Method and apparatus for detecting position of interventional pump, device, and blood pump

Abstract

A method and an apparatus for detecting a position of an interventional pump (10), a device, and a blood pump, belonging to the technical field of artificial hearts. The method for detecting a position of an interventional pump (10) comprises: acquiring operation signal data of the interventional pump (10) and blood pressure data of an auxiliary subject (310); performing conversion processing on the operation signal data to obtain cross-pump net pressure data corresponding to a pump head (13) in the interventional pump (10) (320); determining phase information between the blood pressure data and the cross-pump net pressure data (330); and indicating an interventional position state of the interventional pump (10) on the basis of the phase information and the cross-pump net pressure data (340).

Description

Methods, devices, equipment, and blood pumps for detecting the location of interventional pumps

[0001] Cross-references to related applications

[0002] This patent application claims priority to Chinese Patent Application No. 202510065389.6, filed on January 15, 2025, entitled "Method, Apparatus, Device and Blood Pump for Position Detection of Interventional Pump", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to the field of artificial heart technology, and in particular to a method, apparatus, device, and blood pump for detecting the position of an interventional pump. Background Technology

[0004] Blood pump devices are used to provide mechanical circulatory support for patients (assisted reproductive technologies). An interventional blood pump is a percutaneously implanted device. Its pump head is inserted percutaneously into the heart via a peripheral blood vessel. As the blades in the pump head rotate, they draw blood from the ventricles of the heart towards the aorta, thus enabling ventricular assist function. During operation, the operator typically needs to ensure the pump is correctly positioned within the heart. For example, with a left ventricular assist pump, the correct positioning would be achieved with the pump head inserted across the aortic valve, the distal blood inlet on the left ventricle side, and the proximal blood outlet on the aorta side.

[0005] In some related technologies, a pressure sensor is installed at the pump head of the blood pump. The blood pump controller can determine whether the pump head is in the correct position within the heart based on the pressure signal collected by the built-in pressure sensor at the pump head. For example, some blood pumps have two pressure sensors in the pump head, one located at the distal end and one at the proximal end. The pressure signals collected by these two sensors are used to determine whether the pump head is in the correct position. However, blood pumps with dual sensors in the pump head have problems such as large pump head size, complex structure, and high operating costs. Other blood pumps have a single pressure sensor in the pump head, but relying on the pressure signal collected by a single pressure sensor is insufficient to accurately determine the position of the interventional pump. Summary of the Invention

[0006] According to one or more embodiments of this disclosure, a method for detecting the position of an interventional pump is provided. The method includes: acquiring operating signal data of the interventional pump and blood pressure data of an auxiliary object; performing conversion processing on the operating signal data to obtain cross-pump net pressure data corresponding to the pump head in the interventional pump; determining phase information between the blood pressure data and the cross-pump net pressure data; and indicating the interventional position status of the interventional pump based on the phase information and the cross-pump net pressure data.

[0007] According to one or more embodiments of the present disclosure, an interventional pump position detection device is provided. The device includes: a data acquisition module for acquiring operating signal data of the interventional pump and blood pressure data of the assisted object; a net pressure determination module for converting and processing the operating signal data to obtain cross-pump net pressure data corresponding to the pump head in the interventional pump; a phase determination module for determining phase information between the blood pressure data and the cross-pump net pressure data; and a position determination module for indicating the interventional position status of the interventional pump based on the phase information and the cross-pump net pressure data.

[0008] According to one or more embodiments of the present disclosure, an electronic device is provided, the electronic device including a processor and a memory, the memory storing at least one instruction, at least one program, code set or instruction set, the at least one instruction, at least one program, code set or instruction set being loaded and executed by the processor to implement the above-described interventional pump position detection method.

[0009] According to one or more embodiments of the present disclosure, a blood pump device is provided, the blood pump device including a processor and a memory, the memory storing at least one instruction, at least one program, code set or instruction set, the at least one instruction, at least one program, code set or instruction set being loaded and executed by the processor to implement the above-described interventional pump position detection method.

[0010] According to one or more embodiments of the present disclosure, a computer-readable storage medium is provided, which stores at least one instruction, at least one program, code set or instruction set, wherein the at least one instruction, at least one program, code set or instruction set is loaded and executed by a processor to implement the above-described interventional pump position detection method.

[0011] According to one or more embodiments of this disclosure, a computer program product is provided, comprising computer instructions stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium and executes the computer instructions, causing the computer device to perform the aforementioned method for detecting the position of the interventional pump. Attached Figure Description

[0012] To more clearly illustrate the technical solutions in the embodiments of this disclosure, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0013] Figure 1 is a schematic diagram of a blood pump device provided in an embodiment of this disclosure;

[0014] Figure 2 illustrates a schematic diagram of a connection between an interventional pump and a fluid pipeline.

[0015] Figure 3 is a flowchart of a method for detecting the position of an interventional pump according to an embodiment of this disclosure;

[0016] Figure 4 illustrates an example of the relationship between the location of the intervention pump and the threshold.

[0017] Figure 5 is a block diagram of a position detection device for an interventional pump provided in an embodiment of this disclosure. Detailed Implementation

[0018] To make the objectives, technical solutions, and advantages of this disclosure clearer, embodiments of this disclosure will be further described in detail below with reference to the accompanying drawings. Exemplary embodiments will be described in detail here, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this disclosure as detailed in the appended claims.

[0019] The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The singular forms “a,” “the,” and “the” as used in this disclosure and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any and all possible combinations of one or more of the associated listed items.

[0020] It should be understood that although the terms first, second, third, etc., may be used in this disclosure to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another.

[0021] Before introducing the method embodiments provided in this disclosure, a brief introduction will be given to the relevant technical background, related terms or nouns that may be involved in the method embodiments of this disclosure, so as to facilitate the understanding of those skilled in the art.

[0022] A blood pump device is a circulatory auxiliary device that replaces the function of the ventricles, including but not limited to external blood pump devices, interventional blood pump devices, and implantable blood pump devices.

