Pulse control method and apparatus

Abstract

The application provides a pulsation control method and device. The method comprises: in a first stage, controlling a ventricular assist device to increase rotation speed and controlling a balloon to deflate; and in a second stage, controlling the ventricular assist device to reduce rotation speed and controlling the balloon to inflate. The ventricular assist device and an intra-aortic balloon counterpulsation pump are respectively controlled in a simulated cardiac cycle, precise collaborative control of the ventricular assist device speed pulsation and the balloon counterpulsation is achieved, and the hemodynamic performance of a patient is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a pulse control method and device. Background Technology

[0002] Heart failure is the ultimate outcome of most cardiovascular diseases, with morbidity and mortality rates rising year by year. Ventricular assist devices (VADs) and intra-aortic balloon pumps (IABPs) are currently widely used mechanical circulatory support methods in clinical practice. VADs provide high-flow support by actively pumping blood from the left ventricle into the aorta; IABPs achieve the physiological effect of diastolic pressure increase and systolic pressure reduction through the periodic inflation and deflation of a balloon in the descending aorta, which can reduce left ventricular afterload and increase coronary perfusion.

[0003] While there are clinical strategies that combine VADs and IABPs to achieve a synergistic effect of pump support and counterpulsation, they are essentially two independent systems physically superimposed. To simultaneously reduce cardiac preload and afterload, both devices need to be implanted and adjusted separately. However, due to the dynamic changes in the cardiac cycle, medical staff need to make corresponding adjustments to both devices separately, which is cumbersome and difficult to implement. Summary of the Invention

[0004] This application provides a pulsation control method and device that simulates the cardiac cycle to control the ventricular assist device and the intra-aortic balloon counterpulsation pump respectively, thereby achieving precise coordinated control of the ventricular assist device's pulsation rate and the balloon counterpulsation, and improving the patient's hemodynamic performance.

[0005] In a first aspect, embodiments of this application provide a pulse control method applied to a ventricular assist system. The ventricular assist system includes a ventricular assist device, an intra-aortic balloon counterpulsation pump, and a control device. The ventricular assist device and the intra-aortic balloon counterpulsation pump are respectively communicatively connected to the control device. The intra-aortic balloon counterpulsation pump includes a balloon. The method includes: In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate. In the second stage, the ventricular assist device is controlled to reduce its rotation speed and the balloon is controlled to inflate.

[0006] Secondly, this application provides a ventricular assist system, which includes a ventricular assist device, an intra-aortic balloon counterpulsation pump, and a control device. The ventricular assist device and the intra-aortic balloon counterpulsation pump are respectively communicatively connected to the control device. The intra-aortic balloon counterpulsation pump includes a balloon. The control device includes one or more processors, which are used for: In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate. In the second stage, the ventricular assist device is controlled to reduce its rotation speed and the balloon is controlled to inflate.

[0007] Thirdly, embodiments of this application provide a medical device, the medical device including a processor, a memory, a communication interface, and one or more programs, the one or more programs being stored in the memory and configured to be executed by the processor, the programs including instructions for performing some or all of the steps described in the method described in the first aspect above.

[0008] Fourthly, embodiments of this application provide a computer-readable storage medium storing a computer program for electronic data interchange, wherein the computer program causes a computer to perform some or all of the steps described in the method described in the first aspect above.

[0009] The technical solution provided in this application, in the first stage, controls the ventricular assist device to increase its rotation speed and controls the balloon deflation; in the second stage, it controls the ventricular assist device to decrease its rotation speed and controls the balloon inflation. By simulating the cardiac cycle, the ventricular assist device and the intra-aortic balloon counterpulsation pump are controlled separately, achieving precise and coordinated control of the ventricular assist device's velocity pulsation and the balloon counterpulsation, thereby improving the patient's hemodynamic performance. Attached Figure Description

[0010] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0011] Figure 1 This is a schematic diagram of a ventricular assist system provided in an embodiment of this application; Figure 2 This is a schematic diagram of the structure of a ventricular assist device provided in an embodiment of this application; Figure 3 This is a schematic flowchart of a pulse control method provided in an embodiment of this application; Figure 4This is a schematic diagram of the structure of a medical device provided in an embodiment of this application. Detailed Implementation

[0012] To help those skilled in the art better understand the technical solutions of this application, the technical solutions in 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, and not all embodiments. Based on the description of 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.

[0013] The terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, software, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but also includes steps or units not listed, or other steps or units inherent to such processes, methods, products, or apparatus.

[0014] In this document, the term "embodiment" 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 this phrase 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.

[0015] In this application, "rotational speed" refers to the speed of rotation of a motor or electric motor, which is related to the speed of rotation of the rotor or impeller of the ventricular assist device and can be defined as rotational speed per minute. "Flow rate," "fluid flow rate," and "pump flow rate" refer to the volume of fluid delivered through the ventricular assist device per unit time, which can be estimated and measured in liters per minute.

[0016] It should be noted that in this application, the terms "proximal" or "proximal" refer to the end or side closer to the surgeon; and "distal" or "distal" refer to the end or side farther from the surgeon.

[0017] Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of a ventricular assist system provided in an embodiment of this application. Figure 1As shown, the ventricular assist system includes a ventricular assist device 100, an external control device 200, and an intra-aortic balloon pump. The ventricular assist device 100 and the intra-aortic balloon pump are communicatively connected to the external control device 200, enabling monitoring of both devices. Specifically, this includes functions such as operation control, data display, fault detection and alarm, and data transmission for the ventricular assist device 100 and the intra-aortic balloon pump.

[0018] The ventricular assist device 100 is a miniature axial flow pump or centrifugal pump, which is percutaneously inserted into the aorta 124 via the femoral artery 122 and then passes through the aorta 124 into the left ventricle 128. The fluid inlet of the ventricular assist device 100 is located in the left ventricle, and the fluid outlet is located in the ascending aorta. The control device 200 controls the ventricular assist device 100 to pump blood from the left ventricle 128 into the ascending aorta 124. Alternatively, the ventricular assist device 100 can also be percutaneously inserted into the aorta 124 via the axillary artery 123 and then passes through the aorta 124 into the left ventricle. The balloon of the intra-aortic balloon counterpulsation pump is percutaneously inserted into the aorta 124 via the femoral artery 122 and placed within the descending aorta. The control device 200 controls the counterpulsation by controlling the inflation and deflation of the balloon.

[0019] like Figure 2 As shown, the ventricular assist device 100 includes a cannula 10, an impeller (not shown), a motor (not shown), and a connecting tube 30. The cannula 10 has a proximal end and a distal end. The distal end of the cannula 10 has a fluid inlet 101, and the proximal end of the cannula 10 has a fluid outlet 102. Blood flows in from the fluid inlet 101 and flows out from the fluid outlet 102 through the cannula 10.

