Blood pump speed pulsation control method, system and related products

Abstract

The present application discloses a blood pump speed pulsation control method, system, and related products. The method: based on the electrical signal change information of the blood pump motor within a historical period, detects the start time of the N0 diastole and the start time of the N0 systole of the current patient's heart beat within the historical period; based on these start times, determines the start time of the N1 diastole and the start time of the N1 systole of the heart after the historical period. The method uses the patient's individual historical electrical signal change information as a basis to determine the future start time of the diastole and the start time of the systole of the current patient's heart, ensuring that the speed adjustment time of the blood pump motor is personalized to conform to the physiological contraction law of the individual heart, and realizing the specific output of the blood pump such as the blood pumping time and the blood pumping volume per time to flexibly follow the blood flow pulsation output of the heart beat, that is, to assist the blood pump in generating a pulsating flow synchronized with the natural heart beat, thereby effectively and reliably maintaining the patient's life safety.

Description

Technical Field

[0001] The embodiments of the present application relate to the field of medical technology, and in particular to a blood pump speed pulsation control method, system, and related products. Background Art

[0002] Heart failure is a serious heart disease that causes the heart to be unable to pump enough blood to meet the body's needs. Left Ventricular Assist Device (LVAD), an implantable medical device (or blood pump), assists or replaces a weakened heart's pumping function and has become a treatment option for patients awaiting a heart transplant or with end-stage heart failure. Specifically, the inlet tube of an implantable blood pump connects to the heart's left ventricle, and the outlet connects to an artificial blood vessel, which ultimately connects to the aorta. One of the core components of an implantable blood pump is the motor. When its rotor is driven to rotate, blood is drawn from the left ventricle, flows through the blood pump channel, and is ultimately pumped into the aorta. From there, the aorta delivers blood to the entire body, thereby assisting or replacing the heart's pumping function.

[0003] Currently, most blood pump products approved for short-term assisted transition or long-term assisted therapy provide non-physiological continuous flow control. That is, the blood flow pulsation control output (referred to as pulsatile flow) generated by existing products is not synchronized with, or even unrelated to, the patient's own heart beat pattern. For example, the motor speed of the blood pump used by each patient is fixedly adjusted at regular intervals. For example, once each blood pump motor has run for a cycle, its subsequent speed is fixedly adjusted to fluctuate up or down by 2000 revolutions per minute (RPM).

[0004] It can be seen that this pulsating flow lacks the individual patient's physiological pulsation law (or called heart contraction law). The specific outputs of the blood pump, such as the pumping time and the amount of blood pumped each time, cannot flexibly follow the blood flow pulsation law of the individual heart beat, which may bring or aggravate the risks of postoperative right heart failure, aortic insufficiency, gastrointestinal bleeding, cerebral stroke, etc. Summary of the Invention

[0005] The embodiments of the present application provide a blood pump speed pulsation control method, system and related products for flexibly controlling the activation time (i.e., the start time) of the speed pulsation control of each blood pump motor in an individual, ensuring that the blood pump generates a pulsating flow synchronized with the patient's heart beat pattern, thereby reducing safety risks.

[0006] A first aspect of an embodiment of the present application provides a blood pump speed pulsation control method, comprising:

[0007] For the current patient's implantable blood pump motor, based on information about changes in electrical signals from the motor during a historical period, detecting the start time of the N0th diastole and the start time of the N0th systole of the patient's heart beat during the historical period; the electrical signal change information is used to reflect whether the current patient's heart has entered diastole or systole, and the start time of the systole is the end time of the diastole;

[0008] Based on the N0 start times of diastole and the N0 start times of systole, the N1 start times of diastole and the N1 start times of systole of the heart after the historical period are determined respectively; wherein, the N1 start times of diastole and the N1 start times of systole are the times when the diastole preset speed and the systole preset speed of the motor are correspondingly activated each time, the N0 and the N1 are positive integers, and the diastole preset speed and the systole preset speed are determined at least based on the current physiological condition of the patient.

[0009] Optionally, detecting the N0th diastolic start time and the N0th systolic start time of the heart beat of the current patient in the historical period according to the electrical signal change information of the motor in the historical period includes:

[0010] Extracting electrical signal information corresponding to the motor at different times during a historical period to form an electrical signal waveform jointly depicted by the electrical signal information; the historical period is at least longer than the cumulative duration of N0 cardiac cycles, where one cardiac cycle includes one diastole and one systole;

[0011] When the electrical signal is a motor current, the moment when the N0th falling edge and the N0th rising edge begin to appear in the electrical signal waveform are detected as the N0th diastolic start moment and the N0th systolic start moment of the heart.

[0012] Optionally, determining the N1 start time of diastole and the N1 start time of systole of the heart after the historical period based on the N0 start time of diastole and the N0 start time of systole, respectively, includes:

[0013] Based on the N0 diastolic start time and the N0 systolic start time, calculating the average diastolic duration and systolic duration of each heart beat; the sum of the diastolic duration and the systolic duration is one cardiac cycle;

[0014] The start time of the first diastole and the start time of the first systole in the N1 times are calculated according to the cardiac cycle and the start time of the N0th systole, the start time of the diastole of each of the remaining N1 times is calculated based on the start time of the first systole and the duration of the systole, and the start time of the systole of each of the remaining N1 times is calculated by the start time of each diastole and the duration of the diastole.

[0015] Optionally, based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further includes:

[0016] A preset time difference is added to each of the N1 diastolic start times and the N1 systolic start times to obtain the delayed N1 diastolic start time and the N1 systolic start time.

