Circulation support device, circulation support system, and circulation support method

Abstract

A circulatory support system may include a blood pump, one or more sensors, and a controller. The blood pump may include a driven component and a motor that communicates with the driven component and the controller, and drives the driven component to pump blood through the blood pump. The controller may be configured to determine a command signal based on a value related to the motor speed, provide the command signal to the motor to drive the driven component, determine values ​​for parameters related to the operation of the blood pump based on the command signal and the value related to the motor speed, and output an instruction that a transition of the blood pump is recommended based on the determined values ​​of one or more parameters related to the operation of the blood pump.

Description

[Technical Field]

[0001] This disclosure relates to mechanical circulatory support devices. More specifically, this disclosure relates to the operation of percutaneous ventricular assist devices (PVADs). [Background technology]

[0002] A wide variety of in-vivo and in-vitro medical devices and systems have been developed for medical applications, for example, in cardiac procedures and / or cardiac treatments. Some of these devices and systems include guidewires, catheters, catheter systems, pumps, cardiac assist devices, and the like. These devices and systems can be manufactured by any of several different manufacturing methods and used in any of several different ways. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and systems, as well as alternative methods for manufacturing and using medical devices and systems. [Overview of the Initiative]

[0003] This disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices, including ventricular assist devices. In the first example, the circulatory support system may include a blood pump, which includes a driven component, a motor configured to communicate with the driven component and drive the driven component to pump blood through the blood pump, one or more sensors configured to detect values ​​related to the motor's speed, and a controller that communicates with the motor and one or more sensors configured to detect values ​​related to the motor's speed, the controller may be configured to determine a command signal based on the values ​​related to the motor's speed, provide the command signal to the motor to drive the driven component, determine one or more values ​​of one or more parameters related to the operation of the blood pump based on either or both of the command signal and the values ​​related to the motor's speed, and output an indication that the blood pump should be switched off based on the determined values ​​of one or more parameters related to the operation of the blood pump.

[0004] Alternatively, or in addition to, any of the above examples, in another example, the controller may be further configured to identify trends in two or more values ​​of one or more parameters related to the operation of the blood pump over time, and to output a message recommending a transition of the blood pump if the trend reaches or exceeds a threshold level.

[0005] In an alternative or additional example to any one of the above examples, the controller may include a state observer configured to determine two or more values ​​for two or more parameters related to the operation of the blood pump.

[0006] In an alternative or additional example to any of the above examples, one or more determined values ​​of one or more parameters related to the operation of the blood pump may include one or more values ​​of the left ventricular pressure obtained by the pump.

[0007] Alternatively, or in addition to, any of the above examples, in another example, the controller may be configured to output an instruction recommending a blood pump transition when one or more left ventricular pressure values ​​reach or exceed a threshold level.

[0008] Alternatively, or in addition to, any of the above examples, in another example, the determined values ​​of one or more parameters related to the operation of the blood pump may include one or more values ​​of the flow rate of blood passing through the blood pump.

[0009] Alternatively, or in addition to, any of the above examples, in another example, the controller may be configured to output an instruction recommending a transition of the blood pump when one or more values ​​of the blood flow rate through the blood pump reach or exceed a threshold level.

[0010] Alternatively, or in addition to, any of the above examples, in another example, the determined values ​​of one or more parameters related to the operation of the blood pump may include one or more values ​​of mechanical losses in the blood pump.

[0011] Alternatively, or in addition to, any of the above examples, in another example, the controller may be configured to output an instruction recommending the transition of the blood pump if one or more mechanical losses in the blood pump reach or exceed a threshold level.

[0012] In addition to or alternative to any of the above examples, in another example, instructions recommending a blood pump transition may include a recommended timeframe for when the blood pump transition is recommended.

[0013] In a further example, there is provided a non-transitory computer-readable medium storing instructions executable by a circulatory assist device for use in a patient's heart, the instructions causing the circulatory assist device to perform a method comprising the steps of: determining a command signal based on a value related to a speed of a motor of a blood pump of the circulatory assist device; providing the command signal to the motor to drive a driven component and pump blood flow through the blood pump; determining one or more values of one or more parameters related to operation of the blood pump based on one or both of the command signal and the value related to the motor speed; and outputting an indication that transition of the blood pump is recommended based on two or more values determined over time for the one or more parameters related to operation of the blood pump.

[0014] Alternatively or additionally to any one of the above examples, in another example, the method may further comprise identifying a trend of two or more values of one or more parameters related to operation of the blood pump determined over time.

[0015] Alternatively or additionally to any of the above examples, in another example, the indication that transition of the blood pump is recommended may be output in response to the trend reaching or exceeding a threshold level.

[0016] Alternatively or additionally to any of the above examples, in another example, the step of determining one or more values of one or more parameters related to operation of the blood pump comprises determining two or more values of two or more parameters related to operation of the blood pump selected from the group consisting of left ventricular pressure, blood flow rate through the blood pump, and mechanical loss in the blood pump, and the indication that transition of the blood pump is recommended is output when a trend of two or more values of at least one of left ventricular pressure, blood flow rate through the blood pump, and mechanical loss in the blood pump reaches or exceeds a threshold level.

[0017] In addition to or alternative to any of the above examples, in another example, instructions recommending a blood pump transition may include a recommended timeframe for when the blood pump transition is recommended.

[0018] In a further example, a method for operating a circulatory support system for use in a patient's heart may include the steps of: determining a command signal based on a value related to the speed of the motor of the blood pump of the blood circulation support system; providing the command signal to the motor to drive a driven component and pump blood flow through the blood pump; determining one or more values ​​of one or more parameters related to the operation of the blood pump over time based on either or both the command signal and the value related to the motor speed; and outputting an instruction that a transition of the blood pump is recommended based on two or more values ​​determined over time for one or more parameters related to the operation of the blood pump.

[0019] Alternatively, or in addition to any of the above examples, another example identifies trends in the values ​​of two or more values ​​of one or more parameters related to the operation of the blood pump as determined over time.

[0020] Alternatively, or in addition to, any of the above examples, in another example, a directive recommending a blood pump transition is output in response to the trend reaching or exceeding a threshold level.

[0021] Alternatively, or in addition to, any of the above examples, in another example, the step of determining one or more values ​​of one or more parameters related to the operation of the blood pump includes determining two or more values ​​of two or more parameters related to the operation of the blood pump, selected from the group consisting of left ventricular pressure, blood flow rate through the blood pump, and mechanical loss in the blood pump, and an instruction is output recommending a transition of the blood pump if the trend of at least one of two or more values ​​among left ventricular pressure, blood flow rate through the blood pump, and mechanical loss in the blood pump reaches or exceeds a threshold level.

[0022] In addition to or alternative to any of the above examples, in another example, instructions recommending a blood pump transition may include a recommended timeframe for when the blood pump transition is recommended.

[0023] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of this disclosure. The following drawings and detailed description illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0024] This disclosure can be better understood by referring to the following detailed description in relation to the attached drawings. [Figure 1] This is a schematic partial cross-sectional view of an anatomical structure, and a schematic side view of an exemplary percutaneous ventricular assist device (PVAD) within the anatomical structure. [Figure 2] This is a schematic cross-sectional view of an exemplary PVAD. [Figure 3] This is a schematic detail diagram along line 3-3 of the PVAD shown in Figure 2. [Figure 4] This is a schematic diagram of an exemplary circulatory support system. [Figure 5] This is a schematic diagram of an exemplary computing device or controller and user interface. [Figure 6] This is a schematic diagram of an exemplary circulatory support system. [Figure 7] This is a schematic diagram of an exemplary circulatory support system. [Figure 8] This is a schematic diagram of an exemplary controller configuration. [Figure 9] This is a schematic diagram of an exemplary controller configuration. [Figure 10] This is a schematic diagram of an exemplary controller configuration. [Figure 11] This is a schematic diagram of an exemplary controller configuration. [Figure 12] This is a schematic diagram of an exemplary controller configuration. [Figure 13] This is a schematic diagram of an exemplary controller configuration. [Figure 14] This is a schematic diagram illustrating an exemplary method for operating a circulatory support system. [Modes for carrying out the invention]

[0025] This disclosure follows various modifications and alternative forms, the details of which are shown in the drawings as examples and described in detail. However, it should be understood that the intent is not to limit the invention to any particular embodiment described. On the contrary, this disclosure encompasses all modifications, equivalents, and alternative forms that fall within the technical concept and scope of this disclosure.

[0026] The terms defined below shall apply unless otherwise given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term “approximately,” whether expressly indicated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0027] Numerical ranges specified by endpoints include all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. As used herein and in the appended claims, the term “or” is used generally to mean “and / or” unless the context clearly indicates otherwise.

[0028] Please note that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. In addition, if specific features, structures, and / or characteristics are described in relation to one embodiment, please understand that such features, structures, and / or characteristics may be used in relation to other embodiments, whether explicitly described or not, unless explicitly stated otherwise.

[0029] The following detailed description should be read with reference to the drawings, where similar structures are numbered identically in different drawings. The drawings are not necessarily to a fixed scale and illustrate exemplary embodiments; they are not intended to limit the scope of this disclosure. In addition, note that in any given drawing, some features may be omitted or shown schematically for clarity and / or simplification. Additional details regarding some components and / or method steps may be shown in more detail in other drawings. The apparatus and / or methods disclosed herein may offer many desirable features and advantages, as will be described in more detail below.

