Blood pump flow self-adaptive control method and system and related products

Abstract

The invention discloses a blood pump flow self-adaptive control method and system and a related product, and the method comprises the steps: determining the starting time of the future diastole and the starting time of the future systole of the heart of a current patient based on the historical electric signal change information of an individual patient; the rotating speed adjusting time of the blood pump motor can be ensured to accord with the physiological contraction rule of the individual heart in a personalized manner; wherein the starting moment of the current pulse period is determined according to the duration of one single historical pulse period, and the starting moment of the next pulse period is detected in the latest corresponding duration of the current pulse period, so that specific outputs such as the blood pumping time and the blood pumping volume of each time of a blood pump can flexibly follow the blood flow pulsation output of the heart pulse in real time; the auxiliary blood pump generates pulsating flow synchronous with natural cardiac pulsations, 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 flow adaptive 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 its 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, the motor speed of the blood pump used by each patient is fixedly adjusted at regular intervals of a uniform fixed time period. 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 flow adaptive control method, system and related products for flexibly controlling the activation time (i.e., the start time) of the speed 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 flow adaptive 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 duration of a single historical beating period of the heart of the current patient in the historical period is detected; the beating period is divided into a diastolic period and a systolic period; Taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period, determining the start time of the current beating period according to the duration of one of the single historical beating periods, and detecting the start time of the next beating period within the latest corresponding duration of the current beating period; the current beating period and the next beating period are different; According to the detected start time of the next beating period, the latest corresponding duration of the current beating period is updated as the standby duration corresponding to the next beating period of the same name of the current beating period; the next beating period is used as the new current beating period, and the step of detecting the start time of the next beating period within the latest corresponding duration of the current beating period is returned; The start time of the current beating period and the next beating period is the time when the corresponding beating period preset speed of the motor is activated each time, and the beating period preset speed is determined at least according to the current patient's physiological condition.

[0007] Optionally, detecting the duration of a single historical beat period of the heart of the current patient within the historical period according to the electrical signal change information of the motor within 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, one cardiac cycle includes one diastole and one systole, and N0 is a positive integer greater than or equal to 1; When the electrical signal is a motor current, detecting the moment when the N0th falling edge and the N0th rising edge begin to appear in the electrical signal waveform as the N0th diastolic start time and the N0th systolic start time of the heart; Based on the N0 diastolic start times and the N0 systolic start times, the average duration of each diastolic period and the average duration of each systolic period of the heart during the historical period are calculated as the duration of a single historical beat period.

[0008] Optionally, taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period comprises: When the historical beating period first entered by the heart within the historical time period is one of the diastolic period and the systolic period, the current beating period is set to be the beating period with the same name as the historical beating period.

[0009] Optionally, determining the start time of the current beating period according to the duration of one of the single historical beating periods includes: Determine an anamorphic beating period that is different from the current beating period, and based on the start time of the last anamorphic beating period in the historical period, add the duration of the anamorphic beating period detected correspondingly in the historical period to obtain the start time of the current beating period.

[0010] Optionally, detecting the start time of the next beating period within the latest corresponding duration of the current beating period includes: Extracting the electrical signal information corresponding to the motor at different times within the latest duration corresponding to the current beating period, and forming an electrical signal waveform jointly depicted by each of the electrical signal information; A signal edge corresponding to the next beating period is distinguished from the electrical signal waveform, and a time when the signal edge begins to appear is detected as a start time of the next beating period.

[0011] Optionally, if the start time of the next beating period is still not detected after multiple cumulative detections, the method further includes: Determine whether the sum of the diastolic duration and the systolic duration detected most recently is less than a preset total duration; If yes, increase the latest corresponding duration of the current beating period as the standby duration corresponding to the next beating period of the same name of the current beating period; take the next beating period as the new current beating period, and return to the step of detecting the start time of the next beating period within the latest corresponding duration of the current beating period; If not, after the latest duration corresponding to the current beating period has passed since the start time of the current beating period, 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 the step of detecting the duration of a single historical beating period of the current patient's heart in the historical time period is returned to based on the electrical signal change information of the motor in the historical time period.

[0012] Optionally, detecting the duration of a single historical beat period of the heart of the current patient within the historical period according to the electrical signal change information of the motor within the historical period includes: Since the start time of diastole and the start time of systole are detected for the first time in the historical period, if the n0th detection result among the total N0 times does not meet the preset conditions, at least the n0th systole start time or the adjacent diastole start time is re-detected until the N0th diastole start time and the N0th systole start time that meet the preset conditions are obtained; Among them, the n0 is between 1 and the N0 value; the detection result does not meet the preset conditions including: the difference between the start time of the n0th systole and the start time of the diastole of the adjacent number does not meet the threshold, and / or the number of diastole start times and systole start times detected in the historical period is less than the N0 times.

