Systems and methods for pump speed modulation

Abstract

A method and apparatus are provided for controlling operation of a mechanical circulatory support (MCS) device to promote restoration of native heart function in a patient implanted with an MCS device. The method includes controlling a pump of the MCS device to operate in a first mode, acquiring 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 acquired one or more first cardiac values, and controlling the pump of the MCS device to operate in the second mode when it is determined to transition operation of the MCS device to the second mode.

Description

[Technical Field]

[0001] The present disclosure relates to techniques for modulating the pump speed of a mechanical circulatory assist device. [Background technology]

[0002] Fluid pumps, such as blood pumps, are used in a wide range of applications and purposes within 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 span a heart valve. The intravascular blood pump is typically located at the end of the catheter. Once in position, the pump can be used to assist the heart, pumping blood through the circulatory system and thus temporarily reducing the workload on the patient's heart, such as to allow the heart to recover after a heart attack. An exemplary intravascular blood pump is available from ABIOMED, ​​Inc. (Danvers, MA) under the trade name Impella® heart pump.

[0003] Such pumps can be positioned within a chamber of the heart, such as the left ventricle, to assist the heart. In this case, the blood pump can be inserted via the femoral artery using a hollow catheter and introduced to 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 ejects blood into the aorta. In this manner, the function of the heart can be replaced, or at least assisted, by the action of the pump. Some devices associated with blood pumps inserted into the left ventricle to assist heart function are also commonly referred to as left ventricular assist devices (LVADs). More generally, LVADs are an example of a type of mechanical circulatory support (MCS) device, sometimes referred to as a "ventricular assist device / system," that can be used to support cardiac function in a patient.

[0004] Intravascular blood pumps are typically connected to a heart pump controller that controls the heart pump, such as motor speed, and collects and displays operational data about the blood pump, such as cardiac signal levels, battery temperature, blood flow rate, and tubing integrity. An exemplary heart pump controller is available from ABIOMED, ​​Inc. under the trademark Automated Impella Controller®. The controller may issue an alarm when an operational data value exceeds a predetermined value or range, for example, if a leak, aspiration, and / or pump malfunction is detected. The controller may include a video display screen on which a graphical user interface configured to display the operational data and / or alarms is displayed. Summary of the Invention [Means for solving the problem]

[0005] Described herein are systems and methods for modulating blood pump operation to promote cardiac recovery (e.g., halting or reversing cardiac remodeling that occurs in heart disease) during chronic use of the pump (e.g., over weeks to months to years). The inventors recognize and appreciate that by monitoring physiological and / or pump signals over time, pump flow can be adapted to meet the patient's hemodynamic needs and promote cardiac recovery. In some embodiments, the heart pump may operate in various modes, either automatically or manually, and adapt pump flow by switching between the various modes.

[0006] In some embodiments, a method is provided for controlling operation of a mechanical circulatory support (MCS) device to promote restoration of native heart function in a patient implanted with an MCS device. The method includes controlling a pump of the MCS device to operate in a first mode, acquiring 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 acquired one or more first cardiac values, and controlling the pump of the MCS device to operate in the second mode when it is determined to transition operation of the MCS device to the second mode.

[0007] In one aspect, the first mode is a decompression mode and the second mode is a physiologic mode. In another aspect, the first mode is a physiologic mode and the second mode is a sub-mode of the physiologic mode. In another aspect, a sub-mode of the physiologic mode includes an exercise mode or a sleep mode. In another aspect, the first mode is a physiologic mode and the second mode is a weaning mode. In another aspect, the first mode includes first operating parameters configured to operate the pump using a first flow type and the second mode includes second operating parameters configured to operate the pump using 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., maximal) unloading of the left ventricle of the patient's heart based on a physiologic signal. In another aspect, the second mode modulates the speed of a pump of the MCS device based on the patient's physiological response. In another aspect, the second mode promotes reverse remodeling of cardiac function in the patient. In another aspect, optimized unloading of the left ventricle includes maximal unloading of the left ventricle.

[0008] In another aspect, the method further includes selecting a set of cardiac values ​​to acquire based at least in part on the first mode, and acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device includes acquiring one or more first cardiac values ​​included in the set of cardiac values. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from a pump of the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from one or more sensors external to the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired indirectly from information associated with the one or more sensors. In another aspect, the method further includes processing information associated with the one or more sensors using at least one machine learning model to acquire the one or more first cardiac values.

[0009] In another aspect, the one or more first cardiac values ​​include one or more values ​​obtained from a 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with one or more sensors external to the MCS device. In another aspect, the method further includes determining to adjust a speed of a pump of the MCS device based at least in part on the one or more first cardiac values, and adjusting a speed of the pump of the MCS device when the determination to adjust the speed of the pump is made and when the determination to transition operation of the MCS device to the second mode is not made. In another aspect, the method further includes acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode, deciding to transition operation of the MCS device to a third mode based at least in part on the acquired one or more second cardiac values, and controlling the pump of the MCS device to operate in the third mode when the determination to transition operation of the MCS device to the third mode is made. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a weaning mode. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a physiologic mode. In another aspect, the method further includes selecting a set of cardiac values ​​to acquire based at least in part on the second mode, and acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode includes acquiring one or more second cardiac values ​​included in the set of cardiac values. In another aspect, the MCS device is a left ventricular assist device (LVAD). In another aspect, the first mode is a reduced pressure mode and the second mode is a weaning mode.In another aspect, the method further includes receiving, via the user interface, a command to transition operation of the MCS device to a second mode, wherein controlling the pump to operate in the second mode is performed in response to receiving the command.

