Abnormality detection method, device and system for flushing system of medical equipment

Abstract

The invention discloses a flushing system anomaly detection method, device and system for medical equipment, and belongs to the technical field of medical equipment. The medical equipment is provided with a flushing channel, the method comprises the steps that first detection information and second detection information corresponding to the flushing channel are obtained, the first detection information represents the flushing pressure change condition of the flushing channel within the target duration, and the second detection information comprises at least one of the second detection information and fluid temperature information; the second detection information represents the bubble generation condition in the flushing channel, and the fluid temperature information represents the temperature change condition of fluid in the flushing channel; and according to the first detection information and the second detection information, abnormal alarm information corresponding to the flushing channel is output, and the abnormal alarm information indicates at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position. By means of the method, the abnormity in the flushing channel can be accurately detected.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method, apparatus and system for detecting abnormalities in the flushing system of medical devices. Background Technology

[0002] An interventional blood pump is a medical device used to assist the heart in providing blood circulation. When in operation, a catheter of the interventional blood pump is inserted into the left ventricle through a blood vessel. The inlet is located in the left ventricle, and the outlet is located in the aorta. When the axial flow pump is running, it draws blood in from the inlet at the left ventricle and then returns it to the aorta through the outlet at the aorta, thus achieving the function of cardiac assistance.

[0003] Before use, the interventional blood pump needs to be connected to the flushing tubing to purge air from the pump using flushing fluid. During flushing, the tubing may become blocked or leak at certain points due to bending, damage, or detachment. Leaks or blockages can affect the supply of flushing fluid to varying degrees, leading to malfunctions or damage to the interventional blood pump. Summary of the Invention

[0004] This application provides a method, apparatus, and system for detecting abnormalities in the flushing system of medical devices, the technical solution of which is as follows:

[0005] According to one aspect of this application, a method for detecting abnormalities in the flushing system of a medical device is provided, the medical device having a flushing channel; the method includes:

[0006] First detection information and second detection information corresponding to the flushing channel are obtained. The first detection information characterizes the flushing pressure change of the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0007] Based on the first detection information and the second detection information, an abnormal alarm information corresponding to the rinsing channel is output, wherein the abnormal alarm information indicates at least one of the abnormal location in the rinsing channel and the abnormal state corresponding to the abnormal location.

[0008] According to one aspect of this application, an abnormality alarm device for a medical device is provided, the medical device having a flushing channel; the device includes:

[0009] The monitoring module is used to acquire first detection information and second detection information corresponding to the flushing channel. The first detection information characterizes the flushing pressure change of the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information indicates the generation of bubbles in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0010] The generation module is configured to output abnormal alarm information corresponding to the flushing channel based on the first detection information and the second detection information, wherein the abnormal alarm information indicates at least one of an abnormal location in the flushing channel and an abnormal state corresponding to the abnormal location.

[0011] According to another aspect of this application, a ventricular assist system is provided, the ventricular assist system comprising:

[0012] Flushing channel;

[0013] Sensors are installed in the flushing channel;

[0014] The sensor is used to detect first detection information and second detection information in the flushing channel to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location.

[0015] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0016] According to another aspect of this application, a ventricular assist system is provided, the ventricular assist system comprising: a control device and consumables;

[0017] The control device includes a drive assembly and a bubble sensor. The drive assembly is used to be coupled to the consumable, and the bubble sensor is clamped to the flushing tubing in the consumable.

[0018] The consumables include: flushing tubing and an interventional blood pump, wherein the interventional blood pump is equipped with a pressure sensor;

[0019] The flushing tubing and the interventional blood pump are connected to form a flushing channel. The pressure sensor and the bubble sensor are respectively used to detect the first detection information and the second detection information in the flushing channel to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location.

[0020] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0021] According to another aspect of this application, a control device for a ventricular assist system is provided, the control device comprising: a drive component, a bubble sensor, and a control component;

[0022] The bubble sensor is used to report second detection information to the control component, and the control component is used to determine at least one of the abnormal location and the abnormal state corresponding to the abnormal location in the ventricular assist system based on the second detection information and the first detection information reported by the pressure sensor.

[0023] The first detection information characterizes the change in flushing pressure in the flushing channel of the ventricular assist system within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the generation of bubbles in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0024] According to another aspect of this application, a consumable in a ventricular assist system is provided, the consumable comprising: a flushing tubing and an interventional blood pump, wherein a pressure sensor is disposed within the interventional blood pump;

[0025] The flushing pipeline and the interventional blood pump are connected to form a flushing channel. The pressure sensor is used to report first detection information to the control component. The control component is used to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location based on the second detection information reported by the bubble sensor and the first detection information.

[0026] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0027] According to another aspect of this application, a computer storage medium is provided, wherein at least one computer program is stored in the computer-readable storage medium, the at least one computer program being loaded and executed by a processor to implement the method for detecting abnormalities in a flushing system for medical devices as described above.

[0028] According to another aspect of this application, a computer program product is provided, comprising a computer program stored in a computer-readable storage medium; the computer program is read from and executed by a processor of a computer device from the computer-readable storage medium, causing the computer device to perform the above-described method for detecting abnormalities in a flushing system for medical devices.

[0029] According to another aspect of this application, a chip is provided, the chip including programmable logic circuitry or a program, and a device on which the chip is mounted is used to implement the above-described method for detecting abnormalities in a flushing system for medical devices.

[0030] The beneficial effects of the technical solution provided in this application include at least the following:

[0031] By monitoring real-time changes in flushing pressure within the flushing channel, and by collecting at least one of the following sensor data: real-time bubble information, fluid temperature information, etc., the equipment can accurately locate abnormal locations and / or abnormal states within the flushing channel. When abnormalities occur at different locations within the flushing channel, the changes in flushing pressure, bubble formation, and / or fluid temperature will differ. Based on this information, the location of the abnormality can be accurately pinpointed. Similarly, when different types of abnormal states occur within the flushing channel (e.g., conduit twisting, blockage, leakage, etc.), the changes in flushing pressure, bubble formation, and / or fluid temperature will also differ. Based on this information, the specific abnormal state at the abnormal location within the flushing channel can be determined. Therefore, combining this information allows for accurate location of abnormalities within the flushing channel, facilitating timely and accurate alarm prompts, reducing troubleshooting time, minimizing or avoiding hazards during product use, and improving product safety. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of the architecture of a medical device provided in an exemplary embodiment of this application;

[0034] Figure 2 This is a schematic diagram of an abnormality detection method for a flushing system of a medical device provided in an exemplary embodiment of this application;

[0035] Figure 3This is a schematic diagram of an abnormality detection method for a flushing system of a medical device provided in an exemplary embodiment of this application;

[0036] Figure 4 This is a schematic diagram of an abnormality detection method for a flushing system of a medical device provided in an exemplary embodiment of this application;

[0037] Figure 5 This is a schematic diagram of an abnormality detection method for a flushing system of a medical device provided in an exemplary embodiment of this application;

[0038] Figure 6 This is a flowchart of an exemplary embodiment of the present application for a method for detecting abnormalities in a flushing system of a medical device;

[0039] Figure 7 This is a schematic diagram of an abnormality detection method for a flushing system of a medical device provided in an exemplary embodiment of this application;

[0040] Figure 8 This is a flowchart of an exemplary embodiment of the present application for a method for detecting abnormalities in a flushing system of a medical device;

[0041] Figure 9 This is a flowchart of an exemplary embodiment of the present application for a method for detecting abnormalities in a flushing system of a medical device;

[0042] Figure 10 This is a block diagram of an abnormal alarm device for a medical device provided in an exemplary embodiment of this application;

[0043] Figure 11 This is a schematic diagram of the structure of a medical device provided in an exemplary embodiment of this application. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be further described in detail below with reference to the accompanying drawings. Exemplary embodiments will be described in detail here, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0045] The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The singular forms “a,” “the,” and “the” as used in this disclosure and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any and all possible combinations of one or more of the associated listed items.

[0046] It should be understood that although the terms first, second, third, etc., may be used in this disclosure to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another.

[0047] A ventricular assist system is a circulatory support device system that replaces the function of the ventricles, including but not limited to at least one of an external ventricular assist system, a transcatheter ventricular assist system, and an implantable ventricular assist system.

[0048] Transcatheter ventricular assist system, including transcatheter ventricular assist system control unit (hereinafter referred to as: control component) and transcatheter ventricular assist system catheter pump system (hereinafter referred to as: interventional blood pump) used in conjunction with it, is suitable for providing temporary left ventricular circulation assistance during relevant procedures.

[0049] An interventional blood pump refers to a catheter-based pump used in medical settings to assist the heart in providing the power for blood circulation. Optionally, an interventional blood pump is a cardiac pump that is inserted into a living organism. Optionally, some or all components of an interventional blood pump are inserted into a living organism.

[0050] Figure 1 This diagram illustrates an application scenario of an interventional blood pump 140 provided in one embodiment of this application. The interventional blood pump 140 includes a drive catheter handle 100, a drive catheter 102, and a pump head 103. The drive assembly 101 is coupled to the proximal end of the drive catheter 102 via the drive catheter handle 100, and the pump head 103 is connected to the distal end of the drive catheter 102. The drive assembly 101 is coupled to the drive catheter handle 100, the drive catheter handle 100 is connected to a first end of the drive catheter 102, and the second end of the drive catheter 102 is connected to the pump head 103.

[0051] The pump head 103 in the interventional blood pump 140 can be percutaneously inserted into the heart through a peripheral blood vessel via a drive catheter 102. The pump head 103 is placed between the left ventricle and the aorta. The blood inlet of the pump head 103 is placed into the left ventricle, and the blood outlet of the pump head 103 is placed into the aorta. The drive assembly can be connected to the interventional blood pump to drive the impeller in the pump head to rotate, thereby pumping blood from the left ventricle into the aorta to achieve ventricular assist function.

[0052] For example, a drive shaft is provided inside the drive catheter handle 100, drive catheter 102, and pump head 103. One end of the drive shaft is fixed to the connection between the drive catheter handle 100 and the drive assembly 101. The drive assembly 101 drives one end of the drive shaft to rotate, which in turn drives the impeller (located inside the pump head 103) at the other end of the drive shaft to rotate, thereby generating driving force inside the pump head 103. This drives blood to flow in from the inlet 104 of the pump head 103 and out from the outlet 105 of the pump head 103. Optionally, the drive catheter 102 is inserted through the femoral artery and the pump head 103 is delivered to the left ventricle, so that the inlet 104 of the pump head 103 is located in the left ventricle, and the outlet 105 of the pump head 103 is located in the aorta. When the drive shaft rotates, it can draw blood from the inlet 104 at the left ventricular end and then return it to the aorta through the outlet 105 at the aortic end, thus achieving the function of cardiac assist.

[0053] The interventional blood pump 140 provides active forward blood flow, thereby increasing cardiac output. The blood pumped by the interventional blood pump 140 comes directly from the left ventricle, which can directly reduce left ventricular pressure and volume, reduce ventricular workload, and lower myocardial oxygen consumption. Furthermore, the increased forward blood flow in the aorta and the decrease in ventricular wall tension can also increase coronary blood flow and improve myocardial perfusion. It is suitable for acute myocarditis with poor response to conventional treatment, cardiomyopathy complicated by shock, refractory heart failure, and cardiogenic shock.

[0054] Figure 2 A schematic diagram of a ventricular assist system provided in an exemplary embodiment of this application is shown. The ventricular assist system includes a flushing channel and a sensor disposed in the flushing channel, the sensor including at least one of a pressure sensor 116, a bubble sensor 115, and a temperature sensor 117; the pressure sensor and the temperature sensor may be an integrated fluid sensor.

[0055] The sensor is used to detect first detection information and second detection information in the flushing channel to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location.

[0056] The first detection information characterizes the change in flushing pressure in the flushing channel within the target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the generation of bubbles in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0057] Optionally, the flushing channel includes at least one flushing line for connecting the drive conduit handle 100, the fluid source 106, and the pump head 103. The flushing channel is a semi-closed liquid passage with one end open (at the pump head 103), through which flushing fluid can flow from the fluid source 106 through the drive conduit handle 100 to the pump head 103.

[0058] The drive conduit handle 100 and the fluid source 106 can be connected by a flushing line (or flushing line, which includes multiple conduits connecting different components), and the drive conduit handle 100 and the pump head 103 can be connected by a drive conduit 102.

[0059] Optionally, a drive shaft is installed inside the drive duct handle 100, drive duct 102, and pump head 103. One end of the drive shaft is fixed to the driven member of the drive duct handle 100, and the other end of the drive shaft is connected to the impeller inside the pump head 103. The driven member of the drive duct handle is coupled to the driving member of the drive assembly to transmit the rotational power of the motor in the drive assembly to the drive shaft.

[0060] The drive conduit handle 100 includes a housing, and a flushing chamber is provided inside the housing. The flushing chamber has three interfaces. The first and second interfaces of the flushing chamber are connected to the fluid source 106, and the third interface of the flushing chamber is connected to one end of the drive conduit 102, so that the flushing fluid can flow from the fluid source 106 through the flushing fluid chamber to the drive conduit 102.

[0061] It should be noted that during the rinsing phase, the rinsing fluid will expel the air from the drive catheter 102. To prevent air from entering the subject's body, a rinsing and venting operation must be performed externally before the pump head 103 enters the subject's body to expel the air from the drive catheter 102 and the pump head 103.

[0062] A driven member is provided on one side of the housing of the drive conduit handle 100. When the drive conduit handle is coupled to the drive assembly, the motor in the drive assembly 101 can drive the driving member on the drive assembly 101 to rotate. The driving member can drive the driven member to rotate, thereby causing the driven member to drive the drive shaft to rotate.

[0063] For example, the sensor includes a pressure sensor 116, and at least one of a bubble sensor 115 and a temperature sensor 117.

[0064] The bubble sensor 115 can be installed outside any flushing pipe in the flushing channel; for example, the bubble sensor 115 can be clamped and fixed outside any flushing pipe. The bubble sensor 115 is used to monitor bubbles in the flushing channel.

[0065] The pressure sensor 116 is disposed in the flushing channel. For example, the pressure sensor 116 may be disposed in the drive conduit handle 100, or the pressure sensor 116 may be disposed in the fluid source 106, or the pressure sensor 116 may also be disposed in the flushing pipeline.

[0066] For example, a pressure sensor 116 is disposed on the inner wall of the drive conduit handle 100. A bubble sensor 115 is disposed on the clamping assembly of the control device, which is used to clamp and fix the flushing pipeline, and the bubble sensor 115 can detect whether there are bubbles in the clamped flushing pipeline.

[0067] Temperature sensor 117 is installed in the flushing channel. For example, temperature sensor 117 may be installed in the drive conduit handle 100, or in the fluid source 106, or in the flushing pipeline.

[0068] Optionally, the bubble sensor 115, pressure sensor 116, and temperature sensor 117 are electrically connected to the control component (processor), and the bubble sensor 115, pressure sensor 116, and temperature sensor 117 send signals to the control component through the electrical connection.

[0069] In some embodiments, the temperature sensor 117 is an optional device.

[0070] In one alternative embodiment, such as Figure 2 As shown, the ventricular assist system includes a fluid delivery line and an interventional blood pump. The fluid delivery line includes a first tube 112-1 (a flushing line connecting the fluid source 106 and the first connector 108), a second tube 112-2 (a right-side flushing line connecting the first connector 108 and the fluid inlet of the drive catheter handle 100), and a third tube 112-3 (a left-side flushing line connecting the first connector 108 and the fluid outlet of the drive catheter handle 100), all connected via a first connector 108. The first tube 112-1 connects to the fluid source 106. The second tube 112-2 and the third tube 112-3 are respectively connected to the fluid interfaces (fluid inlet and fluid outlet of the drive catheter handle) of the interventional blood pump, forming a flushing channel. The detection method provided in this application can accurately detect abnormal states and locations of the above flushing channels and is compatible with various flushing channels.

[0071] The interventional blood pump may include at least one of a drive catheter handle 100, a drive catheter 102, and a pump head 103.

[0072] Reference Figure 3As shown, the fluid inlet 118 of the drive conduit handle 100 is used to connect to the first interface 119 of the first connector 108; the fluid outlet 120 of the drive conduit handle 100 is used to connect to the second interface 121 of the first connector 108; the drive outlet 123 located on the right side of the drive conduit handle 100 is used to connect to the pump head 103; the third interface 122 of the first connector 108 is used to connect to the fluid source 106; the flushing channel includes at least one flushing conduit for connecting the fluid source 106, the first connector 108, the drive conduit handle 100, and the pump head 103.

