Control method and system for double-balloon aortic balloon counterpulsation device

Abstract

The invention discloses a double-balloon aorta balloon counterpulsation device control method and system, the device comprises a main balloon and an auxiliary balloon, the inflation and deflation triggering of the main balloon is the same as that of traditional in-aorta balloon counterpulsation, and the main balloon is not affected by the working mode of the auxiliary balloon; the auxiliary balloon is used for calculating the key time point of inflation and deflation according to the heart rate, the working modes and delay parameters on the basis of the inflation and deflation time point of the main balloon, the auxiliary balloon has the three working modes of a synchronous mode, a cardiac displacement enhancement mode and a cardiac displacement enhancement and cardiac-cerebral perfusion enhancement mode, and related time difference parameters can be set in a manual or automatic mode. According to the invention, the counterpulsation effect can be effectively improved, the cardiac discharge volume is increased, the heart-brain perfusion is improved, the side effect can be reduced when the outer membrane of the complex is oxygenated, and the method has important clinical application value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a double-balloon aortic balloon counterpulsation device control method and system. BACKGROUND

[0002] Intra-aortic balloon counterpulsation (IABP) is an important mechanical circulatory assist technology, which places a balloon in the aorta, inflates in diastole to increase coronary perfusion, and deflates in systole to reduce left ventricular afterload, thereby improving cardiac function. The traditional IABP is mostly single-balloon structure, which has certain limitations in clinical application, such as limited effect on improving cardiac output. In order to overcome these limitations, the present application proposes a double-balloon aortic balloon counterpulsation device control method and system. SUMMARY

[0003] The purpose of the present application is to provide a double-balloon aortic balloon counterpulsation device control method and system to solve the problems raised in the background.

[0004] To achieve the above purpose, the present application provides the following technical scheme: a double-balloon aortic balloon counterpulsation device control method, comprising the following steps:

[0005] Step A: device initialization and trigger signal acquisition;

[0006] Step B: main balloon mode selection, parameter setting and charging and discharging control

[0007] According to the actual scene, the operator selects the main balloon working mode and parameters, and the main balloon periodically performs the inflation and deflation actions under the control of the trigger signal according to the charging and discharging logic of the traditional IABP;

[0008] Step C: selection of secondary balloon working mode

[0009] Select the running mode of the secondary balloon from the three preset working modes;

[0010] Step D: calculation of secondary balloon key time points

[0011] Taking the charging and discharging time points of the main balloon as the reference, combining the current heart rate, the selected working mode and the preset delay parameters, the four key time points of the secondary balloon are calculated: inflation start time; inflation completion time; deflation start time; deflation completion time;

[0012] Step E: secondary balloon delay parameter (ΔTs, ΔTd) setting, according to the selected working mode, set the corresponding delay parameters;

[0013] Step F: double-balloon cooperative operation and dynamic adjustment

[0014] The main and auxiliary balloons perform the inflation and deflation actions periodically according to the inflation and deflation timing determined in the above steps under the control of the trigger signal. During the operation, the device monitors the changes of the trigger signal, heart rate and delay parameter in real time. When the change of ΔTs_max reaches the set threshold, the optimization of ΔTs in operation is automatically triggered. The operator can also manually intervene in parameter setting or mode switching to ensure that the counterpulsation effect is adapted to the physiological state of the patient.

[0015] Step G: Special scene adaptation

[0016] When the device is used in combination with VA-ECMO, the auxiliary balloon should adopt mode 2, and through the optimization of ΔTs, the increase of left ventricular afterload caused by ECMO is reduced to protect heart function.

[0017] Preferably, the three modes are defined as follows: mode 1-synchronous mode: simulate traditional single-capsule IABP, the main balloon and the auxiliary balloon are inflated and deflated synchronously;

[0018] Mode 2-Cardiac output enhancement mode: the auxiliary balloon is inflated synchronously with the main balloon, and the deflation process starts relatively delayed to the main balloon;

[0019] Mode 3-Cardiac output enhancement + cerebral perfusion enhancement mode: the auxiliary balloon completes inflation ahead of the main balloon, and the deflation process starts relatively delayed.

