Method for guaranteeing and early warning abnormity of pressure sensor for electric injection booster

Abstract

The invention belongs to the field of medical instruments, discloses a guarantee and abnormity early warning method for a pressure sensor for an electric injection booster, and aims to solve the problem that hidden faults are easy to miss judgment due to the fact that the prior art only depends on factory single-time calibration. According to the technical scheme, before injection is started or in a clearance no-load stage, actual no-load data of a pressure sensor is compared with standard no-load data to obtain a first difference value, and if the first difference value exceeds a first threshold value, a null drift abnormal mode is switched; in an injection process, comparing data of the sensor at a stable stage before and after a zero point (a contact position with an injector push rod) to obtain a second difference value, and warning if the second difference value is lower than a second threshold value; after injection is completed, the equipment is reset, and after a new instruction is received, the cycle number N is recorded and the process is repeated. A whole-process monitoring system is constructed, zero drift is recognized through no-load comparison, real-time faults are captured through zero-point pressure difference monitoring, progressive degradation is early warned through circulation trend analysis, medical risks are avoided, and the operation reliability of the sensor and the clinical injection safety are remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to a pressure sensor protection and abnormality early warning method for an electric injection booster. BACKGROUND

[0002] In the field of medical injection, for the liquid medicine with strict requirements on injection speed and dose accuracy, manual injection is easily affected by human factors such as hand fatigue and shaking of medical staff, and it is difficult to guarantee the stability and accuracy of the injection process. As a key auxiliary device, the electric injection booster effectively solves this problem by replacing manual injection with a mechanical driving structure, and has become an indispensable tool in clinical precise injection operation. The typical working process of such an electric injection booster has clear stage characteristics: the end of the displacement driving mechanism first performs a rapid displacement action to shorten the preparation time from device start to contact with the syringe plunger; when the driving end contacts the end of the syringe plunger and generates an initial pressure, the driving mechanism switches to a constant speed mode to push the plunger, thereby ensuring that the liquid medicine is injected into the patient's body at a preset accurate rate. In order to monitor the contact state of the driving end and the plunger and the pressure change in the injection process and guarantee the stability of the device operation, the existing technology generally adopts a scheme of setting a pressure sensor at the displacement driving end to realize real-time monitoring of the injection process through pressure signal feedback.

[0003] However, the application of the pressure sensor in the current electric injection booster has significant technical defects. The performance protection of the existing device for the pressure sensor relies on single calibration at the factory stage, and lacks a dynamic monitoring mechanism for the use process. In clinical actual application, the pressure sensor is easily affected by factors such as repeated mechanical contact, liquid corrosion, changes in environmental temperature and humidity, and long-term use wear, and is prone to problems such as accuracy drift, zero point offset, or failure of the sensing element. Due to the lack of effective state monitoring and early warning means, these performance degradation or failures cannot be detected in time, which may lead to misjudgment or omission of the contact state and injection pressure by the device.

[0004] The above problems not only destroy the stability of the injection speed and reduce the liquid medicine infusion accuracy, but also may cause serious medical safety risks: if the sensor fails to identify the plunger contact state, it may cause empty pushing or injection lag, delaying critical treatment operations; if the pressure signal is false, it may cause the device to stop abnormally or continuously overload injection, which may cause liquid dose deviation, even cause medical accidents such as tissue damage, and cause irreversible health hazards to patients. Therefore, how to build a reliability protection system for the pressure sensor and establish an effective abnormality early warning mechanism has become a key technical requirement to improve the clinical safety and operation stability of the electric injection booster. SUMMARY

[0005] The purpose of the present application is to provide a pressure sensor construction reliability guarantee system for an electric injection booster and establish an effective abnormality early warning mechanism.

[0006] The embodiments of the present application can be implemented by the following technical solutions: A pressure sensor guarantee and abnormality early warning method for an electric injection booster, comprising the following steps: S1: Before each injection start or in the idle stage of the injection gap, comparing the actual idle data collected by the pressure sensor with the standard idle data in the standard database and obtaining a first difference value; if the first difference value is greater than a first threshold value, switching to a zero drift abnormality mode, otherwise executing step S2; S2: During the execution of a single injection by the electric injection booster, comparing the actual pressure data of the pressure sensor before and after the zero point and obtaining a second difference value and recording; if the second difference value is less than a second threshold value, switching to an early warning mode, otherwise executing step S3; Wherein, the zero point is the position when the end of the pressure sensor contacts the injector push rod; S3: Complete the current single injection operation, control the electric injection booster to reset to a standby state, and wait for the next injection start instruction; S4: After obtaining a new injection start instruction, record the number of cycles N of steps S1-S3 and execute steps S1-S3 cyclically.

[0007] Further, the zero point confirmation in step S2 is implemented by a redundancy mechanism.

[0008] Further, the redundancy mechanism is to confirm the zero point by starting and stopping multiple times within the preset zero point range of the pressure sensor.

[0009] Preferably, the number of start and stop settings is 3-5 times.

[0010] Further, the preset start position of the pressure sensor is determined based on the injector specifications and the preset injection parameters.

[0011] Preferably, the zero point confirmation in step S2 is implemented by combining the sampling frequency improvement mechanism with the redundancy mechanism.

