System and method for pump speed regulation

Abstract

Methods and apparatus are provided for controlling operation of a mechanical circulation support (MCS) device to facilitate recovery of autologous cardiac function of a patient in which the MCS device is implanted. The method includes: controlling a pump of the MCS device to operate in a first mode; obtaining one or more first cardiac values associated with the patient during operation of the MCS device; determining to transition operation of the MCS device to a second mode based at least in part on the obtained one or more first cardiac values; and when it is determined that operation of the MCS device is transitioned to the second mode, controlling the pump of the MCS device to operate in the second mode.

Description

Technical Field

[0001] The present disclosure relates to techniques for regulating the pump speed of a mechanical circulatory support device. Background Art

[0002] Fluid pumps (such as blood pumps) are used for a wide range of applications and purposes in the medical field. An intravascular blood pump is a pump that can be advanced through a patient's vasculature (i.e., veins and / or arteries) to a location within the patient's heart or elsewhere within the patient's circulatory system. For example, an intravascular blood pump can be inserted via a catheter and positioned to straddle a heart valve. An intravascular blood pump is typically disposed at the distal end of a catheter. Once in place, the pump can be used to assist the heart and pump blood through the circulatory system, and thus temporarily reduce the workload of the patient's heart, for example, to enable the heart to recover after a heart attack. An exemplary intravascular blood pump can be purchased from ABIOMED, Inc., Danvers, MA, under the trade name Heart Pump.

[0003] Such pumps can be positioned, for example, within a heart chamber (such as the left ventricle) to assist the heart. In this case, the blood pump can be inserted via a hollow catheter through the femoral artery and introduced upward into and into the left ventricle of the patient's heart. From this position, the blood pump inlet draws in blood and the blood pump outlet discharges the blood into the aorta. In this way, the function of the heart can be replaced or at least assisted by the operation of the pump. Some devices associated with a blood pump inserted into the left ventricle to assist heart function are also commonly referred to as left ventricular assist devices (LVADs). More generally, an LVAD is an example of a type of mechanical circulatory support (MCS) device, sometimes also referred to as a "ventricular assist device / system" that can be used to support a patient's heart function.

[0004] An intravascular blood pump is typically connected to a heart pump controller that controls the heart pump, such as motor speed, and collects and displays operation data regarding the blood pump, such as heart signal level, battery temperature, blood flow rate, and tubing integrity. An exemplary heart pump controller can be purchased from ABIOMED, Inc., under the trade name Automated ImpellaController TM When the operation data values fall outside of a predetermined value or range, for example, if a leak, aspiration, and / or pump failure is detected, then the controller can issue an alarm. The controller can include a video display screen on which a graphical user interface configured to display operation data and / or alarms is presented. Summary of the Invention

[0005] Systems and methods are described herein for regulating the operation of a blood pump during long-term use (e.g., from weeks to months to years) to facilitate cardiac recovery (e.g., halt or reverse cardiac remodeling that occurs in heart disease). The inventors have recognized and appreciated that by monitoring physiological and / or pump signals over time, the pump flow can be adjusted to meet the hemodynamic needs of the patient and facilitate cardiac recovery. In some embodiments, the heart pump can adjust the pump flow by operating automatically or manually in various modes and switching between the various modes.

[0006] In some embodiments, a method is provided for controlling the operation of a mechanical circulatory support (MCS) device to facilitate the recovery of the native cardiac function of a patient in whose body the MCS device is implanted. The method includes: controlling the pump of the MCS device to operate in a first mode; obtaining, during the operation of the MCS device, one or more first cardiac values associated with the patient; determining, at least in part based on the obtained one or more first cardiac values, to transition the operation of the MCS device to a second mode; and when it is determined to transition the operation of the MCS device to the second mode, controlling the pump of the MCS device to operate in the second mode.

[0007] In one aspect, the first mode is a decompression mode and the second mode is a physiological mode. In another aspect, the first mode is a physiological mode and the second mode is a sub-mode of the physiological mode. In another aspect, the sub-mode of the physiological mode includes an exercise mode or a sleep mode. In another aspect, the first mode is a physiological mode and the second mode is a weaning mode. In another aspect, the first mode includes first operating parameters configured to operate the pump in a first flow type, and the second mode includes second operating parameters configured to operate the pump in a second flow type different from the first flow type. In another aspect, the first flow type is continuous flow and the second flow type is pulsatile flow. In another aspect, the first mode is a mode that provides optimized (e.g., maximum) unloading of the left ventricle of the patient's heart based on physiological signals. In another aspect, the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response. In another aspect, the second mode is a mode that promotes reverse remodeling of the patient's cardiac function. In another aspect, the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

[0008] On the other hand, the method further includes selecting a set of cardiac values to be obtained based at least in part on the first mode, and obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtaining the one or more first cardiac values included in the set of cardiac values. On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device. On the other hand, the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device. On the other hand, the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors. On the other hand, the method further includes processing the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

[0009] On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device. On the other hand, the method further includes determining to adjust a speed of the pump of the MCS device at least in part based on the one or more first cardiac values, and adjusting the speed of the pump of the MCS device when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode. On the other hand, the method further includes: obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; determining to transition the operation of the MCS device to a third mode at least in part based on the obtained one or more second cardiac values; and controlling the pump of the MCS device to operate in the third mode when it is determined to transition the operation of the MCS device to the third mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode. On the other hand, the method further includes selecting a set of cardiac values to be obtained at least in part based on the second mode, and obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: obtaining the one or more second cardiac values included in the set of cardiac values. On the other hand, the MCS device is a left ventricular assist device (LVAD). On the other hand, the first mode is a decompression mode, and the second mode is a weaning mode. On the other hand, the method further includes receiving an instruction to transition the operation of the MCS device to the second mode via a user interface, and in response to receiving the instruction, controlling the pump to operate in the second mode.

[0010] In some embodiments, a controller for a pump of a mechanical circulatory support (MCS) device is provided. The controller includes at least one hardware processor configured to: control the pump of the MCS device to operate in the first mode; obtain one or more first cardiac values associated with the patient during operation of the MCS device; determine to transition the operation of the MCS device to a second mode at least in part based on the obtained one or more first cardiac values; and control the pump of the MCS device to operate in the second mode when it is determined to transition the operation of the MCS device to the second mode.

