Blood pump rotating speed pulsation control method and system and related products

Abstract

The invention discloses a blood pump rotating speed pulsation control method and system and related products, and the method comprises the steps that according to electric signal change information of a blood pump motor in a historical period, the N0-time diastole starting moment and the N0-time systole starting moment of cardiac pulsation of a current patient in the historical period are detected; based on the starting moments, N1 diastolic period starting moments and N1 systolic period starting moments of the heart after the historical time period are respectively determined. According to the method, on the basis of individual historical electric signal change information of a patient, the future diastole starting time and the future systole starting time of the heart of the current patient are determined, and it can be guaranteed that the rotating speed adjusting time of a blood pump motor conforms to the physiological systole rule of the individual heart in a personalized mode; and the blood pumping time, the blood pumping volume each time and other specific outputs of the blood pump are flexibly output along with the blood flow pulsation output of the cardiac pulsation, namely, the blood pump is assisted to generate pulsating flow synchronous with the natural cardiac pulsation, so that the life safety of a patient is practically and reliably maintained.

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 pump less blood than the body needs. As an implantable medical device (or blood pump), the Left Ventricular Assist Device (LVAD) assists or replaces a weakened heart to achieve blood pumping function. It has become one of the treatment options for patients waiting for a heart transplant or for patients with end-stage heart failure. Specifically, the inlet tube of the implantable blood pump is connected to the left ventricle of the heart, and the outlet is connected to an artificial blood vessel, which is ultimately connected to the aorta. One of the core components of the implantable blood pump is the motor. When the motor rotor is driven to rotate, blood is drawn from the left ventricle, flows through the blood pump channel, and is eventually pumped into the aorta, which is then sent to the entire body by the aorta, thereby enabling the blood pump to assist or replace the heart in pumping blood.

[0003] At present, among the blood pump products approved for short-term assisted transition or long-term assisted therapy, most products provide non-physiological continuous flow control, that is, the blood flow pulsation control output (which can be called pulsating flow) generated by existing products is not synchronized with or even unrelated to the patient's own heart beat pattern. For example, at regular intervals of a uniform and fixed time period, the motor speed of the blood pump used by each patient is fixedly adjusted. For example, once each blood pump motor has run for a cycle, its subsequent running speed is fixedly adjusted to fluctuate up or down by 2000 revolutions per minute (RPM, Revolutions Per Minute).

[0004] It can be seen that this pulsating flow lacks the individual patient's physiological pulsation law (or 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 risk 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: For the implantable blood pump motor of the current patient, based on the electrical 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 are detected; the electrical signal change information is used to reflect whether the heart of the current patient enters the diastolic period or the systolic period, and the systolic period start time is the diastolic period end time; Based on the N0 diastolic start time and the N0 systolic start time, the N1 diastolic start time and the N1 systolic start time of the heart after the historical period are determined respectively; wherein, the N1 diastolic start time and the N1 systolic start time are the moments when the diastolic preset speed and the systolic preset speed of the motor are correspondingly activated each time, the N0 and the N1 are positive integers, and the diastolic preset speed and the systolic preset speed are determined at least according to the current patient's physiological condition.

[0007] 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: Extracting electrical signal information corresponding to the motor at different times in a historical period to form an electrical signal waveform jointly depicted by each of the electrical signal information; the historical period is at least longer than the cumulative duration of N0 cardiac cycles, and 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 time and the N0th systolic start time of the heart.

[0008] Optionally, the determining, based on the N0 diastolic start time and the N0 systolic start time, respectively the N1 diastolic start time and the N1 systolic start time of the heart after the historical period includes: Based on the N0 diastolic start time and the N0 systolic start time, the average diastolic duration and systolic duration of the heart are calculated each time; the sum of the diastolic duration and the systolic duration is one cardiac cycle; 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 beat cycle and the start time of the N0th systole, the start time of each remaining diastole in the N1 times is calculated based on the start time of the first systole and the duration of the systole, and the start time of each remaining systole in the N1 times is calculated by the start time of each diastole and the duration of the diastole.

