Method, apparatus, and system for detecting abnormalities in flushing system of medical device

Abstract

Provided are a method, apparatus, and system for detecting abnormalities in a flushing system of a medical device, belonging to the technical field of medical devices. The medical device is provided with a flushing channel. The method comprises: acquiring first detection information and second detection information corresponding to the flushing channel, wherein the first detection information characterizes flushing pressure changes of the flushing channel within a target duration, and the second detection information comprises at least one of bubble information and fluid temperature information, the bubble information characterizing bubble generation in the flushing channel, and the fluid temperature information characterizing temperature changes of a fluid in the flushing channel (210); and according to the first detection information and the second detection information, outputting abnormal alarm information corresponding to the flushing channel, 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 (220).

Description

Flush system anomaly detection method, device and system for medical equipment

[0001] The present application claims priority to the patent application No. 2024113889313, filed on September 30, 2024, with the China National Intellectual Property Office and entitled "Flush system anomaly detection method, device and system for medical equipment". TECHNICAL FIELD

[0002] Embodiments of the present application relate to the technical field of medical equipment, in particular to a flush system anomaly detection method, device and system for medical equipment. BACKGROUND

[0003] An interventional blood pump is a medical device used to assist the heart in providing blood circulation power. When working, the catheter of the interventional blood pump is sent to the left ventricle through the 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, blood can be sucked from the inlet at the left ventricle end, and then returned to the aorta through the outlet at the aorta end, i.e. the function of heart assistance is achieved.

[0004] Before use, the interventional blood pump needs to be connected to a flushing pipeline to discharge the air in the interventional blood pump with a flushing liquid. During the flushing process, the flushing pipeline of the interventional blood pump may be blocked or leaked at some positions due to bending, damage, falling off, etc. When leakage or blockage occurs, it will affect the supply of flushing liquid to different degrees, resulting in abnormal operation or damage of the interventional blood pump.

[0005] SUMMARY

[0006] The present application provides a flush system anomaly detection method, device and system for medical equipment, and the technical solution is as follows:

[0007] According to an aspect of the present application, a flush system anomaly detection method for medical equipment is provided, the medical equipment having a flushing channel; the method comprises: acquiring first detection information and second detection information corresponding to the flushing channel, the first detection information representing a flushing pressure change of the flushing channel within a target time length, and 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 of a fluid in the flushing channel; according to the first detection information and the second detection information, outputting abnormal alarm information corresponding to the flushing channel, 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.

[0008] According to an aspect of the present application, an abnormality alarm device for a medical device is provided, the medical device having a flushing channel; the device comprising: a monitoring module configured to acquire first detection information and second detection information corresponding to the flushing channel, the first detection information representing a flushing pressure variation 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 variation of a fluid in the flushing channel; and a generating module configured to output abnormality alarm information corresponding to the flushing channel according to the first detection information and the second detection information, the abnormality alarm information indicating at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position.

[0009] According to another aspect of the present application, a ventricular assist system is provided, the ventricular assist system comprising: a flushing channel; and a sensor disposed in the flushing channel; wherein 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 representing a flushing pressure variation of the flushing channel within a target time length, and 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 variation of a fluid in the flushing channel.

[0010] According to another aspect of the present application, a ventricular assist system is provided, the ventricular assist system comprising: a control device and a consumable; the control device comprising a driving assembly and a bubble sensor, the driving assembly being configured to be coupled to the consumable, and the bubble sensor being clamped to a flushing pipeline in the consumable; and the consumable comprising: the flushing pipeline and an interventional blood pump, the interventional blood pump having a pressure sensor disposed therein; wherein the flushing pipeline and the interventional blood pump are in communication to form a flushing channel, and the pressure sensor and the bubble sensor are respectively 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 representing a flushing pressure variation of the flushing channel within a target time length, and 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 variation of a fluid in the flushing channel.

[0011] According to another aspect of the present application, a control device in a ventricular assist system is provided, the control device comprising: a drive assembly, a bubble sensor, and a control assembly; wherein the bubble sensor is configured to report second detection information to the control assembly, and the control assembly is configured to determine at least one of an abnormal position in the ventricular assist system and an abnormal state corresponding to the abnormal position according to the second detection information and first detection information reported by a pressure sensor; the first detection information characterizes a change in flushing pressure of a flushing channel in the ventricular assist system within a target time length, and the second detection information comprises at least one of bubble information and fluid temperature information; the bubble information characterizes a bubble generation condition in the flushing channel, and the fluid temperature information characterizes a temperature change condition of a fluid in the flushing channel.

[0012] According to another aspect of the present application, a consumable in a ventricular assist system is provided, the consumable comprising: a flushing pipeline and an interventional blood pump, and a pressure sensor is arranged in the interventional blood pump; wherein the flushing pipeline and the interventional blood pump are in communication to form a flushing channel, and 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 the first detection information;

[0013] The first detection information characterizes a change in flushing pressure of the flushing channel within a target time length, and the second detection information comprises at least one of bubble information and fluid temperature information; the bubble information characterizes a bubble generation condition in the flushing channel, and the fluid temperature information characterizes a temperature change condition of a fluid in the flushing channel.

[0014] According to another aspect of the present application, a computer readable storage medium is provided, and at least one computer program is stored in the computer readable storage medium; the at least one computer program is loaded and executed by a processor to implement the flushing system abnormality detection method for a medical device according to the above aspect.

[0015] According to another aspect of the present application, a computer program product is provided, and the computer program product comprises a computer program stored in a computer readable storage medium; 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 executes the flushing system abnormality detection method for a medical device according to the above aspect.

[0016] According to another aspect of the present application, a chip is provided, and the chip comprises programmable logic circuit or program; and a device installed with the chip is configured to implement the flushing system abnormality detection method for a medical device according to the above aspect.

[0017] The technical solutions provided by the present application have at least the following beneficial effects:

[0018] By monitoring the change of the flushing pressure in the flushing channel in real time, and at least one of the sensing data such as bubble information and fluid temperature information, the device can accurately locate the abnormal position in the flushing channel and / or the abnormal state of the abnormal position in combination with the information. When an abnormality occurs at different positions in the flushing channel, the change of the flushing pressure in the flushing channel will be different, the bubble generation will be different, and / or the fluid temperature will also be different, and the position where the abnormality occurs in the flushing channel can be accurately located according to the information; when different types of abnormal states (for example, catheter twisting, blockage, leakage, etc.) occur in the flushing channel, the change of the flushing pressure in the flushing channel will be different, the bubble generation will be different, and / or the fluid temperature will also be different, and the abnormal state of the abnormal position in the flushing channel can also be determined according to the information. Therefore, the abnormality in the flushing channel can be accurately located in combination with the information, the abnormality can be timely and accurately alarmed and prompted, the troubleshooting time of the abnormality is reduced, the danger in the use of the product is reduced or avoided, and the safety factor of the product is improved. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0020] FIG. 1 is a schematic diagram of the architecture of a medical device according to an example embodiment of the present application;

[0021] FIG. 2 is a schematic diagram of a flushing system abnormality detection method for a medical device according to an example embodiment of the present application;

[0022] FIG. 3 is a schematic diagram of a flushing system abnormality detection method for a medical device according to an example embodiment of the present application;

[0023] FIG. 4 is a schematic diagram of a flushing system abnormality detection method for a medical device according to an example embodiment of the present application;

[0024] FIG. 5 is a schematic diagram of a flushing system abnormality detection method for a medical device according to an example embodiment of the present application;

[0025] FIG. 6 is a flowchart of a flushing system abnormality detection method for a medical device according to an example embodiment of the present application;

[0026] FIG. 7 is a schematic diagram of a flushing system anomaly detection method for a medical device according to an example embodiment of the present application;

[0027] FIG. 8 is a flow chart of a flushing system anomaly detection method for a medical device according to an example embodiment of the present application;

[0028] FIG. 9 is a flow chart of a flushing system anomaly detection method for a medical device according to an example embodiment of the present application;

[0029] FIG. 10 is a block diagram of an anomaly alarm device for a medical device according to an example embodiment of the present application;

[0030] FIG. 11 is a schematic diagram of a medical device according to an example embodiment of the present application. DETAILED DESCRIPTION

[0031] For the purpose of clarity, technical solution and advantages of the present application will be further described in detail below with reference to the accompanying drawings. Hereinafter, the example embodiments will be described in detail, and the examples thereof are shown in the accompanying drawings. The following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following example embodiments do not represent all the embodiments consistent with the present application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of the present application as detailed in the appended claims. The terms used in the present disclosure are merely for the purpose of describing particular embodiments and are not intended to limit the present disclosure. The singular forms "a", "an" and "the" used in the present disclosure are also intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" used herein means and includes any or all possible combinations of one or more associated listed items. It should be understood that although the terms first, second, third, etc. can be used in the present disclosure to describe various information, these information should not be limited to these terms. These terms are only used to distinguish one type of information from another.

[0032] The ventricular assist system is a system for assisting circulation by replacing the action of the ventricle, including but not limited to at least one of an extracorporeal ventricular assist system, a trans-catheter ventricular assist system, and an implantable ventricular assist system. The trans-catheter ventricular assist system includes a trans-catheter ventricular assist system control host (hereinafter referred to as a control assembly) and a trans-catheter ventricular assist system catheter pump system (hereinafter referred to as an interventional blood pump) used in cooperation therewith, and is suitable for providing temporary left ventricular circulation assistance in related operations. The interventional blood pump refers to a catheter pump used in a medical scenario to assist the heart to provide blood circulation power. Optionally, the interventional blood pump is an interventional heart pump in a living body. Optionally, part or all of the components of the interventional blood pump are intervented into the living body.

[0033] Figure 1 shows a schematic diagram of an application scenario of an interventional blood pump 140 according to an embodiment of the present application. The interventional blood pump 140 comprises a drive catheter handle 100, a drive catheter 102 and a pump head 103. A drive assembly 101 is coupled to a proximal end of the drive catheter 102 through the drive catheter handle 100, and the pump head 103 is connected to a 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 a second end of the drive catheter 102 is connected to the pump head 103. The pump head 103 in the interventional blood pump 140 can be percutaneously inserted into the heart through the peripheral blood vessels along with the drive catheter 102, and the pump head 103 can be placed between the left ventricle and the 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 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.

[0034] For example, a drive shaft is arranged in the drive catheter handle 100, the drive catheter 102 and the pump head 103. One end of the drive shaft is fixed at the connection between the drive catheter handle 100 and the drive assembly 101. The drive assembly 101 drives the one end of the drive shaft to rotate, and in turn drives the impeller (located in the pump head 103) at the other end of the drive shaft to rotate, so as to form a driving force in the pump head 103 to drive the blood to flow into the pump head 103 from the inlet 104 and to flow out of the pump head 103 from the outlet 105. Optionally, the drive catheter 102 is inserted through the femoral artery and the pump head 103 is sent 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 suck blood from the inlet 104 at the left ventricle end and then back to the aorta through the outlet 105 at the aorta end, thereby achieving the effect of heart assist.

[0035] The interventional blood pump 140 can provide active forward blood flow to increase cardiac output. The blood pumped by the interventional blood pump 140 directly comes from the left ventricle, which can directly reduce the left ventricular pressure and volume, reduce the ventricular work and reduce myocardial oxygen consumption. In addition, the increase of the aortic forward blood flow and the reduction of the ventricular wall tension can also increase the coronary artery blood flow and improve myocardial perfusion. It is suitable for acute myocarditis, myocardial disease combined with shock, refractory heart failure, cardiogenic shock and the like which have poor effect on conventional treatment.

[0036] FIG. 2 shows a schematic diagram of a ventricular assist system provided by an example embodiment of the present application, which 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 can be an integrated fluid sensor. 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 is indicative of a change in flushing pressure of the flushing channel within a target time period, and the second detection information includes at least one of bubble information and fluid temperature information, the bubble information being indicative of a generation of air bubbles in the flushing channel, and the fluid temperature information being indicative of a change in temperature of fluid in the flushing channel.

[0037] Optionally, the flushing channel includes at least one flushing pipeline for connecting the drive catheter handle 100, the fluid source 106, and the pump head 103. The flushing channel is a semi-closed liquid passage with one open end (at the pump head 103), and the flushing liquid can flow from the fluid source 106 to the pump head 103 through the drive catheter handle 100 via the flushing channel.

[0038] The drive catheter handle 100 and the fluid source 106 can be connected via a flushing pipeline (or also referred to as a flushing pipeline, including a plurality of conduits connecting different components), and the drive catheter handle 100 and the pump head 103 are connected via the drive catheter 102.

[0039] Optionally, a drive shaft is arranged in the drive catheter handle 100, the drive catheter 102, and the pump head 103, one end of the drive shaft is fixed to a driven member of the drive catheter handle 100, and the other end of the drive shaft is connected to an impeller in the pump head 103. The driven member of the drive catheter handle is coupled to a driving member of the drive assembly to transmit the rotational power of the motor in the drive assembly to the drive shaft.

[0040] The drive catheter handle 100 includes a housing, and a flushing cavity is arranged in the housing, the flushing cavity has three interfaces, the first interface and the second interface of the flushing cavity are in communication with the fluid source 106, and the third interface of the flushing cavity is in communication with one end of the drive catheter 102, so that the flushing liquid can flow from the fluid source 106 to the drive catheter 102 via the flushing liquid cavity.

