Method, device and apparatus for detecting operating state of ventricular assist device

Abstract

The application discloses a method, device and equipment for detecting the operation state of a ventricular assist device, and belongs to the technical field of medical instruments. The ventricular assist device comprises a driving device and an intervention pump. The driving device is used for driving the intervention pump to operate. The method comprises the following steps: acquiring current data of the driving device in a working state; in the case that the current data indicates that the load of the driving device is increased, performing operation state classification identification on the ventricular assist device according to the change condition of the current data in a first time period; and issuing alarm information corresponding to an identification result, wherein the identification result indicates an abnormal operation state causing the load increase. The method can timely prompt the cause of the abnormal load increase without the aid of a medical contrast imaging device, realizes automatic identification of the abnormal operation state, reduces the safety risk and protects the life safety of an assisted object, and reduces the radiation damage to the human body when the medical contrast imaging device is working.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a method and device for detecting the running state of a ventricular assist device. BACKGROUND

[0002] The ventricular assist device includes an intervention pump and a driving device for driving the intervention pump. In a working state, the driving device can pump blood in the ventricle into the ascending aorta through the intervention pump to assist the pumping function of the heart and reduce the burden on the heart.

[0003] During the operation of the intervention pump, some malfunctions or abnormal running problems may occur due to improper operation or poor device performance. Since the intervention pump is partly in the body of an intervention assist object and partly coupled to the driving device outside the body, the relevant operating personnel cannot directly observe the rotation of the relevant rotating parts in the intervention pump and the bending shape and intervention position of the intervention pump in the body by eyes. Therefore, the relevant personnel cannot directly determine the cause of the above problems. The current related technology also has limited detection and identification capabilities for the abnormal running problems of the ventricular assist device, and cannot detect the specific cause. The relevant personnel need to take photos by a medical imaging device or stop the pump for inspection, which will cause radiation damage to the patient and the relevant personnel, and the stopping of the intervention pump will cause the interruption of the ventricular assistance, causing safety hazards. SUMMARY

[0004] The embodiments of the present application provide a method and device for detecting the running state of a ventricular assist device, which can timely and quickly detect and prompt the abnormal running of the ventricular assist device without causing radiation damage to the human body.

[0005] According to an aspect of an embodiment of the present application, a method for detecting the running state of a ventricular assist device is provided, the ventricular assist device including a driving device and an intervention pump, the driving device being configured to drive the intervention pump to run, and the method including:

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

[0007] in a case where the current data indicates an increase in the load of the driving device, performing running state classification and identification on the ventricular assist device according to the change of the current data in a first time period;

[0008] issuing alarm information corresponding to the identification result, the identification result indicating an abnormal running state causing the increase in the load.

[0009] In one embodiment, the intervention pump includes at least a transmission system, a pump head and a protection end, the transmission system including a tubular member and a coupling rotating part, and the pump head including an impeller.

[0010] The abnormal operating state includes at least one of the following: the transmission system is abnormal, the tubular member is abnormally bent, the coupling rotating member is eccentric, the impeller is abnormal, the pump head is wrapped around the heart tissue, and the protection tip abnormally touches the wall.

[0011] In one embodiment, the protection tip abnormally touching the wall includes at least one of the following:

[0012] The protection tip abuts against the inner wall of the ventricle.

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

[0014] In one embodiment, the intervention pump includes a transmission system for transmitting power of the driving device to an impeller of the intervention pump, and the operating state of the ventricular assist device is classified and recognized according to the change of the current data in the first time period, including:

[0015] In the case where the change of the current data conforms to a first current change characteristic, it is determined that the intervention pump has a transmission system operating abnormality; wherein the first current change characteristic is used to represent a current change condition in which the current rises and tends to be stable.

[0016] The alarm information corresponding to the recognition result is issued, including:

[0017] The alarm information corresponding to the transmission system operating abnormality is issued.

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

[0019] In the case where the rising speed of the current data is greater than a first speed threshold value, and the amplitude of the current data after rising tends to a first current threshold value, it is determined that the intervention pump has a tubular member abnormal bending, and the transmission system operating abnormality includes the tubular member abnormal bending.

[0020] And / or, in the case where the rising speed of the current data is greater than a second speed threshold value, and the amplitude of the current data after rising tends to a second current threshold value, it is determined that the intervention pump has a coupling rotating member eccentricity, and the transmission system operating abnormality includes the coupling rotating member eccentricity.

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

[0022] The alarm information corresponding to the transmission system operating abnormality is issued, including:

[0023] issue an alarm information corresponding to the abnormal bending of the tubular member; and / or, issue an alarm information corresponding to the eccentricity of the coupling rotating member.

[0024] In one embodiment, the intervention pump comprises an impeller, and the operation state of the ventricular assist device is classified and identified according to the variation of the current data in the first time period, comprising:

[0025] In the case that the variation of the current data meets a second current variation feature, it is determined that the intervention pump has an abnormal impeller operation; wherein, the second current variation feature is used to represent a peak variation of current first increasing and then decreasing;

[0026] The alarm information corresponding to the identification result comprises:

[0027] The alarm information corresponding to the abnormal impeller operation is issued.

[0028] In one embodiment, the intervention pump comprises a pump head and / or a protection tip, and the determination of the abnormal impeller operation of the intervention pump comprises:

[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 intervention pump has a situation of the pump head winding around the heart tissue;

[0030] and / or, if the current data periodically has 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 intervention pump has a situation of the protection tip abnormally touching the wall;

[0031] The alarm information corresponding to the abnormal impeller operation comprises:

[0032] The alarm information corresponding to the pump head winding around the heart tissue is issued; and / or, the alarm information corresponding to the protection tip abnormally touching the wall is issued.

[0033] In one embodiment, the determination of the situation of the protection tip abnormally touching the wall of the intervention pump comprises:

[0034] In the case that the feature shape of the peak feature meets a first shape requirement, it is determined that the intervention pump has a situation of the protection tip being straightly pressed and bent;

[0035] In the case that the feature shape of the peak feature meets a second shape requirement, it is determined that the intervention pump has a situation of the protection tip being obliquely pressed and bent;

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

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

[0038] Obtaining rotation speed data of a rotating member in the ventricular assist device;

[0039] The operation state classification and identification of the ventricular assist device according to the change of the current data in the first time period comprises:

[0040] The operation state classification and identification of the ventricular assist device according to the change of the current data and the rotation speed data in the first time period.

[0041] In one embodiment, the intervention pump includes at least one of a tubular member, a coupling rotating member, a pump head and a protection end, and the operation state classification and identification of the ventricular assist device according to the change of the current data and the rotation speed data in the first time period comprises:

[0042] In the case that the rising speed of the current data is greater than a first speed threshold, the amplitude of the current data after rising tends to a first current threshold, the rotation speed data decreases and the decreasing speed is less than a third speed threshold, it is determined that the intervention pump has an abnormal bending of the tubular member;

[0043] And / or, in the case that the rising speed of the current data is greater than a second speed threshold, the amplitude of the current data after rising tends to a second current threshold, the rotation speed data decreases and the decreasing speed is greater than a fourth speed threshold, it is determined that the intervention pump has an eccentric coupling rotating member;

[0044] And / or, in the case that the current data has a first peak characteristic in the first time period, the peak value and peak width of the first peak characteristic meet the first peak characteristic requirement, the rotation speed data decreases at a first time and the amplitude after decreasing is less than a first rotation speed threshold, it is determined that the intervention pump has a winding of the pump head around the heart tissue; the first time is determined based on the time when the current data reaches the peak current;

[0045] And / or, in the case that the current data periodically has a second peak characteristic in the first time period, the peak value and peak width of the second peak characteristic meet the second peak characteristic requirement, and the change amplitude of the rotation speed data in the first time period is less than a first amplitude threshold, it is determined that the intervention pump has an abnormal wall contact of the protection end.

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

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

[0048] In the case where the rotation speed data of the rotating member in the ventricular assist device approaches the target rotation speed, first abnormal 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 abnormal degree information.

[0049] In the case where the rotation speed data decreases relative to the target rotation speed, second abnormal degree information is determined based on at least one of the rising amplitude of the current data and the decreasing amplitude of the rotation speed data.

[0050] The severity indicated by the second abnormal degree information is positively correlated with the decreasing amplitude of the rotation speed data, the severity indicated by the second abnormal degree information is positively correlated with the rising amplitude of the current data, and the severity indicated by the first abnormal degree information is less than the severity indicated by the second abnormal degree information.