[0017] Optionally, based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further includes:

[0018] In the N1 times, each time the start time of the diastole is reached, the speed of the motor in the diastole is adjusted to the preset diastole speed, and each time the start time of the systole is reached, the speed of the motor in the systole is adjusted to the preset systole speed; the preset diastole speed is less than or equal to the preset systole speed.

[0019] Optionally, based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further includes:

[0020] Determining a rotation speed reset time based on the N1th diastolic period start time or the N1th systolic period start time;

[0021] When the speed reset moment is reached, the speed of the motor is adjusted to the initial speed so that the motor runs at the initial speed for a period of time, and then returns to the step of detecting the start time of the N0 diastole and the start time of the N0 systole of the current patient's heart beat in the historical period based on the electrical signal change information of the motor in the historical period.

[0022] Optionally, detecting the N0th diastolic start time and the N0th systolic start time of the heart beat of the current patient in the historical period according to the electrical signal change information of the motor in the historical period includes:

[0023] Since the first detection of the diastolic start time and the systolic start time in the N0 times, if the n-th detection result in the N0 times does not meet the preset conditions, at least the n-th systolic start time or the adjacent diastolic start time is re-detected until the n-th detection result that meets the preset conditions is obtained;

[0024] Among them, the preset conditions include: the difference between the nth start time of the systole and the adjacent start time of the diastole does not meet the threshold, and / or the number of times the start time of the diastole and the start time of the systole are detected in the historical period is greater than or equal to the N0 times, and n is between 1 and the N0 value.

[0025] The method described in the first aspect of the present application can be implemented by using the content described in the second aspect of the present application. The second aspect of the embodiment of the present application provides a blood pump speed pulsation control system, including: an external controller and / or an implantable blood pump;

[0026] The implantable blood pump includes an implantable motor, and the external controller is connected to the implantable blood pump;

[0027] The external controller and / or the implantable blood pump is used to execute the blood pump speed pulsation control method described in the first aspect or any specific implementation of the first aspect, so as to control the motor to enable the preset diastolic speed each time it reaches the start of the diastolic phase of the patient's heart within a preset number of times, and to enable the preset systolic speed each time it reaches the start of the systolic phase of the patient's heart.

[0028] A third aspect of an embodiment of the present application provides a computer-readable storage medium, which stores computer instructions. When the computer instructions are executed by a processor, they implement the method described in the first aspect of the embodiment of the present application or any specific implementation of the first aspect.

[0029] A fourth aspect of an embodiment of the present application provides a computer program product, which includes computer instructions. When the computer instructions are executed by a processor, they implement the method described in the first aspect of the embodiment of the present application or any specific implementation of the first aspect.

[0030] It can be seen from the above technical solutions that the embodiments of the present application have at least the following advantages:

[0031] The embodiment of the present application is based on the patient's individual historical electrical signal change information to determine the future start time of the diastole and the start time of the systole of the current patient's heart, which can ensure that the speed adjustment time of the blood pump motor is personalized to conform to the physiological contraction law of the individual heart, and realize the specific output of the blood pump such as the blood pumping time and the amount of blood pumped each time to flexibly follow the blood flow pulsation output of the heart beat, that is, to assist the blood pump in generating a pulsating flow synchronized with the natural heart beat, thereby effectively and reliably maintaining the patient's life safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments recorded in the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0033] It should be noted that although the steps in the process diagrams involved in the various embodiments are drawn in sequence as indicated by the arrows, unless otherwise specified herein, there is no strict order restriction on the execution of these steps, and these steps can be executed in other orders. Moreover, at least a portion of the steps in the flowcharts involved in the various embodiments may include multiple steps or multiple stages, and these steps or stages are not necessarily executed at the same time, but can be executed at different times. The order of execution of these steps or stages is not necessarily sequential, but can be executed in rotation or alternation with other steps or at least a portion of steps or stages in other steps.

[0034] Figure 1 This is a flow chart of a method for controlling the speed pulsation of a blood pump according to an embodiment of the present application;

[0035] Figure 2 This is a flow chart of adaptive control of the intelligent blood pump implementing heart beat following in an embodiment of the present application;

[0036] Figure 3 A state machine diagram of the blood pump speed pulsation control method according to an embodiment of the present application;

[0037] Figure 4 for Figure 3 The corresponding process diagram in ;

[0038] Figure 5 for Figure 4 The corresponding initialization diagram in ;

[0039] Figure 6 for Figure 4 Schematic diagram of detection of the corresponding diastolic start time;

[0040] Figure 7 for Figure 4 Schematic diagram of detection of the corresponding systolic onset moment;

[0041] Figure 8 for Figure 4 Schematic diagram of determining whether N0 cardiac cycles are detected;

[0042] Figure 9 for Figure 4 Schematic diagram of the corresponding adaptive control motor speed being the preset diastolic speed w1;

[0043] Figure 10 for Figure 4 Schematic diagram of the corresponding adaptive control motor speed being the preset speed w2 during the contraction period;

[0044] Figure 11 for Figure 4 The corresponding schematic diagram of determining whether to continuously control N1 cardiac cycles and adaptively control the motor speed to the initial speed w0;

[0045] Figure 12 for Figure 4 Schematic diagram of entering initialization again after the corresponding delay S1. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical solutions and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. The described embodiments should not be regarded as limiting this application. All other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0047] The terms "comprise," "include," and "have," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or components is not necessarily limited to those steps or components expressly listed but may include other steps or components not expressly listed or inherent to such process, method, product, or apparatus.