[0041] It should be noted that, during the flushing stage, the flushing liquid can expel the air in the drive catheter 102. In order to prevent the air from entering the body of the subject, the flushing and air exhaust operation is performed outside the body in advance before the pump head 103 enters the body of the subject, so as to exhaust the air in the drive catheter 102 and the pump head 103.

[0042] The side shell of the drive catheter handle 100 is provided with a driven member. When the drive catheter handle is coupled with the drive assembly, the motor in the drive assembly 101 can drive the driving member on the drive assembly 101 to rotate, and the driving member can drive the driven member to rotate, thereby driving the drive shaft to rotate.

[0043] For example, the sensors include a pressure sensor 116, and at least one of a bubble sensor 115 and a temperature sensor 117. The bubble sensor 115 can be arranged outside any of the flush lines of the flush channel, for example, the bubble sensor 115 is clamped and fixed outside any of the flush lines. The bubble sensor 115 is used to monitor the bubbles in the flush channel. The pressure sensor 116 is arranged in the flush channel, for example, the pressure sensor 116 can be arranged in the drive catheter handle 100, or the pressure sensor 116 can be arranged in the fluid source 106, or the pressure sensor 116 can also be arranged in the flush line. For example, the pressure sensor 116 is arranged on the inner wall of the drive catheter handle 100. The bubble sensor 115 is arranged on the clamping assembly of the control device, and the clamping assembly is used to clamp and fix the flush line, so that the bubble sensor 115 can detect whether there are bubbles in the clamped flush line. The temperature sensor 117 is arranged in the flush channel, for example, the temperature sensor 117 can be arranged in the drive catheter handle 100, or the temperature sensor 117 can be arranged in the fluid source 106, or the temperature sensor 117 can also be arranged in the flush line. Optionally, the bubble sensor 115, the pressure sensor 116 and the temperature sensor 117 are respectively electrically connected with the control assembly (processor), and the bubble sensor 115, the pressure sensor 116 and the temperature sensor 117 send signals to the control assembly through the electrical connection. In some embodiments, the temperature sensor 117 is an optional device.

[0044] In an optional embodiment, as shown in FIG. 2, 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 flush line connecting the fluid source 106 and the first connector 108), a second tube 112-2 (a right flush line connecting the first connector 108 and the fluid inlet of the drive catheter handle 100) and a third tube 112-3 (a left flush line connecting the first connector 108 and the fluid outlet of the drive catheter handle 100) connected based on the first connector 108, the first tube 112-1 is used to connect the fluid source 106, the second tube 112-2 and the third tube 112-3 are connected with the fluid interface (the fluid inlet and the fluid outlet of the drive catheter handle) of the interventional blood pump, forming a flush channel. The detection method provided in the present application can accurately detect the abnormal state and position of the above flush channel, and is suitable for various flush channels.

[0045] The interventional blood pump can include at least one of the drive catheter handle 100, the drive catheter 102, and the pump head 103.

[0046] Referring to FIG. 3, the fluid inlet 118 of the drive catheter handle 100 is connected to the first interface 119 of the first connector 108; the fluid outlet 120 of the drive catheter handle 100 is connected to the second interface 121 of the first connector 108; the drive outlet 123 on the right side of the drive catheter handle 100 is connected to the pump head 103; the third interface 122 of the first connector 108 is connected to the fluid source 106; the flushing channel includes at least one flushing pipeline for connecting the fluid source 106, the first connector 108, the drive catheter handle 100, and the pump head 103.

[0047] In an optional embodiment, the interventional blood pump includes the fluid inlet 118 and the fluid outlet 120, the second tube 112-2 is connected to the fluid inlet 118, and the third tube 112-3 is connected to the fluid outlet 120; wherein the fluid in the fluid source 106 is delivered to the fluid inlet 118 through the first tube 112-1 and the second tube 112-2 to enter the internal channel of the interventional blood pump; the fluid in the internal channel flows out through the fluid outlet 120 and then flows into the first connector 108 through the third tube 112-3, and a fluid circulation is formed between the second tube 112-2, the interventional blood pump, and the third tube 112-3. The detection method provided in the present application can accurately detect the abnormal state and position of the above circulating flushing channel.

[0048] Optionally, during the flushing stage, the flushing liquid flows in the direction of the arrows as shown in FIG. 2. The flushing liquid flows out of the liquid outlet of the fluid source 106, flows into the first connector 108 from the third interface 122 of the first connector 108; flows out of the first connector 108 from the first interface 119 of the first connector 108 and flows into the drive catheter handle 100 from the fluid inlet 118 of the drive catheter handle 100; flows out of the drive catheter handle 100 from the drive outlet 123 of the drive catheter handle 100 and enters the drive catheter 102, flows into the pump head 103 from the drive catheter 102; flows out of the drive catheter handle 100 from the fluid outlet 120 of the drive catheter handle 100, flows into the first connector 108 from the second interface 121 of the first connector 108, and forms a loop.

[0049] In an alternative embodiment, as shown in FIG. 4, the detectable positions corresponding to the flushing channels include at least one of the fluid infusion channel 124, the circulation inlet channel 125, the circulation outlet channel 126, and the interventional blood pump flushing channel 127; the fluid infusion channel 124 includes a channel formed between the fluid source 106 and the first connector 108; the circulation inlet channel 125 includes a channel formed between the first connector 108 and the fluid inlet 118; the circulation outlet channel 126 includes a channel formed between the fluid outlet 120 and the first connector 108; and the interventional blood pump flushing channel 127 includes a fluid flow channel within the interventional blood pump.

[0050] In the technical scheme provided by the embodiments of the present application, the above-mentioned channel segments are divided, which is conducive to distinguishing abnormal conditions occurring in different segments, and the detection method provided by the present application can accurately detect the abnormalities occurring in the above-mentioned several channel positions, improve the accuracy of abnormal detection, and reduce the troubleshooting range.

[0051] Zero to multiple fluid processing devices can be arranged on the channel. The fluid processing devices include at least one of a bubble filter and a particulate filter.

[0052] In an alternative embodiment, at least one fluid processing device is arranged on the second tube 112-2, and the detectable positions corresponding to the circulation inlet channel 125 include at least one of the channel segments divided by the at least one fluid processing device, the position points in the channel segments, the pipeline connection positions on the circulation inlet channel 125, and the at least one fluid processing device.

[0053] In an alternative embodiment, at least one fluid processing device is arranged on the third tube 112-3, and the detectable positions corresponding to the circulation outlet channel 126 include at least one of the channel segments divided by the at least one fluid processing device, the position points in the channel segments, the pipeline connection positions on the circulation outlet channel 126, and the at least one fluid processing device.

[0054] In an alternative embodiment, the interventional blood pump comprises a drive catheter 102 and a fluid seal 128, the fluid entering the internal passage of the interventional blood pump enters the drive catheter 102, the interventional blood pump comprises a through hole, the fluid seal 128 is used to seal the fluid flowing through the through hole, and the corresponding detectable position of the flushing passage 127 of the interventional blood pump comprises the drive catheter 102 and the fluid seal 128. The interventional blood pump can be inserted into the target object in the body by means of a guide wire. After the guide wire is inserted into the heart through the blood vessel, the guide wire is inserted into the interventional blood pump, the proximal end of the guide wire enters from the pump head of the interventional blood pump, passes through the drive catheter (specifically, the drive shaft in the drive catheter) and then is transmitted out of the through hole at the proximal end of the interventional blood pump, so as to pass through the entire interventional pump. In this way, the interventional pump can be inserted into the target object in the body along the guide wire and reach the specified position in the heart. After the interventional blood pump reaches the specified position, the guide wire can be pulled out of the above-mentioned through hole, and the above-mentioned fluid seal is used to seal the above-mentioned through hole, so as to prevent the flushing liquid from flowing out of the through hole. If the fluid seal does not tightly seal the above-mentioned through hole, flushing liquid leakage may occur. Similarly, if the drive catheter is broken, flushing liquid leakage may also occur.

[0055] The fluid seal can be a threaded cap, and the through hole is a hollow threaded column, which are threadedly connected.

[0056] The detection method provided in the application can accurately detect and alarm abnormalities occurring at more fine positions or components on each pipeline and the internal passage of the interventional pump, further improve the accuracy of abnormality detection, and further narrow the fault troubleshooting range, thereby facilitating the operator to quickly solve the problem.

[0057] Especially after the interventional pump is engaged with the drive assembly, the fluid seal is completely blocked by the drive assembly, and the operator cannot directly see whether the position of the fluid seal leaks. The drive assembly needs to be disassembled to see whether the position of the fluid seal leaks, but the disassembly of the drive assembly will cause the interventional pump to stop running, so that the abnormality of the fluid seal is difficult to check and needs to be stopped. The detection method provided in the application can automatically judge whether the fluid seal is abnormal, without the need to stop and disassemble the drive assembly, thereby improving the troubleshooting efficiency.

[0058] For example, the fluid treatment device on the second tube 112-2 is a bubble filter 111, and the fluid treatment device on the third tube 112-3 is a particle filter 110. Referring to FIG. 4, the circulation inlet passage 125 includes a first passage segment 125-1 and a second passage segment 125-2; the first passage segment 125-1 includes a passage segment before the fluid in the second tube 112-2 flows into the bubble filter 111; the second passage segment 125-2 includes a passage segment after the fluid in the second tube 112-2 flows out of the bubble filter 111; the circulation outlet passage 126 includes a third passage segment 126-1 and a fourth passage segment 126-2; the third passage segment 126-1 includes a passage segment between the outlet of the particle filter 110 and the first connector 108; and the fourth passage segment 126-2 includes a passage segment before the fluid in the third tube 112-3 flows into the particle filter 110.

[0059] Optionally, the fluid inlet 118 of the drive catheter handle 100 is connected to the liquid outlet 129 of the bubble filter 111; and the first interface 119 of the first connector 108 is connected to the liquid inlet 130 of the bubble filter 111.

[0060] For example, the bubble filter 111 is connected between the drive catheter handle 100 and the first connector 108, and is used to filter bubbles in the flushing passage to prevent the bubbles from flowing into the subject.

[0061] Optionally, the fluid outlet 120 of the drive catheter handle 100 is connected to the liquid inlet 131 of the particle filter 110; and the second interface 121 of the first connector 108 is connected to the liquid outlet 132 of the particle filter 110.

[0062] For example, the particle filter 110 is connected between the drive catheter handle and the first connector 108, and is used to filter particles in the flushing passage.

[0063] In an optional embodiment, the system further includes a temperature sensor 117 arranged in the interventional blood pump; and a drive shaft arranged in the interventional blood pump, the drive shaft is rotatably arranged in the interventional blood pump, and rotation of the drive shaft generates heat. The flushing liquid can flush and cool the cavity in which the drive shaft is arranged. Therefore, different drive shaft rotation speeds, different flushing liquid flow rates, and other factors can change the temperature of the flushing liquid in the interventional blood pump. Different abnormal conditions can trigger changes in the above factors, thereby causing changes in the temperature of the flushing liquid. The temperature sensor 117 is used to detect the temperature in the flushing passage, so as to determine abnormal information (abnormal position and / or abnormal position corresponding to abnormal state) in the flushing passage.

[0064] Optionally, the temperature sensor 117 and the pressure sensor 116 can be implemented as one sensor, which can be arranged on the inner wall of the drive catheter handle 100. Exemplarily, the housing of the drive catheter handle 100 has a metal contact, and the sensor (the temperature sensor 117 and / or the pressure sensor 116) in the drive catheter handle 100 can be electrically connected with the metal contact. When the drive catheter handle 100 is coupled with the drive assembly 101, the metal contact on the drive catheter handle 100 is connected with the metal contact on the drive assembly 101, and the metal contact on the drive assembly 101 is electrically connected with the control assembly 113, so that the signal generated by the sensor is transmitted to the control assembly 113.

[0065] In an optional embodiment, the system further comprises a control assembly 113 configured to execute the method for detecting abnormality of a flushing system of a medical device provided in the embodiments.

[0066] Optionally, the control assembly 113 can comprise a processor configured to receive the signal (the first detection information, the second detection information, etc.) sent by the sensor, and generate corresponding alarm information according to the signal sent by the sensor.

[0067] In an optional embodiment, the system further comprises an audio and / or a display connected with the processor; the audio is configured to play the alarm information; and the display is configured to display the alarm information.

[0068] In an optional embodiment, a flushing pump is further arranged on the flushing channel, and the flushing pump provides power for the flushing liquid in the flushing pipeline by means of extrusion. Optionally, the number of the flushing pumps is two, a first flushing pump (also referred to as an infusion pump 107) is arranged at the first pipe 112-1 (the flushing pipeline connecting the fluid source and the first connector), and a second flushing pump (also referred to as a circulation pump 109) is arranged at the second pipe 112-2 (the channel segment connecting the first connector and the bubble filter).

[0069] Exemplarily, the infusion pump 107 and the circulation pump 109 are electrically connected with the control assembly 113, and the control assembly 113 is configured to control the operation of the infusion pump 107 and the circulation pump 109.

