Methods and systems for comprehensively reducing preload and / or correcting the position or curvature of the interventricular septum.

Abstract

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

Description

Technical Field

[0001] Technical Field This application claims the priority of U.S. Provisional Patent Application No. 63 / 464,005, filed on May 4, 2023, the entire content of which is incorporated herein by reference.

[0002] Technical Field The present disclosure relates to methods and systems for providing improved treatment of heart-related problems.

Background Art

[0003] Background A blood pump assembly, such as an intracardiac or intravascular blood pump, can be introduced into the heart to pump blood from the heart into the arteries. Such mechanical circulatory assist devices are often introduced to assist the heart's function after a patient has suffered a heart attack. One type of such device is a series of devices known as "impeller" heart pumps. Some blood pump assemblies can be introduced percutaneously through the vasculature during a cardiac procedure. Specifically, the blood pump assembly can be inserted into the ascending aorta across a valve and into the left ventricle through the femoral artery or axillary / subclavian artery by a catheterization method. The inserted blood pump assembly can be configured to draw blood from the left ventricle of the heart through a cannula and discharge the blood into the aorta. The blood pump assembly can also be configured to draw blood from the inferior vena cava and discharge the blood into the pulmonary artery.

[0004] Systems and methods for treating conditions such as heart failure and / or pulmonary hypertension can include at least partially occluding the flow through the superior vena cava over intervals spanning multiple cardiac cycles. In some cases, a catheter having an occlusion device may include a controller that actuates a drive mechanism to effect at least partial occlusion of the patient's superior vena cava, which can potentially reduce the filling pressure of the heart and induce a favorable shift in the Frank-Starling curve of the patient towards healthy heart function and improved cardiac function. [Overview of the project] [Means for solving the problem]

[0005] overview Methods for therapeutically reducing preload may be provided in various embodiments. These methods may include providing a plurality of devices, including a catheter-based device comprising a ventricular assist device (VAD) and an adjustable flow-limiting element (FRE). These methods may include positioning the VAD at least partially within either the patient's left or right ventricle, and positioning the catheter-based device such that the FRE can be positioned within the patient's superior vena cava (SVC). These methods may include receiving information from at least a first of the plurality of devices. These methods may include determining a first determination value based on the information. These methods may include controlling at least one performance parameter of at least a second of the plurality of devices based on the first determination value.

[0006] The information may come from both the VAD and the catheter-based device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from the catheter-based device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from both the VAD and the catheter-based device. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from the VAD. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from both the VAD and the catheter-based device.

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

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

[0009] At least one performance parameter may be the rotational speed of the VAD motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, the rotational speed may be limited.

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

[0011] This method may include displaying at least one right and left heart hemodynamic index based on information from a VAD and a catheter-based device. This method may include determining the deloading state of one or more ventricles. This method may include automatically and repeatedly performing the receiving, determining, and controlling steps of this method to achieve an operating state in which the deloading state is the most deloaded state without compromising patient safety.

[0012] Methods for correcting the position or curvature of a patient's interventricular septum may be provided in various embodiments. The method may include positioning a VAD at least partially within either the patient's left or right ventricle, and positioning 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 catheter-based device. Based on the first information, the method may include determining a first value representing a first position or curvature of the interventricular septum. The method may include receiving second information from the VAD and / or catheter-based device. Based on the second information, the method may include determining a second value representing a second position or curvature of the interventricular septum. The method may include adjusting at least one performance parameter of the VAD and / or catheter-based device based on the difference between the first and second values, or if the second value exceeds a predetermined threshold.

[0013] The information may come from both the VAD and the catheter-based device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from the catheter-based device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from both the VAD and the catheter-based device. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from the VAD. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from both the VAD and the catheter-based device.

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

[0015] The first piece of information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), differential pressure, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signals, 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). Distance may be the distance between the sensor of the VAD or catheter-based device and at least a portion of the intraventricular septum. Pressure may include pressure within the right heart chambers (e.g., the right atrium and / or right ventricle), pressure within the left heart chambers (e.g., the left atrium and / or left ventricle), pressure within the great vessels of the heart, or a combination thereof.

[0017] At least one performance parameter may be the rotational speed of the VAD motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, the rotational speed may be limited.

