Detailed Description
For better understanding of the technical solutions of the present application by those skilled in the art, the technical solutions of 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, and it is apparent that the described embodiments are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the description of the embodiments of the application without making any inventive effort, are intended to fall within the scope of the application.
The terms first, second and the like in the description and in the claims and in the above-described figures are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. Furthermore, the terms "comprise" and "have," as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, software, article, or apparatus that comprises a list of steps or elements is not limited to only those listed steps or elements but may include other steps or elements not listed or inherent to such process, method, article, or apparatus.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.
The medical device and pump according to the application may be a ventricular assist device (Ventricular ASSIST DEVICES, VAD), such as an implantable ventricular assist device, an interventional ventricular assist device, etc., and the ventricular assist device may comprise at least one blood pump, wherein the blood pump may be a centrifugal pump, an axial flow pump, a magnetic levitation pump, etc.
The term "current" in the present application refers to the current driving the motor or the electric machine, which is associated with the power of the motor or the electric machine, with the supply voltage unchanged. "rotational speed" refers to the rotational speed of a motor or electric machine, which is related to the rotational speed of the rotor or impeller of the ventricular assist device, and may be defined as a rotational speed per minute. "flow," "fluid flow," "pumping flow" refers to the volume of fluid delivered by a ventricular assist device per unit of time, which can be estimated and measured in liters per minute.
Referring to fig. 1, fig. 1 is a schematic diagram of a bi-ventricular assist system according to an embodiment of the application, which includes a left ventricular assist device, a right ventricular assist device, and a control device. The left ventricular assist device is disposed in the left ventricle for pumping blood from the left ventricle to the aorta and the right ventricular assist device is disposed in the right ventricle for pumping blood from the right ventricle to the pulmonary artery.
From the flow of blood, the fluid systems are arranged in series with each other, the blood flowing first through the pulmonary artery to the lungs, the pulmonary system being in direct fluid communication with the left ventricle, the blood returning to the left ventricle after oxygenation of the blood in the lungs. Blood is pumped from the left ventricle into the main artery, where it flows through the vascular system to the right ventricle. Thus, blood in turn forms a fluid circulation in the pulmonary artery, right ventricle, left ventricle and aorta. The flow direction in which blood flows from the right ventricle to the pulmonary artery is called pulmonary circulation, and the flow direction in which blood flows from the left ventricle to the aorta is called systemic circulation.
The left ventricular assist device acts on the left heart, it can be placed on the apex of the left ventricle with its fluid inflow in the left ventricle and its fluid outlet connected to the aorta, it can also span the aortic valve with its proximal end in the aorta and its distal end in the left ventricle, pumping blood in the left ventricle into the aorta. The right ventricular assist device acts on the right heart, it may be disposed on the apex of the right ventricle with its fluid inlet in the right ventricle and its fluid outlet connected to the pulmonary artery, or it may span the pulmonary valve with its proximal end in the pulmonary artery and its distal end in the right ventricle, pumping blood in the right ventricle into the pulmonary artery, thereby effecting circulation of the blood.
For example, the left ventricular assist device may be attached to the apex of the left ventricle of the heart via a ventricular connection assembly (e.g., a top ring, a ventricular cuff) that may be sutured to the apex of the left ventricle of the heart and coupled to the ventricular assist device, and the other end of the left ventricular assist device may be connected to the aorta via an outlet tube and/or an artificial blood vessel connected to the outlet tube, such that the left ventricular assist device may effectively transfer blood from the weakened left ventricle and advance it to the aorta, thereby circulating to the remainder of the vascular system, providing ventricular assist functionality to the user. Similarly, a right ventricular assist device may also be attached to the apex of the right ventricle of the heart by a ventricular connection assembly to provide ventricular assist functionality to the user.
Wherein the control device may be an internal control circuit and/or an external control circuit, the control device may be communicatively connected to the left ventricular assist device and the right ventricular assist device for controlling the operation of the left ventricular assist device and the right ventricular assist device. The left and right ventricular assist devices are illustratively connected by a percutaneous cable through the user's abdominal skin to an in vitro control device for effecting independent actuation of the left and right ventricular assist devices, but with a mutual modulation between the controls, with a predetermined correlation in blood flow, and with the flow rate of fluid pumped by the ventricular assist devices being correlated with the volume of blood in the chamber and with the pressure differential, such that a change in the flow rate of fluid from one ventricular assist device causes a corresponding change in the flow rate of fluid from the other ventricular assist device. For example, an increase in the rotational speed of the left ventricular assist device, a decrease in the volume of blood in the left ventricle causes a decrease in the left ventricular pressure, which favors the flow of blood in the lungs to the left ventricle, thereby causing a decrease in pulmonary arterial pressure. The low pulmonary artery pressure reduces the pressure difference between the pulmonary artery pressure and the right ventricular pressure, so that the blood in the right ventricle can be better pumped into the pulmonary artery.
