Blood Pump System

Abstract

The present disclosure provides a pump housing having a blood flow inlet and a blood flow outlet connected by a passageway, a pump element disposed in the pump housing, and a set rate N set 1. A blood pump system comprising: a blood pump, in particular an intravascular blood pump, having a drive unit configured to drive a pump element at a set speed N ; a sensor array configured to at least intermittently sense at least one circulatory system related parameter CSRP; a controller configured to process the at least one circulatory system related parameter CSRP; and a storage device configured to continuously store the processed at least one circulatory system related parameter, wherein the controller performs a weaning procedure, in which: i) a first sequence of the processed at least one circulatory system related parameter CSRP is stored in the storage device over a first time interval; ii) a first average value AV1 for the first sequence is calculated; and iii) after the first average value AV1 has been calculated, the controller performs a weaning procedure, in which ... set is the deceleration value dN R iv) a second sequence of the processed at least one cardiovascular system related parameter CSRP is stored in a storage device over a second time interval; v) a second average value AV2 for the second sequence is calculated; and vi) a comparison value |Diff| of the difference between the first average value AV1 and the second average value AV2 is measured to be less than a predetermined threshold value TR. CSRP and vii) the controller is configured to repeat steps iv) to vi), and the comparison value |Diff| is compared with a predetermined threshold TR CSRP If it is within, the first counter C up is increased by 1, and the comparison value |Diff| is increased to a predetermined threshold TR CSRP If it is outside, the second counter C down The controller is further configured to perform a departure procedure, wherein the controller is configured to increase the first counter C by one. up is a predetermined first counter maximum value TR Cup When the first counter C reaches the first counter C, steps i) to vii) are repeated. upThe controller is configured to set a second counter C to zero. down is a predetermined second counter maximum value TR Cdown When it reaches the set speed N set is the acceleration value dN I and a second counter C down to zero and repeating steps iv) to vii).

Description

[Technical Field]

[0001] The present invention relates to a blood pump system. In particular, the present invention relates to a blood pump system including a blood pump, in particular an intravascular blood pump for percutaneous insertion into a patient's blood vessel to assist blood flow within the patient's blood vessel. The blood pump may be an intracardiac blood pump, an intravascular blood pump, or any other type of ventricular assist device. [Background technology]

[0002] Various blood pumps are known from the prior art, such as axial flow blood pumps, centrifugal (i.e., radial flow) blood pumps, or mixed-type blood pumps in which blood flow is generated by axial and radial forces. Such blood pumps can be introduced into a patient's heart to assist blood flow from the heart to an artery, such as the aorta. The blood pump can be introduced percutaneously through the vascular system, such as by a catheterization procedure, during a cardiac procedure. Once deployed, the blood pump pumps blood from the left ventricle into the aorta to restore adequate systemic blood flow. Thus, a blood pump typically includes a pump housing having a blood inlet and a blood outlet connected by a passageway, a pump element in the form of an impeller disposed in the pump housing, and a drive unit configured to drive the impeller at an effective speed to generate blood flow between the blood inlet and the blood outlet. A cannula is typically attached to the blood inlet. The cannula may be passed, for example, through the aortic valve and into the left ventricle, and blood may be pumped from the left ventricle through the cannula, exit the pump housing via the blood outlet, and enter the aorta. Of course, such a blood pump may also be used for cardiac assist of the right ventricle of the heart, where the blood pump pumps blood from the right ventricle or right atrium into the pulmonary artery, or pumps blood from the venous system into the patient's heart.

[0003] Such blood pumps are therefore intended to assist the function of a patient's heart in either short-term applications, where the intravascular blood pump is placed within the patient for days or weeks, or long-term applications, where the intravascular blood pump is placed within the patient for weeks or months.

[0004] However, the intravascular blood pump will not be switched off immediately at the scheduled end of treatment. Instead, a controlled weaning of the patient from the intravascular blood pump must occur. However, there is no established method for doing so, and the weaning applied is manual and depends primarily on the skills and experience available at the medical facility or patient care center. A failure during weaning can mean a compromise in the success of the treatment and will significantly prolong the duration of the treatment until the next weaning can occur. Naturally, for the patient's sake, this should be avoided. Summary of the Invention [Problem to be solved by the invention]

[0005] It is therefore an object of the present disclosure to provide a blood pump system that facilitates weaning of the patient from the blood pump, significantly reducing the risk of compromised treatment success. [Means for solving the problem]

[0006] According to a first aspect, a blood pump system includes a blood pump, a sensor array, a controller, and a storage device. The blood pump has a pump housing having a blood inlet and a blood outlet connected by a passageway. A pump element is disposed in the pump housing. The blood pump further includes a drive unit configured to drive the pump element at a set speed to generate a flow between the blood inlet and the blood outlet. The sensor array is configured to at least intermittently sense at least one circulatory system-related parameter. The sensor array may be configured to continuously sense at least one circulatory system-related parameter. The sensor array may be an internal sensor array, an external sensor array, or a combination thereof. For example, the blood pump may have a sensor array in which a sensor is disposed, for example, on the pump housing. The sensor may be an optical sensor.

[0007] The blood pump system further comprises a controller configured to process at least one circulatory system-related parameter, and a storage device configured to continuously store the processed at least one circulatory system-related parameter. The storage device may also be configured to continuously store the directly sensed at least one circulatory system-related parameter. The blood pump according to the invention may correspond to the blood pumps described above, and may therefore be an intravascular blood pump or an intracardiac blood pump.

[0008] The controller includes a disengagement procedure, i) storing a first sequence of the processed at least one cardiovascular system-related parameter in a storage device for a first time interval; ii) a first average value for the first sequence is calculated; iii) after the first average value is calculated, the set speed is reduced by a speed reduction value; iv) storing a second sequence of the processed at least one cardiovascular system-related parameter in the storage device for a second time interval; v) a second average value for the second sequence is calculated; vi) comparing the difference between the first average value and the second average value with a predetermined threshold; vii) the controller is configured to repeat steps iv) to vi); configured to increment the first counter by one if the comparison value is within the predetermined threshold; It is further configured to perform a departure procedure configured to increment a second counter by one if the comparison value is outside a predetermined threshold.

[0009] The controller is further configured to repeat steps i) to vii) when the first counter reaches a predetermined first counter maximum value, and is configured to set the first counter to zero. The controller is further configured to increase the set speed by a speed increase value when the second counter reaches a predetermined second counter maximum value, and is configured to set the second counter to zero, and is configured to repeat steps iv) to vii).