[0070] In an optional embodiment, the ventricular assist system shown in FIG. 2 can be divided into a control device 114 and consumables, and the consumables are disposable consumables, and the control device 114 is a device that can be used repeatedly for multiple times.

[0071] The control device comprises a driving assembly 101 for coupling with the consumable and a bubble sensor 115 clamped with a flushing pipeline in the consumable; the consumable comprises a flushing pipeline 141 and an interventional blood pump 140, and a fluid sensor 116 is arranged in the interventional blood pump 140; wherein the flushing pipeline 141 and the interventional blood pump 140 are communicated to form a flushing channel; first detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; at least one of an abnormal position in the flushing channel and an 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 condition of the flushing channel within a target time length, the second detection information comprises at least one of bubble information and fluid temperature information, the bubble information represents a bubble generation condition in the flushing channel, and the fluid temperature information represents a temperature change condition of a fluid in the flushing channel. Wherein, the bubble sensor can detect the bubble information, and the fluid sensor can detect the flushing pressure and / or the fluid temperature information.

[0072] Exemplarily, the consumable comprises the interventional blood pump 140 and the first connector 108; a first interface (fluid inlet 118) of the interventional blood pump 140 is used for connecting to a first interface 119 of the first connector 108; a second interface (fluid outlet 120) of the interventional blood pump 140 is used for connecting to a second interface 121 of the first connector 108; a driving outlet 123 of the interventional blood pump 140 is used for connecting to the pump head 103; a third interface 122 of the first connector 108 is used for connecting to the fluid source 106; and the flushing channel comprises at least one flushing pipeline for communicating the fluid source 106, the first connector 108, the interventional blood pump 140 and the pump head 103.

[0073] Exemplarily, the consumable comprises the driving catheter handle 100, the first connector 108 and the pump head 103; a first interface (fluid inlet 118) of the driving catheter handle 100 is used for connecting to a first interface 119 of the first connector 108; a second interface (fluid outlet 120) of the driving catheter handle 100 is used for connecting to a second interface 121 of the first connector 108; a driving outlet 123 of the driving catheter handle 100 is used for connecting to the pump head 103; a third interface 122 of the first connector 108 is used for connecting to the fluid source 106; and the flushing channel comprises at least one flushing pipeline for communicating the fluid source 106, the first connector 108, the driving catheter handle 100 and the pump head 103.

[0074] Exemplarily, the control device is configured to execute the flushing system anomaly detection method for a medical device provided by the embodiments of the present application, and the control device comprises a driving assembly 101, a bubble sensor 115, and a control assembly 113; the driving assembly 101 comprises a motor housing, a motor accommodated in the motor housing, and a driving element driven by the motor; wherein the bubble sensor 115 is configured to report bubble information to the control assembly 113, and the control assembly 113 is configured to determine anomaly information in the ventricular assist system according to first detection information and second detection information, wherein the anomaly information comprises at least one of an anomaly position and an anomaly state corresponding to the anomaly position, and the anomaly position is at least one position in the flushing channel.

[0075] The fluid sensor can be a pressure sensor or a pressure-temperature sensor.

[0076] Exemplarily, as shown in FIG. 2, the consumable comprises a first tube 112-1, a first connector 108, a second tube 112-2, a bubble filter 111, a driving catheter handle 100, a third tube 112-3, a particle filter 110, a driving catheter 102, a pump head 103, a pressure sensor 116, and a temperature sensor 117.

[0077] The control device comprises the driving assembly 101, the control assembly 113, an infusion pump 107, a circulation pump 109, and the bubble sensor 115.

[0078] Exemplarily, the use of the interventional blood pump 140 is divided into three stages: a priming stage, a flushing stage, and a blood pumping stage.

[0079] In the priming stage, the interventional blood pump 140 needs to be connected to a flushing pipeline (or also referred to as a flushing pipeline), and a flushing liquid is used to flush the interventional blood pump 140 and the pipeline (i.e., the flushing pipeline 141) connected thereto, so as to discharge air therein. Specifically, the fluid inlet 118 of the driving catheter handle 100 is connected to the second tube 112-2, the fluid outlet 120 of the driving 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 particle filter 110, the driving outlet 123 of the driving catheter handle 100 is connected to the driving catheter 102, and the driving 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 arranged on the clamping assembly of the infusion pump 107 or on the clamping assembly of the circulation pump 109.

[0080] After the priming and air discharge, the flushing stage can be entered, and the driving catheter handle 100 is coupled to the driving assembly 101.

[0081] During the blood pumping stage, the drive assembly 101 is activated to drive the implantable 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 the 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, and the drive catheter 102 is connected to the pump head 103. A hemostatic valve is arranged in the drive catheter 102 near the pump head 103 to prevent blood from flowing back into the drive catheter 102 from the pump head 103. The drive assembly 101 drives the drive shaft to rotate, thereby driving the impeller in the pump head 103 to rotate, forming a suction at the pump head 103, so that blood flows into the pump head 103 from the inlet and flows out of the pump head 103 from the outlet.

[0082] FIG. 5 shows a schematic diagram of a ventricular assist system according to another example embodiment of the present application. The control device 114 includes at least the control assembly 113, the drive assembly 101, the infusion pump 107, and the circulation pump 109. Optionally, the control device 114 can further include a display, on which a clinician can monitor the system status and the physiological parameters of the patient, and provide different levels of circulatory assistance by adjusting the rotational speed of the implantable blood pump 140 according to the needs of the patient, so as to temporarily maintain the blood circulation of the vital organs of the patient and unload the heart.

[0083] The ventricular assist system includes the implantable blood pump 140, the delivery system, and the flush line 141. The implantable blood pump 140 includes the pump head 103 (containing an impeller, a stent, and a covering), the drive catheter 102, the drive catheter handle 100 (containing a catheter locking connector), the pressure sensor 116, the drive catheter 102, and a flush line connector. The implantable blood pump 140 can be percutaneously placed into the heart through 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, the blood outlet of the pump head 103 is placed in the ascending aorta, the drive assembly 101 can be connected to the implantable 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 the ventricular assist function.

[0084] The delivery system includes a dilator, an introducer sheath, and an introducer. The delivery system is used to dilate the blood vessel and provide a passage for the implantable blood pump 140 to be placed into the heart, wherein the introducer and the introducer sheath have the function of folding the pump head. The introducer and the dilator are removed after the implantable blood pump 140 is placed in position. The introducer sheath remains in the blood vessel of the patient until the implantable blood pump 140 is removed, and the introducer sheath also has the function of folding the pump head when the implantable blood pump 140 is removed.

[0085] The flush circuit 141 comprises a flush kit of the interventional blood pump 140. The flush kit comprises the flush circuit, the first connector 108, the fluid source 106, the bubble filter 111 and the particle filter 110. The flush pump can be connected with the flush circuit 141. The flush pump can realize the flush liquid delivery and control function by squeezing the flush circuit, so as to prevent the blood from entering the driving catheter of the interventional blood pump to generate thrombus. The flush pump drives the flush circuit of the flush kit, and the flush liquid in the fluid source 106 connected with the flush circuit can be pumped into the cavity in the driving catheter handle 100 through the flush circuit, so as to avoid the blood from entering the driving catheter 102.

[0086] FIG. 6 is a flowchart of a method for detecting an abnormality of a flush system of a medical device according to an example embodiment of the present application. The method is applied to a medical device having a flush channel, which can be the ventricular assist system described above. The method can be executed by the control device 114 in the ventricular assist system. The method comprises:

[0087] In step 210, first detection information and second detection information corresponding to the flush channel are acquired. The first detection information represents a change of the flush pressure of the flush channel within a target time length. The second detection information comprises at least one of bubble information and fluid temperature information. The bubble information represents a generation of bubbles in the flush channel. The fluid temperature information represents a change of the temperature of the fluid in the flush channel.

[0088] In an example, the method is executed by the control component 113 (processor) in the control device 114. Alternatively, the method is executed by the control component 113 (processor) in the medical device. Alternatively, the method is executed by a server connected with the control device 114 or the medical device through a network.

[0089] Optionally, the medical device comprises a fluid delivery circuit and the interventional blood pump 140. The fluid delivery circuit comprises the first tube 112-1, the second tube 112-2 and the third tube 112-3 connected based on the first connector 108. The first tube 112-1 is used to connect the fluid source 106. The second tube 112-2 and the third tube 112-3 are respectively connected with the fluid interface (including the fluid inlet 118 and the fluid outlet 120) of the interventional blood pump 140, so as to form the flush channel. The method for detecting an abnormality of a flush system according to the example embodiments of the present application can be applied to the flush channel formed by the fluid delivery circuit having at least three branches and the interventional pump, and can be effectively applied to various flush channels of interventional pumps. The fluid directions of the first tube, the second tube and the third tube are not limited in the example embodiments.

[0090] Optionally, the interventional blood pump 140 comprises a fluid inlet 118 and a fluid outlet 120, the second tube 112-2 is connected with the fluid inlet 118, and the third tube 112-3 is connected with the fluid outlet 120; wherein the fluid in the fluid source 106 is transported to the fluid inlet 118 through the first tube 112-1 and the second tube 112-2 to enter the internal passage of the interventional blood pump 140; the fluid in the internal passage flows out through the fluid outlet 120 and then flows into the first connector 108 through the third tube 112-3, and a fluid circulation is formed among the second tube 112-2, the interventional blood pump 140 and the third tube 112-3. The flushing system abnormality detection method provided by the embodiment of the application can perform abnormality detection on the flushing channel with circulating fluid, and can be effectively applied to an interventional pump requiring fluid circulation flushing to determine the abnormality of the flushing system of the interventional pump.

[0091] Optionally, the control assembly 113 obtains the first detection information and the second detection information through a sensor. The sensor comprises at least one of a pressure sensor 116, a bubble sensor 115 and a temperature sensor 117. The pressure sensor 116 is electrically connected with the control assembly 113, the bubble sensor 115 is electrically connected with the control assembly 113, and the temperature sensor 117 is electrically connected with the control assembly 113. The control assembly 113 receives and processes the signal transmitted by at least one of the pressure sensor 116, the bubble sensor 115 and the temperature sensor 117.

[0092] Optionally, the pressure sensor 116 sends the monitored pressure signal to the control assembly 113, and the control assembly 113 obtains the first detection information according to the pressure signal. The first detection information comprises at least one of the following data: pressure value, pressure change trend, pressure change speed and pressure change acceleration.

[0093] Optionally, the bubble sensor 115 sends the monitored bubble signal to the control assembly 113, and the control assembly 113 obtains the second detection information according to the bubble signal. The second detection information comprises at least one of the following data: bubble quantity, bubble detection time, bubble size and bubble speed.

[0094] Optionally, the temperature sensor 117 sends the monitored temperature signal to the control assembly 113, and the control assembly 113 obtains the second detection information according to the temperature signal. The second detection information comprises at least one of the following data: temperature, temperature detection time, temperature change rate and temperature change trend.

[0095] In an optional embodiment, the pressure sensor 116 can continuously measure the pressure value in time, and then the first detection information can comprise the change curve of the pressure value measured by the pressure sensor 116 within a period of time.

[0096] In another alternative embodiment, the pressure sensor 116 can measure the pressure value periodically, for example, the pressure sensor 116 measures the pressure value 60 times per second. The pressure sensor 116 can report the measured pressure value to the control component 113 in real time, or can report the measured pressure value periodically in a reporting period, wherein the reporting period and the measuring period can be the same or different, and the length of the reporting period is greater than the length of the measuring period. After receiving the pressure value measured by the pressure sensor 116, the control component 113 obtains the first detection information according to at least two pressure values. For example, the control component 113 can obtain the change curve of the pressure value according to at least two pressure values. Alternatively, the control component 113 can obtain the change curve of the pressure value by fitting at least two pressure values. The first detection information can be obtained based on the pressure value reported by the pressure sensor 116 in a period of time, and the first detection information can be the change curve of the pressure value obtained based on the pressure value reported by the pressure sensor 116 in a period of time.

[0097] In an alternative embodiment, the bubble sensor 115 can report the bubble signal in real time. The bubble signal is used to indicate the second detection information. When a bubble passes through the bubble sensor, the bubble signal changes, and the control component can obtain the second detection information according to the change of the bubble signal. Alternatively, the bubble sensor 115 can report the bubble signal when detecting a bubble, and the control component 113 can obtain the second detection information according to the bubble signal. Alternatively, the bubble sensor 115 can periodically detect bubbles and periodically report the bubble signal, wherein the reporting period and the measuring period can be the same or different, and the length of the reporting period is greater than the length of the measuring period. The control component 113 can obtain the second detection information according to the reported bubble signal.

[0098] In an alternative embodiment, the temperature sensor 117 can also report the 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 flushing channel in real time and report the detected temperature. The reporting period and the measuring period of the temperature sensor 117 can be the same or different, and the length of the reporting period is not less than the length of the measuring period. The control component 113 can obtain the second detection information according to the reported temperature signal.

[0099] The second detection information can include bubble-related information detected by the bubble sensor 115 in a period of time. The second detection information can include temperature-related information detected by the temperature sensor 117 in a period of time. The second detection information can include bubble-related information detected by the bubble sensor 115 in a period of time and temperature-related information detected by the temperature sensor 117 in a period of time.