The degree of heart failure of the left ventricle and the right ventricle of the user is different at present, and the degree of support assistance of the ventricular assist device is also different. When one of the ventricular assist devices is abnormal in operation or the pumping flow rate thereof cannot meet or exceed the requirement of the user, imbalance occurs in the systemic circulation and the pulmonary circulation of the user, and the mutual influence and the difference in the heart failure degree between the ventricular assist devices aggravate the instability of the hemodynamics in the user, and even damage the lungs or the hearts of the user. Therefore, ensuring the blood balance of the user's systemic circulation and pulmonary circulation according to the real-time situation of each user is an urgent problem to be solved.
Based on the above, the application provides a rotating speed self-adaption method of a double-ventricle auxiliary system, which judges whether the operation of the current double-ventricle auxiliary system is abnormal according to the difference value of the pumping flow of a left ventricle auxiliary device and the pumping flow of a right ventricle auxiliary device, and further when the operation of the current double-ventricle auxiliary system is abnormal, the rotating speed of the left ventricle auxiliary device and/or the right ventricle auxiliary device is self-adaption adjusted to keep the balance of the left cardiac output and the right cardiac output, so that the pumping problem and the overcharging problem of the left ventricle or the right ventricle are prevented, and the operation safety of the double-ventricle auxiliary system is improved.
In connection with the above description, the present application is described below from the viewpoint of a method example.
Referring to fig. 2, fig. 2 is a flow chart of a rotational speed control method of a bi-ventricular assist system according to an embodiment of the application, which is applied to the bi-ventricular assist system shown in fig. 1. As shown in fig. 2, the method includes the following steps.
S210, acquiring a first left pumping flow and a first right pumping flow, wherein the first left pumping flow is the average pumping flow of the left ventricular assist device in a first period, and the first right pumping flow is the average pumping flow of the right ventricular assist device in the first period.
To maintain the human body, the user's systemic and pulmonary circulation are maintained in balance, i.e., the left and right cardiac output are approximately equal. When the left ventricular assist device and the right ventricular assist device are used respectively because of different degrees of heart failure of the left heart and the right heart, the left cardiac output is equal to the sum of the natural cardiac output of the left heart and the pumping flow of the left ventricular assist device, and the right cardiac output is equal to the sum of the natural cardiac output of the right heart and the pumping flow of the right ventricular assist device. Based on the principle that the left cardiac output is approximately equal to the right cardiac output, the control device may determine whether the current left ventricular assist device and the right ventricular assist device are abnormal by detecting whether the left cardiac output is approximately equal to the right cardiac output.
The ventricular assist device delivers blood to a desired location by rotation of an impeller, which is driven by rotation of a motor. At a given impeller speed or motor speed, the flow of fluid through the ventricular assist device depends on the pressure differential that the ventricular assist device is required to overcome. The relationship between the pumping flow of the ventricular assist device and the motor current is monotonic for the range of currents over which the ventricular assist device can operate, so the current-flow relationship at a preset rotational speed can be used to determine a flow estimate for the ventricular assist device. Therefore, the control device can respectively acquire the first left pumping flow rate of the left ventricular assist device and the first right pumping flow rate of the right ventricular assist device by detecting the current flowing through the motor in the left ventricular assist device and the current flowing through the motor in the right ventricular assist device, and further detect and judge whether the current left ventricular assist device and the right ventricular assist device are abnormal according to the first left pumping flow rate and the first right pumping flow rate.
The first period may be set to 1h, 2h, 5h, etc., so as to improve user security, and the first period may also be set to 10min, 30min, 50min, etc. By way of example, the first period may also be set according to the user situation.
S220, determining a target flow difference according to a first heart failure degree and a second heart failure degree, wherein the first heart failure degree is the heart failure degree of the current left ventricle, and the second heart failure degree is the heart failure degree of the current right ventricle.
The degree of heart failure varies in severity, and the natural cardiac output of the heart varies, so that the natural cardiac output of the heart can be estimated according to the degree of heart failure, and the more serious the degree of heart failure, the less the natural cardiac output of the heart. The control device can respectively determine the natural cardiac output of the left heart and the natural cardiac output of the right heart according to the first heart failure degree and the second heart failure degree, and the left cardiac output is approximately equal to the right cardiac output, so that a target flow difference between the pumping flow of the left ventricular assist device and the pumping flow of the right ventricular assist device can be obtained when the body circulation and the pulmonary circulation balance of the user are maintained.
The target flow rate difference may be a specific value, or may be a range of values, for example, a flow rate difference between the pumping flow rate of the left ventricular assist device and the pumping flow rate of the right ventricular assist device of 1LPM, and a value within a range of 1lpm±0.3LPM may be the target flow rate difference.
The first heart failure degree and the second heart failure degree may be input to the control device by a medical staff member, or may be acquired by the control device from a medical device connected to the control device in a communication manner, which is not limited herein.
S230, determining whether the bi-ventricular assist system is abnormal according to the target flow rate difference and a first flow rate difference, wherein the first flow rate difference is a difference value between the first left pumping flow rate and the first right pumping flow rate.
