Method, device and equipment for detecting running state of ventricular assist device

Abstract

The invention discloses an operation state detection method and device of a ventricular assist device and detection equipment, and belongs to the technical field of medical instruments. The ventricular assist device comprises a driving device and an interventional pump, the driving device is used for driving the interventional pump to operate, and the method comprises the following steps: acquiring current data of the driving device in a working state; under the condition that the current data indicates that the load of the driving device is increased, the operation state of the ventricular assist device is classified and identified according to the change condition of the current data in a first time period; and sending alarm information corresponding to an identification result, wherein the identification result indicates an abnormal operation state causing the load increase. According to the method, under the condition that medical radiography imaging equipment is not used, the reason for abnormal load increase is prompted in time, automatic identification of the abnormal operation state is achieved, the safety risk is reduced, the life safety of an auxiliary object is protected, and radiation damage to the human body when the medical radiography imaging equipment works is reduced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a method, device and detection equipment for detecting the operating status of a ventricular assist device. Background Art

[0002] The ventricular assist device includes an interventional pump and a driving device for driving the interventional pump. When in working condition, the driving device can drive the interventional pump to pump blood in the ventricle into the ascending aorta to assist the heart's pumping function and reduce the burden on the heart.

[0003] During the operation of the interventional pump, some faults or abnormal operation may occur due to improper operation or poor equipment performance. Since one part of the interventional pump is inside the body of the interventional assisting object, and the other part is coupled to the drive device outside the body, the relevant operators cannot directly observe the rotation of the relevant rotating parts in the interventional pump and the bending shape and intervention position of the interventional pump in the body with their eyes. Therefore, the relevant personnel cannot directly determine the cause of the above problems. At present, the relevant technology has limited detection and identification capabilities for abnormal operation of ventricular assist devices, and the specific cause cannot be detected. Relevant personnel need to use medical imaging equipment to take pictures or stop the pump for inspection, which will cause radiation damage to patients and relevant personnel, and the shutdown of the interventional pump will cause ventricular assistance to be interrupted, causing safety hazards. Summary of the invention

[0004] The embodiments of the present application provide a method, device and detection equipment for detecting the operating status of a ventricular assist device. The method can promptly and quickly detect and indicate abnormal operation of the ventricular assist device without causing radiation damage to the human body.

[0005] According to one aspect of an embodiment of the present application, a method for detecting an operating state of a ventricular assist device is provided, wherein the ventricular assist device comprises a driving device and an interventional pump, wherein the driving device is used to drive the interventional pump to operate, and the method comprises:

[0006] Acquiring current data of the driving device in a working state;

[0007] When the current data indicates that the load of the driving device has increased, classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first period;

[0008] An alarm message corresponding to the identification result is issued, wherein the identification result indicates an abnormal operating state that causes the load increase.

[0009] In one embodiment, the interventional pump comprises at least a transmission system, a pump head and a protection tip, the transmission system comprises a tubular member, a coupling rotating member, and the pump head comprises an impeller;

[0010] The abnormal operating state includes at least one of the following: abnormal operation of the transmission system, abnormal bending of the tubular component, eccentricity of the coupling rotating part, abnormal operation of the impeller, entanglement of the pump head with heart tissue, and abnormal contact of the protective end with the wall.

[0011] In one embodiment, the abnormal contact of the protection end with the wall includes at least one of the following situations:

[0012] The protection end abuts against the ventricular wall;

[0013] The protection tip abnormally abuts against the inner wall of the ventricle.

[0014] In one embodiment, the interventional pump includes a transmission system, the transmission system is used to transmit power of the driving device to the impeller of the interventional pump, and the classification and identification of the operating state of the ventricular assist device according to the change of the current data in the first time period includes:

[0015] When the change of the current data meets the first current change characteristic, it is determined that the interventional pump has a transmission system operation abnormality; wherein the first current change characteristic is used to characterize the current change situation in which the current rises and tends to be stable;

[0016] The issuing of alarm information corresponding to the recognition result includes:

[0017] An alarm message corresponding to the abnormal operation of the transmission system is issued.

[0018] In one embodiment, the transmission system includes a tubular member and / or a coupled rotating member, and determining that the interventional pump has a transmission system operating abnormality includes:

[0019] When the rising speed of the current data is greater than the first speed threshold, and the amplitude of the rising current data approaches the first current threshold, it is determined that the interventional pump has abnormal bending of the tubular component, and the abnormal operation of the transmission system includes abnormal bending of the tubular component;

[0020] and / or, when the rising speed of the current data is greater than the second speed threshold, and the amplitude of the current data after rising approaches the second current threshold, it is determined that the interventional pump has eccentricity of the coupling rotating part, and the abnormal operation of the transmission system includes eccentricity of the coupling rotating part;

[0021] Wherein, the first speed threshold is greater than the second speed threshold;

[0022] The issuing of alarm information corresponding to the abnormal operation of the transmission system includes:

[0023] Sending an alarm message corresponding to abnormal bending of the tubular component; and / or sending an alarm message corresponding to eccentricity of the coupling rotating part.

[0024] In one embodiment, the interventional pump includes an impeller, and classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first time period includes:

[0025] When the change of the current data meets the second current change characteristic, it is determined that the impeller of the interventional pump has abnormal operation; wherein the second current change characteristic is used to characterize the peak-shaped change of the current that first rises and then falls;

[0026] The issuing of alarm information corresponding to the recognition result includes:

[0027] An alarm message corresponding to the abnormal operation of the impeller is issued.

[0028] In one embodiment, the interventional pump includes a pump head and / or a protection terminal, and determining that an impeller of the interventional pump is operating abnormally includes:

[0029] If the current data has a first peak feature in the first time period, and the peak value and peak width of the first peak feature meet the first peak feature requirement, it is determined that the pump head of the interventional pump is entangled with the heart tissue;

[0030] and / or, if the current data periodically shows a second peak feature in the first time period, and the peak value and peak width of the second peak feature meet the second peak feature requirement, it is determined that the protection terminal of the interventional pump abnormally touches the wall;

[0031] The issuing of alarm information corresponding to the abnormal operation of the impeller includes:

[0032] Sending an alarm message corresponding to the pump head being entangled with the heart tissue; and / or sending an alarm message corresponding to the protective end abnormally touching the wall.

[0033] In one embodiment, determining that the protection tip of the interventional pump abnormally touches the wall includes:

[0034] When the characteristic shape of the peak feature meets the first shape requirement, determining that the interventional pump has a direct pressure bending of the protection terminal;

[0035] When the characteristic shape of the peak feature meets the second shape requirement, determining that the interventional pump has the oblique pressure bending of the protection terminal;

[0036] The alarm information includes a wall contact type corresponding to the abnormal wall contact of the protection terminal, and the wall contact type includes at least one of a direct pressure bending of the protection terminal and an oblique pressure bending of the protection terminal.

[0037] In one embodiment, the method further comprises:

[0038] Acquiring rotation speed data of a rotating part in the ventricular assist device;

[0039] The classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first time period includes:

[0040] The operating state of the ventricular assist device is classified and identified according to changes in the current data and the rotation speed data in the first time period.

[0041] In one embodiment, the interventional pump includes at least one of a tubular member, a coupling rotating member, a pump head, and a protective terminal, and the classifying and identifying the operating state of the ventricular assist device according to the change of the current data and the rotation speed data in the first time period includes:

[0042] When the rising speed of the current data is greater than the first speed threshold, the amplitude of the current data after rising approaches the first current threshold, and the rotation speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular component of the interventional pump is abnormally bent;

[0043] And / or, when the rising speed of the current data is greater than the second speed threshold, the amplitude of the rising current data approaches the second current threshold, and the rotation speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the interventional pump has eccentricity of the coupled rotating part;

[0044] And / or, when the current data has a first peak feature in the first time period, the peak value and peak width of the first peak feature meet the first peak feature requirement, and the rotation speed data decreases at the first moment and the amplitude after the decrease is less than the first rotation speed threshold, it is determined that the pump head of the interventional pump is entangled with the heart tissue; the first moment is determined based on the moment when the current data reaches the peak current;

[0045] And / or, the current data periodically shows a second peak feature in the first time period, the peak value and peak width of the second peak feature meet the second peak feature requirements, and the change amplitude of the speed data in the first time period is less than the first amplitude threshold, and it is determined that the interventional pump has the protection end abnormally touching the wall.

[0046] In one embodiment, the alarm information includes the abnormal operating state and abnormality degree information corresponding to the abnormal operating state, and the abnormality degree information represents the severity of the abnormal operating state.

[0047] In one embodiment, the method further comprises:

[0048] When the rotation speed data of the rotating part in the ventricular assist device approaches the target rotation speed, first abnormality degree information is determined based on the increase amplitude of the current data, and the increase amplitude of the current data is positively correlated with the severity indicated by the first abnormality degree information;

[0049] When the rotation speed data decreases relative to the target rotation speed, determining second abnormality degree information based on at least one of an increase range of the current data and a decrease range of the rotation speed data;

[0050] Among them, the severity indicated by the second abnormality level information is positively correlated with the decrease amplitude of the speed data, the severity indicated by the second abnormality level information is positively correlated with the increase amplitude of the current data, and the severity indicated by the first abnormality level information is less than the severity indicated by the second abnormality level information.

