Suction integrated device for coronary thrombectomy and synergic control method

Abstract

The present application relates to the technical field of biomedical engineering, and in particular to a suction integration device for coronary thrombus removal and a collaborative control method. The present application collects the pressure and flow rate in the suction pipeline in real time during continuous suction, combines the pressure and flow rate dual-dimensional characteristics, accurately quantifies and characterizes the newly added suction blockage parameters and the historically residual cross-stage residual blockage parameters, and analyzes the blockage source to directionally and collaboratively regulate the suction process in combination with the comparison relationship between the suction blockage parameters and the cross-stage residual blockage parameters, so as to realize accurate matching of control intervention and physical blockage causes, avoid repeated blockage and negative pressure mismatch, and improve the suction control effect of the coronary thrombus removal process.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering technology, specifically to an integrated aspiration device and synergistic control method for coronary thrombus removal. Background Technology

[0002] During coronary intervention, intravascular thrombosis can cause acute blood flow interruption, requiring the use of an aspiration catheter to remove the thrombus and restore hemodynamic perfusion to the distal myocardium. Existing aspiration devices typically consist of a catheter, a negative pressure source, a thrombus collection chamber, and a manual control end. The physician determines the negative pressure intensity and timing of aspiration based on blood return, resistance, and angiography results. In practice, a constant negative pressure is often used for continuous suction, or the operator performs staged aspiration and release based on experience to handle the random entry of thrombus fragments.

[0003] However, the size, hardness, and timing of thrombus detachment are highly random, leading to sudden pressure spikes, rapid flow drops, intermittent recovery, or repeated blockages during aspiration. Current techniques struggle to analyze the cross-stage effects of random, disordered thrombus loads during phased aspiration, cannot determine whether the start of the next stage has deviated from the expected recovery point, and cannot coordinate adjustments to negative pressure intensity, aspiration duration, release intervals, and anti-blockage actions accordingly. This results in insufficient aspiration stability and a high risk of tubing blockage and control mismatch. Summary of the Invention

[0004] To address the technical problem of poor aspiration efficiency in existing coronary thrombus removal methods, the present invention aims to provide an integrated aspiration device and coordinated control method for coronary thrombus removal. The specific technical solution adopted is as follows: A method for coordinated control of an integrated aspiration device for coronary thrombus removal, the method comprising: Real-time acquisition of pressure and flow rate within the suction pipeline during continuous suction; sequential division of the continuous suction process to determine the suction cycle; each suction cycle includes at least a negative pressure establishment phase, a continuous suction phase, and a release phase; During the current continuous suction phase, suction blockage parameters are obtained based on the pressure increase trend and flow decrease trend in the suction pipeline; based on the initial pressure and initial flow in the suction pipeline during the current continuous suction phase, combined with the final pressure and final flow in the suction pipeline during the adjacent previous continuous suction phase, cross-phase residual resistance parameters are obtained for the current continuous suction phase. The comprehensive suction blocking parameters for the current continuous suction phase are obtained based on the suction blocking parameters and the cross-stage residual hindrance parameters. The suction process is then adjusted in a targeted manner by combining the comparison between the suction blocking parameters and the cross-stage residual hindrance parameters.

[0005] Furthermore, the methods for dividing the continuous suction process into sequential steps and determining the suction cycle include: The suction cycle starts automatically, maintains a preset establishment time, determines the negative pressure establishment phase, and enters the continuous suction phase after the negative pressure establishment phase ends. If the pressure in the suction pipeline is higher than the preset pressure threshold for a preset first duration, or the flow rate is lower than the preset flow rate threshold for a preset second duration, the continuous suction phase ends and the release phase begins. The release phase is maintained for a preset release time and then ends, completing the current suction cycle and entering the next suction cycle.

[0006] Furthermore, the method for obtaining the suction blockage parameter includes: Extract the initial pressure and maximum pressure in the suction line during the current continuous suction phase, and calculate the pressure increase ratio; During the current continuous suction phase, an analysis window with a preset time span is constructed centered on the moment when the highest pressure occurs; the lowest flow rate within the analysis window is extracted, and the flow rate decay ratio is calculated by combining it with the initial flow rate of the current continuous suction phase. By combining the flow rate attenuation ratio and the pressure increase ratio, the suction blockage parameter is obtained.

[0007] Furthermore, the method for obtaining the cross-stage residual retardation parameters includes: The pressure bearing ratio is calculated based on the deviation of the initial pressure in the suction line during the current continuous suction phase from the preset recovery reference pressure, and the deviation of the final pressure in the suction line during the adjacent previous continuous suction phase from the preset recovery reference pressure. The flow carrying ratio is calculated based on the deviation of the initial flow rate in the suction pipeline during the current continuous suction phase from the preset recovery reference flow rate, and the deviation of the final flow rate in the suction pipeline during the adjacent previous continuous suction phase from the preset recovery reference flow rate. By combining the pressure acceptance ratio and the flow acceptance ratio, the cross-stage residual resistance parameter is obtained; wherein, if the current continuous suction stage is in the first suction cycle, the cross-stage residual resistance parameter is directly set to zero.

[0008] Furthermore, the method for obtaining the preset recovery reference pressure and the preset recovery reference flow rate includes: The calibration aspiration procedure was performed in an in vitro saline environment, with the average pressure under a stable flow field as the preset recovery reference pressure and the average flow rate as the preset recovery reference flow rate.

[0009] Furthermore, the method for obtaining the comprehensive suction blockage parameter includes: During the current continuous suction phase, the negative correlation normalized value of the cross-stage residual resistance parameter is used as the stable margin weight, and the suction blocking parameter is weighted to obtain the new blocking parameter; the sum of the new blocking parameter and the cross-stage residual resistance parameter is used as the comprehensive suction blocking parameter.

[0010] Furthermore, based on the comparison between suction blockage parameters and cross-stage residual retardation parameters, methods for directional adjustment of the suction process include: The source of blockage is determined by comparing the suction blockage parameters with the cross-stage residual blockage parameters, including at least newly added blockage and residual blockage; If the comprehensive suction blockage parameter is less than the lower limit of the preset interval, the suction process parameters in the current continuous suction phase will be maintained in the next suction cycle. If the comprehensive suction blockage parameter is within the preset range and the blockage source is a new blockage, then the continuous suction duration will be reduced by a preset attenuation ratio in the next suction cycle. If the comprehensive suction blockage parameter is within a preset range and the blockage source is residual blockage, then in the next suction cycle, the starting suction pressure is reduced by a preset reduction ratio, and the duration of the release phase is extended by a preset delay ratio. If the overall suction blockage parameter is greater than the upper limit of the preset interval, then the anti-blockage release will be performed in the next suction cycle.