[0030] Various circulatory support devices are known to assist or replace the heart's pumping function in patients with severe heart failure and / or other cardiac-related diseases. These devices may be configured to treat patients with cardiogenic shock, myocardial infarction, acute decompensated heart failure, and / or other cardiac-related conditions. Additionally, or alternatively, circulatory support devices may assist patients during percutaneous coronary intervention and / or other procedures.

[0031] Examples of cardiovascular support devices include, but are not limited to, ventricular assist devices (VADs), total prosthetic hearts, intra-aortic balloon pumps (IABPs), and extracorporeal membrane oxygenation (ECMO). Examples of VADs include left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), and biventricular assist devices (BiVADs). A further exemplary VAD is the percutaneous ventricular assist device (PVAD), which can be inserted into the ventricle of a patient's heart (e.g., the left or right ventricle) via delivery to the ventricle through the femoral artery or femoral vein and / or other suitable vascular system. PVADs can be positioned at a desired location in the patient's anatomical structure via percutaneous access and delivery, which may allow PVADs to be used in emergency medicine, catheterization laboratories, and / or other surgical and / or non-surgical settings.

[0032] Figure 1 shows an exemplary placement of the blood pump 100 (e.g., a percutaneous circulatory support device such as a PVAD in an LVAD configuration) in the anatomical structure of a patient. In Figure 1, the blood pump 100 is positioned with its distal end 103 located in the left ventricle 16 of the heart 18 and its proximal end 107 located in the aorta 20, so that the blood pump 100 extends across the aortic valve 22 between the left ventricle 16 and the aorta 20. With the blood pump 100 extending from the left ventricle 16 to the aorta 20, the blood pump 100 may be configured to pump blood from the left ventricle 16 to the aorta 20 to assist in hemodynamic circulation. Other appropriate placements of the blood pump in relation to the anatomical structure have also been envisioned, including, but are not limited to, a placement of the distal end 103 of the blood pump in the right ventricle of the heart 18 and the proximal end in the pulmonary artery.

[0033] Figure 2 shows a schematic cross-sectional view of an exemplary configuration of the blood pump 100. In some cases, the blood pump 100 may constitute part of a percutaneous circulatory system or circulatory support system, together with a guidewire, introducer sheath, controller, user interface, one or more sensors, and / or other appropriate components.

[0034] The blood pump 100 may include a housing 101 having an impeller housing 102 and a motor housing 104. The impeller housing 102 and the motor housing 104 may be configured as a single unit or integrated structure, but this is not required, and the impeller housing 102 and the motor housing 104 may be separate components configured to be detachable or permanently coupled. In some configurations, the blood pump 100 may lack a motor housing 104 separate from the impeller housing 102, and the impeller housing 102 may be directly coupled to the motor 105, or the motor housing 104 may be configured integrally with the motor 105.

[0035] The impeller housing 102 may house an impeller assembly 106 and a driven magnet 124, which may be part of the impeller assembly 106 or separate from it. The impeller assembly 106 may include an impeller shaft 108 rotatably supported by at least one bearing, such as a bearing 110 and / or other suitable bearings. The impeller assembly 106 may further include an impeller 112 that rotates relative to the impeller housing 102 to allow blood to flow through the blood pump 100. In some configurations, for example as shown, the impeller shaft 108 and the impeller 112 may be separate components, and in other configurations, the impeller shaft 108 and the impeller 112 may be integrated. The impeller assembly 106 as a whole may be considered a driven component, and / or the rotating components of the impeller assembly 106 (e.g., the impeller shaft 108 and / or the impeller 112) may be driven components individually or in combination.

[0036] The impeller 112 is located within the impeller housing 102, and as the impeller 112 rotates, blood may be configured to flow in through a blood inlet 114 formed on or at the location of the impeller housing 102, and to flow out through the impeller housing 102 through a blood outlet 116 formed on or at the location of the impeller housing 102. In some configurations, the impeller housing 102 may be coupled to or include a distally extending cannula (not shown), the cannula which can receive blood (e.g., from the left ventricle 16 of the heart 18 and / or other suitable location) and deliver it to the inlet 114.

[0037] The inlet 114 and outlet 116 may each have any suitable number of openings configured to allow blood to be received into the blood pump 100 and blood to be discharged from the blood pump 100, respectively. In some examples, the inlet 114 and / or outlet 116 may each include multiple openings, and in other examples, one or both of the inlet 114 and outlet 116 may each include a single opening.

[0038] The inlet and outlet 116 may be formed at any suitable location along the impeller housing 102 or at other suitable locations along the blood pump 100, respectively. In some examples, as shown in Figure 2, the inlet 114 may be formed at the end of the impeller housing 102 (e.g., the distal end), and the outlet 116 may be formed on the side of the impeller housing 102 (e.g., proximal to the location of the inlet 114). Other suitable arrangements of the inlet 114 and / or outlet 116 on the impeller housing 102 are also conceivable.

[0039] The motor housing 104 may house the motor 105 along with other suitable components. In some examples, as shown in Figure 2, the motor housing 104 may house at least the motor 105, the drive shaft 120, and the drive magnet 122.

[0040] Motor 105 can be any suitable type of motor. For example, motor 105 may be a brushless direct current (DC) motor (BLDC), but other suitable types of motors are also possible.

[0041] During operation, the motor 105 may be configured to rotationally drive the impeller 112 relative to the impeller housing 102. In some exemplary configurations, the motor 105 may rotate a drive shaft 120 coupled to a drive magnet 122. The rotation of the drive magnet 122 may cause the rotation of a driven magnet 124, which is part of the impeller assembly 106 or is connected to the impeller assembly 106 and rotates together with it. That is, if the impeller shaft 108 is included in the impeller assembly 106, the impeller shaft 108 and the impeller 112 are configured to rotate together with the driven magnet 124. Additionally or alternatively, the motor 105 may be coupled to the impeller assembly 106 via other components.

[0042] As will be described in more detail below, a controller (not shown in Figure 2) may be operably coupled to the motor 105 and configured to control the motor 105 by one or more command signals transmitted from the controller to the motor 105. The controller may be located inside the motor housing 104 and / or outside the motor housing 104 (e.g., inside the housing of the blood pump 100, which is independent of the motor housing 104, outside the patient, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located inside the motor housing 104 and / or separately therefrom.

[0043] The motor housing 104 may be coupled to the catheter 126 at a position on the motor housing 104 opposite to the impeller housing 102. The catheter 126 may be coupled to the motor housing 104 by laser welding, soldering, or various equivalent methods. The catheter 126 may extend proximal to the motor housing 104.

[0044] The catheter 126 may include one or more lumens for housing one or more components of a circulatory support system, including a blood pump 100. In some cases, the catheter 126 may be configured to house a motor cable 128 (e.g., one or more cables configured to enable the operation of a motor 105) within the main lumen 130, and the motor cable 128 may be operably coupled to a controller (not shown) and / or an external power supply (not shown).

[0045] The catheter 126 may include a sensor assembly 132 for measuring pressure within the patient's vascular structure, for example, within the aorta or pulmonary artery. The sensor assembly 132 may be positioned relative to other components of the blood pump 100 to obtain high-precision pressure data. For example, the proximal position of the sensor assembly 132 relative to the motor housing 104 and motor 105 can reduce and / or eliminate measurement errors related to motor speed or dynamic pressure. Such errors are typically seen in other percutaneous circulatory support devices that employ pressure sensors located more distally to the motor or impeller assembly, for example, devices that employ pressure sensors located near the outlet 116.

[0046] Figure 3 shows a schematic detail of the interior of line 3-3 in Figure 2. As shown in Figure 3, the sensor assembly 132 may include a sensor housing 134 having an internal chamber 136. In some examples, the internal chamber 136 may have a counterbore shape, but other suitable shapes and / or configurations of the internal chamber 136 are also conceivable. A pressure sensor 138, such as an optical pressure sensor (e.g., an optical pressure sensor using one or more optical fibers and / or other suitable optical pressure sensors), an electrical pressure sensor, and / or other suitable pressure sensors, may be placed within the internal chamber 136 and configured to detect pressure in the aorta 20 as the blood pump 100 extends into the left ventricle 16 of the heart 18. The sensor housing 134 may protect the pressure sensor 138 when the blood pump 100 is deployed. The sensor housing 134 may also include a distally facing opening 140 of, or coupled to, the internal chamber 136. The opening 140 may allow blood to flow into the internal chamber 136, thereby enabling the pressure sensor 138 to detect the pressure of the blood in the vicinity of the internal chamber 136.

[0047] The sensor housing 134 can take various forms. For example, the sensor housing 134 may be a tube or ferrule manufactured from, for example, one or more metals, one or more plastics, composite materials, and / or other suitable materials. The sensor housing 134 may be coupled to the catheter 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer jacket 144 enclosing at least a portion of the sensor housing 134 and the catheter 126. The sensor housing 134 may also include a sensor mount 145 within an internal chamber 136. The sensor mount 145 allows the pressure sensor 138 to be supported away from the walls of the sensor housing 134 (for example, the sensor mount 145 may be centered on the pressure sensor 138 within the internal chamber 136), thereby enabling high-precision pressure sensing. Other suitable configurations of the sensor housing 134 are also conceivable.