[0051] In one embodiment, after obtaining the current data of the driving device in the working state, the method further includes:

[0052] When the current data exceeds a first amplitude threshold, issuing abnormal information indicating that the load of the driving device has increased;

[0053] In the case where the current data exceeds a second amplitude threshold, abnormal information indicating that the drive device is overloaded is issued, and the first amplitude threshold is smaller than the second amplitude threshold.

[0054] According to one aspect of an embodiment of the present application, a device for detecting the operating state of a ventricular assist device is provided, wherein the ventricular assist device comprises a driving device and an interventional pump, wherein the driving device is used to drive the interventional pump to operate, and the device comprises:

[0055] A data acquisition module, used to acquire current data of the driving device in a working state;

[0056] A state detection module, configured to classify and identify the operating state of the ventricular assist device according to the change of the current data in the first time period when the current data indicates that the load of the driving device has increased;

[0057] The alarm module is used to issue an alarm message corresponding to the recognition result, wherein the recognition result indicates an abnormal operating state that causes the load increase.

[0058] According to one aspect of an embodiment of the present application, an electronic device of a ventricular assist device is provided, the electronic device of the ventricular assist device comprising a processor and a memory, the memory storing at least one instruction, the at least one instruction being loaded and executed by the processor to implement the above-mentioned method for detecting the operating status of the ventricular assist device.

[0059] According to one aspect of an embodiment of the present application, there is provided a ventricular assist device, comprising a drive device, an interventional pump, and the electronic equipment of the aforementioned ventricular assist device.

[0060] According to one aspect of an embodiment of the present application, a computer-readable storage medium is provided, wherein at least one instruction is stored in the storage medium, and the at least one instruction is loaded and executed by a processor to implement the above-mentioned method for detecting the operating status of a ventricular assist device.

[0061] According to one aspect of the embodiments of the present application, a computer program product is provided, the computer program product comprising computer instructions, the computer instructions being stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium, and the processor executes the computer instructions, so that the computer device executes to implement the above-mentioned method for detecting the operating state of a ventricular assist device.

[0062] The technical solution provided in the embodiments of the present application can bring the following beneficial effects:

[0063] An embodiment of the present application provides an operating status detection method for a ventricular assist device, which includes a drive device and an interventional pump. The drive device is used to drive the interventional pump to operate. The operating status detection method monitors the current data of the drive device in a working state, and when the current data indicates that the load of the drive device has increased, by analyzing the changes in the current data within a certain period of time, the abnormal operating state that causes the load of the drive device to increase can be automatically classified and identified, and a corresponding alarm message can be issued. Therefore, without the aid of medical imaging equipment, the abnormal operating state that causes the abnormal increase in the load of the drive device, that is, the specific cause of the abnormal increase in the load, can be promptly and quickly prompted, thereby realizing automatic identification of the abnormal operating state of the ventricular assist device, facilitating relevant operators to adjust and process the interventional pump in a timely manner to solve abnormal problems, reducing the safety risks caused by the abnormal operating state of the ventricular assist device and protecting the life safety of the assisted object, and reducing the radiation damage caused to the human body by the medical imaging equipment when it is working. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0065] Figure 1 is a schematic diagram of a ventricular assist device provided by an embodiment of the present application;

[0066] Figure 2 is a flow chart of a method for detecting the operating status of a ventricular assist device provided by an embodiment of the present application;

[0067] Figure 3 An abnormal state determination method combined with rotation speed data is provided in one embodiment of the present application;

[0068] Figure 4 It is a schematic diagram of a method for identifying an operating state in combination with a rotation speed provided by an embodiment of the present application;

[0069] Figure 5 This is a block diagram of an operating status detection device for a ventricular assist device provided in one embodiment of the present application. DETAILED DESCRIPTION

[0070] Before introducing the method embodiments provided in the present application, a brief introduction is first given to the relevant terms or nouns that may be involved in the method embodiments of the present application to facilitate understanding by technicians in the field of the present application.

[0071] Before describing the embodiments of the present application in detail, the relevant technical background related to the embodiments of the present application is introduced to facilitate understanding by those skilled in the art in the field of the present application.

[0072] The ventricular assist device includes an interventional pump and a driving device for driving the interventional pump. In the working state, the driving device can drive the interventional pump to pump blood in the ventricle into the aorta to assist the heart's pumping function and reduce the heart's burden. During the operation of the ventricular assist device, some failures or abnormal operation may occur due to improper operation or poor performance. Since the operation status and intervention position of the ventricular assist device are difficult to observe and detect intuitively, the current relevant technology has limited ability to detect and identify abnormal operation problems of the ventricular assist device.

[0073] The embodiments of the present application list possible abnormal operation problems of the ventricular assist device and the risks caused by abnormal operation problems:

[0074] (1) Abnormal bending of tubular components:

[0075] Tubular components include but are not limited to drive catheters and drive shafts in interventional pumps that are inserted into the human body percutaneously. The tubular components may have abnormal bending in the internal or external parts. The higher the bending degree, the greater the rotational resistance, which may cause the following problems:

[0076] (1) Friction increases, causing severe heat generation in the tubular components, which damages blood and cells;

[0077] (2) A high degree of curvature will increase the stress of the tubular component, and the intervention part will cause compression on blood vessels and tissues, or the intervention port will be pulled, causing bleeding or injury;

[0078] (3) A high degree of bending will cause abnormal rotation, causing damage to the heart and human body, and will also increase noise during operation.

[0079] (ii) Eccentricity of the coupling rotating parts:

[0080] The interventional pump pumps blood under the drive of the drive device. During the operation of the interventional pump, the coaxiality of the coupling part between the drive device and the interventional pump may be eccentric due to structural looseness, operation wear and other reasons, that is, the coupling rotating part is eccentric. This abnormality may cause the following problems:

[0081] (1) Friction increases, causing the drive device to heat up severely, resulting in a reduction in the life of the drive device or damage. At the same time, the high temperature on the surface of the drive device may cause burns to the human skin in contact (after the interventional pump is percutaneously inserted into the body of the assisted subject, the drive device may be bound to the surface of the assisted subject);

[0082] (2) Eccentricity increases the vibration during operation, causing damage to the heart and human body, and also increases the noise during operation.

[0083] (III) Entangling Heart Tissue

[0084] After the interventional pump enters the heart, the drive device drives the impeller in the pump head of the interventional pump to rotate to pump blood from the ventricle to the aorta. The pump head of the interventional pump may entangle the heart tissue, and the heart tissue (such as chordae tendineae) may be stirred into the fast-rotating impeller, which may cause the following problems:

[0085] (1) The heart tissue is broken by the impeller, which can lead to mitral valve prolapse, valvular insufficiency, blood reflux, and life-threatening conditions;

[0086] (2) The impeller cannot break the heart tissue and stops running after being entangled by the heart tissue: Entanglement of the heart tissue may cause arrhythmia and endanger life;

[0087] The above two situations may also cause the impeller to stop, and the interventional pump cannot pump blood, which is life-threatening.

[0088] (IV) Abnormal protection end position

[0089] The interventional pump also includes a protective tip. After the interventional pump is inserted into the heart, if the position adjustment is inappropriate (such as too many intervention positions), the protective tip may abnormally touch the wall. If the abnormal wall contact is serious, the protective tip will be repeatedly bent and rebounded as the heart beats. The above-mentioned abnormal wall contact of the protective tip includes but is not limited to: the protective tip abuts against the inner wall of the ventricle (in this case, the protective tip should not abut against the inner wall of the ventricle); the protective tip abnormally abuts against the inner wall of the ventricle (in this case, the protective tip can abut against the inner wall of the ventricle within a reasonable limit).

[0090] If the protective end touches the wall abnormally, such as being severely bent by the heart, the following risks may occur:

[0091] (1) The protective end repeatedly presses the inside of the heart, such as the ventricular wall, ventricular septum, and apex. If the frequency of pressing is too high or the force is too strong, it will cause serious damage to the ventricular wall and ventricular septum, damage the myocardium, and may also pierce the apex and other vulnerable parts, endangering life.

[0092] (2) When the protective end is abnormally bent, the intervention pump bearing (the protective end is connected to the distal bearing of the drive shaft) will undergo a certain degree of structural changes, which will affect the operation of the impeller on the drive shaft, causing increased vibration, increased friction, increased resistance, increased noise, etc., affecting the working efficiency and life of the pump.

[0093] In summary, during the operation of the ventricular assist device, many abnormal conditions may occur, including but not limited to bending of tubular components, eccentricity of the coupling rotating parts between the drive device and the interventional pump, entanglement of cardiac tissue and abnormal position of the protective end. However, the relevant technology lacks the ability to quickly detect these abnormal conditions. The main reason is that the operation of the interventional pump in the heart and the interventional position status are very difficult to observe and detect intuitively. The abnormal condition detection schemes commonly used in the relevant technology rely on DSA or ultrasound detection.

[0094] DSA is the abbreviation of Digital Subtraction Angiography. It is a new technology that combines traditional angiography with electronic computers. It is mainly used to observe vascular lesions, locate and measure vascular stenosis, and provide real three-dimensional images for interventional treatment. DSA can cause relatively large radiation damage to the human body. Ultrasonic testing is difficult to detect comprehensive abnormalities, and the clarity is low when judging positional abnormalities. In summary, the relevant technology lacks a technical solution that can quickly detect abnormal operating status of ventricular assist devices without causing radiation damage to the human body.