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

[0019] This method may include displaying at least one right and left heart hemodynamic index based on information from a VAD and a catheter-based device.

[0020] The method may include performing several steps automatically and repeatedly. Such steps may include receiving third information from a VAD and / or catheter-based device. The steps may include determining a third value representing a third position 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 embodiments, for example, a system may be provided to provide a therapeutic measure to reduce preload and / or to optimize or improve the degree of deloading. The system may include a plurality of devices, which may include a catheter-based device comprising an adjustable flow limiting element (FRE), the FRE being configured to be positioned in the patient's superior vena cava (SVC). The system may include one or more controllers, each controller comprising one or more processors and a non-temporary computer-readable storage medium containing instructions, which, when executed by a controller, cause one or more controllers to perform a certain number of steps, individually or in combination. The steps may include receiving information from at least a first device of the plurality of devices. The steps may include determining a first determination value based on the information. The steps may include controlling at least one performance parameter of at least a second device of the plurality of devices based on the first determination value.

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

[0023] In various embodiments, for example, a system for correcting the position of a patient's interventricular septum may be provided. The system may include a plurality of devices, which may include a VAD configured to be positioned at least partially in either the left or right ventricle, and a catheter-based device including an adjustable flow-limiting element (FRE), the FRE being configured to be positioned in 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-temporary computer-readable storage medium (e.g., a storage device) containing instructions, the instructions, when executed by a controller, causing one or more controllers to perform a certain number of steps, individually or in combination. The steps may include receiving first information from the VAD and / or catheter-based device. The steps may include determining a first value representing a first position of the interventricular septum based on the first information. The steps may include receiving second information from the VAD and / or catheter-based device. The steps may include determining a second value representing a second position of the interventricular septum based on the second information. The process may include adjusting at least one performance parameter of the VAD and / or catheter-based device based on the difference between a first value and a second value, or if the second value exceeds a predetermined threshold.

[0024] One or more controllers may include a single controller. The one or more controllers may include a first controller operably coupled to the VAD and a second controller operably coupled to the catheter-based device. The VAD and / or the catheter-based device may include one or more pressure sensors. The VAD and / or the 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 the catheter-based device may include one or more pressure sensors.

[0025] Brief Description of the Drawings 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 below, serve to explain the principles of the invention.

Brief Description of the Drawings

[0026] [Figure 1] It is a diagram of a heart according to an embodiment. [Figure 2] It is a diagram of a heart and a single controller with two medical devices in a predetermined position. [Figure 3] It is a diagram of a heart with two medical devices in a predetermined position and each device having its own controller. [Figure 4] It is a flowchart of a method for therapeutically reducing preload. [Figure 5] It is a flowchart of a method for correcting the position of the intraventricular septum of a patient.

Modes for Carrying Out the Invention

[0027] Please understand that the accompanying drawings are not necessarily to scale and present somewhat simplified representations of various features illustrating the basic principles of the present invention. Specific design features of the series of operations disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes of various illustrated components, are partly determined by the specific intended use and environment. Certain features of the illustrated embodiments are enlarged or distorted relative to other features to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustrative purposes.

[0028] Detailed explanation The following description and drawings are merely illustrative of the principles of the present invention. Those skilled in the art will understand that various arrangements and configurations embodying the principles of the present invention and falling within its scope can be devised, even if not explicitly described or illustrated herein. Furthermore, all examples listed herein are expressly intended to be illustrative only, primarily to help the reader understand the principles of the present invention and the concepts provided by the inventors to advance the art, and should be interpreted as not being limited to such specifically listed examples and conditions. Furthermore, as used herein, the term "or" means non-exclusive "or" unless otherwise indicated (e.g., "or otherwise" or "or alternatively"). Also, since several embodiments can be combined with one or more other embodiments to form new embodiments, the various embodiments described herein are not necessarily mutually exclusive.

[0029] Numerous innovative teachings of this application are described with particular reference to currently preferred exemplary embodiments. However, it should be understood that these types of embodiments provide only a few examples of the many advantageous uses of the innovative teachings herein. In general, the descriptions made in the specification of this application are not necessarily limited to any of the various claimed inventions. Furthermore, some descriptions may apply to some inventive features but not to others. Those skilled in the art who have been informed by the teachings herein will understand that the invention may be applicable to a variety of other arts or embodiments.

