Circulatory support devices, systems, and methods

Abstract

A circulatory support system can include a blood pump, one or more sensors, and a controller. The blood pump can include a driven component and a motor in communication with the driven component and the controller to drive the driven component to pump a flow of blood through the blood pump. The controller can be configured to determine a command signal based on a value related to a speed of the motor, provide the command signal to the motor to drive the driven component, determine a value of a parameter related to operation of the blood pump based on the command signal and the value related to the speed of the motor, and output an indication that a blood pump transition is recommended based on one or more determined values of one or more parameters related to operation of the blood pump.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 538,498, filed September 14, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to mechanical circulatory support devices. More specifically, this disclosure relates to the operation of percutaneous ventricular assist devices (PVADs). Background Technology

[0003] A wide variety of in vivo and extracorporeal medical devices and systems have been developed for medical applications, such as use in cardiac surgery and / or for cardiac treatment. Some of these devices and systems include guidewires, catheters, catheter systems, pump devices, cardiac assist devices, etc. These devices and systems are manufactured using any of a variety of different manufacturing methods and can be used according to any of these methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a continued need for alternative medical devices and systems, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0004] This disclosure provides alternatives for the design, materials, manufacturing methods, and uses of medical devices, including ventricular assist devices.

[0005] In a first example, a circulatory support system may include: a blood pump, the blood pump comprising: a driven component; and a motor, the motor communicating with the driven component and configured to drive the driven component to pump blood flow through the blood pump; one or more sensors configured to sense values ​​related to the speed of the motor; and a controller communicating with the motor and the one or more sensors configured to sense values ​​related to the speed of the motor, wherein the controller may be configured to: determine a command signal based on the values ​​related to the speed of the motor; 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 one or both of the command signal and the values ​​related to the speed of the motor; and output an indication recommending a blood pump switching based on the determined values ​​of one or more parameters related to the operation of the blood pump.

[0006] In a different example, in addition to or supplementing any of the examples above, the controller may be further configured to: identify trends in two or more values ​​of the one or more parameters related to the operation of the blood pump as determined over time; and output an indication recommending a blood pump switch when the trend reaches or exceeds a threshold level.

[0007] In a different example, in addition to or supplementing any of the examples above, the controller may include a state observer configured to determine two or more values ​​of two or more parameters related to the operation of the blood pump.

[0008] In a different example, in addition to or in addition to any of the examples above, the 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 provided by the pump.

[0009] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to output an indication recommending a blood pump switch when one or more values ​​of the left ventricular pressure reach or exceed a threshold level.

[0010] In a different example, in addition to or in addition to any of the examples above, the determined values ​​of one or more parameters related to the operation of the blood pump may include one or more values ​​of the blood flow rate through the blood pump.

[0011] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to output an indication recommending a blood pump switching when one or more values ​​of the blood flow rate through the blood pump reach or exceed a threshold level.

[0012] In a different example, in addition to or in addition to any of the examples above, 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.

[0013] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to output an indication recommending a blood pump switching when one or more values ​​of mechanical loss in the blood pump reach or exceed a threshold level.

[0014] In a different example, in addition to or in addition to any of the examples above, the indication recommending a blood pump transition may include a recommended time for the blood pump transition to occur.

[0015] In a further example, instructions are stored on a non-transitory computer-readable medium, instructions executable by a circulatory support device for a patient's heart, the instructions causing the circulatory support device to perform methods including: determining a command signal based on a value related to the speed of a motor of a blood pump of the circulatory support device; providing the command signal to the motor to drive a driven component to 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 based on one or both of the command signal and the value related to the speed of the motor; and outputting an indication to recommend a blood pump switching based on two or more values ​​of the one or more parameters related to the operation of the blood pump determined over time.

[0016] In a different example, in addition to or supplementing any of the examples above, the method may further include identifying trends in two or more values ​​of the one or more parameters related to the operation of the blood pump over time.

[0017] In a different example, in addition to or in addition to any of the examples above, the indication for recommending a blood pump shift could be in response to the trend reaching or exceeding a threshold level.

[0018] In a different example, in addition to or supplementing any of the examples above, determining one or more values ​​of one or more parameters related to the operation of the blood pump may include: determining two or more values ​​of two or more parameters related to the operation of the blood pump, the two or more parameters being selected from the group consisting of left ventricular pressure, blood flow rate through the blood pump, and mechanical losses in the blood pump; and outputting an indication recommending a blood pump switchover when the trend of two or more values ​​of at least one of left ventricular pressure, blood flow rate through the blood pump, and mechanical losses in the blood pump has reached or exceeded a threshold level.

[0019] In a different example, in addition to or in addition to any of the examples above, the indication recommending a blood pump transition may include a recommended time for the blood pump transition to occur.

[0020] In a further example, a method of operating a circulatory support system for a patient's heart may include: determining a command signal based on a value related to the speed of a motor of a blood pump in the circulatory support system; providing the command signal to the motor to drive a driven component to pump blood flow through the blood pump; determining over time 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 speed of the motor; and outputting an indication recommending a blood pump switching based on two or more values ​​of the one or more parameters related to the operation of the blood pump determined over time.

[0021] In a different example, in addition to or in addition to any of the examples above, a trend is identified in the values ​​of two or more of the parameters related to the operation of the blood pump that are determined over time.

[0022] In a different example, in addition to or in addition to any of the examples above, the indication for recommending a blood pump shift is in response to the trend reaching or exceeding a threshold level.

[0023] In a different example, in addition to or supplementing any of the examples above, 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, the two or more parameters being selected from the group consisting of left ventricular pressure, blood flow rate through the blood pump, and mechanical losses in the blood pump; and outputting an indication recommending a blood pump switch when the trend of two or more values ​​of at least one of left ventricular pressure, blood flow rate through the blood pump, and mechanical losses in the blood pump has reached or exceeded a threshold level.

[0024] In a different example, in addition to or in addition to any of the examples above, the indication recommending a blood pump transition may include a recommended time for the blood pump transition to occur.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation thereof. The following drawings and detailed description illustrate some of these embodiments in more detail. Attached Figure Description

[0026] This disclosure can be more fully understood by considering the following specific embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1 It is a schematic partial cross-section of the anatomical structure and a schematic side view of an illustrative percutaneous ventricular assist device (PVAD) within the anatomical structure;

[0028] Figure 2 This is a schematic cross-sectional view of an illustrative PVAD;

[0029] Figure 3 yes Figure 2 The illustrative PVAD line 3-3 depicts a schematic detailed view.

[0030] Figure 4 This is a schematic diagram of an illustrative loop support system;

[0031] Figure 5 It is an illustrative diagram of a computing device or controller and a user interface;

[0032] Figure 6 This is a schematic diagram of an illustrative loop support system;

[0033] Figure 7 This is a schematic diagram of an illustrative loop support system;

[0034] Figure 8 This is a schematic diagram illustrating the controller configuration;

[0035] Figure 9 This is a schematic diagram illustrating the controller configuration;

[0036] Figure 10 This is a schematic diagram illustrating the controller configuration;

[0037] Figure 11 This is a schematic diagram illustrating the controller configuration;

[0038] Figure 12 This is a schematic diagram illustrating the controller configuration;

[0039] Figure 13 This is a schematic diagram illustrating the controller configuration; and

[0040] Figure 14 This is a schematic diagram illustrating the operational loop support system.

[0041] While this disclosure can be modified and alternatively made in various forms, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0042] For terms defined below, those definitions shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0043] All numerical values ​​in this document are assumed to be modified by the word “approximately”, whether explicitly stated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(i.e., having the same function or result). In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0044] The range of numbers listed by endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0045] As used in this specification and the appended claims, the singular forms “a” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its sense that it includes “and / or” unless the context clearly indicates otherwise.

[0046] It should be noted that references to "embodiments," "some embodiments," and "other embodiments" in the specification refer to the fact that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such enumeration does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that, unless expressly stated to the contrary, such feature, structure, or characteristic may also be used in conjunction with other embodiments, whether or not it is explicitly described.

[0047] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings (not necessarily drawn to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure. Furthermore, it should be noted that in any given drawing, some features may not be shown or may be shown schematically for clarity and / or simplicity. 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 provide several desired features and benefits as described in more detail below.

[0048] Various circulatory support devices are known to assist or replace the pumping function of the heart in patients with severe heart failure and / or other cardiac conditions. Circulatory support devices can be configured to treat patients with cardiogenic shock, myocardial infarction, acute decompensated heart failure, and / or other heart-related conditions. Additionally or alternatively, circulatory support devices can support patients during percutaneous coronary interventions and / or other procedures.

