Method and device for controlling the rotation speed of ventricular assist system

Abstract

This application proposes a method and apparatus for controlling the rotation speed of a ventricular assist device (VAD). The method includes: acquiring a first left ventricular pressure and a first right ventricular pressure, wherein the first left ventricular pressure is the left ventricular pressure of the target user at a first moment when the left ventricular assist device is running at a first left rotation speed, and the first right ventricular pressure is the right ventricular pressure of the target user at a first right rotation speed when the right ventricular assist device is running at a first right rotation speed; adjusting the first left rotation speed and / or the first right rotation speed according to the first left ventricular pressure and the first right ventricular pressure to maintain a balance between the fluid output of the left and right ventricles. This application determines whether the fluid output of the user's left and right ventricles is balanced by real-time detection of ventricular pressure, and then adjusts the rotation speed of the left ventricular assist device and / or the right ventricular assist device to regulate the fluid output of the left or right ventricle when there is an imbalance, thereby ensuring a balance between the systemic and pulmonary circulation flow of the user and preventing aspiration and regurgitation problems in the left or right ventricle.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method and device for controlling the rotational speed of a ventricular assist system. Background Technology

[0002] A ventricular assist device (VAD) can be used to assist the heart of a subject with conditions that impair the heart's pumping ability. Patients using a VAD can benefit from the assistance provided by the heart, as VADs assist the heart's pumping function by pumping blood from either side of the heart. For example, a left ventricular assist device can be provided for conditions that impair the heart's ability to pump blood into the systemic circulation; a right ventricular assist device can be provided for conditions that impair the heart's ability to pump blood into the pulmonary circulation; and a biventricular assist device can be provided for conditions that impair both sides of the heart.

[0003] The patient's condition may result in different output volumes on the left and right sides of the heart, because blood output from one side of the heart is received by the other side. The difference in output volume between the two sides may cause blood to accumulate on the side with lower output volume and suction to occur on the side with higher output volume, making the pulmonary and / or systemic circulation unable to meet the patient's needs.

[0004] Therefore, how to balance pulmonary circulation and systemic circulation during the operation of biventricular assist devices is an urgent problem to be solved. Summary of the Invention

[0005] This application provides a method and apparatus for controlling the rotational speed of a ventricular assist system, which can balance the fluid output of the left ventricle with that of the right ventricle, thereby preventing reflux or suction in the left ventricular assist device and / or the right ventricular assist device.

[0006] In a first aspect, embodiments of this application provide a method for controlling the rotational speed of a ventricular assist system. The ventricular assist system includes a left ventricular assist device and a right ventricular assist device. The left ventricular assist device is used to pump fluid from the left ventricle of a target user to the aorta, and the right ventricular assist device is used to pump fluid from the right ventricle of the target user to the pulmonary artery. The method includes:

[0007] The first left ventricular pressure and the first right ventricular pressure are obtained. The first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed. The first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed.

[0008] The first left rotation speed and / or the first right rotation speed are adjusted according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle.

[0009] Secondly, an embodiment of this application provides a control circuit, the control circuit including one or more processors, the one or more processors being used for:

[0010] The first left ventricular pressure and the first right ventricular pressure are obtained. The first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed. The first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed.

[0011] The first left rotation speed and / or the first right rotation speed are adjusted according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle.

[0012] Thirdly, embodiments of this application provide a ventricular assist system, the ventricular assist system comprising:

[0013] A left ventricular assist device used to pump fluid from the target user's left ventricle to the aorta;

[0014] A right ventricular assist device used to pump fluid from the right ventricle of a target user to the pulmonary artery;

[0015] A control device communicatively connected to the left ventricular assist device and the right ventricular assist device, the control device being used for:

[0016] The first left ventricular pressure and the first right ventricular pressure are obtained. The first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed. The first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed.

[0017] The first left rotation speed and / or the first right rotation speed are adjusted according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle.

[0018] Fourthly, 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.

[0019] Fifthly, 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.

[0020] Sixthly, embodiments of this application provide a computer program product, wherein the computer program product includes a non-transitory computer-readable storage medium storing a computer program, the computer program being operable to cause a computer to perform some or all of the steps described in the method described in the first aspect of embodiments of this application. The computer program product may be a software installation package.