[0020] Preferably, in step D, the specific rules of the key time points in different modes are as follows:

[0021] Mode 1: inflation start, inflation completion, deflation start and deflation completion are completely synchronized with the main balloon;

[0022] Mode 2: inflation start and inflation completion are synchronized with the main balloon, deflation start is delayed by ΔTs time relative to the main balloon, and deflation completion is synchronized with the main balloon;

[0023] Mode 3: inflation start is synchronized or slightly delayed with the main balloon, inflation completion is ahead of the main balloon by ΔTd time, deflation start is delayed by ΔTs time relative to the main balloon, and deflation completion is synchronized with the main balloon.

[0024] Preferably, in step E, the secondary balloon does not require additional parameter settings in mode 1, requires setting ΔTs in mode 2, and requires setting both ΔTs and ΔTd in mode 3. The setting methods include manual setting and automatic optimization: Manual setting: ΔTs can be set using a proportional method or an absolute value method. In the proportional method, ΔTs = Ts_ratio × ΔTs_max, where Ts_ratio ranges from 0 to 100% and has a default value of 100%, and ΔTs_max = main balloon deflation time - minimum secondary balloon deflation time. In the absolute value method, ΔTs is directly set to ΔTs_set, ranging from 0 to ΔTs_max, with a default value of ΔTs_max. When ΔTs_max changes such that ΔTs_set > ΔTs_max, the smaller of the two, min(ΔTs_set, ΔTs_max), is used as the actual operating parameter, and a warning is triggered to remind the operator.

[0025] ΔTd can be set using either a proportional method or an absolute value method. In the proportional method, ΔTd = Td_ratio × ΔTd_max, where Td_ratio ranges from 0 to 100%, and ΔTd_max = main balloon inflation time - minimum auxiliary balloon inflation time. In the absolute value method, ΔTd is directly set as ΔTd_set, ranging from 0 to ΔTd_max. When ΔTd_max changes such that ΔTd_set > ΔTd_max, the smaller of the two, min(ΔTd_set, ΔTd_max), is used as the actual operating parameter, and a warning is triggered to remind the operator.

[0026] Automatic optimization: Based on real-time arterial pressure waveforms or external cardiac output monitoring data, the optimal value is determined by gradually adjusting ΔTs and evaluating the effects, with the goal of minimizing pressure indicators or maximizing CO.

[0027] Preferably, the inflation / deflation triggering modes of the main balloon include the following three modes: automatic mode: the signal source is automatically selected by the device, and the counterpulsation ratio is manually set by the operator; semi-automatic mode: the signal source is manually selected by the operator, and the counterpulsation ratio is manually set by the operator; manual mode: both the signal source and the counterpulsation ratio are manually set by the operator.

[0028] Preferably, the automatic setting of ΔTs is based on real-time arterial pressure waveform or real-time external cardiac output monitoring. The optimization goal is to optimize the selected target parameters. The target parameters include arterial pressure indicators or cardiac output CO. Arterial pressure indicators include systolic blood pressure SBP, diastolic blood pressure DBP, mean systolic blood pressure sMBP, and ΔSBP = SBP - MBP, ΔDBP = DBP - MBP, and ΔsMBP = sMBP - MBP obtained by subtracting the mean arterial pressure from the above data. The lower the pressure indicators are, the better. The optimization goal is to maximize CO.

[0029] Preferably, the automatic optimization process of ΔTs includes initial optimization and in-process optimization. Initial optimization is triggered when the corresponding mode is first started without operator input parameters during the current operation, or is manually triggered by the operator. Starting from ΔTs = 0, the ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. The target parameter is measured and recorded until the target parameter is optimal. Alternatively, the above process is reversed starting from ΔTs = ΔTs_max. In-process optimization is automatically triggered when the change of ΔTs_max reaches a set threshold. It can be manually disabled by the operator and automatically triggered when it is undisabled. The ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. Continuous measurement is performed, attempting to decrease or increase ΔTs, prioritizing changes in the same direction as ΔTs_max. The target parameter is evaluated. If the target parameter improves, it is gradually adjusted in this direction until the target parameter is optimal. If the target parameter deteriorates, ΔTs is gradually adjusted in the reverse direction until the target parameter is optimal. If the target parameter does not improve regardless of whether ΔTs is increased or decreased, the original ΔTs value is maintained.

[0030] Preferably, when the dual-balloon aortic balloon counterpulsation device is used in conjunction with VA-ECMO, the accessory balloon operates in cardiac output enhancement mode.