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

[0052] In the case where the current data exceeds a first amplitude threshold, abnormal information indicating an increase in the load of the driving device is issued.

[0053] In the case where the current data exceeds a second amplitude threshold, abnormal information indicating an overload of the driving device is issued, and the first amplitude threshold is less than the second amplitude threshold.

[0054] According to an aspect of an embodiment of the present application, a ventricular assist device operating state detection device is provided, the ventricular assist device comprising a driving device and an intervention pump, the driving device being used to drive the intervention pump to operate, and the device comprising:

[0055] A data acquisition module is configured to acquire current data of the driving device in a working state.

[0056] A state detection module is configured to, in the case where the current data indicates an increase in the load of the driving device, classify and identify the operating state of the ventricular assist device according to the variation of the current data in a first time period.

[0057] An alarm module is configured to issue alarm information corresponding to the identification result, and the identification result indicates an abnormal operating state causing the increase in the load.

[0058] According to an aspect of the embodiments of the present application, an electronic device of a ventricular assist device is provided, 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 ventricular assist device operating state detection method described above.

[0059] According to an aspect of the embodiments of the present application, a ventricular assist device is provided, comprising a driving device, an intervention pump and the electronic device of the ventricular assist device described above.

[0060] According to an aspect of the embodiments of the present application, a computer readable storage medium is provided, the storage medium storing at least one instruction, the at least one instruction being loaded and executed by a processor to implement the ventricular assist device operating state detection method described above.

[0061] According to an aspect of the embodiments of the present application, a computer program product is provided, comprising computer instructions stored in a computer readable storage medium. The 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 ventricular assist device operating state detection method described above.

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

[0063] The embodiments of the present application provide a ventricular assist device operating state detection method, the ventricular assist device comprising a driving device and an intervention pump, the driving device being used to drive the intervention pump to operate, the operating state detection method monitoring current data of the driving device in a working state, and in the case that the current data indicates an increase in the load of the driving device, the abnormal operating state causing the increase in the load of the driving device can be automatically classified and recognized by analyzing the change of the current data within a certain time, and corresponding alarm information can be issued, so that the abnormal operating state causing the abnormal increase in the load of the driving device, i.e. the specific reason causing the abnormal increase in the load, can be timely and quickly prompted without the aid of a medical imaging device, the automatic recognition of the abnormal operating state of the ventricular assist device is realized, the intervention pump can be adjusted and processed in time by relevant operating personnel to solve abnormal problems, the safety risk caused by the abnormal operating state of the ventricular assist device is reduced and the life safety of the assisted object is protected, and the radiation damage to the human body caused by the operation of the medical imaging device is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0064] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained without creative labor based on these drawings.

[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 flowchart of a method for detecting the operating state of a ventricular assist device provided by an embodiment of the present application;

[0067] Figure 3 is an abnormal state judgment method combined with rotation speed data provided by an embodiment of the present application;

[0068] Figure 4 is a schematic diagram of an operating state recognition method combined with rotation speed provided by an embodiment of the present application;

[0069] Figure 5 is a block diagram of a device for detecting the operating state of a ventricular assist device provided by an embodiment of the present application. DETAILED DESCRIPTION

[0070] Before introducing the method embodiments provided by the present application, the related terms or nouns possibly involved in the method embodiments of the present application are briefly introduced, so as to facilitate the understanding of the present application by those skilled in the art.

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

[0072] The ventricular assist device includes an intervention pump and a driving device for driving the intervention pump. In the working state, the driving device can pump the blood in the ventricle into the aorta through the driving intervention pump, so as to assist the pumping function of the heart and reduce the burden of the heart. During the operation of the ventricular assist device, some faults or operating abnormalities caused by improper operation or poor performance may occur. Since the operation of the ventricular assist device and the intervention position are difficult to be directly observed and detected, the current related technology has limited detection and recognition ability for the operating abnormality problem of the ventricular assist device.

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

[0074] (1) Abnormal folding of the tubular member:

[0075] Tubular members include, but are not limited to, drive catheters and drive shafts in percutaneous interventional pumps that intervene in the human body. Abnormal bending can occur in either the in-vivo or in-vitro part of the tubular member. The higher the degree of bending, the greater the rotational resistance, which can cause the following problems:

[0076] (1) Increased friction, the tubular member generates a lot of heat, damaging blood and cells;

[0077] (2) High degree of bending, which can cause stress to the tubular member, causing compression of blood vessels and tissues, or pulling on the intervention site, leading to bleeding or injury;

[0078] (3) High degree of bending, which can cause abnormal rotation, causing damage to the heart and the human body, and also increasing the noise during operation.

[0079] (B) Eccentricity of the coupling rotating part:

[0080] The interventional pump is driven by the drive device to pump blood. During the operation of the interventional pump, the coaxiality of the coupling part between the drive device and the interventional pump can be eccentric due to loose structure, running wear, etc., i.e., the eccentricity of the coupling rotating part, which can cause the following problems:

[0081] (1) Increased friction, the drive device generates a lot of heat, causing the drive device to have a shorter service life or be damaged, and the high temperature on the surface of the drive device can cause burns to the human skin (after the interventional pump intervenes in the auxiliary object's body, the drive device can be bound to the auxiliary object's body surface);

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

[0083] (C) Wrapping around the 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 can wrap around the heart tissue, and the heart tissue (such as chordae tendineae) can be stirred into the rapidly rotating impeller, which can cause the following problems:

[0085] (1) The heart tissue is broken by the impeller; it can cause mitral valve prolapse, valve insufficiency, blood reflux, and even death;

[0086] (2) The impeller cannot break the heart tissue and stops running after being wrapped by the heart tissue: the heart tissue is wrapped, which can cause arrhythmia and even death;

[0087] Both of the above two cases can also cause the impeller to stop, and the interventional pump cannot pump blood, which can be life-threatening.

[0088] (IV) Protection tip position abnormality

[0089] The intervention pump also comprises a protection tip. If the position adjustment is not appropriate (e.g. the intervention position is too much), the protection tip will abnormally touch the wall after the intervention pump intervenes the heart. If the abnormal wall touching is serious, the protection tip will be repeatedly bent and rebounded with the beating of the heart. The above-mentioned abnormal wall touching of the protection tip includes but is not limited to: the protection tip abuts against the inner wall of the ventricle (in this case, the protection tip should not abut against the inner wall of the ventricle); the protection tip abnormally abuts against the inner wall of the ventricle (in this case, the protection tip can abut against the inner wall of the ventricle within a reasonable limit).

[0090] In the case of abnormal wall touching of the protection tip, such as being seriously bent by the heart, the following risks may be caused:

[0091] (1) The protection tip repeatedly pokes and presses the inside of the heart, such as the ventricular wall, the interventricular septum, the apex of the heart, etc. If the frequency and strength of the poking and pressing are too high, it will cause serious damage to the tissues such as the ventricular wall and the interventricular septum, and the myocardium may be damaged. It is also possible to poke through the relatively fragile parts such as the apex of the heart, which endangers life;

[0092] (2) In the case of abnormal bending of the protection tip, the bearing of the intervention pump (the protection tip is connected with the distal bearing of the driving shaft) will undergo a certain degree of structural change, and the operation of the impeller on the driving shaft will be affected, causing increased vibration, increased friction, increased resistance, increased noise, etc., affecting the working efficiency and service life of the pump.

[0093] In summary, during the operation of the ventricular assist device, many abnormal situations may occur, including but not limited to bending of the tubular member, eccentricity of the coupling rotating part between the driving device and the intervention pump, entanglement of the heart tissue, and position abnormality of the protection tip, etc. However, the related technology lacks the ability to quickly detect these abnormal situations, mainly because the running situation of the intervention pump in the heart and the intervention position state are difficult to observe and detect directly. The abnormal situation detection scheme commonly used in the related technology relies on DSA or ultrasonic detection.

[0094] DSA is the abbreviation of Digital Subtraction Angiography. It is a new technology that combines traditional angiography with electronic computers, mainly used for observing vascular lesions, positioning and measuring vascular stenosis, and providing real stereoscopic images for interventional treatment. DSA can cause relatively large radiation damage to the human body. Ultrasonic detection is difficult to detect comprehensive abnormalities, and the clarity is low when judging position abnormalities. In summary, the related technology lacks a technical scheme that can quickly detect the running state abnormality of the ventricular assist device without causing radiation damage to the human body.