[0009] 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: A preset time difference is added to each of the N1 diastolic start time and the N1 systolic start time to obtain the delayed N1 diastolic start time and the N1 systolic start time.

[0010] 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: In the N1 times, each time the diastole start time is reached, the speed of the motor in the diastole is adjusted to the diastole preset speed, and each time the systole start time is reached, the speed of the motor in the systole is adjusted to the systole preset speed; the diastole preset speed is less than or equal to the systole preset speed.

[0011] 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: Determining a rotation speed reset time based on the N1th diastolic period start time or the N1th systolic period start time; 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 phase and the start time of the N0 systole phase 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.

[0012] 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: Since the diastolic start time and the systolic start time are detected for the first time in the N0 times, if the nth detection result in the N0 times does not meet the preset conditions, at least the nth systolic start time or the diastolic start time of the adjacent times is re-detected until the nth 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 detected in the historical period is greater than or equal to the N0 times, and n is between 1 and the N0 value.

[0013] 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 present application provides a blood pump speed pulsation control system, including: an external controller and / or an implantable blood pump; The implantable blood pump comprises an implantable motor, and the external controller is connected to the implantable blood pump; The external controller and / or the implantable blood pump are 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 diastolic preset speed each time the motor reaches the beginning of the diastolic phase of the patient's heart within a preset number of times, and to enable the systolic preset speed each time the motor reaches the beginning of the systolic phase of the patient's heart.

[0014] 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.

[0015] 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.

[0016] It can be seen from the above technical solutions that the embodiments of the present application have at least the following advantages: The embodiment of the present application is based on the patient's individual historical electrical signal change information to determine the start time of the diastole and the start time of the systole of the current patient's heart in the future, which can ensure that the speed adjustment time of the blood pump motor is personalized to meet the physiological contraction law of the individual heart, and achieve the blood pumping time and blood pumping volume of each time and other specific outputs of the blood pump to flexibly follow the blood flow pulsation output of the heart beat, that is, to assist the blood pump to generate a pulsating flow synchronized with the natural heart beat, thereby effectively and reliably maintaining the patient's life safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. 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.

[0018] 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, and the execution order of these steps or stages is not necessarily sequential, but can be executed in turn or alternately with other steps or at least a portion of the steps or stages in other steps.

[0019] Figure 1 A schematic flow chart of a blood pump speed pulsation control method according to an embodiment of the present application; Figure 2 This is a flow chart of adaptive control of the intelligent blood pump implementing heart beat following in the embodiment of the present application; Figure 3 A state machine diagram of the blood pump speed pulsation control method according to an embodiment of the present application; Figure 4 for Figure 3 The corresponding process diagram in ; Figure 5 for Figure 4 The corresponding initialization diagram in ; Figure 6 for Figure 4 Detection schematic diagram of the corresponding diastolic start time; Figure 7 for Figure 4 Schematic diagram of detection of the corresponding contraction start time; Figure 8 for Figure 4 Schematic diagram of judging whether N0 cardiac cycles are detected; Fig. 9 for Figure 4 The schematic diagram of the corresponding adaptive control motor speed is the preset speed w1 during the diastolic period; Fig.10 for Figure 4 The schematic diagram of the corresponding adaptive control motor speed is the preset speed w2 during the contraction period; Fig.11 for Figure 4 The corresponding schematic diagram of judging whether to continuously control N1 cardiac cycles and adaptively control the motor speed to the initial speed w0; Fig.12 for Figure 4 Schematic diagram of entering initialization again after the corresponding delay S1. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings. The described embodiments should not be regarded as limiting the present application. All other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of this application.

[0021] The terms "comprises," "comprising," and "having," 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.

[0022] In the following description, similar expressions such as "a specific implementation" or "a specific example" are involved, which describe a subset of all possible embodiments, but it can be understood that "a specific implementation" 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, a certain numerical value reaching a threshold mentioned in this application may include a case where the former is greater than the latter of the threshold; 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.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein are only for the purpose of describing the embodiments of this application and are not intended to limit this application.