[0013] Optionally, after detecting the start time of the next beating period within the latest corresponding duration of the current beating period, the method further comprises: The current beating period is divided into a diastole and a systole, which are mutually exclusive. Each time the diastole starts, the rotation speed of the motor in the diastole is adjusted to the preset diastole rotation speed. Each time the systole starts, the rotation speed of the motor in the systole is adjusted to the preset systole rotation speed. The preset diastole rotation speed is less than or equal to the preset systole rotation speed.

[0014] When the method described in the first aspect of the present application is implemented, the content described in the second aspect of the present application can be adopted to achieve it.

[0015] A second aspect of the embodiments of the present application provides a blood pump flow adaptive control system, including: an in vitro controller and / or an 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 are used to execute the blood pump flow adaptive control method described in the first aspect of the embodiment of the present application or any specific implementation method of the first aspect, so as to control the motor to enable a preset diastolic 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 a preset systolic speed each time the motor reaches the beginning of the systolic phase of the patient's heart.

[0016] 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.

[0017] 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.

[0018] 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 phase and the start time of the systole phase 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 specific outputs 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

[0019] 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.

[0020] 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.

[0021] Figure 1 A schematic flow chart of a method for adaptively controlling the flow rate of a blood pump according to an embodiment of the present application; Figure 2 A state machine diagram of the blood pump flow adaptive control method according to an embodiment of the present application; Figure 3 for Figure 2 The corresponding process diagram in ; Figure 4 for Figure 3 The corresponding initialization diagram in ; Figure 5 for Figure 3 Detection schematic diagram of the corresponding diastolic start time; Figure 6 for Figure 3 Schematic diagram of detection of the corresponding contraction start time; Figure 7 for Figure 3 Schematic diagram of judging whether N0 cardiac cycles are detected; Figure 8 for Figure 3The schematic diagram of the corresponding delay specified time S2 and adaptively controlling the motor speed to the diastolic preset speed w1; Fig. 9 for Figure 3 The corresponding delay in a schematic diagram of S3; Fig.10 for Figure 3 The schematic diagram of the corresponding adaptive control motor speed is the preset speed w2 or the initial speed w0 during the contraction period; Fig.11 for Figure 3 Schematic diagram of the corresponding delay of S4; Fig.12 for Figure 3 Schematic diagram of the corresponding adaptive control motor speed being the preset diastolic speed w1 or the initial speed w0; Fig.13 for Figure 3 Schematic diagram of the corresponding delay for a specified time S1. DETAILED DESCRIPTION

[0022] In order to make the objectives, 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] The method of this application will be described in detail below.

[0027] See also Figure 1 In a first aspect, the present application provides a specific embodiment of a blood pump flow adaptive control method, the embodiment comprising the following operating steps: Figure 1 Step S11, for the implantable blood pump motor of the current patient, detecting the duration of a single historical beat period of the heart 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 magnitude of the current i input to the 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.

[0028] (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).

[0029] When the blood pump motor operates at a speed There are three basic situations: 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.

[0030] 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.

[0031] 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.

[0032] (Formula 3)

[0033] Therefore, it can be inferred in reverse that by monitoring the change information of electrical signals such as the blood pump motor current or motor speed, the time when the natural heart that still has the beating function enters the diastole and the time when it enters the systole (i.e., the start time of the beating period) can be extracted; and because the above-mentioned beating period can be divided into two periods, the diastole and systole of the heart (these two periods constitute a heartbeat cycle), the end time of any of these two periods is the start time of the other period, so through the N0 times of diastole start time and N0 times of systole start time extracted in history, the duration of a single diastole duration, a single systole duration, etc. in the historical sense of the patient's heart can be calculated on average by the number of times (which can be called the mean beating period time), as shown below, which will not be repeated here. This duration can be used later to adjust the blood pulsation output according to individual needs (such as increasing the heart's output per beat), or to output a blood pulsation flow with a reasonable phase difference from its heart beat cycle to meet the actual pulsation needs of the individual heart.

[0034] It should be noted that the above N0 (N0 ≥ 1) 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.

[0035] Figure 1Step S12, taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period, determining the start time of the current beating period according to the duration of one of the single historical beating periods, and detecting the start time of the next beating period within the latest corresponding duration of the current beating period; Among them, the start time of the current beating period and the next beating period are the moments when the preset speed of the corresponding beating period of the motor is activated each time; the names of the current beating period and the next beating period are different, that is, the next beating period of the current beating period can be called the alternative beating period of the current beating period.

[0036] The above-mentioned current pulsation period can be a diastolic period or a systolic period. For the convenience of explanation and understanding, the embodiment of the present application mainly takes the diastolic period (its synonymous pulsation period is the systolic period) as an example for explanation, that is, it can be defined that the diastolic period is detected or entered into control first. For example, the start time of the diastolic period entered for the first time after the historical period = the start time of the N0th systolic period + the duration of a single systolic period. When the start time of the first diastolic period is reached, the speed of the blood pump motor will be adjusted to the preset diastolic speed w1; the start time of the first systolic period can be detected within the period of the aforementioned "single diastolic period duration" from the start time of the first diastolic period (the motor speed during this period is w1). If the start time of the first contraction period is successfully detected within this period (i.e., the first diastole), it means that the heart has not actually completely experienced the aforementioned "single diastole duration", and the aforementioned "single diastole duration" can be updated in real time accordingly as the backup duration for the second diastole; if the start time of the first contraction period is not successfully detected, the aforementioned "single diastole duration" is still used, and the start time of the first contraction period can be set as usual = the start time of the first diastole + the aforementioned single diastole duration calculated historically.