[0095] In view of this, an embodiment of the present application provides an operating status detection method for a ventricular assist device, which includes a drive device and an interventional pump. The drive device is used to drive the interventional pump to operate. The operating status detection method monitors the current data of the drive device in a working state, and when the current data indicates that the load of the drive device has increased, by analyzing the changes in the current data within a certain period of time, the abnormal operating state that causes the load of the drive device to increase can be automatically classified and identified, and a corresponding alarm message can be issued, so that the abnormal operating state that causes the abnormal increase in the load of the drive device, that is, the specific cause of the abnormal increase in the load, can be promptly and quickly prompted without the aid of medical imaging equipment, thereby realizing automatic identification of the abnormal operating state of the ventricular assist device, facilitating relevant operators to adjust and process the interventional pump in a timely manner to solve abnormal problems, reducing the safety risks caused by the abnormal operating state of the ventricular assist device and protecting the life safety of the assisted object, and reducing the radiation damage caused to the human body by the medical imaging equipment when it is working.

[0096] Please refer to Figure 1 , which shows a schematic diagram of a ventricular assist device provided in an embodiment of the present application. The ventricular assist device is a transcatheter ventricular assist device, which is composed of a transcatheter ventricular assist device control host (hereinafter referred to as: control host), and a transcatheter ventricular assist device interventional pump system (hereinafter referred to as: interventional pump system) used in conjunction with it. It is an interventional blood pump that can provide mechanical circulatory assistance to patients corresponding to relevant indications. The user can monitor the system status and patient physiological parameters on the control host interface, and provide different degrees of circulatory assistance by adjusting the speed of the interventional pump according to the patient's needs, thereby temporarily maintaining the blood circulation of the patient's important organs and unloading the heart.

[0097] The interventional pump system is mainly composed of an interventional pump, a delivery system, and a flushing pipeline.

[0098] The structure of the interventional pump consists of: a protective end 1, a pump head (including an impeller, a bracket and a membrane), a repositioning sterile sleeve, a drive catheter, and a drive catheter handle 2.

[0099] Functional description of the interventional pump: The interventional pump can be percutaneously inserted into the heart through the peripheral blood vessels. The pump head will be inserted between the left ventricle and the aorta, the blood inlet of the pump head will be inserted into the left ventricle, and the blood outlet of the pump head will be inserted into the aorta, thereby pumping blood from the left ventricle into the aorta to achieve ventricular assist function.

[0100] The control host is mainly composed of a control console 3, an intervention pump driving device 4, and a flushing pump driving device 5.

[0101] The interventional pump driving device 4 can be connected to the interventional pump to drive the impeller in the pump head to rotate, thereby realizing the function of pumping blood from the left ventricle into the aorta. The driving device includes a driving motor, and the speed of the driving motor can be set by rotating the knob of the console 3. During operation, if any high-risk situation occurs, the interventional pump driving device 4 will send an alarm signal to the console 3. The interventional pump driving device 4 includes an active rotating member, and the interventional pump includes a driven rotating member, a tubular member 6 connected to the driven transmission member, and an impeller. After the interventional pump driving device 4 is coupled to the interventional pump, the active rotating member is coaxially coupled with the driven rotating member, the driving motor drives the active rotating member to rotate, the active rotating member is coupled to drive the driven rotating member to rotate, and the driven rotating member drives the tubular member 6 to rotate, thereby driving the impeller connected to the tubular member 6 to rotate. The above-mentioned coupled rotating member includes at least one of the active rotating member and the driven rotating member.

[0102] The flushing pump driving device 5 can be connected to the flushing pipeline, wherein the flushing pump realizes the flushing liquid delivery and control functions by squeezing the flushing pipeline, thereby preventing blood from entering the interventional pump catheter to generate thrombus.

[0103] Console 3 provides users with a simple and intuitive operating interface to achieve the following functions: monitor the operating status of the transcatheter ventricular assist device; display the system operating status and patient physiological data, including speed, blood pressure and flow; control the speed of the drive motor and flushing pump; support the setting of alarm thresholds and system parameters; Console 3 provides different levels of alarms and automatically records various alarm information, and related charts will be displayed in the summary report.

[0104] After the driving catheter handle 2, the flushing pipeline, and the flushing pump driving device 5 in the above-mentioned transcatheter ventricular assist device are connected, a flushing channel will be formed.

[0105] Please refer to Figure 2 , which shows a flow chart of a method for detecting the operating status of a ventricular assist device provided by an embodiment of the present application. The ventricular assist device includes a drive device and an interventional pump. The drive device is used to drive the interventional pump to operate. In one embodiment, the ventricular assist device has Figure 1 The method comprises:

[0106] S201. Obtain current data of the above-mentioned driving device in a working state.

[0107] This application does not limit the current data. For example, the current data refers to any current in the aforementioned ventricular assist device. For example, the current data can be the current of the drive motor in any drive device, or the current of the motor controller corresponding to any drive motor, or can be the current value calculated again based on the above current value, such as the average current value, the current change difference, etc. Among the various operating signals of the ventricular assist device, the current is an easily detectable indicator, which can be detected in vitro or in vivo. This embodiment of the application will not be elaborated on.

[0108] by Figure 1 Taking the ventricular assist device shown in as an example, step S201 can be executed by the control host, that is, the control host obtains current data. Specifically, the current of the flushing pump drive device can be obtained, and the current of the interventional pump drive device can also be obtained. In another embodiment, the operating status detection method of the ventricular assist device can be implemented by the aforementioned console, or by a controller built into the flushing pump drive device, or by the console and the controller built into the flushing pump drive device. The embodiment of the present application does not limit the implementation subject of each step in the operating status detection method of the ventricular assist device, and can be adaptively configured according to the actual internal component composition of the ventricular assist device.

[0109] S202. When the current data indicates that the load of the driving device has increased, classify and identify the operating state of the ventricular assist device according to changes in the current data during the first period.

[0110] After the ventricular assist device enters a stable working state, the current data also tends to be stable. If the current data suddenly rises significantly within a period of time, that is, the load of the drive device increases, then the ventricular assist device is likely to have an abnormal operating state. If the working target of the drive motor has not changed, such as the set speed has not changed, but the current data rises abnormally, it can be considered that the load of the drive device has increased.

[0111] In the embodiment of the present application, the interventional pump at least includes a transmission system 6, a pump head 7 and a protection terminal 1. The transmission system includes a tubular member and a coupling rotating member. The pump head 7 includes an impeller (located inside the pump head, not shown in the figure). Figure 1 Taking the corresponding ventricular assist device as an example, the protective end 1 can be the protective tip of the interventional pump in the ventricular assist device, the tubular structure can be the drive catheter and / or drive shaft (the drive shaft is inserted into the drive catheter) in the ventricular assist device, and the coupling rotating part can refer to the coupling rotating part of the coupling part between the interventional pump drive device and the interventional pump of the ventricular assist device.

[0112] Accordingly, step S202 can detect at least one of the following abnormal operating states: abnormal operation of the transmission system, abnormal bending of the tubular member, eccentricity of the coupling rotating member, abnormal operation of the impeller, entanglement of the pump head with the heart tissue, and abnormal contact of the protective end with the wall. Among them, the abnormal contact of the protective end with the wall is a type of the aforementioned abnormal position of the protective end, that is, the protective end is abnormally in contact with the inner wall of the heart.

[0113] Optionally, the abnormal wall contact of the protection end includes at least one of the following situations:

[0114] The protective end abuts against the inner wall of the ventricle; the protective end abuts against the inner wall of the ventricle abnormally.

[0115] For some interventional pumps, when they are percutaneously placed in the correct position in the heart to pump blood, the protective tip should not abut the inner wall of the heart. At this time, the abnormal touching of the wall by the protective tip may be that the protective tip abuts the inner wall of the ventricle. Specifically, it may be that the interventional pump is placed too deep in the heart, causing the protective tip to abut the inner wall of the heart.

[0116] For other interventional pumps, when they are percutaneously placed in the correct position in the heart to pump blood, the protective end needs to abut against the inner wall of the heart. At this time, the situation where the protective end abnormally touches the wall may be that the protective end abnormally abuts against the inner wall of the ventricle. Specifically, it may be because the interventional pump is placed too deep in the heart, and the abutment between the protective end and the inner wall of the heart exceeds the safe range, which is an abnormal abutment situation. Since it is difficult for the interventional pump device itself to obtain an image of the position of the interventional pump in the heart, the present application determines whether the protective end abnormally touches the wall by judging the change of the current within a certain period of time. Those skilled in the art can determine the specific situation of the protective end abnormally touching the wall based on the specific interventional pump, and the embodiments of the present application are not limited to this.

[0117] By automatically distinguishing and identifying the above-mentioned abnormal operating conditions that cause load increase, the time for operators to investigate the cause of load increase can be effectively shortened. It also covers a variety of situations and improves the alarm accuracy and safety of ventricular assist devices.

[0118] The first time period mentioned above can be one or more time periods of a certain length before the current moment, or it can be the time period from the starting point of the nearest time period to the current moment. The embodiment of the present application does not limit the length of the first time period and the load growth amplitude. For example, it can be limited that if the length of the first time period is less than the preset length and the load growth amplitude is greater than the preset amplitude, step S202 can be triggered. The preset length and preset amplitude can be set according to actual conditions and do not constitute an implementation obstacle. If the length of the first time period is less than the preset length and the load growth amplitude is greater than the preset amplitude, it can be determined that the current data has a significant load increase, and the probability of the ventricular assist device being in an abnormal operating state is high, and step S202 needs to be triggered to classify and identify the operating state of the ventricular assist device.