[0073] In one optional embodiment, the interventional blood pump includes a fluid inlet 118 and a fluid outlet 120. A second tube 112-2 is connected to the fluid inlet 118, and a third tube 112-3 is connected to the fluid outlet 120. Fluid from the fluid source 106 is delivered to the fluid inlet 118 via the first tube 112-1 and the second tube 112-2 to enter the internal channel of the interventional blood pump. After flowing out of the internal channel through the fluid outlet 120, the fluid flows into the first connector 108 via the third tube 112-3, forming a fluid circulation between the second tube 112-2, the interventional blood pump, and the third tube 112-3. The detection method provided in this application can accurately detect abnormal states and locations of the above-mentioned circulation flushing channels.

[0074] Optionally, during the rinsing phase, the rinsing fluid is prepared according to the following... Figure 2 The flow is indicated by the arrows. The flushing fluid flows out from the outlet of the fluid source 106, flows into the first connector 108 from the third interface 122; flows out from the first interface 119 of the first connector 108, and flows into the drive conduit handle 100 from the fluid inlet 118; flows out from the drive outlet 123 of the drive conduit handle 100 and enters the drive conduit 102, flowing into the pump head 103; flows out from the fluid outlet 120 of the drive conduit handle 100, and flows into the first connector 108 from the second interface 121, forming a loop.

[0075] In one alternative embodiment, such as Figure 4 As shown, the detectable locations corresponding to the flushing channels include at least one of the following: fluid infusion channel 124, circulation inlet channel 125, circulation outlet channel 126, and interventional blood pump flushing channel 127;

[0076] The fluid delivery channel 124 includes a channel formed between the fluid source 106 and the first connector 108;

[0077] The circulation inlet channel 125 includes a channel formed between the first connector 108 and the fluid inlet 118;

[0078] The circulation outlet channel 126 includes a channel formed between the fluid outlet 120 and the first connector 108;

[0079] The interventional blood pump flushing channel 127 includes: a fluid flow channel within the interventional blood pump.

[0080] In the technical solution provided by the embodiments of this application, the channel segmentation in the above manner is beneficial to clearly distinguish the abnormal situations that occur in different segments. Furthermore, the detection method provided by this application can accurately detect the abnormalities that occur in the above-divided channel positions, thereby improving the accuracy of abnormality detection and narrowing the scope of fault diagnosis.

[0081] One or more fluid handling devices may be provided on the channel. The fluid handling devices include at least one of the following: bubble filter and particulate filter.

[0082] In one optional embodiment, at least one fluid processing device is provided on the second pipe 112-2, and the detectable position corresponding to the circulation inlet channel 125 includes at least one of the following: a channel segment divided by at least one fluid processing device, a position point in the channel segment, a pipe connection position on the circulation inlet channel 125, and at least one fluid processing device.

[0083] In one optional embodiment, at least one fluid processing device is provided on the third pipe 112-3, and the detectable position corresponding to the circulation outlet channel 126 includes at least one of the following: a channel segment divided by at least one fluid processing device, a position point in the channel segment, a pipe connection position on the circulation outlet channel 126, and at least one fluid processing device.

[0084] In one optional embodiment, the interventional blood pump includes a drive catheter 102 and a fluid plugging device 128. Fluid enters the internal channel of the interventional blood pump and then enters the drive catheter 102. The interventional blood pump includes a through-hole, and the fluid plugging device 128 is used to block the fluid flowing through the through-hole. The detectable position corresponding to the flushing channel 127 of the interventional blood pump includes the drive catheter 102 and the fluid plugging device 128. The interventional blood pump can be inserted into the target body with the aid of a guidewire. After the guidewire is inserted into the heart via a blood vessel, it is inserted into the interventional blood pump. The proximal end of the guidewire enters from the pump head of the interventional blood pump, passes through the drive catheter (specifically, it can pass through the drive shaft inside the drive catheter), and exits from the through-hole at the proximal end of the interventional blood pump, thus penetrating the entire interventional pump. In this way, the interventional pump can be inserted into the target body along the guidewire and reach the designated location in the heart. After the interventional blood pump reaches the designated location, the guidewire can be withdrawn from the through-hole, and the through-hole can be sealed using the fluid plugging device to prevent the flushing fluid from flowing out of the through-hole. If the fluid plug fails to seal the aforementioned through-hole, flushing fluid leakage may occur; similarly, flushing fluid leakage may also occur if the drive conduit ruptures.

[0085] The fluid plugging component mentioned above can be a threaded cap, and the through hole is a hollow threaded post, with the two connected by threads.

[0086] The detection method provided in this application can accurately detect and alarm for abnormalities in more precise locations or components on each section of pipeline and the internal flow channel of the intervention pump, further improving the accuracy of abnormality detection and further narrowing the scope of fault diagnosis, making it easier for operators to quickly solve problems.

[0087] Especially after the interventional pump is connected to its drive assembly, the fluid plugging component is completely obscured by the drive assembly. Operators cannot directly see if there is a leak at the location of the fluid plugging component; the drive assembly must be removed to see if a leak is occurring. However, removing the drive assembly will cause the interventional pump to stop operating. Therefore, it is difficult to check for abnormalities in the fluid plugging component, and checking requires stopping the pump. The detection method provided in this application can automatically determine whether there is an abnormality in the fluid plugging component without stopping the pump and removing the drive assembly, thus improving troubleshooting efficiency.

[0088] The following section uses the example of a bubble filter 111 on the second tube 112-2 and a particulate filter 110 on the third tube 112-3 to introduce some detectable locations.

[0089] refer to Figure 4The circulation inlet channel 125 includes a first channel segment 125-1 and a second channel segment 125-2; the first channel segment 125-1 includes the channel segment before the fluid in the second pipe 112-2 flows into the bubble filter 111; the second channel segment 125-2 includes the channel segment after the fluid in the second pipe 112-2 flows out of the bubble filter 111.

[0090] The circulation outlet channel 126 includes a third channel segment 126-1 and a fourth channel segment 126-2; the third channel segment 126-1 includes a channel segment from the outlet of the particulate filter 110 to the first connector 108; the fourth channel segment 126-2 includes a channel segment in the third pipe 112-3 before the fluid flows into the particulate filter 110.

[0091] Optionally, the fluid inlet 118 of the drive tube handle 100 is used to connect to the outlet 129 of the bubble filter 111; the first interface 119 of the first connector 108 is used to connect to the inlet 130 of the bubble filter 111.

[0092] For example, the bubble filter 111 is connected between the drive catheter handle 100 and the first connector 108 to filter bubbles in the flushing channel and prevent bubbles from flowing into the subject's body.

[0093] Optionally, the fluid outlet 120 of the drive tube handle 100 is used to connect to the inlet 131 of the particulate filter 110; the second interface 121 of the first connector 108 is used to connect to the outlet 132 of the particulate filter 110.

[0094] For example, a particulate filter 110 is connected between the drive conduit handle and the first connector 108 for filtering particulates in the flushing channel.

[0095] In an optional embodiment, the system further includes: a temperature sensor 117 disposed within the interventional blood pump; and a drive shaft disposed within the interventional blood pump, the drive shaft being rotatably inserted within the interventional blood pump. The rotation of the drive shaft generates heat, and the flushing fluid can flush and cool the cavity containing the drive shaft. Therefore, different drive shaft speeds, different flushing fluid flow rates, and other factors will change the temperature of the flushing fluid within the interventional blood pump. Different abnormal conditions may trigger changes in these factors, thereby causing changes in the flushing fluid temperature. The temperature sensor 117 is used to detect the temperature within the flushing channel in order to determine abnormal information (abnormal location and / or the abnormal state corresponding to the abnormal location) within the flushing channel.

[0096] Optionally, the temperature sensor 117 and the pressure sensor 116 can be implemented as a single sensor, which can be disposed on the inner wall of the drive conduit handle 100. Exemplarily, the housing of the drive conduit handle 100 has metal contacts, and the sensors (temperature sensor 117 and / or pressure sensor 116) within the drive conduit handle 100 can be electrically connected to these metal contacts. When the drive conduit handle 100 is coupled to the drive assembly 101, the metal contacts on the drive conduit handle 100 connect with the metal contacts on the drive assembly 101, and the metal contacts on the drive assembly 101 are electrically connected to the control assembly 113, enabling the signals generated by the sensors to be transmitted to the control assembly 113.

[0097] In an optional embodiment, the system further includes a control component 113 for performing the method for detecting abnormalities in a flushing system for medical devices provided in the embodiments of this application.

[0098] Optionally, the control component 113 may include a processor, which is used to receive signals (first detection information, second detection information, etc.) sent by the sensor and generate corresponding alarm information based on the signals sent by the sensor.

[0099] In one alternative embodiment, the system further includes: an audio device and / or a display connected to the processor; the audio device for playing alarm information; and the display for displaying alarm information.

[0100] In an optional embodiment, a flushing pump is also provided on the flushing channel, which provides power to the flushing fluid in the flushing pipeline by squeezing. Optionally, there are two flushing pumps: a first flushing pump (also called infusion pump 107) is located at the first pipe 112-1 (the flushing pipeline connecting the fluid source and the first connector), and a second flushing pump (also called circulation pump 109) is located at the second pipe 112-2 (the channel segment connecting the first connector and the bubble filter).

[0101] For example, the infusion pump 107 and the circulation pump 109 are electrically connected to the control component 113, which is used to control the operation of the infusion pump 107 and the circulation pump 109.

[0102] In an alternative embodiment, it can be Figure 2 The ventricular assist system shown is divided into a control device 114 and consumables. The consumables are disposable items, while the control device 114 is a device that can be reused multiple times.

[0103] The control device includes a drive assembly 101 and a bubble sensor 115. The drive assembly 101 is used for coupling connection with consumables, and the bubble sensor 115 is clamped connection with the flushing tubing in the consumables.

[0104] Consumables include: flushing tubing 141 and interventional blood pump 140, with a fluid sensor 116 installed inside the interventional blood pump 140;

[0105] The flushing line 141 and the interventional blood pump 140 are connected to form a flushing channel; the first detection information and the second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; at least one of the abnormal position in the flushing channel and the abnormal state corresponding to the abnormal position is determined based on the first detection information and the second detection information.

[0106] The first detection information characterizes the change in flushing pressure in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the generation of bubbles in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel. Specifically, the bubble sensor can detect the bubble information, and the fluid sensor can detect the flushing pressure and / or fluid temperature information.

[0107] For example, the consumables include: an interventional blood pump 140 and a first connector 108;

[0108] The first interface (fluid inlet 118) of the interventional blood pump 140 is used to connect to the first interface 119 of the first connector 108;

[0109] The second port (fluid outlet 120) of the interventional blood pump 140 is used to connect to the second port 121 of the first connector 108;

[0110] The drive outlet 123 of the interventional blood pump 140 is used to connect to the pump head 103;

[0111] The third interface 122 of the first connector 108 is used to connect to the fluid source 106;

[0112] The flushing channel includes at least one flushing line for connecting the fluid source 106, the first connector 108, the interventional blood pump 140, and the pump head 103.

[0113] For example, the consumables include: a drive tube handle 100, a first connector 108, and a pump head 103;

[0114] The first interface (fluid inlet 118) of the drive conduit handle 100 is used to connect to the first interface 119 of the first connector 108;

[0115] The second interface (fluid outlet 120) of the drive tube handle 100 is used to connect to the second interface 121 of the first connector 108;

[0116] The drive outlet 123 of the drive tube handle 100 is used to connect to the pump head 103;

[0117] The third interface 122 of the first connector 108 is used to connect to the fluid source 106;

[0118] The flushing channel includes at least one flushing line for connecting the fluid source 106, the first connector 108, the drive conduit handle 100, and the pump head 103.

[0119] For example, the control device is used to perform the abnormal detection method for the flushing system of medical devices provided in the embodiments of this application. The control device includes: a drive component 101, a bubble sensor 115, and a control component 113.

[0120] Drive assembly 101 includes: a motor housing, a motor housed in the motor housing, and an active component driven by the motor;

[0121] The bubble sensor 115 is used to report bubble information to the control component 113. The control component 113 is used to determine abnormal information in the ventricular assist system based on the first detection information and the second detection information. The abnormal information includes at least one of abnormal location and abnormal state corresponding to the abnormal location. The abnormal location is at least one position in the flushing channel.

[0122] The fluid sensor mentioned above can be a pressure sensor or a pressure-temperature sensor.

[0123] For example, such as Figure 2 As shown, the consumables include: a first tube 112-1, a first connector 108, a second tube 112-2, a bubble filter 111, a drive conduit handle 100, a third tube 112-3, a particulate filter 110, a drive conduit 102, a pump head 103, a pressure sensor 116, and a temperature sensor 117.

[0124] The control equipment includes: drive assembly 101, control assembly 113, infusion pump 107, circulation pump 109, and bubble sensor 115.

[0125] For example, the use of the interventional blood pump 140 is divided into three phases: pre-filling phase, flushing phase, and blood pumping phase.

[0126] During the pre-filling phase, the interventional blood pump 140 needs to be connected to a flushing line (or flushing line) to flush the interventional blood pump 140 and its connecting lines (i.e., flushing line 141) with flushing fluid to remove air. Specifically, the fluid inlet 118 of the drive catheter handle 100 is connected to the second tube 112-2, and the fluid outlet 120 of the drive catheter handle 100 is connected to the third tube 112-3 to connect the passage formed by the bubble filter 111, the first connector 108, the fluid source 106, and the particulate filter 110. The drive outlet 123 of the drive catheter handle 100 is connected to the drive catheter 102, and the drive catheter 102 is connected to the pump head 103. The first tube 112-1 is fixed to the infusion pump 107 of the control device 114, and the second tube 112-2 is fixed to the circulation pump 109 of the control device 114. Optionally, the bubble sensor 115 can be mounted on the clamping assembly of the infusion pump 107 or on the clamping assembly of the circulation pump 109.

[0127] After pre-charging and venting, the continuous flushing phase can begin, waiting for the drive duct handle 100 to couple with the drive assembly 101.

[0128] During the pumping phase, the drive assembly 101 is activated, thereby driving the interventional blood pump 140 to assist the heart in pumping blood. The drive catheter handle 100 is coupled to the drive assembly 101. The fluid inlet 118 and fluid outlet 120 of the drive catheter handle 100 are closed. The drive outlet 123 of the drive catheter handle 100 is connected to the drive catheter 102, which is connected to the pump head 103. A hemostatic valve is provided inside the drive catheter 102 near the pump head 103 to prevent blood from flowing back from the pump head 103 into the drive catheter 102. The drive assembly 101 drives the drive shaft to rotate, which in turn drives the impeller inside the pump head 103 to rotate, creating suction at the pump head 103, causing blood to flow in from the inlet and out from the outlet of the pump head 103.

[0129] Figure 5 A schematic diagram of a ventricular assist system provided in another exemplary embodiment of this application is shown. The control device 114 includes at least a control component 113, a drive component 101, an infusion pump 107, and a circulation pump 109. Optionally, the control device 114 may also include a display on which clinical medical personnel can monitor the system status and patient physiological parameters, and provide different levels of circulatory assistance by adjusting the rotation speed of the interventional blood pump 140 according to the patient's needs, thereby temporarily maintaining blood circulation to the patient's vital organs and relieving the burden on the heart.

[0130] The ventricular assist system includes an interventional blood pump 140, a delivery system, and a flushing tubing 141. The interventional blood pump 140 includes a pump head 103 (containing an impeller, a support, and a diaphragm), a drive catheter 102, a drive catheter handle 100 (containing a catheter locking connector), a pressure sensor 116, and a flushing tubing connector. The interventional blood pump 140 can be percutaneously inserted into the heart via a peripheral blood vessel. The pump head 103 is placed between the left ventricle and the ascending aorta. The blood inlet of the pump head 103 is placed in the left ventricle, and the blood outlet of the pump head 103 is placed in the ascending aorta. The drive assembly 101 can be connected to the interventional blood pump 140 to drive the impeller in the pump head 103 to rotate, thereby pumping blood from the left ventricle into the ascending aorta to achieve ventricular assist function.