[0012] Preferably, the step S4 further comprises the following steps: when N is greater than or equal to a first preset number, step S2 is replaced by: during the process of performing a single injection by the electric injection booster, comparing and obtaining a second difference value based on the actual pressure data of the pressure sensor in the stable running phase before and after the zero point and recording, while calling the second difference values recorded in the previous M cycles, counting the number of times that the current second difference value shows a gradual decreasing trend compared with the previous M second difference values, if the number of decreasing times is greater than a second preset number, and the current second difference value is less than a second threshold value, switching to a warning mode, otherwise, performing step S3; wherein N>M>the second preset number.

[0013] Further, the first preset number is determined based on accurate corresponding abnormal pressure difference, and the second preset number is determined based on gradual trend and response sensitivity.

[0014] Further, the second threshold value is determined based on a normal reference value as a basis and combined with safety redundancy.

[0015] Further, in the step S1, the first difference value is calculated by the following formula: ; wherein, is the pressure data of the actual no-load, is the pressure data of the standard no-load, is the pressure data of the standard full scale.

[0016] The method for guaranteeing and abnormally warning the pressure sensor of the electric injection booster provided by the embodiment has at least the following beneficial effects: The application breaks through the limitation of relying only on single calibration at the factory, and constructs a whole-process monitoring system of “self-checking phase-running phase-long-term use phase”. By comparing the no-load before / after injection, the zero drift anomaly is quickly identified; by monitoring the pressure difference before and after the zero point during running, real-time faults are captured; by trend analysis after multiple cycles, progressive degradation such as falling off and sensitivity decrease is accurately identified. The whole cycle covers to avoid the medical risk caused by the accumulation of hidden faults, and significantly improves the operation reliability of the pressure sensor; Through the composite mechanism of redundancy verification and sampling frequency improvement, the node capture problem caused by small pressure difference and contact fluctuation is effectively solved. High-density sampling captures signal details, multiple start-stop verification filters interference, ensures accurate zero point determination, avoids system misjudgment leading to continuous high-speed injection of the booster, and provides core guarantee for uniform infusion; The zero drift processing logic of "quantization threshold + hierarchical response" is adopted, and according to the different ranges of the first difference value, the differential operations of "no calibration-required, calibration-suggested, and device locking" are respectively performed. Both the clinical efficiency affected by the slight zero drift over-intervention is avoided, and the injection precision deviation caused by sensor failure due to device locking in the case of serious zero drift is avoided, so as to realize the balance between safety and practicability. For the faults such as hidden falling of the pressure sensor in long-term use and gradual decline of sensitivity, a trend analysis mechanism based on historical data is designed. By statistically analyzing the decreasing trend of the second difference value, the performance degradation signal is captured in advance and a warning is given, so as to avoid medical accidents caused by sudden failure and guide medical personnel to maintain in time. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 The flowchart of the method for guaranteeing and abnormity warning of the pressure sensor of the electric injection booster in the present application; Figure 2 The data sampling waveform of the 5ml syringe under the condition of 1min injection time; Figure 3 The data sampling waveform of the 5ml syringe under the condition of 30min injection time; Figure 4 The data sampling waveform of the 10ml syringe under the condition of 1min injection time; Figure 5 The data sampling waveform of the 10ml syringe under the condition of 30min injection time; Figure 6 The data sampling waveform of the 20ml syringe under the condition of 1min injection time; Figure 7 The data sampling waveform of the 20ml syringe under the condition of 30min injection time; Figure 8 The pressure reading data in Figures 2-7 Figure 9 The data sampling waveform of the 5ml syringe under the condition of 10min injection time and four start-stop; Figure 10 The data sampling waveform of the 10ml syringe under the condition of 10min injection time and four start-stop; Figure 11 The data sampling waveform of the 20ml syringe under the condition of 10min injection time and four start-stop one; Figure 12 The data sampling waveform of the 20ml syringe under the condition of 10min injection time and four start-stop two; Figure 13 ​the data sampling waveforms of four start-stop of a 20ml syringe in 10min push time; Figure 14 Figures 9-13 the pressure reading data in the DETAILED DESCRIPTION

[0018] Hereinafter, the present application will be further described based on the preferred embodiments and with reference to the accompanying drawings.

[0019] The words in the specification are used for explaining the embodiments of the present application, but are not intended to limit the present application. Unless otherwise explicitly specified and limited, if the terms "arranged", "connected", "linked" appear, they should be interpreted broadly, for example, can be fixedly connected, can be detachably connected, or integrally connected; can be mechanically connected, can be directly connected, or indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be specifically understood.

[0020] In addition, in the description in the embodiments of the present application, various components on the drawing are amplified or reduced for the convenience of understanding, but this practice is not intended to limit the protection scope of the present application.

[0021] Based on the problems in the background art, the present application provides a guarantee and abnormal early warning method for a pressure sensor of an electric injection booster (hereinafter referred to as: the method), Figure 1 The flow chart of the method in the present application is shown as Figure 1 The method comprises the following steps: S1: Before each injection start or in the idle stage of the injection gap, the actual idle data collected by the pressure sensor is compared with the standard idle data in the standard database to obtain a first difference value; if the first difference value is greater than a first threshold value, the zero drift abnormal mode is switched to, otherwise step S2 is executed.