[0048] In the following description, similar expressions such as "a specific embodiment" or "a specific example" are involved, which describe a subset of all possible embodiments, but it can be understood that "a specific embodiment" or "a specific example" can be the same subset or different subsets of all possible embodiments, and can be combined with each other without conflict. In the following description, the term "multiple" refers to at least two. In some specific examples, the numerical value mentioned in this application reaches a threshold value, which may include the case where the former is greater than the latter of the threshold value; if similar expressions such as "any" or "at least one" are mentioned, it can specifically refer to any one of the listed examples or any combination of these examples.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein are for the purpose of describing the embodiments of this application only and are not intended to limit this application.

[0050] The method of this application will be described in detail below.

[0051] See also Figure 1 In a first aspect, the present application provides a specific embodiment of a method for controlling the speed pulsation of a blood pump, the embodiment comprising the following steps:

[0052] Step S11: for the implantable blood pump motor of the current patient, detecting the N0 diastolic start time and the N0 systolic start time of the heart beat of the current patient in the historical period based on the electrical signal change information of the motor in the historical period;

[0053] One of the core components of an implantable blood pump is the implantable motor, and one of the core components of the motor is the rotor; the blood pump speed (which can refer to the rotor speed or motor speed) ) and the electromagnetic torque of the motor There is a corresponding relationship (as shown in Equation 2 below). By controlling the current i of the input motor, the corresponding electromagnetic torque can be generated. (i.e. i and There is a corresponding relationship as shown in Formula 1 below), which drives the rotation of the motor rotor so that the blood pump operates at the speed required by the patient, thereby assisting in generating the blood flow required by the individual heart, as described below.

[0054] (Formula 1)

[0055] (Equation 2)

[0056] in, is the electromagnetic torque; is the electromagnetic torque coefficient of the blood pump motor; i is the current input to the blood pump motor; is the motor speed of the blood pump; is the blood load torque; is the moment of inertia of the blood pump motor rotor; is the moment of inertia of blood load; Can be represented The instantaneous change can be regarded as acceleration; is the friction viscosity coefficient (related to blood load and blood pump motor speed).

[0057] When the blood pump motor operates at a speed There are three basic situations as follows.

[0058] 1. When the natural heart enters diastole, the pressure drops and is transmitted to the blood pump rotor through the blood, which results in a decrease in the blood load torque. As a result, the blood pump rotor speed briefly increases and the blood pump motor current decreases.

[0059] 2. When the natural heart enters the systolic phase, the pressure increases and is transmitted to the blood pump rotor through the blood, which manifests as an increase in the blood load torque. Under this influence, the blood pump rotor speed drops briefly and the blood pump motor current increases.

[0060] 3. If the natural heart completely loses its pulsating function, the blood load torque remains unchanged. Therefore, the blood pump motor speed and motor current are both stable. The above (Equation 2) can be simplified to the following Equation 3.

[0061] (Formula 3)

[0062] Therefore, it can be inferred reversely that by monitoring the changes in electrical signals such as the blood pump motor current or motor speed, the moment when the natural heart, which still has the beating function, enters the diastole and the moment when it enters the systole can be extracted, that is, whether the patient's heart enters the diastole or systole at a certain historical moment can be known, and then the blood pulsation output can be adjusted as needed (such as increasing the heart's beat output), or a blood pulsation flow with a reasonable phase difference from the cardiac cycle can be output to meet the actual pulsation needs of each individual's heart.

[0063] It should be noted that the above-mentioned N0 times can be a continuous or discontinuous statistical number, which can be set according to actual conditions and is not limited here. For the sake of ease of explanation and understanding, the embodiment of this application mainly uses the case of N0 consecutive times as an example. In addition, compared with other types of blood pumps, the embodiment of this application can use a blood pump with a flexible magnetic bearing design, because the current and speed of this type of motor can more easily reflect the patient's heart beat, which can better deploy the ideal intelligent blood pump of the embodiment of this application - it can adaptively assist the damaged heart to achieve beat tracking based on the natural heart beat law.

[0064] Step S12: Based on the N0 diastolic start time and the N0 systolic start time, determine the N1 diastolic start time and the N1 systolic start time of the heart after the historical period.

[0065] The N1 diastolic start time and the N1 systolic start time are the times at which the motor's preset diastolic speed and preset systolic speed are activated, respectively. N0 and N1 are positive integers. Specifically, the desired preset diastolic speed and preset systolic speed for the patient can be determined based on a comprehensive assessment of the patient's current cardiac condition (e.g., cardiac output), pulmonary circulation (e.g., pulmonary artery pressure), and other physiological conditions.

[0066] In summary, the embodiments of the present application are based on the patient's individual historical electrical signal change information to determine the future start time of the diastole and the start time of the systole of the current patient's heart, which can ensure that the speed adjustment time of the blood pump motor is personalized to conform to the physiological contraction law of the individual heart, and realize the specific outputs such as the blood pumping time and the amount of blood pumped each time to flexibly follow the blood flow pulsation output of the heart beat, that is, to assist the blood pump in generating a pulsating flow synchronized with the natural heart beat, thereby effectively and reliably maintaining the patient's life safety.

[0067] Based on the above examples, the method of the present application will be further described in detail below, and some specific possible implementation examples will be provided. In actual applications, the implementation contents between these examples can be combined or implemented separately as needed according to the corresponding functional principles and application logic. If implemented in combination, the execution order between the combined examples can be determined according to their respective processing logic, which can be determined by the actual scenario.

[0068] like Figure 2 As shown, in actual situations, the control method of the embodiment of the present application can be intelligently enabled through software. Specifically, when the blood pump motor is started, if the motor's adaptive pulsation control state is set to 0, this state 0 can be considered an initial state in which the motor speed is at the initial speed w0 or the speed cannot be adaptively pulsated (i.e., does not conform to the natural heart beat pattern). The control method of the embodiment of the present application can be selected to start running, so that the motor speed can be adjusted to the speed of the adaptive pulsation output at the corresponding time (such as the start of diastole and the start of systole).