[0010] Thus, the weaning procedure executed by the controller results in automated weaning of the patient from the blood pump, and if necessary, i.e., if the second counter reaches a predetermined second counter maximum value, the drive unit speed is quickly increased again, thereby reducing the risk of disruption to successful therapy. Furthermore, if the sensed and then processed circulatory system-related parameter is within a predetermined threshold after deceleration, the patient is deemed not to have become unstable due to the deceleration. Rather, in that case, the patient is deemed to still be stable despite the blood pump flow reduction caused by the drive unit deceleration.

[0011] A circulatory system-related parameter in the sense of the present disclosure is any measurable parameter or value related to a patient's organs, such as the heart, blood vessels, and blood. Preferably, at least one sensed or processed circulatory system-related parameter is a cardiovascular system-related parameter.

[0012] It should be noted that thresholds according to the present disclosure may include a single threshold, multiple different thresholds, and / or threshold ranges. Furthermore, when the weaning procedure is initiated for a first time period, it is preferable that both the first counter and the second counter are set to zero. The thresholds may be predetermined by a physician monitoring the weaning procedure. Preferably, the comparison value is an absolute value.

[0013] Preferably, the controller is configured to terminate the weaning procedure when the set speed reaches a predetermined minimum speed or a predetermined maximum speed. The predetermined minimum speed can be a speed at which the flow rate through the blood pump is very low, for example, 0.1 l / min or less. When the set speed reaches the minimum speed, the patient is considered to be weaned and the blood pump can be removed from the patient's body. The predetermined maximum speed can correspond to the set speed before the weaning procedure is initiated for the first time. When the set speed reaches the maximum speed, the patient is considered not ready to be weaned and still requires sufficient blood pump assistance. The minimum and maximum speeds can be predetermined by a physician monitoring the weaning procedure. Instead of specifying a minimum and maximum speed, a minimum blood flow and a maximum blood flow of the blood pump can be specified. In this case, the set speed corresponds to the set blood flow of the blood pump. The controller can be configured to convert speed to blood flow and vice versa. In doing so, the controller can be configured to take into account influencing parameters, for example, motor current or data received from a sensor array.

[0014] Preferably, the at least one processed circulatory system-related parameter includes one or more of heart rate, heart rate variability (sometimes referred to as heart rate variability), mean arterial pressure, left ventricular end-diastolic pressure, and blood pump blood flow. The parameters may be directly sensed by the sensor array or derived by the controller from the sensed parameters. When parameters are used directly, the at least one sensed circulatory system-related parameter corresponds to the at least one processed circulatory system-related parameter. Furthermore, the controller may be configured to take into account fluctuations in the at least one circulatory system-related parameter caused, for example, by the patient's breathing or ventilation. In this regard, the predetermined threshold may include one or more of a threshold for heart rate, a threshold for heart rate variability, a threshold for mean arterial pressure, a threshold for left ventricular end-diastolic pressure, and a threshold for blood pump blood flow.

[0015] Preferably, the first counter maximum is greater than the second counter maximum. Thus, during the weaning procedure, the time interval for acceleration is shorter than the time interval for deceleration. Therefore, if the patient becomes unstable after deceleration, each acceleration is triggered within a relatively short time period. Furthermore, possible further decelerations are triggered only if the patient remains stable for a relatively long time period. In other words, accelerations are much faster than decelerations.

[0016] The first time interval can be greater than the second time interval, and the first average value is based on a larger population of the processed at least one cardiovascular system-related parameter than the second average value. The weaning procedure is therefore based on a stable comparative value to determine whether the set rate should be increased or decreased.

[0017] Preferably, the predetermined threshold value for the at least one processed circulatory system-related parameter includes a lower threshold range and an upper threshold range. Therefore, the controller may be configured to set the deceleration value to a first deceleration value when the comparison value is within the lower threshold range, and to set the deceleration value to a second deceleration value when the comparison value is within the upper threshold range. Preferably, the first deceleration value is greater than the second deceleration value. Therefore, the applied deceleration value may be set according to the variation between the comparison value and the threshold value. Accordingly, in the case of a relatively small variation, the set speed is reduced by a higher value, i.e., the first deceleration value, and accordingly, in the case of an increased variation, the set speed is reduced by a smaller value, i.e., the second deceleration value.

[0018] Preferably, the lower threshold ranges are ±5 mmHg for the cardiovascular system-related parameter indicative of mean arterial blood pressure, ±2.5 mmHg for the cardiovascular system-related parameter indicative of left ventricular end-diastolic pressure, ±10 bpm for the cardiovascular system-related parameter indicative of heart rate, and ±150 msec for the cardiovascular system-related parameter indicative of heart rate variability. Correspondingly, the upper threshold ranges may be ±10 mmHg, ±5 mmHg, ±20 bpm, and ±75 msec, respectively.

[0019] For example, the deceleration value can be in the range of 100 rpm to 600 rpm, the first deceleration value can be in the range of 400 rpm to 600 rpm, and the second speed value can be in the range of 100 rpm to 300 rpm. Accordingly, the first deceleration value can be set to 500 rpm and the second deceleration value can be set to 200 rpm. The deceleration values ​​and the first and second deceleration values ​​can be predetermined by a physician supervising weaning of the patient from the blood pump.

[0020] The controller may be further configured to set the acceleration value to the first acceleration value or the second acceleration value based on, for example, the difference between the comparison value and the threshold value, the value of the second counter, and / or the second average value. Preferably, the first acceleration value is smaller than the second acceleration value. Thus, the degree of patient instability is taken into account when setting the new increased set speed. In other words, if more severe patient instability is detected during the weaning procedure, the set speed is increased by a higher value, i.e., the second acceleration value.

[0021] For example, the speed increase value can be in the range of 400 rpm to 1,500 rpm, the first speed increase value can be in the range of 400 rpm to 600 rpm, and the second speed increase value can be in the range of 800 rpm to 1,200 rpm. Accordingly, the first speed increase value can be set to 500 rpm and the second speed increase value can be set to 1,000 rpm. The speed increase values ​​and the first and second speed increase values ​​can be predetermined by a physician supervising weaning of the patient from the blood pump.

[0022] The first and second time intervals may be based on the heartbeat rate. Alternatively, the first and second time intervals may be based on the duration or number of values ​​for the first and second sequences, respectively. For example, the first sequence may include processed circulatory system-related parameters for every two seconds over a total period of 30 minutes, i.e., 900 consecutive values ​​in total. For example, the second sequence may include processed circulatory system-related parameters for every two seconds over a total period of 10 seconds, i.e., 5 consecutive values ​​in total.

[0023] Preferably, the controller is further configured to perform outlier identification in the first sequence of processed at least one cardiovascular system-related parameter and / or in the second sequence of processed at least one cardiovascular system-related parameter, The outlier identification may be based on common statistical methods such as Grubbs' test or Student's t-test.