[0020] The impeller is located at least partially at the proximal end of the cannula 10, such as at the fluid inlet 101 of the cannula 10, such that when the ventricular assist device 100 is in operation, it drives the impeller to rotate to pump blood from the left ventricle 128 to the aorta 124.

[0021] The motor can be installed inside the body or outside the body. This application embodiment uses the example of the motor being installed inside the body. For example, the motor is installed in the motor housing 201, and the distal end of the motor housing 201 is connected to the proximal end of the sleeve 10. The motor drives the drive shaft to rotate, thereby driving the impeller to rotate, realizing the blood pumping function of the ventricular assist device 100.

[0022] The distal end of the connecting tube 30 is connected to the proximal end of the motor housing 201, and the proximal end of the connecting tube 30 passes through the patient's abdominal skin and connects to the externally located control device 200. For example, the connecting tube 30 may accommodate drive cables and flushing fluid lines connecting the ventricular assist device 100 to the control device 200. For example, the ventricular assist device 100 also includes a distal component 110, such as a pigtail tube, located at the distal end of the cannula 10 and extending distally.

[0023] The ventricular assist device 100 also includes a pressure sensor for detecting the pressure of an external fluid, such as ascending aortic pressure. When the ventricular assist device 100 is positioned correctly across the aorta 124, the pressure sensor is located in the ascending aorta 124, thereby allowing measurement of the ascending aortic pressure. In some embodiments, the pressure sensor is disposed on the outer surface of the proximal end of the cannula 10, i.e., the outer surface at the fluid outlet 102; in some embodiments, the pressure sensor is disposed at the distal end of the motor and within the motor housing 201, with the external fluid pressure detected by providing a detection port on the motor housing 201 corresponding to the location of the pressure sensor; alternatively, the pressure sensor is located outside the motor housing 201.

[0024] The ventricular assist device 100 also includes a control unit, which can be used to perform any of the embodiments, aspects, and methods of this application. The control unit may be located inside or outside the ventricular assist device 100, such as in an external control device 200. The control unit is communicatively connected to a motor and a pressure sensor to detect, monitor, and calculate relevant parameters of the ventricular assist device 100 and the patient, and to control the operation of the ventricular assist device 100. For example, the control unit supplies current to the motor through one or more wires and detects the current through a current detection circuit (such as a phase current detection circuit); controls the rotational speed of the ventricular assist device 100 according to received instructions; receives feedback signals from the pressure sensor to identify the position of the ventricular assist device 100, and so on.

[0025] For example, the control unit is placed in the external control device 200. The control unit operates independently of the external control device 200. The control unit is communicatively connected to the external processor 200 (e.g., the control unit is connected to the processor in the external control device 200). The control unit can transmit the operating data generated during motor operation to the external control device 200 for analysis, display and storage. The control unit can also accept instructions from the external controller 20 to control the motor.

[0026] The intra-aortic balloon counterpulsation pump includes a balloon 310, a connecting tube, and an inflation / deflation device 320. The inflation / deflation device 320 is used to inflate and deflate the balloon 310. The distal end of the connecting tube communicates with the balloon 310, and the proximal end of the connecting tube communicates with the inflation / deflation device 320, providing an inflation / deflation channel between the device and the balloon 310. The inflation / deflation device 320 is communicatively connected to a control device 200, which controls the inflation and deflation of the balloon 310 according to the cardiac cycle to generate active counterpulsation, further increasing the diastolic pressure of the aorta, thereby optimizing coronary perfusion.

[0027] The ventricular assist device 100 has a fluid inlet 101 placed in the left ventricle and a fluid outlet placed in the ascending aorta, thereby pumping blood from the left ventricle into the ascending aorta, providing active forward blood flow thrust. The balloon 310 of the intra-aortic balloon counterpulsation pump is placed in the descending aorta. When the inflation / deflation device 320 inflates, the balloon 310 rapidly inflates, occupying the lumen of the descending aorta, squeezing blood from the aorta towards the proximal end (coronary arteries) and distal end (vital organs), thereby increasing coronary perfusion pressure and blood flow, and improving myocardial blood supply. When the inflation / deflation device 320 deflates, the balloon 310 rapidly deflates, creating a momentary negative pressure chamber within the aorta, thereby reducing cardiac afterload (reducing left ventricular ejection resistance), reducing myocardial oxygen consumption, and increasing cardiac output. The ventricular assist device 100 and the intra-aortic balloon counterpulsation pump complement each other in terms of anatomical space. The ventricular assist device 100 directly increases cardiac output in the ascending aorta, while the intra-aortic balloon counterpulsation pump increases coronary pressure in the descending aorta, thereby achieving an improvement in hemodynamic gain.

[0028] In this application, the balloon 310 can share a puncture point with the ventricular assist device 100, and the connecting tube 30 of the ventricular assist device 100 is integrated with the connecting tube of the intra-aortic balloon counterpulsation pump. Compared with the parallel implantation of multiple devices, the integrated connecting tube reduces surgical trauma, vascular injury risk, and postoperative complication rate. The integrated connecting tube internally integrates the drive cable of the ventricular assist device 100, the flushing fluid channel, and the inflation / deflation channel, enabling simultaneous control of the operation of the ventricular assist device 100 and the inflation / deflation control of the balloon 310 of the intra-aortic balloon counterpulsation pump.

[0029] Based on the above description, this application will now be described from the perspective of method examples.

[0030] Please see Figure 3 , Figure 3 This is a schematic flowchart of a pulse control method provided in an embodiment of this application, which is applied to, for example... Figure 1 The ventricular assist system shown. (Example) Figure 3 As shown, the method includes the following steps.

[0031] S310. In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate.

[0032] In this application, the external control device 200 can control the ventricular assist device 100 to pulsate according to the patient's hemodynamic state, that is, increase the rotation speed of the ventricular assist device 100 to simulate ventricular systole and decrease the rotation speed of the ventricular assist device 100 to simulate ventricular diastole, so as to generate physiological pulsating blood flow. Furthermore, through the physical synergy between the pump speed pulsation and the intra-aortic balloon counterpulsation pump, a physiological level pulse pressure difference is autonomously generated, thereby reconstructing biomimetic pulsating blood flow.