[0069] based on Figure 1 In some specific examples, the specific operation process of step S11 may include: extracting the electrical signal information corresponding to the motor at different times in the historical period to form an electrical signal waveform jointly characterized by each electrical signal information; the historical period is at least more than the cumulative duration of N0 cardiac cycles, and one cardiac cycle includes one diastole and one systole; when the electrical signal is the motor current, detecting the moment when the falling edge starts to appear N0 times and the rising edge starts to appear N0 times in the electrical signal waveform as the starting moment of the N0th diastole period and the starting moment of the N0th systole period of the heart.

[0070] As explained above, the above-mentioned electrical signal information can specifically be the motor current or motor speed of the blood pump. Therefore, the embodiment of the present application can be called a cardiac pulsation adaptive control method based on blood pump motor current detection (method 1), or a cardiac pulsation adaptive control method based on blood pump motor speed detection (method 2). The following will mainly provide a detailed example of this method 1. Method 2 is similar to method 1 and will not be described in detail. The difference is that when the electrical signal is the motor current, the start of the diastole is detected by detecting the falling edge information of the motor current, and the start of the systole is detected by detecting the rising edge information of the motor current; when the electrical signal is the motor speed, the situation is opposite to that when it is the motor current. The start of the diastole is detected by detecting the rising edge information of the motor speed, and the start of the systole is detected by detecting the falling edge information of the motor speed.

[0071] See also Figure 3 The possible solutions shown are Figure 3 This paper describes an adaptive pulsation control scheme for cardiac pulsation following, which involves "pre-detection - control of pulsation output - re-pre-detection". The main implementation process of this scheme includes: pre-detection and extraction of the start time of diastole and pre-detection and extraction of the start time of systole to obtain the cycle information of cardiac pulsation (one diastole and one systole constitute one heartbeat cycle); in the N1 heartbeat cycles after the pre-detection, each time the start time of diastole and the start time of systole are reached, the motor speed is adjusted to the corresponding diastole preset speed and systole preset speed (personalized according to the patient's physiological condition). Specifically, taking the motor current as an electrical signal as an example, if the start time of diastole is detected first:

[0072] 1. The start of the diastole phase of the heartbeat can be detected by detecting the falling edge information of the motor current. As described in the above basic situation 1, when the natural heart begins to enter the diastole phase, the blood pump motor current begins to decrease. Therefore, the start time of each current falling edge can be defined as the corresponding diastole start time.

[0073] 2. The start of the cardiac systole can be detected by monitoring the rising edge of the motor current. As described in Basic Case 2 above, when the natural heart begins systole, the blood pump motor current begins to rise. Therefore, the start of each current rising edge can be defined as the start of systole.

[0074] In actual situations, the slope of the electrical signal waveform can be compared with the slope threshold to detect whether a certain waveform belongs to a rising edge or a falling edge. The detection threshold of the rising edge or the falling edge depends on the design of the blood pump and is not described in detail here.

[0075] 3. N0 ≥ 1, where N0 refers to the number of diastolic periods or systolic periods detected in a round of pre-detection phase.

[0076] 4. w0 is the speed of the blood pump motor when pulsation control is not enabled (i.e., the initial state in which this control method is not enabled or the adaptive pulsation output is not possible). It can be simply understood that w0 is the speed of the blood pump motor when pulsation control is not performed.

[0077] 5. Doctors can set the values ​​of S0, w1, w2 and N1 according to the patient's individual physiological state.

[0078] (1) S0 represents the phase difference between the actual pulsation output and the natural heart pulsation, S0 ≥ 0. S0 can be simply processed in the software, that is, the extended time S0' actually used by the software is set to an integer multiple of the heart beat cycle closest to S0. For example, if the patient's heart beat cycle is detected to be 680 milliseconds, and the doctor sets S0 to 3000 milliseconds, then 3000 milliseconds divided by 680 milliseconds is equal to 4.41, then the software can take an integer multiple of 4, so the S0' used in the software can be Milliseconds = 2720 milliseconds, which ensures that S0 is delayed by 4 complete heart beat cycles, thereby ensuring the accuracy of the start time of the first diastole; and with such data processing (that is, set to 3000 milliseconds, but actually using 2720 milliseconds), the difference of the millisecond level can be ignored.

[0079] (2) w1 is the blood pump operating speed during diastole, i.e., the preset diastolic speed.

[0080] (3) w2 is the blood pump speed during the systolic period, i.e., the preset systolic speed. Generally, w1≤w0≤w2 can be set.

[0081] (4) N1 is the number of cycles of continuous active output cardiac beat control.

[0082] 6. S1 is the transition time between stopping active control of cardiac pulsation and the next pre-detection. The specific value of S1 depends on the design of the blood pump.

[0083] Of course, with Figure 3 The difference is that in some examples, you can also choose to start detecting the start of the systolic period first. Then, the motor speed w0 is adjusted to the preset systolic speed first. This method is the same as Figure 3 The example is similar and will not be repeated here.

[0084] Figure 3 The corresponding process can be as follows Figure 4As shown, from the overall framework, the current state of the blood pump motor (or adaptive pulsation control state) can be determined from the beginning each time through polling, and the corresponding operations can be executed. For example, if the blood pump motor is detected to be in the initial state 0, operation flow A0 is executed (which can be considered the initialization operation process); if the blood pump motor is detected to be in state 1 instead of 0, operation flow A1 is executed, and so on. If the blood pump motor is finally detected to be in state 7, operation flow A7 can be executed, ending the current "pre-detection - pulsation output control" phase and entering the "re-pre-detection" phase. If the blood pump motor is finally detected to be in state 7, the entire adaptive pulsation control scheme can be terminated or exited, and / or manual intervention can be requested.