[0011] On the one hand, the first mode is a decompression mode, and the second mode is a physiological mode. On the other hand, the first mode is a physiological mode, and the second mode is a sub-mode of the physiological mode. On the other hand, the sub-mode of the physiological mode includes an exercise mode or a sleep mode. On the other hand, the first mode is a physiological mode, and the second mode is a weaning mode. On the other hand, the first mode includes first operating parameters configured to operate the pump according to a first flow type, and the second mode includes second operating parameters configured to operate the pump according to a second flow type different from the first flow type. On the other hand, the first flow type is continuous flow, and the second flow type is pulsatile flow. On the other hand, the first mode is a mode that provides optimized (e.g., maximum) unloading of the left ventricle of the patient's heart based on physiological signals. On the other hand, the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response. On the other hand, the second mode is a mode that promotes reverse remodeling of the patient's cardiac function. On the other hand, the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

[0012] On the other hand, the at least one hardware processor is further configured to select a set of cardiac values to be obtained at least in part based on the first mode, and obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtaining the one or more first cardiac values included in the set of cardiac values. On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device. On the other hand, the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device. On the other hand, the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors. On the other hand, the at least one hardware processor is further configured to process the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

[0013] On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with the one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device. On the other hand, the at least one hardware processor is further configured to determine to adjust the speed of the pump of the MCS device at least in part based on the one or more first cardiac values, and when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode, adjust the speed of the pump of the MCS device. On the other hand, the at least one hardware processor is further configured to: obtain one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; determine to transition the operation of the MCS device to a third mode at least in part based on the obtained one or more second cardiac values; and when it is determined to transition the operation of the MCS device to the third mode, control the pump of the MCS device to operate in the third mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode. On the other hand, the at least one hardware processor is further configured to select a set of cardiac values to be obtained at least in part based on the second mode, and obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: obtaining the one or more second cardiac values included in the set of cardiac values. On the other hand, the MCS device is a left ventricular assist device (LVAD). On the other hand, the first mode is a decompression mode, and the second mode is a weaning mode. On the other hand, the at least one hardware processor is further configured to receive an instruction to transition the operation of the MCS device to the second mode via a user interface, and in response to receiving the instruction, control the pump to operate in the second mode.

[0014] In some embodiments, a mechanical circulatory support (MCS) device is provided. The MCS device includes a pump and a controller coupled to the pump, the controller including at least one hardware processor. The at least one hardware processor is configured to: control the pump to operate in a first mode; obtain one or more first cardiac values associated with the patient during operation of the MCS device; determine to transition the operation of the MCS device to a second mode at least in part based on the obtained one or more first cardiac values; and when it is determined to transition the operation of the MCS device to the second mode, control the pump to operate in the second mode.

[0015] On the one hand, the first mode is a decompression mode and the second mode is a physiological mode. On the other hand, the first mode is a physiological mode and the second mode is a sub-mode of the physiological mode. On the other hand, the sub-mode of the physiological mode includes an exercise mode or a sleep mode. On the other hand, the first mode is a physiological mode and the second mode is a weaning mode. On the other hand, the first mode includes first operating parameters configured to operate the pump according to a first flow type, and the second mode includes second operating parameters configured to operate the pump according to a second flow type different from the first flow type. On the other hand, the first flow type is a continuous flow and the second flow type is a pulsatile flow. On the other hand, the first mode is a mode that provides optimized (e.g., maximum) unloading of the left ventricle of the patient's heart based on physiological signals. On the other hand, the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response. On the other hand, the second mode is a mode that promotes reverse remodeling of the patient's cardiac function. On the other hand, the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

[0016] On the other hand, the at least one hardware processor is further configured to select a set of cardiac values to be obtained at least in part based on the first mode, and obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtaining the one or more first cardiac values included in the set of cardiac values. On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device. On the other hand, the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device. On the other hand, the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors. On the other hand, the at least one hardware processor is further configured to process the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

[0017] On the other hand, the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device. On the other hand, the at least one hardware processor is further configured to determine to adjust the speed of the pump of the MCS device at least in part based on the one or more first cardiac values, and when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode, adjust the speed of the pump of the MCS device. On the other hand, the at least one hardware processor is further configured to: obtain one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; determine to transition the operation of the MCS device to a third mode at least in part based on the obtained one or more second cardiac values; and when it is determined to transition the operation of the MCS device to the third mode, control the pump of the MCS device to operate in the third mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode. On the other hand, the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode. On the other hand, the at least one hardware processor is further configured to select a set of cardiac values to be obtained at least in part based on the second mode, and obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: obtaining the one or more second cardiac values included in the set of cardiac values. On the other hand, the MCS device is a left ventricular assist device (LVAD). On the other hand, the first mode is a decompression mode, and the second mode is a weaning mode. On the other hand, the at least one hardware processor is further configured to receive an instruction to transition the operation of the MCS device to the second mode via a user interface, and in response to receiving the instruction, control the pump to operate in the second mode. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1A Illustrates a pump system according to some embodiments of the present technology.

[0019] Figure 1B is Figure 1A a cross-sectional view of a portion of the pump system of.

[0020] Figure 2 Illustrates a process for adjusting the operation of a pump system based on measured cardiac values according to some embodiments of the present technology.

[0021] Figure 3 A process for adjusting the operation of a pump system according to some embodiments of the present technology, the pump system being configured to operate in multiple modes.

[0022] Figure 4 A diagram illustrating exemplary modes of a pump system for operating a mechanical circulatory support (MCS) device according to some embodiments of the present technology.

[0023] Figure 5 A plurality of timelines for adjusting the operation of the pump system of the MCS between different modes according to some embodiments of the present technology.

[0024] Figure 6 Schematically illustrates the restoration of the native heart function over time when transitioning the operation of the pump system of the MCS device between different modes according to some embodiments of the present technology.

[0025] Figure 7 A process for adjusting the operation of the pump system of the MCS device according to some embodiments of the present technology. Detailed Description

[0026] Patients with chronic heart failure (CHF) currently have no reliable options for promoting native heart recovery. Many advanced CHF patients receive durable mechanical circulatory support (MCS) devices (e.g., left ventricular assist devices (LVADs)), but few recover from the disease while on MCS support. One reason such patients do not recover is that conventional MCS devices are typically designed to meet the patient's physiological needs during the acute phase, rather than being designed to promote native heart recovery over a longer support duration. For example, MCS devices for long-term support are typically set at one speed for the duration of the support. Thus, the inventors have recognized the benefits of adjusting the pump speed of the pump system during MCS device support. For example, some embodiments of the techniques described herein are configured to track heart function during the duration of MCS device support and adjust the operation of the device to meet physiological needs and / or place the device in a particular mode / module depending on the treatment / recovery phase the patient is currently in (e.g., initial, recovery, exercise, weaning, etc.) to promote native heart recovery.