[0031] Preferably, a dual-balloon intra-aortic balloon counterpulsation system includes a dual-balloon IABP device, the dual-balloon IABP device including a balloon catheter and a main unit, the balloon catheter including a main balloon, a secondary balloon and a catheter shaft connected in series, the main unit receiving electrocardiogram and / or arterial blood pressure signals, for executing the control method as described in any one of claims 1-7, controlling the inflation and deflation timing of the dual balloons.

[0032] Beneficial effects:

[0033] (1) This invention, by setting up a main balloon and a secondary balloon, and employing three different working modes for the secondary balloon, can be flexibly adjusted according to different clinical needs to improve the counterpulsation effect. The synchronous mode can simulate the traditional single-balloon IABP, ensuring compatibility with traditional technologies; the cardiac output enhancement mode can effectively increase cardiac output and improve cardiac function; the cardiac output enhancement + cardiac and cerebral perfusion enhancement mode can not only increase cardiac output, but also increase cardiac and cerebral perfusion, which is suitable for specific clinical scenarios.

[0034] (2) In this invention, two settings are provided for the time difference parameters ΔTs and ΔTd of the auxiliary balloon: manual and automatic. Manual setting can be flexibly adjusted by the operator based on experience, while automatic setting can be optimized based on real-time monitoring data, which improves the accuracy and convenience of parameter setting.

[0035] The above description is merely an overview of the technical solutions of the embodiments of this application. In order to better understand the technical means of the embodiments of this application and to implement them in accordance with the contents of the specification, and to make the above and other objects, features and advantages of the embodiments of this application more apparent and understandable, specific implementation methods of this application are described below. Attached Figure Description

[0036] Figure 1 This is a flowchart of the workflow of the present invention;

[0037] Figure 2 Phase diagrams for triggering each mode;

[0038] Figure 3 This is a waveform of arterial pressure in displacement enhancement mode;

[0039] Figure 4 This is a schematic diagram of the dual-capsule IABP device.

[0040] In the diagram: main balloon 1, auxiliary balloon 2, catheter shaft 3, main unit 4. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein in the specification of the application is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims and drawings of this application are intended to cover non-exclusive inclusion.

[0043] The term "embodiment" as used herein means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of the phrase "embodiment" in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0044] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings.

[0045] Please see Figures 1-3 The present invention provides the following technical solution: a control method for a dual-balloon aortic balloon counterpulsation device, comprising the following steps:

[0046] Step A: Device initialization and trigger signal acquisition

[0047] The dual-balloon aortic balloon counterpulsation device is activated. The device includes a main balloon and a secondary balloon, which are connected in series in a balloon catheter. The main unit receives trigger signals in real time, including electrocardiogram signals and / or arterial blood pressure signals, as a reference for the inflation and deflation control of the main and secondary balloons.

[0048] Step B: Main balloon mode selection, parameter setting, and inflation / deflation control

[0049] The mode selection, parameter settings, and main balloon, under the control of the trigger signal, periodically perform inflation and deflation actions according to the traditional ABP inflation and deflation logic. Its inflation and deflation trigger mode is not affected by the working mode of the auxiliary balloon.

[0050] Step C: Selecting the working mode of the auxiliary balloon

[0051] Select the operating mode of the auxiliary balloon from the three preset working modes. The three modes are defined as follows: Mode 1 - Synchronous mode: simulates the traditional single-balloon IABP, with the main balloon and auxiliary balloon inflating and deflating synchronously.

[0052] Mode 2 - Cardiac Output Enhancement Mode: The accessory balloon inflates synchronously with the main balloon, and the deflation process starts with a delay relative to the main balloon;

[0053] Mode 3 - Enhanced cardiac output + enhanced cardiac and cerebral perfusion mode: The auxiliary balloon is inflated earlier than the main balloon, and the deflation process starts later;

[0054] Step D: Calculation of key time points for the auxiliary balloon

[0055] Based on the inflation and deflation time of the main balloon, and combined with the current heart rate, selected working mode, and preset delay parameters, four key time points of the auxiliary balloon are calculated: inflation start time; inflation completion time; deflation start time.