[0085] like Figure 5 As shown, the operation flow of item A0 corresponding to state 0 (which can be regarded as the initialization operation process) is described: a detection counter for counting the number of pre-detection times and a control counter for counting the number of adaptive control times can be configured. The detection counter can be subdivided into a detection counter for the start time of the diastole and a detection counter for the start time of the systole. At the beginning of each round of pre-detection (to detect N0 heartbeat cycles), the detection counter and the control counter can be set to 0. After that, the detection counter is increased by 1 each time a historical diastole start time and systole start time are detected, until N0 times in history are detected. Heartbeat cycle; in addition, the cumulative value of the diastolic period and the cumulative value of the systolic period detected in this round of pre-detection stage can be counted (the cumulative value can be set to 0 when it is not detected initially), so that the duration of each diastolic period (or the average time of a single diastolic period) can be calculated based on the cumulative value of the diastolic period and the detection count value at the beginning of the diastolic period. Similarly, the duration of each systolic period (or the average time of a single systolic period) can be calculated based on the cumulative value of the systolic period and the detection count value at the beginning of the systolic period. The state can be set to 1 to end the A0 operation flow, so that Figure 4 Start polling from the beginning to determine the current state of the blood pump motor (ie, the adaptive pulsation control state).

[0086] Because the A0 operation flow has set the state to 1, the next execution will be as follows Figure 6 The operation flow of item A1 shown (detecting the start time of the diastole): once the falling edge of the motor current is detected at a certain moment, the moment T0 can be immediately defined as the start time of the diastole; and the state is set to jump to the adaptive pulsation control state 2.

[0087] according to Figure 3 、 Figure 4 The logic is similar, and the next execution will be as follows Figure 7The A2 operation flow shown (detecting the end of diastole and the start of systole) in the adaptive pulsation control state 2 no longer detects the falling edge (there is no end of the falling edge), but always detects the moment of the rising edge. The moment T1 when each rising edge begins can be defined as the start of systole. If T1-T0>P0, the diastole time can be set to T1-T0 (i.e., the length of a single diastole), and the jump to the adaptive pulsation control state 3 can be set thereafter. Since the systole of a heart beat is generally one-third of the heart beat cycle, the value of P0 can be determined based on the actual situation of the blood pump's expected patient population. For example, if the heart rate of the target patient population is between 50 and 120 beats / minute, then Figure 7 The P0 value in can be set to be slightly less than 160ms, that is, P0 is slightly less than 1 / 3 of the upper limit of the human heart rate.

[0088] In some specific examples, the specific operation process of step S11 may include: since the start time of diastole and the start time of systole are detected for the first time in N0 times, if the nth detection result in N0 times does not meet the preset conditions, at least the nth start time of systole or the start time of diastole of the adjacent times are redetected until the nth detection result that meets the preset conditions is obtained; wherein the preset conditions include: the difference between the nth start time of systole and the start time of diastole of the adjacent times is greater than the threshold value P0, and / or the number of times the start time of diastole and the start time of systole are detected in the historical period is greater than or equal to N0 times, and n is between 1 and N0 values.

[0089] Taking the case of first detecting the start of diastole as an example,

[0090] (1). If Figure 7 As shown, if T1-T0≤P0, the process may return to the step of detecting the start time of the current contraction period again.

[0091] (2). If Figure 8 As shown, if the number of detected diastolic start times and systolic start times is less than N0, the adaptive pulsation control state jump can be set to 2 in order to detect the start time of N0 times or more.

[0092] The above-mentioned coping methods (1) and (2) describe that if N0 valid start times cannot be detected, the test will be returned for retesting to ensure that the extracted times are N0 valid diastolic start times and N0 valid systolic start times; specifically, N0 times can be continuous or discontinuous.

[0093] based on Figure 1According to the example content, in some specific examples, the specific operation process of step S12 may include: based on the N0 diastolic start time and the N0 systolic start time, calculating the average diastolic duration and systolic duration of the heart each time; the sum of the diastolic duration and the systolic duration is a cardiac cycle; according to the cardiac cycle and the N0 systolic start time, calculating the first diastolic start time and the first systolic start time in N1 times, calculating the diastolic start time of each of the remaining N1 times based on the first systolic start time and the systolic duration, and calculating the systolic start time of each of the remaining N1 times by the diastolic start time and diastolic duration of each time.

[0094] like Figure 8 As shown, the operation flow of item A3 in the adaptive pulsation control state 3 (detecting the start time of the next diastole and the end time of the systole) is similar to Figure 6 , the moment T2 when the motor current starts to fall can be defined as the start of the diastole, and the systole time can be set to T2-T1 (i.e., the duration of a single systole).

[0095] (1) The systolic period of a heart beat is generally one-third of the heart beat cycle, that is, under normal circumstances, the duration of a single diastole is ≥ the duration of a single systole. At this time, the test result can be considered normal and valid, and the detection counter can be added by 1 based on the last count. The cumulative value of the diastolic period can be set to be the cumulative value of the last diastolic period + the current diastolic period, and the cumulative value of the systolic period can be set to be the cumulative value of the last systolic period + the current systolic period. Afterwards, if the number of times the diastolic period start time and the systolic period start time are detected N≥N0, the following results can be calculated according to the formula: 1 (or single) diastolic mean time = diastolic period cumulative value ÷ detection count value about the diastolic period start time, 1 systolic mean time = systolic period cumulative value ÷ detection count value about the systolic period start time; then, the adaptive pulsation control state can be set to 4.