[0024] The controller may further be configured to modify the set speed to avoid backflow through the blood pump. This is particularly relevant when the set speed is close to or at a predetermined minimum speed for intravascular or intracardiac blood pumps. When these blood pumps reach through a cardiac valve (e.g., an aortic valve), an open path through the valve is established that allows backflow when the blood pump is not driven or driven at a very low speed because the pressure in the blood vessel is higher than the pressure in the ventricle during the diastolic phase. Thus, the controller may be configured to take backflow into account and thus avoid it. A particularly suitable control method is disclosed in the applicant's International Publication No. 2019 / 034775, the entire contents of which are incorporated herein by reference.

[0025] The foregoing summary, and the following detailed description of the preferred embodiments, will be better understood when read in conjunction with the accompanying drawings. For purposes of illustrating the present disclosure, reference is made to the drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings. [Brief explanation of the drawings]

[0026] [Figure 1a] 1 is a diagram showing a schematic overall view of a blood pump system according to a first embodiment. [Figure 1b] FIG. 1 is a diagram showing a schematic overall view of a blood pump system according to a second embodiment. [Figure 2] 1 is a flow chart of an exemplary weaning procedure. DETAILED DESCRIPTION OF THE INVENTION

[0027] 1a shows a schematic overview of a blood pump system 10 according to a first embodiment. The blood pump system 10 comprises a blood pump 12, a sensor array 14, a controller 16, and a storage device 18. The blood pump 12, the sensor array 14, and the storage device 18 are connected to the controller 16 by suitable devices, e.g., cables. Of course, wireless connections are also possible. In addition, the storage device 18 may be an integral part of the controller 16.

[0028] Blood pump 12 may be an intravascular blood pump from the applicant's Impella® product line. Blood pump 12 has a pump housing 20 having a blood inlet 22 and a blood outlet 24. Blood inlet 22 is connected to blood outlet 24 by a passageway 26. Here, pump housing 20 has a plurality of blood outlets 24 evenly distributed around the circumference of blood pump housing 20.

[0029] A drive unit 28 is disposed within the pump housing 20. The drive unit 28 drives a pumping element 30 in the form of an impeller disposed within the pump housing 20 at a set speed N set Although the illustrated embodiment has the drive unit 28 located within the pump housing 20, the drive unit 28 could also be located outside the body and connected to the impeller 30 by a suitable device.

[0030] Rotation of impeller 30 may be effected by a direct connection between drive unit 28 and impeller 30, or by an indirect connection, such as magnetic coupling. Rotation of impeller 30 causes blood to flow from blood inlet 22, along passageway 26, to blood outlet 24. In particular, when blood pump 12 is used as left ventricular assist, blood inlet 22 is positioned so that blood from the left ventricle of the patient's heart can be drawn into blood pump 12 and exit blood pump 12 through blood outlet 24 and into the aorta. Of course, blood pump 12 may also be used as right ventricular assist to deliver blood from the venous system into the patient's heart or to pump blood from the patient's heart into the pulmonary artery.

[0031] FIG. 1b shows a schematic overview of a blood pump system 10 according to a second embodiment. The blood pump system 10 according to the second embodiment differs from the blood pump system according to the first embodiment in that the blood pump 12 includes a sensor array 14. Of course, it is also possible for the blood pump 12 to include only a portion of the sensor array. For example, a first sensor for measuring arterial pressure may be supported by the pump housing 20. A second sensor for measuring left ventricular pressure may also be supported by the pump housing 20. Alternatively, the first and / or second sensors may be located remotely from the blood pump 12 to measure the parameter of interest. Heart rate may be calculated by the controller 16 from appropriate signals, such as an ECG signal, motor current, or blood pressure. In this regard, it should be noted that heart rate, when determined based on pressure signals, may also be referred to as pulse rate. However, only the term heart rate will be used hereinafter.

[0032] 1a and 1b, the sensor array 14 is configured to sense at least one cardiovascular system-related parameter (CSRP). In particular, the sensor array 14 may be configured to sense the at least one cardiovascular system-related parameter (CSRP) continuously or intermittently. The at least one cardiovascular system-related parameter (CSRP) is preferably at least one cardiovascular system-related parameter and may include one or more of heart rate (HR), heart rate variability (HRV), mean arterial pressure (MAP), and left ventricular end-diastolic pressure (LVEDP).

[0033] The at least one circulatory system-related parameter CSRP sensed and output by sensor array 14 either directly yields the at least one circulatory system-related parameter CSRP of interest, or is further processed by controller 16 to yield the processed at least one circulatory system-related parameter CSRP of interest. In either case, the data output by sensor array 14 and the data processed by controller 16 can be stored in storage device 18. In particular, storage device 18 is configured to store several sequences of data received from controller 16. Preferably, storage device 18 stores data continuously, and controller 16 is configured to retrieve needed data from storage device 18, as described in more detail below.

[0034] Hereinafter, the present disclosure will be described in terms of a blood pump 12 used as left ventricular assist, although it will be appreciated that the present disclosure may also be used in the case of a blood pump used as right ventricular assist.

[0035] As described above, blood pump 12 is intended to assist the function of a patient's heart in either short-term applications, where an intravascular blood pump is placed within the patient for days or weeks, or long-term applications, where blood pump 12 is placed within the patient for weeks or months. When treatment is scheduled to end, blood pump 12 will not be immediately turned off or removed. Instead, the patient will be weaned from blood pump 12.

[0036] Therefore, the controller 16 is configured to perform a disengagement procedure as described below with reference to the flow chart shown in FIG.

[0037] Before starting the weaning procedure, in step S10, the physician or medical staff enters the parameters intended for the patient's weaning. In particular, the physician enters the patient's age and sex, and the minimum speed N min , maximum speed N max , first deceleration value dN R1 , second deceleration value dN R2 , the first acceleration value dN I1 , the second acceleration value dN I2 and various thresholds TR CSRP To do so, the physician uses an appropriate input device of the blood pump system 10, such as a tablet computer, touch screen, keyboard, etc.

