Methods and systems for overall pre-load reduction and / or modification of location or curvature of chamber spacing

Abstract

A method for providing therapeutic treatment to reduce pre-load may be provided. The method may include placing a ventricular assist device (VAD) at least partially within a left ventricle or a right ventricle of a patient, and placing a catheter-based device including an adjustable flow limiting element (FRE) such that the FRE is disposed within a superior vena cava (SVC) of the patient. The method may include receiving information from the VAD and / or conduit-based FRE device, determining a first determination value based on the information, and controlling at least one performance parameter of the VAD and / or conduit-based device based on the first determination value.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 464,005, filed May 4, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] This disclosure relates to methods and systems for providing improved treatment for heart-related problems. Background Technology

[0003] Blood pump components (such as intracardiac or intravascular blood pumps) can be introduced into the heart to deliver blood from the heart into the arteries. These mechanical circulatory support devices are commonly introduced to support heart function after a patient has suffered a heart attack. One such type of device is a group of devices known as the "Impella" heart pump. Some blood pump components can be percutaneously introduced through the vascular system during cardiac surgery. Specifically, the blood pump component can be inserted via a catheter insertion procedure through the femoral or axillary / subclavian artery into the ascending aorta, through the valves, and into the left ventricle. The inserted blood pump component can be configured to pull blood from the left ventricle of the heart through a cannula and drain blood into the aorta. Blood pump components can also be configured to draw blood from the inferior vena cava and drain blood into the pulmonary artery.

[0004] Systems and methods for treating conditions such as heart failure and / or pulmonary hypertension may include at least partial occlusion of flow through the superior vena cava over intervals spanning multiple cardiac cycles. In some cases, the catheter with the occlusion device may be equipped with a controller that actuates a drive mechanism to provide at least partial occlusion of the patient's superior vena cava, which can reduce cardiac filling pressure and may cause a favorable shift of the patient's Frank-Starling curve toward healthy cardiac function and improved cardiac performance. Summary of the Invention

[0005] In various aspects, a method for therapeutically reducing preload can be provided. The method may include providing multiple devices, including ventricular assist devices (VADs) and catheter-based devices, the catheter-based devices including adjustable flow limiting elements (FREs). The method may include placing the VAD at least partially within the left or right ventricle of a patient and positioning the catheter-based device such that the FRE can be positioned within the patient's superior vena cava (SVC). The method may include receiving information from at least a first device among the multiple devices. The method may include determining a first determined value based on the information. The method may include controlling at least one performance parameter of at least a second device among the multiple devices based on the first determined value.

[0006] This information can come from both the VAD and the catheter-based device. In some embodiments, the information can come from the VAD, and at least one performance parameter being controlled can be a performance parameter of the catheter-based device. In some embodiments, the information can come from the VAD, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based device. In some embodiments, the information can come from the catheter-based device, and at least one performance parameter being controlled can be a performance parameter of the VAD. In some embodiments, the information can come from the catheter-based device, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based device.

[0007] This information can be received by a single controller. The single controller can be configured to control both the VAD and the catheter-based device. In some embodiments, any information from the VAD can be received by a first controller, and any information from the catheter-based device can be received by a second controller, and the first and second controllers can operatively communicate with each other.

[0008] This information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure gradient, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

[0009] At least one performance parameter may be the rotational speed of the VAD's motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, a limit may be imposed on the rotational speed.

[0010] At least one performance parameter may be the FRE's duty cycle. In some embodiments, the duty cycle may be increased. In some embodiments, the duty cycle may be decreased. In some embodiments, the duty cycle may be paused.

[0011] The method may include displaying at least one right and left hemodynamic parameter based on information from VAD and catheter-based devices. The method may include determining the deload state of one or more ventricles. The method may include automatically and iteratively performing the receiving, determining, and controlling steps of the method to achieve an operational state, wherein the deload state may be the maximum deload state without compromising patient safety.

[0012] In various aspects, a method for modifying the location or curvature of a patient's interventricular septum can be provided. The method may include placing a VAD (ventricular artery septum) at least partially within the patient's left or right ventricle, and placing a catheter-based device including an adjustable flow-limiting element (FRE) such that the FRE can be positioned within the patient's superior vena cava (SVC). The method may include receiving first information from the VAD and / or the catheter-based device. The method may include determining a first value representing a first location or curvature of the interventricular septum based on the first information. The method may include receiving second information from the VAD and / or the catheter-based device. The method may include determining a second value representing a second location or curvature of the interventricular septum based on the second information. The method may include adjusting at least one performance parameter of the VAD and / or the catheter-based device based on the difference between the first and second values, or if the second value exceeds a predetermined threshold.

[0013] This information can come from both the VAD and the catheter-based device. In some embodiments, the information can come from the VAD, and at least one performance parameter being controlled can be a performance parameter of the catheter-based device. In some embodiments, the information can come from the VAD, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based device. In some embodiments, the information can come from the catheter-based device, and at least one performance parameter being controlled can be a performance parameter of the VAD. In some embodiments, the information can come from the catheter-based device, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based device.