[0024] The method of this application will be described in detail below.

[0025] See also Figure 1 In a first aspect, the present application provides a specific embodiment of a blood pump speed pulsation control method, the embodiment comprising the following operating steps: 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 according to the electrical signal change information of the motor in the historical period; 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 be referred to as 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.

[0026] (Formula 1) (Formula 2) 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 moment; is the moment of inertia of the blood pump motor rotor; is the moment of inertia of blood load; Can be expressed The instantaneous change of can be regarded as acceleration; is the friction viscosity coefficient (related to blood load and blood pump motor speed).

[0027] When the blood pump motor operates at a speed There are three basic situations as follows.

[0028] 1. When the natural heart enters diastole, the pressure drops, and the pressure is transmitted to the blood pump rotor through the blood, which means that the blood load torque decreases. Affected by this, the blood pump rotor speed increases briefly and the blood pump motor current decreases.

[0029] 2. When the natural heart enters the contraction 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. Affected by this, the blood pump rotor speed drops briefly and the blood pump motor current increases.

[0030] 3. If the natural heart completely loses its pulsating function, the blood load torque will not change. Therefore, the blood pump motor speed and motor current are both in a stable state, and the above (Equation 2) can be simplified to the following equation 3.

[0031] (Formula 3) Therefore, it can be inferred reversely that by monitoring the change information of electrical signals such as the blood pump motor current or motor speed, the moment when the natural heart that 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.

[0032] It should be noted that the above N0 times can be a continuous or discontinuous statistical number, which can be set according to the actual situation and is not limited here; for the convenience of explanation and understanding, the embodiment of the present application mainly takes the case of N0 consecutive times as an example. In addition, compared with other types of blood pumps, the embodiment of the present 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, and can better deploy the ideal intelligent blood pump of the embodiment of the cost application - it can adaptively assist the diseased heart to achieve beat tracking based on the natural heart beat law.

[0033] 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.

[0034] Among them, 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 activated each time, and N0 and N1 are positive integers. Specifically, the diastolic preset speed and the systolic preset speed required by the current patient can be comprehensively judged and determined according to the current patient's heart condition (such as cardiac output), pulmonary circulation (such as pulmonary artery pressure) and other physiological conditions.

[0035] In summary, the embodiments of the present application are based on the patient's individual historical electrical signal change information to determine the start time of the diastole and the start time of the systole of the current patient's heart in the future, 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 achieve the blood pumping time and blood pumping volume of each time and other specific outputs 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.

[0036] Based on the above example descriptions, 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 logics, which may be determined by the actual scenario.

[0037] like Figure 2As shown, in actual situations, the control method of the embodiment of the present application can be enabled intelligently through software. Specifically, when the blood pump motor is started, if the adaptive pulsation control state of the motor is set to 0, this state 0 can be regarded as the initial state in which the motor speed is the initial speed w0 or the speed cannot be adaptively pulsated output (i.e., it does not conform to the natural heart beat law), and 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 adaptive pulsation output at the corresponding time (such as the start time of the diastole and the start time of the systole).

[0038] 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 heart beat cycles, and one heart beat cycle includes one diastole and one contraction period; 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 time of the N0th diastole period and the N0th contraction period of the heart.

[0039] As described 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 description 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 time of the diastole is detected by detecting the falling edge information of the motor current, and the start time of the systole is detected by detecting the rising edge information of the motor current; when the electrical signal is the motor speed, it is the opposite of the situation when it is the motor current. The start time of the diastole is detected by detecting the rising edge information of the motor speed, and the start time of the systole is detected by detecting the falling edge information of the motor speed.