[0030] If a patient's heart pumping function is insufficient despite other medical interventions, the circulatory system can be assisted by a ventricular assist device (VAD). 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) may be additionally placed in the patient's superior vena cava (SVC) to assist in regulating the amount of venous blood returning to the heart. By adjusting the flow limiting device, the amount of blood returning to the heart can be controlled.

[0031] However, the inventors recognize that controlling such complex procedures can be difficult because various performance parameters controlling the devices may cancel each other out. Therefore, embodiments disclosed herein include controlling the process using a comprehensive approach to provide improved results. For example, in some embodiments, the use of ventricular assist devices and flow-limiting devices may be used as preload reduction therapy. For example, as described herein, VADs and flow-limiting devices may be controlled to mechanically adjust preload. In some embodiments, preload can be mechanically adjusted using measurements of one and / or both devices. In yet another embodiment, devices may be used to address the effects of septal deviation, as described herein.

[0032] Referring to Figure 1, we can see the heart (1). As can be seen from the figure, blood (12) returning to the heart from the superior vena cava (7) passes through the right atrium (5), enters the right ventricle (3), and is then sent to the lungs. Blood returning from the lungs enters the left atrium (4), then the left ventricle (2), and then the blood (13) leaves the heart and is sent to the aortic arch (6).

[0033] A cardiac problem can alter the volume of the space defined by the left or right ventricle, causing displacement of the interventricular septum (8) and potentially leading to a decrease in the volume of either the left or right ventricle. For example, in Figure 1, an increase in pressure within the right ventricle (3) can create high stress on the walls, potentially causing the interventricular septum to shift from its original position (9) to a new position (10).

[0034] In some embodiments, the position and / or curvature of the interventricular septum may define the ratio of the left ventricle's volume to the combined volume of the left and right ventricles. For example, as the interventricular septum curves or bends toward the left ventricle (i.e., moves from position (9) to a new position (10)), the ratio of the left ventricle's volume to the combined volume of both ventricles decreases. In some embodiments, the curvature of the interventricular septum may be determined or estimated as a function of the ventricular distance and / or volume.

[0035] In some embodiments, the widths (20) of the left ventricle and (21) of the right ventricle may vary with respect to the position of the intraventricular septum. Width (20) may be defined as the distance between the surface (22) and the outer wall (24) of the intraventricular septum defining the left ventricle (2). Similarly, width (21) may be defined as the distance between the surface (23) and the outer wall (24) of the intraventricular septum defining the right ventricle (3). As the position of the septum changes, the widths (20, 22) change.

[0036] In various embodiments, as the pressure in the right ventricle increases relative to the pressure in the left ventricle, the septum shifts to the left (i.e., the volume of the left ventricle decreases and the volume of the right ventricle increases). Similarly, as the pressure in the left ventricle increases relative to the pressure in the right ventricle, the septum shifts to the right (i.e., the volume of the right ventricle decreases and the volume of the left ventricle increases).

[0037] Various systems and methods may be offered. Referring to Figure 2, multiple devices, including a ventricular assist device (VAD) (100) such as a percutaneous cardiac pump and a catheter-based device (200) containing an adjustable flow limiting element (FRE) (202) (also referred to herein as a catheter-based FRE device), may be introduced into the patient's cardiovascular system (e.g., the patient's heart).

[0038] As shown in this figure, the VAD may include a catheter (102) operably coupled to a controller (300) at its proximal end. The VAD may include a pump section (101) coupled to the distal end of the catheter. The pump section may include a rotor section (104) which may include a rotor (not shown), configured to draw blood into a blood inlet (103) (which may be located, e.g., in the left or right ventricle) and out through a blood outlet (105) (which may be located, e.g., in the aortic arch). By adjusting various operating parameters (such as rotor speed), the amount of blood transported from one part of the body to another can be controlled. As is to 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.