[0049] Examples of cardiac circulatory assist devices include, but are not limited to, ventricular assist devices (VADs), total artificial hearts, intra-aortic balloon pump (IABP), and extracorporeal membrane oxygenation (ECMO). Example VADs include left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), and biventricular assist devices (BiVADs). A further illustrative VAD is a percutaneous ventricular assist device (PVAD), which can be inserted into the ventricle of the patient's heart (e.g., the left or right ventricle) via delivery through the femoral artery or vein and / or other suitable vascular systems. PVADs can be placed at the desired location on the patient's anatomy via percutaneous access and delivery, enabling their use in emergency medicine, catheterization labs, and / or other surgical and / or non-surgical settings.

[0050] Figure 1 Illustrative positioning of the blood pump 100 (e.g., a percutaneous circulatory support device, such as a PVAD in an LVAD configuration) within the patient's anatomy is depicted. Figure 1 In this configuration, the blood pump 100 is positioned such that its distal end 103 is located in the left ventricle 16 of the heart 18 and its proximal end 107 is located in the aorta 20, such 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 can be configured to pump blood from the left ventricle 16 into the aorta 20 to assist blood circulation. Other suitable locations of the blood pump relative to the anatomical structures are contemplated, and these locations include, but are not limited to, the distal end 103 of the blood pump being positioned in the right ventricle of the heart 18, with the proximal end positioned in the pulmonary artery.

[0051] Figure 2 A schematic cross-sectional view depicting an illustrative configuration of the blood pump 100 is shown. In some cases, the blood pump 100 may be integrated with a guidewire, guide sheath, controller, user interface, one or more sensors, and / or other suitable components to form part of a percutaneous or circulatory support system.

[0052] 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 constructed integrally or in a single unit, but this is not required, and the impeller housing 102 and the motor housing 104 may be separate components configured to be removably 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 integrally constructed with the motor 105.

[0053] Impeller housing 102 may house impeller assembly 106 and driven magnet 124, which may be part of or separate from impeller assembly 106. Impeller assembly 106 may include impeller shaft 108, which is rotatably supported by at least one bearing (e.g., bearing 110 and / or other suitable bearing). Impeller assembly 106 may further include impeller 112, which rotates relative to impeller housing 102 to drive blood through blood pump 100. In some configurations, and as shown, impeller shaft 108 and impeller 112 may be separate components, and in other configurations, impeller shaft 108 and impeller 112 may be integral. Impeller assembly 106 as a whole may be considered a driven component, and / or rotating components of impeller assembly 106 (e.g., impeller shaft 108 and / or impeller 112) may be driven components individually or in combination.

[0054] Impeller 112 may be configured within impeller housing 102 such that, when impeller 112 rotates, blood flows through impeller housing 102 from blood inlet 114 formed on or at impeller housing 102 and out of impeller housing 116 formed on or at impeller housing 102. In some configurations, impeller housing 102 may be coupled to or include a distally extending conduit (not shown), and the conduit may receive blood and deliver blood to inlet 114 (e.g., from left ventricle 16 of heart 18 and / or from other suitable locations).

[0055] Inlet 114 and outlet 116 may each have any suitable number of orifices configured to facilitate the reception of blood at blood pump 100 and the discharge of blood from blood pump 100, respectively. In some examples, inlet 114 and / or outlet 116 may each include multiple orifices, and in other examples, one or both of inlet 114 and outlet 116 may each include a single orifice.

[0056] The inlet and outlet 116 can each be formed at any suitable location along the impeller housing 102 or at other suitable locations along the blood pump 100. In some examples, and as such... Figure 2 As depicted, inlet 114 may be formed on an end portion (e.g., a distal portion) of impeller housing 102, and outlet 116 may be formed on a side portion of impeller housing 102 (e.g., near the location of inlet 114). Other suitable positioning configurations of inlet 114 and / or outlet 116 on impeller housing 102 are conceivable.

[0057] The motor housing 104 can accommodate the motor 105 and other suitable components. In some examples, and such as... Figure 2 As depicted, the motor housing 104 can at least accommodate the motor 105, the drive shaft 120, and the drive magnet 122.

[0058] Motor 105 can be any suitable type of motor. In one example, motor 105 can be a brushless DC (BLDC) motor, but other suitable motor types are also conceivable.

[0059] In operation, motor 105 can be configured to rotatably drive impeller 112 relative to impeller housing 102. In some example configurations, motor 105 can rotate drive shaft 120, which is coupled to drive magnet 122. Rotation of drive magnet 122 can cause rotation of driven magnet 124, which is part of or connected to impeller assembly 106 and rotates with impeller assembly. That is, when impeller shaft 108 is included in impeller assembly 106, impeller shaft 108 and impeller 112 are configured to rotate together with driven magnet 124. Additionally or alternatively, motor 105 can be coupled to impeller assembly 106 via other components.

[0060] As discussed in more detail below, the controller ( Figure 2 (Not shown) can be operatively coupled to motor 105 and configured to control motor 105 via one or more command signals sent from the controller to motor 105. The controller may be located within motor housing 104 and / or may be located outside motor housing 104 (e.g., within a blood pump 100 housing separate from motor housing 104, outside the patient's body, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located within motor housing 104 and / or configured to be separate from motor housing 104.

[0061] The motor housing 104 can be connected to the conduit 126 at a position opposite to the impeller housing 102. The conduit 126 can be connected to the motor housing 104 in various ways (such as laser welding, brazing, etc.). The conduit 126 can extend proximally away from the motor housing 104.

[0062] The catheter 126 may include one or more lumens for receiving one or more components of a circulatory support system (including the blood pump 100). In some cases, the catheter 126 may be configured to carry a motor cable 128 (e.g., one or more cables configured to facilitate operation of a motor 105) within the main lumen 130, and the motor cable 128 may operatively connect the motor 105 to a controller (not shown) and / or an external power source (not shown).

[0063] The catheter 126 may carry a sensor assembly 132 for measuring pressure within a patient's vascular system (e.g., within the aorta or pulmonary artery). The sensor assembly 132 may be positioned relative to other components of the blood pump 100 to obtain highly accurate pressure data. For example, a proximal position of the sensor assembly 132 relative to the motor housing 104 and the motor 105 can reduce and / or eliminate sensing inaccuracies related to motor speed or dynamic pressure. Such inaccuracies are typical for other percutaneous circulation support devices employing pressure sensors located more distal to the motor or impeller assembly (e.g., devices employing pressure sensors located near outlet 116).

[0064] Figure 3 Depicting Figure 2 A schematic detailed view of the interior of line 3-3. (See also...) Figure 3 As depicted, sensor assembly 132 may include sensor housing 134 having an internal chamber 136. In some examples, internal chamber 136 may have a countersunk shape, but other suitable shapes and / or configurations of internal chamber 136 are also contemplated. 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 sensor, may be disposed within internal chamber 136 and configured to sense pressure in aorta 20 when blood pump 100 is extended into left ventricle 16 of heart 18. Sensor housing 134 may protect pressure sensor 138 during deployment of blood pump 100. Sensor housing 134 may also include a distally facing orifice 140 of internal chamber 136 or include a distally facing orifice coupled to internal chamber 136. Orifice 140 may allow blood to enter internal chamber 136, and orifice 140 thereby allows pressure sensor 138 to sense blood pressure in the vicinity of internal chamber 136.

[0065] The sensor housing 134 can take various forms. For example, the sensor housing 134 can be a tube or sleeve made of, for example, one or more metals, one or more plastics, composite materials, and / or other suitable materials. The sensor housing 134 can be coupled to the conduit 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer sheath 144 surrounding at least a portion of the sensor housing 134 and the conduit 126. The sensor housing 134 may also include a sensor mount 145 within the internal chamber 136. The sensor mount 145 can facilitate supporting the pressure sensor 138 separately from the wall of the sensor housing 134 (e.g., the sensor mount 145 can center the pressure sensor 138 within the internal chamber 136), which in turn facilitates highly accurate pressure sensing. Other suitable configurations of the sensor housing 134 are also contemplated.

