Position anomaly detection method and device

Abstract

The invention provides a position anomaly detection method and device, and the method comprises the steps: obtaining detection data which is the operation data of a ventricular assist device and / or the image data of a target user after the ventricular assist device is implanted into the target user; calculating target detection parameters according to the detection data; and if the target detection parameter is greater than the target threshold, determining that the position of the ventricular assist device in the target user is abnormal. Whether the relative position of the ventricular assist device and the heart is changed or not is detected by acquiring the operation data of the ventricular assist device and / or the image data of other detection equipment, so that the problems of over-aspiration, flow reduction, thrombus generation, bleeding and the like caused by the change of the position of the ventricular assist device relative to the heart can be avoided.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a method and device for detecting abnormal positions. Background Art

[0002] The short-term ventricular assist device is one of the effective treatment methods for heart failure and related complications. By providing hemodynamic support for patients in the short term, it promotes the rapid recovery of the heart and other important tissues and organs. Among them, the ventricular assist device that assists the heart's pumping function is the key. The relative position of the ventricular assist device in the heart during operation determines whether the implantable ventricular assist device can assist the patient in achieving the pumping function.

[0003] However, for implantable ventricular assist devices, they are prone to compression and change in direction during the perioperative period after surgery, resulting in a change in the relative position between the ventricular assist device and the heart, which may lead to phenomena such as wall suction, inlet blockage, and outlet kinking, thereby increasing the risks of over-suction, reduced flow, thrombosis, or bleeding, and affecting perioperative management and the patient's recovery process. Summary of the Invention

[0004] Embodiments of this application provide a method and device for detecting abnormal positions, which can detect whether the position of the ventricular assist device in the target user is abnormal.

[0005] In a first aspect, embodiments of this application provide a method for detecting abnormal positions, which is applied to a ventricular assist device. The method includes:

[0006] Obtain detection data, where the detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user;

[0007] Calculate a target detection parameter according to the detection data;

[0008] If the target detection parameter is greater than a target threshold, determine that the position of the ventricular assist device in the target user is abnormal.

[0009] In a second aspect, a controller of a ventricular assist device provided by embodiments of this application includes one or more processors, and the one or more processors are used for:

[0010] Obtain detection data, where the detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user;

[0011] Calculate a target detection parameter according to the detection data;

[0012] If the target detection parameter is greater than the target threshold, it is determined that the position of the ventricular assist device in the target user is abnormal.

[0013] In a third aspect, an embodiment of the present application provides a medical device, which includes a processor, a memory, a communication interface, and one or more programs. The one or more programs are stored in the memory and are configured to be executed by the processor. The programs include instructions for performing some or all of the steps described in the method of the first aspect above.

[0014] In a fourth aspect, an embodiment of the present application provides a computer-readable storage medium, which stores a computer program for electronic data exchange. The computer program causes a computer to execute some or all of the steps described in the method of the first aspect above.

[0015] In a fifth aspect, an embodiment of the present application provides a computer program product. The computer program product includes a non-transitory computer-readable storage medium storing a computer program. The computer program is operable to cause a computer to execute some or all of the steps described in the method of the first aspect of the embodiments of the present application. The computer program product can be a software installation package.

[0016] The technical solution provided by the present application is to obtain detection data, which is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user; calculate a target detection parameter according to the detection data; if the target detection parameter is greater than the target threshold, it is determined that the position of the ventricular assist device in the target user is abnormal. By obtaining the operation data of the ventricular assist device and / or the image data of other detection devices to detect whether the relative position of the ventricular assist device and the heart has changed, problems such as over-suction, reduced flow rate, thrombus formation, and bleeding caused by the change in the relative position of the ventricular assist device and the heart can be avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0018] Figure 1 is a schematic diagram of a ventricular assist system provided by an embodiment of the present application;

[0019] Figure 2 is a schematic structural diagram of a ventricular assist device provided by an embodiment of the present application;

[0020] Figure 3 It is a schematic diagram of a medical monitoring system provided by an embodiment of the present application;

[0021] Figure 4 It is a schematic flowchart of a method for detecting abnormal positions provided by an embodiment of the present application;

[0022] Figure 5 It is a schematic diagram of determining whether the position of a ventricular assist device is abnormal by an X-ray image provided by an embodiment of the present application;

[0023] Figure 6 It is a schematic diagram of determining whether the position of a ventricular assist device is abnormal by an ultrasonic image provided by an embodiment of the present application;

[0024] Figure 7 It is a schematic diagram of the structure of a medical device provided by an embodiment of the present application. Detailed implementation manners

[0025] For better understanding of the technical solutions of the present application by those skilled in the art, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, rather than all embodiments. Based on the description of the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative efforts fall within the scope protected by the present application.

[0026] Terms such as "first" and "second" in the specification and claims of the present application and the above-mentioned drawings are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, software, product or device that includes a series of steps or units is not limited to the listed steps or units, but also includes unlisted steps or units, or other steps or units inherent to these processes, methods, products or devices.

[0027] Referring to "embodiment" herein means that a specific feature, structure or characteristic described in connection with the embodiment may be included in at least one embodiment of the present application. The phrase appears in various places in the specification and does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art will explicitly and implicitly understand that the embodiments described herein may be combined with other embodiments.

[0028] The medical device involved in this application can be a ventricular assist device in medical auxiliary devices. The ventricular assist device can be an implantable or interventional ventricular assist device (Ventricular Assist Devices, VAD), and the VAD can be attached to the left ventricle, or the right ventricle, or both ventricles of the heart. The ventricular assist device can further include a centrifugal pump, an axial flow pump, etc. that can deliver the entire output to the left ventricle according to pulmonary circulation or blood circulation.

[0029] The "current" in this application refers to the current that drives a motor or an electric machine, which is associated with the power of the motor or the electric machine under the condition of a constant supply voltage. The "rotation speed" refers to the rotational speed of the motor or the electric machine, which is associated with the rotational speed of the rotor or impeller of the ventricular assist device and can be defined as revolutions per minute. The "flow rate", "fluid flow rate", and "pumping flow rate" refer to the volume of fluid delivered through the ventricular assist device per unit time, which can be estimated and measured in liters per minute.

