Control method and control apparatus for ventricular auxiliary apparatus and ventricular auxiliary apparatus

Abstract

A control method and control apparatus for a ventricular auxiliary apparatus and a ventricular auxiliary apparatus. The present invention pertains to the field of medical instruments. The ventricular auxiliary apparatus comprises a first component and is provided with a first control mode and a second control mode. The method comprises: acquiring a control operation for the first component, and controlling, in response to the control operation, the operation of the first component in a manner not restricted by constraints, wherein the constraints are constraints that apply when the first component operates in the second control mode. In the second control mode, the operation of the first component is restricted by the constraints, while in the first control mode, the operation of the first component is not restricted by the constraints. Compared to the second control mode, the first control mode masks the restriction of the operation parameters of the first component by the constraints, so that the degree of freedom of controlling the first component is improved, facilitating the adjustment and testing of the operation of the first component.

Description

Control methods, control devices, and ventricular assist devices

[0001] This application claims priority to Chinese Patent Application No. 202410674838.2, filed on May 28, 2024, entitled “Control Method, Control Device and Ventricular Assist Device”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical devices, and in particular to a control method, control device, and ventricular assist device for a ventricular assist device. Background Technology

[0003] Ventricular assist devices are technical equipment used in clinical medicine to assist the heart in performing its pumping function.

[0004] In related technologies, the operation of components in ventricular assist devices is subject to certain constraints. Taking transcatheter ventricular assist devices as an example, the operation of the interventional pump in a transcatheter ventricular assist device is constrained by certain conditions. For instance, the interventional pump needs to operate within a preset speed range to assist the heart in its pumping function; and the control panel needs to issue alarms under preset alarm conditions.

[0005] The above control methods are relatively fixed and cannot meet the special control requirements of some special application scenarios, such as testing scenarios and special clinical application scenarios. How to flexibly control the various components in the ventricular assist device is an urgent problem to be solved. Summary of the Invention

[0006] This application provides a control method, a control device, and a ventricular assist device, the technical solution of which is as follows:

[0007] According to one aspect of this application, a control method for a ventricular assist device is provided, the ventricular assist device including a first component, the ventricular assist device providing a first control mode and a second control mode, the method comprising:

[0008] Obtain control operations for the first component, wherein the control operations refer to operations associated with the first control mode;

[0009] In response to the control operation, the first component is controlled to operate in an unrestricted manner, the restriction being the restriction on the first component operating in the second control mode.

[0010] According to another aspect of this application, a control device for a ventricular assist device is provided, the ventricular assist device including a first component, the ventricular assist device providing a first control mode and a second control mode, the device comprising:

[0011] The acquisition module is used to acquire control operations for the first component, wherein the control operations refer to operations associated with the first control mode;

[0012] A control module is configured to control the operation of the first component in response to the control operation in a manner unconstrained by the constraints that are the constraints imposed on the first component when it is operating in the second control mode.

[0013] According to another aspect of this application, a ventricular assist device is provided, the ventricular assist device comprising: a first component, a processor, and a memory; the memory storing at least one instruction, at least one program, a code set, or an instruction set, wherein the at least one instruction, the at least one program, the code set, or the instruction set is loaded and executed by the processor to implement the control method of the ventricular assist device as described above.

[0014] According to another aspect of this application, a computer-readable storage medium is provided, wherein at least one instruction, at least one program, code set, or instruction set is stored therein, wherein the at least one instruction, the at least one program, the code set, or the instruction set is loaded and executed by a processor to implement the control method of the ventricular assist device as described above.

[0015] According to another aspect of this application, a computer program product is provided, the computer program product including computer instructions stored in a computer-readable storage medium, wherein a processor reads from the computer-readable storage medium and executes the computer instructions to implement the control method of the ventricular assist device as described above.

[0016] The beneficial effects of the technical solution provided in this application include at least the following:

[0017] In the second control mode provided by the ventricular assist device (VAP), the operation of the first component is constrained by limiting conditions. In the first control mode, however, the device can respond to control operations and control the operation of the first component in the VAP without these constraints. Compared to the second control mode, the first control mode shields the first component from these constraints, allowing for relatively independent and flexible control. This facilitates more autonomous and flexible control of the VAP in unconventional application scenarios by entering the first control mode, increasing the freedom and flexibility of controlling the first component and meeting the specific control needs of the VAP in special clinical or testing scenarios. Furthermore, the two control modes make it easier for users to distinguish the current control mode, ensuring that special control needs are met in the first control mode without affecting the effectiveness of the limiting conditions in the second control mode. This enhances the control flexibility of the VAP while maintaining its safety.

[0018] Especially in debugging and testing scenarios, equipment operators can directly operate the components in the ventricular assist device through the first control mode without having to modify the program code of the ventricular assist device through the host computer, which reduces the operational complexity and testing efficiency of the ventricular assist device. Attached Figure Description

[0019] Figure 1 is a schematic diagram of a transcatheter ventricular assist device provided in an exemplary embodiment of this application;

[0020] Figure 2 is a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application;

[0021] Figure 3 is a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application;

[0022] Figure 4 is a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application;

[0023] Figure 5 is a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application;

[0024] Figure 6 is a schematic diagram of a settings interface provided in an exemplary embodiment of this application;

[0025] Figure 7 is a schematic diagram of a debugging interface provided in an exemplary embodiment of this application;

[0026] Figure 8 is a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application;

[0027] Figure 9 is a structural block diagram of the control device of a ventricular assist device provided in an exemplary embodiment of this application;

[0028] Figure 10 is a structural block diagram of a ventricular assist device provided in an exemplary embodiment of this application.

[0029] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in further detail below with reference to the accompanying drawings.

[0031] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0032] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0033] It should be understood that although the terms first, second, etc., may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, a first parameter may also be referred to as a second parameter, and similarly, a second parameter may also be referred to as a first parameter. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0034] Figure 1 shows a schematic diagram of a ventricular assist device provided in an exemplary embodiment of this application. The ventricular assist device is a transcatheter ventricular assist device, comprising at least a control device 130, an interventional pump 120, a flushing assembly, and a flushing tubing 110. The control device 130 includes at least a console 131 and a drive motor 132. The flushing assembly includes an infusion pump 151 and a circulation pump 152, which can be collectively referred to as the flushing pump. Clinical medical personnel can monitor the system status and patient physiological parameters on the control host interface, and provide different levels of ventricular assist by adjusting the rotation speed of the interventional pump 120 according to the patient's needs, thereby temporarily maintaining blood circulation to the patient's vital organs and relieving the burden on the heart.

[0035] The interventional pump system includes an interventional pump 120. The interventional pump 120 includes a pump head 123 (containing an impeller, a support, and a diaphragm), a drive catheter 122, a drive catheter handle 121 (containing a drive catheter locking connector), a flushing pressure sensor, and a drive catheter handle flushing tubing connector. The interventional pump 120 can be percutaneously inserted into the heart via a peripheral blood vessel. The pump head 123 is inserted into the heart, with its blood inlet in the left ventricle and its blood outlet in the ascending aorta. A drive motor 132 can be connected to the interventional pump to drive the impeller in the pump head 123 to rotate, thereby pumping blood from the left ventricle into the ascending aorta to achieve ventricular assist function.

[0036] The flushing line 110 includes at least an infusion line, a connecting structure, a circulation inlet pipe, and a circulation outlet pipe, wherein the infusion line is connected to the liquid storage device 140, and the circulation inlet pipe and circulation outlet pipe are respectively connected to the drive catheter handle 121 of the interventional pump 120.

[0037] The infusion pump 151 and the circulation pump 152 can be connected to the flushing tubing 110. The infusion pump 151 delivers and controls the flushing fluid by squeezing the flushing tubing, thereby preventing blood from entering the drive catheter 122 of the interventional pump and causing thrombus formation.

[0038] Specifically, the infusion pump 151 can drive the flushing pump tube on the infusion line, which can pump the flushing fluid in the storage device 140 connected to the infusion line into the cavity inside the interventional pump through the flushing tube 110, thereby preventing blood from entering the interventional pump drive catheter 122.

[0039] The circulation pump 152 can be connected to at least one of the circulation inlet pipe and circulation outlet pipe, thereby driving the flushing fluid to form a flushing fluid circulation between the intervention pump 120 and the flushing line 110 to cool the rotor inside the drive catheter handle.

[0040] The above is an introduction to a transcatheter ventricular assist device. However, it should be noted that the technical solution provided in this application is not limited to transcatheter ventricular assist devices, but can also be applied to various types of ventricular assist devices such as external ventricular assist devices, implantable ventricular assist devices, long-term ventricular assist devices, medium-term ventricular assist devices, and short-term ventricular assist devices. The control modes that the ventricular assist device can provide are introduced below.