[0056] Step E: Setting the auxiliary balloon delay parameters (ΔTs, ΔTd). Set the corresponding delay parameters according to the selected working mode;

[0057] Step F: Dual-balloon coordinated operation and dynamic adjustment

[0058] The main and auxiliary balloons periodically perform inflation and deflation actions under the control of the trigger signal, according to the inflation and deflation sequence determined by the above steps. During operation, the device monitors the trigger signal, heart rate and delay parameter changes in real time. When the change of ΔTs_max reaches the set threshold, the device automatically triggers the in-operation optimization of ΔTs. The operator can also manually intervene in parameter settings or mode switching to ensure that the counterpulsation effect is adapted to the patient's physiological state.

[0059] Step G: Adaptation to Special Scenarios

[0060] When the device is used in conjunction with VA-ECMO, the auxiliary balloon is switched to mode 2 by default. Through the optimized setting of ΔTs, the increase in left ventricular afterload caused by ECMO is reduced, thus protecting cardiac function.

[0061] In this invention, the specific rules for key time points in different modes during step D are as follows:

[0062] Mode 1: Inflation start, inflation completion, deflation start, and deflation completion are all completely synchronized with the main balloon;

[0063] Mode 2: Inflation start and completion are synchronized with the main balloon; deflation start is delayed by ΔTs time relative to the main balloon; deflation completion is synchronized with the main balloon.

[0064] Mode 3: Inflation begins synchronously with or slightly delayed from the main balloon, inflation is completed ΔTd time earlier than the main balloon, deflation begins ΔTs time later than the main balloon, and deflation is completed synchronously with the main balloon.

[0065] Preferably, in step E, mode 1 requires setting a delay parameter, mode 2 requires setting ΔTs, and mode 3 requires setting both ΔTs and ΔTd. The setting methods include manual setting and automatic optimization: Manual setting: ΔTs can be set using a proportional method or an absolute value method. In the proportional method, ΔTs = Ts_ratio × ΔTs_max, where Ts_ratio ranges from 0 to 100% and has a default value of 100%. ΔTs_max = main balloon deflation time - shortest auxiliary balloon deflation time. In the absolute value method, ΔTs is directly set to ΔTs_set, ranging from 0 to ΔTs_max, with a default value of ΔTs_max. When ΔTs_max changes such that ΔTs_set > ΔTs_max, the smaller of the two, min(ΔTs_set, ΔTs_max), is used as the actual operating parameter, and a warning is triggered to remind the operator.

[0066] ΔTd can be set using either a proportional method or an absolute value method. In the proportional method, ΔTd = Td_ratio × ΔTd_max, where Td_ratio ranges from 0 to 100%, and ΔTd_max = main balloon inflation time - minimum auxiliary balloon inflation time. In the absolute value method, ΔTd is directly set as ΔTd_set, ranging from 0 to ΔTd_max. When ΔTd_max changes such that ΔTd_set > ΔTd_max, the smaller of the two, min(ΔTd_set, ΔTd_max), is used as the actual operating parameter, and a warning is triggered to remind the operator.

[0067] Automatic optimization: Based on real-time arterial pressure waveforms or external cardiac output monitoring data, the optimal value is determined by gradually adjusting ΔTs and evaluating the effects, with the goal of minimizing pressure indicators or maximizing CO.

[0068] In this invention, the inflation / deflation triggering modes of the main balloon include the following three types: automatic mode: the signal source is automatically selected by the device, and the counterpulsation ratio is manually set by the operator; semi-automatic mode: the signal source is manually selected by the operator, and the counterpulsation ratio is manually set by the operator; manual mode: both the signal source and the counterpulsation ratio are manually set by the operator.

[0069] In this invention, the automatic setting of ΔTs is based on real-time arterial pressure waveform or real-time external cardiac output monitoring. The optimization objective is to optimize the selected target parameters, which include arterial pressure indices or cardiac output (CO). Arterial pressure indices include systolic blood pressure (SBP), diastolic blood pressure (DBP), mean systolic pressure (sMBP) (defined as the average arterial pressure during the left ventricular systolic phase, or approximately the average arterial pressure during the aortic valve opening phase), and ΔSBP = SBP - MBP, ΔDBP = DBP - MBP, and ΔsMBP = sMBP - MBP obtained by subtracting the mean arterial pressure from the above data. All of the above pressure indices are better when they are lower, and the optimization objective is to maximize CO.