[0011] Furthermore, the method for obtaining the source of the blockage includes: The cross-stage residual obstruction parameter is weighted using a preset scale alignment coefficient, and the source parameter is obtained by subtracting the weighted result from the suction obstruction parameter. The preset scale alignment coefficient is pre-calibrated based on the difference in magnitude between the suction obstruction parameter and the cross-stage residual obstruction parameter. When the source parameter is greater than 0, the obstruction source is newly added obstruction; when the source parameter is less than or equal to 0, the obstruction source is residual obstruction.

[0012] Furthermore, the method for obtaining the preset interval includes: In an in vitro calibration environment, a non-blocking aspiration state is simulated. The lower limit of the preset interval is determined based on the extreme value of the fluctuation of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset fluctuation margin. In an in vitro calibration environment, a completely blocked aspiration state is simulated. The upper limit of the preset interval is determined based on the critical value of the blockage of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset safety margin. The preset interval is determined based on the upper limit and lower limit of the interval.

[0013] An integrated aspiration device for coronary thrombus removal includes a device body, wherein the device implements the steps of the coordinated control method for the integrated aspiration device for coronary thrombus removal.

[0014] The present invention has the following beneficial effects: This invention collects pressure and flow rate within the suction pipeline in real time during continuous suction, providing a data foundation for subsequent analysis. The random suction process is then divided into quantifiable control cycles, each including at least a negative pressure establishment phase, a continuous suction phase, and a release phase. Within the current continuous suction phase, suction blockage parameters characterizing newly added blockages are obtained based on the pressure increase and flow rate decrease trends within the suction pipeline. Furthermore, based on the initial pressure and flow rate within the suction pipeline during the current continuous suction phase, combined with the final pressure and flow rate of the suction pipeline in the adjacent previous continuous suction phase, cross-stage residual resistance parameters characterizing historical residual blockages from the previous continuous suction phase are obtained. This allows for the comprehensive acquisition of the current continuous suction blockage parameters. The comparison between the suction blockage parameters and the cross-stage residual resistance parameters is then used to analyze the source of blockage and directionally adjust the suction process. This invention combines pressure and flow characteristics to accurately quantify newly added aspiration blockage parameters and historical residual blockage parameters across stages. It also analyzes the source of blockage to directionally and synergistically regulate the aspiration process, achieving precise matching between control intervention and physical blockage causes. This avoids repeated blockages and negative pressure mismatch, and improves the aspiration control effect in the coronary thrombus removal process. Attached Figure Description

[0015] Figure 1 This is a flowchart illustrating a collaborative control method for an integrated aspiration device for coronary thrombus removal, provided as an embodiment of the present invention. Detailed Implementation

[0016] The following description, in conjunction with the accompanying drawings, details the specific scheme of the integrated aspiration device and synergistic control method for coronary thrombus removal provided by the present invention.

[0017] This invention provides an integrated aspiration device for coronary thrombus removal, specifically by adding a control module to the existing device body for coordinated control of the aspiration process.

[0018] The device body includes an aspiration catheter, a thrombus collection chamber, a negative pressure pump, a release valve, a pressure detection unit, and a flow detection unit. The front end of the aspiration catheter is used to enter the coronary artery to aspirate thrombi, and the rear end is connected to the thrombus collection chamber and the negative pressure pump via tubing. The thrombus collection chamber is used to contain the aspirated thrombus and blood mixture. The negative pressure pump is used to establish a controllable negative pressure environment within the aspiration tubing, driving the thrombus and blood to flow from the front end of the catheter towards the collection chamber. The pressure detection unit is located at the rear end of the aspiration catheter or the front end of the thrombus collection chamber to collect real-time pressure changes within the aspiration tubing (the absolute value of the negative pressure within the tubing, representing the absolute vacuum degree; the higher the value, the higher the vacuum degree and the greater the aspiration resistance). The flow detection unit is located before the negative pressure pump or after the thrombus collection chamber to collect real-time flow changes of the blood and thrombus mixture flowing through the tubing. The release valve is located on the tubing and is used to respond to control commands to perform short-term pressure reduction, on / off release, or anti-blockage release actions.

[0019] The control module is electrically connected to the pressure detection unit, flow detection unit, negative pressure pump, and release valve, and includes a processor and a memory. The memory stores a computer program that can run on the processor. The control module receives timing data from the pressure detection unit and flow detection unit, runs a collaborative control program through the processor, and outputs control commands to the negative pressure pump and release valve, thereby executing the collaborative control method for the integrated aspiration device for coronary thrombus removal described in steps S1-S3 below.

[0020] Please see Figure 1 The diagram illustrates a flowchart of a collaborative control method for an integrated aspiration device for coronary thrombus removal according to an embodiment of the present invention, specifically including: Step S1: Real-time acquisition of pressure and flow rate in the suction pipeline during continuous suction; sequential division of the continuous suction process to determine the suction cycle; each suction cycle includes at least a negative pressure establishment stage, a continuous suction stage, and a release stage.

[0021] Coronary thrombi typically enter the aspiration catheter port randomly as fragments of varying sizes, hardness, and adhesion. The timing, sequence, and degree of blockage they cause are unpredictable and sudden. Real-time acquisition of pressure and flow within the aspiration tubing during continuous aspiration can capture dynamic changes in tubing load, providing a basis for subsequently defining independently assessable aspiration cycles. This, in turn, prepares the groundwork for further analysis of thrombus obstruction and adjustments to the aspiration process.

[0022] As an example, the pressure detection unit has a hardware sampling frequency set to 500Hz due to its fast response speed; the flow detection unit has a hardware sampling frequency set to 100Hz due to the influence of fluid inertia. After continuous suction is started, the control module continuously reads the pressure and flow rate in the pipeline through the pressure detection unit and the flow detection unit according to their corresponding sampling frequencies. Since the hardware sampling rates of the pressure detection unit and the flow detection unit often differ, in order to ensure that the pressure change point and the flow decay point are accurately matched on the time axis in the subsequent analysis, it is necessary to unify the time scale of pressure and flow. Specifically, the lower 100Hz flow sampling time axis can be used as the reference time scale, and a flow sampling value can be extracted every 10 milliseconds. At the same time, five pressure sampling values ​​within the corresponding time window are extracted and mean filtered to align the asynchronously acquired hardware signals. In other embodiments, the acquisition frequencies of the two units can be set to be the same for synchronous acquisition.

