spirit of this invention based on the above embodiments and make different extensions and variations, but as long as they do not depart from the spirit of this invention, they are all within the protection scope of this invention.

Claims

1. A doubly redundant pressure-protected perfusion fluid suspension device, characterized in that, include: Suspension assembly for supporting the filling fluid container; The infusion assembly includes an infusion line and an infusion needle, with the infusion line connected to the outlet of the infusion fluid container and the infusion needle at both ends, respectively. The dual-redundant pressure monitoring module includes two independent pressure acquisition paths, which acquire pressure in the bone marrow cavity and pressure in the perfusion tubing, respectively. Both acquisition paths are simultaneously connected to a temperature compensation unit to correct for interference from ambient temperature and perfusion fluid temperature on pressure acquisition. The dual-redundant pressure protection actuator module includes an electric pressure relief valve and a mechanical pressure relief valve, which can work together according to the degree of pressure abnormality. The adaptive control unit is electrically connected to the dual-redundant pressure monitoring module, the dual-redundant pressure protection execution module, the body position linkage component, and the temperature compensation unit, respectively. It has a built-in dynamic adaptation module for children's bone growth and a pipeline deformation recognition module. The dynamic adaptation module for children's bone growth updates the pressure protection threshold according to the tibial growth stage, and the pipeline deformation recognition module can identify the pressure loss caused by the deformation of the infusion pipeline and trigger compensation. The body position linkage component is located between the irrigation needle and the suspension component. When the body position of the irrigation needle is detected to be offset, in addition to the linkage suspension component to adjust the container height and pre-start the dual redundant pressure protection execution module, the pressure deviation is also corrected through the pipeline deformation compensation logic. The temperature compensation unit, independent of the dual redundant pressure monitoring module, collects the temperature of the perfusion fluid and the ambient temperature in real time, providing dynamic calibration for the pressure acquisition data.

2. The doubly redundant pressure-protected perfusion fluid suspension device according to claim 1, characterized in that, The dual-redundant pressure monitoring module includes an intracavity pressure sensor and a pipeline pressure sensor, and works in conjunction with a temperature compensation unit. The intracavitary pressure sensor is integrated into the end of the irrigation needle and is inserted into the tibial medullary cavity along with the irrigation needle. The pipeline pressure sensor is located near the outlet of the injection fluid container in the injection pipeline. It uses a different signal transmission protocol than the intracavity pressure sensor to achieve independent transmission of the two pressure data. The temperature compensation unit is attached to the cavity pressure sensor and the pipeline pressure sensor respectively, and has a built-in temperature-pressure correction model. When the temperature of the injection fluid or the ambient temperature changes, it automatically corrects the pressure data collected by the two sensors. The output signals of the intracavity pressure sensor, pipeline pressure sensor and temperature compensation unit are all connected to the adaptive control unit, forming a three-level monitoring logic of "pressure acquisition-temperature calibration-data cross-verification"; The temperature-pressure correction model achieves dynamic calibration of pressure data using the following formula: ； in, This is the pressure value after temperature calibration. The raw pressure value collected by the sensor. The temperature coefficient of the injection fluid. For ambient temperature coefficient, For real-time perfusion fluid temperature, For real-time ambient temperature, This is the standard reference temperature.

3. The perfusion fluid suspension device with dual redundancy pressure protection according to claim 1, characterized in that, The electric pressure relief valve is connected in series in the injection pipeline and electrically connected to the adaptive control unit, which adjusts the valve opening according to the degree of pressure abnormality. The mechanical pressure relief valve is connected in parallel to the electric pressure relief valve and adopts a spring-type structure. Its trigger pressure threshold and the graded adjustment threshold of the electric pressure relief valve form a stepped protection. Moreover, the trigger threshold of the mechanical pressure relief valve is higher than the highest graded adjustment threshold of the electric pressure relief valve. When the electric pressure relief valve fails or the injection pressure rises suddenly beyond the adjustment range of the electric pressure relief valve, the mechanical pressure relief valve automatically opens to release pressure. The dual-redundant pressure protection execution module also includes a flow coordination unit, which is linked to the electric pressure relief valve, the mechanical pressure relief valve and the suspension assembly respectively. When any pressure relief valve is activated, the flow coordination unit synchronously sends a flow adjustment command to the suspension assembly to maintain the irrigation flow rate within the preset range by finely adjusting the height of the irrigation fluid container. The target opening degree for the graded adjustment of the electric pressure relief valve is calculated using the following formula: ； in, The target opening degree for the electric pressure relief valve. This is the maximum safe opening degree of the electric pressure relief valve. This is the real-time pressure value after temperature calibration. To ensure the maximum safe pressure for rinsing, The upper limit of the flushing warning pressure is less than the trigger threshold of the mechanical pressure relief valve. This forms a tiered protection system.