[0119] Obviously, by setting the preset duration and the preset amplitude, the start timing of step S202 can be controlled, that is, the frequency and sensitivity of the operation status detection in the embodiment of the present application can be controlled. The operation status classification identification in the embodiment of the present application can analyze whether the ventricular assist device is in an abnormal operation state, and can further analyze what abnormal operation state the ventricular assist device is in.

[0120] S203. Issue an alarm message corresponding to the identification result, wherein the identification result indicates an abnormal operating state that causes the load increase.

[0121] The embodiments of the present application do not limit the specific content of the alarm information. In one embodiment, the alarm information may indicate the abnormal operating state that causes the above-mentioned load increase. In another embodiment, the alarm information includes the above-mentioned abnormal operating state and the abnormality degree information corresponding to the above-mentioned abnormal operating state, and the above-mentioned abnormality degree information represents the severity of the above-mentioned abnormal operating state. In this embodiment, the alarm information will not only indicate the abnormal operating state that causes the above-mentioned load increase, but also indicate the severity of the abnormal operating state. By distinguishing the abnormality degree information and giving an alarm, it can effectively help the operator distinguish the abnormality degree of the abnormal state, and help distinguish different levels of alarm sounds and / or alarm volumes.

[0122] In another embodiment, the alarm information may include the abnormal operation state and at least one of the following: abnormality degree information corresponding to the abnormal operation state, current data change, speed data change of the rotating part in the ventricular assist device, and probability of abnormal operation state. The embodiment of the present application does not limit the rotating part in the ventricular assist device, which may be a drive motor, a drive shaft, etc., or an impeller.

[0123] In one embodiment, different abnormal operation states may generate different alarm messages. Different alarm messages may be expressed in different ways. The present application embodiment does not limit the content and expression of the alarm message. The present application embodiment does not limit the subject that issues the alarm message. For example, the alarm message may be Figure 1 The ventricular assist device may be connected to the control console or other equipment.

[0124] In one embodiment, a target speed corresponding to the rotating part can be set, and the driving device will drive the interventional pump to rotate according to the target speed, so as to stably maintain the speed of the interventional pump at around the target speed, thereby achieving a stable blood pumping flow. If an abnormal condition occurs in the ventricular assist device that causes an increase in load, the above-mentioned speed may change, or the current that maintains the target speed may change. The degree of speed change and current change caused by different abnormal operating conditions may not be the same. In some cases, the load of the driving device increases slightly, and the driving device can drive the speed data of the rotating part in the ventricular assist device to continue to approach the target speed by increasing the driving current, thereby avoiding a decrease in speed due to an increase in load.

[0125] When the rotation speed data of the rotating part in the ventricular assist device approaches the target rotation speed, the first abnormality degree information is determined based on the rising amplitude of the current data, and the rising amplitude of the current data is positively correlated with the severity indicated by the first abnormality degree information.

[0126] The increase range can be determined based on the difference between the stable current data after the speed data approaches the target speed and the stable current data before the current data changes. The first degree information, such as the severity level, is then determined based on the corresponding relationship between the current increase range and the severity.

[0127] The embodiment of the present application does not limit the method for determining the first abnormality degree information, which can be achieved through experimental methods and data analysis, and does not constitute an implementation obstacle. In addition, the embodiment of the present application does not limit the clear mapping formula between the increase in the current data and the severity indicated by the above-mentioned first abnormality degree information, as long as the increase in the current data is positively correlated with the severity indicated by the above-mentioned first abnormality degree information.

[0128] In other cases, the load of the drive device may increase significantly. At this time, even if the drive device increases the current to the upper limit in time, it may not be able to overcome the rotational resistance. Therefore, the speed of the rotating part may decrease. In this case, the change amplitude of the current and the change amplitude of the speed can reflect the severity of the abnormal operating state.

[0129] In the case where the speed data decreases relative to the target speed, the second abnormality degree information is determined based on at least one of the increase amplitude of the current data and the decrease amplitude of the speed data; wherein, the severity indicated by the second abnormality degree information is positively correlated with the decrease amplitude of the speed data, and the severity indicated by the second abnormality degree information is positively correlated with the increase amplitude of the current data, wherein the decrease amplitude of the speed data represents the magnitude of the decrease in the speed data, and the increase amplitude of the current data represents the magnitude of the increase in the current data.

[0130] The embodiment of the present application does not limit the method for determining the second abnormality degree information, which can be achieved through experimental methods and data analysis, and does not constitute an implementation obstacle. In addition, the embodiment of the present application does not limit the explicit mapping formula between the severity indicated by the second abnormality degree information and the decrease amplitude of the above speed data, nor does it limit the explicit mapping formula between the severity indicated by the second abnormality degree information and the increase amplitude of the above current data, as long as a certain correlation is satisfied.

[0131] The first abnormality level information and the second abnormality level information are abnormality level information determined in the above two situations respectively. The severity level indicated by the first abnormality level information is less than the severity level indicated by the second abnormality level information.

[0132] In an embodiment of the present application, if the increase in motor load is not too serious, the motor controller can increase the output current to drive the motor to rotate, thereby continuing to maintain the speed at the target speed, and the speed will not drop significantly in this case. However, if the motor load increases seriously, that is, the abnormal situation is serious, even if the current output by the motor controller reaches the maximum upper limit, it will not be able to continue to maintain the speed to the target speed, and the speed data will drop significantly. In the scenario of calculating the second abnormality level information, not only the current load increases seriously, but also the speed drops. Therefore, the severity indicated by the second abnormality level information is greater than the severity indicated by the first abnormality level information.

[0133] The alarm method for the first abnormality degree information and the second abnormality degree information can be issued through alarms of different levels, and different alarm contents can be used to reflect different abnormality severities, which is not limited in the embodiments of the present application.

[0134] In some embodiments, a linkage alarm can also be generated according to the abnormal operation state, that is, other associated alarms related to the abnormal operation state are generated at the same time. For example, when the impeller is entangled by cardiac tissue or the protective end abnormally touches the wall, the alarm information corresponding to the impeller being entangled by cardiac tissue or the protective end abnormally touching the wall can be independently issued, and the alarm information corresponding to the abnormal operation of the impeller can also be output together, and the alarm information corresponding to the load increase can also be output.

[0135] In some embodiments, a broader alarm message can be directly output. When the above current data exceeds the first amplitude threshold, abnormal information indicating that the load of the drive device has increased is issued; when the above current data exceeds the second amplitude threshold, abnormal information indicating that the drive device is overloaded is issued, and the above first amplitude threshold is less than the above second amplitude threshold. The embodiment of the present application does not limit the first amplitude threshold and the second amplitude threshold. As long as the relative relationship is satisfied, the first amplitude threshold and the second amplitude threshold can be set through experiments and do not constitute an implementation obstacle. By issuing the above-mentioned broader alarm message, the risk of missing an alarm in the case of missed detection or false detection of abnormal operating conditions can be avoided. Regardless of whether the device can identify the specific cause of the load increase, abnormal information indicating an increase or overload of the drive load will be issued, thereby improving the safety of the device.

[0136] This alarm method can directly alarm based on abnormal current conditions, and the specific cause of the load increase or overload can be judged by manual experience. Combining manual experience and timely load abnormality alarm, on the one hand, the alarm sensitivity can be improved, and on the other hand, the cause of the load abnormality can be accurately determined as soon as possible. If the load abnormality is caused by increased friction in the impeller bearing or extreme bending of the tubular component, specifically extreme bending of the extracorporeal part, the tubular component can be adjusted. If the load abnormality is caused by eccentricity of the coupled rotating parts, such as eccentricity in the connection between the drive motor and the interventional pump, the user can reconnect it. If the load abnormality is caused by excessive bending of the protective end of the interventional pump, the intervention position of the interventional pump can be readjusted through DSA.

[0137] In one embodiment, the interventional pump includes a transmission system, which is used to transmit the power of the drive device to the impeller of the interventional pump. The operation status of the ventricular assist device is classified and identified based on the change of the current data in the first time period, including: when the change of the current data conforms to the first current change characteristic, it is determined that the interventional pump has an abnormal operation of the transmission system; wherein the first current change characteristic is used to characterize the current change situation in which the current rises and tends to be stable; and the issuance of alarm information corresponding to the identification result includes: issuing alarm information corresponding to the abnormal operation of the transmission system.

[0138] The abnormal operation of the transmission system may include the abnormal operation of any component in the transmission system. For example, if the transmission system includes a tubular member and / or a coupling rotating member, the abnormal operation of the transmission system includes the abnormal operation of the coupling rotating member or the abnormal bending of the tubular member. The embodiment of the present application does not limit the rising speed of the first current change characteristic and the current value of the stable situation. It can be set according to the actual situation and does not constitute an implementation obstacle. The abnormal operation of the transmission system usually does not cause a sharp increase in current. The rising speed is relatively slow compared to the rising speed caused by the interventional pump head being entangled in the heart tissue or the abnormal contact between the protective end and the inner wall of the heart. Therefore, by limiting the current rising speed in the first current change characteristic, the abnormal operation of the transmission system can also be preliminarily screened. For example, if the current rising speed in the first current change characteristic is less than a preset value, it can be preliminarily ruled out that the interventional pump head is entangled in the heart tissue or the protective end is abnormally abutted against the inner wall of the heart, and it is reasonable to suspect that the transmission system has abnormal operation.

