Blood pump system

Abstract

The present disclosure relates to a blood pump system comprising a blood pump, in particular an intravascular blood pump, a sensor device, a controller and a storage device. The blood pump has a pump housing having a blood flow inlet and a blood flow outlet connected by a channel, a pump element disposed in the pump housing, and a drive unit configured to drive the pump element at a set speed (Nset) such that a flow is generated between the blood flow inlet and the blood flow outlet. The sensor device is configured to at least intermittently sense at least one circulatory system related parameter (CSRP); the controller is configured to process at least one circulatory system related parameter (CSRP); the storage device is configured to continuously store the processed at least one circulatory system related parameter; wherein the controller is further configured to execute a detachment procedure in which i) a first sequence of processed at least one circulatory system related parameter (CSRP) is stored in the storage device for a first time interval; ii) calculating a first average value (AV1) of the first sequence; iii) reducing the set speed (Nset) by a speed reduction value (dNR) after calculating the first average value (AV1); iv) storing a second sequence of processed at least one circulatory system related parameter (CSRP) in the storage device for a second time interval; v) calculating a second mean value (AV2) of the second sequence; vi) comparing a comparison value (Diff) of the difference between the first average value (AV1) and the second average value (AV2) with a predetermined threshold value (TRCSRP); vii) wherein the controller is configured to repeat steps iv) to vi) and to add 1 to the first counter (Cup) if the comparison value (Diff) is within a predetermined threshold value (TRCSRP) and to add 1 to the second counter (Cdown) if the comparison value (Diff) is outside the predetermined threshold value (TRCSRP); and wherein the controller is configured to repeat steps i) to vii) and to set the first counter (Cup) to zero when the first counter (Cup) reaches a predetermined first counter maximum value (TRCup), and wherein the controller is configured to increase the set speed (Nset) by a speed increase value (dNI) and to set the second counter (Cdown) to zero, and a controller configured to repeat steps iv) to vii) when the second counter (Cdown) reaches a predetermined second counter maximum value (TRCdown).

Description

Technical Field

[0001] The present invention relates to a blood pump system. More specifically, the present invention relates to a blood pump system comprising a blood pump, particularly an intravascular blood pump for percutaneous insertion into a patient's blood vessel to support blood flow in the patient's blood vessel. The blood pump may also be an intracardiac blood pump, an intravascular blood pump, or any other type of ventricular support device. Background Art

[0002] There are a variety of known blood pumps in the prior art, such as axial blood pumps, centrifugal (i.e. radial) blood pumps or hybrid blood pumps, in which blood flow is caused by axial force and radial force. Such blood pumps can be introduced into the patient's heart to support blood flow from the heart to the artery, such as the aorta. The blood pump can be introduced percutaneously through the vascular system during cardiac surgery, such as by catheterization. After the blood pump is placed, the blood pump discharges blood from the left ventricle to the aorta to restore sufficient systemic blood flow. Therefore, a blood pump generally includes a pump housing with a blood flow inlet and a blood flow outlet connected by a channel, a pump element having an impeller form arranged in the pump housing, and a drive unit configured to drive the impeller at an actual speed so as to generate blood flow between the blood flow inlet and the blood flow outlet. In general, a cannula is attached to the blood flow inlet. The cannula passes through, for example, the aortic valve and enters the left ventricle, and blood is discharged from the left ventricle through the cannula and leaves the pump housing through the blood flow outlet and enters the aorta. Of course, such a blood pump can also be used for cardiac assist of the right ventricle of the heart, wherein 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 a blood pump is therefore intended to support the function of the patient's heart, either in short-term applications, where the intravascular blood pump is placed in the patient's body for days or weeks, or in long-term applications, where the intravascular blood pump is placed in the patient's body for weeks or months.

[0004] However, the intravascular blood pump may not be turned off immediately at the expected end of treatment. Instead, a controlled weaning of the patient from the intravascular blood pump is required. However, there is no established method for this, and the weaning that is applied is performed manually and depends largely on the skill and experience of the medical institution or center caring for the patient. Failure during weaning may mean treatment failure and may significantly extend the time required for treatment until the next weaning can be performed. Of course, for the benefit of the patient, this situation should be avoided.

[0005] Therefore, an object of the present disclosure is to provide a blood pump system that facilitates weaning of the patient from the blood pump and greatly reduces the risk of treatment failure. Summary of the Invention

[0006] According to a first aspect, a blood pump system includes a blood pump, a sensor device, a controller, and a storage device. The blood pump has a pump housing having a blood flow inlet and a blood flow outlet connected by a channel. A pump element is arranged in the pump housing. The blood pump also includes a drive unit, which is configured to drive the pump element at a set speed so as to generate a flow between the blood flow inlet and the blood flow outlet. The sensor device is configured to sense at least one circulatory system-related parameter at least intermittently. The sensor device can be configured to continuously sense at least one circulatory system-related parameter. The sensor device can be an in vivo sensor device, an in vitro sensor device, or a combination thereof. For example, the blood pump can include a sensor device, wherein the sensor is positioned, for example, at the pump housing. The sensor can be an optical sensor.

[0007] The blood pump system further includes 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 directly and continuously store the sensed at least one circulatory system-related parameter.

[0008] The blood pump according to the invention may correspond to the aforementioned blood pump. Thus, the blood pump may be an intravascular blood pump or an intracardiac blood pump.

[0009] The controller is further configured to execute a weaning procedure, wherein

[0010] i) storing the processed first sequence of at least one circulatory system related parameter in a storage device for a first time interval;

[0011] ii) calculating a first average value of the first sequence;

[0012] iii) reducing the set speed by the speed reduction value after calculating the first average value;

[0013] iv) storing the processed second sequence of at least one circulatory system related parameter in a storage device for a second time interval;

[0014] v) calculating a second mean value of the second sequence;

[0015] vi) comparing a comparison value of a difference between the first average value and the second average value with a predetermined threshold value;

[0016] vii) wherein the controller is configured to repeat steps iv) to vi) and is configured to increment the first counter by 1 if the comparison value is within the predetermined threshold, and is configured to increment the second counter by 1 if the comparison value is outside the predetermined threshold.

[0017] The controller is further configured to repeat steps i) to vii) and is configured to set the first counter to zero when the first counter reaches a predetermined first counter maximum value. The controller is further configured to increase the set speed by the speed increment value, and is configured to set the second counter to zero, and is configured to repeat steps iv) to vii) when the second counter reaches a predetermined second counter maximum value.