4. The doubly redundant pressure-protected perfusion fluid suspension device according to claim 3, characterized in that, The adaptive control unit has a built-in dynamic adaptation module for pediatric bone growth, which can receive tibial imaging data obtained before or during surgery, and dynamically update the action threshold of the dual-redundant pressure protection execution module according to the growth changes of the child's tibia during the irrigation cycle. The pipeline deformation identification module identifies pressure loss caused by bending and squeezing of the infusion pipeline by comparing the rate of change of the difference between the data collected by the cavity pressure sensor and the pipeline pressure sensor in real time. When the rate of change of the difference exceeds the preset range, the compensation action of the body position linkage component is automatically triggered, and the pressure protection threshold of the dual redundant pressure protection execution module is corrected to eliminate the interference of pipeline deformation on pressure monitoring. The adaptive control unit also has a fault self-diagnosis function, which can locate the failed component in the dual redundant pressure monitoring module or dual redundant pressure protection execution module, and give priority to activating the backup monitoring path or backup protection unit. The dynamic threshold update for children's bone growth is calculated using the following formula to determine the real-time safe pressure limit: ； in, The upper limit of safe rinsing pressure for children in real time. For initial safety pressure, For the rinsing cycle, This is the current diameter of the tibial medullary cavity. This represents the initial diameter of the tibial medullary cavity; The formula for correcting pressure loss due to pipeline deformation is: ； ； in, Pressure loss due to pipeline deformation The intracavity pressure is calibrated for temperature. For temperature-calibrated pipeline pressure, This is the pressure difference value of a normal pipeline. To correct for the actual intracavity pressure after pipeline deformation.

5. The perfusion fluid suspension device with dual redundancy pressure protection according to claim 4, characterized in that, The body position linkage component includes a body position sensor, an electric lifting mechanism, and a pipeline deformation compensation algorithm. The body position sensor is integrated into the tail of the irrigation needle and uses a three-axis gyroscope to monitor the spatial attitude of the irrigation needle in real time. When the irrigation needle is detected to be tilted or displaced, a signal containing complete attitude information is generated. The electric lifting mechanism is located on the suspension assembly. After receiving the attitude signal, in addition to adjusting the height of the infusion fluid container, it also calculates the change in the length of the infusion pipeline caused by the displacement of the infusion needle through the pipeline deformation compensation algorithm, and then corrects the container height adjustment amount. When the displacement of the infusion needle exceeds the safe range, the body position linkage component, in addition to triggering the pre-start of the dual redundant pressure protection execution module, also sends a command to the flexible positioning structure on the outer wall of the infusion needle. The micro-deformation of the flexible positioning structure helps to fix the infusion needle and reduce its further displacement. The height correction for the filling fluid container is calculated using the following formula: ； in, This is the container height correction amount. To correct for the actual intracavity pressure after pipeline deformation, To achieve the target of rinsing pressure, The density of the perfusion fluid, It is the acceleration due to gravity. The effective length of the injection pipeline. This refers to the offset angle of the irrigation needle.

6. The doubly redundant pressure-protected perfusion fluid suspension device according to claim 5, characterized in that, The dual-redundant pressure monitoring module also has a built-in backup fiber optic pressure sensor, and the adaptive control unit is equipped with sensor active switching logic. The backup fiber optic pressure sensor, together with the cavity pressure sensor and the pipeline pressure sensor, forms a "three-path pressure monitoring" system. The adaptive control unit monitors the signal stability of the cavity pressure sensor and pipeline pressure sensor in real time. When electromagnetic interference is detected that causes the conventional sensor data to be distorted, the signal transmission of the conventional sensor is automatically cut off and the pressure data is switched to the backup fiber optic pressure sensor. During the switching process, the pressure data continuity is maintained by the temperature compensation unit. Once the electromagnetic interference disappears, the adaptive control unit gradually switches the pressure monitoring path back to the conventional sensor to avoid pressure monitoring fluctuations caused by frequent switching. The formula for determining signal distortion in conventional sensors is: ； when This is determined to be signal distortion. in, The standard deviation of the calibration pressure over the past 30 seconds. This refers to the number of pressure samples taken within the last 30 seconds. For the first Secondary calibration pressure value. The average calibration pressure over the past 30 seconds. This is the preset maximum permissible standard deviation of signal fluctuation.

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