[0095] Therefore, the embodiment of the present application provides a method for detecting the running state of a ventricular assist device, the ventricular assist device comprising a driving device and an intervention pump, the driving device being used for driving the intervention pump to run, the method for detecting the running state of the ventricular assist device monitoring current data of the driving device in a working state, and in the case that the current data indicates that the load of the driving device is increased, the abnormal running state causing the load of the driving device to be increased can be automatically classified and recognized by analyzing the change of the current data within a certain time, and corresponding alarm information is sent, so that the abnormal running state causing the load of the driving device to be abnormally increased, i.e. the specific reason causing the load to be abnormally increased, can be timely and quickly prompted without the aid of a medical imaging device, the automatic recognition of the abnormal running state of the ventricular assist device is realized, the intervention pump can be adjusted and processed in time by relevant operating personnel to solve abnormal problems, the safety risk caused by the abnormal running state of the ventricular assist device is reduced and the life safety of an assisted object is protected, and the radiation damage caused to the human body by the medical imaging device is reduced.

[0096] Please refer to Figure 1 , which shows a schematic diagram of a ventricular assist device provided by the embodiment of the present application. The ventricular assist device is a trans-catheter ventricular assist device, which is composed of a trans-catheter ventricular assist device control host (hereinafter referred to as a control host) and a trans-catheter ventricular assist device intervention pump system (hereinafter referred to as an intervention pump system) used in cooperation with the control host, and is an interventional blood pump which can mechanically assist the circulation of patients with corresponding indications. The user can monitor the system state and physiological parameters of the patient on the control host interface, and provide different degrees of circulation assistance by adjusting the rotation speed of the intervention pump according to the needs of the patient, so as to temporarily maintain the blood circulation of important organs of the patient and unload the heart.

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

[0098] The structure of the intervention pump comprises a protection end 1, a pump head (containing an impeller, a support and a covering film), a repositioning sterile sleeve, a driving catheter and a driving catheter handle 2.

[0099] The function of the intervention pump is described as follows: the intervention pump can be percutaneously placed into the heart through the peripheral blood vessels, the pump head is placed between the left ventricle and the aorta, the blood inlet of the pump head is placed in the left ventricle, and the blood outlet of the pump head is placed in the aorta, so as to pump blood from the left ventricle into the aorta, thereby realizing the ventricular assist function.

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

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

[0102] The flush pump driving device 5 can be connected with the flush pipeline. The flush pump in the flush pump driving device 5 realizes the functions of flush liquid delivery and control by extruding the flush pipeline, so as to prevent blood from entering the intervention pump catheter to form a thrombus.

[0103] The console 3 provides a simple and intuitive operation interface for the user to realize the following functions: monitoring the running state of the trans-catheter ventricular assist device; displaying the system running state and patient physiological data, including rotation speed, blood pressure and flow; controlling the rotation speed of the driving motor and the flush pump; supporting the setting of alarm threshold and system parameters; the console 3 provides different levels of alarms, and automatically records each alarm information. Relevant charts will be displayed in the summary report.

[0104] After the above-mentioned driving catheter handle 2, flush pipeline and flush pump driving device 5 are connected, a flush channel is formed.

[0105] Please refer to Figure 2 , which shows a flowchart of a method for detecting the running state of a ventricular assist device provided by an embodiment of the present application. The above-mentioned ventricular assist device includes a driving device and an intervention pump. The above-mentioned driving device is used to drive the above-mentioned intervention pump to run. In one embodiment, the ventricular assist device has the structure of Figure 1 . The method includes the following steps:

[0106] S201. Obtain the current data of the driving device in the working state.

[0107] This application does not limit the current data. For example, the current data refers to any type of current in the aforementioned ventricular assist device. For instance, the current data could be the current of the drive motor in any drive device, the current of the motor controller corresponding to any drive motor, or a current value recalculated based on the aforementioned current value, such as the average current value or the difference in current variation. Among the various operating signals of the ventricular assist device, current is an easily detectable indicator, which can be detected externally or internally. This application will not elaborate on this aspect in its embodiments.

[0108] by Figure 1 Taking the ventricular assist device shown as an example, step S201 can be executed by the control host, that is, the control host acquires current data. Specifically, it can acquire the current of the flushing pump drive device or the current of the interventional pump drive device. In another embodiment, the ventricular assist device operation status detection method can be implemented by the aforementioned console, or by a controller built into the flushing pump drive device, or by a combination of the console and the controller built into the flushing pump drive device. This application does not limit the implementing entity for each step in the ventricular assist device operation status detection method; it can be adaptively configured according to the actual internal component composition of the ventricular assist device.

[0109] S202. When the current data indicates an increase in the load of the drive device, the operating status of the ventricular assist device is classified and identified based on the changes in the current data during the first time period.

[0110] After the ventricular assist device (VAM) reaches a stable operating state, the current data also tends to stabilize. If the current data suddenly and significantly increases over a period of time, indicating an increased load on the drive unit, the VAM is likely experiencing an operational malfunction. If the drive motor's operating target remains unchanged, such as the set speed, but the current data increases abnormally, it can be assumed that the load on the drive unit has increased.

[0111] In this embodiment, the aforementioned interventional pump includes at least a transmission system 6, a pump head 7, and a protective end 1. The transmission system includes a tubular component and a coupling rotating component. The pump head 7 includes an impeller (located inside the pump head, not shown in the figure). Figure 1 Taking a 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 component can be the drive catheter and / or drive shaft in the ventricular assist device (the drive shaft passes through the drive catheter), and the coupling rotating component can refer to the coupling rotating component of the coupling part between the interventional pump drive device and the interventional pump in the ventricular assist device.

[0112] Correspondingly, the step S202 can detect at least one of the following abnormal operating states: the abnormal operation of the transmission system, the abnormal bending of the tubular member, the eccentricity of the coupling rotating member, the abnormal operation of the impeller, the wrapping of the pump head around the heart tissue, and the abnormal contact of the protection tip with the inner wall of the heart. The abnormal contact of the protection tip with the inner wall of the heart is one type of the abnormal position of the protection tip, i.e., the abnormal contact between the protection tip and the inner wall of the heart.

[0113] Optionally, the abnormal contact of the protection tip with the inner wall of the heart includes at least one of the following situations:

[0114] The protection tip contacts the inner wall of the ventricle.

[0115] For some intervention pumps, the protection tip should not contact the inner wall of the heart when the intervention pump is correctly placed in the heart for pumping. In this case, the situation of the abnormal contact of the protection tip with the inner wall of the heart can be that the protection tip contacts the inner wall of the ventricle, which can be caused by the intervention pump being placed too deep in the heart.

[0116] For other intervention pumps, the protection tip needs to contact the inner wall of the heart when the intervention pump is correctly placed in the heart for pumping. In this case, the situation of the abnormal contact of the protection tip with the inner wall of the heart can be that the protection tip abnormally contacts the inner wall of the ventricle, which can be caused by the intervention pump being placed too deep in the heart, and the contact between the protection tip and the inner wall of the heart exceeds the safe range, i.e., the abnormal contact. Since the intervention pump itself cannot obtain the position image of the intervention pump in the heart, the application determines whether the situation of the abnormal contact of the protection tip with the inner wall of the heart occurs by judging the change of the current in a certain period of time. Those skilled in the art can determine the specific situation of the abnormal contact of the protection tip with the inner wall of the heart according to the specific intervention pump, which is not limited in the embodiments of the application.

[0117] By automatically distinguishing and identifying the above several abnormal operating states that cause the load increase, the time for the operator to investigate the cause of the load increase can be effectively shortened, and various situations are covered, thereby improving the alarm accuracy and safety of the ventricular assist device.

[0118] The first time period can be one or more time periods before the current time, or a time period from the start of the latest time period to the current time. Embodiments of the present application do not limit the length of the first time period and the load growth rate. For example, if the length of the first time period is less than a preset length and the load growth rate is greater than a preset rate, step S202 can be triggered. The preset length and the preset rate can be set according to actual conditions, and do not constitute an implementation barrier. If the length of the first time period is less than a preset length and the load growth rate is greater than a preset rate, it can be determined that the current data has a significant load increase, and the ventricular assist device is more likely to be in an abnormal operating state, 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 length and the preset rate, the starting time of step S202 can be controlled, that is, the frequency and sensitivity of the operating state detection in embodiments of the present application can be controlled. The operating state classification and identification in embodiments of the present application can analyze whether the ventricular assist device is in an abnormal operating state, and can further analyze the abnormal operating state of the ventricular assist device.

