EP-4739378-A1 - SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM

Abstract

A flow restriction system may include an implantable controller system for controlling an implantable flow restrictor. The controller system may include: an implantable housing, an actuator at least partially disposed within the implantable housing, the actuator having a first configuration corresponding to the implantable flow restrictor being in the low profile state and a second configuration corresponding to the implantable flow restrictor being in the high profile pressure restricting state, an internal power source configured to supply current to the actuator, and a processor configured to control operation of the actuator using power from the internal power source.

Inventors

• COOPER, Alexander, H.
• SUSSMAN, Matthew, A.
• SCHWARTZ, Juliet, Laura
• PASSMAN, Joseph, Arthur
• RATZ, J. BRENT
• QUADRI, ARSHAD

Assignees

• Relief Cardiovascular, Inc.

Dates

Publication Date

20260513

Application Date

20240703

Claims (20)

1. 1. A system comprising: an implantable controller system for controlling a blood flow modulator, the implantable controller system comprising a housing enclosing: a microcontroller comprising: one or more computer readable storage devices configured to store a plurality of computer-executable instructions; one or more hardware computer processors in communication with the one or more computer readable storage devices; and a first communication module; an actuator comprising: a control member having a first end coupled with the blood flow modulator and a second end configured to be disposed adjacent to or in the housing; and a motor coupled to the second end of the control member to actuate the control member, wherein actuation of the control member causes the blood flow modulator to move between a low profile state and a high profile pressure modulating state; and a first power source disposed in the housing and configured to generate current for the actuator.
2. 2. The system of claim 1, further comprising: a pressure sensor configured to generate a pressure signal to be transmitted to the microcontroller as an input for changing states of the blood flow modulator.
3. 3. The system of claim 1 or claim 2, further comprising: an external device comprising a second housing enclosing: a second power source; and a second communication module, the second communication module configured to communicate with the first communication module.
4. 4. The system of claim 3, wherein the computer-executable instructions, when executed, configure the one or more hardware computer processors to: receive, from the pressure sensor, a first pressure signal; and generate and transmit, to the external device via the first communication module, an electronic communication including a first pressure measurement corresponding to the first pressure signal.
5. 5. The system of claim 4, wherein the external device is configured to display, via a graphical user interface, an indicator related to the first pressure measurement.
6. 6. The system of claim 5, wherein the indicator comprises a first notification when the first pressure measurement is within a threshold or a second notification when the first pressure measurement is above the threshold.
7. 7. The system of claim 6, wherein the second notification includes a treatment option or an option to cancel treatment.
8. 8. The system of claim 7, wherein the computer-executable instructions, when executed, further configure the one or more hardware computer processors to: receive, from the external device via the second communication module, treatment instructions based on the treatment option, the treatment instructions comprising a treatment duration and a target state for the blood flow modulator; and activate the actuator such that a traveler translates a first distance in a first direction, the first distance corresponding to the target state.
9. 9. The system of claim 8, wherein the external device provides the first power source with power via a receiver to activate the actuator or charge a third power source electrically coupled to the microcontroller.
10. 10. The system of claim 8 or claim 9, wherein the treatment instructions further comprise a request for a second pressure measurement during or after the traveler translates to the target state.
11. 11. The system of claim 10, wherein the computer-executable instructions, when executed, further configure the one or more hardware computer processors to: receive, from the pressure sensor, a second pressure signal; and generate and transmit, to the external device via the first communication module, an electronic communication including the second pressure measurement corresponding to the second pressure signal.
12. 12. The system of any of claims 8 to 11, wherein the computer-executable instructions, when executed, further configure the one or more hardware computer processors to: determine, that the treatment duration has expired; and activate the actuator such that the traveler translates the first distance in a second direction, the second direction opposite the first direction.
13. 13. The system of claim 12, wherein the blood flow modulator returns to an original state once the traveler translates the first distance in the second direction.
14. 14. The system of any of claims 1 to 13, wherein the implantable controller system further comprises a third power source electrically coupled to the microcontroller.
15. 15. The system of any of claims 3 to 14, wherein the external device comprises a mobile device.
16. 16. The system of claim 15, wherein the mobile device is configured to communicate with a remote server configured to receive and store data from the pressure sensor and treatment details used by and transmitted from the implantable controller system to the mobile device.
17. 17. The system of any of claims 8 to 16, wherein the traveler further comprises a magnet and the implantable controller system further comprises a plurality of hall effect sensors positioned along a length of the control member, the plurality of hall effect sensors configured to detect a magnetic field produced by the magnet and transmit a corresponding output voltage to the microcontroller.
18. 18. The system of claim 17, wherein the computer-executable instructions, when executed, configure the one or more hardware computer processors to: receive, from the plurality of hall effect sensors, output voltages; and determine, a relative position of the traveler within the housing.
19. 19. The system of claim 18, wherein the relative position of the traveler corresponds to a state of the blood flow modulator.
20. 20. The system of any of claims 17 to 19, wherein the plurality of hall effect sensors comprises three hall effect sensors equally spaced along the length of the control member.