[0139] Through the above-mentioned first current change characteristic, it is possible to accurately identify that the abnormal range of the abnormal state belongs to the traditional system, rather than intervening in the pump head or protecting the end, which can effectively prompt the operator to make corresponding adjustments to solve the abnormal problem and shorten the scope of troubleshooting and troubleshooting time.

[0140] In the embodiment of the present application, the above-mentioned determination that the transmission system of the above-mentioned interventional pump is operating abnormally includes at least one of the following:

[0141] (1) When the rising speed of the current data is greater than the first speed threshold, and the amplitude of the current data after rising approaches the first current threshold, it is determined that the tubular component of the interventional pump is abnormally bent, and the abnormal operation of the transmission system includes the abnormal bending of the tubular component.

[0142] (2) When the rising speed of the above-mentioned current data is greater than the second speed threshold, and the amplitude of the above-mentioned current data after rising approaches the second current threshold, it is determined that the above-mentioned interventional pump has eccentricity of the coupled rotating part, and the abnormal operation of the above-mentioned transmission system includes the eccentricity of the above-mentioned coupled rotating part; wherein the above-mentioned first speed threshold is greater than the above-mentioned second speed threshold.

[0143] Correspondingly, the above-mentioned issuing of alarm information corresponding to abnormal operation of the above-mentioned transmission system includes: issuing alarm information corresponding to abnormal bending of the above-mentioned tubular component; and / or issuing alarm information corresponding to eccentricity of the above-mentioned coupling rotating part.

[0144] The above judgment conditions are the current data change characteristics determined by the inventor based on the location of the abnormal state, its impact on the system operation and related experiments. For interventional pumps of different models or different interventional pumps of the same model, the specific values ​​of the first speed threshold, the second speed threshold, the first current threshold and the second current threshold may be different, but the trend of current change and the relative data characteristics are basically the same. Therefore, this application does not limit the specific values ​​of the first speed threshold, the second speed threshold, the first current threshold and the second current threshold, and can be set according to actual conditions without constituting an implementation obstacle. As long as the relative relationship that the first speed threshold is greater than the second speed threshold is satisfied.

[0145] The embodiment of the present application proposes that the eccentricity of the coupling rotating part or the abnormal bending of the tubular member may cause the current data to rise within a period of time, and the rising speed is relatively slow compared to the rising speed caused by the interventional pump head being entangled in the heart tissue or the abnormal contact between the protective end and the inner wall of the heart. Among them, in many cases, the rising speed of the current speed caused by the eccentricity of the coupling rotating part may also be lower than the rising speed of the current speed caused by the abnormal bending of the tubular member. This is because the abnormal bending of the tubular member is mostly caused by external forces, so the load increase is sudden and the current rises quickly. However, after the interventional pump and the drive motor are coupled and connected, the coupling relationship between the coupling rotating part is fixed, and the degree of eccentricity will have an upper limit. The occurrence of eccentricity may occur gradually, so the current rise speed is lower than the current speed when the tubular member is abnormally bent. Of course, the rising speed can be determined by the amplitude of the current change and the time interval of the change. The calculation method of the rising speed is not elaborated in the embodiment of the present application.

[0146] When the coupling rotating part is eccentric, the current data will have an upward trend. With the different degrees of eccentricity, the current will gradually increase. When the eccentricity reaches a certain degree, the current data tends to the second current threshold. The embodiment of the present application does not set the size of the second current threshold, and it can be set with reference to the actual situation. If the difference between the current data and the second current threshold gradually decreases over a period of time and does not exceed the second current threshold, it can be determined that the current data tends to the second current threshold, and it can be determined that the coupling rotating part is eccentric.

[0147] The eccentricity of the coupling rotating part and the abnormal bending of the tubular component may cause the current data to rise to a limit value and then stabilize. In some cases, the speed of the current rise caused by the abnormality of the tubular component may be greater than the speed of the current rise caused by the eccentricity of the coupling rotating part, that is, the first speed threshold is greater than the second speed threshold. Of course, the first speed threshold and the second speed threshold can be set according to actual conditions. The method for judging whether the current data approaches the first current threshold is the same as the method for judging whether the current data approaches the second current threshold in the previous text, and will not be repeated here.

[0148] In the embodiment of the present application, the first current threshold or the second current threshold can be expressed by a proportional coefficient, which represents the ratio relative to the normal current. If the interventional pump is in operation and the tubular component is abnormally bent, when the bending reaches a certain degree, the current will rise rapidly, and the rise may exceed a certain proportion of the original normal operating current. Therefore, the first current threshold is limited by the proportional coefficient to quickly determine whether the determination condition of the abnormal bending of the tubular component is met. The embodiment of the present application does not limit the proportional coefficient, and the proportional coefficient can be set to assist in determining the abnormal bending of the tubular component. Of course, the embodiment of the present application does not limit the setting method and specific value of the proportional coefficient. The above-mentioned first current threshold and the second current threshold can also be preset thresholds.

[0149] In one embodiment, the interventional pump includes an impeller, and the operation status of the ventricular assist device is classified and identified based on the change of the current data in the first time period, including: when the change of the current data conforms to the second current change characteristic, it is determined that the interventional pump has an impeller operation abnormality; wherein the second current change characteristic is used to characterize the peak-shaped change of the current that first rises and then falls; and the issuing of the alarm information corresponding to the identification result includes: issuing the alarm information corresponding to the impeller operation abnormality.

[0150] Abnormal operation of the impeller may include abnormal operation of any component closely related to the impeller, for example, the above-mentioned abnormal operation of the impeller includes abnormal position of the pump head and / or abnormal position of the protection terminal. The embodiment of the present application does not limit the rising speed of the second current change characteristic and the maximum current in the process of first rising and then falling, which can be set according to actual conditions and does not constitute an implementation obstacle. The most significant morphological manifestation of the second current change characteristic is the appearance of a peak in the current waveform, so the second current change characteristic is also expressed as a peak characteristic in the embodiment of the present application. In one embodiment, the current rise rate in the peak characteristic can be higher than the current rise rate when the aforementioned transmission system operates abnormally, that is, the current rise rate of the second current change characteristic can be higher than the current rise rate of the first current change characteristic.

[0151] Therefore, by limiting the current rising rate in the second current change characteristic, it is also possible to preliminarily screen for impeller operation abnormalities. For example, if the current rising rate is greater than a preset value and the current change conforms to a peak-shaped change characteristic of first rising and then falling, it can be preliminarily determined that impeller operation abnormalities are likely to occur.

[0152] In the embodiment of the present application, the above-mentioned determination that the impeller of the above-mentioned interventional pump is operating abnormally includes at least one of the following:

[0153] (1) If the current data shows a first peak feature in the first time period, and the peak value and peak width of the first peak feature meet the first peak feature requirements, it is determined that the pump head of the interventional pump is entangled with cardiac tissue;

[0154] When the interventional pump is in operation and the pump head is entangled with the heart tissue, the current will increase sharply, and the speed of increase will be very obvious. The current increase rate is significantly higher than the current increase rate under abnormal conditions of the transmission system, so that the situation of the pump head entangled with the heart tissue can be clearly distinguished from the two situations of abnormal bending of the tubular component and eccentricity of the coupling rotating part. The first peak feature requirement in the embodiment of the present application is essentially a peak shape requirement for the peak feature, which includes peak value and seam width, and its specific content can be set according to the actual situation of heart tissue entanglement, and the embodiment of the present application does not limit this.

[0155] (2) If the current data periodically shows a second peak feature in the first time period, and the peak value and peak width of the second peak feature meet the second peak feature requirements, it is determined that the interventional pump has the protective end abnormally touching the wall;

[0156] Correspondingly, the above-mentioned issuing of alarm information corresponding to the abnormal operation of the impeller includes: issuing of alarm information corresponding to the pump head being entangled with the heart tissue; and / or issuing of alarm information corresponding to the abnormal contact of the protective end with the wall.

[0157] When the interventional pump is in operation and the protective end abnormally touches the wall, the protective end will bend. Since the bending process of the protective end will cause changes in the bearing structure and position, it will cause changes in the impeller rotation torque, which will be reflected in the change of the current. When the protective end is bent, the current will rise rapidly. When the compression state of the protective end is released, the current will drop rapidly again, forming a second peak feature. As the heart beats, the protective end will also undergo periodic bending changes, so the second peak feature also appears periodically. The second peak feature is similar to the first peak feature waveform, but the specific shape may be different. The current growth rate indicated by the second peak feature is not as obvious as the current growth rate indicated by the first peak feature, that is, the current growth rate indicated by the second peak feature requirement is less than the current growth rate indicated by the first peak feature requirement. The second peak feature requirement can be specifically set according to the shape of the peak feature caused by the abnormal contact between the actual protective end and the inner wall of the heart, and the embodiment of the present application does not limit this.

[0158] By distinguishing the above-mentioned first peak feature and the second peak feature, it is possible to accurately determine whether the specific cause of the abnormal operation of the impeller is the pump head entangled with the heart tissue or the protective end abnormally touching the wall, thereby improving the accuracy of the alarm.

[0159] The present application does not limit the method for determining the peak value and peak width of the first peak characteristic requirement and the second peak characteristic requirement and their specific values, which does not constitute an implementation obstacle and can be set according to actual conditions.