[0131] The delivery system includes a dilator, an interventional sheath, and a delivery device. The system dilates the blood vessel and provides access for the interventional blood pump 140 to be inserted into the heart. The delivery device and interventional sheath function as a retractor for the pump head. The delivery device and dilator are removed after the interventional blood pump 140 is in place. The interventional sheath remains in the patient's blood vessel until the interventional blood pump 140 is removed; during removal, the sheath continues to function as a retractor for the pump head.

[0132] The flushing line 141 includes a flushing kit for the interventional blood pump 140. The flushing kit includes a flushing line, a first connector 108, a fluid source 106, a bubble filter 111, and a particulate filter 110.

[0133] The flushing pump can be connected to the flushing line 141. The flushing pump delivers and controls the flushing fluid by squeezing the flushing line, thereby preventing blood from entering the drive catheter of the interventional blood pump and causing thrombosis.

[0134] The flushing pump drives the flushing tubing on the flushing kit, which can pump the flushing fluid in the fluid source 106 connected to the flushing tubing into the cavity inside the drive catheter handle 100, thereby preventing blood from entering the drive catheter 102.

[0135] Figure 6 This is a flowchart illustrating an exemplary embodiment of a method for detecting anomalies in a flushing system of a medical device. The method is applied to a medical device having a flushing channel, which may be the aforementioned ventricular assist system; the method can be executed by a control device 114 within the ventricular assist system. The method includes:

[0136] Step 210: Obtain the first detection information and the second detection information corresponding to the flushing channel. The first detection information represents the change in flushing pressure in the flushing channel within the target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information represents the generation of bubbles in the flushing channel, and the fluid temperature information represents the temperature change of the fluid in the flushing channel.

[0137] For example, the method is executed by a control component 113 (processor) in control device 114. Alternatively, the method is executed by a control component 113 (processor) in a medical device. Or, the method is executed by a server connected to control device 114 or medical device via a network.

[0138] Optionally, the medical device includes a fluid delivery line and an interventional blood pump 140. The fluid delivery line includes a first tube 112-1, a second tube 112-2, and a third tube 112-3 connected via a first connector 108. The first tube 112-1 is used to connect to a fluid source 106. The second tube 112-2 and the third tube 112-3 are respectively connected to the fluid interface (including a fluid inlet 118 and a fluid outlet 120) of the interventional blood pump 140, forming a flushing channel. The flushing system anomaly detection method provided in this application embodiment can detect anomalies in the flushing channel formed by a fluid delivery line with at least three branches and the interventional pump, and can be effectively applied to various interventional pump flushing channels. This application embodiment does not limit the fluid direction of the first tube, second tube, and third tube.

[0139] Optionally, the interventional blood pump 140 includes a fluid inlet 118 and a fluid outlet 120. A second tube 112-2 is connected to the fluid inlet 118, and a third tube 112-3 is connected to the fluid outlet 120. Fluid from the fluid source 106 is delivered to the fluid inlet 118 via the first tube 112-1 and the second tube 112-2 to enter the internal channel of the interventional blood pump 140. After flowing out of the internal channel through the fluid outlet 120, the fluid flows into the first connector 108 via the third tube 112-3, forming a fluid circulation between the second tube 112-2, the interventional blood pump 140, and the third tube 112-3. The flushing system anomaly detection method provided in this application embodiment can detect anomalies in flushing channels with circulating fluid and can be effectively applied to interventional pumps requiring fluid circulation flushing to determine abnormal conditions in the flushing system of this type of interventional pump.

[0140] Optionally, the control component 113 acquires first and second detection information via sensors. The sensors include at least one of a pressure sensor 116, a bubble sensor 115, and a temperature sensor 117. The pressure sensor 116, the bubble sensor 115, and the temperature sensor 117 are electrically connected to the control component 113. The control component 113 receives and processes signals transmitted from at least one of the pressure sensor 116, the bubble sensor 115, and the temperature sensor 117.

[0141] Optionally, the pressure sensor 116 sends the monitored pressure signal to the control component 113, and the control component 113 obtains first detection information based on the pressure signal. The first detection information includes at least one of the following data: pressure value, pressure change trend, pressure change rate, and pressure change acceleration.

[0142] Optionally, the bubble sensor 115 sends the detected bubble signal to the control component 113, and the control component 113 obtains second detection information based on the bubble signal. The second detection information includes at least one of the following data: number of bubbles, bubble detection time, bubble size, and bubble speed.

[0143] Optionally, the temperature sensor 117 sends the monitored temperature signal to the control component 113, and the control component 113 obtains second detection information based on the temperature signal. The second detection information includes at least one of the following data: temperature, temperature detection time, temperature change rate, and temperature change trend.

[0144] In an optional embodiment, the pressure sensor 116 can continuously measure pressure values ​​over time, and the first detection information can include a curve of pressure value change measured by the pressure sensor 116 over a period of time.

[0145] In another optional embodiment, the pressure sensor 116 can periodically measure pressure values, for example, the pressure sensor 116 measures pressure values ​​60 times per second. The pressure sensor 116 can report the measured pressure values ​​to the control component 113 in real time, or it can periodically report the pressure values ​​measured within the current period. The reporting period and the measurement period can be the same or different, with the reporting period being longer than the measurement period. After receiving the pressure values ​​measured by the pressure sensor 116, the control component 113 obtains first detection information based on at least two pressure values. For example, the control component 113 can obtain a pressure value change curve based on at least two pressure values. Alternatively, the control component 113 can fit a pressure value change curve based on at least two pressure values. The first detection information can then be obtained based on the pressure values ​​reported by the pressure sensor 116 over a period of time, and the first detection information can be based on the pressure value change curve of the pressure values ​​reported by the pressure sensor 116 over a period of time.

[0146] In one optional embodiment, the bubble sensor 115 can report bubble signals in real time. The bubble signal is used to indicate second detection information. When a bubble passes by the bubble sensor, the bubble signal changes, and the control component can obtain the second detection information based on the change in the bubble signal. Alternatively, the bubble sensor 115 can report a bubble signal when it detects a bubble, and the control component 113 can obtain the second detection information based on the bubble signal. Alternatively, the bubble sensor 115 can periodically detect bubbles and periodically report bubble signals, wherein the reporting period and the measurement period can be the same or different, and the length of the reporting period is longer than the length of the measurement period. The control component 113 can obtain the second detection information based on the reported bubble signals.

[0147] In an optional embodiment, the temperature sensor 117 can also report a temperature signal in real time. The temperature signal is used to indicate the second detection information. The temperature sensor 117 can detect the temperature in the rinsing channel in real time and report the detected temperature. The reporting period and measurement period of the temperature sensor 117 can be the same or different, but the length of the reporting period is not less than the length of the measurement period. The control component 113 can obtain the second detection information based on the reported temperature signal.

[0148] The second detection information may include bubble-related information detected by the bubble sensor 115 over a period of time. The second detection information may also include temperature-related information detected by the temperature sensor 117 over a period of time. The second detection information may include both bubble-related information detected by the bubble sensor 115 and temperature-related information detected by the temperature sensor 117 over a period of time.

[0149] For example, the second detection information and the first detection information correspond to the same time period. For instance, if the first detection information corresponds to a first time period, the second detection information also corresponds to the first time period. That is, the first and second detection information reflect the first and second detection information in the rinsing channel within the same time period.

[0150] Step 220: Based on the first detection information and the second detection information, output the abnormal alarm information corresponding to the rinsing channel. The abnormal alarm information indicates at least one of the abnormal position in the rinsing channel and the abnormal state corresponding to the abnormal position.

[0151] The control component 113 matches the corresponding abnormal location and / or the abnormal state corresponding to the abnormal location based on the monitored first detection information and second detection information.

[0152] For example, the abnormal location includes the location in the detectable location corresponding to the flushing channel where an abnormal state occurs. The detectable location refers to the location in the flushing channel where an abnormal state can be detected. The detectable location includes at least one channel segment and / or at least one location point in the flushing channel. The abnormal state includes at least one of the following: blockage, loosening, bending, twisting, leakage, abnormal fluid pressure, abnormal power source, or abnormal pump extrusion. In this way, the equipment can detect the location of abnormal states on a channel segment or location point basis, and can detect multiple abnormal states, facilitating operators to troubleshoot and resolve abnormalities, and improving the accuracy of abnormal detection in the flushing system.

[0153] For example, multiple abnormal flushing conditions include at least two of the following: blockage of fluid infusion channel 124, leakage of fluid infusion channel 124, blockage of circulation inlet channel 125, leakage of circulation inlet channel 125, blockage of circulation outlet channel 126, leakage of circulation outlet channel 126, leakage of interventional pump flushing channel 127, abnormal pressure of fluid infusion channel 124, abnormal pressure of circulation inlet channel 125, abnormal pressure of circulation outlet channel 126, abnormal pressure of interventional pump flushing channel 127, presence of air bubbles in fluid infusion channel 124, presence of air bubbles in circulation inlet channel 125, presence of air bubbles in circulation outlet channel 126, presence of air bubbles in interventional pump flushing channel 127, abnormal temperature of fluid infusion channel 124, abnormal temperature of circulation inlet channel 125, abnormal temperature of circulation outlet channel 126, and abnormal temperature of interventional pump flushing channel 127. The technical solution provided in this application embodiment can detect the above multiple abnormal flushing conditions, improving the comprehensiveness of abnormal detection in the flushing system.

[0154] For example, control component 113 stores at least two detectable locations and at least two candidate abnormal states. Control component 113 also stores matching conditions corresponding to each detectable location and matching conditions corresponding to each candidate abnormal state. The matching conditions are conditions set for the first detection information and the second detection information, and the matching conditions can be set based on pipeline characteristics, fluid flow characteristics, and experience.

[0155] For example, at least two detectable locations may have different flushing distances along the flushing channel compared to the pressure sensor; and / or, at least two detectable locations may have different flushing distances along the flushing channel compared to the bubble sensor; and / or, at least two detectable locations may have different flushing distances along the flushing channel compared to the temperature sensor; and / or, the flow direction of the flushing fluid may be different at at least two detectable locations; and / or, the composition of the flushing fluid may be different at at least two detectable locations; and / or, the flow rate of the flushing fluid may be different at at least two detectable locations. In the flushing channel, anomalies at different locations may have different effects on the fluid flow throughout the channel, such as changes in unflushed pressure, bubble formation, and temperature. Therefore, by comparing the first and second detection information with the matching conditions described above, abnormal locations and abnormal states can be detected.

[0156] When the first detection information and the second detection information meet the matching conditions corresponding to the detectable location, the detectable location is determined to be an abnormal location. When the first detection information and the second detection information meet the matching conditions corresponding to the candidate abnormal state, the candidate abnormal state is determined to be an abnormal state.

[0157] In one optional embodiment, a matching condition corresponds to a detectable location and a candidate abnormal state. That is, the abnormal location and the abnormal state occurring at that abnormal location can be determined based on the first detection information and the second detection information. When the first detection information and the second detection information satisfy a certain matching condition, the abnormal location is determined to be the detectable location corresponding to that matching condition, and the abnormal state is determined to be the candidate abnormal state corresponding to that matching condition.

[0158] That is, to determine the abnormal information corresponding to the first detection information and the second detection information, the abnormal information includes the abnormal location and the abnormal state.

[0159] In another alternative embodiment, the control component 113 may store at least one machine learning model, which can extract features from the first detection information and the second detection information, and output the corresponding abnormal location and / or abnormal state based on the extracted features.

[0160] For example, the control component 113 may store an abnormal location prediction model (machine learning model) and an abnormal state prediction model (machine learning model). The abnormal location prediction model is used to output the abnormal location based on the first detection information and the second detection information input; the abnormal state prediction model is used to output the abnormal state based on the first detection information and the second detection information input.

[0161] Alternatively, the control component 113 stores an anomaly prediction model, which is used to output the anomaly location and anomaly state based on the input first detection information and second detection information.

[0162] See Figure 4 The flushing channel may include at least one of the following channels: a fluid delivery channel 124 connecting the outlet of the fluid source 106 to the third interface 122 of the first connector 108 via a fluid delivery line; a first channel segment 125-1 connecting the first interface 119 of the first connector 108 to the inlet 130 of the bubble filter 111 via a fluid delivery line; a second channel segment 125-2 connecting the outlet 129 of the bubble filter 111 to the fluid inlet 118 of the drive conduit handle 100 via a fluid delivery line; a fourth channel segment 126-2 connecting the fluid outlet 120 of the drive conduit handle 100 to the inlet 131 of the particulate filter 110 via a fluid delivery line; a third channel segment 126-1 connecting the outlet 132 of the particulate filter 110 to the second interface 121 of the first connector 108 via a fluid delivery line; a passage connecting the drive conduit handle 100 to the pump head 103 via a drive conduit 102 at the connection point between the drive conduit handle 100 and the drive assembly 101.

[0163] Alternatively, the flushing channel may include at least one of the following channels: a fluid delivery channel 124 connecting the outlet of the fluid source 106 to the third interface 122 of the first connector 108 via a fluid delivery line; a circulation inlet channel 125 connecting the first interface 119 of the first connector 108 to the fluid inlet 118 of the drive conduit handle 100 via a flushing line; a circulation outlet channel 126 connecting the second interface 121 of the drive conduit handle 100 to the fluid outlet 120 of the first connector 108 via a flushing line; a passage in the drive conduit handle 100 connected to the drive assembly 101 via a drive conduit 102; and a passage connecting the drive conduit handle 100 to the pump head 103 via a drive conduit 102.

[0164] An abnormal location is any location within the flushing channel. For example, refer to the reference... Figure 7 As shown, the abnormal location may include at least one of the following detectable locations: flushing pipeline location 1, flushing pipeline location 2, flushing pipeline location 3, flushing pipeline location 4, flushing pipeline location 5, fluid plug 128, and drive conduit 102.

[0165] Among them, flushing tubing position 1 includes any position on the fluid infusion channel 124, flushing tubing position 3 includes any position on the first channel segment 125-1, flushing tubing position 5 includes any position on the second channel segment 125-2, flushing tubing position 2 includes any position on the third channel segment 126-1, flushing tubing position 4 includes any position on the fourth channel segment 126-2, the sixth detectable position includes any position in the interventional blood pump 140 connected to the drive assembly 101, and the seventh detectable position includes any position in the interventional blood pump 140 connected to the drive catheter 102.

[0166] Alternatively, flushing tubing position 1 includes any position between the outlet of fluid source 106 and the third interface 122 of first connector 108; flushing tubing position 3 includes any position between the first interface 119 of first connector 108 and the inlet 130 of bubble filter 111; flushing tubing position 5 includes any position between the outlet 129 of bubble filter 111 and the fluid inlet 118 of interventional blood pump 140; flushing tubing position 2 includes any position between the fluid outlet 120 of interventional blood pump 140 and the inlet 131 of particulate filter 110; flushing tubing position 4 includes any position between the outlet 132 of particulate filter 110 and the second interface 121 of first connector 108; the sixth detectable position includes any position in interventional blood pump 140 connected to drive assembly 101; and the seventh detectable position includes any position in interventional blood pump 140 connected to drive catheter 102.

[0167] Exemplary Reference Figure 2 The detectable location may also include at least one of the following: bubble filter 111, particulate filter 110.

[0168] Abnormal conditions include at least one of the following: blockage, loosening, bending, twisting, leakage, abnormal fluid pressure, abnormal power source, and abnormal pump squeezing state. Twisting can refer to the twisting of the fluid delivery pipeline or drive conduit (hose), reducing or even blocking the internal passageway. Blockage can refer to blockage at the interface (connection between pipelines), within the fluid delivery pipeline, or within the drive conduit. Leakage can refer to a gap at the interface, within the fluid delivery pipeline, or within the drive conduit, causing fluid to leak outwards. Loosening can refer to the connection at the flushing pipeline interface becoming loose or detached. Bending can refer to the flushing pipeline being bent or folded, obstructing the flow of flushing fluid. Abnormal fluid pressure refers to abnormal flushing fluid pressure within the flushing channel, such as excessive or insufficient pressure. Abnormal power source can refer to an abnormality in the power provided by the pump body pumping the fluid, such as an abnormal power supply to an infusion pump or circulation pump. Since the pump body can be a peristaltic pump or a squeezing pump (e.g., infusion pumps and circulation pumps are squeezing pumps), abnormal pump squeezing state refers to an abnormality in the pump body's squeezing function, such as an abnormal squeezing state caused by an open pump cover.