Description

SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS [0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63/512,152, filed July 6, 2023, U.S. Provisional Patent Application No. 63/591,304, filed October 18, 2023, and U.S. Provisional Patent Application No. 63/667,040, filed July 2, 2024. All of the above-mentioned applications are hereby incorporated by reference herein in their entireties. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. TECHNICAL FIELD [0002] The present disclosure relates to systems, devices, and methods for treating heart failure, including systems, devices, and methods for controllably and selectively occluding, restricting, and/or diverting flow within a patient’s vasculature. LIMITED COPYRIGHT AUTHORIZATION [0003] A portion of the disclosure of this patent document includes material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyrights whatsoever. BACKGROUND [0004] An identified issue in heart failure is volume overload, wherein there is an excess of pressure built up in the venous system which can cause the heart to not work as well as a pump. Reducing the total volume of fluid in the body, such as by the administration of diuretics, is one method to reduce volume overload and improve heart function. Another way to improve heart function in heart failure is to shift the distribution of blood in the vascular system. Such a shift in the distribution of blood can affect the preload on the heart and thus the heart’s ability to pump effectively. Additionally, shifting venous blood volume away from the renal system and/or lymphatic ducts can enhance diuresis, further reducing volume overload and improving heart function. SUMMARY [0005] Current nonpharmacological therapies aimed at reducing volume overload and/or reducing preload lack chronic controllability and/or adjustability. Additionally, cunent methods to improve and/or control diuresis include systemic application of diuretics, which can significantly affect patient quality of life. A more controllable method of controlling diuresis is desired. To address these and other unmet needs, the present disclosure describes various implementations of a chronic, implantable flow restriction systems, devices, and methods for controllably and selectively occluding, restricting, and/or diverting flow within a patient’s vasculature. The chronic, implantable flow restriction systems devices described herein include various controller systems for actuating a blood flow modulator in a variety of ways. Furthermore, the chronic, implantable flow restriction systems and devices described herein can be configured to control the blood flow modulator to provide partial and/or full occlusion of a vessel from within the vessel and/or external to the vessel. Such ability to chronically control the occlusion of a patient’s vessel(s) can allow, for example, the control of diuresis without systemic drugs/medication. [0006] In one embodiment, an implantable controller system for controlling a blood flow modulator is provided that includes a housing enclosing a microcontroller, an actuator, and a first power source. The microcontroller can include one or more computer readable storage devices configured to store a plurality of computer-executable instructions, one or more hardware computer processors in communication with the one or more computer readable storage devices, and a first communication module. The actuator can include a control member and a motor. The control member can have a first end coupled with the blood flow modulator and a second end configured to be disposed adjacent to or in the housing. The motor can be coupled to the second end of the control member to actuate the control member. Actuation of the control member can cause the blood flow modulator to move between a low profile state and a high profile pressure modulating state/high profile pressure flow restricting state. The first power source can be disposed in the housing and can be configured to generate current for the actuator. [0007] In another embodiment, a system is provided that includes an implantable controller system and an external device. The implantable controller system can be configured to control an implantable flow restrictor between a low profile state and a high profile flow restricting. The implantable controller system can include an implantable housing, an actuator, an internal power source, and a processor. The actuator can be a