[0014] This information can be received by a single controller. The single controller can be configured to control both the VAD and the catheter-based device. In some embodiments, any information from the VAD can be received by a first controller, and any information from the catheter-based device can be received by a second controller, and the first and second controllers can operatively communicate with each other.

[0015] The first information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure gradient, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

[0016] The first piece of information may be a value representing pressure, distance, or motor current (such as the motor current of a VAD or catheter-based FRE device). The distance may be the distance between a sensor on a VAD or catheter-based device and at least a portion of the ventricular septum. Pressure may include pressure in the right chambers of the heart (e.g., the right atrium and / or right ventricle), pressure in the left chambers of the heart (e.g., the left atrium and / or left ventricle), pressure in the great vessels of the heart, or a combination thereof.

[0017] At least one performance parameter may be the rotational speed of the VAD's motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, a limit may be imposed on the rotational speed.

[0018] At least one performance parameter may be the FRE's duty cycle. In some embodiments, the duty cycle may be increased. In some embodiments, the duty cycle may be decreased. In some embodiments, the duty cycle may be paused.

[0019] The method may include displaying at least one right and left hemodynamic parameter based on information from VAD and catheter-based devices.

[0020] The method may include automatically iteratively performing several steps. Such steps may include receiving third information from a VAD and / or catheter-based device. Steps may include determining a third value representing a third location or curvature of the interventricular septum based on the third information. The method may include adjusting at least one performance parameter of the VAD and / or catheter-based device based on the difference between the third value and one or more previously determined values, or if the third value exceeds a predetermined threshold.

[0021] In various aspects, a system may be provided for, for example, providing therapeutic treatment to reduce preload and / or optimize or improve deload levels. The system may include multiple devices, including a VAD configured to be at least partially disposed in the left or right ventricle, and a catheter-based device including an adjustable flow limiting element (FRE) configured to be disposed within the patient's superior vena cava (SVC). The system may include one or more controllers, each controller including one or more processors and a non-transitory computer-readable storage medium containing instructions that, when executed by the controller, cause the one or more controllers to perform several steps individually or in combination. The steps may include receiving information from at least a first device among the multiple devices. The steps may include determining a first determined value based on the information. The steps may include controlling at least one performance parameter of at least a second device among the multiple devices based on the first determined value.

[0022] One or more controllers may include a single controller. One or more controllers may include a first controller operatively coupled to the VAD and a second controller operatively coupled to the catheter-based device. The VAD and / or the catheter-based device may include one or more pressure sensors.

[0023] In various aspects, a system may be provided, for example, for modifying the location of a patient's interventricular septum. The system may include multiple devices, including a VAD configured to be at least partially disposed in the left or right ventricle, and a catheter-based device including an adjustable flow-limiting element (FRE) configured to be disposed within the patient's superior vena cava (SVC). The system may include one or more controllers, each controller including one or more processors and a non-transitory computer-readable storage medium (e.g., a storage device) containing instructions that, when executed by the controller, cause the one or more controllers to perform several steps individually or in combination. The steps may include receiving first information from the VAD and / or the catheter-based device. The steps may include determining a first value representing a first location of the interventricular septum based on the first information. The steps may include receiving second information from the VAD and / or the catheter-based device. The steps may include determining a second value representing a second location of the interventricular septum based on the second information. The steps may include adjusting at least one performance parameter of the VAD and / or the catheter-based device based on the difference between the first and second values, or if the second value exceeds a predetermined threshold.

[0024] One or more controllers may include a single controller. One or more controllers may include a first controller operatively coupled to the VAD and a second controller operatively coupled to the catheter-based device. The VAD and / or catheter-based device may include one or more pressure sensors. The VAD and / or catheter-based device may include one or more optical sensors. At least one of the one or more optical sensors may be configured to determine distance. The VAD and / or catheter-based device may include one or more pressure sensors. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0026] Figure 1 This is an illustration of a heart according to one embodiment.

[0027] Figure 2 This is an illustration of a heart with two medical devices in place and a single controller.

[0028] Figure 3It is a diagram of a heart with two medical devices in place, each with its own controller.

[0029] Figure 4 This is a flowchart of a method for therapeutically reducing preload.

[0030] Figure 5 This is a flowchart of a method for modifying the positioning of the ventricular septum in a patient.

[0031] It should be understood that the accompanying drawings are not necessarily drawn to scale, but rather present a slightly simplified representation of various features illustrating the basic principles of the invention. Specific design features of the operational sequence disclosed herein, including, for example, the specific dimensions, orientations, positions, and shapes of the various illustrated components, will be determined in part by the specific intended application and usage environment. Some features of the illustrated embodiments are enlarged or distorted relative to other features for visualization and clarity. In particular, thin features may be thickened, for example, for clarity or illustration. Detailed Implementation

[0032] The following description and accompanying drawings are merely illustrative of the principles of the invention. Therefore, it should be understood that those skilled in the art will be able to devise various arrangements that, while not explicitly described or shown herein, embody the principles of the invention and are included within its scope. Furthermore, all examples described herein are primarily and explicitly for illustrative purposes only, to aid the reader in understanding the principles of the invention and the concepts contributed by (one or more) the inventors to advance the technology, and should be construed as not being limited to these specifically described examples and conditions. Additionally, unless otherwise stated (e.g., “otherwise” or “or in alternatives”), the term “or” as used herein means non-exclusive. Moreover, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

[0033] Numerous innovative teachings of this application will be described with particular reference to the presently preferred exemplary embodiments. However, it should be understood that such embodiments provide only a few examples of the many advantageous uses of the innovative teachings herein. Generally, the statements made in the specification of this application do not necessarily limit any of the various claimed inventions. Furthermore, some statements may apply to some inventive features but not to others. Those skilled in the art, and those who have acquired knowledge through the teachings herein, will recognize that the invention is also applicable to a variety of other technical fields or embodiments.