[0100] For example, the second detection information corresponds to the first time period when the first detection information corresponds to the first time period. That is, the first detection information and the second detection information reflect the first detection information and the second detection information in the flushing channel in the same time period.

[0101] Step 220: According to the first detection information and the second detection information, outputting the abnormal alarm information corresponding to the flushing channel, the abnormal alarm information indicating at least one of the abnormal position in the flushing channel and the abnormal state corresponding to the abnormal position.

[0102] The control component 113 matches the corresponding abnormal position and / or the abnormal state corresponding to the abnormal position according to the monitored first detection information and the second detection information.

[0103] For example, the abnormal position includes a position in which an abnormal state occurs in a detectable position corresponding to the flushing channel, the detectable position refers to a position in the flushing channel that can be detected to have an 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. In this way, the device can detect the position where the abnormal state occurs in units of channel segments or position points, and can detect the above-mentioned multiple abnormal states, facilitating the operator to troubleshoot and solve abnormal problems, and improving the accuracy of the flushing system abnormality detection.

[0104] For example, the multiple abnormal flushing conditions include at least two of the following: fluid infusion channel 124 blockage, fluid infusion channel 124 leakage, circulation inlet channel 125 blockage, circulation inlet channel 125 leakage, circulation outlet channel 126 blockage, circulation outlet channel 126 leakage, interventional pump flushing channel 127 leakage, fluid infusion channel 124 pressure abnormality, circulation inlet channel 125 pressure abnormality, circulation outlet channel 126 pressure abnormality, interventional pump flushing channel 127 pressure abnormality, fluid infusion channel 124 bubble existence, circulation inlet channel 125 bubble existence, circulation outlet channel 126 bubble existence, interventional pump flushing channel 127 bubble existence, fluid infusion channel 124 temperature abnormality, circulation inlet channel 125 temperature abnormality, circulation outlet channel 126 temperature abnormality, and interventional pump flushing channel 127 temperature abnormality. The technical solution provided in the embodiments of the present application can detect the above-mentioned multiple abnormal flushing conditions, and improve the comprehensiveness of the flushing system abnormality detection.

[0105] Exemplarily, the control component 113 stores at least two detectable positions and at least two candidate abnormal states. The control component 113 also stores matching conditions corresponding to each detectable position, 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 according to pipeline characteristics, fluid flow characteristics, and experience.

[0106] Exemplarily, different detectable positions in the at least two detectable positions have different flushing distances of the pressure sensor along the flushing channel; and / or, different detectable positions in the at least two detectable positions have different flushing distances of the bubble sensor along the flushing channel; and / or, different detectable positions in the at least two detectable positions have different flushing distances of the temperature sensor along the flushing channel; and / or, different detectable positions in the at least two detectable positions have different flow directions of the flushing liquid; and / or, different detectable positions in the at least two detectable positions have different compositions of the flushing liquid; and / or, different detectable positions in the at least two detectable positions have different flow rates of the flushing liquid. In the flushing flow channel, abnormal conditions at different positions can have different effects on fluid flow in the entire flow channel, which can manifest as changes in unflushed pressure, changes in bubbles, changes in temperature, etc. Therefore, by comparing the first detection information and the second detection information with the matching conditions, the abnormal position and the abnormal state can be detected.

[0107] When the first detection information and the second detection information satisfy the matching conditions corresponding to the detectable position, it is determined that the detectable position is the abnormal position. When the first detection information and the second detection information satisfy the matching conditions corresponding to the candidate abnormal state, it is determined that the candidate abnormal state is the abnormal state.

[0108] In an optional embodiment, one matching condition corresponds to one detectable position and one candidate abnormal state, that is, the abnormal position and the abnormal state occurring at the abnormal position can be determined according to the first detection information and the second detection information. When the first detection information and the second detection information satisfy a certain matching condition, it is determined that the abnormal position is the detectable position corresponding to the matching condition, and the abnormal state is the candidate abnormal state corresponding to the matching condition.

[0109] That is, the abnormal information corresponding to the first detection information and the second detection information is determined, and the abnormal information includes the abnormal position and the abnormal state.

[0110] In another optional embodiment, the control component 113 can 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 position and / or abnormal state based on the extracted features.

[0111] For example, the control component 113 can store therein an abnormal position prediction model (machine learning model) for outputting an abnormal position according to the input first detection information and second detection information, and an abnormal state prediction model (machine learning model) for outputting an abnormal state according to the input first detection information and second detection information. Alternatively, the control component 113 can store therein an abnormal prediction model for outputting an abnormal position and an abnormal state according to the input first detection information and second detection information.

[0112] Referring to FIG. 4, the flushing channel can include at least one of the following channels: a fluid infusion channel 124 connecting the outlet of the fluid source 106 and the third interface 122 of the first connector 108 using a fluid delivery tubing, a first channel segment 125-1 connecting the first interface 119 of the first connector 108 and the inlet 130 of the bubble filter 111 using a fluid delivery tubing, a second channel segment 125-2 connecting the outlet 129 of the bubble filter 111 and the fluid inlet 118 of the drive catheter handle 100 using a fluid delivery tubing, a fourth channel segment 126-2 connecting the fluid outlet 120 of the drive catheter handle 100 and the inlet 131 of the particulate filter 110 using a fluid delivery tubing, a third channel segment 126-1 connecting the outlet 132 of the particulate filter 110 and the second interface 121 of the first connector 108 using a fluid delivery tubing, a passage in the drive catheter handle 100 connecting the drive catheter handle 100 and the pump head 103 using the drive catheter 102.

[0113] Alternatively, the flushing channel can include at least one of the following channels: a fluid infusion channel 124 connecting the outlet of the fluid source 106 and the third interface 122 of the first connector 108 using a fluid delivery tubing, a circulating inlet channel 125 connecting the first interface 119 of the first connector 108 and the fluid inlet 118 of the drive catheter handle 100 using a flushing tubing, a circulating outlet channel 126 connecting the second interface 121 of the drive catheter handle 100 and the fluid outlet 120 of the first connector 108 using a flushing tubing, a passage in the drive catheter handle 100 connecting the drive catheter handle 100 and the pump head 103 using the drive catheter 102.

[0114] The abnormal position is any position in the flushing channel. For example, in combination with reference to FIG. 7, the abnormal position can include at least one of the following detectable positions: flushing tubing position 1, flushing tubing position 2, flushing tubing position 3, flushing tubing position 4, flushing tubing position 5, fluid block 128, drive catheter 102.

[0115] Wherein, the flush line position 1 includes any position on the fluid infusion channel 124, the flush line position 3 includes any position on the first channel segment 125-1, the flush line position 5 includes any position on the second channel segment 125-2, the flush line position 2 includes any position on the third channel segment 126-1, the flush line 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 where it connects to the drive assembly 101, and the seventh detectable position includes any position in the interventional blood pump 140 where it connects to the drive catheter 102.

[0116] Alternatively, the flush line position 1 includes any position between the outlet of the fluid source 106 and the third interface 122 of the first connector 108, the flush line position 3 includes any position between the first interface 119 of the first connector 108 and the inlet 130 of the bubble filter 111, the flush line position 5 includes any position between the outlet 129 of the bubble filter 111 and the fluid inlet 118 of the interventional blood pump 140, the flush line position 2 includes any position between the fluid outlet 120 of the interventional blood pump 140 and the inlet 131 of the particulate filter 110, the flush line position 4 includes any position between the outlet 132 of the particulate filter 110 and the second interface 121 of the first connector 108, the sixth detectable position includes any position in the interventional blood pump 140 where it connects to the drive assembly 101, and the seventh detectable position includes any position in the interventional blood pump 140 where it connects to the drive catheter 102.

[0117] Referring to FIG. 2, the detectable positions can further include at least one of the following: at the bubble filter 111, at the particulate filter 110.

[0118] The abnormal conditions include at least one of the following: clogging, loosening, bending, twisting, leaking, fluid pressure abnormality, power source abnormality, and pump squeezing state abnormality. The twisting can mean that the fluid delivery line or the drive catheter (hose) is twisted, which reduces the size of the passage in the tube or even closes or blocks the passage. The clogging can mean that the interface (the connection between the line and the interface), the fluid delivery line, or the drive catheter is clogged. The leaking can mean that a gap is formed in the interface, the fluid delivery line, or the drive catheter, causing fluid to leak out. The loosening can mean that the interface of the flush line is loose or detached. The bending can mean that the flush line is bent or folded, which hinders the flow of the flush fluid. The fluid pressure abnormality can mean that the pressure of the flush fluid in the flush channel is abnormal, such as too high or too low. The power source abnormality can mean that the power provided by the pump body for pumping fluid is abnormal, such as the power of an infusion pump or a circulation pump. Since the pump body can be a peristaltic pump or a squeezing pump, for example, the infusion pump and the circulation pump are squeezing pumps, the pump squeezing state abnormality can mean that the squeezing function of the pump body is abnormal, such as the squeezing state abnormality caused by the opening of the pump cover.

[0119] Optionally, for each abnormal position, the abnormal state occurred can also be divided into an abnormal level according to the abnormal degree. The abnormal level corresponding to the first detection information and the second detection information is determined. That is, the abnormal information corresponding to the first detection information and the second detection information is determined, and the abnormal information includes at least one of the abnormal position, the abnormal state and the abnormal level. The abnormal level is used to indicate the severity of the abnormal state. For example, for the abnormal state of twisting, when the catheter is completely twisted to close the catheter internal passage, a first twisting level can be corresponded; when the catheter is half twisted to block the catheter internal passage, a second twisting level can be corresponded. Or, for the abnormal state of blockage, when the liquid cannot flow due to complete blockage, a first blockage level can be corresponded; when the liquid can still flow due to half blockage, a second blockage level can be corresponded.

[0120] The control component 113 can generate alarm information according to at least one of the identified abnormal position and abnormal state. The alarm information can include at least one of the abnormal position and the abnormal state. For example, the alarm information can indicate the abnormal position and the abnormal state occurred at the abnormal position.

[0121] For example, the control component 113 can be connected with a sound and / or a display, the alarm audio corresponding to the alarm information is played through the sound, and / or the alarm information is displayed on the display.

[0122] In summary, the method provided by the embodiment can accurately locate the abnormal position in the flushing channel and / or the abnormal state of the abnormal position by monitoring the change of the flushing pressure in the flushing channel, the bubble information, the fluid temperature information and the like in real time, and combining these information. When different positions in the flushing channel are abnormal, the change of the flushing pressure in the flushing channel will be different, the bubble generation will be different, and the fluid temperature will also be different, so the position of the abnormal position in the flushing channel can be accurately located according to these information. When different types of abnormal states (for example, catheter twisting, blockage, leakage and the like) occur in the flushing channel, the change of the flushing pressure in the flushing channel will be different, the bubble generation will be different, and the fluid temperature will also be different, so the abnormal state occurred at the abnormal position in the flushing channel can also be determined according to these information. Therefore, the abnormality in the flushing channel can be accurately located by combining these information, the abnormality can be timely and accurately alarmed and prompted, the danger in the use of the product is reduced or avoided, and the safety factor of the product is improved.

[0123] In an alternative embodiment, the control component 113 stores the pressure change characteristic condition corresponding to each abnormal flushing condition and the corresponding bubble generation characteristic condition, and the control component 113 can match the real-time monitored first detection information and second detection information with the pressure change characteristic condition and bubble generation characteristic condition corresponding to each abnormal flushing condition respectively, and identify the abnormal position and abnormal state according to the matching result.

[0124] FIG. 8 is a flowchart of a method for detecting abnormality of a flushing system of a medical device according to an example embodiment of the present application. The method is applied to a medical device having a flushing channel, which can be an interventional cardiac catheter pump device, i.e., the ventricular assist system described above; and the method can be executed by the control device 114 in the ventricular assist system. Based on the embodiment shown in FIG. 6, step 220 includes step 221.

[0125] Step 210: obtaining first detection information and second detection information corresponding to the flushing channel.

[0126] Optionally, the first detection information represents the flushing pressure change condition of the flushing channel within a target time length, and the second detection information includes bubble information representing the bubble generation condition in the flushing channel. The control component 113 receives the pressure signal transmitted by the pressure sensor 116, and generates the first detection information according to the pressure signal. The control component 113 receives the bubble signal transmitted by the bubble sensor 115, and generates the second detection information according to the bubble signal.

[0127] Step 221: outputting abnormal alarm information corresponding to a target abnormal flushing condition, in a case where 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.

[0128] 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 an abnormal state occurs in at least one position in the flushing channel, and each set of characteristic conditions includes the pressure change characteristic condition corresponding to an abnormal flushing condition, and at least one of the bubble generation characteristic condition and the temperature change characteristic condition corresponding to the abnormal flushing condition.

[0129] For different abnormal flushing conditions, the flushing fluid pressure can change, but not necessarily both the bubbles and the temperature change. For example, in a leakage condition, the flushing fluid temperature can not change, but bubbles can be generated; or in some blockage or distortion conditions, no bubbles can be generated, but the flushing flow rate can decrease, causing the flushing fluid temperature to increase. However, all the above conditions can cause the flushing fluid to change. Therefore, for the judgment of each abnormal flushing condition, it is necessary to analyze the flushing fluid pressure change, and at least one of the bubble generation condition and the temperature change condition can be analyzed.