[0038] Minimum speed N min represents the speed of the pumping element 30 at which the patient is considered to be weaned from the device. Preferably, the blood pump 12 operates at a minimum speed N min When operated at a maximum speed of N, it produces a minimum blood flow of 0.1 l / min or less. max represents the speed of the pumping element 30 at which the patient is not ready to be weaned from the blood pump 12 and is still considered to require the assistance of the blood pump 12. Preferably, the maximum speed N max corresponds to the current speed applied before the start of the weaning process, i.e., the speed at which the patient's condition is stable. This speed may be, for example, 25,000 rpm. The first deceleration value dN R1 is preferably in the range between 400 rpm and 600 rpm. In the exemplary embodiment described below, the first deceleration value dN R1 is set to 500 rpm. R2 is preferably in the range between 100 rpm and 300 rpm. In the exemplary embodiment described below, the second deceleration value dN R2is set to 200 rpm. I1 is preferably in the range between 400 rpm and 600 rpm. In the exemplary embodiment described below, the first speed increase value dN I1 is set to 500 rpm. The second acceleration value dN I2 is preferably in the range between 800 rpm and 1,200 rpm. In the exemplary embodiment described below, the second speed increase value dN I2 is set to 1,000 rpm. Depending on which circulatory system-related parameter CSRP is monitored to apply the weaning procedure, the physician may select a threshold TR for each parameter. CSRP In the following exemplary embodiment, four circulatory system-related parameters CSRP, namely, heart rate HR, heart rate variability HRV, mean arterial pressure MAP, and left ventricular end-diastolic pressure LVEDP, are used. Therefore, the respective thresholds, namely, the threshold TR for heart rate, HR , the threshold TR for heart rate variability HRV , the threshold value for mean arterial pressure TR MAP and the threshold TR for left ventricular end-diastolic pressure LVEDP Preferably, the threshold value is a threshold value TR for mean arterial pressure. MAP ±10mmHg, threshold for left ventricular end-diastolic pressure TR LVEDP ±5mmHg, heart rate threshold TR HR ±20 bpm, and the threshold for heart rate variability TR HRV The controller 16 adjusts the threshold value TR of the circulatory system-related parameter CSRP to ±75 msec. CSRP the upper threshold TR upper and an upper threshold TR upper For example, the threshold TR CSRP The lower threshold TR can be calculated by halving or doubling the TR or by taking into account the patient's age and sex. lower It will be appreciated that the respective lower thresholds TR lower It is also possible for the lower threshold TR to be individually set by the physician. lower are the upper thresholds TRupper or threshold TR CSRP It is set to be half or double of each.

[0039] Thereafter, in step S12, the physician initiates the weaning procedure. In particular, a signal is sent to the controller 16 to execute the weaning procedure. The controller 16 counts up a first counter C up Set the second counter C to zero. down Further, the controller 16 sets the second deceleration value dN R2 , i.e., the deceleration value dN R This stipulates:

[0040] In step S14, a first sequence of heart rate HR, heart rate variability HRV, mean arterial pressure MAP, and left ventricular end-diastolic pressure LVEDP is stored by controller 16 in storage device 18 over a first time interval. In this exemplary embodiment, the first sequence includes one value for each of the processed cardiovascular system-related parameters CSRP for every two seconds within the first time interval of, for example, 30 minutes. Thus, 900 values ​​for each of the processed cardiovascular system-related parameters CSRP are stored in storage device 18. Controller 16 may be configured to perform outlier identification in the first sequence of processed cardiovascular system-related parameters CSRP.

[0041] Thereafter, in step S16, the controller calculates a first average value AV1 for the first sequence. Thus, in the embodiment shown in Figure 2, a first average value for the first sequence of heart rate HR, a first average value for the first sequence of heart rate variability HRV, a first average value for the first sequence of mean arterial pressure MAP, and a first average value for the first sequence of left ventricular end-diastolic pressure LVEDP are calculated.

[0042] After the first average value AV1 is calculated, the set speed N set is the deceleration value dN RIn the exemplary embodiment, the current set speed is 25,000 rpm, which is thus reduced by 200 rpm. Therefore, the new set speed N set is 24,800 rpm.

[0043] Set speed N set After the decrease in , in step S20, a second sequence of heart rate HR, heart rate variability HRV, mean arterial pressure MAP, and left ventricular end-diastolic pressure LVEDP is stored by controller 16 in storage device 18 over a second time interval. In this exemplary embodiment, the second sequence includes, for example, one value for each of the processed cardiovascular system-related parameters CSRP for every two-second time point within the second time interval of 10 seconds. Thus, five values ​​for each of the processed cardiovascular system-related parameters CSRP are stored in storage device 18. Controller 16 may be configured to perform outlier identification in the second sequence of processed cardiovascular system-related parameters CSRP.

[0044] Thereafter, in step S22, the controller calculates a second average value AV2 for the second sequence. Thus, in the embodiment shown in Figure 2, a second average value for the second sequence of heart rate HR, a second average value for the second sequence of heart rate variability HRV, a second average value for the second sequence of mean arterial pressure MAP, and a second average value for the second sequence of left ventricular end-diastolic pressure LVEDP are calculated.

[0045] In step S24, the controller 16 calculates a comparison value |Diff| of the difference between the first average value AV1 and the second average value AV2 for each of the circulatory system-related parameters CSRP. In this exemplary embodiment, the comparison value for each of the circulatory system-related parameters CSRP is the absolute value |Diff| for each of the circulatory system-related parameters CSRP. For example, the first average value AV1 for the heart rate HR may be 80.25 bpm, and the second average value AV2 for the heart rate HR may be 86.00 bpm. Therefore, the comparison value |Diff| for the heart rate is |80.25 bpm-86.00 bpm|=5.75 bpm.

[0046] The controller then determines whether the absolute value |Diff| is greater than or equal to the threshold TR CSRP If so, in step S26, the absolute value |Diff| is compared with a respective threshold value TRCSRP as follows: Heart rate |Diff|≦TR HR =20 bpm; Heart Rate Variability (HRV) |Diff|≧TR HRV =75msec; |Diff| ≤ TR for mean arterial pressure (MAP) MAP = 10 mmHg; and |Diff|≦TR for left ventricular end-diastolic pressure (LVEDP) LVEDP =5mmHg.

[0047] The absolute value |Diff| of each circulatory system-related parameter CSRP is calculated based on the respective threshold TR CSRP Instead of comparing with the respective threshold TR, the comparison value may be calculated as a simple difference. CSRP is a threshold range defined by a doctor. For example, the threshold TR for heart rate HR Continuing with the example above for heart rate HR, the comparison value is calculated as -5.75 bpm, which is the threshold value for heart rate TR HR It's inside.

[0048] In step S26, it is determined whether the metric is met and whether all the absolute values ​​|Diff| are greater than or equal to the threshold TR CSRP If so, in step S28, the first counter C up is increased by 1 by the controller 16. In this regard, depending on the configuration of the controller 16, the respective threshold TR CSRP It must be emphasized that absolute values ​​|Diff| equal to can be considered to be inside or outside the threshold.