[0037] Figure 1 Step S13, updating the latest duration corresponding to the current beating period according to the detected start time of the next beating period as the standby duration corresponding to the next beating period of the same name of the current beating period; taking the next beating period as the new current beating period, and returning to the step of detecting the start time of the next beating period within the latest duration corresponding to the current beating period; based on Figure 1According to the description of step S12, the next pulsation period of the first diastolic period, i.e., the first systolic period, can be taken as the new current pulsation period. Similarly, when the first systolic period starts, the speed of the blood pump motor will be adjusted to the preset systolic period speed w2, and the start time of the second diastolic period can be detected during the period of the aforementioned "single systolic period duration" from the start time of the first systolic period (the motor speed during this period is w2). If the start time of the second diastolic period is successfully detected within this period (i.e., the first systolic period), it means that the heart has not actually completely experienced the aforementioned "single systolic period duration", and this "single systolic period duration" can be updated in real time accordingly as the standby duration of the second systolic period. It can be seen that the operation here is equivalent to similarly repeating the above. Figure 1 Step S12 is used to determine the timing of adjusting the motor speed each time (ie, switching the speed back and forth between w1 and w2) after N0 historical detection stages.

[0038] Specifically, the diastolic preset speed w1 and systolic preset speed w2 required by the current patient can be comprehensively judged and determined based on the patient's current heart condition (such as cardiac output), pulmonary circulation (such as pulmonary artery pressure) and other physiological conditions.

[0039] In summary, the embodiment of the present application uses the patient's individual historical electrical signal change information as a basis to determine the start time of the patient's heart's future diastole and systole, 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 specific outputs 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. In addition, due to Figure 1 In step S12, the duration of the beat period is updated in real time, rather than consistently citing or relying on the historically detected duration of the beat period, so as to dynamically adjust the timing of each future change in the motor speed. Therefore, it can be understood that the embodiment of the present application can achieve an adaptive pulsating output that follows the heart beat in real time (or continuously follows), that is, it can more effectively assist in generating the blood flow required by the individual heart.

[0040] 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.

[0041] 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 diastole and the start time of systole).

[0042] based on Figure 1 In some specific examples, Figure 1 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 various electrical signal information; the historical period is at least more than the cumulative duration of N0 heart beat cycles, one heart beat cycle includes one diastole and one systole, and N0 is a positive integer greater than or equal to 1; when the electrical signal is the motor current, detecting the moment when the falling edge begins to appear N0 times and the rising edge begins to appear N0 times in the electrical signal waveform, as the N0 diastole start time and the N0 systole start time of the heart; based on the N0 diastole start time and the N0 systole start time, calculating the average diastole duration and systole duration of the heart in the historical period as the duration of a single historical beat period.

[0043] 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.

[0044] See also Figure 2 The possible solutions shown are Figure 2An 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 the scheme includes: pre-detection extraction of the start time of diastole and pre-detection extraction of the start time of systole (each can be detected N0 times) to obtain the cycle information of heart beat (one diastole duration and one systole duration constitute one heart beat cycle); in the N1 heart beat 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. Of course, in some cases, the specific value of N1 may not be limited.

[0045] Specifically, taking the motor current as an electrical signal, if the first detection is the start time of the diastole: 1. The start time of the diastole period 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 period, the blood pump motor current begins to decrease, so the moment when each current falling edge begins to appear can be defined as the start time of the diastole period.

[0046] 2. The start time of the cardiac systolic period 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 systolic period, the blood pump motor current begins to rise, so the time when each current rising edge begins to appear can be defined as the start time of the systolic period.

[0047] 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 for the rising edge or the falling edge depends on the design of the blood pump and is not described in detail here.

[0048] 3. N0 ≥ 1, N0 refers to the number of diastolic phases or systolic phases detected in a round of pre-detection stage.

[0049] 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 adaptive pulsation output is not possible). It can be simply understood that w0 is the initial speed of the blood pump motor when pulsation control is not performed.

[0050] 5. Doctors can set the values ​​of S2, w1, w2 and N1 according to the individual physiological state of the patient. (1) S2 represents the phase difference between the actual pulsation output and the natural heart pulsation, S2 ≥ 0. For example, S2 can be one heart beat cycle calculated in the pre-detection stage. S2 can be simply processed in the software, that is, the extension time S2' actually used by the software is set to an integer multiple of the heart beat cycle closest to S2. For example, if the patient's heart beat cycle detected is 680 milliseconds, and the doctor sets S2 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 final S2' used in the software can be 4*680 milliseconds = 2720 milliseconds, so as to ensure that S2 is delayed by 4 complete heart beat cycles, thereby ensuring the correctness of the start time of the first diastole; and such data processing (i.e. set to 3000 milliseconds, but actually using 2720 milliseconds), the difference in milliseconds can be ignored.