[0018] The disconnection procedure executed by the controller thus provides for automatic disconnection of the patient from the blood pump and reduces the risk of treatment failure, because the speed of the drive unit is rapidly increased again when necessary, i.e., when the second counter reaches a predetermined second counter maximum value. Furthermore, if the circulatory system-related parameters sensed and processed after the speed reduction are within predetermined thresholds, it can be assumed that the speed reduction did not cause patient instability. Furthermore, it can be assumed that the patient remains stable despite the reduction in blood pump flow caused by the speed reduction of the drive unit.

[0019] A circulatory system related parameter in the sense of the present disclosure is any parameter or value that is measurable and related to the 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.

[0020] It should be noted that the threshold value according to the present disclosure may include a single threshold value, a plurality of different threshold values, and / or a threshold value range. Furthermore, preferably, upon first initiating the disengagement procedure, both the first counter and the second counter are set to zero. The threshold value may be predefined by the physician overseeing the disengagement procedure. Preferably, the comparison value is an absolute value.

[0021] 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 may 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 deemed to have been weaned and the blood pump can be removed from the patient's body. The predetermined maximum speed may correspond to the set speed before the weaning procedure is first initiated. If the set speed reaches the maximum speed, the patient is deemed not yet ready for weaning and still requires the full support of the blood pump. The minimum and maximum speeds may be predefined by the physician overseeing the weaning procedure. Instead of defining a minimum and maximum speed, a minimum blood flow rate for the blood pump and a maximum blood flow rate for the blood pump may also be defined. In this case, the set speed corresponds to the set blood flow rate of the blood pump. The controller may be configured to convert speed into blood flow rate, and vice versa. In doing so, the controller may be configured to take into account influencing parameters, such as motor current or data received from a sensor device.

[0022] Preferably, the processed at least one circulatory system-related parameter includes one or more of heart rate, heart rate variability (sometimes also referred to as heart rate variability), mean arterial pressure, left ventricular end-diastolic pressure, and blood flow of the blood pump. These parameters can be directly sensed by the sensor device, or can be derived from the sensed parameters by the controller. In the case where the parameters are used directly, at least one sensed circulatory system-related parameter corresponds to at least one processed circulatory system-related parameter. In addition, the controller can be configured to take into account fluctuations of the at least one circulatory system-related parameter caused by, for example, the patient's respiration or ventilation. In this regard, the predetermined threshold value can include one or more of a heart rate threshold value, a heart rate variability threshold value, a mean arterial pressure threshold value, a left ventricular end-diastolic pressure threshold value, and a blood flow threshold value of the blood pump.

[0023] Preferably, the maximum value of the first counter is greater than the maximum value of the second counter. Therefore, during the disengagement procedure, the time interval for speed increases is shorter than the time interval for speed reductions. Accordingly, if the patient becomes unstable after a speed reduction, a corresponding speed increase is triggered within a relatively short period of time. Furthermore, any further speed reduction is only triggered if the patient stabilizes within a relatively long period of time. In other words, speed increases are much faster than speed reductions.

[0024] The first time interval may be greater than the second time interval. Thus, the first average value is based on a larger population of processed at least one circulatory system-related parameter than the second average value. Thus, the decision whether to increase or decrease the set speed is based on a stable comparative value.

[0025] Preferably, the predetermined threshold value of the at least one processed circulatory system-related parameter includes a lower threshold range and an upper threshold range. Therefore, the controller can be configured to set the speed reduction value to a first speed reduction value when the comparison value is within the lower threshold range, and to set the speed reduction value to a second speed reduction value when the comparison value is within the upper threshold range. Preferably, the first speed reduction value is greater than the second speed reduction value. Therefore, the speed reduction value to be applied can be set based on the change between the comparison value and the threshold value. Thus, in the case of relatively small changes, the set speed will be reduced by a higher value, i.e., the first speed reduction value, while in the case of increased changes, the set speed will be reduced by a lower value, i.e., the second speed reduction value.

[0026] Preferably, for circulatory system-related parameters describing mean arterial blood pressure, the lower threshold range is ±5 mmHg; for circulatory system-related parameters describing left ventricular end-diastolic pressure, the lower threshold range is ±2.5 mmHg; for circulatory system-related parameters describing heart rate, the lower threshold range is ±10 bpm; and for circulatory system-related parameters describing heart rate variability, the lower threshold range is ±150 msec. Accordingly, the upper threshold ranges may be ±10 mmHg, ±5 mmHg, ±20 bpm, and ±75 msec, respectively.

[0027] For example, the speed reduction value may be in the range of 100 rpm to 600 rpm, wherein the first speed reduction value may be in the range of 400 rpm to 600 rpm, and the second speed reduction value may be in the range of 100 rpm to 300 rpm. Thus, the first speed reduction value may be set to 500 rpm, and the second speed reduction value may be set to 200 rpm. The speed reduction values ​​and the first and second speed reduction values ​​may be predefined by a physician supervising the patient's weaning from the blood pump.

[0028] The controller can also be configured to set the speed increase value to the first speed increase value or the second speed increase value based on, for example, a difference between the comparison value and a threshold value, and / or based on the value of a second counter, and / or based on a second average value. Preferably, the first speed increase value is less than the second speed increase value. Thus, the degree of patient instability is taken into account when setting a new and 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 speed increase value.

[0029] For example, the speed increase value may be in the range of 400 rpm to 1,500 rpm, wherein the first speed increase value may be in the range of 400 rpm to 600 rpm, and the second speed increase value may be in the range of 800 rpm to 1,200 rpm. Thus, the first speed increase value may be set to 500 rpm, and the second speed increase value may be set to 1,000 rpm. The speed increase value, the first speed increase value, and the second speed increase value may be predefined by a physician supervising the patient's weaning from the blood pump.

[0030] The first time interval and the second time interval may be based on the number of heartbeats. Alternatively, the first time interval and the second time interval may be based on a time span or on a plurality of values ​​of the first sequence and the second sequence, respectively. For example, the first sequence may include the processed circulatory system-related parameter at every two-second time point over a total time span of 30 minutes, i.e., a total of 900 consecutive values. For example, the second sequence may include the processed circulatory system-related parameter at every two-second time point over a total time span of 10 seconds, i.e., a total of five consecutive values.

[0031] Preferably, the controller is further configured to perform outlier identification in the first sequence of the processed at least one circulatory system-related parameter and / or in the second sequence of the processed at least one circulatory system-related parameter. Outlier identification may be based on common statistical methods, such as Grubbs's test or Student's t-test.