[0039] In some embodiments, a FRE (202) of a catheter-based device (200) can be operably coupled to a catheter (201) so that the FRE can be positioned within the superior vena cava 7. The FRE typically has a fully expanded configuration (blocking flow) and a fully contracted configuration (allowing flow), and may have one or more intermediate configurations. By controlling the degree to which the FRE can be expanded, the amount of blood flowing into the right ventricle can be controlled at least partially. The FRE can also typically operate on a duty cycle; that is, a first predetermined time period may elapse in a first configuration (e.g., a fully expanded configuration), and thereafter the FRE may be switched to a second configuration (e.g., a fully contracted configuration) for a second predetermined time period. The first and second predetermined time periods may be the same (e.g., 1 second expanded, 1 second contracted) or different (e.g., 1 second expanded, 2 seconds contracted). In some embodiments, the duty cycle may be configured such that the FRE can be in the expanded configuration longer than in the contracted configuration. In some embodiments, the duty cycle may be configured such that the FRE can be in a deflated configuration for a longer period than in an expanded configuration. The proximal end of the catheter-based device may be operably coupled to a controller (300).

[0040] As shown in Figure 2, there may be a single controller that controls the VAD and the catheter-based FRE device. As shown in Figure 3, there may be multiple controllers (300, 301). In some embodiments, the controller may consist of a single controller. For example, one controller (300) may be operably coupled to the VAD (100), and a second controller (301) may be operably coupled to the catheter-based device (200). The controllers may communicate operably with each other, for example, via wired or wireless connections, so that the VAD and the catheter-based FRE device can be comprehensively controlled to manage, for example, preload and / or septal deviation.

[0041] The controller may be configured to receive information from the VAD (100) and / or the catheter-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 Figures 2 and 3), and / or the catheter-based FRE device may include one or more sensors or transducers (205, 206) (see Figure 2).

[0042] As used herein, the term “controller” may mean, may be part of, or include: application-specific integrated circuits (ASICs); digital circuits, analog circuits, or mixed analog / digital discrete circuits; digital integrated circuits, analog integrated circuits, or mixed analog / digital integrated circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processor circuits for executing code (shared, dedicated, or combined); memory circuits for storing code executed by the processor circuits (shared, dedicated, or combined); other suitable hardware components that provide the functions described; or any combination of some or all of the above, such as a system-on-a-chip.

[0043] A 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 functions of any given controller of the present invention may be distributed among multiple controllers connected via interface circuits. For example, multiple controllers may enable load balancing. In further examples, a server (also called a remote or cloud) controller may perform certain functions on behalf of a client controller.

[0044] The controller may include one or more displays and one or more buttons and / or switches. The controller may include memory and, when executed, one or more non-temporary computer-readable storage media containing instructions that cause the controller to perform various processes.

[0045] In some embodiments, one or more sensors or transducers may include pressure sensors or ultrasonic transducers. In some embodiments, at least one pressure sensor may be located in a first chamber of the heart (e.g., the left ventricle), and at least one pressure sensor may be located 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 sensor may be, for example, an optical sensor or an electrical sensor. In some embodiments, the catheter-based FRE device may also include at least one pressure sensor. In some embodiments, the VAD may include at least one pressure sensor. In some embodiments, 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 where the sensor is located.

[0046] Although described as a pressure sensor, it will be understood that other suitable sensors may be used. For example, in some embodiments, the sensor may include a transducer such as an ultrasonic transducer. In other embodiments, other sensors may also be used as needed.

[0047] In some embodiments, there may be sensors or transducers (106, 206) capable of determining distance (207, 208) (e.g., the distance from the sensor to the intraventricular septum). In some embodiments, such distance sensors or transducers may be present in a catheter-based FRE device. In some embodiments, such distance sensors or transducers may be present in a VAD. In some embodiments, such distance sensors or transducers may be present in both the catheter-based FRE device and the VAD.

[0048] In some embodiments, the sensor or transducer is configured to transmit information to the controller.

[0049] In some embodiments, the information may include performance characteristics of VAD and / or catheter-based FRE devices.

[0050] Referring to Figure 3, such systems can also be used comprehensively to therapeutically reduce cardiac preload. As used herein, the term “cardiac preload” refers to the initial stretching of cardiomyocytes before systole. Increased venous return to the heart increases the end-diastolic pressure and volume of the ventricles, which in turn stretches the sarcomeres and increases their preload. In contrast, a decrease in blood volume resulting from loss of blood volume (e.g., bleeding) leads to decreased ventricular filling and, consequently, a shortening of sarcomere length (a decrease in preload).