The abnormal operation of the bi-ventricular assist system comprises at least one of the problems of excessive unloading, pumping, overcharging and the like of the left ventricle caused by mismatching of the pumping flow rate of the left ventricular assist device and the output requirement of the left heart, and the problems of excessive unloading, pumping, overcharging and the like of the right ventricle caused by mismatching of the pumping flow rate of the right ventricular assist device and the output requirement of the right heart.
Optionally, the determining whether the biventricular assist system is abnormal according to the target flow rate difference and the first flow rate difference includes calculating a target value, wherein the target value is a difference value between the first flow rate difference and the target flow rate difference, and determining that the left ventricular assist device and/or the right ventricular assist device is abnormal if an absolute value of the target value is greater than or equal to a preset value.
The control device periodically acquires a first left pumping flow rate of the left ventricular assist device and a first right pumping flow rate of the right ventricular assist device, if a flow difference between the first left pumping flow rate and the first right pumping flow rate is too large compared with a flow difference determined according to the heart failure degree, the control device indicates that the pumping flow rate of the current left ventricular assist device and/or the right ventricular assist device is not matched with the output quantity required by the heart, namely, the pumping flow rate of the left ventricular assist device exceeds or is lower than the output quantity required by the left heart, or the pumping flow rate of the right ventricular assist device exceeds or is lower than the output quantity required by the right heart, and the mismatch can cause imbalance of systemic circulation and pulmonary circulation, cause problems such as pumping, collapsing or pre-filling of the left ventricle and/or the right ventricle, pulmonary or vascular damage and the like.
Specifically, the control device calculates a difference (target value) between the first flow rate difference and the target flow rate difference, if the target value is not within a reasonable range, that is, if the absolute value of the target value is greater than or equal to a preset value, the pumping flow rate of the current left ventricular assist device and the pumping flow rate of the right ventricular assist device are not matched with the output quantity required by the heart of the user, and if the body circulation of the user and the pulmonary circulation are unbalanced, the abnormal operation of the current left ventricular assist device and/or the right ventricular assist device is determined.
And if the target value is a negative value and the absolute value of the target value is greater than or equal to a preset value, the current first left pumping flow is too small and/or the first right pumping flow is too large.
For example, the preset value may be set to 0.5, 0.7, 1.0, 1.2, etc., or may be determined according to the heart failure degree of the user, which is not limited herein.
And S240, when the bi-ventricular assist system is abnormal, adjusting the rotating speed of the left ventricular assist device and/or the right ventricular assist device so as to balance the left cardiac output and the right cardiac output.
In the application, when the left ventricular assist device and/or the right ventricular assist device are/is abnormal in operation, and the first left pumping flow and/or the first right pumping flow are/is overlarge or undershot, the control device can directly adjust the rotating speed of the left ventricular assist device and/or the right ventricular assist device, so that the left cardiac output and the right cardiac output can be kept balanced, and the problems of excessive unloading, excessive suction, excessive pre-charge and the like are avoided.
Optionally, when the bi-ventricular assist system is abnormal, the rotational speed of the left ventricular assist device and/or the right ventricular assist device is/are adjusted, and the method comprises the steps of obtaining a first characteristic curve, a first left rotational speed, a second characteristic curve and a first right rotational speed, wherein the first characteristic curve is a pressure flow characteristic curve of the left ventricular assist device, the second characteristic curve is a pressure flow characteristic curve of the right ventricular assist device, the first left rotational speed is an average rotational speed of the left ventricular assist device in the first period, the first right rotational speed is an average rotational speed of the right ventricular assist device in the first period, estimating a left ventricular differential pressure according to the first characteristic curve and the first left pumping flow, estimating a right ventricular differential pressure according to the second characteristic curve and the first right pumping flow, calculating a first target rotational speed according to the left ventricular differential pressure, calculating a second target rotational speed according to the right ventricular differential pressure, and respectively balancing the left ventricular assist device and the right ventricular assist device with the left ventricular assist device and the right ventricular assist device.
Wherein, in ventricular systole, the aortic valve or pulmonary valve is opened, blood in the ventricle is pumped to the aorta or pulmonary artery, the blood volume in the ventricle is gradually reduced and the blood volume in the ventricle is gradually reduced, and in ventricular diastole, the mitral valve or tricuspid valve is opened, blood in the atrium flows to the ventricle, the blood volume in the ventricle is gradually increased and the ventricular pressure is also gradually increased. That is, the change in blood volume within the ventricle coincides with the change in ventricular pressure, and the pressure difference between the inside and outside of the ventricle determines how much of the pumping flow, e.g., the greater the pressure difference between the aortic pressure and the left ventricular pressure difference, the more pumping is the left ventricle. At a certain rotational speed, there is a mapping relation between the flow and the pressure difference, so the pumping flow of the left ventricular assist device can be represented by the left ventricular pressure difference, and the pumping flow of the right ventricular assist device can be represented by the right ventricular pressure difference. The reason for abnormality of the left ventricular assist device and/or the right ventricular assist device can be determined according to the left ventricular pressure difference and the right ventricular pressure difference, and then a strategy for adjusting the rotation speed of the left ventricular assist device and/or the right ventricular assist device is determined according to the reason for abnormality.