[0032] The controller can also be configured to change the set speed to prevent backflow through the blood pump. This is particularly critical when the set speed is close to or at a predetermined minimum speed of an intravascular blood pump or an intracardiac blood pump. When these blood pumps arrive through a heart valve (e.g., the aortic valve), an open path through the valve is established, which allows backflow when the blood pump is not driven or is driven at a very low speed because the pressure in the blood vessels during diastole is higher than the pressure in the ventricle. Therefore, the controller can be configured to take this into account and prevent backflow. A particularly suitable control method is disclosed in the applicant's WO 2019 / 034775 A1, which is incorporated herein by reference in its entirety. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The foregoing summary of the invention and the following detailed description of the preferred embodiments will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the present disclosure, reference will be made to the accompanying drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the accompanying drawings. In the accompanying drawings:

[0034] Figure 1a FIG2 is a schematic diagram of a blood pump system according to a first embodiment;

[0035] Figure 1b FIG2 is a schematic diagram of a blood pump system according to a second embodiment; and

[0036] Figure 2 Shown is a flow chart illustrating the internal separation procedure. DETAILED DESCRIPTION

[0037] Figure 1aFIG. 1 is a schematic diagram of a blood pump system 10 according to a first embodiment. The blood pump system 10 includes a blood pump 12, a sensor device 14, a controller 16, and a storage device 18. The blood pump 12, sensor device 14, and storage device 18 are connected to the controller 16 via suitable means, such as a cable. Of course, wireless connections are also possible. Alternatively, the storage device 18 may be an integral part of the controller 16.

[0038] The blood pump 12 may be a The blood pump 12 includes a pump housing 20 having a blood flow inlet 22 and a blood flow outlet 24. The blood flow inlet 22 is connected to the blood flow outlet 24 via a channel 26. The pump housing 20 includes a plurality of blood flow outlets 24 evenly distributed around the circumference of the pump housing 20.

[0039] The drive unit 28 is disposed within the pump housing 20. The drive unit 28 is configured to pump the pump at a set speed N set The drive unit 28 is arranged in the pump housing 20 in the form of an impeller pump element 30, which will be explained in more detail below. Although in the embodiment shown the drive unit 28 is arranged in the pump housing 20, the drive unit 28 can also be arranged outside the body and connected to the impeller 30 by suitable means.

[0040] The rotation of the impeller 30 can be caused by a direct connection between the drive unit 28 and the impeller 30 or an indirect connection (such as a magnetic coupling). When the impeller 30 rotates, blood flow is generated between the blood flow inlet 22 and the blood flow outlet 24 along the channel 26. In particular, when the blood pump 12 is used to support the left ventricle, the blood flow inlet 22 is positioned so that blood from the left ventricle of the patient's heart can be drawn into the blood pump 12 and can exit the blood pump 12 through the blood flow outlet 24 and enter the aorta. Of course, the blood pump 12 can also be used to support the right ventricle, to transport blood from the venous system to the patient's heart, or to discharge blood from the patient's heart into the pulmonary artery.

[0041] Figure 1bShown is a schematic diagram 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 device 14. Of course, the blood pump 12 may also include only a portion of the sensor device. For example, a first sensor may be supported by the pump housing 20 to measure arterial pressure. A second sensor may also be supported by the pump housing 20 to measure left ventricular pressure. Alternatively, the first sensor and / or the second sensor may be placed away from the blood pump 12 to measure the parameter of interest. The heart rate can be calculated by the controller 16 based on appropriate signals, such as electrocardiogram (ECG) signals, motor current, or blood pressure. In this regard, it must be mentioned that the heart rate may also be referred to as the pulse rate when it is determined based on the pressure signal. However, only the term heart rate will be used hereinafter.

[0042] exist Figure 1a and Figure 1b In the illustrated embodiment, the sensor device 14 is configured to sense at least one circulatory system related parameter (CSRP). Specifically, the sensor device 14 may be configured to continuously or intermittently sense the at least one circulatory system related parameter CSRP. The at least one circulatory 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).

[0043] The at least one circulatory system-related parameter (CSRP) sensed and output by the sensor device 14 directly provides the at least one circulatory system-related parameter (CSRP) of interest, or is further processed by the controller 16 to provide a processed at least one circulatory system-related parameter (CSRP) of interest. In any case, the data output by the sensor device 14 and the data processed by the controller 16 can be stored in the storage device 18. Specifically, the storage device 18 is configured to store multiple data sequences received from the controller 16. Preferably, the storage device 18 continuously stores data, and the controller 16 is configured to retrieve required data from the storage device 18, as will be described in more detail below.

[0044] Next, the present disclosure will describe a blood pump 12 for supporting the left ventricle. Of course, the present disclosure can also be applied to a blood pump for supporting the right ventricle.

[0045] As described above, the blood pump 12 is intended to support the function of the patient's heart, whether in short-term applications, where the intravascular blood pump is placed in the patient's body for days or weeks, or in long-term applications, where the blood pump 12 is placed in the patient's body for weeks or months. At the expected end of treatment, the blood pump 12 may not be immediately turned off and removed. Instead, the patient will undergo a procedure to wean the blood pump 12.

[0046] Therefore, the controller 16 is configured to execute a disengagement procedure, which will be referred to below. Figure 2 The flowchart shown is described.

[0047] Before starting the weaning procedure, the doctor or medical staff enters the parameters intended for the patient to be weaned in step S10. Specifically, the doctor enters the patient's age and gender, and further defines the minimum speed N min , maximum speed N max , first speed reduction value dN R1 , the second speed reduction value dN R2 , the first speed increase value dN I1 , the second speed increase value dN I2 and different thresholds TR CSRP To this end, the physician uses a suitable input device of the blood pump system 10 , such as a tablet computer, a touch screen, a keyboard, or the like.

