Systems and methods for treating neurological disorders
Inventors
George, David Mager • Claude, John Patrick • Willey, Kevin E. • Denison, Andy Edward • Kent, Darrin James
Assignees
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Publication Number
US-12178966-B2
Publication Date
2024-12-31
Expiration Date
Abstract
Caloric stimulation and pressure stimulation can be applied to the ear for treatment of neurological disorders, such as migraine, pain, and headache. Heat can be applied first to increase the sensitivity of the mechanoreceptors in the ear. The pressure can be applied after heating to produce a stronger neurological response than would occur without the heating. In some cases, cooling can be used. Valves can be used to direct fluid flow to a right ear, a left ear, or both. Valves can be used to transition the system between an irrigation or caloric mode and a pressure mode. Green eyewear can be used for therapeutic relief.
Core Innovation
The invention relates to a treatment system and methods for functional neurology treatment of neurological disorders. The system uses ear-based caloric stimulation and pressure stimulation applied to an external ear canal to generate a neuromodulation stimulus at a tympanic membrane. An earpiece seals the external ear canal and works with fluid conduits and a fluid flow generator to deliver neuromodulation stimulus to the ear.
The system operates in an irrigation mode and a pressure mode. In irrigation mode, an outlet valve is opened and the fluid flow generator applies a flow of fluid through the fluid conduit, through the earpiece, and out the outlet valve to an ambient area. In pressure mode, the outlet valve is closed and the fluid flow generator applies a pressure differential between external ear canal pressure and ambient pressure.
The system further includes components and control features that enable switching between caloric/irrigation and pressure mode while optionally maintaining earpiece sealing. A temperature modifier is used to heat or cool fluid for caloric stimulation, and pressure mode can use feedback via a pressure sensor to implement a pressure treatment profile. Valve modules and configurations can direct flow to a right ear, a left ear, or both, including dual-ear configurations, and can include features such as check valves, a flow diverter, and actuators to support the transition and delivery behavior.
Claims Coverage
The document includes one independent claim (clm-00001) that defines a two-mode ear-based treatment system, with dependent claims mainly refining valve-module structure, flow backflow prevention, sensing/feedback, temperature modification, and multi-ear or reconfigurable delivery. The main inventive features center on a controller-driven mode change between an irrigation mode using an outlet valve and a pressure mode using a closed outlet valve to create an ear-canal-to-ambient pressure differential.
Two-mode ear canal fluid treatment using outlet valve control
A treatment system comprising an earpiece, a fluid flow generator, a fluid conduit between the fluid flow generator and the earpiece, an outlet valve, and a controller configured to operate in an irrigation mode by opening the outlet valve and operating the fluid flow generator to apply a flow of fluid through the fluid conduit and through the earpiece to an ambient area, and configured to operate in a pressure mode by closing the outlet valve and operating the fluid flow generator to apply a pressure differential between an external ear canal pressure and an ambient pressure.
Irrigation mode valve-module flow arrangement
The system of the independent claim further includes a valve module having an outlet valve and an inlet check valve that allows fluid to flow from an ambient environment in an irrigation mode.
Outlet check valve impeding backflow
The system of the independent claim includes an outlet check valve that allows fluid to flow to the ambient area through the outlet valve while preventing ambient-area fluid from flowing back into the outlet valve.
Pressure sensor feedback control using a pressure treatment profile
The system of the independent claim includes a pressure sensor and a controller configured to provide feedback control and implement a pressure treatment profile in pressure mode.
Temperature modifier during irrigation mode
The system further includes a temperature modifier controlled to change a temperature of the fluid during an irrigation mode.
Reconfigurable dual-ear flow direction using two configurations
A treatment system configured in two alternative configurations to redirect fluid flow between an earpiece and an additional earpiece by directing flow to one while impeding flow to the other.
Across the independent claim and its refinements, the coverage is focused on a controller-operated two-mode ear treatment system that switches between irrigation mode (open outlet valve, flow to ambient) and pressure mode (closed outlet valve, pressure differential between external ear canal pressure and ambient). Dependent features add valve-module flow control, backflow prevention, pressure-sensor feedback implementing a pressure treatment profile, optional temperature modification in irrigation mode, and reconfigurable flow between an earpiece and an additional earpiece.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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