[0022] Step S1 is the troubleshooting in the self-checking stage of the pressure sensor, and the implementation occasion is the preparation stage before each injection start and the gap period between adjacent two injections. In this stage, the pressure sensor is in an idle state without external pressure. By collecting the actual idle data of the pressure sensor at the above key nodes and accurately comparing with the preset pressure-free reference value in the standard database, the zero drift abnormality caused by factors such as long-term use wear, environmental temperature and humidity fluctuation, and mechanical contact fatigue of the pressure sensor can be quickly identified, potential hidden faults can be checked in advance, and the distortion of pressure monitoring data in the subsequent injection process caused by the accumulation of zero drift problems can be avoided. This pre-emptive and normalized self-checking method provides protection for the operation reliability of the pressure sensor from the source.

[0023] ​In the present application, the construction of the standard database is centered on accurate calibration. Through standardized calibration process and rigorous data processing method, the accuracy and reliability of the database mapping relationship are ensured, providing an authoritative reference benchmark for subsequent pressure sensor state monitoring. The specific construction process is as follows: first, the standard environmental conditions required for calibration are determined, i.e. the controlled environmental temperature is 23℃±2℃, and the relative humidity is 50%RH±5%, to avoid the interference of temperature and humidity fluctuations on the output characteristics of the sensor; a standard pressure gauge with precision level ≥0.05 level (such as Druck DPI610 type standard pressure gauge) is selected as the calibration reference tool to ensure the accuracy of the applied pressure. Taking a pressure sensor with a range of 0-100kPa as an example, five standard pressure levels are set within its full range, i.e. 0 kPa (empty position)、25 kPa, 50 kPa, 75 kPa and 100 kPa (full range position); at each calibration level, the corresponding standard pressure is first applied to the pressure sensor and stabilized for 30s, and then the output voltage value is recorded after the sensor output signal is stabilized. Multiple data collection is repeated at each level to eliminate accidental errors, and the average value of multiple output voltage data at the same level is calculated as the standard output value of the sensor corresponding to the standard pressure level. Through the above process, the mapping relationship of "standard pressure value-sensor corresponding output voltage average value" is established, forming the initial standard pressure-output voltage database.

[0024] Further, when the system triggers the zero drift abnormal mode, in order to eliminate the influence of zero drift on the pressure monitoring accuracy of the pressure sensor, it is necessary to determine whether to perform calibration operation on the pressure sensor according to the severity of zero drift. The calibration process is centered on accurately establishing the corresponding relationship between pressure and voltage to ensure the reliability of subsequent monitoring data.

[0025] In some specific embodiments of the present application, the calibration operation adopts a linear regression algorithm to fit a calibration function, which realizes the correction of zero drift deviation by establishing a quantitative corresponding relationship between the actual pressure value of the pressure sensor and the real-time output voltage value. The calibration formula is as follows: wherein, P is the actual pressure value of the pressure sensor (unit: kPa ), V is the real-time output voltage value of the pressure sensor (unit: V ), k is the calibration coefficient (i.e. the sensitivity of the sensor, reflecting the linear correlation degree of voltage change and pressure change), b is the zero pressure offset (used to correct the voltage offset error under no pressure state).

[0026] To ensure the accuracy of the calibration coefficient k and the zero pressure offset b , the least squares method is used for solving: by calling the standard database "standard pressure value-output voltage average" multiple mapping data as a sample, substitute into the least squares calculation model, solve the optimal linear fitting parameters, that is, the calibration coefficient k and the zero pressure offset b ; at the same time, the calculated k , b value, and the initial zero pressure value (0 kPa gear corresponding to the standard output voltage average) are stored together as the reference parameters for subsequent pressure sensor state verification.

[0027] Specifically, the calibration coefficient k is calculated by the least squares method: The zero pressure offset b is calculated by .

[0028] In the zero drift abnormal mode, the calculation of the first difference needs to combine the reference data in the standard database with the actual sensor data, and the specific formula is as follows: ; Wherein, is the pressure data of the pressure sensor in the actual empty state (calculated from the real-time output voltage value by the calibration function), is the standard empty pressure data recorded in the standard database (corresponding to the standard output voltage average value of 0 kPa gear conversion result), is the standard full range pressure data recorded in the standard database (corresponding to the standard output voltage average conversion result of the full range gear of the sensor).

[0029] In order to quantify the degree of zero drift and clarify the calibration requirements, the calibration degree is classified and limited based on the calculation result of the first difference : When ≤5%, it is determined that the sensor self-check is qualified, the zero drift deviation is within the allowable range, and no calibration operation is required, and the device can continue to be used normally; When 5%< ≤10%, the "mild zero drift" warning is triggered, and at this time the zero drift deviation does not affect the current injection accuracy, and the current injection operation is allowed to be completed normally, that is, it will be normally jumped from step S1 to step S2, but the system will prompt the user to calibrate the pressure sensor before next use; When When the deviation is greater than 10%, it is judged as "severe zero drift". At this time, the zero drift deviation has exceeded the safety threshold, which may cause serious distortion of pressure monitoring data. The system will immediately lock the operation permission of the electric injection booster and prohibit it from starting new injection operations until the staff completes manual calibration and passes the self-test before it can be unlocked and used.