[0023] In actual pipeline operation, the mechanical pulsation of the negative pressure pump, the patient's own heart rate and blood pressure fluctuations, and the high-frequency electrical noise of the sensor will all generate highly interfering high-frequency spikes in the signal. Therefore, it is necessary to filter the pressure and flow separately. Specifically, a first-order low-pass filter algorithm can be used to filter out the pump mechanical pulsation noise and heart rate physiological fluctuation noise with frequencies higher than 10Hz to 20Hz, and only retain the slow decay and abrupt trend of fluid resistance caused by the actual thrombus load, so as to eliminate high-frequency hardware spikes. Implementers can also use other filtering methods such as moving average filtering, which are all conventional techniques in this field and will not be elaborated further.

[0024] It should be noted that the pressure and flow rates involved in the subsequent analysis are all filtered.

[0025] A single continuous aspiration session is insufficient to distinguish between newly aspirated thrombi and retained old thrombi. However, dividing the continuous aspiration process into multiple aspiration cycles—each containing a negative pressure establishment phase, a continuous aspiration phase, and a release phase—transforms the unpredictable, random aspiration process into a quantifiable, controllable cycle. The negative pressure establishment phase provides initial transport force, the continuous aspiration phase captures and transports the thrombus, and the release phase unloads the negative pressure in the tubing, clears the blockage, and restores patency. These three phases constitute a complete work-restoration closed loop, enabling precise quantification of the current cycle's obstruction status and the residual blockage effects across cycles.

[0026] Preferably, in one embodiment of the present invention, since the negative pressure pump needs a certain amount of time to establish a vacuum and overcome the static inertia of the fluid in the tube during the initial stage of aspiration, the pressure rise at this time is a normal pressure building behavior, rather than an abnormal blockage caused by thrombus; maintaining a preset establishment time during the negative pressure establishment phase can shield the interference of this dynamic establishment process and prevent misjudgment; since the continuous aspiration phase is the main window for random thrombus entry, introducing time-dimensional anti-shake judgment (i.e., when the pressure continuously exceeds the threshold or the flow rate continuously falls below the threshold for a preset time) can filter transient disturbances (such as the instantaneous pressure spikes or flow troughs caused by the smooth aspiration of small thrombus fragments or the catheter being briefly attached to the wall due to the influence of heartbeat). Only when the high pressure or low flow state persists for a certain period of time can it be said that the catheter has been substantially blocked, at which point continuous aspiration needs to be terminated and the release phase begins; finally, maintaining a preset release time during the release phase can ensure that the vacuum inside the tube is fully released, so that the local flow field is completely reset, providing a reliable benchmark state for assessing the residual blockage across stages; thus, the method for dividing the continuous aspiration process and determining the aspiration cycle includes: The suction cycle starts automatically, maintains a preset establishment time, establishes a negative pressure establishment phase, and enters a continuous suction phase after the negative pressure establishment phase ends. If the pressure in the suction pipeline remains higher than the preset pressure threshold for a preset first duration, or the flow rate remains lower than the preset flow rate threshold for a preset second duration, the continuous suction phase ends and the release phase begins. The release phase maintains a preset release time and then ends, completing the current suction cycle and entering the next suction cycle.

[0027] As an example, when the control module receives the aspiration start command, the negative pressure pump starts and the preset setup time is set to 1 second. The expectation is that the pressure inside the aspiration catheter will reach the target value, such as 40 kPa (negative pressure - 40 kPa), within 1 second. This ensures that before formal blood aspiration begins, the tubing has the basic power level required to overcome the initial static inertia of the blood and the flow resistance along the flow path. During this stage, the focus is mainly on the initial accumulation of aspiration power, and the fluid may not yet have formed a completely stable continuous flow in the tubing. Blindly performing a blockage judgment at this point could easily lead to false alarms; therefore, no blockage judgment is performed. In other examples, the implementer can also adjust the preset setup time according to the catheter specifications and the performance of the negative pressure pump. After the negative pressure establishment phase ends, the continuous aspiration phase begins. During this phase, the filtered pressure and flow rate are monitored in real time to determine if any blockage has occurred. The criteria for determination include: the pressure in the aspiration tubing remains above a preset pressure threshold (e.g., 60 kPa) for a preset first duration (e.g., 200 ms); the flow rate in the aspiration tubing remains below a preset flow rate threshold (e.g., 10 ml / min) for a preset second duration (e.g., 200 ms). If any of these conditions are met, a non-transient effective blockage is determined, and the continuous aspiration phase must be terminated immediately. In other examples, the implementer can adjust the preset pressure threshold, preset first duration, preset flow rate threshold, and preset second duration according to the catheter specifications and other actual conditions. For example, for large-lumen catheters, the flow rate threshold can be appropriately increased to 15 mL / min. In another example, an aspiration duration limit can be added, whereby the physical running time of the continuous aspiration phase reaches the maximum limit of the set continuous aspiration duration. If any of the above three conditions are met, the continuous aspiration phase is terminated.

[0028] Then, the release phase begins. The negative pressure pump is stopped, the release valve is opened, and the preset release time, such as 300ms, is maintained. The negative pressure in the aspiration tubing is actively released, allowing the thrombus fragments around the catheter opening to detach from the opening under pressure fluctuations or a slight positive pressure, restoring patency. The preset release time can be calibrated based on the time required for the release valve to open and the flow rate to return to normal levels in an in vitro simulated occlusion test. This is a conventional technique and will not be elaborated further. Finally, the release valve is closed to complete the current suction cycle, and the negative pressure pump is restarted to enter the negative pressure establishment stage of the next suction cycle; the suction cycle is iterated and divided until the operator issues a stop command or the set total suction time is reached.

[0029] Step S2: During the current continuous suction phase, obtain suction blockage parameters based on the pressure increase trend and flow decrease trend in the suction pipeline; based on the initial pressure and initial flow rate in the suction pipeline during the current continuous suction phase, and combined with the final pressure and final flow rate in the suction pipeline during the adjacent previous continuous suction phase, obtain the cross-stage residual resistance parameters for the current continuous suction phase.

[0030] It should be noted that since the pressure changes during the negative pressure establishment and release phases are actively controlled and cannot reflect thrombus obstruction, the analysis scope of aspiration obstruction is limited to the continuous aspiration phase within each aspiration cycle. The negative pressure establishment and release phases are only used for state switching and recovery and are not involved in the analysis and calculation. The data processing and evaluation logic for the continuous aspiration phase in each aspiration cycle is completely consistent. For the sake of brevity, the following embodiments only use the current continuous aspiration phase as an example for illustration. Those skilled in the art should understand that the formula calculations and control logic described for the current continuous aspiration phase are equally applicable to the continuous aspiration phase in every aspiration cycle during continuous aspiration.