[0048] The sensor assembly 132 may include a sensor cable 147 coupled to a pressure sensor 138. The sensor cable 147 may operably couple the pressure sensor 138 to a controller (not shown). As shown, the sensor cable 147 may extend through a sensor mount 145 and support the pressure sensor 138 away from the wall of the sensor housing 134. The sensor cable 147 may extend proximal through an adhesive 142 and through a cable lumen 149 of the catheter 126 or a cable lumen 149 coupled to the catheter 126. In some examples, the cable lumen 149 may be coupled to the catheter 126 via one or more welds (not shown), adhesive (not shown), and / or an outer jacket 144. In other examples, the cable lumen 149 may be omitted, and the sensor cable 147 may extend through the main lumen 130 of the catheter 126 or be located directly beneath the outer jacket 144. An exemplary suitable sensor assembly 132 is disclosed in U.S. Patent Application Publication No. 2022 / 0149699, filed November 16, 2023, entitled “Percutaneous Circulation Support Device Including Proximal Pressure Sensor,” which is incorporated herein by reference in its entirety.

[0049] Figure 4 shows a schematic diagram of an exemplary circulatory support system 10. Along with other additional and / or alternative components, the circulatory support system 10 may include a blood pump 100, a pressure sensor 138, a controller 146, and a user interface 148. As described, the blood pump 100 may include a motor 105 connected to the controller 146 and an impeller 112 connected to the motor 105.

[0050] In some examples, the blood pump 100 may include, or be coupled to, one or more sensors 150 (e.g., one or more position sensors and / or other suitable speed sensors) configured to detect the speed of the motor 105. If one or more of the sensors 150 are included, one or more of the sensors 150 may be connected to the controller 146 through the catheter 126 and / or via one or more cables extending along the catheter 126. In some cases, the speed or position of the motor 105 may be detected directly from the electrical signals used by the controller 146 to drive the motor 105. In such cases, the motor may be an implicit sensor, used with or without explicit sensors.

[0051] One or more sensors 150 may be any suitable type of sensor for detecting the motor speed. Examples of suitable types of sensors 150 include, but are not limited to, position sensors, Hall effect sensors, magnetic induction sensors, optical encoders, eddy current sensors, Doppler effect sensors, tachometers, and / or other suitable types of sensors.

[0052] Figure 5 shows a schematic diagram of an exemplary configuration of the controller 146 (e.g., a computing device) and user interface 148 of the circulatory support system 10. The controller 146 may be any suitable computing device configured to process data from or for the circulatory support system 10 (e.g., motor 105, pressure sensor 138, sensor 150, patient examination results, user input, patient monitor, etc.). In some cases, one or more components of the circulatory support system 10 may be incorporated into the controller 146 and / or user interface 148. Furthermore, one or more components of the circulatory support system 10 may incorporate one or more computing devices having similar or identical components to the controller 146 and / or user interface 148.

[0053] The controller 146 may be configured to enable the operation of the circulation assistance system 10. In some cases, the controller 146 may be configured to control the operation of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 by establishing and / or outputting control signals to the components of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150, and by controlling and / or monitoring the operation of these units and devices.

[0054] The controller 146 may communicate with a remote server or other suitable computing device. If the controller 146, or at least a part of the controller 146, is a component separate from the structure of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150, the controller 146 may communicate with the electronic components of the circulation assistance system 10 via one or more wired connections, wireless connections, or networks (e.g., LAN and / or WAN).

[0055] The controller 146 may be, may include, or may be included in, one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more composite PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination thereof and / or other components. Although the controller 146 may be referred to in the singular form herein, the controller 146 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, and / or similarly.

[0056] The exemplary controller 146 may include one or more processors 152, memory 154, and / or one or more I / O units 156, in addition to other suitable components. Other exemplary components of the controller 146 not specifically shown in Figure 2 may include, but are not limited to, communication components, touchscreens, selectable buttons, housings, and / or other suitable components of the controller. As described above, one or more components of the controller 146 may be separate from and / or incorporated into the components of the circulation assistance system 10.

[0057] The controller 146 may include and / or communicate with various subcontrollers. Exemplary subcontrollers that may be included in or communicate with the controller 146 may include, but are not limited to, motor subcontrollers, flow subcontrollers, pressure subcontrollers, motor torque subcontrollers, motor mechanical loss subcontrollers, stall pressure subcontrollers, pressure loss subcontrollers, and / or other suitable subcontrollers.

[0058] The processor 152 of the controller 146 may include a single processor or two or more processors operating individually or in conjunction with each other. The processor 152 may be configured to receive and execute instructions, including instructions that can be loaded into memory 154 and / or other suitable memory. Exemplary components of the processor 152 may include, but are not limited to, a central processing unit, a microprocessor, a microcontroller, a multicore processor, a graphical processing unit, a digital signal processor, an application-specific integrated circuit (ASIC), an artificial intelligence accelerator, a field-programmable gate array (FPGA), discrete circuits, and / or other suitable types of data processing devices.

[0059] The memory 154 of the controller 146 may include a single memory component or two or more memory components, each operating individually or in conjunction with one another. Exemplary types of memory 154 may include random access memory (RAM), EEPROM, flash, a suitable volatile storage device, a suitable non-volatile storage device, persistent memory (e.g., read-only memory (ROM), a hard drive, flash memory, optical disc memory, and / or other suitable types of memory), and / or other suitable types of memory. Memory 154 may be or include a non-temporary computer-readable medium. Memory 154 may include instructions stored on the computer-readable medium in a temporary and / or non-temporary state, which may be executed by the processor 152 to cause the processor to perform one or more of the methods and / or techniques described herein.

[0060] The I / O unit 156 of the controller 146 may include a single I / O component, or two or more I / O components that operate individually or in conjunction with each other. The exemplary I / O unit 156 may be, or include, any suitable type of communication hardware and / or software, including, but not limited to, a communication port configured to communicate with the electronic components and / or other suitable computing devices or systems of the circulation support system 10. Exemplary types of I / O units 156 may include, but are not limited to, wired communication components (e.g., HDMI® components, Ethernet® components, VGA components, serial communication components, parallel communication components, component video ports, S-Video components, composite audio / video components, DVI components, USB components, optical communication components, and / or other suitable wired communication components), wireless communication components (e.g., radio frequency (RF) components, low energy Bluetooth® protocol components, Bluetooth® protocol components, near-field communication (NFC) protocol components, Wi-Fi protocol components, optical communication components, Zigbee® protocol components, and / or other suitable wireless communication components), and / or other suitable I / O units 156.

[0061] The user interface 148 may be configured to communicate with the controller 146 via one or more wired or wireless connections. The user interface 148 may include one or more display devices 158, one or more input devices 160, one or more output devices 162, and / or one or more other suitable functions.

[0062] The display device 158 may be any suitable display. Examples of suitable displays include, but are not limited to, touchscreen displays, non-touchscreen displays, liquid crystal display (LCD) screens, light-emitting diode (LED) displays, head-mounted displays, virtual reality displays, augmented reality displays, and / or other suitable display types.

[0063] Input device(s) 160 may be and / or include any suitable components and / or functions for receiving user input via a user interface. Exemplary input device(s) 160 may include, but are not limited to, a touchscreen, keypad, mouse, touchpad, microphone, selectable button, selectable knob, optical input, camera, gesture sensor, eye tracker, voice recognition control (e.g., a microphone connected to a suitable natural language processing component), and / or other suitable input device(s).

[0064] Output devices(s) 162 may be any suitable components and / or functions for providing information and / or data to the user and / or other computing components, and / or may include such components. Exemplary output devices(s) 162 may include, but are not limited to, displays, speakers, vibration systems, haptic feedback systems, optical outputs, cables, lights, and / or other suitable output devices.

[0065] Various parameters of the blood pump 100, the blood flow through the blood pump 100, or the vicinity of the blood pump 100 (e.g., pressure, flow rate, etc.) may be operationally and / or clinically relevant performance parameters of the blood pump 100 placed in a patient, or for the blood pump 100. For example, a clinician may be interested in ventricular pressure data, vascular pressure data (e.g., aortic pressure data, pulmonary artery pressure data, etc.), differential pressure data at both ends of the blood pump 100 (e.g., between the ventricle and the aorta, etc.), flow rate data related to the blood flowing through the blood pump 100, impeller speed data, motor speed data, and / or other data related to the operation of the blood pump 100 (data for decision-making regarding additional or alternative therapies, assessment of the patient's condition, assessment of the blood pump's condition, assessment of the blood pump's operation, assessment of the blood pump's effectiveness, and data for controlling the blood pump's operation). Furthermore, calculation results based on pressure and flow rate data related to and / or for the blood flowing through the blood pump 100, other blood pump data related to the operation of the blood pump 100, and / or data related to the blood flowing through the blood pump 100 may be used by the controller 146 to control the operation of the blood pump 100 automatically and / or in response to user input (e.g., by adjusting command signals).

[0066] The management of patients with intracardiac MCS devices (e.g., PVADs such as blood flow pump 100 and / or other suitable blood flow pumps) may depend on one or more variables, so it is not always clear to the user (e.g., physician, clinician, etc.) which pump to use to treat the patient (e.g., a pump with a lower flow capacity or a pump with a higher flow capacity). Because high-flow pumps are more likely to cause adverse effects on the patient (e.g., hemolysis) than low-flow pumps, users may tend to introduce a low-flow pump to the patient initially, understanding that a high-flow pump may be needed in the future. Additionally, or alternatively, the patient's needs may change during treatment, and a high-flow or low-flow blood pump may be needed or preferred. Furthermore, because the capacity of a blood pump decreases over time, a new high-flow pump may be needed to meet the patient's needs. If a patient's needs exceed the capacity of the blood pump currently being used to treat them, a transition to a higher-flow blood pump or multiple blood pumps (e.g., device escalation) may be necessary. Furthermore, if, for example, a patient's need for circulatory support decreases, a transition to a lower-flow blood pump (e.g., device de-escalation or downgrade) may also be considered.