[0010] In some embodiments, a controller for a pump of a mechanical circulatory support (MCS) device is provided, the controller including at least one hardware processor configured to control the pump of the MCS device to operate in a first mode, acquire one or more first cardiac values ​​associated with a patient during operation of the MCS device, determine to transition operation of the MCS device to a second mode based at least in part on the acquired 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 operation of the MCS device to the second mode.

[0011] In one aspect, the first mode is a decompression mode and the second mode is a physiologic mode. In another aspect, the first mode is a physiologic mode and the second mode is a sub-mode of the physiologic mode. In another aspect, a sub-mode of the physiologic mode includes an exercise mode or a sleep mode. In another aspect, the first mode is a physiologic mode and the second mode is a weaning mode. In another aspect, the first mode includes first operating parameters configured to operate the pump using a first flow type and the second mode includes second operating parameters configured to operate the pump using 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., maximal) unloading of the left ventricle of the patient's heart based on a physiologic signal. In another aspect, the second mode modulates the speed of a pump of the MCS device based on the patient's physiological response. In another aspect, the second mode promotes reverse remodeling of cardiac function in the patient. In another aspect, optimized unloading of the left ventricle includes maximal unloading of the left ventricle.

[0012] In another aspect, the at least one hardware processor is further configured to select a set of cardiac values ​​to acquire based at least in part on the first mode, and acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device includes acquiring one or more first cardiac values ​​included in the set of cardiac values. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from a pump of the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from one or more sensors external to the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired indirectly from information associated with the one or more sensors. In another aspect, the at least one hardware processor is further configured to process information associated with the one or more sensors using at least one machine learning model to acquire the one or more first cardiac values.

[0013] In another aspect, the one or more first cardiac values ​​include one or more values ​​obtained from a 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with one or more sensors external to the MCS device. In another aspect, the at least one hardware processor is further configured to determine to adjust a speed of a pump of the MCS device based at least in part on the one or more first cardiac values, and to 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 operation of the MCS device to the second mode. In another aspect, the at least one hardware processor is further configured to acquire one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode, determine to transition operation of the MCS device to a third mode based at least in part on the acquired 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 operation of the MCS device to the third mode. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a weaning mode. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a physiologic mode. In another aspect, the at least one hardware processor is further configured to select a set of cardiac values ​​to acquire based at least in part on the second mode, and acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode includes acquiring one or more second cardiac values ​​included in the set of cardiac values. In another aspect, the MCS device is a left ventricular assist device (LVAD). In another aspect, the first mode is a reduced pressure mode and the second mode is a weaning mode.In another aspect, the at least one hardware processor is further configured to receive, via the user interface, an instruction to transition operation of the MCS device to a second mode, and controlling the pump to operate in the second mode is performed in response to receiving the instruction.

[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 comprising at least one hardware processor. The at least one hardware processor is configured to control the pump to operate in a first mode, acquire one or more first cardiac values ​​associated with the patient during operation of the MCS device, determine to transition operation of the MCS device to a second mode based at least in part on the acquired one or more first cardiac values, and control the pump to operate in the second mode when it is determined to transition operation of the MCS device to the second mode.

[0015] In one aspect, the first mode is a decompression mode and the second mode is a physiologic mode. In another aspect, the first mode is a physiologic mode and the second mode is a sub-mode of the physiologic mode. In another aspect, a sub-mode of the physiologic mode includes an exercise mode or a sleep mode. In another aspect, the first mode is a physiologic mode and the second mode is a weaning mode. In another aspect, the first mode includes first operating parameters configured to operate the pump using a first flow type and the second mode includes second operating parameters configured to operate the pump using 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., maximal) unloading of the left ventricle of the patient's heart based on a physiologic signal. In another aspect, the second mode modulates the speed of a pump of the MCS device based on the patient's physiological response. In another aspect, the second mode promotes reverse remodeling of cardiac function in the patient. In another aspect, optimized unloading of the left ventricle includes maximal unloading of the left ventricle.

[0016] In another aspect, the at least one hardware processor is further configured to select a set of cardiac values ​​to acquire based at least in part on the first mode, and acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device includes acquiring one or more first cardiac values ​​included in the set of cardiac values. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from a pump of the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired from one or more sensors external to the MCS device. In another aspect, the one or more first cardiac values ​​include one or more values ​​acquired indirectly from information associated with the one or more sensors. In another aspect, the at least one hardware processor is further configured to process information associated with the one or more sensors using at least one machine learning model to acquire the one or more first cardiac values.