[0041] The ventricular assist device of this application provides a first control mode and a second control mode. Exemplarily, the first control mode is a special control mode, debugging mode, or maintenance mode of the ventricular assist device, and the second control mode is a regular control mode or ordinary use mode of the ventricular assist device. In the first control mode, the operating parameters of the ventricular assist device are not constrained by any limiting conditions. The special control mode can correspond to the regular control mode, and the debugging mode or maintenance mode can correspond to the use mode. The distinction between the first control mode and the second control mode can be made according to the actual application scenario, and this application embodiment does not limit this distinction.

[0042] In the first control mode, the operating parameters of the transcatheter ventricular assist device are not subject to restrictions. In the second control mode, the operating parameters of the ventricular assist device are subject to restrictions.

[0043] In some embodiments, the limiting condition is used to indicate the limited range of the target working state that can be achieved when the first component is running. Specifically, it may be the range of parameters in some working states, such as the rotational speed in the running state, the adjustment step size in the speed adjustment state, etc. The limited range may be a subset of all possible working states of the first component.

[0044] In some embodiments, the limiting condition is used to indicate the conditions under which the target operating state corresponding to the control operation can be achieved. When the ventricular assist device is in the second control mode and the limiting condition is met, the target operating state indicated by the control operation can be achieved in response to the control operation. Conversely, when the ventricular assist device is in the second control mode and the limiting condition is not met, the target operating state indicated by the control operation cannot be achieved.

[0045] For example, the constraints include at least one of parameter constraints and dependency constraints. Wherein:

[0046] The parameter constraints are restrictions on the operating parameters of the first component in the ventricular assist device; the dependency constraints are restrictions on the interrelationship between the first and second components in the ventricular assist device.

[0047] The parameter constraints and dependency constraints will be further described separately in the following examples.

[0048] Figure 2 illustrates a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application. The method is applied to a ventricular assist device. Specifically, it can be applied to a control device within a ventricular assist device. The method includes:

[0049] Step 410: Obtain control operations for the first component;

[0050] The first component is a component of a ventricular assist device, which is used to assist the heart in performing its pumping function. The first component includes at least one of the following: a control host, a display screen, a speaker (such as a horn), an external blood pump (such as a centrifugal pump), an interventional pump 120, a flushing pump, a drive motor, a sensor, a valve, etc.

[0051] The flushing pump may include the aforementioned infusion pump 151 and circulation pump 152, and the aforementioned first component may also be one of the infusion pump 151 and circulation pump 152. The aforementioned drive motor 132 includes a motor for driving at least one of the aforementioned interventional pump 120, flushing pump, and other pump bodies. The aforementioned sensors include, but are not limited to, temperature sensors, flushing pressure sensors, and blood pressure sensors.

[0052] For example, the first component described above may be a component that operates electrically, or it may be referred to as a first electronic component.

[0053] The control operation in step 410 specifically refers to the operation associated with the first control mode. In some embodiments, the control operation may be used to instruct changes to the operating parameters of the first component, and the control operation includes at least one of the following:

[0054] • The control operation is used to indicate changes to the operating parameters of the first component for continuous use over a period of time. For example, the first component includes at least one pump body such as a centrifugal pump, a quenching pump, or a flushing pump, and the control operation is used to indicate changes to at least one of the fluid control parameters such as the pump body's rotational speed, the flow rate of the liquid pumped by the pump body, and the liquid pressure that the pump body needs to maintain; the first component includes a drive motor 132 corresponding to the aforementioned pump body, and the control operation is used to indicate changes to at least one of the motor control parameters such as the drive motor 132's rotational speed and current; the first component includes a screen, and the control operation is used to indicate changes to at least one of the user interface parameters such as the screen's display brightness parameter, operable state, locked state, or display status parameter of the interface components; the first component includes a speaker, and the control operation is used to indicate changes to at least one of the speaker's volume parameter, sound source parameter, or other audio parameters.

[0055] • Control operations are used to indicate changes in the start / stop status of the first component. For example, if the first component includes a drive motor 132, the control operations are used to indicate starting or stopping the drive motor 132; if the first component includes a sensor, the control operations are used to indicate starting or stopping the sensor from sampling data.

[0056] In some embodiments, a control operation refers to an operation associated with a first control mode provided by the ventricular assist device. In one example, the control operation is an operation received by the ventricular assist device while it is in the first control mode. In another example, the control operation is also used to instruct the ventricular assist device to switch its control mode to the first control mode. Specifically, in response to receiving a control operation, the ventricular assist device changes from a second control mode to the first control mode. In yet another example, the control operation is also used to instruct the transcatheter ventricular assist device to switch its control mode to the first control mode and control the operation of a first component. For example, in response to receiving a control operation (such as receiving an interventional pump start operation on the control interface corresponding to the first control mode), the transcatheter ventricular assist device changes from a second control mode to the first control mode and controls the operation of a first component (such as entering a commissioning control mode and starting the interventional pump).

[0057] For example, the control operations can be implemented in ways including but not limited to pressing, clicking, sliding, and rotating; such as pressing a physical button, clicking a touchscreen, sliding a touchscreen, and rotating a physical knob.

[0058] Step 420: In response to a control operation, control the operation of the first component in a manner unconstrained by any restrictions;

[0059] In the second control mode, due to the constraints, the first component can only achieve the target operating state and / or operating parameter range allowed by the constraints. However, in the first control mode, the operation of the first component is not constrained by the constraints. Regardless of whether the operating parameters indicated by the control operation exceed the constraints, it is not subject to the constraints of the second control mode, and the operation of the first component can be controlled according to the operating parameters indicated by the control operation.

[0060] It can be seen that the operation mode of the first component based on the control operation can exceed the limitations of the second control mode, or it can meet the limitations of the second control mode.

[0061] In summary, the method provided in this embodiment, under the second control mode of the ventricular assist device, the operation of the first component is constrained by limiting conditions. However, in the first control mode, the device can respond to control operations and control the operation of the first component in the ventricular assist device in an unconstrained manner. Compared to the second control mode, the first control mode shields the first component from the constraints imposed by limiting conditions, thereby enabling relatively independent and flexible control of the first component in the ventricular assist device. This facilitates more autonomous and flexible control of the ventricular assist device in unconventional application scenarios by entering the first control mode, improving the freedom and flexibility of controlling the operation of the first component in the ventricular assist device and meeting the special control needs of the ventricular assist device in special clinical or debugging / testing scenarios. Furthermore, the two control modes make it easier for users to distinguish the current control mode of the device, ensuring that special control needs are met in the first control mode without affecting the effectiveness of the limiting conditions in the second control mode. This improves the control flexibility of the ventricular assist device while also ensuring its safety.

[0062] Parameter constraints;

[0063] Figure 3 shows a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application. This method is applied to a ventricular assist device. Specifically, in the embodiment shown in Figure 2, step 420 can be implemented as step 422:

[0064] Step 422: In response to the control operation, control the operation of the first component in a control mode that exceeds the parameter limits;

[0065] In this embodiment, the limiting conditions include parameter limiting conditions for the operating parameters of the first component.

[0066] The control method that exceeds the parameter limit is the control method that the first component cannot be set under the parameter limit in the second control mode.

[0067] In response to the control operation that controls the operation of the first component, the system achieves control of the first component's operation beyond the constraints of parameter limitations, thereby freeing it from those limitations. This provides the first component with a control method that cannot be set under the parameter limitations of the second control mode. Compared to the second control mode, the control operation can control the operation of the first component outside the restricted range indicated by the parameter limitations, facilitating the debugging of the first component's operation.

[0068] Furthermore, there are at least four types of parameter constraints, which include at least one of the following: the allowed range of operating parameters; the allowed adjustment step size when modifying operating parameters; the first effective duration of operating parameters in the second control mode; and the preconditions that must be met when operating in the second control mode. Each type is described below.

[0069] For type one parameter restrictions: the allowed range of operating parameters; the operating parameter range is used to limit the working range of the operating parameters of the first component.

[0070] Under the constraints of type one parameter limitations (such as in the second control mode), the operating parameters of the first component cannot exceed the operating parameter range.

[0071] The operating parameter range includes the parameter range corresponding to at least one operating parameter. At least one operating parameter can be at least one of the following parameters:

[0072] Display parameters such as screen brightness, contrast ratio, and sharpness;

[0073] The interface state parameters, such as the operable state and the locked state, are corresponding to the interface.

[0074] Fluid control parameters such as start / stop status, speed, flow rate, and fluid pressure for pumps such as centrifugal pumps, intervention pumps, and flushing pumps;

[0075] The motor control parameters corresponding to the start / stop status, speed, current, voltage, etc. of the motor driving the pump body;

[0076] Sensor parameters such as information sampling rate and sampling accuracy corresponding to sensor components;

[0077] Audio parameters such as speaker volume and sound source parameters.