[0051] (2) w1 is the blood pump operating speed during diastole, i.e., the preset diastolic speed.

[0052] (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.

[0053] (4) N1 is the number of cycles of continuous active output cardiac beat control.

[0054] 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.

[0055] Of course, with Figure 2 The difference is that in some examples, you can also choose to start detecting the start time of the systolic period first. Then, correspondingly, the "control pulsation output" stage can be to enter the systolic period first and then the diastolic period. The motor speed w0 (i.e., the motor speed in the pre-detection stage) is first adjusted to the preset speed of the systolic period and then to the preset speed of the diastolic period. This method is similar to Figure 2 The example is similar and will not be repeated here.

[0056] Figure 2 The corresponding process can be as follows Figure 3As 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 B0 operation flow (which can be regarded as the initialization operation process) is executed; if it is detected that the current state of the blood pump motor is not 0 but 1, the B1 operation flow is executed, and so on. If it is finally detected that the current state of the blood pump motor is 9, the B9 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 9, the entire adaptive pulsation control scheme can be ended or exited, and / or manual intervention can be requested.

[0057] like Figure 4 As shown, the operation flow of item B0 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 (specifically, detecting the start time of the historical beating period) can be configured, and a control counter for counting the number of adaptive controls (that is, the number of times the motor speed switches back and forth between w1 and w2, N1) can be configured. The detection counter can be subdivided into a detection counter for the start time of the diastole period and a detection counter for the start time of the systole period. 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 the start time of the diastole period and the start time of the systole period are detected, until N0 heartbeat cycles in history are detected. 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 single diastolic mean time or the diastolic time) can be calculated based on the cumulative value of the diastolic duration and the detection count value about the start time of the diastolic period. Similarly, the duration of each systolic period (or the single systolic mean time or the systolic time) can be calculated based on the cumulative value of the systolic duration and the detection count value about the start time of the systolic period. During initialization, the heart beat diastolic mean update flag and the heart beat systolic mean update flag can be initialized to 0. In the subsequent control pulsation output stage, each time the rising edge of the motor current or the falling edge of the motor current is detected, the flag can be updated to assist in determining whether the diastolic mean or the systolic mean can be updated (see below for details). After a series of such set-to-0 operations, the state can be set to 1 to end the B0 operation flow and execute Figure 3 The process is to continuously poll to determine the current state of the blood pump motor (i.e., the adaptive pulsation control state), and jump to and execute the corresponding operation flow under this state.

[0058] Because the B0 operation flow has set the state to 1, the next Figure 3 The B1 operation flow (detecting the start time of diastole, see Figure 5 ): Once the falling edge of the motor current is detected at a certain moment, this moment T0 can be immediately defined as the beginning of the diastole period; and the state is set to jump to the adaptive pulsation control state 2 thereafter.

[0059] according to Figure 2 , Figure 3 Similarly, the next execution will be as follows Figure 6 The B2 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 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 and 120 beats / minute, then Figure 6 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.

[0060] In some specific examples, Figure 1 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 the historical time period, if the n0th detection result among a total of N0 times does not meet the preset conditions, at least re-detect the n0th start time of systole or the start time of diastole of the adjacent times, until the N0th start time of diastole and the N0th start time of systole that meet the preset conditions are obtained; wherein n0 is between 1 and N0 values; the detection result does not meet the preset conditions including: the difference between the n0th start time of systole and the adjacent start time of diastole does not meet the threshold value P0, and / or the number of times the diastole start time and the systole start time are detected in the historical time period is less than N0 times; N0 can be regarded as the total number of times.

[0061] Taking the case of first detecting the start time of diastole as an example, (1) If Figure 6 As shown, if the difference between the start time of the systolic period and the start time of the adjacent diastolic period is T1-T0≤P0, the process may return to the step of detecting the start time of the systolic period again.

[0062] (2) If Figure 7As 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 effective start times of N0 times or more.

[0063] 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.

[0064] It should be noted that the above-mentioned operation process of "using the N0 diastolic start time and the N0 systolic start time extracted in history to average out the duration of a single diastolic period and a single systolic period in the patient's heart history (which can be called the mean beat period time)" can be as follows: Figure 7 The B3 operation flow shown (detecting the start time of the next diastole and the end time of the systole) is similar to Figure 5 , you can Figure 7 The moment T2 when the motor current starts to fall is defined as the start time of the current diastole, and the current systole time is set to T2-T1 (i.e. the duration of a single systole). Figure 7 As shown, (1) The systolic period of a heart beat is generally one-third of the heart beat cycle. Therefore, when the duration of a single diastolic period is ≥ the duration of a single systolic period, the test result can be considered normal and valid. The test counter can be increased 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 is N ≥ N0, the following results can be calculated according to the formula: 1 diastolic mean time (or heart beat diastolic period time) = diastolic period cumulative value ÷ detection count value about the diastolic start time, 1 systolic mean time (or heart beat systolic period time) = systolic period cumulative value ÷ detection count value about the systolic start time. Subsequently, the adaptive pulsation control state can be set to 4.