[0017] In another aspect, the one or more first cardiac values ​​include one or more values ​​obtained from a 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with one or more sensors external to the MCS device. In another aspect, the at least one hardware processor is further configured to determine to adjust a speed of a pump of the MCS device based at least in part on the one or more first cardiac values, and to 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 operation of the MCS device to the second mode. In another aspect, the at least one hardware processor is further configured to acquire one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode, determine to transition operation of the MCS device to a third mode based at least in part on the acquired 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 operation of the MCS device to the third mode. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a weaning mode. In another aspect, the first mode is a reduced pressure mode, the second mode is a physiologic mode, and the third mode is a physiologic mode. In another aspect, the at least one hardware processor is further configured to select a set of cardiac values ​​to acquire based at least in part on the second mode, and acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode includes acquiring one or more second cardiac values ​​included in the set of cardiac values. In another aspect, the MCS device is a left ventricular assist device (LVAD). In another aspect, the first mode is a reduced pressure mode and the second mode is a weaning mode.In another aspect, the at least one hardware processor is further configured to receive, via the user interface, an instruction to transition operation of the MCS device to a second mode, and controlling the pump to operate in the second mode is performed in response to receiving the instruction. [Brief explanation of the drawings]

[0018] [Figure 1A] FIG. 1A illustrates a pump system in accordance with some embodiments of the present technology.

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

[0020] [Figure 2] FIG. 2 illustrates a process for modulating operation of a pump system based on measured cardiac values, in accordance with some embodiments of the present technology.

[0021] [Figure 3] FIG. 3 illustrates a process for modulating the operation of a pump system configured to operate in multiple modes in accordance with some embodiments of the present technology.

[0022] [Figure 4] FIG. 4 illustrates a chart of exemplary modes for operating a pump system of a mechanical circulatory support (MCS) device, in accordance with some embodiments of the present technology.

[0023] [Figure 5] FIG. 5 illustrates multiple timelines for transitioning operation of a pump system of an MCS between different modes in accordance with some embodiments of the present technology.

[0024] [Figure 6]FIG. 6 schematically illustrates restoration of native heart function as a function of time as operation of the pump system of an MCS device is transitioned between different modes in accordance with some embodiments of the present technology.

[0025] [Figure 7] FIG. 7 illustrates a process for adjusting the operation of a pump system of an MCS device in accordance with some embodiments of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0026] Detailed Description Patients with chronic heart failure (CHF) currently lack reliable options for promoting native heart recovery. While many patients with late-stage CHF receive durable mechanical circulatory support (MCS) devices (e.g., left ventricular assist devices (LVADs)), few recover from the disease while supported using an MCS device. One reason such patients fail to recover is that conventional MCS devices are typically designed to meet the patient's physiological needs in the acute phase, rather than to promote native heart recovery over longer durations of support. For example, MCS devices used for long-term support are typically set to one speed for the duration of support. Thus, the present inventors have recognized the benefits of modulating the pump speed of a pump system during support using an MCS device. For example, some embodiments of the technology described herein are configured to track cardiac function over the duration of MCS device assistance, modulate device operation to meet physiological demands, and / or place the device in a particular mode / module depending on the phase of treatment / recovery the patient is currently in (e.g., initial, recovery, exercise, weaning, etc.) in order to promote native heart recovery.

[0027] Turning now to the figures, a pump system 100 (e.g., part of an MCS device) for use with some embodiments of the present technology is shown in FIGS. 1A and 1B. As shown, pump system 100 may be coupled to a control unit 200. Pump 100 may 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 catheter 120, a handle 130, a cable 140, and a motor 150. As will be appreciated, although shown with an atraumatic tip, in some embodiments, the pump may not include such a tip. Pump housing 104 may be configured as a frame structure formed, at least in part, by a mesh with openings that may be covered by an elastic material. A proximal portion of the pump housing 104 may extend into and be mounted within the hollow interior of the outflow tube 106, and a distal portion of the pump housing 104 may extend distally beyond the distal end of the outflow tube 106. An exposed opening in the pump housing 104 extending distally beyond the outflow tube 106 may form an inlet 116 of the pump 100. The proximal end of the outflow tube 106 may include a plurality of openings that form an outlet 118 of the pump 100. A rotor 108 may be mounted for rotation between a distal bearing 110 and a proximal bearing 112 and may be coupled to a distal end of a drive shaft 114. The drive shaft 114 may be flexible and may extend through the catheter 120, through the hollow interior of the outflow tube 106, and into a handle 130, which is housed within the handle 130, and is coupled to a motor 150. The proximal end of the handle 130 may be coupled to a control unit 200 via a cable 140. Fluid may be circulated through catheter 120 adjacent drive shaft 114 and within the space surrounding distal bearing 110 and proximal bearing 112 to lubricate those components and reduce friction during operation of pump 100.

[0028] The control unit 200 may 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 may comprise one or more microcontrollers, one or more microprocessors, one or more application specific integrated circuits (ASICs), one or more digital signal processors, program memory, or other computing components. The processor 204 may 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 may be configured to control one or more operations of the pump 100. As a non-limiting example, the control unit 200 may be implemented as an Automated Impella Controller® manufactured by ABIOMED, ​​Inc. (Danvers, MA). 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, processor 204 may be configured to control power delivered to motor 150 by power supply lines (not shown) in cable 140 (e.g., by controlling a power supply source (not shown)), thereby controlling the speed of motor 150. Current sensor 208 may be configured to sense a motor current associated with an operating state of motor 150, and processor 204 may be configured to receive the output of current sensor 208 as a motor current signal. Processor 204 may further be configured to determine flow through pump 100 based, at least in part, on the motor current signal and the motor speed, as described in more detail below. Current sensor 208 may be included in control unit 200 or may be located along any portion of the power supply lines in cable 140. Additionally or alternatively, current sensor 208 may be included in motor 150, and processor 204 may be configured to receive the motor current signal via a data line (not shown) in cable 140 that is coupled to processor 204 and motor 150.

