Method and apparatus for treating sleep apnea
Inventors
Kent, Steven Thomas • Harter, Laurence Wylie • Kent, Harold Byron • Puldon, Karena Yadira
Assignees
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Publication Number
US-10195426-B2
Publication Date
2019-02-05
Expiration Date
Abstract
An oral appliance provides electrical stimulation to a patient's tongue in a manner that prevents collapse of the tongue and/or soft palate during sleep. More specifically, the appliance may induce a reversible current or currents in a lateral direction across the tongue in a manner that shortens the patient's Palatoglossus muscle, which in turn pulls the patient's soft palate downward towards a base of the tongue, and/or decreases a volume of the tongue.
Core Innovation
The invention provides a non-invasive, removable oral appliance configured to provide electrical stimulation to an oral cavity of a patient for obstructive sleep apnea. The appliance includes a body with first and second lateral arms, each terminating in a posterior-most free end, and first and second electrodes carried by the lateral arms. Each electrode includes a first portion directly attached to a lingual side of the posterior-most free end of its corresponding lateral arm and a second portion extending posteriorly beyond the posterior-most free end.
The first and second electrodes are configured to be angularly oriented with respect to the floor of the patient's mouth so that the electrodes face opposite lateral sides of the tongue and are adapted to contact opposite sublingual sides of the tongue proximate to lateral points at which the Palatoglossus muscle inserts into the tongue. A control circuit induces a current in a lateral direction across the tongue via the first and second electrodes to generate the electrical stimulation.
The document contrasts targeting the Palatoglossus with other approaches such as stimulation of the Hypoglossal nerve or the Genioglossus muscle. The document further describes optional sensing and closed-loop control in which the control circuit receives signals related to respiration function and snoring, including electromyogram sensing and acoustic or vibration sensing, and dynamically adjusts the stimulation waveform accordingly.
The document further describes reversible current and zero-sum waveforms to reduce discomfort, including carrier depletion, and a resistive-capacitive (RC) time constant model associated with the tongue to set pulse duration.
Claims Coverage
Two independent claims are directed to a lateral-arm oral appliance with electrodes arranged to face opposite sides of the tongue and a control circuit that induces a lateral current across the tongue. Across the families, multiple dependent claim sets refine the stimulation mechanism, anatomical placement, closed-loop behavior, sensing, and constraints about avoidance of particular nerves.
Lateral-arm oral appliance with posterior-most free ends and electrode portions
A body having first and second lateral arms each terminating in a posterior-most free end; a first electrode including a first portion directly attached to a lingual side of the posterior-most free end of the first lateral arm and including a second portion extending posteriorly beyond the posterior-most free end of the first lateral arm; and a second electrode including a first portion directly attached to a lingual side of the posterior-most free end of the second lateral arm and including a second portion extending posteriorly beyond the posterior-most free end of the second lateral arm.
Angular electrode orientation to face opposite lateral sides of the tongue
The first and second electrodes are configured to be angularly oriented with respect to a floor of the patient's mouth such that the first and second electrodes are adapted to face opposite lateral sides of the patient's tongue.
Control circuit inducing lateral-direction current across the tongue
A control circuit coupled to the appliance and to the electrodes, the control circuit configured to induce a current in a lateral direction across the tongue via the first and second electrodes to generate the electrical stimulation.
Contacting opposite sublingual sides proximate to Palatoglossus insertion points
The first and second electrodes are configured to be angularly oriented with respect to a floor of the patient's mouth such that the first and second electrodes are adapted to contact opposite sublingual sides of the patient's tongue proximate to lateral points at which a Palatoglossus muscle inserts into the tongue.
The independent claims cover an oral appliance with first and second lateral arms that position electrodes extending posteriorly beyond posterior-most free ends, an angular orientation that places the electrodes facing opposite lateral sides or contacting opposite sublingual sides of the tongue, and a control circuit that induces a lateral-direction current across the tongue. Dependent claims further narrow operation toward inducing effects via the Palatoglossus while avoiding targeting the Hypoglossal nerve, and they optionally include reversible or zero-sum waveforms, RC time-constant-based pulse length, respiration and snoring sensing, and closed-loop waveform adjustment.
Stated Advantages
Reduces discomfort by using reversible current and zero-sum waveforms including carrier depletion [procedural detail omitted for safety].
Avoids waking or discomfort by not moving the tongue anteriorly.
Prevents posterior tongue collapse.
Shortens the Palatoglossus muscle while avoiding targeting the Hypoglossal nerve.
Documented Applications
Use of the device or oral appliance for obstructive sleep apnea in a patient by providing electrical stimulation to the oral cavity.
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