[0160] In one embodiment, the above-mentioned determination that the above-mentioned interventional pump has the above-mentioned protection terminal abnormally touching the wall includes: when the characteristic shape of the above-mentioned peak feature meets the first shape requirement, determining that the above-mentioned interventional pump has the above-mentioned protection terminal being directly pressure-bent; when the characteristic shape of the above-mentioned peak feature meets the second shape requirement, determining that the above-mentioned interventional pump has the above-mentioned protection terminal being oblique pressure-bent; the above-mentioned alarm information includes the wall-touching type corresponding to the above-mentioned protection terminal abnormally touching the wall, and the above-mentioned wall-touching type includes at least one of the above-mentioned protection terminal direct pressure-bending and the above-mentioned protection terminal oblique pressure-bending.

[0161] The embodiment of the present application does not limit the first shape requirement and the second shape requirement, which can be set by experiments according to actual conditions and do not constitute an implementation obstacle. For example, the highest current corresponding to the peak feature can be used as a reference, and the feature formed by the process of the current rising to the highest current in the peak feature is the first half feature, and the feature formed by the process of the current starting to drop from the highest current in the peak feature is the second half feature. If the first half feature and the above-mentioned second half feature are basically axially symmetrical features, or the axial symmetry of the first half feature and the second half feature meets the preset requirements, it can be determined that the protection terminal is bent by direct pressure, otherwise, it can be determined that the protection terminal is bent by oblique pressure.

[0162] By identifying the shape of the peak feature, it is possible to quickly determine whether the protective end of the interventional pump is touching the wall in the ventricle without the aid of DSA or ultrasound imaging, thereby giving the operator a timely alarm so that the operator can quickly adjust the position of the interventional pump.

[0163] In one embodiment, the abnormal state can be further judged in combination with the rotation speed data of the rotating parts in the ventricular assist device. Figure 3 , which shows an abnormal state judgment method combined with speed data in one implementation of an embodiment of the present application. The above method includes:

[0164] Step S301. Obtaining the rotation speed data of the rotating part in the ventricular assist device;

[0165] The embodiments of the present application do not limit the rotating parts. The rotating parts have been described above and will not be repeated here.

[0166] Step S302: Classify and identify the operating status of the ventricular assist device according to the changes of the current data and the speed data in the first time period.

[0167] In the embodiment of the present application, in addition to using the current data, the rotation speed data may be further introduced to classify and identify the above-mentioned abnormal operating state, thereby further improving the accuracy of identifying the abnormal operating state.

[0168] Please refer to Figure 4 , which shows a schematic diagram of a method for identifying a running state in combination with a rotation speed according to an embodiment of the present application. The present application embodiment can classify and identify the running state in combination with the rotation speed data by at least one of the following methods:

[0169] (1) when the rising speed of the current data is greater than the first speed threshold, the amplitude of the current data after rising approaches the first current threshold, and the rotation speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular component of the interventional pump is abnormally bent;

[0170] The first speed threshold and the first current threshold have been described above and will not be repeated here. In many cases, when abnormal bending of a tubular component occurs and the abnormal bending of the tubular component reaches a certain degree, the current will rise rapidly, and the increase may exceed a certain proportion of the original normal operating current. If the bending continues to increase, the rotation speed will decrease relatively slowly due to excessive friction. At this time, the change in rotation speed can be combined to improve the recognition accuracy of abnormal bending of the tubular component. The embodiment of the present application does not limit the value and determination method of the third speed threshold, and does not constitute an implementation obstacle. In one embodiment, when the difference between the above current data and the first current threshold is less than a preset value, it can be determined that the above current data is approaching the above first current threshold. When the above current data approaches the above first current threshold, if the above rotation speed data decreases and the decrease speed is less than the third speed threshold, it is determined that the above tubular component is abnormally bent.

[0171] (2) when the rising speed of the current data is greater than the second speed threshold, the amplitude of the current data after rising approaches the second current threshold, and the rotation speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the coupling rotating part of the intervention pump is eccentric;

[0172] The second speed threshold and the second current threshold have been explained above and will not be repeated here. In many cases, when the eccentricity of the coupled rotating part occurs and reaches a certain degree, the current will rise until it approaches a certain proportion of the original normal operating current. If the eccentricity of the coupled rotating part continues to increase, the rotational speed may also drop rapidly due to excessive friction. At this time, the change in rotational speed can be combined to improve the accuracy of identifying the eccentricity of the coupled rotating part. The embodiment of the present application does not limit the value and determination method of the fourth speed threshold, and does not constitute an implementation obstacle. In one embodiment, when the difference between the current data and the second current threshold is less than a preset value, it can be determined that the current data is approaching the second current threshold. After the current data approaches the second current threshold, if the rotational speed data decreases and the decrease speed is greater than the fourth speed threshold, it is determined that the interventional pump has the eccentricity of the coupled rotating part.

[0173] (3) when the current data shows a first peak feature in the first time period, the peak value and peak width of the first peak feature meet the first peak feature requirement, and the speed data decreases at the first moment and the amplitude after the decrease is less than the first speed threshold, it is determined that the pump head of the interventional pump is entangled with the heart tissue; the first moment is determined based on the moment when the current data reaches the peak current;

[0174] The requirements for the first peak feature have been recorded in the previous text and will not be repeated here. If the pump head is entangled with the heart tissue, when the entanglement reaches the maximum degree, the current data will reach a local peak, and then the entanglement will enter a stable state. The rotating part will stop running or run at a lower speed depending on the degree of entanglement. During the entanglement process, the change in current will show the first peak feature. Therefore, the prediction accuracy and sensitivity of the pump head entanglement with the heart tissue can be improved by combining the first peak feature with the speed change. Of course, the embodiment of the present application does not limit the value and determination method of the first speed threshold, and does not constitute an implementation obstacle. In addition, there is no limitation on the timing of the speed reduction, as long as it has a definite relationship with the timing when the current data reaches the peak current. The timing of the speed reduction is the first moment, which can be determined based on experiments.

[0175] (4) The above-mentioned current data periodically shows a second peak feature in the above-mentioned first time period, the peak value and peak width of the above-mentioned second peak feature meet the second peak feature requirements, and the change amplitude of the above-mentioned speed data in the above-mentioned first time period is less than the first amplitude threshold, it is determined that the above-mentioned interventional pump has the above-mentioned protection end abnormally touching the wall.

[0176] The second peak feature requirement has been described above and will not be repeated here. When the protection terminal abnormally touches the wall, the rotation speed data will not change significantly. Therefore, if the change amplitude of the above rotation speed data in the above first period is less than the first amplitude threshold, it can be combined with the identification of the second peak feature to determine whether the protection terminal abnormally touches the wall. Of course, the embodiment of the present application does not limit the value and determination method of the first amplitude threshold, and does not constitute an implementation obstacle.

[0177] The embodiment of the present application further provides Table 1 based on the foregoing, which shows the comparison results of the criteria for each operating state identified in the embodiment of the present application.

[0178] Table 1

[0179]

[0180]

[0181] Based on the criteria in Table 1, the embodiment of the present application can respectively identify four situations: bending of the tubular component, eccentricity of the coupling rotating part, entanglement of the pump head with the heart tissue, or abnormal contact of the protective end with the wall.

[0182] The embodiment of the present application can classify and identify the operating status of the ventricular assist device by detecting changes in current data during the operation of the interventional pump, in conjunction with changes in rotational speed data. Specifically, it can identify normal operating status and abnormal operating status, wherein the abnormal operating status may include bending of tubular components, eccentricity of the coupling rotating parts, entanglement of the pump head with heart tissue, or abnormal contact of the protective end with the wall.

[0183] When the interventional pump is working inside the heart, there is a possibility that the pump head will be entangled with the heart tissue or the protective end will abnormally touch the wall. By detecting the changes in the current waveform and the speed when the impeller is entangled with the heart tissue or the protective end abnormally touches the wall and is bent, it is possible to detect that the impeller of the interventional pump is entangled with the heart tissue or the protective end abnormally abuts the heart and bends, and an alarm will be issued to remind the user to prevent danger and injury. In addition, the abnormal bending of the tubular component and the eccentricity of the coupling rotating part can be detected based on the current change combined with the speed change, and the alarm information can be generated in time to remind the user to take appropriate measures to resolve the abnormal state as soon as possible, such as adjusting the position of the pump, withdrawing and re-intervention, etc., to prevent the problem from further deteriorating and ensure the patient's life safety.

[0184] The embodiments of the present application achieve the technical purpose of quickly detecting abnormal working conditions such as bending of tubular components, eccentricity of coupled rotating parts, entanglement of pump heads with heart tissues, or abnormal contact of protective end with the wall, without the need to use DSA and ultrasound and without causing radiation damage to users, and giving users instant alarms; and promptly notifying users to make adjustments and processing, thereby avoiding reduction in equipment life or damage, reducing risks and protecting patients' lives.

[0185] The following is an embodiment of the device of the present application, which can be used to execute the embodiment of the method of the present application. For details not disclosed in the embodiment of the device of the present application, please refer to the embodiment of the method of the present application.