[0067] Because many variables influence patient needs and the operation of the MCS device, and the values ​​of these variables can change over time, device transitions are common in the use of MCS devices. However, determining when a device transition is necessary can be difficult, and as a result, device transitions often only occur after a more powerful or less powerful device has been required. The concepts described herein improve the operation of the MCS device and its application to patients by providing predictive control of the blood pump 100 and predictive decisions regarding device transitions (e.g., escalation or de-escalation). For example, the controller 146 of the circulatory support system 10 may be configured to monitor key patient characteristics (e.g., arterial pressure, ventricular pressure, flow rate through the MCS device, etc.) to predict when the capacity of the MCS device in a patient will become insufficient to treat the patient and when device escalation will be necessary.

[0068] Figure 6 shows a schematic diagram of an exemplary control system for the circulation support system 10. In some cases, the control system may be a closed-loop or partially closed-loop control system, but this is not mandatory.

[0069] As shown in Figure 6, the controller 146 communicates with the motor 105 of the blood pump 100 via the commutation board 164 to drive or otherwise rotate the impeller shaft 108 and the impeller 112. The commutation board 164 and / or its components may be incorporated into the controller 146, incorporated into the motor 105, and / or may be components separate from either or both of the controller 146 and the motor 105. In some examples, the commutation board 164 may be omitted.

[0070] During operation, the commutation block 166 of the commutation board 164 may be configured to receive a command signal 168 and the output of a sensor 150 that detects an indicator (measure) related to the position and / or speed of the motor 105. The commutation block 166 may use the output of the sensor 150 to synchronize the command signal 168 with the operation of the motor 105 and supply a control signal 170 to the motor 105 based on the command signal 168 and the output of the sensor 150.

[0071] Furthermore, the high-pass filter (HPF) 172 of the commutation board 164 may be configured to receive the output of the sensor 150. The HPF 172 may be configured to acquire the derivative of the position signal, filter out noise in the velocity signal obtained from the position sensor 150, and supply the filtered signal as an output to the controller 146. In some examples, the HPF 172 may be omitted, and if a velocity sensor is used, the HPF 172 may be replaced with an LPF (low-pass filter), and / or other suitable filters may be used.

[0072] Controller 146 may be and / or include any suitable type of controller. For example, controller 146 may be and / or include one or more proportional controllers, proportional-integral (PI) controllers, proportional-integral-derivative (PID) controllers, read-lag controllers, nonlinear table controllers, linear table controllers, and / or other suitable types of controllers. In some examples, controller 146 may be, but is not required, one or more PI controllers having proportional components 174 and integral components 176, as shown in Figure 6. Furthermore, although not required, controller 146 may include multiple control loops and / or be configured to adjust intermediate states.

[0073] During operation, the controller 146 may be configured to receive a value of a reference parameter 178 input to the motor subcontroller 180. In one example, the received value of the reference parameter 178 may be a value related to the speed of the motor 105 (e.g., a setpoint, threshold, acceptable speed range, etc.), and the motor subcontroller 180 may process the value related to the speed of the motor 105 to generate a command signal 168 configured to operate the motor at or proportional to the speed indicated by the received value, thereby driving the driven components of the blood pump 100 (e.g., the driven or impeller shaft 108 and / or impeller 112). In some examples, as shown in Figure 6, the motor subcontroller 180 may include proportional and integral components 174 and 176 of a PI controller configured to process the value of the reference parameter 178, a value related to the received value of the reference parameter 178, and / or other appropriate data to generate the command signal 168 and output the command signal 168 (e.g., to the motor 105).

[0074] The value of reference parameter 178 may be any appropriate type of input from a user, component, or system communicating with the controller 146. In some cases, the value of reference parameter 178 may be a setpoint and / or one or more thresholds provided by the user interface 148, but this is not required. Reference parameter 178 may be any parameter related to the operation of the blood pump 100, including but not limited to the motor speed, the flow rate of blood passing through the blood pump 100, the intraventricular pressure of the heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), the differential pressure at both ends of the blood pump 100 (e.g., the pressure difference between the intraventricular pressure and the pressure in the aorta), mean arterial pressure (MAP), total cardiac output (TCO), and / or other appropriate values. In some examples, the value of reference parameter 178 may be a setpoint for the speed of the motor 105, but this is not required.

[0075] If the value of reference parameter 178 is the setpoint for the speed of motor 105, the value of reference parameter 178 may be configured to be added in adder 182 (e.g., an adding component) to the output from sensor 150 (e.g., whether or not it has passed through HPF 172). If the value of reference parameter 178 is not the setpoint for the speed of motor 105, the value of a parameter based on the value of reference parameter 178 (e.g., a speed determined based on the reference value) may be added in adder 182 to the output of sensor 150. Alternatively or additionally, if the value of reference parameter 178 is not the setpoint for the speed of motor 105 (e.g., a value such as pressure or flow rate), the value of reference parameter 178 may be compared in adder 182 to the value of a parameter based on the output of sensor 150 (e.g., pressure or flow rate). In some examples, if there is a "-" sign near the comparator, the difference between operands may be identified in adder 182 and / or other comparators described herein.

[0076] In Figure 6, a PI controller is shown as the type of controller between adder 182 and adder 183, but additional and / or alternative controller types may be used. If controller 146 includes proportional components 174 and integral components 176, the output of adder 182 may be processed by proportional components 174 and integral components 176. The outputs of proportional components 174 and integral components 176 may be added together in adder 183, which outputs command signal 168. The value added in adder 183 may be added to generate command signal 168, but this is not required. Other suitable configurations of the motor subcontroller 180 are also assumed.

[0077] The controller 146 may determine or calculate one or more parameters using outputs and / or signals from the control and / or operation of the blood pump 100, including the motor 105 and impeller 112 (e.g., command signal 168, detected motor speed, detected aortic pressure, etc.). Additionally or alternatively, the controller 146 may determine or calculate one or more parameters using outputs from one or more other sensors of the blood pump 100 or the circulatory support system 10 related to the operation of the blood pump 100, the outputs from one or more sensors including, but not limited to, outputs from a pressure sensor, an output from a flow sensor, and / or outputs from one or more other suitable sensors.

[0078] The parameters determined or calculated by the controller 146 may include one or more values ​​of parameters relating to the blood flow pumped through the blood pump 100 and / or otherwise relating to the operation of the blood pump 100. In some examples, the controller 146 may be configured to determine or calculate values ​​of one or more values ​​of the flow rate of blood passing through the blood pump 100, one or more pressures in the vicinity of the blood pump 100 (e.g., left ventricular pressure, right ventricular pressure, differential pressure at both ends of the blood pump 100, etc.), motor mechanical losses, and / or other appropriate parameters relating to the blood flow pumped through the blood pump 100 and / or otherwise relating to the operation of the blood pump 100.

[0079] To enable the determination or calculation of one or more values ​​of parameters related to the blood flow pumped through the blood pump 100 and / or otherwise related to the operation of the blood pump 100, the controller 146 may include a state observer 151. The state observer 151 may be configured to receive outputs and / or signals from the controller 146 and / or outputs and / or signals from the operation of the motor 105 and impeller 112 (e.g., command signal 168, detected motor speed, detected pressure, detected flow rate, etc.). In some examples, as shown in Figure 6, the state observer 151 may be configured to receive command signal 168 and detected motor speed from motor speed sensor 150. Other configurations are also conceivable, and additional or alternative inputs may be received by the state observer 151.

[0080] The status monitor 151 may be configured to monitor received inputs and determine or calculate values ​​for one or more parameters related to the operation of the blood pump 100 based on the inputs. For example, the status monitor 151 may be configured to use the received parameter values ​​(e.g., the value of the command signal 168, a value related to the speed of the motor 105, and / or other appropriate values) to calculate or determine values ​​for the flow rate of blood passing through the blood pump 100, the pressure supplied by the blood pump 100, the ventricular pressure, the differential pressure at both ends of the blood pump 100, the arterial pressure, the stall pressure of the motor 105, the pressure loss passing through the blood pump 100, the motor mechanical loss, the motor torque, and / or other parameters.

[0081] Once the parameter values ​​are calculated or determined at the state observer 151 and / or at other locations in the controller 146, some or all of the parameter values ​​may be provided to the storage component 153. The storage component 153 may be and / or contain memory 154 and / or other suitable memory. Although the storage component 153 is shown as part of the controller 146, it may be physically separate from the rest of the controller 146.

[0082] The storage component 153 can be configured in any suitable way. In some examples, the storage component 153 may be or include a sample-by-sample storage system in which each received value is stored individually in memory. Additionally or alternatively, in some examples, the storage component 153 may be or include a filter (e.g., a low-pass filter, a high-pass filter with a long time constant) configured to collect enough computed or determined values ​​for a parameter, analyze those values, and determine whether a device migration is necessary. In some cases, the storage component 153 may be configured, but is not required, to store values ​​received from the state observer 151 along with values ​​for similar parameters.