[0066] Sensor assembly 132 may include a sensor cable 147 coupled to pressure sensor 138. Sensor cable 147 operatively couples pressure sensor 138 to a controller (not shown). As shown, sensor cable 147 may extend through sensor mount 145 and support pressure sensor 138, separating it from the wall of sensor housing 134. Sensor cable 147 may extend proximally, through adhesive 142, and through or to a cable lumen 149 of conduit 126. In some examples, cable lumen 149 may be coupled to conduit 126 via one or more solder joints (not shown), adhesive (not shown), and / or outer sheath 144. In other examples, cable lumen 149 may be omitted, and sensor cable 147 may extend through main lumen 130 of conduit 126 or directly beneath outer sheath 144. An example suitable sensor assembly 132 is disclosed in U.S. Patent Application Publication No. 2023 / 0149699 A1, entitled “Percutaneous Circulatory Support Device Including Proximal Pressure Sensor,” filed November 16, 2022, which is hereby incorporated herein by reference in its entirety.

[0067] Figure 4 A schematic diagram of an illustrative circulatory support system 10 is depicted. Among other additional and / or alternative components, the circulatory support system 10 may also include a blood pump 100, a pressure sensor 138, a controller 146, and a user interface 148. As discussed, the blood pump 100 may include a motor 105 communicating with the controller 146 and an impeller 112 communicating with the motor 105.

[0068] 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 sense the speed of the motor 105. When one or more sensors 150 are included, they may be coupled to the controller 146 via one or more cables extending through and / or along the conduit 126. In some cases, the speed or position of the motor 105 may be sensed 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 in conjunction with an explicit sensor 150, or an implicit sensor that eliminates the need for an explicit sensor.

[0069] The one or more sensors 150 can be any suitable type of sensor for sensing the speed of the motor. Exemplary 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.

[0070] Figure 5 A schematic diagram depicts an illustrative configuration of a controller 146 (e.g., a computing device) and a user interface 148 for a circulatory support system 10. The controller 146 can be and / or may include any suitable computing device configured to process data from the circulatory support system 10 or data for the circulatory support system (e.g., data from or derived from motor 105, pressure sensor 138, sensor 150, patient test results, user input, patient monitors, etc.). In some cases, one or more components of the circulatory support system 10 may be integrated into the controller 146 and / or the user interface 148. Further, one or more components of the circulatory support system 10 may be integrated with one or more computing devices similar to or having components similar to the controller 146 and / or the user interface 148.

[0071] The controller 146 can be configured to facilitate the operation of the cyclic support system 10. In some cases, the controller 146 can be configured to control the operation of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 by establishing control signals and / or outputting control signals to components of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 to control and / or monitor the operation of these units and devices.

[0072] Controller 146 can communicate with a remote server or other suitable computing device. When controller 146, or at least a portion thereof, is a component structurally separate from motor 105, pressure sensor 138, user interface 148, and / or sensor 150, controller 146 can communicate with the electronics of the circulation support system 10 via one or more wired or wireless connections or networks (e.g., LAN and / or WAN).

[0073] 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 complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more special-purpose processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. Although controller 146 may be referred to herein in the singular, controller 146 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc.

[0074] In addition to other suitable components, the illustrative controller 146 may also include one or more processors 152, memory 154, and / or one or more I / O units 156. The controller 146 is not described in... Figure 2 Other suitable components specifically depicted may include, but are not limited to, communication components, touchscreens, selection buttons, housings, and / or other suitable components of the controller. As discussed above, one or more components of the controller 146 may be detachable from and / or integrated into the components of the circulation support system 10.

[0075] Controller 146 may include and / or communicate with a variety of sub-controllers. Examples of sub-controllers that may be included in or communicate with controller 146 may include, but are not limited to, motor sub-controllers, flow rate sub-controllers, pressure sub-controllers, motor torque sub-controllers, motor mechanical loss sub-controllers, stall pressure sub-controllers, pressure loss sub-controllers, and / or other suitable sub-controllers.

[0076] The processor 152 of the controller 146 may include a single processor, or more than one processor that operates independently 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 memories. Examples of components of the processor 152 may include, but are not limited to, a central processing unit, a microprocessor, a microcontroller, a multi-core processor, a graphics processing unit, a digital signal processor, an application-specific integrated circuit (ASIC), an artificial intelligence accelerator, a field-programmable gate array (FPGA), discrete circuitry, and / or other suitable types of data processing devices.

[0077] The memory 154 of controller 146 may include a single memory component, or more than one memory component that operates independently or in conjunction with each other. Example types of memory 154 may include random access memory (RAM), EEPROM, flash memory, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read-only memory (ROM), hard disk drive, flash memory, optical disk drive, and / or other suitable persistent memory), and / or other suitable types of memory. Memory 154 may be or may include non-transitory computer-readable media. Memory 154 may include instructions stored in a transient and / or non-transitory state on a computer-readable medium, which may be executable by processor 152 to cause the processor to implement one or more of the methods and / or techniques described herein.

[0078] The I / O unit 156 of the controller 146 may include a single I / O component, or more than one I / O component that operates independently or in conjunction with each other. Example I / O unit 156 may be or may include any suitable type of communication hardware and / or software, including but not limited to communication ports configured to communicate with the electronics of the loop support system 10 and / or with other suitable computing devices or systems. Example types of I / O unit 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, Bluetooth Low Energy 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.

[0079] User interface 148 can be configured to communicate with controller 146 via one or more wired or wireless connections. 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 features.

[0080] Display device 158 can be any suitable display. Exemplary suitable displays include, but are not limited to, touch screen displays, non-touch screen 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.

[0081] Input device 160 may be and / or may include any suitable components and / or features for receiving user input via a user interface. Example input device 160 includes, but is not limited to, touchscreen, keypad, mouse, touchpad, microphone, selection button, selection knob, optical input device, camera, gesture sensor, eye tracker, voice recognition control (e.g., a microphone coupled to an appropriate natural language processing component), and / or other suitable input devices.

[0082] Output device 162 may be and / or may include any suitable components and / or features for providing information and / or data to a user and / or other computing components. Example output devices 162 include, but are not limited to, displays, speakers, vibration systems, haptic feedback systems, optical outputs, cables, lamps, and / or other suitable output devices.

[0083] Various parameters of or near the blood pump 100 (e.g., pressure, flow rate, etc.) can be performance parameters related to or clinically relevant to the operation of the blood pump 100 located within the patient or relative to the blood pump within the patient. For example, clinicians may be interested in obtaining data such as: ventricular pressure data, vascular system pressure data (e.g., aortic pressure data, pulmonary artery pressure data, etc.), differential pressure data across the blood pump 100 (e.g., differential pressure data 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, in order to make decisions regarding adjunctive or alternative therapies, assess the patient's condition, assess the condition of the blood pump, assess the operation of the blood pump, assess the effectiveness of the blood pump, control the operation of the blood pump, etc. Furthermore, data relating to and / or for the pressure and flow rate of the blood flowing through the blood pump 100, other blood pump data relating to the operation of the blood pump 100, and / or calculations based on data relating to the blood flowing through the blood pump 100 can be used by the controller 146 to automatically and / or in response to user input to control the operation of the blood pump 100 (e.g., adjusting command signals, etc.).

[0084] The management of patients with an MCS device (e.g., a PVAD, such as the Blood Pump 100 and / or other suitable blood pumps) located within their heart can depend on one or more variables, and therefore, users (e.g., physicians, clinicians, etc.) may not always be clear which pump to use to treat the patient (e.g., a pump with a lower flow rate capacity compared to a pump with a higher flow rate capacity). Because a higher flow rate pump may be more likely to have adverse effects on the patient (e.g., hemolysis, etc.) than a lower flow rate pump, users may initially administer a lower flow rate pump to the patient, while understanding that a higher flow rate pump may be needed in the future. Additionally or alternatively, the patient's needs may change during treatment, and a higher flow rate pump or a lower flow rate pump may be needed or preferred. Furthermore, the capacity of a blood pump may decrease over time, necessitating a new, higher flow rate pump to meet the patient's needs. When the patient's needs exceed the capacity of the blood pump currently used to treat the patient, it is necessary to upgrade the blood pump to a higher flow rate pump or multiple blood pumps (e.g., device upgrade). Furthermore, for example, when a patient's need for circulatory support decreases (e.g., device downgrade or degrade), it is conceivable that the blood pump could be converted to a lower flow pump.

[0085] Device simplification is common when using MCS devices because many variables can influence patient needs and the operation of the MCS device, and the values ​​of these variables can change over time. However, it can be difficult to determine when a device simplification is needed, and therefore, it often doesn't occur until a more powerful or less powerful device is required. The concepts discussed in this paper improve the operation of the MCS device and its application to patients by providing active control over the blood pump 100 and active device simplification (e.g., upgrade or downgrade) decisions. For example, the controller 146 of the circulatory support system 10 can be configured to monitor key patient characteristics (e.g., arterial pressure, ventricular pressure, flow rate across the MCS device, etc.) and predict when the capacity of the MCS device within the patient is insufficient to treat the patient, necessitating a device upgrade.