[0021] The technical solution provided in this application acquires a first left ventricular pressure and a first right ventricular pressure. The first left ventricular pressure is the left ventricular pressure of the target user at a first moment when the left ventricular assist device is running at a first left rotation speed, and the first right ventricular pressure is the right ventricular pressure of the target user at a first moment when the right ventricular assist device is running at a first right rotation speed. The first left and / or first right rotation speeds are adjusted based on the first left and first right ventricular pressures to maintain a balance between the fluid output of the left and right ventricles. This application determines whether the fluid output of the user's left and right ventricles is balanced by real-time detection of ventricular pressure. If there is an imbalance, the rotation speed of the left and / or right ventricular assist devices is adjusted to regulate the fluid output of the left or right ventricle, ensuring a balance in the user's systemic and pulmonary circulation flow and preventing aspiration and regurgitation problems in the left or right ventricle. Attached Figure Description

[0022] 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.

[0023] Figure 1 This is a structural block diagram of a ventricular assist system provided in an embodiment of this application;

[0024] Figure 2 This is a schematic flowchart of a speed control method for a ventricular assist system provided in an embodiment of this application;

[0025] Figure 3 This is a schematic diagram of the structure of a medical device provided in an embodiment of this application. Detailed Implementation

[0026] 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.

[0027] 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.

[0028] 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.

[0029] The medical devices and pumps involved in this application can be ventricular assist devices, such as implantable ventricular assist devices, interventional ventricular assist devices, etc.; the ventricular assist device can include at least one blood pump, wherein the blood pump can be a centrifugal pump, axial flow pump, magnetic levitation pump, etc.

[0030] 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.

[0031] Please see Figure 1 , Figure 1 This application provides a ventricular assist system, which includes a left ventricular assist device, a right ventricular assist device, and a control device. The left ventricular assist device is disposed in the patient's left ventricle and is used to pump blood from the patient's left ventricle to the aorta; the right ventricular assist device is disposed in the patient's right ventricle and is used to pump blood from the patient's right ventricle to the pulmonary artery.

[0032] From the perspective of blood flow, the fluid systems are arranged in series. Blood first flows to the lungs through the pulmonary artery. The pulmonary system is directly connected to the left ventricle. After being oxygenated in the lungs, the blood returns to the left ventricle. From the left ventricle, the blood is pumped into the aorta, and from there, it flows through the user's vascular system to the right ventricle. Therefore, blood circulates sequentially in the pulmonary artery, right ventricle, left ventricle, and aorta. The flow of blood from the right ventricle to the pulmonary artery is called pulmonary circulation, and the flow of blood from the left ventricle to the aorta is called systemic circulation.

[0033] A left ventricular assist device (LVAD) acts on the left side of the heart. It can be placed at the apex of the left ventricle, with its fluid inlet located within the user's left ventricle and its fluid outlet connected to the user's aorta. Alternatively, the LVAD can cross the user's aortic valve, with its proximal end located within the aorta and its distal end within the left ventricle, thereby pumping blood from the left ventricle into the aorta. A right ventricular assist device (RVC) acts on the right side of the heart. It can be placed at the apex of the right ventricle, with its fluid inlet located within the right ventricle and its fluid outlet connected to the pulmonary artery. Alternatively, the second LVAD can cross the user's pulmonary valve, with its proximal end located within the pulmonary artery and its distal end within the right ventricle, allowing the user to pump blood from the right ventricle into the pulmonary artery, thus achieving blood circulation.

[0034] For example, a left ventricular assist device (LVAP) can be attached to the apex of the left ventricle of the heart via a ventricular connection assembly (such as a top loop, ventricular cuff, or ventricular linker). This ventricular connection assembly can be sutured to the apex of the left ventricle and attached to the LVAP device. The other end of the LVAP device can be connected to the aorta via an outlet tube and / or an artificial blood vessel connected to the outlet tube. This allows the LVAP device to effectively divert blood from the weakened left ventricle and propel it into the aorta, thereby circulating it to the remainder of the patient's vascular system and providing ventricular assist. Similarly, a right ventricular assist device can also be attached to the apex of the right ventricle of the heart via a ventricular connection assembly to provide ventricular assist.