[0169] Optionally, for each abnormal state occurring at an abnormal location, an abnormality level can be classified based on the severity of the abnormality. The abnormality level corresponding to the first and second detection information is determined. That is, the abnormal information corresponding to the first and second detection information is determined, and the abnormal information includes at least one of abnormal location, abnormal state, and abnormality level. The abnormality level is used to indicate the severity of the abnormal state.

[0170] For example, regarding the abnormal state of twisting, when the catheter is completely twisted and the internal passage is blocked, it corresponds to the first level of twisting; when the catheter is partially twisted and the internal passage is blocked, it corresponds to the second level of twisting. Alternatively, regarding the abnormal state of blockage, when the fluid cannot flow due to complete blockage, it corresponds to the first level of blockage; when the fluid can still flow due to partial blockage, it corresponds to the second level of blockage.

[0171] Control component 113 can generate alarm information based on at least one of the identified abnormal location and abnormal state. The alarm information may include at least one of the abnormal location and abnormal state. For example, the alarm information may indicate the abnormal location and the abnormal state occurring at that location.

[0172] For example, the control component 113 may be connected to an audio system and / or a display, which can play alarm audio corresponding to the alarm information through the audio system and / or display the alarm information on the display.

[0173] In summary, the method provided in this embodiment accurately locates abnormal locations and / or abnormal states within the flushing channel by real-time monitoring of flushing pressure changes, bubble formation, and fluid temperature. When abnormalities occur at different locations within the flushing channel, the flushing pressure changes, bubble formation, and fluid temperature will differ, allowing for accurate location of the abnormality. Furthermore, different types of abnormal states (e.g., conduit twisting, blockage, leakage) will also result in different flushing pressure changes, bubble formation, and fluid temperature, further confirming the specific abnormal state at the abnormal location. Therefore, combining this information allows for accurate location of abnormalities in the flushing channel, facilitating timely and accurate alarm prompts, reducing or avoiding hazards during product use, and improving product safety.

[0174] In an optional embodiment, the control component 113 stores pressure change characteristic conditions and corresponding bubble generation characteristic conditions corresponding to each abnormal flushing situation. The control component 113 can match the real-time monitored first detection information and second detection information with the pressure change characteristic conditions and bubble generation characteristic conditions corresponding to each abnormal flushing situation, and identify the abnormal location and abnormal state based on the matching results.

[0175] Figure 8 This is a flowchart illustrating an exemplary embodiment of a method for detecting anomalies in a flushing system of a medical device. The method is applied to a medical device with a flushing channel, which may be an interventional cardiac catheter pump device, i.e., the aforementioned ventricular assist system; the method can be executed by the control device 114 within the ventricular assist system. Based on Figure 6 In the illustrated embodiment, step 220 includes step 221.

[0176] Step 210: Obtain the first detection information and the second detection information corresponding to the rinsing channel.

[0177] Optionally, the first detection information characterizes the change in flushing pressure in the flushing channel within a target duration, and the second detection information includes bubble information, which characterizes the generation of bubbles in the flushing channel. The control component 113 receives a pressure signal transmitted by the pressure sensor 116 and generates the first detection information based on the pressure signal. The control component 113 also receives a bubble signal transmitted by the bubble sensor 115 and generates the second detection information based on the bubble signal.

[0178] Step 221: If the first detection information satisfies the pressure change characteristic condition corresponding to the target abnormal flushing condition, and the second detection information satisfies the bubble generation characteristic condition and / or temperature change characteristic condition corresponding to the target abnormal flushing condition, output the abnormal alarm information corresponding to the target abnormal flushing condition.

[0179] Among them, the target abnormal flushing situation is the abnormal flushing situation that matches the first detection information and the second detection information among multiple abnormal flushing situations. Multiple abnormal flushing situations correspond one-to-one with multiple sets of feature conditions. Each abnormal flushing situation represents the situation where at least one position in the flushing channel is in an abnormal state. Each set of feature conditions includes a pressure change feature condition corresponding to an abnormal flushing situation, and at least one of the bubble generation feature condition and temperature change feature condition corresponding to an abnormal flushing situation.

[0180] Different abnormal flushing conditions may all lead to changes in flushing fluid pressure, but not every abnormal flushing condition will necessarily cause changes in both bubbles and temperature. For example, in the case of a leak, the flushing fluid temperature may not change, but bubbles may be generated; or in some cases of blockage or distortion, bubbles may not be generated, but the flushing flow rate will decrease, leading to an increase in flushing fluid temperature. However, all of these situations will cause changes in the flushing fluid. Therefore, for the assessment of each abnormal flushing condition, it is necessary to analyze the changes in flushing fluid pressure, and at least one of the following should be analyzed: bubble generation or temperature change.

[0181] For example, the control component 113 stores at least one candidate abnormal flushing condition and a set of characteristic conditions corresponding to each candidate abnormal flushing condition. Each set of characteristic conditions includes a pressure change characteristic condition corresponding to the abnormal flushing condition, and at least one of a bubble generation characteristic condition and a temperature change characteristic condition corresponding to the abnormal flushing condition. The pressure change characteristic condition, the bubble generation characteristic condition, and the temperature change characteristic condition can be obtained by analyzing the flow of fluid in the flushing channel and by experiments, and characterize the pressure change characteristics, bubble generation characteristics, and / or temperature change characteristics in the flushing channel when the candidate abnormal flushing condition occurs.

[0182] If the first detection information matches the pressure change characteristic condition corresponding to a candidate abnormal flushing condition, and the second detection information matches the bubble generation characteristic condition and / or temperature generation characteristic condition corresponding to the candidate abnormal flushing condition, then it can be determined that the candidate abnormal flushing condition has occurred, and the candidate abnormal state can be identified as the target abnormal flushing condition.

[0183] For example, pressure change characteristic conditions include pressure changes in the flushing channel under abnormal flushing conditions. These pressure change characteristic conditions include at least one of the following: pressure range conditions (e.g., pressure changes to a certain range), pressure change trend conditions (at least one of pressure increase, decrease, initial increase followed by decrease, initial decrease followed by increase, or fluctuation), pressure change rate threshold conditions, and pressure change acceleration threshold conditions. Bubble generation characteristic conditions include bubble generation in the flushing channel under abnormal flushing conditions. These bubble generation characteristic conditions include at least one of the following: bubble detection result conditions (bubbles detected, bubbles not detected), bubble quantity conditions, bubble detection time conditions, bubble size conditions, and bubble velocity conditions. Temperature change characteristic conditions include temperature changes in the flushing fluid in the flushing channel under abnormal flushing conditions. These temperature change characteristic conditions include at least one of the following: temperature range conditions (e.g., temperature changes to a certain range), temperature change trend conditions (at least one of temperature increase, decrease, initial increase followed by decrease, initial decrease followed by increase, or fluctuation), temperature change rate threshold conditions, and temperature change acceleration threshold conditions.

[0184] For example, the pressure change characteristic condition can be a judgment condition. When the first detection information meets the judgment condition, the first detection information matches the pressure change characteristic condition. For example, the pressure change characteristic condition includes: the pressure value changes to a certain range. Then, when the pressure value in the first detection information changes to the specified range, it is determined that the first detection information matches the pressure change characteristic condition.

[0185] Similarly, the bubble generation characteristic condition can also be a judgment condition. When the second detection information includes bubble information and the bubble information meets the judgment condition, the bubble information matches the bubble generation characteristic condition. For example, the bubble generation characteristic condition includes: a bubble is detected, no bubble is detected, or the bubble detection time (e.g., the bubble detection time is 2-5 seconds after the pressure begins to decrease, and the number of bubbles is 1-5). Then, when the bubble information indicates that the time of bubble detection is 3 seconds after the pressure begins to decrease, and the number of detected bubbles is 4, it is determined that the bubble information matches the bubble generation characteristic condition.

[0186] Temperature change characteristic conditions can also be a judgment condition. When the second detection information includes fluid temperature information and the fluid temperature information meets the judgment condition, the fluid temperature information matches the temperature change characteristic condition. For example, if the temperature change characteristic condition includes: temperature rise, then when the temperature value in the fluid temperature information changes to a specified range, it is determined that the fluid temperature information matches the temperature change characteristic condition.

[0187] Optionally, the pressure change characteristic conditions corresponding to the first detection information are determined; and the bubble generation characteristic conditions and / or temperature change characteristic conditions corresponding to the second detection information are determined; and the detectable locations corresponding to the pressure change characteristic conditions, the bubble generation characteristic conditions, and / or temperature change characteristic conditions are determined as abnormal locations.

[0188] For example, the control component 113 stores at least one detectable location, and pressure change characteristic conditions corresponding to each detectable location, as well as bubble generation characteristic conditions and / or temperature change characteristic conditions corresponding to each detectable location. The pressure change characteristic conditions, bubble generation characteristic conditions, and temperature change characteristic conditions can be obtained by analyzing the flow of fluid in the flushing channel and by prior experiments, and can characterize the pressure change, bubble change, and temperature change in the flushing channel when an anomaly occurs at the detectable location.

[0189] If the first detection information matches the pressure change characteristic condition corresponding to the detectable location, and the bubble information (if any) in the second detection information matches the bubble generation characteristic condition corresponding to the detectable location, and / or the fluid temperature information (if any) in the second detection information matches the temperature change characteristic condition corresponding to the detectable location, then it can be determined that the detectable location is abnormal and the detectable location is identified as an abnormal location.

[0190] For example, the control component 113 stores at least one set of abnormal flushing conditions, each set including a detectable location and a candidate abnormal state. The control component also stores pressure change characteristic conditions corresponding to each set of abnormal flushing conditions, as well as bubble generation characteristic conditions and / or temperature change characteristic conditions corresponding to each set of abnormal flushing conditions. The pressure change characteristic conditions, bubble generation characteristic conditions, and temperature change characteristic conditions can be obtained by analyzing the flow of fluid within the flushing channel and through prior experiments, and can characterize the pressure changes, bubble changes, and temperature changes within the flushing channel when an abnormality occurs at the detectable location.

[0191] If the first detection information matches the pressure change characteristic condition corresponding to the abnormal flushing situation, and the bubble information (if any) in the second detection information matches the bubble generation characteristic condition corresponding to the detectable location, and / or the fluid temperature information (if any) in the second detection information matches the temperature change characteristic condition corresponding to the detectable location, then it can be determined that the candidate abnormal state has occurred at the detectable location, the detectable location in the abnormal flushing situation is determined as an abnormal location, and the candidate abnormal state in the abnormal flushing situation is determined as an abnormal state.

[0192] For example, the pressure change characteristic conditions include pressure change characteristic conditions in the flushing channel when an anomaly occurs at a detectable location. These pressure change characteristic conditions include at least one of the following: pressure value range condition, pressure change trend condition, pressure change rate condition, and pressure change acceleration condition. The bubble generation characteristic conditions include bubble generation characteristic conditions in the flushing channel when an anomaly occurs at a detectable location. These bubble generation characteristic conditions include at least one of the following: bubble detection result condition, bubble quantity condition, bubble detection time condition, bubble size condition, and bubble velocity condition. The temperature change characteristic conditions include temperature change characteristic conditions in the flushing channel when an anomaly occurs at a detectable location. These temperature change characteristic conditions include at least one of the following: temperature value range condition, temperature change trend condition, temperature change rate condition, and temperature change acceleration condition.

[0193] For example, when the pressure change feature condition includes the pressure change feature condition curve and the bubble generation feature condition includes the target bubble detection result, if the similarity between the first detection information and the pressure change feature condition curve is greater than the first threshold and the bubble information is consistent with the target bubble detection result, the candidate abnormal state corresponding to the pressure change feature condition curve and the target bubble detection result is determined as an abnormal state, and the detectable position corresponding to the pressure change feature condition curve and the target bubble detection result is determined as an abnormal position.

[0194] As exemplarily shown in Table 1, the control component 113 stores a one-to-one correspondence table of detectable positions, candidate abnormal states, pressure change characteristic conditions, and bubble generation characteristic conditions.

[0195] Table 1

[0196]

[0197] For example, referring to Table 1, multiple abnormal flushing situations include at least two of the following:

[0198] The first abnormal flushing condition includes: the abnormal location is the fluid infusion channel 124 or a location point in the fluid infusion channel 124 (flushing pipeline location 1), and / or, the abnormal state is twisting; the pressure change characteristic conditions corresponding to the first abnormal flushing condition include: the rate of decrease of the fluid pressure data is lower than the first speed threshold, and after the first duration, the fluid pressure data decreases to within the first pressure range, the first pressure range is a floating range based on the first pressure data; the bubble generation characteristic conditions corresponding to the first abnormal flushing condition include the appearance of bubbles, and / or, the location of the first bubble appearance; the location of the first bubble appearance includes the position between the twisting position and the inlet of the infusion pump 107, the infusion pump 107 being located in the fluid infusion channel 124;

[0199] The second abnormal flushing condition includes: the abnormal location is the first channel segment 125-1 in the circulation inlet channel 125 or the location point in the first channel segment 125-1 (flushing pipeline location 3), and / or, the abnormal state is twisting; the pressure change characteristic conditions corresponding to the second abnormal flushing condition include: the fluid pressure data drops to the second pressure range within the second time period, and then rises back from the second pressure range to the pressure range before the drop within the third time period; the bubble generation characteristic conditions corresponding to the second abnormal flushing condition include no bubbles appearing; a bubble filter 111 is provided on the second pipe 112-2, and the first channel segment 125-1 includes the channel segment in the second pipe 112-2 before the fluid flows into the bubble filter 111;

[0200] The third abnormal flushing condition includes: the abnormal location is the second channel segment 125-2 in the circulation inlet channel 125 or the location point in the second channel segment 125-2 (flushing pipeline location 5), and / or, the abnormal state is twisting; the pressure change characteristic conditions corresponding to the third abnormal flushing condition include: the fluid pressure data first drops to the third pressure range within the fourth time period and then rises from the third pressure range to the floating range corresponding to the pressure before the drop at a speed lower than the second speed threshold; the bubble generation characteristic conditions corresponding to the third abnormal flushing condition include no bubbles appearing; a bubble filter 111 is provided on the second pipe 112-2, and the second channel segment 125-2 includes the channel segment in the second pipe 112-2 after the fluid flows out of the bubble filter 111;

[0201] The fourth abnormal flushing condition includes: the abnormal location is the third channel segment 126-1 in the circulation outlet channel 126 or the location point in the third channel segment 126-1 (flushing pipeline location 2), and / or, the abnormal state is twisting; the pressure change characteristic conditions corresponding to the fourth abnormal flushing condition include: the fluid pressure data rises to the fourth pressure range within the fifth time period, then falls back to the pressure value before the rise, and fluctuates up and down based on the pressure value before the rise; the bubble generation characteristic conditions corresponding to the fourth abnormal flushing condition include the appearance of bubbles, and / or, the location of the second bubble appearance; the location of the second bubble appearance includes the position between the infusion pump 107 and the first connector 108; a particulate filter 110 is provided on the third pipe 112-3, and the third channel segment 126-1 includes the channel segment from the outlet of the particulate filter 110 to the first connector 108;

[0202] The fifth abnormal flushing condition includes: the abnormal location is the fourth channel segment 126-2 in the circulation outlet channel 126 or the location point in the fourth channel segment 126-2 (flushing pipeline location 4), and / or the abnormal state is twisting; the pressure change characteristic conditions corresponding to the fifth abnormal flushing condition include: the fluid pressure data rises to the fifth pressure range within the sixth time period; the bubble generation characteristic conditions corresponding to the fifth abnormal flushing condition include no bubbles appearing; a particulate filter 110 is installed on the third pipe 112-3, and the fourth channel segment 126-2 includes the channel segment in the third pipe 112-3 before the fluid flows into the particulate filter 110;

[0203] The sixth abnormal flushing condition includes: the abnormal location is fluid delivery channel 124 or a point within fluid delivery channel 124 (fluid pipeline position 1), and / or, the abnormal state is leakage; the pressure change characteristic conditions corresponding to the sixth abnormal flushing condition include: fluid pressure data drops to the sixth pressure range, the sixth pressure range is a floating range based on the second pressure data; the bubble generation characteristic conditions corresponding to the sixth abnormal flushing condition include the appearance of bubbles, and / or, the location of the third bubble appearance; the location of the third bubble appearance includes fluid delivery channel 124;

[0204] The seventh abnormal flushing condition includes: the abnormal location is the first channel segment 125-1 in the circulation inlet channel 125 or the location point in the first channel segment 125-1 (flushing pipeline location 3), and / or, the abnormal state is leakage; the pressure change characteristic conditions corresponding to the seventh abnormal flushing condition include: the fluid pressure data drops to the seventh pressure range within the seventh time period, then drops to the eighth pressure range, and then rises back to the ninth pressure range and remains stable; the bubble generation characteristic conditions corresponding to the seventh abnormal flushing condition include the appearance of bubbles, and / or, the location of the fourth bubble appearance; the location of the fourth bubble appearance includes the first channel segment 125-1;

[0205] The eighth abnormal flushing condition includes: the abnormal location is the second channel segment 125-2 of the circulation inlet channel 125 or a point within the second channel segment 125-2 (flushing pipeline position 5), and / or, the abnormal state is leakage; the pressure change characteristic conditions corresponding to the eighth abnormal flushing condition include: the fluid pressure data drops to the tenth pressure range within the eighth time period and remains stable; the bubble generation characteristic conditions corresponding to the eighth abnormal flushing condition include no bubbles appearing.