[0030] S2: During a single injection by the electric injection booster, the actual pressure data of the pressure sensor before and after the zero point is compared and a second difference is obtained and recorded; if the second difference is less than the second threshold, the system switches to the warning mode; otherwise, step S3 is executed. The zero point is the position where the end of the pressure sensor contacts the syringe plunger.

[0031] Determining the zero point is crucial during the operation of the electric injection booster. Only after confirming the zero point can the target drug be pushed at a constant and set speed. Before the zero point, the movement speed can be set to a faster speed. Figures 2-7 The pressure sensor data sampling waveforms for three different syringe sizes (5ml, 10ml, and 20ml) are shown for injection durations of 1 minute and 30 minutes, respectively. Figures 2-7 As shown, before the zero point, the pressure value monitored by the pressure sensor is the value under no-load conditions. At the zero point, when the pressure sensor contacts the syringe plunger, the pressure sensor will fluctuate for a short time, and the pressure value will gradually stabilize after the fluctuation. During this stage, the pressure difference between the two pressures before and after the zero point is compared and recorded to understand the degree of difference of the pressure sensor before and after the load. If the difference is too large, and the no-load data in the self-test stage has been confirmed to be within the threshold range, it indicates that the detection value of the pressure sensor in the operation stage is abnormal. It is necessary to switch to the warning state to warn the user of the pressure sensor problem, so as to prevent further damage and wear to the pressure sensor caused by continued use, which could endanger the patient's life.

[0032] In the clinical application of electric injection boosters, accurate zero-point determination is a core prerequisite for ensuring the stability of the injection process and the accuracy of drug infusion. It directly determines the accuracy of injection speed switching and the reliability of pressure monitoring baseline. Only after zero-point confirmation can the booster push the target drug at the preset precise and uniform speed. During the displacement phase before zero-point confirmation, the plunger can be set to a faster movement speed to shorten the preparation time from device startup to contact with the syringe plunger handle, thereby improving clinical operation efficiency.

[0033] Figures 2-7The pressure sensor real-time data sampling waveform chart of 5ml, 10ml, 20ml three different specifications of syringes under 1min, 30min two preset injection time length is shown respectively. From the above waveform chart, the common law of pressure change can be clearly observed: before zero point confirmation, the booster push rod is in the process of displacement to the syringe push handle, the pressure sensor is not affected by external load, and the pressure value monitored by the pressure sensor always maintains a stable value in the unloaded state; when the push rod is displaced to the zero position, the pressure sensor is in contact with the end of the syringe push rod, and the detection value of the pressure sensor will fluctuate in a short time due to the influence of mechanical contact impact; after the contact is stable, with the push rod pushing the liquid medicine at a constant speed, the pressure value gradually tends to be stable and maintains a stable interval in the loaded state.

[0034] Based on the above pressure change characteristics, in the actual monitoring process, the unloaded pressure value before zero point confirmation and the loaded pressure value after zero point confirmation need to be extracted, the pressure difference value of the two is calculated and recorded. Through the pressure difference data, the response consistency of the pressure sensor in the unloaded and loaded states can be intuitively reflected: if the pressure difference exceeds the preset reasonable range, and the unloaded data of the pressure sensor has been confirmed in the self-checking stage that it is within the set threshold (excluding initial faults such as zero drift), it can be determined that the detection performance of the pressure sensor in the injection running stage is abnormal, and there may be problems such as sensor element sensitivity drift and poor contact.

[0035] At this time, the system needs to immediately switch to the early warning state and send an explicit abnormal prompt to the medical staff. This early warning mechanism not only avoids the continuous work of the pressure sensor in the abnormal state, reduces its further mechanical wear or performance degradation, but also eliminates the problems of injection speed deviation and inaccurate liquid medicine dose caused by abnormal sensor detection from the root, effectively avoids potential medical risks such as delayed treatment and tissue damage, and provides key protection for the safety of patient medication.

[0036] In some specific embodiments of the present application, the second threshold value is determined based on a normal reference value and combined with safety redundancy. The normal reference value is the second difference value standard parameter value of the pressure sensor in the stable stage before and after the zero point when the system is in a stable and risk-free running state. Its determination needs to be verified by theory and practice: first, through theoretical calculation, combined with the core parameters such as the design sensitivity of the pressure sensor, the push rod load characteristics of the syringe specifications (such as 5ml, 10ml, 20ml), the preset injection rate, etc., the theoretical reasonable range of the second difference is derived; then through small batch entity verification, in the standard environment of 23℃±2℃, 50%RH±5%, for different injection time (such as 1min, 30min), multiple repetitive tests are carried out, the second difference data during stable operation is collected and counted, and the central characteristic value (such as the average value or the median) of the data distribution is taken as the final normal reference value, which ensures that it is highly consistent with the actual running scene and provides a reliable reference for abnormal judgment.

[0037] The safety redundancy is an additional safety fluctuation space reserved on the basis of the normal reference value. Its setting is aimed at non-fault interference factors in clinical practice, such as transient mechanical impact of the push rod and the push handle during injection, temporary small fluctuation of environmental temperature and humidity, and temporary change of load caused by difference in drug viscosity, etc. Such factors will cause the second difference to temporarily deviate from the normal range, but are not sensor performance degradation. By reserving safety redundancy, such non-fault fluctuations can be effectively filtered, avoiding system false triggering of early warning and interfering with normal clinical operation; at the same time, the redundancy will be strictly controlled within a reasonable range (such as 5%-10% of the normal reference value), ensuring that when the sensor is truly degraded (such as sensitivity decrease, hidden shedding), the second difference will still be able to trigger an early warning in time, without missing potential risks.

