Blood pump flow adaptive control method, system and related products

Abstract

The present application discloses a blood pump flow adaptive control method, system and related products. The embodiments of the present application use the patient's individual historical electrical signal change information as a basis 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 and conforms to the physiological contraction law of the individual heart; wherein, the start time of the current beating period is determined according to the duration of one single historical beating period, and the start time of the next beating period is detected within the latest corresponding duration of the current beating period, which can achieve the specific outputs of the blood pump such as the blood pumping time and the blood pumping volume each time to flexibly follow the blood flow pulsation output of the heart beat in real time, that is, to assist the blood pump in generating a pulsating flow synchronized with the natural heart beat, thereby effectively and reliably maintaining the patient's life safety.

Description

Technical Field

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

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

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

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

[0005] The embodiments of the present application provide a blood pump flow adaptive control method, system and related products for flexibly controlling the activation time (i.e., the starting 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:

[0007] For the implantable blood pump motor of the current patient, detecting the duration of a single historical heart beat period of the current patient during the historical period based on information on changes in electrical signals of the motor during the historical period; the heart beat period is divided into a diastole and a systole;

[0008] taking a subsequent beating period that the heart first enters after the historical period as a current beating period, determining a start time of the current beating period based on a duration of one of the single historical beating periods, and detecting a start time of a next beating period within the latest duration corresponding to the current beating period; the current beating period and the next beating period are different;

[0009] 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 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;

[0010] The start time of each 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 physiological condition of the patient.

[0011] Optionally, detecting the duration of a single historical heart beat of the current patient within the historical period based on the electrical signal change information of the motor within the historical period includes:

[0012] Extracting electrical signal information corresponding to the motor at different times during a historical period to form an electrical signal waveform jointly depicted by the electrical signal information; the historical period is at least a cumulative duration of N0 cardiac cycles, where one cardiac cycle includes one diastole and one systole, and N0 is a positive integer greater than or equal to 1;

[0013] When the electrical signal is a motor current, detecting the moment when the falling edge starts to appear N0 times and the moment when the rising edge starts to appear N0 times in the electrical signal waveform as the moment when the N0 diastole starts and the N0 systole starts of the heart;

[0014] Based on the N0 diastolic start times and the N0 systolic start times, the average diastolic duration and systolic duration of the heart during the historical period are calculated as the duration of a single historical beat period.

[0015] Optionally, taking the subsequent beating period that the heart first enters after the historical period as the current beating period includes:

[0016] 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.

[0017] Optionally, determining the start time of the current beating period according to the duration of one of the single historical beating periods includes:

[0018] Determine an aliased beating period that is different from the current beating period, and based on the start time of the last aliased beating period in the historical period, add the duration of the aliased beating period detected correspondingly in the historical period to obtain the start time of the current beating period.

[0019] Optionally, detecting the start time of the next beating period within the latest corresponding duration of the current beating period includes:

[0020] 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 the electrical signal information;

[0021] 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.

[0022] Optionally, if the start time of the next beating period is not detected after multiple accumulated attempts, the method further includes:

[0023] Determine whether the sum of the most recently detected diastolic duration and systolic duration is less than a preset total duration;

[0024] If yes, increase the duration corresponding to the latest 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 duration corresponding to the latest current beating period;

[0025] If not, after the latest corresponding duration of the current beating period has passed since the start moment 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 returns to the step of detecting the duration of a single historical beating period of the current patient's heart in the historical period based on the electrical signal change information of the motor in the historical period.

[0026] Optionally, detecting the duration of a single historical heart beat of the current patient within the historical period based on the electrical signal change information of the motor within the historical period includes:

[0027] Since the first detection of the diastolic start time and the systolic start time within the historical period, if the n0th detection result among a total of N0 times does not meet the preset conditions, at least the n0th systolic start time or the adjacent diastolic start time are re-detected until the N0th diastolic start time and the N0th systolic start time that meet the preset conditions are obtained;

[0028] 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 times the diastole start time and the systole start time are detected in the historical period is less than the N0 times.

[0029] Optionally, after detecting the start time of the next beating period within the latest corresponding duration of the current beating period, the method further includes:

[0030] The current beating period is divided into a diastole period and a systole period, which are mutually exclusive. Each time the diastole period starts, the speed of the motor in the diastole period is adjusted to the preset diastole speed. Each time the systole period starts, the speed of the motor in the systole period is adjusted to the preset systole speed. The preset diastole speed is less than or equal to the preset systole speed.

[0031] When the method described in the first aspect of this application is specifically implemented, the content described in the second aspect of this application can be used to achieve it.

[0032] A second aspect of the embodiments of the present application provides a blood pump flow adaptive control system, comprising: an external controller and / or an implantable blood pump;

[0033] 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 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 the preset diastolic speed each time it reaches the start of the diastolic phase of the patient's heart within a preset number of times, and to enable the preset systolic speed each time it reaches the start of the systolic phase of the patient's heart.

[0034] 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.