[0070] In this invention, the automatic optimization process of ΔTs includes initial optimization and in-process optimization. Initial optimization is triggered when the corresponding mode is first started without operator input parameters during the current operation, or it can be manually triggered by the operator. Starting from ΔTs = 0, the ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. The target parameter is measured and recorded until the target parameter is optimal. Alternatively, the above process can be reversed starting from ΔTs = ΔTs_max. In-process optimization is automatically triggered when the change of ΔTs_max reaches a set threshold. It can be manually disabled by the operator and automatically triggered when it is undisabled. The ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. Continuous measurement is performed, attempting to decrease or increase ΔTs. Priority is given to changing in the same direction as ΔTs_max. The target parameter is evaluated. If the target parameter improves, it is gradually adjusted in this direction until the target parameter is optimal. If the target parameter deteriorates, it is gradually adjusted in the reverse direction until the target parameter is optimal. If the target parameter does not improve after increasing or decreasing ΔTs, the original ΔTs value is maintained.

[0071] In this invention, when the dual-balloon aortic balloon counterpulsation device is used in conjunction with VA-ECMO, the accessory balloon operates in cardiac output enhancement mode.

[0072] Please see Figure 4 The present invention also discloses a dual-balloon intra-aortic balloon counterpulsation system, comprising a dual-balloon IABP device, wherein the dual-balloon IABP device comprises a balloon catheter and a main unit, the balloon catheter comprising a main balloon, a secondary balloon and a catheter shaft connected in series, and the main unit receiving electrocardiogram and / or arterial blood pressure signals, for executing the control method as described in any one of claims 1-7, and controlling the inflation and deflation timing of the dual balloons.

[0073] Example 1:

[0074] Secondary balloon operation mode 2 (displacement enhancement mode)

[0075] System composition: The dual-balloon IABP device includes a balloon catheter (containing a main balloon, a secondary balloon, and a catheter shaft connected in series) and a main unit. The main unit receives electrical / arterial pressure signals and controls the inflation and deflation sequence of the two balloons.

[0076] Trigger control (mode 2):

[0077] The main balloon is triggered according to the traditional IABP mode: deflate during systole and inflate during diastole.

[0078] Accessory balloon timing:

[0079] The charging start / complete time is synchronized with the main balloon.

[0080] Start time delay ΔTs

[0081] The completion time of the evacuation is synchronized with that of the main balloon.

[0082] Parameter settings:

[0083] ΔTs can be set using either the conventional method or the absolute value method (directly setting ΔTs triggers an over-limit alarm).

[0084] Default value: ΔTs = ΔTs_max (optimal displacement gain).

[0085] 4. Effects: Delayed drainage of the accessory balloon increases proximal suction of the main balloon and reduces left ventricular outflow resistance.

[0086] It reduces retrograde flow distal to the balloon, significantly reduces left ventricular afterload, and is suitable for: single-use balloon resuscitation.

[0087] Mechanical assistance for function and cycle.

[0088] IABP-ECMO combined response: synergistic response to mechanical circulatory support to reduce left ventricular afterload increase caused by femoral artery VA-ECMO.

[0089] Example 2:

[0090] Accessory balloon operation mode 3 (displacement + enhanced cerebral perfusion mode)

[0091] System configuration: Same as in Example 1.

[0092] Control process:

[0093] The main balloon is triggered according to the traditional IABP mode: deflate during systole and inflate during diastole.

[0094] Accessory balloon timing (Mode 3):

[0095] The charging start / complete time is synchronized with the main balloon.

[0096] Charging completion time advanced by ΔTd

[0097] Start time delay ΔTs

[0098] The completion time of the evacuation is synchronized with that of the main balloon.

[0099] Parameter settings:

[0100] ΔTd is adjusted starting from a relatively small value (to avoid excessively affecting the distal flow of the balloon, or the supply to abdominal organs and lower limbs), and is set using either the example method or the absolute value method.

[0101] During the period, urine output, abdominal organ function indicators, and abdominal / lower limb flow were monitored.

[0102] Effect:

[0103] Flow allocation optimization: Pre-inflation of the accessory balloon increases distal resistance, improves aortic pressure proximal to the balloon, and increases perfusion pressure and flow in the coronary arteries and cerebral tubes.

[0104] Example 3:

[0105] Dynamic parameter optimization system

[0106] Dynamic optimization:

[0107] The operator adjusts ΔTs / ΔTd based on the real-time arterial pressure waveform:

[0108] Standard: Optimized ΔSBP = SBP - MBP or ΔsMBP = sMBP - MBP (sMBP: mean arterial pressure during ventricular systole).