[0130] For example, the control component 113 stores at least one candidate abnormal flushing condition and a set of feature conditions corresponding to each candidate abnormal flushing condition. Each set of feature conditions includes a pressure change feature condition corresponding to the abnormal flushing condition, and at least one of a bubble generation feature condition and a temperature change feature condition corresponding to the abnormal flushing condition. The pressure change feature condition, the bubble generation feature condition, and the temperature change feature condition can be obtained by analyzing the flow of the fluid in the flushing channel and experiments, and represent the conditions of the pressure change feature, the bubble generation feature, and / or the temperature change feature in the flushing channel when the candidate abnormal flushing condition occurs.

[0131] If the first detection information matches the pressure change feature condition corresponding to a candidate abnormal flushing condition, and the second detection information matches the bubble generation feature condition and / or the temperature generation feature condition corresponding to the candidate abnormal flushing condition, it can be determined that the candidate abnormal flushing condition occurs, and the candidate abnormal state is determined as the target abnormal flushing condition.

[0132] For example, the pressure change feature condition includes the pressure change condition in the flushing channel when the abnormal flushing condition occurs, and the pressure change feature condition includes at least one of a pressure value range condition (such as a pressure change to a certain range), a pressure change trend condition (at least one of pressure increase, decrease, first increase and then decrease, first decrease and then increase, or fluctuation), a pressure change speed threshold condition, a pressure change acceleration threshold condition, etc. The bubble generation feature condition includes the bubble generation condition in the flushing channel when the abnormal flushing condition occurs, and the bubble generation feature condition includes at least one of a bubble detection result condition (detecting bubbles or not detecting bubbles), a bubble number condition, a bubble detection time condition, a bubble size condition, and a bubble speed condition. The temperature change feature condition includes the temperature change condition of the flushing fluid in the flushing channel when the abnormal flushing condition occurs, and the temperature change feature condition includes at least one of a temperature value range condition (such as a temperature change to a certain range), a temperature change trend condition (at least one of temperature increase, decrease, first increase and then decrease, first decrease and then increase, or fluctuation), a temperature change speed threshold condition, a temperature change acceleration threshold condition, etc.

[0133] Exemplarily, the pressure change feature condition can be a determination condition, when the first detection information satisfies the determination condition, the first detection information matches the pressure change feature condition. For example, the pressure change feature condition includes: the pressure value changes to a certain range, 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 feature condition.

[0134] Similarly, the bubble generation feature condition can also be a determination condition, when the second detection information includes bubble information and the bubble information satisfies the determination condition, the bubble information matches the bubble generation feature condition. For example, the bubble generation feature condition includes: detecting a bubble, not detecting a bubble, or the bubble detection time (such as the bubble detection time is 2-5s after the pressure starts to drop, and the number of bubbles is 1-5). When the bubble information indicates that the time of detecting the bubble is 3s after the pressure starts to drop, and the number of detected bubbles is 4, it is determined that the bubble information matches the bubble generation feature condition.

[0135] The temperature change feature condition can also be a determination condition, when the second detection information includes fluid temperature information and the fluid temperature information satisfies the determination condition, the fluid temperature information matches the temperature change feature condition. For example, the temperature change feature condition includes: temperature rise, 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 feature condition.

[0136] Optionally, determining the pressure change feature condition corresponding to the first detection information; and determining the bubble generation feature condition and / or the temperature change feature condition corresponding to the second detection information; determining the detectable position corresponding to the pressure change feature condition, and the bubble generation feature condition and / or the temperature change feature condition as the abnormal position.

[0137] Exemplarily, the control component 113 stores at least one detectable position, the pressure change feature condition corresponding to each detectable position, and the bubble generation feature condition and / or the temperature change feature condition corresponding to each detectable position. The pressure change feature condition, the bubble generation feature condition, and the temperature change feature condition can be obtained by analyzing the flow of the fluid in the flushing channel and through experiments in advance, and can represent the feature conditions of the pressure change, the bubble change, and the temperature change in the flushing channel when the abnormality occurs at the detectable position.

[0138] If the first detection information matches the pressure change characteristic condition corresponding to the detectable position, and the bubble information (if any) in the second detection information matches the bubble generation characteristic condition corresponding to the detectable position, and / or the fluid temperature information (if any) in the second detection information matches the temperature change characteristic condition corresponding to the detectable position, it can be determined that the detectable position is abnormal, and the detectable position is determined as the abnormal position.

[0139] For example, the control component 113 stores at least one set of abnormal flushing conditions, and each set of abnormal flushing conditions includes one detectable position and one candidate abnormal state. The control component also stores the pressure change characteristic condition corresponding to each set of abnormal flushing conditions, and the bubble generation characteristic condition and / or the temperature change characteristic condition corresponding to each set of abnormal flushing conditions. The pressure change characteristic condition, the bubble generation characteristic condition, and the temperature change characteristic condition can be obtained by analyzing the flow of the fluid in the flushing channel and through experiments in advance, and can represent the characteristic conditions of the pressure change, the bubble change, and the temperature change in the flushing channel when the detectable position is abnormal.

[0140] If the first detection information matches the pressure change characteristic condition corresponding to the abnormal flushing condition, and the bubble information (if any) in the second detection information matches the bubble generation characteristic condition corresponding to the detectable position, and / or the fluid temperature information (if any) in the second detection information matches the temperature change characteristic condition corresponding to the detectable position, it can be determined that the detectable position is abnormal, and the detectable position is determined as the abnormal position, and the candidate abnormal state in the abnormal flushing condition is determined as the abnormal state.

[0141] For example, the pressure change characteristic condition includes the pressure change characteristic condition in the flushing channel when the detectable position is abnormal, and the pressure change characteristic condition includes at least one of the following: a pressure value range condition, a pressure change trend condition, a pressure change speed condition, and a pressure change acceleration condition. The bubble generation characteristic condition includes the bubble generation characteristic condition in the flushing channel when the detectable position is abnormal, and the bubble generation characteristic condition includes at least one of the following: a bubble detection result condition, a bubble number condition, a bubble detection time condition, a bubble size condition, and a bubble speed condition. The temperature change characteristic condition includes the temperature change characteristic condition in the flushing channel when the detectable position is abnormal, and the temperature change characteristic condition includes at least one of the following: a temperature value range condition, a temperature change trend condition, a temperature change speed condition, and a temperature change acceleration condition.

[0142] Exemplarily, when the pressure change feature condition comprises a pressure change feature condition curve, the bubble generation feature condition comprises a target bubble detection result, the similarity between the first detection information and the pressure change feature condition curve is greater than a 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 the abnormal state, and the detectable position corresponding to the pressure change feature condition curve and the target bubble detection result is determined as the abnormal position.

[0143] Exemplarily, as shown in Table 1, the control component 113 stores a one-to-one correspondence table of the detectable position, the candidate abnormal state, the pressure change feature condition and the bubble generation feature condition.

[0144] Table 1

[0145] Exemplarily, referring to Table 1, the plurality of abnormal flushing conditions include at least two of the following:

[0146] The first abnormal flushing condition; the first abnormal flushing condition includes that the abnormal position is the fluid infusion channel 124 or a position point (flushing pipeline position 1) in the fluid infusion channel 124, and / or the abnormal state is kink; the pressure change feature condition corresponding to the first abnormal flushing condition includes 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 being a floating interval based on the first pressure data; the bubble generation feature condition corresponding to the first abnormal flushing condition includes that a bubble appears, and / or a first bubble appearance position; the first bubble appearance position includes a position between the kink position and the inlet of the infusion pump 107, and the infusion pump 107 is located in the fluid infusion channel 124;

[0147] The second abnormal flushing condition; the second abnormal flushing condition includes that the abnormal position is the first channel segment 125-1 in the circulation access channel 125 or a position point (flushing pipeline position 3) in the first channel segment 125-1, and / or the abnormal state is kink; the pressure change feature condition corresponding to the second abnormal flushing condition includes that the fluid pressure data falls into a second pressure interval within a second time length, and then rises from the second pressure interval to the pressure interval before falling within a third time length; the bubble generation feature condition corresponding to the second abnormal flushing condition includes that no bubble appears; the bubble filter 111 is arranged on the second tube 112-2, and the first channel segment 125-1 includes a channel segment of the second tube 112-2 before the fluid flows into the bubble filter 111;

[0148] The third abnormal flushing condition includes: the abnormal position is the second channel segment 125-2 in the circulation inlet channel 125 or a position point in the second channel segment 125-2 (flushing pipeline position 5), and / or the abnormal state is kink; the pressure change feature condition corresponding to the third abnormal flushing condition includes that the fluid pressure data first falls to the third pressure interval and then rises from the third pressure interval to the floating interval corresponding to the pressure before falling at a speed lower than the second speed threshold within the fourth time length; the bubble generation feature condition corresponding to the third abnormal flushing condition includes that no bubbles appear; the second pipe 112-2 is provided with a bubble filter 111, and the second channel segment 125-2 includes a channel segment after the fluid flows out of the bubble filter 111 in the second pipe 112-2;

[0149] The fourth abnormal flushing condition includes: the abnormal position is the third channel segment 126-1 in the circulation outlet channel 126 or a position point in the third channel segment 126-1 (flushing pipeline position 2), and / or the abnormal state is kink; the pressure change feature condition corresponding to the fourth abnormal flushing condition includes that the fluid pressure data rises to the fourth pressure interval within the fifth time length, then falls to the pressure value before rising, and fluctuates up and down based on the pressure value before rising; the bubble generation feature condition corresponding to the fourth abnormal flushing condition includes that bubbles appear, and / or the second bubble appearance position; the second bubble appearance position includes a position between the infusion pump 107 and the first connector 108; the third pipe 112-3 is provided with a particle filter 110, and the third channel segment 126-1 includes a channel segment between the particle filter 110 outlet and the first connector 108;

[0150] The fifth abnormal flushing condition includes: the abnormal position is the fourth channel segment 126-2 in the circulation outlet channel 126 or a position point in the fourth channel segment 126-2 (flushing pipeline position 4), and / or the abnormal state is kink; the pressure change feature condition corresponding to the fifth abnormal flushing condition includes that the fluid pressure data rises to the fifth pressure interval within the sixth time length; the bubble generation feature condition corresponding to the fifth abnormal flushing condition includes that no bubbles appear; the third pipe 112-3 is provided with a particle filter 110, and the fourth channel segment 126-2 includes a channel segment before the fluid flows into the particle filter 110 in the third pipe 112-3;

[0151] The sixth abnormal flushing situation; the sixth abnormal flushing situation includes: the abnormal position is the fluid infusion channel 124 or a position point in the fluid infusion channel 124 (flushing pipeline position 1), and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the sixth abnormal flushing situation includes that 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 characteristic condition corresponding to the sixth abnormal flushing situation includes that a bubble appears, and / or a third bubble appearance position; the third bubble appearance position includes the fluid infusion channel 124;

[0152] The seventh abnormal flushing situation; the seventh abnormal flushing situation includes: the abnormal position is the first channel segment 125-1 in the circulation inlet channel 125 or a position point in the first channel segment 125-1 (flushing pipeline position 3), and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the seventh abnormal flushing situation includes that 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 characteristic condition corresponding to the seventh abnormal flushing situation includes that a bubble appears, and / or a fourth bubble appearance position; the fourth bubble appearance position includes the first channel segment 125-1;

[0153] The eighth abnormal flushing situation; the eighth abnormal flushing situation includes: the abnormal position is the second channel segment 125-2 of the circulation inlet channel 125 or a position point in the second channel segment 125-2 (flushing pipeline position 5), and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the eighth abnormal flushing situation includes that the fluid pressure data drops into a tenth pressure interval and maintains stable within an eighth time length; the bubble generation characteristic condition corresponding to the eighth abnormal flushing situation includes that no bubble appears;

[0154] The ninth abnormal flushing situation; the ninth abnormal flushing situation includes: the abnormal position is the third channel segment 126-1 in the circulation outlet channel 126 or a position point in the third channel segment 126-1 (flushing pipeline position 2), and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the ninth abnormal flushing situation includes that the fluid pressure data drops into an eleventh pressure interval, and fluctuates up and down within the eleventh pressure interval; the bubble generation characteristic condition corresponding to the ninth abnormal flushing situation includes that a bubble appears, and / or a fifth bubble appearance position; the fifth bubble appearance position includes the third channel segment 126-1;

[0155] The tenth abnormal flushing condition; the tenth abnormal flushing condition includes: the abnormal position is the fourth channel segment 126-2 in the circulation outlet channel 126 or a position point in the fourth channel segment 126-2 (flushing pipeline position 4), and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the tenth abnormal flushing condition includes: the fluid pressure data decreases to the twelfth pressure interval and maintains stable within the ninth time length; the bubble generation characteristic condition corresponding to the tenth abnormal flushing condition includes no bubbles.

[0156] The eleventh abnormal flushing condition; the eleventh abnormal flushing condition includes: the abnormal position is the fluid blocking piece 128 of the interventional blood pump 140, and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the eleventh abnormal flushing condition includes: the fluid pressure data decreases to the positive pressure floating interval based on the third pressure data within the tenth time length; the bubble generation characteristic condition corresponding to the eleventh abnormal flushing condition includes no bubbles.