[0035] 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.

[0036] It can be seen from the above technical solutions that the embodiments of the present application have at least the following advantages:

[0037] The embodiment of the present application is based on the patient's individual historical electrical signal change information to determine the future start time of the diastole and the start time of the systole of the current patient's heart, which can ensure that the speed adjustment time of the blood pump motor is personalized to conform to the physiological contraction law of the individual heart, and realize that the specific outputs such as the blood pumping time and the amount of blood pumped each time can 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

[0038] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments recorded in the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0039] It should be noted that although the steps in the process diagrams involved in the various embodiments are drawn in sequence as indicated by the arrows, unless otherwise specified herein, there is no strict order restriction on the execution of these steps, and these steps can be executed in other orders. Moreover, at least a portion of the steps in the flowcharts involved in the various embodiments may include multiple steps or multiple stages, and these steps or stages are not necessarily executed at the same time, but can be executed at different times. The order of execution of these steps or stages is not necessarily sequential, but can be executed in rotation or alternation with other steps or at least a portion of the steps or stages in other steps.

[0040] Figure 1 A flow chart of a method for adaptively controlling the flow rate of a blood pump according to an embodiment of the present application;

[0041] Figure 2 A state machine diagram of the blood pump flow adaptive control method according to an embodiment of the present application;

[0042] Figure 3 for Figure 2 The corresponding process diagram in ;

[0043] Figure 4 for Figure 3 The corresponding initialization diagram in ;

[0044] Figure 5 for Figure 3 Schematic diagram of detection of the corresponding diastolic start time;

[0045] Figure 6 for Figure 3 Schematic diagram of detection of the corresponding systolic onset moment;

[0046] Figure 7 for Figure 3 Schematic diagram of determining whether N0 cardiac cycles are detected;

[0047] Figure 8 for Figure 3 Schematic diagram of delaying the motor to a specified time S2 and adaptively controlling the motor speed to a preset diastolic speed w1;

[0048] Figure 9 for Figure 3 The corresponding delay diagram of S3;

[0049] Figure 10 for Figure 3 Schematic diagram of the corresponding adaptive control motor speed being the preset speed w2 during contraction or the initial speed w0;

[0050] Figure 11 for Figure 3 The corresponding delay diagram of S4;

[0051] Figure 12 for Figure 3 Schematic diagram of the corresponding adaptive control motor speed being the preset diastolic speed w1 or the initial speed w0;

[0052] Figure 13 for Figure 3 Schematic diagram of the corresponding delay of a specified time S1. DETAILED DESCRIPTION

[0053] In order to make the purpose, technical solutions and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. The described embodiments should not be regarded as limiting this application. All other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0054] The terms "comprise," "include," and "have," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or components is not necessarily limited to those steps or components expressly listed but may include other steps or components not expressly listed or inherent to such process, method, product, or apparatus.

[0055] In the following description, similar expressions such as "a specific embodiment" or "a specific example" are involved, which describe a subset of all possible embodiments, but it can be understood that "a specific embodiment" or "a specific example" can be the same subset or different subsets of all possible embodiments, and can be combined with each other without conflict. In the following description, the term "multiple" refers to at least two. In some specific examples, the numerical value mentioned in this application reaches a threshold value, which may include the case where the former is greater than the latter of the threshold value; if similar expressions such as "any" or "at least one" are mentioned, it can specifically refer to any one of the listed examples or any combination of these examples.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein are for the purpose of describing the embodiments of this application only and are not intended to limit this application.

[0057] The method of this application will be described in detail below.

[0058] See also Figure 1 In a first aspect, the present application provides a specific embodiment of a blood pump flow adaptive control method, which includes the following steps:

[0059] Figure 1 Step S11: for the implantable blood pump motor of the current patient, detecting the duration of a single historical heart beat of the current patient in the historical period based on the electrical signal change information of the motor in the historical period;

[0060] One of the core components of an implantable blood pump is the implantable motor, and one of the core components of the motor is the rotor; the blood pump speed (which can refer to the rotor speed or motor speed) ) and the electromagnetic torque of the motor There is a corresponding relationship (as shown in Equation 2 below). By controlling the 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.

[0061] (Formula 1)

[0062] (Equation 2)

[0063] in, is the electromagnetic torque; is the electromagnetic torque coefficient of the blood pump motor; i is the current input to the blood pump motor; is the motor speed of the blood pump; is the blood load torque; is the moment of inertia of the blood pump motor rotor; is the moment of inertia of blood load; Can represent The instantaneous change can be regarded as acceleration; is the friction viscosity coefficient (related to blood load and blood pump motor speed).

[0064] When the blood pump motor operates at a speed There are three basic situations:

[0065] 1. When the natural heart enters diastole, the pressure drops and is transmitted to the blood pump rotor through the blood, which results in a decrease in the blood load torque. As a result, the blood pump rotor speed briefly increases and the blood pump motor current decreases.