[0034] If a patient's heart pumping function remains insufficient despite other medical treatments, a ventricular assist device (VAD) can be used to assist the circulatory system. For example, in some embodiments, a percutaneous blood pump can be inserted into the patient's heart to assist the heart in pumping blood. In some cases, a flow-limiting device (which may include, for example, an inflatable balloon) can be additionally implanted into the patient's superior vena cava (SVC) to help regulate venous blood return to the heart. By adjusting the flow-limiting device, the amount of blood flowing back to the heart can be controlled.

[0035] However, the inventors have recognized that controlling such combined processing can be challenging because various performance parameters of the control devices may cancel each other out. Therefore, the embodiments disclosed herein include using a holistic approach to control the process to provide improved results. For example, in some embodiments, the use of a ventricular assist device (VAD) and a flow-limiting device can be used as a preload reduction treatment. For example, as described herein, the VAD and flow-limiting device can be controlled to mechanically adjust the preload. In some embodiments, measurements from one and / or both devices can be used to mechanically adjust the preload. In a further embodiment, as described herein, the device can be used to address septal shift effects.

[0036] refer to Figure 1 The heart (1) can be seen. As shown, blood (12) returning to the heart from the superior vena cava (7) passes through the right atrium (5) and enters the right ventricle (3) before being sent to the lungs. Blood returning from the lungs enters the left atrium (4), then enters the left ventricle (2), and then blood (13) leaves the heart and enters the aortic arch (6).

[0037] Heart problems can cause changes in the volume of the space defined by the left or right ventricle, thereby shifting the position of the interventricular septum (8) to reduce the volume within the left or right ventricle. For example, in Figure 1 If the pressure in the right ventricle (3) increases, the wall may be subjected to high stress, and the interventricular septum may shift from its original position (9) to a new position (10).

[0038] In some embodiments, the location and / or curvature of the interventricular septum can define the ratio of the volume of the left ventricle to the combined volume of the left and right ventricles. For example, when the ventricular septum bends or flexes toward the left ventricle (i.e., moves from position (9) to a new position (10)), the ratio of the volume of the left ventricle to the combined volume of the two ventricles becomes smaller. In some embodiments, the curvature of the interventricular septum can be determined or estimated based on the distance and / or volume of the ventricles.

[0039] In some embodiments, the width (20) of the left ventricle and the width (21) of the right ventricle may vary relative to the positioning of the intraventricular septum. The width (20) may be defined as the distance between the surface (22) of the intraventricular septum defining the left ventricle (2) and its outer wall (24). Similarly, the width (21) may be defined as the distance between the surface (23) of the intraventricular septum defining the right ventricle (3) and its outer wall (24). The widths (20, 22) will change when the positioning of the septum changes.

[0040] In all respects, as the pressure in the right ventricle increases relative to the pressure in the left ventricle, the diaphragm shifts to the left (i.e., decreasing the volume of the left ventricle and increasing the volume of the right ventricle). Similarly, when the pressure in the left ventricle increases relative to the pressure in the right ventricle, the diaphragm shifts to the right (i.e., decreasing the volume of the right ventricle and increasing the volume of the left ventricle).

[0041] Various systems and methods can be provided. (Reference) Figure 2 Multiple devices can be introduced into a patient’s vascular system (e.g., the patient’s heart), including ventricular assist devices (VAD) (100), such as percutaneous heart pumps, and catheter-based devices (200) including adjustable flow limiting elements (FRE) (202) (also referred to herein as catheter-based FRE devices).

[0042] As shown in the view, the VAD may include a catheter (102) operatively coupled to a controller (300) at its proximal end. The VAD may include a pump portion (101) coupled to the distal end of the catheter. The pump portion may include a rotor portion (104), which may include a rotor (not shown) configured to allow blood to flow into a blood inlet (103) (which may be located, for example, in the left or right ventricle), through the rotor, and out through a blood outlet (105) (which may be located, for example, in the aortic arch). The amount of blood delivered from one part of the body to another can be controlled by adjusting various operating parameters, such as rotor speed. As will be understood, although shown as being located in the left heart, in other embodiments, the VAD may be inserted into the right heart to assist blood flow.