[0031] Since the continuous aspiration phase is the only working window in the entire aspiration cycle that is actually used to capture and transport thrombi, when thrombus fragments with a certain volume or viscosity enter the aspiration catheter, the effective flow cross-sectional area of ​​the tubing will decrease instantly, resulting in obstruction of fluid transport, which is macroscopically manifested as a decrease in aspiration flow rate; at the same time, due to the obstruction at the front end, while the negative pressure pump continues to force aspiration at the rear end, this will cause the absolute vacuum in the closed section of the catheter to rise rapidly, which is macroscopically manifested as an increase in aspiration pressure. During the current continuous aspiration phase, collaborative analysis of the pressure increase and flow decrease trends within the aspiration tubing not only ensures that the analyzed pressure and flow changes are caused solely by random thrombus load, eliminating interference from dynamic start-stop cycles, but also allows for cross-verification of the pressure increase and flow decrease trends to confirm their synchronous abrupt changes. This enables accurate identification of the true obstruction caused by random thrombus load and quantification of aspiration obstruction parameters during the current continuous aspiration phase.

[0032] Preferably, in one embodiment of the present invention, considering that the initial pressure represents the background vacuum level before interference from new thrombi during the current continuous aspiration phase, while the maximum pressure represents the extreme aspiration resistance during thrombus obstruction, the pressure rise ratio can be calculated. Due to the elastic deformation of the long catheter and the dynamic inertia of the fluid, the occurrence times of the pressure peak and the flow trough are usually not completely coincident. If the minimum flow rate during the current continuous aspiration phase is directly extracted, it is easy to mistakenly obtain irrelevant flow troughs caused by physiological fluctuations in heartbeat. Constructing an analysis window with a preset time span centered on the moment when the maximum pressure occurs can accurately capture the minimum flow rate associated with this pressure surge, avoiding mismatch of heterogeneous data, thereby allowing the flow attenuation ratio to be calculated in conjunction with the initial flow rate. Finally, using the pressure rise ratio as a basic prerequisite for the occurrence of obstruction, combined with the flow attenuation ratio representing the severity of actual physical stagnation, false obstruction can be eliminated, and the severity of effective obstruction caused by thrombi can be accurately quantified. The method for obtaining aspiration obstruction parameters includes: Extract the initial pressure and maximum pressure in the suction line during the current continuous suction phase, and calculate the pressure increase ratio; During the current continuous suction phase, an analysis window with a preset time span is constructed centered on the moment when the highest pressure occurs; the lowest flow rate within the analysis window is extracted, and the flow rate decay ratio is calculated by combining it with the initial flow rate of the current continuous suction phase. By combining the flow rate attenuation ratio and the pressure increase ratio, suction blockage parameters can be obtained.

[0033] As an example, during the current continuous suction phase, the difference between the highest pressure and the initial pressure (the pressure at the start of the phase) is normalized to obtain the pressure rise ratio. The normalization method can be: set a maximum pressure change (e.g., 50 kPa, representing the typical pressure increment from normal flow to complete blockage), divide the difference by the maximum pressure change to normalize, remove the dimensions, and limit the pressure rise ratio to [0,1]. Implementers can also use other normalization methods, or directly calculate the pressure rise rate and then map it to [0,1] to obtain the pressure rise ratio. Set a preset time span, such as 600ms, and extend it by 300ms along the time sequence direction and the reverse time sequence direction, with the moment when the highest pressure occurs as the center, to construct an analysis time window with a total span of 600ms. The preset time span can be calibrated according to the compliance of the conduit and the response time of the sensor, and is usually in the range of 400 to 1000ms. The implementer can also adjust it himself. It should be noted that the termination scale of the extended search within the analysis window must not exceed the current continuous suction phase.

[0034] The difference between the initial flow rate (flow rate at the start of the current continuous suction phase) and the lowest flow rate within the analysis window is normalized to obtain the flow rate attenuation ratio. The normalization method can be as follows: set a maximum flow rate change (e.g., 35 mL / min, representing the typical flow rate decrease from normal flow to complete blockage), divide the difference by the maximum flow rate change to normalize, remove the dimensions, and limit the flow rate attenuation ratio to [0,1]. Implementers can also use other normalization methods, or directly calculate the flow rate attenuation rate and then map it to [0,1] to obtain the flow rate attenuation ratio. Due to the slight changes in blood pressure pulsation and local blood viscosity during the cardiac cycle, normal slight flow fluctuations can occur inside the tubing. At the same time, when a thrombus actually blocks the catheter, the flow inside the tubing will collapse substantially. If linear multiplication is used directly, not only will the normal slight fluctuations be proportionally amplified into a blockage signal and misjudged, but a moderate decrease in flow may also forcibly weaken the weight of a sudden pressure surge, resulting in a delayed control response. Finally, a nonlinear fusion approach is adopted, treating the pressure increase ratio as the basic quantity of resistance enhancement, and the flow rate decrease ratio as the exponential saturation function mapping result of the independent variable x, as shown below. Considered as an effective blocking conversion factor, the two are multiplied together to obtain the suction blocking parameter.

[0035] In other embodiments, implementers may also use other fusion methods such as weighted summation, which will not be elaborated further.

[0036] Because coronary thrombi are highly adhesive, thrombus fragments from one aspiration cycle may remain near the catheter or inside the lumen, causing further blockage in the next aspiration cycle. If only the newly created blockage in the current stage (i.e., aspiration blockage parameters) is considered while ignoring historical residues, a mismatch between high residue levels and continued aspiration can easily occur, leading to repeated blockages, persistently high negative pressure, or even complete blockage. Therefore, this embodiment of the invention obtains cross-stage residual blockage parameters to accurately determine whether the blockage in the current continuous aspiration stage is caused by the cross-stage transmission of residual thrombi that were not successfully cleared in the previous continuous aspiration stage, providing a basis for distinguishing the source of blockage. Furthermore, the ending pressure and flow rate of the previous continuous suction phase represent the maximum physical blockage state reached by the pipeline before the release phase intervention; while the starting pressure and flow rate of the current continuous suction phase directly reflect the initial restored unobstructed state of the pipeline after the adjustment of the intermediate release phase; if the release and unblocking are effective, the current starting state should return to the preset recovery benchmark, forming a significant data difference with the previous ending state; if the release and unblocking are ineffective, the current starting state will directly inherit the abnormally high pressure and low flow rate of the previous ending state. Based on this, the embodiments of the present invention will, according to the starting pressure and starting flow rate in the suction pipeline during the current continuous suction phase, and combined with the ending pressure and ending flow rate in the suction pipeline during the adjacent previous continuous suction phase, calculate the relative deviation between the current starting state and the previous ending state to quantify the extent to which the physical resistance of the previous continuous suction phase continues to the cross-stage residual resistance parameter of the current continuous suction phase.