[0030] Memory 202 may be configured to store computer-readable instructions and other information related to the various functions of the components of control unit 200. In one aspect, memory 202 includes volatile and / or non-volatile memory, such as an 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., to convey information regarding the operation of the pump 100 and / or provide alerts.

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

[0033] As described herein, the operation (e.g., rate) of conventional MCS devices is manually configured primarily to meet the patient's physiological needs during the acute phase. Longer-term improvements in cardiac function are typically not considered when configuring the operation of such devices. Because MCS devices are typically configured to maintain acute physiological function, few patients currently recover from chronic heart failure while supported with an MCS device. Some embodiments of the technology described herein are configured to identify and track improvements in cardiac function over time and may modulate the operation of the MCS device to meet the patient's acute physiological needs while also promoting the potential for native cardiac recovery.

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

[0035] The inventors recognize and appreciate that it may be advantageous to consider multiple inputs when determining how to modulate the operation of an MCS device when used to support a patient over longer periods of time (e.g., weeks to months to years). FIG. 3 illustrates a process for modulating the operation of a blood pump of an MCS device in response to multiple inputs, according to some embodiments. Similar to the process shown in FIG. 2, in the example of FIG. 3, a controller 310 of the MCS device may be configured to control the operation (e.g., speed) of a pump 320 of the MCS device based, at least in part, on input signals provided to the controller 310. However, rather than monitoring a single cardiac value as described in FIG. 2, in the example of FIG. 3, the input signal is provided to the controller 310 from a mode selector 330 that receives multiple inputs, including one or more cardiac 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 condition. 3 as a separate component, it should be understood that in some embodiments, the mode selector 330 may be incorporated within the controller 310. Additionally, while the mode selector 330 is shown as receiving input from three sources, it should be understood that in some embodiments, the mode selector 330 may receive input from more than three sources or from fewer than three sources.

[0036] The 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 volume (AoV) opening, contractility, heart rate (HR), cardiac output (CO), contractility index (CI), stroke volume, dP / dt, and tau. Monitoring data 340 may include, but are not limited to, various signal values ​​from additional monitoring (e.g., blood pressure (BP), wall tension, coronary blood flow, strain, muscle oxygenation, sympathetic nervous system (SNS) innervation, etc.). Indirect data 350 may include, but are not limited to, values ​​related to mitral regurgitation (MR), septum position, and artificial intelligence / machine learning (AI / ML) assessment of cardiac function improvement over time.

[0037] In some embodiments, the mode selector 330 may be configured to provide the controller 310 with a series of modules (also referred to herein as “modes”) as input, each defining instructions for providing a type of MCS device support tailored to the patient's current physiological needs and / or native heart recovery goals. For example, in some embodiments, the modules may include a vacuum module with control instructions for reducing acute injury and fully (or partially) unloading the left ventricle without the use of suction. The modules may also include a physiological module configured to promote reversing cardiac remodeling that occurs with cardiac disease. The physiological module may include one or more sub-modules for the patient's particular physiological needs. For example, the sub-modules may include an exercise mode, in which more MCS device support is needed; a sleep mode, in which little MCS device support is needed; and an everyday or “normal” mode, in which an average amount of MCS device support is needed. By utilizing sub-modules to allow for variations in the level of MCS device assistance needed when the device is operating according to a physiological module, a patient's daily routine requiring different levels of MCS device assistance can be accommodated. In some embodiments, switching between different modules and / or sub-modules may be based, at least in part, on various inputs provided to the mode selector 330. For example, one or more sensors may be used to determine when the patient sits up, stands, or is in some other physiological state in which additional pump assistance would be helpful in supporting the patient's cardiac function. In such cases, the mode selector 330 may be configured to automatically switch to a different module or sub-module that provides a pump flow consistent with the patient's current physiological state. The modules may also include a weaning module that reduces MCS device assistance prior to removing the MCS device.In each of the multiple modules, the speed of the pump and / or the type of assistance provided may be modulated.

[0038] 4 illustrates a chart describing various characteristics of three exemplary modes for controlling the operation (e.g., speed) of an MCS device, according to some embodiments. The modes shown in FIG. 4 and described in more detail herein are reduced pressure mode, physiological mode, and weaning mode. However, it should be understood that any suitable number and / or type of modes for controlling the operation of an MCS device may be used, and embodiments are not limited in this respect.

[0039] As described herein, in some embodiments, the controller of the MCS device may be configured to operate in one of a number of modes based, at least in part, on the type and / or level of support required by the patient according to their current stage of treatment. Characteristics of operation that may differ across modes may 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 stimulation and / or clinical target values ​​monitored to determine operating parameters (e.g., pump speed) when in the mode, and whether the mode includes one or more sub-modes within which the MCS device is configured to operate with different parameters. As discussed herein, in some embodiments, the MCS device may transition between modes (or sub-modes) (e.g., either in response to user input or automatically without explicit user input) to promote restoration of native heart function.