[0043] In some embodiments, the FRE (202) of the catheter-based device (200) can be operatively coupled to the catheter (201) so that the FRE can be positioned within the superior vena cava 7. The FRE typically has a fully deployed configuration (blocking flow) and a fully collapsed configuration (allowing flow), and may have one or more intermediate configurations. By controlling the degree to which the FRE can deploy, the amount of blood flowing into the right ventricle can be controlled at least partially. The FRE can also typically be in a duty cycle—that is, it can spend a first predetermined amount of time in a first configuration (such as the fully deployed configuration), and then the FRE can switch to a second configuration (such as the fully collapsed configuration) for a second predetermined amount of time. The first and second predetermined amounts of time can be the same (e.g., 1 second deployment, 1 second collapse) or they can be different (e.g., 1 second deployment, 2 seconds collapse). In some embodiments, the duty cycle can be configured such that the FRE can be in a deployed configuration for a longer period than the collapsed configuration. In some embodiments, the duty cycle can be configured such that the FRE can be in a collapsed configuration for a longer period than the deployed configuration. The proximal end of the catheter-based device can be operatively coupled to a controller (300).

[0044] like Figure 2 As shown, a single controller can exist to control both the VAD and the conduit-based FRE device. For example... Figure 3 As shown, multiple controllers (300, 301) may exist. In some embodiments, the controllers may include a single controller. For example, one controller (300) may be operatively coupled to the VAD (100), while a second controller (301) may be operatively coupled to the catheter-based device (200). The controllers may be operatively communicating with each other, for example via wired or wireless connections, enabling overall control of the VAD and the catheter-based FRE device to manage, for example, preload and / or septal shift.

[0045] One or more controllers may be configured to receive information from the VAD (100) and / or the conduit-based FRE device (200). For example, the VAD may include one or more sensors or transducers (e.g., a first transducer (106), a second transducer (107), etc.) (see [link to documentation]). Figure 2 and Figure 3 ), and / or catheter-based FRE devices may include one or more sensors or transducers (205, 206) (see Figure 2 ).

[0046] As used herein, the term "controller" may refer to, be part of, or include the following: application-specific integrated circuits (ASICs); digital, analog, or mixed-signal analog / digital discrete circuits; digital, analog, or mixed-signal analog / digital integrated circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processor circuitry (shared, dedicated, or combined) for executing code; memory circuitry (shared, dedicated, or combined) for storing code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or combinations of some or all of the above, such as in a system-on-a-chip.

[0047] The controller may include one or more interface circuits. In some examples, the interface circuits may include wired or wireless interfaces to a local area network (LAN), the Internet, a wide area network (WAN), or a combination thereof. The functionality of any given controller of the present invention can be distributed across multiple controllers connected via the interface circuits. For example, multiple controllers can allow for load balancing. In another example, a server (also known as a remote or cloud) controller may perform certain functions on behalf of a client controller.

[0048] The controller may include one or more displays and may include one or more buttons and / or switches. The controller may include memory and may include one or more non-transitory computer-readable storage media containing instructions that, when executed, cause the controller to perform various steps.

[0049] In some embodiments, one or more sensors or transducers may include pressure sensors or ultrasound transducers. In some embodiments, at least one pressure sensor may be present in a first chamber of the heart (e.g., the left ventricle), and at least one pressure sensor may be present in a second chamber of the heart (e.g., the right ventricle). In some embodiments, only a single pressure sensor may be present. The pressure sensors (one or more) may be, for example, optical or electrical sensors. In some embodiments, a catheter-based FRE device may also include at least one pressure sensor. In some embodiments, a VAD may include at least one pressure sensor. In some embodiments, both the catheter-based FRE device and the VAD may each include at least one pressure sensor. In some embodiments, the pressure sensor may be configured to determine the pressure in the chamber of the heart in which the sensor is present.

[0050] Although described as a pressure sensor, it should be understood that other suitable sensors may be used. For example, in some embodiments, the sensor(s)(s) may include transducers, such as ultrasonic transducers. Other sensors may also be appropriately used in other embodiments.

[0051] In some embodiments, a sensor or transducer (106, 206) may be present, which can determine distances (207, 208) (e.g., the distance from the sensor to the ventricular septum). In some embodiments, such a distance sensor or transducer may be present on a catheter-based FRE device. In some embodiments, such a distance sensor or transducer may be present on a VAD. In some embodiments, such a distance sensor(s) or transducer(s) may be present on both a catheter-based FRE device and a VAD.

[0052] In some embodiments, the sensor or transducer is configured to send information to the controller.

[0053] In some embodiments, the information may include performance characteristics of VAD and / or catheter-based FRE devices.

[0054] refer to Figure 3 This system can also be used holistically to therapeutically reduce cardiac preload. As used herein, the term “cardiac preload” refers to the initial stretching of cardiomyocytes before contraction. When venous return to the heart increases, the end-diastolic pressure and volume of the ventricles increase, which stretches the sarcomeres and increases their preload. Conversely, low blood volume caused by blood loss (e.g., hemorrhage) results in less ventricular filling and thus shorter sarcomere length (reduced preload).