[0033] In the first phase of the pulsatile cycle (simulating ventricular systole), the control device 200 controls the ventricular assist device 100 to increase the rotation speed to increase the blood flow pumped into the ascending aorta. At the same time, the control device 200 controls the balloon 310 to deflate, and the sudden reduction in the volume of the balloon 310 reduces the peripheral resistance of the aorta. As a result, the peripheral resistance of the blood pumped by the ventricular assist device 100 is reduced, thereby maximizing the reduction of cardiac output resistance.

[0034] Optionally, controlling the ventricular assist device to increase its rotation speed and controlling the balloon to deflate includes: during a first duration of the first stage, increasing the ventricular assist device's rotation speed from a first speed to a second speed and maintaining the balloon in an inflated state, wherein the inflated state is such that the balloon maintains a preset volume; during a second duration of the first stage, increasing the ventricular assist device's rotation speed from the second speed to a third speed and deflating the balloon to zero volume; and during a third duration of the first stage, maintaining the ventricular assist device's rotation speed at the third speed and maintaining the balloon at zero volume.

[0035] In this application, the control device 200 needs to actively construct a complete biomimetic pulsating pressure waveform by superimposing the inertial flow wave generated by the pump speed pulsation and the volume displacement wave generated by the inflation and deflation of the balloon 310 in the ascending aorta in terms of time phase.

[0036] During the first duration of the first phase, the control device 200 increases the rotational speed of the ventricular assist device 100 from a first speed v1 to a second speed v2, while keeping the balloon 310 inflated, i.e., maintaining the balloon volume at a preset volume v0. Therefore, during the first duration, the rapid increase in the rotational speed of the ventricular assist device 100 gradually increases the blood flow pumped to the ascending aorta, and the ascending aortic pressure gradually rises. During the second duration, the control device 200 increases the rotational speed of the ventricular assist device 100 from the second speed v2 to a third speed v3, while simultaneously deflating the balloon 310 to zero volume, i.e., emptying the gas from the balloon 310. Therefore, during the second duration, the rotational speed of the ventricular assist device 100 increases to its maximum speed, causing the blood flow pumped to the ascending aorta to reach its peak. Simultaneously, the balloon 310 gradually deflates to zero, causing the peripheral resistance of the blood in the ascending aorta to gradually decrease to its lowest point, and the ascending aortic pressure to gradually rise to the peak ascending aortic pressure during the artificial systolic phase (first phase). During the third duration, the control device 200 maintains the rotation speed of the ventricular assist device 100 at the third rotation speed v3 and maintains the balloon volume at zero volume, so that the ascending aortic pressure is maintained at the peak ascending aortic pressure during the artificial systolic period during the third duration, thereby increasing cardiac output.

[0037] Specifically, at the start time t0 of the first stage, the control device 200 linearly accelerates the rotational speed of the ventricular assist device 100 from a first speed v1 (the minimum speed of the velocity pulsation) to a second speed v2 (the reference speed of the velocity pulsation), while simultaneously maintaining the gas volume within the intra-aortic balloon counterpulsation pump balloon 310 at a preset volume v0. At the start time t0, the rotational speed of the ventricular assist device 100 begins to increase from the minimum speed v1, and the blood flow pumped into the ascending aorta begins to increase, as does the ascending aortic pressure. At the first time t1, the rotational speed of the ventricular assist device 100 reaches the second speed v2, and simultaneously, the intra-aortic balloon counterpulsation pump balloon 310 begins to deflate at a preset deflation rate. At the first time t1, the balloon volume of the intra-aortic balloon counterpulsation pump begins to decrease, causing a drop in peripheral resistance in the descending aorta. Consequently, the peripheral resistance encountered by the blood pumped into the ascending aorta by the ventricular assist device 100 begins to decrease, leading to a sharp increase in the rate of rise of the ascending aortic pressure (dp / dt), resulting in a steep early systolic shock wave. At the second time t2, the rotational speed of the ventricular assist device 100 increases to the third speed v3 (the maximum speed of the velocity pulsation), and simultaneously, the balloon volume of the intra-aortic balloon counterpulsation pump is deflated to zero, meaning the gas in the balloon 310 is completely emptied. At this point, the blood flow pumped into the ascending aorta by the ventricular assist device 100 reaches its peak (e.g., 6.5 L / min ~ 7.2 L / min), while the peripheral resistance of the blood in the ascending aorta drops to its lowest point, and the ascending aortic pressure reaches the peak pressure of the ascending aorta during artificial systole (e.g., 100 mmHg ~ 120 mmHg).

[0038] Between the second time point t2 and the third time point t3, i.e., the third time interval, the control device 200 maintains the rotational speed of the ventricular assist device 100 at the third rotational speed v3 and keeps the balloon volume at zero. During this period, the blood flow pumped into the ascending aorta by the ventricular assist device 100 is maintained at its peak, and the peripheral resistance of the blood in the ascending aorta remains at its lowest point, thereby maintaining the ascending aortic pressure at the peak pressure of the ascending aorta during artificial systole.

[0039] The peak systolic pressure (SBP) of the ascending aorta is the inertial pressure increase of blood after the ventricular assist device rotates at 100 rpm. The deflation of the P-pump and balloon 310 reduces the blood flow in the ascending aorta, decreasing peripheral resistance and thus reducing afterload. The combined effect of P_afterload and the inertial pressure boost generated by the ventricular assist device 100. Afterload reduction effect of P_pump and balloon 310 release After time-phase matching of P_afterload, a steeper pressure peak than any single action will be generated. Therefore, this application maximizes the reduction of cardiac output resistance and increases cardiac output by coordinating the acceleration of the ventricular assist device 100 and the deflation of the balloon 310 of the intra-aortic balloon counterpulsation pump in time phase during the first stage.

[0040] The preset volume v0 ranges from 30 mL to 40 mL, and the preset deflation rate of the balloon 310 is greater than or equal to 20 mL / 50 ms; the specific values ​​can be determined according to the patient's specific condition. The permissible range of the rotation speed of the ventricular assist device 100 can be determined according to the product type and model of the ventricular assist device 100, and then the ranges of the first rotation speed v1, the second rotation speed v2, and the third rotation speed v3 can be determined based on the permissible range of the rotation speed of the ventricular assist device 100.

[0041] For example, the permissible range of rotational speed for the ventricular assist device 100 is 15,000 RPM to 46,000 RPM. Further, within this permissible range, a first rotational speed v1, a second rotational speed v2, and a third rotational speed v3 are determined. The initial value of the second rotational speed v2 can be selected within this permissible range based on the patient's physiological baseline information (such as height, weight, body surface area, vascular condition, and severity of heart failure). The first rotational speed v1 and the third rotational speed v3 can be determined based on the velocity pulsation amplitude, which is ±15% to ±30% of the second rotational speed v2. The minimum value for the first rotational speed v1 is 15,000 RPM, and the maximum value for the third rotational speed v3 is 46,000 RPM.