[0040] In reduced pressure mode, a patient may require continuous / maximal support from the MCS device to address acute symptoms of heart failure. In such a mode, the MCS device controller 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 reduced pressure mode may be to provide volume unloading and / or optimized unloading of the patient's left ventricle without suction. For example, in some cases, optimized unloading may be maximum unloading of the left ventricle based on physiological (e.g., cardiac) signals. Examples of cardiac values ​​that may be monitored and used to determine pump speed when in reduced pressure mode include, but are not limited to, one or more of left ventricular end-diastolic pressure (LVEDP), left ventricular end-diastolic volume (LVEDV), left ventricular end-diastolic diameter (LVEDD), and septum position. However, it should be understood that other cardiac values ​​may additionally or alternatively be used to modulate operating parameters within the reduced pressure mode and / or to determine when to transition from the reduced pressure mode to another mode (e.g., a physiological mode), such cardiac values ​​including, but not limited to, those described herein.

[0041] In physiologic mode, the patient may require less and / or different support from the MCS device than when the MCS device is operating in reduced pressure mode. For example, the patient's native heart function may have been restored to the point where continuous flow and maximum unloading of the heart are no longer required. In physiologic mode, the type of support provided by the MCS device may promote the restoration of the patient's native heart function and / or aid in the reversal of cardiac remodeling associated with heart disease. For example, in physiologic mode, the flow type may be pulsatile rather than continuous to more closely mimic the function of a native heart, and the aortic valve may open every few cycles (e.g., every five cycles) to maximize unloading while allowing native valve function. The goal of physiologic mode may be to facilitate the restoration of native heart function in the patient while adapting to physiological responses and supporting the patient's needs in their daily lives.

[0042] Flexibility to accommodate different support needs while in physiologic mode can be achieved in some embodiments by defining a set of submodes that modulate MCS device operation based on the patient's anticipated cardiac demands during different activities throughout the day. For example, when more MCS device support is expected to be required during exercise, the MCS device controller may be instructed to operate in an exercise mode, adjusting the pump speed to maintain a target mean arterial pressure (MAP) above a certain threshold (e.g., above 75-80 mmHg). In contrast, when less MCS device support is expected to be required during sleep, the MCS device controller may be instructed to operate in a sleep mode, slowing the pump speed and thereby relying on natural heart function to provide the needed support. An everyday, or "normal," mode may provide an average level of support as the patient goes about their daily activities. Any appropriate cardiac values ​​may be monitored and used to determine the operating parameters of the MCS device when the controller is instructed to be in physiologic mode, and the monitored cardiac values ​​may vary depending on the particular submode currently implemented by the controller. Examples of cardiac values ​​that may be monitored and used to determine pump speed when in physiologic 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 with respect to exercise mode. However, it should be understood that other cardiac values ​​may additionally or alternatively be used to modulate operating parameters within reduced pressure mode and / or to determine when to transition from physiologic mode to another mode (e.g., weaning mode), such cardiac values ​​including, but not limited to, those described herein.

[0043] In a weaning mode, the patient's native heart function may have recovered to the point where it may be possible to transition toward removal of the MCS device. In such a weaning mode, the pump speed may be gradually reduced to facilitate the weaning process. In a weaning mode, the flow type may be pulsatile, continuous, or a combination of pulsatile and continuous, and may be driven, at least in part, according to values ​​associated with the patient's native heart function. In a weaning mode, it is expected that the patient's aortic valve will open most of the time, transitioning the patient's heart from reliance on the MCS device to provide cardiac support. Any appropriate cardiac value may be monitored and used to determine operating parameters for the MCS device when the controller is commanded to be in a weaning mode. Examples of cardiac values ​​that may be monitored and used to determine the pump speed when in a weaning mode include, but are not limited to, one or more of the following: native cardiac output (CO) or cardiac index (CI), native stroke volume, and ejection fraction (EF). However, it should be understood that other cardiac values, including, but not limited to, those described herein, may be used in addition or instead.

[0044] As a patient recovers native cardiac function during chronic use of the MCS device, the controller of the MCS device may be instructed to transition between different operating modes of the device to promote recovery of native cardiac function and / or reverse cardiac remodeling, which occurs in cardiac disease. The timeline for transitioning between different modes may be patient-specific to optimize the level and / or type of assistance being provided by the MCS device according to that patient's unique metrics regarding native cardiac function.

[0045] 5 diagrammatically illustrates three example timelines (510, 520, 530) for three different patients transitioning between different operational modules / modes of an MCS device, according to some embodiments. In each of the illustrated timelines, the initial mode is a reduced pressure mode in which the MCS device is controlled to provide maximal unloading of the heart after the MCS device is implanted within the patient.

[0046] As illustrated in both timeline 510 and timeline 530, the MCS device mode may transition from reduced pressure mode to physiologic mode to weaning mode, albeit at different times. In timeline 510, the transition between reduced pressure mode and physiologic mode occurs within one week of initiating reduced pressure mode. In contrast, the transition between reduced pressure mode and physiologic mode in timeline 530 occurs after a longer period of time (e.g., 10 weeks). As discussed herein, the transition between reduced pressure mode and physiologic mode may be guided, at least in part, based on characteristics of the patient's native heart function. In timeline 530, the patient may have a more severe cardiac condition in which the patient's native heart function prior to MCS device implantation was insufficient and therefore longer support in reduced pressure mode may be required compared to the patient in timeline 510, who may have a less severe form of cardiac condition. Other reasons for delaying the transition from reduced pressure mode to physiologic mode in timeline 530 relative to timeline 510 are also possible. In timeline 510, operation of the MCS device remains in physiologic mode for 13 weeks before transitioning to a weaning mode where it remains for one week prior to removal of the MCS device. In timeline 530, operation of the MCS device remains in physiologic mode for a shorter period (one week) before transitioning to a weaning mode where it remains for one week prior to removal of the MCS device.