[0048] Minimum speed N min The speed of the pump element 30 at which the patient is considered to be able to be weaned from the device is depicted. Preferably, the blood pump 12 is moving at a minimum speed N min The minimum blood flow during operation is 0.1 l / min or less. Maximum speed N max Depicts the speed of the pump element 30 at which the patient is assumed not to be ready for weaning and still requires support from the blood pump 12. Preferably, the maximum speed N max corresponds to the current speed applied before the weaning procedure was started, i.e. the speed at which the patient's condition was stable. This speed could be, for example, 25,000 rpm. The first speed reduction value dN R1 Preferably, it is in the range of 400 rpm to 600 rpm. In the exemplary embodiment described below, the first speed reduction value dN R1 The second speed reduction value dN is set to 500 rpm. R2 Preferably, it is in the range of 100 rpm to 300 rpm. In the exemplary embodiment described below, the second speed reduction value dN R2 The first speed increase value dN is set to 200 rpm. I1 Preferably, it is in the range of 400 rpm to 600 rpm. In the exemplary embodiment described below, the first speed increase value dN I1The second speed increase value dN is set to 500 rpm. I2 Preferably, it is in the range of 800 rpm to 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 parameters CSRP are monitored for the weaning procedure, the physician sets a threshold TR for each parameter. CSRP In the exemplary embodiment below, four circulatory system related parameters CSRP are used, namely heart rate HR, heart rate variability HRV, mean arterial pressure MAP and left ventricular end-diastolic pressure LVEDP. Thus, corresponding threshold values ​​are defined, namely the heart rate threshold TR HR , heart rate variability threshold TR HRV , mean arterial pressure threshold TR MAP and the threshold of left ventricular end-diastolic pressure TR LVEDP Preferably, the threshold value TR for the mean arterial pressure is MAP , the threshold is ±10mmHg; the threshold for left ventricular end-diastolic pressure is TR LVEDP , the threshold is ±5mmHg; for the heart rate threshold TR HR , the threshold is ±20bpm; for the heart rate variability threshold TR HRV , the threshold is ±75 msec. The controller 16 may be configured to use the threshold TR of the circulatory system related parameter CSRP CSRP As the upper threshold TR upper , and calculate the lower threshold TR lower , for example by setting the threshold TR CSRP Halve or double, or by considering the patient's age and gender. Of course, the corresponding lower threshold TR lower It can also be set individually by the doctor. In the following exemplary embodiments, the lower threshold TR lower are set as the corresponding upper threshold TR upper or TR CSRP half or twice as much.

[0049] Next, the doctor starts the disengagement procedure in step S12. Specifically, a signal is sent to the controller 16 to execute the disengagement procedure. The controller 16 sets the first counter C to the value of the first counter C when the disengagement procedure is initially executed. up Set to zero and set the second counter C down In addition, the controller 16 reduces the speed by a value dN R Defined as corresponding to the second speed reduction value dN R2 , that is 200rpm.

[0050] In step S14, the controller 16 stores a first sequence of heart rate (HR), heart rate variability (HRV), mean arterial pressure (MAP), and left ventricular end-diastolic pressure (LVEDP) in the storage device 18 for a first time interval. In this exemplary embodiment, the first sequence includes values ​​of each of the processed circulatory system-related parameters (CSRP) at every 2-second time point within the first time interval, for example, 30 minutes. Thus, for each of the processed circulatory system-related parameters (CSRP), 900 values ​​are stored in the storage device 18. The controller 16 can be configured to perform outlier identification in the first sequence of processed circulatory system-related parameters (CSRP).

[0051] Next, in step S16, the controller 16 calculates the first average value AV1 of the first sequence. Figure 2 In the embodiment shown, a first mean value of a first sequence of heart rate HR, a first mean value of a first sequence of heart rate variability HRV, a first mean value of a first sequence of mean arterial pressure MAP, and a first mean value of a first sequence of left ventricular end-diastolic pressure LVEDP are thus calculated.

[0052] After calculating the first average value AV1, in step S18, the current set speed N set Reduce speed reduction value dN R In 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 24,800rpm.

[0053] When reducing the set speed N set Then, in step S20, the controller 16 stores a second sequence of heart rate (HR), heart rate variability (HRV), mean arterial pressure (MAP), and left ventricular end-diastolic pressure (LVEDP) in the storage device 18 for a second time interval. In this exemplary embodiment, the second sequence includes values ​​of each of the processed circulatory system-related parameters (CSRP) at every 2-second time point within a second time interval of, for example, 10 seconds. Thus, for each of the processed circulatory system-related parameters (CSRP), five values ​​are stored in the storage device 18. The controller 16 may be configured to perform outlier identification in the second sequence of processed circulatory system-related parameters (CSRP).

[0054] Next, in step S22, the controller calculates the second average value AV2 of the second sequence. Figure 2 In the embodiment shown, a second mean value of a second series of heart rate HR, a second mean value of a second series of heart rate variability HRV, a second mean value of a second series of mean arterial pressure MAP and a second mean value of a second series of left ventricular end-diastolic pressure LVEDP are therefore calculated.

[0055] In step S24, the controller 16 calculates a comparison value |Diff| representing 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| of each circulatory system-related parameter CSRP. For example, the first average value AV1 of the heart rate HR may be 80.25 bpm, while the second average value AV2 of the heart rate HR may be 86.00 bpm. This results in the comparison value |Diff| of the heart rate being |80.25 bpm - 86.00 bpm| = 5.75 bpm.

[0056] Then, in step S26, the controller 16 compares the absolute value |Diff| with the corresponding threshold value TR CSRP , especially whether the absolute value |Diff| is within the threshold TR CSRP Within:

[0057] Heart rate HR |Diff|≤TR HR =20bpm;

[0058] Heart rate variability HRV |Diff| ≥ TR HRV =75msec;

[0059] |Diff| for ≤ TR of mean arterial pressure MAP MAP =10 mmHg; and

[0060] Left ventricular end-diastolic pressure LVEDP|Diff]≤TR LVEDP =5mmHg.

[0061] In addition to comparing the absolute value |Diff| of each circulatory system related parameter CSRP with the corresponding threshold TR CSRP , it is also possible to calculate only the difference as the comparison value. In this case, the corresponding threshold TR CSRP It is a threshold range defined by a doctor. For example, the heart rate threshold TR HR It can be defined as a threshold range of ±20bpm. Taking the above heart rate HR as an example, the calculated comparison value is -5.75bpm, which is within the heart rate threshold TR HR Within.

[0062] In step S26, it is determined whether the criterion is satisfied and whether all absolute values ​​|Diff| are within the threshold TR CRSP If yes, then in step S28 the controller 16 sets the first counter C up Increase by 1. It must be emphasized here that, depending on the configuration of the controller 16, the absolute value |Diff| is equal to the corresponding threshold value TRCSRP Can be considered within or outside the threshold.

[0063] Next, in step S30 the first counter C is evaluated. up Is the value lower than the predetermined first counter maximum value TR Cup For example, the predetermined first counter maximum value TR Cup It can be 180. If the first counter C up Lower than the first counter maximum value TR Cup , the controller is configured to return to step S20. up Corresponding to the maximum value TR of the first counter Cup , the controller is configured to evaluate the set speed N in step S32 set Does it correspond to the minimum speed N? min If the speed N is set set Corresponding to the minimum speed N min , the patient is considered to be completely detached and the blood pump 12 can be removed. The detachment procedure is thus terminated.