[0051] Active deloading of the left ventricle through controlled use of a VAD can reduce left ventricular end-diastolic pressure (LVEDP). Restricting flow (e.g., preventing blood from entering the right ventricle) can reduce both right and left ventricular filling pressures, as expressed by right atrial pressure (RAP) and LVEDP. Combining these two approaches can reduce wall resistance, septal displacement, RAP, and LVEDP, and safely improve myocardial structure, including valve leaflet junctions. For example, operating a VAD at high speed while blocking all blood flow from the SVC to the right atrium and right ventricle for extended periods using FRE can lead to undesirable safety events (e.g., aspiration events). Therefore, the system requires communication between the two devices to operate safely while reducing preload and / or septal displacement, such as to maximize deloading and circulatory support.

[0052] In some embodiments, the disclosed techniques may be used to address pulmonary hypertension (e.g., elevated blood pressure in the pulmonary arteries). Elevated pressure in the pulmonary vessels may be accompanied by increased back pressure in the right ventricle (RV). Increased back pressure in the RV typically leads to RV dilation (and thus septal deviation), which can lead to right heart failure. By blocking the scapular ventricle (SVC), reducing the load on the right atrium (RA), and decreasing the amount of blood flowing into the RA, it may be possible to reduce the load on the RV and / or help the RV recover.

[0053] In some embodiments, the controller may receive information from various sensors and may be configured to determine left heart pressure (e.g., pressure within the left ventricle). The controller may then be configured to provide automatic titration assistance and reduce the load on the left (or right) ventricle based on the determined pressure.

[0054] In various embodiments, methods for therapeutically reducing preload may be provided. Referring to Figure 4, method (400) may include providing a plurality of devices, including a catheter-based device (referred herein to as a “catheter-based FRE device”) that includes a ventricular assist device (VAD) and an adjustable flow-limiting element (FRE).

[0055] The method may include positioning the device in an appropriate location (420). The VAD may be positioned at least partially inside either the patient's left or right ventricle, and the catheter-based FRE device may be positioned so that the FRE can be positioned inside the patient's superior vena cava (SVC).

[0056] This method may include receiving information from at least one of several devices (430).

[0057] The information may come from both the VAD and the catheter-based FRE device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from the catheter-based FRE device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from both the VAD and the catheter-based FRE device. In some embodiments, the information may come from the catheter-based FRE device, and at least one controlled performance parameter may come from the VAD. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from both the VAD and the catheter-based device.

[0058] The information may be received by a single controller. The single controller may be configured to control both the VAD and the catheter-based FRE device. In some embodiments, any information from the VAD may be received by a first controller, any information from the catheter-based FRE device may be received by a second controller, and the first and second controllers may be able to communicate with each other in an operable manner.

[0059] The information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), differential pressure, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signals, or a combination thereof.

[0060] The information may include distances, such as the distance from one of the device's sensors to the surface of the intraventricular septum.

[0061] In some embodiments, the information includes at least one pressure and at least one distance.

[0062] 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 the VAD and / or catheter-based FRE device.

[0063] Although illustrated and described as receiving information from one or both devices, it will be understood that information may also be obtained from another device (e.g., a wearable patch). In such embodiments, additional information may be transmitted to a first controller and / or a second controller and used to monitor and comprehensively control the preload.

[0064] This method may include determining a first determined value based on the information (440).

[0065] In some embodiments, the determined value may be pressure. In some embodiments, the determined value may be the 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 change in pressure. In some embodiments, the determined value may be the maximum, minimum, average, or function of distance. In some embodiments, the determined value may be a change in distance (e.g., a change in maximum distance, minimum distance, or average distance).

[0066] The method may include controlling at least one performance parameter of at least second of multiple devices based on a first determined value (450).

[0067] At least one performance parameter may be the rotational speed of the VAD motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, the rotational speed may be limited.