[0037] Preferably, in one embodiment of the present invention, considering that the initial pressure and initial flow rate in the unobstructed state will vary depending on the coronary vessel diameter, blood viscosity, and the length and inner diameter of the selected aspiration catheter; if a clear reference baseline is not set, it will be impossible to determine whether the initial pressure in the subsequent aspiration process is due to natural resistance or residual blockage. Therefore, a preset recovery baseline pressure and a preset recovery baseline flow rate are first determined as a unified absolute reference zero point to measure whether the tubing has truly returned to its healthy initial state during the aspiration cycle; furthermore, considering that numerical differences alone cannot objectively quantify the degree of erosion of the aspiration system performance by residual thrombus, and considering the end state parameters (pressure and flow rate) of the adjacent previous continuous aspiration stage, The deviation ratio of the initial state parameters (pressure and flow rate) of the current continuous suction phase relative to the preset recovery benchmark can reflect the degree of conversion of residual resistance into actual delivery function loss. This allows for the calculation of the pressure conversion ratio and flow rate conversion ratio, and then, using residual pressure as the basis and flow rate conversion as verification, accurately quantifying the cross-stage residual resistance parameters. Since the pipeline is in an initial, clean, and brand-new startup state during the first suction cycle, there is no historical data or action accumulation from the previous stage on the timeline. To avoid affecting subsequent calculations, the cross-stage residual resistance parameters are directly set to zero to ensure the integrity of the algorithm's temporal logic. The methods for obtaining the cross-stage residual resistance parameters include: The pressure bearing ratio is calculated based on the deviation of the initial pressure in the suction line during the current continuous suction phase from the preset recovery reference pressure, and the deviation of the final pressure in the suction line during the adjacent previous continuous suction phase from the preset recovery reference pressure. The flow carrying ratio is calculated based on the deviation of the initial flow rate in the suction pipeline during the current continuous suction phase from the preset recovery reference flow rate, and the deviation of the final flow rate in the suction pipeline during the adjacent previous continuous suction phase from the preset recovery reference flow rate. By integrating the pressure handling ratio and the flow handling ratio, the residual resistance parameter across stages can be obtained; if the current continuous suction stage is in the first suction cycle, the residual resistance parameter across stages is directly set to zero.

[0038] As an example, first determine the preset recovery baseline pressure and preset recovery baseline flow rate; In a preferred embodiment of the present invention, considering that performing the calibration aspiration procedure in an in vitro physiological saline environment can eliminate complex dynamic interference factors within the organism, obtain the purest, pulsation-free, and impurity-free ideal flow field state, thereby ensuring the objectivity and reliability of the reference parameters; the method for obtaining the preset recovery reference pressure and preset recovery reference flow rate includes: The calibration aspiration procedure was performed in an in vitro saline environment, with the average pressure under a stable flow field as the preset recovery reference pressure and the average flow rate as the preset recovery reference flow rate.

[0039] Specifically, the tip of the aspiration tube of the integrated aspiration device is completely immersed in a container filled with room temperature physiological saline. The negative pressure pump is started and the calibration aspiration program is executed. The physiological saline is allowed to flow continuously in one direction within the aspiration tube for 3 seconds to allow the flow field within the tube to reach a stable state without bubbles or pulsations. In the subsequent 10-second analysis window, the pressure and flow rate within the aspiration tube are collected in real time. The pressure is calculated by removing peaks and troughs and then taking the arithmetic mean to obtain the preset recovery reference pressure. The flow rate is calculated by removing extreme values ​​and then taking the arithmetic mean to obtain the preset recovery reference flow rate.

[0040] It should be noted that the above calibration process is independent of this continuous aspiration process and can be calibrated and stored in advance for later retrieval; the above calibration methods are all conventional technical methods in this field and will not be described in detail.

[0041] In other embodiments, the implementer may also perform sliding updates based on the unobstructed health phases in the historical aspiration process to determine the preset recovery baseline pressure and preset recovery baseline flow rate; specifically, the comprehensive aspiration blockage parameter of each completed continuous aspiration phase (obtained in subsequent step S3) is recorded, and several unobstructed historical phases with comprehensive aspiration blockage parameters lower than the preset minimum health threshold (e.g., 0.1) are selected, and the average pressure within the unobstructed historical phase is used as the preset recovery baseline pressure; similarly, the preset recovery baseline flow rate can be determined.

[0042] Then, the pressure bearing ratio is calculated. Specifically, the difference between the initial pressure in the suction line during the current continuous suction phase and the preset recovery reference pressure is used as the numerator. The difference between the final pressure in the suction line during the previous continuous suction phase and the preset recovery reference pressure is also calculated. To prevent the calculation from crashing due to a zero denominator, a very small constant ε, such as 0.001, is introduced and added to the difference as the denominator. The ratio is then limited to [0,1] to obtain the pressure bearing ratio. Specifically, the ratio can be mapped to the sigmoid function, or the upper limit can be directly truncated, which will not be elaborated further. Similarly, the flow rate carrying ratio is calculated. Specifically, the difference between the preset recovery baseline flow rate and the initial flow rate in the suction pipeline during the current continuous suction phase is used as the numerator. The difference between the preset recovery baseline flow rate and the final flow rate in the suction pipeline during the previous continuous suction phase is calculated. To prevent the calculation from crashing due to a zero denominator, a very small constant ε, such as 0.001, is introduced and added to the difference as the denominator. The ratio is then limited to [0,1] to obtain the flow rate carrying ratio. Specifically, the ratio can be mapped to the sigmoid function, or the upper limit can be directly truncated, which will not be elaborated further. It should be noted that in the calculation of the pressure acceptance ratio and flow acceptance ratio, when either the numerator or the denominator is negative, the corresponding acceptance ratio is directly forced to be 0; only when both the numerator and the denominator are greater than 0, the ratio is calculated and the corresponding acceptance ratio is obtained by limiting the range. Finally, a nonlinear fusion approach was adopted, mapping the traffic handling ratio as the independent variable x to a nonlinear exponential decay model, such as... The mapping result is then multiplied by the pressure carrying ratio to obtain the cross-stage residual obstruction parameter. Here, 1-x represents the degree to which the pipeline has truly recovered healthy and unobstructed flow. When the flow carrying ratio approaches 1 (i.e., the flow loss in the previous stage is almost fully and maliciously carried over), the exponential term approaches 0, the mapping result approaches 1, and pressure carrying is considered as residual obstruction. When the flow carrying ratio approaches 0 (i.e., the residual blockage at the flow angle has been completely cleared), the mapping result will decay more rapidly, thereby significantly reducing the cross-stage residual obstruction parameter. The nonlinear exponential verification fusion can ensure that it maintains extremely high alarm sensitivity in the semi-blocked state where the flow is slightly restored but the pressure is still dangerously high, while achieving rapid fault tolerance and zeroing in the unobstructed state where the flow is completely restored.

