Control method and device of double-ventricle auxiliary system

Abstract

The invention provides a control method and device for a double-ventricle auxiliary system. The method comprises the following steps: acquiring a first parameter and a second parameter in a first period; adjusting the rotating speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; acquiring a third parameter in a second period; and adjusting the rotating speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so that the cardiac function state of the target user is kept normal. The rotating speed of the ventricular assist device is adjusted according to the obtained physiological parameters of the user in the first period, so that the left ventricle of the user is in the normal operation state, and then the rotating speed of the ventricular assist device is adjusted by obtaining the adjusted physiological parameters of the user in the second period; the left heart and the right heart of the user are in a normal operation state, so that systemic circulation and pulmonary circulation of the user are kept balanced, the pumping effect of the double-ventricle auxiliary system is improved, and the heart failure symptom of the user is improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and in particular, to a control method and device for a biventricular assist system. Background Art

[0002] Heart failure is a serious heart disease that affects both the left ventricle and the right ventricle of a patient simultaneously. A ventricular assist device (VAD) can be used to assist the heart of a subject with a condition that impairs the heart's pumping ability and is an important device for treating heart failure. However, currently, the ventricular assist devices for the left heart and the right heart often operate independently, without considering the influence between the ventricular assist devices and lacking an effective coordination mechanism. Summary of the Invention

[0003] Embodiments of this application provide a control method and device for a biventricular assist system, which can dynamically adjust the operation of the ventricular assist device, improve the pumping effect of the biventricular assist system, and alleviate the heart failure symptoms of the user.

[0004] In a first aspect, embodiments of this application provide a control method for a biventricular assist system. The biventricular assist system includes: a first ventricular assist device for the left ventricle of a target user, a second ventricular assist device for the right ventricle of the target user, and a controller communicatively connected to the first ventricular assist device and the second ventricular assist device. The method includes:

[0005] Obtain a first parameter and a second parameter. The first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first period;

[0006] Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter;

[0007] Obtain a third parameter. The third parameter is a physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotation speed is adjusted;

[0008] Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter to keep the cardiac function state of the target user normal.

[0009] Second aspect, a controller of a biventricular assist system provided by an embodiment of the present application, the controller is communicatively connected to a first ventricular assist device for the left heart of a target user and a second ventricular assist device for the right heart of the target user in the biventricular assist system, the controller includes one or more processors, and the one or more processors are configured to:

[0010] Obtain a first parameter and a second parameter, where the first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first period;

[0011] Adjust the rotational speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter;

[0012] Obtain a third parameter, where the third parameter is a physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotational speed is adjusted;

[0013] Adjust the rotational speed of the first ventricular assist device or the second ventricular assist device according to the third parameter so as to keep the cardiac function state of the target user normal.

[0014] Third aspect, an embodiment of the present application provides a biventricular assist system, and the biventricular assist system includes:

[0015] A first ventricular assist device for the left ventricle of a target user;

[0016] A second ventricular assist device for the right ventricle of the target user;

[0017] A controller communicatively connected to the first ventricular assist device and the second ventricular assist device, and the controller is configured to:

[0018] Obtain a first parameter and a second parameter, where the first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first period;

[0019] Adjust the rotational speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter;

[0020] Obtain a third parameter, where the third parameter is a physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotational speed is adjusted;

[0021] Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so as to keep the cardiac function state of the target user normal.

[0022] In a fourth aspect, an embodiment of the present application provides a medical device, which includes the controller described in the second aspect above or the biventricular assist system described in the third aspect above.

[0023] In a fifth aspect, an embodiment of the present application provides a computer-readable storage medium, which stores a computer program for electronic data exchange. Wherein, the computer program enables a computer to execute some or all of the steps described in the method of the first aspect above.

[0024] In a sixth aspect, an embodiment of the present application provides a computer program product. Wherein, the computer program product includes a non-transitory computer-readable storage medium storing a computer program, and the computer program is operable to enable a computer to execute some or all of the steps described in the method of the first aspect of the embodiments of the present application. This computer program product can be a software installation package.

[0025] The technical solution provided by the present application is to obtain a first parameter and a second parameter. The first parameter is the physiological parameter of the target user when the first ventricular assist device operates in the first cycle, and the second parameter is the physiological parameter of the target user when the second ventricular assist device operates in the first cycle; adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; obtain a third parameter, and the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in the second cycle; adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so as to keep the cardiac function state of the target user normal. By first adjusting the rotation speed of the first ventricular assist device or the second ventricular assist device according to the physiological parameters of the user obtained in the first cycle, the present application enables the left ventricle of the user to be in a normal operating state, and then obtains the physiological parameters of the user in the adjusted second cycle to adjust the rotation speed of the first ventricular assist device or the second ventricular assist device, so that both the left heart and the right heart of the user are in a normal operating state, thereby keeping the systemic circulation and pulmonary circulation of the user balanced, improving the pumping effect of the biventricular assist system, and improving the heart failure symptoms of the user. Description of the Drawings

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for use in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0027] Figure 1 It is a schematic diagram of a biventricular assist system provided by an embodiment of the present application;

[0028] Figure 2 It is a schematic flow chart of a control method for a biventricular assist system provided by an embodiment of the present application;

[0029] Figure 3 It is a schematic structural diagram of a medical device provided by an embodiment of the present application. Detailed implementation manners

[0030] For better understanding of the technical solutions of the present application by those skilled in the art, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the description of the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative efforts fall within the scope protected by the present application.

[0031] The terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "comprising" and "having" 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 unlisted steps or units, or further includes other steps or units inherent to these processes, methods, products or devices.