[0120] S203. issuing alarm information corresponding to the identification result, the identification result indicating the abnormal operating state causing the load increase.

[0121] Embodiments of the present application do not limit the specific content of the alarm information. In one embodiment, the alarm information can indicate the abnormal operating state causing the load increase. In another embodiment, the alarm information includes the abnormal operating state and abnormal degree information corresponding to the abnormal operating state, the abnormal degree information representing the severity of the abnormal operating state. In this embodiment, the alarm information not only indicates the abnormal operating state causing the load increase, but also indicates the severity of the abnormal operating state. By distinguishing the abnormal degree information, the operator can effectively distinguish the abnormal degree of the abnormal state, and help to distinguish different levels of alarm sound and / or alarm volume.

[0122] In another embodiment, the alarm information can include the abnormal operating state, and further include at least one of the following: abnormal degree information corresponding to the abnormal operating state, current data change, change of rotational speed data of a rotating part in the ventricular assist device, and probability of occurrence of the abnormal operating state. Embodiments of the present application do not limit the rotating part in the ventricular assist device, which can be a driving motor, a driving shaft, or a impeller.

[0123] In one embodiment, different abnormal operating states can generate different alarm information. The expression of different alarm information can be different, and the content and expression form of the alarm information are not limited in the embodiments of the present application. The subject of sending the alarm information is not limited in the embodiments of the present application, for example, the alarm information can be sent by the console of the control device, or by other devices connected to the ventricular assist device. Figure 1

[0124] In one embodiment, the target rotating speed corresponding to the rotating member can be set, and the driving device drives the intervention pump to rotate according to the target rotating speed, so as to stably maintain the rotating speed of the intervention pump at the target rotating speed or around the target rotating speed, and further achieve a stable blood flow. If the ventricular assist device has an abnormal situation that causes an increase in load, the rotating speed can change, or the current for maintaining the target rotating speed can change. The rotating speed change and the current change caused by different abnormal operating states can not be the same. In some cases, the load of the driving device increases slightly, and the driving device can continue to approach the target rotating speed of the rotating member of the ventricular assist device by increasing the driving current, so as to avoid the decrease in the rotating speed caused by the increase in the load.

[0125] In the case where the rotating speed data of the rotating member in the ventricular assist device approaches the target rotating 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 rising amplitude can be determined according to the difference between the stable current data after the rotating speed data approaches the target rotating speed and the stable current data before the current data changes. Then, the first degree information, such as the severity level, is determined according to the corresponding relationship between the rising amplitude of the current and the severity.

[0127] The embodiments of the present application do not limit the determination method of the first abnormality degree information, which can be realized by experimental methods and data analysis, and do not constitute an implementation obstacle. Moreover, the embodiments of the present application do not limit the explicit mapping formula between the rising amplitude of the current data and the severity indicated by the first abnormality degree information, as long as the rising amplitude of the current data is positively correlated with the severity indicated by the first abnormality degree information.

[0128] In other cases, the load of the driving device can increase significantly, and at this time, the driving device cannot overcome the rotating resistance even if the current is increased to the upper limit in time, and therefore, the rotating speed of the rotating member can decrease. In this case, the change amplitude of the current and the change amplitude of the rotating speed can both reflect the severity of the abnormal operating state.

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

[0130] The embodiments of the present application do not limit the determination manner of the second abnormality degree information, which can be realized by experimental methods and data analysis, and do not constitute an implementation obstacle. Moreover, the embodiments of the present application do not limit the explicit mapping formula between the severity indicated by the second abnormality degree information and the decrease amplitude of the rotation speed data, and do not limit the explicit mapping formula between the severity indicated by the second abnormality degree information and the increase amplitude of the current data, as long as a certain correlation is met.

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

[0132] In the embodiments of the present application, if the increase in the motor load is not too serious, the motor controller can increase the output current to drive the motor to rotate, so as to continue to maintain the rotation speed at the target rotation speed, and the rotation speed will not decrease obviously in this case. However, if the increase in the motor load is serious, that is, the abnormality is serious, even if the current output by the motor controller reaches the maximum upper limit value, the rotation speed cannot continue to reach the target rotation speed, and the rotation speed data will obviously decrease. In the scenario of calculating the second abnormality degree information, not only the serious increase in the current load occurs, but also the decrease in the rotation speed occurs. Therefore, the severity indicated by the second abnormality degree information is greater than the severity indicated by the first abnormality degree information.

[0133] For the alarm manner of the first abnormality degree information and the second abnormality degree information, different levels of alarms can be issued, and different alarm contents can be used to reflect different abnormality severities, and the embodiments of the present application do not limit this.

[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 together. For example, when the impeller is wrapped by the heart tissue or the protection end abnormally touches the wall, alarm information corresponding to the impeller being wrapped by the heart tissue or the protection end abnormally touching the wall can be independently issued, alarm information corresponding to the impeller operation abnormality can be output together, and alarm information corresponding to the load increase can also be output.

[0135] In some embodiments, a relatively broad alarm information can be directly output. In the case where the current data exceeds the first amplitude threshold, abnormal information indicating that the load of the driving device is increased is sent; in the case where the current data exceeds the second amplitude threshold, abnormal information indicating that the driving device is overloaded is sent, and the first amplitude threshold is less than the second amplitude threshold. The embodiments of the present application do not limit the first amplitude threshold and the second amplitude threshold as long as the relative relationship is met, and the first amplitude threshold and the second amplitude threshold can be set through experiments, which does not constitute an implementation obstacle. By sending the relatively broad alarm information, the risk of missing the alarm in the case of missing or false detection of the abnormal operating state can be avoided. Regardless of whether the device can identify the specific reason for the load increase, abnormal information indicating that the driving load is increased or overloaded is sent, thereby improving the safety of the device.

[0136] This alarm mode can directly alarm based on the abnormal current condition, and the specific reason for the load increase or overload can be determined by manual experience. In combination with manual experience and timely load abnormality alarm, on the one hand, the alarm sensitivity can be improved, and on the other hand, the reason for the load abnormality can be determined as soon as possible and accurately. If the load abnormality is caused by an increase in friction of the impeller bearing or extreme bending of the tubular member, such as extreme bending of the extracorporeal part, the tubular member can be adjusted. If the load abnormality is caused by eccentricity of the coupled rotating member, such as eccentricity of the connection between the driving motor and the intervention pump, the user can re-connect. If the load abnormality is caused by excessive bending of the protection end of the intervention pump, the intervention position of the intervention pump can be adjusted through DSA.

[0137] In one embodiment, the intervention pump includes a transmission system for transmitting power of the driving device to an impeller of the intervention pump, and the operating state of the ventricular assist device is classified and recognized according to the change of the current data in the first time period, including: in the case where the change of the current data meets the first current change characteristic, it is determined that the transmission system of the intervention pump is abnormal; wherein the first current change characteristic is used to represent the current change condition that the current rises and tends to be stable; and the alarm information corresponding to the recognition result includes: sending alarm information corresponding to the transmission system operating abnormally.

[0138] The transmission system operation abnormality can include an operation abnormality of any component in the transmission system. For example, if the transmission system includes a tubular member and / or a coupling rotating member, the transmission system operation abnormality includes an operation abnormality of the coupling rotating member or an abnormal bending of the tubular member. Embodiments of the present application do not limit the rising speed of the first current change feature and the current value in the stable state, which can be set according to actual conditions and do not constitute an implementation obstacle. The transmission system operation abnormality usually does not cause a sharp rise in current, and the rising speed is relatively slow compared with the rising speed caused by the intervention pump head winding into the heart tissue or the abnormal abutment of the protection end and the inner wall of the heart. Therefore, by limiting the current rising speed in the first current change feature, the transmission system operation abnormality can be preliminarily screened. For example, if the current rising speed in the first current change feature is less than a certain preset value, the intervention pump head winding into the heart tissue or the abnormal abutment of the protection end and the inner wall of the heart can be preliminarily excluded, and the transmission system operation abnormality is reasonably suspected.

