Self-adaptive control method and device of double-ventricle auxiliary system

Abstract

The invention provides a self-adaptive control method and device for a double-ventricle auxiliary system. The method comprises the steps that target aortic pressure detected by a first pressure sensor, target left ventricular end diastolic pressure detected by a second pressure sensor, target right atrial pressure detected by a third pressure sensor and target pulmonary artery pressure detected by a fourth pressure sensor are obtained; and determining a strategy for adjusting the left ventricular assist device or the right ventricular assist device according to the target left ventricular end diastolic pressure, the target right ventricular pressure and the target pulmonary arterial pressure when the peripheral perfusion of the target user is insufficient or the lung is over-perfused. The pressure sensors are arranged to detect the pressure of the inlets and the outlets of the left ventricular assist device and the right ventricular assist device, whether adverse events such as peripheral insufficiency or pulmonary hyperperfusion occur to a user or not is judged according to the detected pressure, and then the adverse events are relieved or even solved by adjusting the rotating speeds of the left ventricular assist device and the right ventricular assist device. And the safety of the user is greatly improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a self-adaptive control method and device of a biventricular assist system. BACKGROUND

[0002] A ventricular assist device (VAD) can be used to assist the heart of a subject suffering from a condition impairing the heart's pumping ability. The provision of assistance provided by a VAD can allow the heart to heal, and the VAD assists the heart in pumping blood by pumping on either side or both sides of the patient's heart. For example, for a condition impairing the heart's ability to pump blood into the systemic circulation on the left side, a left ventricular assist device can be provided for the patient; for a condition impairing the heart's ability to pump blood into the pulmonary circulation on the right side, a right ventricular assist device can be provided for the patient; and for a condition impairing both sides of the heart, a biventricular assist device can be provided for the patient.

[0003] The condition of the patient can cause the left side and the right side of the heart to have different output amounts, and the mismatch between the left heart output and the right heart output can cause adverse events such as suction, insufficient perfusion, and pulmonary edema. Therefore, how to timely adjust the operation of the ventricular assist device to reduce the occurrence of adverse events during the operation of the biventricular assist device is an urgent problem to be solved. SUMMARY

[0004] Embodiments of the present application provide a self-adaptive control method and device of a biventricular assist system, which can reduce the occurrence of adverse events of a user.

[0005] In a first aspect, the embodiments of the present application provide a self-adaptive control method of a biventricular assist system, the biventricular assist system comprising a left ventricular assist device for implanting into a left heart of a target user, a right ventricular assist device for implanting into a right heart of the target user, a first pressure sensor and a second pressure sensor respectively arranged at an inlet and an outlet of the left ventricular assist device, and a third pressure sensor and a fourth pressure sensor respectively arranged at an inlet and an outlet of the right ventricular assist device; the method comprising:

[0006] obtaining a target aortic pressure detected by the first pressure sensor, a target left ventricular end diastolic pressure detected by the second pressure sensor, a target right atrial pressure detected by the third pressure sensor, and a target pulmonary artery pressure detected by the fourth pressure sensor;

[0007] determining whether the target user has peripheral insufficient perfusion or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure, and the target pulmonary artery pressure;

[0008] determine a strategy for adjusting the left ventricular assist device or the right ventricular assist device based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure when the target user is experiencing peripheral underperfusion or pulmonary overperfusion.

[0009] In a second aspect, the embodiments of the present application provide a controller of a biventricular assist system, the biventricular assist system further comprising a left ventricular assist device for implanting into a left heart of a target user, a right ventricular assist device for implanting into a right heart of the target user, a first pressure sensor and a second pressure sensor respectively arranged at outlets of the left ventricular assist device, and a third pressure sensor and a fourth pressure sensor respectively arranged at outlets of the right ventricular assist device, the controller comprising one or more processors, the one or more processors being configured to:

[0010] obtain a target aortic pressure detected by the first pressure sensor, a target left ventricular end-diastolic pressure detected by the second pressure sensor, a target right atrial pressure detected by the third pressure sensor, and a target pulmonary artery pressure detected by the fourth pressure sensor;

[0011] determine whether the target user is experiencing peripheral underperfusion or pulmonary overperfusion based on the target aortic pressure, the target left ventricular end-diastolic pressure, and the target pulmonary artery pressure;

[0012] determine a strategy for adjusting the left ventricular assist device or the right ventricular assist device based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure when the target user is experiencing peripheral underperfusion or pulmonary overperfusion.

[0013] In a third aspect, the embodiments of the present application provide a ventricular assist device, characterized in that the ventricular assist device comprises:

[0014] a left ventricular assist device for implanting into a left heart of a target user;

[0015] a right ventricular assist device for implanting into a right heart of the target user;

[0016] a first pressure sensor and a second pressure sensor respectively arranged at outlets of the left ventricular assist device;

[0017] a third pressure sensor and a fourth pressure sensor respectively arranged at outlets of the right ventricular assist device;

[0018] a controller in communication connection with the left ventricular assist device and the right ventricular assist device, the controller being configured to execute instructions for part or all of the steps described in the method of the first aspect.

[0019] In a fourth aspect, an embodiment of the present application provides a medical device, the medical device comprising a processor, a memory, a communication interface, and one or more programs stored in the memory and configured to be executed by the processor, the program comprising instructions for performing some or all of the steps described in the method of the first aspect.

[0020] In a fifth aspect, an embodiment of the present application provides a computer readable storage medium storing a computer program for electronic data exchange, wherein the computer program causes a computer to perform some or all of the steps described in the method of the first aspect.

[0021] In a sixth aspect, an embodiment of the present application provides a computer program product, wherein the above computer program product includes a non-transitory computer-readable storage medium storing a computer program, and the computer program is operable to cause a computer to perform some or all of the steps described in the method of the first aspect of the present application. The computer program product can be a software installation package.