[0206] The ninth abnormal flushing condition includes: the abnormal location is the third channel segment 126-1 in the circulation outlet channel 126 or the location point in the third channel segment 126-1 (flushing pipeline location 2), and / or, the abnormal state is leakage; the pressure change characteristic conditions corresponding to the ninth abnormal flushing condition include: the fluid pressure data drops to the eleventh pressure range and fluctuates within the eleventh pressure range; the bubble generation characteristic conditions corresponding to the ninth abnormal flushing condition include the appearance of bubbles, and / or, the location of the fifth bubble; the location of the fifth bubble includes the third channel segment 126-1;

[0207] The tenth abnormal flushing condition includes: the abnormal location is the fourth channel segment 126-2 in the circulation outlet channel 126 or the location point in the fourth channel segment 126-2 (flushing pipeline location 4), and / or, the abnormal state is leakage; the pressure change characteristic conditions corresponding to the tenth abnormal flushing condition include: the fluid pressure data drops to the twelfth pressure range within the ninth time period and remains stable; the bubble generation characteristic conditions corresponding to the tenth abnormal flushing condition include no bubbles appearing.

[0208] Eleventh abnormal flushing condition; The eleventh abnormal flushing condition includes: the abnormal location is the fluid plug 128 of the interventional blood pump 140, and / or the abnormal state is leakage; The pressure change characteristic conditions corresponding to the eleventh abnormal flushing condition include: the fluid pressure data drops to the positive pressure floating range based on the third pressure data within the tenth time period; The bubble generation characteristic conditions corresponding to the eleventh abnormal flushing condition include no bubbles appearing.

[0209] The twelfth abnormal flushing condition includes: the abnormal location is the drive catheter 102 of the interventional blood pump 140 or a location point in the drive catheter 102, and / or the abnormal state is leakage; the pressure change characteristic conditions corresponding to the twelfth abnormal flushing condition include: the fluid pressure data drops to the negative pressure floating range based on the fourth pressure data within the eleventh time period; the bubble generation characteristic conditions corresponding to the twelfth abnormal flushing condition include no bubbles appearing.

[0210] For example, if no corresponding candidate abnormal state and / or detectable location is matched based on the first detection information and the second detection information, an alarm message can be generated directly based on the first detection information and the second detection information.

[0211] For example, the control component 113 may also be configured with pressure anomaly conditions and bubble anomaly conditions. If no corresponding detectable location and / or candidate abnormal state is matched based on the first detection information and the second detection information, and the first detection information meets the pressure anomaly condition, an alarm message corresponding to the pressure anomaly condition can be issued. If no corresponding detectable location and / or candidate abnormal state is matched based on the first detection information and the second detection information, and the second detection information meets the bubble anomaly condition, an alarm message corresponding to the bubble anomaly condition can be issued.

[0212] For example, abnormal pressure conditions may include: the pressure value is greater than threshold 1, or the pressure value is less than threshold 2; abnormal bubble conditions may include: the number of bubbles is greater than 5, or the time interval between detecting bubbles is less than 2 seconds.

[0213] For example, the alarm message corresponding to an abnormal pressure condition could be: "Pressure abnormality." The alarm message corresponding to an abnormal bubble condition could be: "Bubbling abnormality."

[0214] In summary, the method provided in this embodiment matches the first detection information with pressure change characteristic conditions stored in the control component, matches the bubble information (if any) in the second detection information with bubble generation characteristic conditions stored in the control component, and / or matches the fluid temperature information (if any) in the second detection information with temperature change characteristic conditions stored in the control component. Based on the successfully matched pressure change characteristic conditions, bubble generation characteristic conditions, and / or temperature change characteristic conditions, the abnormal location and / or abnormal state in the flushing channel are determined. This facilitates timely and accurate alarm prompts for abnormalities, reduces or avoids hazards during product use, and improves product safety.

[0215] The method provided in this embodiment addresses the issue that, because the flushing channel is a semi-enclosed fluid transport channel, pressure imbalances can occur when abnormalities such as blockages, loosening, bending, twisting, leakage, power source malfunctions, or pump compression abnormalities exist in certain locations within the flushing channel. Some abnormalities may also lead to gas leakage, bubble formation, and / or temperature changes. Furthermore, different abnormalities at different locations within the flushing channel will result in different pressure changes, bubble formation, and temperature variations. Therefore, based on the pressure changes, bubble formation, and / or temperature changes within the flushing channel, the location of the abnormality and the type of abnormal state can be identified. By analyzing the fluid flow within the flushing channel and calculating the pressure changes and bubble formation at different locations under different abnormal states, the pressure changes, bubble formation (if any), and temperature changes (if any) corresponding to different locations and abnormal states can be summarized. Based on this correspondence, the location and type of abnormality in the flushing channel can be accurately identified, and alarm information can be generated in a timely manner to remind users. This facilitates timely and accurate alarm notifications for abnormalities, reduces or avoids dangers during product use, and improves the product's safety factor.

[0216] For example, because the drive shaft inside the interventional blood pump rotates at a very high speed, when the power of the flushing pump malfunctions, the fluid flow velocity decreases, causing the flushing fluid to be unable to flow and dissipate heat properly, resulting in an abnormal rise in fluid temperature. Alternatively, when an abnormality occurs within the flushing channel, the high-speed rotation of the drive shaft may also cause abnormal temperatures within the flushing channel. Therefore, combining information on temperature changes within the flushing channel can help to more accurately pinpoint the location and state of the abnormality.

[0217] Figure 9 This is a flowchart illustrating an exemplary embodiment of a method for detecting anomalies in a flushing system of a medical device. The method is applied to a medical device with a flushing channel, which may be an interventional cardiac catheter pump device, i.e., the aforementioned ventricular assist system; the method can be executed by the control device 114 within the ventricular assist system. Based on Figure 6 In the illustrated embodiment, step 220 includes step 222.

[0218] Step 210: Obtain the first detection information and the second detection information corresponding to the rinsing channel.

[0219] Optionally, the medical device includes an interventional blood pump 140 and an flushing pump. The interventional blood pump 140 includes a fluid inlet 118; the fluid inlet 118 is connected to a fluid delivery line to form a flushing channel; the flushing pump is connected to the fluid delivery line and is used to squeeze the fluid delivery line to deliver fluid.

[0220] Optionally, the first detection information characterizes the flushing pressure change in the flushing channel within a target duration, and the second detection information includes fluid temperature information, which characterizes the temperature change within the flushing channel. The control component 113 receives a pressure signal transmitted from the pressure sensor 116 and generates the first detection information based on the pressure signal. The control component 113 also receives a temperature signal transmitted from the temperature sensor 117 and generates the second detection information based on the temperature signal.

[0221] The control component 113 receives a pressure signal transmitted by the pressure sensor 116 and generates first detection information based on the pressure signal. The control component 113 also receives a temperature signal transmitted by the temperature sensor 117 and generates second detection information based on the temperature signal.

[0222] Optionally, the temperature sensor 117 is electrically connected to the control component 113, and the control component 113 receives and processes the signal transmitted by the temperature sensor 117.

[0223] Optionally, the temperature sensor 117 sends the monitored temperature signal to the control component 113, and the control component 113 obtains temperature change information based on the temperature signal. The temperature change information includes at least one of the following data: temperature value, temperature change trend, temperature change rate, and temperature change acceleration.

[0224] In one alternative embodiment, the temperature sensor 117 can continuously measure temperature values ​​over time, and the temperature change information can include a curve of temperature change measured by the temperature sensor 117 over a period of time.

[0225] In another optional embodiment, the temperature sensor 117 can periodically measure temperature values, for example, the temperature sensor 117 measures the temperature value 60 times per second. The temperature sensor 117 can report the measured temperature values ​​to the control component 113 in real time, or it can periodically report the temperature values ​​measured within the current period. The reporting period and the measurement period can be the same or different, with the reporting period being longer than the measurement period. After receiving the temperature values ​​measured by the temperature sensor 117, the control component 113 obtains temperature change information based on at least two temperature values. For example, the control component 113 can obtain a temperature change curve based on at least two temperature values. Alternatively, the control component 113 can fit a temperature change curve based on at least two temperature values. The temperature change information can be obtained based on the temperature values ​​reported by the temperature sensor over a period of time, and the temperature change information can be based on the temperature change curve of the temperature values ​​reported by the temperature sensor over a period of time.

[0226] Step 222: If the first detection information meets the pressure change characteristic condition corresponding to the abnormal pump extrusion state, and the fluid temperature information meets the temperature change characteristic condition corresponding to the abnormal pump extrusion state, output the abnormal alarm information corresponding to the abnormal pump extrusion state; abnormal pump extrusion state refers to the abnormal extrusion state of the flushing pump on the fluid delivery pipeline.

[0227] Optionally, the abnormal location corresponding to the first detection information and the fluid temperature information is determined, and / or, the abnormal state corresponding to the first detection information and the fluid temperature information is determined.

[0228] For example, control component 113 stores at least two detectable locations and at least two candidate abnormal extrusion states. Control component 113 also stores matching conditions corresponding to each detectable location and matching conditions corresponding to each candidate abnormal extrusion state. The matching conditions are conditions set based on the first detection information and fluid temperature information, and the matching conditions may be set based on the fluid flow conditions in the flushing channel and experience.

[0229] For example, the detectable location corresponding to the flushing channel includes: the squeezing section of the flushing pump; abnormal pump squeezing status includes abnormal release status of the squeezing section and / or abnormal release duration of the squeezing section.

[0230] For example, the flushing pump includes an infusion pump 107 and a circulation pump 109. The abnormal pump squeezing state includes at least one of the following: the squeezing part of the infusion pump 107 is released; the squeezing part of the circulation pump 109 is released; the squeezing part of the infusion pump 107 is released for a long time; the squeezing part of the circulation pump 109 is released for a long time; wherein, the long time is a preset duration or a duration identified based on preset conditions.

[0231] When the first detection information and the fluid temperature information meet the matching conditions corresponding to the detectable location, the detectable location is determined to be an abnormal location. When the first detection information and the fluid temperature information meet the matching conditions corresponding to the candidate abnormal state, the candidate abnormal state is determined to be an abnormal state.

[0232] Optionally, the control component 113 can determine the pressure change characteristic conditions corresponding to the first detection information; and determine the temperature change characteristic conditions corresponding to the fluid temperature information; identify the candidate abnormal states corresponding to the pressure change characteristic conditions and the temperature change characteristic conditions as abnormal states; and identify the detectable locations corresponding to the pressure change characteristic conditions and the temperature change characteristic conditions as abnormal locations.

[0233] For example, the temperature change characteristic condition can be a judgment condition. When the fluid temperature change information meets the judgment condition, the temperature change information matches the temperature change characteristic condition. For example, the temperature change characteristic condition includes: the temperature value changes to a certain range. Then, when the temperature value in the temperature change information changes to the specified range, it is determined that the temperature change information matches the temperature change characteristic condition.

[0234] Alternatively, the temperature change feature condition may include a temperature change feature condition curve. When the similarity between the temperature change information and the temperature change feature condition curve meets a threshold, it can be determined that the temperature change information matches the temperature change feature condition.

[0235] That is, if the similarity between the first detection information and the pressure change characteristic condition curve is greater than a first threshold, and the similarity between the fluid temperature information and the temperature change characteristic condition curve is greater than a third threshold, the candidate abnormal extrusion states corresponding to the pressure change characteristic condition curve and the temperature change characteristic condition curve are determined as abnormal pump extrusion states. The extrusion section of the flushing pump corresponding to the pressure change characteristic condition curve and the temperature change characteristic condition curve is determined as the abnormal extrusion location.

[0236] For example, by monitoring the changes in flushing pressure and flushing fluid temperature at the moment the pump cover of the infusion pump 107 or the circulation pump 109 is opened and within a certain period of time, the changes in pressure and temperature parameters when the infusion pump 107 and the circulation pump 109 are opened individually or simultaneously can be analyzed to identify when the pump cover is opened and issue a corresponding alarm to remind the user to troubleshoot the problem.

[0237] During operation of the control component 113, the normal operation of the infusion pump 107 and the circulation pump 109 requires that the pump cover be strictly closed after the fluid delivery pipeline is installed into the slot of the pump head; otherwise, the flushing fluid cannot be delivered normally. However, during equipment use, there are several situations in which the user may forget to close the pump cover after opening it:

[0238] 1. In some cases (such as blockage), the pressure in the flushing pipeline may be too high. Users may need to actively depressurize to reduce the risk. During the depressurization operation of the flushing pipeline, the pump cover needs to be opened to release the pressure from the liquid bag. During this operation, the pump cover may be forgotten to be closed again.

[0239] 2. During the process of changing the flushing fluid bag, the user may open the pump cover to check whether the flushing fluid is supplied normally, and may forget to close the pump cover again during this operation;

[0240] 3. If the flushing line malfunctions, the user may need to replace the flushing line. During the replacement process, the user needs to open the pump cover to install the new line. In this process, the user may forget to close the pump cover again.

[0241] 4. During normal surgical procedures, users may accidentally open the pump cover and forget to close it again.

[0242] In the above-mentioned situations, if the system lacks alarm mechanisms and the user forgets to close the pump cover, the flushing fluid may not be delivered properly, leading to malfunction due to insufficient flushing fluid supply and endangering patient safety. When the pump cover of the flushing pump or circulation pump is open, the roller pump will be unable to apply pressure to the pump tubing, thus failing to apply or maintain pressure on the flushing fluid. The flushing fluid pressure and temperature will change differently depending on whether the pump cover of the two roller pumps is open. The relevant characteristics are shown in Table 2.

[0243] Table 2

[0244]

[0245] For example, referring to Table 2, abnormal pump compression status may include at least one of the following:

[0246] The first pump's squeezing state is abnormal; the abnormal squeezing state of the first pump includes: the abnormal location is the squeezing part of the infusion pump 107, and / or, the abnormal state is that the squeezing part of the infusion pump 107 is released for a long time; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the first pump include: the rate of decrease of the fluid pressure data is higher than the third speed threshold, and it decreases to the thirteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the first pump include that the temperature remains stable.

[0247] The second pump's extrusion state is abnormal; the abnormal extrusion state of the second pump includes: the abnormal location is the extrusion section of the circulation pump 109, and / or, the abnormal state is that the extrusion section of the circulation pump 109 is released for a long time; the pressure change characteristic conditions corresponding to the abnormal extrusion state of the second pump include: the fluid pressure data remains stable; the temperature change characteristic conditions corresponding to the abnormal extrusion state of the second pump include temperature rise.

[0248] The third pump's squeezing state is abnormal; the abnormal squeezing state of the third pump includes: the abnormal location is the squeezing part of the infusion pump 107 and the squeezing part of the circulation pump 107, and / or, the abnormal state is that the squeezing part of the infusion pump is released for a long time and the squeezing part of the circulation pump is released for a long time; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the third pump include: the rate of decrease of the fluid pressure data is higher than the fourth speed threshold, and it decreases to the fourteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the third pump include temperature increase.

[0249] The method provided in this embodiment prevents false alarms or frequent alarms when the pump cover of the flushing pump or circulation pump is opened for a short period, thus avoiding disruption to user operation. If the pump cover is opened for an extended period due to incorrect operation or accidental circumstances, the system can quickly trigger an alarm to prevent potential hazards. By combining pressure and temperature monitoring, the system can accurately locate the fault position in the flushing pump and circulation pump, providing precise alarms and assisting users in troubleshooting.