[0032] Referring to "embodiment" herein means that a specific feature, structure or characteristic described in connection with the embodiment may be included in at least one embodiment of the present application. The phrase appears at various positions in the specification and does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art explicitly and implicitly understand that the embodiments described herein may be combined with other embodiments.

[0033] The medical device and the pump involved in the present application may be ventricular assist devices, such as implantable ventricular assist devices, interventional ventricular assist devices, etc.; the ventricular assist device may include at least one blood pump, wherein the blood pump may be a centrifugal pump, an axial flow pump, a magnetic levitation pump, etc.

[0034] The "rotation speed" in the present application refers to the rotational speed of a motor or an electric machine, which is associated with the rotational speed of the rotor or impeller of the ventricular assist device and can be defined as revolutions per minute. The "flow rate", "fluid flow rate", "pumping flow rate" refer to the volume of fluid transported through the ventricular assist device per unit time, which can be estimated and measured in liters per minute.

[0035] Please refer to Figure 1 , Figure 1 which is a bi-ventricular assist system provided by an embodiment of the present application. The bi-ventricular assist system includes a first ventricular assist device, a second ventricular assist device, and a controller. The first ventricular assist device is disposed in the left ventricle of the user and is configured to pump blood from the left ventricle of the user to the aorta; the second ventricular assist device is disposed in the right ventricle of the user and is configured to pump blood from the right ventricle of the user to the pulmonary artery.

[0036] In terms of the flow direction of the user's blood, the fluid systems are arranged in series with each other. Blood first flows through the pulmonary artery to the lungs. The pulmonary system is in direct fluid communication with the left ventricle. After the blood in the lungs is oxygenated, the blood returns to the left ventricle. Then the blood is pumped from the left ventricle into the aorta, and the blood in the aorta flows through the user's vascular system to the right ventricle via the user's vascular system. Therefore, blood forms a fluid cycle in the pulmonary artery, right ventricle, left ventricle, and aorta in sequence. Among them, 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.

[0037] The first ventricular assist device acts on the left heart. It can be disposed at the apex of the left ventricle. Its fluid inlet is located within the left ventricle of the user, and its fluid outlet is connected to the aorta of the user. The first ventricular assist device can also cross the aortic valve of the user, with its proximal end located within the aorta of the user and its distal end located within the left ventricle of the user, so as to pump the blood in the left ventricle of the user into the aorta. The second ventricular assist device acts on the right heart. It can be disposed at the apex of the right ventricle. Its fluid inlet is located within the right ventricle of the user, and its fluid outlet is connected to the pulmonary artery of the user; or the second ventricular assist device can cross the pulmonary valve of the user, with its proximal end located within the pulmonary artery of the user and its distal end located within the right ventricle of the user, and the user pumps the blood in the right ventricle into the pulmonary artery, thereby realizing blood circulation.

[0038] Exemplarily, the first ventricular assist device can be attached to the apex position of the left ventricle of the heart via a ventricular connection component (such as a top ring, ventricular cuff, ventricular sleeve). The ventricular connection component can be sutured to the apex of the left ventricle of the heart and connected to the first ventricular assist device. The other end of the first 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 first ventricular assist device can effectively transfer blood from the weakened left ventricle and propel it into the aorta, thereby circulating to the remaining part of the patient's vascular system and providing ventricular assist function for the user. Similarly, the second ventricular assist device can also be attached to the apex position of the right ventricle of the heart via a ventricular connection component to provide ventricular assist function for the user.

[0039] Among them, the first ventricular assist device and the second ventricular assist device are connected to an external controller through a percutaneous cable passing through the abdominal skin of the user, and are used to control the operation of the first ventricular assist device and the second ventricular assist device. The controller is used to achieve independent driving of the first ventricular assist device and the second ventricular assist device, but there is mutual coordination between the controls. The blood flow has a predetermined mutual relationship, and the fluid flow pumped by the ventricular assist device is related to the blood volume and pressure in the ventricle, so that a change in the fluid flow of one ventricular assist device will cause a corresponding change in the fluid flow of the other ventricular assist device. For example, when the rotational speed of the first ventricular assist device increases, the decrease in the blood volume in the left ventricle causes the pressure in the left ventricle to decrease. The decrease in the left ventricular pressure is beneficial to the blood flow from the lungs to the left ventricle, thereby reducing the pulmonary artery pressure. The decrease in the pulmonary artery pressure reduces the pressure difference between the pulmonary artery pressure and the right ventricular pressure, enabling the blood in the right ventricle to be better pumped into the pulmonary artery.

[0040] Exemplarily, the biventricular assist system may further include a plurality of pressure sensors. The pressure sensors may be disposed on the outer surface at the fluid inlet of the first ventricular assist device for real-time measurement of the left ventricular pressure of the patient. Exemplarily, pressure sensors may also be disposed on the outer surface at the fluid inlet of the second ventricular assist device for real-time measurement of the right ventricular pressure of the patient.

[0041] Combined with the above description, the present application will be described from the perspective of method examples below.

[0042] Please refer to Figure 2 , Figure 2 which is a schematic flowchart of a control method for a biventricular assist system provided by an embodiment of the present application, and is applied to the biventricular assist system as described in Figure 1 . As shown in Figure 2 , the method includes the following steps.

[0043] S210. Obtain a first parameter and a second parameter. The first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first period.