[0030] The embodiments of this application are described by taking a centrifugal magnetic levitation pump as an example.

[0031] For example, please refer to Figure 1 , the ventricular assist system includes a ventricular assist device 100, an external controller 200, and a transmission component 300 that connects the ventricular assist device 100 to the external controller 200. One end of the transmission component 300 is connected to the motor inside the ventricular assist device 100, and the other end passes through the patient's skin and is connected to the external controller 200 arranged outside the body. The external controller 200 is used to monitor the ventricular assist device 100, and it can implement functions such as control and data display of the ventricular assist device 100, fault detection and alarm, and data recording. The transmission component 300 can be a percutaneous cable, and the cable can include one or more power supply cables and one or more communication cables.

[0032] The ventricular assist device 100 can be attached to the heart via a ventricular connection component (such as a top ring, a ventricular cuff, a ventricular sleeve), and the ventricular connection component can be sutured to the heart and connected to the blood pump. One end of the ventricular assist device 100 enters the left ventricle through the apex of the heart via an inlet tube, and the other end of the ventricular assist device 100 is connected to the ascending aorta via an outlet tube and / or an artificial blood vessel connected to the outlet tube. In this way, the ventricular assist device 100 can pump the blood in the left ventricle into the aorta, effectively transferring the blood from the weakened ventricle and pushing it into the aorta, so as to circulate to the remaining part of the patient's vascular system and provide ventricular assist function for the patient.

[0033] For example, please refer to Figure 2 , Figure 2FIG. 0 is a schematic structural diagram of a ventricular assist device 100 provided by an embodiment of the present application. The ventricular assist device 100 includes a housing assembly, an impeller 20 disposed in the housing assembly, and a motor 10 that drives the impeller 20 to rotate in a suspended manner.

[0034] The housing assembly has an inlet pipe 14, an outlet pipe 15, and a first chamber 30 and a second chamber 40 that are spaced apart. Both the inlet pipe 14 and the outlet pipe 15 communicate with the first chamber 30. In the illustrated embodiment, the central axis 21 of the inlet pipe 14 and the central axis of the outlet pipe 15 are perpendicular; the first chamber 30 and the second chamber 40 are arranged along the central axis 21 of the inlet pipe 14. Among them, the first chamber 30 has a first chamber wall 31 and a second chamber wall 32 that are spaced apart and opposite along the central axis 21 of the inlet pipe 14. The second chamber 40 is disposed close to the second chamber wall 32.

[0035] The impeller 20 is rotatably disposed in the first chamber 30. Among them, the impeller 20 is located between the first chamber wall 31 and the second chamber wall 32. Specifically, when the impeller 20 operates smoothly, the rotation axis 21 of the impeller 20 coincides with the central axis of the inlet pipe 14. By the rotation of the impeller 20, external liquid (such as blood) enters the first chamber 30 from the inlet pipe 14 and flows out from the outlet pipe 15.

[0036] The motor 10 includes a stator 11 and a rotor 13. The stator 11 is disposed in the second chamber 40, the rotor 13 is disposed in the first chamber 30, and the rotor 13 is fixedly connected to the impeller 20. Among them, the stator 11 can drive the rotor 13 to rotate in a suspended manner, and the impeller 20 can rotate in a suspended manner with the rotor 13. Specifically, the rotor 13 is disposed inside the impeller 20. The suspended rotation of the impeller 20 means that the impeller 20 does not contact the chamber wall of the first chamber 30 during rotation.

[0037] Exemplarily, the motor 10 can be a three-phase brushless direct current (BLDC) motor. The stator 11 has three windings controlled by different corresponding phases U, V, and W of the power input controlled by a three-phase motor. The motor 10 may further include an inverter circuit, and the inverter circuit can be used to convert the DC input into a three-phase output. Exemplarily, the ventricular assist device 100 can receive a three-phase AC input.

[0038] The impeller 20 moves axially relative to the housing assembly along the rotation axis 21. During rotation, the impeller 20 is suspended within the housing assembly by a contactless bearing, such as a magnetic bearing, which can generate a magnetic levitation system. For example, in some embodiments, magnets (not shown in the figures) are further provided in the housing assembly and the impeller 20 respectively. The magnets in the housing assembly and the impeller 20 together constitute a magnetic bearing. The acting force generated by the magnetic bearing on the impeller 20 and the magnetic force generated between the stator 11 and the rotor 13 act on the impeller 20 together, so that the impeller 20 is suspended in the first chamber 30 in a state of magnetic force balance, thereby realizing the suspended rotation motion state of the impeller 20. The control unit 33 can control the suspended attitude and position of the impeller 20 by controlling the magnetic force between the stator 11 and the rotor 13. At the same time, in the direction perpendicular to the rotation axis 21, a torsional force is generated by using the attraction and repulsion between the stator 11 and the rotor 13, and this torsional force causes the impeller 20 to rotate in this direction. When the impeller 20 rotates at a preset speed, the attraction or thrust between the stator 11 and the rotor 13 causes the impeller 20 in the first chamber 30 to rotate while suspended in the first chamber 30.

[0039] The ventricular assist device 100 further includes a control unit 33 and a sensor 50. The control unit 33 is electrically connected to an external controller 200. The external controller 200 supplies power to the control unit 33 and sends operation control commands (such as a motor start command, a speed setting command, etc.) to the control unit 33 according to user operations. The control unit 33 controls the operation of the motor using a stored application software program, thereby realizing the pumping function of the ventricular assist device 100. The control unit 33 is electrically connected to the stator 11, and the sensor 50 is electrically connected to the control unit 33. The sensor 50 is used to detect the magnetic pole angle and the suspended height of the impeller 20. The control unit 33 is used to receive the detection results of the sensor 50 and can control the speed and the suspended height of the impeller 20 through the motor 10 according to the detection results. Specifically, the suspended height of the impeller 20 is the distance of the impeller 20 relative to the second chamber wall 32.