[0043] In other embodiments, implementers may also use other fusion methods such as weighted summation, which will not be elaborated further.

[0044] Step S3: Obtain the comprehensive suction blockage parameter of the current continuous suction stage based on the suction blockage parameter and the cross-stage residual stagnation parameter, and adjust the suction process in a targeted manner by combining the comparison relationship between the suction blockage parameter and the cross-stage residual stagnation parameter.

[0045] Further comprehensive characterization of the current blockage suction parameters and the cross-stage residual blockage parameters of historical residual blockages will yield comprehensive suction blockage parameters for the current continuous suction phase, preparing for subsequent adjustments to the suction process.

[0046] Preferably, in one embodiment of the present invention, considering that there is an absolute physical upper limit to the unobstructedness of the pipeline, and that the process of the pipeline becoming blocked is essentially a progressive encroachment on it; the cross-stage residual stagnation parameter characterizing historical residual blockage is regarded as the initial stagnation space of the pipeline, and the cross-stage residual stagnation parameter is negatively correlated and normalized to determine the remaining unblocked space. Therefore, the suction blockage parameter characterizing the current blockage can only encroach on the remaining unblocked space, thereby determining the new blockage parameter; the new blockage parameter is then superimposed with the cross-stage residual stagnation parameter to determine the final comprehensive suction blockage parameter; the method for obtaining the comprehensive suction blockage parameter includes: During the current continuous suction phase, the negative correlation normalized value of the cross-stage residual blocking parameter is used as the stable margin weight, and the suction blocking parameter is weighted to obtain the new blocking parameter; the sum of the new blocking parameter and the cross-stage residual blocking parameter is used as the comprehensive suction blocking parameter.

[0047] As an example, since the value range of the cross-stage residual hindrance parameter is [0,1], the constant 1 is directly subtracted from the cross-stage residual hindrance parameter to perform negative correlation normalization, resulting in a stable margin weight. Then, the stable margin weight is multiplied by the suction blocking parameter to obtain the new blocking parameter. Finally, the sum of the new blocking parameter and the cross-stage residual hindrance parameter is used as the comprehensive suction blocking parameter. The comprehensive suction blocking parameter is still within [0,1].

[0048] While comprehensive aspiration blockage parameters can determine the blockage status during the current continuous aspiration phase, they cannot distinguish whether the blockage is dominated by the current blockage (a newly entered thrombus during the current continuous aspiration phase) or by residual blockage (a thrombus left over from the previous continuous aspiration phase). Since different adjustment strategies are required for the two types of blockage, after obtaining comprehensive aspiration blockage parameters, it is necessary to further combine the comparison relationship between aspiration blockage parameters and cross-phase residual blockage parameters to determine the source of blockage, thereby adjusting the aspiration process in a targeted manner.

[0049] Preferably, in one embodiment of the present invention, since the main source of blockage in the complex control of suction will fail due to mismatch of subsequent control measures if the source of blockage is not identified, the source of blockage is first determined by comparing the suction blockage parameter with the cross-stage residual resistance parameter; further, a preset interval is set to judge the pipeline blockage situation, providing a basis for subsequent targeted intervention and adjustment; then, based on the comparison relationship between the suction blockage parameter and the cross-stage residual resistance parameter, the method for targeted adjustment of the suction process includes: The source of blockage is determined by comparing the suction blockage parameters with the cross-stage residual blockage parameters, including at least newly added blockage and residual blockage; If the overall suction blockage parameter is less than the lower limit of the preset interval, the suction process parameters in the current continuous suction phase will be maintained in the next suction cycle. If the overall suction blockage parameter is within the preset range and the blockage source is a newly added blockage, then the continuous suction duration will be reduced by a preset attenuation ratio in the next suction cycle. If the overall suction blockage parameter is within the preset range and the blockage source is residual blockage, then in the next suction cycle, the starting suction pressure will be reduced by a preset reduction ratio, and the duration of the release phase will be extended by a preset delay ratio. If the overall suction blockage parameter is greater than the upper limit of the preset interval, then the anti-blockage release will be performed in the next suction cycle.

[0050] As an example, first determine the source of the blockage; In a preferred embodiment of the present invention, since the suction blocking parameter and the cross-stage residual hindrance parameter are calculated using different methods during quantitative evaluation, their natural numerical distribution ranges and extreme value upper limits objectively differ mathematically. Direct subtraction and comparison may lead to misjudgment. Therefore, a preset scale alignment coefficient must be introduced. The preset scale alignment coefficient is pre-calibrated based on the difference in numerical magnitude between the suction blocking parameter and the cross-stage residual hindrance parameter. By using it to weight the cross-stage residual hindrance parameter, the distribution range of the latter can be forcibly mapped and compressed / stretched to the same scale as the former, thereby eliminating the interference of the underlying algorithm function characteristics on physical decision-making, accurately determining the source parameter, and identifying the source of blocking. The method for obtaining the source of blocking includes: The residual blocking parameter across stages is weighted using a preset scale alignment coefficient. The source parameter is obtained by subtracting the weighted result from the suction blocking parameter. The preset scale alignment coefficient is pre-calibrated based on the difference in magnitude between the suction blocking parameter and the residual blocking parameter across stages. When the source parameter is greater than 0, the source of blocking is newly added blocking. When the source parameter is less than or equal to 0, the source of blocking is residual blocking.

[0051] Specifically, firstly, the preset scale alignment coefficient is calibrated; based on the analysis of the calculation process of the two parameters, it can be seen that the upper limit of the suction blockage parameter is affected by the exponential term. The maximum value is limited to 0.632; while the upper limit of the cross-stage residual retardation parameter is 1; therefore, the preset scale alignment coefficient can be calibrated to 0.632 to eliminate the difference in numerical magnitude; implementers can also calibrate it themselves according to actual applications, which will not be elaborated further. Then, the preset scale alignment coefficient is multiplied by the cross-stage residual hindrance parameter, and the product is subtracted from the suction hindrance parameter to obtain the source parameter. When the source parameter is greater than 0, it indicates that the suction hindrance parameter is dominant, and the hindrance source is set as the new hindrance. When the source parameter is less than or equal to 0, it indicates that the cross-stage residual hindrance parameter is dominant, and the hindrance source is set as the residual hindrance.