[0040] See also Figure 3 The possible solutions shown are Figure 3 An adaptive pulsation control scheme of "pre-detection - control of pulsation output - pre-detection again" for heart beat following is described. The main implementation process of this scheme includes: pre-detection extraction of the start time of diastole and pre-detection extraction of the start time of systole to obtain the cycle information of heart beat (one diastole and one systole constitute one heartbeat cycle); in the N1 heartbeat cycles after 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: 1. The start time of the diastole phase of the heart beat can be detected by detecting the falling edge information of the motor current; because 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, so the start time of each current falling edge can be defined as the start time of the diastole phase.

[0041] 2. The start time of the cardiac contraction phase can be detected by detecting the rising edge information of the motor current. As described in the above basic situation 2, when the natural heart begins to enter the contraction phase, the blood pump motor current begins to rise, so the start time of each current rising edge can be correspondingly defined as the start time of the contraction phase.

[0042] In actual situations, the slope of the electrical signal waveform can be compared with the slope threshold to detect whether a certain waveform is 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.

[0043] 3. N0 ≥ 1, N0 refers to the number of diastolic phases or systolic phases detected in a round of pre-detection stage.

[0044] 4. w0 is the speed of the blood pump motor when pulsation control is not enabled (i.e., the initial state where this control method is not enabled or the pulsation output cannot be adaptively adapted). It can be simply understood that w0 is the speed of the blood pump motor when pulsation control is not performed.

[0045] 5. Doctors can set the values ​​of S0, w1, w2 and N1 according to the individual physiological state of the patient. (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 detected is 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 correctness of the start time of the first diastole; and with such data processing (that is, it is set to 3000 milliseconds, but 2720 milliseconds is actually used), the difference in milliseconds can be ignored.

[0046] (2) w1 is the blood pump operating speed during diastole, i.e., the preset diastole speed.

[0047] (3) w2 is the blood pump operating speed during the systolic period, that is, the preset systolic speed. Generally, w1≤w0≤w2 can be set.

[0048] (4) N1 is the number of cycles of continuous active output heart beat control.

[0049] 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.

[0050] Of course, with Figure 3 The difference is that in some examples, it is also possible to choose to start detecting the start time of the contraction period first, then accordingly, the motor speed w0 is first adjusted to the preset contraction speed. This method is similar to Figure 3 The example is similar and will not be repeated here.

[0051] Figure 3 The corresponding process can be as follows Figure 4 As shown, from the overall framework, each time, the current state of the blood pump motor (or adaptive pulsation control state) can be determined by polling from the beginning, and the relevant operations corresponding to this state can be executed. For example, if it is detected that the current state of the blood pump motor is the initial state 0, the A0 operation flow is executed (which can be regarded as the initialization operation process); if it is detected that the current state of the blood pump motor is not 0 but 1, the A1 operation flow is executed, and so on. If the blood pump motor is finally detected to be in a state of 7, the A7 operation flow can be executed, that is, the current round of "pre-detection-control pulsation output" stage is ended, and the "pre-detection again" stage is entered. If it is finally detected that the current state of the blood pump motor is not 7, the entire adaptive pulsation control scheme can be ended or exited, and / or manual intervention can be requested.

[0052] 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, each time a historical diastole start time and systole start time are detected, the detection counter is increased by 1 until N0 times in history are detected. Heartbeat cycle; in addition, the cumulative value of the diastolic duration and the cumulative value of the systolic duration detected in this round of pre-detection stage can be counted (the cumulative value can be set to 0 when there is no detection at the beginning), 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 duration 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 duration 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).

[0053] 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 diastole): once the falling edge of the motor current is detected at a certain moment, this moment T0 can be immediately defined as the start time of diastole; and then it is set to jump to the adaptive pulsation control state 2.

[0054] according to Figure 3 , Figure 4 Similarly, the next execution will be as follows Figure 7 The A2 operation flow shown (detecting the end of the diastolic period and the beginning of the systolic period) 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 when the rising edge appears. The moment T1 when each rising edge begins to appear can be defined as the beginning of the systolic period; if T1-T0>P0, the diastolic period time of this time can be set to T1-T0 (i.e., the length of a single diastolic period), and the setting jumps to the adaptive pulsation control state 3 thereafter. Because the systolic period of the 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 expected patient population of the blood pump. For example, if the heart rate of the target patient population is between 50 beats / minute 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 heart rate of the crowd.