[0044] When the first ventricular assist device and the second ventricular assist device are implanted and operate in the target user, the controller can detect the physiological parameters of the target user in real time to monitor the impact of the operation of the first ventricular assist device and the second ventricular assist device on the target user. Furthermore, when the target user is about to or has already shown an abnormal state, the rotational speed of the first ventricular assist device and / or the second ventricular assist device is adjusted to achieve the balance of the left and right ventricular functions of the target user, so as to maintain the pumping demand of the target user.

[0045] Among them, the first parameter includes: left ventricular pressure and left ventricular ejection fraction; the second parameter and the third parameter include: blood oxygen saturation and central venous pressure. The left ventricular pressure can be used to indicate the blood volume in the left ventricle. The higher the left ventricular pressure, the more blood flow is contained in the current left ventricle. The left ventricular ejection fraction represents the systolic function of the heart and can be used to judge the degree of heart failure of the left heart of the target user. The higher the left ventricular ejection fraction, the lower the degree of heart failure, and the more blood is pumped out by the left ventricle, so the more blood flows back to the right atrium through the systemic circulation. The blood oxygen saturation is the blood oxygen concentration in the blood, which can be used to indicate the blood volume pumped out by the right ventricle and can also be used to judge the degree of heart failure of the right heart of the target user. The higher the blood oxygen saturation, the lower the degree of heart failure, and the more blood is pumped out by the right ventricle, and the more blood flows back to the left atrium through the pulmonary circulation. The central venous pressure can be used to indicate the blood volume in the right ventricle. The higher the central venous pressure, the more blood flow is contained in the current right ventricle.

[0046] The left ventricular pressure can be measured by a pressure sensor provided on the first ventricular assist device. The left ventricular ejection fraction, blood oxygen saturation, and central venous pressure can be obtained through corresponding detection devices. For example, inserting a catheter with a camera into the heart can estimate the left ventricular ejection fraction based on the captured images, using a blood oxygen detector to detect the blood oxygen saturation of the target user, and using a venous detector to detect the central venous pressure of the target user. The detection device can be connected to the controller to transmit the detected data to the controller. The controller analyzes the operating state of the heart function of the current target user in the first cycle according to the obtained first parameter and second parameter, and then maintains the balance of the heart function by adjusting the rotation speed of the first ventricular assist device or the second ventricular assist device.

[0047] The first cycle can be set to be a multiple n of the time required for the blood to circulate in the body once. The n can be selected between [1, 10], and this application does not limit this.

[0048] S220. Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter.

[0049] After obtaining the first parameter and the second parameter, the controller first adjusts the rotation speed of the first ventricular assist device or the second ventricular assist device according to the values of the first parameter and the second parameter to restore the functional state of the left heart of the target user to normal.

[0050] Optionally, adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter includes: determining the state of the left ventricle of the target user according to the first parameter; and adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the state of the left ventricle and the second parameter.

[0051] Wherein, the left heart of the target user has the natural pumping of the left ventricle and the assisted pumping of the first ventricular assist device. The controller can determine the functional state of the left heart of the target user in the first cycle according to the left ventricular pressure and the left ventricular ejection fraction. Furthermore, when the functional state of the left heart is abnormal or about to be abnormal, the rotational speed of the first ventricular assist device or the second ventricular assist device is adjusted according to the abnormal state indicated by the first parameter and the second parameter to restore the functional state of the left ventricle to normal.

[0052] Optionally, determining the state of the left ventricle of the target user according to the first parameter includes: if the left ventricular ejection fraction is greater than the first ejection threshold and the left ventricular pressure is greater than the first ventricular pressure threshold, determining that the left ventricle of the target user is in the first state; if the left ventricular ejection fraction is greater than the first ejection threshold and the left ventricular pressure is less than the second ventricular pressure threshold, determining that the left ventricle of the target user is in the second state, where the first ventricular pressure threshold is greater than the second ventricular pressure threshold; if the left ventricular ejection fraction is less than the second ejection threshold and the left ventricular pressure is greater than the first ventricular pressure threshold, determining that the left ventricle of the target user is in the third state, where the first ejection threshold is greater than the second ejection threshold; if the left ventricular ejection fraction is less than the second ejection threshold and the left ventricular pressure is less than the second ventricular pressure threshold, determining that the left ventricle of the target user is in the fourth state.

[0053] The normal range of the left ventricular pressure is between 90 mmHg and 180 mmHg. A left ventricular pressure lower than this normal range indicates that the current blood volume in the left ventricle is too small, which may cause aspiration problems; a left ventricular pressure higher than this normal range indicates that the current blood volume in the left ventricle is too large, which may cause left ventricular overload problems. For example, the first ventricular pressure threshold is set to 180 mmHg, and the second ventricular pressure threshold is set to 90 mmHg. The normal range of the left ventricular ejection fraction is 50% - 75%. When the left ventricular ejection fraction is lower than this normal range, it indicates that the user has heart failure. The lower the left ventricular ejection fraction, the more severe the heart failure. For example, the first ejection threshold is set to 45%, and the second ejection threshold is set to 35%. If the left ventricular ejection fraction is greater than 45%, it indicates that the heart failure degree of its left ventricle is relatively mild. If the left ventricular ejection fraction is less than 35%, it indicates that the heart failure degree of its left ventricle is severe.