[0022] The technical solution provided in the present application obtains a target aortic pressure detected by a first pressure sensor, a target left ventricular end diastolic pressure detected by a second pressure sensor, a target right atrial pressure detected by a third pressure sensor, and a target pulmonary artery pressure detected by a fourth pressure sensor; determines whether the target user suffers from peripheral perfusion deficiency or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure, and the target pulmonary artery pressure; and determines an adjustment strategy for the left ventricular assist device or the right ventricular assist device according to the target left ventricular end diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure when the target user suffers from peripheral perfusion deficiency or pulmonary overperfusion. The present application detects the pressures at the inlets and outlets of the left and right ventricular assist devices by setting multiple pressure sensors, determines whether the user suffers from the adverse events of peripheral perfusion deficiency or pulmonary overperfusion according to the detected pressures, and then adjusts the rotation speeds of the left and right ventricular assist devices to relieve or even solve the occurrence of adverse events, which can prevent the user from suffering from adverse events such as suction, perfusion deficiency, and pulmonary overperfusion in long-term management, and greatly improves the safety of the user. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings described in the following are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without any creative effort.

[0024] Figure 1 is a schematic diagram of a biventricular assist system provided by an embodiment of the present application;

[0025] Figure 2 is a flowchart of an adaptive control method of a biventricular assist system provided by an embodiment of the present application.

[0026] Figure 3 is a structural schematic diagram of a medical device provided by an embodiment of the present application. DETAILED DESCRIPTION

[0027] In order for those skilled in the art to better understand the technical solutions of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the description of the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the present application.

[0028] The terms "first", "second", and the like in the specification and claims of the present application and the above-described drawings are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, software, product, or device 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 the process, method, product, or device.

[0029] Reference to "an embodiment" in this document means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present application. The appearance of the phrase in various places in the specification does not necessarily all refer to the same embodiment, nor is it necessarily independent or alternative to other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0030] The medical device and the pump involved in the present application can be a ventricular assist device, such as an implantable ventricular assist device, an interventional ventricular assist device, etc. The ventricular assist device can include at least one blood pump, wherein the blood pump can be a centrifugal pump, an axial flow pump, a magnetic suspension pump, etc.

[0031] "Rotational speed" in the present application refers to the rotational speed of a motor or an electric motor, which is associated with the rotational speed of a rotor or an impeller of a ventricular assist device, and can be defined as revolutions per minute.

[0032] Please refer to Figure 1 , Figure 1The dual ventricular assist system comprises a left ventricular assist device, a right ventricular assist device and a controller. The left ventricular assist device is arranged in the left ventricle of the user to pump blood from the left ventricle of the user to the aorta; and the right ventricular assist device is arranged in the right ventricle of the user to pump blood from the right ventricle of the user to the pulmonary artery.

[0033] From the flow direction of the blood of the user, the fluid systems are arranged in series with each other, the blood flows to the lung through the pulmonary artery, the lung system is in direct fluid communication with the left ventricle, and after the blood in the lung is oxygenated, the blood returns to the left ventricle. The blood is then pumped from the left ventricle into the aorta, and the blood in the aorta flows through the vascular system of the user to the right ventricle. Therefore, the blood forms a fluid circulation in the pulmonary artery, the right ventricle, the left ventricle and the aorta in turn. The flow direction of the blood from the right ventricle to the pulmonary artery is called pulmonary circulation, and the flow direction of the blood from the left ventricle to the aorta is called systemic circulation.

[0034] The left ventricular assist device acts on the left heart, which can be arranged on the apex of the left ventricle, and the fluid inlet is located in the left ventricle of the user, and the fluid outlet is connected to the aorta of the user. The left ventricular assist device can also cross the aortic valve of the user, so that the proximal end is located in the aorta of the user and the distal end is located in the left ventricle of the user, thereby pumping the blood in the left ventricle of the user into the aorta. The right ventricular assist device acts on the right heart, which can be arranged on the right atrium, and the fluid inlet is located in the right atrium of the user, and the fluid outlet is connected to the pulmonary artery of the user; or the right ventricular assist device can cross the pulmonary valve of the user, so that the proximal end is located in the pulmonary artery of the user and the distal end is located in the right ventricle of the user, thereby pumping the blood in the right ventricle of the user into the pulmonary artery, thereby realizing the circulation of the blood.

[0035] For example, the left ventricular assist device can be attached to the apex position of the left ventricle of the heart via a ventricular connection assembly (such as a top ring, a ventricular cuff, a ventricular sleeve), which can be sutured to the apex of the left ventricle of the heart and coupled to the left ventricular assist device, and the other end of the left ventricular assist device can be connected to the aorta via an outlet tube and / or an artificial blood vessel connected to the outlet tube, so that the left ventricular assist device can effectively divert the blood from the weakened left ventricle and push it into the aorta, thereby circulating to the remaining part of the vascular system of the patient, thereby providing ventricular assist function for the user. Similarly, the right ventricular assist device can also be attached to the position of the right atrium of the heart via a ventricular connection assembly, thereby providing ventricular assist function for the user.

[0036] The left ventricular assist device and the right ventricular assist device are connected to a controller arranged outside the body through a percutaneous cable for controlling the operation of the left ventricular assist device and the right ventricular assist device. The controller is used to realize the independent driving of the left ventricular assist device and the right ventricular assist device, but the control is coordinated with each other, the blood flow has a predetermined relationship with each other, and the fluid flow pumped by the ventricular assist device is related to the blood volume and pressure in the ventricle, so that the change of the fluid flow of one ventricular assist device will cause the corresponding change of the fluid flow of the other ventricular assist device. For example, the increase of the rotation speed of the left ventricular assist device, the decrease of the blood volume in the left ventricle and the decrease of the pressure in the left ventricle make the blood in the lung flow to the left ventricle, thereby reducing the pressure in the pulmonary artery. The decrease of the pressure in the pulmonary artery reduces the pressure difference between the pulmonary artery and the right ventricle, so that the blood in the right ventricle can be better pumped into the pulmonary artery.