Specifically, the control device acquires a pressure flow characteristic curve of the left ventricular assist device and a rotational speed thereof (first left rotational speed), acquires a pressure flow characteristic curve of the right ventricular assist device and a rotational speed thereof (first right rotational speed). The left ventricular pressure difference corresponding to the first left rotating speed and the first left pumping flow can be searched from the first characteristic curve, and the right ventricular pressure difference corresponding to the first right rotating speed and the first right pumping flow can be searched from the second characteristic curve. The cause of the imbalance between left and right cardiac output is determined based on the left and right ventricular pressure differences to determine a strategy for regulating the rotational speed of the left and/or right ventricular assist device.
In the application, before the left ventricular assist device and the right ventricular assist device leave the factory, the left ventricular assist device and the right ventricular assist device are placed in a test environment to measure the characteristic curves of pumping flow and ventricular pressure difference under different rotating speeds. The pressure flow characteristic curve for each rotational speed is then stored in the control device. When the left ventricular assist device and the right ventricular assist device are operated, the current rotation speeds and pumping flows of the left ventricular assist device and the right ventricular assist device are obtained, then the ventricular pressure difference of the current left ventricular assist device and the current ventricular assist device is estimated according to the pressure flow characteristic curve, and the reason of abnormal operation of the current left ventricular assist device or the current ventricular assist device is determined according to the magnitude of the ventricular pressure difference.
If the left ventricular pressure difference is smaller than a first left pressure difference threshold or larger than a second left pressure difference threshold, calculating a first flow variable, wherein the first flow variable is a difference value between the first left pumping flow and a second left pumping flow, and the second left pumping flow is an average pumping flow of the left ventricular assist device in a second period, and the second period is earlier than the first period; determining a first regulating rotating speed according to the first flow variable quantity and the first characteristic curve, determining a first target formula according to the left ventricular pressure difference and the right ventricular pressure difference, substituting the first left rotating speed and the first regulating rotating speed into the first target formula, and calculating to obtain the first target rotating speed.
The left differential pressure is the differential pressure of the aortic pressure and the left ventricular pressure, and the first left differential pressure threshold value and the second left differential pressure threshold value are respectively the minimum value and the maximum value of the differential pressure of the normal human aortic pressure and the left ventricular pressure. For example, the first left differential pressure threshold is 60 mmHg and the second left differential pressure threshold is 80 mmHg. When the left ventricular pressure difference of the user is lower than the first left pressure difference threshold value, the left ventricular pressure of the current user is excessively high or the aortic pressure is excessively low, and when the left ventricular pressure difference is higher than the second left pressure difference threshold value, the left ventricular pressure of the current user is excessively low or the aortic pressure is excessively high.
The arterial pressure may be too high because of the high blood pressure due to the excessive vascular resistance, and the blood is deposited in the left ventricle and cannot be pumped to the aorta. The user's left ventricle may be depressed because of too little blood volume in the left ventricle due to too high a rotational speed of the left ventricular assist device, or too little blood volume in the left ventricle due to systemic hypovolemia or right heart failure. The user's arterial pressure may be too low or the left ventricular pressure may be too high due to excessive left ventricular volume caused by too low a rotational speed of the left ventricular assist device.
The control device can judge the severity of the abnormal operation of the current left ventricular assist device according to the change condition of the pumping flow of the left ventricular assist device in the adjacent period, and further determine the speed of the rotating speed of the left ventricular assist device to be increased or decreased according to the severity of the abnormal operation.
The application considers the tolerance of heart failure degree of the left heart to the increase or decrease of pumping flow and the influence degree of the operation of the right ventricular assist device on the left ventricle, and adjusts the rotating speed of the left ventricular assist device according to the change condition of the pumping flow of the left ventricular assist device. Specifically, the pumping flows corresponding to the left ventricular differential pressure at different rotation speeds are different, and when the pumping flow of the first flow variation is increased or decreased, the adjustment rotation speed which needs to be increased or decreased can be determined from the first characteristic curve after the left ventricular differential pressure and the first flow variation are acquired. And then the final rotation speed of increasing or decreasing the adjustment rotation speed on the basis of the first left rotation speed is taken as a first target rotation speed, namely the first left rotation speed and the first adjustment rotation speed are substituted into a first target formula to calculate the first target rotation speed.
The first target formula may be expressed asThe saidFor the first left rotation speed, theAs a first interference influencing factor, theIs the first heart failure affecting factor, theFor the first adjustment speed, the first interference influence factor is an influence factor of the right ventricular assist device on the left ventricular assist device, the first heart failure influence factor is an influence factor of the heart failure degree of the left ventricle on the left ventricular assist device, the first interference influence factor is a first interference influence factor of the right ventricular assist device on the left ventricular assist device, the first interference influence factor is a second interference influence factorAnd saidAre all greater than 0 and less than 1. The more severe the first degree of heart failure,The larger. The more severe the second degree of heart failure,The larger.