[0065] (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 re-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.

[0066] In some specific examples, Figure 1 The specific operation process of "taking the subsequent beating period that the heart enters for the first time after the historical time period as the current beating period" in step S12 may include: when the historical beating period that the heart enters for the first time in the historical time period is one of the diastole and the systole, setting the current beating period to the beating period with the same name as the historical beating period.

[0067] like Figure 2 As shown, since the first historical pulsation period entered in the "pre-detection" stage is the diastolic period, the first diastolic period in the "control pulsation output" stage can be set as the current pulsation period; of course, this current pulsation period can also be a pulsation period (i.e., systolic period) with a different name and mutually exclusive with this historical pulsation period (such as diastolic period), which can be determined by the needs and is not limited here. For the convenience of explanation and understanding, the embodiment of the present application mainly takes the current pulsation period as the same name as the first historical pulsation period (such as both are diastolic periods) for explanation.

[0068] In some specific examples, Figure 1 The specific operation process of "determining the start time of the current beating period according to the duration of one single historical beating period" in step S12 may include: determining an alternative beating period different from the current beating period, and based on the start time of the last alternative beating period in the historical time period, increasing the duration of the alternative beating period detected correspondingly in the historical time period (i.e. increasing the phase difference) to obtain the start time of the current beating period.

[0069] Specifically, the diastolic period can be selected as the current beating period, and its synonymous beating period is the systolic period. Afterwards, the start time of the current beating period in the "control pulsating output" stage can be determined based on the duration of the systolic period (or the mean systolic period time) detected in the "pre-detection" stage as above. Among them, in the "control pulsating output" (that is, the motor speed switches back and forth between w1 and w2) stage, the number of times N1 of switching back and forth between w1 and w2 can be limited or not limited. When limiting the number N1, the setting can be that the initialization and "re-pre-detection" stage will not be entered until the speed of N1 heartbeat cycles is generated; the reason for not limiting the number N1 may be that the initialization condition for enabling the initial speed w0 is not triggered in the "control pulsating output" stage, that is, the condition of continuously switching back and forth between w1 and w2 is met. For details, please see Figure 2 and below.

[0070] For example, in the process of controlling the pulsation output N1 times (i.e., the motor speed switches back and forth between w1 and w2 N1 times), when n1=1, the control generates the first current pulsation period (such as diastole), and the corresponding first diastole start time can be the end time of the last (N0th) historically effectively detected systole (such as Figure 7 "Get the current time T0" in the code - this may mean that you are about to enter Figure 8 Delay S2 operation link) "delay specified time" (ie Figure 2 The time it arrives after a "delay of one S2") (see Figure 8 "Get current time T0" in the delay. The time T0 reached here is the time when the motor speed is adjusted from the initial speed w0 to the diastolic speed w1. Among them, the upper limit of n1 is N1, the phase difference S2 ≥ 0, the initial value of S2 is 0, and the actual specific value is set by the doctor according to the individual physiological condition of the patient to ensure the flexibility of the individual when using the blood pump. After the delay S2, the state can be set to 5 and enter the B5 operation flow. It should be noted that when S2 is 0, in Figure 7 A complete transition to a contraction period has been achieved (corresponding to Figure 7 The motor current falling edge detected in the process is then set to state 4), and the Figure 8 Since S2 is 0, the software will quickly enter the B4 operation flow. Fig. 9 The B5 operation flow is used for diastolic regulation; in other words, S2 is Figure 7 The timing starts when the falling edge of the current is detected (i.e. the end of the contraction period). Figure 7 The end of the pre-test is at the end of the systolic period (i.e. the beginning of the diastolic period). Fig. 9The diastolic speed pulsation control is enabled, and the entire pulsation cycle is connected reasonably. Furthermore, S2 can be set to a multiple of the time of one pulsation cycle (i.e., one diastolic period + one systolic period), thereby continuing to achieve a reasonable connection of the pulsation cycle control.

[0071] Under normal circumstances: when n1=1, the start time of the first systolic period = the start time of the first diastolic period + the mean time of the diastolic period, that is, the start time of the systolic period can be reached after one mean time of the diastolic period from the start time of the diastolic period. When n1>1, the corresponding start time of the n1th diastolic period = the start time of the n1-1th systolic period + the mean time of the systolic period, the start time of the n1th systolic period = the start time of the n1-1th diastolic period + the mean time of the diastolic period, and the upper limit of n1 is N1. However, considering that there may be a slight time difference between each heartbeat cycle, the embodiment of the present application innovatively proposes that the "control pulsation output" stage can update the duration of the pulsation period in real time, that is, the time difference between the start time of each pulsation period after n1>1 is not necessarily the same, so as to better fit 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 heartbeat.