[0049] Next, in step S30, the first counter C up The value of the first counter is a predetermined maximum value TR Cup For example, it is evaluated whether the first counter maximum value TR is less than a predetermined first counter maximum value TR. Cup can be 180. The first counter C up is the first counter maximum value TR Cup If the first counter C is less than up is the first counter maximum value TR Cup If so, the controller sets the set speed N set is the minimum speed N min The system is configured to evaluate whether the set speed N set is the minimum speed N min , the patient is considered to be fully weaned and the blood pump 12 can be removed, and the weaning process is therefore terminated.

[0050] Optionally, the controller 16 may adjust the set speed N to avoid backflow through the blood pump 12 prior to the draw of the blood pump 12. set Therefore, the blood pump 12 then operates in a "zero flow" mode, which provides a further indication to the physician as to the patient's stability. A matching process is described, for example, in WO 2019 / 034775, which is incorporated by reference.

[0051] In step S32, the set speed N set is the minimum speed N min If it exceeds the threshold, the controller 16 counts up the first counter C in step S34. up The controller 16 then sets |Diff| to zero in step S36. lower In particular, it is established whether the absolute value |Diff| for the heart rate HR is less than or equal to 10 bpm, whether the absolute value |Diff| for the heart rate variability HRV is greater than or equal to 150 msec, whether the absolute value |Diff| for the mean arterial pressure MAP is less than or equal to 5 mmHg, and whether the absolute value |Diff| for the left ventricular end-diastolic pressure LVEDP is less than or equal to 2.5 mmHg. If so, in step S38, the controller 16 determines whether the deceleration value dN R The first deceleration value dN R1 , i.e., 500 rpm. Otherwise, in step S40, the controller 16 sets the deceleration value dN R The second deceleration value dN R2 After each of steps S38 or S40, the controller 16 returns to step S14.

[0052] In step S26, the controller 16 calculates whether the absolute value |Diff| of at least one of the four circulatory system-related parameters CSRP is equal to or greater than the respective threshold value TR CSRP If it is determined that the count is not within the range of 1 / 2, the controller counts up the second counter C in step S42. down Increase by 1.

[0053] Next, in step S44, the second counter C down The value of the second counter is a predetermined maximum value TR Cdown For example, it is evaluated whether the second counter maximum value TR is less than a predetermined second counter maximum value TR. Cdown can be 12. In any case, the second counter maximum value TR Cdown Obviously, the first counter maximum value TRCup It is 10 to 20 times smaller than

[0054] Second counter C down The value of the second counter maximum value TR Cdown If the second counter C is smaller than the value of the first counter C, the controller 16 is configured to return to step S20. down The value of the second counter maximum value TR Cdown If so, in step S46 the controller adjusts the set speed N set is the maximum speed N max The set speed N is determined to be set is the maximum speed N max , it is assumed that the patient is not ready to be weaned and still requires full assistance from blood pump 12. Therefore, the weaning procedure is terminated.

[0055] Set speed N set is the maximum speed N max If it is less than 1, the controller 16 counts up the second counter C down is set to zero. Then, in step S50, the controller 16 sets the acceleration value dN I In particular, the controller 16 determines whether one of the absolute values ​​|Diff| calculated for the cardiovascular system-related parameter CSRP is greater than or equal to the acceleration value dN I The indicators may be, for example, the absolute value |Diff| and the respective threshold value TR CSRP The gap between the second counter C up The value of the second counter C up or the second average value AV2. I If dN should be increased, the controller 16 sets the acceleration value dN I the second acceleration value dN I2 Set to.

[0056] Acceleration value dN IIf there is no indication of an increase in the speed increase value dN I is the first acceleration value dN I1 After each of steps S52 or S54, in step S56 the controller 16 sets the set speed N set is the acceleration value dN I 2 can be further modified without departing from the scope of the present invention. For example, steps S36-S40 can be omitted and only one predetermined deceleration value dN R Therefore, it is possible to omit steps S50 to S54 and to use only one predetermined deceleration value dN R Furthermore, in step S10, the blood pump system 10 may be configured to suggest reasonable values ​​for the parameters entered by the physician based on, for example, the age and sex of the patient.

[0057] Additionally, in step S50, the controller 16 may, for example, count a second counter C up The frequency of increase in |Diff| and all calculated absolute values ​​|Diff| and their respective thresholds TR CSRP If such a serious condition is detected, the controller 16 may be configured to increase the set rate N set Maximum speed N max , and may be configured to terminate the weaning procedure or return to step S12. Of course, the controller 16 may also be configured to issue a signal to the physician if such a serious condition is detected.