[0052] Then, a preset range is determined for graded quantification of the blocking state for targeted regulation; In a preferred embodiment of the present invention, considering that under ideal unobstructed conditions, the comprehensive suction blockage parameter should theoretically be absolute zero; however, during actual suction, minor vibrations of the pump body, fluid inertial impacts during valve switching, and the inherent noise of the sensor itself will inevitably cause normal, slight fluctuations in the comprehensive parameter; if zero is taken as the safety baseline, these inherent noises will frequently trigger false alarms; by simulating an unobstructed state externally, capturing the extreme fluctuation values ​​of this parameter under normal operating conditions, and superimposing an appropriate preset fluctuation margin, the lower limit of the interval is determined to ensure that only when a true unobstructed state is reached. Intervention is only triggered when there is actual blockage; considering that when the pipeline reaches a completely blocked state, the comprehensive suction blockage parameter theoretically approaches the extreme value of 1, if the anti-blockage release is only initiated after the parameter reaches its maximum value, or even after the negative pressure pump actually stops and the pipe wall is torn by strong suction, it will cause a serious accident; by simulating a completely blocked state externally, the blockage critical value of the pipeline at the moment of deadlock is accurately captured and a preset safety margin is actively reserved to determine the upper limit of the range, ensuring that before irreversible physical deadlock occurs, forced cut-off and fine-tuning can be performed and emergency release can be initiated; the methods for obtaining the preset range include: In an in vitro calibration environment, a non-blocking aspiration state is simulated. The lower limit of the preset interval is determined based on the extreme value of the fluctuation of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset fluctuation margin. In an in vitro calibration environment, a completely blocked aspiration state is simulated. The upper limit of the preset interval is determined based on the critical value of the blockage of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset safety margin. The preset interval is determined based on the upper limit and lower limit of the interval.

[0053] Specifically, under in vitro calibration conditions, the aspiration catheter is completely immersed in physiological saline and allowed to run smoothly to simulate an unobstructed aspiration state; the comprehensive aspiration obstruction parameter is continuously monitored in 10 aspiration cycles, and the maximum comprehensive aspiration obstruction parameter is extracted as the fluctuation extreme value; to prevent false alarms caused by background noise, a preset fluctuation margin such as 0.05 is introduced, and the fluctuation extreme value is added to the preset fluctuation margin to determine the lower limit of the preset interval; Under the same external calibration environment, the front end of the suction tube was completely clamped by a water-stop clamp to simulate a completely blocked suction state; the surge curve of the comprehensive suction blockage parameter was recorded during the process of the pipeline from unobstructed to completely blocked, and the comprehensive suction blockage parameter at the moment when the negative pressure pump was about to overload or reached the rated ultimate vacuum degree was extracted as the blockage critical value; a preset safety margin such as 0.15 was introduced, and the blockage critical value was subtracted from the preset safety margin to determine the upper limit of the preset range; The preset interval is finally determined based on the upper and lower limits of the interval.

[0054] In other examples, the preset interval can also be determined offline based on historical clinical data. Collect comprehensive aspiration blockage parameters in a stable aspiration state from a large number of past cases and calculate their statistical distribution. Use the maximum value as the upper limit of the interval and the mean + 3 times the standard deviation as the lower limit of the interval. The implementer can also dynamically generate it based on the trial aspiration stage in the patient's body, which will not be elaborated further.

[0055] Ultimately, based on the comprehensive suction blockage parameters and sources during the current continuous suction phase, the suction process is directionally controlled, including: When the overall suction blockage parameter is less than the lower limit of the interval, the pipeline is only affected by a small background noise and is in a completely safe state. Frequent intervention will lead to reduced efficiency of control oscillation, so no intervention is made in the next suction cycle. When the overall aspiration blockage parameter is within the preset range, it must be adjusted according to the source of the blockage: If the source of the blockage is a new blockage, it means that a large number of new thrombi are being aspirated. If aspiration continues, it is very easy for the thrombi to become compacted and stuck due to prolonged negative pressure dehydration. Therefore, the duration of aspiration is reduced by a preset attenuation ratio, for example, 20% (for example, if the duration of aspiration in the current aspiration phase is 5 seconds, the duration of aspiration in the next aspiration phase will be updated to 4 seconds) to interrupt the accumulation process in advance. If the source of the blockage is a residual blockage, it means that the previous release was insufficient. Therefore, the initial aspiration pressure is reduced by a preset reduction ratio, for example, 25% (i.e., the target value is 40 kPa, and the target value in the next aspiration phase will be updated to 30 kPa) to reduce the impact. The release time is extended by a preset delay ratio, for example, 50% (e.g., 300 ms, and the release time in the next aspiration phase will be updated to 450 ms) to give the residual thrombi a sufficient window for loosening and emptying. When the overall suction blockage parameter is greater than the upper limit of the range, the physical channel of the pipeline is almost completely blocked. At this time, any conventional fine-tuning is ineffective and extremely dangerous (it can easily cause pump overload or blood vessel wall adhesion tearing). Therefore, forced anti-blockage release should be performed immediately in the next suction cycle (such as immediately stopping the negative pressure pump, opening the release valve to completely release the negative pressure in the pipeline, or performing a very short reverse flush).

[0056] In summary, this invention collects pressure and flow rate within the suction pipeline in real time during continuous suction; sequentially divides the continuous suction process to determine suction cycles; each suction cycle includes at least a negative pressure establishment phase, a continuous suction phase, and a release phase; within the current continuous suction phase, suction blockage parameters are obtained based on the pressure increase trend and flow rate decrease trend within the suction pipeline; based on the initial pressure and initial flow rate within the suction pipeline in the current continuous suction phase, combined with the final pressure and final flow rate within the suction pipeline in the adjacent previous continuous suction phase, cross-stage residual resistance parameters are obtained for the current continuous suction phase; based on the suction blockage parameters and cross-stage residual resistance parameters, a comprehensive suction blockage parameter for the current continuous suction phase is obtained, and by combining the comparison relationship between the suction blockage parameters and cross-stage residual resistance parameters, the suction process is adjusted in a targeted manner. This invention combines pressure and flow characteristics to accurately quantify newly added aspiration blockage parameters and historical residual blockage parameters across stages. It also analyzes the source of blockage to directionally and synergistically regulate the aspiration process, achieving precise matching between control intervention and physical blockage causes. This avoids repeated blockages and negative pressure mismatch, and improves the aspiration control effect in the coronary thrombus removal process.