[0037] The biventricular assist system can further comprise a plurality of pressure sensors, which can be arranged on the inner surface of the fluid inlet and outlet of the left ventricular assist device and the right ventricular assist device respectively, for measuring the left heart pressure and the right heart pressure of the patient in real time. For example, a first pressure sensor is arranged on the inner surface of the fluid outlet of the left ventricular assist device, which can measure the fluid outlet pressure of the left ventricular assist device, and the outlet pressure is about 15 mmHg greater than the aortic pressure. The average pressure measured by the first pressure sensor in a cardiac cycle is subtracted by 15 mmHg to obtain the aortic pressure of the patient. A second pressure sensor is arranged on the inner surface of the fluid inlet of the left ventricular assist device, which is used to measure the fluid inlet pressure of the left ventricular assist device, and the inlet pressure can represent the left ventricular pressure of the patient. The minimum pressure measured by the second pressure sensor in a cardiac cycle is taken as the left ventricular end diastolic pressure of the patient. A third pressure sensor is arranged on the inner surface of the fluid inlet of the right ventricular assist device, which can measure the fluid inlet pressure of the left ventricular assist device, and the average pressure measured by the third pressure sensor in a cardiac cycle is taken as the right atrial pressure of the patient. A fourth pressure sensor is arranged on the inner surface of the fluid outlet of the right ventricular assist device, and the outlet pressure is about 20 mmHg less than the pulmonary artery pressure. The average pressure measured by the fourth pressure sensor in a cardiac cycle is added by 20 mmHg to obtain the pulmonary artery pressure of the patient. Alternatively, in order to improve the accuracy of the measurement of the pulmonary artery pressure, a fourth pressure sensor can be arranged on the inner surface of the outlet of the artificial blood vessel of the right ventricular assist device, which is used to directly measure the pulmonary artery pressure of the patient.

[0038] In combination with the above description, the present application will be described below from the perspective of method examples.

[0039] Please refer to Figure 2 , Figure 2 A flow chart of an adaptive control method of a biventricular assist system provided by an embodiment of the present application is shown in the figure, which is applied to the biventricular assist system as shown inFigure 1 The biventricular assist system is shown. As Figure 2 The method includes the following steps.

[0040] S210, acquiring the target aortic pressure detected by the first pressure sensor, the target left ventricular end diastolic pressure detected by the second pressure sensor, the target right atrial pressure detected by the third pressure sensor, and the target pulmonary artery pressure detected by the fourth pressure sensor.

[0041] Among them, after the biventricular assist system is started, the first pressure sensor, the second pressure sensor, the third pressure sensor and the fourth pressure sensor can detect in real time, and send the detected pressure value to the controller, which is processed and displayed by the controller.

[0042] The controller receives the feedback pressure value in real time, and analyzes and processes the pressure value in each cycle. The cycle can be the cardiac cycle of the target user; it can also be a fixed value set in advance, such as 1s, 2s, 5s, etc. The controller calculates the average value of the pressure value of the first pressure sensor in the cycle, and takes the average value as the target aortic pressure of the target user. The minimum pressure value of the second pressure sensor in the cycle is taken as the left ventricular end diastolic pressure of the target user. At the same time, the controller calculates the average value of the pressure value of the third pressure sensor in the cycle, and takes the average value as the target right atrial pressure of the target user, and takes the average value of the pressure value of the fourth pressure sensor in the cycle as the target pulmonary artery pressure of the target user. With the cycle as a sliding window, the controller can obtain the aortic pressure, left ventricular end diastolic pressure, right atrial pressure and pulmonary artery pressure of the target user in each cycle.

[0043] S220, judging whether the target user has peripheral perfusion deficiency or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure and the target pulmonary artery pressure.

[0044] Peripheral perfusion deficiency refers to the reduction of blood supply or the slowing of blood flow in the body periphery (mainly the skin, subcutaneous tissue and extremities). Peripheral perfusion deficiency can cause changes in the pumping flow of the ventricular assist device and changes in the pressure of the blood vessels and heart of the target user. The overall blood flow of the target user, left heart congestion, right heart congestion, and pulmonary congestion can all cause the target user to have peripheral perfusion deficiency. In some cases, adjusting the speed of the left ventricular assist device or the right ventricular assist device can alleviate or even solve the problem of peripheral perfusion deficiency of the target user.

[0045] Pulmonary overperfusion refers to an abnormal increase in blood flow in a certain area of the lung or the entire lung, which exceeds the normal physiological demand or alveolar ventilation. Pulmonary overperfusion can also cause changes in the pumping flow of the ventricular assist device and the pressure changes in the blood vessels and heart of the target user. The overall excessive blood flow of the target user, left heart congestion, right heart congestion, and problems in the pulmonary blood vessels can all cause pulmonary overperfusion in the target user. In some cases, the problem of pulmonary overperfusion in the target user can be alleviated or even solved by adjusting the speed of the left ventricular assist device or the right ventricular assist device.

[0046] In the long-term management of patients after biventricular assist system implantation, the mismatch between the left ventricular assist device and / or the right ventricular assist device and the needs of the patient can cause adverse problems such as insufficient suction, perfusion, and pulmonary edema. The present application sets up pressure sensors to detect the pressure at each position, and then determines the cause of peripheral perfusion deficiency or pulmonary overperfusion according to the pressure changes at each position, and then determines the speed of the left ventricular assist device and the right ventricular assist device according to the cause, thereby alleviating or even solving the problem.