[0157] The twelfth abnormal flushing condition; the twelfth abnormal flushing condition includes: the abnormal position is the drive catheter 102 of the interventional blood pump 140 or a position point in the drive catheter 102, and / or the abnormal state is leakage; the pressure change characteristic condition corresponding to the twelfth abnormal flushing condition includes: the fluid pressure data decreases to the negative pressure floating interval based on the fourth pressure data within the eleventh time length; the bubble generation characteristic condition corresponding to the twelfth abnormal flushing condition includes no bubbles.

[0158] For example, if the corresponding candidate abnormal state and / or detectable position are not matched according to the first detection information and the second detection information, the alarm information can be generated directly according to the first detection information and the second detection information.

[0159] For example, the pressure abnormal condition and the bubble abnormal condition can also be arranged in the control component 113. If the corresponding detectable position and / or candidate abnormal state are not matched according to the first detection information and the second detection information, and the first detection information meets the pressure abnormal condition, the alarm information corresponding to the pressure abnormal condition can be sent. If the corresponding detectable position and / or candidate abnormal state are not matched according to the first detection information and the second detection information, and the second detection information meets the bubble abnormal condition, the alarm information corresponding to the bubble abnormal condition can be sent.

[0160] For example, the pressure abnormal condition can include: the pressure value is greater than a threshold value 1, or the pressure value is less than a threshold value 2; the bubble abnormal condition can include: the number of bubbles is greater than 5, or the time interval of detecting bubbles is less than 2s. For example, the alarm information corresponding to the pressure abnormal condition can be: pressure abnormality. The alarm information corresponding to the bubble abnormal condition can be: bubble abnormality.

[0161] In summary, the method provided in the embodiment matches the first detection information with the pressure change characteristic condition stored in the memory of the control assembly, matches the bubble information (if any) in the second detection information with the bubble generation characteristic condition stored in the memory of the control assembly, and / or matches the fluid temperature information (if any) in the second detection information with the temperature change characteristic condition stored in the memory of the control assembly, so as to determine the abnormal position and / or abnormal state in the flushing channel according to the successfully matched pressure change characteristic condition, and the successfully matched bubble generation characteristic condition and / or temperature change characteristic condition. The abnormality can be timely and accurately alarmed, the danger in the use of the product is reduced or avoided, and the safety factor of the product is improved.

[0162] The method provided in the embodiment can identify the abnormal position in the flushing channel and the type of the abnormal state according to the pressure change condition, and the bubble generation condition and / or temperature change condition in the flushing channel. The pressure change condition, bubble generation condition and / or temperature change condition in the flushing channel can be calculated according to the flow condition of the fluid in the flushing channel, and the pressure change condition, bubble generation condition and / or temperature change condition corresponding to different positions and different abnormal states can be summarized. The abnormal position in the flushing channel and the type of the abnormal state can be accurately identified according to the corresponding relationship, and alarm information can be generated in time to remind the user, so as to timely and accurately alarm the abnormality, reduce or avoid the danger in the use of the product, and improve the safety factor of the product.

[0163] For example, the rotation speed of the drive shaft arranged in the interventional blood pump is very high, and when the power of the flushing pump is abnormal, the fluid flow speed decays, which can cause the flushing liquid to fail to flow and dissipate heat normally, thereby causing abnormal temperature rise of the fluid. Alternatively, when the abnormality occurs in the flushing channel, the high-speed rotation of the drive shaft can also cause temperature abnormality in the flushing channel. Therefore, the temperature change information in the flushing channel can also be combined to more accurately locate the abnormal position and abnormal state.

[0164] FIG. 9 is a flow chart of a method for detecting abnormality of a flush system of a medical device according to an example embodiment of the present application. The method is applied to a medical device having a flush channel, which can be an interventional cardiac catheter pump device, i.e., the ventricular assist system as described above. The method can be performed by the control device 114 in the ventricular assist system. Based on the example embodiment shown in FIG. 6, step 220 includes step 222.

[0165] Step 210: obtaining first detection information and second detection information corresponding to the flush channel.

[0166] Optionally, the medical device includes an interventional blood pump 140 and a flush pump. The interventional blood pump 140 includes a fluid inlet 118, the fluid inlet 118 is connected with the fluid delivery pipeline to form the flush channel, and the flush pump is connected with the fluid delivery pipeline, and the flush pump is used to squeeze the fluid delivery pipeline to deliver fluid.

[0167] Optionally, the first detection information represents a change of flush pressure of the flush channel within a target time length, and the second detection information includes fluid temperature information representing a change of temperature in the flush channel. The control component 113 receives a pressure signal transmitted by the pressure sensor 116 and generates the first detection information according to the pressure signal. The control component 113 receives a temperature signal transmitted by the temperature sensor 117 and generates the second detection information according to the temperature signal.

[0168] The control component 113 receives a pressure signal transmitted by the pressure sensor 116 and generates the first detection information according to the pressure signal. The control component 113 receives a temperature signal transmitted by the temperature sensor 117 and generates the second detection information according to the temperature signal.

[0169] Optionally, the temperature sensor 117 is electrically connected with the control component 113, and the control component 113 receives and processes a signal transmitted by the temperature sensor 117. Optionally, the temperature sensor 117 sends a monitored temperature signal to the control component 113, and the control component 113 obtains temperature change information according to the temperature signal. The temperature change information includes at least one of the following data: a temperature value, a temperature change trend, a temperature change speed, and a temperature change acceleration.

[0170] In an alternative embodiment, the temperature sensor 117 can measure the temperature value continuously in time, and the temperature change information can include a change curve of the temperature values measured by the temperature sensor 117 in a period of time. In another alternative embodiment, the temperature sensor 117 can measure the temperature value periodically, for example, the temperature sensor 117 measures the temperature value 60 times per second. The temperature sensor 117 can report the measured temperature value to the control component 113 in real time, or can report the temperature value measured in the current period periodically, where the reporting period and the measuring period can be the same or different, and the length of the reporting period is greater than the length of the measuring period. After receiving the temperature values measured by the temperature sensor 117, the control component 113 obtains the temperature change information according to at least two temperature values. For example, the control component 113 can obtain a change curve of the temperature values according to at least two temperature values. Alternatively, the control component 113 can fit a change curve of the temperature values according to at least two temperature values. The temperature change information can be obtained based on the temperature values reported by the temperature sensor in a period of time, and the temperature change information can be a change curve of the temperature values obtained based on the temperature values reported by the temperature sensor in a period of time.

[0171] Step 222: In a case where the first detection information satisfies the pressure change characteristic condition corresponding to the pump extrusion state abnormality, and the fluid temperature information satisfies the temperature change characteristic 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 the extrusion state of the flushing pump to the fluid conveying pipeline is abnormal.

[0172] Optionally, determining an abnormal position corresponding to the first detection information and the fluid temperature information, and / or determining an abnormal state corresponding to the first detection information and the fluid temperature information.

[0173] For example, the control component 113 stores at least two detectable positions and at least two candidate abnormal extrusion states. The control component 113 also stores a matching condition corresponding to each detectable position, and a matching condition corresponding to each candidate abnormal extrusion state. The matching condition is a condition set for the first detection information and the fluid temperature information, and the matching condition can be set according to the flow of the fluid in the flushing channel and experience.

[0174] For example, the detectable position corresponding to the flushing channel includes an extrusion part of the flushing pump, and the pump extrusion state abnormality includes a loosening state abnormality of the extrusion part and / or a loosening duration state abnormality of the extrusion part.

[0175] Exemplarily, the flush pump comprises the infusion pump 107 and the circulation pump 109, and the pump extrusion state abnormality comprises at least one of the following: the extrusion part of the infusion pump 107 is loosened; the extrusion part of the circulation pump 109 is loosened; the extrusion part of the infusion pump 107 is loosened for a long time; the extrusion part of the circulation pump 109 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.

[0176] When the first detection information and the fluid temperature information satisfy the matching condition corresponding to the detectable position, it is determined that the detectable position is an abnormal position. When the first detection information and the fluid temperature information satisfy the matching condition corresponding to the candidate abnormal state, it is determined that the candidate abnormal state is an abnormal state.

[0177] Optionally, the control component 113 can determine a pressure change characteristic condition corresponding to the first detection information; and determine a temperature change characteristic condition corresponding to the fluid temperature information; determine the candidate abnormal state corresponding to the pressure change characteristic condition and the temperature change characteristic condition as an abnormal state. Determine the detectable position corresponding to the pressure change characteristic condition and the temperature change characteristic condition as an abnormal position.

[0178] Exemplarily, the temperature change characteristic condition can be a judgment condition, when the fluid temperature change information satisfies the judgment condition, the temperature change information matches the temperature change characteristic condition. For example, the temperature change characteristic condition comprises: the temperature value changes to a certain range, 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.

[0179] Alternatively, the temperature change characteristic condition can comprise a temperature change characteristic condition curve, when the similarity of the temperature change information and the curve of the temperature change characteristic condition curve satisfies a threshold value, it can be determined that the temperature change information matches the temperature change characteristic condition.

[0180] That is, in the case that the similarity of the first detection information and the pressure change characteristic condition curve is greater than a first threshold value, and the similarity of the fluid temperature information and the temperature change characteristic condition curve is greater than a third threshold value, the candidate abnormal extrusion state corresponding to the pressure change characteristic condition curve and the temperature change characteristic condition curve is determined as an abnormal pump extrusion state. The extrusion part of the flush pump corresponding to the pressure change characteristic condition curve and the temperature change characteristic condition curve is determined as an abnormal extrusion position.

[0181] Exemplarily, by monitoring the moment when the pump cover of the infusion pump 107 or the circulation pump 109 is opened and the change characteristics of the flush pressure and the flush liquid temperature within a certain time, the change characteristics of the pressure and temperature parameters in the case that the infusion pump 107 and the circulation pump 109 are opened alone or simultaneously are analyzed, the case that the pump cover is opened can be identified, and corresponding alarm can be made to remind the user to troubleshoot.

[0182] During the operation of the control assembly 113, the normal operation of the infusion pump 107 and the circulation pump 109 requires that the fluid delivery pipeline be installed into the clamping groove of the pump head, and the pump cover needs to be strictly closed, otherwise the flushing liquid cannot be normally delivered. However, during the use of the device by the user, there are several cases in which the pump cover is opened and forgotten to be closed:

[0183] 1. In some cases (such as blockage), the flushing pipeline may have a pressure that is too high, and the user may need to actively release the pressure to reduce the risk. During the pressure release operation of the flushing pipeline, the pump cover needs to be opened to release the pressure from the liquid bag, and the pump cover may be forgotten to be closed again during this operation;

[0184] 2. During the replacement of the flushing liquid bag, the user may open the pump cover to check whether the flushing liquid is normally supplied, and the pump cover may be forgotten to be closed again during this operation;

[0185] 3. In the case of failure of the flushing pipeline, the user may need to replace the flushing pipeline, and the user needs to open the pump cover to install the new pipeline during the replacement of the flushing pipeline, and the pump cover may be forgotten to be closed again during this operation;

[0186] 4. During the normal operation of the surgery, the user may also open the pump cover due to misoperation and forget to close the pump cover again.

[0187] In the above cases, if the system does not have an alarm measure and the user forgets to close the cover, the flushing liquid cannot be normally delivered, resulting in failure due to lack of flushing liquid supply, which affects the safety of the patient's life. When the pump cover of the flushing pump or the circulation pump is opened, the roller pump cannot apply a squeezing action to the pump pipe, so that the pressure of the flushing liquid cannot be applied or maintained. For different cases in which the pump covers of the two roller pumps are opened, the flushing liquid pressure and the flushing liquid temperature will change differently. The relevant characteristics are shown in Table 2.

[0188] Table 2

[0189] For example, referring to Table 2, the pump squeezing state anomaly can include at least one of the following:

[0190] The first pump squeezing state anomaly includes: the abnormal position 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 loosened for a long time; the pressure change characteristic condition corresponding to the first pump squeezing state anomaly includes: the falling speed of the fluid pressure data is higher than the third speed threshold, and falls to the thirteenth pressure interval and maintains stable; the temperature change characteristic condition corresponding to the first pump squeezing state anomaly includes that the temperature maintains stable;

[0191] The second pump extrusion state anomaly includes: the abnormal position is the extrusion part of the circulating pump 109, and / or the abnormal state is that the extrusion part of the circulating pump 109 is loosened for a long time; the pressure change characteristic condition corresponding to the second pump extrusion state anomaly includes that the fluid pressure data is maintained stable; and the temperature change characteristic condition corresponding to the second pump extrusion state anomaly includes temperature rise.

[0192] The third pump extrusion state anomaly includes: the abnormal position is the extrusion part of the infusion pump 107 and the extrusion part of the circulating pump 107, 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 circulating pump is loosened for a long time; the pressure change characteristic 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 characteristic condition corresponding to the third pump extrusion state anomaly includes temperature rise.

[0193] The method provided in the embodiment can prevent the system from misreporting or frequently alarming in the case that the pump cover of the flushing pump or the circulating pump is opened for a short time, thereby affecting the use of the user. In the case that the pump cover is opened for a long time due to incorrect operation or accidental situation, the system can quickly alarm, thereby avoiding the occurrence of danger. The combination of pressure and temperature monitoring can accurately locate the fault position of the flushing pump and the circulating pump, accurately alarm, and help the user to troubleshoot problems.