[0038] This setting mechanism of "reference value anchoring + redundancy buffer" realizes the balance between early warning accuracy and anti-interference ability, which not only provides accurate and practical quantitative basis for abnormal judgment of the pressure sensor, but also fully adapts to the uncertainty of the clinical environment, further ensuring the stability of the electric injection booster and the safety of patient medication.

[0039] Further, combined with experimental data and actual application scene analysis, Figure 8 For Figures 2-7 The summary result of the pressure sensor sampling data. From Figure 8It can be clearly seen that in the experimental simulation process, no matter which specification of the syringe is used, 5ml, 10ml or 20ml, or whether the injection time is set to 1min or 30min, the numerical fluctuation range of the second pressure difference (i.e. the pressure difference value between the stable stage before zero and the stable stage after zero, corresponding to the voltage signal difference value) is at a very low level, and the stability performance is highly consistent. This stability feature is the key basis for zero point confirmation - it can provide a reliable signal reference for the system, help to preliminarily lock the stable stages before and after the zero point, and avoid signal misreading caused by random fluctuations of the pressure difference.

[0040] In actual application, attention should be paid to the risk of decreasing pressure difference trend and early warning should be established: Although the pressure difference is stable under the current experimental conditions, in long-term use, the second pressure difference may show a gradual downward trend due to factors such as push rod wear, sensor aging, and poor compatibility of syringes. Therefore, a warning mechanism should be designed simultaneously to monitor the pressure difference change rate, set a warning threshold (such as a continuous decrease in pressure difference by more than 10% of the previous stable value), and timely warn to prevent the risk of zero point determination failure.

[0041] This experimental phenomenon puts high requirements on the detection accuracy of the pressure sensor: on the one hand, the sensor needs to have high enough resolution to accurately capture the pressure change before and after the load; on the other hand, when the pusher push rod is displaced to the zero point position, the short-term pressure fluctuation amplitude caused by mechanical contact impact should not be too large. In this case, the system will face great difficulties in determining the zero point only relying on a single "contact fluctuation signal".

[0042] If the system cannot successfully find the zero point, it will directly cause serious medical safety risks: the booster will misjudge that the zero point has not been confirmed, and continue to inject the drug at a faster speed before the zero point confirmation, rather than switching to the preset accurate uniform speed mode. The fast injection speed will cause a large amount of drug to enter the patient's body in a short time, especially for chemotherapy drugs, anesthetics and other drugs sensitive to infusion rate, which may cause serious adverse reactions such as tissue damage and drug poisoning, endangering the safety of patients' lives.

[0043] To solve the above technical problems and ensure the accuracy and reliability of zero point confirmation, in the preferred embodiment of the present application, the zero point confirmation involved in step S2 is realized by using a redundant verification mechanism.

[0044] Specifically, the core design logic of the redundancy mechanism is to exclude the interference of accidental fluctuations through multiple verifications. When the booster push rod is displaced to a specific position to cause pressure fluctuations, the system first identifies the zero point candidate position based on the fluctuation signal. Then, the booster is controlled to perform multiple start-stop actions near the preliminary position. After each start-stop, the push rod is slightly displaced towards the potential zero point, and the real-time signal of the pressure sensor is synchronously collected. By comparing the change rules of the pressure signals in multiple start-stop processes (such as the consistency of the pressure difference after each fluctuation), the stable and repeatedly appearing contact feature points are screened out, and the accurate confirmation of the zero point is finally completed. This "preliminary identification + multiple verification" mode can exclude the interference of accidental fluctuations through multiple data even if the pressure difference is insufficient due to the trend of becoming smaller, ensuring the accuracy of zero point determination, adapting to the current stable pressure difference scene, and providing reliable protection for the future trend of smaller pressure difference, ensuring the safety of zero point confirmation throughout the life cycle.

[0045] In some preferred embodiments of the present application, the number of start-stop settings is 3-5 times. This range is determined by considering the effectiveness of redundancy verification, the efficiency of clinical operation, and the mechanical wear of the equipment, and is the optimal solution. After experimental verification and actual scene adaptation optimization, if the number of start-stop is less than 3 times, the sample size of multiple sampling is insufficient, it is difficult to fully filter the accidental fluctuation interference at the moment of push rod contact, which may lead to insufficient precision of stable node capture, and the anti-interference advantage of the redundancy mechanism cannot be fully utilized. If the number of start-stop is more than 5 times, the preparation time before injection will be significantly prolonged, reducing the efficiency of continuous clinical operation. At the same time, too many mechanical start-stop actions may increase unnecessary wear of the push rod, pressure sensor and other components, affecting the overall service life of the equipment. The start-stop setting of 3-5 times can obtain sufficient signal feature data through repeated sampling, accurately lock the stable nodes before and after the zero point by comparing the consistency of the pressure signals in different start-stop periods, effectively exclude the interference of transient fluctuations, and ensure the reliability of zero point confirmation. At the same time, the preparation time can be controlled within the clinically acceptable range, avoiding unnecessary delay of the diagnosis and treatment process, and achieving a balance between verification accuracy and operation efficiency, further adapting to the actual application needs of clinical practice.