[0035] The control device can be an internal control circuit and / or an external control circuit. The control device can communicatively connect to the left ventricular assist device (LVAD) and the right ventricular assist device (RAVD) for controlling their operation. For example, the LVAD and RAVD are connected to an external control device via percutaneous cables passing through the patient's abdominal skin. The control device enables independent actuation of the LVAD and RAVD, but with mutual modulation. Blood flow rates have a predetermined relationship, and the fluid flow rate pumped by the ventricular assist devices is related to the blood volume and pressure within the ventricles. Therefore, a change in the fluid flow rate of one ventricular assist device will cause a corresponding change in the fluid flow rate of the other. For instance, increasing the rotational speed of the first ventricular assist device reduces the blood volume in the left ventricle, thus decreasing the pressure within the left ventricle. This reduced pressure facilitates blood flow from the lungs to the left ventricle, thereby lowering the pulmonary artery pressure. The decreased pulmonary artery pressure reduces the pressure difference between the pulmonary artery and right ventricular pressures, allowing for better pumping of blood from the right ventricle into the pulmonary artery.

[0036] In this application, the ventricular assist system may further include multiple pressure sensors, which may be disposed on the outer surface of the fluid inlet of the left ventricular assist device for real-time measurement of the patient's left ventricular pressure, and disposed on the outer surface of the fluid inlet of the right ventricular assist device for real-time measurement of the patient's right ventricular pressure.

[0037] Please see Figure 2 , Figure 2 This is a schematic flowchart of a speed control method for a ventricular assist system provided in an embodiment of this application, which is applied to, for example... Figure 1 The ventricular assist system shown. (Example) Figure 2 As shown, the method includes the following steps.

[0038] S310. Obtain the first left ventricular pressure and the first right ventricular pressure, wherein the first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed, and the first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed.

[0039] In this application, when the left ventricular assist device is implanted in the left ventricle of the target user and is running, and when the right ventricular assist device is implanted in the right ventricle of the target user, the pressure sensors installed on the left and right ventricular assist devices can detect the left and right ventricular pressures of the target user in real time, and feed the left and right ventricular pressures back to the control device. The control device processes the received left and right ventricular pressures to determine whether the flow rates of the systemic and pulmonary circulations of the target user are currently balanced.

[0040] The first left rotation speed can be the rotation speed currently set by the user for the left ventricular assist device (LVAD) or the current rotation speed of the LVAD obtained through measurement estimation; the first right rotation speed can be the rotation speed currently set by the user for the right ventricular assist device (LVAD) or the current rotation speed of the right ventricular assist device obtained through measurement estimation. The first moment is the current moment of the left ventricular assist device and the right ventricular assist device.

[0041] S320. Adjust the first left rotation speed and / or the first right rotation speed according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle.

[0042] A ventricular assist device (VAP) delivers blood to the desired location via a rotating impeller driven by a motor. At a given impeller or motor speed, the fluid flow rate through the VAP depends on the pressure differential it needs to overcome. During ventricular systole, the greater the pressure differential between the aortic pressure and the left ventricular pressure, the greater the blood flow pumped by the heart. At a given speed, there is a mapping relationship between flow rate and pressure; therefore, the left ventricular pressure can represent the fluid output of the left ventricle, and the right ventricular pressure can represent the fluid output of the right ventricle. Furthermore, the first left ventricular pressure and the first right ventricular pressure can be used to determine whether the systemic and pulmonary circulations of the current target user are balanced.

[0043] Optionally, adjusting the first left rotation speed and / or the first right rotation speed based on the first left ventricular pressure and the first right ventricular pressure includes: calculating a first right mean pressure value and a first left mean pressure value, wherein the first left mean pressure value is the average pressure of the left ventricle within a first time period, and the first right mean pressure value is the average pressure of the right ventricle within the first time period, and the first moment is within the first time period; comparing the first right mean pressure value with a second right mean pressure value, and the first left mean pressure value with a second left mean pressure value, respectively, to determine whether to increase or decrease the first left rotation speed and / or the first right rotation speed, wherein the second right mean pressure value is the average pressure of the right ventricle within a second time period, and the second left mean pressure value is the average pressure of the left ventricle within the second time period, and the second time period is later than the first time period.