[0078] For example, the operating parameter range includes the speed range corresponding to the pump body speed.

[0079] In the first control mode, in response to a control operation, the first component is controlled to operate in a manner unconstrained by the parameter limitations of type one. Regardless of whether the operating parameters indicated by the control operation exceed the range of operating parameters included in the parameter limitations, it is not constrained by the parameter limitations of the second control mode, thus enabling the operation of the first component to be controlled by the operating parameters indicated by the control operation. Furthermore, in a control method exceeding the range of operating parameters, the operating parameters of the first component are indicated, and the first component is controlled to operate with operating parameters exceeding the range of operating parameters.

[0080] In an optional example, the first component includes a blood pump and / or flushing pump in a ventricular assist device, such as an interventional pump and / or flushing pump in a transcatheter ventricular assist device. Exemplarily, a ventricular assist device including an interventional pump and / or flushing pump can be implemented as a transcatheter ventricular assist device; the operating parameter range in the parameter limiting conditions includes at least one of the following: the rotational speed range, flow rate range, and pump body maintaining pressure range of the blood pump and / or flushing pump. For example, the operating parameter range includes the rotational speed range of the blood pump and / or flushing pump. Accordingly, step 422 above can be implemented as sub-step one:

[0081] Sub-step 1: In response to the speed setting operation, control the operation of the blood pump and / or flushing pump at a set speed that is not within the speed range;

[0082] In this embodiment, the control operation includes a speed setting operation, and the operating parameters indicated by the speed setting operation include, but are not limited to, setting the speed.

[0083] In the first control mode, the set speed indicated by the speed setting operation is not constrained by the parameter limitation condition—the speed range—as in the second control mode. Regardless of whether the set speed exceeds the speed range, the first control mode is not constrained by parameter limitations, enabling the operation of the blood pump and / or flushing pump to be controlled by the set speed.

[0084] In the second control mode, the rotational speed of the interventional pump and / or flushing pump can only be set to a value within the specified range. In the first control mode, however, there is no constraint from the rotational speed range, allowing control of the blood pump and / or flushing pump operation based on the rotational speed setting instruction. Furthermore, it is possible to control the operation of the interventional pump and / or flushing pump at a set rotational speed exceeding the specified range, thus expanding the settable rotational speed range of the blood pump and / or flushing pump and increasing the flexibility of controlling the blood pump and / or flushing pump in the ventricular assist device in terms of rotational speed setting.

[0085] Taking the flushing pump as an example, in the first control mode, the speed of the flushing pump in the ventricular assist device can be adjusted. The speed setting operation includes adjusting the speed of the flushing pump control control on the function entry (such as the debugging interface) corresponding to the first control mode.

[0086] In one possible implementation, to meet clinical needs and considering the ease of use and safety of the ventricular assist device, the parameter constraints in the second control mode limit the flushing pump's rotational speed to a preset speed, thereby restricting the flow rate and preventing arbitrary changes. In other words, the allowed rotational speed range (i.e., flow rate range) for the flushing pump in the second control mode is a preset value. In the first control mode, the flushing pump's rotational speed, as indicated by the speed setting operation, may not fall within the aforementioned range. The device can operate at a speed exceeding this set range, allowing for flexible adjustment of the flushing pump's speed to achieve speeds that cannot be set in the second control mode. This satisfies the special flushing flow requirements of the ventricular assist device in commissioning and clinical use scenarios, such as the need for pressure relief in the flushing tubing during clinical use and pressure testing of the flushing tubing during commissioning. For pressure relief in the flushing tubing, the fluid pressure can be reduced by decreasing the flushing pump's speed; in commissioning testing scenarios, the tubing pressure resistance test can be conducted by increasing the flushing pump's speed.

[0087] In some examples, the number of flushing pumps is at least two, as illustrated in Figure 1, where the flushing pumps include an infusion pump 151 and a circulation pump 152. In the second control mode, each flushing pump can rotate at a preset speed, and the flow rates of at least two of the flushing pumps may be correlated. For example, infusion pump 151 rotates at a speed corresponding to flow rate 'a', and circulation pump 152 rotates at a speed corresponding to flow rate 'b', with a correlation between 'a' and 'b'. In the first control mode, the speed setting operation in sub-step one above can be used to individually set the speed of some flushing pumps, such as individually setting the speed of infusion pump 151 or circulation pump 152.

[0088] Taking the transcatheter ventricular assist device shown in Figure 1 as an example, in the first control mode, the speed setting operation for the infusion pump 151 can be controlled by a first set speed. This first set speed is not within the speed range of the infusion pump 151 in the second control mode, allowing the infusion pump 151 to reach a speed that cannot be set in the second control mode. Similarly, in the first control mode, the speed setting operation for the circulation pump 152 is controlled by a second set speed. This second set speed is not within the speed range of the circulation pump 152 in the second control mode, allowing the circulation pump 152 to reach a speed that cannot be set in the second control mode. For flushing pumps including both the infusion pump 151 and the circulation pump 152, where their speeds are related, the speed of either the infusion pump 151 or the circulation pump 152 can also be set individually in the first control mode.

[0089] For type two parameter constraints: the allowed adjustment step size when modifying running parameters;

[0090] In the second control mode, the modification of operating parameters is subject to the parameter restriction conditions of type two. When modifying the operating parameters of the first component, the adjustment step size shall not exceed the above-mentioned allowable adjustment step size.

[0091] The aforementioned adjustment step size can be a range of one or more candidate adjustment step sizes. Taking the adjustment step size as an example of the permissible speed adjustment step size when modifying the pump's rotational speed, a candidate speed adjustment step size could be 1000 revolutions per second (RPM), indicating that the speed adjustment is performed in 1000 RPM steps when modifying the pump's rotational speed. In different examples, the adjustment step size can also include the step size when modifying other types of operating parameters. For example, the adjustment step size could also be the permissible numerical interval for a single modification when modifying operating parameters such as the liquid flow rate of the infusion device or the information sampling rate of the sensor component.

[0092] In the first control mode, in response to a control operation, the device can control the operation of the first component in a manner unconstrained by the parameter limitations of Type 2. Regardless of whether the adjustment step size indicated by the control operation modifies the operating parameters exceeds the allowable adjustment step size in the second control mode, it is not bound by these limitations, and can achieve modification of the relevant operating parameters with the adjustment step size indicated by the control operation, thereby controlling the operation of the first component. Furthermore, in the first control mode, the device can modify the operating parameters of the first component with an adjustment step size not permitted in the second control mode, using a control method exceeding the allowable adjustment step size.

[0093] In an optional example, the first component includes a blood pump and / or flushing pump in the ventricular assist device. For example, a ventricular assist device including an interventional pump and / or flushing pump can be implemented as a transcatheter ventricular assist device; the adjustment step size in the parameter constraints includes candidate adjustment step sizes corresponding to the blood pump and / or flushing pump in the second control mode; correspondingly, step 422 above can be implemented as sub-step two:

[0094] Sub-step 2: In response to the speed adjustment operation, change the speed of the blood pump and / or flushing pump by adjusting the first speed step size, which is not among the candidate adjustment step sizes;

[0095] In this embodiment, the control operation includes a speed adjustment operation, which is used to change the speed of the blood pump and / or the flushing pump.

[0096] In the second control mode, the speed of the blood pump and / or flushing pump can only be changed with candidate adjustment step sizes. However, in the first control mode, when modifying the speed of the blood pump and / or flushing pump through speed adjustment operations, it is not constrained by the candidate adjustment step sizes allowed in the second control mode. Regardless of whether the speed adjustment operation modifies the speed in a manner belonging to the candidate adjustment step size, the device can adjust the speed of the blood pump and / or flushing pump with the speed adjustment step size indicated by the speed adjustment operation, i.e., changing the speed of the blood pump and / or flushing pump with the first speed adjustment step size. In the first control mode, the device can change the speed of the blood pump and / or flushing pump with more diverse adjustment step sizes, expanding the speed adjustment step size range and speed adjustment accuracy of the blood pump and / or flushing pump. It can change the speed with larger adjustment step sizes to improve speed adjustment efficiency, and it can change the speed with smaller adjustment step sizes to improve speed adjustment accuracy, thus increasing the flexibility of controlling the speed adjustment range of the blood pump and / or flushing pump in the ventricular assist device.