[0047] Optionally, the determination of whether the target user is suffering from peripheral perfusion deficiency or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure, and the target pulmonary artery pressure comprises: if the target aortic pressure is less than a preset aortic pressure threshold, it is determined that the target user is suffering from peripheral perfusion deficiency; and if the target aortic pressure is less than the preset aortic pressure threshold, the target pulmonary artery pressure is greater than the upper limit of a preset pulmonary artery range, and the target left ventricular end diastolic pressure is greater than the upper limit of a preset left ventricular end diastolic pressure range, it is determined that the target user is suffering from pulmonary overperfusion.

[0048] The preset aortic pressure threshold can be set as the lower limit of the range of aortic pressure of a normal person, the preset pulmonary artery range can be set as the range of pulmonary artery pressure of a normal person, and the preset left ventricular end diastolic pressure range can be set as the range of left ventricular end diastolic pressure of a normal person. For example, the average value of aortic pressure of a normal person in a cardiac cycle is in the range of 70-100 mmHg, the pulmonary artery pressure is in the range of 9-118 mmHg, and the preset left ventricular end diastolic pressure range is 5-12 mmHg. The preset aortic pressure threshold can be set as 70 mmHg, the upper limit of the preset pulmonary artery pressure range is 18 mmHg, and the preset left ventricular end diastolic range is 12 mmHg.

[0049] Aortic pressure refers to the pressure generated by blood flowing in the aorta against the vessel wall, which is a key indicator of systemic blood pressure and cardiac afterload. Mean arterial pressure (MAP) is critical to maintain blood flow to vital organs such as the heart, brain, and kidneys. When aortic pressure is less than the lower limit of the range of the average aortic pressure of normal people, it can lead to organ ischemia, i.e., peripheral perfusion insufficiency. Therefore, when the target aortic pressure is less than the preset aortic pressure threshold, it is considered that the current target patient has peripheral perfusion insufficiency. If the target aortic pressure is greater than the preset aortic pressure threshold, it can be further determined whether the target user has a problem of pulmonary overperfusion when the peripheral perfusion is sufficient.

[0050] When the target aortic pressure is greater than the preset aortic pressure threshold, the controller compares the target pulmonary artery pressure and the left ventricular end-diastolic pressure. If the target pulmonary artery pressure is greater than the upper limit of the preset pulmonary artery range and the target left ventricular end-diastolic pressure is greater than the upper limit of the preset left ventricular end-diastolic pressure range, it is determined that the current target user has a problem of pulmonary overperfusion.

[0051] S230, when the target user has peripheral perfusion insufficiency or pulmonary overperfusion, determining a strategy for adjusting the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

[0052] When it is determined that the target user has peripheral perfusion insufficiency or pulmonary overperfusion, the controller can further determine the cause of peripheral perfusion insufficiency or pulmonary overperfusion according to the pressure of each part, and then determine whether the cause of peripheral perfusion insufficiency or pulmonary overperfusion can be alleviated or eliminated by adjusting the speed of the left ventricular assist device or the right ventricular assist device.

[0053] Optionally, the determining a strategy for adjusting the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure comprises: determining whether the overall blood volume of the target user is abnormal according to the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure; if the overall blood volume of the target user is abnormal, directly alarming; otherwise, increasing or decreasing the speed of the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

[0054] The reasons for peripheral perfusion insufficiency of the target user include: insufficient blood volume, such as insufficient overall blood volume of the target user; and blood accumulation in other parts and unable to circulate to the periphery of the body in time, such as blood accumulation in the left heart, blood accumulation in the right heart, and blood accumulation in the lungs. The reasons for lung overperfusion of the target user include: excessive blood volume, such as excessive overall blood volume of the target user; and high pulmonary capillary wedge pressure (PCWP), such as blood accumulation in the left heart or the right heart pumping blood too fast to cause high PCWP.

[0055] When peripheral perfusion insufficiency or lung overperfusion occurs due to abnormalities such as insufficient or excessive overall blood volume of the target user, adjusting the speed of the left ventricular assist device or the right ventricular assist device cannot solve the problem. Therefore, when it is confirmed that the overall blood volume of the target user is insufficient, an alarm is directly given to prompt the user that the current blood volume is insufficient or excessive, and medical treatment is needed as soon as possible. When peripheral perfusion insufficiency or lung overperfusion occurs due to left heart or right heart accumulation, the controller can adjust the speed of the left ventricular assist device or the right ventricular assist device to alleviate or even solve the accumulation problem.

[0056] The method comprises: determining whether the overall blood volume of the target user is abnormal according to the target left ventricular end diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure. If the target right atrial pressure is less than the upper limit of a preset right atrial pressure range, the target left ventricular end diastolic pressure is less than the lower limit of a preset left ventricular end diastolic pressure range, and the target pulmonary artery pressure is less than the lower limit of a preset pulmonary artery pressure range, it is determined that the overall blood volume of the target user is insufficient. If the target right atrial pressure is greater than the upper limit of the preset right atrial pressure range, and the target left ventricular end diastolic pressure is greater than the upper limit of the preset left ventricular end diastolic pressure range, it is determined that the overall blood volume of the target user is excessive.

[0057] When peripheral perfusion insufficiency occurs due to insufficient overall blood volume, the pressure of each part will decrease accordingly due to the decrease in blood volume. Therefore, when the target right atrial pressure is less than the upper limit of a preset right atrial pressure range (indicating insufficient right heart blood volume), the target left ventricular end diastolic pressure is less than the lower limit of a preset left ventricular end diastolic pressure range (indicating insufficient right heart blood volume), and the target pulmonary artery pressure is less than the lower limit of a preset pulmonary artery pressure range (indicating that blood is not accumulated in the lungs), it is considered that the overall blood volume of the target user is insufficient. When lung overperfusion occurs due to excessive overall blood volume, the pressure of each part will increase accordingly due to the increase in blood volume. Therefore, when the target right atrial pressure is greater than the upper limit of a preset right atrial pressure range (excessive right heart blood volume), and the target left ventricular end diastolic pressure is greater than the upper limit of a preset left ventricular end diastolic pressure range (excessive left heart blood volume), it is determined that the overall blood volume of the target user is excessive.