[0109] If there is an external flow rate monitoring segment (such as PiCCO or Swan-Ganz catheter), the optimal stroke volume (SV) or stroke rate (CO) shall be used as the benchmark.

[0110] After each adjustment, evaluate the results after the system has stabilized for a period of time (e.g., 5-10 seconds or 5-10 cycles).

[0111] Dynamic optimization:

[0112] Triggering conditions: ΔTs_max changes beyond the threshold, or secondary startup mode, or operator startup.

[0113] Optimization metrics:

[0114] Arterial pressure signal (taking ΔSBP as an example): Optimize ΔSBP.

[0115] Or external emission monitoring (such as PiCCO): Optimized CO.

[0116] In summary, this invention, by setting up a main balloon and a secondary balloon, and employing three different operating modes for the secondary balloon, can be flexibly adjusted according to different clinical needs, thereby improving counterpulsation effectiveness. The synchronous mode can simulate traditional single-balloon IABP, ensuring compatibility with traditional technologies; the cardiac output enhancement mode can effectively increase cardiac output and improve cardiac function; the cardiac output enhancement + cerebral perfusion enhancement mode not only increases cardiac volume but also enhances cerebral perfusion, making it suitable for specific clinical scenarios.

[0117] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A control method for a dual-balloon aortic balloon counterpulsation device, characterized in that: Includes the following steps: Step A: Device initialization and trigger signal acquisition; Step B: Main balloon mode selection, parameter setting, and inflation / deflation control Depending on the actual scenario, the operator selects the working mode and parameters of the main balloon. Under the control of the trigger signal, the main balloon periodically performs inflation and deflation actions according to the traditional IABP inflation and deflation logic. Step C: Selecting the working mode of the auxiliary balloon Select the operating mode of the auxiliary balloon from the three preset operating modes; Step D: Calculation of key time points for the auxiliary balloon Based on the inflation and deflation time of the main balloon, and combined with the current heart rate, selected working mode, and preset delay parameters, four key time points of the auxiliary balloon are calculated: inflation start time; inflation completion time; deflation start time. Exhaust completion time; Step E: Setting the auxiliary balloon delay parameters (ΔTs, ΔTd). Set the corresponding delay parameters according to the selected working mode; Step F: Dual-balloon coordinated operation and dynamic adjustment The main and auxiliary balloons periodically perform inflation and deflation actions under the control of the trigger signal, according to the inflation and deflation sequence determined by the above steps. During operation, the device monitors the trigger signal, heart rate and delay parameter changes in real time. When the change of ΔTs_max reaches the set threshold, the device automatically triggers the in-operation optimization of ΔTs. The operator can also manually intervene in parameter settings or mode switching to ensure that the counterpulsation effect is adapted to the patient's physiological state. Step G: Adaptation to Special Scenarios When the device is used in conjunction with VA-ECMO, the auxiliary balloon adopts mode 2. Through the optimized setting of ΔTs, the increase in left ventricular afterload caused by ECMO is reduced, thus protecting cardiac function.

2. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 1, characterized in that: The three modes are defined as follows: Mode 1 - Synchronous mode: simulates traditional single-balloon IABP, with the main balloon and the accessory balloon inflating and deflating simultaneously; Mode 2 - Cardiac Output Enhancement Mode: The accessory balloon inflates synchronously with the main balloon, and the deflation process starts with a delay relative to the main balloon; Mode 3 - Enhanced cardiac output + enhanced cardiac and cerebral perfusion: The auxiliary balloon is inflated earlier than the main balloon, and the deflation process starts later.

3. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 1, characterized in that: In step D, the specific rules for key time points under different modes are as follows: Mode 1: Inflation start, inflation completion, deflation start, and deflation completion are all completely synchronized with the main balloon; Mode 2: Inflation start and completion are synchronized with the main balloon; deflation start is delayed by ΔTs time relative to the main balloon; deflation completion is synchronized with the main balloon. Mode 3: Inflation begins synchronously with or slightly delayed from the main balloon, inflation is completed ΔTd time earlier than the main balloon, deflation begins ΔTs time later than the main balloon, and deflation is completed synchronously with the main balloon.

4. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 1, characterized in that: In step E, mode 1 requires setting a delay parameter, mode 2 requires setting ΔTs, and mode 3 requires setting both ΔTs and ΔTd. The setting methods include manual setting and automatic optimization: Manual setting: ΔTs can be set using either a proportional method or an absolute value method. In the proportional method, ΔTs = Ts_ratio × ΔTs_max, where Ts_ratio ranges from 0 to 100% and has a default value of 100%. ΔTs_max = main balloon deflation time - shortest auxiliary balloon deflation time. In the absolute value method, ΔTs is directly set to ΔTs_set, ranging from 0 to ΔTs_max, with a default value of ΔTs_max. When ΔTs_max changes such that ΔTs_set > ΔTs_max, the smaller of the two, min(ΔTs_set, ΔTs_max), is used as the actual operating parameter, and a warning is triggered to alert the operator. ΔTd can be set using either a proportional method or an absolute value method. In the proportional method, ΔTd = Td_ratio × ΔTd_max, where Td_ratio ranges from 0 to 100%, and ΔTd_max = main balloon inflation time - minimum auxiliary balloon inflation time. In the absolute value method, ΔTd is directly set as ΔTd_set, ranging from 0 to ΔTd_max. When ΔTd_max changes such that ΔTd_set > ΔTd_max, the smaller of the two, min(ΔTd_set, ΔTd_max), is used as the actual operating parameter, and a warning is triggered to remind the operator. Automatic optimization: Based on real-time arterial pressure waveforms or external cardiac output monitoring data, the optimal value is determined by gradually adjusting ΔTs and evaluating the effects, with the goal of minimizing pressure indicators or maximizing CO.

5. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 1, characterized in that: The inflation / deflation triggering modes of the main balloon include the following three modes: automatic mode: the signal source is automatically selected by the device, and the counterpulsation ratio is manually set by the operator; semi-automatic mode: the signal source is manually selected by the operator, and the counterpulsation ratio is manually set by the operator; manual mode: both the signal source and the counterpulsation ratio are manually set by the operator.

6. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 5, characterized in that: The automatic setting of ΔTs is based on real-time arterial pressure waveforms or real-time external cardiac output monitoring. The optimization goal is to optimize the selected target parameters, which include arterial pressure indices or cardiac output CO. Arterial pressure indices include systolic blood pressure (SBP), diastolic blood pressure (DBP), mean systolic blood pressure (sMBP), and the values ​​obtained by subtracting mean arterial pressure (MBP) from the above data: ΔSBP = SBP - MBP, ΔDBP = DBP - MBP, ΔsMBP = sMBP - MBP. All of the above pressure indices are better when they are lower. When using CO as the optimization index, it should be maximized as much as possible.

7. A control method for a dual-balloon aortic balloon counterpulsation device according to claim 6, characterized in that: The automatic optimization process of ΔTs includes initial optimization and in-process optimization. Initial optimization is triggered when the corresponding mode is first started without operator input parameters during the current operation, or it can be manually triggered by the operator. Starting from ΔTs = 0, the ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. The target parameter is measured and recorded until the target parameter is optimal. Alternatively, the above process can be reversed starting from ΔTs = ΔTs_max. In-process optimization is automatically triggered when the change of ΔTs_max reaches a set threshold. It can be manually disabled by the operator and automatically triggered when it is undisabled. The ΔTs parameter is gradually increased by a set amount T_step. After each adjustment, it is maintained for t seconds to stabilize the blood pressure. Continuous measurement is performed, and attempts are made to decrease or increase ΔTs. Priority is given to changes in the same direction as ΔTs_max. The target parameter is evaluated. If the target parameter improves, it is gradually adjusted in this direction until the target parameter is optimal. If the target parameter deteriorates, ΔTs is gradually adjusted in the reverse direction until the target parameter is optimal. If the target parameter does not improve after increasing or decreasing ΔTs, the original ΔTs value is maintained.

8. The control method for a dual-balloon aortic balloon counterpulsation device according to claim 1, characterized in that: When the dual-balloon aortic balloon counterpulsation device is used in conjunction with VA-ECMO, the accessory balloon operates in cardiac output enhancement mode.

9. A dual-balloon aortic balloon counterpulsation system, characterized in that, The device includes a dual-balloon IABP device, which includes a balloon catheter and a main unit. The balloon catheter includes a main balloon (1), a secondary balloon (2), and a catheter shaft (3) connected in series. The main unit (4) receives electrocardiogram and / or arterial blood pressure signals and is used to perform the control method as described in any one of claims 1-8 to control the inflation and deflation timing of the dual balloons.

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