[0055] 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 re-detect the nth start time of systole or the start time of diastole of the adjacent number of times 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 adjacent start time of diastole is greater than a 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.

[0056] Taking the case of first detecting the start time of diastole as an example, (1) If Figure 7 As shown, if T1-T0≤P0, the process can return to the step of detecting the start time of the current contraction period again.

[0057] (2) If Figure 8As 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.

[0058] The above-mentioned coping methods (1) and (2) describe that if N0 valid start times cannot be detected, the test will be returned for re-detection to ensure that the extracted time is N0 valid diastolic start time and N0 valid systolic start time; specifically, the number of these times can be continuous or discontinuous N0.

[0059] based on Figure 1 According 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 N1 times based on the first systolic start time and the systolic duration, and calculating the systolic start time of each of the N1 times through the diastolic start time and diastolic duration of each time.

[0060] 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 time of the current diastole, and the current systole time can be set to T2-T1 (i.e., the duration of a single systole).

[0061] (1) The systolic period of cardiac pulsation is generally one-third of the cardiac pulsation cycle, that is, under normal circumstances, the duration of a single diastolic period is ≥ the duration of a single systolic period. At this time, the detection 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 start time and the systolic 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 start time, 1 systolic mean time = systolic period cumulative value ÷ detection count value about the systolic start time; then, the adaptive pulsation control state can be jumped to 4.

[0062] (2) On the contrary, if the duration of a single diastolic period is less than the duration of a single systolic period, 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 diastolic mean time and 1 systolic mean time. The diastolic periods selected by the two states 0 can be the same period or different periods (that is, there is a time difference). Similarly, the systolic 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 limitation.

[0063] After calculating the average time of a single diastole (or the diastole time of the heart beat) and the average time of a single systole (or 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, it means that 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 current time T0") "Delay specified time S0" (see Figure 3 ) after reaching the time (see Fig. 9 "Get current time T0"), S0≥0; and when n1=1, the first systolic start time = the first diastolic start time + the cardiac diastolic time. When n1>1, the corresponding n1th diastolic start time = n1-1th systolic start time + cardiac systolic time, the n1th systolic start time = n1-1th diastolic start time + cardiac diastolic time, and the upper limit of n1 is N1.

[0064] 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 heart beat following with a phase difference, i.e., delay S0): adding a preset time difference to each of the N1 diastolic start times and the N1 systolic start times, to obtain the N1 diastolic start times and the N1 systolic start times after the delay S0.

[0065] At this time, S0>0, as described above, if the diastolic period is detected first, the specified time S0 can be delayed from the source, so that the start time of the M-1 times of subsequent regulation is also delayed by S0. Figure 3 The doctor may select the specific values ​​of delay S0 and S0, or choose not to delay S0, based on the individual physiological condition of the patient, to ensure the flexibility of the individual in using the blood pump.

[0066] 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 time 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 time 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.

[0067] Fig. 9 , Fig.10 , Fig.11 It can be regarded as the process of adaptively adjusting the speed in the stage of controlling the pulsation output. Fig. 9 As shown, in Figure 8 Based on the last acquired time T0, it is delayed by S0 and arrives at Fig. 9 At the current time T0 (i.e., the start time of the first diastolic period), the adaptive pulsation control state can be set to 5, and the motor speed can be adjusted from the initial speed w0 to the diastolic preset speed w1. Figure 3 , Fig.10 As shown, in Fig. 9 Based on the last acquired T0 moment, after a heart beat diastole time (during which the speed is W1), the first systolic phase begins (corresponding to Fig.10 At the current time T0 obtained in , the adaptive pulsation control state can be set to 6, and the motor speed is adjusted from the preset speed w1 in the diastolic period to the preset speed w2 in the systolic period. Figure 3 , Fig.11 As shown, after a cardiac contraction period (during which the speed is w2), the control counter count +1 can be used to indicate that the control has generated a speed of one cardiac cycle (i.e., a process of adaptively adjusting the speed of one cycle). If the speed of N1 cardiac cycles is not generated, the adaptive pulsation control state can be set to 5, and when the next diastolic period starts, the motor speed is adjusted from the preset speed of the contraction period w2 to the preset speed of the diastolic period w1, until the speed of N1 cardiac cycles is generated; wherein, w1≤w0≤w2.

