JP-2026514536-A - 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 positioning a ventricular assist device (VAD) at least partially inside either the patient's left or right ventricle, and positioning a catheter-based device including an adjustable flow-limiting element (PRE) such that the PRE is positioned 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.

Inventors

• カーラン，ジェラルド
• キム，ス，ヨン

Assignees

• アビオメド インコーポレイテッド

Dates

Publication Date

20260511

Application Date

20240503

Priority Date

20230504

Claims (20)

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 left or right ventricle of the patient, and the catheter-based FRE device is positioned such that the FRE is located inside the superior vena cava (SVC) of the patient. 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 obtained 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 being 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 being 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 aforementioned 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 and second controllers are operably communicating 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 being 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 VAD motor.
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 rotational 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.

Description

Technical Field This application claims priority to U.S. Provisional Patent Application No. 63/464,005, filed on 4 May 2023, which is incorporated herein by reference in its entirety. Technical field. This disclosure relates to methods and systems for providing improved treatment of heart-related problems. Background Blood pump assemblies, such as intracardiac or intravascular blood pumps, can be introduced into the heart to pump blood from the heart into the arteries. Such mechanical circulatory support devices are often introduced to assist cardiac 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 vascular system during cardiac procedures. Specifically, a blood pump assembly can be inserted into the left ventricle via catheterization, crossing the valves, into the ascending aorta through the femoral artery or axillary/subclavian artery. The inserted blood pump assembly may be configured to draw blood from the left ventricle of the heart through a cannula and drain the blood into the aorta. A blood pump assembly may also be configured to draw blood from the inferior vena cava and drain the blood into the pulmonary artery. Systems and methods for treating conditions such as heart failure and/or pulmonary hypertension may include at least partial occlusion of the flow through the superior vena cava over intervals spanning multiple cardiac cycles. In some cases, a catheter with an occlusion device may include a controller that activates a drive mechanism to perform at least partial occlusion of the patient's superior vena cava, which may reduce cardiac filling pressure and induce a favorable shift in the patient's Frank-Stirling curve toward healthy and improved cardiac function. This is a diagram of a heart according to one embodiment.This is a diagram of a heart and a single controller with two medical devices in place.This is a diagram of a heart with two medical devices in place, each having its own controller.This is a flowchart of methods for therapeutically reducing preload.This is a flowchart showing how to correct the position of the intraventricular septum in a patient. Please understand that the attached drawings are not necessarily to scale and present a somewhat simplified representation of various features illustrating the fundamental 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 partially determined by the specific intended use and operating 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. Detailed Description 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. 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 this specification 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 and informed by the teachings herein will understand that the invention may be applicable to various other arts or embodiments. 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 som