[0054] Among them, the first state is a mild overload state, the second state is a mild ischemia state, the third state is a severe overload state, and the fourth state is a severe ischemia state. When the left ventricular ejection fraction in the first parameter is greater than 45% and the left ventricular pressure is greater than 180 mmHg, it indicates that the degree of left ventricular heart failure of the target user is low but the blood flow volume accommodated is excessive in the first cycle, and the left ventricle is in a mild overload state. When the left ventricular ejection fraction in the first parameter is greater than 45% and the left ventricular pressure is less than 90 mmHg, it indicates that the degree of left ventricular heart failure of the target user is low but the blood flow volume accommodated is too small in the first cycle, and the left ventricle is in a mild ischemia state. When the left ventricular ejection fraction in the first parameter is less than 35% and the left ventricular pressure is greater than 180 mmHg, it indicates that the degree of left ventricular heart failure of the target user is severe and the blood flow volume accommodated is excessive in the first cycle, and the left ventricle is in a severe overload state. When the left ventricular ejection fraction in the first parameter is less than 35% and the left ventricular pressure is less than 90 mmHg, it indicates that the degree of left ventricular heart failure of the target user is severe and the blood flow volume accommodated is too small in the first cycle, and the left ventricle is in a severe ischemia state. If the left ventricular ejection fraction in the first parameter is less than 45% and greater than 35%, and the left ventricular pressure is less than 180 mmHg and greater than 90 mmHg, it means that the current function of the left heart is normal, the natural cardiac output of the left ventricle and the pumping output of the first ventricular assist device meet the user's needs, and the controller can maintain the rotation speeds of the current first ventricular assist device and the second ventricular assist device.

[0055] Due to the circulation between the systemic circulation and the pulmonary circulation, improving the functional state of the left ventricle can be achieved by directly adjusting the rotation speed of the first ventricular assist device to regulate the blood flow output of the first ventricular assist device, or indirectly adjusting the rotation speed of the second ventricular assist device to regulate the blood flow input of the left ventricle. At the same time, the change in the functional state of the left ventricle will also affect the change in the functional state of the right ventricle. Based on this, the controller can further judge whether to adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the current physiological parameters of the right ventricle to achieve the functional recovery of the left heart.

[0056] Optionally, adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the state of the left ventricle and the second parameter includes: if the left ventricle is in the first state, the blood oxygen saturation is greater than the first blood oxygen threshold, and the central venous pressure is less than the first venous pressure threshold, then reducing the second ventricular assist device by a first speed value; otherwise, increasing the first ventricular assist device by a second speed value, where the second speed value is greater than the first speed value; if the left ventricle is in the second state, and the blood oxygen saturation is less than the second blood oxygen threshold, and the central venous pressure is greater than the second venous pressure threshold, then increasing the second ventricular assist device by the first speed value; otherwise, reducing the first ventricular assist device by the second speed value, where the first blood oxygen threshold is greater than the second blood oxygen threshold, and the first venous pressure threshold is less than the second venous pressure threshold; if the left ventricle is in the third state, and the central venous pressure is less than the second venous pressure threshold, then reducing the second ventricular assist device by the first speed value; otherwise, increasing the first ventricular assist device by a third speed value, where the third speed value is greater than the second speed value; if the left ventricle is in the fourth state, and the central venous pressure is greater than the first venous pressure threshold, then increasing the second ventricular assist device by the second speed value; otherwise, reducing the first ventricular assist device by the third speed value.

[0057] Among them, the normal venous blood oxygen saturation should be greater than 75%. When the blood oxygen saturation is less than 75%, it indicates that the current right ventricle has heart failure. For example, the first blood oxygen threshold is set to 75%, and the second blood oxygen threshold is set to 70%. When the blood saturation is less than 70%, it indicates that the degree of right heart failure is severe and the amount of blood pumped out by the right ventricle is small. When the blood oxygen saturation is greater than 70% and less than 75%, it indicates that the degree of right heart failure is lower and the current amount of blood pumped out by the right ventricle is larger. The normal range of the central venous pressure is 5 cmH2O to 12 cmH2O. When the central venous pressure is greater than 15 cmH2O, it indicates right heart failure and excessive blood volume in the right ventricle. When the central venous pressure is less than 5 cmH2O, it indicates insufficient right atrial filling or insufficient blood volume. For example, the first venous pressure threshold is set to 5 cmH2O, and the first venous pressure threshold is set to 15 cmH2O.

[0058] Specifically, when the left ventricle is in a slightly overloaded state, if the oxygen saturation of the right heart is greater than 70% and less than 75%, and the central venous pressure is less than 5 cmH2O, it indicates that the total output of the current right ventricle is excessive, resulting in right ventricular ischemia. Then, the rotation speed of the second ventricular assist device can be reduced to reduce the pumping output of the right ventricle, thereby indirectly reducing the input of the left ventricle. In the case of a relatively high left ventricular ejection fraction, the ischemia problem of the right ventricle and the overload problem of the left ventricle can be alleviated simultaneously; otherwise, directly increase the rotation speed of the first ventricular assist device to reduce the blood volume in the left ventricle, thereby increasing the input of the right ventricle and alleviating the ischemia problem of the right ventricle. When the left ventricle is in a severely overloaded state, if the central venous pressure is less than 5 cmH2O, it indicates that the current right ventricle is ischemic. Therefore, the rotation speed of the second ventricular assist device can be reduced to reduce the pumping output of the right ventricle, thereby indirectly reducing the input of the left ventricle. In the case of a relatively high left ventricular ejection fraction, the overload problem of the left heart can be solved; otherwise, directly increase the rotation speed of the first ventricular assist device to reduce the blood volume in the left ventricle, thereby increasing the input of the right ventricle and alleviating the ischemia problem of the right ventricle.