[0086] Figure 6 A schematic diagram illustrating the control system of the cyclic support system 10 is shown. In some cases, the control system may be a closed-loop or partially closed-loop control system, but this is not necessary.

[0087] like Figure 6 As depicted, controller 146 can communicate with motor 105 of blood pump 100 via converter plate 164 to drive or otherwise rotate impeller shaft 108 and impeller 112. Converter plate 164 and / or components thereof may be incorporated into controller 146, may be incorporated into motor 105, and / or may be components separate from one or both of controller 146 and motor 105. In some examples, converter plate 164 may be omitted.

[0088] In operation, the conversion block 166 of the conversion board 164 can be configured to receive a command signal 168 and the output of a sensor 150, which senses the position of the motor 105 and / or a speed-related measure. The conversion block 166 can use the output of the sensor 150 to synchronize the command signal 168 with the operation of the motor 105, and provide a control signal 170 to the motor 105 based on the command signal 168 and the output of the sensor 150.

[0089] Furthermore, the high-pass filter (HPF) 172 of the conversion board 164 can be configured to receive the output of the sensor 150. The HPF 172 can be configured to differentiate the position signal and filter noise in the resulting velocity signal from the position sensor 150, providing the filtered signal as output to the controller 146. In some examples, the HPF 172 can be omitted; if a velocity sensor is used, an LPF (low-pass filter) can be used instead, and / or other suitable filters can be utilized.

[0090] Controller 146 may be and / or may include any suitable type of controller. For example, controller 146 may be and / or may include one or more proportional controllers, proportional-integral (PI) controllers, proportional-integral-derivative (PID) controllers, lead-lag controllers, nonlinear table controllers, linear table controllers, and / or other suitable types of controllers. In some examples, controller 146 may be or may include one or more PI controllers having a proportional component 174 and an integral component 176, such as... Figure 6 As depicted, but not required. Furthermore, although not required, controller 146 may include multiple control loops and / or may be configured to regulate intermediate states.

[0091] In operation, controller 146 can be configured to receive values ​​of reference parameters 178, which are input to motor sub-controller 180. In one example, the received reference parameter 178 may be a value related to the speed of motor 105 (e.g., setpoint, threshold, acceptable speed range, etc.), and motor sub-controller 180 may process the speed-related value of motor 105 into a command signal 168, which is configured to cause the motor to operate at or proportionally to the speed indicated in the received value and drive the driven components of blood pump 100 (e.g., driven shaft or impeller shaft 108 and / or impeller 112). In some examples and as shown... Figure 6As depicted, the motor sub-controller 180 may include a proportional component 174 and an integral component 176 of a PI controller, which are configured to process the value of a reference parameter 178, values ​​related to the received value of the reference parameter 178, and / or other suitable data into a command signal 168 and output the command signal 168 (e.g., to the motor 105).

[0092] The value of reference parameter 178 can be any suitable type of input from a user, a component communicating with controller 146, or a system. In some cases, the value of reference parameter 178 can be a setpoint value and / or one or more thresholds provided by the user via user interface 148, but this is not required. Reference parameter 178 can be any parameter related to the operation of blood pump 100, including but not limited to motor speed, blood flow rate across blood pump 100, pressure in the ventricles of heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), differential pressure across blood pump 100 (e.g., the pressure difference between ventricular pressure and pressure in the aorta), mean arterial pressure (MAP), total cardiac output (TCO), and / or other suitable values. In some examples, the value of reference parameter 178 can be a setpoint for the speed of motor 105, but this is not required.

[0093] When the value of reference parameter 178 is the setpoint of the speed of motor 105, the value of reference parameter 178 can be configured to be added at adder 182 (e.g., a summing unit) to the output from sensor 150 (e.g., which may or may not pass through HPF 172). When the value of reference parameter 178 is not the setpoint of the speed of motor 105, the value of a parameter obtained based on the value of reference parameter 178 (e.g., the speed determined based on a reference value) can be added at adder 182 to the output of sensor 150. Alternatively or additionally, when the value of reference parameter 178 is not the setpoint of the speed of motor 105 (e.g., but a value of pressure, flow rate, etc.), the value of reference parameter 178 can be compared at adder 182 to the value of a parameter obtained based on the output of sensor 150 (e.g., pressure, flow rate, etc.). In some examples, when the "-" sign is near the comparator, the difference of operands can be identified at adder 182 and / or other comparators discussed herein.

[0094] Although the PI controller is Figure 6The controller type described is between adder 182 and adder 183, but additional and / or alternative controller types may also be used. When the controller 146 includes a proportional component 174 and an integral component 176, the output of adder 182 can be processed using the proportional component 174 and the integral component 176. The outputs of the proportional component 174 and the integral component 176 can be added together at adder 183, which can output a command signal 168. The values ​​added at adder 183 can be summed to generate the command signal 168, but this is not necessary. Other suitable configurations of the motor sub-controller 180 are also conceivable.

[0095] The controller 146 may use outputs and / or signals (e.g., command signal 168, sensed motor speed, sensed aortic pressure, etc.) from the control and / or operation of the blood pump 100, including the motor 105 and impeller 112, to determine or calculate one or more parameters. Additionally or alternatively, the controller 146 may use 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 to determine or calculate one or more parameters, wherein the outputs from said one or more sensors may include, but are not limited to, outputs from a pressure sensor, an output from a flow sensor, and / or outputs from one or more other suitable sensors.

[0096] The parameters determined or calculated by controller 146 may include one or more values ​​of parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump 100. In some examples, controller 146 may be configured to determine or calculate values ​​of blood flow velocity across blood pump 100, one or more pressures near blood pump 100 (e.g., left ventricular pressure, right ventricular pressure, differential pressure across blood pump 100, etc.), one or more values ​​of motor mechanical losses, and / or other suitable parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump 100.

[0097] To facilitate the determination or calculation of one or more values ​​of parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump 100, controller 146 may include a status observer 151. Status observer 151 may be configured to receive outputs and / or signals (e.g., command signal 168, sensed motor speed, sensed pressure, sensed flow rate, etc.) from controller 146 and / or from the operation of motor 105 and impeller 112. In some examples and as... Figure 6As depicted, the state observer 151 can be configured to receive a command signal 168 and a sensed motor speed from the motor speed sensor 150. Other configurations are also conceivable, and additional or alternative inputs can be received at the state observer 151.

[0098] The status observer 151 can be configured to monitor inputs received at the status observer and determine or calculate values ​​of one or more parameters related to the operation of the blood pump 100 based on the inputs. For example, the status observer 151 can be configured to use the values ​​of the received parameters (e.g., the value of command signal 168, values ​​related to the speed of motor 105, and / or other suitable values) to calculate or determine the values ​​of blood flow rate through the blood pump 100, pressure provided by the blood pump 100, ventricular pressure, differential pressure across the blood pump 100, arterial pressure, stall pressure of motor 105, pressure loss across the blood pump 100, motor mechanical loss, motor torque, and / or other parameters.

[0099] Once the values ​​of the parameters have been calculated or determined at state observer 151 and / or other locations on controller 146, some or all of the parameter values ​​can be provided to storage unit 153. Storage unit 153 may be and / or may include memory 154 and / or other suitable memory. Although storage unit 153 is depicted as part of controller 146, storage unit 153 may be physically separate from other parts of controller 146.

[0100] Storage component 153 can be configured in any suitable manner. In some examples, storage component 153 may be or may include a per-sample storage system, wherein each received value is stored individually in memory. Additionally or alternatively, in some examples, storage component 153 may be or may include a filter (e.g., a low-pass filter, a high-pass filter with a long time constant, etc.) configured to allow sufficient values ​​of the calculated or determined parameters to be collected for analysis of those values ​​and to determine whether a device transition is required. In some cases, storage component 153 may be configured to store values ​​received from state observer 151, as well as values ​​of similar parameters, but this is not required.

[0101] The stored data can be analyzed by analysis component 155 to identify trends in calculated or determined data stored at storage component 153 and / or received directly from state observer 151. The trend of the calculated or determined data (e.g., the value of a calculated or determined parameter) can involve at least two values, wherein a trend can be identified from one or more values ​​of each of two or more parameters or from two or more values ​​of a single parameter. Analysis component 155 can utilize any suitable statistical analysis to identify the trend over time of two or more values ​​of one or more parameters related to the operation of the blood pump. In some examples, the trend of the calculated or determined data may include, but is not limited to, the rate of change of the calculated or determined data values, the average or moving average of the calculated data values, the values ​​of two or more parameters exceeding a threshold for those two or more parameters, and / or other suitable types of trends.