[0066] 2. When the natural heart enters the systolic phase, the pressure increases and is transmitted to the blood pump rotor through the blood, which manifests as an increase in the blood load torque. Under this influence, the blood pump rotor speed drops briefly and the blood pump motor current increases.

[0067] 3. If the natural heart completely loses its pulsating function, the blood load torque remains unchanged. Therefore, the blood pump motor speed and motor current are both stable. The above (Equation 2) can be simplified to the following Equation 3.

[0068] (Formula 3)

[0069] Therefore, it can be inferred that by monitoring changes in electrical signals such as the blood pump motor current or motor speed, the time when a natural heart, still capable of beating, enters diastole and systole (i.e., the start of the beating period) can be extracted. Furthermore, because the beating period can be divided into two periods, diastole and systole (these two periods constitute a heartbeat cycle), the end of one period is the beginning of the other. Therefore, by using the N0 diastole start times and N0 systole start times extracted historically, the duration of a patient's historical heart, such as the duration of a single diastole and systole, can be calculated (referred to as the mean beating period duration). Details will be provided below and will not be elaborated here. This duration can subsequently be used to adjust the patient's blood pulsation output according to individual needs (e.g., increasing the heart's stroke volume) or to deliver a blood pulsation flow with a reasonable phase difference from the heart's beating cycle to meet the individual's actual heart pulsation needs.

[0070] It should be noted that the above-mentioned N0 (N0 ≥ 1) times can be a continuous or discontinuous statistical number, which can be set according to actual conditions and is not limited here. For the sake of ease of explanation and understanding, the embodiment of this application mainly uses the case of N0 consecutive times as an example. In addition, compared with other types of blood pumps, the embodiment of this application can use a blood pump with a flexible magnetic bearing design, because the current and speed of this type of motor can more easily reflect the patient's heart beat, which can better deploy the ideal intelligent blood pump of the embodiment of this application - it can adaptively assist the damaged heart to achieve beat tracking based on the natural heart beat law.

[0071] Figure 1 Step 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;

[0072] Among them, the starting time of the current beating period and the next beating period is the moment when the corresponding beating period preset speed 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.

[0073] The current pulsation period mentioned above can be either the diastolic period or the systolic period. For ease of explanation and understanding, the embodiments of this application primarily use the diastolic period (its alternative name is the systolic period) as an example. This means that the diastolic period can be defined as the first period to be detected or entered into control. For example, the start time of the first diastolic period entered after a historical period = the start time of the N0th systolic period + the duration of a single systolic period. When this first diastolic period start time 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 a period of time starting from this first diastolic period and lasting for the aforementioned "single diastolic period duration" (during which the motor speed is w1). If the start time of the first systole is successfully detected within this period (i.e., the first diastole), it means that the heart has not actually fully experienced the aforementioned "single diastole duration", and the aforementioned "single diastole duration" can be updated accordingly in real time as the backup duration for the second diastole; if the start time of the first systole is not successfully detected, the aforementioned "single diastole duration" is still used, and the start time of the first systole can be set as usual = the start time of the first diastole + the aforementioned single diastole duration calculated historically.

[0074] Figure 1Step S13: 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 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;

[0075] based on Figure 1 According to the description of step S12, the next beat period of the first diastolic period, i.e. the first systolic period, can be used as the new current beat 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 can be indicated that the heart has not actually fully experienced the aforementioned "single systolic period duration", and this "single systolic period duration" can be updated in real time accordingly as the backup duration for the second systolic period. It can be seen that the operation here is equivalent to similarly repeating the above Figure 1 In step S12, the timing for adjusting the motor speed (ie, switching the speed back and forth between w1 and w2) each time after the N0 historical detection stages is determined.

[0076] 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.

[0077] 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 and in line with the individual's physiological contraction law of the 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 beat period duration is updated in real time, rather than consistently citing or relying on the historically detected beat period duration, so as to dynamically adjust the timing of each future change in motor speed. Therefore, it can be understood that the embodiment of the present application can achieve adaptive pulsation output that follows the heart beat in real time (or continuously follows), that is, it can more effectively and efficiently assist in generating the blood flow required by the individual heart.

[0078] Based on the above examples, the method of the present application will be further described in detail below, and some specific possible implementation examples will be provided. In actual applications, the implementation contents between these examples can be combined or implemented separately as needed according to the corresponding functional principles and application logic. If implemented in combination, the execution order between the combined examples can be determined according to their respective processing logic, which can be determined by the actual scenario.

[0079] In practical situations, the control method of the embodiments of the present application can be intelligently enabled through software. Specifically, when the blood pump motor is started, if the motor's adaptive pulsation control state is set to 0, this state 0 can be considered an initial state in which the motor speed is at the initial speed w0 or the speed cannot be adaptively pulsated (i.e., does not conform to the natural heart beat pattern). The control method of the embodiments of the present application can be selectively activated to adjust the motor speed to the adaptive pulsation output speed at corresponding moments (e.g., the start of diastole and the start of systole).