[0097] Taking the interventional pump as an example, in the second control mode, the candidate adjustment step size in the parameter constraints for the interventional pump's rotational speed is 1000 revolutions per second. This parameter constraint indicates that the interventional pump's rotational speed is modified in 1000-revolution steps, such as increasing or decreasing the speed by 1000 revolutions for each unit rotation of the knob. In the first control mode, in response to the speed adjustment operation, the device can modify the interventional pump's rotational speed in a first speed adjustment step size, such as 500 revolutions. This allows for observation of abnormal speed operation states that are not permitted in the second control mode, and enables control over the speed adjustment rate as needed. Alternatively, in the first control mode, a target value for the interventional pump's operation can be directly set. The device can then directly use the difference between this target value and the current speed value as the first speed adjustment step size to modify the interventional pump's rotational speed, without needing to adjust the speed multiple times according to the candidate adjustment step size in the second control mode.

[0098] In the first control mode, the candidate adjustment step size in the second control mode can be exceeded, and the operating rate of the interventional pump and / or flushing pump can be changed with a speed adjustment step size that cannot be achieved in the second control mode. This improves the flexibility of speed adjustment of the interventional pump and / or flushing pump in the transcatheter ventricular assist device, and facilitates the commissioning of the pump at unconventional speeds. This meets the needs of transcatheter ventricular assist devices in special clinical scenarios or commissioning scenarios, where the pump needs to operate at unconventional speeds other than the second control mode.

[0099] For type three parameter constraints: the first effective duration of the operating parameters in the second control mode;

[0100] In the second control mode, the effective duration of the operating parameters is constrained by the parameter restriction conditions of type three, and the effective duration of the operating parameters is maintained at the first effective duration or cannot exceed the first effective duration.

[0101] Optionally, the operating parameters can be operating parameters with duration conditions. The first effective duration can be the duration of the operating parameters of the first component, or the effective duration of the operating parameters. For example, it can be at least one of the following durations: the duration of controlling the ventricular assist device to be in a silent state (which can be understood from the opposite perspective as the effective duration of the non-silent state), the duration of controlling the pump rotation, etc. Furthermore, regarding the parameter constraints of type three, the ventricular assist device can be specifically implemented as a transcatheter ventricular assist device.

[0102] In the first control mode, regardless of whether the effective duration of the operating parameters indicated by the control operation exceeds the first effective duration, it is not subject to the parameter limitation conditions in the second control mode, and can achieve the setting of the operating parameters of the first component based on the effective duration of the control operation indication.

[0103] Furthermore, in the first control mode, the validity duration of the operating parameters indicated by the control operation exceeds the parameter limit conditions. In one example, in the first control mode, the operating parameters indicated by the control operation have no validity duration (the default operating parameters continue indefinitely), or the second validity duration of the operating parameters indicated by the control operation is different from the first validity duration indicated by the parameter limit conditions.

[0104] In an optional example, the first valid duration includes the maximum alarm silence duration. Accordingly, step 422 above is followed by sub-step three:

[0105] Sub-step 3: In response to the ventricular assist device switching to the first control mode, control the ventricular assist device to be in a silent state in a manner that exceeds the maximum alarm silence duration;

[0106] The maximum alarm silence duration in the second control mode is the maximum duration that the ventricular assist device can maintain in silence, starting from the time it is set to the silence state. In the second control mode, if an alarm event occurs during the silence period, the alarm can be reactivated.

[0107] In the first control mode, the duration of the silent state is not constrained by the maximum alarm silence duration in the second control mode. The ventricular assist device can exceed the maximum alarm silence duration, remaining silent for a longer period or continuously. Optionally, in the first control mode, the silent state is maintained according to the silence duration in the first control mode and will not be interrupted by new alarms occurring during the silent state.

[0108] In some examples, considering the safety of the ventricular assist device, the maximum alarm silence duration in the second control mode is 60 seconds. In response to any operation that switches the control mode to the first control mode, the controller can either keep the ventricular assist device silent for a period exceeding 60 seconds, or remain silent throughout the first control mode.

[0109] In the first control mode, the ventricular assist device (VAD) is kept silent for a longer period, such as continuously. This meets the needs of debugging, maintenance, and testing scenarios (e.g., testing the blood pump and / or flushing pump) and / or special clinical applications (where alarms generate undesirable noise interference) where the VAD requires a longer period of silence. This avoids interference caused by the VAD automatically resuming its alarm sound after the maximum alarm silence duration has been reached. Compared to the second control mode, the first control mode is no longer constrained by the maximum alarm silence duration and does not require the VAD to be silenced again after the maximum alarm silence duration has been exceeded.

[0110] For type four parameter constraints: Prerequisite constraints that must be met when operating in the second control mode;

[0111] In the second control mode, when the operation of the first component or the entire ventricular assist device is constrained by parameter limitations (such as in the second control mode), the operation of the first component must meet the pre-existing limitations.

[0112] The preconditions can be preconditions for the first component to operate in the second control mode, or preconditions for the entire ventricular assist device to operate in the second control mode. Furthermore, regarding the parameter constraints of type four, the ventricular assist device can be specifically implemented as a transcatheter ventricular assist device.

[0113] In the second control mode, if the operating conditions of the ventricular assist device do not meet the preconditions, even if a control operation instructing the first component to operate according to the operating parameters is received, the first component will not be able to operate according to the operating parameters indicated by the control operation.

[0114] In the first control mode, regardless of whether the ventricular assist device's operating conditions meet the pre-existing limitations, it is not constrained by the pre-existing limitations and can control the operation of the first component with the operating parameters indicated by the control operation. Specifically, in the first control mode, even if the ventricular assist device does not meet the pre-existing limitations, it can still exceed the constraints of the pre-existing limitations and control the first component to operate with the operating parameters indicated by the control operation.

[0115] In one optional example, the aforementioned preconditions include operational condition constraints for the transcatheter ventricular assist device. These operational condition constraints include restrictions on the operational status of at least one component.

[0116] In an optional example, the preconditions include the operating temperature range and / or operating humidity range of the ventricular assist device; correspondingly, step 422 above can be implemented as sub-step four:

[0117] Sub-step four: In response to parameter setting operations, control the operation of the first component when the operating temperature and / or operating humidity ranges are exceeded;

[0118] In this embodiment, the control operation includes parameter setting operation. The operating parameters indicated by the parameter setting operation include at least one of the following: screen display brightness, pump speed, infusion device liquid flow rate, sensor component information sampling rate, speaker volume, pump start / stop status, motor start / stop status, etc.

[0119] In the first control mode, the parameter setting operation controls the operation of the first component without being constrained by the operating temperature range and / or operating humidity range. Regardless of whether the operating environment detected by the ventricular assist device or the operating temperature or humidity of the first electronic component meets the operating temperature range and / or operating humidity range, the operation of the first component can be controlled by parameter setting.

[0120] Compared to the second control mode, the operation of the first component in the first control mode is not constrained by the operating temperature range and / or operating humidity range, which meets the needs of observing the operation of the ventricular assist device in extreme temperature and / or humidity environments during commissioning and testing scenarios, such as the need to test the continuous high-temperature operation of the drive motor.

[0121] Furthermore, it is possible to control the operation of the first component even when it exceeds the operating temperature and / or operating humidity range. Specifically, this can include at least the following situations:

[0122] • Scenario 1: The ambient temperature of the ventricular assist device exceeds its operating temperature range;

[0123] In scenario one, the operating temperature range is the ambient temperature at which the ventricular assist device is suitable for operation.

[0124] Excessively high or low ambient temperatures may cause ventricular assist devices (VADs) to malfunction. In the second control mode, for safety reasons, the operation of the VAD may be limited in excessively high or low ambient temperatures. However, in the first control mode, the VAD can continue to operate even in excessively high or low ambient temperatures. This allows for observation of the VAD's operation in high-temperature or low-temperature environments, facilitating the recording of potential operational risks in these conditions, such as meeting the control requirements of high-temperature aging tests in testing scenarios.

[0125] • Scenario 2: The temperature of the ventricular assist device exceeds its operating temperature range;

[0126] In scenario two, the operating temperature range is the equipment temperature at which the ventricular assist device is suitable for operation.

[0127] When the ventricular assist device (VAP) operates continuously at extremely high power, related components may overheat, exceeding the device's operating temperature range. In the second control mode, for safety reasons, the VAP can automatically limit its operation to protect itself. In the first control mode, even if the device temperature exceeds the operating temperature range, the pump within the VAP can be controlled to maintain high-speed operation. This allows for observation of the VAP's operation under high-speed load conditions, facilitating the recording of potential operational risks and meeting the testing requirements for the motor's high-temperature resistance in various scenarios.

[0128] • Scenario 3: The ambient humidity of the ventricular assist device exceeds the operating humidity range;

[0129] In scenario three, the operating humidity range is the ambient humidity suitable for the ventricular assist device to operate.