[0047] Timeline 520 illustrates a different sequence of transitions between modes of MCS device operation compared to those shown in timelines 510 and 530. In timeline 520, MCS device operation may be transitioned from reduced pressure mode to physiologic mode, albeit a shorter time (e.g., 5 hours) after implantation of the MCS device. The MCS device remains in physiologic mode for two weeks, after which transition to weaning mode occurs, potentially with the expectation that removal of the MCS device will occur shortly thereafter. However, based on the patient's monitored cardiac values, it may be determined that the patient would benefit from reversing MCS device operation to physiologic mode prior to removal. Thus, MCS device operation is transitioned from weaning mode to physiologic mode, where it remains for one week, before transitioning back to weaning mode, followed by removal. Timeline 520 illustrates the flexibility of some embodiments to transition freely between different modes based on monitored cardiac values ​​associated with the patient for patient-specific care provided using the MCS device. For example, while only a transition from weaning mode back to physiologic mode is shown in FIG. 5 , in some embodiments, a transition from physiologic mode back to reduced pressure mode may also be possible if monitored cardiac values ​​associated with the patient indicate that the patient would benefit from the additional MCS device support provided in reduced pressure mode. The timeline shown in FIG. 5 and described herein is exemplary only; other timelines are also contemplated, including timelines in which fewer than all of the possible modules / modes are present. For example, in one possible timeline, operation of the MCS device may transition directly from reduced pressure mode to weaning mode without first transitioning to physiologic mode.

[0048] Figure 6 diagrammatically illustrates how incorporating different operating modules / modes for an MCS device during chronic use of the device according to the techniques described herein can promote restoration of native heart function in a patient. Figure 6 shows the trajectories of recovery for native heart function (e.g., left ventricular function) for three different patients with MCS devices implanted for chronic use. As shown, each patient initially has insufficient native heart function, and therefore the MCS device is controlled to operate in a reduced pressure mode, providing optimized (e.g., maximal) unloading of the left ventricle. Over time, each patient's native heart function begins to improve, albeit at different rates specific to each individual patient. As native heart function improves, operation of the MCS device is transitioned to different modes to promote further restoration of the patient's native heart function. It should be understood that module 2 ("Reverse Remodeling") shown in FIG. 6 may correspond to the "physiologic mode" described in FIGS. 4 and 5, and module 3 ("Exercise Training") shown in FIG. 6 may correspond to the "exercise mode" submode included as part of the physiological mode described in FIG. 4.

[0049] As shown in Figure 6, each patient experienced some recovery of native heart function while the MCS device was operated in reduced pressure mode, but recovery of native heart function while the MCS device was operated in reverse remodeling (e.g., physiologic mode) provided substantial improvement in native heart function, albeit at different rates. As native heart function recovers to a certain level, operation of the MCS device may be transitioned to a weaning mode to prepare the patient for device removal, as described herein.

[0050] FIG. 7 illustrates a process 700 for modulating operation of an MCS device during chronic use within a patient, according to some embodiments of the present disclosure. Process 700 begins with act 710, in which an operating mode for the pump controller of the MCS device is selected. As described herein, the initial operating mode following implantation may be selected as a reduced pressure mode, in which optimized (e.g., maximal) unloading of the left ventricle is provided to ensure that the patient has adequate support from the MCS device to compensate for relatively weak native heart function. Process 700 may then proceed to act 712, in which one or more cardiac values ​​associated with the patient in whom the MCS device is implanted are acquired. As described herein, the acquired cardiac values ​​may include values ​​obtained directly from the MCS device, values ​​obtained directly from one or more sensors external to the MCS device, and / or values ​​obtained indirectly 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 in turn provide values. In other embodiments, the obtained values ​​may be received without issuing a request. In still further embodiments, at least some of the values ​​may be obtained in response to a request, while other values ​​may be obtained without issuing a request.

[0051] Process 700 may then proceed to act 714, where it is determined, at least in part, based on the acquired cardiac values, whether to adjust the operating mode of the MCS device. As described herein, the decision to transition the operating mode of the MCS device from one mode (e.g., reduced pressure mode) to another mode (e.g., physiologic mode) may be based, at least in part, on the current recovery status of the patient's native heart function. The recovery status of the patient's native heart function may be determined, at least in part, based on the cardiac values ​​acquired in act 712. If, in act 714, it is determined that the operating mode of the MCS device should be adjusted, process 700 returns to act 710, where a new operating mode for the pump controller of the MCS device is selected. The new operating mode may be, for example, physiologic mode, weaning mode, or a submode of the currently selected mode (e.g., exercise submode of physiologic mode).

[0052] If it is determined in act 714 that the operating mode of the MCS device should not be adjusted, process 700 proceeds to act 716, where it is determined whether the pump speed should be adjusted within the currently selected operating mode. If it is determined in act 716 that the pump speed does not need to be adjusted, process 700 returns to act 712, where cardiac values ​​are again acquired. If this is determined in act 716, process 700 proceeds to act 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 ​​acquired in act 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 submode (e.g., exercise mode) within the currently selected operating mode.