[0102] Analysis component 155 can be configured to analyze stored and / or received data to determine (e.g., predict) that a patient's needs may differ from the capabilities of blood pump 100. For example, analysis component 155 can be configured to analyze stored and / or received data to determine (e.g., predict) that the required output of blood pump 100 (e.g., patient demand for blood pump 100) will exceed the available output of blood pump 100 due to increased patient demand and / or wear and tear from use, and / or determine that patient demand has decreased (e.g., determining that a blood pump upgrade is needed or will be needed). In some examples, analysis component 155 can indicate the date and / or time when a blood pump conversion (e.g., upgrade or downgrade) is needed or recommended. Analysis component 155 can utilize any suitable statistical analysis (e.g., linear analysis and / or other suitable statistical analysis) to identify trends over time in two or more values ​​of one or more parameters related to the operation of the blood pump, and to identify when the capabilities of blood pump 100 will be insufficient to treat the patient.

[0103] In some cases, analysis component 155 may determine over time, based on one or more values ​​of one or more parameters related to the operation of blood pump 100, that a blood pump transition (e.g., upgrade or downgrade) will be required. In some examples, analysis component 155 may determine when a blood pump transition is needed or will be needed based on comparing the value of a parameter to a threshold associated with that parameter, and indicating that a blood pump transition is needed or will be needed if the value of the parameter reaches or exceeds the threshold. Additionally or alternatively, in some examples, analysis component 155 may determine when a blood pump transition is needed or will be needed based on comparing one or more trends in the values ​​of one or more parameters to a threshold, and indicating that a blood pump transition is needed or will be needed if the trend exceeds the threshold.

[0104] The analysis unit 155 can be configured to output the analysis results of the stored data to the user interface 148 for display at the user interface 148, and / or provide alarms to the user and / or the motor sub-controller 180. In some cases, the analysis unit 155 can continuously provide the analysis results of the stored data to the user interface 148 for graphical display, as the date of device transition (e.g., the date and / or time when a transition to a different pump should occur), as the probability that a device transition will be required, as the probability of when a device transition will be required, and / or other suitable display information. Additionally or alternatively, the analysis unit can output warning signals and / or alarms when a device transition is urgently needed. In some examples, the urgency of the warnings and / or alarms (sound, color change, etc.) may increase as the device transition becomes more urgent over time.

[0105] Figure 6 The configuration of the circulatory support system 10 facilitates proactively meeting the patient's needs over time by automating the process of ensuring that the blood pump in the patient's body has and will continue to have sufficient capacity to meet the patient's needs. Furthermore, the described configuration of the circulatory support system 10 facilitates reducing the time spent monitoring the operation of the blood pump 100, as the user can rely on the system 10 to identify when device changes (e.g., upgrades or downgrades) are needed.

[0106] Figure 7 A schematic diagram of an illustrative control system for the cyclic support system 10 is shown, which is similar to... Figure 6 The control system depicted includes a state observer 151 and a storage unit 153, which are configured to calculate or determine and then store values ​​of blood flow velocity across the blood pump 100, left ventricular pressure, and motor mechanical losses (e.g., damping of the motor 105 of the blood pump 100 over time). Figure 7 As depicted, the status observer 151 may include: a flow rate observer 184 (e.g., a sub-controller or other suitable observer) configured to calculate or determine one or more values ​​of blood flow rate across the blood pump 100; a pressure observer 186 (e.g., a sub-controller or other suitable observer) configured to calculate or determine one or more values ​​of left ventricular pressure and / or other suitable pressure values; and a motor mechanical loss observer 216 (e.g., a sub-controller or other suitable observer) configured to determine or calculate one or more values ​​of mechanical loss of the motor 105. The status observer 151 may include other suitable observers of the controller 146 or other suitable observers in communication with the controller to calculate or determine values ​​of parameters related to the operation of the blood pump 100.

[0107] The flow rate observer 184 can be configured to calculate or determine the blood flow rate across the blood pump 100 entirely or at least partially based on the received command signal value and the sensed motor speed value. Other suitable parameter values ​​can be used to calculate the flow rate as needed. Alternatively or additionally, the flow rate can be directly sensed and filtered or calibrated as needed. The calculated or determined flow rate can then be stored in the flow rate partition 153a of the storage unit 153. As discussed herein, regarding Figures 8 to 10 The illustrative configuration for calculating or determining the blood flow rate across the blood pump 100 is described in more detail.

[0108] Pressure observer 186 can be configured to calculate or determine left ventricular pressure entirely or at least partially based on received command signal values, sensed motor speed values, and sensed pressure values ​​from pressure sensor 138 (which can be configured to sense aortic pressure). Other suitable parameter values ​​can be used to calculate left ventricular pressure as needed. Additionally or alternatively, pressure can be sensed directly, and / or filtered or calibrated as needed. The calculated or determined pressure can then be stored in pressure partition 153b of storage unit 153. As discussed herein, regarding Figures 9 to 13 The illustrative configuration for calculating or determining left ventricular pressure is described in more detail.

[0109] The motor mechanical loss observer 216 can be configured to calculate or determine the motor mechanical loss entirely or at least partially based on the received command signal value and the sensed motor speed value. Other suitable parameter values ​​can be used to calculate or determine the motor mechanical loss of the blood pump 100 as needed. The calculated or determined motor mechanical loss can then be stored in the motor mechanical loss partition 153c of the storage unit 153. As discussed herein, regarding Figure 10 A more detailed illustrative configuration for calculating or determining motor mechanical losses is described.

[0110] The analysis component 155 can be configured to use values ​​of one or more of the flow rate, pressure, and / or motor mechanical losses calculated or determined over time (e.g., one or more values, two or more values ​​over time, etc.) to identify one or more trends indicating that the blood pump will be insufficient to meet the patient's needs at a foreseeable future time. In some examples, values ​​of one or more of the calculated or determined parameters (e.g., flow rate, pressure, and / or motor mechanical losses) reaching or exceeding a threshold associated with the parameter may indicate or suggest the need for or imply the need for a blood pump upgrade. In some examples, a trend indicating that motor mechanical losses are increasing and the blood flow rate across blood pump 100 is decreasing indicates or suggests the need for or imply the need for a device upgrade. In some examples, the flow rate required to maintain the desired MAP is increasing at a rate that will exceed the capacity of blood pump 100 or cause rapid wear of blood pump 100 may indicate or suggest the need for or imply the need for a device upgrade. In some examples, the value of MAP (e.g., as determined by pressure observer 186 or otherwise calculated or sensed) may increase at a rate that would prevent the pump from reaching the desired flow rate value, which could indicate or suggest that an upgrade of the unit is needed or will be required. Other examples are also conceivable.

[0111] In some cases, trends in calculated or determined parameters can be used to provide the probability that a transition (e.g., upgrade or downgrade) will be required. Further, trends in calculated or determined parameters can be used to identify dates and / or times when a device transition may be necessary. In some examples, trends in one or more values ​​of one or more parameters calculated or determined over time can be compared to one or more thresholds that are associated with a patient's needs, and when the trend reaches or exceeds a threshold, an indication of the date and / or time when a blood pump transition is required can be output from controller 146 (e.g., to user interface 148 and / or to the user). For example, if a patient has a known minimum flow rate (e.g., a threshold) that makes blood pump 100 useful, and the maximum flow rate produced by the blood pump is decreasing at a known rate (e.g., the trend of two or more calculated flow rate values ​​is decreasing linearly or non-linearly), analysis component 155 can determine when a device upgrade may be necessary and output an alert to user interface 148 indicating when a device upgrade is required.

[0112] When using thresholds to identify when a blood pump switch is needed, the threshold can be based on any suitable factor. For example, the threshold can be based on the patient's needs, the time required to prepare for the placement of the new blood pump in the patient, the severity of the device switch requirement, and / or other suitable factors.

[0113] Analysis unit 155 may optionally be configured to output the results of its analysis to state observer 151, which can facilitate slow implicit feedback loops. In some examples, state observer 151 may use the output of analysis unit 155 to update the coefficients used by the state observer (e.g., C discussed below). L C N wait).