[0130] Excessive humidity may cause short circuits in the power supply components of the ventricular assist device (VAP), while excessively low humidity may cause electrostatic discharge (ESD) problems. In the second control mode, for safety reasons, the VAP can automatically limit its operation in excessively high or low humidity conditions. In the first control mode, the VAP can continue operating even in excessively high or low humidity environments. This allows for observation of the VAP's operation in both humid and dry environments, facilitating the recording of potential operational risks in these conditions.

[0131] Dependency constraints;

[0132] Figure 4 shows a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application. The method is applied to a ventricular assist device. Specifically, in the embodiment shown in Figure 2, step 420 can be implemented as step 520:

[0133] Step 520: In response to the control operation, control the operation of the first component in a control manner that exceeds the dependency constraints;

[0134] In this embodiment, the ventricular assist device further includes a second component, which is a different component from the first component. Similar to the first component, the second component may be a component that operates electrically or magnetically, and may also be referred to as a second electronic component.

[0135] In this embodiment, the limiting conditions include the dependency limiting conditions between the first component and the second component; when the ventricular assist device is in the second control mode, if the dependency limiting conditions between the first component and the second component are met, the control operation can achieve the corresponding control target; otherwise, the control target cannot be achieved. However, in the first control mode, such dependency limiting conditions can be removed or partially removed, and even if the dependency limiting conditions between the first component and the second component are not met, the control operation can still achieve the corresponding control target.

[0136] Furthermore, the dependency constraint between the first component and the second component can be that the operating parameters of the first component depend on the operating parameters of the second component for related changes, or that the operation of the second component depends on the operation of the first component for related changes.

[0137] In this embodiment, under the first control mode, regardless of whether the changed operating parameters of the first component and the operating parameters maintained by the second component satisfy the dependency constraint conditions, it is not constrained by the dependency constraint conditions and can achieve the control objective of the control operation and control the operation of the first component with the operating parameters corresponding to the control operation.

[0138] Optionally, in the first control mode, the operating parameters of the first component indicated by the control operation are operating parameters that are prohibited from being achieved under the constraints of the dependency limitations of the second control mode.

[0139] Compared to the second control mode, the first component is no longer limited by dependency constraints in the first control mode. It can control the operation of the first component in a way that exceeds the dependency constraints, and can perform independent control of the first component without constraints, which facilitates the debugging of the operating status of the first component.

[0140] Furthermore, dependency constraints include at least two types: operational state dependencies and mechanical connection dependencies, which will be introduced one by one below. That is, dependency constraints include at least: operational state constraints between the first component and the second component; and connection state constraints between the first component and the second component.

[0141] In one type, the dependency constraint is the dependency relationship of the running state, and the running start and stop states of the first component and the running start and stop states of the second component are related to each other.

[0142] In the second control mode, the control objective corresponding to the control operation is constrained by the dependency relationship of the operating state; the control objective that the control operation can achieve satisfies the dependency relationship of the operating states between the first component and the second component.

[0143] In an optional example, the dependency constraints include operational state constraints between the first component and the second component, where the first component includes a blood pump and the second component includes a flushing pump; the operational state constraints include: prohibiting the blood pump from being started when the flushing pump is in a non-operating state. For example, a ventricular assist device including an interventional pump and / or a flushing pump can be implemented as a transcatheter ventricular assist device; correspondingly, step 520 above can be implemented as sub-step five:

[0144] Sub-step 5: In response to the blood pump activation operation, start the interventional pump if the flushing pump is not in operation;

[0145] In this embodiment, the blood pump start operation is a trigger operation on the blood pump start function entry in the first control mode. The blood pump start function entry can be at least one of a physical knob, a physical button, or a control on the touch screen. Optionally, in the first control mode, the blood pump start operation includes triggering a control on the touch screen, and the blood pump start function entry is a function entry in the debugging interface displayed on the touch screen. The debugging interface corresponding to the first control mode will be described below through a separate embodiment.

[0146] In the second control mode, the operational dependencies between the interventional pump and the flushing pump include: the activation of the interventional pump depends on the flushing pump being activated; the blood pump must not be activated when the flushing pump is not in operation. This operational dependency constrains the sequential activation order between the flushing pump and the blood pump. Taking a transcatheter ventricular assist device (TAVED) as an example, the interventional pump is an interventional pump inserted into the human body; therefore, it needs to be pre-charged before use to ensure that the flushing fluid fills the internal gaps of the interventional pump, preventing air from entering the target body and preventing blood backflow and thrombus formation through the gaps. Specifically, the flushing pump can drive the flushing fluid to pre-charge the interventional pump; only after pre-charging can the interventional pump be activated to enter the working state, preventing errors in the operational sequence.

[0147] Therefore, when the ventricular assist device is in the second control mode, the working status of the flushing pump is checked in response to the activation operation of the blood pump;

[0148] If the flushing pump is in operation, start the blood pump;

[0149] If the flushing pump is not in operation, restrict the activation of the blood pump and / or issue a warning message restricting the activation of the blood pump.

[0150] In the first control mode, the blood pump start-up operation can exceed the constraints of the operating state dependency, and can successfully start the blood pump even when the flushing pump is not in operation.

[0151] In the first control mode, the blood pump is independently controlled beyond the constraints of the operating state dependency. This allows the blood pump to be started when the flushing pump is not in operation, which facilitates the elimination of the influence of the flushing pump during aging tests of the blood pump; or, when the blood pump malfunctions and the cause of the malfunction is analyzed, the operating state of the blood pump can be adjusted separately; thus improving the flexibility of independently controlling the blood pump in the ventricular assist device.

[0152] In another type, the dependency is based on the mechanical connection between components, such as the mutual connection between the first component and the second component. The dependency constraints include the connection state constraints between the first component and the second component.

[0153] In the second control mode, the control objective corresponding to the control operation is constrained by the mechanical connection dependency; when the connection method between the first component and the second component satisfies the mechanical connection dependency, the control operation can achieve the corresponding control objective.

[0154] In an optional example, the first component includes a drive motor 132, and the second component includes a blood pump; the connection status restriction includes: prohibiting the drive motor 132 from being started when the drive motor 132 and the blood pump are not connected; exemplary, a ventricular assist device including an interventional pump 120 can be implemented as a transcatheter ventricular assist device; correspondingly, step 520 above can be implemented as sub-step six:

[0155] Sub-step six: In response to the blood pump start-up operation, start the drive motor 132 when the drive motor 132 and the blood pump are not connected;

[0156] In the second control mode, the dependency between the drive motor 132 and the blood pump is that the start of the drive motor 132 depends on the mechanical connection between the drive motor 132 and the blood pump. In the second control mode, the drive motor 132 can only start when the drive motor 132 and the blood pump are connected. If the drive motor 132 is detected to be disconnected from the blood pump, the start of the drive motor 132 is prohibited.

[0157] That is, when the ventricular assist device is in the second control mode, in response to the start operation of the blood pump, the connection status of the drive motor 132 and the blood pump is checked;

[0158] If the drive motor 132 and the blood pump are connected, start the drive motor 132;

[0159] If the drive motor 132 and the blood pump are in a disconnected state, restrict the start of the drive motor 132 and / or issue a prompt message restricting the start of the drive motor 132.

[0160] For example, taking a transcatheter ventricular assist device as an example, when the drive motor 132 and the interventional pump 120 are connected, the way to start the drive motor 132 to drive the interventional pump 120 to rotate is based on electromagnetic traction. However, this application does not exclude other ways in which the drive motor 132 drives the interventional pump 120 to rotate, such as by gear meshing, rigid connection of connecting rods, etc.

[0161] In the first control mode, beyond the constraints of mechanical connection dependence, it is possible to successfully start the drive motor 132 even when the drive motor 132 and the blood pump are not connected.

[0162] In the first control mode, the starting and working state of the drive motor 132 is independently controlled, exceeding the constraints of mechanical connection. This allows the drive motor 132 to be started even when it is not connected to the blood pump, facilitating independent control of the drive motor 132. This enables debugging and testing of the drive motor 132's working state, realizing a new control method for independently controlling the drive motor 132 in a ventricular assist device. It also facilitates testing the working condition of the drive motor 132, or checking the health status of the drive motor 132 before the interventional pump 120 is used in the human body, thus preventing the drive motor 132 from causing abnormal operation of the interventional pump 120 and harming the human body.

[0163] The function entry point for receiving control operations;

[0164] Figure 5 shows a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application. This method is applied to a ventricular assist device. Specifically, in the embodiment shown in Figure 2, step 410 can be implemented as steps 410a and 410b:

[0165] Step 410a: In response to the mode selection command, activate the function entry corresponding to the first control mode;

[0166] Function entry points are used to receive control operations, which are human-computer interaction operations performed on the function entry point. For example, function entry points include the following three types:

[0167] • The function entry point is the function control displayed on the screen; in response to the mode selection command, the function control is added to the display screen.