[0046] In some specific embodiments of the present application, Figures 9-14 The pressure sensor data sampling waveforms of 5ml, 10ml, 20ml and other different specifications of syringes under four consecutive start-stop operations are presented respectively. From these waveform graphs, the key role of the redundancy verification mechanism in node capture can be clearly observed: in a single start-stop process, due to the mechanical impact of the push rod contacting the syringe handle at the moment, the pressure signal will appear a short and irregular fluctuation, and the fluctuation amplitude is even close to the small second pressure difference before and after the zero point. At this time, if only relying on single sampling, it is easy to misjudge the transient peak value in the fluctuation as a stable node, leading to deviation of zero point confirmation.

[0047] And through four consecutive start-stop operations, the advantages of the redundancy mechanism are fully embodied: in multiple start-stop processes, although the fluctuation characteristics of the pressure signal are different, the signal characteristics of the stable stage before and after the zero point (the empty stable stage and the load stable stage) show significant consistency - for example, the pressure value in the empty stage is always stable in the same interval, and the pressure value after the load stabilizes also forms a repeatable baseline. By comparing the waveform data of the four start-stop operations, the system can effectively filter out accidental interference in single fluctuations, accurately lock the stable nodes with consistent characteristics in multiple samplings, and thus reliably distinguish between "transient fluctuations" and "true stable stages".

[0048] This experimental phenomenon directly verifies the effectiveness of the redundancy mechanism: through repeated verification of multiple start-stop operations, even in the face of double interference of small pressure difference and contact fluctuation, it can still ensure the stable capture of key nodes before and after the zero point, provide accurate data basis for subsequent pressure difference calculation, and thus ensure the reliability of pressure sensor abnormal warning, fundamentally avoiding the risk of high-speed injection caused by node misjudgment.

[0049] To further eliminate the interference caused by small pressure difference and contact fluctuation and ensure the accuracy of zero point confirmation, the zero point confirmation in step S2 adopts a composite scheme combining the sampling frequency improvement mechanism and the redundancy verification mechanism, and a more reliable zero point determination system is constructed through the synergistic effect of the two mechanisms.

[0050] Specifically, although a single redundancy verification mechanism can exclude some accidental errors through multiple start-stop operations, in the presence of high-frequency fluctuations at the contact moment, in order to fully capture the signal details in the fluctuation process and avoid missing key features due to too large sampling interval, the sampling frequency of the pressure sensor needs to be dynamically improved (such as from the conventional 10Hz to 100Hz or above). High-density sampling data can clearly restore the complete waveform of the fluctuation, helping the system accurately distinguish between "transient fluctuation stage" and "stable stage", and provide accurate signal basis for subsequent zero point confirmation.

[0051] High-density sampling data can more comprehensively and detailedly reflect the pressure change at the contact moment, clearly distinguishing the signal characteristics of "transient fluctuation stage" and "stable stage" - even if the fluctuation amplitude is similar to the second pressure difference, the trend analysis of consecutive data points (such as the convergence slope after the fluctuation peak, the standard deviation of stable stage data, etc.) can accurately locate the empty stable stage before the zero point and the load stable stage after the zero point. And on this basis, the redundancy verification mechanism can filter out the most consistent feature points as the final zero point through signal feature comparison in multiple start-stop processes, further excluding possible abnormal interference in single sampling.

[0052] When the system completes the zero point determination and enters the stable running phase of the drug injection, the pressure signal is in a stable state as a whole without high-frequency fluctuation interference, and there is no need to capture the fine signal characteristics related to the zero point at this time. Therefore, the sampling frequency of the pressure sensor can be reduced to the normal level, which can meet the needs of real-time monitoring of the injection pressure and reduce unnecessary data collection, reduce the system data processing load, and avoid resource waste.

[0053] The combination of the two mechanisms forms a double guarantee of "detail capture + trend verification": the increase of the sampling frequency ensures that no key signal characteristics are missed, and the redundant verification ensures the stability and repeatability of the characteristics, thereby significantly reducing the risk of misjudgment caused by node capture failure, avoiding the continuous high-speed injection of the booster, and providing more solid technical support for the speed accuracy of clinical injection and patient safety.

[0054] In some specific embodiments of the present application, the preset starting position of the pressure sensor is determined based on the specifications of the syringe and the preset injection parameters, wherein the preset injection parameters are determined based on the clinical order. The specifications of the syringe include but are not limited to the capacity of the syringe (such as 5ml, 10ml, 20ml, etc.), the effective stroke of the plunger, the mechanical characteristic parameters such as the size of the push handle structure, etc., which directly determine the relative initial position reference of the pressure sensor and the plunger of the syringe; the preset injection parameters are the quantitative parameters converted from the diagnosis and treatment requirements such as the injection dose, injection rate, infusion time, etc. in the clinical order, which are used as the functional adaptation basis of the starting position of the pressure sensor to ensure the accurate matching of the starting position and the actual injection requirements. Through the cooperative calibration of the above-mentioned double parameters, the preset starting position of the pressure sensor not only meets the mechanical installation adaptation requirements of different specifications of the syringe, but also meets the execution requirements of specific clinical diagnosis and treatment scenes, providing an accurate initial position reference for subsequent zero point confirmation, pressure monitoring and abnormal warning.