[0053] The embodiments described above can be implemented in any of numerous ways. One or more aspects and embodiments of the present disclosure involving the implementation of a process or method may utilize program instructions executable by a device (e.g., a computer, processor, or other device) to perform or control the implementation 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) (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, circuitry within a field programmable gate array or other semiconductor device, or other tangible computer storage medium) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods that implement one or more of the various embodiments described above. The computer-readable medium or media may be transportable, such that the stored program or programs can be loaded onto one or more different computers or other processors to implement various of the aspects described above. In some embodiments, the computer-readable medium may be non-transitory.

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

[0055] Further, it should be understood that the computer may be embodied in any of several forms, such as, by way of non-limiting examples, a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. In addition, the computer may be embedded within devices not generally considered computers but with suitable processing capabilities, including personal digital assistants (PDAs), smartphones, or any other suitable portable or fixed electronic device.

[0056] A computer may also have one or more input and output devices. These devices can be used, among other things, to present a user interface. Examples of output devices that can be used to provide a user interface include a printer or 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 keyboards and pointing devices such as mice, touchpads, and digitizing tablets. As another example, a computer may receive input information through speech recognition or in other audible formats.

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

[0058] Also, as described, some aspects may be embodied as one or more methods. Acts performed as part of a method may be ordered in any suitable manner. Thus, although illustrated embodiments show acts as sequential, embodiments may be constructed in which acts are performed in an order different from that shown, which may include performing some acts simultaneously.

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

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

[0061] As used herein, the word "and / or," as used in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or," i.e., "one or more" of the elements so conjoined, should be interpreted in the same manner. Other elements, whether related or unrelated to those specifically identified elements, may optionally be present other than the elements specifically identified by the "and / or" clause. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open language such as "comprising," can refer, in one embodiment, to "A only" (optionally including elements other than B), in another embodiment to "B only" (optionally including elements other than A), and 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," referring to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of each and every element specifically listed in the list of elements, and does not exclude any combinations of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. 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, be "at least one, optionally including more than one, A, with no B present" (optionally including elements other than B); in another embodiment, "at least one, optionally including more than one, B, with no A present" (optionally including elements other than A); in yet another embodiment, "at least one, optionally including more than one, A" and "at least one, optionally including more than one, B (optionally, including more than one B)" (optionally, including other elements), etc.

[0063] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0064] In the claims and the above specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., meaning "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 such as "first," "second," "third," etc. in the claims to modify claim elements does not, by itself, imply any priority, precedence, or ordering of one claim element relative to another, or the chronological order in which acts of a method are performed, but rather merely distinguishes one claim element having a certain name from another element having the same name (absent the use of ordinal terms) and is used as a marker to distinguish between claim elements.

Claims

1. 1. A method of controlling operation of a mechanical circulatory support (MCS) device to promote restoration of native heart function in a patient implanted with the MCS device, the method comprising: controlling a pump of the MCS device to operate in a first mode; acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device; determining, based at least in part on the obtained one or more first cardiac values, to transition operation of the MCS device to a second mode; controlling 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; A method comprising:

2. The method of claim 1 , wherein the first mode is a reduced pressure mode and the second mode is a physiological mode.

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

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

6. the first mode includes first operating parameters configured to operate the pump using a first flow type; the second mode includes second operating parameters configured to operate the pump using a second flow type different from the first flow type. The method of claim 1.

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

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

9. 10. The method of claim 8, wherein the second mode modulates the speed of the pump of the MCS device based on a physiological response of the patient.

10. 9. The method of claim 8, wherein the second mode is a mode that promotes reverse remodeling of cardiac function in the patient.

11. The method of claim 8 , wherein the optimized unloading of the left ventricle comprises maximal unloading of the left ventricle.

12. selecting a set of cardiac values ​​to acquire based at least in part on the first mode; 2. The method of claim 1, wherein acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device comprises acquiring the one or more first cardiac values ​​included in the set of cardiac values.

13. The method of 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 of 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 of claim 1 , wherein the one or more first cardiac values ​​comprise one or more values ​​obtained indirectly from information associated with one or more sensors.

16. 15. The method of 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. 10. The method of 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with the one or more sensors external to the MCS device.

18. determining to adjust a speed of the pump of the MCS device based at least in part on the one or more first cardiac values; 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 operation of the MCS device to the second mode; The method of claim 1 further comprising:

19. acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode; determining, based at least in part on the obtained one or more second cardiac values, to transition operation of the MCS device to a third mode; 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; The method of claim 1 further comprising:

20. 20. The method of claim 19, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a weaning mode.

21. 20. The method of claim 19, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a physiological mode.

22. selecting a set of cardiac values ​​to acquire based at least in part on the second mode; 20. The method of claim 19, wherein acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode comprises acquiring the one or more second cardiac values ​​included in the set of cardiac values.

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

24. The method of claim 1 , wherein the first mode is a depressurization mode and the second mode is a disengagement mode.

25. receiving, via a user interface, an instruction to transition operation of the MCS device to the second mode; The method of claim 1 , wherein controlling the pump to operate in the second mode is performed in response to receiving the command.

26. 1. A controller for a pump of a mechanical circulatory support (MCS) device, the controller comprising: at least one hardware processor, controlling a pump of the MCS device to operate in a first mode; acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device; determining, based at least in part on the obtained one or more first cardiac values, to transition operation of the MCS device to a second mode; controlling 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; at least one hardware processor configured to perform A controller comprising:

27. 27. The controller of claim 26, wherein the first mode is a reduced pressure mode and the second mode is a physiological mode.