[0139] The abnormal range of the abnormal state can be accurately identified as the traditional system by the first current change feature, rather than the intervention pump head or the protection end, which can effectively prompt the operator to make corresponding adjustments to solve the abnormal problem, reduce the troubleshooting range and troubleshooting time.

[0140] In embodiments of the present application, the determination of the transmission system operation abnormality of the intervention pump includes at least one of the following:

[0141] (1) In the case where the rising speed of the current data is greater than a first speed threshold, and the amplitude of the current data after rising tends to a first current threshold, it is determined that the tubular member of the intervention pump is abnormally bent, and the transmission system operation abnormality includes the abnormal bending of the tubular member.

[0142] (2) In the case where the rising speed of the current data is greater than a second speed threshold, and the amplitude of the current data after rising tends to a second current threshold, it is determined that the coupling rotating member of the intervention pump is eccentric, and the transmission system operation abnormality includes the eccentricity of the coupling rotating member; wherein the first speed threshold is greater than the second speed threshold.

[0143] Correspondingly, the transmission system operation abnormality corresponding alarm information includes: the tubular member abnormal bending corresponding alarm information; and / or, the coupling rotating member eccentricity corresponding alarm information.

[0144] The judgment condition is the current data change characteristic determined by the inventors according to the abnormal state occurrence position, its influence on system operation and related experiments. For different types of intervention pumps or different intervention pumps of the same type, 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 current change trend and the relative data characteristic are basically the same, therefore, the specific values of the first speed threshold, the second speed threshold, the first current threshold and the second current threshold are not limited in the present application, and can be set according to the actual situation, which does not constitute an implementation obstacle. As long as the relative relationship that the first speed threshold is greater than the second speed threshold is met.

[0145] The embodiment of the present application proposes that the eccentricity of the coupling rotating member or the abnormal bending of the tubular member can cause the current data to rise in a period of time, and the rising speed is relatively slow compared with the rising speed caused by the intervention pump head being wrapped into the heart tissue or the abnormal contact of the protection end with the inner wall of the heart. In many cases, the rising speed of the current caused by the eccentricity of the coupling rotating member may also be less than the rising speed of the current caused by the abnormal bending of the tubular member, because the abnormal bending of the tubular member is mostly caused by external force, so the load increase is sudden, and the current rising speed is fast, but after the intervention pump and the driving motor are coupled, the coupling relationship between the coupling rotating members is fixed, the eccentricity has an upper limit, and the occurrence of the eccentricity may be gradual, so the current rising speed is less than the current speed in the case of abnormal bending of the tubular member. Of course, the rising speed can be determined by the amplitude of the current change and the time interval of the change, and the calculation method of the rising speed is not described in the embodiment of the present application.

[0146] When the coupling rotating member is eccentric, the current data will have a rising trend, and as the degree of eccentricity is different, the current will gradually increase, and when the eccentricity reaches a certain degree, the current data tends to the second current threshold. The size of the second current threshold is not set in the embodiment of the present application, and can be set according to the actual situation. If the difference between the current data and the second current threshold gradually decreases and does not exceed the second current threshold in a period of time, it can be determined that the current data tends to the second current threshold, and it can be determined that the coupling rotating member is eccentric.

[0147] The eccentricity of the coupling rotating member and the abnormal bending of the tubular member can both cause the current data to rise to a limit value and then tend to be stable. In some cases, the rising speed of the current caused by the abnormal bending of the tubular member may be greater than the rising speed of the current caused by the eccentricity of the coupling rotating member, 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 the actual situation. The judgment method of the current data tending to the first current threshold is the same as the method of judging the current data tending to the second current threshold, which is not described herein.

[0148] The first current threshold or the second current threshold in the embodiments of the present application can be expressed by a proportional coefficient, which represents a proportion relative to the normal current. If the tubular member is abnormally bent during the operation of the intervention pump, when the bending reaches a certain degree, the current will rapidly rise, and the rising amplitude can exceed a certain proportion of the original normal operating current. Therefore, using the proportional coefficient to limit the first current threshold can quickly determine whether the determination condition of the abnormal bending of the tubular member is met. The embodiments of the present application do not limit the proportional coefficient, and the proportional coefficient can be set to assist in judging the abnormal bending of the tubular member. Of course, the embodiments of the present application do not limit the setting method and specific value of the proportional coefficient. The first current threshold and the second current threshold described above can also be preset thresholds.

[0149] In one embodiment, the intervention pump includes an impeller, and the operation state classification and identification of the ventricular assist device according to the change of the current data in the first time period includes: determining that the intervention pump has an impeller operation abnormality in a case where the change of the current data meets a second current change characteristic; wherein the second current change characteristic is used to represent a peak change condition in which the current first rises and then falls; and the alarm information corresponding to the identification result includes: issuing alarm information corresponding to the impeller operation abnormality.

[0150] The impeller operation abnormality can include an operation abnormality of any component closely related to the impeller, such as the impeller operation abnormality including a pump head position abnormality and / or a protection end position abnormality. The embodiments of the present application do not limit the rising speed of the second current change characteristic and the maximum current in the first-rising-and-then-falling process, which can be set according to actual conditions and do not constitute an implementation obstacle. The most prominent form of the second current change characteristic is that the current waveform appears as a sharp peak, so the second current change characteristic is also expressed as a sharp peak characteristic in the embodiments of the present application. In one embodiment, the current rising speed in the sharp peak characteristic can be higher than the current rising speed in the aforementioned transmission system operation abnormality, that is, the current rising speed of the second current change characteristic can be higher than the current rising speed of the first current change characteristic.

[0151] Therefore, by limiting the current rising speed in the second current change characteristic, the impeller operation abnormality can also be preliminarily screened, such as if the current rising speed is greater than a certain preset value and the current change meets the peak change characteristic of first rising and then falling, it can be preliminarily determined that the impeller operation abnormality is likely to occur.

[0152] In the embodiments of the present application, the determination that the intervention pump has an impeller operation abnormality includes at least one of the following:

[0153] (1) if the current data in the first time period appears a first peak characteristic, and the peak value and the peak width of the first peak characteristic meet a first peak characteristic requirement, it is determined that the intervention pump appears the situation of the pump head winding the heart tissue;

[0154] When the intervention pump is running, if the pump head is winding the heart tissue, the current will increase sharply, and the speed of the increase will be very obvious, which is obviously higher than the speed of the current increase in the abnormal situation of the transmission system, so that the situation of the pump head winding the heart tissue can be distinguished from the two situations of the abnormal bending of the tubular member and the eccentricity of the coupling rotating part. The first peak characteristic requirement in the embodiment of the application is essentially a peak shape requirement of the peak characteristic, which includes the peak value and the peak width, and the specific content can be set according to the actual situation of the heart tissue winding, which is not limited in the embodiment of the application.

[0155] (2) if the current data in the first time period periodically appears a second peak characteristic, and the peak value and the peak width of the second peak characteristic meet a second peak characteristic requirement, it is determined that the intervention pump appears the situation of the protection end abnormally touching the wall;

[0156] Correspondingly, the alarm information corresponding to the abnormal operation of the impeller includes: alarm information corresponding to the situation of the pump head winding the heart tissue; and / or, alarm information corresponding to the situation of the protection end abnormally touching the wall.

[0157] When the intervention pump is running, if the protection end abnormally touches the wall, the protection end will be bent, and the bearing structure and position will change due to the bending process of the protection end, which causes the change of the rotating torque of the impeller, and thus the change of the current. When the protection end is pressed and bent, the current will rapidly increase, and when the pressed state of the protection end is released, the current will rapidly decrease, forming a second peak characteristic. With the beating of the heart, the protection end will also periodically change, so the second peak characteristic also appears periodically. The second peak characteristic is similar to the first peak characteristic in waveform, but the specific shape may be different. The current increase speed indicated by the second peak characteristic is not as obvious as the current increase speed indicated by the first peak characteristic, that is, the current increase speed indicated by the second peak characteristic requirement is less than the current increase speed indicated by the first peak characteristic requirement. The second peak characteristic requirement can be set according to the shape of the peak characteristic generated by the abnormal touching of the actual protection end and the inner wall of the heart, and the embodiment of the application does not limit this.

[0158] Through the discrimination of the first peak characteristic and the second peak characteristic, the specific reason for the abnormal operation of the impeller can be accurately determined, that is, whether the pump head is winding the heart tissue or the protection end is abnormally touching the wall, so as to improve the accuracy of the alarm.