Wherein increasing or decreasing the rotational speed of the left ventricular assist device is required to be determined based on the current state of the left and right ventricles. The determining a first target formula according to the left ventricular pressure difference and the right ventricular pressure difference includes if the left ventricular pressure difference is less than the first left pressure difference threshold and the right ventricular pressure difference is less than a first right pressure difference threshold, the first target formula is: If the left ventricular pressure difference is smaller than the first left pressure difference threshold, and the right ventricular pressure difference is greater than or equal to the first right pressure difference threshold, the first target formula is: if the left ventricular pressure difference is greater than the second left pressure difference threshold, and the right ventricular pressure difference is less than the first right pressure difference threshold, the first target formula is: If the left ventricular pressure difference is greater than the second left pressure difference threshold, and the right ventricular pressure difference is greater than or equal to the first right pressure difference threshold, the first target formula is: 。
the greater the pumping flow of the left ventricular assist device, the more blood flow that flows back to the right atrium via the systemic circulation, and the greater the pumping flow of the right ventricular assist device, the more blood flow that flows back to the left atrium via the pulmonary circulation.
If the pressure difference of the left ventricle is smaller than the first pressure difference threshold, the speed of the left ventricular assist device is too low to cause excessive blood volume in the left ventricle, and the speed of the left ventricular assist device is required to be increased, if the pressure difference of the right ventricle is larger than or equal to the first pressure difference threshold, the current right ventricle is in a normal state or the speed of the right ventricular assist device is too high to cause insufficient blood volume in the right ventricle, and the speed of the left ventricular assist device is required to be rapidly increased at the moment, so the first target formula can be determined as follows. When the left ventricular pressure difference is smaller than the first left pressure difference threshold and the rotational speed of the left ventricular assist device needs to be increased, if the right ventricular pressure difference is also smaller than the first right pressure difference threshold, the rotational speed of the right ventricular assist device is too low to cause excessive blood volume in the right ventricle, and the rotational speed of the left ventricular assist device cannot be increased too fast to prevent the right ventricle from being excessively unloaded to damage the right ventricle, so the first target formula can be determined as follows。
If the pressure difference of the left ventricle is larger than the second threshold value of the left pressure difference, the current left ventricular assist device is too high to cause the blood volume in the left ventricle to be too small, the rotation speed of the left ventricular assist device needs to be reduced, if the pressure difference of the right ventricle is also smaller than the first threshold value of the right pressure difference, the current right ventricular assist device is too low to cause the blood volume in the right ventricle to be too large, and the rotation speed of the left ventricular assist device needs to be reduced in a accelerating way, so that the first target formula is determined to be. If the left ventricular pressure difference is greater than the second left pressure difference threshold and the rotational speed of left ventricular assist is required to be reduced, if the right ventricular pressure difference is also greater than or equal to the first right pressure difference threshold, the right ventricle is in a normal state or the rotational speed of the right ventricular assist device is too high to cause too little blood volume in the right ventricle, and the rotational speed of the left ventricular assist device cannot be increased rapidly to aggravate the problem of too little blood volume in the right ventricle, so the first target formula can be determined as。
The calculating of the second target rotating speed according to the right ventricular pressure difference comprises the steps of calculating a second flow variable quantity if the right ventricular pressure difference is smaller than a first right pressure difference threshold or larger than a second right pressure difference threshold, wherein the second flow variable quantity is a difference value between the first right pumping flow and the second right pumping flow, the second right pumping flow is an average pumping flow of the right ventricular assist device in a second period, the second period is earlier than the first period, a second adjusting rotating speed is determined according to the second flow variable quantity and the second flow characteristic curve, a second target formula is determined according to the left ventricular pressure difference and the right ventricular pressure difference, and the first right rotating speed and the second adjusting rotating speed are substituted into the second target formula to obtain the first right rotating speed through calculation.
The right differential pressure is the differential pressure of pulmonary artery pressure and right ventricular pressure, and the first right differential pressure threshold and the second right differential pressure threshold are respectively the minimum value and the maximum value of the differential pressure of normal pulmonary artery pressure and right ventricular pressure. For example, the first right differential pressure threshold is 20 mmHg and the second right differential pressure threshold is 30 mmHg. When the right ventricular pressure difference of the user is lower than a first right differential pressure threshold value, the right ventricular pressure of the current user is excessively high or the pulmonary artery pressure is excessively low, and when the right ventricular pressure difference is higher than a second right differential pressure threshold value, the right ventricular pressure of the current user is excessively low or the pulmonary artery pressure is excessively high.
The pulmonary hypertension may be caused by excessive vascular resistance and high blood pressure, and the blood is accumulated in the right ventricle and cannot be pumped to the pulmonary artery. The user's right ventricle may be depressed because of too little blood volume in the right ventricle due to too high a rotational speed of the right ventricular assist device, or too little blood volume in the right ventricle due to systemic hypovolemia or right heart failure. The user's pulmonary artery pressure is too low or the right ventricle pressure is too high, which may be caused by too low a rotational speed of the right ventricular assist device, resulting in too much blood volume in the right ventricle.