[0027] Referring now to the figures, Figure 1A and 1BShown is a pump system 100 (e.g., part of an MCS device) used with some embodiments of the present technology. As shown, the pump system 100 can be coupled to a control unit 200. The pump 100 can include a distal atraumatic tip 102, a pump housing 104 surrounding a rotor 108, an outflow tube 106, a distal bearing 110, a proximal bearing 112, an inlet 116, an outlet 118, a conduit 120, a handle 130, a cable 140, and a motor 150. As will be appreciated, although shown as having an atraumatic tip, in some embodiments the pump may not include this tip. The pump housing 104 can be configured as a frame structure formed by a grid with openings that can be at least partially covered by an elastic material. The proximal portion of the pump housing 104 can extend into the hollow interior of the outflow tube 106 and be mounted therein, and the distal portion of the pump housing 104 can extend distally beyond the distal end of the outflow tube 106. The exposed openings in the pump housing 104 that extend distally beyond the outflow tube 106 can form the inlet 116 of the pump 100. The proximal end of the outflow tube 106 can include a plurality of openings that form the outlet 118 of the pump 100. The rotor 108 can be rotatably mounted between the distal bearing 110 and the proximal bearing 112 and can be coupled to the distal end of a drive shaft 114. The drive shaft 114 can be flexible and can extend through the conduit 120, through the hollow interior of the outflow tube 106 into the handle 130, and be coupled to a motor 150 housed in the handle 130. The proximal end of the handle 130 can be coupled to the control unit 200 via the cable 140. Fluid can access the drive shaft 114 and circulate through the conduit 120 in the space surrounding the distal bearing 110 and the proximal bearing 112 to lubricate those components and reduce friction during operation of the pump 100.

[0028] The control unit 200 can include one or more memories 202, one or more processors 204, a user interface 206, and one or more sensors, such as a current sensor 208. The processor 204 can include one or more microcontrollers, one or more microprocessors, one or more application specific integrated circuits (ASICs), one or more digital signal processors, program memories, or other computing components. The processor 204 can be communicatively coupled to other components of the control unit 200 (e.g., the memory 202, the user interface 206, the current sensor 208), and can be configured to control one or more operations of the pump 100. As a non-limiting example, the control unit 200 can be implemented as an Automated Impella Controller from Abiomed, Inc. of Danvers, Massachusetts TM In some aspects, the memory 202 is included as part of the processor 204 rather than being provided as a separate component.

[0029] During operation, the processor 204 may be configured to control the power delivered to the motor 150 by a power supply line (not shown) in the cable 140 (e.g., by controlling a power supply (not shown)), thereby controlling the speed of the motor 150. The current sensor 208 may be configured to sense the motor current associated with the operating state of the motor 150, and the processor 204 may be configured to receive the output of the current sensor 208 as a motor current signal. The processor 204 may further be configured to determine the flow rate through the pump 100 at least in part based on the motor current signal and the motor speed, as described in more detail below. The current sensor 208 may be included in the control unit 200 or may be located along any portion of the power supply line in the cable 140. Additionally or alternatively, the current sensor 208 may be included in the motor 150, and the processor 204 may be configured to receive the motor current signal via a data line (not shown) in the cable 140 that is coupled to the processor 204 and the motor 150.

[0030] The memory 202 may be configured to store computer-readable instructions for the various functions of the components of the control unit 200 and other information. In one aspect, the memory 202 includes volatile and / or non-volatile memory, such as electrically erasable programmable read-only memory (EEPROM).

[0031] The user interface 206 may be configured to receive user input via one or more buttons, switches, knobs, etc. Additionally, the user interface 206 may include a display configured to display information and one or more indicators, such as light indicators, audio indicators, etc., for communicating information and / or providing warnings regarding the operation of the pump 100.

[0032] The pump 100 can be designed to be insertable into a patient's body, for example, into the left ventricle of the heart, via an introducer system, for example. Although some of the systems and / or methods disclosed herein are described with respect to regulating the pump speed of a pump inserted into the left ventricle of the heart, it should be understood that the systems and / or methods described herein can also be applied to other types of ventricular support systems, such as ventricular support systems inserted into the right ventricle of the heart. In one aspect, the housing 104, the rotor 108, and the outflow tube 106 can be radially compressible so that the pump 100 can achieve a relatively small outer diameter, such as 9Fr (3 mm), during insertion. When the pump 100 is inserted into a patient's body, for example, into the left ventricle, the handle 130 and the motor 150 can remain disposed outside the patient's body. As will be appreciated, in other embodiments, the motor of the pump system can be disposed inside the patient's body after insertion. During operation, the motor 150 is controlled by the processor 204 to drive the rotation of the drive shaft 114 and the rotor 108 to pump blood from the inlet 116 to the outlet 118. It should be understood that the rotor 108 can be rotated in the reverse direction by the motor 150 to pump blood in the opposite direction (in this case, the opening of 118 forms the inlet and the opening of 116 forms the outlet). In one aspect, the pump 100 can be configured to be used for weeks to months to years to support the cardiac function of a patient suffering from chronic heart failure, but it should be understood that the techniques described herein are not limited to any particular type of process and / or duration of use.

[0033] As described herein, the operation (e.g., speed) of conventional MCS devices is primarily manually configured to meet the physiological needs of the patient during the acute phase. When setting the operation of such devices, the improvement of cardiac function over a longer period of time is generally not considered. Since MCS devices are typically configured to maintain acute physiological function, there are currently few patients who recover from chronic heart failure while being supported by an MCS device. Some embodiments of the techniques described herein are configured to identify and track the improvement of cardiac function over time and can adjust the operation of the MCS device to promote the likelihood of autologous cardiac recovery while also meeting the acute physiological needs of the patient.