[0042] S320. In the second stage, control the ventricular assist device to reduce its rotation speed and control the balloon to inflate.

[0043] In the second phase of the pulse cycle (simulating ventricular diastole), the control device 200 controls the ventricular assist device 100 to reduce its rotation speed to ensure adequate ventricular filling, while simultaneously controlling the balloon 310 to inflate. The pumping flow of the ventricular assist device 100 decreases while the balloon volume increases, causing the balloon 310 to push blood in the descending aorta backward to the ascending aorta, thereby increasing diastolic coronary perfusion pressure and maximizing myocardial blood supply efficiency.

[0044] Optionally, controlling the ventricular assist device to reduce its rotational speed and controlling the intra-aortic balloon counterpulsation pump to inflate includes: during the fourth duration of the second stage, reducing the ventricular assist device's rotational speed from the third speed to the first speed while simultaneously inflating the balloon; during the fifth duration of the second stage, maintaining the ventricular assist device's rotational speed at the first speed while simultaneously inflating the balloon to the inflated state; and during the sixth duration of the second stage, maintaining the ventricular assist device's rotational speed at the first speed while simultaneously maintaining the balloon in the inflated state.

[0045] During the fourth duration of the second phase, the control device 200 directly reduces the rotational speed of the ventricular assist device 100 from the third speed v3 to the first speed v1, while simultaneously controlling the balloon 310 to inflate slowly. Therefore, during the fourth duration, the rapid decrease in the rotational speed of the ventricular assist device 100 causes a rapid reduction in the blood flow pumped to the ascending aorta, resulting in a drop in ascending aortic pressure. During the fifth duration, the control device 200 maintains the rotational speed of the ventricular assist device 100 at the low first speed v1, while simultaneously inflating the balloon 310 to a set volume v0, thus inflating the balloon 310. Therefore, during the fifth duration, the increase in balloon volume gradually pushes blood from the descending aorta backwards to the ascending aorta. This reverse flow of blood to the ascending aorta compensates for the reduction in blood flow in the ascending aorta caused by the deceleration of the ventricular assist device 100, preventing a significant drop in ascending aortic pressure due to the deceleration of the ventricular assist device 100. During the sixth time period, the control device 200 maintains the rotation speed of the ventricular assist device 100 at a low first rotation speed v1 while keeping the balloon in an inflated state. During this sixth time period, the continuous reverse flow of blood in the descending aorta allows the diastolic pressure of the ascending aorta to be maintained at a high level, thereby continuously supplying blood to the coronary system and providing sufficient coronary perfusion to the myocardium.

[0046] Specifically, at the start of the second stage (t3, the third time of the first stage), the control device 200 linearly decelerates the rotational speed of the ventricular assist device 100 from the third speed v3 (maximum speed of the velocity pulsation) to the first speed v1 (minimum speed of the velocity pulsation), while simultaneously controlling the intra-aortic balloon counterpulsation pump balloon 310 to slowly inflate, i.e., the balloon 310 inflates at a preset inflation rate. At the start of diastole (t3), the rotational speed of the ventricular assist device 100 decreases from the maximum speed v3, the blood flow pumped into the ascending aorta begins to decrease, and the ascending aortic pressure also begins to decrease from the peak pressure of the ascending aorta during artificial systole. At the fourth time (t4), the rotational speed of the ventricular assist device 100 directly reaches the low speed of the first speed v1, while the intra-aortic balloon counterpulsation pump balloon 310 continues to inflate at a preset inflation rate. At time t4, the increased balloon volume causes blood in the descending aorta to flow backward into the ascending aorta. This reverse flow of blood in the descending aorta compensates for the decrease in blood flow in the ascending aorta caused by the reduced rotational speed of the ventricular assist device 100, thus preventing a sharp decrease in ascending aortic pressure due to the reduced rotational speed of the ventricular assist device 100. At time t5, the control device 200 maintains the rotational speed of the ventricular assist device 100 at a low speed (v1) and keeps the balloon volume inflated. At this time, the blood flow in the ascending aorta drops to its minimum (e.g., 4.0 L / min ~ 4.5 L / min), and the balloon volume reaches its maximum. The reverse flow of blood in the descending aorta continues to compensate for the decrease in blood flow in the ascending aorta caused by the reduced rotational speed of the ventricular assist device 100. Between time t5 and time t6 (end-diastole), i.e., the sixth time interval, the control device 200 continues to maintain the rotational speed of the ventricular assist device 100 at a low speed (v1) and keeps the balloon 310 inflated. During this period, the blood flow pumped into the ascending aorta by the ventricular assist device 100 is maintained at a minimum value, the peripheral resistance of the blood in the ascending aorta remains at a maximum, and the reverse flow of blood in the descending aorta keeps the diastolic pressure of the ascending aorta at a high level (e.g., 60 mmHg ~ 80 mmHg), providing sufficient coronary perfusion to the myocardium.

[0047] Ascending aortic artificial diastolic pressure (DBP) = Forward inertial flow of blood after the ventricular assist device reduces its rotation speed by 100 ( P_pum) + Reverse volume displacement wave generated by balloon 310 inflation ( (P_balloon). The reverse blood volume generated by the inflation of the balloon 310 can just compensate for the reduction in blood flow caused by the deceleration of the ventricular assist device 100, significantly improving diastolic coronary perfusion pressure and maximizing myocardial blood supply efficiency.

[0048] The pulse cycle consists of the period from the start time t0 of the first stage to the sixth time t6 of the second stage, with t0-t3 simulating ventricular systole and t3-t6 simulating ventricular diastole. In the first stage, the control device 200 controls the pressure within the ascending aorta by controlling the time phase difference between the acceleration start point of the ventricular assist device 100 and the deflation start point of the balloon 310, as well as the time phase difference between the deceleration start point of the ventricular assist device 100 and the inflation start point of the balloon 310, thereby creating a physiological-level pulse pressure difference to simulate the pulsatile blood flow characteristics of a natural heart.

[0049] For example, the start time of the first stage is t0=0, the first time is t1=50ms, the second time is t2=100ms, the third time is t3=150ms, the fourth time is t4=250ms, the fifth time is t5=350ms, and the sixth time is t6=400ms. This application, through precise matching of time phases (e.g., controlling the time phase difference between the acceleration start point of the ventricular assist device 100 and the deflation start point of the balloon 310 to 50ms±10ms; and controlling the time phase difference between the deceleration start point of the ventricular assist device 100 and the inflation start point of the balloon 310 to 20ms±10ms), can stably generate a physiological pulse pressure gradient greater than 50 mmHg in the ascending aorta, thereby simulating the pulsatile blood flow characteristics of a natural heart.