[0080] 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 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 the motor current, detecting the moment when the falling edge starts to appear N0 times and the rising edge starts to appear N0 times in the electrical signal waveform as the starting moment of the N0 diastole and the starting moment of the N0 systole of the heart; based on the N0 diastole starting time and the N0 systole starting 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.

[0081] As explained above, the above-mentioned electrical signal information can specifically be the motor current or motor speed of the blood pump. Therefore, the embodiment of the present application can be called a cardiac pulsation adaptive control method based on blood pump motor current detection (method 1), or a cardiac pulsation adaptive control method based on blood pump motor speed detection (method 2). The following will mainly provide a detailed example of this method 1. Method 2 is similar to method 1 and will not be described in detail. The difference is that when the electrical signal is the motor current, the start of the diastole is detected by detecting the falling edge information of the motor current, and the start of the systole is detected by detecting the rising edge information of the motor current; when the electrical signal is the motor speed, the situation is opposite to that when it is the motor current. The start of the diastole is detected by detecting the rising edge information of the motor speed, and the start of the systole is detected by detecting the falling edge information of the motor speed.

[0082] See also Figure 2The possible solutions shown are Figure 2 This paper describes an adaptive pulsation control scheme for cardiac pulsation tracking based on a "pre-detection-control pulsation output-re-pre-detection" approach. The scheme's main implementation process includes: pre-detecting and extracting the start of diastole and the start of systole (each can be detected N0 times) to obtain cardiac cycle information (one diastole and one systole constitute one cardiac cycle); then, during the N1 cardiac cycles following the pre-detection, the motor speed is adjusted to the corresponding preset diastole and systole speeds each time the start of diastole and systole are reached. Of course, in some cases, the specific value of N1 may not be limited.

[0083] Specifically, taking the motor current as an electrical signal, if the start of the diastole is detected first:

[0084] 1. The start of the diastole of the heartbeat can be detected by detecting the falling edge information of the motor current. As described in the above basic situation 1, when the natural heart begins to enter the diastole, the blood pump motor current begins to decrease. Therefore, the moment when each current falling edge begins to appear can be defined as the start of the diastole.

[0085] 2. The onset of cardiac systole can be detected by monitoring the rising edge of the motor current. As described in Basic Case 2 above, the blood pump motor current begins to rise when the natural heart enters systole. Therefore, the onset of systole can be defined as the moment when each current rising edge begins.

[0086] 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.

[0087] 3. N0 ≥ 1, where N0 refers to the number of diastolic periods or systolic periods detected in a round of pre-detection phase.

[0088] 4. w0 is the speed of the blood pump motor when pulsation control is not enabled (i.e., the initial state in which this control method is not enabled or the adaptive pulsation output is not possible). It can be simply understood that w0 is the initial speed of the blood pump motor when pulsation control is not performed.

[0089] 5. Doctors can set the values ​​of S2, w1, w2 and N1 according to the patient's individual physiological state.

[0090] (1) S2 represents the phase difference between the actual pulsation output and the natural heart pulsation, S2 ≥ 0. For example, S2 can be the time of one heart beat cycle calculated in the pre-detection stage. S2 can be simply processed in the software, that is, the extended 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 the 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 used 2720 milliseconds) can ignore the difference of millisecond level.

[0091] (2) w1 is the blood pump speed during diastole, i.e., the preset diastolic speed.

[0092] (3) w2 is the blood pump speed during the systolic period, i.e., the preset systolic speed. Generally, w1≤w0≤w2 can be set.

[0093] (4) N1 is the number of cycles of continuous active output cardiac beat control.

[0094] 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.

[0095] Of course, with Figure 2 The difference is that in some examples, you can also choose to start detecting the start time of the systole first. Then, correspondingly, the "control pulsation output" stage can be to enter the systole first and then the diastole. The motor speed w0 (i.e., the motor speed in the pre-detection stage) is then adjusted to the preset speed for the systole first and then to the preset speed for the diastole. This method is the same as Figure 2 The example is similar and will not be repeated here.

[0096] Figure 2 The corresponding process can be as follows Figure 3As shown, from the overall framework, the current state of the blood pump motor (or adaptive pulsation control state) can be determined from the beginning each time through polling, and the corresponding operations can be executed. For example, if the blood pump motor is detected to be in the initial state 0, the operation flow B0 is executed (which can be considered the initialization operation process); if the blood pump motor is detected to be in a state other than 0 but 1, the operation flow B1 is executed, and so on. If the blood pump motor is finally detected to be in a state of 9, the operation flow B9 can be executed, ending the current "pre-detection - pulsation output control" phase and entering the "re-pre-detection" phase. If the blood pump motor is finally detected to be in a state other than 9, the entire adaptive pulsation control scheme can be terminated or exited, and / or manual intervention can be requested.