[0083] The stored data can be analyzed by the analysis component 155 to identify trends in the calculated or determined data stored in the storage component 153 and / or received directly from the state observer 151. Trends in the calculated or determined data (e.g., calculated or determined values ​​of parameters) may include at least two values, and the trend may be identified from one or more values ​​of each of two or more parameters, or from two or more values ​​of a single parameter. The analysis component 155 may utilize any appropriate statistical analysis to identify trends in two or more values ​​of one or more parameters related to the operation of the blood pump determined or calculated over time. In some examples, trends in the calculated or determined data may include, but are not limited to, the rate of change of the calculated or determined data values, the mean or moving average of the calculated data values, the thresholds of two or more parameters, and / or other appropriate types of trends.

[0084] The analysis component 155 may be configured to analyze stored and / or received data to determine (e.g., predict) that the patient's needs may differ from the capacity of the blood pump 100. For example, the analysis component 155 may be configured to analyze stored and / or received data to determine (e.g., predict) that the output required from the blood pump 100 (e.g., the patient's needs from the blood pump 100) exceeds the available output of the blood pump 100 due to increased patient needs and / or wear and tear on the blood pump 100 due to use, and / or determine that the patient's needs have decreased (e.g., determine that an escalation of the blood pump is needed or will be needed). In some examples, the analysis component 155 may indicate the date and / or time when a transition of the blood pump (e.g., escalation or deescalation) is needed or recommended. The analysis component 155 may use any appropriate statistical analysis (e.g., linear analysis and / or other appropriate statistical analysis) to identify trends in two or more values ​​of one or more parameters related to the operation of the blood pump determined or calculated over time, and to identify when the capacity of the blood pump 100 becomes insufficient to treat the patient.

[0085] In some cases, the analysis component 155 may determine whether a blood pump transition (e.g., escalation or deescalation) is necessary based on one or more values ​​of one or more parameters related to the operation of the blood pump 100 calculated or determined over time. In some examples, the analysis component 155 may determine when or will be necessary for a blood pump transition based on comparing the value of a parameter to a threshold associated with the parameter, and if the value of the parameter reaches or exceeds a threshold indicating that a blood pump transition is necessary or will be necessary. Additionally or alternatively, in some examples, the analysis component 155 may determine when or will be necessary for a blood pump transition based on comparing the trend of one or more values ​​of one or more parameters to a threshold, and if the trend exceeds a threshold that may indicate that a blood pump transition is necessary or will be necessary.

[0086] The analysis component 155 may be configured to output the results of its analysis of the stored data to the user interface 148 for display and / or to provide alerts to the user and / or the motor subcontroller 180. In some cases, the analysis component 155 may continuously provide the results of its analysis of the stored data to the user interface 148 and display them graphically as the date of device migration (e.g., the date and / or time when the migration to a different pump should take place), the probability that a device migration will be necessary, the probability of when a device migration will be necessary, and / or other appropriate format of display information. Additionally or alternatively, the analysis component may output warning signals and / or alerts when a device migration is urgently needed. In some examples, the warnings and / or alerts may increase in urgency (e.g., sound, color change) as the urgency of the device migration increases over time.

[0087] The configuration of the circulatory support system 10 in Figure 6 may enable the predictive meeting of patient needs over time by ensuring, in an automated manner, that the patient's blood pump has and continues to have sufficient capacity to meet the patient's needs. Furthermore, the described configuration of the circulatory support system 10 may reduce the time spent monitoring the operation of the blood pump 100, as the user can rely on the system 10 to identify when a device transition (e.g., escalation or deescalation) is required.

[0088] Figure 7 shows a schematic diagram of an exemplary control system for a circulatory support system 10 similar to the control system shown in Figure 6, but includes a state monitor 151 and a storage component 153 configured to calculate or determine and then store values ​​for the flow rate of blood passing through the blood pump 100, the left ventricular pressure, and the mechanical loss of the motor (e.g., the decay of the motor 105 of the blood pump 100 over time). As shown in Figure 7, the state monitor 151 may include a flow monitor 184 (e.g., a subcontroller or other suitable monitor) configured to calculate or determine one or more values ​​for the flow rate of blood passing through the blood pump 100, a pressure monitor 186 (e.g., a subcontroller or other suitable monitor) configured to calculate or determine one or more values ​​for the left ventricular pressure and / or other suitable pressure values, and a motor mechanical loss monitor 216 (e.g., a subcontroller or other suitable monitor) configured to determine or calculate one or more values ​​for the mechanical loss of the motor 105. The status monitor 151 may be included in the controller 146 or may include other suitable monitors that communicate with the controller 146 in order to calculate or determine the values ​​of parameters related to the operation of the blood pump 100.

[0089] The flow rate monitor 184 may be configured to calculate or determine the flow rate of blood passing through the blood pump 100 based, in whole or at least in part, on the received command signal value and the detected motor speed value. If necessary, the flow rate may be calculated using other appropriate parameter values. Additionally or alternatively, the flow rate may be directly detected and filtered or calibrated as necessary. The calculated or determined flow rate may then be stored in the flow rate compartment 153a of the storage component 153. Exemplary configurations for calculating or determining the flow rate of blood passing through the blood pump 100 are described in more detail with respect to Figures 8 to 10, which are described herein.

[0090] The pressure meter 186 may be configured to calculate or determine left ventricular pressure entirely or at least partially based on the received command signal value, the detected motor speed value, and the detected pressure value from the pressure sensor 138, which may be configured to detect aortic pressure. If necessary, the left ventricular pressure may be calculated using other appropriate parameter values. Additionally or alternatively, the pressure may be directly detected and / or filtered or calibrated as necessary. The calculated or determined pressure may then be stored in the pressure compartment 153b of the storage component 153. Exemplary configurations for calculating or determining left ventricular pressure are described in more detail with respect to Figures 9–13 described herein.

[0091] The motor mechanical loss meter 216 may be configured to calculate or determine the motor mechanical loss based entirely or at least partially on the received command signal value and the detected motor speed value. The motor mechanical loss of the blood pump 100 may be calculated or determined, as desired, using other appropriate parameter values. The calculated or determined motor mechanical loss may then be stored in the motor mechanical loss compartment 153c of the storage component 153. An exemplary configuration for calculating or determining the motor mechanical loss will be described in more detail with respect to Figure 10, which is illustrated herein.

[0092] The analysis component 155 may be configured to use one or more values ​​of flow rate, pressure, and / or motor mechanical loss calculated or determined over time (e.g., one or more values, two or more values ​​over time) to identify one or more trends indicating that the blood pump will become insufficient to meet the patient's needs in a predictable future time. In some examples, one or more values ​​of the calculated or determined parameters (e.g., flow rate, pressure, and / or motor mechanical loss) reaching or exceeding thresholds associated with the parameters may indicate or suggest that a blood pump transition is necessary or will be necessary. In some examples, a trend indicating increasing motor mechanical loss and a decreasing flow rate of blood passing through the blood pump 100 indicates or suggests that device escalation is necessary or will be necessary. In some examples, a flow rate required to maintain a desired MAP exceeding the capacity of the blood pump 100 or increasing at a rate that causes rapid wear of the blood pump 100 may indicate or suggest that device escalation is necessary or will be necessary. In some cases, a MAP value (e.g., determined by pressure gauge 186, or otherwise calculated or detected) increasing at a rate that prevents the pump from reaching a desired flow rate may indicate or suggest that device escalation is necessary or will be necessary. Other examples are also possible.

[0093] In some cases, the trends of the calculated or determined parameters can be used to provide the probability that a transition (e.g., escalation or deescalation) will be required. Furthermore, the trends of the calculated or determined parameters can be used to identify the date and / or time when a device transition will be required. In some examples, the trends of one or more values ​​of one or more parameters calculated or determined over time are compared to one or more thresholds, one or more thresholds associated with the patient's needs, and if the trend reaches or exceeds the threshold, an instruction may be output from the controller 146 (e.g., to the user interface 148 and / or the user) indicating that a blood pump transition is required by the date and / or time. For example, if a patient has a known minimum flow rate (e.g., a threshold) for the blood pump 100 to be useful, and the maximum flow rate generated by the blood pump is decreasing at a known rate (e.g., the trend of two or more calculated flow rate values ​​decreasing linearly or non-linearly), the analysis component 155 may determine when device escalation is likely to be necessary and output an alert to the user interface 148 indicating when device escalation is required.

[0094] When thresholds are used to determine when a blood pump transition is necessary, the thresholds may be based on any appropriate factors. For example, the thresholds may be based on the patient's needs, the time required to prepare the patient for the placement of a new blood pump, the severity of the need for device transition, and / or other appropriate factors.

[0095] The analysis component 155 may optionally be configured to output the results of its analysis to the state observer 151, thereby enabling a loose implicit feedback loop. In some examples, the state observer 151 uses the output of the analysis component 155 to obtain the coefficients used by the state observer (e.g., C described below). L , C N (etc.) can be updated.