[0050] In this application, the control device 200 anatomically matches and coordinates the blood flow pumped by the ventricular assist device 100 in the ascending aorta with the counterpulsation of the intra-aortic balloon counterpulsation pump 310 in the descending aorta, achieving hemodynamic gains that cannot be achieved by a single device (independent operation control of the ventricular assist device 100 and the intra-aortic balloon counterpulsation pump). Through precise phase matching between the rotational speed pulsation and the counterpulsation of the balloon 310, a pulse pressure gradient of greater than or equal to 50 mmHg is stably generated in the ascending aorta. Compared with the ascending aortic pulse pressure gradient achieved by existing ventricular assist devices (less than 10 mmHg), this fully restores the physiological shear stress environment of the vascular endothelium (approximately 15~30 dyn / cm²), effectively preventing vascular complications related to continuous advection (such as acquired von Willebrand syndrome, gastrointestinal vascular dysplasia bleeding, etc.).

[0051] Furthermore, in order to achieve precise control of the ventricular assist device 100 and the intra-aortic balloon counterpulsation pump, the control device 200 can receive the ascending aortic pressure feedback from the pressure sensor in real time to perform closed-loop control. That is, the rotation speed of the ventricular assist device 100 and the balloon volume of the intra-aortic balloon counterpulsation pump are adjusted according to the changes in the ascending aortic pressure to ensure that the pulse pressure difference of the ascending aorta is stabilized above 50 mmHg, simulating the pulsatile blood flow characteristics of a natural heart.

[0052] For example, the method further includes: if the first aortic pressure is less than the first preset systolic pressure, then increasing the third rotation speed by a first rotation speed step, wherein the first aortic pressure is the average value of the ascending aortic pressure within the third time period; if the first aortic pressure is greater than the second preset systolic pressure, then decreasing the third rotation speed by a second rotation speed step, wherein the second rotation speed step is determined based on the difference between the first aortic pressure and the first preset systolic pressure, wherein the minimum value of the third rotation speed is the first preset rotation speed and the maximum value of the third rotation speed is the second preset rotation speed.

[0053] In this application, in order to increase cardiac output, the control device 200 adjusts the upper limit of the speed pulsation of the ventricular assist device 100, i.e. the third speed v3, according to the artificial systolic pressure of the ascending aorta fed back by the pressure sensor (the pressure detected by the pressure sensor within the third time period of the first stage).

[0054] In the first phase, the ventricular assist device 100 increases its rotational speed to simulate the ventricular systolic phase of a natural heart. During the third duration, the blood flow pumped into the ascending aorta by the ventricular assist device 100 remains at its peak, and the ascending aortic pressure reaches its maximum value and remains at this value throughout the third duration. Therefore, the average ascending aortic pressure detected by the pressure sensor during the third duration is taken as the first aortic pressure (ascending aortic artificial systolic pressure). If the first aortic pressure is less than the first preset systolic pressure, it indicates that the current ascending aortic artificial systolic pressure is insufficient, and the third rotational speed v3 needs to be increased to increase the blood flow pumped into the ascending aorta, thereby increasing the ascending aortic artificial systolic pressure. If the first aortic pressure is greater than the second preset systolic pressure, it indicates that the current ascending aortic artificial systolic pressure is too high, and the third rotational speed v3 needs to be decreased to decrease the blood flow pumped into the ascending aorta, thereby decreasing the ascending aortic artificial systolic pressure.

[0055] The desired range for the artificial systolic blood pressure in the ascending aorta is 100 mmHg to 120 mmHg. If the first aortic pressure is within this desired range, there is no need to adjust the third rotation speed v3. For example, the first preset systolic pressure is 90 mmHg, and the second preset systolic pressure is 120 mmHg. Specifically, if the first aortic pressure is less than 90 mmHg, then in each pulse cycle following the current pulse cycle, the third rotation speed v3 is increased by the first rotation speed step until the first aortic pressure is within the desired range or the third rotation speed v3 reaches the maximum allowable rotation speed. If the first aortic pressure is greater than 120 mmHg, then in each pulse cycle following the current pulse cycle, the third rotation speed v3 is decreased by the second rotation speed step until the first aortic pressure is within the desired range or the third rotation speed v3 reaches the minimum allowable rotation speed.

[0056] The first speed step is less than or equal to 500 RPM. Within each pulse cycle, if the first aortic pressure is between 120 mmHg and 130 mmHg, which poses little or no immediate harm to the patient, the third speed (v3) can be fixed, and the second speed step is set to 500 RPM. If the first aortic pressure is between 130 mmHg and 150 mmHg, which may pose a risk to the patient, the second speed step is set to 1,000 RPM + (first aortic pressure - 130) × 100 RPM, dynamically increasing the third speed (v3) to rapidly reduce the ascending aortic artificial systolic pressure. If the first aortic pressure is greater than 150 mmHg, the second speed step is directly set to 10% of the third speed (v3) to significantly reduce the third speed (v3).

[0057] For example, when the permissible rotational speed range of the ventricular assist device 100 is 15,000 RPM to 46,000 RPM, the first preset rotational speed is set to 22,000 RPM, and the second preset rotational speed is set to 46,000 RPM. This means the maximum permissible rotational speed of the third rotational speed v3 is 46,000 RPM, and the minimum permissible rotational speed of the third rotational speed v3 is 22,000 RPM. Furthermore, to ensure the safe operation of the ventricular assist device 100, when the third rotational speed v3 is greater than the maximum permissible speed of 46,000 RPM, it is directly set to 46,000 RPM to avoid a significant increase in the risk of hemolysis due to an excessively high third rotational speed v3. When the third rotational speed v3 is less than the minimum permissible speed of 22,000 RPM, it is directly set to 22,000 RPM to avoid insufficient blood flow pumped to the ascending aorta by the ventricular assist device 100 to maintain basic circulation due to an excessively low third rotational speed v3.

[0058] For example, the method further includes: if the second aortic pressure is less than the first preset diastolic pressure, then increasing the first rotation speed by a third rotation speed step, wherein the second aortic pressure is the average value of the ascending aortic pressure within the sixth time period; if the second aortic pressure is greater than the second preset diastolic pressure, then decreasing the first rotation speed by a fourth rotation speed step, wherein the minimum value of the first rotation speed is a third preset rotation speed, and the maximum value of the first rotation speed is n times the second rotation speed, wherein n is less than 1.