[0096] (2) On the contrary, if the duration of a single diastole is less than the duration of a single systole, a retry mechanism can be enabled, that is, the adaptive pulsation control state jump is set to 0, thereby attempting to detect a valid 1 diastole mean time and 1 systole mean time. The diastole periods selected by the two states 0 can be the same period or different periods (that is, there is a time difference). Similarly, the systole periods selected by the two states 0 can be the same period or different periods. In other words, the detected N0 heartbeat cycles can be continuous or discontinuous N0 times, without specific restrictions.

[0097] After calculating the average time of a single diastole (or called the diastole time of the heart beat) and the average time of a single systole (or called the systole time of the heart beat) as above, the start time of each diastole and the start time of each systole in the next N1 times can be calculated based on this and the time information contained in the heart beat cycle. For example, when n1=1 in a total of N1 times, the first diastole is controlled to be generated, and the corresponding start time of the first diastole can be the end time of the systole detected in the most recent (N0th) time (such as Figure 8 "Get the current time T0") "Delay the specified time S0" (see Figure 3 ) after the arrival time (see Figure 9 ("Get current time T0" in the "Get current time T0"), S0 ≥ 0; and when n1 = 1, the start time of the first systole = the start time of the first diastole + the diastolic duration of the cardiac beat. When n1 > 1, the corresponding start time of the n1th diastole = the start time of the n1th - 1st systole + the systolic duration of the cardiac beat, and the start time of the n1th systole = the start time of the n1th - 1st diastole + the diastolic duration of the cardiac beat. The upper limit of n1 is N1.

[0098] The above description can be summarized as follows: in some specific examples, after step S12, the method of the embodiment of the present application may further include (realizing the pulsating output of the cardiac beat following with a phase difference, i.e., delay S0): adding a preset time difference to each of the N1 start times of diastole and the N1 start time of systole to obtain the N1 start time of diastole and the N1 start time of systole after the delay S0.

[0099] At this time, S0>0, specifically as described above, if the diastole is detected first, the specified time S0 can be delayed from the source, so that the start time of the subsequent M-1 times will also be delayed by S0. Figure 3 The specific values ​​of delay S0 and S0, or the choice of not delaying S0, can be set by the doctor according to the individual physiological condition of the patient to ensure the flexibility of the individual in using the blood pump.

[0100] In some specific examples, after step S12, the method of the embodiment of the present application may further include: in N1 times, each time the start moment of the diastole is reached, the speed of the motor in the diastole is adjusted to the preset speed of the diastole, and each time the start moment of the systole is reached, the speed of the motor in the systole is adjusted to the preset speed of the systole; the preset speed of the diastole is less than or equal to the preset speed of the systole.

[0101] Figure 9 、 Figure 10 、 Figure 11 It can be regarded as the process of adaptive speed adjustment in the stage of controlling pulsation output. Figure 9 As shown, in Figure 8Based on the last acquired T0 time, it is delayed by S0 and arrives at Figure 9 At the current time T0 (i.e., the start time of the first diastole), the adaptive pulsation control state can be set to 5, and the motor speed can be adjusted from the initial speed w0 to the diastole preset speed w1. Figure 3 、 Figure 10 As shown, in Figure 9 Based on the last acquired T0 moment, after a cardiac diastolic period (during which the speed is W1), the first systolic period begins (corresponding to Figure 10 At the current moment T0 obtained in , the adaptive pulsation control state can be set to 6, and the motor speed is adjusted from the preset diastolic speed w1 to the preset systolic speed w2. Figure 3 、 Figure 11 As shown, after one cardiac systolic period (during which the speed is w2), the control counter count can be increased by 1 to indicate that the control has generated a speed for one cardiac cycle (i.e., one cycle of adaptive speed adjustment has been completed). If the speed for N1 cardiac cycles has not been generated, the adaptive pulsation control state can be set to 5, and at the start of the next diastolic period, the motor speed is adjusted from the preset systolic speed w2 to the preset diastolic speed w1, until a speed for N1 cardiac cycles is generated; where w1≤w0≤w2.

[0102] In some specific examples, after step S12, the method of the embodiment of the present application may further include: determining the speed reset time based on the start time of the N1th diastole or the start time of the N1th systole; when the speed reset time is reached, adjusting the speed of the motor to the initial speed, so that the motor runs at the initial speed for a period of time, and then returning to the step of detecting the start time of the N0th diastole and the start time of the N0th systole of the current patient's heart beat in the historical time period based on the electrical signal change information of the motor in the historical time period.

[0103] like Figure 11 As shown, if the speed of full N1 heartbeat cycles is generated, the adaptive pulsation control state can be set to 7, and the motor speed is adjusted from the diastolic preset speed w1 to the initial speed w0, so that the motor runs at the initial speed w0 for a period of time S1 and then returns to step S11 (as can be seen Figure 12), returning to the initial state 0 and entering the "pre-test again" phase, which then initiates the next round of the "pre-test - control pulsation output" phase. Here, after a delay of S1, returning to the initial state 0 and entering the "pre-test again" phase takes into account the fact that speed regulation may cause electrical signal instability, affecting the blood pump's subsequent accurate adaptive pulsation output. Therefore, the motor is allowed to stabilize at the initial speed w0 for a period of time before entering the pre-test phase, thereby balancing or compensating for errors introduced by the hardware and software in the early stages.