[0097] 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-detections (specifically, detecting the start time of the historical beating period) can be configured, and a control counter for counting the number of adaptive controls (i.e., the number N1 of times the motor speed switches back and forth between w1 and w2) 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. Each subsequent detection of the start time of the historical diastole and the start time of the systole will increase by 1 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 not detected initially), so that the duration of each diastolic period (or the single diastolic mean time or 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 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 both be initialized to 0. In the subsequent control pulse output stage, whenever 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 the relevant operation flow corresponding to the execution of this state.

[0098] Because the B0 operation flow has set the state to 1, the next Figure 3 The B1 operation flow will be executed in sequence (detecting the start time of diastole, see Figure 5 ): Once the motor current starts to fall at a certain moment, T0 can be immediately defined as the start of the diastole period; and the system can be set to jump to the adaptive pulsation control state 2.

[0099] according to Figure 2 、 Figure 3 The logic is similar, and the next execution will be as follows Figure 6 The B2 operation flow shown (detecting the end of diastole and the start of systole) in the adaptive pulsation control state 2 no longer detects the falling edge (there is no end of the falling edge), but always detects the moment of the rising edge. The moment T1 when each rising edge begins can be defined as the start of systole. If T1-T0>P0, the diastole time can be set to T1-T0 (i.e., the length of a single diastole), and the jump to the adaptive pulsation control state 3 can be set thereafter. Since the systole of a heart beat is generally one-third of the heart beat cycle, the value of P0 can be determined based on the actual situation of the blood pump's expected patient population. For example, if the heart rate of the target patient population is between 50 and 120 beats / minute, then Figure 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 human heart rate.

[0100] In some specific examples, Figure 1 The specific operation process of step S11 may include: since the first detection of the start time of the diastole and the start time of the systole within 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 the systole or the adjacent number of diastole start times until N0 diastole start times and N0 systole start times 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 the systole and the adjacent number of diastole start times does not meet the threshold value P0, and / or the number of times the diastole start time and the systole start time are detected within the historical time period is less than N0 times; N0 can be regarded as the total number of times.

[0101] Taking the case of first detecting the start of diastole as an example,

[0102] (1) If Figure 6 As shown, if the difference between the start time of the systole and the start time of the adjacent diastole is T1-T0≤P0, the process may return to the step of detecting the start time of the systole again.

[0103] (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 valid start times of N0 times or more.

[0104] The above-mentioned coping methods (1) and (2) describe that if N0 valid start times cannot be detected, the test will be returned for retesting to ensure that the extracted times are N0 valid diastolic start times and N0 valid systolic start times; specifically, N0 times can be continuous or discontinuous.

[0105] It is to be noted that the above-mentioned operation process of "using the N0 diastolic start time and N0 systolic start time extracted in history to calculate the duration of the patient's heart's single diastolic period and single systolic period in history (which can be called the mean beat period time) on average by the number of times" 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 of the diastole, and the systole time is set to T2-T1 (i.e. the duration of a single systole). Figure 7 As shown,

[0106] (1) The systolic period of a heart beat is generally one-third of the heart beat cycle. Therefore, when the duration of a single diastole is greater than or equal to the duration of a single systole, the test result can be considered normal and valid. The test 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 duration of this diastole, and the cumulative value of the systolic period can be set to be the cumulative value of the last systolic period + the duration of this systolic period. Afterwards, if the number of times the start of the diastole and the start of the systole is detected is N≥N0, the following results can be calculated according to the formula: 1 mean diastolic period time (or cardiac pulsation diastolic period time) = the cumulative value of the diastolic period ÷ the detection count value regarding the start of the diastole, 1 mean systolic period time (or cardiac pulsation systolic period time) = the cumulative value of the systolic period ÷ the detection count value regarding the start of the systole. Subsequently, the adaptive pulsation control state can be set to 4.

[0107] (2) On the contrary, if the duration of a single diastole is less than the duration of a single systole, a retry mechanism can be enabled, that is, the adaptive pulsation control state is set to 0, thereby attempting to re-detect a valid 1 diastole mean time and 1 systole mean time. The diastole periods selected by the two states 0 can be the same or different periods (that is, there is a time difference). Similarly, the systole periods selected by the two states 0 can be the same or different periods. In other words, the detected N0 heartbeat cycles can be continuous or discontinuous N0 times, without specific restrictions.

[0108] 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 period as the current beating period" in step S12 may include: when the historical beating period that the heart enters for the first time within the historical 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.

[0109] like Figure 2 As shown, because the first historical pulsation period entered during the "pre-detection" phase is the diastolic period, the first diastolic period during the "control pulsation output" phase can be set as the current pulsation period. Of course, this current pulsation period can also be a pulsation period (i.e., a systolic period) that has a different name and is mutually exclusive with this historical pulsation period (e.g., the diastolic period). The specific definition is user-defined and is not limited here. For ease of explanation and understanding, this embodiment of the application primarily uses the example of the current pulsation period having the same name as the first historical pulsation period (e.g., both are diastolic periods) for description.