Claims

1. A method for coordinated control of an integrated aspiration device for coronary thrombus removal, characterized in that, The method includes: Real-time acquisition of pressure and flow rate within the suction pipeline during continuous suction; sequential division of the continuous suction process to determine the suction cycle; each suction cycle includes at least a negative pressure establishment phase, a continuous suction phase, and a release phase; During the current continuous suction phase, suction blockage parameters are obtained based on the pressure increase trend and flow decrease trend in the suction pipeline; based on the initial pressure and initial flow in the suction pipeline during the current continuous suction phase, combined with the final pressure and final flow in the suction pipeline during the adjacent previous continuous suction phase, cross-phase residual resistance parameters are obtained for the current continuous suction phase. The comprehensive suction blocking parameters for the current continuous suction phase are obtained based on the suction blocking parameters and the cross-stage residual hindrance parameters. The suction process is then adjusted in a targeted manner by combining the comparison between the suction blocking parameters and the cross-stage residual hindrance parameters.

2. The collaborative control method of the integrated aspiration device for coronary thrombus removal according to claim 1, characterized in that, Methods for dividing the continuous suction process into sequential steps and determining the suction cycle include: The suction cycle starts automatically, maintains a preset establishment time, determines the negative pressure establishment phase, and enters the continuous suction phase after the negative pressure establishment phase ends. If the pressure in the suction pipeline is higher than the preset pressure threshold for a preset first duration, or the flow rate is lower than the preset flow rate threshold for a preset second duration, the continuous suction phase ends and the release phase begins. The release phase is maintained for a preset release time and then ends, completing the current suction cycle and entering the next suction cycle.

3. The collaborative control method of the integrated aspiration device for coronary thrombus removal according to claim 1, characterized in that, The method for obtaining the suction blockage parameter includes: Extract the initial pressure and maximum pressure in the suction line during the current continuous suction phase, and calculate the pressure increase ratio; During the current continuous suction phase, an analysis window with a preset time span is constructed centered on the moment when the highest pressure occurs; the lowest flow rate within the analysis window is extracted, and the flow rate decay ratio is calculated by combining it with the initial flow rate of the current continuous suction phase. By combining the flow rate attenuation ratio and the pressure increase ratio, the suction blockage parameter is obtained.

4. The collaborative control method of the integrated aspiration device for coronary thrombus removal according to claim 1, characterized in that, The method for obtaining the cross-stage residual retardation parameters includes: The pressure bearing ratio is calculated based on the deviation of the initial pressure in the suction line during the current continuous suction phase from the preset recovery reference pressure, and the deviation of the final pressure in the suction line during the adjacent previous continuous suction phase from the preset recovery reference pressure. The flow carrying ratio is calculated based on the deviation of the initial flow rate in the suction pipeline during the current continuous suction phase from the preset recovery reference flow rate, and the deviation of the final flow rate in the suction pipeline during the adjacent previous continuous suction phase from the preset recovery reference flow rate. By combining the pressure acceptance ratio and the flow acceptance ratio, the cross-stage residual resistance parameter is obtained; wherein, if the current continuous suction stage is in the first suction cycle, the cross-stage residual resistance parameter is directly set to zero.

5. The coordinated control method of the integrated aspiration device for coronary thrombus removal according to claim 4, characterized in that, The method for obtaining the preset recovery reference pressure and the preset recovery reference flow rate includes: The calibration aspiration procedure was performed in an in vitro saline environment, with the average pressure under a stable flow field as the preset recovery reference pressure and the average flow rate as the preset recovery reference flow rate.

6. The collaborative control method of the integrated aspiration device for coronary thrombus removal according to claim 1, characterized in that, The method for obtaining the comprehensive suction blockage parameters includes: During the current continuous suction phase, the negative correlation normalized value of the cross-stage residual resistance parameter is used as the stable margin weight, and the suction blocking parameter is weighted to obtain the new blocking parameter; the sum of the new blocking parameter and the cross-stage residual resistance parameter is used as the comprehensive suction blocking parameter.

7. The coordinated control method of the integrated aspiration device for coronary thrombus removal according to claim 1, characterized in that, Based on the comparison between suction blockage parameters and cross-stage residual retardation parameters, methods for targeted adjustment of the suction process include: The source of blockage is determined by comparing the suction blockage parameters with the cross-stage residual blockage parameters, including at least newly added blockage and residual blockage; If the comprehensive suction blockage parameter is less than the lower limit of the preset interval, the suction process parameters in the current continuous suction phase will be maintained in the next suction cycle. If the comprehensive suction blockage parameter is within the preset range and the blockage source is a new blockage, then the continuous suction duration will be reduced by a preset attenuation ratio in the next suction cycle. If the comprehensive suction blockage parameter is within a preset range and the blockage source is residual blockage, then in the next suction cycle, the starting suction pressure is reduced by a preset reduction ratio, and the duration of the release phase is extended by a preset delay ratio. If the overall suction blockage parameter is greater than the upper limit of the preset interval, then the anti-blockage release will be performed in the next suction cycle.

8. The coordinated control method of the integrated aspiration device for coronary thrombus removal according to claim 7, characterized in that, The method for obtaining the source of the blockage includes: The cross-stage residual obstruction parameter is weighted using a preset scale alignment coefficient, and the source parameter is obtained by subtracting the weighted result from the suction obstruction parameter. The preset scale alignment coefficient is pre-calibrated based on the difference in magnitude between the suction obstruction parameter and the cross-stage residual obstruction parameter. When the source parameter is greater than 0, the obstruction source is newly added obstruction; when the source parameter is less than or equal to 0, the obstruction source is residual obstruction.

9. The coordinated control method of the integrated aspiration device for coronary thrombus removal according to claim 7, characterized in that, The method for obtaining the preset interval includes: In an in vitro calibration environment, a non-blocking aspiration state is simulated. The lower limit of the preset interval is determined based on the extreme value of the fluctuation of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset fluctuation margin. In an in vitro calibration environment, a completely blocked aspiration state is simulated. The upper limit of the preset interval is determined based on the critical value of the blockage of the comprehensive aspiration blockage parameter in the aspiration cycle and in combination with the preset safety margin. The preset interval is determined based on the upper limit and lower limit of the interval.

10. An integrated aspiration device for coronary thrombus removal, comprising a device body, characterized in that, The device implements the steps of the coordinated control method for the integrated aspiration device for coronary thrombus removal as described in any one of claims 1 to 9.

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