[0044] When the fluid output of the left ventricle increases, both central venous pressure and right ventricular pressure also increase. In this case, the increase in flow rate pumped by the ventricular assist device (VAD) itself is not significant, requiring an increase in the initial left rotation speed of the VAD to reduce right ventricular pressure. Conversely, when the fluid output of the right ventricle increases, pulmonary artery pressure increases; therefore, a decrease in the initial right rotation speed of the VAD is necessary to reduce pulmonary artery pressure.

[0045] In this application, to save resources, a time period can be set. Within each time period, the balance between systemic and pulmonary circulation is determined by comparing the pressure of the current time period with that of the previous time period. This time period can be set to 4h, 6h, 12h, 24h, etc. The control device can store the left ventricular pressure value and right ventricular pressure value fed back by the pressure sensor, and calculate and store the average left ventricular pressure value and the average right ventricular pressure value within each time period, and then adjust the first left rotation speed or the first right rotation speed by comparing the changes in the average left ventricular pressure value and the average right ventricular pressure value.

[0046] The step of comparing the first right average pressure value with the second right average pressure value and the first left average pressure value with the second left average pressure value to determine whether to increase or decrease the first left rotation speed and / or the first right rotation speed includes: if the first right average pressure value is greater than the second right average pressure value and the first left average pressure value is less than the second left average pressure value, then decrease the first left rotation speed; if the first right average pressure value is greater than the second right average pressure value and the first left average pressure value is greater than or equal to the second left average pressure value, increase the first right rotation speed; if the first right average pressure value is less than the second right average pressure value and the first left average pressure value is less than or equal to the second left average pressure value, then decrease the first right rotation speed; if the first right average pressure value is less than the second right average pressure value and the first left average pressure value is greater than the second left average pressure value, then increase the first right rotation speed.

[0047] Specifically, if the average right ventricular pressure in the current time period is higher than that in the previous time period, it indicates that the right ventricle is currently experiencing excessive blood storage, and the first right rotation speed should be increased or the first left rotation speed decreased. Therefore, the average left ventricular pressure in the current time period is further compared with that in the previous time period. If the average left ventricular pressure in the current time period is less than that in the previous time period, it indicates that the left ventricular assist device is unloaded too much and the pumping flow rate is too high, so the first left rotation speed should be decreased; if the average left ventricular pressure in the current time period is greater than or equal to that in the previous time period, it indicates that the pumping flow rate of the left ventricular assist device is appropriate, so the first right rotation speed should be increased.

[0048] Furthermore, if the average right ventricular pressure in the current time period is equal to the average right ventricular pressure in the previous time period, it indicates that the right ventricle is currently experiencing excessive blood storage, while the average right ventricular pressure in the previous time period indicates insufficient blood volume. In this case, the first right rotation speed should be reduced or the first left rotation speed increased. Therefore, based on this, the average left ventricular pressure in the current time period is further compared with the average left ventricular pressure in the previous time period. If the average left ventricular pressure in the current time period is less than or equal to the average left ventricular pressure in the previous time period, it indicates that the flow rate pumped by the left ventricular assist device is appropriate, and the first right rotation speed should be reduced. If the average left ventricular pressure in the current time period is greater than or equal to the average left ventricular pressure in the previous time period, it indicates that the unloading of the left ventricular assist device is too small and the pumping flow rate is too small, and the first left rotation speed should be increased.

[0049] For example, the increment or decrement of the first left rotation speed and the first right rotation speed can be 20 rpm. When an imbalance between systemic and pulmonary circulation is detected, the control device can decrease or increase the first left rotation speed or the first right rotation speed in each time cycle to regulate the left ventricular pressure and the right ventricular pressure, so that the left ventricular pressure and the right ventricular pressure can remain stable during the operation of the left ventricular assist device and the right ventricular assist device.

[0050] It should be noted that the first right average pressure value, the second right average pressure value, the first left average pressure value, and the second left average pressure value calculated in this application are all within the pressure value range of the user's normal physiological activity level.

[0051] In one possible example, the method further includes: determining the left cardiac cycle and the right cardiac cycle based on the first left ventricular pressure and the first right ventricular pressure, respectively, wherein the left cardiac cycle is the cardiac cycle in which the left ventricle is located at the first moment, and the right cardiac cycle is the cardiac cycle in which the right ventricle is located at the first moment; determining the first left flow rate corresponding to the first left ventricular pressure and the first right flow rate corresponding to the first right ventricular pressure based on the flow-pressure curves; adjusting the first left rotation speed based on the first left flow rate and the left cardiac cycle, and adjusting the first right rotation speed based on the first right flow rate and the right cardiac cycle.