[0068] 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 with restricted blood flow to the right atrium and right ventricle (i.e., the FRE is in an extended configuration). In some embodiments, the duty cycle may be paused with unrestricted or minimally restricted blood flow to the right atrium and right ventricle (i.e., the FRE is in a contracted configuration).

[0069] The method may include performing one or more additional steps (460). Such additional steps may include displaying at least one right and left heart hemodynamic index based on information from the VAD and catheter-based device (462). Such additional steps may include determining the deloading state of one or more ventricles (464).

[0070] This method may include automatically and repeatedly performing the receiving step (430), determining step (440), and controlling step (450) of this method in order to achieve an operating state in which the deloading state can be the most deloaded state without compromising patient safety.

[0071] In various embodiments, methods for correcting the position of a patient's interventricular septum may be provided. Referring to Figure 5, the method (500) may include positioning a VAD at least partially inside either the patient's left or right ventricle (510) and positioning a catheter-based FRE device including an adjustable FRE such that the FRE can be positioned within the patient's superior vena cava (SVC).

[0072] This method may include receiving first information from a VAD and / or a catheter-based FRE device (520).

[0073] The information may come from both the VAD and the catheter-based FRE device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from the catheter-based device. In some embodiments, the information may come from the VAD, and at least one controlled performance parameter may come from both the VAD and the catheter-based FRE device. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from the VAD. In some embodiments, the information may come from the catheter-based device, and at least one controlled performance parameter may come from both the VAD and the catheter-based device. In some embodiments, the information may come from a non-catheter-based device, and at least one controlled performance parameter may come from the VAD, the catheter-based FRE device, or both.

[0074] The information may be received by a single controller. The single controller may be configured to control both the VAD and the catheter-based FRE device. In some embodiments, any information from the VAD may be received by a first controller, any information from the catheter-based device may be received by a second controller, and the first and second controllers may be able to communicate with each other in an operable manner.

[0075] The information may include left ventricular end-diastolic pressure (LVEDP), right ventricular end-diastolic pressure (RVEDP), left atrial pressure (LAP), right atrial pressure (RAP), differential pressure, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signals, or a combination thereof.

[0076] The information may include distances, such as the distance from one of the device's sensors or transducers to the surface of the interventricular septum. The first information may be a value representing pressure, distance, or both. The distance may be the distance between a sensor or transducer of a VAD or catheter-based FRE device and at least a portion of the interventricular septum. The pressure may include pressure in the right heart chambers, pressure in the left heart chambers, 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.

[0077] 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 the VAD and / or catheter-based device.

[0078] The method may include determining a first value representing a first position of the interventricular septum based on first information (530). For example, the position of the septum can be estimated based on the difference between the measured pressure difference between the left ventricle and the right ventricle and the pressure difference in such cavities when the septum is in a stress-free or low-stress state.

[0079] In some embodiments, the first value may be a quantitative relative value (such as the distance to the outer wall of the heart or the distance to a predetermined target value). In some embodiments, the first value may be a subjective value or classification. For example, the value may be "0" if the stress on the septum is "none or low", "±1" (for example, a positive value if the septum is displaced to the right, and a negative value if the septum is displaced to the left) if the stress in one or the other direction is "moderate", and "±2" if the stress is "high".

[0080] The method may include receiving second information from a VAD and / or a catheter-based device (540). The method may include determining a second value representing a second position of the intraventricular septum based on the second information (550).

[0081] The method may include adjusting at least one performance parameter of a VAD and / or catheter-based FRE device based on the difference between a first value and a second value, or when the second value exceeds a predetermined threshold (560).

[0082] At least one performance parameter may be the rotational speed of the VAD motor. In some embodiments, the rotational speed may be increased. In some embodiments, the rotational speed may be decreased. In some embodiments, the rotational speed may be limited.

[0083] At least one performance parameter can be the duty cycle of the FRE. In some embodiments, the duty cycle can be increased. In some embodiments, the duty cycle can be decreased. In some embodiments, the duty cycle can be paused.

[0084] In some embodiments, any adjustments to the VAD may be based at least partially on information received from the catheter-based device. In some embodiments, any adjustments to the catheter-based FRE device may be based on information received from the VAD.