[0040] Furthermore, the control unit 33 is used to monitor and control the start and subsequent operation of the motor 10, including implementing a Field-Oriented Control (FOC) method. The control unit 33 can be a module independent of the stator 11 or can be built into the stator 11. The control unit 33 includes hardware and software for controlling various aspects of the operation of the motor 10. The control unit 33 can be coupled to the motor 10 through an interface for collecting at least one data of the motor 10. The at least one data can include the measured current flowing through the stator 11, the data measured by the sensor 50, the motor speed, the pressure difference across the pump, the flow pulsatility, the fluid flow rate, and so on.

[0041] The sensor 50 can be a Hall sensor, an eddy current sensor, a distance sensor, etc.

[0042] In a possible example, the ventricular assist system can be communicatively connected to the medical system of a hospital, that is, the controller 200 is connected to the electronic devices or medical devices in the medical system. The controller 200 can send the operation data of the ventricular assist device 100 and the basic user data of the user associated with the ventricular assist device to the medical system. The medical system can analyze and process the received operation data of the ventricular assist device 100 and the data detected by the medical devices in the medical system for the associated user, and can realize the monitoring and treatment of the associated user.

[0043] In another possible example, as Figure 3 shown, the embodiment of the present application further provides a medical monitoring system. The medical monitoring system includes a plurality of first medical devices, a plurality of second medical devices, and a server. The server is communicatively connected to the plurality of first medical devices and the plurality of second medical devices respectively. The first medical device is used to be implanted into a user's body and provide a cardiac assist function for the user; the second medical device is used to monitor the health status of the user. The plurality of first medical devices and the plurality of second medical devices are used to simultaneously implement the treatment and monitoring of the user.

[0044] Exemplarily, the medical device can be the above Figure 1 ventricular assist system. The server can be communicatively connected to the controller 200 in each ventricular assist system for the user. The second medical device can include at least one of the following: a vital sign monitoring device, an imaging examination device, a laboratory testing device. For example, an electrocardiogram monitor, a comprehensive vital sign monitor, an ultrasound device, a CT device, an X-ray device, a blood analyzer, a biochemical analyzer, etc.

[0045] The server receives in real time the operation data of the first medical device, as well as the vital sign data, laboratory data, imaging results, etc. sent by the second medical device. The server processes and analyzes these data to assist medical staff in judging the hemodynamic characteristics and physiological state of the user after surgery, and can predict and judge postoperative complications and whether there are current abnormalities in the user and the ventricular assist device according to the analysis results. Furthermore, when an abnormality occurs to the user, the first medical device and the medication plan for the user can be adjusted to prevent the user from deteriorating and aggravating the condition.

[0046] A ventricular assist device can be implanted in a user's body for a long time to assist the pumping function of the user's heart. After the target user undergoes the operation of implanting the ventricular assist device, during the recovery stage of the target user and the normal life stage after discharge, neither the user nor the medical staff can monitor in real time whether the relative position of the ventricular assist device and the heart has changed. When the orientation of the inlet tube of the ventricular assist device changes, it may cause phenomena such as wall suction, inlet tube blockage, and outlet tube (artificial blood vessel) folding, which may further increase the risks of over-suction, reduced flow rate, thrombosis, or bleeding, affecting the user's recovery and health.

[0047] Based on this, the present application proposes a method for detecting abnormal position, which detects whether the relative position of the ventricular assist device and the heart has changed by obtaining the operation data of the ventricular assist device and / or the image data of other detection devices, so as to avoid problems such as over-suction, reduced flow rate, thrombosis, and bleeding caused by the change of the relative position of the ventricular assist device relative to the heart.

[0048] Combined with the above description, taking the implantation of the ventricular assist device in the left ventricle as an example, the present application will be described from the perspective of method examples below.

[0049] Please refer to Figure 4 , Figure 4 which is a schematic flow chart of a method for detecting abnormal position provided by an embodiment of the present application, and is applied to the ventricular assist device as shown in Figure 1 . As shown in Figure 4 , the method includes the following steps.

[0050] S410. Obtain detection data, where the detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted in the target user.

[0051] Among them, the detection data can be the operation data from the first medical device (i.e., the ventricular assist device 100), or the data detected or monitored by the second medical device (other medical devices). By way of example, the detection data can be at least one of the pumping flow curve of the ventricular assist device 100 implanted in the target user's body, the standard X-ray chest image of the target user after implanting the ventricular assist device 100 collected by the X-ray device, and the ultrasonic image of the target user after implanting the ventricular assist device 100 collected by the ultrasonic device.

[0052] S420. Calculate a target detection parameter according to the detection data.

[0053] When the ventricular assist device 100 passes through the apex of the heart and is attached to the heart via a ventricular connection assembly, the desired position of the ventricular assist device is such that the inlet tube of the ventricular assist device faces the mitral valve, that is, the central axis 21 of the inlet tube coincides as much as possible with the central axis between the apex of the heart and the mitral valve, so that the inlet tube of the ventricular assist device is away from the inner wall of the left ventricle, thereby avoiding problems such as tissue in the left ventricle blocking the inlet tube or wall suction caused by the inlet tube being close to the inner wall of the left ventricle.

[0054] The server or medical system can obtain the image data of the ventricular assist device and / or other medical devices that detect the target user, calculate the target detection parameters that can judge the relative position change of the ventricular assist device with respect to the heart, and determine whether the position of the ventricular assist device in the target user is abnormal by discriminating the target detection parameters.

[0055] Exemplarily, when the detection data is the X-ray chest film image of the target user, the calculating the target detection parameters according to the detection data includes: identifying a first central axis and a second central axis from the X-ray chest film image, where the first central axis is the central axis of the inlet tube of the ventricular assist device, and the second central axis is the central axis from the apex of the heart of the target user to the mitral valve; calculating a target angle, where the target angle is the angle between the first central axis and the second central axis.