The control device can judge the severity of the abnormal operation of the current right ventricular assist device according to the change condition of the pumping flow of the right ventricular assist device in the adjacent period, and further determine the speed of increasing or decreasing the rotating speed of the right ventricular assist device according to the severity.
The application considers the tolerance of heart failure degree of the right heart to the increase or decrease of pumping flow and the influence degree of the operation of the left ventricular assist device on the right ventricle, and adjusts the rotating speed of the right ventricular assist device according to the change condition of the pumping flow of the right ventricular assist device. Specifically, the pumping flows corresponding to the differential pressure of the right ventricle at different rotation speeds are different, and when the differential pressure of the right ventricle and the second flow variation are obtained, the pumping flow which is increased or decreased in the second flow variation can be determined from the second characteristic curve, and the rotation speed needs to be increased or decreased. And then the final rotation speed of increasing or decreasing the adjustment rotation speed on the basis of the first right rotation speed is taken as a second target rotation speed, namely the first right rotation speed and the second adjustment rotation speed are substituted into a second target formula to calculate the second target rotation speed.
The second target formula may be expressed asThe saidFor the first right rotational speed, theAs a second interference influencing factor, saidIs the second heart failure influencing factor, theFor the second adjustment speed, the second interference influence factor is an influence factor of the left ventricular assist device on the right ventricular assist device, the second heart failure influence factor is an influence factor of the heart failure degree of the right ventricle on the right ventricular assist device, the first interference influence factor is a difference between the left ventricular assist device and the right ventricular assist device, the second interference influence factor is a difference between the left ventricular assist device and the right ventricular assist deviceAnd saidAre all greater than 0 and less than 1. The more severe the second heart failure degree, theThe greater the first heart failure degree, the more severe theThe larger.
Wherein increasing or decreasing the rotational speed of the right ventricular assist device is required to be determined based on the current left and right ventricular conditions. The determining a second target formula according to the left ventricular pressure difference and the right ventricular pressure difference includes if the right ventricular pressure difference is smaller than the first right differential pressure threshold value and the left ventricular pressure difference is smaller than a first left differential pressure threshold value, the second target formula is: if the right ventricular pressure difference is smaller than the first right differential pressure threshold, and the left ventricular pressure difference is greater than or equal to the first left differential pressure threshold, the first target formula is: If the right ventricular pressure difference is greater than the second right differential pressure threshold, and the left ventricular pressure difference is less than the first left differential pressure threshold, the first target formula is: If the right ventricular pressure difference is greater than the second right differential pressure threshold, and the left ventricular pressure difference is greater than or equal to the first left differential pressure threshold, the first target formula is: 。
Specifically, if the pressure difference of the right ventricle is smaller than the first threshold value, it indicates that the rotational speed of the right ventricular assist device is too low to cause excessive blood volume in the right ventricle, and the rotational speed of the right ventricular assist device needs to be increased, and if the pressure difference of the left ventricle is larger than or equal to the first threshold value, it indicates that the current left ventricle is in a normal state or the rotational speed of the left ventricular assist device is too high to cause insufficient blood volume in the left ventricle, and at this time, the rotational speed of the right ventricular assist device needs to be increased rapidly, so the second target formula can be determined as . When the right ventricular pressure difference is smaller than the first right pressure difference threshold and the rotational speed of the right ventricular assist device needs to be increased, if the left ventricular pressure difference is also smaller than the first left pressure difference threshold, the rotational speed of the left ventricular assist device is too low to cause excessive left ventricular volume, and the rotational speed of the left ventricular assist device cannot be increased too fast to prevent the left ventricle from being excessively damaged by left ventricular unloading, so the second target formula can be determined as follows. If the pressure difference of the right ventricle is larger than the second threshold value of the right pressure difference, the current speed of the right ventricular assist device is too high to reduce the blood volume in the right ventricle, and the speed of the right ventricular assist device is required to be reduced, if the pressure difference of the left ventricle is also smaller than the first threshold value of the left pressure difference, the current speed of the left ventricular assist device is too low to reduce the blood volume in the left ventricle, and the speed of the right ventricular assist device is required to be reduced, so that the second target formula is determined to be. If the pressure difference of the right ventricle is greater than the second threshold value, and the pressure difference of the left ventricle is greater than or equal to the first threshold value, the left ventricle is in a normal state or the rotational speed of the left ventricular assist device is too high to reduce the blood volume in the left ventricle, and the rotational speed of the right ventricular assist device cannot be increased rapidly to aggravate the problem of the reduced blood volume in the left ventricle, so the second target formula can be determined as。
In the application, when the abnormal operation of the left ventricular assist device and/or the right ventricular assist device is detected, the control device considers the influence of the left heart failure degree and the right heart failure degree of the user on the left ventricular assist device and the right ventricular assist device, directly calculates the rotating speeds required by the left ventricular assist device and the right ventricular assist device when the body circulation and the pulmonary circulation of the user reach balance again, can reduce the times of blind rotation speed adjustment of the left ventricular assist device and/or the right ventricular assist device, avoid more serious hemodynamic unstable influence on a target user in the rotation speed adjustment process and avoid acute lung injury, and can also quickly maintain the balance of the left heart output and the right heart output, prevent the suction problem and the pre-charging problem of the left ventricle or the right ventricle and improve the operation safety of the double-ventricle assist system.