[0058] In an example, when the target user is in peripheral perfusion deficiency, the increasing or decreasing the rotation speed of the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure and the target pulmonary artery pressure comprises: if a first ratio is greater than a first preset value, increasing the rotation speed of the left ventricular assist device, the first ratio being a ratio of the target left ventricular end-diastolic pressure to the target right atrial pressure; if the first ratio is less than or equal to the first preset value and a second ratio is less than or equal to a second preset value, increasing the rotation speed of the right ventricular assist device, the second ratio being a ratio of the target pulmonary artery pressure to the target right atrial pressure.

[0059] In an example, the first preset value can be a ratio of an upper limit of the left ventricular end-diastolic pressure of a normal person to an upper limit of the right atrial pressure, and the second preset value can be a ratio of an upper limit of the pulmonary artery pressure of a normal person to the upper limit of the right atrial pressure.

[0060] When the current target user is in peripheral perfusion deficiency due to left heart congestion or right heart congestion, the controller can relieve or solve the peripheral perfusion deficiency problem by adjusting the rotation speed of the left ventricular assist device or the right ventricular assist device. In the case of left heart congestion, the excessive blood volume in the left ventricle causes the left ventricular pressure to increase, and the pumping flow of the left ventricular assist device decreases. Therefore, when the target left ventricular end-diastolic pressure exceeds the range of the left ventricular end-diastolic pressure of a normal person, it can be considered that the current target user is currently in peripheral perfusion deficiency due to left heart congestion. In order to exclude individual differences of patients, the controller can calculate a first ratio between the target left ventricular end-diastolic pressure and the target right atrial pressure, and if the first ratio is greater than a first preset value, it is determined that the current left heart is congested. In the case of left ventricular congestion, the controller can increase the rotation speed of the left ventricular assist device to speed up the pumping of blood in the left ventricle to the aorta, so as to relieve the degree of congestion in the left ventricle.

[0061] When the first ratio is less than or equal to the first preset value, i.e., the current left heart of the target user is not congested, the controller further determines whether the right heart is congested. In the case of right heart congestion, the excessive blood volume in the right atrium causes the right atrial pressure to increase, and the pumping flow of the right ventricular assist device decreases. Therefore, when the target right atrial pressure exceeds the range of the right atrial pressure of a normal person, it can be considered that the current target user is currently in peripheral perfusion deficiency due to right heart congestion. In order to exclude individual differences of patients, the controller can calculate a second ratio between the target pulmonary artery pressure and the target right atrial pressure, and if the second ratio is greater than a second preset value, it is determined that the current right heart is congested. In the case of right ventricular congestion, the controller can increase the rotation speed of the right ventricular assist device to speed up the pumping of blood in the right atrium to the pulmonary artery, so as to relieve the degree of congestion in the right atrium.

[0062] When the target user is determined to have left heart or right heart congestion, the controller increases the rotational speed of the left ventricular assist device or the right ventricular assist device by a preset rotational speed step. After the rotational speed is increased again, the controller determines whether the target user still has peripheral perfusion deficiency according to the pressure values of each part of the next sliding window, and according to this method, until an alarm occurs or the target user does not have peripheral perfusion deficiency or pulmonary overperfusion. The preset rotational speed step can be set to 50 RPM, 100 RPM, 200 RPM, etc.

[0063] For example, when the target user has pulmonary overperfusion, the increasing or decreasing the rotational speed of the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure and the target pulmonary artery pressure comprises: if the first ratio is greater than the first preset value, increasing the rotational speed of the left ventricular assist device; if the first ratio is less than or equal to the first preset value and the first ratio is less than or equal to a third preset value, decreasing the rotational speed of the right ventricular assist device.

[0064] When the PCWP of the target user is too high, there is a risk of pulmonary overperfusion. An increase in left ventricular end-diastolic pressure will cause an increase in left atrial pressure, and in turn an increase in pulmonary vein pressure, which will increase PCWP. An increase in the pumping flow of the right ventricular assist device will increase the blood flow into the pulmonary artery, thereby increasing the pressure in the lungs. When it is determined that the current target user has pulmonary overperfusion and it is not caused by excessive overall blood flow, the controller can determine the cause of the pulmonary overperfusion according to the pressure values detected by the pressure sensor.

[0065] When there is left heart congestion, the excessive blood volume in the left ventricle increases the left ventricular pressure, and the pumping flow of the left ventricular assist device decreases. Therefore, when the target left ventricular end-diastolic pressure exceeds the range of the left ventricular end-diastolic pressure of a normal person, it can be considered that the current target user currently has peripheral perfusion deficiency due to left heart congestion. In order to exclude individual differences of patients, the controller can calculate a first ratio between the target left ventricular end-diastolic pressure and the target right atrial pressure, and if the first ratio is greater than a first preset value, it is determined that the current left heart is congested. When the left ventricle is congested, the controller can increase the rotational speed of the left ventricular assist device to speed up the pumping of blood in the left ventricle to the aorta, thereby reducing the degree of congestion in the left ventricle and reducing PCWP.