[0059] In this application, in order to increase the diastolic coronary perfusion pressure, the control device 200 adjusts the lower limit of the velocity pulsation of the ventricular assist device 100, i.e. the first rotational speed v1, based on the artificial diastolic pressure of the ascending aorta fed back by the pressure sensor (the pressure detected by the pressure sensor within the sixth time period of the second phase).

[0060] In the second phase, the ventricular assist device 100 reduces its rotational speed to simulate the diastolic phase of a natural heart. During the sixth time period, the blood flow pumped into the ascending aorta by the ventricular assist device 100 is maintained at a minimum. Therefore, the average ascending aortic pressure detected by the pressure sensor during the sixth time period is used as the second aortic pressure (artificial diastolic pressure of the ascending aorta). If the second aortic pressure is less than the first preset diastolic pressure, it indicates that the current artificial diastolic pressure of the ascending aorta is too low, which may lead to insufficient coronary perfusion. The first rotational speed v1 needs to be increased to increase the blood flow pumped into the ascending aorta, thereby increasing the artificial diastolic pressure of the ascending aorta. If the second aortic pressure is greater than the second preset diastolic pressure, it indicates that the current artificial diastolic pressure of the ascending aorta is too high, which may prevent the pulse pressure gradient of the ascending aorta from being maintained within the desired value. Therefore, the first rotational speed v1 needs to be reduced to decrease the blood flow pumped into the ascending aorta, thereby reducing the artificial diastolic pressure of the ascending aorta.

[0061] The desired range for the artificial diastolic pressure in the ascending aorta is 60 mmHg to 80 mmHg. A diastolic pressure within this range is suitable for coronary perfusion, maximizing myocardial blood supply efficiency. If the second aortic pressure is within this desired range, there is no need to adjust the first rotational speed v1. For example, the first preset diastolic pressure is 55 mmHg, and the second preset diastolic pressure is 80 mmHg. Specifically, if the second aortic pressure is less than 55 mmHg, then in each pulse cycle following the current pulse cycle, the first rotational speed v1 is increased by a third rotational speed step until the second aortic pressure is within the desired range or the first rotational speed v1 reaches the maximum permissible speed. If the second aortic pressure is greater than 80 mmHg, then in each pulse cycle following the current pulse cycle, the first rotational speed v1 is decreased by a fourth rotational speed step until the second aortic pressure is within the desired range or the first rotational speed v1 reaches the minimum permissible speed.

[0062] For example, the third speed step is 200 RPM, and the fourth speed step is less than or equal to 1000 RPM. When the permissible speed range of the ventricular assist device 100 is 15000 RPM to 46000 RPM, the third preset speed is set to 13000 RPM, and the fourth preset speed is set to n times the second speed v2. That is, the maximum permissible speed of the first speed v1 is n times the second speed v2, and the minimum permissible speed of the third speed v3 is 13000 RPM. For example, n is set to 0.85.

[0063] Furthermore, to ensure the safe operation of the ventricular assist device 100, when the first rotational speed v1 is greater than the maximum allowable rotational speed, the first rotational speed v1 is directly set to a second preset rotational speed to ensure sufficient pulsation amplitude space for speed pulsation. When the first rotational speed v1 is less than the minimum allowable rotational speed of 13000 RPM, the first rotational speed v1 is directly set to 13000 RPM to avoid the risk of pumping regurgitation and shutdown of the ventricular assist device 100 due to the first rotational speed v1 being too low.

[0064] The method further includes: if the target average pulsation pressure is greater than the first preset pulsation pressure, increasing the second rotation speed by a fifth rotation speed step, wherein the target average pulsation pressure is the average value of the ascending aortic pressure in the first stage and the second stage; if the target average pulsation pressure is less than the first preset pulsation pressure, decreasing the second rotation speed by the fifth rotation speed step.

[0065] In this application, to ensure the physiologically optimal coronary perfusion pressure, the control device 200 adjusts the reference speed of the ventricular assist device 100, namely the second rotation speed v2, based on the average ascending aortic pressure (the average pressure detected by the pressure sensor within the pulse cycle) fed back by the pressure sensor.

[0066] The first preset arterial pressure is set to 75 mmHg. Maintaining a mean pulse pressure of 75 mmHg achieves the physiologically optimal coronary perfusion pressure, maximizing myocardial blood supply efficiency. Therefore, within each pulse cycle, if the target mean pulse pressure is greater than 75 mmHg, the control device 200 reduces the second rotation speed of the next pulse cycle by a fifth rotation speed step; if the target mean pulse pressure is less than 75 mmHg, the control device 200 increases the second rotation speed of the next pulse cycle by a fifth rotation speed step. This fifth rotation speed step can be set to less than or equal to 300 RPM to prevent sudden changes in the rotation speed of the ventricular assist device 100.

[0067] The method further includes: if the target average pulsation pressure is less than the second preset pulsation pressure, the second rotation speed is continuously set to the second preset rotation speed for a seventh time period; if the target average pulsation pressure is greater than the third preset pulsation pressure, the second rotation speed is reduced for the seventh time period.

[0068] Furthermore, if the target mean arterial pressure differs too much from 75 mmHg, in order to ensure patient safety, the control device 200 can forcibly lock the second speed v2 of the ventricular assist device 100, that is, directly set the second speed v2.

[0069] The second preset pulse pressure is set to 40 mmHg, and the third preset pulse pressure is set to 95 mmHg. If the target average pulse pressure is less than 40 mmHg, it indicates that the average pressure of the blood pumped by the heart in the ascending aorta is insufficient, which will affect the perfusion of various organs throughout the body. In other words, the current pumping flow of the ventricular assist device 100 is too low. The control device 200 can continuously set the second rotation speed to the maximum allowable rotation speed of the ventricular assist device 100 for a seventh duration to increase the blood flow pumped by the ventricular assist device 100 into the ascending aorta at full speed, thereby rapidly increasing the ascending aortic pressure. If the target average pulse pressure is greater than 95 mmHg, it indicates that the pressure load on the ascending aorta is continuously too high. The control device 200 can gradually reduce the second rotation speed v2 for a seventh duration to gradually reduce the blood flow pumped into the ascending aorta, thereby reducing the ascending aortic pressure. At the same time, the control device 200 can also trigger an audible and visual alarm to remind medical personnel. The seventh duration can be set according to the actual application scenario; for example, the seventh duration is set to 10 seconds.

[0070] For example, the method further includes: if the target pulse pressure difference is less than a first preset pulse pressure difference, increasing the preset volume by a first volume step, wherein the target pulse pressure difference is the difference between the first aortic pressure and the second aortic pressure; if the target pulse pressure difference is greater than a second preset pulse pressure difference, decreasing the preset volume by a second volume step, wherein the minimum value of the preset volume is the first volume, and the maximum value of the preset volume is the second volume.