[0034] Figure 2 A process for adjusting the pump speed of an MCS device based on the monitoring of cardiac values associated with the operation of the MCS device is schematically illustrated. In one example, the monitored cardiac value can correspond to the left ventricular systolic pressure (LVSP). As Figure 2As shown, a target heart value (e.g., a target LVSP value) can be compared with a measured heart value (e.g., a measured LVSP value) determined at least in part based on the output from the MCS device. Based on the comparison of the target and the measured heart value, the controller 210 of the MCS device can be configured to adjust the speed of the pump 220 according to the patient's needs to improve the performance of the MCS device. For example, if the measured heart value is less than the target heart value, the controller can be configured to increase (or alternatively decrease) the speed of the pump to attempt to align the measured heart value with the target heart value. In this way, the speed of the pump can be adjusted continuously or periodically to achieve a specific heart performance goal.

[0035] The inventors have recognized and appreciated that when supporting a patient over a long period of time (e.g., weeks to months to years), it can be advantageous to consider multiple inputs when determining how to adjust the operation of the MCS device. Figure 3 Describe a process for adjusting the operation of the blood pump of an MCS device in response to multiple inputs. Similar to the process shown in Figure 2 In the example of Figure 3 the controller 310 of the MCS device can be configured to control the operation (e.g., speed) of the pump 320 of the MCS device at least in part based on input signals provided to the controller 310. However, in the example of Figure 3 the input signals are provided from a mode selector 330 to the controller 310, and the mode selector 330 receives multiple inputs, including one or more heart values 322 obtained from the pump 320 and / or another component of the MCS device, monitored data 340 measured using one or more sensors separate from the MCS device, and indirect data 350 determined based on information associated with the patient's physiological state, rather than monitoring a single heart value as described in Figure 2 Although the mode selector 330 is shown as a separate component in Figure 3 it should be understood that in some embodiments, the mode selector 330 can be incorporated within the controller 310. Additionally, although the mode selector 330 is shown as receiving inputs from three sources, it should be understood that in some embodiments, the mode selector 330 can receive inputs from more or fewer than three sources.

[0036] One or more measured cardiac values 322 obtained from the MCS device may include, but are not limited to, left ventricular end diastolic pressure (LVEDP), left ventricular end diastolic volume (LVEDV), aortic pressure (AoP), aortic opening volume (AoV), contractility, heart rate (HR), cardiac output (CO), contractility index (CI), stroke volume, dP / dt, and tau. The monitored data 340 may include, but are not limited to, various signal values from additional monitors (e.g., blood pressure (BP), wall tension, coronary blood flow, strain, muscle oxygenation, sympathetic nervous system (SNS) innervation, etc.). The indirect data 350 may include, but are not limited to, mitral regurgitation (MR) values, septal position, and artificial intelligence / machine learning (AI / ML) assessments of cardiac function improvement over time.

[0037] In some embodiments, the mode selector 330 may be configured to provide a selection of one of a plurality of modules (also referred to herein as "modes") to the controller 310 as an input, where each of the modules specifies instructions for providing a type of MCS device support customized to the patient's current physiological needs and / or autologous cardiac recovery goals. For example, in some embodiments, the plurality of modules may include a decompression module having control instructions for alleviating acute injury and fully (or partially) unloading the left ventricle without suction. The plurality of modules may also include a physiological module configured to promote reversal of cardiac remodeling associated with the development of heart disease. The physiological module may include one or more sub-modules for the patient's specific physiological needs. For example, the sub-modules may include an exercise mode that requires more MCS device support, a sleep mode that requires less MCS device support, or a daily or "normal" mode that requires an average amount of MCS device support. By utilizing the sub-modules to vary the level of MCS device support required when the device operates according to the physiological module, the daily life of patients who require different levels of MCS device support can be accommodated. In some embodiments, switching between different modules and / or sub-modules may be at least partially based on various inputs provided to the mode selector 330. For example, one or more sensors may be used to determine when the patient wakes up, stands up, or is in some other physiological state where additional pump support would help support the patient's cardiac function. In such examples, the mode selector 330 may be configured to automatically switch to a different module or sub-module that provides a pump flow rate consistent with the patient's current physiological state. The plurality of modules may also include a weaning module that reduces MCS device support prior to explanting the MCS device. Within each of the plurality of modules, the speed of the pump and / or the type of support provided may be adjustable.

[0038] Figure 4 A graph illustrating various characteristics of three exemplary modes for controlling the operation (e.g., speed) of an MCS device according to some embodiments. In Figure 4The modes shown and described in more detail herein are the decompression mode, the physiological mode, and the weaning mode. However, it should be understood that any suitable number and / or type of modes for controlling the operation of the MCS device may be used, and the embodiments are not limited in this regard.

[0039] As described herein, in some embodiments, the controller of the MCS device may be configured to operate in one of a plurality of modes based at least in part on the type and / or level of support required by the patient according to their current treatment stage. Characteristics of the operation that may vary across modes include, but are not limited to, the type of flow through the pump (e.g., continuous, pulsatile, or a combination of continuous and pulsatile), the stimuli and / or clinical target values that are monitored to determine the operating parameters (e.g., pump speed) while in the mode, and whether the mode includes one or more sub-modes, in which the MCS device is configured to operate according to different parameters within the mode. As discussed herein, in some embodiments, the MCS device may transition (e.g., in response to user input or automatically without explicit user input) between modes (or sub-modes) to facilitate the restoration of native heart function.

[0040] In the decompression mode, the patient may require continuous / maximal support from the MCS device to address the acute symptoms of heart failure. In this mode, the controller of the MCS device may be instructed to provide continuous flow through the device with the patient's aortic valve closed most of the time. The goal of the decompression mode may be to provide volume unloading of the patient's left ventricle and / or optimized unloading without suction. For example, in some cases, the optimized unloading may be the maximal unloading of the left ventricle based on physiological (e.g., cardiac) signals. Examples of cardiac values that may be monitored and used to determine the pump speed when in the decompression mode include, but are not limited to, one or more of the following: left ventricular end-diastolic pressure (LVEDP), left ventricular end-diastolic volume (LVEDV), left ventricular end-diastolic diameter (LVEDD), and septal position. However, it should be understood that other cardiac values may additionally or alternatively be used to adjust the operating parameters within the decompression mode and / or determine when to transition from the decompression mode to another mode (e.g., the physiological mode), such cardiac values including, but not limited to, the cardiac values described herein.