[0052] In this application, the control device can also dynamically adjust the rotation speed of the left ventricular assist device and / or the right ventricular assist device in real time to avoid hemodynamic instability in the patient or to avoid problems such as regurgitation or suction of the left ventricular assist device and / or the right ventricular assist device.

[0053] During the operation of a ventricular assist device (VAP), its pumping flow rate must be synchronized with the target user's cardiac cycle to avoid problems such as aspiration and collapse. For example, if blood flow to the heart decreases, blood may be pumped out of the ventricles by the VAP at a rate faster than the ventricular filling rate, which usually leads to ventricular aspiration. Simultaneously, even a slight mismatch between the amount of blood pumped by the VAP and the amount of blood entering the heart can dangerously increase venous pressure, leading to life-threatening congestion in the lungs or systemic veins. Therefore, the fluid output of the left and right ventricles can be monitored at different cardiac cycles to avoid these problems.

[0054] The step of determining the left and right cardiac cycles based on the first left ventricular pressure and the first right ventricular pressure, respectively, includes: calculating the left pressure differential and the right pressure differential, wherein the left pressure differential is the difference between the first left ventricular pressure and the second left ventricular pressure, the second left ventricular pressure is the left ventricular pressure of the target user at a second moment when the left ventricular assist device is running at a first left rotation speed, and the right pressure differential is the difference between the first right ventricular pressure and the second right ventricular pressure, the second right ventricular pressure is the right ventricular pressure of the target user at a second moment when the right ventricular assist device is running at a first right rotation speed, the second moment being earlier than the first moment; if the left pressure differential is greater than a preset value, then the left cardiac cycle is determined to be in the systolic phase, otherwise the left cardiac cycle is in the diastolic phase; if the right pressure differential is greater than the preset value, then the right cardiac cycle is determined to be in the systolic phase, otherwise the right cardiac cycle is in the diastolic phase.

[0055] When the heart enters the ventricular systolic phase, the strong contraction of the ventricular myocardium gradually increases the pressure in the left ventricle; when the heart enters the ventricular diastolic phase, both the mitral and aortic valves close, and the pressure in the left ventricle gradually decreases. Therefore, by judging the changes in left and right ventricular pressure within a preset time period, the current cardiac cycle of the ventricle can be determined.

[0056] Specifically, the control device compares the left ventricular pressure (right ventricular pressure) at the first moment and the second moment. If the left ventricular pressure (first right ventricular pressure) at the first moment is greater than the left ventricular pressure (second right ventricular pressure) at the second moment, it indicates that the left ventricular pressure (right ventricular pressure) is gradually increasing, and therefore it is determined that the left ventricle (right ventricle) is currently in the systolic phase. Similarly, if the left ventricular pressure (first right ventricular pressure) at the first moment is less than the left ventricular pressure (second right ventricular pressure) at the second moment, it indicates that the left ventricular pressure (right ventricular pressure) is gradually decreasing, and therefore it is determined that the left ventricle (right ventricle) is currently in the diastolic phase.

[0057] Specifically, the difference between the first and second time points is less than the target user's contraction and relaxation times. Furthermore, this preset value can be set based on the difference between the first and second time points. The preset value increases as the difference between the first and second time points increases.

[0058] For example, the control device can also sample the real-time received left ventricular pressure and right ventricular pressure, such as setting the sampling frequency to T / 20, where T is the target user's cardiac cycle. Then, it compares the left ventricular pressure from n consecutive samples. If the left ventricular pressure from the n samples gradually increases over time, it determines that the current left ventricle is in the systolic phase; if the left ventricular pressure from the n samples gradually decreases over time, it determines that the current left ventricle is in the diastolic phase. Similarly, it compares the right ventricular pressure from n consecutive samples. If the right ventricular pressure from the n samples gradually increases over time, it determines that the current right ventricle is in the systolic phase; if the right ventricular pressure from the n samples gradually decreases over time, it determines that the current right ventricle is in the diastolic phase. Here, n can be set to 2, 3, 4, 5, etc.

