Apparatus and method to control an implant

Patent No. US8718776 (titled "Apparatus and method to control an implant") on Sep 28, 2012. The application was issued on May 6, 2014.

'776 is related to the field of neuromodulation, specifically devices and methods for modulating nerves through the delivery of energy. The background of the invention lies in addressing various physiological conditions like obstructive sleep apnea (OSA), migraine headaches, and hypertension by interacting with the body's nervous system. Current treatments for these conditions often have limitations, motivating the need for improved neural modulation techniques.

The underlying idea behind '776 is to wirelessly deliver energy to an implanted device to modulate a target nerve. The external unit transmits a primary signal containing a pulse train powered by a battery to an implanted unit. This signal induces a secondary signal in the implant, which then generates an electric field via electrodes to stimulate or inhibit the target nerve, such as the hypoglossal nerve for OSA treatment.

The claims of '776 focus on a sleep disordered breathing therapy device comprising an external housing containing a battery, a primary antenna, and a processor. The processor is configured to transmit a primary signal from the primary antenna to an implanted unit in the neck, chin, or head region. This primary signal, powered by the battery, includes a pulse train with stimulation pulses delivered over at least three hours, causing stimulation of the hypoglossal nerve.

In practice, the external unit is placed on the skin near the implant. The processor in the external unit controls the signal source and amplifier to generate the primary signal, which is then transmitted via the primary antenna. The implant's secondary antenna receives this signal, and internal circuitry converts it into a voltage potential across the implant electrodes, generating an electric field that modulates the target nerve. The system can also use feedback mechanisms to adjust the power level based on the degree of coupling between the external and implanted antennas.

This approach differs from prior solutions by offering a non-invasive method for delivering energy to an implantable device for nerve modulation. Instead of requiring direct contact or wired connections, the wireless energy transfer allows for greater patient comfort and flexibility. The use of a pulse train with specific parameters (pulse duration, frequency, and temporal spacing) enables precise control over the nerve stimulation, optimizing treatment efficacy while minimizing power consumption and potential side effects.

How does this patent fit in bigger picture?

Technical Landscape

In the early 2010s when ’776 was filed, implantable neuromodulation systems were typically implemented using active internal components that required local power storage or complex internal processing to manage stimulation delivery. At a time when systems commonly relied on implanted batteries or large internal capacitors to generate therapeutic pulses, the engineering constraints of miniaturization and long-term biocompatibility made the development of fully passive internal units non-trivial. Consequently, the standard architecture for nerve stimulation often involved significant hardware footprints within the subject's body to ensure the consistent generation of pulse trains required for multi-hour treatment sessions.

Prosecution Position

The examiner allowed the application because the design features a sleep apnea treatment system where all the intelligent components—those responsible for creating and sending the stimulation pulses—are located in an external unit rather than the implant. This allows the internal implant to be entirely passive, meaning it does not store energy or contain the circuitry needed to independently generate pulses. While previous technologies used external coils to send power to an internal device, those internal devices still used capacitors to store that energy and then create their own stimulation signals. The examiner noted that moving all the 'smart' technology to the external unit, so that the pulses sent from the outside are the same ones that stimulate the nerve, is not a simple design choice and requires significant changes to size, power, and configuration.

Claims

This patent includes 18 claims, with claim 1 serving as the independent claim. The independent claim focuses on a sleep disordered breathing therapy device with a housing, antenna, and processor configured to transmit a primary signal to an implant unit for hypoglossal nerve stimulation. The dependent claims generally elaborate on specific features and parameters of the device described in the independent claim, such as the characteristics of the stimulation pulses, battery capacity, and electrode configurations.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)	Support for Specification	Interpretation
Hypoglossal nerve (Claim 1)	In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses provided over a period of at least three hours in duration, wherein the plurality of stimulation pulses cause stimulation of a hypoglossal nerve.	A nerve that is stimulated by the stimulation pulses.
Primary antenna (Claim 1)	A device according to some embodiments of the present disclosure includes a housing configured to retain a battery, a primary antenna associated with the housing, and at least one processor in electrical communication with the battery and the primary antenna. In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.	An antenna associated with the housing of the device, used to transmit a primary signal to an implant unit.
Primary signal (Claim 1)	In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.	A signal transmitted from the primary antenna to an implant unit, generated using power supplied by the battery, and including a pulse train.
Pulse train (Claim 1)	In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.	A series of stimulation pulses included in the primary signal.
Stimulation pulses (Claim 1)	In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses provided over a period of at least three hours in duration, wherein the plurality of stimulation pulses cause stimulation of a hypoglossal nerve.	Pulses within the pulse train that cause stimulation of a hypoglossal nerve.

Litigation Cases New

US Latest litigation cases involving this patent.

Case Number	Filing Date	Title
1:25-cv-01147	Sep 15, 2025	Nyxoah SA et al. v. Inspire Medical Systems, Inc.

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US8718776

Application Number: US13629819A
Filing Date: Sep 28, 2012
Publication Date: May 6, 2014
External Links: Slate, USPTO, Google Patents

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