[0114] Analysis unit 155 may optionally be configured to output the results of its analysis to motor sub-controller 180 for comparison with the value of reference parameter 178 and / or the speed of the motor. For example, when analysis unit 155 identifies that motor mechanical losses are increasing over time, it may provide an indication of this trend to motor sub-controller 180 (e.g., adder 182, proportional unit 174, and / or integrator 176) to create a command signal 168 that actively takes into account motor mechanical losses and is configured to cause motor 105 to achieve a speed proportional to the received value of reference parameter 178 despite the presence of mechanical losses in motor 105. In some cases, the trend results from analysis unit 155 may be used to modify the coefficients in the equations used to calculate command signal 168, but this is not necessary. Other suitable examples are also conceivable of using the results of analysis unit 155 and / or the values ​​calculated or determined at state observer 151 at motor sub-controller 180 to create command signal 168 and control the operation of the blood pump.

[0115] The parameters determined or calculated by controller 146 (e.g., by state observer 151) may include one or more values ​​of parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump 100. In some examples and as discussed, controller 146 may be configured to: determine or calculate one or more values ​​of blood flow velocity across blood pump 100 at flow rate observer 184 (e.g., sub-controller or other suitable observer); determine or calculate one or more values ​​of one or more pressures (e.g., left ventricular pressure, right ventricular pressure, differential pressure across blood pump 100, etc.) near blood pump 100 at pressure observer 186 (e.g., sub-controller or other suitable observer); determine or calculate one or more values ​​of motor mechanical loss at motor mechanical loss observer 216 (e.g., sub-controller or other suitable observer); and / or determine or calculate other suitable values ​​of parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump.

[0116] The flow rate and / or pressure at or near the blood pump can be calculated in any suitable manner. In some examples, the flow rate and / or pressure at or near the blood pump can be based on Bernoulli's principle: in Let g be the fluid density, g be the acceleration of the fluid due to gravity, P be the pressure at a point in the fluid, v be the velocity of the fluid at that point, h be the height at that point, and C be a constant based on the physical properties of the working fluid.

[0117] The flow rate and / or pressure at or near the blood pump can also be calculated using Newton's force balance equations; specifically... Where 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 A schematic diagram illustrating a controller configuration used to calculate or determine parameter values ​​is provided. 2023 September 25, 2019 The U.S. patent application filed under the title "Cyclic Support Devices, Systems, and Methods" 63 / 540,346 The U.S. patent application describes exemplary suitable techniques for calculating or determining the value of a parameter, the entirety of which is hereby incorporated by reference.

[0118] Flow rate observer 184 and pressure observer 186 can utilize command signal 168 output from motor sub-controller 180 as parameter values ​​representing the operation of motor 105. In some cases, command signal 168 may include a voltage level or value or voltage signal configured to achieve a desired motor rotation or speed. Parameter values ​​can be determined using the voltage level or value in command signal 168, rather than using sensed current at motor 105, and may be more advantageous than using such sensed current at motor 105 to determine parameter values ​​related to the operation of blood pump 100. For example, using command signal 168 can allow for faster flow rate and / or pressure determination or calculation time compared to using sensed current values ​​at motor 105 to determine parameter values, because it does not require waiting for the motor to implement command signal 168 and for the sensors to sense the current used by motor 105 in response to the implemented command signal 168. Using command signal 168 as input to determine parameter values ​​allows for determination based on how motor 105 will operate, rather than how motor 105 has operated in the past. How it will operate is identified using sensed current or voltage at motor 105, because it takes time to move the sensed current or voltage value to controller 146, which may include passing the sensed current or voltage value through one or more filters (e.g., HPF 172 and / or other suitable filters). Furthermore, using the voltage level or value of command signal 168 reduces the amount of noise when determining parameter values ​​compared to using sensed current and / or voltage values ​​at motor 105, thus reducing the complexity of determining or calculating flow rate and / or pressure.

[0119] Figure 8 A diagram schematically depicting the illustrative operation of a flow rate observer 184 configured to determine or calculate the flow rate of blood flowing across blood pump 100 is provided. The flow rate observer 184 may be configured to receive values ​​from command signal 168 (e.g., voltage level or value and / or other suitable values) and sensed motor speed 187 or related values. Based on the received signals or values, the flow rate observer 184 may determine or calculate the motor torque output 188 of motor 105 and the mechanical losses 190 of motor 105 (e.g., the amount of torque or energy required to rotate motor 105).

[0120] The motor torque output 188 and mechanical losses 190 can be determined in any suitable manner. Regarding... Figure 9 An illustrative configuration for determining the motor torque output 188 is discussed. Regarding... Figure 10 An illustrative configuration for determining mechanical loss 190 is discussed.

[0121] Once the motor torque output 188 and the mechanical losses 190 of motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 can be added to one or more values ​​of the mechanical losses 190 of motor 105 at adder 192. In some examples, the difference between these values ​​can be identified at adder 192. The difference between the motor torque output 188 (e.g., the total torque produced by motor 105) and the mechanical losses 190 of motor 105 (e.g., the amount of torque required to rotate motor 105) represents the amount of torque that motor 105 uses to pump blood through blood pump 100.

[0122] Once the difference between the motor torque output 188 and the mechanical loss 190 is identified, one or more pump coefficients (e.g., torque-flow rate pump coefficients) can be applied to that difference to correlate the determined motor 105 torque available for pumping fluid through the blood pump 100 with the flow rate of the fluid through the blood pump 100. In some examples, these one or more coefficients can be determined experimentally and are specific to the configuration of the blood pump 100.

[0123] exist Figure 8 In the illustrated example configuration, two pump coefficients can be applied, each relating to a value related to the difference between the determined motor torque output 188 and the mechanical loss 190 of the motor 105. The first pump coefficient K can be... FR0 194 is applied to the difference between the motor torque output 188 and the mechanical loss 190. First pump coefficient K FR0 194 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the motor torque of blood pump 100 with the flow rate through blood pump 100. Furthermore, the square root 196 of the difference between the motor torque output 188 and the mechanical loss 190 can be determined, and the second torque-flow rate coefficient K can be... FR1 198 is applied to the value of the square root 196. Second torque-velocity coefficient K FR1 198 can be an experimental value for blood pump 100, which correlates the square root of the motor torque of blood pump 100 with the flow rate through blood pump 100.

[0124] At adder 200, the first torque-flow coefficient K will be passed through. FR0 194 is a value determined by applying the difference between the motor torque output 188 and the mechanical loss 190, and by using the second torque-flow rate coefficient K. FR1198 is the sum of values ​​determined by the square root of the difference between the motor torque output 188 and the mechanical loss 190. This sum can be a determined or calculated value of the flow rate 202 through the blood pump 100, or a value associated with that flow rate. The flow rate 202 can be output to the user interface 148 or other user interfaces for use by practitioners when treating patients with the blood pump 100 and / or to automatically control the operation of the blood pump 100 by providing the determined or calculated flow rate to the motor sub-controller 180, and / or can be output in one or more other suitable ways.

[0125] Figure 9 A diagram schematically depicts the illustrative operation of a motor torque output observer 204 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the motor torque 188 of the motor 105 of the blood pump 100. The motor torque output observer 204 can be configured to receive values ​​from a command signal 168 (e.g., a voltage value and / or other suitable value) and sensed motor speed 187 or related values. Based on the received signals or values, the motor torque output observer 204 can determine or calculate the motor torque output 188 of the motor 105.

[0126] Once command signal 168 and sensed motor speed 187 are received, one or more coefficients can be applied to the values ​​of command signal 168 and sensed motor speed 187, or values ​​related to the command signal and sensed motor speed. In some examples, these one or more coefficients can be determined experimentally and / or specific to the configuration of motor 105, and the voltage value can be correlated with the torque output of motor 105. In some cases, one or more of the coefficients for correlating voltage with torque output can be provided on the datasheet of motor 105.

[0127] exist Figure 9 In the illustrated example configuration, two coefficients can be applied to the received voltage command signal 168 and the sensed motor speed 187, respectively. The torque-voltage coefficient K can be... T 206 is applied to the value of the sensed motor speed 187 or a value related to the sensed motor speed to generate a voltage value (e.g., the inverse EMF value of motor 105 and / or other suitable value), which can be added to the value of command signal 168 at adder 208. Torque-voltage coefficient K T 206 can be the motor torque constant, which can be a parameter value found in the motor datasheet.

[0128] At adder 208, it can be determined that by controlling the torque-voltage coefficient K... T206 is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. This is achieved by using the torque-voltage coefficient K... T The value determined by 206 based on the sensed motor speed 187 can be the amount of voltage generated inside the motor 105 based on the speed of the motor 105, or an amount that can represent that voltage. To determine the accurate value of the motor torque output 188, the torque-voltage coefficient K can be subtracted from the command voltage in the command signal 168. T 206 is the value determined by applying the sensed motor speed 187.