[0068] 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 heart beat of the current patient in the historical time period based on the electrical signal change information of the motor in the historical time period.

[0069] like Fig.11As 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 preset diastolic 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 (it can be seen that Fig.12 ), that is, return to the initial state 0, enter the "pre-detection again" stage, and then start the next round of "pre-detection-control pulsation output" stage. Here, after a delay of S1, return to the initial state 0 and enter the "pre-detection again". Considering that speed regulation may cause electrical signal instability and affect the subsequent accurate adaptive pulsation output effect of the blood pump, it is possible to choose to let the motor maintain the initial speed w0 stable state for a period of time before entering the pre-detection stage to balance or compensate for the errors caused by the hardware and software in the early stage.

[0070] For example Figure 3 As shown, to be more precise, because after the delay from S0, the speed adaptive control (speed adjusted to w1) starts from the diastole period, and after the speed of N1 diastole periods and N1 systole periods is completely controlled, this corresponds to the start time of the N1+1th diastole period. At this time, it should jump to "adjust the speed to w0, delay fixed time S1" before entering the pre-detection stage. In short, the running speed of the motor during S1 and the pre-detection stage is the initial speed w0, and the running speed of the motor is adaptively adjusted back and forth between the preset speeds w1 and w2 during the control of the pulsation output stage. In some specific examples, if the start time of the diastole period is detected first, the end time of the N1th systole period can actually be regarded as the speed reset time.

[0071] In some specific examples, in order to improve the accuracy of diastolic and systolic detection, the detection of the motor current peak value and the detection of the edge (such as the rising edge and falling edge) of the motor electrical signal can also be combined to detect the cardiac pulsation information. For example, after the peak value of the motor electrical signal is detected, the detection of the start time of the diastolic period is started to reduce the probability of false detection.

[0072] In summary, the embodiment of the present application can also be called an intelligent blood pump based on adaptive control of cardiac pulsation and its control method, which predicts the adjustment timing of the speed required by the individual motor in the future (i.e., the start time of diastole and the start time of systole) 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, so as to realize the adaptive pulsation output of delayed following (or intermittent following) of cardiac pulsation; it should be noted that the delay or intermittency here mainly refers to the situation that, compared with the situation of real-time detection of the timing of speed regulation of w1 or w2, the situation of using the historically measured N0 start times to predict the aforementioned timing is lagging. In addition, it can be seen that the embodiment of the present application: (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 a motor current or a motor speed, the historical beat signal of the natural heart can be detected to achieve blood flow pulsation output that follows the heart beat.

[0073] (2) No excessive circuit signal resources are required, and no additional sensors are required, so the blood pump system design can be kept low in complexity and low in cost.

[0074] (3) Based on the detected heart beat signal, the speed modulation strategy can achieve synchronous following of the heart beat output with or without phase difference (i.e., S0). In other words, the blood flow pulsation generated by the blood pump can be flexibly associated or synchronized with the patient's own heart beat. The specific value S0 can be set by the doctor according to the individual patient's condition.

[0075] (4) The intelligent blood pump can independently complete the above-mentioned cardiac pulsation pre-detection (i.e., the detection of the historical start time) and open adaptive control (including adjusting the motor speed back and forth to w1 or w2), and can realize multi-parameter pulsation regulation, which is convenient 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 rules. Blood pump auxiliary function.

[0076] 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; The implantable blood pump includes an implantable motor, and an external controller is connected to the implantable blood pump; The extracorporeal 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 method embodiment of the first aspect, so as to control the motor to enable the diastolic preset speed each time the motor reaches the beginning of the diastolic phase of the patient's heart within a preset number of times, and to enable the systolic preset speed each time the motor reaches the beginning of the systolic phase of the patient's heart.