[0071] In this application, in the first stage, the size of the balloon volume affects the peripheral resistance of blood in the ascending aorta; in the second stage, the size of the balloon volume affects the blood flow from the descending aorta to the ascending aorta. To ensure the physiologically optimal coronary perfusion pressure, the control device 200 adjusts the balloon volume of the intra-aortic balloon counterpulsation pump balloon 310 in the inflated state, i.e., the preset volume v0, according to the pulse pressure of the ascending aorta (the difference between the first aortic pressure and the second aortic pressure).

[0072] When the pulse pressure gradient in the ascending aorta is within the range of 55 mmHg to 70 mmHg, the physiologically optimal coronary perfusion pressure is achieved, exhibiting the best pulsatile blood flow characteristics. The first preset pulse pressure gradient is set to 45 mmHg, and the second preset pulse pressure gradient is set to 75 mmHg. If the target pulse pressure gradient is less than 45 mmHg, it indicates that the current pulse pressure gradient in the ascending aorta is too small. In each subsequent pulse cycle, the preset volume v0 of the intra-aortic balloon counterpulsation pump balloon 310 can be increased by a first volume step until the target pulse pressure gradient is greater than or equal to 55 mmHg or the volume of balloon 310 reaches its maximum value, thereby increasing the first aortic pressure and thus increasing the target pulse pressure gradient. If the target pulse pressure difference is greater than 75 mmHg, it indicates that the current pulse pressure difference in the ascending aorta is too large. The preset volume v0 of the intra-aortic balloon counterpulsation pump balloon 310 can be reduced by a second volume step until the target pulse pressure difference is less than or equal to 70 mmHg or the volume of balloon 310 reaches the minimum value. This will quickly reduce the shear stress on the ascending aortic vessel wall and increase the second aortic pressure, thereby reducing the target pulse pressure difference.

[0073] The inflation volume of the intra-aortic balloon counterpulsation pump balloon 310 can be determined according to the patient's descending aortic diameter. For example, the adjustable range of the inflation volume of the balloon 310 is 20 mL to 45 mL. The first volume step ranges from 1.5 mL to 2.0 mL, and the second volume step is set to 5 mL.

[0074] Furthermore, to ensure patient safety and the counterpulsation effect of the intra-aortic balloon counterpulsation pump, during the adjustment of the balloon volume, if the preset volume v0 exceeds the maximum balloon volume, the control device 200 can directly set the preset volume v0 to the maximum volume to prevent the risk of aortic rupture caused by the balloon volume exceeding the maximum volume; if the preset volume v0 is lower than the maximum balloon volume, the control device 200 can directly set the preset volume v0 to the minimum volume to avoid the counterpulsation effect of the intra-aortic balloon counterpulsation pump being weak due to the balloon volume being lower than the maximum volume.

[0075] For example, the maximum volume can be set to 45 mL depending on the size of the descending aorta; the minimum volume can be set to 15 mL depending on the counterpulsation effect of the intra-aortic balloon pump.

[0076] In this application, the control device 200 uses the ascending aortic pressure fed back by the pressure sensor to perform closed-loop control of the ventricular assist device 100 and the intra-aortic balloon counterpulsation pump, ensuring that the parameter adjustments during operation are smooth and gradual, avoiding the risk of hypotension or hypertension caused by over-adjustment, and enabling the patient to have stable hemodynamic characteristics.

[0077] As can be seen, this application proposes a pulsation control method. In the first stage, the rotation speed of the ventricular assist device (VAD) is increased, and the balloon is deflated. In the second stage, the rotation speed of the VAD is decreased, and the balloon is inflated. By simulating the cardiac cycle, the VAD and the intra-aortic balloon counterpulsation pump are controlled separately, achieving precise and coordinated control of the VAD's pulsation speed and the balloon counterpulsation, thereby improving the patient's hemodynamic performance.

[0078] The above primarily describes the solutions of the embodiments of this application from the perspective of the method execution process. It is understood that, in order to achieve the above functions, the network device includes corresponding hardware structures and / or software modules for executing each function. Those skilled in the art should readily recognize that, in conjunction with the units and algorithm steps of the various examples described in the embodiments provided herein, this application can be implemented in hardware or a combination of hardware and computer software. Whether a function is executed in hardware or by computer software driving hardware depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0079] For example, this application also provides a medical device that includes the ventricular assist system described above.

[0080] The medical devices in each of the above solutions have the function of performing the corresponding steps executed by the control device 200 in the above methods; the function can be implemented by hardware or by hardware executing corresponding software.

[0081] Please see Figure 4 , Figure 4 This is a schematic diagram of the structure of a medical device provided in an embodiment of this application. The medical device includes: one or more processors, one or more memories, one or more communication interfaces, and one or more programs; the one or more programs are stored in the memories and configured to be executed by the one or more processors.

[0082] The above procedure includes instructions for performing the following steps: In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate. In the second stage, the ventricular assist device is controlled to reduce its rotation speed and the balloon is controlled to inflate.

[0083] All relevant content in each scenario involved in the above method embodiments can be referenced from the functional description of the corresponding functional module, and will not be repeated here.

[0084] It should be understood that the aforementioned memory may include read-only memory and random access memory, and provides instructions and data to the processor. A portion of the memory may also include non-volatile random access memory. For example, the memory may also store information about the device type.

[0085] In the embodiments of this application, the processor of the above-described device may be a central processing unit (CPU), or it may be other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or any conventional processor, etc.

[0086] It should be understood that "at least one" in the embodiments of this application refers to one or more, and "more than one" refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone, where A and B can be singular or plural. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or plural items. For example, at least one of a, b, or c can represent: a, b, c, ab, ac, bc, or abc, where a, b, and c can be single or multiple.

[0087] Furthermore, unless otherwise stated, the ordinal numbers such as "first" and "second" mentioned in the embodiments of this application are used to distinguish multiple objects and are not used to limit the order, timing, priority, or importance of multiple objects. For example, "first information" and "second information" are only used to distinguish different information and do not indicate differences in the content, priority, sending order, or importance of these two types of information.

[0088] In implementation, each step of the above method can be completed by integrated logic circuits in the processor's hardware or by instructions in software. The steps of the method disclosed in the embodiments of this application can be directly manifested as execution by a hardware processor, or as a combination of hardware and software units within the processor. The software units can reside in random access memory, flash memory, read-only memory, programmable read-only memory, electrically erasable programmable memory, registers, or other mature storage media in the art. This storage medium is located in memory, and the processor executes the instructions in the memory, combining them with its hardware to complete the steps of the above method. To avoid repetition, detailed descriptions are omitted here.