[0159] The application does not limit the determination of the peak value and the peak width of the first peak feature requirement and the second peak feature requirement, and does not constitute an implementation obstacle. The actual situation can be set according to the actual situation.

[0160] In one embodiment, the determination of the abnormal wall contact of the protection end of the intervention pump includes: in the case that the feature shape of the peak feature meets the first shape requirement, determining that the intervention pump has a straight pressure bending of the protection end; in the case that the feature shape of the peak feature meets the second shape requirement, determining that the intervention pump has an oblique pressure bending of the protection end; and the alarm information includes a wall contact type corresponding to the abnormal wall contact of the protection end, and the wall contact type includes at least one of the straight pressure bending of the protection end and the oblique pressure bending of the protection end.

[0161] The embodiments of the application do not limit the first shape requirement and the second shape requirement, which can be set according to the actual situation through experiments, and do not constitute an implementation obstacle. For example, the highest current corresponding to the peak feature can be taken as a reference, the feature formed in the process of the current rising to the highest current is the first half feature, and the feature formed in the process of the current starting to decline from the highest current is the second half feature. If the first half feature and the second half feature are substantially axisymmetric features, or the axisymmetric degree of the first half feature and the second half feature meets a preset requirement, it can be determined that the straight pressure bending of the protection end occurs, otherwise, it can be determined that the oblique pressure bending of the protection end occurs.

[0162] By identifying the shape of the peak feature, the wall contact of the protection end of the intervention pump in the ventricle can be quickly determined without the aid of DSA or ultrasonic imaging, so as to timely alarm the operator and facilitate the operator to quickly adjust the position of the intervention pump.

[0163] In one embodiment, the rotational speed data of the rotating member in the ventricular assist device can be further combined for abnormal state judgment. Please refer to Figure 3 which shows an abnormal state judgment method combined with rotational speed data in one embodiment of the application. The method includes:

[0164] Step S301. Obtain the rotational speed data of the rotating member in the ventricular assist device;

[0165] The embodiments of the application do not limit the rotating member, and the foregoing description of the rotating member is not repeated here.

[0166] Step S302. According to the change of the current data and the rotational speed data in the first time period, the running state of the ventricular assist device is classified and identified.

[0167] In the embodiments of the present application, in addition to using the current data, the rotational speed data can be further introduced for the classification and identification of the abnormal operating state, so as to further improve the identification accuracy of the abnormal operating state.

[0168] Reference can be made to Figure 4 which shows a schematic diagram of the operating state identification method combined with the rotational speed according to the embodiments of the present application. The embodiments of the present application can be combined with the rotational speed data for the classification and identification of the operating state by at least one of the following methods:

[0169] (1) In the case that the rising speed of the current data is greater than the first speed threshold, the amplitude of the current data after rising tends to the first current threshold, and the rotational speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular member of the intervention 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 the tubular member is abnormally bent and the tubular member is abnormally bent to a certain extent, the current will rapidly rise, and the rising amplitude may exceed a certain percentage of the original normal operating current. If the bending continues to increase, the rotational speed will relatively slowly decrease due to excessive friction. At this time, the change of the rotational speed can be combined to improve the identification accuracy of the tubular member abnormal bending. The embodiments of the present application do not limit the value and determination method of the third speed threshold, which does not constitute an implementation obstacle. In one embodiment, in the case that the difference between the current data and the first current threshold is less than a preset value, it is determined that the current data tends to the first current threshold. When the current data tends to the first current threshold, if the rotational speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular member is abnormally bent.

[0171] (2) In the case that the rising speed of the current data is greater than the second speed threshold, the amplitude of the current data after rising tends to the second current threshold, and the rotational speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the intervention pump has a coupling rotating member eccentricity.

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

[0173] (3) When the current data has the first peak characteristic in the first time period, the peak value and the peak width of the first peak characteristic meet the first peak characteristic requirement, and the speed data decreases at the first time and the amplitude after the decrease is less than the first speed threshold, it is determined that the intervention pump has the pump head winding heart tissue. The first time is determined based on the time when the current data reaches the peak current.

[0174] The first peak characteristic requirement has been described above and will not be repeated here. If the pump head winding heart tissue occurs, when the winding reaches the maximum degree, the current data will reach a local peak, and then the winding enters a stable state. The rotating member will stop running or run at a lower speed depending on the degree of winding. During the winding process, the change in current will exhibit the first peak characteristic. Therefore, the prediction accuracy and sensitivity of the pump head winding heart tissue can be improved by combining the first peak characteristic and the speed change. Of course, the embodiments of the present application do not limit the value and determination method of the first speed threshold, which does not constitute an implementation obstacle. Moreover, the timing of the speed decrease is not limited, as long as it has a certain relationship with the timing of the current data reaching the peak current. The timing of the speed decrease is the first time, which can be determined according to experiments.

[0175] (4) When the current data periodically has the second peak characteristic in the first time period, the peak value and the peak width of the second peak characteristic meet the second peak characteristic requirement, and the change amplitude of the speed data in the first time period is less than the first amplitude threshold, it is determined that the intervention pump has the protection end abnormal contact wall condition.

[0176] The second peak feature has been described above and will not be repeated here. The speed data will not change significantly in the case of abnormal contact of the protection end with the wall, so if the change in the speed data in the first time period is less than the first amplitude threshold, the occurrence of the abnormal contact of the protection end with the wall can be determined in combination with the recognition of the second peak feature. Of course, the value and determination method of the first amplitude threshold are not limited in the embodiments of the present application, which do not constitute an implementation obstacle.

[0177] The embodiments of the present application further give Table 1 according to the above, which shows the criterion comparison results of each operating state recognized in the embodiments of the present application.

[0178] Table 1

[0179]

[0180]

[0181] Based on the criteria in Table 1, the four cases of bending of the tubular member, eccentricity of the coupling rotating member, winding of the pump head around the heart tissue, and abnormal contact of the protection end with the wall can be recognized respectively.

[0182] The embodiments of the present application can classify and recognize the operating states of the ventricular assist device by detecting the change of the current data and the change of the speed data during the operation of the interventional pump. Specifically, the normal operating state and the abnormal operating state can be recognized, and the abnormal operating state can include the bending of the tubular member, the eccentricity of the coupling rotating member, the winding of the pump head around the heart tissue, or the abnormal contact of the protection end with the wall.

[0183] During the operation of the interventional pump in the heart, the possibility of winding of the pump head around the heart tissue or abnormal contact of the protection end with the wall exists. By detecting the change of the current waveform and the change of the speed when the impeller is wound around the heart tissue or the protection end is abnormally contacted with the wall, the winding of the impeller around the heart tissue or the bending of the protection end abnormally contacted with the heart can be detected, and an alarm is generated to prompt the user, so as to prevent danger and harm. In addition, the abnormal bending of the tubular member and the eccentricity of the coupling rotating member can also be detected according to the change of the current combined with the change of the speed, and an alarm information is generated in time to prompt the user to take corresponding measures as soon as possible to remove the abnormal state, such as adjusting the position of the pump, withdrawing and re-intervening, etc., to prevent the problem from continuing to worsen and to ensure the safety of the patient's life.

[0184] The embodiment of the present application can quickly detect abnormal working states of the tubular member, such as bending, eccentricity of the coupling rotating member, winding of the pump head around heart tissue, or abnormal contact of the protection end with the wall, without using DSA and ultrasound, without causing radiation damage to the user, and without causing the device to reduce the service life or be damaged, thereby reducing the risk and protecting the life safety of the patient.

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

[0186] Please refer to Figure 5 which shows a block diagram of a running state detection device of a ventricular assist device according to an embodiment of the present application. The ventricular assist device includes a driving device and an intervention pump, and the driving device is used to drive the intervention pump to run. The device can include:

[0187] A data acquisition module 501 is configured to acquire current data of the driving device in a working state.

[0188] A state detection module 502 is configured to, in a case where the current data indicates that the load of the driving device is increased, classify and identify the running state of the ventricular assist device according to the change of the current data in a first time period.

[0189] An alarm module 503 is configured to issue alarm information corresponding to the identification result, and the identification result indicates an abnormal running state causing the load increase.

[0190] In an embodiment, the intervention pump at least includes a transmission system, a pump head, and a protection end, the transmission system includes a tubular member and a coupling rotating member, and the pump head includes an impeller.