[0055] Controlled use of the VAD allows for active deloading of the left ventricle, reducing left ventricular end-diastolic pressure (LVEDP). Flow restriction (e.g., preventing blood from entering the right ventricle) reduces the filling pressures of both the right and left ventricles, as represented by right atrial pressure (RAP) and LVEDP. Combining these two approaches can safely reduce wall stress, septal displacement, RAP, LVEDP, and improve myocardial structure, including valve engagement. For example, high-speed operation of the VAD while using a FRE to prevent all blood from flowing from the SVC into the right atrium and right ventricle for an extended period can lead to undesirable safety events (e.g., suction events). Therefore, this system requires communication between the two devices to operate safely while reducing preload and / or altering septal positioning to maximize deloading and circulatory support.

[0056] In some embodiments, the disclosed techniques can be used to address pulmonary hypertension (e.g., elevated blood pressure in the pulmonary arteries). Increased pressure in the pulmonary vessels may involve increased back pressure in the right ventricle (RV). Increased back pressure in the RV typically leads to RV dilation (and therefore, septal displacement), which can result in right heart failure. The load on the RV and / or aiding RV recovery can be reduced by blocking the SVC, decreasing the load on the right atrium (RA), and reducing blood flow from the RA.

[0057] In some embodiments, one or more controllers may receive information from various sensors, and one or more controllers may be configured to determine left-side pressure (e.g., pressure in the left ventricle). The controllers may then be configured to automatically titrate support based on the determined pressure to offload the left (or right) ventricle.

[0058] In various aspects, a method for therapeutically reducing preload can be provided. (Reference) Figure 4 The method (400) may include providing (410) a plurality of devices, including ventricular assist devices (VAD) and catheter-based devices including adjustable flow limiting elements (FRE) (referred to herein as "catheter-based FRE devices").

[0059] The method may include placing (420) the device in an appropriate location. The VAD may be placed at least partially in the left or right ventricle of the patient, and the catheter-based FRE device may be placed such that the FRE can be placed within the patient's superior vena cava (SVC).

[0060] The method may include receiving (430) information from at least a first device among a plurality of devices.

[0061] This information can come from both the VAD and the catheter-based FRE device. In some embodiments, the information can come from the VAD, and at least one controlled performance parameter can be a performance parameter of the catheter-based FRE device. In some embodiments, the information can come from the VAD, and at least one controlled performance parameter can be a performance parameter of both the VAD and the catheter-based FRE device. In some embodiments, the information can come from the catheter-based FRE device, and at least one controlled performance parameter can be a performance parameter of the VAD. In some embodiments, the information can come from the catheter-based device, and at least one controlled performance parameter can be a performance parameter of both the VAD and the catheter-based device.

[0062] This information can be received by a single controller. The single controller can be configured to control both the VAD and the catheter-based FRE device. In some embodiments, any information from the VAD can be received by a first controller, and any information from the catheter-based FRE device can be received by a second controller, and the first and second controllers can operatively communicate with each other.

[0063] This information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure gradient, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

[0064] This information can include distances, such as the distance from a sensor on one of the devices to the surface of the diaphragm in the ventricle.

[0065] In some embodiments, the information includes at least one pressure and at least one distance.

[0066] In some embodiments, the information includes at least one performance parameter. Such a performance parameter may include, for example, voltage, current, pressure, resistance, etc., related to the operation of VAD and / or catheter-based FRE devices.

[0067] Although shown and described as receiving information from only one or both of the devices, it will be appreciated that information can also be retrieved from another device (e.g., a wearable patch). In such embodiments, additional information may be sent to the first and / or second controllers and used for monitoring and overall control of the preload.

[0068] The method may include determining (440) a first determined value based on the information.

[0069] In some embodiments, the determined value may be pressure. In some embodiments, the determined value may be a maximum, minimum, average, or function of pressure. In some embodiments, the determined value may be multiple pressures. In some embodiments, the determined value may be a variation in pressure. In some embodiments, the determined value may be a maximum, minimum, average, or function of distance. In some embodiments, the determined value may be a variation in distance (e.g., a variation in maximum, minimum, or average distance).

[0070] The method may include controlling at least one performance parameter of at least a second device among a plurality of devices based on a first determined value (450).

[0071] At least one performance parameter may be the rotational speed of the VAD's motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, a limit may be imposed on the rotational speed.

[0072] At least one performance parameter may be the duty cycle of the FRE. In some embodiments, the duty cycle may be increased. In some embodiments, the duty cycle may be decreased. In some embodiments, the duty cycle may be paused. In some embodiments, the duty cycle may be paused while restricting blood flow to the right atrium and right ventricle (i.e., the FRE is in an expanded configuration). In some embodiments, the duty cycle may be paused where blood flow to the right atrium and right ventricle is unrestricted or minimally restricted (i.e., the FRE is in a collapsed configuration).

[0073] The method may include performing one or more additional steps (460). Such additional steps may include displaying (462) at least one right and left hemodynamic parameter based on information from the VAD and catheter-based devices. Such additional steps may include determining (464) the deload status of one or more ventricles.

[0074] The method may include automatically iteratively performing the receiving (430), determining (440), and controlling (450) steps of the method to achieve an operational state, wherein the deload state may be the maximum deload state without compromising patient safety.