[0023] An interventional blood pump device refers to a catheter-based pump used in medical settings to assist the heart in providing blood circulation. An interventional blood pump device includes an interventional blood pump (or simply interventional pump) and a control device used in conjunction with it, suitable for providing temporary ventricular circulatory support during relevant surgeries. Optionally, the interventional blood pump is a cardiac pump inserted into a living organism. Optionally, some or all components of the interventional blood pump are inserted into the living organism. In operation, the drive device in the control device drives the interventional pump to pump blood from the ventricles into the arteries, thereby assisting the heart's pumping function and reducing the burden on the heart.

[0024] Figure 1 is a schematic diagram of a blood pump device provided in an embodiment of this disclosure. Referring to Figure 1, the blood pump device is an interventional blood pump device, including an interventional pump 10 and a control device 20, which are detachably connected to the interventional pump 10. The interventional pump 10 is a consumable component.

[0025] The control device 20 includes, but is not limited to, a console 21, a drive motor 22, and a flushing device 23. The console 21 is used at least to respond to human-machine interface operations and system control operations, allowing operators to monitor system status and patient physiological data, and adjust the speed of the blood pump according to the patient's needs to provide different levels of circulatory assistance, thereby temporarily maintaining blood circulation to the patient's vital organs and relieving the burden on the heart. The drive motor 22 is used at least to drive the interventional pump 10.

[0026] The interventional pump 10 includes a drive catheter handle 11, a drive catheter 12, a pump head 13, and a protective end 14. The pump head 13 includes, but is not limited to, an impeller, a support, and a membrane.

[0027] The interventional pump 10 can be percutaneously inserted into the heart through peripheral blood vessels. The pump head 13 is placed between the left ventricle and the aorta. The blood inlet of the pump head 13 is placed into the left ventricle, and the blood outlet of the pump head is placed into the aorta, thereby pumping blood from the left ventricle into the aorta to achieve ventricular assist function.

[0028] Since the interventional pump 10 needs to be inserted into the human body, it needs to be pre-charged before use and kept flushed during use to prevent air from entering the body through the gaps inside the interventional pump 10 and to prevent blood from stagnating in the gaps inside the interventional pump 10 and forming thrombi. Therefore, the interventional pump 10 can also be connected to a flushing line. The flushing device 23 is used to drive the flushing fluid in the flushing line to pre-charge, vent, and flush the gaps inside the interventional pump 10, thereby preventing blood from entering the drive catheter 12 and forming thrombi, and preventing air from entering the patient's body through the gaps inside the interventional pump and forming air embolisms. The flushing device 23 may include a peristaltic pump, which drives and squeezes the pump tube in the flushing line to pump the flushing fluid into the interventional pump 10, thereby preventing air bubbles from entering the drive catheter 12 of the interventional pump 10.

[0029] Optionally, the interventional pump system can monitor the patient's blood pressure. The interventional pump 10 has an arterial pressure measurement channel that remains connected to a blood vessel. An arterial pressure sensor is installed in the arterial pressure measurement channel; when the channel is connected to the blood vessel fluid, the sensor can detect the patient's arterial pressure. Therefore, the interventional pump 10 can also be connected to an arterial pressure measurement tubing. The arterial pressure measurement tubing has a periodically openable flushing valve. Pressure is applied to the fluid bag connected to the tubing via a pressure bag, which can also drive fluid to flush the arterial pressure measurement pathway, preventing thrombosis.

[0030] As an example, see Figure 2, which exemplarily illustrates a schematic diagram of an interventional pump connected to a fluid line. The fluid line includes a flushing line and an arterial pressure monitoring line 40. The flushing line includes an infusion line 31, a circulation inlet line 32, and a circulation outlet line 33. The infusion line 31 can be driven and squeezed by the infusion pump 231 in the flushing device 23 (as shown in Figure 1), and the circulation inlet line 32 can be driven and squeezed by the circulation pump 232 in the flushing device 23.

[0031] After the drive catheter handle 11 is connected to the flushing pipeline, a flushing flow path is formed. Specifically, the flushing fluid inlet 111 of the drive catheter handle 11 is connected to the circulation inlet pipe 32 of the flushing pipeline, the flushing fluid outlet 112 of the drive catheter handle 11 is connected to the circulation outlet pipe 33 of the flushing pipeline, and the infusion pipe 31 of the flushing pipeline is connected to the fluid bag, forming the flushing flow path of the intervention pump 10. The infusion pump 231 drives the pump tube on the infusion pipe 31 to pump the flushing fluid in the fluid bag to the circulation inlet pipe 32, thereby driving the flushing fluid to enter the drive catheter handle 11 through the flushing fluid inlet 111. After the flushing fluid enters the drive catheter handle 11, part of it enters the drive catheter 12 through the flushing fluid chamber and is discharged to the human body from the pump head 13; the other part enters the coupling cooling chamber and flows back into the flushing pipeline from the flushing fluid outlet 112. The circulating pump 232 is used to drive the flushing fluid to circulate between the circulating inlet pipe 32, the drive guide handle 11, and the circulating outlet pipe 33 to cool the flushing fluid and prevent the high temperature generated by the coupled rotation between the drive motor 22 (as shown in Figure 1) and the intervention pump 10 (as shown in Figure 1) from causing the flushing fluid to reach a high temperature. At the same time, the circulating flushing fluid has a cooling effect on the coupled rotor.

[0032] After the drive catheter handle 11 is connected to the arterial pressure measurement tubing 40, an arterial pressure measurement flow path is formed. Specifically, the pressure measurement inlet 113 of the drive catheter handle 11 is connected to the arterial pressure measurement tubing 40, and the pressure measurement outlet 114 of the drive catheter handle 11 is connected to the pressure measurement interface 51 of the interventional sheath 50. The interventional sheath 50, after being percutaneously inserted into the blood vessel, provides a pathway for the interventional pump 10 to be placed into the heart, and the interventional sheath 50 remains in the patient's blood vessel until the interventional pump 10 is removed. The fluid in the fluid bag connected to the arterial pressure measurement tubing 40 fills the entire arterial pressure measurement channel in the arterial pressure measurement tubing 40 and the interventional pump 10, and connects to the gap 53 between the interventional sheath 50 and the drive catheter 12, thereby maintaining communication with the blood in the blood vessel. Thus, the arterial pressure sensor 115 in the interventional pump can detect the patient's arterial pressure. The aforementioned arterial pressure sensor 115 is located outside the patient's body.