[0056] Among them, the outlines of the heart, chest cavity, and ventricular assist device are depicted in the X-ray chest film images in the supine and lateral positions. The position of the ventricular assist device in the heart of the target user can be seen from the outlines of the heart and the ventricular assist device. Therefore, collect the X-ray chest film images of the target user in the supine and lateral positions after implanting the ventricular assist device, and depict the outlines of the heart, chest cavity, and ventricular assist device in the X-ray chest film images through image recognition.

[0057] The mitral valve is located between the left atrium and the left ventricle. In the X-ray film image, the outline of the heart is composed of the projections of each heart chamber and large blood vessels. For the outline of the heart in the X-ray chest film image in the supine position, the left atrial appendage is a part of the left atrium and is located beside the pulmonary artery segment. The mitral valve may be located below the left atrial appendage and above the left ventricle. Therefore, in the left heart border, the area between the lower part of the pulmonary artery segment and the apex of the heart may correspond to the left ventricle, and the position of the mitral valve may be inside the junction of the pulmonary artery segment and the left ventricle segment. In the lateral X-ray film, the mitral valve may be located at the junction of the left atrium and the left ventricle behind the heart, close to the spine.

[0058] Specifically, first determine the anatomical positions of various parts of the heart from the heart contour, and infer the position of the mitral valve based on the positional relationships of these parts. On a supine X-ray film, from top to bottom, the left cardiac margin is successively the aortic knuckle, pulmonary artery segment, left atrial appendage, and left ventricle. The left atrium is usually located posteriorly and may not directly form the cardiac margin in the frontal view unless it is enlarged. Therefore, the position of the mitral valve may be at the atrioventricular groove between the left atrial appendage and the left ventricle, that is, in the middle and lower part of the left cardiac margin, near the area where the pulmonary artery segment and the left ventricle meet. The position of the atrioventricular groove is more easily observed on a lateral or oblique X-ray film. For example, on a left lateral chest radiograph, the anterior margin of the heart is the right ventricle, the upper part of the posterior margin is the left atrium, and the lower part is the left ventricle. The mitral valve is located between the left atrium and the left ventricle and may be in the middle of the posterior margin of the heart, near the position where the esophagus is compressed by the enlarged left atrium during barium swallow examination of the esophagus.

[0059] After identifying the mitral valve from the heart contour, mark the axis from the apex of the heart to the center of the mitral valve, that is, the second central axis X2; mark the central axis of the inlet tube from the contour of the ventricular assist device, that is, the first central axis X1. Calculate the angle α between the first central axis X1 and the second central axis X2, as Figure 5 shown. Exemplarily, the first central axis X1 coincides with the rotation axis 21.

[0060] Furthermore, to eliminate the deviation caused by the irradiation position and angle of the X-ray chest film image each time, before outlining the contour of the X-ray chest film image, appropriate image rotation can be performed first to make the thoracic contour in the X-ray chest film image coincide with the thoracic contours of the supine and lateral X-ray chest film images of the ventricular assist device in the normal position in the target user, and then outline the heart contour and the contour of the ventricular assist device.

[0061] Exemplarily, when the detection data is the ultrasonic image of the target user; calculating the target detection parameter according to the detection data includes: identifying the first ventricular wall, the second ventricular wall, the first central axis, and the second central axis from the ultrasonic image, where the first ventricular wall is the left ventricular free wall of the left ventricle, the second ventricular wall is the ventricular septum of the left ventricle, the first central axis is the central axis of the inlet tube of the ventricular assist device, and the second central axis is the axis from the apex of the heart of the target user to the center of the mitral valve; calculating the first distance, the second distance, and the target angle, where the first distance is the shortest distance from the first ventricular wall to the first central axis, the second distance is the shortest distance from the second ventricular wall to the first central axis, and the target angle is the angle between the first central axis and the second central axis.

[0062] The hearts of different users will vary, and the target user may not be able to take X-rays every day after surgery. Therefore, when performing a cardiac ultrasound, left ventricular long-axis sectional ultrasound images and apical four-chamber sectional ultrasound images can be obtained. The left ventricular long-axis section shows the longitudinal section of the heart, and structures such as the left atrium, left ventricle, right ventricle, ascending aorta, descending aorta, coronary sinus, interventricular septum, left ventricular posterior wall, right ventricular anterior wall, pericardium, aortic valve, and mitral valve can be observed. The apical four-chamber section shows the four chambers of the heart and the structures of the mitral and tricuspid valves.

[0063] The left ventricular free wall and interventricular septum can also be depicted in the ultrasound image. Therefore, while calculating the target angle from the ultrasound image, the first distance and the second distance between the ventricular assist device and the left ventricle can also be calculated.

[0064] Among them, the ultrasound image of the chest can depict the outline of the heart, the outline of the thoracic cavity, and the outline of the ventricular assist device. After the target user implants the ventricular assist device, the apical four-chamber sectional imaging and left ventricular long-axis switching imaging of the target user's heart can be performed through an ultrasound device, and the parasternal left ventricular long-axis sectional ultrasound image and apical four-chamber sectional ultrasound image can be collected. After obtaining the ultrasound image of the chest, the outline of the left ventricular free wall, the outline of the interventricular septum, the outline of the mitral valve, and the outline of the inlet tube of the ventricular assist device can be identified. Determine the central axis X1 of the inlet tube from the outline of the inlet tube of the ventricular assist device, and the central axis X2 of the mitral valve, and calculate the angle b between the central axis X1 and the central axis X2. At the same time, according to the outline of the left ventricular free wall and the outline of the inlet tube of the ventricular assist device, calculate the distance from the inlet of the inlet tube of the ventricular assist device to the outline of the left ventricular free wall, that is, the shortest distance S1 from the intersection of the central axis X1 and the inlet of the inlet tube to the outline of the left ventricular free wall; according to the outline of the interventricular septum and the outline of the inlet tube of the ventricular assist device, calculate the distance from the inlet of the inlet tube of the ventricular assist device to the outline of the interventricular septum, that is, the shortest distance S2 from the intersection of the central axis X1 and the inlet of the inlet tube to the outline of the interventricular septum, as Figure 6 shown.