[0085] For example, in some embodiments, to deviate the septum to the left (i.e., to reduce the volume of the left ventricle), the system may change the FRE to a systolic configuration or modify the duty cycle to have a longer duration in the systolic configuration, allowing more blood to flow into the right atrium and right ventricle. Alternatively, the system may reduce the rotation speed of the VAD (i.e., reduce the flow rate of blood leaving the left ventricle). Based on information received by the controller, the system may set a lower limit for the rotation speed of the VAD so that it cannot fall below the lower limit in future speed adjustments, or set an upper limit for the rotation speed of the VAD so that it cannot exceed the upper limit in future speed adjustments. These limitations may persist, for example, until the controller receives information indicating that it is safe to remove these limitations.

[0086] In some embodiments, to shift the septum to the right (i.e., to reduce the volume of the right ventricle), the system may change the FRE to an expanded configuration or modify the duty cycle to have a longer duration in the expanded configuration, allowing less blood to flow into the right atrium and right ventricle. Alternatively, the system may increase the rotation speed of the VAD (i.e., increase the flow rate of blood leaving the left ventricle). Based on information received by the controller, the system may set a lower limit for the rotation speed of the VAD so that it cannot fall below the lower limit in future speed adjustments, or set an upper limit for the rotation speed of the VAD so that it cannot exceed the upper limit in future speed adjustments. These limitations may persist, for example, until the controller receives information indicating that it is safe to remove these limitations.

[0087] The method may include performing one or more additional steps (595). Such additional steps may include displaying at least one right and left heart hemodynamic index based on information from the VAD and catheter-based device (596). Such additional steps may include determining the deloading state of one or more ventricles (597).

[0088] The method may also include performing several steps automatically and repeatedly. Such steps may include receiving third information from a VAD and / or catheter-based device (570). The steps may include determining a third value representing a third position of the interventricular septum based on the third information (580). 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 (590).

[0089] Various modifications can be made to the systems, methods, apparatus, mechanisms, techniques, and parts thereof described herein with respect to various drawings, and such modifications are considered to be within the scope of the present invention. For example, while specific sequences of processes or arrangements of functional elements are presented in various embodiments described herein, various other sequences / arrangements of processes or functional elements may be used in the context of various embodiments. Furthermore, while modifications to embodiments may be considered individually, various embodiments may use multiple modifications simultaneously or sequentially, or use a combination of modifications, etc.

[0090] Although various embodiments incorporating the teachings of the present invention have been described in detail herein, those skilled in the art can easily devise many other various embodiments that still incorporate these teachings. Therefore, although the above relates to various embodiments of the present invention, other and further embodiments of the present invention can be devised without departing from its basic scope.

Claims

1. A method for providing a therapeutic measure to reduce preload, The provision of multiple devices, including ventricular assist devices (VADs) and catheter-based flow-limiting element (FRE) devices with adjustable FREs, The VAD is positioned at least partially inside either the patient's left ventricle or right ventricle, and the catheter-based FRE device is positioned such that the FRE is located inside the patient's superior vena cava (SVC). Receiving information from at least one of the aforementioned multiple devices, Based on the aforementioned information, a first determination value is made, Based on the first determined value, control at least one performance parameter of at least a second device among the plurality of devices, Methods that include...

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

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

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

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

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

7. The method according to claim 1, wherein the information is received by a single controller.

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

9. The method according to 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 controller and the second controller are in operable communication with each other.

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

11. The method according to 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), differential pressure, left ventricular systolic pressure, right ventricular systolic pressure, arterial pressure, jugular venous pressure (JVP), motor current, integrated ECG signal, or a combination thereof.

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

13. The method according to claim 12, wherein the rotational speed is increased.

14. The method according to claim 12, wherein the rotational speed is reduced.

15. The method according to claim 12, wherein the rotation speed is limited.

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

17. The method according to claim 16, wherein the duty cycle is increased.

18. The method according to claim 16, wherein the duty cycle is reduced.

19. The method according to claim 16, wherein the duty cycle is paused.

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

21. The method according to claim 1, further comprising determining the deloading state of one or more ventricles.

22. The method according to claim 21, further comprising automatically and repeatedly performing the receiving step, the determining step, and the controlling step in order to achieve an operating state in which the deloading state is a state in which the load is deloaded to the maximum extent without impairing patient safety.