[0033] The blood pump device shown in Figures 1 and 2 is only an example, and the specific type of interventional blood pump device disclosed herein is not limited.

[0034] For interventional blood pumps, interventional size, structural complexity, and interventional location are technical indicators that need to be considered simultaneously. The interventional location needs to be detected by relevant sensor signals. However, if too many sensors are set in the pump head of the interventional blood pump, it will increase the structural complexity and interventional size of the interventional blood pump. To resolve this contradiction and achieve more accurate interventional location detection, this disclosure provides an interventional pump location detection method.

[0035] Please refer to Figure 3, which shows a flowchart of an interventional pump position detection method according to an embodiment of this disclosure. This method can be applied to electronic devices, which are those capable of data calculation and processing. For example, the executing entity for each step can be related electronic equipment in the blood pump device shown in Figure 1, such as the control console 21, flushing device 23, etc. The method may include the following steps (310-340).

[0036] Step 310: Obtain the operating signal data of the interventional pump and the blood pressure data of the assisted subject.

[0037] Optionally, the aforementioned blood pressure data includes the arterial pressure data of the assisted individual. This arterial pressure data can be based on arterial pressure data detected by a pressure sensor located outside the assisted individual's body. This pressure sensor can be a blood pressure monitoring device located outside the interventional pump, or it can be an arterial pressure sensor installed within the drive catheter handle of the interventional pump, such as the arterial pressure sensor 115 shown in Figure 2. The arterial pressure data can also be the aortic pressure data of the assisted individual.

[0038] Optionally, the operating signal data includes, but is not limited to, at least one of the following: speed signal data, torque sensing data, and current data corresponding to the intervention pump.

[0039] The speed signal data may include, but is not limited to, at least one of the following: motor speed data, impeller speed data, speed error data, and coupled speed difference data. Speed ​​error data refers to the error data between the target speed and the actual speed, and coupled speed difference data refers to the speed difference data between coupled drive components in the blood pump system.

[0040] Current data may include, but is not limited to, at least one of motor controller current data and motor current data.

[0041] The motor controller current data may include, but is not limited to, at least one of the following: the net output current of the motor controller, the proportional term current corresponding to the PID control module, current data determined based on the proportional and derivative term currents corresponding to the PID control module, and current data determined based on the proportional and integral term currents corresponding to the PID control module. The motor controller may include a PID control module.

[0042] The motor current may include, but is not limited to, at least one of the following: the current of at least one motor winding, the average current of at least two motor windings, or the orthogonal axis current determined based on the motor winding current. The motor winding current may be obtained based on a change in motor position.

[0043] Those skilled in the art can select appropriate operating signal data and blood pressure data to implement this method based on the specific type of interventional pump and the application scenario; this disclosure does not limit this.

[0044] In one example, in a system where the intervention pump operates in real time, it can be at a fixed frequency f. s Collect arterial pressure data p aop and the current signal i of the drive motor Q The collected results are then stored in an array.

[0045] Step 320: The operating signal data is converted and processed to obtain the cross-pump net pressure data corresponding to the pump head in the intervention pump.

[0046] Optionally, the above-mentioned cross-pump net pressure data is used to characterize the pressure difference between the blood inlet and blood outlet at the pump head.

[0047] The aforementioned interventional pump begins operation after its pump head is percutaneously inserted into the heart. The pump's drive motor rotates the impeller, pumping blood from the ventricles to the aorta. During the operation of the interventional pump, the periodic beating of the heart affects the pressure corresponding to the pump head. These pressure changes also cause changes in the relevant operating signals within the interventional pump. Therefore, historical data can be selected as samples to determine the conversion relationship between changes in operating signals during the heartbeat cycle and changes in the cross-pump net pressure corresponding to the pump head, thus achieving the conversion of operating signal data into cross-pump net pressure data.

[0048] In one example, the cross-pump net pressure data pnet,ac,raw can be obtained from the drive motor current i. Q The calculation yields the following formula: pnet,ac,raw=i Q *K IP

[0049] Among them, K IP For current i Q The influence coefficient of the inter-pump net pressure data pnet,ac,raw. This influence coefficient can be determined based on the actual intervention pump and historical data, and this disclosure does not limit it. The inter-pump net pressure data can be determined based on the current of the drive motor using the above formula.

[0050] Because the interventional pump head operates across the heart valves, the periodic heartbeats cause periodic changes in the load on the pump head. To maintain the interventional pump at a set support level, the drive current of the interventional pump also changes periodically with the heartbeat cycle. For example, when the load decreases, the drive current can be reduced to prevent the rotational speed from exceeding the target speed; similarly, when the load increases, the drive current can be increased to prevent the rotational speed from falling below the target speed. Therefore, the drive motor current changes with the heartbeat cycle. The main factors causing the aforementioned load changes are the ventricular contraction and relaxation processes and the opening and closing of the valves. Specifically, this results in the pressure difference across the pump head (i.e., the net pressure across the pump) changing periodically with the heartbeat cycle. The net pressure across the pump is an important indicator of load changes; therefore, changes in the drive motor current and changes in the net pressure across the pump are linked and have a corresponding relationship. In one possible implementation, the motor current data and cross-pump net pressure data at the same moment in historical operating data can be matched to obtain multiple sets of key-value pairs of motor current data and cross-pump net pressure data. Regression analysis can then be performed to obtain the mapping relationship between the motor current data and the cross-pump net pressure data, such as the calculation formula corresponding to the cross-pump net pressure data pnet,ac,raw above, thus obtaining the aforementioned K. IP This influence coefficient. Optionally, K IP These are the coefficients determined through regression analysis based on historical data. For different types of interventional pumps, K... IP It may be different, but it can be determined through multiple experiments using the above methods. The embodiments disclosed herein address K. IP The specific size is not limited.