[0059] Specifically, when the left ventricle is in a slightly ischemic state, if the oxygen saturation of the right heart is less than 70%, and the central venous pressure is greater than 15 cmH2O, it indicates that the total output of the current right ventricle is too small, resulting in right ventricular overload. Then, the rotation speed of the second ventricular assist device can be increased to increase the pumping output of the right ventricle, thereby indirectly increasing the input of the left ventricle. The overload problem of the right ventricle and the ischemia problem of the left ventricle can be alleviated simultaneously; otherwise, directly reduce the rotation speed of the first ventricular assist device to reduce the output of the left ventricle, thereby reducing the input of the right ventricle and alleviating the overload problem of the right ventricle. When the left ventricle is in a severely ischemic state, if the central venous pressure is greater than 15 cmH2O, it indicates that the current right ventricle is overloaded. Then, the rotation speed of the second ventricular assist device can be increased to increase the pumping output of the right ventricle, thereby indirectly increasing the input of the left ventricle. The overload problem of the right ventricle and the ischemia problem of the left ventricle can be alleviated simultaneously; otherwise, directly reduce the rotation speed of the first ventricular assist device to reduce the output of the left ventricle, thereby reducing the input of the right ventricle and alleviating the overload problem of the right ventricle.

[0060] Among them, since the left ventricular ejection fraction in the slightly overloaded state is greater than that in the severely overloaded state, when increasing or decreasing the rotation speed of the first ventricular assist device, the speed step in the slightly overloaded state is greater than that in the severely overloaded state to prevent the left ventricle from having a suction problem, that is, the second speed value is greater than the first speed value, and the third speed value is greater than the second speed value. For example, the first speed value can be set to 10 rpm, the second speed value can be set to 20 rpm, and the third speed value can be set to 30 rpm.

[0061] It should be noted that during the process of adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device, the rotational speeds of the first ventricular assist device and the second ventricular assist device have always been within their normal rotational speed ranges.

[0062] S230. Obtain a third parameter, where the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotational speed is adjusted.

[0063] The restoration of the left heart function will have a certain impact on the right heart function. Therefore, after the left heart function is restored, the right heart function can be restored. Specifically, after the rotational speed of the first ventricular assist device or the second ventricular assist device is adjusted, the controller can also obtain the physiological parameter of the right heart in the period after the rotational speed is adjusted, and specify the adjustment measure for the restoration of the right heart function by analyzing this physiological parameter.

[0064] Among them, the duration of the second period can be the same as the duration of the first period; the duration of the second period can also be greater than the duration of the first period to more effectively reflect the impact of the restoration of the left heart function on the right heart function. This application does not limit this.

[0065] S240. Adjust the rotational speed of the first ventricular assist device or the second ventricular assist device according to the third parameter so that the cardiac function state of the target user remains normal.

[0066] Optionally, the adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the third parameter includes: if the blood oxygen saturation is greater than a first blood oxygen threshold and the central venous pressure is less than a first venous pressure threshold, then reduce the second ventricular assist device by a second speed value; if the blood oxygen saturation is less than a second blood oxygen threshold and greater than the first blood oxygen threshold, and the central venous pressure is less than the first venous pressure threshold, then increase the first ventricular assist device by a fourth speed value, where the fourth speed value is less than the second speed value; if the blood oxygen saturation is greater than the first blood oxygen threshold and the central venous pressure is greater than a second venous pressure threshold, then increase the second ventricular assist device by the second speed value; if the blood oxygen saturation is less than the second blood oxygen threshold and greater than the first blood oxygen threshold, and the central venous pressure is greater than the second venous pressure threshold, then reduce the first ventricular assist device by the fourth speed value; if the blood oxygen saturation is less than the second blood oxygen threshold and the central venous pressure is less than the first venous pressure threshold, then reduce the second ventricular assist device by a first speed value; if the blood oxygen saturation is less than the second blood oxygen threshold and the central venous pressure is greater than the second venous pressure threshold, then increase the second ventricular assist device by the first speed value.

[0067] Among them, due to the circulation of the systemic circulation and the pulmonary circulation, when the right heart function is abnormal, the right ventricular output can be adjusted by directly regulating the rotation speed of the second ventricular assist device, or the right ventricular input can be adjusted by indirectly adjusting the rotation speed of the first ventricular assist device.

[0068] In the present application, the controller determines the state of the right heart according to the central venous pressure, and then determines whether to adjust the first ventricular assist device or the second ventricular assist device and the rotation speed step to be adjusted according to the state of the right heart and the blood oxygen saturation.

[0069] The abnormalities of the right heart function include: right ventricular overload and right ventricular ischemia. If the central venous pressure in the second cycle is less than 5 cmH2O, it indicates that the right ventricle is in an ischemic state in the second cycle; if the central venous pressure in the second cycle is greater than 15 cmH2O, it indicates that the right ventricle is in an overloaded state in the second cycle; if the central venous pressure in the second cycle is greater than 5 cmH2O and less than 15 cmH2O, it indicates that the right ventricle is in a normal state in the second cycle.

[0070] Specifically, when the right ventricle is in an ischemic state in the second cycle, if the blood oxygen saturation is less than 70% or greater than 75%, the sum of the natural cardiac output of the right ventricle and the pumping volume of the second ventricular assist device may exceed the flow demand of the target user, that is, the rotation speed of the second ventricular assist device is too high, resulting in right ventricular ischemia. Therefore, the rotation speed of the second ventricular assist device can be directly reduced to reduce the output of the right ventricle; if the blood oxygen saturation is greater than 70% and less than 75%, the sum of the natural cardiac output of the right ventricle and the pumping volume of the second ventricular assist device can meet the flow demand of the user. Therefore, the rotation speed of the first ventricular assist device can be indirectly increased to increase the input of the right ventricle to solve the problem of right ventricular ischemia.