[0110] In some specific examples, Figure 1 The specific operation process of "determining the start time of the current beating period based on the duration of one of the single historical beating periods" in step S12 may include: determining an alternative beating period that is different from the current beating period, and based on the start time of the last alternative beating period in the historical period, increasing the duration of the alternative beating period detected correspondingly in the historical period (i.e., increasing the phase difference) to obtain the start time of the current beating period.

[0111] Specifically, the diastole period can be selected as the current beating period, and its synonym for the beating period is the systole period. Afterwards, the start time of the current beating period in the "control pulsating output" stage can be determined based on the systole duration (or systole mean time) detected in the "pre-detection" stage as above. In the "control pulsating output" (i.e., 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.

[0112] For example, in a 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 detected systole (such as Figure 7 "Get the current time T0" - this may mean that you are about to enter Figure 8 Delay S2 operation link) "delay specified time" (ie Figure 2 The moment it arrives after a "delay of one S2") (see Figure 8 "Get current time T0" in the delay) where the time T0 reached by the delay 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, 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 set to 4), and the Figure 8 Since S2 is 0, the software will quickly enter the B4 operation flow. Figure 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 systole (i.e. the beginning of the diastole). Figure 9By enabling diastolic speed pulsation control, 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 reasonable connection of pulsation cycle control.

[0113] Under normal circumstances: when n1=1, the start time of the first systolic period = the start time of the first diastolic period + the mean diastolic period time, that is, it takes one mean diastolic period time from the start time of the diastolic period to reach the start time of the systolic period. When n1>1, the corresponding start time of the n1th diastolic period = the start time of the n1-1th systolic period + the mean systolic period time, and the start time of the n1th systolic period = the start time of the n1-1th diastolic period + the mean diastolic period time, 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 output of the blood pump, such as the blood pumping time and the amount of blood pumped each time, to flexibly follow the blood flow pulsation output of the heartbeat.

[0114] 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 each 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.

[0115] Similar to the process of detecting the start time of the beating period through the rising edge or falling edge of the electrical signal waveform in the above-mentioned "pre-detection" stage, the start time of the next beating period (i.e., the alternative beating period of the current beating period) can be attempted to be detected within the current beating period of the "control pulsation output" stage.

[0116] 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 this transition is w1). Figure 2 As shown, from the beginning of the first diastole (see Figure 8 The motor speed is w1 during the period S3 from the "Get current time T0" in ... Figure 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 Figure 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. Accordingly, the cardiac systolic mean update flag can be set to 1, the speed can be adjusted to w2, and the state can be set to 7. In addition, if the cardiac 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 rising edge start time can be regarded as the complete diastolic period time, so the diastolic mean can be updated to T1-T3 (see Figure 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 has not entered the systolic period as usual without a complete duration of a historical diastolic mean time (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 has not entered the diastolic period as usual without a complete duration of a historical systolic mean time (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 corresponds to the diastolic period, Figure 8 The corresponding systolic period) can be used to update the corresponding beat period mean. In other words, these two flags are set to 1 only when the most recent falling 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, Figure 10 In the illustrated B6 operation flow, after detecting the rising edge of the motor current (i.e., determining the end time of the diastole, T1), if the cardiac diastolic mean update flag is also 1, this means that the start time of the recently ended diastole has also been updated. Therefore, the value T1 - T3 is subtracted from the newly detected end time T1 to accurately represent the single diastolic period. Generally, after the diastolic mean value is updated, the corresponding mean update flag needs to be set to 0 to indicate that the corresponding edge start time has been successfully determined the next time.

[0117] 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, this 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, it is determined whether the sum of the latest 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 spare duration corresponding to the next beating period of the same name of the current beating period (i.e., update the duration of the current beating period in a way of catching 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 Figure 11 and Figure 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 Figure 13 ), returns to the step of detecting the duration of a single historical beat period of the current patient's heart within the historical period based on the electrical signal change information of the motor within the historical period (see Figure 3 and Figure 4 ).

[0118] like Figure 2 、 Figure 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 the 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 for the failure of the motor current rising edge detection 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 so that the number of times the start time of the systolic period is not successfully detected can be restarted in the next round (the motor speed switches back and forth between w1 and w2 once, which is one round); the above + S6 is based on the consideration 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 the time to reduce the impact of changes in the patient's physiological condition. S6 can be determined based on the patient's individual physiological condition, etc. (2) If it is greater than or equal to S5, after a complete diastolic mean 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 Figure 13 、 Figure 2 ), returning to the initial state of 0 and entering the "pre-test" phase, which then initiates the next round of the "pre-test-pulsation output control" phase. Here, after a delay of S1 (which can be customized), the system returns to the initial state 0 and enters the "pre-test" phase. This is because speed regulation may cause electrical signal instability, affecting the blood pump's subsequent accurate adaptive pulsation output. Therefore, the motor is allowed to run continuously at the initial speed w0 for a period of time, achieving stability before entering the pre-test phase. This can offset or compensate for errors caused by previous speed fluctuations.