[0041] In the physiological mode, the patient may require less and / or different support from the MCS device compared to when the MCS device is operating in the decompression mode. For example, the patient's native heart function may have recovered to the extent that continuous flow and maximal unloading of the heart are no longer required. In the physiological mode, the type of support provided by the MCS device may facilitate the recovery of the patient's native heart function and / or may contribute to the reversal of cardiac remodeling associated with heart disease. For example, in the physiological mode, the flow type may be pulsatile rather than continuous to more closely mimic the function of the native heart, and the aortic valve may open once every few cycles (e.g., every 5 cycles) to maximize unloading while allowing native valve function. The goal of the physiological mode may be to accommodate the patient's physiological responses and support needs during their daily life while encouraging the recovery of the patient's native heart function.

[0042] In some embodiments, flexibility in accommodating different support needs while in the physiological mode may be achieved by defining a set of sub - modes that regulate the operation of the MCS device based on the expected cardiac demands during different activities of the patient throughout the day. For example, when more MCS device support is expected during exercise, the controller of the MCS device may be instructed to operate in an exercise mode, which adjusts the pump speed to maintain a target mean arterial pressure (MAP) above a specific threshold (e.g., greater than 75 mmHg to 80 mmHg). In contrast, when less MCS device support is expected during sleep, the controller of the MCS device may be instructed to operate in a sleep mode, which slows down the pump speed, thereby relying on native heart function to provide the required support. A daily or "normal" mode may provide an average level of support when the patient is performing their daily activities. When the controller is instructed to be in the physiological mode, any suitable cardiac values may be monitored and used to determine the operating parameters of the MCS device, and the monitored cardiac values may vary depending on the specific sub - mode that the controller is currently implementing. Examples of cardiac values that may be monitored and used to determine the pump speed when in the physiological mode include, but are not limited to, one or more of aortic pressure (AoP), aortic wall tension, and mean arterial pressure (MAP), as described herein for the exercise mode. However, it should be understood that other cardiac values may additionally or alternatively be used to regulate the operating parameters within the decompression mode and / or to determine when to transition from the physiological mode to another mode (e.g., the weaning mode), such cardiac values including, but not limited to, the cardiac values described herein.

[0043] In the weaning mode, the patient's native heart function may have recovered to the extent that a transition to explantation of the MCS device can be made. In this weaning mode, the speed of the pump can be gradually decreased to facilitate the weaning process. In the weaning mode, the flow type can be pulsatile, continuous, or a combination of pulsatile and continuous, and can be driven at least in part with respect to values associated with the patient's native heart function. In the weaning mode, it is expected that the patient's aortic valve will be open most of the time, allowing the patient's heart to transition to no longer relying on the MCS device to provide cardiac support. When the controller is indicated to be in the weaning mode, any suitable cardiac values can be monitored and used to determine the operating parameters of the MCS device. Examples of cardiac values that can be monitored and used to determine pump speed when in the weaning mode include, but are not limited to, one or more of native cardiac output (CO) or cardiac index (CI), native stroke volume, and ejection fraction (EF). However, it should be understood that other cardiac values can be used additionally or alternatively, including but not limited to the cardiac values described herein.

[0044] When a patient's native heart function recovers during long-term use of an MCS device, the controller of the MCS device can be instructed to transition between different operating modes of the device to facilitate native heart function recovery and / or reverse cardiac remodeling that occurs in heart disease. The timeline for the transition between different modes can be patient-specific to optimize the level and / or type of support provided by the MCS device based on patient-specific metrics regarding the patient's native heart function.

[0045] Figure 5 Schematically illustrate three exemplary timelines (510, 520, 530) for transitions between different operating modules / modes of an MCS device for three different patients according to some embodiments. In each of the illustrated timelines, the initial mode is the decompression mode, in which the MCS device is controlled to provide maximum unloading of the heart after the MCS device is implanted in the patient.

[0046] As illustrated in both timeline 510 and timeline 530, the mode of the MCS device can transition from a decompression mode to a physiological mode to an explant mode, but at different times. In timeline 510, the transition between the decompression mode and the physiological mode occurs within one week of initiating the decompression mode. In contrast, in timeline 530, the transition between the decompression mode and the physiological mode occurs after a longer period (e.g., 10 weeks). As discussed herein, the transition between the decompression mode and the physiological mode can be guided at least in part based on the characteristics of the patient's native heart function. In timeline 530, the patient may have a more severe heart disease, where the native function of the patient's heart is poorer prior to MCS device implantation, and thus may require longer support in the decompression mode compared to the patient in timeline 510, who may have a less severe form of heart disease. Other reasons for delaying the transition from the decompression mode to the physiological mode in timeline 530 relative to timeline 510 are also possible. In timeline 510, the operation of the MCS device remains in the physiological mode for 13 weeks before transitioning to the explant mode, which remains in the explant mode for one week before explantation of the MCS device. In timeline 530, the operation of the MCS device remains in the physiological mode for a shorter period (1 week) before transitioning to the explant mode (followed by explantation of the MCS device).

[0047] Timeline 520 illustrates a transition sequence between the operating modes of the MCS device that is different from the transition sequences shown in timelines 510 and 530. In timeline 520, the operation of the MCS device can transition from the decompression mode to the physiological mode, but after a short time (e.g., 5 hours) after implantation of the MCS device. The MCS device remains in the physiological mode for 2 weeks, after which a transition to the explant mode occurs, and it is expected that explantation of the MCS device will occur shortly thereafter. However, based on the monitored cardiac values of the patient, it can be determined that the patient would benefit from returning the operation of the MCS device to the pre-explant physiological mode. Accordingly, the operation of the MCS device transitions from the explant mode to the physiological mode, which remains in the physiological mode for 1 week before transitioning again to the explant mode followed by explantation. Timeline 520 illustrates the flexibility of some embodiments to freely transition between different modes based on the monitored cardiac values associated with the patient to provide patient-specific care using the MCS device. For example, although only a transition from the explant mode back to the physiological mode is shown in Figure 5 , in some embodiments, if the monitored cardiac values associated with the patient indicate that the patient would benefit from additional MCS device support provided in the decompression mode, then a transition from the physiological mode back to the decompression mode is also possible. In Figure 5The timelines shown and described herein are exemplary only, and other timelines are also contemplated, including timelines in which fewer than all possible modules / mode are present. For example, in one possible timeline, operation of the MCS device may transition directly from a decompression mode to an explant mode without first transitioning to a physiological mode.