[0071] Specifically, when the right ventricle is in an overloaded state in the second cycle, if the blood oxygen saturation is less than 70% or greater than 75%, the sum of the natural cardiac output of the right ventricle and the pumping volume of the second ventricular assist device may be lower than the flow demand of the target user, that is, the rotation speed of the second ventricular assist device is too low, resulting in right ventricular overload. Therefore, the rotation speed of the second ventricular assist device can be directly increased to increase the output of the right ventricle; if the blood oxygen saturation is greater than 70% and less than 75%, the sum of the natural cardiac output of the right ventricle and the pumping volume of the second ventricular assist device meets the flow demand of the user. Therefore, the rotation speed of the first ventricular assist device can be indirectly reduced to reduce the input of the right ventricle to solve the problem of right ventricular overload.

[0072] Among them, the lower the blood oxygen saturation, the more serious the heart failure of the target user. To reduce further damage to the right ventricle, the higher the blood oxygen saturation, the greater the allowable adjustment speed step. Therefore, when the central venous pressure is less than 5 cmH2O, the rotation speed of the second ventricular assist device decreases by the second speed value when the blood oxygen saturation is greater than 75%, the rotation speed of the second ventricular assist device decreases by the first speed value when the blood oxygen saturation is less than 70%, and the rotation speed of the second ventricular assist device decreases by the fourth speed value when the blood oxygen saturation is in the range of 70% - 75%. When the central venous pressure is greater than 15 cmH2O, the rotation speed of the second ventricular assist device increases by the second speed value when the blood oxygen saturation is greater than 75%, the rotation speed of the second ventricular assist device increases by the first speed value when the blood oxygen saturation is less than 70%, and the rotation speed of the second ventricular assist device increases by the fourth speed value when the blood oxygen saturation is in the range of 70% - 75%. By way of example, the value range of the fourth speed value is between the first speed value and the second speed value, such as the fourth speed value is set to 15 rpm.

[0073] Furthermore, if both the central venous pressure and the blood oxygen saturation are within the normal range, the rotation speeds of the current first ventricular assist device and the second ventricular assist device can be maintained.

[0074] In this application, first, the physiological parameters in the first cycle are obtained to automatically adjust the rotation speed of the first ventricular assist device or the second ventricular assist device, and then the physiological parameters of the right heart after the rotation speed is adjusted are obtained to monitor the impact on the right heart function during the adjustment process of the left heart function recovery. Furthermore, the rotation speed of the first ventricular assist device or the second ventricular assist device is automatically adjusted according to the physiological parameters of the right heart in the second cycle to achieve the recovery of the right heart function. Since the recovery of the right heart function may affect the left heart function, the physiological parameters of the left heart and the right heart in the third cycle can be obtained and the right heart function can be recovered according to the above method. This process is repeated in a cycle, and the recovery of the right heart function and the left heart function are achieved by continuously automatically adjusting the rotation speed of the first ventricular assist device or the second ventricular assist device, so as to maintain the balance of the systemic circulation and the pulmonary circulation of the target user.

[0075] It should be noted that although this application only describes the adjustment of the rotation speed of the first ventricular assist device or the second ventricular assist device in the first cycle and the second cycle. However, in subsequent cycle times, the controller can continuously and automatically adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the above method to maintain the balance of the systemic circulation and the pulmonary circulation, that is, this application can use the first cycle and the second cycle as a cycle period, and continuously execute the above method until the physiological parameters of the left heart and the right heart are both within the allowable normal range.

[0076] It can be seen that the present application proposes a control method for a biventricular assist system, which acquires a first parameter and a second parameter. The first parameter is the physiological parameter of the target user when the first ventricular assist device operates in a first cycle, and the second parameter is the physiological parameter of the target user when the second ventricular assist device operates in the first cycle. The rotation speed of the first ventricular assist device or the second ventricular assist device is adjusted according to the first parameter and the second parameter. A third parameter is acquired, and the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second cycle. The rotation speed of the first ventricular assist device or the second ventricular assist device is adjusted according to the third parameter so that the cardiac function state of the target user remains normal. In the present application, the rotation speed of the first ventricular assist device or the second ventricular assist device is first adjusted according to the acquired physiological parameter of the user in the first cycle, so that the left ventricle of the user is in a normal operating state. Furthermore, the physiological parameter of the user in the adjusted second cycle is acquired to adjust the rotation speed of the first ventricular assist device or the second ventricular assist device, so that both the left heart and the right heart of the user are in a normal operating state, thereby keeping the systemic circulation and the pulmonary circulation of the user balanced, improving the pumping effect of the biventricular assist system, and alleviating the heart failure symptoms of the user.

[0077] The above mainly introduces the solution of the embodiment of the present application from the perspective of the execution process on the method side. It can be understood that in order for a network device to implement the above functions, it includes corresponding hardware structures and / or software modules for executing each function. Those skilled in the art should easily realize that, in combination with the units 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 way of hardware or computer software driving hardware depends on the specific application and design constraints of the technical solution. Professional technicians can use different methods to implement the described functions for each specific application, but such implementation should not be considered to exceed the scope of the present application.

[0078] Exemplarily, the present application further provides a controller, which is the controller in the above biventricular assist system. The controller includes one or more processors, and the one or more processors are used for: acquiring a first parameter and a second parameter, where the first parameter is the physiological parameter of the target user when the first ventricular assist device operates in a first cycle, and the second parameter is the physiological parameter of the target user when the second ventricular assist device operates in the first cycle; adjusting the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; acquiring a third parameter, where the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second cycle, and the second cycle is the cycle after the rotation speed is adjusted; adjusting the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter so that the cardiac function state of the target user remains normal.