[0250] The fourth pump's squeezing state is abnormal; the abnormal squeezing state of the fourth pump includes: the abnormal location is the squeezing part of the infusion pump 107, and / or, the abnormal state is that the squeezing part of the infusion pump 107 is released; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the fourth pump include: the rate of decrease of the fluid pressure data is higher than the fifth speed threshold, and it decreases to the fifteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the fourth pump include that the temperature remains stable.

[0251] The fifth pump's extrusion state is abnormal; the fifth pump's extrusion state abnormality includes: the abnormal location is the extrusion section of the circulation pump 109, and / or, the abnormal state is that the extrusion section of the circulation pump 109 is loosened; the pressure change characteristic conditions corresponding to the fifth pump's extrusion state abnormality include: the fluid pressure data remains stable; the temperature change characteristic conditions corresponding to the fifth pump's extrusion state abnormality include temperature rise.

[0252] The sixth pump's compression state is abnormal; the sixth pump's compression state abnormality includes: the abnormal location is the compression section of the infusion pump 107 and the compression section of the circulation pump, and / or, the abnormal state is that the compression section of the infusion pump 107 is released and the compression section of the circulation pump is released; the pressure change characteristic conditions corresponding to the sixth pump's compression state abnormality include: the rate of decrease of the fluid pressure data is higher than the sixth speed threshold, and it decreases to the sixteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the sixth pump's compression state abnormality include temperature increase.

[0253] For example, if no corresponding candidate abnormal state and / or detectable location is matched based on the first detection information and the second detection information, an alarm message can be generated directly based on the first detection information and the second detection information.

[0254] For example, the control component 113 may also be configured with temperature anomaly conditions. If no corresponding detectable location and / or candidate abnormal state is found based on the first detection information and the second detection information, and the temperature change information meets the temperature anomaly conditions, an alarm message corresponding to the temperature anomaly conditions can be issued.

[0255] For example, abnormal temperature conditions may include: a temperature value higher than 40°C, or a temperature value lower than 20°C.

[0256] For example, the alarm message corresponding to abnormal temperature conditions could be: abnormal temperature.

[0257] In summary, the method provided in this embodiment matches the first detection information with the pressure change characteristic conditions stored in the control component, and matches the second detection information with the temperature change characteristic conditions stored in the control component. Based on the successfully matched pressure and temperature change characteristic conditions, it determines the abnormal extrusion status of the circulation pump and the flushing pump. This facilitates timely and accurate alarm prompts for abnormal states where the extrusion section has loosened, reducing or avoiding hazards during product use and improving product safety.

[0258] The method provided in this embodiment addresses the issue that the flushing fluid is propelled by a flushing pump to flow through the flushing channel. When the flushing pump malfunctions, such as when the pump cover opens or the pump stops working, it causes abnormal fluid flow within the flushing channel. Since the flushing channel is a semi-closed system with only one fluid outlet, this abnormal flow leads to pressure and temperature imbalances. By analyzing the fluid flow within the channel and calculating the pressure and temperature changes in the flushing channel under different abnormal pump conditions, the pressure and temperature changes corresponding to different flushing pumps and different abnormal compression states can be summarized. Based on this correspondence, the flushing pump causing the fluid dynamics abnormality due to compression abnormalities, as well as the type of abnormal compression state occurring in that pump, can be accurately identified. Alarm information can be generated promptly to alert the user, facilitating timely and accurate alarm notifications for abnormalities, reducing or avoiding hazards during product use, and improving product safety.

[0259] Optionally, the aforementioned fluid delivery pipeline includes a first pipe and a second pipe connected via a first connector. The first pipe is used to connect to a fluid source, and the second pipe is connected to a fluid inlet. An infusion pump is mounted on the first pipe, and a circulation pump is mounted on the second pipe. This allows for... Figure 2 The flushing system shown identifies and alarms when the flushing pump's squeezing status is abnormal.

[0260] Figure 10 A schematic diagram of an abnormal alarm device for a medical device according to an exemplary embodiment of this application is shown. This device can be implemented as all or part of a control component through software, hardware, or a combination of both. The device includes:

[0261] Monitoring module 401 is used to acquire first detection information and second detection information corresponding to the flushing channel. The first detection information characterizes the flushing pressure change of the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0262] The generation module 403 is used to output abnormal alarm information corresponding to the flushing channel based on the first detection information and the second detection information, wherein the abnormal alarm information indicates at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position.

[0263] In one optional embodiment, the abnormal location includes the location in the detectable location corresponding to the flushing channel where the abnormal state occurs, and the detectable location refers to the location in the flushing channel where the abnormal state can be detected.

[0264] The detectable location includes at least one channel segment and / or at least one location point in the flushing channel, and the abnormal state includes at least one of the following: blockage, loosening, bending, twisting, leakage, abnormal fluid pressure, abnormal power source, and abnormal pump extrusion state.

[0265] In an optional embodiment, the generation module 403 is configured to output abnormal alarm information corresponding to the target abnormal flushing situation when the first detection information satisfies the pressure change characteristic condition corresponding to the target abnormal flushing situation, and the second detection information satisfies the bubble generation characteristic condition and / or temperature change characteristic condition corresponding to the target abnormal flushing situation.

[0266] The target abnormal flushing situation is an abnormal flushing situation that matches the first detection information and the second detection information among multiple abnormal flushing situations. The multiple abnormal flushing situations correspond one-to-one with multiple sets of feature conditions. Each abnormal flushing situation represents the situation where the abnormal state occurs at least at a location in the flushing channel. Each set of feature conditions includes a pressure change feature condition corresponding to an abnormal flushing situation, and at least one of the bubble generation feature condition and the temperature change feature condition corresponding to the abnormal flushing situation.

[0267] In one alternative embodiment, the medical device includes: a fluid delivery line and an interventional blood pump, the fluid delivery line including a first tube, a second tube and a third tube connected based on a first connector, the first tube being used to connect to a fluid source, and the second tube and the third tube being respectively connected to the fluid interface of the interventional blood pump to form the flushing channel.

[0268] In one optional embodiment, the interventional blood pump includes a fluid inlet and a fluid outlet, the second tube is connected to the fluid inlet, and the third tube is connected to the fluid outlet;

[0269] The fluid in the fluid source is delivered to the fluid inlet through the first tube and the second tube to enter the internal channel of the interventional blood pump; the fluid in the internal channel flows out through the fluid outlet and then flows into the first connector through the third tube, forming a fluid circulation between the second tube, the interventional blood pump and the third tube.

[0270] In one optional embodiment, the detectable location corresponding to the flushing channel includes at least one of the following: a fluid infusion channel, a circulation inlet channel, a circulation outlet channel, and an interventional blood pump flushing channel;

[0271] The fluid delivery channel includes: a channel formed between the fluid source and the first connector;

[0272] The circulation inlet channel includes: a channel formed between the first connector and the fluid inlet;

[0273] The circulation outlet channel includes: a channel formed between the fluid outlet and the first connector;

[0274] The interventional blood pump flushing channel includes: the fluid flow channel of the interventional blood pump.

[0275] In one optional embodiment, the plurality of abnormal flushing conditions includes at least two of the following:

[0276] The fluid infusion channel is blocked, the fluid infusion channel is leaking, the circulatory inlet channel is blocked, the circulatory inlet channel is leaking, the circulatory outlet channel is blocked, the circulatory outlet channel is leaking, the interventional blood pump flushing channel is leaking, the fluid infusion channel pressure is abnormal, the circulatory inlet channel pressure is abnormal, and the circulatory outlet channel pressure is abnormal.

[0277] In one optional embodiment, at least one fluid processing device is provided on the second pipe, and the detectable position corresponding to the circulation inlet channel includes at least one of the following: a channel segment divided by the at least one fluid processing device, a position point in the channel segment, a pipe connection position on the circulation inlet channel, and the at least one fluid processing device.

[0278] In one optional embodiment, at least one fluid processing device is provided on the third pipe, and the detectable position corresponding to the circulation outlet channel includes at least one of the following: a channel segment divided by the at least one fluid processing device, a position point in the channel segment, a pipe connection position on the circulation outlet channel, and the at least one fluid processing device.

[0279] In one optional embodiment, the interventional blood pump includes a drive catheter and a fluid plugging device. The fluid enters the internal channel of the interventional blood pump and then enters the drive catheter. The interventional blood pump includes a through hole, and the fluid plugging device is used to block the fluid flowing through the through hole. The detectable position corresponding to the flushing channel of the interventional blood pump includes the drive catheter and the fluid plugging device.

[0280] In one optional embodiment, the plurality of abnormal flushing conditions includes at least two of the following:

[0281] The first abnormal flushing condition includes: the abnormal location being the fluid infusion channel or a point within the fluid infusion channel, and / or the abnormal state being a distortion; the pressure change characteristic conditions corresponding to the first abnormal flushing condition include: the rate of decrease of the fluid pressure data being lower than a first speed threshold, and after a first duration, the fluid pressure data decreasing to within a first pressure range, the first pressure range being a floating range based on the first pressure data; the bubble generation characteristic conditions corresponding to the first abnormal flushing condition include the appearance of bubbles, and / or the location of the first bubble appearance; the location of the first bubble appearance includes the position between the distortion location and the inlet of the infusion pump, the infusion pump being located in the fluid infusion channel;

[0282] The second abnormal flushing condition includes: the abnormal location is a first channel segment or a location point within the first channel segment in the circulation inlet channel, and / or the abnormal state is distortion; the pressure change characteristic condition corresponding to the second abnormal flushing condition includes: the fluid pressure data drops to a second pressure range within a second time period, and then rises back to the pressure range before the drop within a third time period; the bubble generation characteristic condition corresponding to the second abnormal flushing condition includes no bubbles appearing; a bubble filter is provided on the second pipe, and the first channel segment includes the channel segment in the second pipe before the fluid flows into the bubble filter;

[0283] The third abnormal flushing condition includes: the abnormal location is a second channel segment or a position point within the second channel segment in the circulation inlet channel, and / or the abnormal state is distortion; the pressure change characteristic condition corresponding to the third abnormal flushing condition includes: the fluid pressure data first drops to the third pressure range within a fourth time period and then rises from the third pressure range to the floating range corresponding to the pressure before the drop at a speed lower than the second speed threshold; the bubble generation characteristic condition corresponding to the third abnormal flushing condition includes no bubbles appearing; the second pipe is provided with the bubble filter, and the second channel segment includes the channel segment after the fluid in the second pipe flows out of the bubble filter;

[0284] The fourth abnormal flushing condition includes: the abnormal location being a segment of the third channel in the circulation outlet channel or a point within the third channel segment, and / or, the abnormal state being distortion; the pressure change characteristic conditions corresponding to the fourth abnormal flushing condition include: the fluid pressure data rising to the fourth pressure range within a fifth time period, then falling back to the pressure value before the rise, and fluctuating around the pressure value before the rise; the bubble generation characteristic conditions corresponding to the fourth abnormal flushing condition include the appearance of bubbles, and / or, the location of the second bubble appearance; the location of the second bubble appearance includes the position between the infusion pump and the first connector; a particulate filter is provided on the third tube, and the third channel segment includes the channel segment from the particulate filter outlet to the first connector;

[0285] The fifth abnormal flushing condition includes: the abnormal location being a segment of the fourth channel in the circulation outlet channel or a point within the fourth channel segment, and / or, the abnormal state being distortion; the pressure change characteristic condition corresponding to the fifth abnormal flushing condition includes: the fluid pressure data rising to the fifth pressure range within a sixth time period; the bubble generation characteristic condition corresponding to the fifth abnormal flushing condition includes no bubbles appearing; the third pipe is equipped with the particulate filter, and the fourth channel segment includes the channel segment in the third pipe before the fluid flows into the particulate filter;

[0286] The sixth abnormal flushing condition includes: the abnormal location being the fluid delivery channel or a point within the fluid delivery channel, and / or the abnormal state being leakage; the pressure change characteristic condition corresponding to the sixth abnormal flushing condition includes: the fluid pressure data dropping to a sixth pressure range, the sixth pressure range being a floating range based on the second pressure data; the bubble generation characteristic condition corresponding to the sixth abnormal flushing condition includes the appearance of bubbles, and / or, the location of a third bubble appearance; the location of the third bubble appearance includes the fluid delivery channel;

[0287] The seventh abnormal flushing situation includes: the abnormal location being the first channel segment or a location point within the first channel segment in the circulation inlet channel, and / or, the abnormal state being leakage; the pressure change characteristic conditions corresponding to the seventh abnormal flushing situation include: the fluid pressure data decreasing to the seventh pressure range within a seventh time period, then decreasing to the eighth pressure range, and then rising back to the ninth pressure range and remaining stable; the bubble generation characteristic conditions corresponding to the seventh abnormal flushing situation include the appearance of bubbles, and / or, the location of the fourth bubble appearance; the location of the fourth bubble appearance includes the first channel segment;

[0288] The eighth abnormal flushing situation includes: the abnormal location is a segment of the second channel of the circulation inlet channel or a location point within the segment of the second channel, and / or the abnormal state is leakage; the pressure change characteristic conditions corresponding to the eighth abnormal flushing situation include: the fluid pressure data drops to the tenth pressure range within the eighth time period and remains stable; the bubble generation characteristic conditions corresponding to the eighth abnormal flushing situation include no bubbles appearing.

[0289] The ninth abnormal flushing condition includes: the abnormal location being a segment of the third channel in the circulation outlet channel or a point within the segment of the third channel, and / or, the abnormal state being leakage; the pressure change characteristic conditions corresponding to the ninth abnormal flushing condition include: the fluid pressure data dropping to the eleventh pressure range and fluctuating within the eleventh pressure range; the bubble generation characteristic conditions corresponding to the ninth abnormal flushing condition include the appearance of bubbles, and / or, the location of the fifth bubble appearance; the location of the fifth bubble appearance includes the third channel segment;

[0290] The tenth abnormal flushing situation includes: the abnormal location is the fourth channel segment or a location point in the fourth channel segment of the circulation outlet channel, and / or the abnormal state is leakage; the pressure change characteristic conditions corresponding to the tenth abnormal flushing situation include: the fluid pressure data drops to the twelfth pressure range within the ninth time period and remains stable; the bubble generation characteristic conditions corresponding to the tenth abnormal flushing situation include no bubbles appearing.

[0291] Eleventh abnormal flushing condition; the eleventh abnormal flushing condition includes: the abnormal location is the fluid sealing component of the interventional blood pump, and / or, the abnormal state is leakage; the pressure change characteristic condition corresponding to the eleventh abnormal flushing condition includes: the fluid pressure data drops to the positive pressure floating range based on the third pressure data within the tenth time period; the bubble generation characteristic condition corresponding to the eleventh abnormal flushing condition includes no bubbles appearing.

[0292] The twelfth abnormal flushing condition includes: the abnormal location being the drive catheter of the interventional blood pump or a location point within the drive catheter, and / or the abnormal state being leakage; the pressure change characteristic conditions corresponding to the twelfth abnormal flushing condition include: the fluid pressure data decreasing to a negative pressure floating range based on the fourth pressure data within the eleventh time period; the bubble generation characteristic conditions corresponding to the twelfth abnormal flushing condition include no bubbles appearing.

[0293] In one optional embodiment, the medical device includes: an interventional blood pump and a flushing pump, the interventional blood pump including a fluid inlet; the fluid inlet being connected to a fluid delivery line to form the flushing channel; the flushing pump being connected to the fluid delivery line and used to squeeze the fluid delivery line to deliver the fluid;

[0294] The generation module 403 is used to output abnormal alarm information corresponding to the abnormal pump squeezing state when the first detection information meets the pressure change characteristic condition corresponding to the abnormal pump squeezing state and the fluid temperature information meets the temperature change characteristic condition corresponding to the abnormal pump squeezing state; the abnormal pump squeezing state refers to the situation where the squeezing state of the flushing pump on the fluid delivery pipeline is abnormal.

[0295] In one optional embodiment, the detectable location corresponding to the flushing channel includes: the squeezing section of the flushing pump; the abnormal pump squeezing state includes an abnormal release state of the squeezing section and / or an abnormal release duration of the squeezing section.

[0296] In one alternative embodiment, the flushing pump includes an infusion pump and a circulation pump, and the pump squeezing abnormality includes at least one of the following:

[0297] The squeezing section of the infusion pump is released;

[0298] The extrusion section of the circulating pump is released;

[0299] The squeezing mechanism of the infusion pump is released for an extended period of time;

[0300] The compression of the circulating pump is released for a long time;

[0301] The "time period" refers to a preset duration or a duration identified based on preset conditions.