[0186] Please refer to Figure 5 , which shows a block diagram of an operating state detection device for a ventricular assist device provided by an embodiment of the present application. The ventricular assist device includes a driving device and an interventional pump, the driving device is used to drive the interventional pump to operate, and the device may include:

[0187] The data acquisition module 501 is used to acquire the current data of the driving device in the working state;

[0188] A state detection module 502 is used to classify and identify the operating state of the ventricular assist device according to the change of the current data in the first period when the current data indicates that the load of the driving device has increased;

[0189] The alarm module 503 is used to issue an alarm message corresponding to the recognition result, where the recognition result indicates an abnormal operating state that causes the load increase.

[0190] In one embodiment, the interventional pump at least comprises a transmission system, a pump head and a protection terminal, the transmission system comprises a tubular member and a coupling rotating member, and the pump head comprises an impeller;

[0191] The abnormal operating state includes at least one of the following: abnormal operation of the transmission system, abnormal bending of the tubular component, eccentricity of the coupling rotating part, abnormal operation of the impeller, entanglement of the pump head with heart tissue, and abnormal contact of the protective end with the wall.

[0192] In one embodiment, the interventional pump includes a transmission system, and the transmission system is used to transmit power of the driving device to the impeller of the interventional pump. The classification and identification of the operating state of the ventricular assist device according to the change of the current data in the first time period includes:

[0193] When the change of the current data meets the first current change characteristic, it is determined that the transmission system of the interventional pump is abnormal; wherein the first current change characteristic is used to characterize the current change in which the current rises and tends to be stable;

[0194] The alarm information corresponding to the identification result includes:

[0195] Issue an alarm message corresponding to the abnormal operation of the above transmission system.

[0196] In one embodiment, the transmission system includes a tubular member and / or a coupling rotating member, and the determining that the interventional pump has a transmission system operating abnormality includes:

[0197] When the rising speed of the current data is greater than the first speed threshold, and the amplitude of the current data after rising approaches the first current threshold, it is determined that the tubular component of the interventional pump is abnormally bent, and the abnormal operation of the transmission system includes the abnormal bending of the tubular component;

[0198] and / or, when the rising speed of the current data is greater than the second speed threshold, and the amplitude of the current data after rising approaches the second current threshold, it is determined that the interventional pump has eccentricity of the coupling rotating part, and the abnormal operation of the transmission system includes eccentricity of the coupling rotating part;

[0199] Wherein, the first speed threshold is greater than the second speed threshold;

[0200] The above-mentioned alarm information corresponding to the abnormal operation of the transmission system includes:

[0201] Sending an alarm message corresponding to abnormal bending of the tubular component; and / or sending an alarm message corresponding to eccentricity of the coupling rotating part.

[0202] In one embodiment, the interventional pump includes an impeller, and the classification and identification of the operating state of the ventricular assist device according to the change of the current data in the first period includes:

[0203] When the change of the current data meets the second current change characteristic, it is determined that the impeller of the interventional pump has abnormal operation; wherein the second current change characteristic is used to characterize the peak change of the current first rising and then falling;

[0204] The alarm information corresponding to the identification result includes:

[0205] An alarm message corresponding to the above-mentioned abnormal operation of the impeller is issued.

[0206] In one embodiment, the interventional pump includes a pump head and / or a protection terminal, and the determination that an impeller of the interventional pump is abnormally operating includes:

[0207] If the current data shows a first peak feature in the first time period, and the peak value and peak width of the first peak feature meet the first peak feature requirement, it is determined that the pump head of the interventional pump is entangled with the heart tissue;

[0208] And / or, if the current data periodically shows a second peak feature in the first time period, and the peak value and peak width of the second peak feature meet the second peak feature requirement, it is determined that the interventional pump has the protective end abnormally touching the wall;

[0209] The above-mentioned alarm information corresponding to the abnormal operation of the impeller includes:

[0210] Sending an alarm message corresponding to the pump head being entangled with the heart tissue; and / or sending an alarm message corresponding to the abnormal wall contact of the protection terminal.

[0211] In one embodiment, the determining that the interventional pump has the abnormal contact of the protection tip with the wall includes:

[0212] When the characteristic shape of the peak feature meets the first shape requirement, it is determined that the interventional pump has the direct pressure bending of the protection terminal;

[0213] When the characteristic shape of the peak feature meets the second shape requirement, it is determined that the interventional pump has the oblique pressure bending of the protection terminal;

[0214] The alarm information includes the wall contact type corresponding to the abnormal wall contact of the protection terminal, and the wall contact type includes at least one of the straight pressure bending of the protection terminal and the oblique pressure bending of the protection terminal.

[0215] In one embodiment, the above method further comprises:

[0216] Acquiring rotation speed data of a rotating component in the ventricular assist device;

[0217] The classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first period includes:

[0218] The operating status of the ventricular assist device is classified and identified based on changes in the current data and the speed data in the first time period.

[0219] In one embodiment, the interventional pump includes at least one of a tubular member, a coupling rotating member, a pump head, and a protective terminal, and the classifying and identifying the operating state of the ventricular assist device according to the change of the current data and the rotation speed data in the first time period includes:

[0220] When the rising speed of the current data is greater than the first speed threshold, the amplitude of the current data after rising approaches the first current threshold, and the rotation speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular component of the interventional pump is abnormally bent;

[0221] and / or, when the rising speed of the current data is greater than the second speed threshold, the amplitude of the current data after rising approaches the second current threshold, and the rotation speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the interventional pump has eccentricity of the coupled rotating part;

[0222] And / or, when the current data shows a first peak feature in the first time period, the peak value and peak width of the first peak feature meet the first peak feature requirement, and the rotation speed data decreases at the first moment and the amplitude after the decrease is less than the first rotation speed threshold, it is determined that the pump head of the interventional pump is entangled with the heart tissue; the first moment is determined based on the moment when the current data reaches the peak current;

[0223] And / or, the current data periodically shows a second peak feature in the first time period, the peak value and peak width of the second peak feature meet the second peak feature requirements, and the change amplitude of the speed data in the first time period is less than the first amplitude threshold, and it is determined that the interventional pump has the protective end abnormally touching the wall.

[0224] In one embodiment, the alarm information includes the abnormal operating state and abnormality degree information corresponding to the abnormal operating state, and the abnormality degree information represents the severity of the abnormal operating state.

[0225] In one embodiment, the above method further comprises:

[0226] When the rotation speed data of the rotating member in the ventricular assist device approaches the target rotation speed, first abnormality degree information is determined based on the increase amplitude of the current data, and the increase amplitude of the current data is positively correlated with the severity indicated by the first abnormality degree information;

[0227] In a case where the rotation speed data decreases relative to the target rotation speed, determining second abnormality degree information based on at least one of an increase range of the current data and a decrease range of the rotation speed data;

[0228] Among them, the severity indicated by the above-mentioned second abnormality degree information is positively correlated with the decrease amplitude of the above-mentioned speed data, the severity indicated by the above-mentioned second abnormality degree information is positively correlated with the increase amplitude of the above-mentioned current data, and the severity indicated by the above-mentioned first abnormality degree information is less than the severity indicated by the above-mentioned second abnormality degree information.

[0229] In one embodiment, after obtaining the current data of the driving device in the working state, the method further includes:

[0230] When the current data exceeds the first amplitude threshold, abnormal information indicating that the load of the driving device has increased is issued;

[0231] When the current data exceeds the second amplitude threshold, abnormal information indicating that the drive device is overloaded is issued, and the first amplitude threshold is smaller than the second amplitude threshold.

[0232] It should be noted that the device provided in the above embodiment, when implementing its functions, is only illustrated by the division of the above functional modules. In actual applications, the above functions can be assigned to different functional modules as needed, that is, the internal structure of the device is divided into different functional modules to complete all or part of the functions described above. In addition, the device and method embodiments provided in the above embodiment belong to the same concept, and the specific implementation process is detailed in the method embodiment, which will not be repeated here.

[0233] An embodiment of the present application also provides an electronic device for a ventricular assist device, the electronic device for the ventricular assist device comprising a processor and a memory, the memory storing at least one instruction, the at least one instruction being loaded and executed by the processor to implement the operating status detection method for the ventricular assist device.

[0234] The above electronic devices include but are not limited to Figure 1 The control host in the embodiment.

[0235] An embodiment of the present application also provides a ventricular assist device, including a drive device, an interventional pump, and the electronic equipment of the aforementioned ventricular assist device.

[0236] In an exemplary embodiment, a computer-readable storage medium is also provided, in which at least one instruction, at least one program, a code set or an instruction set is stored. When the at least one instruction, the at least one program, the code set or the instruction set is executed by a processor, the operating status detection method of the ventricular assist device is implemented.

[0237] Optionally, the computer readable storage medium may include: ROM (Read On ly Memory), RAM (Random Access Memory), SSD (Solid State Drives) or optical disk, etc. Among them, the random access memory may include ReRAM (Resistance Random Access Memory) and DRAM (Dynamic Random Access Memory).

[0238] In an exemplary embodiment, a computer program product or a computer program is also provided, the computer program product or the computer program comprising computer instructions, the computer instructions being stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium, and the processor executes the computer instructions, so that the computer device performs the above-mentioned method for detecting the operating state of a ventricular assist device.

[0239] It should be understood that the "multiple" mentioned in this article refers to two or more. "And / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. The character " / " generally indicates that the objects associated before and after are in an "or" relationship. In addition, the step numbers described in this article only illustrate a possible execution sequence between the steps. In some other embodiments, the above steps may not be executed in the order of the numbers, such as two steps with different numbers are executed at the same time, or two steps with different numbers are executed in the opposite order to the diagram. The embodiments of the present application are not limited to this.