[0077] In the embodiment of the present application, the operation performed by the blood pump speed pulsation control system is similar to the operation described in the first aspect or any specific method embodiment of the first aspect, and will not be described in detail here. Of course, the specific implementation process of each operation in the first aspect of the present application can also refer to the relevant description of the second aspect.

[0078] The present application provides a computer-readable storage medium, comprising instructions, which, when executed on a computer, enable the computer to execute the method described in the first aspect or any specific implementation of the first aspect.

[0079] 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.

[0080] It is understandable that in various embodiments of the present application, the sequence number of each step does not mean the order of execution, and the execution order 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 method, system or product does not necessarily have to be executed in the specific implementation. If more than two operations are added, these operations can be implemented in combination or separately, depending on the actual scenario.

[0081] Those skilled in the art can 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.

[0082] In the several embodiments provided in the present 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.

[0083] The components described as separate components may or may not be physically separated, and the components displayed as components may or may not be physical components, that is, they may be located in one place, or they may be distributed on 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, each functional component in each embodiment 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.

[0084] 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 is essentially 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, including several instructions to enable 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: U disk, mobile hard disk, read-only memory (ROM, read-only memory), random access memory (RAM, random access memory), disk or optical disk and other media that can store program codes.

Claims

1. A blood pump speed pulsation control method, characterized in that: include: For the implantable blood pump motor of the current patient, based on the electrical 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 are detected; the electrical signal change information is used to reflect whether the heart of the current patient enters the diastolic period or the systolic period, and the systolic period start time is the diastolic period end time; Based on the N0 diastolic start time and the N0 systolic start time, the N1 diastolic start time and the N1 systolic start time of the heart after the historical period are determined respectively; wherein, the N1 diastolic start time and the N1 systolic start time are the moments when the diastolic preset speed and the systolic preset speed of the motor are correspondingly activated each time, the N0 and the N1 are positive integers, and the diastolic preset speed and the systolic preset speed are determined at least according to the current patient's physiological condition.

2. The blood pump speed pulsation control method according to claim 1, characterized in that: The detecting, based on the electrical 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, comprises: Extracting electrical signal information corresponding to the motor at different times in a historical period to form an electrical signal waveform jointly depicted by each of the electrical signal information; the historical period is at least longer than the cumulative duration of N0 cardiac cycles, and 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 time and the N0th systolic start time 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 the N1 diastolic start time and the N1 systolic start time of the heart after the historical period, comprises: Based on the N0 diastolic start time and the N0 systolic start time, the average diastolic duration and systolic duration of the heart are calculated each time; the sum of the diastolic duration and the systolic duration is one cardiac cycle; 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 beat cycle and the start time of the N0th systole, the start time of each remaining diastole in the N1 times is calculated based on the start time of the first systole and the duration of the systole, and the start time of each remaining systole in the 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 includes: A preset time difference is added to each of the N1 diastolic start time and the N1 systolic start time 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 includes: In the N1 times, each time the diastole start time is reached, the speed of the motor in the diastole is adjusted to the diastole preset speed, and each time the systole start time is reached, the speed of the motor in the systole is adjusted to the systole preset speed; the diastole preset speed is less than or equal to the systole preset 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 includes: Determine the 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 phase and the start time of the N0 systole phase 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 electrical 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, comprises: Since the diastolic start time and the systolic start time are detected for the first time in the N0 times, if the nth detection result in the N0 times does not meet the preset conditions, at least the nth systolic start time or the diastolic start time of the adjacent times is re-detected until the nth 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 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: an external controller and / or an implantable blood pump; The implantable blood pump comprises 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 diastolic preset speed each time the motor reaches the beginning of the diastolic phase of the patient's heart within a preset number of times, and to enable the systolic preset speed each time the motor reaches the beginning 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, which implement the method according to any one of claims 1 to 7 when executed by a processor.

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