[0059] The step of adjusting the first left rotation speed based on the first left flow rate and the left cardiac cycle includes: if the left cardiac cycle is in the systolic phase and the first left flow rate is less than or equal to a first threshold, then the first left rotation speed is decreased; if the left cardiac cycle is in the diastolic phase and the first left flow rate is less than or equal to the first threshold, then the first left rotation speed is increased.

[0060] When the left ventricle is in the systolic phase, if the flow rate pumped by the left ventricular assist device (LVAD) at the first moment is less than or equal to the first threshold at the first left rotation speed, it indicates that the blood volume in the left ventricle is too low at the first moment. Continuing to operate the LVAD at the first left rotation speed may cause left ventricular aspiration and collapse. Therefore, the control device can control the LVAD to reduce the first left rotation speed until the flow rate pumped by the LVAD exceeds the first threshold. Similarly, when the right ventricle is in the systolic phase, if the flow rate pumped by the right ventricular assist device (LVAD) at the first moment is less than or equal to the first threshold at the first right rotation speed, it indicates that the blood volume in the right ventricle is too low at the first moment. Continuing to operate the LVAD at the first right rotation speed may cause right ventricular aspiration and collapse. Therefore, the control device can control the right ventricular assist device to reduce the first right rotation speed until the flow rate pumped by the right ventricular assist device exceeds the first threshold, preventing aspiration problems during systole.

[0061] The step of adjusting the first right rotation speed based on the first right flow rate and the right cardiac cycle includes: if the right cardiac cycle is in the systolic phase and the first right flow rate is less than or equal to a second threshold, then the first right rotation speed is decreased; if the right cardiac cycle is in the diastolic phase and the first right flow rate is less than or equal to the second threshold, then the first right rotation speed is increased.

[0062] When the left ventricle is in diastole, if the flow rate pumped by the left ventricular assist device (LVAD) at the first moment is less than or equal to the second threshold at the first left rotation speed, it indicates that blood is flowing back from the artificial blood vessel to the left ventricle via the LVAD. Therefore, the control device can increase the first left rotation speed of the LVAD until the flow rate pumped by the LVAD exceeds the first threshold, thus pumping blood from the left ventricle to the aorta. Similarly, when the right ventricle is in diastole, if the flow rate pumped by the right ventricular assist device (LVAD) at the first moment is less than or equal to the first threshold at the first right rotation speed, it indicates that blood is flowing back from the artificial blood vessel to the right ventricle via the LVAD. Therefore, the control device can increase the first right rotation speed of the LVAD until the flow rate pumped by the LVAD exceeds the first threshold, thus pumping blood from the right ventricle to the pulmonary artery, preventing backflow during diastole.

[0063] The first threshold and the second threshold can be the same, such as both being set to 0; or the first threshold and the second threshold can be different, such as the first threshold being set to 0.5 L / min and the second threshold being set to 0.

[0064] It should be noted that the control device can simultaneously control the left ventricular assist device and the right ventricular assist device to reduce their rotation speed during systole, and can also simultaneously control the left ventricular assist device and the right ventricular assist device to increase their rotation speed during diastole.

[0065] As can be seen, this application proposes a method for controlling the rotation speed of a ventricular assist device (VAD). It acquires a first left ventricular pressure and a first right ventricular pressure. The first left ventricular pressure is the left ventricular pressure of the target user at a first moment when the VAD is running at a first left rotation speed, and the first right ventricular pressure is the right ventricular pressure of the target user at a first moment when the VAD is running at a first right rotation speed. The first left rotation speed and / or the first right rotation speed are adjusted based on the first left and first right ventricular pressures to maintain a balance between the fluid output of the left and right ventricles. This application determines whether the fluid output of the user's left and right ventricles is balanced by real-time detection of ventricular pressure. If there is an imbalance, the rotation speed of the VAD and / or the VAD is adjusted to regulate the fluid output of the left or right ventricle, ensuring a balance between the user's systemic and pulmonary circulation flow and preventing aspiration and regurgitation problems in the left or right ventricle.

[0066] 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.