[0055] S3: complete a single injection operation, control the electric injection booster to reset to the standby state, and wait for the next injection start instruction.

[0056] Step S3 is the finishing action of a single injection operation, which aims to ensure the closed loop of the injection operation and the reset of the device state, laying a stable foundation for the next injection operation. When the electric injection booster completes the preset dose and speed to complete the drug injection, it is determined that the current injection has reached the preset end point (i.e. the drug has been completely injected into the patient's body), and the injection completion confirmation signal is triggered immediately.

[0057] Subsequently, the system starts the reset control logic: the driving mechanism drives the plunger to move reversely from the injection end position, smoothly returns to the zero point along the original path, and at the same time, the pressure sensor monitors the pressure change in real time during the reset process to ensure that the plunger returns to the idle state after being separated from the syringe push handle, providing a reference for the idle self-check before the next injection.

[0058] S4: After obtaining a new injection start instruction, record the number of cycles N of steps S1-S3 and execute steps S1-S3 cyclically.

[0059] When the electric injection booster completes the last injection operation and resets to the standby state, the system will continue to be in the instruction listening mode, responding to the injection start signal in real time issued by the medical staff through the operation panel, wireless control terminal or linkage infusion system. After receiving a new valid injection start instruction, first call and update the cycle execution counter: if it is the first execution of the injection process, the cycle execution number N is initialized to 1; if it is a subsequent continuous injection, the counter will automatically add 1 based on the last cycle number, and the updated N value is stored in the storage module of the device control system in real time.

[0060] Subsequently, the system will trigger the cyclic execution mechanism to restart the complete process of steps S1-S3: first, complete the self-checking of the pressure sensor under no load and the zero drift investigation through standard database comparison, and then accurately confirm the zero point and monitor the pressure difference before and after the zero point through the composite mechanism of redundant verification and sampling frequency improvement during the injection process, until the accurate injection of the liquid medicine is completed and the device is reset.

[0061] Further, when N≥the first preset number, due to the cumulative effects of long-term mechanical contact impact, slight loosening of the installation structure, etc., the performance of the pressure sensor may gradually deteriorate after multiple cycles of use — for example, the connection between the sensor and the drive end may be implicitly loose (i.e., there is a potential risk of falling off), or the sensitivity of the sensor element may gradually decrease due to wear and fatigue. Such faults often show a slight decreasing trend in the second difference in the early stage, which is difficult to distinguish from normal fluctuations in a single monitoring, but if left unchecked, it may lead to serious distortion of the pressure detection in the later stage.

[0062] In order to capture such progressive faults, more targeted trend analysis is needed to strengthen monitoring capability, so in step S4, the following steps are also included: when N≥the first preset number, step S2 is optimized and replaced by: during the execution of a single injection by the electric injection booster, compare and obtain the second difference based on the actual pressure data of the pressure sensor before and after the zero point in the stable running phase, record it at the same time, and call the second difference recorded in the last M cycles, count the number of times that the current second difference shows a gradual decreasing trend compared with the last M second differences, if the decreasing number >the second preset number, and the current second difference <the second threshold, switch to the warning mode, otherwise execute step S3; where N>M>the second preset number.

[0063] The optimization mechanism based on historical data trend analysis can effectively identify potential hidden faults such as falling off or sensitivity decrease of the pressure sensor during long-term use. By capturing the cumulative characteristics of performance degradation in advance, early warning of faults is realized, thereby further ensuring the operation reliability of the pressure sensor throughout its life cycle.

[0064] In some embodiments of the present application, the original sampling pressure data collected by the pressure sensor needs to be pre-processed by multi-dimensional filtering algorithms such as smoothing filtering and extreme value filtering. Smoothing filtering can eliminate high-frequency random noise in the data and avoid the interference of transient fluctuations on differential pressure calculation. Extreme value filtering can eliminate abnormal extreme points caused by mechanical vibration and electromagnetic interference, ensuring that the data used for calculation are effective data reflecting the real pressure state. After obtaining the purified pressure data, the calculation of the first difference and the second difference is performed to provide accurate data basis for subsequent abnormality judgment.

[0065] The first preset number is determined based on the accurate corresponding abnormal pressure difference. The "accurate corresponding abnormal pressure difference" refers to a pressure difference benchmark that can exactly match the characteristic change threshold of the second difference when the pressure sensor shows early performance degradation (such as slight decrease in sensitivity or hidden loosening of installation structure). This pressure difference benchmark can accurately reflect the critical characteristics of the transition of the sensor from normal state to abnormal state, and is a key judgment index for triggering the system to start historical trend analysis.