[0064] Alternatively, the controller 16 may be configured to change the set speed N set To prevent backflow through the blood pump 12 before the blood pump 12 is removed. Therefore, the blood pump 12 is then operated in a "zero flow" mode, which provides the physician with further indication of the patient's stability. A corresponding procedure is described, for example, in WO 2019 / 034775 A1, which is incorporated herein by reference.

[0065] In step S32, the speed N is set. set Above minimum speed N min In the case of up Then, the controller 16 evaluates in step S36 whether the absolute values ​​|Diff| of all four circulatory system related parameters CSRP are within the lower limit threshold value TR of the corresponding circulatory system related parameter CSRP. lower Specifically, it is determined whether the absolute value |Diff| of the heart rate HR is less than or equal to 10 bpm, whether the absolute value |Diff| of the heart rate variability HRV is greater than or equal to 150 msec, whether the absolute value |Diff| of the mean arterial pressure MAP is less than or equal to 5 mmHg, and whether the absolute value |Diff| of the left ventricular end-diastolic pressure LVEDP is less than or equal to 2.5 mmHg. If so, the controller 16 reduces the speed by the value dN in step S38. R Set to the first speed reduction value dN R1, i.e. set to 500 rpm. If not, the controller 16 reduces the speed by the value dN in step S40. R Set to the second speed reduction value dN R2 , i.e. set to 200 rpm. After step S38 or S40 respectively, the controller 16 returns to step S14.

[0066] If the controller 16 determines in step S26 that the absolute value |Diff| of at least one of the four circulatory system related parameters CSRP is not below the corresponding threshold value TR CSRP If the controller sets the second counter C down Increase by 1.

[0067] Next, in step S44 the second counter C is evaluated. down Is the value lower than the predetermined second counter maximum value TR Cdown For example, the predetermined second counter maximum value TR Cdown It can be 12. In any case, the second counter maximum value TR Cdown Significantly smaller than the maximum value TR of the first counter Cup , which is 1 / 10 to 1 / 20 of the latter.

[0068] In the second counter C down The value is less than the second counter maximum value TR Cdown If the value of the second counter C is , the controller 16 is configured to return to step S20. down The value corresponds to the second counter maximum value TR Cdown , then in step S46 the controller is configured to determine the current set speed N set Does it correspond to the maximum speed N max If the speed N is set set Corresponding to the maximum speed N max , the patient is deemed not yet ready for weaning and still requires the full support of the blood pump 12. The weaning procedure is thus terminated.

[0069] If the speed N is set set Below maximum speed N max , the controller 16 sets the second counter C down Thereafter, the controller 16 determines in step S50 whether to change the speed increase value dN. I Specifically, the controller 16 evaluates whether one of the absolute values ​​|Diff| calculated for the circulatory system related parameter CSRP is giving a speed increase value dN I The indication to be increased can be based on the absolute value |Diff| and the corresponding threshold value TR CSRPThe difference between the second counter C down The value of the second counter C down If the speed increase value dN is to be increased, I , the controller 16 increases the speed by the value dN in step S52 I Set to the second speed increase value dN I2 .

[0070] If there is no speed increase value dN for increasing I In step S54, the speed is increased by a value dN. I Set as the first speed increase value dN I1 After step S52 or S54, the controller 16 sets the speed N in step S56. set Increase speed increase value dN I , and return to step S20. Without departing from the scope of the present invention, the above Figure 2 The described disengagement procedure can be further modified. For example, it is also possible to skip steps S36 to S40 and only apply a predetermined speed reduction value dN R Accordingly, steps S50 to S54 can also be skipped and only a predetermined speed reduction value dN is applied. R Furthermore, the blood pump system 10 may be configured to suggest reasonable values ​​for the parameters input by the physician in step S10 , for example based on the patient's age and gender.

[0071] Furthermore, the controller 16 may be configured to, for example, down The increasing frequency and the absolute value of all calculated |Diff| and the corresponding threshold TR CSRP The difference between the two is evaluated in step S50 to determine whether the patient has or is expected to have a serious health condition. If such a serious condition is detected, the controller 16 can be configured to directly set the speed N set Set to maximum speed N max And end and break away from program or return to step S12.Of course, controller 16 also can be arranged to send signal to doctor when detecting this serious condition.

[0072] As an alternative to the above exemplary embodiment, the doctor can also define the minimum blood flow and the maximum blood flow instead of the minimum velocity N. min With maximum speed N max Therefore, the first speed is reduced by the value dN R1 , the second speed reduction value dN R2 , the first speed increase value dN I1 , and the second speed increase dN I2It is related to the blood flow of the blood pump, not the speed. Therefore, set the speed N set This corresponds to the set blood flow rate of the blood pump 12. In this regard, the at least one circulatory system-related parameter CSRP may also include the average blood flow rate of the blood pump 12. In short, the controller is configured to gradually reduce the rate from the current average blood flow rate, for example, 2.5 l / min, to a given average blood flow rate, for example, 0.5 l / min (which corresponds to a defined minimum blood flow rate). When the minimum average blood flow rate is reached, the weaning procedure ends and the patient is ready for removal of the blood pump 12.

[0073] [Exemplary Embodiments]

[0074] As already described, the technology described herein can be implemented in various ways. In this regard, the previously disclosed content is intended to include, but is not limited to, the systems, methods, and combinations and sub-combinations thereof set forth in the following exemplary embodiments. The following paragraphs will describe preferred embodiments:

[0075] A1 A blood pump system includes: a blood pump, in particular an intravascular blood pump, which has a pump housing, a pump element and a drive unit, the pump housing having a blood flow inlet and a blood flow outlet connected by a channel; the pump element is arranged in the pump housing, and the drive unit is configured to drive the pump element at a set speed so as to generate a flow between the blood flow inlet and the blood flow outlet; a sensor device, which is configured to at least intermittently sense at least one circulatory system-related parameter; a controller, which is configured to process at least one circulatory system-related parameter; and a storage device, which is configured to continuously store at least one processed circulatory system-related parameter; wherein the controller is also configured to execute a disengagement procedure.

[0076] A2. The blood pump system of paragraph A1, wherein the controller is further configured to execute a weaning procedure in which a first sequence of processed at least one circulatory system-related parameters is stored in the memory device for a first time interval.

[0077] A3 The blood pump system of paragraph A2, wherein the controller is configured to calculate a first average value of the first sequence.