[0096] The analysis component 155 may optionally be configured to output the results of its analysis to the motor subcontroller 180 for comparison with the value of the reference parameter 178 and / or the motor speed. For example, if the analysis component 155 identifies that the motor mechanical loss is increasing over time, this trend indication may be provided to the motor subcontroller 180 (e.g., adder 182, proportional component 174, and / or integral component 176) to generate a command signal 168 that predictively takes the motor mechanical loss into account, and is configured such that the motor 105 achieves a speed proportional to the received reference parameter 178 regardless of the motor's mechanical loss. In some cases, the trend results from the analysis component 155 may be used, though not required, to modify the coefficients in the formula used to calculate the command signal 168. Other suitable examples are also conceivable in which the motor subcontroller 180 uses the results from the analysis component 155 and / or values ​​calculated or determined in the state observer 151 to generate the command signal 168 and control the operation of the blood pump.

[0097] The parameters determined or calculated by the controller 146 (e.g., by the state monitor 151) may include one or more values ​​of parameters relating to the blood flow pumped through the blood pump 100 and / or otherwise relating to the operation of the blood pump 100. In some examples, as described, the controller 146 may be configured to determine or calculate values ​​of one or more values ​​of the blood flow rate passing through the blood pump 100 in the flow monitor 184 (e.g., a subcontroller or other suitable monitor), one or more pressures near the blood pump 100 (e.g., left ventricular pressure, right ventricular pressure, differential pressure at both ends of the blood pump 100, etc.) in the pressure monitor 186 (e.g., a subcontroller or other suitable monitor), motor mechanical loss in the motor mechanical loss monitor 216 (e.g., a subcontroller or other suitable monitor), and / or other suitable parameters relating to the blood flow pumped through the blood pump 100 and / or otherwise relating to the operation of the blood pump.

[0098] The flow rate and / or pressure in or near the blood pump 100 can be calculated by any suitable method. In some cases, the flow rate and / or pressure in or near the blood pump 100 can be calculated based on Bernoulli's theorem.

[0099]

number

[0100] Here, ρ is the fluid density, g is the acceleration due to gravity, P is the pressure at a point in the fluid, v is the fluid velocity at that point, h is the height at that point, and C is a constant based on the physical properties of the working fluid.

[0101] The flow rate and / or pressure in or near the blood pump 100 can also be calculated using Newton's force equilibrium equations.

[0102]

number

[0103] Here, F is the force applied by the motor, m is the mass of the fluid in motion, and a is the acceleration applied to the working fluid. Figures 8 to 13 show schematic diagrams of exemplary controller configurations for calculating or determining the parameter values. Exemplary suitable techniques for calculating or determining the parameter values ​​are described in U.S. Patent Application No. 63 / 540,346, filed September 25, 2023, entitled "Circulation Support Devices, System, and Methods," which is incorporated herein by reference in its entirety.

[0104] The flow rate monitor 184 and the pressure monitor 186 may utilize the command signal 168 output from the motor subcontroller 180 as a parameter value representing the operation of the motor 105. In some cases, the command signal 168 may include a voltage level or value, or a voltage signal, configured to achieve a desired motor rotation or speed. The voltage level or value in the command signal 168 may be used to determine the parameter value instead of using the current detected in the motor 105, which may offer advantages over using the current detected in the motor 105 when determining the parameter value related to the operation of the blood pump 100. For example, by using the command signal 168, there is no need to wait for the motor to execute the command signal 168 and for the sensor to detect the current used by the motor 105 operating in response to the executed command signal 168, which may allow for faster determination or calculation of flow rate and / or pressure compared to determining the parameter value using the value of the current detected in the motor 105. By using command signal 168 as input for determining parameter values, it becomes possible to determine parameter values ​​based on how motor 105 will operate, rather than how motor 105 was operating, which is identified using the current or voltage detected in motor 105. This is because transmitting the detected current or voltage values ​​to controller 146 takes time, which may involve passing the detected current or voltage values ​​through one or more filters (e.g., HPF 172 and / or other suitable filters). Furthermore, by using the voltage level or value of command signal 168, the amount of noise in determining parameter values ​​can be reduced compared to the noise level when using detected current and / or voltage values ​​in motor 105 to determine parameter values, thereby reducing the complexity in determining or calculating flow rate and / or pressure.

[0105] Figure 8 schematically illustrates the operation of an exemplary flow meter 184 configured to determine or calculate the flow rate of blood flowing across the blood pump 100. The flow meter 184 may be configured to receive values ​​from a command signal 168 (e.g., voltage level or value and / or other appropriate values) and the detected motor speed 187 or related values. Based on the received signals or values, the flow meter 184 may determine or calculate the motor torque output 188 of the motor 105 and the mechanical loss 190 of the motor 105 (e.g., the amount of torque or energy required to rotate the motor 105).

[0106] The motor torque output 188 and the mechanical loss 190 can be determined by any suitable method. An exemplary configuration for determining the motor torque output 188 is described with reference to Figure 9. An exemplary configuration for determining the mechanical loss 190 is described with reference to Figure 10.

[0107] Once the motor torque output 188 and mechanical loss 190 of motor 105 are determined or calculated, one or more of the determined values ​​of motor torque output 188 and one or more of the mechanical loss 190 of motor 105 may be added together in adder 192. In some examples, the difference between these values ​​may be identified in adder 192. The difference between motor torque output 188 (e.g., the total torque generated by motor 105) and mechanical loss 190 of motor 105 (e.g., the amount of torque required to rotate motor 105) represents the amount of torque used by motor 105 to pump blood through the blood pump 100.

[0108] Once the difference between the motor torque output 188 and the mechanical loss 190 is determined, one or more pump coefficients (e.g., torque-flow pump coefficients) are applied to the difference so that the determined torque of the motor 105 available for pumping fluid through the blood pump 100 can be associated with the flow rate of fluid through the blood pump 100. In some examples, one or more coefficients may be determined experimentally and be specific to the configuration of the blood pump 100.

[0109] In the exemplary configuration shown in Figure 8, two pump coefficients can be applied separately to values ​​related to the determined difference between the motor torque output 188 of the motor 105 and the mechanical loss 190. The first pump coefficient K FR0 (194) can be applied to the difference between the motor torque output 188 and the mechanical loss 190. First pump coefficient K FR0 (194) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the motor torque of the blood pump 100 with the flow rate through the blood pump 100. Furthermore, the square root 196 of the difference between the motor torque output 188 and the mechanical loss 190 is determined, and the second torque-flow coefficient K FR1 (198) can be applied to the value of the square root 196. Second torque-flow coefficient K FR1 (198) may be an experimentally determined value for the blood pump 100, which correlates the square root of the motor torque of the blood pump 100 with the flow rate through the blood pump 100.

[0110] In the adder 200, the first torque-flow coefficient K FR0 The value obtained by applying (194) to the difference between the motor torque output 188 and the mechanical loss 190 is the second torque-flow coefficient K FR1 (198) is added to the value obtained by applying (198) to the square root of the difference between the motor torque output 188 and the mechanical loss 190. This sum may be or may be the value of the determined or calculated flow rate 202 passing through the blood pump 100. The flow rate 202 may be output to the user interface 148 or other user interface and used by healthcare professionals when treating a patient with the blood pump 100, and / or may be used to automatically control the operation of the blood pump 100 by providing the determined or calculated flow rate to the motor subcontroller 180, and / or in one or more other suitable ways.

[0111] FIG. 9 schematically illustrates a diagram of an exemplary operation of a motor torque output observer 204 (e.g., a sub-controller or other suitable observer) configured to determine or calculate a motor torque 188 of a motor 105 of the blood pump 100. The motor torque output observer 204 may be configured to receive a value from the command signal 168 (e.g., a voltage value and / or other suitable value) and the detected motor speed 187 or a value associated therewith. The motor torque output observer 204 may determine or calculate a motor torque output 188 of the motor 105 based on the received signals or values.

[0112] Once the command signal 168 and the detected motor speed 187 are received, one or more coefficients may be applied to the values of the command signal 168 and the detected motor speed 187 or values associated therewith. In some examples, the one or more coefficients may be experimentally determined and / or specific to the configuration of the motor 105, and may correlate voltage values with the torque output of the motor 105. In some cases, one or more of the coefficients that relate voltage and torque output may be provided on a data sheet of the motor 105.

[0113] In the exemplary configuration shown in FIG. 9, two coefficients may be separately applied to the received voltage command signal 168 and the detected motor speed 187, respectively. A torque-voltage coefficient K T (206) is applied to the value of the detected motor speed 187 or a value associated therewith, and may generate a voltage value (e.g., a back EMF value of the motor 105 and / or other suitable value) that is added to the value of the command signal 168 in an adder 208. The torque-voltage coefficient K T (206) may be a motor torque constant and may be a parameter value found on a motor data sheet.

[0114] In the adder 208, a difference between a value determined by applying the torque-voltage coefficient K T (206) to the detected motor speed 187 and the value of the command signal 168 may be determined. The torque-voltage coefficient K TThe value obtained by applying (206) to the detected motor speed 187 may be the amount of voltage internally generated for the motor 105 based on the speed of the motor 105, or may represent the amount of voltage. To determine the exact value of the motor torque output 188, the torque-voltage coefficient K T The value obtained by applying (206) to the detected motor speed 187 can be subtracted from the command voltage in the command signal 168.

[0115] The ratio coefficient 210 is the torque-voltage coefficient K T (206) can be applied to the difference between the value obtained by applying it to the detected motor speed 187 and the value of the command signal 168. The ratio coefficient 210 is the torque voltage coefficient K T (206) can be determined by dividing it by the winding resistance of motor 105. Winding (or terminal) resistance R of motor 105 w (212) can be experimentally determined for motor 105 and / or the winding resistance R of motor 105. w (212) may be a value found in the datasheet for motor 105.