[0072] In some specific examples, Figure 1 The specific operation process of "detecting the start time of the next beating period within the latest corresponding duration of the current beating period" in step S13 may include: extracting the electrical signal information corresponding to the motor at different times within the latest corresponding duration of the current beating period, forming an electrical signal waveform jointly characterized by various electrical signal information; distinguishing the signal edge corresponding to the next beating period from the electrical signal waveform, and detecting the moment when the signal edge begins to appear as the start time of the next beating period.

[0073] Similar to the process of detecting the start time of a beat period through the rising or falling edge of the electrical signal waveform in the above-mentioned "pre-detection" stage, the start time of the next beat period (i.e., the alternative beat period of the current beat period) can be detected within the current beat period in the "control pulsation output" stage.

[0074] The following will explain in detail the operations that occur during the transition from the start of the diastole to the start of the systole in the "control pulsation output" phase (the motor speed during the transition period is w1). Figure 2 As shown, from the beginning of the first diastole (see Figure 8 The motor speed is w1 during a period of time S3 from the "Get current time T0" in the above example. After this duration is reached (i.e., when the motor speed reaches w1), the motor speed is w1 during a period of time S3. Fig. 9 "Get current time T0"), you can try to detect the start time of the systolic period within the period of "1 diastolic period average time - S3" (see Fig.10). Taking the motor current signal as an example, once the rising edge of the current signal waveform is successfully detected within the period of "1 diastolic mean time-S3", the moment when the motor current starts to rise can be used as the start time of the systolic period. Correspondingly, the heart beat systolic mean update flag can be set to 1, the speed is adjusted to w2, and the state can be set to 7. In addition, if the heart beat diastolic mean update flag is 1, it means that the last falling edge of the motor current signal waveform in the control pulsation output stage has also been successfully determined. The time interval between the continuously determined falling edge start time and the rising edge start time can be regarded as the complete diastolic period time, so the diastolic mean can be updated to T1-T3 (see Fig.10 ). Among them, the diastolic mean update flag is set from 0 to 1, which can be used to indicate that the most recent motor current falling edge start time has been successfully determined in the control pulsation output stage (for example, the first diastolic start time determined after the delay S2), and can indicate that the current period has not completely continued for a historical diastolic mean time as usual before entering the systolic period (that is, the motor speed will be adjusted to w2); and the cardiac systolic mean update flag is set from 0 to 1, which can be used to indicate that the most recent motor current rising edge start time has been successfully determined in the control pulsation output stage, and can indicate that the current period has not completely continued for a historical systolic mean time as usual before entering the diastolic period (that is, the motor speed will be adjusted to w1). When these two flags are both 1, it means that the two moments between the updates of these two flags are a complete pulsation period information ( Figure 6 The corresponding period is the diastolic period. Figure 8 The corresponding systolic period) can update the corresponding beat period mean. In other words, these two flags are set to 1 only when the most recent falling edge or rising edge of the motor current is detected. If these two flags are 1 at the same time, it means that the edges corresponding to the two flags are consecutive, for example, Fig.10 In the B6 operation flow shown, after the rising edge of the motor current is detected (i.e., the end time of the diastole T1 is determined), if the heart beat diastole mean update flag is also 1, it means that the start time of the diastole that has just ended has also just been updated, so the T1-T3 value obtained by subtracting the updated start time T3 from the newly detected end time T1 is the accurate single diastole time. Generally, after the beat period mean is updated, the corresponding mean update flag needs to be set to 0 so that the next time it indicates that the corresponding edge start time has been successfully determined.

[0075] The above-mentioned start time of the next beating period may not be detected within the time period of "1 diastolic mean time - S3". For example, the blood pump has been running continuously at a speed of w1 for a complete historical diastolic mean time, and no rising edge of the motor current has been detected during this period. Therefore, the method of the embodiment of the present application may also include the following countermeasures: set the motor current falling edge detection failure counter ++ (i.e., self-increment). If the failure counter is <N2, the speed is adjusted to w2, the state can be set to 7, and the systolic period control is started. If the failure counter is ≥N2, determine whether the sum of the most recently detected diastolic duration and systolic duration is less than the preset total duration: if so, increase the latest corresponding duration of the current beating period and use it as the standby duration corresponding to the next beating period of the same name as the current beating period (i.e., update the duration of the current beating period in a way that catches up with the time); use the next beating period as the new current beating period, and return to the step of detecting the start time of the next beating period within the latest corresponding duration of the current beating period (see Fig.11 and Fig.12 If not, after the latest duration corresponding to the current beating period has passed since the start of the current beating period, the motor speed is adjusted to the initial speed so that the motor runs at the initial speed for a period of time (see Fig.13 ), returns to the step of detecting the duration of a single historical beat period of the current patient's heart in the historical period according to the change information of the motor's electrical signal in the historical period (see Figure 3 and Figure 4 ).