[0168] • The function entry point is the debugging interface displayed on the screen; in response to the mode selection command, the screen will jump to the debugging interface.

[0169] • Function entry is a physical button or physical knob; in response to mode selection command, the physical button or physical knob that is not in operation is activated.

[0170] In one example, the mode selection instruction includes triggering a maintenance mode control, which is displayed on the settings interface. Figure 6 shows a schematic diagram of a settings interface provided in an exemplary embodiment of this application. Taking a transcatheter ventricular assist device as an example, the settings interface 610 is used to display the function settings entry of the transcatheter ventricular assist device. The settings interface is the interface displayed when the settings bar menu 610a is selected. It can be understood that other function menus are also displayed on the settings interface, and in response to selecting other function menus, the user is redirected to the function interface corresponding to the function menu.

[0171] Specifically, the settings interface 610 can display four controls: Alarm Limits 612, Device Setup 614, Maintenance 616, and About 618.

[0172] The alarm limit control 612 is used to set the operating limit values ​​and sensor alarm limit values ​​of the components of the transcatheter ventricular assist device (TAVM), such as the upper limit of the rotational speed and temperature range of the interventional pump 120 of the TAVM. The device setting control 614 is used to set the device options of the TAVM, such as the brightness of the display screen. The control 618 provides attribute information of the TAVM, such as at least one of the following: device model, device identification, etc.

[0173] The maintenance mode control 616 provides a functional entry point for entering the first control mode, specifically, it provides a functional entry point for entering the debugging interface. In one example, in response to a trigger operation on the maintenance mode control 616, a password input control is displayed. After obtaining the correct password, the user is redirected to the debugging interface, thus activating the functional entry point corresponding to the first control mode. Trigger operations on the maintenance mode control 616 include, but are not limited to, any one of the following operations on the touchscreen: clicking, double-clicking, or long-pressing the maintenance mode control 616.

[0174] For example, Figure 7 shows a schematic diagram of a debugging interface 620 provided in an exemplary embodiment of this application. The debugging interface 620 is the display interface corresponding to the debugging label 620a. The debugging interface 620 displays the function entry of the activated first control mode and the function entry of one or more components in the transcatheter ventricular assist device. This embodiment describes the debugging interface 620 displaying the function entry of the flushing pump and interventional pump 120 of the transcatheter ventricular assist device as an example. The debugging interface 620 includes a first display area 622 and a second display area 624. The first display area 622 is used to display the controls corresponding to the manual control of the interventional pump 120, and the second display area 624 is used to display the controls corresponding to the manual control of the flushing pump.

[0175] Step 410b: Receive control operations based on the function entry point;

[0176] Optionally, the kinetic energy input of the first control mode and the functional input of the second control mode can be the same or different. By distinguishing the functional inputs of the two modes, it helps to prevent accidental operation and can indicate to the user which mode the control operation is performed in.

[0177] The system receives control operations based on at least one of the following actions on the function entry point: clicking, pressing, sliding, rotating, etc.

[0178] In one example, the control operation includes starting the interventional pump 120. When the function entry is a function control displayed on the screen, as shown in Figure 7, the starting operation of the interventional pump 120 is a trigger operation of the start control 622a in the first display area 622. When the function entry is a physical button, the starting operation of the interventional pump 120 is a pressing or rotating operation of the physical button that has the interventional pump 120 starting function.

[0179] In one example, the control operation includes adjusting the rotational speed of the interventional pump 120 and / or the flushing pump. When the function entry is a function control displayed on the screen, taking the adjustment of the rotational speed of the interventional pump 120 as an example, as shown in Figure 7, increasing the rotational speed of the interventional pump 120 includes triggering the speed increase control 622b in the first display area 622; decreasing the rotational speed of the interventional pump 120 includes triggering the speed decrease control 622c in the first display area 622. When the function entry is a physical knob, increasing the rotational speed of the interventional pump 120 includes turning the physical knob clockwise; decreasing the rotational speed of the interventional pump 120 includes turning the physical knob counterclockwise. Optionally, in the first control mode, the rotational speed of the interventional pump 120 can be adjusted via a physical knob; in the second control mode, the rotational speed of the interventional pump 120 is controlled via speed control controls in the first display area 622, such as the speed increase control 622b and the speed decrease control 622c, thereby distinguishing the control function entry in the two modes.

[0180] In one example, the control operation includes starting the flushing pump. When the function entry is a function control displayed on the screen, as shown in Figure 7, starting the flushing pump includes triggering the start control 624a in the second display area 624. Triggering the start control 624a allows manual starting of the flushing pump. Starting the flushing pump also includes triggering the pre-charge control 624b in the second display area 624. The start control 624a and pre-charge control 624b correspond to different flushing pump operating modes, with the pre-charge control 624b corresponding to the pre-charge operating mode and the start control 624a corresponding to the flushing operating mode (normal flushing after pre-charge). In the first control mode, operating the above controls allows the flushing pump to be started independently, without being restricted by the start sequence in the second control mode. When the function entry is a physical button, starting the flushing pump includes pressing the physical button with the flushing pump start function.

[0181] In one example, the control operation includes stopping the flush pump. When the function entry is a function control displayed on the screen, as shown in Figure 7, stopping the flush pump includes triggering a stop control 624c in the second display area 624 to manually stop the flush pump. When the function entry is a physical button, stopping the flush pump includes pressing a physical button with a flush pump stop function.

[0182] In summary, the method provided in this embodiment distinguishes between the first control mode and the second control mode through mode switching selection. When switching to the first control mode, the corresponding function entry of the first control mode can be activated, and control operations can be received based on the function entry. This avoids accidental entry into the first control mode and ensures the safe operation of the ventricular assist device.

[0183] The ventricular assist device has mode switching restrictions when entering the first control mode;

[0184] In an alternative implementation of the embodiment shown in Figure 5, the method further includes the following step before step 420:

[0185] Detect the working status of the target component;

[0186] The target component can be at least one of the first component and the second component in the ventricular assist device, or it can be other components in the ventricular assist device other than the first component and the second component.

[0187] In one example, taking a transcatheter ventricular assist device as an example, the target component includes a blood pump and / or flushing pump in the ventricular assist device; when the ventricular assist device is in a second control mode and the working state of the target component meets the preset operating state conditions, a step is performed in response to a control operation to control the operation of the first component in a manner unconstrained by the limiting conditions.

[0188] When a ventricular assist device switches from the second control mode to the first control mode to perform control operations, it is necessary to detect the operating status of the target component in the transcatheter ventricular assist device to ensure that the target component is in a non-operating state. In one example, the operating status of the target component meets preset operating conditions, including that the blood pump and / or flushing pump is in a non-operating state. This ensures that the switch to the first control mode is achieved even when the blood pump and / or flushing pump stops operating.

[0189] In summary, the method provided in this embodiment detects the working status of the target component before entering the first control mode. If the preset operating status conditions are met, the method allows the receiving of control operations, thereby switching the control mode and preventing the ventricular assist device in normal clinical use under the second control mode from entering the first control mode due to misoperation.

[0190] Input masking in the first control mode;

[0191] Figure 8 shows a flowchart of a control method for a ventricular assist device provided in an exemplary embodiment of this application. The method is applied to a ventricular assist device. Specifically, in the embodiment shown in Figure 2, step 410 can be implemented as step 412, and further includes steps 415 and 425:

[0192] Step 412: Obtain the control operation received by the first input device among at least two input devices;

[0193] The ventricular assist device includes at least two input components; the at least two input components include at least one of a touch screen, a physical knob, a physical button, and a voice recognition input component.

[0194] Step 415: Obtain the interference control operations received by other input components besides the first input component, as well as the interference shielding control operations;

[0195] When an interference control operation is received from another input component, the system does not respond to the interference control operation; that is, it only changes the operating state of the first component when a control operation is received from the first input component, and does not respond to interference control operations received from other input components, and does not change the operating state of the first component according to the interference control operation.

[0196] In one example, the control operation and interference control operation are operations received by the ventricular assist device in the first control mode. In the first control mode, only the control operation from the first input component is received to avoid negative consequences caused by accidental triggering of interference control operations.

[0197] Furthermore, the first input component is a touchscreen, and the control operation is a trigger operation on the control on the debugging interface shown in Figure 7. For controlling the start of the interventional pump 120, the control control of the interventional pump 120 on the debugging interface corresponds to the first control mode, and the first input component includes the interventional pump 120 control component in the debugging interface. Before entering the settings interface shown in Figure 6, a main control interface is also displayed. The start / stop control of the interventional pump 120 on the main control interface and the speed knob of the interventional pump 120 on the main unit both correspond to the second control mode and belong to the other input components mentioned in step 415. For the flushing pump control in the first control mode, such as start / stop and speed adjustment, the flushing pump control control on the debugging interface shown in Figure 7 corresponds to the first control mode and belongs to the first input component. The flushing interface of the ventricular assist device also has a flushing pump start / stop control, corresponding to the second control mode and belonging to the other input components mentioned in step 415. In the first control mode, the control method of controlling the start / stop of the flushing pump through the flushing interface is disabled to avoid misoperation of the flushing pump.