[0048] Figure 6 Schematically shows how different operational modules / mode incorporated into the MCS device during long-term use according to the techniques described herein can facilitate restoration of the patient's native heart function. Figure 6 Shows the restoration trajectories of the native heart function (e.g., left ventricular function) of three different patients with an implanted MCS device for long-term use. As shown, each patient initially has poor native heart function, and thus, the MCS device is controlled to operate in a decompression mode, which provides optimized (e.g., maximum) unloading of the left ventricle. Over time, the native heart function of each patient begins to improve, but at different rates specific to the individual patient. As the native heart function improves, the operation of the MCS device transitions to different modes to facilitate further restoration of the patient's native heart function. It should be understood that Figure 6 Module 2 (“reverse remodeling”) shown in Figure 4 and 5 may correspond to the “physiological mode” described in Figure 6 and module 3 (“exercise training”) shown in Figure 4 may correspond to the “exercise mode” sub-mode included as part of the physiological mode described in

[0049] As Figure 6 shown, while each patient experiences a modest restoration of native heart function when the MCS device operates in the decompression mode, a significant improvement in native heart function is provided when the MCS device operates in reverse remodeling (e.g., physiological mode), although at different rates. When the native heart function has been restored to a certain level, the operation of the MCS device may transition to the explant mode to prepare the patient for explantation of the device, as described herein.

[0050] Figure 7Describe process 700 for adjusting the operation of an MCS device during long-term patient use. Process 700 begins with action 710, where an operation mode of a pump controller of the MCS device is selected. As described herein, the initial operation mode after implantation may be selected as a decompression mode, where optimized (e.g., maximum) unloading of the left ventricle is provided to ensure that the patient has sufficient support from the MCS device to compensate for relatively weak native heart function. Process 700 may then proceed to action 712, where one or more cardiac values associated with the patient in whose body the MCS device is implanted are obtained. As described herein, the obtained cardiac values may include values directly obtained from the MCS device, values directly obtained from one or more sensors external to the MCS device, and / or values indirectly obtained from sensor data associated with the patient (e.g., from one or more models or algorithms). In some embodiments, a request may be provided to one or more sensors, which may then provide the values. In other embodiments, the obtained values may be received without a request being issued. In additional embodiments, at least some values may be obtained in response to a request, while other values may be obtained without a request being issued.

[0051] Next, process 700 may proceed to action 714, where it is determined whether to adjust the operation mode of the MCS device, at least in part based on the obtained cardiac values. As described herein, the decision to transition the operation mode of the MCS device from one mode (e.g., decompression mode) to another mode (e.g., physiological mode) may be based at least in part on the current recovery state of the patient's native heart function. The recovery state of the patient's native heart function may be determined at least in part based on the cardiac values obtained in action 712. If it is determined in action 714 that the operation mode of the MCS device should be adjusted, then process 700 returns to action 710, where a new operation mode of the pump controller of the MCS device is selected. The new operation mode may be, for example, a physiological mode, a weaning mode, or a sub-mode of the currently selected mode (e.g., an exercise sub-mode of the physiological mode).

[0052] If it is determined in action 714 that the operation mode of the MCS device should not be adjusted, then process 700 proceeds to action 716, where it is determined whether the pump speed should be adjusted within the currently selected operation mode. If it is determined in action 716 that no adjustment to the pump speed is needed, then process 700 returns to action 712 to obtain the cardiac values again. If it is determined in action 716, then process 700 proceeds to action 718, where the pump speed is adjusted. For example, the pump speed may be adjusted at least in part based on one or more of the cardiac values obtained in action 712 to maintain a particular amount of desired MCS device support for the patient. In some embodiments, the pump speed may be adjusted based on a sub-mode (e.g., an exercise mode) within the currently selected operation mode.

[0053] The above embodiments can be implemented in any of a number of ways. One or more aspects and embodiments of the present disclosure related to the execution of a process or method may utilize program instructions executable by a device (such as a computer, a processor, or other device) to perform or control the execution of the process or method. In this regard, various inventive concepts may be embodied as a computer-readable storage medium (or multiple computer-readable storage media) encoded with one or more programs (such as computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, circuit configurations in a field-programmable gate array or other semiconductor device, or other tangible computer storage media), the one or more programs, when executed on one or more computers or other processors, perform the methods implementing one or more of the various embodiments described above. One or more computer-readable media or several media may be transportable, such that the one or more programs stored thereon can be loaded onto one or more different computers or other processors to implement various aspects of the aspects described above. In some embodiments, the computer-readable media may be non-transitory media.

[0054] The above embodiments of the present technology can be implemented in any of a number of ways. For example, the embodiments can be implemented using hardware, software, or a combination thereof. When implemented in software, the software code can be executed on any suitable processor or set of processors, whether provided in a single computer or distributed among multiple computers. It should be understood that any component or collection of components that perform the functions described above can be regarded as a controller that controls the functions described above as a whole. The controller can be implemented in many ways, such as by using dedicated hardware or by using general-purpose hardware (such as one or more processors) programmed with microcode or software to perform the functions described above, and can be implemented in a combination of multiple ways when the controller corresponds to multiple components of the system.

[0055] In addition, it should be understood that, by way of non-limiting example, a computer can be embodied in any of several forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computer can be embedded in a device that is not typically regarded as a computer but has suitable processing capabilities, including a personal digital assistant (PDA), a smart phone, or any other suitable portable or fixed electronic device.

[0056] Furthermore, a computer can have one or more input and output devices. In addition to this, these devices can be used to present a user interface. Examples of output devices that can be used to provide a user interface include a printer or a display screen for visual presentation of output, and a speaker or other sound generating device for audible presentation of output. Examples of input devices that can be used for a user interface include a keyboard and a pointing device, such as a mouse, a touch pad, and a digitizing tablet. As another example, a computer can receive input information by voice recognition or in other audible formats.

[0057] Such computers can be interconnected through one or more networks in any suitable form, including local area networks or wide area networks, such as enterprise networks and intelligent networks (IN) or the Internet. Such networks can be based on any suitable technology and can operate according to any suitable protocol, and can include wireless networks, wired networks, or fiber optic networks.

[0058] Furthermore, as described, some aspects can be embodied as one or more methods. The actions performed as part of the method can be ordered in any suitable manner. Thus, embodiments can be constructed in which the actions are performed in a different order than that illustrated, the order can include performing some actions simultaneously, even though they are shown as sequential actions in the illustrative embodiments.

