Obstructive sleep apnea treatment devices, systems and methods
Inventors
Bolea, Stephen L. • Hoegh, Thomas B. • Persson, Bruce J. • Atkinson, Robert E. • Mazar, Scott T.
Assignees
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Publication Number
US-11517746-B2
Publication Date
2022-12-06
Expiration Date
Abstract
A stimulation system for delivery of a stimulation signal to a hypoglossal nerve of a patient to treat obstructive sleep apnea. The stimulation system includes an implantable receiver coil configured to be implanted under a mandible of the patient; a nerve electrode coupled to the implantable receiver coil, the nerve electrode configured to deliver the stimulation signal to the hypoglossal nerve of the patient; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal from the external pulse generator to the implantable receiver coil, the external transmitter coil being carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible of the patient.
Core Innovation
The disclosed invention is an OSA treatment neurostimulation system that delivers a stimulation signal to a hypoglossal nerve of a patient to treat obstructive sleep apnea. The system includes an implantable receiver coil configured to be implanted under a mandible or in a subcutaneous pocket under a mandible, together with a nerve electrode coupled to the implantable receiver coil for delivering the stimulation signal to the hypoglossal nerve. An external pulse generator is provided to generate the stimulation signal.
The system further includes an external transmitter coil configured to wirelessly transmit the stimulation signal from the external pulse generator to the implantable receiver coil. The external transmitter coil is carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible. Wireless inductive coupling between the external transmitter coil and the implantable receiver coil is described, including embodiments that use air core wire coils.
In described embodiments, respiration-triggered and sensor-based control is used to generate or adjust stimulation based on one or more parameters associated with respiration of the patient. Signal processing is described to extract respiration-related events such as apnea/hypopnea and central sleep apnea/OSA and sleep-stage fiducials, and predictive self-adjusting trigger algorithms generate stimulation in advance of inspiration. Coil configuration options are described, including matched winding characteristics and coaxial and parallel arrangements, together with system controls such as physician programmer and patient controller, auto titration, shutoff, alarm/telemetry.
Claims Coverage
Independent claims are directed to a hypoglossal-nerve stimulation system for treating obstructive sleep apnea using an implantable receiver coil under the mandible, an external pulse generator, and an external transmitter coil carried by an adhesive patch under the mandible. The inventive features across the independent claims include coil air-core implementations, inductive wireless transmission, and specific respiration-parameter and position-based stimulation generation/adjustment, with additional coil-matching constraints and respiration-sensor options.
Hypoglossal nerve stimulation system with implantable receiver coil under the mandible and adhesive-patch transmitter coil
A stimulation system comprising an implantable receiver coil configured to be implanted under a mandible of the patient; a nerve electrode coupled to the implantable receiver coil configured to deliver the stimulation signal to the hypoglossal nerve; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal to the implantable receiver coil, the external transmitter coil being carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible. The implantable receiver coil and the external transmitter coil each comprise air core wire coils.
Hypoglossal nerve stimulation system with matched winding characteristics and adhesive-patch transmitter coil
A stimulation system comprising an implantable receiver coil configured to be implanted under a mandible of the patient; a nerve electrode coupled to the implantable receiver coil configured to deliver the stimulation signal to the hypoglossal nerve; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal to the implantable receiver coil, the external transmitter coil configured to be adhesively attached to the patient adjacent the implantable receiver coil under the mandible. The implantable receiver coil and the external transmitter coil have at least one of matched wind diameters, matched numbers of wire turns, or matched wire gauges.
Respiration-parameter and position-based stimulation generation for hypoglossal-nerve OSA treatment with sensor-controlled external pulse generator
A stimulation system comprising an implantable receiver coil configured to be implanted in a subcutaneous pocket under a mandible; a nerve electrode coupled to the implantable receiver coil configured to deliver the stimulation signal to the hypoglossal nerve; an external pulse generator configured to generate the stimulation signal; and an external transmitter coil configured to wirelessly transmit the stimulation signal to the implantable receiver coil, the external transmitter coil being carried by an adhesive patch configured to be placed on the skin adjacent the implantable receiver coil under the mandible. A sensor in communication with the external pulse generator is configured to measure one or more parameters associated with respiration of the patient, where the external pulse generator is configured to generate the stimulation signal based on the one or more parameters, and where the sensor is a position sensor and the external pulse generator is configured to adjust the stimulation signal based on a body position of the patient.
Across the independent claims, the core coverage is a hypoglossal-nerve stimulation system for obstructive sleep apnea that uses an implantable receiver coil under the mandible and an external transmitter coil carried by an adhesive patch under the mandible, wirelessly transmitting a stimulation signal from an external pulse generator. The independent claims additionally cover air core wire coils, matched winding characteristics between the implantable and external coils, and sensor-based generation/adjustment of stimulation using respiration parameters and a position sensor.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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