[0051] Step 330: Determine the phase information between the blood pressure data and the cross-pump net pressure data.

[0052] Optionally, the heart rate (or heart cycle) can be determined based on the above blood pressure data. Both the blood pressure data and the transpump net pressure data are heart rate-related communication signals. Blood pressure data fluctuates with the heartbeat; transpump net pressure data changes with the heart cycle. During the heart cycle, when the aortic valve opens, the pressures at the blood inlet and outlet on both sides of the pump head are almost equal, and the transpump net pressure drops to around 0. When the aortic valve closes, the pressures at the blood inlet and outlet on both sides of the pump head begin to change, and the transpump net pressure rises to a certain level until the ventricular pressure opens the aortic valve. Then, the transpump net pressure continues to decrease, and this cycle continues.

[0053] In one possible implementation, the aforementioned blood pressure data includes arterial pressure data. The arterial pressure data is subjected to two low-pass filters, and the filtered results are subtracted to obtain a pressure signal containing only the AC component. Next, rising and falling edge detection is performed, and the edge time difference and number of edges are recorded. Finally, the average time of the rising and falling edges is calculated, and excessively large or small values ​​are filtered out to obtain the heart rate, i.e., the heartbeat cycle.

[0054] The aforementioned phase information is used to characterize the phase relationship between blood pressure data and cross-pump net pressure data.

[0055] In an exemplary embodiment, the phase relationship between the blood pressure data and the interpump net pressure data can be further determined by determining the phase angles corresponding to each of them. Step 330 may include the following steps: determining a first phase angle corresponding to the blood pressure data; determining a second phase angle corresponding to the interpump net pressure data; and determining the phase difference between the blood pressure data and the interpump net pressure data based on the first and second phase angles. The phase information may include the phase difference between the blood pressure data and the interpump net pressure data.

[0056] Because blood pressure and transpump net pressure data are both periodic signals, with the period being the heartbeat cycle, analyzing their Fourier series allows us to observe the amplitude of different fundamental components and determine their phase angle.

[0057] Optionally, a Fourier series transform is performed on the blood pressure data to obtain the amplitude of the first fundamental component in the blood pressure data (hereinafter referred to as the first amplitude); and a Fourier series transform is performed on the interpump net pressure data to obtain the amplitude of the first fundamental component in the interpump net pressure data (hereinafter referred to as the second amplitude); using the relationship between amplitude and phase, the first phase angle corresponding to the blood pressure data can be determined based on the first amplitude, and the second phase angle corresponding to the interpump net pressure can be determined based on the second amplitude.

[0058] The formula for calculating Fourier series is as follows: For -π≤θ≤π

[0059] Where θ represents the phase, f(θ) represents the signal to be transformed, a0 is a constant, n is the series, and a n b is the magnitude of the cosine term corresponding to the nth-order component. n This represents the amplitude of the sine term corresponding to the nth-order component.

[0060] In one example, the arterial pressure and the net transpump pressure can be transformed using the Fourier series formula to obtain the first and second amplitudes mentioned above.

[0061] The first amplitude includes the amplitude a of the first cosine term corresponding to the first fundamental component of the arterial pressure. 1,aop and the amplitude of the first sine term b 1,aop The second amplitude includes the second cosine term amplitude 'a' corresponding to the first fundamental component of the cross-pump net pressure. 1,net The amplitude of the second sine term b 1,net .

[0062] The phase angles corresponding to the arterial pressure and the net transpump pressure can then be determined based on the first and second amplitudes mentioned above. Optionally, the phase angles can be determined using the following formula: θ = arctan(b / a)

[0063] Where θ represents the phase angle, b represents the magnitude of the sine term, and a represents the magnitude of the cosine term.

[0064] Therefore, the first phase angle θ corresponding to the blood pressure data can be determined separately. aop And the second phase angle θ corresponding to the cross-pump net pressure data. net This allows us to determine the phase difference θ between the arterial pressure signal and the net transpump pressure signal. diff Optionally, the phase difference θ diff The calculation formula is as follows: θ diff =θ aop -θ net

[0065] Step 340: Indicate the intervention position status of the intervention pump based on phase information and cross-pump net pressure data.

[0066] The inventors of this disclosure discovered that when the interventional pump is not compressed or subjected to mechanical interference, the phase difference between blood pressure data and interpump net pressure data is approximately 90°; conversely, their phases are close. In the latter case, the interpump net pressure amplitude overlaps with the interpump net pressure amplitude at incorrect locations, leading to erroneous location determination. Therefore, it is necessary to perform phase alignment on the interpump net pressure amplitude so that the aligned interpump net pressure amplitude can be clearly distinguished at various locations.

[0067] The above-mentioned interventional position status is used to characterize the placement of the interventional pump in the heart, such as correct position, incorrect position, and unknown position.

[0068] As can be seen from the detection principle embodied in the above method, the interventional pump position detection method provided in this disclosure does not require the installation of a sensor at the distal part of the interventional pump inserted into the human body. Blood pressure data can be collected based on a pressure sensor located outside the body of the patient. Of course, the blood pressure sensor can also be installed in the part of the interventional pump inserted into the body of the patient, such as a pressure sensor installed in the part of the interventional pump located inside the artery. Even if no pressure sensor is installed in the part of the interventional pump inserted into the ventricle of the patient, the method provided in this disclosure can still be used to detect the interventional pump's insertion position. Furthermore, since the interventional pump position detection method provided in this disclosure performs position detection based on the phase relationship between the cross-pump net pressure and blood pressure, it can effectively adapt to interventional pump usage scenarios with varying loads. Even if the drive motor corresponding to the interventional pump can be located outside the body of the patient, the interventional pump position detection method provided in this disclosure can overcome the effects of long transmission distances, curved transmission paths, and related mechanical interference, and can accurately determine whether the interventional pump's insertion position is correct.

[0069] In an exemplary embodiment, step 340 above may include the following steps: performing phase processing on the cross-pump net pressure data based on phase information to obtain a first cross-pump net pressure amplitude, the first cross-pump net pressure amplitude being a cross-pump net pressure amplitude adjusted based on phase information; and indicating the intervention position status of the intervention pump according to the first cross-pump net pressure amplitude.