[0119] See also Figure 11 、 Figure 12 The operations that occur during the transition from the start of the systole to the start of the 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 the diastole to the start of the systole in the above-mentioned "control pulsating output" stage, including: continuously detecting the start of the 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 described in detail; the duration S6 increased in these two periods can be equal or different, depending on the specific situation.

[0120] As explained 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 period and a systole period, which are mutually exclusive, and adjusting the speed of the motor in the diastole period to the preset diastole speed each time the diastole period starts, and adjusting the speed of the motor in the systole period to the preset systole speed each time the systole period starts; the preset diastole speed is less than or equal to the preset systole speed.

[0121] 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 the diastole, and is adjusted to the diastolic preset speed w2 every time it reaches the beginning of the systole, so as to adapt to the regular operation of the individual heart's pumping function, where w1≤w2.

[0122] In some specific examples, to improve the accuracy of diastolic and systolic phase detection, cardiac pulse information can be detected by combining motor current peak detection with motor signal edge (e.g., rising and falling edge) detection. For example, after detecting the peak of the motor signal, detection of the onset of diastole can be initiated to reduce the probability of false detection.

[0123] In summary, the embodiment of the present application can also be called an intelligent blood pump based on cardiac pulsation adaptive control and its control method. Through the cardiac pulsation signal obtained by historical detection (i.e., the above-mentioned N0 historical diastolic start times and N0 historical systolic start times) and the speed modulation strategy, the adjustment timing of the speed required by the individual motor in the future (i.e., the diastolic start time and the systolic start time) is predicted in real time, thereby achieving an adaptive pulsation output that follows the cardiac pulsation in real time (or continuously follows). It should be noted that the real-time here mainly refers to the real-time update of the pulsation period duration, thereby predicting the timing of the motor speed adjustment to w1 or w2 in real time. In addition, it can be seen that the embodiment of the present application:

[0124] (1) There is no need to configure an additional independent heart beat sensor (such as a flow sensor, a pressure sensor, an ECG signal sensor, etc.). Based on a single electrical signal such as the motor current or the motor speed, the historical beat signal of the natural heart can be detected, and the blood flow pulsation output following the heart beat can be achieved.

[0125] (2) No excessive circuit signal resources are required, and no additional sensors are needed, which can keep the blood pump system design low-complexity and low-cost.

[0126] (3) Based on the detected cardiac pulse signal, a speed modulation strategy can be used to synchronize the cardiac pulse output with or without a phase difference (i.e., S2). In other words, the blood flow pulsation generated by the blood pump can be flexibly associated with or synchronized with the patient's own cardiac pulse. The specific value S2 can be set by the doctor based on the individual patient's condition.

[0127] (4) The intelligent blood pump can independently complete the above-mentioned cardiac pulsation pre-detection (i.e., the detection history start time) and open adaptive control (including adjusting the motor speed back and forth to w1 or w2), and can realize multi-parameter pulsation adjustment, which makes it easier for doctors to implement individualized treatment according to the patient's condition, flexibly generate blood pulsation output that adapts to the individual's needs, and provide patients with individual physiological pulsation regularity blood pumping auxiliary functions.

[0128] A second aspect of the present application provides a specific embodiment of a blood pump flow adaptive control system, the system comprising: an external controller and / or an implantable blood pump;

[0129] The implantable blood pump includes an implantable motor, and an external controller is connected to the implantable blood pump;

[0130] The extracorporeal controller and / or implantable blood pump is used to execute the blood pump speed pulsation control method described in the first aspect or any specific method embodiment of the first aspect, so as to control the motor to enable the preset diastolic speed each time it reaches the beginning of the diastolic phase of the patient's heart within a preset number of times, and to enable the preset systolic speed each time it reaches the beginning of the systolic phase of the patient's heart.

[0131] In the embodiments of the present application, the operations performed by the blood pump flow adaptive control system are similar to those 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 be implemented by referring to the relevant description of the second aspect.

[0132] 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.

[0133] 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 caused to execute the method described in the first aspect or any specific implementation of the first aspect.

[0134] It is understood that in the various embodiments of the present application, the sequence number of each step does not mean the order of execution. The order of execution of each step should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application. The operation content added or refined in each example scheme of the above-mentioned method, system or device does not necessarily have to be executed during the specific implementation. If two or more operations are added, these operations can be implemented in combination or separately, depending on the actual scenario.

[0135] Those skilled in the art will 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.

[0136] In the several embodiments provided in this 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 merely schematic. For example, the division within the system is only a logical function division. In actual implementation, there may be other division methods, such as 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.

[0137] The components described as separate parts may or may not be physically separate, and the components shown as components may or may not be physical components, that is, they may be located in one place or distributed across multiple network components. Some or all of these components may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0138] In addition, the functional components in the various embodiments of the present application may be integrated into a processing component, or each component may exist physically separately, or two or more components may be integrated into a single component. The above-mentioned integrated components may be implemented in the form of hardware or software functional components.