[0078] A4 The blood pump system of paragraph A3, wherein the controller is further configured to reduce the set speed by the speed reduction value after calculating the first average value.

[0079] A5 A blood pump system according to any of the preceding paragraphs A1 to A4, wherein the controller is further configured to execute a disengagement procedure, wherein a second sequence of processed at least one circulatory system-related parameters is stored in the storage device for a second time interval.

[0080] A6. The blood pump system of paragraph A5, wherein the controller is configured to calculate a second average value for the second sequence.

[0081] A7 The blood pump system of paragraph A6, wherein the controller is further configured to compare a comparison value of a difference between the first average value and the second average value with a predetermined threshold value.

[0082] A8 The blood pump system of paragraph A7, wherein the controller is configured to increment the first counter by 1 if the comparison value is within a predetermined threshold.

[0083] A9 The blood pump system of paragraph A7 or A8, wherein the controller is configured to increment the second counter by one if the comparison value is outside a predetermined threshold.

[0084] A10 The blood pump system of any of the foregoing paragraphs A7 to A9, wherein the controller is configured to repeat the steps defined in paragraphs A5 to A9.

[0085] A11 A blood pump system according to any of the foregoing 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.

[0086] 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.

[0087] A13. The blood pump system of any of the foregoing 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.

[0088] A14 The blood pump system of any of the foregoing paragraphs A7 to A13, wherein the controller is configured to increase the set speed by a speed increase value when the second counter reaches a predetermined second counter maximum value.

[0089] A15 The blood pump system of any of the foregoing 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.

[0090] A16 A blood pump system according to any of the foregoing paragraphs A1 to A15, wherein the controller is configured to end the weaning procedure when the set speed reaches a predetermined minimum speed or a predetermined maximum speed.

[0091] A17 A blood pump system according to any one of the preceding paragraphs A1 to A16, wherein the processed at least one circulatory system-related parameter includes one or more of heart rate, heart rate variability, mean arterial pressure, and left ventricular end-diastolic pressure.

[0092] A18 A blood pump system according to any one of the preceding paragraphs A7 to A17, wherein the predetermined threshold comprises one or more of a heart rate threshold, a heart rate variability threshold, a mean arterial pressure threshold, and a left ventricular end-diastolic pressure threshold.

[0093] A19 A blood pump system according to any of the foregoing paragraphs A11 to A19, wherein the first counter maximum value is greater than the second counter maximum value.

[0094] A20 The blood pump system of paragraph A19, wherein the maximum value of the first counter is 10 to 20 times the maximum value of the second counter.

[0095] A21 A blood pump system according to any of the foregoing paragraphs A2 to A20, wherein the first time interval is greater than the second time interval.

[0096] A22 The blood pump system of paragraph A21, wherein the first time interval is 30 minutes or longer.

[0097] A23 A blood pump system according to paragraph A21 or A22, wherein the second time interval is 2 minutes or less.

[0098] A24 A blood pump system according to any one of the preceding paragraphs A7 to A23, wherein the predetermined threshold value of at least one processed circulatory system-related parameter comprises a lower threshold range and an upper threshold range.

[0099] A25 The blood pump system of paragraph A24, wherein the controller is configured to set the speed reduction value to the first speed reduction value when the comparison value is within a lower threshold range.

[0100] A26. The blood pump system of paragraph A24 or A25, wherein the controller is configured to set the speed reduction value to the second speed reduction value when the comparison value is within the upper threshold value.

[0101] A27 A blood pump system according to paragraph A26, wherein the first speed reduction value is greater than the second speed reduction value.

[0102] A28 A blood pump system according to any of the foregoing paragraphs A4 to A27, wherein the speed reduction value is in a range between 100 rpm and 600 rpm.

[0103] A29 A blood pump system according to any of the foregoing paragraphs A26 to A28, wherein the first speed reduction value is in the range between 400 rpm and 600 rpm, wherein the first speed reduction value is preferably 500 rpm.

[0104] A30 A blood pump system according to any of the foregoing paragraphs A26 to A29, wherein the second speed reduction value is in a range between 100 rpm and 300 rpm, wherein the second speed reduction value is preferably 200 rpm.

[0105] A31 A blood pump system according to any one of the preceding paragraphs A11 to A30, wherein the controller is configured to set the speed increase value to the first speed increase value or the second speed increase value based on the gap between the comparison value and the threshold value and / or based on the value of the second counter and / or based on the increase frequency of the second counter and / or based on the second average value.

[0106] A32 A blood pump system according to any of the foregoing paragraphs A11 to A31, wherein the speed increase value ranges between 400 rpm and 1,500 rpm.

[0107] A33 A blood pump system according to paragraph A31 or A32, wherein the first speed increase value is in a range between 400 rpm and 600 rpm, wherein the first speed increase value is preferably 500 rpm.

[0108] A34 A blood pump system according to any of the foregoing paragraphs A31 to A33, wherein the second speed increase value is in a range between 800 rpm and 1,200 rpm, wherein the second speed increase value is preferably 1,000 rpm.

[0109] A35 A blood pump system according to any of the foregoing paragraphs A2 to A34, wherein the first time interval is based on the number of heartbeats.

[0110] A36 A blood pump system according to any of the foregoing paragraphs A5 to A35, wherein the second time interval is based on the number of heartbeats.

[0111] A37 A blood pump system according to any of the foregoing paragraphs A2 to A36, wherein the controller is further configured to perform outlier identification in the processed first sequence of at least one circulatory system-related parameter.

[0112] A38 A blood pump system according to any of the foregoing paragraphs A2 to A37, wherein the controller is further configured to perform outlier identification in the second sequence of processed at least one circulatory system-related parameter.

[0113] A39 A blood pump system according to any of the foregoing paragraphs A1 to A38, wherein the controller is configured to change the set speed to prevent backflow through the blood pump.

[0114] A40 A blood pump system according to any of the foregoing paragraphs A1 to A39, wherein the comparison value is an absolute value.

[0115] B1 A method for automatically disconnecting a patient from a blood pump, in particular an intravascular blood pump, wherein the blood pump has a pump housing, a pump element and a drive unit, the pump housing having a blood flow inlet and a blood flow outlet connected by a channel, the pump element is arranged in the pump housing, and the drive unit is configured to drive the pump element at a set speed so as to generate a flow between the blood flow inlet and the blood flow outlet; wherein the sensor device is configured to at least intermittently sense at least one circulatory system-related parameter; wherein the controller is configured to process at least one circulatory system-related parameter; and wherein the storage device is configured to continuously store at least one processed circulatory system-related parameter; wherein the controller is configured to execute the disconnection method.