The application provides a rotating speed self-adaption method of a double-ventricle auxiliary system, which comprises the steps of obtaining a first left pumping flow and a first right pumping flow, wherein the first left pumping flow is the average pumping flow of a left ventricle auxiliary device in a first period, the first right pumping flow is the average pumping flow of a right ventricle auxiliary device in the first period, determining a target flow difference according to a first heart failure degree and a second heart failure degree, the first heart failure degree is the heart failure degree of a current left ventricle, the second heart failure degree is the heart failure degree of the current right ventricle, determining whether the double-ventricle auxiliary system is abnormal according to the target flow difference and the first flow difference, wherein the first flow difference is the difference between the first left pumping flow and the first right pumping flow, and adjusting the rotating speed of the left ventricle auxiliary device and/or the right ventricle auxiliary device when the double-ventricle auxiliary system is abnormal, so that the left heart output quantity and the right heart output quantity are balanced. According to the application, whether the operation of the current double-ventricle auxiliary system is abnormal or not is judged according to the difference value of the pumping flow rate of the left ventricle auxiliary device and the pumping flow rate of the right ventricle auxiliary device, and further when the operation is abnormal, the left cardiac output and the right cardiac output are kept balanced by adaptively adjusting the rotating speed of the left ventricle auxiliary device and/or the right ventricle auxiliary device, so that the pumping problem and the overcharging problem of the left ventricle or the right ventricle are prevented, and the operation safety of the double-ventricle auxiliary system is improved.
The foregoing description of the embodiments of the present application has been presented primarily in terms of a method-side implementation. It will be appreciated that the network device, in order to implement the above-described functions, includes corresponding hardware structures and/or software modules that perform the respective functions. Those of skill in the art will readily appreciate that the various illustrative elements and algorithm steps described in connection with the embodiments disclosed herein may be implemented as hardware or combinations of hardware and computer software. Whether a function is implemented as hardware or computer software driven hardware depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application.
By way of example, the present application provides a control device for a biventricular assist system comprising a left ventricular assist device for pumping fluid from a left ventricle to an aorta and a right ventricular assist device for pumping fluid from a right ventricle to a pulmonary artery, the control device being in communication with the left ventricular assist device and the right ventricular assist device, the control device comprising one or more processors for:
Acquiring a first left pumping flow and a first right pumping flow, wherein the first left pumping flow is the average pumping flow of the left ventricular assist device in a first period, and the first right pumping flow is the average pumping flow of the right ventricular assist device in the first period;
Determining a target flow difference according to a first heart failure degree and a second heart failure degree, wherein the first heart failure degree is the heart failure degree of the current left ventricle, and the second heart failure degree is the heart failure degree of the current right ventricle;
Determining whether the bi-ventricular assist system is abnormal in operation according to the target flow rate difference and a first flow rate difference, the first flow rate difference being a difference between the first left pumping flow rate and the first right pumping flow rate;
In the event of an abnormal operation of the bi-ventricular assist system, the rotational speed of the left ventricular assist device and/or the right ventricular assist device is adjusted to balance left cardiac output with right cardiac output.
Illustratively, the present application also provides a biventricular assist system comprising:
A left ventricular assist device for pumping fluid from the left ventricle to the aorta;
A right ventricular assist device for pumping fluid from the right ventricle to the pulmonary artery;
And a control device in communication with the left ventricular assist device and the right ventricular assist device, the control device configured to execute instructions for some or all of the steps described in the method described above.
The application also provides, for example, a medical device comprising the control apparatus or the bi-ventricular assist system described above.
The control device of each scheme has the function of realizing the corresponding steps executed by the medical equipment in the method, and the function can be realized by hardware or can be realized by executing corresponding software by hardware.
In an embodiment of the present application, the control device may also be a chip or a system on chip (SoC), for example.
Referring to fig. 3, fig. 3 is a schematic structural diagram of a medical device according to an embodiment of the present application, where the medical device includes one or more processors, one or more memories, one or more communication interfaces, and one or more programs, and the one or more programs are stored in the memories and configured to be executed by the one or more processors.
The program includes instructions for performing the steps of:
Acquiring a first left pumping flow and a first right pumping flow, wherein the first left pumping flow is the average pumping flow of the left ventricular assist device in a first period, and the first right pumping flow is the average pumping flow of the right ventricular assist device in the first period;
Determining a target flow difference according to a first heart failure degree and a second heart failure degree, wherein the first heart failure degree is the heart failure degree of the current left ventricle, and the second heart failure degree is the heart failure degree of the current right ventricle;
Determining whether the bi-ventricular assist system is abnormal in operation according to the target flow rate difference and a first flow rate difference, the first flow rate difference being a difference between the first left pumping flow rate and the first right pumping flow rate;
In the event of an abnormal operation of the bi-ventricular assist system, the rotational speed of the left ventricular assist device and/or the right ventricular assist device is adjusted to balance left cardiac output with right cardiac output.