[0302] In one alternative embodiment, the flushing pump includes an infusion pump and a circulation pump, and the pump squeezing abnormality includes at least one of the following:

[0303] The first pump's squeezing state is abnormal; the abnormal squeezing state of the first pump includes: the abnormal location is the squeezing part of the infusion pump, and / or, the abnormal state is that the squeezing part of the infusion pump is released for a long time; the pressure change characteristic condition corresponding to the abnormal squeezing state of the first pump includes: the rate of decrease of the fluid pressure data is higher than the third speed threshold, and it decreases to the thirteenth pressure range and remains stable; the temperature change characteristic condition corresponding to the abnormal squeezing state of the first pump includes that the temperature remains stable.

[0304] The second pump's extrusion state is abnormal; the abnormal extrusion state of the second pump includes: the abnormal location is the extrusion section of the circulation pump, and / or, the abnormal state is that the extrusion section of the circulation pump is released for a long time; the pressure change characteristic condition corresponding to the abnormal extrusion state of the second pump includes: the fluid pressure data remains stable; the temperature change characteristic condition corresponding to the abnormal extrusion state of the second pump includes temperature increase;

[0305] The third pump's squeezing state is abnormal; the abnormal squeezing state of the third pump includes: the abnormal location being the squeezing section of the infusion pump and the squeezing section of the circulation pump, and / or, the abnormal state being the squeezing section of the infusion pump being released for a long time and the squeezing section of the circulation pump being released for a long time; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the third pump include: the rate of decrease of the fluid pressure data is higher than the fourth speed threshold, and it decreases to the fourteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the third pump include temperature increase;

[0306] The fourth pump's squeezing state is abnormal; the abnormal squeezing state of the fourth pump includes: the abnormal location is the squeezing section of the infusion pump, and / or, the abnormal state is that the squeezing section of the infusion pump is released; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the fourth pump include: the rate of decrease of the fluid pressure data is higher than the fifth speed threshold, and it decreases to the fifteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the fourth pump include that the temperature remains stable;

[0307] The fifth pump's extrusion state is abnormal; the abnormal extrusion state of the fifth pump includes: the abnormal location is the extrusion section of the circulation pump, and / or, the abnormal state is that the extrusion section of the circulation pump is released; the pressure change characteristic condition corresponding to the abnormal extrusion state of the fifth pump includes: the fluid pressure data remains stable; the temperature change characteristic condition corresponding to the abnormal extrusion state of the fifth pump includes temperature increase;

[0308] The sixth pump's squeezing state is abnormal; the abnormal squeezing state of the sixth pump includes: the abnormal location being the squeezing section of the infusion pump and the squeezing section of the circulation pump, and / or, the abnormal state being the squeezing section of the infusion pump being released and the squeezing section of the circulation pump being released; the pressure change characteristic conditions corresponding to the abnormal squeezing state of the sixth pump include: the rate of decrease of the fluid pressure data is higher than the sixth speed threshold, and it decreases to the sixteenth pressure range and remains stable; the temperature change characteristic conditions corresponding to the abnormal squeezing state of the sixth pump include temperature increase.

[0309] In one optional embodiment, the fluid delivery pipeline includes a first pipe and a second pipe connected by a first connector, the first pipe being used to connect to a fluid source and the second pipe being connected to the fluid inlet; wherein the infusion pump is disposed on the first pipe and the circulation pump is disposed on the second pipe.

[0310] Figure 11 A structural block diagram of a computer device 900 illustrated in an exemplary embodiment of this application is shown. This computer device can be implemented as a control component of the medical device described above in this application. The computer device 900 includes a Central Processing Unit (CPU) 901, a system memory 904 including Random Access Memory (RAM) 902 and Read-Only Memory (ROM) 903, and a system bus 905 connecting the system memory 904 and the CPU 901. The computer device 900 also includes a mass storage device 906 for storing an operating system 909, application programs 910, and other program modules 911.

[0311] The mass storage device 906 is connected to the central processing unit 901 via a mass storage controller (not shown) connected to the system bus 905. The mass storage device 906 and its associated computer-readable media provide non-volatile storage for the computer device 900. That is, the mass storage device 906 may include computer-readable media (not shown) such as a hard disk or a compact disc read-only memory (CD-ROM) drive.

[0312] Without loss of generality, the computer-readable medium may include computer storage media and communication media. Computer storage media include volatile and non-volatile, removable and non-removable media implemented using any method or technology for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer storage media include RAM, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other solid-state storage technologies, CD-ROM, digital versatile disc (DVD) or other optical storage, magnetic tape cassettes, magnetic tape, disk storage, or other magnetic storage devices. Of course, those skilled in the art will recognize that the computer storage media are not limited to the above-mentioned types. The system memory 904 and mass storage device 906 described above can be collectively referred to as memory.

[0313] According to various embodiments of this disclosure, the computer device 900 can also be connected to a remote computer on a network, such as the Internet. That is, the computer device 900 can be connected to a network 908 via a network interface unit 907 connected to the system bus 905, or it can use the network interface unit 907 to connect to other types of networks or remote computer systems (not shown).

[0314] The memory also includes at least one computer program stored in the memory, and the central processing unit 901 executes the at least one program to implement all or part of the steps in the abnormal detection method for the flushing system of medical devices shown in the above embodiments.

[0315] This application embodiment also provides a ventricular assist system, the ventricular assist system comprising:

[0316] Flushing channel;

[0317] Sensors are installed in the flushing channel;

[0318] The sensor is used to detect first detection information and second detection information in the flushing channel to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location.

[0319] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0320] This application embodiment also provides a ventricular assist system, the ventricular assist system comprising: control equipment and consumables;

[0321] The control device includes a drive assembly and a bubble sensor. The drive assembly is used to be coupled to the consumable, and the bubble sensor is clamped to the flushing tubing in the consumable.

[0322] The consumables include: a flushing tubing and an interventional blood pump, wherein the interventional blood pump is equipped with a fluid sensor; the fluid sensor includes a pressure sensor, or includes a pressure sensor and a temperature sensor, or includes both a pressure sensor and a temperature sensor.

[0323] The flushing tubing and the interventional blood pump are connected to form a flushing channel. The first detection information and the second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor. At least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location is determined based on the first detection information and the second detection information.

[0324] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0325] This application embodiment also provides a control device for a ventricular assist system, the ventricular assist system having a flushing channel, the control device being used to execute any of the above-described methods for detecting abnormalities in the flushing system of medical devices. Optionally, the control device includes: a drive component, a bubble sensor, and a control component;

[0326] The bubble sensor is used to report bubble information to the control component, and the control component is used to determine at least one of the abnormal location and the abnormal state corresponding to the abnormal location in the ventricular assist system based on the second detection information and the first detection information reported by the pressure sensor.

[0327] The first detection information characterizes the change in flushing pressure in the flushing channel of the ventricular assist system within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the generation of bubbles in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0328] This application embodiment also provides a consumable in a ventricular assist system, the consumable including: a flushing tubing and an interventional blood pump, wherein a pressure sensor is provided inside the interventional blood pump;

[0329] The flushing pipeline and the interventional blood pump are connected to form a flushing channel. The pressure sensor is used to report first detection information to the control component. The control component is used to determine at least one of the abnormal location in the flushing channel and the abnormal state corresponding to the abnormal location based on the second detection information reported by the bubble sensor and / or temperature sensor and the first detection information.

[0330] The first detection information characterizes the flushing pressure change in the flushing channel within a target duration. The second detection information includes at least one of bubble information and fluid temperature information. The bubble information characterizes the bubble generation in the flushing channel, and the fluid temperature information characterizes the temperature change of the fluid in the flushing channel.

[0331] This application also provides a computer-readable storage medium storing at least one computer program, which is loaded and executed by a processor to implement the above-described method embodiments for detecting abnormalities in the flushing system of a medical device.

[0332] This application also provides a chip, which includes a programmable logic circuit or a program, and a device equipped with the chip is used to implement the above-described method for detecting abnormalities in a flushing system for medical devices.

[0333] This application also provides a computer program product, which includes a computer program stored in a computer-readable storage medium. The computer program is read from and executed by a processor of a computer device, causing the computer device to perform an abnormality detection method for a flushing system of a medical device provided in the above-described method embodiments.

[0334] It is understood that, in the specific embodiments of this application, the data related to flushing fluid information, historical data, and user data processing such as profiles that are related to user identity or characteristics, when applied to specific products or technologies, require user permission or consent, and the collection, use and processing of related data must comply with the relevant laws, regulations and standards of the relevant countries and regions.

[0335] It should be noted that, unless otherwise expressly defined herein, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field. Unless otherwise expressly stated, all references to "an element, device, component, apparatus, step, etc." are openly interpreted as referring to at least one instance of an element, device, component, apparatus, step, etc. Unless expressly stated otherwise, the steps of any method disclosed herein are not necessarily to be performed in the exact order disclosed.

[0336] It should be understood that "multiple" as used in this article refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone. The character " / " generally indicates that the preceding and following related objects have an "or" relationship.

[0337] Those skilled in the art will understand that all or part of the steps of the above embodiments can be implemented by hardware or by a program instructing related hardware. The program can be stored in a computer-readable storage medium, such as a read-only memory, a disk, or an optical disk.

[0338] The above description is merely an optional embodiment of this application and is not intended to limit this application. Any modifications, equivalent switching, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A flushing system anomaly detection method for a medical device, the method comprising: The medical device has a flushing channel; the method comprises: obtaining first detection information and second detection information corresponding to the flushing channel, the first detection information representing a flushing pressure change condition of the flushing channel within a target time length, the second detection information including at least one of bubble information and fluid temperature information, the bubble information representing a bubble generation condition in the flushing channel, and the fluid temperature information representing a temperature change condition of fluid in the flushing channel; outputting abnormal alarm information corresponding to the flushing channel according to the first detection information and the second detection information, the abnormal alarm information indicating at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position.

2. The method of claim 1, wherein, The abnormal position includes a position in which the abnormal state occurs in a detectable position corresponding to the flushing channel, and the detectable position refers to a position in the flushing channel that can be detected to have the abnormal state; The detectable position includes at least one channel segment and / or at least one position point in the flushing channel, and the abnormal state includes at least one of blockage, loosening, bending, twisting, leakage, fluid pressure abnormality, power source abnormality, and pump extrusion state abnormality; Optionally, the outputting of the abnormal alarm information corresponding to the flushing channel according to the first detection information and the second detection information comprises: in a case where the first detection information satisfies a pressure change characteristic condition corresponding to a target abnormal flushing condition, and the second detection information satisfies a bubble generation characteristic condition and / or a temperature change characteristic condition corresponding to the target abnormal flushing condition, outputting abnormal alarm information corresponding to the target abnormal flushing condition; wherein the target abnormal flushing condition is an abnormal flushing condition matched with the first detection information and the second detection information among a plurality of abnormal flushing conditions, the plurality of abnormal flushing conditions correspond to a plurality of sets of characteristic conditions one-to-one, each abnormal flushing condition represents a case where at least one position in the flushing channel has the abnormal state, and each set of characteristic conditions includes a pressure change characteristic condition corresponding to one abnormal flushing condition, and at least one of a bubble generation characteristic condition and a temperature change characteristic condition corresponding to the one abnormal flushing condition; Optionally, the medical device comprises a fluid delivery pipeline and an interventional blood pump, the fluid delivery pipeline comprises a first pipe, a second pipe and a third pipe connected based on a first connector, the first pipe is used to connect a fluid source, and the second pipe and the third pipe are connected with fluid interfaces of the interventional blood pump respectively to form the flushing channel; Optionally, the interventional blood pump comprises a fluid inlet and a fluid outlet, the second pipe is connected with the fluid inlet, and the third pipe is connected with the fluid outlet; wherein fluid in the fluid source is delivered to the fluid inlet through the first pipe and the second pipe to enter an internal channel of the interventional blood pump, and fluid in the internal channel flows out through the fluid outlet and then flows into the first connector through the third pipe, forming a fluid circulation among the second pipe, the interventional blood pump and the third pipe. Optionally, the detectable position corresponding to the flushing channel comprises at least one of a fluid infusion channel, a circulation inlet channel, a circulation outlet channel, and an interventional blood pump flushing channel. The fluid infusion channel comprises a channel formed between the fluid source and the first connector. The circulation inlet channel comprises a channel formed between the first connector and the fluid inlet. The circulation outlet channel comprises a channel formed between the fluid outlet and the first connector. The interventional blood pump flushing channel comprises a fluid flow channel of the interventional blood pump. Optionally, the plurality of abnormal flushing conditions comprises at least two of the following: The fluid infusion channel is blocked, the fluid infusion channel leaks, the circulation inlet channel is blocked, the circulation inlet channel leaks, the circulation outlet channel is blocked, the circulation outlet channel leaks, the interventional blood pump flushing channel leaks, the fluid infusion channel pressure is abnormal, the circulation inlet channel pressure is abnormal, and the circulation outlet channel pressure is abnormal. Optionally, the second tube is provided with at least one fluid processing device, and the detectable position corresponding to the circulation inlet channel comprises at least one of a channel segment divided by the at least one fluid processing device, a position point in the channel segment, a pipeline connection position on the circulation inlet channel, and the at least one fluid processing device. Optionally, the third tube is provided with at least one fluid processing device, and the detectable position corresponding to the circulation outlet channel comprises at least one of a channel segment divided by the at least one fluid processing device, a position point in the channel segment, a pipeline connection position on the circulation outlet channel, and the at least one fluid processing device. Optionally, the interventional blood pump comprises a driving catheter and a fluid blocking member, the fluid enters the driving catheter after entering the internal channel of the interventional blood pump, the interventional blood pump comprises a through hole, the fluid blocking member is used to block the fluid flowing through the through hole, and the detectable position corresponding to the interventional blood pump flushing channel comprises the driving catheter and the fluid blocking member.