[0116] B2 The method according to paragraph B1, wherein the processed first sequence of at least one circulatory system-related parameter is stored in the storage device for a first time interval.

[0117] B3 The method according to paragraph B2, wherein a first average value of the first sequence is calculated.

[0118] B4 The method according to paragraph B3, wherein a speed reduction value is set after the first average value is calculated.

[0119] B5 A method according to any of the preceding paragraphs B1 to B4, wherein the processed second sequence of at least one circulatory system-related parameter is stored in the storage device for a second time interval.

[0120] B6 The method according to paragraph B5, wherein a second average value of the second sequence is calculated.

[0121] B7 A method according to paragraph B6, wherein a comparison value of the difference between the first average value and the second average value is compared with a predetermined threshold value.

[0122] B8 The method of paragraph B7, wherein if the comparison value is within a predetermined threshold, the first counter is incremented by 1.

[0123] B9 The method of paragraph B7 or B8, wherein if the comparison value is outside a predetermined threshold, the second counter is incremented by 1.

[0124] B10 A method according to any one of the preceding paragraphs B7 to B9, wherein the steps defined in paragraphs B5 to B9 are repeated.

[0125] B11 A method according to any one of the preceding paragraphs B7 to B10, wherein the first counter is set to zero when the first counter reaches a predetermined first counter maximum value.

[0126] B12 The method according to paragraph B11, wherein the steps defined in paragraphs B2 to B11 are repeated when the first counter reaches a predetermined first counter maximum value.

[0127] B13 A method according to any one of the preceding paragraphs B7 to B12, wherein the second counter is set to zero when the second counter reaches a predetermined second counter maximum value.

[0128] B14 A method according to any one of the preceding paragraphs B7 to B13, wherein the speed is set to be increased by a speed increase value when the second counter reaches a predetermined second counter maximum value.

[0129] B15 A method according to any one of the preceding 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.

[0130] B16 A method for automatically weaning a patient from a blood pump, particularly an intravascular blood pump, wherein the blood pump comprises a pump housing, a pump element, and a drive unit, the pump housing having a blood flow inlet and a blood flow outlet connected by a channel, the pump element being disposed in the pump housing, and the drive unit being configured to drive the pump element at a set speed so as to generate a flow between the blood flow inlet and the blood flow outlet; wherein the sensor device is configured to at least intermittently sense at least one circulatory system-related parameter; wherein the controller is configured to process the at least one circulatory system-related parameter; and wherein the storage device is configured to continuously store the processed at least one circulatory system-related parameter; wherein the method comprises the following steps:

[0131] i) storing the processed first sequence of at least one circulatory system related parameter in a storage device for a first time interval;

[0132] ii) calculating a first average value of the first sequence;

[0133] iii) reducing the set speed by the speed reduction value after calculating the first average value;

[0134] iv) storing the processed second sequence of at least one circulatory system related parameter in a storage device for a second time interval;

[0135] v) calculating a second mean value of the second sequence;

[0136] vi) comparing a comparison value of a difference between the first average value and the second average value with a predetermined threshold value;

[0137] vii) wherein the controller is configured to repeat steps iv) to vi) and is configured to increment the first counter by 1 if the absolute value is within a predetermined threshold, and is configured to increment the second counter by 1 if the comparison value is outside the predetermined threshold; and

[0138] wherein the controller is configured to repeat steps i) to vii) and is configured to set the first counter to zero when the first counter reaches a predetermined first counter maximum value, and

[0139] The controller is configured to increase the set speed by the speed increase value, to set the second counter to zero, and to repeat steps iv) to vii) when the second counter reaches a predetermined second counter maximum value.

[0140] B17 A method according to any one of the preceding paragraphs B1 to B16, wherein the disengagement procedure is ended when the set speed reaches a predetermined minimum speed or a predetermined maximum speed.

[0141] B18 A method according to any one of the preceding paragraphs B1 to B17, wherein the processed at least one circulatory system-related parameter includes one or more of heart rate, heart rate variability, mean arterial pressure, and left ventricular end-diastolic pressure.

[0142] B19 A method according to any one of the preceding paragraphs B7 to B18, wherein the predetermined threshold comprises one or more of a heart rate threshold, a heart rate variability threshold, a mean arterial pressure threshold, and a left ventricular end-diastolic pressure threshold.

[0143] B20 A method according to any one of the preceding paragraphs B11 to B20, wherein the maximum value of the first counter is greater than the maximum value of the second counter.

[0144] B21 The method of paragraph B20, wherein the first counter maximum value is 10 to 20 times greater than the second counter maximum value.

[0145] B22 A method according to any one of the preceding paragraphs B2 to B21, wherein the first time interval is greater than the second time interval.

[0146] B23 The method according to paragraph B22, wherein the first time interval is 30 minutes or longer.

[0147] B24 A method according to paragraph B22 or B23, wherein the second time interval is 2 minutes or less.

[0148] B25 A method according to any one of the preceding paragraphs B7 to B24, wherein the predetermined threshold value of at least one circulatory system-related parameter after processing includes a lower threshold range and an upper threshold range.

[0149] B26 The method according to paragraph B25, wherein the speed reduction value is set to the first speed reduction value when the comparison value is within a lower threshold range.

[0150] B27 A method according to paragraph B25 or B26, wherein the speed reduction value is set to the second speed reduction value when the comparison value is within the upper threshold range.

[0151] B28 The method of paragraph B27, wherein the first speed reduction value is greater than the second speed reduction value.

[0152] B29 A method according to any of the preceding paragraphs B4 to B28, wherein the speed reduction value is in a range between 100 rpm and 600 rpm.

[0153] B30 A method according to any one of the preceding paragraphs B27 to B29, wherein the first speed reduction value is in the range between 400 rpm and 600 rpm, wherein the first speed reduction value is preferably 500 rpm.

[0154] B31 A method according to any of the preceding paragraphs B27 to B30, wherein the second speed reduction value is in the range between 100 rpm and 300 rpm, wherein the second speed reduction value is preferably 200 rpm.

[0155] B32 A method according to any one of the preceding paragraphs B11 to B31, wherein the speed increase value is set to the first speed increase value or the second speed increase value based on the gap between the comparison value and the threshold value and / or based on the value of the second counter and / or based on the increase frequency of the second counter and / or based on the second average value.

[0156] B33 A method according to any of the foregoing paragraphs B11 to B32, wherein the speed increase value is in a range between 400 rpm and 1,500 rpm.