[0129] The ratio factor 210 can be applied by using the torque-voltage coefficient K T 206 is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. The ratio coefficient 210 can be adjusted by using the torque-voltage coefficient K. T The value is determined by dividing 206 by the winding resistance of motor 105. The winding (or terminal) resistance R of motor 105 is... w 212 can be determined experimentally for motor 105, and / or the winding resistance R of motor 105. w 212 can be a value found in the datasheet for motor 105.

[0130] It is applied to the torque-voltage coefficient K T The output of the ratio factor 210, which is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168, can represent the motor torque output 188. In some cases, such as... Figure 9 As depicted, the low-pass filter 214 can be applied to the ratio factor 210 applied to the torque-voltage coefficient K. T The output value is obtained by applying the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. The low-pass filter 214 can be configured to filter out all values ​​with frequencies higher than a predetermined frequency threshold to filter out noise.

[0131] Figure 10 A diagram schematically depicts the illustrative operation of a motor mechanical loss observer 216 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the mechanical loss 190 of the motor 105 of the blood pump 100 based on force balance equations. The motor mechanical loss observer 216 can be configured to receive sensed motor speed 187 or values ​​associated with it. Based on the received signal or value, the motor mechanical loss observer 216 can determine or calculate the motor mechanical loss 190 of the motor 105.

[0132] Once the sensed motor speed 187 is received, a low-pass filter 218 can be applied to the sensed motor speed 187. The low-pass filter 218 can be the same as a low-pass filter 214 with the same frequency threshold or a different low-pass filter with different frequency thresholds, to filter noise from the received sensed motor speed 187. The output of the low-pass filter 218 can be processed and summed in several separate steps to obtain the determined or calculated motor mechanical loss 190.

[0133] In the step, the derivative 220 of the output of the low-pass filter 218 can provide the acceleration of the motor 105. The inertial equation J 222 can be applied to the determined or calculated acceleration of the motor 105, wherein the output obtained by applying the inertial equation J 222 to the acceleration of the motor 105 can represent or can be the calculated or determined force required to overcome the inertia of the motor 105.

[0134] In the additional processing steps, the output of the low-pass filter 218 can be squared (224), and the nonlinear drag coefficient C can be... N 226 is applied to the square of the output of the low-pass filter 218. Nonlinear resistance coefficient C. N 226 can correspond to nonlinear force and / or power lost to the environment as heat due to low efficiency in motor 105, and the nonlinear drag coefficient C N The output obtained by applying 226 to the output of the low-pass filter 218 can represent or may be the calculated or determined force required to overcome the nonlinear resistance on the motor 105.

[0135] The calculated or determined force required to overcome the inertia of motor 105 can be added at adder 228 to the calculated or determined force used to overcome the resistance on motor 105. The output of adder 228 can be or may represent the calculated or determined net inertial and nonlinear forces acting on motor 105.

[0136] In further processing steps, the linear drag coefficient C can be... L 230 is applied to the output of the low-pass filter 218. Linear resistance coefficient C L 230 can correspond to linear force and / or power lost to the environment as heat due to low efficiency in motor 105, and the linear drag coefficient C L The output obtained by applying 230 to the output of low-pass filter 218 can represent or may be the calculated or determined force required to overcome the linear resistance on motor 105.

[0137] The calculated or determined net inertial and nonlinear forces acting on motor 105 can be added at adder 232 to the calculated or determined force required to overcome the linear resistance on motor 105. The output of adder 232 can be or may represent the calculated or determined net forces acting on motor 105 (e.g., inertial force, nonlinear resistance, and linear resistance). In other words, the output of adder 232 can be the motor mechanical loss 190.

[0138] Figure 11 A diagram schematically depicts the illustrative operation of a pressure observer 186 configured to determine or calculate pressure (e.g., ventricular pressure, such as left ventricular pressure and / or right ventricular pressure, depending on which ventricle the blood pump 100 extends into) distal to impeller 112 (or proximal to the direction of blood flow). The distal end of the impeller may be located in a ventricle (e.g., the left or right ventricle of a patient's heart). The pressure observer 186 may be configured to receive values ​​from command signal 168 (e.g., voltage values ​​or levels and / or other suitable values), sensed motor speed 187 or values ​​associated therewith, and values ​​from pressure sensor 138 (e.g., a pressure sensor that senses pressure proximal to impeller 112 or distal to the direction of blood flow (e.g., pressure in a patient's aorta)). Based on the received signals or values, the pressure observer 186 can determine or calculate the motor torque output 188 of the motor 105, the mechanical losses 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 can be the pressure at which blood no longer moves through the blood pump 100.

[0139] The motor torque output 188 and mechanical losses 190 can be determined in any suitable manner, including but not limited to those described herein. Figure 9 and Figure 10 As described. Furthermore, the stall pressure 234 can be determined in any suitable manner. Regarding... Figure 12 An illustrative configuration for determining stall pressure 234 is discussed.

[0140] Once the motor torque output 188 and the mechanical loss 190 of the motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 can be added to one or more values ​​of the mechanical loss 190 of the motor 105 at adder 236. In some examples, the difference between these values ​​can be identified at adder 236, which can represent the amount of torque used by the motor 105 to pump blood through the blood pump 100, similar to the above regarding... Figure 9 The subject of discussion.

[0141] Once the difference between the motor torque output 188 and the mechanical loss 190 is identified, the pressure observer 186 can use this difference, along with the sensed motor speed 187, to calculate or determine the pressure loss 238 caused by blood flow through the blood pump 100. Regarding Figure 13 An illustrative configuration for determining pressure loss 238 is discussed.

[0142] exist Figure 11 In the example configuration depicted, the calculated or determined pressure loss 238 can be added to the calculated or determined stall pressure 234 at adder 240. The difference between the stall pressure 234 and the pressure loss 238 can be and / or can represent the instantaneous pressure drop across the pump for a given blood flow through the pump 100. In some examples, the pressure drop represents the difference between the pressure in the ventricle (e.g., left or right ventricle) where the pump 100 is located and the arterial pressure in the artery (e.g., aorta or left pulmonary artery) where the pump 100 is located.

[0143] The determined pressure drop across the blood pump 100 can be added at adder 242 to the pressure value sensed by pressure sensor 138 and / or a pressure value based on a measurement sensed by that pressure sensor (e.g., pressure at a location proximal to impeller 112, such as the patient's aorta). At adder 242, the determined pressure drop across the blood pump 100 can be subtracted to determine a distal pressure value 244 of the pressure distal to impeller 112 (e.g., ventricular pressure, such as left ventricular pressure or right ventricular pressure). The distal pressure value 244 can be output to user interface 148 or other user interfaces for use by practitioners when treating patients with blood pump 100 and / or to automatically control the operation of blood pump 100 by providing the determined or calculated distal pressure value 244 to motor sub-controller 180 and / or can be output in one or more other suitable ways.

[0144] Figure 12 A schematic diagram illustrates the illustrative operation of a motor stall pressure observer 246 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the stall pressure 234 of the motor 105 of the blood pump 100. The stall pressure observer 246 can be configured to receive sensed motor speed 187 or a value associated with it. Based on the received signal or value, the stall pressure observer 246 can determine or calculate the stall pressure 234 of the motor 105.

[0145] Once the sensed motor speed 187 is received, a low-pass filter 248 can be applied to the sensed motor speed 187. The low-pass filter 248 can be the same as one or both of low-pass filters 214, 218 with the same frequency threshold or different low-pass filters with different frequency thresholds, to filter noise from the received sensed motor speed 187 value. The output of the low-pass filter 218 can be processed in several separate steps to obtain the determined or calculated stall pressure 234 of the motor 105.

[0146] In this step, the derivative 220 of the output of the low-pass filter 248 can provide the acceleration of the motor 105. In an additional processing step, the output 224 of the low-pass filter 248 can be squared.

[0147] Once the acceleration of motor 105 is determined and squared by the output of low-pass filter 248, one or more coefficients (e.g., speed-pressure loss pump coefficients) can be applied to correlate the sensed motor speed 187 with the stall pressure 234. In some examples, these one or more pump coefficients can be determined experimentally and are specific to the configuration of blood pump 100. In some examples, a second pump coefficient K can be used. SP1 221 is applied to the acceleration of motor 105, and the first pump coefficient K can be used. SP0 225 is applied to the square of the motor speed output from the low-pass filter 248. Second pump coefficient K SP1 221 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the acceleration of the motor 105 of blood pump 100 with the stall pressure of blood pump 100. First pump coefficient K SP0 225 could be an experimental value for the blood pump 100, which correlates the square of the sensed motor speed 187 with the stall pressure of the blood pump 100.