[0075] In various aspects, a method for modifying the location of a patient's ventricular septum can be provided. (Reference) Figure 5 The method (500) may include placing (510) at least partially in the left or right ventricle of the patient with a VAD and placing a catheter-based FRE device including an adjustable FRE such that the FRE can be placed in the patient's superior vena cava (SVC).

[0076] The method may include receiving (520) first information from a VAD and / or a catheter-based FRE device.

[0077] This information can come from both a VAD and a catheter-based FRE device. In some embodiments, the information can come from a VAD, and at least one performance parameter being controlled can be a performance parameter of the catheter-based device. In some embodiments, the information can come from a VAD, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based FRE device. In some embodiments, the information can come from a catheter-based device, and at least one performance parameter being controlled can be a performance parameter of the VAD. In some embodiments, the information can come from a catheter-based device, and at least one performance parameter being controlled can be a performance parameter of both the VAD and the catheter-based device. In some embodiments, the information comes from a non-catheter-based device, and at least one performance parameter being controlled can be a performance parameter of the VAD, the catheter-based FRE device, or both.

[0078] This information can be received by a single controller. The single controller can be configured to control both the VAD and the catheter-based FRE device. In some embodiments, any information from the VAD can be received by a first controller, and any information from the catheter-based device can be received by a second controller, and the first and second controllers can operatively communicate with each other.

[0079] This information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure gradient, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

[0080] This information may include distance, such as the distance from a sensor or transducer on one of the devices to a surface of the interventricular septum. The first piece of information may be a value representing pressure, distance, or both. The distance may be the distance between a sensor or transducer on a VAD or catheter-based FRE device and at least a portion of the interventricular septum. Pressure may include pressure in the right chamber of the heart, pressure in the left chamber of the heart, pressure in the great vessels of the heart, or a combination thereof. In some embodiments, the information includes at least one pressure and at least one distance.

[0081] In some embodiments, the information includes at least one performance parameter. Such a performance parameter may include, for example, voltage, current, pressure, resistance, etc., which are related to the operation of VADs and / or catheter-based devices.

[0082] The method may include determining (530) a first value representing a first location of the interventricular septum based on first information. For example, the location of the septum may be estimated based on the difference between a pressure difference measured between the left and right ventricles and such a pressure difference in the chamber when the septum is in a stress-free or low-stress state.

[0083] In some embodiments, the first value may be a quantitative relative value (e.g., a distance relative to the outer wall of the heart, or a distance relative to a predetermined target value). In some embodiments, the first value may be a subjective value or a classification. For example, the value may be "0" for "no or low" stress on the diaphragm, "±1" for "moderate" stress in one or another direction (e.g., a positive value for rightward displacement of the diaphragm, a negative value for leftward displacement of the diaphragm), and "±2" for "high" stress.

[0084] The method may include receiving (540) second information from a VAD and / or catheter-based device. The method may include determining (550) a second value representing a second location of the ventricular septum based on the second information.

[0085] The method may include adjusting at least one performance parameter of the (560)VAD and / or the catheter-based FRE device based on the difference between a first value and a second value, or if the second value exceeds a predetermined threshold.

[0086] At least one performance parameter may be the rotational speed of the VAD's motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, a limit may be imposed on the rotational speed.

[0087] At least one performance parameter may be the FRE's duty cycle. In some embodiments, the duty cycle may be increased. In some embodiments, the duty cycle may be decreased. In some embodiments, the duty cycle may be paused.

[0088] In some embodiments, any adjustment to the VAD may be based at least in part on information received from the catheter-based device. In some embodiments, any adjustment to the catheter-based FRE device may be based on information received from the VAD.

[0089] For example, in some embodiments, to move the diaphragm to the left (i.e., reduce the volume of the left ventricle), the system can switch the FRE to a collapsed configuration or change the duty cycle to have a longer period in the collapsed configuration, thereby allowing more blood to flow into the right atrium and right ventricle. The system can also, or alternatively, reduce the rotational speed of the VAD (i.e., reduce the rate of blood outflow from the left ventricle). Based on information already received by the controller, the system can set a lower limit for the VAD's rotational speed such that future speed adjustments cannot fall below the lower limit, or it can set an upper limit for the VAD's rotational speed such that future speed adjustments will not allow the VAD to exceed the upper limit. These limits can remain in place until, for example, the controller receives information indicating that removing the limits is safe.

[0090] In some embodiments, to move the diaphragm to the right (i.e., reduce the volume of the right ventricle), the system may change the FRE to an expanded configuration or change the duty cycle to have a longer period in the expanded configuration, thereby allowing less blood to flow into the right atrium and right ventricle. The system may also, or alternatively, increase the rotational speed of the VAD (i.e., increase the rate of blood flow out of the left ventricle). Based on information already received by the controller, the system may set a lower limit for the VAD's rotational speed such that future speed adjustments cannot fall below the lower limit, or it may set an upper limit for the VAD's rotational speed such that future speed adjustments will not allow the VAD to exceed the upper limit. These limits may remain in place until, for example, the controller receives information indicating that removing the limits is safe.

[0091] The method may include performing one or more additional steps (595). Such additional steps may include displaying (596) at least one right and left hemodynamic parameter based on information from the VAD and catheter-based devices. Such additional steps may include determining (597) the deload status of one or more ventricles.