[0058] As an alternative to the exemplary embodiment described above, the physician may also min and maximum speed N max Alternatively, a minimum and a maximum blood flow may be defined instead of the first deceleration value dN R1 , second deceleration value dN R2, the first acceleration value dN I1 and a second acceleration value dN I2 is related to the blood flow of the blood pump, not to its speed. Therefore, in that case, the set speed N set corresponds to the set blood flow of the blood pump 12. In this regard, the at least one circulatory system-related parameter CSRP may further include the average blood flow of the blood pump 12. Briefly, in that case, the controller is configured to gradually reduce the speed from a current average blood flow of, for example, 2.5 l / min to a predetermined average blood flow of, for example, 0.5 l / min (corresponding to a defined minimum blood flow). Once the minimum average blood flow is reached, the weaning procedure is completed and the patient is ready to withdraw the blood pump 12. Exemplary Implementation As previously explained, the techniques described herein may be implemented in a variety of ways. In that regard, the above disclosure is intended to include, but not be limited to, the systems, methods, and combinations and subcombinations thereof described in the following exemplary implementations. Preferred embodiments are described in the following paragraphs. A1 A blood pump system comprising: a blood pump, in particular an intravascular blood pump, having a pump housing having a blood inlet and a blood outlet connected by a passage, a pump element disposed in the pump housing, and a drive unit configured to drive the pump element at a set speed so as to generate a flow between the blood inlet and the blood outlet; a sensor array configured to at least intermittently sense at least one circulatory system-related parameter; a controller configured to process the at least one circulatory system-related parameter; and a storage device configured to continuously store the processed at least one circulatory system-related parameter, wherein the controller is further configured to perform a weaning procedure. A2. The blood pump system of paragraph A1, wherein the controller is further configured to perform a weaning procedure, wherein a first sequence of processed at least one circulatory system-related parameter is stored in a storage device for a first time interval. A3. The blood pump system of paragraph A2, wherein the controller is configured to calculate a first average value for the first sequence. A4. The blood pump system of paragraph A3, wherein the controller is further configured to decrease the set speed by the deceleration value after the first average value is calculated. A5. A blood pump system as described in any one of paragraphs A1 to A4, wherein the controller is further configured to perform a weaning procedure, in which a second sequence of the processed at least one circulatory system-related parameter is stored in the storage device for a second time interval. A6. The blood pump system of paragraph A5, wherein the controller is configured to calculate a second average value for the second sequence. A7. The blood pump system of paragraph A6, wherein the controller is configured to compare a comparison value of the difference between the first average value and the second average value with a predetermined threshold value. A8. The blood pump system of paragraph A7, wherein the controller is configured to increase the first counter by one if the comparison value is within a predetermined threshold. A9. The blood pump system of paragraph A7 or A8, wherein the controller is configured to increase the second counter by one if the comparison value is outside a predetermined threshold. A10. The blood pump system of any one of paragraphs A7 to A9, wherein the controller is configured to repeat the steps defined in paragraphs A5 to A9. A11. The blood pump system of any one of paragraphs A7 to A10, wherein the controller is configured to set the first counter to zero when the first counter reaches a predetermined first counter maximum value. A12. The blood pump system of paragraph A11, wherein the controller is further configured to repeat the steps defined in paragraphs A2 to A11 when the first counter reaches a predetermined first counter maximum value. A13. The blood pump system of any one of paragraphs A7 to A12, wherein the controller is configured to set the second counter to zero when the second counter reaches a predetermined second counter maximum value. A14. The blood pump system of any one of paragraphs A7 to A13, wherein the controller is configured to increase the set speed by the increase speed value when the second counter reaches a predetermined second counter maximum value. A15. A blood pump system according to any one of paragraphs A7 to A14, wherein the controller is configured to repeat the steps defined in paragraphs A2 to A14 when the second counter reaches a predetermined second counter maximum value. A16. The blood pump system of any one of paragraphs A1 to A15, wherein the controller is configured to terminate the weaning procedure when the set speed reaches a predetermined minimum speed or a predetermined maximum speed. A17. A blood pump system according to any one of paragraphs A1 to A16, wherein the at least one processed circulatory system related parameter comprises one or more of heart rate, heart rate variability, mean arterial pressure and left ventricular end-diastolic pressure. A18. A blood pump system according to any one of paragraphs A7 to A17, wherein the predetermined thresholds include one or more of a threshold for heart rate, a threshold for heart rate variability, a threshold for mean arterial pressure, and a threshold for left ventricular end-diastolic pressure. A19. The blood pump system of any one of paragraphs A11 to A18, wherein the first counter maximum value is greater than the second counter maximum value. A20. The blood pump system of paragraph A19, wherein the first counter maximum value is 10 to 20 times greater than the second counter maximum value. A21. The blood pump system of any one of paragraphs A2 to A20, wherein the first time interval is greater than the second time interval. A22. The blood pump system of paragraph A21, wherein the first time interval is 30 minutes or longer. A23. The blood pump system of paragraph A21 or A22, wherein the second time interval is 2 minutes or less. A24. A blood pump system according to any one of paragraphs A7 to A23, wherein the predetermined threshold value for the at least one processed circulatory system related parameter comprises a lower threshold range and an upper threshold range. A25. The blood pump system of paragraph A24, wherein the controller is configured to set the deceleration value to the first deceleration value if the comparison value is within the lower threshold range. A26. The blood pump system of paragraph A24 or A25, wherein the controller is configured to set the deceleration value to the second deceleration value if the comparison value is within the upper threshold range. A27. The blood pump system of paragraph A26, wherein the first deceleration value is greater than the second deceleration value. A28. The blood pump system of any one of paragraphs A4 to A27, wherein the second deceleration value is in the range between 100 rpm and 600 rpm. A29. The blood pump system of any one of paragraphs A26 to A28, wherein the first deceleration value is in the range between 400 rpm and 600 rpm, and preferably the first deceleration value is 500 rpm. A30. The blood pump system of any one of paragraphs A26 to A29, wherein the second deceleration value is in the range between 100 rpm and 300 rpm, and the second deceleration value is preferably 200 rpm. A31. A blood pump system according to any one of paragraphs A11 to A30, wherein the controller is configured to set the acceleration value to the first acceleration value or the second acceleration value based on the distance between the comparison value and the threshold value, and / or based on the value of the second counter, and / or based on the frequency of increments of the second counter, and / or based on the second average value. A32. The blood pump system of any one of paragraphs A11 to A31, wherein the speed increase value is in the range between 400 rpm and 1,500 rpm. A33. The blood pump system according to paragraph A31 or A32, wherein the first speed increase value is in the range between 400 rpm and 600 rpm, and the first speed increase value is preferably 500 rpm. A34. A blood pump system according to any one of paragraphs A31 to A33, wherein the second speed increase value is in the range between 800 rpm and 1,200 rpm, and the second speed increase value is preferably 1,000 rpm. A35. The blood pump system of any one of paragraphs A2 to A34, wherein the first time interval is based on heart rate. A36. The blood pump system of any one of paragraphs A5 to A35, wherein the second time interval is based on heart rate. A37. A blood pump system according to any one of paragraphs A2 to A36, wherein the controller is further configured to perform outlier identification in the first sequence of processed at least one circulatory system related parameter. A38. A blood pump system according to any one of paragraphs A2 to A37, wherein the controller is further configured to perform outlier identification in the second sequence of the processed at least one circulatory system related parameter. A39. The blood pump system of any one of paragraphs A1 to A38, wherein the controller is configured to vary the set speed to avoid backflow through the blood pump. A40. A blood pump system according to any one of paragraphs A1 to A39, wherein the comparison value is an absolute value. B1 A method for automated weaning of a patient from a blood pump, in particular an intravascular blood pump, the blood pump having a pump housing having a blood inlet and a blood outlet connected