[0148] The second pump coefficient K can be obtained from adder 250. SP1 Subtract the first pump coefficient K from the output obtained by applying the acceleration of motor 105. SP0 The output obtained by applying it to the output of low-pass filter 248. The first pumping coefficient K, determined at adder 250. SP0 The output obtained by applying the square of the output of the low-pass filter 248 and the second pump coefficient K SP1 The difference in output obtained by applying acceleration to motor 105 can be stall pressure 234, where stall pressure 234 can be the maximum pressure that blood pump 100 may be able to generate.

[0149] Figure 13A diagram schematically depicts the illustrative operation of a pressure loss observer 252 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the pressure loss 238 of the motor 105 of the blood pump 100. The pressure loss observer 252 may be configured to receive a sensed motor speed 187 or a value associated therewith, and a residual motor torque 254 or a value associated therewith. 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 observer 252 can determine or calculate the pressure loss 238 of the motor 105.

[0150] Once the sensed motor speed 187 and residual motor torque 254 values ​​are received, a low-pass filter 256 can be applied to the sensed motor speed(s) values ​​187. The low-pass filter 256 can be the same as one or both of low-pass filters 214, 218, 248 with the same frequency threshold or different low-pass filters with different frequency thresholds, to filter noise from the received sensed motor speed 187 values. The output of the low-pass filter 218 can be provided to the multiplier 258.

[0151] The residual motor torque 254 can be processed using one or more coefficients in multiple steps, which can correlate the residual motor torque 254 and / or the sensed motor speed 187 with the pressure loss 238. In some examples, one or more of these coefficients can be determined experimentally and are specific to the configuration of the blood pump 100.

[0152] In one step, the first pump coefficient K can be... PL0 255 is applied to residual motor torque. First pump coefficient K PL0 255 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the residual motor torque of blood pump 100 with the pressure loss 238. A first pump coefficient K can be applied. PL0 The result obtained is provided to adder 260.

[0153] Furthermore, the square root 196 of the residual motor torque 254 can be calculated or determined and applied to the multiplier 258. The values ​​received at the multiplier 258 can then be multiplied.

[0154] Once the values ​​received at multiplier 258 are multiplied, the second pump coefficient K can be obtained. PL1 259 is applied to the product of the values ​​provided to multiplier 258. Second pump coefficient K PL1259 can be an experimentally derived value for blood pump 100, which correlates the product of residual motor torque 254 and sensed motor speed 187 with pressure loss 238. The second pump coefficient K... PL1 259 is applied to the product of the values ​​provided to multiplier 258, and the result can be provided to adder 260.

[0155] At adder 260, the first pump coefficient K can be used to... PL0 The value of 194, applied to the residual motor torque of 254, is obtained by combining the second pump coefficient K. PL1 259 is applied to the sum of the values ​​generated from the output of multiplier 258 to determine or calculate the value of pressure loss 238. The determined value of pressure loss 238 can be used to determine distal pressure or ventricular pressure 244 and / or other suitable parameters.

[0156] Figures 8 to 13 The constants or coefficients depicted and discussed in these graphs can be based on the values ​​of one or more parameters. In some examples, Figures 7 to 12 The constants or coefficients in the equation can be values ​​planned based on motor or pump speed, motor or pump temperature, motor or pump power, motor or pump operating time, combinations of these parameters, and / or values ​​of additional or alternative parameters used to compensate for changes in pump performance when pump operating conditions change.

[0157] Figure 14 A schematic method or technique 300 for operating a circulatory support system for a patient's heart is depicted. Method 300 may include determining a command signal 302 based on the value of the reference parameter. In some examples, the value of the reference parameter may be a value related to the speed of the motor of a blood pump in the circulatory support system. The value of the reference parameter may be received at a controller of the circulatory support system, and the command signal may be determined based on the value of the reference parameter, as discussed herein or otherwise. The determined command signal may be provided 304 to the motor of the blood pump to cause the motor to drive a driven component (e.g., an impeller) of the blood pump, thereby pumping blood through the blood pump at a speed proportional to the received value of the reference parameter.

[0158] One or more values ​​of one or more parameters related to the operation of the blood pump can be determined over time based on one or more of a command signal, a value related to the speed of the motor, and / or other values ​​of suitable parameters. Parameters related to the operation of the blood pump may include, but are not limited to, pressure parameters of the pressure near the blood pump, flow velocity parameters of blood flowing across the blood pump, motor mechanical losses (e.g., damping) parameters, and / or other suitable parameters. In some examples, the determined values ​​of the one or more parameters can be stored and / or analyzed, as discussed herein or otherwise.

[0159] In some examples, determining one or more values ​​of one or more parameters related to the operation of the blood pump over time may include determining two or more values ​​of two or more parameters related to the operation of the blood pump over time. In such a configuration, the two or more parameters related to the operation of the blood pump over time may include two or more of the following: blood flow rate through the blood pump, left ventricular pressure, mechanical losses in the blood pump, and / or other suitable parameters.

[0160] Indications recommending a change in the blood pump device (e.g., upgrade or downgrade) can be determined and output based on one or more values ​​of one or more parameters related to the operation of the blood pump over time. 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 in the values ​​of the one or more parameters) can indicate that the blood pump will become insufficient to meet the patient's needs, and indicate when a change in the blood pump should be performed when compared to the patient's needs (e.g., one or more thresholds). The output indications can be provided to a user interface and / or one or more users, as discussed herein or otherwise.

[0161] It should be understood that this disclosure is illustrative in many respects only. Changes in detail, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include using any feature of one example embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A loop support system, comprising: Blood pump, the blood pump comprising: Driven component; and A motor, which is in communication with the driven component and configured to drive the driven component to pump blood flow through the blood pump; One or more sensors configured to sense values ​​related to the speed of the motor; and A controller that communicates with the motor and one or more sensors configured to sense values ​​related to the speed of the motor, and The controller is configured to: The command signal is determined based on the value related to the speed of the motor. The command signal is provided to the motor to drive the driven component. One or more values ​​of one or more parameters related to the operation of the blood pump are determined based on one or both of the command signal and the value related to the speed of the motor. An instruction to recommend a blood pump switch is output based on one or more values ​​of one or more parameters determined in relation to the operation of the blood pump.

2. The system as claimed in claim 1, wherein, The controller is further configured to: identify trends in two or more values ​​of the one or more parameters related to the operation of the blood pump over time; and output an indication recommending a blood pump switch when the trend reaches or exceeds a threshold level.

3. The system as claimed in claim 1 or claim 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 as described in any one of claims 1 to 3, wherein, The determined values ​​of one or more parameters related to the operation of the blood pump include one or more values ​​of left ventricular pressure provided by the blood pump.

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

6. The system as described in any one of claims 1 to 5, wherein, The determined values ​​of one or more parameters related to the operation of the blood pump include one or more values ​​of the blood flow rate through the blood pump.

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

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

9. The system of claim 8, wherein, The controller is configured to output an indication recommending a blood pump switch when one or more values ​​of mechanical loss in the blood pump reach or exceed a threshold level.

10. The system as claimed in any one of claims 1 to 9, wherein, The recommended indication for blood pump switching includes a recommended time for the blood pump switching to take place.

11. A non-transitory computer-readable medium storing instructions executable by a circulatory support device for a patient's heart, the instructions causing the circulatory support device to perform methods including: The command signal is determined based on a value related to the speed of the motor of the blood pump in the circulatory support device; The command signal is provided to the motor to drive the driven component to pump blood flow through the blood pump; One or more values ​​of one or more parameters related to the operation of the blood pump are determined based on one or both of the command signal and the value related to the speed of the motor; as well as An indication recommending a blood pump switch is output based on two or more values ​​of one or more parameters related to the operation of the blood pump, which are determined over time.

12. The non-transitory computer-readable medium of claim 11, wherein, The method further includes: Identify trends in two or more values ​​of one or more parameters related to the operation of the blood pump over time.

13. The non-transitory computer-readable medium of claim 12, wherein, The indication for recommended blood pump switching is in response to the trend reaching or exceeding a threshold level.

14. The non-transitory computer-readable medium as claimed in any one of claims 11 to 13, wherein: The determination of 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, wherein the two or more parameters are selected from the group consisting of left ventricular pressure, blood flow velocity through the blood pump, and mechanical losses in the blood pump; and When the 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, the indicator recommending a blood pump switch is output.

15. The non-transitory computer-readable medium as claimed in any one of claims 11 to 14, wherein, The recommended indication for a blood pump transition includes a recommended time for the transition to occur.

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