[0194] The fourth pump extrusion state anomaly includes: the abnormal position is the extrusion part of the infusion pump 107, and / or the abnormal state is that the extrusion part of the infusion pump 107 is loosened; the pressure change characteristic 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 characteristic condition corresponding to the fourth pump extrusion state anomaly includes temperature maintenance.

[0195] The fifth pump extrusion state anomaly includes: the abnormal position is the extrusion part of the circulating pump 109, and / or the abnormal state is that the extrusion part of the circulating pump 109 is loosened; the pressure change characteristic condition corresponding to the fifth pump extrusion state anomaly includes that the fluid pressure data is maintained stable; and the temperature change characteristic condition corresponding to the fifth pump extrusion state anomaly includes temperature rise.

[0196] The sixth pump extrusion state anomaly includes: the abnormal position is the extrusion part of the infusion pump 107 and the extrusion part of the circulating pump, and / or the abnormal state is that the extrusion part of the infusion pump 107 is loosened and the extrusion part of the circulating pump is loosened; the pressure change characteristic 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 characteristic condition corresponding to the sixth pump extrusion state anomaly includes temperature rise.

[0197] For example, if the corresponding candidate abnormal state and / or detectable position cannot be matched according to the first detection information and the second detection information, the alarm information can be generated directly according to the first detection information and the second detection information. For example, the temperature abnormal condition can also be set in the control component 113. If the corresponding detectable position and / or candidate abnormal state cannot be matched according to the first detection information and the second detection information, and the temperature change information meets the temperature abnormal condition, the alarm information corresponding to the temperature abnormal condition can be sent. For example, the temperature abnormal condition can include that the temperature value is higher than 40℃, or the temperature value is lower than 20℃. For example, the alarm information corresponding to the temperature abnormal condition can be temperature abnormality.

[0198] In summary, the method provided in the embodiment matches the first detection information with the pressure change characteristic condition stored in the control component, and matches the second detection information with the temperature change characteristic condition stored in the control component, so as to determine the abnormal extrusion condition of the circulating pump and the flushing pump according to the matched pressure change characteristic condition and temperature change characteristic condition. The abnormal state of the extrusion part loosening can be timely and accurately alarmed and prompted, the danger in the use of the product is reduced or avoided, and the safety factor of the product is improved.

[0199] The method provided in the embodiment can summarize the pressure change condition and the temperature change condition corresponding to different flushing pumps and different abnormal extrusion states, by analyzing the flow condition of the fluid in the flow channel and calculating the pressure change condition and the temperature change condition in the flushing channel when the flushing pump is in different abnormal states. According to the corresponding relationship, the flushing pump in which the extrusion abnormality occurs to cause the fluid power abnormality can be accurately identified, as well as the abnormal extrusion state type of the flushing pump, and alarm information can be generated in time to remind the user, so as to timely and accurately alarm and prompt the abnormality, reduce or avoid the danger in the use of the product, and improve the safety factor of the product.

[0200] Optionally, the fluid delivery pipeline includes a first pipe and a second pipe connected based on the first connector, the first pipe is used to connect the fluid source, and the second pipe is connected with the fluid inlet; wherein the infusion pump is arranged on the first pipe, and the circulating pump is arranged on the second pipe. In this way, the flushing pump extrusion state abnormality of the flushing system shown in FIG. 2 can be identified and alarmed.

[0201] FIG. 10 shows a structural schematic diagram of an abnormality alarm device for a medical device according to an example embodiment of the present application. The device can be implemented by software, hardware or a combination of both to be all or part of a control component, and the device comprises: a monitoring module 401 configured to acquire first detection information and second detection information corresponding to the flushing channel, the first detection information representing a flushing pressure variation condition of the flushing channel within a target time length, and the second detection information comprising 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 variation condition of a fluid in the flushing channel; and a generating module 403 configured to output abnormality alarm information corresponding to the flushing channel according to the first detection information and the second detection information, the abnormality alarm information indicating at least one of an abnormal position in the flushing channel and an abnormal state corresponding to the abnormal position.

[0202] In an optional embodiment, the abnormal position comprises a position in which the abnormal state occurs in a detectable position corresponding to the flushing channel, the detectable position being a position in the flushing channel that can be detected to have the abnormal state; the detectable position comprises at least one channel segment and / or at least one position point in the flushing channel, and the abnormal state comprises at least one of blockage, loosening, bending, twisting, leakage, fluid pressure abnormality, power source abnormality and pump extrusion state abnormality.

[0203] In an optional embodiment, the generating module 403 is configured to output abnormality alarm information corresponding to a target abnormal flushing condition in a case where the first detection information satisfies a pressure variation feature condition corresponding to the target abnormal flushing condition, and the second detection information satisfies a bubble generation feature condition and / or a temperature variation feature condition corresponding to the target abnormal flushing condition; wherein the target abnormal flushing condition is an abnormal flushing condition in a plurality of abnormal flushing conditions that matches the first detection information and the second detection information, the plurality of abnormal flushing conditions correspond to a plurality of feature conditions one by one, each of the abnormal flushing conditions represents a case where the abnormal state occurs at at least one position in the flushing channel, and each of the feature conditions comprises at least one of a pressure variation feature condition corresponding to one abnormal flushing condition, a bubble generation feature condition corresponding to the one abnormal flushing condition and a temperature variation feature condition corresponding to the one abnormal flushing condition. In an optional embodiment, 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 configured to connect a fluid source, and the second pipe and the third pipe are respectively connected to a fluid interface of the interventional blood pump to form the flushing channel.

[0204] In an alternative embodiment, the interventional blood pump comprises 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; wherein the fluid in the fluid source is delivered to the fluid inlet through the first tube and the second tube 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 tube, and a fluid circulation is formed among the second tube, the interventional blood pump and the third tube.

[0205] In an alternative embodiment, the detectable positions corresponding to the flushing channels comprise 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; and the interventional blood pump flushing channel comprises a fluid flow passage of the interventional blood pump.

[0206] In an alternative embodiment, the plurality of abnormal flushing conditions comprises at least two of a blockage of the fluid infusion channel, a leakage of the fluid infusion channel, a blockage of the circulation inlet channel, a leakage of the circulation inlet channel, a blockage of the circulation outlet channel, a leakage of the circulation outlet channel, a leakage of the interventional blood pump flushing channel, an abnormal pressure of the fluid infusion channel, an abnormal pressure of the circulation inlet channel and an abnormal pressure of the circulation outlet channel.

[0207] In an alternative embodiment, at least one fluid processing device is arranged on the second tube, and the detectable positions corresponding to the circulation inlet channel comprise 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. In an alternative embodiment, at least one fluid processing device is arranged on the third tube, and the detectable positions corresponding to the circulation outlet channel comprise 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. In an alternative embodiment, the interventional blood pump comprises a driving catheter and a fluid blocking member, the fluid entering the internal passage of the interventional blood pump enters the driving catheter, 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 positions corresponding to the interventional blood pump flushing channel comprise the driving catheter and the fluid blocking member.

[0208] In an alternative embodiment, the plurality of abnormal flushing conditions comprises at least two of:

[0209] a first abnormal flushing condition; the first 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 kink; the pressure change characteristic condition corresponding to the first abnormal flushing condition comprises: 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 being a floating interval based on the first pressure data; the bubble generation characteristic condition corresponding to the first abnormal flushing condition comprises: a bubble appears, and / or a first bubble appearance position; the first bubble appearance position comprises a position between a kink position and an inlet of an infusion pump, the infusion pump being located in the fluid infusion channel;

[0210] a second abnormal flushing condition; the second abnormal flushing condition comprises: the abnormal position is a first channel segment in the circulation access channel or a position point in the first channel segment, and / or the abnormal state is kink; the pressure change characteristic condition corresponding to the second abnormal flushing condition comprises: the fluid pressure data falls into a second pressure interval within a second time length, and then rises from the second pressure interval to a pressure interval before falling within a third time length; the bubble generation characteristic condition corresponding to the second abnormal flushing condition comprises: no bubble appears; a bubble filter is arranged on the second tube, and the first channel segment comprises a channel segment in the second tube before the fluid flows into the bubble filter;

[0211] a third abnormal flushing condition; the third abnormal flushing condition comprises: the abnormal position is a second channel segment in the circulation access channel or a position point in the second channel segment, and / or the abnormal state is kink; the pressure change characteristic condition corresponding to the third abnormal flushing condition comprises: the fluid pressure data falls into a third pressure interval within a fourth time length, and then rises from the third pressure interval to a floating interval corresponding to the pressure interval before falling at a speed lower than a second speed threshold; the bubble generation characteristic condition corresponding to the third abnormal flushing condition comprises: no bubble appears; the bubble filter is arranged on the second tube, and the second channel segment comprises a channel segment in the second tube after the fluid flows out of the bubble filter;

[0212] A fourth abnormal flushing condition; the fourth abnormal flushing condition includes: 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 kink; the pressure change feature condition corresponding to the fourth abnormal flushing condition includes: the fluid pressure data rises to a fourth pressure interval within a fifth time length, then falls 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 includes: a gas bubble appears, and / or a second gas bubble appearance position; the second gas bubble appearance position includes a position between the infusion pump and the first connector; a particulate filter is arranged on the third tube, and the third channel segment includes a channel segment between the particulate filter outlet and the first connector;

[0213] A fifth abnormal flushing condition; the fifth abnormal flushing condition includes: 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 kink; the pressure change feature condition corresponding to the fifth abnormal flushing condition includes: 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 includes: no gas bubble appears; the particulate filter is arranged on the third tube, and the fourth channel segment includes a channel segment in the third tube before the fluid flows into the particulate filter;

[0214] A sixth abnormal flushing condition; the sixth abnormal flushing condition includes: the abnormal position is the fluid infusion channel or a position point in the fluid infusion channel, and / or the abnormal state is leakage; the pressure change feature condition corresponding to the sixth abnormal flushing condition includes: the fluid pressure data falls to 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 includes: a gas bubble appears, and / or a third gas bubble appearance position; the third gas bubble appearance position includes the fluid infusion channel;

[0215] A seventh abnormal flushing condition; the seventh abnormal flushing condition includes: 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 leakage; the pressure change feature condition corresponding to the seventh abnormal flushing condition includes: the fluid pressure data falls by a seventh pressure interval within a seventh time length, then falls to 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 includes: a gas bubble appears, and / or a fourth gas bubble appearance position; the fourth gas bubble appearance position includes the first channel segment;

[0216] An eighth abnormal flushing condition; the eighth abnormal flushing condition comprises: the abnormal position is the second channel segment of the circulation inlet channel or a position point in the second channel segment, and / or the abnormal state is leakage; the pressure change feature condition corresponding to the eighth abnormal flushing condition comprises: the fluid pressure data drops to 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 appearing;

[0217] 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 leakage; the pressure change feature condition corresponding to the ninth abnormal flushing condition comprises: the fluid pressure data drops to 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 appearing, and / or a fifth bubble appearing position; the fifth bubble appearing position comprises the third channel segment;

[0218] 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 leakage; the pressure change feature condition corresponding to the tenth abnormal flushing condition comprises: the fluid pressure data drops to 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 appearing;

[0219] An eleventh abnormal flushing condition; the eleventh abnormal flushing condition comprises: the abnormal position is a fluid sealing 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 comprises: the fluid pressure data drops to a positive pressure floating interval with the third pressure data as a reference within a tenth time length; the bubble generation feature condition corresponding to the eleventh abnormal flushing condition comprises no bubble appearing;

[0220] A twelfth abnormal flushing condition; the twelfth abnormal flushing condition comprises: the abnormal position is a drive catheter of the interventional blood pump or a position point in the drive catheter, and / or the abnormal state is leakage; the pressure change feature condition corresponding to the twelfth abnormal flushing condition comprises: the fluid pressure data drops to a negative pressure floating interval with the fourth pressure data as a reference within an eleventh time length; the bubble generation feature condition corresponding to the twelfth abnormal flushing condition comprises no bubble appearing.

[0221] In an optional embodiment, the medical device comprises: an interventional blood pump comprising a fluid inlet; the fluid inlet is connected with a fluid delivery pipeline to form the flushing channel; a flushing pump connected with the fluid delivery pipeline, the flushing pump being configured to squeeze the fluid delivery pipeline to deliver the fluid; the generation module 403 is configured to output abnormal alarm information corresponding to a pump squeezing state abnormality in a case where the first detection information satisfies a pressure change characteristic condition corresponding to the pump squeezing state abnormality, and the fluid temperature information satisfies a temperature change characteristic condition corresponding to the pump squeezing state abnormality. The pump squeezing state abnormality refers to a case where the squeezing state of the flushing pump on the fluid delivery pipeline is abnormal. In an optional embodiment, the detectable position corresponding to the flushing channel comprises: a squeezing part of the flushing pump; the pump squeezing state abnormality comprises a loosening state abnormality of the squeezing part and / or a loosening duration state abnormality of the squeezing part. In an optional embodiment, the flushing pump comprises a transfusion pump and a circulation pump, and the pump squeezing state abnormality comprises at least one of the following: the squeezing part of the transfusion pump is loosened; the squeezing part of the circulation pump is loosened; the squeezing part of the transfusion pump is loosened for a long time; the squeezing part of the circulation 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.