23. A method for correcting the position or curvature of a patient's interventricular septum, The ventricular assist device (VAD) is positioned at least partially inside either the patient's left or right ventricle, and the catheter-based device, including a flow-limiting element (FRE) (catheter-based FRE device), is positioned such that the FRE is positioned within the patient's superior vena cava (SVC), wherein the FRE is adjustable. Receiving first information from the VAD and / or the catheter-based FRE device, Based on the first information, a first value representing the first position or curvature of the interventricular septum is determined, Receiving second information from the VAD and / or the catheter-based FRE device, Based on the second information, a second value representing the second position or curvature of the interventricular septum is determined, Adjusting at least one performance parameter of the VAD and / or the catheter-based FRE device based on the difference between the first value and the second value, or when the second value exceeds a predetermined threshold, Methods that include...

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

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

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

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

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

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

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

31. The method according to 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 controller and the second controller are in operable communication with each other.

32. The method according to 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), differential pressure, 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 according to claim 23, wherein the first piece of information is a value representing pressure, distance, or motor current.

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

35. The method according to claim 33, wherein the pressure includes the pressure inside the right ventricle, the pressure inside the left ventricle, or both.

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

37. The method according to claim 36, wherein the rotational speed is increased.

38. The method according to claim 36, wherein the rotational speed is reduced.

39. The method according to claim 36, wherein the rotation speed is limited.

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

41. The method according to claim 40, wherein the duty cycle is increased.

42. The method according to claim 40, wherein the duty cycle is reduced.

43. The method according to claim 40, wherein the duty cycle is paused.

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

45. The process further includes automatically and repeatedly executing multiple steps, wherein the multiple steps are: Receiving third information from the VAD and / or the catheter-based FRE device, Based on the third piece of information, a third value representing the third position or curvature of the intraventricular septum is determined, Adjusting at least one performance parameter of the VAD and / or the catheter-based FRE device based on the difference between the third value and one or more previously determined values, or when the third value exceeds a predetermined threshold, The method according to claim 23, including the method described in claim 23.

46. A system for providing therapeutic measures to reduce preload, Multiple devices, A ventricular assist device (VAD) configured to be positioned at least partially in either the left or right ventricle, A catheter-based device comprising a flow limiting element (FRE) (catheter-based FRE device), wherein the FRE is configured to be placed in the patient's superior vena cava (SVC), and Including multiple devices, One or more controllers, each controller comprising one or more processors and a non-temporary computer-readable storage medium containing instructions, wherein, when the instructions are executed by the controllers, they are sent to the one or more controllers individually or in combination. Information is received from at least one of the aforementioned multiple devices, Based on the aforementioned information, a first determination value is determined. Based on the first determined value, control at least one performance parameter of at least a second device among the plurality of devices. One or more controllers, A system that includes this.

47. The system according to claim 46, wherein the one or more controllers consist of a single controller.

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

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

50. A system for correcting the position or curvature of a patient's interventricular septum, Multiple devices, A ventricular assist device (VAD) configured to be positioned at least partially in either the left or right ventricle, A catheter-based device comprising a flow limiting element (FRE) (catheter-based FRE device), wherein the FRE is configured to be placed in the patient's superior vena cava (SVC), and Including multiple devices, One or more controllers, each controller comprising one or more processors and a non-temporary computer-readable storage medium containing instructions, wherein, when the instructions are executed by the controllers, they are sent to the one or more controllers individually or in combination. The first information is received from the VAD and / or the catheter-based device. Based on the first information, a first value representing the first position or curvature of the interventricular septum is determined. Receiving second information from the VAD and / or the catheter-based device, Based on the second information, a second value representing the second position or curvature of the interventricular septum is determined, Based on the difference between the first value and the second value, or if the second value exceeds a predetermined threshold, adjust at least one performance parameter of the VAD and / or the catheter-based device. One or more controllers, A system that includes this.

51. The system according to claim 50, wherein the one or more controllers consist of a single controller.

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

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

54. The system according to claim 53, wherein at least one of the one or more optical sensors or the ultrasonic transducer is configured to determine distance.

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

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