[0092] The method may also include automatically iteratively performing several steps. Such steps may include receiving (570) third information from a VAD and / or catheter-based device. Steps may include determining (580) a third value representing a third location of the interventricular septum based on the third information. The method may include adjusting (590) at least one performance parameter of the VAD and / or catheter-based device based on the difference between the third value and one or more previously determined values, or if the third value exceeds a predetermined threshold.

[0093] Various modifications can be made to the systems, methods, apparatuses, mechanisms, techniques, and portions thereof described herein with reference to the various accompanying drawings, and these modifications are considered to be within the scope of the invention. For example, while a specific order of steps or arrangement of functional elements is presented in the various embodiments described herein, various other orders / arrangements of steps or functional elements may be utilized in the context of the various embodiments. Furthermore, while modifications to the embodiments may be discussed individually, various embodiments may employ multiple modifications, compound modifications, etc., simultaneously or sequentially.

[0094] Although various embodiments incorporating the teachings of the invention have been shown and described in detail herein, those skilled in the art can readily devise many other variations that still incorporate these teachings. Therefore, while the foregoing relates to various embodiments of the invention, other and further embodiments of the invention can be devised without departing from the basic scope of the invention.

Claims

1. A method for providing therapeutic treatment to reduce pre-load, the method comprising: providing a plurality of devices, the plurality of devices including a ventricular assist device (VAD) and a catheter-based flow restriction element (FRE) device, the catheter-based FRE device including an adjustable FRE; placing the VAD at least partially within a left or right ventricle of a patient and placing the catheter-based FRE device such that the FRE is disposed within a superior vena cava (SVC) of the patient; receiving information from at least a first device of the plurality of devices; determining a first determined value based on the information; and controlling at least one performance parameter of at least a second device of the plurality of devices based on the first determined value.

2. The method of claim 1, wherein, The information is from both the VAD and the catheter-based FRE device.

3. The method of claim 1, wherein, The information is from the VAD and the at least one performance parameter that is controlled is a performance parameter of the catheter-based FRE device.

4. The method of claim 1, wherein, The information is from the VAD and the at least one performance parameter that is controlled is a performance parameter of both the VAD and the catheter-based FRE device.

5. The method of claim 1, wherein, The information is from the catheter-based FRE device and the at least one performance parameter that is controlled is a performance parameter of the VAD.

6. The method of claim 1, wherein, The information is from the catheter-based FRE device and the at least one performance parameter that is controlled is a performance parameter of both the VAD and the catheter-based device.

7. The method of claim 1, wherein, The information is received by a single controller.

8. The method of claim 7, wherein, The single controller is configured to control both the VAD and the catheter-based FRE device.

9. The method of claim 1, wherein any information from the VAD is received by a first controller, any information from the catheter-based device is received by a second controller, and the first and second controllers are in operable communication with each other.

10. The method of claim 1, wherein, The information is from a non-catheter-based device and the at least one performance parameter that is controlled is a performance parameter of the VAD, the catheter-based FRE device, or both.

11. The method of claim 1, wherein, The information includes left ventricular end diastolic pressure (LVEDP), right ventricular end diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure differential, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or combinations thereof.

12. The method of claim 1, wherein, The at least one performance parameter is a rotational speed of a motor of the VAD.

13. The method of claim 12, wherein, The rotational speed is increased.

14. The method of claim 12, wherein, The rotational speed is decreased.

15. The method of claim 12, wherein, A limit is imposed on the rotational speed.

16. The method of claim 1, wherein, The at least one performance parameter is a duty cycle of the adjustable FRE.

17. The method of claim 16, wherein, The duty cycle is increased.

18. The method of claim 16, wherein, The duty cycle is decreased.

19. The method of claim 16, wherein, The duty cycle is paused.

20. The method of claim 1, further comprising displaying at least one right and left hemodynamic indicator based on information from the VAD and the catheter-based FRE device.

21. The method of claim 1, further comprising determining a de- loading state of one or more ventricles.

22. The method of claim 21, further comprising automatically iteratively performing the receiving, determining, and controlling steps to achieve an operational state, wherein, The de-loading state is a maximum de-loading state that does not compromise patient safety.

23. A method for modifying a positioning or curvature of a septum of a patient, the method comprising: placing a ventricular assist device (VAD) at least partially within a left or right ventricle of a patient, and placing a catheter-based device (catheter-based FRE device) including a flow restricting element (FRE) such that the FRE is disposed within a superior vena cava (SVC) of the patient, the FRE being adjustable; receiving first information from the VAD and / or the catheter-based FRE device; determining a first value indicative of a first positioning or curvature of the septum based on the first information; receiving second information from the VAD and / or the catheter-based FRE device; determining a second value indicative of a second positioning or curvature of the septum based on the second information; and adjusting at least one performance parameter of the VAD and / or the catheter-based FRE device based on a difference between the first value and the second value, or if the second value exceeds a predetermined threshold.

24. The method of claim 23, wherein, The first information is from both the VAD and the catheter-based FRE device.

25. The method of claim 23, wherein, The first information is from the VAD, and the at least one performance parameter controlled is a performance parameter of the catheter-based FRE device.