[0198] By shielding the control operations received by the ventricular assist device from input components other than the first input component, negative consequences caused by erroneous responses of the start / stop input components are avoided. The debugging interface ensures that the trigger position of the control operation received by the touch screen and the display position of the control feedback information (such as the top of page 620 of the debugging interface) are adjacent, thus realizing the display of control feedback information in adjacent positions and highlighting its visual significance.

[0199] Steps 412 and 415 in this embodiment can be combined with step 420 in Figure 2 to form a new embodiment and be implemented separately. This application does not impose any restrictions on this.

[0200] Step 425: Obtain status change feedback for the first component;

[0201] Status change feedback is used to indicate that the operating status of the first component has changed. Status change feedback is reported by the first component in the ventricular assist device, or detected by sensors in the ventricular assist device.

[0202] Furthermore, after obtaining the status change feedback, the status change feedback is displayed. Taking the status change feedback as a prompt displayed on the ventricular assist device's screen as an example, the status change feedback is highlighted visually, such as by bolding the font or changing the font color. Combined with sub-step three above, in response to the ventricular assist device switching to the first control mode, the ventricular assist device is controlled to enter a silent state by exceeding the maximum alarm silence duration. The status change feedback is used to indicate that the ventricular assist device has changed to a silent state, and the display status of the silence icon on the screen is adjusted to be highlighted.

[0203] Taking the status change feedback displayed by the indicator light of the ventricular assist device as an example, the status change feedback should be highlighted in a visually significant way, such as adding a flash or modifying the color of the indicator light.

[0204] Step 425 in this embodiment can be combined with steps 410 and 420 in Figure 2 to form a new embodiment and be implemented separately; this application does not limit this.

[0205] In summary, the method provided in this embodiment only responds to control operations received by the first input component in the first control mode, and blocks interference control operations received by other input components. This avoids negative consequences caused by misoperation of other input components on the ventricular assist device in debugging scenarios, ensuring the safe operation of the ventricular assist device. Furthermore, by highlighting the control feedback information visually through state change feedback, the changes in the operating state of the first component are promptly reported.

[0206] Those skilled in the art will understand that the above embodiments can be implemented independently, or the above embodiments can be freely combined to create new embodiments to implement the control method of the ventricular assist device of this application.

[0207] Figure 9 shows a structural block diagram of a control device for a ventricular assist device provided in an exemplary embodiment of this application. The ventricular assist device includes a first component, and the ventricular assist device provides a first control mode and a second control mode. The device includes:

[0208] The acquisition module 810 is used to acquire control operations for the first component, wherein the control operations refer to operations associated with the first control mode;

[0209] The control module 820 is configured to control the operation of the first component in response to the control operation in a manner unconstrained by the constraints, the constraints being the constraints imposed on the first component when it operates in the second control mode.

[0210] In an optional design of this embodiment, the limiting conditions include parameter limiting conditions for the operating parameters of the first component; the control module 820 is further configured to:

[0211] In response to the control operation, the operation of the first component is controlled in a control manner that exceeds the parameter limitations;

[0212] The control method is a control method that cannot be set under the constraints of the parameter limitations in the second control mode.

[0213] In an optional design of this embodiment, the parameter constraints include at least one of the following:

[0214] The range of allowed runtime parameters;

[0215] The allowable adjustment step size when modifying the operating parameters;

[0216] The first effective duration of the operating parameters in the second control mode;

[0217] Prerequisite constraints must be met for operation in the second control mode.

[0218] In an optional design of this embodiment, the first component includes a blood pump and / or a flushing pump in the ventricular assist device, and the operating parameter range includes the rotational speed range of the blood pump and / or the flushing pump; the control module 820 is further configured to:

[0219] In response to a speed setting operation, the operation of the blood pump and / or the flushing pump is controlled at a set speed that is not within the speed range.

[0220] In an optional design of this embodiment, the first component includes a blood pump and / or a flushing pump in the ventricular assist device, and the adjustment step size includes candidate adjustment step sizes corresponding to the blood pump and / or the flushing pump in the second control mode; the control module 820 is further configured to:

[0221] In response to the speed adjustment operation, the speed of the blood pump and / or the flushing pump is changed by a first speed adjustment step that is not part of the candidate adjustment step.

[0222] In an optional design of this embodiment, the first effective duration includes the maximum alarm silence duration; the control module 820 is further configured to:

[0223] In response to the ventricular assist device switching to the first control mode, the ventricular assist device is controlled to be in a silent state in a manner that exceeds the maximum alarm silence duration.

[0224] In an optional design of this embodiment, the preconditions include the operating temperature range and / or operating humidity range of the ventricular assist device;

[0225] The control module 820 is also used for:

[0226] In response to parameter setting operations, the operation of the first component is controlled if the operating temperature range and / or operating humidity range are exceeded.

[0227] In an optional design of this embodiment, the ventricular assist device further includes a second component, and the limiting conditions include dependency limiting conditions relating to the first component and the second component; the control module 820 is further configured to:

[0228] In response to the control operation, the first component is controlled to operate in a control manner that exceeds the dependent constraints.

[0229] In an optional design of this embodiment, the dependency constraint includes: an operational state constraint between the first component and the second component; the first component includes a blood pump, the second component includes a flushing pump, and the operational state constraint includes: prohibiting the blood pump from starting when the flushing pump is in a non-operating state; the control module 820 is further configured to:

[0230] In response to the blood pump start-up operation, the blood pump is started when the flushing pump is not in operation.

[0231] In an optional design of this embodiment, the control module 820 is further configured to:

[0232] When the ventricular assist device is in the second control mode, the operating status of the flushing pump is checked in response to the start-up operation of the blood pump;

[0233] If the flushing pump is in operation, start the blood pump;

[0234] If the flushing pump is not in operation, restrict the activation of the blood pump and / or issue a prompt message restricting the activation of the blood pump.

[0235] In an optional design of this embodiment, the dependency constraint includes: a connection state constraint between the first component and the second component; the first component includes a drive motor 132, the second component includes a blood pump, and the connection state constraint includes: prohibiting the drive motor 132 from starting when the drive motor 132 and the blood pump are not connected; the control module 820 is further configured to:

[0236] In response to the blood pump start-up operation, the drive motor 132 is started when the drive motor 132 and the blood pump are not connected.

[0237] In an optional design of this embodiment, the control module 820 is further configured to:

[0238] When the ventricular assist device is in the second control mode, in response to the start operation of the blood pump, the connection status of the drive motor 132 and the blood pump is checked;

[0239] If the drive motor 132 and the blood pump are connected, start the drive motor 132;

[0240] If the drive motor 132 and the blood pump are in a non-connected state, restrict the start of the drive motor 132 and / or issue a prompt message restricting the start of the drive motor 132.

[0241] In an optional design of this embodiment, the acquisition module 810 is further configured to:

[0242] In response to the mode selection command, the function entry corresponding to the first control mode is activated;

[0243] The control operation is received based on the aforementioned function entry point.

[0244] In an optional design of this embodiment, the control module 820 is further configured to:

[0245] Detect the working status of the target component;

[0246] When the ventricular assist device is in the second control mode and the working state of the target component meets the preset operating state conditions, the step of controlling the operation of the first component in response to the control operation is executed in a manner that is not constrained by the restrictions.

[0247] It should be noted that the device provided in the above embodiments is only illustrated by the division of the above functional modules when implementing its functions. In actual applications, the above functions can be assigned to different functional modules according to actual needs, that is, the content structure of the device can be divided into different functional modules to complete all or part of the functions described above.

[0248] Regarding the apparatus in the above embodiments, the specific manner in which each module performs its operation has been described in detail in the embodiments of the relevant method; the technical effects achieved by each module performing its operation are the same as the technical effects in the embodiments of the relevant method, and will not be elaborated here.

[0249] This application embodiment also provides a ventricular assist device, which includes: a first component, a processor, and a memory, wherein the memory stores a computer program; the processor is used to execute the computer program in the memory to implement the control method of the ventricular assist device provided in the above method embodiments. In an optional example, the ventricular assist device further includes a second component, and the first component and the second component have an interdependent relationship in terms of their operating states.

[0250] For example, FIG10 is a structural block diagram of a ventricular assist device provided in an exemplary embodiment of this application. Typically, the ventricular assist device 2300 includes: a processor 2301, a memory 2302, and a first component 2311.