[0066] When the first ratio is less than or equal to the first preset value, i.e., the target user is currently not congested in the left heart, the controller further determines whether the right heart causes the lung pressure to be too high. When the right ventricular assist device rotates too fast to cause the lung pressure to be too high, the right atrial pressure decreases, and the pulmonary artery pressure increases. In order to exclude the individual differences of the patient, the controller can calculate a second ratio between the target pulmonary artery pressure and the target right atrial pressure, and if the second ratio is less than or equal to a second preset value, it is determined that the current right ventricular assist device pumps too fast. The controller can reduce the rotation speed of the right ventricular assist device to reduce the pumping of blood in the right atrium to the pulmonary artery, so as to relieve the lung blood volume and thus reduce the PCWP.

[0067] wherein the left ventricular assist device or the right ventricular assist device is increased or decreased by a preset rotation speed step, and after increasing or decreasing the rotation speed once, the controller determines whether the target user still has lung overperfusion according to the pressure values of each part of the next sliding window. According to this method, an alarm is generated or the target user does not have peripheral underperfusion or lung overperfusion.

[0068] Further, the method further comprises: if the second ratio is greater than the second preset value, determining that the target user has lung abnormalities and generating an alarm.

[0069] In the present application, when blood is accumulated in the lungs, it also causes lung overperfusion, and when the lungs have problems, it causes blood to be unable to circulate normally to the periphery of the body, and the lung abnormalities cannot be solved by adjusting the rotation speed of the right ventricular assist device or the left ventricular assist device. Therefore, when the second ratio is greater than the second preset value, i.e., the current target pulmonary artery pressure increases beyond the range of the pulmonary artery pressure of a normal person, it is considered that the target user has lung abnormalities, and the controller can generate an alarm to prompt the target user to seek medical treatment as soon as possible.

[0070] It can be seen that the present application proposes an adaptive control method of a biventricular assist system, obtains a target aortic pressure detected by a first pressure sensor, a target left ventricular end diastolic pressure detected by a second pressure sensor, a target right atrial pressure detected by a third pressure sensor, and a target pulmonary artery pressure detected by a fourth pressure sensor; determines whether the target user has peripheral underperfusion or lung overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure, and the target pulmonary artery pressure; and determines a strategy for adjusting the left ventricular assist device or the right ventricular assist device according to the target left ventricular end diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure when the target user has peripheral underperfusion or lung overperfusion. The present application detects the pressures at the inlets and outlets of the left and right ventricular assist devices by setting multiple pressure sensors, determines whether the user has adverse events of peripheral underperfusion or lung overperfusion according to the detected pressures, and then adjusts the rotation speeds of the left and right ventricular assist devices to relieve or even solve the occurrence of adverse events, which can prevent the user from having adverse events such as suction, underperfusion, and lung overperfusion in long-term management, and greatly improves the safety of the user.

[0071] The above describes the scheme of the embodiments of the present application mainly from the perspective of the process of executing the method. It can be understood that, in order to implement the above functions, the network device comprises a hardware structure and / or a software module corresponding to the execution of each function. Those skilled in the art should easily realize that, in combination with the unit and algorithm steps of each example described in the embodiments provided herein, the present application can be implemented in the form of hardware or a combination of hardware and computer software. Whether a certain function is executed in the form of hardware or computer software driving hardware depends on the specific application and design constraints of the technical solution. The skilled person can use different methods to implement the described functions for each specific application, but such implementation should not be considered as beyond the scope of the present application.

[0072] For example, the present application also provides a controller of a biventricular assist system, the biventricular assist system further comprising a left ventricular assist device for implanting into a left heart of a target user, a right ventricular assist device for implanting into a right heart of the target user, a first pressure sensor and a second pressure sensor respectively arranged at an inlet and an outlet of the left ventricular assist device, and a third pressure sensor and a fourth pressure sensor respectively arranged at an inlet and an outlet of the right ventricular assist device, the controller comprising one or more processors, the one or more processors being configured to:

[0073] obtain a target aortic pressure detected by the first pressure sensor, a target left ventricular end-diastolic pressure detected by the second pressure sensor, a target right atrial pressure detected by the third pressure sensor, and a target pulmonary artery pressure detected by the fourth pressure sensor;

[0074] determine whether the target user is suffering from peripheral perfusion deficiency or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end-diastolic pressure, and the target pulmonary artery pressure;

[0075] determine a strategy for adjusting the left ventricular assist device or the right ventricular assist device according to the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure when the target user is suffering from peripheral perfusion deficiency or pulmonary overperfusion.

[0076] The embodiments of the present application provide a ventricular assist device, characterized in that the ventricular assist device comprises:

[0077] a left ventricular assist device for implanting into a left heart of a target user;

[0078] a right ventricular assist device for implanting into a right heart of the target user;

[0079] a first pressure sensor and a second pressure sensor respectively arranged at an inlet and an outlet of the left ventricular assist device;

[0080] A third pressure sensor and a fourth pressure sensor are respectively arranged at the inlet and outlet of the right ventricular assist device.

[0081] A controller is communicatively connected with the left ventricular assist device and the right ventricular assist device, and is configured to execute instructions of part or all of the steps described in the method.

[0082] The controller of each of the above schemes has a function of implementing the corresponding steps of the medical device in the above method; the function can be implemented by hardware, or by hardware executing corresponding software.

[0083] In the embodiments of the present application, the controller can also be a chip or a chip system, for example, a system on chip (SoC).

[0084] Please refer to Figure 3 , Figure 3 is a structural schematic diagram of a medical device provided by the embodiments of the present application, which comprises 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 memory and configured to be executed by the one or more processors.