[0076] like Figure 2 , Fig.10As shown, if the start time of the systolic period is still not detected after N2 times or more, it can be determined whether the sum of the latest detected diastolic mean time and systolic mean time is less than the preset total time length S5. (1) If it is less than S5, the new diastolic mean time can be set to = the most recently determined diastolic mean time + S6 (this updated diastolic mean is expected to be used at the start of the next diastolic period), and the counter of the motor current rising edge detection failure is set to 0, the motor speed is adjusted to w2, and the state is set to 7. Among them, the failure count is set to 0 here in order to restart the accumulation of the number of times the start time of the systolic period is not successfully detected in the next round (the motor speed switches back and forth between w1 and w2 once, which is one round); the above + S6 is considered that in some cases, the patient's heart beat cycle during the blood pump software pre-detection may be shorter than the patient's heart beat cycle during the pulsation control, so the gap is made up by catching up with the time to reduce the impact of changes in the patient's physiological condition. S6 can be determined based on the individual physiological condition of the patient. (2) If it is greater than or equal to S5, after a complete diastolic average time, the adaptive pulsation control state can be set to 9, and the motor speed can be 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 S1 and then returns to Figure 1 Step S11 (see Fig.13 , Figure 2 ), that is, return to the initialization state of 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 a period of time S1 (which can be determined by the needs), 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 run continuously at the initial speed w0 for a period of time, and then enter the pre-detection stage after reaching a stable state, so as to balance or compensate for the error caused by the previous speed change.

[0077] See also Fig.11 , Fig.12 The operations that occur during the transition from the start of systole to the start of diastole in the "control pulsating output" stage shown (the motor speed during the transition period is w2) can be similarly referred to the operations during the transition from the start of diastole to the start of systole in the above-mentioned "control pulsating output" stage, including: continuously detecting the start of diastole within the time period of "1 systolic mean time - S4", and updating the systolic mean time (such as increasing the duration S6), etc., which are not elaborated on; the increased duration S6 during these two periods can be equal or unequal, depending on the specific situation.

[0078] As described above, in some specific examples, Figure 1After step S12, the method of the embodiment of the present application may further include (adaptive speed adjustment): dividing the current beating period into a diastole and a systole which are mutually exclusive, and adjusting the speed of the motor in the diastole to the preset diastole speed each time the start time of the diastole is reached, and adjusting the speed of the motor in the systole to the preset systole speed each time the start time of the systole is reached; the preset diastole speed is less than or equal to the preset systole speed.

[0079] Specifically, in the "control pulsation output" stage, the control motor is adjusted to the diastolic preset speed w1 every time it reaches the beginning of diastole, and is adjusted to the diastolic preset speed w2 every time it reaches the beginning of systole, so as to adapt to the regular operation of the blood pumping function of the individual heart, where w1≤w2.

[0080] 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 rising edge and falling edge) of the motor electrical signal can 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.

[0081] 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 uses the cardiac pulsation signal obtained by historical detection (i.e., the above-mentioned N0 historical diastolic start times, N0 historical systolic start times) and the speed modulation strategy to predict in real time 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), and realizes the adaptive pulsation output of real-time following (or continuous following) of the cardiac pulsation; it should be noted that the real-time here mainly refers to the real-time update of the duration of the pulsation period, so as to predict in real time the timing of the motor speed adjustment to w1 or w2. 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.

[0082] (2) No excessive circuit signal resources are required, and no additional sensors are needed, thus keeping the blood pump system design low-complexity and low-cost.

[0083] (3) Based on the detected heart beat signal, the speed modulation strategy can achieve synchronous follow-up of the heart beat output with or without phase difference (i.e., S2). 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 S2 can be set by the doctor according to the individual patient's condition.

[0084] (4) The intelligent blood pump can independently complete the above-mentioned cardiac pulsation pre-detection (i.e., the detection history start time) and turn on 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 regularity blood pumping auxiliary functions.

[0085] A second aspect of the present application provides a specific embodiment of a blood pump flow adaptive control system, the system comprising: an in vitro 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.

[0086] In the embodiment of the present application, the operation performed by the blood pump flow adaptive 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.

[0087] 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.

[0088] 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.

[0089] 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 contents added or refined in each example scheme of the above method, system or device do 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.

[0090] Those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working processes of the systems and devices described above can refer to the corresponding processes in the aforementioned method embodiments and will not be repeated here.

[0091] In the several embodiments provided in the present application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are only 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 device, 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 an indirect coupling or communication connection through some interfaces, devices or components, which can be electrical, mechanical or other forms.

[0092] The components described as separate components may or may not be physically separated, and the components shown as components may or may not be physical components, that is, they may be located in one place or distributed on multiple network components. Some or all of the components may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0093] 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 integrated components may be implemented in the form of hardware or in the form of software functional components.