[0089] This application also provides a computer storage medium storing a computer program for electronic data interchange, which causes a computer to perform some or all of the steps of any of the methods described in the above method embodiments.

[0090] This application also provides a computer program product, which includes a non-transitory computer-readable storage medium storing a computer program operable to cause a computer to perform some or all of the steps of any of the methods described in the above method embodiments. This computer program product can be a software installation package.

[0091] It should be noted that, for the sake of simplicity, the foregoing method embodiments are all described as a series of actions. However, those skilled in the art should understand that this application is not limited to the described order of actions, as some steps may be performed in other orders or simultaneously according to this application. Furthermore, those skilled in the art should also understand that the embodiments described in the specification are preferred embodiments, and the actions and modules involved are not necessarily essential to this application.

[0092] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0093] In the several embodiments provided in this application, it should be understood that the disclosed apparatus can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of the units described above is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between devices or units may be electrical or other forms.

[0094] The units described above as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of the embodiments of this application, depending on actual needs.

[0095] Furthermore, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.

[0096] If the aforementioned integrated units are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage device (CMD). Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a memory and includes several instructions to cause a computer device (which may be a personal computer, server, or TRP, etc.) to execute all or part of the steps of the methods of the various embodiments of this application. The aforementioned memory includes various media capable of storing program code, such as USB flash drives, read-only memory (ROM), random access memory (RAM), portable hard drives, magnetic disks, or optical disks.

[0097] Those skilled in the art will understand that all or part of the steps in the various methods of the above embodiments can be implemented by a program instructing related hardware. The program can be stored in a computer-readable storage device, which may include a flash drive, ROM, RAM, disk, or optical disk, etc.

[0098] The embodiments of this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A pulse control method, characterized in that, The invention relates to a ventricular assist system, which includes a ventricular assist device, an intra-aortic balloon counterpulsation pump, and a control device. The ventricular assist device and the intra-aortic balloon counterpulsation pump are respectively communicatively connected to the control device. The intra-aortic balloon counterpulsation pump includes a balloon. The method includes: In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate. In the second stage, the ventricular assist device is controlled to reduce its rotation speed and the balloon is controlled to inflate.

2. The method according to claim 1, characterized in that, The control of increasing the rotation speed of the ventricular assist device and controlling the deflation of the balloon includes: During the first duration of the first stage, the ventricular assist device is increased from a first rotation speed to a second rotation speed and the balloon is kept in an inflated state, wherein the inflated state is the state in which the balloon maintains a preset volume; During the second duration of the first phase, the ventricular assist device is increased from the second rotation speed to the third rotation speed, and the balloon is deflated to zero volume; During the third duration of the first phase, the rotational speed of the ventricular assist device is maintained at the third rotational speed, and the balloon is maintained at zero volume.

3. The method according to claim 2, characterized in that, The control of reducing the rotation speed of the ventricular assist device and controlling the inflation of the intra-aortic balloon counterpulsation pump includes: During the fourth duration of the second phase, the ventricular assist device is reduced from the third rotation speed to the first rotation speed while the balloon is inflated. During the fifth duration of the second phase, the rotation speed of the ventricular assist device is maintained at the first rotation speed, while the balloon is inflated to the inflated state. During the sixth duration of the second phase, the rotational speed of the ventricular assist device is maintained at the first rotational speed, while the balloon is maintained in the inflated state.

4. The method according to any one of claims 2 and 3, characterized in that, The ventricular assist device includes a pressure sensor for detecting ascending aortic pressure; The method further includes: If the first aortic pressure is less than the first preset systolic pressure, the third rotation speed is increased by the first rotation speed step, and the first aortic pressure is the average value of the ascending aortic pressure within the third time period; If the first aortic pressure is greater than the second preset systolic pressure, the third rotation speed is reduced by a second rotation speed step. The second rotation speed step is determined based on the difference between the first aortic pressure and the first preset systolic pressure. The minimum value of the third rotation speed is the first preset rotation speed, and the maximum value of the third rotation speed is the second preset rotation speed.

5. The method according to claim 4, characterized in that, The method further includes: If the second aortic pressure is less than the first preset diastolic pressure, the first rotation speed is increased by a third rotation speed step, and the second aortic pressure is the average value of the ascending aortic pressure within the sixth time period; If the second aortic pressure is greater than the second preset diastolic pressure, the first rotation speed is reduced by a fourth rotation speed step. The minimum value of the first rotation speed is the third preset rotation speed, and the maximum value of the first rotation speed is n times the second rotation speed, where n is less than 1.

6. The method according to claim 5, characterized in that, The method further includes: If the target pulse pressure difference is less than the first preset pulse pressure difference, the preset volume is increased by the first volume step, and the target pulse pressure difference is the difference between the first aortic pressure and the second aortic pressure; If the target pulse pressure difference is greater than the second preset pulse pressure difference, the preset volume is reduced by a second volume step. The minimum value of the preset volume is the first volume, and the maximum value of the preset volume is the second volume.

7. The method according to claim 5, characterized in that, The method further includes: If the target average pulsation pressure is greater than the first preset pulsation pressure, the second rotation speed is increased by a fifth rotation speed step, and the target average pulsation pressure is the average value of the ascending aortic pressure in the first stage and the second stage; If the target average pulsation pressure is less than the first preset pulsation pressure, the second rotational speed is reduced by the fifth rotational speed step.

8. The method according to claim 7, characterized in that, The method further includes: If the target average pulsation pressure is less than the second preset pulsation pressure, the second rotation speed will be continuously set to the second preset rotation speed for the seventh time period; If the target average pulsation pressure is greater than the third preset pulsation pressure, the second rotation speed is reduced within the seventh time period.

9. A ventricular assist system, characterized in that, The ventricular assist system includes a ventricular assist device, an intra-aortic balloon pump, and a control device. The ventricular assist device and the intra-aortic balloon pump are communicatively connected to the control device. The intra-aortic balloon pump includes a balloon. The control device includes one or more processors, which are used for: In the first stage, the ventricular assist device is controlled to increase its rotation speed and the balloon is controlled to deflate. In the second stage, the ventricular assist device is controlled to reduce its rotation speed and the balloon is controlled to inflate.

10. A medical device, characterized in that, The method includes a processor, a memory, and a communication interface, wherein the memory stores one or more programs, and the one or more programs are executed by the processor, the one or more programs including instructions for performing the steps of the method as described in any one of claims 1-8.

11. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program for electronic data interchange, wherein the computer program causes a computer to perform the steps of the method as described in any one of claims 1-8.

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