[0139] If the integrated components are implemented in the form of software functional components and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application, or the part that contributes to the prior art, or all or part of the technical solution can be embodied in the form of a software product. The computer software product (or computer program product) is stored in a storage medium and includes several instructions for enabling a computer device (which can be a personal computer, a business server, or a network device, etc.) to execute all or part of the steps of the method described in each embodiment of the present application. The aforementioned storage medium includes various media that can store program code, such as a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk, or an optical disk.

Claims

1. A blood pump flow adaptive control method, characterized in that: include: For the current patient's implantable blood pump motor, based on information on changes in electrical signals of the motor during a historical period, detecting the average duration of each historical heart beat period of the current patient assigned by name during the historical period; the heart beat period is divided into diastole and systole by name; Taking the subsequent beating period that the heart enters for the first time after the historical period as the current beating period, determining a beating period with a different name from the current beating period, and adding the mean value of the duration assigned to the beating period with a different name based on the start time of the last beating period with a different name in the historical period to determine the start time of the current beating period; or determining the last beating period with the same name as the current beating period in the historical period, and adding a preset delay time based on the start time of the last beating period with the same name to determine the start time of the current beating period; wherein, when the delay time is greater than 0, it is determined based on the mean value of the duration assigned to the beating period with a different name and the beating period with the same name of the current beating period based on the start time; Detecting the start time of the next odd-named beating period within the latest corresponding duration mean of the current beating period; According to the detected start time of the next pulsating period with another name, the latest corresponding duration mean value of the current pulsating period is updated as the latest corresponding duration mean value of the next pulsating period with the same name of the current pulsating period; the next pulsating period with another name is taken as the new current pulsating period, and the step of detecting the start time of the next pulsating period with another name within the latest corresponding duration mean value of the current pulsating period is returned; wherein, when the first two pulsating periods after the historical time period are successively used as the current pulsating period, the latest corresponding duration mean value of the first two pulsating periods is the average duration value assigned to the pulsating periods with the same name in the historical time period; when each pulsating period after the first two times is successively used as the current pulsating period, if the latest corresponding duration mean value of the previous pulsating period with the same name is updated, the latest corresponding duration mean value of each pulsating period after the first two times is the updated duration mean value; The start time of the current beating period and the next odd-name 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 within the historical period, the average duration of each historical beat period of the current patient's heart assigned by name within the historical period includes: Extracting electrical signal information corresponding to the motor at different times during a historical period to form an electrical signal waveform jointly depicted by the electrical signal information; the historical period is at least a cumulative duration of N0 cardiac cycles, where 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 falling edge starts to appear N0 times and the moment when the rising edge starts to appear N0 times in the electrical signal waveform as the moment when the N0 diastole starts and the N0 systole starts of the heart; Based on the N0 diastolic start times and the N0 systolic start times, the average diastolic duration and systolic duration of the heart during the historical period are calculated as the average duration assigned to a single historical beat period by name.

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: The detecting the start time of the next unequal beat period within the latest corresponding duration mean of the current beat period includes: Extracting the electrical signal information corresponding to the motor at different times within the latest duration mean 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 odd-name beat 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 odd-name beat period.

5. The blood pump flow adaptive control method according to any one of claims 1 to 4, characterized in that: If the start time of the next odd-name beat period is not detected after multiple accumulated detections, the method further includes: Determine whether the sum of the latest detected mean diastolic duration and mean systolic duration is less than a preset total duration; If so, increase the latest corresponding duration mean of the current beating period as the standby duration mean corresponding to the next beating period of the same name of the current beating period; take the next beating period of the opposite name as the new current beating period, and return to the step of detecting the start time of the next beating period of the opposite name within the latest corresponding duration mean of the current beating period; If not, after the latest corresponding duration average of the current beating period has passed since the start moment 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 returns to the step of detecting the duration average of a single historical beating period of the current patient's heart assigned by name within the historical period based on the electrical signal change information of the motor within the historical period.

6. The blood pump flow adaptive control method according to any one of claims 1 to 4, characterized in that: The detecting, based on the electrical signal change information of the motor within the historical period, the average duration of each historical beat period of the current patient's heart assigned by name within the historical period includes: Since the first detection of the diastolic start time and the systolic start time within the historical period, if the n0th detection result among a total of N0 times does not meet the preset conditions, at least the n0th systolic start time or the adjacent diastolic start time are re-detected until the N0th diastolic start time and the N0th systolic 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 times the diastole start time and the systole start time are detected in the historical period is less than the N0 times.

7. The blood pump flow adaptive control method according to any one of claims 1 to 4, characterized in that: After detecting the start time of the next eccentric beating period within the latest corresponding duration mean of the current beating period, the method further includes: The current beating period is divided into a diastole period and a systole period, which are mutually exclusive. Each time the diastole period starts, the speed of the motor in the diastole period is adjusted to the preset diastole speed. Each time the systole period starts, the speed of the motor in the systole period is adjusted to the preset systole speed. The preset diastole speed is less than or equal to the preset systole speed.

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

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

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

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