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

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

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

31. the first mode includes first operating parameters configured to operate the pump using a first flow type; the second mode includes second operating parameters configured to operate the pump using a second flow type different from the first flow type.

27. The controller of claim 26.

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

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

34. 34. The controller of claim 33, wherein the second mode modulates a speed of a pump of the MCS device based on a physiological response of the patient.

35. 34. The controller of claim 33, wherein the second mode is a mode that promotes reverse remodeling of cardiac function in the patient.

36. 34. The controller of claim 33, wherein the optimized unloading of the left ventricle comprises maximum unloading of the left ventricle.

37. The at least one hardware processor further comprises: configured to select a set of cardiac values ​​to acquire based at least in part on the first mode; 27. The controller of claim 26, wherein acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device comprises acquiring the one or more first cardiac values ​​included in the set of cardiac values.

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

39. 27. The controller of 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. 27. The controller of claim 26, wherein the one or more first cardiac values ​​include one or more values ​​obtained indirectly from information associated with one or more sensors.

41. The at least one hardware processor further comprises:

41. The controller of claim 40, 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. 27. The controller of 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with the one or more sensors external to the MCS device.

43. The at least one hardware processor further comprises: determining to adjust a speed of the pump of the MCS device based at least in part on the one or more first cardiac values; 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 operation of the MCS device to the second mode; 27. The controller of claim 26 configured to:

44. The at least one hardware processor further comprises: acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode; determining, based at least in part on the obtained one or more second cardiac values, to transition operation of the MCS device to a third mode; 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; 27. The controller of claim 26 configured to:

45. 45. The controller of claim 44, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a weaning mode.

46. 45. The controller of claim 44, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a physiological mode.

47. The at least one hardware processor further comprises: configured to select a set of cardiac values ​​to acquire based at least in part on the second mode; 45. The controller of claim 44, wherein acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode comprises acquiring the one or more second cardiac values ​​included in the set of cardiac values.

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

49. 27. The controller of claim 26, wherein the first mode is a depressurization mode and the second mode is a disengagement mode.

50. The at least one hardware processor further comprises: configured to receive, via a user interface, a command to transition operation of the MCS device to the second mode; 27. The controller of claim 26, wherein controlling the pump to operate in the second mode is performed in response to receiving the command.

51. 1. A mechanical circulatory support (MCS) device comprising: A pump and a controller coupled to the pump, the controller comprising at least one hardware processor, the at least one hardware processor comprising: controlling the pump to operate in a first mode; acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device; determining, based at least in part on the obtained one or more first cardiac values, to transition operation of the MCS device to a second mode; controlling the pump to operate in the second mode when it is determined to transition operation of the MCS device to the second mode; a controller configured to: An MCS device comprising:

52. 52. The MCS device of claim 51, wherein the first mode is a reduced pressure mode and the second mode is a physiological mode.

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

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

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

56. the first mode includes first operating parameters configured to operate the pump using a first flow type; the second mode includes second operating parameters configured to operate the pump using a second flow type different from the first flow type.

52. The MCS device of claim 51.

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

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

59. 59. The MCS device of claim 58, wherein the second mode modulates the speed of the pump of the MCS device based on the patient's physiological response.

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

61. 59. The MCS device of claim 58, wherein the optimized unloading of the left ventricle comprises maximal unloading of the left ventricle.

62. The at least one hardware processor further comprises: configured to select a set of cardiac values ​​to acquire based at least in part on the first mode; 52. The MCS device of claim 51 , wherein acquiring one or more first cardiac values ​​associated with the patient during operation of the MCS device comprises acquiring the one or more first cardiac values ​​included in the set of cardiac values.

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

64. 52. The MCS device of 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. 52. The MCS device of claim 51, wherein the one or more first cardiac values ​​include one or more values ​​obtained indirectly from information associated with one or more sensors.

66. The at least one hardware processor further comprises:

66. The MCS device of claim 65, 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. 62. The MCS device of 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 ​​obtained indirectly from one or more sensors associated with the MCS device and / or information associated with the one or more sensors external to the MCS device.

68. The at least one hardware processor further comprises: determining to adjust a speed of the pump of the MCS device based at least in part on the one or more first cardiac values; 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 operation of the MCS device to the second mode; 52. The MCS device of claim 51 configured to:

69. The at least one hardware processor further comprises: acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode; determining, based at least in part on the obtained one or more second cardiac values, to transition operation of the MCS device to a third mode; 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; 52. The MCS device of claim 51 configured to:

70. 70. The MCS device of claim 69, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a weaning mode.

71. 70. The MCS device of claim 69, wherein the first mode is a reduced pressure mode, the second mode is a physiological mode, and the third mode is a physiological mode.

72. The at least one hardware processor further comprises: configured to select a set of cardiac values ​​to acquire based at least in part on the second mode; 70. The MCS device of claim 69, wherein acquiring one or more second cardiac values ​​associated with the patient during operation of the MCS device in the second mode comprises acquiring the one or more second cardiac values ​​included in the set of cardiac values.

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

74. 52. The MCS device of claim 51, wherein the first mode is a decompression mode and the second mode is a disengagement mode.

75. The at least one hardware processor further comprises: configured to receive, via a user interface, a command to transition operation of the MCS device to the second mode; 52. The MCS device of claim 51, wherein controlling the pump to operate in the second mode is performed in response to receiving the command.

Images