[0070] Since the cross-pump net pressure data is a periodically changing signal, the above phase processing can be used to adjust the amplitude of the cross-pump net pressure data based on the phase difference. Specifically, it can include the following steps: determining the second cross-pump net pressure amplitude corresponding to the cross-pump net pressure data, where the second cross-pump net pressure amplitude is the original amplitude corresponding to the cross-pump net pressure data; determining an adjustment factor based on the phase difference, where the adjustment factor is used to adjust the amplitude of the second cross-pump net pressure based on the phase difference; and fusing the adjustment factor and the second cross-pump net pressure amplitude to obtain the first cross-pump net pressure amplitude.

[0071] Optionally, the adjustment factor includes the sine value corresponding to the phase difference. The above fusion method can be to multiply the sine value corresponding to the phase difference with the net pressure amplitude of the second cross-pump to obtain the net pressure amplitude of the first cross-pump. The net pressure amplitude of the first cross-pump is the net pressure amplitude of the cross-pump after phase alignment.

[0072] Optionally, the aforementioned second cross-pump net pressure amplitude can be based on the second cosine term amplitude 'a' corresponding to the first fundamental component in the cross-pump net pressure data. 1,net The amplitude of the second sine term b 1,net Sure.

[0073] Optionally, the net pressure amplitude P of the second cross-pump net The calculation formula is:

[0074] Optionally, the first cross-pump net pressure amplitude P aligned,net The calculation formula is: P aligned,net =P net *sin(θ diff )

[0075] Among them, P aligned,net P represents the net pressure amplitude of the first pump. net Indicates the net pressure amplitude of the second span pump, sin(θ) diff ) is the adjustment factor, and θ is the phase difference. diff .

[0076] In an exemplary embodiment, the first cross-pump net pressure amplitude can be compared with relevant thresholds to determine whether the intervention position of the intervention pump is correct. The specific process of indicating the intervention position status of the intervention pump based on the first cross-pump net pressure amplitude can be as follows: acquiring at least two thresholds corresponding to the operating signal data; wherein, the at least two thresholds include a first threshold and a second threshold, the first threshold being a position judgment threshold for the intervention pump's transmission system under normal load, and the second threshold being a position judgment threshold for the intervention pump's transmission system under abnormal load; comparing the first cross-pump net pressure amplitude with the first threshold and the second threshold to obtain a comparison result; and indicating the intervention position status based on the comparison result.

[0077] During implementation, the correspondence between operating signal data and inter-pump net pressure thresholds can be determined based on historical data, and this correspondence can be stored in a lookup table. During operation, the corresponding threshold can be found in the lookup table based on the current operating signal data, such as impeller speed, for position determination. As mentioned above, there are two types of inter-pump net pressure thresholds: one is the position determination threshold for the interventional pump's drive system under abnormal load conditions, which can be referred to as the structural bending threshold; the other is the position determination threshold for the interventional pump's drive system under normal load conditions, which can be referred to as the correct position threshold. The purpose of these two thresholds is to assist in determining the position of the interventional pump under any load condition. The amplitude of the interventional pump's correct position under different load conditions is explained below.

[0078] When the intervention pump is in the correct position (not bent, under normal load), the net pressure amplitude across the pump is large; when the intervention pump is in the wrong position, the net pressure amplitude across the pump is small; when the intervention pump is in the correct position (under abnormal load conditions such as being squeezed, having mechanical interference, or having the protective end bent), the net pressure amplitude across the pump is large and in the opposite direction (negative value).

[0079] Optionally, if the net pressure amplitude of the first cross-pump is greater than or equal to the first threshold, a first indication message indicating that the intervention pump is in the correct position is issued. The first indication message is used to indicate that the intervention pump is in the correct position under normal load conditions.

[0080] Optionally, if the net pressure amplitude of the first cross-pump is less than the first threshold and greater than the second threshold, a second indication message indicating that the intervention pump is in an incorrect position is issued.

[0081] Optionally, if the net pressure amplitude of the first cross-pump is less than or equal to the second threshold, a third indication message indicating that the interventional pump is in an unknown position is issued, or a fourth indication message indicating that the interventional pump is in the correct position is issued. The fourth indication message is used to indicate that the interventional pump is in the correct position under abnormal load conditions.

[0082] A specific example can be found in Figure 4, which exemplifies the relationship between the position of the interventional pump and a threshold. As shown in Figure 4, when the cross-pump net pressure amplitude after phase alignment is greater than or equal to the correct position threshold (i.e., the first threshold mentioned above), the determination result is that the interventional pump is in the correct position; when the cross-pump net pressure amplitude after phase alignment is between the structural bending threshold (i.e., the second threshold mentioned above) and the correct position threshold, the determination result is that the interventional pump is in the wrong position; when the cross-pump net pressure amplitude after phase alignment is less than the structural bending threshold, the determination result is an unknown position, which may be the correct position under bending conditions.

[0083] In one possible embodiment, if the interventional pump is under abnormal load but in the correct position, the device can issue the aforementioned fourth indication information to indicate that the interventional pump is in the correct position but under abnormal load.

[0084] Simultaneously, the device can also issue a warning message indicating an abnormality in the interventional pump's drive system, suggesting that the interventional pump is under abnormal load. Specifically, if the net pressure amplitude across the first interpump is less than or equal to a second threshold, the method may further include the step of issuing a warning message indicating an abnormality in the interventional pump's drive system.

[0085] The aforementioned abnormal load conditions include, but are not limited to: compression and bending of the protective end in the interventional pump, mechanical interference within the interventional pump, and compression or structural bending of the drive shaft in the interventional pump. The blood pump device shown in Figures 1 and 2 is an interventional blood pump with an external motor. Its drive motor is located outside the auxiliary object body. As shown in Figure 1, the drive motor 22 is coupled to the drive catheter handle 11 of the interventional pump outside the auxiliary object body. A drive shaft passes through the drive catheter handle 11. The proximal end of the drive shaft is coupled to the drive motor 22, and the distal end of the drive shaft is connected to the impeller in the pump head 13. The rotor of the drive motor 22 drives the drive shaft to rotate, thereby driving the impeller to rotate.