[0066] Based on the accurate corresponding abnormal pressure difference, the value of the first preset number is usually set small. The core mechanism is as follows: if the first preset number is too large, the system needs to wait for multiple injection cycles before starting trend analysis, which may cause the pressure difference characteristics of early degradation of the sensor to be masked for a long time, increasing the risk of missing the gradual fault. By setting a small first preset number, the system can start trend analysis based on the recorded second difference data after a small number of injection cycles (such as 3-5 cycles), and in combination with the accuracy of pre-processed data, the decreasing trend of the second difference can be reliably captured even with a small number of cycles, thereby realizing timely identification of early abnormalities of the sensor and effectively avoiding delayed fault judgment due to improper number setting, further ensuring the continuity of the operation of the pressure sensor and the safety of clinical injection.

[0067] In some specific embodiments of the present application, the second preset number of times is determined based on a gradual trend and a response sensitivity. From the performance degradation law of the sensor, its aging (such as gradual decline in sensitivity, implicit loosening of the installation structure) is essentially a slow cumulative process. A small change in the second difference in a single detection may be caused by accidental factors such as instantaneous mechanical fluctuations and environmental disturbances, rather than a real degradation trend. If the second preset number of times is set too small, accidental fluctuations may be misjudged as a gradual change, leading to unnecessary warnings and interfering with normal clinical operations. If the number of times is set too large, although more accidental disturbances can be filtered, the trend confirmation period will be lengthened, making it difficult to respond to sudden rapid degradation (such as accelerated loosening of the sensor connection, sudden failure of the core element leading to a sudden drop in sensitivity), thereby delaying the response and increasing the safety risk.

[0068] Therefore, the setting mechanism of the second preset number of times focuses on balancing verification accuracy and response speed. For a regular slow aging scenario, the number of times needs to meet the requirement of "continuous multiple data comparison". By analyzing the consistency of multiple sets of second differences, accidental disturbances can be excluded, and the real decreasing trend can be accurately captured to ensure the reliability of the warning. For a rapid degradation scenario, the number of times also needs to be controlled within the "short period confirmation" range. When the change rate of the second difference exceeds the regular gradual change threshold, the accelerated degradation can be quickly determined in a small number of continuous times, and the warning can be triggered in time. This setting method that adapts to the degradation characteristics not only avoids clinical interference caused by misjudgment, but also prevents the risk from being expanded due to delayed response. Ultimately, it realizes accurate monitoring and efficient warning of the sensor state, and guarantees its operation reliability and clinical injection safety.

[0069] The specific embodiments of the present application are described in detail above. For those skilled in the art, without departing from the principles of the present application, some improvements and modifications can be made to the present application, and these improvements and modifications also belong to the protection scope of the claims of the present application.

Claims

1. A method for guarantee and abnormality early warning of a pressure sensor for an electric injection booster, characterized in that, The method comprises the following steps: S1: Before each injection start or in the idle stage of the injection gap, the actual idle data collected by the pressure sensor is compared with the standard idle data in the standard database to obtain a first difference value; if the first difference value is greater than a first threshold value, the system switches to a zero drift abnormal mode, otherwise, step S2 is executed; S2: During the execution of a single injection by the electric injection booster, the actual pressure data of the pressure sensor before and after the zero point and in the stable running stage are compared to obtain a second difference value and record it; if the second difference value is less than a second threshold value, the system switches to a warning mode, otherwise, step S3 is executed; Wherein, the zero point is the position when the end of the pressure sensor contacts the injection rod; S3: After completing the current single injection operation, the electric injection booster is controlled to reset to a standby state, and waits for the next injection start instruction; S4: After obtaining a new injection start instruction, the number N of the cyclic execution of steps S1-S3 is recorded and steps S1-S3 are cyclically executed.

2. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 1, wherein: The zero point confirmation in step S2 is realized by a redundancy mechanism.

3. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 2, wherein: The redundancy mechanism is to confirm the zero point by starting and stopping multiple times within the preset zero point range of the pressure sensor.

4. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 3, wherein: The number of starting and stopping is 3-5 times.

5. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 3, wherein: The preset start position of the pressure sensor is determined based on the injection device specification and the preset injection parameters.

6. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 2, wherein: The zero point confirmation in step S2 is realized by combining the sampling frequency improvement mechanism with the redundancy mechanism.

7. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 1, wherein: Step S2 in step S4 is replaced by the following step when N≥the first preset number: during the execution of a single injection by the electric injection booster, the actual pressure data of the pressure sensor before and after the zero point and in the stable running stage are compared to obtain a second difference value and record it, and the second difference values recorded in the previous M cycles are called, the number of times that the current second difference value shows a gradually decreasing trend compared with the previous M second difference values is counted, if the number of times of decreasing >the second preset number and the current second difference value <the second threshold value, the system switches to a warning mode, otherwise, step S3 is executed; wherein N>M≥the second preset number.

8. The fault and abnormal warning method for the pressure sensor of the electric injection booster according to claim 7, wherein: The first preset number of times is determined based on a precise corresponding abnormal pressure difference, and the second preset number of times is determined based on a gradual trend and a response sensitivity. 9.The method according to claim 1, wherein the method further comprises: determining the second threshold value based on a normal reference value and a safety redundancy. The second threshold value is determined based on a normal reference value as a basis and in combination with a safety redundancy. 10.The method according to claim 1, wherein the method further comprises: determining the second threshold value based on a normal reference value and a safety redundancy. In the step S1, the first difference The calculation formula is: ； wherein P0 is the pressure data at actual zero load, P0 is the pressure data at standard zero load, P0 is the pressure data at standard full scale.

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