[0191] The abnormal running state includes at least one of the following: transmission system running abnormally, the tubular member is abnormally bent, the coupling rotating member is eccentric, the impeller is running abnormally, the pump head is wound around the heart tissue, and the protection end is abnormally in contact with the wall.

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

[0193] In a case where the change of the current data meets a first current change characteristic, it is determined that the transmission system of the intervention pump is running abnormally, and the first current change characteristic is used to represent a current change condition in which the current rises and tends to be stable.

[0194] The alarm information corresponding to the recognition result is sent, including:

[0195] The alarm information corresponding to the transmission system operation abnormality is sent.

[0196] In an embodiment, the transmission system includes a tubular member and / or a coupling rotating member, and the determination of the transmission system operation abnormality of the intervention pump includes:

[0197] In a case where the rising speed of the current data is greater than a first speed threshold, and the amplitude of the current data after rising tends to approach a first current threshold, it is determined that the intervention pump has a tubular member abnormal bending, and the transmission system operation abnormality includes the tubular member abnormal bending;

[0198] And / or, in a case where the rising speed of the current data is greater than a second speed threshold, and the amplitude of the current data after rising tends to approach a second current threshold, it is determined that the intervention pump has a coupling rotating member eccentricity, and the transmission system operation abnormality includes the coupling rotating member eccentricity;

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

[0200] The alarm information corresponding to the transmission system operation abnormality is sent, including:

[0201] The alarm information corresponding to the tubular member abnormal bending is sent; and / or, the alarm information corresponding to the coupling rotating member eccentricity is sent.

[0202] In an embodiment, the intervention pump includes an impeller, and the operation state classification recognition of the ventricular assist device according to the change of the current data in the first time period includes:

[0203] In a case where the change of the current data conforms to a second current change characteristic, it is determined that the intervention pump has an impeller operation abnormality; the second current change characteristic is used to represent a peak change of rising first and then falling;

[0204] The alarm information corresponding to the recognition result is sent, including:

[0205] The alarm information corresponding to the impeller operation abnormality is sent.

[0206] In an embodiment, the intervention pump includes a pump head and / or a protection end, and the determination of the impeller operation abnormality of the intervention pump includes:

[0207] if the current data has a first peak characteristic in the first time period, and a peak value and a peak width of the first peak characteristic meet first peak characteristic requirements, it is determined that the intervention pump has a pump head winding heart tissue condition;

[0208] and / or, if the current data periodically has a second peak characteristic in the first time period, and a peak value and a peak width of the second peak characteristic meet second peak characteristic requirements, it is determined that the intervention pump has an abnormal protection tip touching wall condition;

[0209] The alarm information corresponding to the abnormal impeller operation is issued, including:

[0210] The alarm information corresponding to the pump head winding heart tissue is issued; and / or, the alarm information corresponding to the abnormal protection tip touching wall is issued.

[0211] In one embodiment, the determination of the abnormal protection tip touching wall condition of the intervention pump includes:

[0212] In the case where the characteristic shape of the peak characteristic meets first shape requirements, it is determined that the intervention pump has a straight pressure bending condition of the protection tip;

[0213] In the case where the characteristic shape of the peak characteristic meets second shape requirements, it is determined that the intervention pump has an oblique pressure bending condition of the protection tip;

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

[0215] In one embodiment, the method further includes:

[0216] Obtaining rotational speed data of a rotating member in the ventricular assist device;

[0217] The running state classification identification of the ventricular assist device according to the change of the current data in the first time period includes:

[0218] The running state classification identification of the ventricular assist device according to the change of the current data and the rotational speed data in the first time period.

[0219] In one embodiment, the intervention pump includes at least one of a tubular member, a coupling rotating member, a pump head and a protection tip, and the running state classification identification of the ventricular assist device according to the change of the current data and the rotational speed data in the first time period includes:

[0220] In a case where 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, the rotating speed data decreases and the decreasing speed is less than the third speed threshold, it is determined that the tubular member of the intervention pump is abnormally bent.

[0221] And / or, in a case where 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, the rotating speed data decreases and the decreasing speed is greater than the fourth speed threshold, it is determined that the coupling rotating member of the intervention pump is eccentric.

[0222] And / or, in a case where the current data has a first peak characteristic in the first time period, the peak value and the peak width of the first peak characteristic meet the first peak characteristic requirement, the rotating speed data decreases at the first time and the amplitude after decreasing is less than the first rotating speed threshold, it is determined that the pump head of the intervention pump is entangled with the heart tissue; the first time is determined based on the time when the current data reaches the peak current.

[0223] And / or, in a case where the current data periodically has a second peak characteristic in the first time period, the peak value and the peak width of the second peak characteristic meet the second peak characteristic requirement, and the change amplitude of the rotating speed data in the first time period is less than the first amplitude threshold, it is determined that the protection end of the intervention pump abnormally touches the wall.

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

[0225] In an embodiment, the method further includes:

[0226] In a case where the rotating speed data of the rotating member of the ventricular assist device approaches a target rotating speed, a first abnormal 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 abnormal degree information.

[0227] In a case where the rotating speed data decreases relative to the target rotating speed, a second abnormal degree information is determined based on at least one of the rising amplitude of the current data and the decreasing amplitude of the rotating speed data.

[0228] The severity indicated by the second abnormal degree information is positively correlated with the decreasing amplitude of the rotating speed data, the severity indicated by the second abnormal degree information is positively correlated with the rising amplitude of the current data, and the severity indicated by the first abnormal degree information is less than the severity indicated by the second abnormal degree information.

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

[0230] In the case that the current data exceeds a first amplitude threshold, abnormal information indicating an increase in the load of the driving device is sent out;

[0231] In the case that the current data exceeds a second amplitude threshold, abnormal information indicating an overload of the driving device is sent out, and the first amplitude threshold is less than the second amplitude threshold.

[0232] It should be noted that the device provided in the above embodiment is only used as an example to divide the above functional modules when realizing its functions, and in actual application, the above functions can be completed by different functional modules according to needs, that is, the internal structure of the device is divided into different functional modules to complete all or part of the above described functions. 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 described here.

[0233] The embodiment of the present application also provides an electronic device of a ventricular assist device, which comprises a processor and a memory, the memory stores at least one instruction, and the at least one instruction is loaded and executed by the processor to realize the operation state detection method of the ventricular assist device.

[0234] The electronic device includes but is not limited to Figure 1 The control host in the embodiment.

[0235] The embodiment of the present application also provides a ventricular assist device, which comprises a driving device, an intervention pump and the electronic device of the ventricular assist device.

[0236] In the exemplary embodiment, a computer readable storage medium is also provided, the storage medium stores at least one instruction, at least one program, a code set or an instruction set, and the at least one instruction, the at least one program, the code set or the instruction set is executed by the processor to realize the operation state detection method of the ventricular assist device.

[0237] Optionally, the computer readable storage medium can include: a ROM (Read Only Memory), a RAM (Random Access Memory), a SSD (Solid State Drives), an optical disc, or the like. Among them, the random access memory can include ReRAM (Resistance Random Access Memory) and DRAM (Dynamic Random Access Memory).

[0238] In the example embodiment, a computer program product or computer program is also provided, which includes computer instructions stored in a computer readable storage medium. The processor of the computer device reads the computer instructions from the computer readable storage medium, and the processor executes the computer instructions to enable the computer device to perform the operation state detection method of the ventricular assist device.

[0239] It should be understood that "multiple" referred to herein refers to two or more. The "and / or" describes the association relationship of the associated objects, which means that there can be three relationships, for example, A and / or B can represent: A exists alone, A and B exist together, and B exists alone. The character " / " generally represents that the associated objects before and after it are in an "or" relationship. In addition, the step numbers described herein only exemplarily show a possible execution order between steps, and in some other embodiments, the above steps can also be executed in a non-numbered order, such as simultaneously executing two steps with different numbers, or executing two steps with different numbers in an order opposite to the illustration, and the embodiments of the present application do not limit 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 target, and can be implemented entirely or partially by using software, hardware (such as a processing circuit or a memory) or a combination thereof. Similarly, one 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 a part of an integral module or unit that includes the functions of the module or unit.

[0241] In addition, in the specific embodiments of the present application, data related to user information and the like are involved, and when the above embodiments of the present application are applied to specific products or technologies, the user's permission or consent needs to be obtained, and the collection, use and processing of related data need to comply with relevant laws, regulations and standards in relevant countries and regions.