[0085] The above program comprises instructions for executing the following steps:

[0086] Obtaining a target aortic pressure detected by the first pressure sensor, a target left ventricular end diastolic pressure detected by the second pressure sensor, a target right atrial pressure detected by the third pressure sensor, and a target pulmonary artery pressure detected by the fourth pressure sensor;

[0087] Determining whether the target user is suffering from peripheral perfusion deficiency or pulmonary overperfusion according to the target aortic pressure, the target left ventricular end diastolic pressure, and the target pulmonary artery pressure;

[0088] When the target user is suffering from peripheral perfusion deficiency or pulmonary overperfusion, determining an adjustment strategy of the left ventricular assist device or the right ventricular assist device according to the target left ventricular end diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

[0089] Wherein all the related contents of each scene involved in the above method embodiments can be cited to the function description of the corresponding function module, which will not be repeated here.

[0090] It should be understood that the above memory can include read-only memory and random access memory, and provide instructions and data to the processor. A part of the memory can also include non-volatile random access memory. For example, the memory can also store device type information.

[0091] In the embodiments of the present application, the processor of the apparatus can be a central processing unit (CPU), and can also be other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field programmable gate arrays (FPGA) or other programmable logic devices, discrete gates or transistor logic, discrete hardware components, etc. The general-purpose processor can be a microprocessor or the processor can also be any conventional processor.

[0092] It should be understood that "at least one" in the embodiments of the present application refers to one or more, and "multiple" refers to two or more. The "and / or" describes the association relationship of the associated objects, which means that there can be three relationships, for example, A and / or B can represent the following three cases: A exists alone, A and B exist together, and B exists alone, where A and B can be singular or plural. The character " / " generally represents an "or" relationship between the associated objects before and after it. "At least one of the following" or similar expressions means any combination of these items, including any combination of single or multiple items. For example, at least one of a, b, or c can represent a, b, c, a-b, a-c, b-c, or a-b-c, where a, b, and c can be single or multiple.

[0093] In addition, unless otherwise stated, the ordinal numbers "first", "second", etc. mentioned in the embodiments of the present application are used to distinguish multiple objects, and are not used to limit the order, time sequence, priority or importance of the multiple objects. For example, the first information and the second information are only used to distinguish different information, and do not mean that the contents, priority, sending order or importance of the two kinds of information are different.

[0094] In the implementation process, each step of the above method can be completed by the integrated logic circuit of hardware in the processor or the instruction in the form of software. The steps of the method disclosed in the embodiments of the present application can be directly embodied as hardware processor execution completion, or executed by the combination of hardware and software units in the processor. The software unit can be located in a mature storage medium in the field, such as random access memory, flash memory, read-only memory, programmable read-only memory, electrically erasable programmable memory, register, etc. The storage medium is located in the memory, and the processor executes the instructions in the memory, and combines the hardware to complete the steps of the above method. To avoid repetition, it will not be described in detail here.

[0095] The embodiments of the present application also provide a computer storage medium, wherein the computer storage medium stores a computer program for electronic data exchange, and the computer program enables the computer to execute part or all steps of any method described in the above method embodiments.

[0096] The embodiment of the present application further provides a computer program product, which comprises a non-transitory computer readable storage medium storing a computer program, and the computer program is operable to cause a computer to execute part or all of the steps of any method described in the above method embodiments. The computer program product can be a software installation package.

[0097] It should be noted that, for the above-mentioned method embodiments, in order to simply describe, they are all described as a series of action combinations, but those skilled in the art should know that the present application is not limited to the action sequence described, because according to the present application, some steps can be performed in other sequences or simultaneously. Secondly, those skilled in the art should know that the embodiments described in the specification all belong to preferred embodiments, and the actions and modules involved are not necessarily necessary for the present application.

[0098] In the above embodiments, the description of each embodiment has its own focus, and the parts not described in detail in a certain embodiment can be referred to the related description of other embodiments.

[0099] In several embodiments provided by the present application, it should be understood that the disclosed apparatus can be implemented in other ways. For example, the apparatus embodiments described above are only schematic. The division of the above units is only a logical function division. There can be another division manner for actual implementation, for example, a plurality of units or components can be combined or integrated into another system, or some features can be ignored or not executed. In addition, the displayed or discussed coupling or direct coupling or communication connection between each set can be indirect coupling or communication connection through some interface, device or unit, and can be electrical or other form.

[0100] The units described as separate components can or can not be physically separate, and the components shown as units can or can not be physical units, that is, they can be located in one place, or can be distributed on a plurality of network units. According to actual needs, part or all of the units can be selected to achieve the purpose of the embodiment of the present application.

[0101] In addition, each functional unit in each embodiment of the present application can be integrated in one processing unit, or each unit can exist physically, or two or more units can be integrated in one unit. The integrated unit can be realized in the form of hardware or in the form of software functional unit.

[0102] If the above integrated unit is realized in the form of a software function unit and sold or used as an independent product, it can be stored in a computer readable memory. Based on this understanding, the technical solutions of the present application essentially or say the part that contributes to the prior art or the whole or part of the technical solutions can be embodied in the form of a software product. The computer software product is stored in a memory and includes a plurality of instructions for causing a computer device (which can be a personal computer, a server or a TRP, etc.) to execute all or part of the steps of the embodiments of the present application. The aforementioned memory includes: a U disk, a read-only memory (ROM), a random access memory (RAM), a mobile hard disk, a magnetic disk or an optical disk, and various media that can store program codes.

[0103] A person of ordinary skill in the art can understand that all or part of the steps of the various methods of the above embodiments can be completed by a program instructing relevant hardware, and the program can be stored in a computer readable memory, which can include a flash disk, a ROM, a RAM, a magnetic disk or an optical disk, etc.

[0104] The embodiments of the present application are described in detail above, and the principles and implementation manners of the present application are described by applying specific examples. The above description of the embodiments is only used to help understand the method of the present application and its core idea; meanwhile, for those of ordinary skill in the art, according to the idea of the present application, the specific implementation manner and application range will be changed, and the above description of the embodiments should not be understood as a limitation of the present application.