[0251] Processor 2301 may include one or more processing cores, such as a quad-core processor, an octa-core processor, etc. Processor 2301 may be implemented using at least one hardware form selected from Digital Signal Processing (DSP), Field-Programmable Gate Array (FPGA), and Programmable Logic Array (PLA). Processor 2301 may also include a main processor and a coprocessor. The main processor, also known as a central processing unit (CPU), is used to process data in the wake-up state; the coprocessor is a low-power processor used to process data in the standby state. In some embodiments, processor 2301 may integrate a Graphics Processing Unit (GPU), which is responsible for rendering and drawing the content to be displayed on the screen. In some embodiments, processor 2301 may also include an Artificial Intelligence (AI) processor, which is used to handle computational operations related to machine learning.

[0252] The memory 2302 may include one or more computer-readable storage media, which may be non-transitory. The memory 2302 may also include high-speed random access memory and non-volatile memory, such as one or more disk storage devices or flash memory devices. In some embodiments, the non-transitory computer-readable storage media in the memory 2302 are used to store at least one instruction, which is executed by the processor 2301 to implement the control method of the ventricular assist device provided in the method embodiments of this application.

[0253] In some embodiments, the ventricular assist device 2300 may optionally include an input interface 2303 and an output interface 2304. The processor 2301, memory 2302, and input interface 2303 and output interface 2304 can be connected via a bus or signal line. The first component 2311 can be connected to the input interface 2303 and output interface 2304 via a bus, signal line, or circuit board. The input interface 2303 and output interface 2304 can be used to connect at least one input / output (I / O) related peripheral device to the processor 2301 and memory 2302. In some embodiments, the processor 2301, memory 2302, and input interface 2303 and output interface 2304 are integrated on the same chip or circuit board; in some other embodiments, any one or two of the processor 2301, memory 2302, and input interface 2303 and output interface 2304 can be implemented on separate chips or circuit boards, and this application embodiment does not limit this.

[0254] Those skilled in the art will understand that the structure shown above does not constitute a limitation on the ventricular assist device 2300, and may include more or fewer components than shown, or combine certain components, or use different component arrangements.

[0255] In an exemplary embodiment, a chip is also provided, the chip including programmable logic circuitry and / or program instructions, which, when the chip is run on a computer device, are used to implement the control method of the ventricular assist device described above.

[0256] In an exemplary embodiment, a computer program product is also provided, comprising computer instructions stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium and executes the computer instructions to implement the control method for the ventricular assist device provided in the above-described method embodiments.

[0257] In an exemplary embodiment, a computer-readable storage medium is also provided, which stores a computer program that is loaded and executed by a processor to implement the control method of the ventricular assist device provided in the above-described method embodiments.

[0258] Those skilled in the art will understand that all or part of the steps of the above embodiments can be implemented by hardware or by a program instructing related hardware. The program can be stored in a computer-readable storage medium, such as a read-only memory, a disk, or an optical disk.

[0259] Those skilled in the art will recognize that the functions described in the embodiments of this application in one or more of the above examples can be implemented using hardware, software, firmware, or any combination thereof. When implemented using software, these functions can be stored in a computer-readable medium or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media include computer storage media and communication media, wherein communication media include any medium that facilitates the transfer of a computer program from one place to another. Storage media can be any available medium that can be accessed by a general-purpose or special-purpose computer.

[0260] The above description is merely an optional embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A control method of a ventricular assist device, wherein, The ventricular assist device includes a first component, the ventricular assist device provides a first control mode and a second control mode, and the method includes: Obtain control operations for the first component, wherein the control operations refer to operations associated with the first control mode; In response to the control operation, the first component is controlled to operate in an unrestricted manner, the restriction being the restriction on the first component operating in the second control mode.

2. The method of claim 1, wherein, The limiting conditions include parameter limiting conditions for the operating parameters of the first component; The control operation, in response to the control operation, to control the operation of the first component in a manner unconstrained by any restrictions, includes: In response to the control operation, the operation of the first component is controlled in a control manner that exceeds the parameter limitations; The control method is a control method that cannot be set under the constraints of the parameter limitations in the second control mode.

3. The method of claim 2, wherein, The parameter constraints include at least one of the following: The range of allowed runtime parameters; The allowable adjustment step size when modifying the operating parameters; The first effective duration of the operating parameters in the second control mode; Prerequisite constraints must be met for operation in the second control mode.

4. The method of claim 3, wherein, The first component includes the blood pump and / or flushing pump in the ventricular assist device, and the operating parameter range includes the rotational speed range of the blood pump and / or the flushing pump; The control of the first component in response to the control operation, using a control method exceeding the parameter limitations, includes: In response to a speed setting operation, the operation of the blood pump and / or the flushing pump is controlled at a set speed that is not within the speed range.

5. The method of claim 3, wherein, The first component includes the blood pump and / or flushing pump in the ventricular assist device, and the adjustment step size includes the candidate adjustment step size corresponding to the blood pump and / or the flushing pump in the second control mode; The control of the first component in response to the control operation, using a control method exceeding the parameter limitations, includes: In response to the speed adjustment operation, the speed of the blood pump and / or the flushing pump is changed by a first speed adjustment step that is not part of the candidate adjustment step.

6. The method according to claim 3, wherein, The first effective duration includes the maximum alarm silence duration; the method further includes: In response to the ventricular assist device switching to the first control mode, the ventricular assist device is controlled to be in a silent state in a manner that exceeds the maximum alarm silence duration.

7. The method according to claim 3, wherein, The preconditions include the operating temperature range and / or operating humidity range of the ventricular assist device; The control of the first component in response to the control operation, using a control method exceeding the parameter limitations, includes: In response to parameter setting operations, the operation of the first component is controlled if the operating temperature range and / or operating humidity range are exceeded.

8. The method according to claim 1, wherein, The ventricular assist device further includes a second component, and the limiting conditions include dependency limiting conditions between the first component and the second component; The control operation, in response to the control operation, to control the operation of the first component in a manner unconstrained by any restrictions, includes: In response to the control operation, the first component is controlled to operate in a control manner that exceeds the dependent constraints.

9. The method according to claim 8, wherein, The dependency constraints include: operational status constraints between the first component and the second component; the first component includes a blood pump, the second component includes a flushing pump, and the operational status constraints include: prohibiting the blood pump from being started when the flushing pump is in a non-working state; The control of the first component in response to the control operation, in a control manner exceeding the dependent constraints, includes: In response to the blood pump start-up operation, the blood pump is started when the flushing pump is not in operation. And / or, the method further includes: When the ventricular assist device is in the second control mode, the operating status of the flushing pump is checked in response to the start-up operation of the blood pump; If the flushing pump is in operation, start the blood pump; If the flushing pump is not in operation, restrict the activation of the blood pump and / or issue a prompt message restricting the activation of the blood pump.

10. The method according to claim 8, wherein, The dependency constraints include: connection status constraints between the first component and the second component; the first component includes a drive motor, the second component includes a blood pump, and the connection status constraints include: prohibiting the drive motor from being started when the drive motor and the blood pump are not connected; The control of the first component in response to the control operation, in a control manner exceeding the dependent constraints, includes: In response to the blood pump start-up operation, the drive motor is started when the drive motor and the blood pump are not connected; And / or, the method further includes: When the ventricular assist device is in the second control mode, in response to the start operation of the blood pump, the connection status of the drive motor and the blood pump is checked; If the drive motor and the blood pump are connected, start the drive motor; If the drive motor and the blood pump are in a disconnected state, restrict the start of the drive motor and / or issue a prompt message restricting the start of the drive motor.

11. The method according to any one of claims 1 to 10, wherein, The acquisition of control operations for the first component includes: In response to the mode selection command, the function entry corresponding to the first control mode is activated; The control operation is received based on the aforementioned function entry point; And / or, the method further includes: Detect the working status of the target component; When the ventricular assist device is in the second control mode and the working state of the target component meets the preset operating state conditions, the step of controlling the operation of the first component in response to the control operation is executed in a manner that is not constrained by the restrictions.

12. A control device for a ventricular assist device, wherein, The ventricular assist device includes a first component, and the ventricular assist device provides a first control mode and a second control mode. The device includes: The acquisition module is used to acquire control operations for the first component, wherein the control operations refer to operations associated with the first control mode; A control module is configured to control the operation of the first component in response to the control operation in a manner unconstrained by the constraints that are the constraints imposed on the first component when it is operating in the second control mode.

13. A ventricular assist device, wherein, The ventricular assist device includes: a first component, a processor, and a memory; the ventricular assist device provides a first control mode and a second control mode, and the memory stores at least one program; the processor is used to execute the at least one program in the memory to implement the control method of the ventricular assist device as described in any one of claims 1 to 11.

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