[0240] In the embodiments of the present application, the term "module" or "unit" refers to a computer program or a part of a computer program with a predetermined function, and works together with other related parts to achieve a predetermined goal, and can be implemented in whole or in part by using software, hardware (such as processing circuits or memories) or a combination thereof. Similarly, a processor (or multiple processors or memories) can be used to implement one or more modules or units. In addition, each module or unit can be part of an overall module or unit that includes the function of the module or unit.

[0241] In addition, in the specific implementation of this application, related data such as user information is involved. When the above embodiments of this application are applied to specific products or technologies, user permission or consent is required, and the collection, use and processing of relevant data must comply with relevant laws, regulations and standards of relevant countries and regions.

[0242] The above are merely exemplary embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A method for detecting the operating status of a ventricular assist device, characterized in that: The ventricular assist device comprises a driving device and an interventional pump, wherein the driving device is used to drive the interventional pump to operate, and the method comprises: Acquiring current data of the driving device in a working state; When the current data indicates that the load of the driving device has increased, classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first period; An alarm message corresponding to the identification result is issued, wherein the identification result indicates an abnormal operating state that causes the load increase.

2. The method according to claim 1, characterized in that: The interventional pump at least comprises a transmission system, a pump head and a protection terminal, wherein the transmission system comprises a tubular member and a coupling rotating member, and the pump head comprises an impeller; The abnormal operating state includes at least one of the following: abnormal operation of the transmission system, abnormal bending of the tubular component, eccentricity of the coupling rotating part, abnormal operation of the impeller, entanglement of the pump head with heart tissue, and abnormal contact of the protective end with the wall.

3. The method according to claim 2, characterized in that The abnormal wall contact of the protection end includes at least one of the following situations: The protection end abuts against the ventricular wall; The protection tip abnormally abuts against the inner wall of the ventricle.

4. The method according to claim 1, characterized in that: The interventional pump includes a transmission system, and the transmission system is used to transmit the power of the driving device to the impeller of the interventional pump. The classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first time period includes: When the change of the current data meets the first current change characteristic, it is determined that the interventional pump has a transmission system operation abnormality; wherein the first current change characteristic is used to characterize the current change situation in which the current rises and tends to be stable; The issuing of alarm information corresponding to the recognition result includes: An alarm message corresponding to the abnormal operation of the transmission system is issued.

5. The method according to claim 4, characterized in that The transmission system includes a tubular member and / or a coupling rotating member, and determining that the interventional pump has a transmission system operating abnormality includes: When the rising speed of the current data is greater than the first speed threshold, and the amplitude of the rising current data approaches the first current threshold, it is determined that the interventional pump has abnormal bending of the tubular component, and the abnormal operation of the transmission system includes abnormal bending of the tubular component; and / or, when the rising speed of the current data is greater than the second speed threshold, and the amplitude of the current data after rising approaches the second current threshold, it is determined that the interventional pump has eccentricity of the coupling rotating part, and the abnormal operation of the transmission system includes eccentricity of the coupling rotating part; Wherein, the first speed threshold is greater than the second speed threshold; The issuing of alarm information corresponding to the abnormal operation of the transmission system includes: Sending an alarm message corresponding to abnormal bending of the tubular component; and / or sending an alarm message corresponding to eccentricity of the coupling rotating part.

6. The method according to claim 1, characterized in that The interventional pump includes an impeller, and classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first period includes: When the change of the current data meets the second current change characteristic, it is determined that the impeller of the interventional pump has abnormal operation; wherein the second current change characteristic is used to characterize the peak-shaped change of the current that first rises and then falls; The issuing of alarm information corresponding to the recognition result includes: An alarm message corresponding to the abnormal operation of the impeller is issued.

7. The method according to claim 6, characterized in that The interventional pump includes a pump head and / or a protection terminal, and the determining that an impeller of the interventional pump is operating abnormally includes: If the current data has a first peak feature in the first time period, and the peak value and peak width of the first peak feature meet the first peak feature requirement, it is determined that the pump head of the interventional pump is entangled with the heart tissue; and / or, if the current data periodically shows a second peak feature in the first time period, and the peak value and peak width of the second peak feature meet the second peak feature requirement, it is determined that the protection terminal of the interventional pump abnormally touches the wall; The issuing of alarm information corresponding to the abnormal operation of the impeller includes: Sending an alarm message corresponding to the pump head being entangled with the heart tissue; and / or sending an alarm message corresponding to the protective end abnormally touching the wall.

8. The method according to claim 7, characterized in that The determining that the interventional pump has the protective end abnormally touching the wall includes: When the characteristic shape of the peak feature meets the first shape requirement, determining that the interventional pump has a direct pressure bending of the protection terminal; When the characteristic shape of the peak feature meets the second shape requirement, determining that the interventional pump has the oblique pressure bending of the protection terminal; The alarm information includes a wall contact type corresponding to the abnormal wall contact of the protection terminal, and the wall contact type includes at least one of a direct pressure bending of the protection terminal and an oblique pressure bending of the protection terminal.

9. The method according to claim 1, characterized in that: The method further comprises: Acquiring rotation speed data of a rotating part in the ventricular assist device; The classifying and identifying the operating state of the ventricular assist device according to the change of the current data in the first time period includes: The operating state of the ventricular assist device is classified and identified according to changes in the current data and the rotation speed data in the first time period.

10. The method according to claim 9, characterized in that The interventional pump includes at least one of a tubular member, a coupling rotating member, a pump head, and a protective terminal. The classifying and identifying the operating state of the ventricular assist device according to the change of the current data and the rotation speed data in the first time period includes: When the rising speed of the current data is greater than the first speed threshold, the amplitude of the current data after rising approaches the first current threshold, and the rotation speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular component of the interventional pump is abnormally bent; And / or, when the rising speed of the current data is greater than the second speed threshold, the amplitude of the rising current data approaches the second current threshold, and the rotation speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the interventional pump has eccentricity of the coupled rotating part; And / or, when the current data has a first peak feature in the first time period, the peak value and peak width of the first peak feature meet the first peak feature requirement, and the rotation speed data decreases at the first moment and the amplitude after the decrease is less than the first rotation speed threshold, it is determined that the pump head of the interventional pump is entangled with the heart tissue; the first moment is determined based on the moment when the current data reaches the peak current; And / or, the current data periodically shows a second peak feature in the first time period, the peak value and peak width of the second peak feature meet the second peak feature requirements, and the change amplitude of the speed data in the first time period is less than the first amplitude threshold, and it is determined that the interventional pump has the protection end abnormally touching the wall.

11. The method according to any one of claims 1 to 10, characterized in that The alarm information includes the abnormal operating state and abnormality degree information corresponding to the abnormal operating state, and the abnormality degree information represents the severity of the abnormal operating state.

12. The method according to claim 11, characterized in that The method further comprises: When the rotation speed data of the rotating part in the ventricular assist device approaches the target rotation speed, first abnormality degree information is determined based on the increase amplitude of the current data, and the increase amplitude of the current data is positively correlated with the severity indicated by the first abnormality degree information; When the rotation speed data decreases relative to the target rotation speed, determining second abnormality degree information based on at least one of an increase range of the current data and a decrease range of the rotation speed data; Among them, the severity indicated by the second abnormality level information is positively correlated with the decrease amplitude of the speed data, the severity indicated by the second abnormality level information is positively correlated with the increase amplitude of the current data, and the severity indicated by the first abnormality level information is less than the severity indicated by the second abnormality level information.

13. The method according to any one of claims 1 to 10, characterized in that After obtaining the current data of the driving device in the working state, the method further includes: When the current data exceeds a first amplitude threshold, issuing abnormal information indicating that the load of the driving device has increased; In the case where the current data exceeds a second amplitude threshold, abnormal information indicating that the drive device is overloaded is issued, and the first amplitude threshold is smaller than the second amplitude threshold.

14. A device for detecting the operating state of a ventricular assist device, characterized in that: The ventricular assist device comprises a driving device and an interventional pump, wherein the driving device is used to drive the interventional pump to operate, and the device comprises: A data acquisition module, used to acquire current data of the driving device in a working state; A state detection module, configured to classify and identify the operating state of the ventricular assist device according to the change of the current data in the first time period when the current data indicates that the load of the driving device has increased; The alarm module is used to issue an alarm message corresponding to the recognition result, wherein the recognition result indicates an abnormal operating state that causes the load increase.

15. An electronic device for a ventricular assist device, characterized in that: The electronic device of the ventricular assist device includes a processor and a memory, wherein the memory stores at least one instruction, and the at least one instruction is loaded and executed by the processor to implement the operating status detection method of the ventricular assist device as described in any one of claims 1 to 13.

16. A ventricular assist device, characterized in that: An electronic device comprising a drive device, an interventional pump and the ventricular assist device of claim 15.

17. A computer-readable storage medium, characterized in that: The storage medium stores at least one instruction, and the at least one instruction is loaded and executed by the processor to implement the operating status detection method of the ventricular assist device according to any one of claims 1 to 13.

18. A computer program product, characterized in that The computer program product includes computer instructions, which are stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium, and the processor executes the computer instructions, so that the computer device executes to implement the operating status detection method of a ventricular assist device as described in any one of claims 1 to 13.

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