[0116] Torque-voltage coefficient K T The output obtained by applying the ratio coefficient 210 to the difference between the value obtained by applying (206) to the detected motor speed 187 and the value of the command signal 168 may represent the motor torque output 188. In some cases, as shown in Figure 9, for example, the low-pass filter 214 has a torque-voltage coefficient K T The output value obtained by applying (206) to the detected motor speed 187 and applying the ratio coefficient 210 to the difference between that value and the value of the command signal 168 can be applied. The low-pass filter 214 may be configured to filter out noise by filtering out all values ​​with frequencies higher than a predetermined frequency threshold.

[0117] Figure 10 schematically illustrates the operation of an exemplary motor mechanical loss meter 216 (e.g., a subcontroller or other suitable meter) configured to determine or calculate the mechanical loss 190 of the motor 105 of the blood pump 100 based on a force equilibrium equation. The motor mechanical loss meter 216 may be configured to receive a detected motor speed 187 or a related value. Based on the received signal or value, the motor mechanical loss meter 216 may determine or calculate the motor mechanical loss 190 of the motor 105.

[0118] When a value(s) of the detected motor speed 187 is received, a low-pass filter 218 may be applied to the value(s) of the detected motor speed 187. The low-pass filter 218 may be the same as the low-pass filter 214 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and it filters out noise from the received value(s) of the detected motor speed 187. The output of the low-pass filter 218 may be processed in several separate steps and added to obtain the determined or calculated motor mechanical loss 190.

[0119] In one step, the derivative 220 of the output of the low-pass filter 218 may provide the acceleration of the motor 105. The equation of inertia J(222) may be applied to the determined or calculated acceleration of the motor 105, and the output of applying the equation of inertia J(222) to the acceleration of the motor 105 may represent, or may be, the calculated or determined force required to overcome the inertial force of the motor 105.

[0120] In the additional processing step, the output of the low-pass filter 218 is squared (224), and the nonlinear drag coefficient C N (226) can be applied to the square of the output of the low-pass filter 218. Nonlinear drag coefficient C N (226) corresponds to the nonlinear force and / or power lost to the environment as heat due to the inefficiency of the motor 105, and the nonlinear drag coefficient C NThe output obtained by applying (226) to the output of the low-pass filter 218 may represent, or may be, a calculated or determined force necessary to overcome the nonlinear drag acting on the motor 105.

[0121] The calculated or determined force required to overcome the inertia of motor 105 and the calculated or determined force to overcome the drag of motor 105 can be added together in adder 228. The output of adder 228 may be, or represent, the calculated or determined net inertia and nonlinear force acting on motor 105.

[0122] In yet another processing step, the linear drag coefficient C L (230) can be applied to the output of the low-pass filter 218. Linear drag coefficient C L (230) corresponds to the linear force and / or power lost to the environment as heat due to the inefficiency of the motor 105, and the linear drag coefficient C L The output obtained by applying (230) to the output of the low-pass filter 218 may represent, or may be, a calculated or determined force required to overcome the linear drag acting on the motor 105.

[0123] The calculated or determined net inertial and nonlinear forces acting on motor 105, and the calculated or determined forces required to overcome the linear drag of motor 105, can be added in adder 232. The output of adder 232 may be the calculated or determined net forces acting on motor 105 (e.g., inertial force, nonlinear drag, and linear drag), or may represent the calculated or determined net forces. In other words, the output of adder 232 may be the motor mechanical loss 190.

[0124] Figure 11 schematically shows an exemplary operation of a pressure monitor 186 configured to determine or calculate the pressure distal to (or proximal to the direction of blood flow) the impeller 112 (e.g., ventricular pressure such as left ventricular pressure and / or right ventricular pressure, depending on which ventricle the blood pump 100 extends into), where the distal end of the impeller may be located in a ventricle (e.g., the left or right ventricle of the patient's heart). The pressure monitor 186 may be configured to receive values ​​from a command signal 168 (e.g., a voltage value or level and / or other appropriate value), a detected motor speed 187 or a related value, and values ​​from a pressure sensor 138 (e.g., a pressure sensor that detects pressure proximal to the impeller 112 or distal to the direction of blood flow, such as pressure in the patient's aorta). Based on the received signal or value, the pressure meter 186 may determine or calculate the motor torque output 188 of the motor 105, the mechanical loss 190 of the motor 105 (e.g., the amount of torque or energy required to rotate the motor 105), and the stall pressure (e.g., head pressure or zero flow pressure), which may be the pressure at which blood is no longer moving through the blood pump 100.

[0125] The motor torque output 188 and mechanical losses 190 can be determined by any suitable method, including, but not limited to, those described herein with respect to Figures 9 and 10. Furthermore, the stall pressure 234 can be determined by any suitable method. An exemplary configuration for determining the stall pressure 234 is described with respect to Figure 12.

[0126] Once the motor torque output 188 and mechanical loss 190 of motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 and one or more values ​​of the mechanical loss 190 of motor 105 may be added together in adder 236. In some examples, the difference between these values ​​may be identified in adder 236, and this difference may represent the amount of torque used by motor 105 to pump blood through the blood pump 100, as described above with respect to Figure 9.

[0127] Once the difference between the motor torque output 188 and the mechanical loss 190 is determined, the pressure gauge 186 may use the difference between the motor torque output 188 and the mechanical loss 190 and the detected motor speed 187 to calculate or determine the pressure loss 238 caused by the blood flow passing through the blood pump 100. An exemplary configuration for determining the pressure loss 238 is described with reference to Figure 13.

[0128] In the exemplary configuration shown in Figure 11, the calculated or determined pressure loss 238 can be added to the stall pressure 234 calculated or determined in the adder 240. The difference between the stall pressure 234 and the pressure loss 238 may be and / or represent the instantaneous pressure drop across the entire pump for a particular blood flow passing through the blood pump 100. In some examples, the pressure drop represents the difference between the pressure in the ventricle where the blood pump is located (e.g., the left ventricle or the right ventricle) and the arterial pressure in the artery where the blood pump 100 is located (e.g., the aorta or the left pulmonary artery).

[0129] The determined pressure drop passing through the blood pump 100 can be added in the adder 242 to a pressure value based on the pressure sensor 138 and / or an index detected by the pressure sensor 138 (e.g., the pressure at a location proximal to the impeller 112, such as the patient's aorta). In the adder 242, the pressure value can be subtracted from the determined pressure drop passing through the blood pump 100 to determine a distal pressure value 244, which is the distal pressure of the impeller 112 (e.g., ventricular pressure such as left ventricular pressure or right ventricular pressure). The distal pressure value 244 can be output to the user interface 148 or other user interfaces and used by healthcare professionals when treating a patient with the blood pump 100, and / or used to automatically control the operation of the blood pump 100 by providing the determined or calculated distal pressure value 244 to the motor subcontroller 180, and / or can be output in one or more other appropriate forms.

[0130] Figure 12 schematically illustrates the operation of an exemplary motor stall pressure meter 246 (e.g., a subcontroller or other suitable meter) configured to determine or calculate the stall pressure 234 of the motor 105 of the blood pump 100. The stall pressure meter 246 may be configured to receive the detected motor speed 187 or a related value. Based on the received signal or value, the stall pressure meter 246 may determine or calculate the stall pressure 234 of the motor 105.

[0131] When a value(s) of the detected motor speed 187 is received, a low-pass filter 248 may be applied to the value(s) of the detected motor speed 187. The low-pass filter 248 may be the same as one or both of the low-pass filters 214, 218 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and is used to filter out noise from the received value(s) of the detected motor speed 187. The output of the low-pass filter 218 may be processed in several separate steps to determine the motor 105 or to obtain a calculated stall pressure 234.

[0132] In one step, the derivative 220 of the output of the low-pass filter 248 may provide the acceleration of the motor 105. In an additional processing step, the output of the low-pass filter 248 may be squared (224).

[0133] Once the acceleration of motor 105 is determined and the output of low-pass filter 248 is squared, one or more coefficients (e.g., speed-pressure loss pump coefficients) can be applied to relate the detected motor speed 187 to the stall pressure 234. In some examples, one or more pump coefficients may be experimentally determined and specific to the configuration of blood pump 100. In some examples, a second pump coefficient K SP1 (221) can be applied to the acceleration of motor 105, and the first pump coefficient K SP0 (225) can be applied to the squared motor speed output from the low-pass filter 248. Second pump coefficient K SP1(221) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the acceleration of the motor 105 of the blood pump 100 with the stall pressure of the blood pump 100. First pump coefficient K SP0 (225) may be an experimentally determined value for the blood pump 100 that correlates the square of the detected motor speed 187 with the stall pressure of the blood pump 100.

[0134] First pump coefficient K SP0 The output obtained by applying this to the output of the low-pass filter 248 is used in the adder 250 to obtain the second pump coefficient K SP1 The first pump coefficient K can be subtracted from the output obtained by applying it to the acceleration of motor 105. SP0 The output obtained by applying this to the squared output of the low-pass filter 248, and the second pump coefficient K SP1 The difference determined in the adder 250 between the output obtained by applying this to the acceleration of motor 105 may be the stall pressure 234, which may be the maximum pressure that the blood pump 100 can generate.