[0086] In an exemplary embodiment, before using the above-mentioned operating signal data and blood pressure data to detect the intervention position, it is necessary to check the validity of the operating signal data and / or blood pressure data. If the operating signal data, the cross-pump net pressure data, and the blood pressure data are all valid data, then the step of indicating the intervention position status of the intervention pump based on phase information and cross-pump net pressure data is performed.

[0087] If the operating signal data, inter-pump net pressure data, or blood pressure data is invalid, an indication that the interventional pump is in an unknown position will be issued. If any of the operating signal data, inter-pump net pressure data, or blood pressure data is invalid, the device can directly report an unknown position prompt, thereby reducing the waste of computing resources.

[0088] Among them, the following are the situations in which the operating signal data, cross-pump net pressure data, or blood pressure data are not considered valid data: the motor current data is greater than the current threshold; the motor speed data is greater than the speed threshold; the average value of the blood pressure data is less than the mean arterial pressure threshold; the amplitude of the blood pressure data is less than the arterial pressure amplitude threshold; there is abnormal noise in the blood pressure data; the heart rate corresponding to the blood pressure data is greater than the upper limit of the heart rate threshold or less than the lower limit of the heart rate threshold; the average value of the cross-pump net pressure data is less than the mean net pressure threshold; and the amplitude of the cross-pump net pressure data is greater than the upper limit of the net pressure amplitude or less than the lower limit of the net pressure amplitude.

[0089] In summary, the technical solution provided by the embodiments of this disclosure, by converting the operating signal data of the interventional pump, can obtain the cross-pump net pressure of the pump head even when dual sensors or differential pressure sensors are not installed on the pump head. The cross-pump net pressure of the pump head can be used to detect whether the pump head is located in the correct position within the heart. However, considering that the interventional pump may experience abnormal loads such as compression or mechanical interference during operation, which may cause changes in the phase relationship between the cross-pump net pressure and the true heart rate, there is a risk of incorrect interventional position detection. Therefore, this disclosure also utilizes the blood pressure signal, which can reflect the true heart rate of the assisted subject, to determine the phase relationship between the two AC signals, namely the pump head net pressure and the blood pressure signal. Thus, based on the pump head net pressure, the phase information of both signals is combined to predict the position of the interventional pump, reducing the adverse effects of the aforementioned abnormal load conditions on the accuracy of interventional pump position detection, thereby more accurately predicting the position of the interventional pump in the heart and further improving the accuracy of interventional pump position detection.

[0090] The following are embodiments of the apparatus disclosed herein, which can be used to execute embodiments of the method disclosed herein. For details not disclosed in the apparatus embodiments of this disclosure, please refer to the embodiments of the method disclosed herein.

[0091] Please refer to Figure 5, which shows a block diagram of an interventional pump position detection device according to an embodiment of this disclosure. This device has the function of implementing the above-described interventional pump position detection method; the function can be implemented in hardware or by hardware executing corresponding software. The device can be a computer device or can be installed within a computer device. The device 500 may include: a data acquisition module 510 for acquiring operating signal data of the interventional pump and blood pressure data of the assisted object; a net pressure determination module 520 for converting and processing the operating signal data to obtain cross-pump net pressure data corresponding to the pump head in the interventional pump; a phase determination module 530 for determining the phase information between the blood pressure data and the cross-pump net pressure data; and a position determination module 540 for indicating the interventional position status of the interventional pump based on the phase information and the cross-pump net pressure data.

[0092] In summary, the technical solution provided by the embodiments of this disclosure, by converting the operating signal data of the interventional pump, can obtain the cross-pump net pressure of the pump head even when dual sensors or differential pressure sensors are not installed on the pump head. The cross-pump net pressure of the pump head can be used to detect whether the pump head is located in the correct position within the heart. However, considering that the interventional pump may experience abnormal loads such as compression or mechanical interference during operation, which may cause changes in the phase relationship between the cross-pump net pressure and the true heart rate, there is a risk of incorrect interventional position detection. Therefore, this disclosure also utilizes the blood pressure signal, which can reflect the true heart rate of the assisted subject, to determine the phase relationship between the two AC signals, namely the pump head net pressure and the blood pressure signal. Thus, based on the pump head net pressure, the phase information of both signals is combined to predict the position of the interventional pump, reducing the adverse effects of the aforementioned abnormal load conditions on the accuracy of interventional pump position detection, thereby more accurately predicting the position of the interventional pump in the heart and further improving the accuracy of interventional pump position detection.

[0093] It should be noted that the apparatus provided in the above embodiments is only illustrated by the division of the above functional modules when implementing its functions. In actual applications, the above functions can be assigned to different functional modules as needed, that is, the internal structure of the device can be divided into different functional modules to complete all or part of the functions described above. In addition, the apparatus and method embodiments provided in the above embodiments belong to the same concept, and the specific implementation process can be found in the method embodiments, which will not be repeated here.

[0094] This disclosure provides an electronic device in one embodiment. The electronic device can be a control console in a blood pump device, or a computer device within a flushing device of a blood pump device. The electronic device includes a processor and a memory. The memory stores at least one instruction, at least one program, a code set, or an instruction set. The processor loads and executes the at least one instruction, at least one program, code set, or instruction set to implement the interventional pump position detection method provided in the above embodiment. Specifically:

[0095] Typically, electronic devices include a processor and memory.

[0096] The processor may include one or more processing cores, such as a quad-core processor or an octa-core processor. The processor may be implemented using at least one hardware form of DSP (Digital Signal Processing), FPGA (Field Programmable Gate Array), or PLA (Programmable Logic Array). The processor may also include a main processor and coprocessors. The main processor, also known as the CPU (Central Processing Unit), is used to process data in the wake-up state; the coprocessor is a low-power processor used to process data in the standby state. In some embodiments, the processor may integrate a GPU (Graphics Processing Unit), which is responsible for rendering and drawing the content to be displayed on the screen. In some embodiments, the processor may also include an AI (Artificial Intelligence) processor, which handles computational operations related to machine learning.