[0242] The above merely provides exemplary embodiments of the present application, and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall fall within the protection scope of the present application.

Claims

1. A method of detecting an operating state of a ventricular assist device, characterized by The ventricular assist device comprises a driving device and an intervention pump, the driving device is used for driving the intervention pump to operate, and the method comprises: obtaining current data of the driving device in a working state and rotating speed data of a rotating part in the ventricular assist device; in the case that the current data indicates that the load of the driving device increases, according to the change of the current data and the rotating speed data in a first period, the operating state of the ventricular assist device is classified and identified; an alarm information corresponding to the identification result is sent, and the identification result indicates an abnormal operating state causing the load increase.

2. The method of claim 1, wherein, The intervention pump at least comprises a transmission system, a pump head and a protection end, the transmission system comprises a tubular member and a coupling rotating part, and the pump head comprises an impeller; The abnormal operating state comprises at least one of the following: the transmission system operates abnormally, the tubular member is abnormally bent, the coupling rotating part is eccentric, the impeller operates abnormally, the pump head is wound around the heart tissue, and the protection end abnormally touches the wall.

3. The method of claim 2, wherein, The protection end abnormally touching the wall comprises at least one of the following situations: The protection end abuts against the inner wall of the ventricle; The protection end abnormally abuts against the inner wall of the ventricle.

4. The method of claim 1, wherein, The intervention pump comprises a transmission system, the transmission system is used for transmitting power of the driving device to an impeller of the intervention pump, and according to the change of the current data and the rotating speed data in a first period, the operating state of the ventricular assist device is classified and identified, which comprises: In the case that the change of the current data meets a first current change characteristic, it is determined that the transmission system of the intervention pump operates abnormally; wherein the first current change characteristic is used to represent a current change condition that the current rises and tends to be stable; The alarm information corresponding to the identification result is sent, which comprises: The alarm information corresponding to the abnormal operation of the transmission system is sent.

5. The method of claim 4, wherein, The transmission system comprises a tubular member and / or a coupling rotating part, and the determination that the intervention pump has a transmission system operating abnormally comprises: In the case that the rising speed of the current data is greater than a first speed threshold value, and the amplitude of the current data after rising tends to a first current threshold value, it is determined that the tubular member of the intervention pump is abnormally bent, and the transmission system operating abnormally comprises the tubular member being abnormally bent; And / or, in the case that the rising speed of the current data is greater than a second speed threshold value, and the amplitude of the current data after rising tends to a second current threshold value, it is determined that the coupling rotating part of the intervention pump is eccentric, and the transmission system operating abnormally comprises the coupling rotating part being eccentric; Wherein, the first speed threshold value is greater than the second speed threshold value; The alarm information corresponding to the abnormal operation of the transmission system is sent, which comprises: The alarm information corresponding to the abnormal bending of the tubular member is sent; and / or, the alarm information corresponding to the eccentricity of the coupling rotating part is sent.

6. The method of claim 1, wherein, The intervention pump comprises an impeller, and according to the change of the current data and the rotating speed data in a first period, the operating state of the ventricular assist device is classified and identified, which comprises: In a case where the variation of the current data conforms to a second current variation feature, it is determined that the impeller of the intervention pump is abnormal; wherein the second current variation feature is used to represent a peak-type variation in which the current first increases and then decreases; The alarm information corresponding to the identification result is sent, including: The alarm information corresponding to the impeller abnormality is sent.

7. The method of claim 6, wherein, The intervention pump includes a pump head and / or a protection end, and the determination of the impeller abnormality of the intervention pump 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 intervention pump is wound around the heart tissue; And / or, if the current data periodically has 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 end of the intervention pump is abnormally touched against the wall; The alarm information corresponding to the impeller abnormality is sent, including: The alarm information corresponding to the pump head wound around the heart tissue is sent; and / or, the alarm information corresponding to the protection end abnormally touched against the wall is sent.

8. The method of claim 7, wherein, The determination of the intervention pump appearing the protection end abnormally touched against the wall includes: In a case where the feature shape of the peak feature conforms to a first shape requirement, it is determined that the intervention pump appears the protection end straightly pressed and bent; In a case where the feature shape of the peak feature conforms to a second shape requirement, it is determined that the intervention pump appears the protection end obliquely pressed and bent; The alarm information includes a wall type corresponding to the protection end abnormally touched against the wall, and the wall type includes at least one of the protection end straightly pressed and bent and the protection end obliquely pressed and bent.

9. The method of claim 1, wherein, The intervention pump includes at least one of a tubular member, a coupling rotating member, a pump head and a protection end, and the operation state classification identification of the ventricular assist device according to the variation of the current data and the rotating speed data in the first time period includes: In a case where the rising speed of the current data is greater than a first speed threshold, the amplitude of the current data after rising tends to a first current threshold, the rotating speed data decreases and the decreasing speed is less than a third speed threshold, it is determined that the intervention pump appears the tubular member abnormally bent; And / or, in a case where the rising speed of the current data is greater than a second speed threshold, the amplitude of the current data after rising tends to a second current threshold, the rotating speed data decreases and the decreasing speed is greater than a fourth speed threshold, it is determined that the intervention pump appears the coupling rotating member eccentric; And / or, in a case where 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 rotating speed data decreases at a first time and the amplitude after decreasing is less than a first rotating speed threshold, it is determined that the pump head of the intervention pump is wound around the heart tissue; the first time is determined based on the time when the current data reaches the peak current. And / or, the current data periodically appears a second peak feature in the first time period, the peak value and the peak width of the second peak feature meet second peak feature requirements, and the change amplitude of the rotation speed data in the first time period is less than a first amplitude threshold, it is determined that the intervention pump appears the protection end abutting a wall situation.

10. The method according to any one of claims 1 to 9, characterized in that, The alarm information includes the abnormal operating state and abnormal degree information corresponding to the abnormal operating state, and the abnormal degree information represents the severity of the abnormal operating state.

11. The method of claim 10, wherein, The method further includes: In the case where the rotation speed data of the rotating member in the ventricular assist device approaches a target rotation speed, first abnormal 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 abnormal degree information. In the case where the rotation speed data decreases relative to the target rotation speed, second abnormal degree information is determined based on at least one of the rising amplitude of the current data and the decreasing amplitude of the rotation speed data. The severity indicated by the second abnormal degree information is positively correlated with the decreasing amplitude of the rotation speed data, the severity indicated by the second abnormal degree information is positively correlated with the rising amplitude of the current data, and the severity indicated by the first abnormal degree information is less than the severity indicated by the second abnormal degree information.

12. The method according to any one of claims 1 to 9, characterized in that, After the current data of the driving device in the working state is obtained, the method further includes: In the case where the current data exceeds a first amplitude threshold, abnormal information indicating that the driving device load is increased is issued; In the case where the current data exceeds a second amplitude threshold, abnormal information indicating that the driving device is overloaded is issued, and the first amplitude threshold is less than the second amplitude threshold.

13. A device for detecting the operating state of a ventricular assist device, characterized by The ventricular assist device includes a driving device and an intervention pump, and the device includes: A data acquisition module is configured to acquire current data of the driving device in a working state and rotation speed data of a rotating member in the ventricular assist device. A state detection module is configured to, in the case where the current data indicates that the load of the driving device is increased, classify and identify the operating state of the ventricular assist device according to the change of the current data and the rotation speed data in a first time period. An alarm module is configured to issue alarm information corresponding to the identification result, and the identification result indicates an abnormal operating state causing the load increase.

14. An electronic device of a ventricular assist device, characterized by The electronic device of the ventricular assist device includes a processor and a memory, and the memory stores at least one instruction, which is loaded and executed by the processor to implement the operating state detection method of the ventricular assist device according to any one of claims 1 to 12.

15. A ventricular assist device, characterized by The electronic device of the ventricular assist device includes a driving device, an intervention pump, and the ventricular assist device according to claim 14.

16. A computer-readable storage medium, characterized in that, The storage medium stores at least one instruction, which is loaded and executed by the processor to implement the operating state detection method of the ventricular assist device according to any one of claims 1 to 12.

17. A computer program product, characterised in that, The computer program product comprises computer instructions stored in a computer readable storage medium, a processor of a computer device reads the computer instructions from the computer readable storage medium, and the processor executes the computer instructions, so that the computer device executes to realize the operation state detection method of the ventricular assist device according to any one of claims 1 to 12.

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