[0067] For example, this application provides a control circuit including one or more processors, the one or more processors being configured to: acquire a first left ventricular pressure and a first right ventricular pressure, the first left ventricular pressure being the left ventricular pressure of a target user at a first moment when the left ventricular assist device is running at a first left rotation speed, and the first right ventricular pressure being the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at a first right rotation speed; and adjust the first left rotation speed and / or the first right rotation speed according to the first left ventricular pressure and the first right ventricular pressure to maintain a balance between the fluid output of the left ventricle and the fluid output of the right ventricle.

[0068] For example, this application also provides a ventricular assist system, comprising: a left ventricular assist device for pumping fluid from the left ventricle of a target user to the aorta; a right ventricular assist device for pumping fluid from the right ventricle of the target user to the pulmonary artery; and a control device communicatively connected to the left ventricular assist device and the right ventricular assist device, the control device being configured to: acquire a first left ventricular pressure and a first right ventricular pressure, the first left ventricular pressure being the left ventricular pressure of the target user at a first moment when the left ventricular assist device is running at a first left rotation speed, and the first right ventricular pressure being the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at a first right rotation speed; and adjust the first left rotation speed and / or the first right rotation speed according to the first left ventricular pressure and the first right ventricular pressure to maintain a balance between the fluid output of the left ventricle and the fluid output of the right ventricle.

[0069] For example, this application also provides a medical device that includes the control circuit or ventricular assist system described above.

[0070] The control circuits of the above-mentioned schemes have the function of implementing the corresponding steps performed by the medical device in the above-mentioned methods; the function can be implemented by hardware or by hardware executing corresponding software.

[0071] In embodiments of this application, the control circuit may also be a chip or a chip system, such as a system on chip (SoC).

[0072] Please see Figure 3 , Figure 3 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.

[0073] The above procedure includes instructions for performing the following steps: acquiring a first left ventricular pressure and a first right ventricular pressure, wherein the first left ventricular pressure is the left ventricular pressure of the target user at a first moment when the left ventricular assist device is running at a first left rotation speed, and the first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at a first right rotation speed; adjusting the first left rotation speed and / or the first right rotation speed according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle balanced with the fluid output of the right ventricle.

[0074] 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.

[0075] 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.

[0076] In the embodiments of this application, the processor of the above-described device may be a Central Processing Unit (CPU), which may also 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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 ventricular assist system, characterized in that, The ventricular assist system includes: A left ventricular assist device used to pump fluid from the target user's left ventricle to the aorta; A right ventricular assist device used to pump fluid from the right ventricle of a target user to the pulmonary artery; A control device communicatively connected to the left ventricular assist device and the right ventricular assist device, the control device being used for: The first left ventricular pressure and the first right ventricular pressure are obtained. The first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed. The first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed. The first left rotation speed and / or the first right rotation speed are adjusted according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle. The control device is further configured to: determine the left cardiac cycle and the right cardiac cycle based on the first left ventricular pressure and the first right ventricular pressure, respectively, wherein the left cardiac cycle is the cardiac cycle in which the left ventricle is located at the first moment, and the right cardiac cycle is the cardiac cycle in which the right ventricle is located at the first moment; and determine the first left flow rate corresponding to the first left ventricular pressure and the first right flow rate corresponding to the first right ventricular pressure based on the flow-pressure curves, respectively. If the left cardiac cycle is in the systolic phase and the first left flow is less than or equal to the first threshold, then the first left rotation speed is decreased; if the left cardiac cycle is in the diastolic phase and the first left flow is less than or equal to the first threshold, then the first left rotation speed is increased. If the right cardiac cycle is in the systolic phase and the first right flow is less than or equal to the second threshold, then the first right rotation speed is decreased; if the right cardiac cycle is in the diastolic phase and the first right flow is less than or equal to the second threshold, then the first right rotation speed is increased.

2. The ventricular assist system according to claim 1, characterized in that, In adjusting the first left rotational speed and / or the first right rotational speed according to the first left ventricular pressure and the first right ventricular pressure, the control device is used to: Calculate the first right mean pressure value and the first left mean pressure value. The first left mean pressure value is the average pressure of the left ventricle within the first time period. The first right mean pressure value is the average pressure of the right ventricle within the first time period. The first moment is within the first time period. The first right mean pressure value is compared with the second right mean pressure value, and the first left mean pressure value is compared with the second left mean pressure value to determine whether to increase or decrease the first left rotation speed and / or the first right rotation speed. The second right mean pressure value is the average pressure of the right ventricle during the second time period, and the second left mean pressure value is the average pressure of the left ventricle during the second time period. The second time period is later than the first time period.