[0065] Exemplarily, when the detection data is the pumping flow curve of the ventricular assist device; the calculating the target detection parameter according to the detection data includes: extracting a first value, a second value, and a third value from the pumping flow curve, where the first value is the difference between the maximum flow and the minimum flow within the target period, the second value is the average value of the pumping flow within the target period, and the third value is the ratio of the duration of the flow rise to the target period; calculating the flow offset according to the first value, the second value, and the third value.

[0066] When the ventricular assist device 100 is operating normally, the waveform of its pumping flow curve is generally in the shape of a sine wave. When problems such as blockage of the inlet tube due to abnormal position of the ventricular assist device or wall suction caused by the inlet tube being close to the inner wall of the left ventricle occur, resulting in suction or over - suction of the ventricular assist device 100, the waveform of the pumping flow curve of the ventricular assist device 100 will change. For example, if suction occurs during the systolic phase of the cardiac cycle, the pumping flow during the systolic phase of this cardiac cycle will decrease sharply or even decrease to 0. If suction occurs during the diastolic phase of the cardiac cycle, the pumping flow during the systolic phase of this cardiac cycle will continue to remain at a low value or suddenly decrease to a smaller pumping flow or even decrease to 0.

[0067] In this application, it is possible to determine whether there are abnormal problems such as suction or over - suction in the current ventricular assist device by calculating the offset between the pumping flow of the current ventricular assist device and the pumping flow when the ventricular assist device is operating normally.

[0068] Specifically, the pumping flow curve of the ventricular assist device is obtained in real - time, and the pumping flow curve is divided according to the cardiac cycle of the target user to obtain the pumping flow curves within multiple cardiac cycles. Then, the flow offset value of the pumping flow curve of each cardiac cycle is calculated. For the pumping flow curve of any cardiac cycle, calculate the average flow value, the maximum flow value, and the minimum flow value of the pumping flow curve; calculate the first value according to the maximum flow value and the minimum flow value, take the average flow value as the second value, and take the ratio of the duration of the rising flow in the pumping flow curve to the cardiac cycle as the third value. After calculating the first value, the second value, and the third value, substitute them into the target formula to calculate the flow offset.

[0069] Among them, calculating the flow offset according to the first value, the second value, and the third value includes: substituting the first value, the second value, and the third value into the target formula to calculate the flow offset;

[0070] The target formula is

[0071] The a1 i is the first value in the i - th target cycle, the a2 i is the second value in the i - th target cycle, the a3 i is the third value in the i - th target cycle, the a10 is the first value when the position of the ventricular assist device is normal, the a20 is the second value when the position of the ventricular assist device is normal, and the a30 is the third value when the position of the ventricular assist device is normal.

[0072] In this application, the pumping flow curve of the ventricular assist device when its position in the target user is normal in the early stage after implantation can be collected first as the pumping flow reference data, and the first value, the second value, and the third value in the pumping flow curve of each cardiac cycle can be extracted respectively, and the average value of the first value, the average value of the second value, and the average value of the third value of the pumping flow curve of each cardiac cycle can be calculated. The average value of the first value is taken as a10, the average value of the second value is taken as a20, and the average value of the third value is taken as a30.

[0073] S430. If the target detection parameter is greater than the target threshold, it is determined that the position of the ventricular assist device in the target user is abnormal.

[0074] The target detection parameter may include one or more. After calculating the target detection parameter, the target detection parameter can be compared with the corresponding threshold respectively. If there is a target detection parameter greater than the corresponding target threshold, it can be determined that the position of the ventricular assist device in the target user is abnormal.

[0075] Exemplarily, when the detection data is the X-ray chest radiograph image of the target user, the target detection parameter is the target angle. When the ventricular assist device is in the normal position, that is, the central axis of the inlet tube of the ventricular assist device coincides with the central axis of the mitral valve or the included angle is small. At this time, the inlet tube of the ventricular assist device does not touch the inner wall of the left ventricle or is even at a certain distance. In this way, the ventricular assist device is not only not prone to suction or over-suction problems, but also can increase the pumping flow of the ventricular assist device because it is facing the mitral valve.

[0076] Therefore, the target angle is compared with the preset angle. If the target angle is greater than the preset angle, it indicates that the position of the ventricular assist device is abnormal, resulting in the deviation of the inlet tube of the ventricular assist device. The preset angle can be obtained according to clinical trials. For example, the preset angle is set to 15°, 20°, or 25°.

[0077] Exemplarily, when the detection data is the ultrasonic image of the target user; if the target detection parameter is greater than the target threshold, determining that the position of the ventricular assist device in the target user is abnormal includes: if at least one of the first distance is less than the first distance threshold, the second distance is less than the second distance threshold, and the target angle is greater than the preset angle exists, it is determined that the position of the ventricular assist device in the target user is abnormal.

[0078] When the detection data is the ultrasonic image of the target user, the target detection parameters include the first distance, the second distance, and the target angle. The position of the ventricular assist device is abnormal, resulting in the deviation of the inlet tube of the ventricular assist device. If the inlet tube deviates towards the left ventricular free wall, it will not only cause the target angle to increase, but also cause the shortest distance X1 between the central axis X1 of the inlet tube and the left ventricular free wall of the left ventricle to decrease, and the shortest distance X between the central axis X1 of the inlet tube and the interventricular septum of the left ventricle to increase. If the inlet tube deviates towards the interventricular septum, it will not only cause the target angle to increase, but also cause the shortest distance X2 between the central axis X1 of the inlet tube and the interventricular septum of the left ventricle to decrease, and the shortest distance X1 between the central axis X1 of the inlet tube and the left ventricular free wall of the left ventricle to increase. Therefore, by comparing the first distance, the second distance, and the target angle with their corresponding thresholds respectively, it is not only possible to determine whether the position of the ventricular assist device in the target user is abnormal, but also to detect the deviation direction of the position.