[0079] Exemplarily, the present application further provides a biventricular assist system, which includes:

[0080] A first ventricular assist device for the left ventricle of the target user;

[0081] A second ventricular assist device for the right ventricle of the target user;

[0082] A controller communicatively connected to the first ventricular assist device and the second ventricular assist device, and the controller is configured to:

[0083] Obtain a first parameter and a second parameter, where the first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first cycle, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first cycle;

[0084] Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter;

[0085] Obtain a third parameter, where the third parameter is a physiological parameter of the target user when the second ventricular assist device operates in a second cycle, and the second cycle is the cycle after adjusting the rotation speed;

[0086] Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so as to keep the cardiac function state of the target user normal.

[0087] Wherein, the controller of each of the above solutions has the function of implementing the corresponding steps executed by the medical device in the above method; the function can be implemented by hardware or by hardware executing corresponding software.

[0088] In an embodiment of the present application, the controller may also be a chip or a chip system, for example: a system on chip (SoC).

[0089] Please refer to Figure 3 , Figure 3 which is a schematic structural diagram of a medical device provided by an embodiment of the present 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 memory and are configured to be executed by the one or more processors.

[0090] The above program includes instructions for performing the following steps: obtaining a first parameter and a second parameter, where the first parameter is the physiological parameter of the target user when the first ventricular assist device operates in a first cycle, and the second parameter is the physiological parameter of the target user when the second ventricular assist device operates in the first cycle; adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; obtaining a third parameter, where the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second cycle, and the second cycle is the cycle after the rotational speed is adjusted; adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the third parameter so that the cardiac function state of the target user remains normal.

[0091] Among them, all relevant contents of each scenario involved in the above method embodiments can be cited in the function descriptions of the corresponding functional modules, and will not be elaborated here.

[0092] It should be understood that the above memory may include a read-only memory and a random access memory, and provide instructions and data to the processor. A part of the memory may also include a non-volatile random access memory. For example, the memory may also store information about the device type.

[0093] In the embodiments of the present application, the processor of the above device may be a central processing unit (CPU), and the processor 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 the processor may also be any conventional processor, etc.

[0094] Moreover, unless otherwise stated, the ordinal numbers such as "first" and "second" mentioned in the embodiments of the present application are used to distinguish multiple objects and are not used to limit the order, timing, priority or importance of multiple objects. For example, the first information and the second information are only used to distinguish different information, rather than indicating differences in the content, priority, sending order or importance of these two types of information.

[0095] In the implementation process, each step of the above method can be completed by the integrated logic circuit of the hardware in the processor or the instructions in the form of software. The steps of the method disclosed in combination with the embodiments of the present application can be directly embodied as being executed and completed by the hardware processor, or executed and completed by the combination of the hardware and software units in the processor. The software unit can be located in a mature storage medium in the art such as random access memory, flash memory, read-only memory, programmable read-only memory, or electrically erasable programmable memory, register, etc. This storage medium is located in the memory, and the processor executes the instructions in the memory and combines its hardware to complete the steps of the above method. To avoid repetition, it will not be described in detail here.

[0096] The embodiments of the present application further provide a medical device, and the medical device has the above-mentioned controller or biventricular assist system.

[0097] The embodiments of the present application further 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 some or all of the steps of any method described in the above method embodiments.

[0098] The embodiments of the present application further provide a computer program product. The above computer program product includes a non-transitory computer-readable storage medium storing a computer program, and the above computer program is operable to enable the computer to execute some or all of the steps of any method described in the above method embodiments. The computer program product can be a software installation package.

[0099] It should be noted that for the foregoing method embodiments, for the sake of simple description, they are all expressed as a series of action combinations. However, those skilled in the art should know that the present application is not limited by the described action sequence, because according to the present application, certain steps can be performed in other sequences or simultaneously. Secondly, those skilled in the art should also know that the embodiments described in the specification are all preferred embodiments, and the actions and modules involved are not necessarily essential to the present application.

[0100] In the above embodiments, the descriptions of the various embodiments have their own emphases. For the parts not detailed in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0101] Those of ordinary skill in the art can understand that all or part of the steps in the various methods of the above embodiments can be completed by instructing relevant hardware through a program, and the program can be stored in a computer-readable memory. The memory can include: flash drive, ROM, RAM, magnetic disk or optical disc, etc.

[0102] The above has introduced the embodiments of the present application in detail. Specific examples are used in this text to elaborate on the principle and implementation manner of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application; at the same time, for those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific implementation manner and application scope. In summary, the content of this specification should not be construed as a limitation to the present application.

Claims

1. A control method for a biventricular assist system, characterized in that, The dual-ventricle assist system includes: a first ventricle assist device for the left ventricle of a target user, a second ventricle assist device for the right ventricle of the target user, and a controller communicatively connected to the first ventricle assist device and the second ventricle assist device. The method includes: Obtaining a first parameter and a second parameter, where the first parameter is a physiological parameter of the target user when the first ventricle assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricle assist device operates in the first period; Adjusting the rotational speed of the first ventricle assist device or the second ventricle assist device according to the first parameter and the second parameter; Obtaining a third parameter, where the third parameter is a physiological parameter of the target user when the second ventricle assist device operates in a second period, and the second period is the period after the rotational speed is adjusted; Adjusting the rotational speed of the first ventricle assist device or the second ventricle assist device according to the third parameter so as to keep the cardiac function state of the target user normal.