by a passageway, a pump element disposed in the pump housing, and a drive unit configured to drive the pump element at a set speed so as to generate a flow between the blood inlet and the blood outlet, a sensor array configured to at least intermittently sense at least one circulatory system related parameter, a controller configured to process the at least one circulatory system related parameter, a storage device configured to continuously store the processed at least one circulatory system related parameter, and the controller configured to execute the weaning method. B2. The method of paragraph B1, wherein the first sequence of the processed at least one cardiovascular system-related parameter is stored in a storage device for a first time interval. B3. The method of paragraph B2, wherein a first average value for the first sequence is calculated. B4. The method of paragraph B3, wherein after the first average value is calculated, the set speed is decreased by the deceleration value. B5. The method of any one of paragraphs B1 to B4, wherein a second sequence of the processed at least one cardiovascular system-related parameter is stored in a storage device for a second time interval. B6 The method of paragraph B5, wherein a second average value for the second sequence is calculated. B7. The method of paragraph B6, wherein a comparison of the difference between the first average value and the second average value is compared to a predetermined threshold value. B8. The method of paragraph B7, wherein if the comparison value is within a predetermined threshold, the first counter is incremented by one. B9 The method of paragraph B7 or B8, wherein the second counter is incremented by one if the comparison value is outside the predetermined threshold. B10 The method of any one of paragraphs B7 to B9, wherein the steps defined in paragraphs B5 to B9 are repeated. B11 The method of any one of paragraphs B7 to B10, wherein the first counter is set to zero when the first counter reaches a predetermined first counter maximum value. B12. The method of paragraph B11, wherein the steps defined in paragraphs B2 through B11 are repeated when the first counter reaches a predetermined first counter maximum value. B13 The method of any one of paragraphs B7 to B12, wherein the second counter is set to zero when the second counter reaches a predetermined second counter maximum value. B14 The method of any one of paragraphs B7 to B13, wherein the set speed is increased by the increase value when the second counter reaches a predetermined second counter maximum value. B15 The method of any one of paragraphs B7 to B14, wherein the steps defined in paragraphs B2 to B14 are repeated when the second counter reaches a predetermined second counter maximum value. B16 A method for automated weaning of a patient from a blood pump, in particular an intravascular blood pump, the blood pump having a pump housing with a blood inlet and a blood outlet connected by a passageway, a pump element disposed in said pump housing, and a drive unit configured to drive the pump element at a set speed to create a flow between the blood inlet and the blood outlet, wherein a sensor array is configured to at least intermittently sense at least one circulatory system related parameter, a controller is configured to process the at least one circulatory system related parameter, and a storage device is configured to continuously store the processed at least one circulatory system related parameter, the method comprising the following steps: i) storing a first sequence of the processed at least one cardiovascular system-related parameter in a storage device for a first time interval; ii) a first average value for the first sequence is calculated; iii) after the first average value is calculated, the set speed is decreased by the deceleration value; iv) storing a second sequence of the processed at least one cardiovascular system-related parameter in a storage device for a second time interval; v) a second average value for the second sequence is calculated; vi) comparing the difference between the first average value and the second average value with a predetermined threshold value; vii) a controller configured to repeat steps iv) to vi), and configured to increment the first counter by 1 if the comparison value is within a predetermined threshold, and configured to increment the second counter by 1 if the comparison value is outside the predetermined threshold; the controller is configured to repeat steps i) to vii) when the first counter reaches a predetermined first counter maximum value, and is also configured to set the first counter to zero; The controller is configured to increase the set speed by the increase value when the second counter reaches a predetermined second counter maximum value, and is also configured to set the second counter to zero, and is also configured to repeat steps iv) to vii). B17 The method of any one of paragraphs B1 to B16, wherein the disengagement procedure is terminated when the set speed reaches a predetermined minimum speed or a predetermined maximum speed. B18. The method of any one of paragraphs B1 to B17, wherein the at least one cardiovascular system-related parameter processed comprises one or more of heart rate, heart rate variability, mean arterial pressure, and left ventricular end-diastolic pressure. B19 The method of any one of paragraphs B7 to B18, wherein the predetermined thresholds include one or more of a threshold for heart rate, a threshold for heart rate variability, a threshold for mean arterial pressure, and a threshold for left ventricular end-diastolic pressure. B20 The method of any one of paragraphs B11 to B19, wherein the first counter maximum value is greater than the second counter maximum value. B21 The method of paragraph B20, wherein the first counter maximum value is 10 to 20 times greater than the second counter maximum value. B22. The method of any one of paragraphs B2 to B21, wherein the first time interval is greater than the second time interval. B23 The method of paragraph B22, wherein the first time interval is 30 minutes or longer. B24. The method of paragraph B22 or B23, wherein the second time interval is 2 minutes or less. B25. The method of any one of paragraphs B7 to B24, wherein the predetermined threshold value for the processed at least one cardiovascular system-related parameter comprises a lower threshold range and an upper threshold range. B26 The method of paragraph B25, wherein if the comparison value is within the lower threshold range, the deceleration value is set to the first deceleration value. B27 The method of paragraph B25 or B26, wherein if the comparison value is within the upper threshold range, the deceleration value is set to the second deceleration value. B28 The method of paragraph B27, wherein the first deceleration value is greater than the second deceleration value. B29 The method of any one of paragraphs B4 to B28, wherein the reduction value is in the range between 100 rpm and 600 rpm. B30 The method of any one of paragraphs B27 to B29, wherein the first reduction value is in the range between 400 rpm and 600 rpm, and the first reduction value is preferably 500 rpm. B31 The method according to any one of paragraphs B27 to B30, wherein the second reduction value is in the range between 100 rpm and 300 rpm, and the second reduction value is preferably 200 rpm. B32 The method of any one of paragraphs B11 to B31, wherein the acceleration value is set to the first acceleration value or the second acceleration value based on the distance between the comparison value and the threshold value, and / or based on the value of the second counter, and / or based on the frequency of increments of the second counter, and / or based on the second average value. B33 The method of any one of paragraphs B11 to B32, wherein the speed increase value is in the range between 400 rpm and 1,500 rpm. B34 The method according to paragraph B32 or B33, wherein the first speed increase value is in the range between 400 rpm and 600 rpm, and the first speed increase value is preferably 500 rpm. B35 The method of any one of paragraphs B32 to B34, wherein the second speed increase value is in the range between 800 rpm and 1,200 rpm, and the second speed increase value is preferably 1,000 rpm. B36 The method of any one of paragraphs B2 to B35, wherein the first time interval is based on heart rate. B37 The method of any one of paragraphs B5 to B36, wherein the second time interval is based on heart rate. B38 The method of any one of paragraphs B2 to B37, wherein outlier identification is performed in the first sequence of processed at least one cardiovascular system related parameter. B39 The method of any one of paragraphs B2 to B38, wherein outlier identification is performed in the second sequence of processed at least one cardiovascular system related parameter. B40 The method of any one of paragraphs B1 to B39, wherein the set point is changed to avoid backflow through the blood pump. B41 The method according to any one of paragraphs B7 to B40, wherein the comparison value is an absolute value. As used herein, the terms "approximately," "about," "substantially," and similar terms are intended to have broad meanings consistent with commonly accepted usage by those skilled in the art to which the subject matter of the present disclosure belongs. It should be understood by those skilled in the art who review the present disclosure that these terms are intended to allow for the description of the particular features being described without limiting the scope of these features to the precise numerical ranges provided. These terms should therefore be interpreted to indicate that insubstantial or insignificant variations or modifications of the subject matter being described are considered to be within the scope of the present disclosure. The terms "at least partially" or "partially," as used herein, refer to both partially and entirely or completely, respectively.