[0079] Specifically, the first distance is compared with the first distance threshold, the second distance is compared with the second distance threshold, and the target angle is compared with the preset angle. If it is detected that the target angle is greater than the preset angle, it is determined that the position of the ventricular assist device in the target user is abnormal. If it is detected that any two of the following occur: the first distance is less than the first distance threshold, the second distance is greater than the second distance threshold, and the target angle is greater than the preset angle, it is determined that the position of the ventricular assist device in the target user is abnormal and deviates towards the left ventricular free wall. If it is detected that any two of the following occur: the first distance is greater than the first distance threshold, the second distance is less than the second distance threshold, and the target angle is greater than the preset angle, it is determined that the position of the ventricular assist device in the target user is abnormal and deviates towards the interventricular septum of the left ventricle.

[0080] Among them, the first distance threshold and the second distance threshold can be obtained in clinical trials, and the first distance threshold and the second distance threshold can be set to be equal or unequal. For example, both the first distance threshold and the second distance threshold are set to 1 cm. Another example is that the first distance threshold is set to 1 cm and the second distance threshold is set to 1.5 cm.

[0081] Exemplarily, when the detection data is the pumping flow curve of the ventricular assist device, the target detection parameter is the flow offset amount in each cardiac cycle. If there are continuously multiple (such as 8, 10, 20, 50, etc.) flow offset amounts greater than the preset offset amount in the pumping flow curves of multiple cardiac cycles, it is determined that the position of the ventricular assist device in the target user is abnormal. The preset offset amount can be determined in clinical trials. For example, the preset offset amount can be calculated from the pumping flow curve when the position of the ventricular assist device is normal. For example, the preset offset amount is set to k times the value calculated by (a10 + a20 + a30) / 3, where k is greater than 1. Exemplarily, k is set to 1.1, 1.2, 1.3, etc.

[0082] Exemplarily, the method further includes: when the flow offset is greater than a preset offset, sending a first signal to the ventricular assist device, the first signal being used to instruct the ventricular assist device to adjust its rotational speed; obtaining adjusted detection data, where the adjusted detection data is the pumping flow curve after the ventricular assist device adjusts its rotational speed; calculating the flow offset value according to the detection data; if the flow offset value is less than or equal to the preset offset, determining that the rotational speed of the ventricular assist device is abnormal; if the flow offset is greater than the preset offset, determining that the position of the ventricular assist device within the target user is abnormal.

[0083] Among them, when the rotational speed of the ventricular assist device is too low or too high, it will also cause abnormal pumping flow of the ventricular assist device. For example, when the rotational speed of the ventricular assist device is too low, the pumping flow of the ventricular assist device will decrease, and blood will accumulate in the left ventricle and cannot be pumped into the aorta, causing left ventricular overload; when the rotational speed of the ventricular assist device is too high, during the ventricular contraction phase, the pumping flow of the ventricular assist device increases and the maximum value of its flow increases; during the ventricular diastolic phase, especially when the aorta is closed and the mitral valve is opened, at this time the volume of the left ventricle remains unchanged and the amount of blood in the left ventricle reaches the minimum, and too high a rotational speed of the ventricular assist device will cause over-suction or aspiration problems.

[0084] To improve the accuracy of position abnormality detection and reduce or even eliminate the interference caused by abnormal pumping flow curves of the ventricular assist device due to too high a rotational speed, when it is first detected that the flow offset is greater than the preset offset, first control the ventricular assist device to operate at a reduced rotational speed for a preset time, and then collect the pumping flow curve of the ventricular assist device after the preset time. When the abnormality of the pumping flow curve is caused by too high a rotational speed of the ventricular assist device, reducing the rotational speed can, to a certain extent, reduce or eliminate its flow offset. Therefore, calculate the flow offset of the pumping flow curve of the ventricular assist device after reducing the rotational speed. If the flow offset after reducing the rotational speed is smaller than the flow offset before reducing the rotational speed, or the flow offset after reducing the rotational speed is less than or equal to the preset offset, it can be considered that the abnormal pumping flow of the current ventricular assist device is caused by too high a rotational speed of the ventricular assist device. If the difference between the flow offset after reducing the rotational speed and the flow offset before reducing the rotational speed is small (such as 0.1, 0.2), or the flow offset after reducing the rotational speed is still greater than the preset offset, it can be considered that the abnormal pumping flow of the current ventricular assist device is caused by the position abnormality of the ventricular assist device.

[0085] Further, an alarm can be given for the abnormal position of the ventricular assist device in the target user. Within one day or within one detection period (one day, two days, one week, etc.), if it can be determined that the position of the ventricular assist device in the target user is abnormal based on all of the following three items: the pumping flow curve of the ventricular assist device, the X-ray chest film image of the target user, and the ultrasonic image of the target user, a high-priority alarm is sent to the ventricular assist device, indicating the current abnormal position of the ventricular assist device and the offset direction, and at the same time, an emergency prompt is issued to prompt the medical staff to intervene as soon as possible; if it can be determined that the position of the ventricular assist device in the target user is abnormal based on two of the above items, a medium-priority alarm is sent to the ventricular assist device, indicating the current abnormal position of the ventricular assist device and / or the offset direction, and at the same time, a general prompt is issued to prompt the medical staff to intervene as soon as possible; if it can be determined that the position of the ventricular assist device in the target user is abnormal based on only one of the above items, a low-priority alarm is sent to the ventricular assist device, indicating the current abnormal position of the ventricular assist device and / or the offset direction, and at the same time, a general prompt is issued to prompt the medical staff to recheck and confirm.