2. The method according to claim 1, characterized in that The first parameter includes: left ventricular pressure and left ventricular ejection fraction; the second parameter and the third parameter include: blood oxygen saturation and central venous pressure.

3. The method according to claim 2, wherein The adjusting the rotational speed of the first ventricle assist device or the second ventricle assist device according to the first parameter and the second parameter includes: Determining the state of the left ventricle of the target user according to the first parameter; Adjusting the rotational speed of the first ventricle assist device or the second ventricle assist device according to the state of the left ventricle and the second parameter.

4. The method according to claim 3, wherein The determining the state of the left ventricle of the target user according to the first parameter includes: If the left ventricular ejection fraction is greater than a first ejection threshold and the left ventricular pressure is greater than a first ventricular pressure threshold, determining that the left ventricle of the target user is in a first state; If the left ventricular ejection fraction is greater than the first ejection threshold and the left ventricular pressure is less than a second ventricular pressure threshold, determining that the left ventricle of the target user is in a second state, where the first ventricular pressure threshold is greater than the second ventricular pressure threshold; If the left ventricular ejection fraction is less than a second ejection threshold and the left ventricular pressure is greater than the first ventricular pressure threshold, determining that the left ventricle of the target user is in a third state, where the first ejection threshold is greater than the second ejection threshold; If the left ventricular ejection fraction is less than the second ejection threshold and the left ventricular pressure is less than the second ventricular pressure threshold, determining that the left ventricle of the target user is in a fourth state.

5. The method according to claim 4, characterized in that, The adjusting the rotational speed of the first ventricle assist device or the second ventricle assist device according to the state of the left ventricle and the second parameter includes: If the left ventricle is in the first state, the blood oxygen saturation is greater than a first blood oxygen threshold, and the central venous pressure is less than a first venous pressure threshold, reducing the second ventricle assist device by a first speed value; otherwise, increasing the first ventricle assist device by a second speed value, where the second speed value is greater than the first speed value; If the left ventricle is in the second state, and the blood oxygen saturation is less than the second blood oxygen threshold and the central venous pressure is greater than the second venous pressure threshold, increase the first speed value of the second ventricular assist device; otherwise, decrease the second speed value of the first ventricular assist device. The first blood oxygen threshold is greater than the second blood oxygen threshold, and the first venous pressure threshold is less than the second venous pressure threshold; If the left ventricle is in the third state and the central venous pressure is less than the second venous pressure threshold, decrease the first speed value of the second ventricular assist device; otherwise, increase the third speed value of the first ventricular assist device. The third speed value is greater than the second speed value; If the left ventricle is in the fourth state and the central venous pressure is greater than the first venous pressure threshold, increase the second speed value of the second ventricular assist device; otherwise, decrease the third speed value of the first ventricular assist device.

6. The method according to claim 2, wherein Adjusting the rotational speed of the first ventricular assist device or the second ventricular assist device according to the third parameter includes: If the blood oxygen saturation is greater than the first blood oxygen threshold and the central venous pressure is less than the first venous pressure threshold, decrease the second speed value of the second ventricular assist device; If the blood oxygen saturation is less than the second blood oxygen threshold and greater than the first blood oxygen threshold, and the central venous pressure is less than the first venous pressure threshold, increase the fourth speed value of the first ventricular assist device. The fourth speed value is less than the second speed value; If the blood oxygen saturation is greater than the first blood oxygen threshold and the central venous pressure is greater than the second venous pressure threshold, increase the second speed value of the second ventricular assist device; If the blood oxygen saturation is less than the second blood oxygen threshold and greater than the first blood oxygen threshold, and the central venous pressure is greater than the second venous pressure threshold, decrease the fourth speed value of the first ventricular assist device; If the blood oxygen saturation is less than the second blood oxygen threshold and the central venous pressure is less than the first venous pressure threshold, decrease the first speed value of the second ventricular assist device; If the blood oxygen saturation is less than the second blood oxygen threshold and the central venous pressure is greater than the second venous pressure threshold, increase the first speed value of the second ventricular assist device.

7. A controller for a biventricular assist system, characterized in that, The controller is communicatively connected to a first ventricular assist device for the left heart of a target user and a second ventricular assist device for the right heart of the target user in the biventricular assist system. The controller includes one or more processors configured to: Obtain a first parameter and a second parameter. The first parameter is a physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is a physiological parameter of the target user when the second ventricular assist device operates in the first period; Adjust the rotational speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; Obtain a third parameter, where the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotation speed is adjusted; Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so as to keep the cardiac function state of the target user normal.

8. A biventricular assist system, characterized in that, The biventricular assist system includes: A first ventricular assist device for the left ventricle of the target user; A second ventricular assist device for the right ventricle of the target user; A controller communicatively connected to the first ventricular assist device and the second ventricular assist device, and the controller is configured to: Obtain a first parameter and a second parameter, where the first parameter is the physiological parameter of the target user when the first ventricular assist device operates in a first period, and the second parameter is the physiological parameter of the target user when the second ventricular assist device operates in the first period; Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the first parameter and the second parameter; Obtain a third parameter, where the third parameter is the physiological parameter of the target user when the second ventricular assist device operates in a second period, and the second period is the period after the rotation speed is adjusted; Adjust the rotation speed of the first ventricular assist device or the second ventricular assist device according to the third parameter, so as to keep the cardiac function state of the target user normal.

9. A medical device, characterized in that, Includes the controller according to claim 7 or the biventricular assist system according to claim 8.

10. 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 execute the steps of the method according to any one of claims 1-6.

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