[0104] For example Figure 3 More precisely, after the delay from S0, adaptive speed control begins during diastole (adjusted to w1). After fully controlling the speed for N1 diastole periods and N1 systole periods, the start of the N1+1th diastole period should be reached. At this point, the program should jump to "Adjust speed to w0, delay for fixed time S1" before entering the pre-detection phase. In short, during S1 and the pre-detection phase, the motor's operating speed is the initial speed w0. It is during the controlled pulsation output phase that the motor's operating speed adaptively adjusts between the preset speeds w1 and w2. In some specific examples, if the start of diastole is detected first, the end of the N1th systole can be considered the speed reset moment.

[0105] In some specific examples, to improve the accuracy of diastolic and systolic phase detection, cardiac pulse information can be detected by combining motor current peak detection with motor signal edge (e.g., rising and falling edge) detection. For example, after detecting the peak of the motor signal, detection of the onset of diastole can be initiated to reduce the probability of false detection.

[0106] In summary, the embodiment of the present application can also be called an intelligent blood pump based on cardiac pulsation adaptive control and its control method. Through the cardiac pulsation signal obtained by historical detection (i.e., the above-mentioned N0 historical diastolic start times and N0 historical systolic start times) and the speed modulation strategy, the adjustment timing of the speed required by the individual motor in the future (i.e., the diastolic start time and the systolic start time) is predicted, and the adaptive pulsation output of delayed following (or intermittent following) of the cardiac pulsation is achieved; it should be noted that the delay or intermittency here mainly refers to the fact that compared with the case of real-time detection of the speed adjustment time of w1 or w2, the case of using the historically measured N0 start times to predict the aforementioned timing has a lag. In addition, it can be seen that the embodiment of the present application:

[0107] (1) There is no need to configure an additional independent heart beat sensor (such as a flow sensor, a pressure sensor, an ECG signal sensor, etc.). Based on a single electrical signal such as the motor current or the motor speed, the historical beat signal of the natural heart can be detected, and the blood flow pulsation output following the heart beat can be achieved.

[0108] (2) No excessive circuit signal resources are required, and no additional sensors are needed, which can keep the blood pump system design low-complexity and low-cost.

[0109] (3) Based on the detected cardiac pulse signal, a speed modulation strategy can be used to synchronize the cardiac pulse output with or without a phase difference (i.e., S0). In other words, the blood flow pulsation generated by the blood pump can be flexibly associated with or synchronized with the patient's own cardiac pulse. The specific value S0 can be set by the doctor based on the individual patient's condition.

[0110] (4) The intelligent blood pump can independently complete the above-mentioned cardiac pulsation pre-detection (i.e., the detection history start time) and open adaptive control (including adjusting the motor speed back and forth to w1 or w2), and can realize multi-parameter pulsation adjustment, which makes it easier for doctors to implement individualized treatment according to the patient's condition, flexibly generate blood pulsation output that adapts to the individual's needs, and provide patients with individual physiological pulsation regularity blood pumping auxiliary functions.

[0111] A second aspect of the present application provides a specific embodiment of a blood pump speed pulsation control system, the system comprising: an external controller and / or an implantable blood pump;

[0112] The implantable blood pump includes an implantable motor, and an external controller is connected to the implantable blood pump;

[0113] The extracorporeal controller and / or implantable blood pump is used to execute the blood pump speed pulsation control method described in the first aspect or any specific method embodiment of the first aspect, so as to control the motor to enable the preset diastolic speed each time it reaches the beginning of the diastolic phase of the patient's heart within a preset number of times, and to enable the preset systolic speed each time it reaches the beginning of the systolic phase of the patient's heart.

[0114] In the embodiments of the present application, the operations performed by the blood pump speed pulsation control system are similar to those described in the first aspect or any specific method embodiment of the first aspect, and are not described in detail here. Of course, the specific implementation process of each operation in the first aspect of the present application can also be implemented by referring to the relevant description of the second aspect.

[0115] The present application provides a computer-readable storage medium, comprising instructions. When the instructions are executed on a computer, the computer executes the method described in the first aspect or any specific implementation of the first aspect.

[0116] The present application provides a computer program product comprising instructions or a computer program. When the computer program product is run on a computer, the computer is enabled to execute the method described in the first aspect or any specific implementation of the first aspect.

[0117] It is understood that in the various embodiments of the present application, the sequence number of each step does not mean the order of execution. The order of execution of each step should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application. The operation content added or refined in each example scheme of the above-mentioned method, system or product does not necessarily have to be executed during the specific implementation. If two or more operations are added, these operations can be implemented in combination or separately, depending on the actual scenario.

[0118] Those skilled in the art will clearly understand that, for the convenience and brevity of description, the specific working processes of the systems and products described above can refer to the corresponding processes in the aforementioned method embodiments and will not be repeated here.

[0119] In the several embodiments provided in this application, it should be understood that the disclosed systems, products and methods can be implemented in other ways. For example, the product embodiments described above are merely schematic. For example, the division within the system is only a logical function division. There may be other division methods in actual implementation. For example, multiple components within the system can be combined or integrated into another system or product, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of products or components, which can be electrical, mechanical or other forms.

[0120] The components described as separate parts may or may not be physically separated, and the parts displayed as components may or may not be physical components, that is, they may be located in one place, or they may be distributed across multiple network components. Some or all of the components may be selected according to actual needs to achieve the purpose of the scheme of this embodiment. In addition, the functional components in the various embodiments of the present application may be integrated into a processing component, or each component may exist physically separately, or two or more components may be integrated into one component. The above-mentioned integrated components may be implemented in the form of hardware or in the form of software functional components.