[0086] It can be seen that the present application proposes a method for detecting abnormal position, which obtains detection data. The detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user; calculates a target detection parameter according to the detection data; and if the target detection parameter is greater than the target threshold, determines that the position of the ventricular assist device in the target user is abnormal. By obtaining the operation data of the ventricular assist device and / or the image data of other detection devices to detect whether the relative position of the ventricular assist device and the heart has changed, problems such as over-suction, reduced flow, thrombus formation, and bleeding caused by the change in the relative position of the ventricular assist device and the heart can be avoided.

[0087] The above mainly introduces the solution of the embodiment of the present application from the perspective of the execution process on the method side. It can be understood that in order for the network device to implement the above functions, it includes the corresponding hardware structure and / or software module for executing each function. Those skilled in the art should easily realize that, in combination with the units and algorithm steps of each example described in the embodiments provided in this article, the present application can be implemented in the form of hardware or a combination of hardware and computer software. Whether a certain function is executed in the way of hardware or computer software driving hardware depends on the specific application and design constraints of the technical solution. Professional technicians can use different methods to implement the described functions for each specific application, but such implementation should not be considered to exceed the scope of the present application.

[0088] For example, the present application provides a controller for a ventricular assist device. The controller includes one or more processors, and the one or more processors are used for:

[0089] Obtain detection data, where the detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user;

[0090] Calculate a target detection parameter according to the detection data;

[0091] If the target detection parameter is greater than a target threshold, determine that the position of the ventricular assist device in the target user is abnormal.

[0092] Exemplarily, the present application further provides a medical device, which is a medical device in a hospital medical system or a device having the function of performing the above corresponding steps.

[0093] Exemplarily, the present application further provides an electronic device, which is an electronic device communicatively connected to a ventricular assist system and / or a medical device in a hospital or an electronic device having the function of performing the above corresponding steps.

[0094] Among them, the controller in each of the above solutions has the function of implementing the corresponding steps performed by the medical device in the above method; the function can be implemented by hardware or by hardware executing corresponding software.

[0095] In an embodiment of the present application, the processor in the controller may also be a chip or a chip system, for example: a system on chip (SoC).

[0096] Please refer to Figure 7 , Figure 7 FIG. is a schematic structural diagram of a medical device provided by an embodiment of the present application. The medical device includes: one or more processors, one or more memories, one or more communication interfaces, and one or more programs; the one or more programs are stored in the memory and are configured to be executed by the one or more processors.

[0097] The above program includes instructions for performing the following steps:

[0098] Obtain detection data, where the detection data is the operation data of the ventricular assist device and / or the image data of the target user after the ventricular assist device is implanted into the target user;

[0099] Calculate a target detection parameter according to the detection data;

[0100] If the target detection parameter is greater than a target threshold, determine that the position of the ventricular assist device in the target user is abnormal.

[0101] Among them, all relevant contents of each scenario involved in the above method embodiment can be cited in the function description of the corresponding functional module, and will not be repeated here.

[0102] It should be understood that the above-mentioned memory may include a read-only memory and a random access memory, and provide instructions and data to the processor. A part of the memory may also include a non-volatile random access memory. For example, the memory may also store information about the device type.

[0103] In an embodiment of the present application, the processor of the above-mentioned device may be a central processing unit (CPU), and the processor may also be other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or the processor may also be any conventional processor, etc.

[0104] It should be understood that the “at least one” involved in the embodiments of the present application refers to one or more, and the “multiple” refers to two or more. “And / or” describes the association relationship of associated objects and indicates that three relationships may exist. For example, A and / or B may indicate: A exists alone, A and B exist simultaneously, and B exists alone, where A and B may be singular or plural. The character “ / ” generally indicates that the associated objects before and after are in an “or” relationship. “At least one (item)” or similar expressions thereof refer to any combination of these items, including any combination of single item (item) or plural items (items). For example, at least one (item) of a, b, or c may indicate: a, b, c, a - b, a - c, b - c, or a - b - c, where a, b, and c may be single or multiple.

[0105] Moreover, unless otherwise stated, the ordinal numbers such as “first” and “second” mentioned in the embodiments of the present application are used to distinguish multiple objects and are not used to limit the order, timing, priority, or importance of multiple objects. For example, the first information and the second information are only used to distinguish different information, rather than indicating differences in the content, priority, transmission order, or importance of these two types of information, etc.

[0106] In the implementation process, each step of the above method can be completed by the integrated logic circuit of the hardware in the processor or the instructions in the form of software. The steps of the method disclosed in combination with the embodiments of the present application can be directly embodied as being executed and completed by the hardware processor, or executed and completed by the combination of the hardware and software units in the processor. The software unit can be located in a mature storage medium in the art such as random access memory, flash memory, read-only memory, programmable read-only memory, or electrically erasable programmable memory, register, etc. This storage medium is located in the memory, and the processor executes the instructions in the memory and combines its hardware to complete the steps of the above method. To avoid repetition, it will not be described in detail here.

[0107] The embodiments of the present application also provide a computer storage medium, wherein the computer storage medium stores a computer program for electronic data exchange, and the computer program enables the computer to execute some or all of the steps of any of the methods described in the above method embodiments.

[0108] The embodiments of the present application also provide a computer program product. The above computer program product includes a non-transitory computer-readable storage medium storing a computer program. The above computer program is operable to enable the computer to execute some or all of the steps of any of the methods described in the above method embodiments. The computer program product can be a software installation package.

[0109] It should be noted that for the foregoing method embodiments, for the sake of simple description, they are all expressed as a series of action combinations. However, those skilled in the art should know that the present application is not limited by the described action sequence, because according to the present application, certain steps can be performed in other sequences or simultaneously. Secondly, those skilled in the art should also know that the embodiments described in the specification are all preferred embodiments, and the actions and modules involved are not necessarily essential to the present application.