All relevant contents of each scenario related to the above method embodiment may be cited to the functional description of the corresponding functional module, which is not described herein.
It should be appreciated that the memory described above may include read only memory and random access memory and provide instructions and data to the processor. A portion of the memory may also include non-volatile random access memory. For example, the memory may also store information of the device type.
In an embodiment of the present application, the processor of the above apparatus may be a central processing unit (Central Processing Unit, CPU), which may 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 gate or transistor logic devices, discrete hardware components, or the like. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like.
It should be understood that references to "at least one" in embodiments of the present application mean one or more, and "a plurality" means two or more. "and/or" describes an association of associated objects, meaning that there may be three relationships, e.g., A and/or B, and that there may be A alone, while A and B are present, and B alone, where A, B may be singular or plural. The character "/" generally indicates that the context-dependent object is an "or" relationship. "at least one of" or the like means any combination of these items, including any combination of single item(s) or plural items(s). For example, at least one (a, b, or c) of a, b, c, a-b, a-c, b-c, or a-b-c may be represented, wherein a, b, c may be single or plural.
And, unless specified to the contrary, references to "first," "second," etc. ordinal words of embodiments of the present application are used for distinguishing between multiple objects and are not used for limiting the order, timing, priority, or importance of the multiple objects. For example, the first information and the second information are only for distinguishing different information, and are not indicative of the difference in content, priority, transmission order, importance, or the like of the two information.
In implementation, the steps of the above method may be performed by integrated logic circuits of hardware in a processor or by instructions in the form of software. The steps of the method disclosed in connection with the embodiments of the present application may be embodied directly in a hardware processor for execution, or in a combination of hardware and software elements in the processor for execution. The software elements may be located in a random access memory, flash memory, read-only memory, programmable read-only memory or electrically erasable programmable memory, registers, etc. as well known in the art. The storage medium is located in a memory, and the processor executes instructions in the memory to perform the steps of the method described above in conjunction with its hardware. To avoid repetition, a detailed description is not provided herein.
The embodiment of the present application also provides a computer storage medium storing a computer program for electronic data exchange, where the computer program causes a computer to execute some or all of the steps of any one of the methods described in the above method embodiments.
Embodiments of the present application also provide a computer program product comprising a non-transitory computer-readable storage medium storing a computer program operable to cause a computer to perform part or all of the steps of any one of the methods described in the method embodiments above. The computer program product may be a software installation package.
It should be noted that, for simplicity of description, the foregoing method embodiments are all described as a series of acts, but it should be understood by those skilled in the art that the present application is not limited by the order of acts described, as some steps may be performed in other orders or concurrently in accordance with the present application. Further, those skilled in the art will also appreciate that the embodiments described in the specification are all preferred embodiments, and that the acts and modules referred to are not necessarily required for the present application.
In the foregoing embodiments, the descriptions of the embodiments are emphasized, and for parts of one embodiment that are not described in detail, reference may be made to related descriptions of other embodiments.
In the several embodiments provided by the present application, it should be understood that the disclosed apparatus may be implemented in other manners. For example, the above-described apparatus embodiments are merely illustrative, and the division of elements, such as those described above, is merely a logical function division, and may be implemented in other manners, such as multiple elements or components may be combined or integrated into another system, or some features may be omitted, or not performed. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be an indirect coupling or communication connection via some interfaces, devices or units, or may be in electrical or other forms.
The units described above as separate components may or may not be physically separate, and components shown as units may or may not be physical units, may be located in one place, or may be distributed over a plurality of network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the embodiment of the present application.
In addition, each functional unit in the embodiments of the present application may be integrated in one processing unit, or each unit may exist alone physically, or two or more units may be integrated in one unit. The integrated units may be implemented in hardware or in software functional units.
The integrated units described above, if implemented in the form of software functional units and sold or used as stand-alone products, may be stored in a computer readable memory. Based on such understanding, the technical solution of the present application may be embodied essentially or partly in the form of a software product or all or part of the technical solution, which is stored in a memory, and includes several instructions for causing a computer device (which may be a personal computer, a server, or TRP, etc.) to perform all or part of the steps of the method of the embodiments of the present application. The Memory includes a U disk, a Read-Only Memory (ROM), a random access Memory (RAM, random Access Memory), a removable hard disk, a magnetic disk, or an optical disk, etc. which can store the program codes.
Those of ordinary skill in the art will appreciate that all or a portion of the steps of the various methods of the above embodiments may be implemented by a program that instructs associated hardware, and the program may be stored in a computer readable memory, which may include a flash disk, a ROM, a RAM, a magnetic disk, an optical disk, etc.
The foregoing has outlined rather broadly the more detailed description of embodiments of the application, wherein the principles and embodiments of the application are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the application; meanwhile, as those skilled in the art will have variations in the specific embodiments and application scope in accordance with the ideas of the present application, the present description should not be construed as limiting the present application in view of the above.