Claims

1. A pump housing (20) having a blood flow inlet (22) and a blood flow outlet (24) connected by a passage (26), a pump element (30) disposed in the pump housing (20), and a set speed (N) for generating a flow between the blood flow inlet (22) and the blood flow outlet (24). ｓｅｔ a blood pump (12), in particular an intravascular blood pump, having a drive unit (28) configured to drive said pump element (30) with a a sensor array (14) configured to at least intermittently sense at least one cardiovascular system related parameter (CSRP); a controller (16) configured to process the at least one cardiovascular system related parameter (CSRP); a storage device (18) configured to continuously store the processed at least one cardiovascular system related parameter (CSRP); Equipped with The controller (16) includes a disengagement procedure, i) storing a first sequence of the processed at least one cardiovascular system related parameter (CSRP) in the storage device (18) for a first time interval; ii) a first average value (AV) for the first sequence １ ) is calculated, iii) the first average value (AV １ After the set speed (N ｓｅｔ ) is the deceleration value (dN Ｒ ) is reduced by iv) storing a second sequence of the processed at least one cardiovascular system related parameter (CSRP) in the storage device (18) for a second time interval; v) a second average value (AV) for the second sequence ２ ) is calculated, vi) the first average value (AV １ ) and the second average value (AV ２ ) and the comparison value (|Diff|) of the difference with a predetermined threshold (TR ＣＳＲＰ ) and vii) the controller (16) is configured to repeat steps iv) to vi), and the comparison value (|Diff|) is adjusted to the predetermined threshold value (TR ＣＳＲＰ ), the first counter (C ｕｐ ) by 1, and the comparison value (|Diff|) is increased by the predetermined threshold value (TR ＣＳＲＰ ), a second counter (C ｄｏｗｎ ) by one; further configured to perform a weaning procedure; The controller (16) controls the first counter (C ｕｐ ) is a predetermined first counter maximum value (TR Ｃｕｐ ) is reached, repeating steps i) to vii), and ｕｐ ) to zero, The controller (16) controls the second counter (C ｄｏｗｎ ) is a predetermined second counter maximum value (TR Ｃｄｏｗｎ ), the set speed (N ｓｅｔ ) to the acceleration value (dN Ｉ ) and the second counter (C ｄｏｗｎ ) to zero, and repeating steps iv) to vii).

2. 2. A blood pump system (10) according to claim 1, The controller (16) controls the set speed (N ｓｅｔ ) is the predetermined minimum speed (N ｍｉｎ ) or the specified maximum speed (N ｍａｘ ) is reached, the blood pump system (10) is characterized in that it is configured to terminate the weaning procedure.

3. A blood pump system (10) according to claim 1 or 2, A blood pump system (10), characterized in that the at least one processed circulatory system related parameter (CSRP) includes one or more of heart rate (HR), heart rate variability (HRV), mean arterial pressure (MAP), and left ventricular end-diastolic pressure (LVEDP).

4. 4. A blood pump system (10) according to claim 3, comprising: The predetermined threshold (TR ＣＳＲＰ ) is the threshold value for heart rate (TR ＨＲ ), heart rate variability threshold (TR ＨＲＶ ), threshold for mean arterial pressure (TR ＭＡＰ ) and the threshold for left ventricular end-diastolic pressure (TR ＬＶＥＤＰ ) . A blood pump system (10).

5. 5. A blood pump system (10) according to any one of claims 1 to 4, wherein the first counter maximum value (TR Ｃｕｐ ) is the second counter maximum value (TR Ｃｄｏｗｎ ) is larger than the blood pump system (10).

6. 6. The blood pump system (10) according to any one of claims 1 to 5, wherein the first time interval is greater than the second time interval.

7. 7. A blood pump system (10) according to any one of claims 1 to 6, wherein the predetermined threshold value (TR) for the at least one processed circulatory system related parameter (CSRP) is ＣＳＲＰ ) is the lower threshold range (TR ｌｏｗｅｒ ) and the upper threshold range (TR ｕｐｐｅｒ A blood pump system (10) comprising:

8. 8. A blood pump system (10) according to claim 7, comprising: When the comparison value (|Diff|) is within the lower threshold range (TR ｌｏｗｅｒ ), the deceleration value (dN Ｒ ) is configured to be set to a first deceleration value (dN Ｒ１ ), and when the comparison value (|Diff|) is within the upper threshold range (TR ｕｐｐｅｒ ), the deceleration value (dN Ｒ ) is configured to be set to a second deceleration value (dN Ｒ２ ). The blood pump system (10) is characterized by this.

9. 9. A blood pump system (10) according to claim 8, comprising: The first deceleration value (dN Ｒ１ ) is the second deceleration value (dN Ｒ２ ) is larger than the blood pump system (10).

10. A blood pump system (10) according to any one of claims 1 to 9, The deceleration value (dN Ｒ ) is in the range between 100 rpm and 600 rpm, and the first deceleration value (dN Ｒ１ ) is preferably in the range between 400 rpm and 600 rpm, and said second deceleration value (dN Ｒ２ ) is preferably in the range between 100 rpm and 300 rpm.

11. A blood pump system (10) according to any one of claims 1 to 10, The controller (16) is configured to set the acceleration value (dN) to a first acceleration value (dN) or a second acceleration value (dN) based on the gap between the comparison value (|Diff|) and the threshold value (TR), and / or based on the value of the second counter (C), and / or based on the second average value (AV). ＣＳＲＰ ), and / or based on the value of the second counter (C), and / or based on the second average value (AV), ｕｐ ), and / or based on the second average value (AV), ２ ), the acceleration value (dN) is Ｉ ), to a first acceleration value (dN) or a second acceleration value (dN), Ｉ１ ), or a second acceleration value (dN), Ｉ２ ). The blood pump system (10) is characterized in that it is configured as such.

12. 12. A blood pump system (10) according to claim 11, The acceleration value (dN Ｉ ) is in the range between 400 rpm and 1,500 rpm, and the first acceleration value (dN Ｉ１ ) is preferably in the range between 400 rpm and 600 rpm, and said second acceleration value (dN Ｉ２ ) is preferably in the range between 800 rpm and 1,200 rpm.

13. A blood pump system (10) according to any one of claims 1 to 12, A blood pump system (10) characterized in that the first time interval and the second time interval are based on heart rate.

14. A blood pump system (10) according to any one of claims 1 to 13, The blood pump system (10), characterized in that the controller (16) is further configured to perform outlier identification in the first sequence of processed at least one circulatory system related parameter (CSRP) and / or the second sequence of processed at least one circulatory system related parameter.

15. A blood pump system (10) according to any one of claims 1 to 14, The controller (16) adjusts the set speed (N) to avoid backflow through the blood pump (12). ｓｅｔ 2. A blood pump system (10) configured to change the flow rate of a blood pump.

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