3. The method of claim 2, wherein, The plurality of abnormal flushing conditions comprises at least two of the following: The first abnormal flushing condition comprises that the abnormal position is the fluid infusion channel or a position point in the fluid infusion channel, and / or the abnormal state is a twist; the pressure change feature condition corresponding to the first abnormal flushing condition comprises that the falling speed of the fluid pressure data is lower than a first speed threshold, and the fluid pressure data falls into a first pressure interval after a first time length, the first pressure interval is a floating interval based on a first pressure data; the bubble generation feature condition corresponding to the first abnormal flushing condition comprises a bubble, and / or a first bubble appearance position; the first bubble appearance position comprises a position between a twist position and an inlet of an infusion pump, and the infusion pump is located in the fluid infusion channel. a second abnormal flushing condition; the second abnormal flushing condition comprises: the abnormal position is a first channel segment in the circulation inlet channel or a position point in the first channel segment, and / or the abnormal state is a twist; the pressure change feature condition corresponding to the second abnormal flushing condition comprises: the fluid pressure data drops to a second pressure interval within a second time length, and then rises from the second pressure interval to a pressure interval before the drop within a third time length; the bubble generation feature condition corresponding to the second abnormal flushing condition comprises no bubbles; the second pipe is provided with a bubble filter, and the first channel segment comprises a channel segment before the fluid flows into the bubble filter in the second pipe; a third abnormal flushing condition; the third abnormal flushing condition comprises: the abnormal position is a second channel segment in the circulation inlet channel or a position point in the second channel segment, and / or the abnormal state is a twist; the pressure change feature condition corresponding to the third abnormal flushing condition comprises: the fluid pressure data drops to a third pressure interval within a fourth time length, and then rises from the third pressure interval to a floating interval corresponding to a pressure before the drop at a speed lower than a second speed threshold; the bubble generation feature condition corresponding to the third abnormal flushing condition comprises no bubbles; the second pipe is provided with the bubble filter, and the second channel segment comprises a channel segment after the fluid flows out of the bubble filter in the second pipe; a fourth abnormal flushing condition; the fourth abnormal flushing condition comprises: the abnormal position is a third channel segment in the circulation outlet channel or a position point in the third channel segment, and / or the abnormal state is a twist; the pressure change feature condition corresponding to the fourth abnormal flushing condition comprises: the fluid pressure data rises to a fourth pressure interval within a fifth time length, then drops to a pressure value before the rise, and fluctuates based on the pressure value before the rise; the bubble generation feature condition corresponding to the fourth abnormal flushing condition comprises bubbles, and / or a second bubble occurrence position; the second bubble occurrence position comprises a position between the infusion pump and the first connector; the third pipe is provided with a particulate filter, and the third channel segment comprises a channel segment between the particulate filter outlet and the first connector; a fifth abnormal flushing condition; the fifth abnormal flushing condition comprises: the abnormal position is a fourth channel segment in the circulation outlet channel or a position point in the fourth channel segment, and / or the abnormal state is a twist; the pressure change feature condition corresponding to the fifth abnormal flushing condition comprises: the fluid pressure data rises to a fifth pressure interval within a sixth time length; the bubble generation feature condition corresponding to the fifth abnormal flushing condition comprises no bubbles; the third pipe is provided with the particulate filter, and the fourth channel segment comprises a channel segment before the fluid flows into the particulate filter in the third pipe; a sixth abnormal flushing condition; the sixth abnormal flushing condition comprises: the abnormal position is the fluid infusion channel or a position point in the fluid infusion channel, and / or the abnormal state is a leakage; the pressure change feature condition corresponding to the sixth abnormal flushing condition comprises: the fluid pressure data drops into a sixth pressure interval, and the sixth pressure interval is a floating interval based on the second pressure data; the bubble generation feature condition corresponding to the sixth abnormal flushing condition comprises: a bubble appears, and / or a third bubble appearance position; the third bubble appearance position comprises the fluid infusion channel; a seventh abnormal flushing condition; the seventh abnormal flushing condition comprises: the abnormal position is the first channel segment in the circulation inlet channel or a position point in the first channel segment, and / or the abnormal state is a leakage; the pressure change feature condition corresponding to the seventh abnormal flushing condition comprises: the fluid pressure data drops by a seventh pressure interval within a seventh time length, then drops into an eighth pressure interval, and then rises to a ninth pressure interval and maintains stable; the bubble generation feature condition corresponding to the seventh abnormal flushing condition comprises: a bubble appears, and / or a fourth bubble appearance position; the fourth bubble appearance position comprises the first channel segment; an eighth abnormal flushing condition; the eighth abnormal flushing condition comprises: the abnormal position is the second channel segment in the circulation inlet channel or a position point in the second channel segment, and / or the abnormal state is a leakage; the pressure change feature condition corresponding to the eighth abnormal flushing condition comprises: the fluid pressure data drops into a tenth pressure interval and maintains stable within an eighth time length; the bubble generation feature condition corresponding to the eighth abnormal flushing condition comprises: no bubble appears; a ninth abnormal flushing condition; the ninth abnormal flushing condition comprises: the abnormal position is the third channel segment in the circulation outlet channel or a position point in the third channel segment, and / or the abnormal state is a leakage; the pressure change feature condition corresponding to the ninth abnormal flushing condition comprises: the fluid pressure data drops into an eleventh pressure interval, and fluctuates up and down within the eleventh pressure interval; the bubble generation feature condition corresponding to the ninth abnormal flushing condition comprises: a bubble appears, and / or a fifth bubble appearance position; the fifth bubble appearance position comprises the third channel segment; a tenth abnormal flushing condition; the tenth abnormal flushing condition comprises: the abnormal position is the fourth channel segment in the circulation outlet channel or a position point in the fourth channel segment, and / or the abnormal state is a leakage; the pressure change feature condition corresponding to the tenth abnormal flushing condition comprises: the fluid pressure data drops into a twelfth pressure interval and maintains stable within a ninth time length; the bubble generation feature condition corresponding to the tenth abnormal flushing condition comprises: no bubble appears; Eleventh abnormal flushing condition; the eleventh abnormal flushing condition includes: the abnormal position is a fluid blocking member of the interventional blood pump, and / or the abnormal state is leakage; the pressure change feature condition corresponding to the eleventh abnormal flushing condition includes: the fluid pressure data decreases to a positive pressure floating interval based on the third pressure data within a tenth time length; the bubble generation feature condition corresponding to the eleventh abnormal flushing condition includes no bubbles appearing; Twelfth abnormal flushing condition; the twelfth abnormal flushing condition includes: the abnormal position is a driving catheter of the interventional blood pump or a position point in the driving catheter, and / or the abnormal state is leakage; the pressure change feature condition corresponding to the twelfth abnormal flushing condition includes: the fluid pressure data decreases to a negative pressure floating interval based on the fourth pressure data within an eleventh time length; the bubble generation feature condition corresponding to the twelfth abnormal flushing condition includes no bubbles appearing.

4. The method of claim 1, wherein, The medical device includes: an interventional blood pump and a flushing pump, the interventional blood pump includes a fluid inlet; the fluid inlet is connected with a fluid delivery pipeline to form the flushing channel; the flushing pump is connected with the fluid delivery pipeline, and the flushing pump is used to extrude the fluid delivery pipeline to deliver the fluid; The outputting of the abnormal alarm information corresponding to the flushing channel according to the first detection information and the second detection information includes: In a case where the first detection information meets a pressure change feature condition corresponding to a pump extrusion state abnormality, and the fluid temperature information meets a temperature change feature condition corresponding to the pump extrusion state abnormality, outputting abnormal alarm information corresponding to the pump extrusion state abnormality; the pump extrusion state abnormality refers to a case where an extrusion state of the flushing pump on the fluid delivery pipeline is abnormal; Optionally, the detectable position corresponding to the flushing channel includes: an extrusion part of the flushing pump; the pump extrusion state abnormality includes a loosening state abnormality of the extrusion part and / or a loosening time length state abnormality of the extrusion part; Optionally, the flushing pump includes a transfusion pump and a circulating pump, and the pump extrusion state abnormality includes at least one of the following: The extrusion part of the transfusion pump is loosened; The extrusion part of the circulating pump is loosened; The extrusion part of the transfusion pump is loosened for a long time; The extrusion part of the circulating pump is loosened for a long time; Wherein, the long time is a preset time length or a time length identified based on a preset condition; Optionally, the flushing pump includes a transfusion pump and a circulating pump, and the pump extrusion state abnormality includes at least one of the following: First pump extrusion state abnormality; the first pump extrusion state abnormality includes: the abnormal position is an extrusion part of the transfusion pump, and / or the abnormal state is that the extrusion part of the transfusion pump is loosened for a long time; the pressure change feature condition corresponding to the first pump extrusion state abnormality includes: the descending speed of the fluid pressure data is higher than a third speed threshold, and the fluid pressure data decreases to a thirteenth pressure interval and maintains stable; the temperature change feature condition corresponding to the first pump extrusion state abnormality includes that the temperature maintains stable; a second pump extrusion state anomaly; the second pump extrusion state anomaly includes that the abnormal position is the extrusion part of the circulation pump, and / or the abnormal state is that the extrusion part of the circulation pump is loosened for a long time; the pressure change feature condition corresponding to the second pump extrusion state anomaly includes that the fluid pressure data is maintained stable; and the temperature change feature condition corresponding to the second pump extrusion state anomaly includes temperature rise; a third pump extrusion state anomaly; the third pump extrusion state anomaly includes that the abnormal position is the extrusion part of the infusion pump and the extrusion part of the circulation pump, and / or the abnormal state is that the extrusion part of the infusion pump is loosened for a long time and the extrusion part of the circulation pump is loosened for a long time; the pressure change feature condition corresponding to the third pump extrusion state anomaly includes that the descending speed of the fluid pressure data is higher than a fourth speed threshold value, and the fluid pressure data is maintained stable in a fourteenth pressure interval; and the temperature change feature condition corresponding to the third pump extrusion state anomaly includes temperature rise; a fourth pump extrusion state anomaly; the fourth pump extrusion state anomaly includes that the abnormal position is the extrusion part of the infusion pump, and / or the abnormal state is that the extrusion part of the infusion pump is loosened; the pressure change feature condition corresponding to the fourth pump extrusion state anomaly includes that the descending speed of the fluid pressure data is higher than a fifth speed threshold value, and the fluid pressure data is maintained stable in a fifteenth pressure interval; and the temperature change feature condition corresponding to the fourth pump extrusion state anomaly includes temperature maintained stable; a fifth pump extrusion state anomaly; the fifth pump extrusion state anomaly includes that the abnormal position is the extrusion part of the circulation pump, and / or the abnormal state is that the extrusion part of the circulation pump is loosened; the pressure change feature condition corresponding to the fifth pump extrusion state anomaly includes that the fluid pressure data is maintained stable; and the temperature change feature condition corresponding to the fifth pump extrusion state anomaly includes temperature rise; a sixth pump extrusion state anomaly; the sixth pump extrusion state anomaly includes that the abnormal position is the extrusion part of the infusion pump and the extrusion part of the circulation pump, and / or the abnormal state is that the extrusion part of the infusion pump is loosened and the extrusion part of the circulation pump is loosened; the pressure change feature condition corresponding to the sixth pump extrusion state anomaly includes that the descending speed of the fluid pressure data is higher than a sixth speed threshold value, and the fluid pressure data is maintained stable in a sixteenth pressure interval; and the temperature change feature condition corresponding to the sixth pump extrusion state anomaly includes temperature rise; Optionally, the fluid delivery pipeline includes a first pipe and a second pipe connected based on a first connector, the first pipe is used for connecting a fluid source, and the second pipe is connected with the fluid inlet; wherein the infusion pump is arranged on the first pipe, and the circulation pump is arranged on the second pipe.

5. An abnormality alarm device for a medical device, characterized by comprising: The medical device has a flushing channel; and the device includes: The monitoring module is configured to acquire first detection information and second detection information corresponding to the flushing channel, the first detection information representing a change in flushing pressure of the flushing channel within a target time length, and the second detection information including at least one of bubble information representing a generation of bubbles in the flushing channel and fluid temperature information representing a change in temperature of fluid in the flushing channel. The generating module is configured to output abnormal alarm information corresponding to the flushing channel according to the first detection information and the second detection information, the abnormal alarm information indicating at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position.

6. A ventricular assist system, characterized by The ventricular assist system includes: a flushing channel; a sensor arranged in the flushing channel; The sensor is configured to detect first detection information and second detection information in the flushing channel to determine at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position. The first detection information represents a change in flushing pressure of the flushing channel within a target time length, and the second detection information includes at least one of bubble information representing a generation of bubbles in the flushing channel and fluid temperature information representing a change in temperature of fluid in the flushing channel.

7. The system of claim 6, wherein, The ventricular assist system includes a fluid delivery pipeline and an interventional blood pump, the fluid delivery pipeline including a first pipe, a second pipe and a third pipe connected based on a first connector, the first pipe being configured to connect a fluid source, and the second pipe and the third pipe being connected with fluid interfaces of the interventional blood pump to form the flushing channel. Optionally, the interventional blood pump includes a fluid inlet and a fluid outlet, the second pipe is connected with the fluid inlet, and the third pipe is connected with the fluid outlet. The fluid in the fluid source is delivered to the fluid inlet through the first pipe and the second pipe to enter an internal passage of the interventional blood pump; the fluid in the internal passage flows out through the fluid outlet and then flows into the first connector through the third pipe, and a fluid circulation is formed between the second pipe, the interventional blood pump and the third pipe. Optionally, the detectable positions corresponding to the flushing channel include at least one of a fluid infusion channel, a circulation inlet channel, a circulation outlet channel and an interventional blood pump flushing channel. The fluid infusion channel includes a channel formed between the fluid source and the first connector. The circulation inlet channel includes a channel formed between the first connector and the fluid inlet. The circulation outlet channel includes a channel formed between the fluid outlet and the first connector. The interventional blood pump flushing channel includes a fluid flow passage of the interventional blood pump. Optionally, the second tube is provided with at least one fluid treatment device, and the detectable position corresponding to the circulation inlet channel includes at least one of a channel segment divided by the at least one fluid treatment device, a position point in the channel segment, a pipeline connection position on the circulation inlet channel, and the at least one fluid treatment device; Optionally, the third tube is provided with at least one fluid treatment device, and the detectable position corresponding to the circulation outlet channel includes at least one of a channel segment divided by the at least one fluid treatment device, a position point in the channel segment, a pipeline connection position on the circulation outlet channel, and the at least one fluid treatment device; Optionally, the interventional blood pump includes a driving catheter and a fluid blocking member, the fluid entering the internal channel of the interventional blood pump enters the driving catheter, the interventional blood pump includes a through hole, the fluid blocking member is used to block the fluid flowing through the through hole, and the flush channel of the interventional blood pump corresponds to the detectable position of the driving catheter and the fluid blocking member; Optionally, the second tube is provided with a bubble filter, and the third tube is provided with a particle filter; The circulation inlet channel includes a first channel segment and a second channel segment; the first channel segment includes a channel segment of the second tube before the fluid flows into the bubble filter; and the second channel segment includes a channel segment of the second tube after the fluid flows out of the bubble filter; The circulation outlet channel includes a third channel segment and a fourth channel segment; the third channel segment includes a channel segment between the outlet of the particle filter and the first connector; and the fourth channel segment includes a channel segment of the third tube before the fluid flows into the particle filter; Optionally, the sensor includes at least one of a pressure sensor and a bubble sensor; The pressure sensor is arranged in the interventional blood pump; The bubble sensor is clamped on one flush pipeline in the flush channel; Optionally, the system further includes: a temperature sensor arranged in the interventional blood pump; a driving shaft arranged in the interventional blood pump, and the driving shaft is rotatably arranged in the interventional blood pump; The temperature sensor is used to detect the temperature condition in the flush channel, so as to determine the abnormal information in the flush channel; Optionally, the system further includes: a control assembly, which is used to execute the flush system abnormality detection method for medical equipment according to any one of claims 1 to 4.

8. A ventricular assist system, characterized by The ventricular assist system includes a control device and a consumable; The control device includes a driving assembly and a bubble sensor, the driving assembly is used to be coupled with the consumable, and the bubble sensor is clamped with a flush pipeline in the consumable; The consumable includes a flush pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flush pipeline and the interventional blood pump are communicated to form a flush channel; First detection information and second detection information in the flush channel are detected based on the bubble sensor and the fluid sensor; At least one of the abnormal position in the flushing channel and the abnormal state corresponding to the abnormal position is determined based on the first detection information and the second detection information. The first detection information represents a flushing pressure change of the flushing channel within a target time length, and the second detection information includes at least one of bubble information and fluid temperature information, the bubble information representing a bubble generation condition in the flushing channel, and the fluid temperature information representing a temperature change condition of a fluid in the flushing channel.

9. The system of claim 8, wherein, The consumable includes an interventional blood pump, a first connector, and a pump head. The first interface of the interventional blood pump is configured to be connected to a first interface of the first connector. The second interface of the interventional blood pump is configured to be connected to a second interface of the first connector. The third interface of the interventional blood pump is configured to be connected to the pump head. The third interface of the first connector is configured to be connected to a fluid source. The flushing channel includes at least one flushing pipeline for connecting the fluid source, the first connector, the interventional blood pump, and the pump head.

10. A control device in a ventricular assist system, characterized in that The ventricular assist system has a flushing channel, and the control device is configured to perform the flushing system abnormality detection method for a medical device according to any one of claims 1 to 4.

11. A consumable in a ventricular assist system, characterized by The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a pressure sensor. The flushing pipeline and the interventional blood pump are connected to form a flushing channel, the pressure sensor is configured to report first detection information to a control assembly, and the control assembly is configured to determine at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position according to second detection information reported by a bubble sensor and / or a temperature sensor and the first detection information. The first detection information represents a flushing pressure change of the flushing channel within a target time length, and the second detection information includes at least one of bubble information and fluid temperature information, the bubble information representing a bubble generation condition in the flushing channel, and the fluid temperature information representing a temperature change condition of a fluid in the flushing channel.

12. A computer storage medium, characterized in that, The computer readable storage medium stores at least one computer program, and the at least one computer program is loaded and executed by the processor to implement the flushing system abnormality detection method for a medical device according to any one of claims 1 to 4.

13. A computer program product, characterised in that, The computer program product includes a computer program stored in a computer readable storage medium, and the computer program is read and executed by a processor of a computer device from the computer readable storage medium, so that the computer device performs the flushing system abnormality detection method for a medical device according to any one of claims 1 to 4.

14. A chip, characterized by The chip includes programmable logic circuit or program, and the device installed with the chip is configured to implement the flushing system abnormality detection method for a medical device according to any one of claims 1 to 4.

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