[0094] 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 flow adaptive control method, characterized in that: include: For the implantable blood pump motor of the current patient, detecting the duration of a single historical beat period of the heart of the current patient in the historical period according to the electrical signal change information of the motor in the historical period; The pulsation period is divided into a diastolic period and a systolic period; Taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period, determining the start time of the current beating period according to the duration of one of the single historical beating periods, and detecting the start time of the next beating period within the latest corresponding duration of the current beating period; the current beating period and the next beating period are different; updating the latest duration corresponding to the current beating period according to the detected start time of the next beating period as a standby duration corresponding to the next beating period of the same name as the current beating period; Taking the next beating period as the new current beating period, and returning to the step of detecting the start time of the next beating period within the duration corresponding to the latest current beating period; The start time of the current beating period and the next beating period is the time when the corresponding beating period preset speed of the motor is activated each time, and the beating period preset speed is determined at least according to the current patient's physiological condition.

2. The blood pump flow adaptive control method according to claim 1, characterized in that: The detecting, based on the electrical signal change information of the motor in the historical time period, the duration of a single historical beat period of the heart of the current patient in the historical time 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, one cardiac cycle includes one diastole and one systole, and N0 is a positive integer greater than or equal to 1; When the electrical signal is a motor current, detecting the moment when the N0th falling edge and the N0th rising edge begin to appear in the electrical signal waveform as the N0th diastolic start time and the N0th systolic start time of the heart; Based on the N0 diastolic start times and the N0 systolic start times, the average duration of each diastolic period and the average duration of each systolic period of the heart during the historical period are calculated as the duration of a single historical beat period.

3. The blood pump flow adaptive control method according to claim 1, characterized in that: The step of taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period comprises: When the historical beating period first entered by the heart within the historical time period is one of the diastolic period and the systolic period, the current beating period is set to be the beating period with the same name as the historical beating period.

4. The blood pump flow adaptive control method according to claim 1, characterized in that: Determining the start time of the current beating period according to the duration of one of the single historical beating periods includes: Determine an anamorphic beating period that is different from the current beating period, and based on the start time of the last anamorphic beating period in the historical period, add the duration of the anamorphic beating period detected correspondingly in the historical period to obtain the start time of the current beating period.

5. The blood pump flow adaptive control method according to claim 1, characterized in that: The detecting the start time of the next beating period within the latest corresponding duration of the current beating period comprises: Extracting the electrical signal information corresponding to the motor at different times within the latest duration corresponding to the current beating period, and forming an electrical signal waveform jointly depicted by each of the electrical signal information; A signal edge corresponding to the next beating period is distinguished from the electrical signal waveform, and a time when the signal edge begins to appear is detected as a start time of the next beating period.

6. The blood pump flow adaptive control method according to any one of claims 1 to 5, characterized in that: If the start time of the next beating period is still not detected after multiple accumulated times, the method further includes: Determine whether the sum of the diastolic duration and the systolic duration detected most recently is less than a preset total duration; If yes, increase the latest corresponding duration of the current beating period as the standby duration corresponding to the next beating period of the same name of the current beating period; take the next beating period as the new current beating period, and return to the step of detecting the start time of the next beating period within the latest corresponding duration of the current beating period; If not, after the latest duration corresponding to the current beating period has passed since the start time of the current beating period, 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 the step of detecting the duration of a single historical beating period of the current patient's heart in the historical time period is returned to based on the electrical signal change information of the motor in the historical time period.

7. The blood pump flow adaptive control method according to any one of claims 1 to 5, characterized in that: The detecting, based on the electrical signal change information of the motor in the historical time period, the duration of a single historical beat period of the heart of the current patient in the historical time period comprises: Since the start time of diastole and the start time of systole are detected for the first time in the historical period, if the n0th detection result among the total N0 times does not meet the preset conditions, at least the n0th systole start time or the adjacent diastole start time is re-detected until the N0th diastole start time and the N0th systole start time that meet the preset conditions are obtained; Among them, the n0 is between 1 and the N0 value; the detection result does not meet the preset conditions including: the difference between the start time of the n0th systole and the start time of the diastole of the adjacent number does not meet the threshold, and / or the number of diastole start times and systole start times detected in the historical period is less than the N0 times.

8. The blood pump flow adaptive control method according to any one of claims 1 to 5, characterized in that: After detecting the start time of the next beating period within the latest corresponding duration of the current beating period, the method further includes: The current beating period is divided into a diastole and a systole, which are mutually exclusive. Each time the diastole starts, the rotation speed of the motor in the diastole is adjusted to the preset diastole rotation speed. Each time the systole starts, the rotation speed of the motor in the systole is adjusted to the preset systole rotation speed. The preset diastole rotation speed is less than or equal to the preset systole rotation speed.

9. A blood pump flow adaptive control system, characterized in that: include: an external controller and / or an 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 flow adaptive control method as described in any one of claims 1 to 8, so as to control the motor to enable a preset diastolic 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 a preset systolic speed each time the motor reaches the beginning of the systolic phase of the patient's heart.

10. 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 8 is implemented.

11. 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 8 when executed by a processor.

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