[0222] In an optional embodiment, the flushing pump comprises a transfusion pump and a circulation pump, and the pump squeezing state abnormality comprises at least one of the following:

[0223] a first pump squeezing state abnormality; the first pump squeezing state abnormality comprises: the abnormal position is a squeezing part of the transfusion pump, and / or the abnormal state is that the squeezing part of the transfusion pump is loosened for a long time; the pressure change characteristic condition corresponding to the first pump squeezing state abnormality comprises: the falling speed of the fluid pressure data is higher than a third speed threshold, and falls to a thirteenth pressure interval and maintains stable; the temperature change characteristic condition corresponding to the first pump squeezing state abnormality comprises temperature maintaining stable;

[0224] a second pump squeezing state abnormality; the second pump squeezing state abnormality comprises: the abnormal position is a squeezing part of the circulation pump, and / or the abnormal state is that the squeezing part of the circulation pump is loosened for a long time; the pressure change characteristic condition corresponding to the second pump squeezing state abnormality comprises: the fluid pressure data maintains stable; the temperature change characteristic condition corresponding to the second pump squeezing state abnormality comprises temperature rising;

[0225] The third pump extrusion state anomaly includes: the abnormal position is the extrusion part of the infusion pump and the extrusion part of the circulating 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 circulating pump is loosened for a long time; the pressure change characteristic condition corresponding to the third pump extrusion state anomaly includes: the descending speed of the fluid pressure data is higher than a fourth speed threshold value, and is maintained stable in a fourteenth pressure interval; the temperature change characteristic condition corresponding to the third pump extrusion state anomaly includes temperature rise;

[0226] The fourth pump extrusion state anomaly includes: 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 characteristic condition corresponding to the fourth pump extrusion state anomaly includes: the descending speed of the fluid pressure data is higher than a fifth speed threshold value, and is maintained stable in a fifteenth pressure interval; the temperature change characteristic condition corresponding to the fourth pump extrusion state anomaly includes temperature maintaining stable;

[0227] The fifth pump extrusion state anomaly includes: the abnormal position is the extrusion part of the circulating pump, and / or the abnormal state is that the extrusion part of the circulating pump is loosened; the pressure change characteristic condition corresponding to the fifth pump extrusion state anomaly includes: the fluid pressure data is maintained stable; the temperature change characteristic condition corresponding to the fifth pump extrusion state anomaly includes temperature rise.

[0228] The sixth pump extrusion state anomaly includes: the abnormal position is the extrusion part of the infusion pump and the extrusion part of the circulating pump, and / or the abnormal state is that the extrusion part of the infusion pump is loosened and the extrusion part of the circulating pump is loosened; the pressure change characteristic condition corresponding to the sixth pump extrusion state anomaly includes: the descending speed of the fluid pressure data is higher than a sixth speed threshold value, and is maintained stable in a sixteenth pressure interval; the temperature change characteristic condition corresponding to the sixth pump extrusion state anomaly includes temperature rise.

[0229] In an optional embodiment, the fluid delivery pipeline includes a first pipe and a second pipe connected based on a first connector, the first pipe is used to connect 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 circulating pump is arranged on the second pipe.

[0230] FIG. 11 shows a structural block diagram of a computer device 900 according to an example embodiment of the present application. The computer device can be implemented as the control component of the medical device in the above-mentioned solutions of the present application. The computer device 900 includes a central processing unit (CPU) 901, a system memory 904 including a random access memory (RAM) 902 and a read-only memory (ROM) 903, and a system bus 905 connecting the system memory 904 and the central processing unit 901. The computer device 900 further includes a mass storage device 906 for storing an operating system 909, application programs 910, and other program modules 911. The mass storage device 906 is connected to the central processing unit 901 through a mass storage controller (not shown) connected to the system bus 905. The mass storage device 906 and its associated computer readable media provide nonvolatile storage for the computer device 900. That is, the mass storage device 906 can include a computer readable medium (not shown) such as a hard disk or a compact disc read-only memory (CD-ROM) drive. Without limitation, the computer readable medium can include computer readable storage media and communication media. Computer readable storage media include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer readable storage media include RAM, erasable programmable read only memory (EPROM), electrically-erasable programmable read-only memory (EEPROM), flash memory or other solid state memory technology, CD-ROM, digital versatile discs (DVD), or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices. Of course, those skilled in the art will recognize that the computer readable storage media need not be tangible and can be transitory in nature. The system memory 904 and the mass storage device 906 described above can be collectively referred to as a memory. According to various embodiments of the present disclosure, the computer device 900 can also operate in a networked environment using a network connection to one or more remote computers. That is, the computer device 900 can be connected to a network 908 through a network interface unit 907 connected to the system bus 905, or can be connected to other types of networks or remote computer systems (not shown) using the network interface unit 907.

[0231] The memory further includes at least one piece of computer program stored in the memory, and the central processing unit 901 implements all or part of the steps in the flushing system anomaly detection method for medical devices shown in the various embodiments above by executing the at least one piece of program.

[0232] The embodiments of the present application also provide a ventricular assist system, which comprises a flushing channel and 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 flushing pressure change condition 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 represents a bubble generation condition in the flushing channel, and the fluid temperature information represents a temperature change condition of a fluid in the flushing channel.

[0233] The embodiments of the present application also provide a ventricular assist system, which comprises a control device and consumables; the control device comprises a driving assembly and a bubble sensor, the driving assembly is configured to be coupled with the consumables, and the bubble sensor is clamped with a flushing pipeline in the consumables; the consumables comprise a flushing pipeline and an interventional blood pump, and a fluid sensor is arranged in the interventional blood pump; the fluid sensor comprises a pressure sensor, or comprises a pressure sensor, a temperature sensor, or comprises a pressure temperature sensor; the flushing pipeline and the interventional blood pump are communicated to form a flushing channel, first detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; at least one of an abnormal position in the flushing channel and an 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 condition 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 represents a bubble generation condition in the flushing channel, and the fluid temperature information represents a temperature change condition of a fluid in the flushing channel.

[0234] The embodiment of the present application also provides a control device in a ventricular assist system, the ventricular assist system having a flushing channel, and the control device is used to execute any of the above flushing system anomaly detection methods for medical devices. Optionally, the control device comprises a driving assembly, a bubble sensor and a control assembly; wherein the bubble sensor is used to report bubble information to the control assembly, and the control assembly is used to determine at least one of an abnormal position in the ventricular assist system and an abnormal state corresponding to the abnormal position according to second detection information and first detection information reported by a pressure sensor; the first detection information represents a flushing pressure change condition of the flushing channel in the ventricular assist system within a target time length, and the second detection information comprises at least one of bubble information and fluid temperature information, the bubble information represents a bubble generation condition in the flushing channel, and the fluid temperature information represents a temperature change condition of a fluid in the flushing channel.

[0235] The embodiment of the present application also provides a consumable in a ventricular assist system, the consumable comprising a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a pressure sensor; wherein the flushing pipeline and the interventional blood pump are communicated to form a flushing channel, and the pressure sensor is used to report first detection information to a control assembly; the control assembly is used 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 condition of the flushing channel within a target time length, and the second detection information comprises at least one of bubble information and fluid temperature information, the bubble information represents a bubble generation condition in the flushing channel, and the fluid temperature information represents a temperature change condition of a fluid in the flushing channel.

[0236] The embodiment of the present application also provides a computer readable storage medium, the storage medium storing at least one computer program, and the at least one computer program is loaded and executed by a processor to implement the flushing system anomaly detection method for medical devices provided by the above method embodiments.

[0237] The embodiment of the present application also provides a chip, the chip comprising programmable logic circuits or programs, and a device installed with the chip is used to implement the flushing system anomaly detection method for medical devices as described in the above aspects.

[0238] The embodiment of the present application further provides a computer program product, which comprises a computer program stored in a computer readable storage medium; the computer program is read by a processor of a computer device from the computer readable storage medium and executed, so that the computer device executes to implement the flushing system anomaly detection method for a medical device provided by each method embodiment.

[0239] It can be understood that, in the specific embodiments of the present application, the flushing liquid information, historical data, and data related to user data processing related to user identity or characteristics, etc. When the above embodiments of the present application are applied to specific products or technologies, the user's permission or consent is required, and the collection, use and processing of related data need to comply with relevant laws, regulations and standards of the country and region. It should be noted that, unless otherwise defined herein, all terms used in the claims are interpreted according to their ordinary meanings in the technical field. Unless explicitly stated otherwise, all references to "one element, device, component, apparatus, step, etc." will be open to interpretation as referring to at least one instance of the element, device, component, apparatus, step, etc. Unless explicitly stated, the steps of any method disclosed herein are not necessarily performed in the exact order disclosed. It should be understood that "a plurality of" referred to herein means two or more. The association relationship of the associated objects described by "and / or" indicates that there can be three relationships, for example, A and / or B can represent: A exists alone, A and B exist together, and B exists alone. The character " / " generally represents that the associated objects before and after it are in an "or" relationship. Those skilled in the art can understand that all or part of the steps of the above embodiments can be completed by hardware, or by a program instructing related hardware to complete, and the program can be stored in a computer readable storage medium. The storage medium mentioned above can be a read-only memory, a magnetic disk or an optical disk, etc. The above is only an optional embodiment of the present application, and is not used to limit the present application. Any modification, equivalent switching, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A 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 representing a bubble generation condition in the flushing channel and 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.

3. The method of claim 2, wherein, 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.

4. The method of claim 3, wherein, 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, the second pipe and the third pipe are connected with fluid interfaces of the interventional blood pump respectively, forming the flushing channel.

5. The method of claim 4, wherein, 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 the 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; the fluid in the internal channel flows out through the fluid outlet and then flows into the first connector through the third pipe, and the second pipe, the interventional blood pump and the third pipe form a fluid circulation.

6. The method of claim 5, wherein, 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.

7. The method of claim 6, wherein, The multiple abnormal flushing conditions comprise 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.

8. The method of claim 6, wherein, 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 the following: 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.

9. The method of claim 6, wherein, 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 the following: 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.

10. The method of claim 6, wherein, 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.

11. The method of claim 6, wherein, The multiple abnormal flushing conditions comprise 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 that a bubble appears, 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.

12. The method of claim 2, 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.

13. The method of claim 12, wherein, The detectable position corresponding to the flushing channel includes: an extrusion part of the flushing pump; the pump extrusion state abnormality includes an extrusion part loosening state abnormality and / or an extrusion part loosening time length state abnormality.

14. The method of claim 13, wherein, 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; The long time is a preset time length or a time length identified based on a preset condition.

15. The method of claim 12, wherein, 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 temperature maintaining stable; a second pump extrusion state anomaly; the second pump extrusion state anomaly includes: 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: 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: the falling 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: 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: the falling 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: 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: 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: the falling 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.

16. The method according to claim 14 or 15, characterized in that, The fluid conveying pipeline includes a first pipe and a second pipe connected based on a first connector, the first pipe is used to connect 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.

17. An abnormality alarm device for a medical device, characterized by 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.

18. 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.

19. The system of claim 18, 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.

20. The system of claim 19, wherein, The interventional blood pump includes a fluid inlet and a fluid outlet, the second pipe being connected with the fluid inlet, and the third pipe being 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, and the fluid in the internal passage 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.

21. The system of claim 20, wherein, The detectable position corresponding to the flushing channel includes 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.

22. The system of claim 21, wherein, 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 the following: 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.

23. The system of claim 21, wherein, 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 the following: 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.

24. The system of claim 21, wherein, 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 for blocking the fluid flowing through the through hole, and the detectable position corresponding to the flushing channel of the interventional blood pump includes the driving catheter and the fluid blocking member.

25. The system of claim 21, wherein, 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.

26. The system of claim 19, wherein, 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 flushing pipeline in the flushing channel.

27. The system of claim 19, wherein, The system further includes: A temperature sensor arranged in the interventional blood pump. A driving shaft arranged in the interventional blood pump, the driving shaft being rotatably arranged in the interventional blood pump. The temperature sensor is used for detecting the temperature condition in the flushing channel, so as to determine the abnormal information in the flushing channel.

28. The system of any one of claims 18 to 27, wherein, The system further includes: A control assembly, which is used for executing the flushing system abnormality detection method for a medical device according to any one of claims 1 to 16.

29. A ventricular assist system, comprising: 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and 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 for coupling connection with the consumable, and the bubble sensor is clamped connection with a flushing pipeline in the consumable; The consumable includes a flushing pipeline and an interventional blood pump, and the interventional blood pump is provided with a fluid sensor; The flushing pipeline and the interventional blood pump are in communication to form a flushing channel; First detection information and second detection information in the flushing channel are detected based on the bubble sensor and the fluid sensor; and The ventricular assist system includes a control device and a consumable; The control device includes a driving 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.

30. The system of claim 29, 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.

31. A control device in a ventricular assist system, characterized by 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 16.

32. 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.

33. A computer-readable 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 16.

34. 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 16.

35. A chip, comprising: 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 16.

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