[0059] All definitions defined and used herein should be understood to control dictionary definitions, definitions in documents incorporated by reference, and / or the ordinary meaning of the defined terms.

[0060] As used herein in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless expressly stated to the contrary.

[0061] As used herein in the specification and claims, the phrase "and / or" should be understood to mean "either or both" of the elements so combined (i.e., elements that exist combined in some cases and separately in other cases). Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so combined. Other elements may exist as appropriate, whether or not related to the elements expressly identified by the "and / or" clause. Thus, as a non-limiting example, when used in conjunction with open-ended language (such as "comprising"), a reference to "A and / or B" can in one embodiment refer only to A (optionally including elements other than B); in another embodiment, only to B (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0062] As used herein in the specification and claims, the phrase "at least one" with respect to a list of one or more elements shall be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows for the presence, as appropriate, of elements other than those specifically identified within the list of elements, where the phrase "at least one" refers to the elements so specifically identified (whether or not relevant). Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") can in one embodiment refer to at least one (optionally including more than one) A without B (and optionally including elements other than B); in another embodiment, to at least one (optionally including more than one) B without A (and optionally including elements other than A); in yet another embodiment, to at least one (optionally including more than one) A and at least one (optionally including more than one) B (and optionally including other elements); and so on.

[0063] Furthermore, the language and terminology used herein are for descriptive purposes and should not be regarded as limiting. The use herein of "comprising", "including" or "having", "containing", "involving" and variations thereof is intended to cover the items listed thereafter and their equivalents as well as additional items.

[0064] In the claims as well as in the foregoing specification, all transitional phrases such as "comprising", "including", "carrying", "having", "containing", "involving", "holding", "consisting of" and the like shall be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively.

[0065] The use of ordinal terms in the claims (e.g., "first", "second", "third", etc.) that modify claim elements does not by itself imply any priority, precedence or order of one claim element over another claim element, or the temporal order of acts of a method, but is only used as a label to distinguish one claim element having a particular name from another claim element having the same name (except for the use of the ordinal term) to distinguish the claim elements.

Claims

1. A method of controlling the operation of a mechanical circulatory support (MCS) device to facilitate restoration of the patient's native heart function in a patient in whose body the MCS device is implanted, the method comprising: Controlling the pump of the MCS device to operate in a first mode; Obtaining one or more first cardiac values associated with the patient during operation of the MCS device; Determining to transition the operation of the MCS device to a second mode based at least in part on the obtained one or more first cardiac values; and When it is determined to transition the operation of the MCS device to the second mode, controlling the pump of the MCS device to operate in the second mode.

2. The method according to claim 1, wherein the first mode is a decompression mode and the second mode is a physiological mode.

3. The method according to claim 1, wherein the first mode is a physiological mode and the second mode is a sub-mode of the physiological mode.

4. The method according to claim 1, wherein the sub-mode of the physiological mode includes an exercise mode or a sleep mode.

5. The method according to claim 1, wherein the first mode is a physiological mode and the second mode is a weaning mode.

6. The method according to claim 1, wherein The first mode includes first operating parameters configured to operate the pump according to a first flow type, and the second mode includes second operating parameters configured to operate the pump according to a second flow type different from the first flow type.

7. The method according to claim 6, wherein the first flow type is continuous flow and the second flow type is pulsatile flow.

8. The method according to claim 1, wherein the first mode is a mode that provides optimized unloading of the left ventricle of the patient's heart based on physiological signals.

9. The method according to claim 8, wherein the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response.

10. The method according to claim 8, wherein the second mode is a mode that promotes reverse remodeling of the patient's heart function.

11. The method according to claim 8, wherein the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

12. The method according to claim 1, further comprising: Selecting a set of cardiac values to be obtained based at least in part on the first mode, wherein obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtaining the one or more first cardiac values included in the set of cardiac values.

13. The method according to claim 1, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device.

14. The method according to claim 1, wherein the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device.

15. The method according to claim 1, wherein the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors.

16. The method according to claim 14, further comprising: processing the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

17. The method according to claim 1, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with the one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device.

18. The method according to claim 1, further comprising: determining to adjust the speed of the pump of the MCS device based at least in part on the one or more first cardiac values; and when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode, adjusting the speed of the pump of the MCS device.

19. The method according to claim 1, further comprising: obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; determining to transition the operation of the MCS device to a third mode based at least in part on the one or more obtained second cardiac values; and when it is determined to transition the operation of the MCS device to the third mode, controlling the pump of the MCS device to operate in the third mode.

20. The method according to claim 19, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode.

21. The method according to claim 19, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode.

22. The method according to claim 19, further comprising: selecting a set of cardiac values to be obtained based at least in part on the second mode, wherein obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: obtaining the one or more second cardiac values included in the set of cardiac values.

23. The method according to claim 1, wherein the MCS device is a left ventricular assist device (LVAD).

24. The method according to claim 1, wherein the first mode is a decompression mode, and the second mode is a weaning mode.

25. The method according to claim 1, further comprising: receiving, via a user interface, an instruction to transition the operation of the MCS device to the second mode, wherein in response to receiving the instruction, controlling the pump to operate in the second mode.

26. A controller for a pump of a mechanical circulatory support (MCS) device, the controller comprising: at least one hardware processor configured to: control the pump of the MCS device to operate in a first mode; obtain one or more first cardiac values associated with a patient during operation of the MCS device; determine to transition the operation of the MCS device to a second mode based at least in part on the one or more first cardiac values obtained; and when it is determined to transition the operation of the MCS device to the second mode, control the pump of the MCS device to operate in the second mode.

27. The controller according to claim 26, wherein the first mode is a decompression mode and the second mode is a physiological mode.

28. The controller according to claim 26, wherein the first mode is a physiological mode and the second mode is a sub-mode of the physiological mode.

29. The controller according to claim 26, wherein the sub-mode of the physiological mode includes an exercise mode or a sleep mode.

30. The controller according to claim 26, wherein the first mode is a physiological mode and the second mode is a weaning mode.

31. The controller according to claim 26, wherein the first mode includes first operating parameters configured to operate the pump in a first flow type, and the second mode includes second operating parameters configured to operate the pump in a second flow type different from the first flow type.

32. The controller according to claim 31, wherein the first flow type is continuous flow and the second flow type is pulsatile flow.