[0097] The memory may include one or more computer-readable storage media, which may be non-transitory. The memory may also include high-speed random access memory and non-volatile memory, such as one or more disk storage devices or flash memory devices. In some embodiments, the non-transitory computer-readable storage media in the memory is used to store at least one instruction, at least one program, code set, or instruction set, and is configured to be executed by one or more processors to implement the above-described interventional pump position detection method and / or the above-described interventional pump position detection method.

[0098] In some embodiments, the electronic device may also optionally include: a peripheral device interface and at least one peripheral device. The processor, memory, and peripheral device interface can be connected via a bus or signal line. Each peripheral device can be connected to the peripheral device interface via a bus, signal line, or circuit board. Specifically, the peripheral device includes at least one of: radio frequency circuitry, a touch display screen, a camera assembly, an audio circuit, a positioning assembly, and a power supply.

[0099] Those skilled in the art will understand that the above structure does not constitute a limitation on the electronic device, and may include more or fewer components, or combine certain components, or adopt different component arrangements.

[0100] In some possible implementations, the position detection method for the interventional pump described herein can be implemented in the software of an electronic device. Some hardware electronic device platforms particularly suitable for implementation include microcontrollers, FPGAs, operating system-based microprocessor platforms, or cloud computing platforms. The former allows for faster and more direct access to data, while the latter is more likely to utilize complex models. It can also be implemented in analog circuits.

[0101] In an exemplary embodiment, a blood pump device is also provided, which includes a processor and a memory. The memory stores at least one instruction, at least one program, code set, or instruction set. The processor loads and executes the at least one instruction, at least one program, code set, or instruction set to implement the above-described interventional pump position detection method and / or interventional pump position detection method.

[0102] In an exemplary embodiment, a computer-readable storage medium is also provided, which stores at least one instruction, at least one program, code set, or instruction set, wherein the at least one instruction, at least one program, code set, or instruction set is executed by a processor to implement the above-described method for detecting the position of the interventional pump.

[0103] Optionally, the computer-readable storage medium may include: ROM (Read Only Memory), RAM (Random Access Memory), SSD (Solid State Drives), or optical disc, etc. The random access memory may include ReRAM (Resistance Random Access Memory) and DRAM (Dynamic Random Access Memory).

[0104] In an exemplary embodiment, a computer program product or computer program is also provided, which includes computer instructions stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium and executes the computer instructions, causing the computer device to perform the aforementioned position detection method for the interventional pump.

[0105] It should be understood that "multiple" as used herein refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. Furthermore, the step numbers described herein are merely illustrative of one possible execution order. In some other embodiments, the steps may not be executed in numerical order, such as two steps with different numbers being executed simultaneously, or two steps with different numbers being executed in the reverse order of the illustration. This disclosure does not limit this.

[0106] Furthermore, in the specific embodiments of this disclosure, data such as user information are involved. When the above embodiments of this disclosure are applied to specific products or technologies, user permission or consent is required, and the collection, use and processing of related data must comply with the relevant laws, regulations and standards of the relevant countries and regions.

[0107] The above description is merely an exemplary embodiment of this disclosure and is not intended to limit this disclosure. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure should be included within the protection scope of this disclosure.

Claims

1. A method for detecting the position of an interventional pump, wherein, The method includes: Acquire the operating signal data of the interventional pump and the blood pressure data of the assisted patient; The operating signal data is converted and processed to obtain the cross-pump net pressure data corresponding to the pump head in the intervention pump; Determine the phase information between the blood pressure data and the cross-pump net pressure data; and The intervention position status of the intervention pump is indicated based on the phase information and the cross-pump net pressure data.

2. The method according to claim 1, wherein, The method of indicating the intervention position status of the intervention pump based on the phase information and the cross-pump net pressure data includes: Based on the phase information, phase processing is performed on the cross-pump net pressure data to obtain a first cross-pump net pressure amplitude, wherein the first cross-pump net pressure amplitude is an adjusted cross-pump net pressure amplitude based on the phase information; and The intervention position status of the intervention pump is indicated by the net pressure amplitude of the first cross-pump.

3. The method according to claim 2, wherein, The step of indicating the intervention position status of the intervention pump based on the net pressure amplitude of the first cross-pump includes: The first cross-pump net pressure amplitude is compared with at least two thresholds corresponding to the operating signal data to obtain a comparison result. The at least two thresholds include a first threshold and a second threshold. The first threshold is a position determination threshold for the interventional pump's drive system under normal load conditions, and the second threshold is a position determination threshold for the interventional pump's drive system under abnormal load conditions. The comparison results indicate the status of the intervention location.

4. The method according to claim 3, wherein, The step of indicating the intervention location status based on the comparison result includes: In response to the first cross-pump net pressure amplitude being greater than or equal to a first threshold, a first indication message is issued indicating that the interventional pump is in the correct position, the first indication message indicating that the interventional pump is in the correct position under normal load conditions; or In response to the first cross-pump net pressure amplitude being less than the first threshold and greater than the second threshold, a second indication message indicating that the intervention pump is in an incorrect position is issued.

5. The method according to claim 3, wherein, The step of indicating the intervention location status based on the comparison result includes: In response to the first cross-pump net pressure amplitude being less than or equal to the second threshold, a third indication message is issued indicating that the interventional pump is in an unknown position, or a fourth indication message is issued indicating that the interventional pump is in the correct position, the fourth indication message being used to indicate that the interventional pump is in the correct position under the abnormal load condition.

6. The method according to claim 5, wherein, In response to the first cross-pump net pressure amplitude being less than or equal to the second threshold, the method further includes: A warning message indicating an abnormality in the drive system of the intervention pump is issued.

7. The method according to claim 3, wherein, The abnormal load condition includes at least one of the following: the protective end of the interventional pump is compressed and bent, mechanical interference occurs in the interventional pump, and the drive shaft of the interventional pump is squeezed or structurally bent.