[0110] In the above embodiments, the descriptions of the various embodiments have their own emphases. For the parts not detailed in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0111] In the several embodiments provided by the present application, it should be understood that the disclosed device can be implemented in other ways. For example, the device embodiments described above are only illustrative. For example, the above division of units is only a logical function division. In actual implementation, there can be other division methods. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the displayed or discussed coupling or direct coupling or communication connection to each other can be through some interfaces. The indirect coupling or communication connection of the device or unit can be in an electrical or other form.

[0112] The units described above as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place, or may be distributed over multiple network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiments of the present application.

[0113] In addition, each functional unit in the various embodiments of the present application may be integrated into one processing unit, may be physically present separately for each unit, or two or more units may be integrated into one unit. The above integrated unit may be implemented in the form of hardware or in the form of a software functional unit.

[0114] If the above integrated unit is implemented in the form of a software functional unit and sold or used as an independent product, it can be stored in a computer-readable memory. Based on such an understanding, the technical solution of the present application, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a memory and includes several instructions for causing a computer device (which may be a personal computer, a server, or a TRP, etc.) to execute all or part of the steps of the methods of the various embodiments of the present application. The aforementioned memory includes: various media such as USB flash drives, read-only memories (ROMs), random access memories (RAMs), mobile hard disks, magnetic disks, or optical discs that can store program codes.

[0115] Those of ordinary skill in the art can understand that all or part of the steps in the various methods of the above embodiments can be completed by instructing relevant hardware through a program, and this program can be stored in a computer-readable memory. The memory may include: flash drives, ROMs, RAMs, magnetic disks, or optical discs, etc.

[0116] The above has introduced the embodiments of the present application in detail. Specific examples are used in this article to elaborate on the principle and implementation manner of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application; at the same time, for those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific implementation manner and application scope. In summary, the content of this specification should not be construed as a limitation to the present application.

Claims

1. A method for detecting abnormal positions, characterized in that, Applied to a ventricular assist device, the method includes: Obtaining detection data, where the detection data is the operation data of the ventricular assist device and / or the imaging data of the target user after the ventricular assist device is implanted into the target user; Calculating a target detection parameter based on the detection data; If the target detection parameter is greater than a target threshold, determining that the position of the ventricular assist device in the target user is abnormal.

2. The method according to claim 1, characterized in that, The detection data is the X-ray chest image of the target user; The calculating the target detection parameter based on the detection data includes: Identifying a first central axis and a second central axis from the X-ray chest image, where the first central axis is the central axis of the inlet tube of the ventricular assist device, and the second central axis is the central axis from the apex of the heart of the target user to the mitral valve; Calculating a target angle, where the target angle is the angle between the first central axis and the second central axis.

3. The method according to claim 1, wherein The detection data is the ultrasonic image of the target user; The calculating the target detection parameter based on the detection data includes: Identifying a first ventricular wall, a second ventricular wall, a first central axis, and a second central axis from the ultrasonic image, where the first ventricular wall is the left ventricular free wall of the left ventricle, the second ventricular wall is the ventricular septum of the left ventricle, the first central axis is the central axis of the inlet tube of the ventricular assist device, and the second central axis is the central axis from the apex of the heart of the target user to the mitral valve; Calculating a first distance, a second distance, and a target angle, where the first distance is the shortest distance from the first ventricular wall to the first central axis, the second distance is the shortest distance from the second ventricular wall to the first central axis, and the target angle is the angle between the first central axis and the second central axis.

4. The method according to claim 3, wherein The if the target detection parameter is greater than the target threshold, determining that the position of the ventricular assist device in the target user is abnormal includes: If there is at least one of the first distance being less than a first distance threshold, the second distance being less than a second distance threshold, and the target angle being greater than a preset angle, determining that the position of the ventricular assist device in the target user is abnormal.

5. The method according to claim 1, wherein The detection data is the pumping flow curve of the ventricular assist device; The calculating the target detection parameter based on the detection data includes: Extracting a first value, a second value, and a third value from the pumping flow curve, where the first value is the difference between the maximum flow rate and the minimum flow rate within a target period, the second value is the average pumping flow rate within the target period, and the third value is the ratio of the duration of the flow rate increase to the target period; Calculating a flow offset based on the first value, the second value, and the third value.

6. The method according to claim 5, wherein The calculating the flow offset based on the first value, the second value, and the third value includes: Substituting the first value, the second value, and the third value into a target formula to calculate the flow offset; The target formula is The a1 i is the first value in the i-th target cycle, the a2 i is the second value in the i-th target cycle, the a3 i is the third value in the i-th target cycle, the a10 is the first value when the ventricular assist device is in the normal position, the a20 is the second value when the ventricular assist device is in the normal position, and the a30 is the third value when the ventricular assist device is in the normal position.

7. The method according to claim 5 or 6, characterized in that The method further includes: When the flow offset is greater than a preset offset, sending a first signal to the ventricular assist device, where the first signal is used to instruct the ventricular assist device to adjust the rotation speed; Obtain the adjusted detection data, where the adjusted detection data is the pumping flow curve after the ventricular assist device adjusts its rotational speed; Calculate the flow offset value according to the detection data; If the flow offset value is less than or equal to the preset offset amount, determine that the rotational speed of the ventricular assist device is abnormal; If the flow offset amount is greater than the preset offset amount, determine that the position of the ventricular assist device within the target user is abnormal.

8. A controller of a ventricular assist device, characterized in that, The controller includes one or more processors, and the one or more processors are configured to: Obtain detection data, where the detection data is the operating data of the ventricular assist device and / or the imaging data of the target user after the ventricular assist device is implanted into the target user; Calculate a target detection parameter according to the detection data; If the target detection parameter is greater than a target threshold, determine that the position of the ventricular assist device within the target user is abnormal.

9. A medical device, characterized in that, Comprising a processor, a memory, and a communication interface, the memory stores one or more programs, and the one or more programs are executed by the processor, and the one or more programs include instructions for performing the steps in the method according to any one of claims 1-7.

10. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program for electronic data exchange, wherein the computer program causes a computer to execute the steps of the method according to any one of claims 1-7.

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