Claims

1. An adaptive control method for a dual ventricular assist system, characterized in that, The biventricular assist system includes a left ventricular assist device for implantation into the left ventricle of the target user, a right ventricular assist device for implantation into the right ventricle of the target user, a first pressure sensor and a second pressure sensor respectively disposed at the inlet and outlet of the left ventricular assist device, and a third pressure sensor and a fourth pressure sensor respectively disposed at the inlet and outlet of the right ventricular assist device; the method includes: The target aortic pressure detected by the first pressure sensor, the target left ventricular end-diastolic pressure detected by the second pressure sensor, the target right atrial pressure detected by the third pressure sensor, and the target pulmonary artery pressure detected by the fourth pressure sensor are obtained. The target aortic pressure, the target left ventricular end-diastolic pressure, and the target pulmonary artery pressure are used to determine whether the target user has peripheral hypoperfusion or pulmonary hyperperfusion. When the target user experiences peripheral hypoperfusion or pulmonary hyperperfusion, a strategy for adjusting the left ventricular assist device or the right ventricular assist device is determined based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

2. The method according to claim 1, characterized in that, The step of determining whether the target user has peripheral hypoperfusion or pulmonary hyperperfusion based on the target aortic pressure, the target left ventricular end-diastolic pressure, and the target pulmonary artery pressure includes: If the target aortic pressure is less than a preset aortic pressure threshold, it is determined that the target user has insufficient peripheral perfusion; If the target aortic pressure is less than the preset aortic pressure threshold, the target pulmonary artery pressure is greater than the upper limit of the preset pulmonary artery range, and the target left ventricular end-diastolic pressure is greater than the upper limit of the preset left ventricular end-diastolic pressure range, then the target user is determined to have pulmonary overperfusion.

3. The method according to claim 2, characterized in that, The strategy for determining the adjustment of the left ventricular assist device or the right ventricular assist device based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure includes: The overall blood volume of the target user is determined based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure. If the target user's overall blood volume is abnormal, an alarm will be triggered immediately; Otherwise, the rotational speed of the left ventricular assist device or the right ventricular assist device is increased or decreased based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

4. The method according to claim 3, characterized in that, The step of determining whether the target user's overall blood volume is abnormal based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure includes: If the target right atrial pressure is less than the upper limit of the preset right atrial pressure range, the target left ventricular end-diastolic pressure is less than the lower limit of the preset left ventricular end-diastolic pressure range, and the target pulmonary artery pressure is less than the lower limit of the preset pulmonary artery range, then the target user is determined to have insufficient overall blood volume. If the target right atrial pressure is greater than the upper limit of the preset right atrial pressure range, and the target left ventricular end-diastolic pressure is greater than the upper limit of the preset left ventricular end-diastolic pressure range, then the target user is determined to have excessive overall blood volume.

5. The method according to claim 4, characterized in that, When the target user has insufficient peripheral perfusion, the step of increasing or decreasing the rotational speed of the left ventricular assist device or the right ventricular assist device based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure includes: If the first ratio is greater than the first preset value, the rotation speed of the left ventricular assist device is increased. The first ratio is the ratio of the target left ventricular end-diastolic pressure to the target right atrial pressure. If the first ratio is less than or equal to the first preset value and the second ratio is less than or equal to the second preset value, then the rotation speed of the right ventricular assist device is increased, where the second ratio is the ratio of the target pulmonary artery pressure to the target right atrial pressure.

6. The method according to claim 4 or 5, characterized in that, During lung overperfusion of the target user, increasing or decreasing the rotational speed of the left ventricular assist device or right ventricular assist device based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure includes: If the first ratio is greater than the first preset value, then the rotational speed of the left ventricular assist device is increased; If the first ratio is less than or equal to the first preset value and the first ratio is less than or equal to the third preset value, then reduce the rotation speed of the right ventricular assist device.

7. The method according to claim 6, characterized in that, The method further includes: If the second ratio is greater than the second preset value, an abnormality in the lungs of the target user is determined and an alarm is triggered.

8. A controller for a dual ventricular assist system, characterized in that, The biventricular assist system further includes a left ventricular assist device for implantation in the left ventricle of the target user, a right ventricular assist device for implantation in the right ventricle of the target user, a first pressure sensor and a second pressure sensor respectively disposed at the inlet and outlet of the left ventricular assist device, and a third pressure sensor and a fourth pressure sensor respectively disposed at the inlet and outlet of the right ventricular assist device. The controller includes one or more processors, the one or more processors being used for: The target aortic pressure detected by the first pressure sensor, the target left ventricular end-diastolic pressure detected by the second pressure sensor, the target right atrial pressure detected by the third pressure sensor, and the target pulmonary artery pressure detected by the fourth pressure sensor are obtained. The target aortic pressure, the target left ventricular end-diastolic pressure, and the target pulmonary artery pressure are used to determine whether the target user has peripheral hypoperfusion or pulmonary hyperperfusion. When the target user experiences peripheral hypoperfusion or pulmonary hyperperfusion, a strategy for adjusting the left ventricular assist device or the right ventricular assist device is determined based on the target left ventricular end-diastolic pressure, the target right atrial pressure, and the target pulmonary artery pressure.

9. A ventricular assist device, characterized in that, The ventricular assist device includes: A left ventricular assist device to be implanted in the left ventricle of the target user; A right ventricular assist device for implantation into the right heart of the target user; A first pressure sensor and a second pressure sensor are respectively installed at the inlet and outlet of the left ventricular assist device; The third and fourth pressure sensors are respectively installed at the inlet and outlet of the right ventricular assist device; A controller communicatively connected to the left ventricular assist device and the right ventricular assist device, the controller being configured to execute instructions for the steps of the method as described in any one of claims 1-7.

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 1-7.

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 1-7.

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