8. The method according to claim 2, wherein, The phase information includes the phase difference between the blood pressure data and the interpump net pressure data. The step of performing phase processing on the interpump net pressure data based on the phase information to obtain a first interpump net pressure amplitude includes: Determine the second cross-pump net pressure amplitude corresponding to the cross-pump net pressure data, wherein the second cross-pump net pressure amplitude is the original amplitude corresponding to the cross-pump net pressure data; An adjustment factor is determined based on the phase difference, and the adjustment factor is used to adjust the amplitude of the second cross-pump net pressure based on the phase difference; and The adjustment factor and the second cross-pump net pressure amplitude are fused to obtain the first cross-pump net pressure amplitude.

9. The method according to claim 8, wherein, The adjustment factor includes the sine value corresponding to the phase difference. The process of fusing the adjustment factor and the second cross-pump net pressure amplitude to obtain the first cross-pump net pressure amplitude includes: Multiply the sine value corresponding to the phase difference by the net pressure amplitude of the second cross-pump to obtain the net pressure amplitude of the first cross-pump.

10. The method according to claim 8, wherein, The net pressure amplitude of the first cross-pump is determined according to the following formula: P aligned,net =P net *sin(θ diff ) Among them, P aligned,net P represents the net pressure amplitude of the first cross-pump. net θ represents the net pressure amplitude of the second transpump. diff The phase difference is represented by sin(θ). diff ) represents the adjustment factor.

11. The method according to claim 8, wherein, Determining the phase information between the blood pressure data and the cross-pump net pressure data includes: Determine the first phase angle corresponding to the blood pressure data; Determine the second phase angle corresponding to the cross-pump net pressure data; and Based on the first phase angle and the second phase angle, the phase difference between the blood pressure data and the cross-pump net pressure data is determined.

12. The method according to claim 1, wherein, The blood pressure data includes the arterial pressure data of the assisted object, and the operating signal data includes at least one of the following: the rotational speed signal data, torque sensing data, and current data corresponding to the interventional pump.

13. The method according to claim 12, wherein, The speed signal data includes at least one of motor speed data, impeller speed data, speed error data, and coupled speed difference data; the speed error data refers to the error data between the target speed and the actual speed, and the coupled speed difference data refers to the speed difference data between the coupled drive components in the blood pump system.

14. The method according to any one of claims 12 to 13, wherein, The current data includes at least one of motor controller current data and motor current data; The motor controller current data includes at least one of the following: the net output current of the motor controller, the proportional term current corresponding to the PID control module, the current data determined based on the proportional term current and the derivative term current corresponding to the PID control module, and the current data determined based on the proportional term current and the integral term current corresponding to the PID control module; the motor controller includes the PID control module. The motor current includes at least one of the following: the current of at least one motor winding in the motor, the average current of at least two motor windings, and the orthogonal axis current determined based on the motor winding current; wherein the motor winding current is obtained based on the motor position transformation.

15. The method according to any one of claims 12 to 14, wherein, The method further includes: In response to the fact that the operating signal data, the cross-pump net pressure data, and the blood pressure data are all valid data, the step of indicating the interventional position status of the interventional pump based on the phase information and the cross-pump net pressure data is performed; In response to the fact that the operating signal data, the cross-pump net pressure data, or the blood pressure data are not valid data, an indication message is issued that the interventional pump is in an unknown position; Where the operating signal data, the cross-pump net pressure data, or the blood pressure data are not valid data, at least one of the following situations applies: The motor current data is greater than the current threshold. The motor speed data is greater than the speed threshold; The average value of the blood pressure data is less than the mean arterial pressure threshold. The amplitude of the blood pressure data is less than the arterial pressure amplitude threshold. The blood pressure data contained abnormal noise. The heart rate corresponding to the blood pressure data is greater than the upper limit threshold of heart rate or less than the lower limit threshold of heart rate. The average value of the cross-pump net pressure data is less than the average net pressure threshold; and The amplitude corresponding to the cross-pump net pressure data is greater than the upper limit amplitude of net pressure or less than the lower limit amplitude of net pressure.

16. The method according to any one of claims 1 to 15, wherein, The drive motor corresponding to the interventional pump is located outside the body of the assisted object. The blood pressure data is collected based on a pressure sensor located outside the body of the assisted object, and no pressure sensor is installed in the part of the interventional pump that enters the ventricle of the assisted object.

17. A position detection device for an interventional pump, wherein, The device includes: The data acquisition module is used to acquire the operating signal data of the interventional pump and the blood pressure data of the assisted object; The net pressure determination module is used to convert and process the operating signal data to obtain the cross-pump net pressure data corresponding to the pump head in the intervention pump; A phase determination module is used to determine the phase information between the blood pressure data and the cross-pump net pressure data; and A position determination module is used to indicate the intervention position status of the intervention pump based on the phase information and the cross-pump net pressure data.

18. An electronic device, wherein, The control device includes a processor and a memory, wherein the memory stores at least one instruction, at least one program, a code set, or an instruction set, and the at least one instruction, the at least one program, the code set, or the instruction set is loaded and executed by the processor to implement the position detection method of the interventional pump as described in any one of claims 1 to 16.

19. A blood pump device, wherein, The blood pump includes a processor and a memory, wherein the memory stores at least one instruction, at least one program, a code set, or an instruction set, and the at least one instruction, the at least one program, the code set, or the instruction set is loaded and executed by the processor to implement the interventional pump position detection method as described in any one of claims 1 to 16.

20. A computer-readable storage medium, wherein, The storage medium stores at least one instruction, at least one program, code set, or instruction set, wherein the at least one instruction, the at least one program, the code set, or instruction set is loaded and executed by a processor to implement the position detection method of the interventional pump as described in any one of claims 1 to 16.

21. A computer program product, wherein, The computer program product includes computer instructions stored in a computer-readable storage medium. The processor of the computer device reads the computer instructions from a computer-readable storage medium, and the processor executes the computer instructions to cause the computer device to perform the method for detecting the position of the interventional pump as described in any one of claims 1 to 16.

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