[0135] Figure 13 schematically illustrates the operation of an exemplary pressure loss meter 252 (e.g., a subcontroller or other suitable meter) configured to determine or calculate the pressure loss 238 of the motor 105 of the blood pump 100. The pressure loss meter 252 may be configured to receive a detected motor speed 187 or a related value and a residual motor torque 254 or a related value. The residual motor torque 254 may be the difference between the motor torque output 188 and the motor mechanical loss 190. Based on the received signals or values, the pressure loss meter 252 may determine or calculate the pressure loss 238 of the motor 105.

[0136] When the detected motor speed 187 and residual motor torque 254 values ​​(multiple values) are received, a low-pass filter 256 may be applied to the detected motor speed 187 value (multiple values). The low-pass filter 256 may be the same as one or both of the low-pass filters 214, 218, and 248 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and may be used to filter out noise from the received detected motor speed 187 value. The output of the low-pass filter 218 may be provided to a multiplier 258.

[0137] The residual motor torque 254 may be processed in several steps using one or more coefficients relating the residual motor torque 254 and / or the detected motor speed 187 to the pressure loss 238. In some examples, one or more coefficients may be experimentally determined and specific to the configuration of the blood pump 100.

[0138] In one step, the first pump coefficient K PL0 (255) can be applied to the residual motor torque. First pump coefficient K PL0 (255) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the residual motor torque of the blood pump 100 with the pressure loss 238. First pump coefficient K PL0 The result obtained by applying (255) may be provided to the adder 260.

[0139] Furthermore, the square root 196 of the residual motor torque 254 can be calculated or determined and applied to the multiplier 258. The value received in the multiplier 258 can be multiplied. After the value received by the multiplier 258 is multiplied, the second pump coefficient K is applied to the product of the values ​​provided to the multiplier 258. PL1 (259) may be applicable. Second pump coefficient K PL1(259) may be an experimentally determined value for the blood pump 100, which correlates the product of the residual motor torque 254 and the detected motor speed 187 with the pressure loss 238. The second pump coefficient K is added to the product of the values ​​supplied to the multiplier 258. PL1 The result obtained by applying (259) can be supplied to adder 260.

[0140] In the adder 260, the first pump coefficient K PL0 The value obtained by applying (194) to the residual motor torque 254 and the value output from the multiplier 258 are given by the second pump coefficient K PL1 The value of the pressure loss 238 can be determined or calculated by adding the value obtained by applying (259). The determined value of the pressure loss 238 can be used in determining the distal pressure or ventricular pressure 244 and / or other appropriate parameters.

[0141] The constants or coefficients shown and described in Figures 8 to 13 may be values ​​based on one or more parameters. In some examples, the constants or coefficients in Figures 7 to 12 may be values ​​scheduled based on the motor or pump speed, motor or pump temperature, motor or pump power, motor or pump operating time, combinations of these parameter values, and / or additional or alternative parameter values ​​used to compensate for changes in pump performance due to changes in pump operating conditions.

[0142] Figure 14 shows a schematic method or technique 300 for operating a blood circulation support system for use in a patient's heart. Method 300 may include a step 302 of determining a command signal based on a value of a reference parameter. In some examples, the value of the reference parameter may be a value related to the speed of the motor of the blood pump of the blood circulation support system. The value of the reference parameter is received by the controller of the blood circulation support system, and a command signal may be determined based on the value of the reference parameter, as described herein or otherwise. The determined command signal is provided to the motor of the blood pump (304), which may drive the driven components of the blood pump (e.g., the impeller) to pump blood through the blood pump at a speed proportional to the received value of the reference parameter.

[0143] The values ​​of one or more parameters relating to the operation of the blood pump may be determined over time based on one or more of the values ​​of command signals, values ​​relating to motor speed, and / or other appropriate parameters (306). Parameters relating to the operation of the blood pump may include, but are not limited to, pressure parameters relating to the pressure near the blood pump, flow parameters relating to the blood flowing across the blood pump, motor mechanical loss (e.g., damping) parameters, and / or other appropriate parameters. In some examples, the determined values ​​of one or more parameters may be stored and / or analyzed in the manner described herein or otherwise.

[0144] In some examples, determining one or more values ​​of one or more parameters relating to the operation of the blood pump over time (306) may include determining two or more values ​​of two or more parameters relating to the operation of the blood pump over time. In such configurations, the two or more parameters relating to the operation of the blood pump over time may include two or more of the flow rate of blood passing through the blood pump, left ventricular pressure, mechanical losses in the blood pump, and / or other suitable parameters.

[0145] Based on one or more values ​​of one or more parameters related to the operation of the blood pump determined over time, instructions recommending a transition (e.g., escalation or deescalation) of the blood pump device may be determined and output (308). In some cases, two or more values ​​of one or more parameters related to the operation of the blood pump over time (e.g., one or more trends of the values ​​of one or more parameters) may indicate that the blood pump is becoming insufficient to meet the patient's needs and, by comparison with the patient's needs (e.g., one or more thresholds), may indicate when a transition of the blood pump should be made. The output instructions may be provided to the user interface and / or one or more users in the manner described herein or otherwise.

[0146] It should be understood that this disclosure is illustrative in many respects. Modifications can be made without exceeding the scope of this disclosure, particularly with respect to details, shape, size, and step arrangement. This may include, to a reasonable extent, the use of any feature of one exemplary embodiment used in other embodiments. The scope of this disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A circulatory support system The system includes a blood pump, and the blood pump is Driven components and, A motor configured to communicate with the driven component and drive the driven component to pump blood through the blood pump, One or more sensors configured to detect a value related to the speed of the motor, A controller that communicates with the motor and one or more sensors configured to detect values ​​related to the speed of the motor, The aforementioned controller, A command signal is determined based on a value related to the speed of the motor. The command signal is supplied to the motor to drive the driven component, Based on one or both of the command signal and the motor speed-related values, one or more values ​​of one or more parameters related to the operation of the blood pump are determined. A system configured to output an instruction recommending the transition of the blood pump based on the determined values ​​of the one or more parameters related to the operation of the blood pump.

2. The system according to claim 1, wherein the controller is further configured to identify trends in two or more values ​​of one or more parameters related to the operation of the blood pump determined over time, and to output an instruction that a transition of the blood pump is recommended when the trend reaches or exceeds a threshold level.

3. The system according to claim 1 or 2, wherein the controller includes a state observer configured to determine two or more values ​​of two or more parameters related to the operation of the blood pump.

4. The system according to any one of claims 1 to 3, wherein the determined one or more values ​​of the one or more parameters related to the operation of the blood pump include one or more values ​​of the left ventricular pressure obtained by the blood pump.

5. The system according to claim 4, wherein the controller is configured to output an instruction recommending the transition of the blood pump when one or more of the left ventricular pressure values ​​reach or exceed a threshold level.

6. The system according to any one of claims 1 to 5, wherein the determined one or more values ​​of the one or more parameters relating to the operation of the blood pump include one or more values ​​of the flow rate of blood passing through the blood pump.

7. The system according to claim 6, wherein the controller is configured to output an instruction recommending the transition of the blood pump when one or more values ​​of the blood flow rate passing through the blood pump reach or exceed a threshold level.

8. The system according to any one of claims 1 to 6, wherein the determined one or more values ​​of the one or more parameters relating to the operation of the blood pump include one or more values ​​of mechanical losses in the blood pump.

9. The system according to claim 8, wherein the controller is configured to output an instruction recommending the transition of the blood pump when one or more of the mechanical losses in the blood pump reach or exceed a threshold level.

10. The system according to any one of claims 1 to 9, wherein the instruction recommending the transfer of the blood pump includes a recommended time in which the transfer of the blood pump is recommended.

11. A non-temporary computer-readable medium containing instructions that can be executed by a circulatory support device for use in a patient's heart, wherein the instructions are to be executed by the circulatory support device. The steps include determining a command signal based on a value related to the speed of the motor of the blood pump of the circulatory support device, The steps include providing the command signal to the motor to drive the driven component and pumping blood flow through the blood pump, A step of determining one or more values ​​of one or more parameters related to the operation of the blood pump based on one or both of the command signal and the value related to the motor speed, A non-temporary computer-readable medium that causes a method to be performed, which includes the step of outputting an instruction that a transition of the blood pump is recommended based on two or more values ​​determined over time for one or more parameters related to the operation of the blood pump.

12. The above method further, A non-temporary computer-readable medium according to claim 11, comprising the step of identifying trends in the values ​​of two or more of the one or more parameters related to the operation of the blood pump as determined over time.

13. The non-temporary computer-readable medium according to claim 12, wherein the instruction recommending the transfer of the blood pump is output in response when the trend reaches or exceeds a threshold level.

14. The step of determining one or more values ​​of one or more parameters related to the operation of the blood pump includes determining two or more values ​​of two or more parameters related to the operation of the blood pump, selected from the group consisting of left ventricular pressure, the flow rate of blood passing through the blood pump, and mechanical losses in the blood pump. A non-temporary computer-readable medium according to any one of claims 11 to 13, wherein an instruction recommending the transition of the blood pump is output when the trend of two or more values ​​among at least one of the left ventricular pressure, the flow rate of blood passing through the blood pump, and the mechanical loss in the blood pump reaches or exceeds a threshold level.

15. The non-temporary computer-readable medium according to any one of claims 11 to 14, wherein the instruction recommending the transfer of the blood pump includes a recommended time in which the transfer of the blood pump is recommended.

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