33. The controller according to claim 26, wherein the first mode is a mode that provides optimized unloading of the left ventricle of the patient's heart based on physiological signals.

34. The controller according to claim 33, wherein the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response.

35. The controller according to claim 33, wherein the second mode is a mode that promotes reverse remodeling of the patient's cardiac function.

36. The controller according to claim 33, wherein the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

37. The controller according to claim 26, wherein the at least one hardware processor is further configured to: select a set of cardiac values to be obtained based at least in part on the first mode, Obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtain the one or more first cardiac values included in the set of cardiac values.

38. The controller according to claim 26, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device.

39. The controller according to claim 26, wherein the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device.

40. The controller according to claim 26, wherein the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors.

41. The controller according to claim 40, wherein the at least one hardware processor is further configured to: process the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

42. The controller according to claim 26, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with the one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device.

43. The controller according to claim 26, wherein the at least one hardware processor is further configured to: Determine to adjust the speed of the pump of the MCS device based at least in part on the one or more first cardiac values; and Adjust the speed of the pump of the MCS device when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode.

44. The controller according to claim 26, wherein the at least one hardware processor is further configured to: Obtain one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; Determine to transition the operation of the MCS device to a third mode based at least in part on the obtained one or more second cardiac values; and Control the pump of the MCS device to operate in the third mode when it is determined to transition the operation of the MCS device to the third mode.

45. The controller according to claim 44, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode.

46. The controller according to claim 44, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode.

47. The controller according to claim 44, wherein the at least one hardware processor is further configured to: Select a set of cardiac values to be obtained based at least in part on the second mode, Obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: Obtain the one or more second cardiac values included in the set of cardiac values.

48. The controller according to claim 26, wherein the MCS device is a left ventricular assist device (LVAD).

49. The controller according to claim 26, wherein the first mode is a decompression mode, and the second mode is a weaning mode.

50. The controller according to claim 26, wherein the at least one hardware processor is further configured to: Receive an instruction to transition the operation of the MCS device to the second mode via a user interface, and in response to receiving the instruction, control the pump to operate in the second mode.

51. A mechanical circulatory support (MCS) device, comprising: A pump; And A controller coupled to the pump, the controller including at least one hardware processor configured to: Control the pump to operate in a first mode; Obtain one or more first cardiac values associated with a patient during operation of the MCS device; Determine to transition the operation of the MCS device to a second mode based at least in part on the one or more first cardiac values obtained; and When it is determined to transition the operation of the MCS device to the second mode, control the pump to operate in the second mode.

52. The MCS device according to claim 51, wherein the first mode is a decompression mode and the second mode is a physiological mode.

53. The MCS device according to claim 51, wherein the first mode is a physiological mode and the second mode is a sub-mode of the physiological mode.

54. The MCS device according to claim 51, wherein the sub-mode of the physiological mode includes an exercise mode or a sleep mode.

55. The MCS device according to claim 51, wherein the first mode is a physiological mode and the second mode is a weaning mode.

56. The MCS device according to claim 51, wherein the first mode includes first operating parameters configured to operate the pump in a first flow type, and the second mode includes second operating parameters configured to operate the pump in a second flow type different from the first flow type.

57. The MCS device according to claim 56, wherein the first flow type is continuous flow and the second flow type is pulsatile flow.

58. The MCS device according to claim 51, wherein the first mode is a mode that provides optimized unloading of the left ventricle of the patient's heart based on physiological signals.

59. The MCS device according to claim 58, wherein the second mode is a mode that adjusts the speed of the pump of the MCS device based on the patient's physiological response.

60. The MCS device according to claim 58, wherein the second mode is a mode that promotes reverse remodeling of the patient's cardiac function.

61. The MCS device according to claim 58, wherein the optimized unloading of the left ventricle includes maximum unloading of the left ventricle.

62. The MCS device according to claim 51, wherein the at least one hardware processor is further configured to: select a set of cardiac values to be obtained based at least in part on the first mode, Obtaining one or more first cardiac values associated with the patient during operation of the MCS device includes: obtain the one or more first cardiac values included in the set of cardiac values.

63. The MCS device according to claim 51, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device.

64. The MCS device according to claim 51, wherein the one or more first cardiac values include one or more values obtained from one or more sensors external to the MCS device.

65. The MCS device according to claim 51, wherein the one or more first cardiac values include one or more values indirectly obtained from information associated with one or more sensors.

66. The MCS device according to claim 65, wherein the at least one hardware processor is further configured to: process the information associated with the one or more sensors with at least one machine learning model to obtain the one or more first cardiac values.

67. The MCS device according to claim 61, wherein the one or more first cardiac values include one or more values obtained from the pump of the MCS device, one or more values obtained from one or more sensors external to the MCS device, and one or more values indirectly obtained from information associated with the one or more sensors associated with the MCS device and / or the one or more sensors external to the MCS device.

68. The MCS device according to claim 51, wherein the at least one hardware processor is further configured to: Determine to adjust the speed of the pump of the MCS device at least in part based on the one or more first cardiac values; and Adjust the speed of the pump of the MCS device when it is determined to adjust the speed of the pump and when it is not determined to transition the operation of the MCS device to the second mode.

69. The MCS device according to claim 51, wherein the at least one hardware processor is further configured to: obtain one or more second cardiac values associated with the patient during operation of the MCS device in the second mode; Determine to transition the operation of the MCS device to a third mode at least in part based on the obtained one or more second cardiac values; and Control the pump of the MCS device to operate in the third mode when it is determined to transition the operation of the MCS device to the third mode.

70. The MCS device according to claim 69, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a weaning mode.

71. The MCS device according to claim 69, wherein the first mode is a decompression mode, the second mode is a physiological mode, and the third mode is a physiological mode.

72. The MCS device according to claim 69, wherein the at least one hardware processor is further configured to: Select a set of cardiac values to be obtained at least in part based on the second mode, Obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode includes: Obtain the one or more second cardiac values included in the set of cardiac values.

73. The MCS device according to claim 51, wherein the MCS device is a left ventricular assist device (LVAD).

74. The MCS device according to claim 51, wherein the first mode is a decompression mode, and the second mode is a weaning mode.

75. The MCS device according to claim 51, wherein the at least one hardware processor is further configured to: Receive an instruction to transition the operation of the MCS device to the second mode via a user interface, wherein in response to receiving the instruction, control the pump to operate in the second mode.

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