[0157] B34 The method of paragraph B32 or B33, wherein the first speed increase value is in the range between 400 rpm and 600 rpm, wherein the first speed increase value is preferably 500 rpm.

[0158] B35 A method according to any of the foregoing paragraphs B32 to B34, wherein the second speed increase value is in a range between 800 rpm and 1,200 rpm, wherein the second speed increase value is preferably 1,000 rpm.

[0159] B36 A method according to any one of the preceding paragraphs B2 to B36, wherein the first time interval is based on the number of heartbeats.

[0160] B37 A method according to any one of the preceding paragraphs B5 to B36, wherein the second time interval is based on the number of heartbeats.

[0161] B38 A method according to any one of the preceding paragraphs B2 to B37, wherein outlier identification is performed in a first sequence of at least one circulatory system-related parameter after processing.

[0162] B39 A method according to any one of the preceding paragraphs B2 to B38, wherein outlier identification is performed in a second sequence of at least one circulatory system-related parameter after processing.

[0163] B40 A method according to any of the foregoing paragraphs B1 to B39, wherein the set speed is changed to prevent backflow through the blood pump.

[0164] B41 A method according to any one of the preceding paragraphs B7 to B40, wherein the comparison value is an absolute value.

[0165] As used herein, the terms "approximately," "about," "substantially," and similar terms are intended to have a broad meaning consistent with common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure relates. It should be understood by those skilled in the art, reviewing this disclosure, that these terms are intended to allow description of certain features described without limiting the scope of those features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating insubstantial or insignificant modifications or alterations of the subject matter described and are considered to be within the scope of this disclosure. As used herein, the terms "at least in part" or "partially" mean both partly and entirely or completely, respectively.

Claims

1. A blood pump system (10), comprising: A blood pump (12), in particular an intravascular blood pump, comprises a pump housing (20), a pump element (30) and a drive unit (28), wherein the pump housing (20) comprises a blood flow inlet (22) and a blood flow outlet (24) connected via a channel (26), the pump element (30) being arranged in the pump housing (20), and the drive unit (28) being configured to pump blood at a set speed (N set ) driving the pump element (30) to generate a flow between the blood flow inlet (22) and the blood flow outlet (24); a sensor device (14) configured to at least intermittently sense at least one circulatory system related parameter (CSRP); a controller (16) configured to process the at least one circulatory system related parameter (CSRP); as well as a storage device (18) configured to continuously store at least one circulatory system related parameter (CSRP) after processing; The controller (16) is further configured to execute a disengagement procedure, wherein i) storing said processed first sequence of at least one circulatory system related parameter (CSRP) in said storage device (18) for a first time interval; ii) calculating a first average value (AV1) of the first sequence; iii) after calculating the first average value (AV1), the set speed (N set )Reduction speed reduction value (dN) R ); iv) storing said processed second sequence of at least one circulatory system related parameter (CSRP) in said storage device (18) for a second time interval; v) calculating a second average value (AV2) of the second sequence; vi) comparing a comparison value (|Diff|) of a difference between the first average value (AV1) and the second average value (AV2) with a predetermined threshold value (TR CSRP ) for comparison; vii) wherein the controller (16) is configured to repeat steps iv) to vi), and is configured to if the comparison value (|Diff|) is within the predetermined threshold value (TR CSRP ), Then the first counter (C up ) increases by 1, and is configured to if the comparison value (|Diff|) is within the predetermined threshold value (TR CSRP ), Then the second counter (C down ) is increased by 1; and The controller (16) is configured to repeat steps i) to vii) and is configured to count the number of times the first counter (C up ) reaches the predetermined first counter maximum value (TR Cup ) when the first counter (C up ) is set to zero, and The controller (16) is configured to set the set speed (N set ) Increase speed increase value (dN) I ), and is configured to set the second counter (C down ) is set to zero, and is configured to be in the second counter (C down ) reaches the predetermined second counter maximum value (TR Cdown ) and repeat steps iv) to vii).

2. The blood pump system (10) according to claim 1, wherein The controller (16) is configured to set ) reaches the predetermined minimum speed (N min ) or the predetermined maximum speed (N max ) ends the separation procedure.

3. The blood pump system (10) according to claim 1 or 2, wherein The processed at least one 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. The blood pump system (10) according to claim 3, wherein The predetermined threshold (TR CSRP ) includes the heart rate threshold (TR HR ), the threshold value of the heart rate variability (TR HRV ), the threshold value of mean arterial pressure (TR MAP ) and the threshold value of the left ventricular end-diastolic pressure (TR LVEDP ) in one or more of the following.

5. The blood pump system (10) according to any one of the preceding claims, wherein The first counter maximum value (TR Cup ) is greater than the second counter maximum value (TR Cdown ).

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

7. The blood pump system (10) according to any one of the preceding claims, wherein wherein the predetermined threshold value (TR CSRP ) including the lower threshold range (TR lower ) and upper threshold range (TR upper ).

8. The blood pump system (10) according to claim 7, wherein The controller (16) is configured to control the comparison value (|Diff|) to be within the lower threshold range (TR lower ), reduce the speed by a value (dN R ) is set as the first speed reduction value (dN R1 ), and is configured to be within the upper threshold range (TR upper ), reduce the speed by a value (dN R ) is set as the second speed reduction value (dN R2 ).

9. The blood pump system (10) according to claim 8, wherein The first speed reduction value (dN R1 ) is greater than the second speed reduction value (dN R2 ).

10. The blood pump system (10) according to any one of the preceding claims, wherein The speed reduction value (dN R ) is in the range between 100 rpm and 600 rpm, wherein the first speed reduction value (dN R1 ) is preferably in the range of 400 rpm to 600 rpm, and wherein the second speed reduction value (dN R2 ) is preferably in the range between 100 rpm and 300 rpm.

11. The blood pump system (10) according to any one of the preceding claims, wherein The controller (16) is configured to determine the difference between the comparison value (|Diff|) and the predetermined threshold value (TR CSRP ) and / or based on the second counter (C up ) value and / or based on the second average value (AV2), the speed increase value (dN I ) is set as the first speed increase value (dN I1 ) or the second speed increase value (dN I2 ).

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

13. The blood pump system (10) according to any one of the preceding claims, wherein The first time interval and the second time interval are based on the number of heartbeats.

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

15. The blood pump system (10) according to any one of the preceding claims, wherein The controller (16) is configured to change the set speed (N set ) to prevent backflow through the blood pump (12).

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