[0121] If the integrated components are implemented in the form of software functional components and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application, or the part that contributes to the prior art, or all or part of the technical solution can be embodied in the form of a software product. The computer software product (or computer program product) is stored in a storage medium and includes several instructions for enabling a computer device (which can be a personal computer, a business server, or a network device, etc.) to execute all or part of the steps of the method described in each embodiment of the present application. The aforementioned storage medium includes various media that can store program code, such as a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk, or an optical disk.

Claims

1. A blood pump speed pulsation control method, characterized in that: include: For the current patient's implantable blood pump motor, based on information about changes in electrical signals from the motor during a historical period, detecting the start time of the N0th diastole and the start time of the N0th systole of the patient's heart beat during the historical period; the electrical signal change information is used to reflect whether the current patient's heart has entered diastole or systole, and the start time of the systole is the end time of the diastole; Based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period; wherein the N1 diastolic start time and the N1 systolic start time are the times when the diastolic preset speed and the systolic preset speed of the motor are each correspondingly activated, N0 and N1 are positive integers, and the diastolic preset speed and the systolic preset speed are determined based on at least the current physiological condition of the patient; The determining, based on the N0 diastolic start time and the N0 systolic start time, respectively, of the N1 diastolic start time and the N1 systolic start time of the heart after the historical period includes: calculating, based on the N0 diastolic start time and the N0 systolic start time, the average diastolic duration and systolic duration of each heart beat; the sum of the diastolic duration and the systolic duration being one cardiac cycle; Taking the start time of the N0th systole or the start time of the N0th diastole as the starting time, the start time of each diastole in the N1 times is determined according to the cardiac beat cycle and the starting time; the start time of each systole in the N1 times is determined by the start time of each diastole in the N1 times and the diastole duration.

2. The blood pump speed pulsation control method according to claim 1, characterized in that: The detecting, based on the electric signal change information of the motor in the historical period, the N0 diastolic start time and the N0 systolic start time of the heart beat of the current patient in the historical period, includes: Extracting electrical signal information corresponding to the motor at different times during a historical period to form an electrical signal waveform jointly depicted by the electrical signal information; the historical period is at least longer than the cumulative duration of N0 cardiac cycles, where one cardiac cycle includes one diastole and one systole; When the electrical signal is a motor current, the moment when the N0th falling edge and the N0th rising edge begin to appear in the electrical signal waveform are detected as the N0th diastolic start moment and the N0th systolic start moment of the heart.

3. The blood pump speed pulsation control method according to claim 1, characterized in that: The determining, based on the N0 diastolic start time and the N0 systolic start time, respectively, of the N1 diastolic start time and the N1 systolic start time of the heart after the historical period includes: The start time of the first diastole and the start time of the first systole in the N1 times are calculated according to the cardiac cycle and the start time of the N0th systole, the start time of the diastole of each of the remaining N1 times is calculated based on the start time of the first systole and the duration of the systole, and the start time of the systole of each of the remaining N1 times is calculated by the start time of each diastole and the duration of the diastole.

4. The blood pump speed pulsation control method according to claim 1, characterized in that: Based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further comprising: A preset time difference is added to each of the N1 diastolic start times and the N1 systolic start times to obtain the delayed N1 diastolic start time and the N1 systolic start time.

5. The blood pump speed pulsation control method according to claim 1 or 4, characterized in that: Based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further comprising: In the N1 times, each time the start time of the diastole is reached, the speed of the motor in the diastole is adjusted to the preset diastole speed, and each time the start time of the systole is reached, the speed of the motor in the systole is adjusted to the preset systole speed; the preset diastole speed is less than or equal to the preset systole speed.

6. The blood pump speed pulsation control method according to claim 1 or 4, characterized in that: Based on the N0 diastolic start time and the N0 systolic start time, respectively determining the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, the method further comprising: Determining a rotation speed reset time based on the start time of the N1th diastole or the start time of the N1th systole; When the speed reset moment is reached, the speed of the motor is adjusted to the initial speed so that the motor runs at the initial speed for a period of time, and then returns to the step of detecting the start time of the N0 diastole and the start time of the N0 systole of the current patient's heart beat in the historical period based on the electrical signal change information of the motor in the historical period.

7. The blood pump speed pulsation control method according to claim 1, characterized in that: The detecting, based on the electric signal change information of the motor in the historical period, the N0 diastolic start time and the N0 systolic start time of the heart beat of the current patient in the historical period, includes: Since the first detection of the diastolic start time and the systolic start time in the N0 times, if the n-th detection result in the N0 times does not meet the preset conditions, at least the n-th systolic start time or the adjacent diastolic start time is re-detected until the n-th detection result that meets the preset conditions is obtained; Among them, the preset conditions include: the difference between the nth start time of the systole and the adjacent start time of the diastole does not meet the threshold, and / or the number of times the start time of the diastole and the start time of the systole are detected in the historical period is greater than or equal to the N0 times, and n is between 1 and the N0 value.

8. A blood pump speed pulsation control system, characterized in that: include: external controller and / or implantable blood pump; The implantable blood pump includes an implantable motor, and the external controller is connected to the implantable blood pump; The external controller and / or the implantable blood pump is used to execute the blood pump speed pulsation control method as described in any one of claims 1 to 7, so as to control the motor to enable the preset diastolic speed each time it reaches the start of the diastolic phase of the patient's heart within a preset number of times, and to enable the preset systolic speed each time it reaches the start of the systolic phase of the patient's heart.

9. A readable storage medium, characterized in that The readable storage medium stores computer instructions, and when the computer instructions are executed by a processor, the method according to any one of claims 1 to 7 is implemented.

10. A computer program product, characterized in that The computer program product comprises computer instructions, and when the computer instructions are executed by a processor, the method according to any one of claims 1 to 7 is implemented.

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