3. The ventricular assist system according to claim 2, characterized in that, The step of comparing the first right average pressure value with the second right average pressure value and the first left average pressure value with the second left average pressure value to determine whether to increase or decrease the first left rotational speed and / or the first right rotational speed includes: If the first right average pressure value is greater than the second right average pressure value, and the first left average pressure value is less than the second left average pressure value, then reduce the first left rotation speed; If the first right average pressure value is greater than the second right average pressure value, and the first left average pressure value is greater than or equal to the second left average pressure value, increase the first right rotation speed; If the first right average pressure value is less than the second right average pressure value, and the first left average pressure value is less than or equal to the second left average pressure value, then reduce the first right rotation speed; If the first right average pressure value is less than the second right average pressure value, and the first left average pressure value is greater than the second left average pressure value, then the first right rotation speed is increased.

4. The ventricular assist system according to claim 1, characterized in that, The step of determining the left cardiac cycle and the right cardiac cycle based on the first left ventricular pressure and the first right ventricular pressure, respectively, includes: Calculate the left pressure differential and the right pressure differential. The left pressure differential is the difference between the first left ventricular pressure and the second left ventricular pressure. The second left ventricular pressure is the left ventricular pressure of the target user at a second moment when the left ventricular assist device is running at a first left rotation speed. The right pressure differential is the difference between the first right ventricular pressure and the second right ventricular pressure. The second right ventricular pressure is the right ventricular pressure of the target user at a second moment when the right ventricular assist device is running at a first right rotation speed. The second moment is earlier than the first moment. If the left pressure differential is greater than a preset value, then the left cardiac cycle is determined to be in the systolic phase; otherwise, the left cardiac cycle is in the diastolic phase. If the right pressure differential is greater than the preset value, then the right cardiac cycle is determined to be in the systolic phase; otherwise, the right cardiac cycle is in the diastolic phase.

5. The ventricular assist system according to claim 4, characterized in that, The difference between the first time point and the second time point is less than the contraction time and relaxation time of the target user.

6. The ventricular assist system according to any one of claims 1-4, characterized in that, The speed increment for increasing or decreasing the first left speed and the first right speed is 20 RPM.

7. A control circuit, characterized in that, The control circuit includes one or more processors, the one or more processors being used for: The first left ventricular pressure and the first right ventricular pressure are obtained. The first left ventricular pressure is the left ventricular pressure of the target user at the first moment when the left ventricular assist device is running at the first left rotation speed. The first right ventricular pressure is the right ventricular pressure of the target user at the first moment when the right ventricular assist device is running at the first right rotation speed. The first left rotation speed and / or the first right rotation speed are adjusted according to the first left ventricular pressure and the first right ventricular pressure to keep the fluid output of the left ventricle in balance with the fluid output of the right ventricle. The processor is further configured to: determine the left cardiac cycle and the right cardiac cycle based on the first left ventricular pressure and the first right ventricular pressure, respectively, wherein the left cardiac cycle is the cardiac cycle in which the left ventricle is located at the first moment, and the right cardiac cycle is the cardiac cycle in which the right ventricle is located at the first moment; and determine the first left flow rate corresponding to the first left ventricular pressure and the first right flow rate corresponding to the first right ventricular pressure based on the flow-pressure curves, respectively. If the left cardiac cycle is in the systolic phase and the first left flow is less than or equal to the first threshold, then the first left rotation speed is decreased; if the left cardiac cycle is in the diastolic phase and the first left flow is less than or equal to the first threshold, then the first left rotation speed is increased. If the right cardiac cycle is in the systolic phase and the first right flow is less than or equal to the second threshold, then the first right rotation speed is decreased; if the right cardiac cycle is in the diastolic phase and the first right flow is less than or equal to the second threshold, then the first right rotation speed is increased.

8. A medical device, characterized in that, The system includes a processor, a memory, and a communication interface. The memory stores one or more programs, which are executed by the processor. The one or more programs include instructions for performing steps performed by the control device in any one of claims 1-6.

9. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program for electronic data exchange, wherein the computer program causes a computer to perform steps performed by a control device in any one of claims 1-6.

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