26. The method of claim 23, wherein, The first information is from the VAD, and the at least one performance parameter controlled is a performance parameter of both the VAD and the catheter-based FRE device.

27. The method of claim 23, wherein, The first information is from the catheter-based FRE device, and the at least one performance parameter controlled is a performance parameter of the VAD.

28. The method of claim 23, wherein, The second information is from the catheter-based FRE device, and the at least one performance parameter controlled is a performance parameter of both the VAD and the catheter-based FRE device.

29. The method of claim 23, wherein, The first information is received by a single controller.

30. The method of claim 29, wherein, The single controller is configured to control both the VAD and the catheter-based FRE device.

31. The method of claim 23, wherein, Any first information from the VAD is received by a first controller, any second information from the catheter-based FRE device is received by a second controller, and the first and second controllers are in operable communication with one another.

32. The method of claim 23, wherein, The first information includes left ventricular end diastolic pressure (LVEDP), right ventricular end diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), pressure differential, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

33. The method of claim 23, wherein, The first information is a value indicative of pressure, distance, or motor current.

34. The method of claim 33, wherein, The distance is a distance between a sensor or transducer on the VAD or the catheter-based FRE device and at least a portion of the septum.

35. The method of claim 33, wherein, The pressure includes a pressure in the right ventricle, a pressure in the left ventricle, or both.

36. The method of claim 23, wherein, The at least one performance parameter is a rotational speed of a motor of the VAD.

37. The method of claim 36, wherein, The rotational speed is increased.

38. The method of claim 36, wherein, The rotational speed is decreased.

39. The method of claim 36, wherein, A limit is imposed on the rotational speed.

40. The method of claim 23, wherein, The at least one performance parameter is a duty cycle of the FRE.

41. The method of claim 40, wherein, The duty cycle is increased.

42. The method of claim 40, wherein, The duty cycle is decreased.

43. The method of claim 40, wherein, The duty cycle is suspended.

44. The method of claim 23, further comprising displaying at least one right and left hemodynamic indicator based on information from the VAD and the catheter-based FRE device.

45. The method of claim 23, further comprising automatically iteratively performing a plurality of steps, the plurality of steps comprising: receiving third information from the VAD and / or the catheter-based FRE device; determining a third value representing a third positioning or curvature of the intraventricular septum based on the third information; and adjusting at least one performance parameter of the VAD and / or the catheter-based FRE device based on a difference between the third value and one or more previously determined values, or if the third value exceeds a predetermined threshold.

46. A system for providing therapeutic treatment to reduce preload, comprising: a plurality of devices, comprising: a ventricular assist device (VAD) configured to be at least partially disposed in a left or right ventricle; and a catheter-based device comprising a flow restriction element (FRE) (catheter-based FRE device), the FRE configured to be disposed within a superior vena cava (SVC) of a patient; and one or more controllers, each controller comprising one or more processors and a non-transitory computer-readable storage medium containing instructions that, when executed by the controller, cause the one or more controllers, individually or in combination, to: receive information from at least a first device of the plurality of devices; determine a first determined value based on the information; and control at least one performance parameter of at least a second device of the plurality of devices based on the first determined value.

47. The system of claim 46, wherein, The one or more controllers comprise a single controller.

48. The system of claim 46, wherein, The one or more controllers comprise a first controller operably coupled to the VAD, and a second controller operably coupled to the catheter-based FRE device.

49. The system of claim 46, wherein, The VAD and / or the catheter-based FRE device comprise one or more pressure sensors.

50. A system for modifying a positioning or curvature of an interventricular septum of a patient, comprising: a plurality of devices, comprising: a ventricular assist device (VAD) configured to be at least partially disposed in a left or right ventricle; and a catheter-based device comprising a flow restriction element (FRE) (catheter-based FRE device), the FRE configured to be disposed within a superior vena cava (SVC) of a patient; and one or more controllers, each controller comprising one or more processors and a non-transitory computer-readable storage medium containing instructions that, when executed by the controller, cause the one or more controllers, individually or in combination, to: receive first information from the VAD and / or the catheter-based device; determine a first value representing a first positioning or curvature of the interventricular septum based on the first information; receive second information from the VAD and / or the catheter-based device; determine a second value representing a second positioning or curvature of the interventricular septum based on the second information; and control at least one performance parameter of the VAD and / or the catheter-based device based on a difference between the first and second values. adjust at least one performance parameter of the VAD and / or the catheter-based device based on a difference between the first value and the second value, or if the second value exceeds a predetermined threshold.

51. The system of claim 50, wherein, The one or more controllers comprise a single controller.

52. The system of claim 50, wherein, The one or more controllers comprise a first controller operably coupled to the VAD, and a second controller operably coupled to the catheter-based device.

53. The system of claim 50, wherein, The VAD and / or the catheter-based device comprise one or more optical sensors or ultrasonic transducers.

54. The system of claim 53, wherein, At least one of the one or more optical sensors or ultrasonic transducers is configured to determine a distance.

55. The system of claim 50, wherein, The VAD and / or the catheter-based device comprise one or more pressure sensors.

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