Devices for treatment of sleep apnea
Patent No. US9415216 (titled "Devices for treatment of sleep apnea") on Oct 16, 2015. The application was issued on Aug 16, 2016.
What is this patent about?
'216 is related to the field of neuromodulation, specifically devices and methods for communicating between an implantable device and an external unit. This technology aims to treat various physiological conditions by modulating the activity of the nervous system, including nerve stimulation and inhibition. Applications range from addressing obstructive sleep apnea (OSA) to managing migraine headaches and hypertension, highlighting the broad potential of targeted neural intervention.
The underlying idea behind '216 is to provide a system for selectively modulating nerves, particularly the hypoglossal nerve for treating sleep apnea, using an implantable device powered and controlled by an external unit. The key inventive insight is to use an electric field generated by electrodes on a flexible carrier to stimulate a specific branch of the hypoglossal nerve, distal to its bifurcation, to dilate the airway. This approach aims to minimize off-target effects by focusing the stimulation on the medial branch of the hypoglossal nerve responsible for genioglossus muscle activation.
The claims of '216 focus on a system comprising a flexible carrier with stimulation electrodes and a neurostimulation device. The flexible carrier is designed to be placed near the genioglossus muscle, and the electrodes are configured to dilate the airway by stimulating a specific portion of the hypoglossal nerve. Crucially, the stimulation is limited to a single section of the medial branch of the hypoglossal nerve, distal to its bifurcation, ensuring targeted activation of the genioglossus muscle.
In practice, the external unit wirelessly transmits power to the implanted device, which then generates an electric field via the electrodes. The external unit can adjust the power level and pulse characteristics of the transmitted signal to control the intensity and duration of the nerve stimulation. The system may also incorporate feedback mechanisms to optimize the stimulation parameters based on physiological signals or coupling measurements between the external and implanted antennas. This allows for personalized therapy tailored to the individual's needs and condition.
The differentiation from prior approaches lies in the selective targeting of the medial branch of the hypoglossal nerve. Traditional methods might stimulate the entire hypoglossal nerve, potentially leading to unwanted side effects due to the activation of other tongue muscles. By focusing the electric field on a specific section of the medial branch, the '216 system aims to achieve more precise and effective airway dilation with reduced risk of unintended muscle contractions. This targeted approach is facilitated by the flexible carrier's design, which allows for precise placement of the electrodes relative to the genioglossus muscle and the hypoglossal nerve.
How does this patent fit in bigger picture?
Technical Landscape
In the late 2000s when ’216 was filed, the field of neuromodulation was characterized by a reliance on bulky, battery-dependent implantable pulse generators often requiring extensive tunneling of leads to the stimulation site. At a time when sleep apnea was typically implemented using external positive airway pressure masks or invasive tissue ablation, the development of miniaturized, wirelessly powered implants was non-trivial due to the engineering constraints of efficient energy transfer through tissue and the precise placement required to target specific cranial nerves. Systems commonly relied on direct physical contact between electrodes and nerve tissue, as maintaining effective stimulation through an electric field from a distance was technically challenging within the power budgets of the era.
Prosecution Position
The examiner allowed the claims because the prior art did not demonstrate a system where stimulation electrodes could open a patient's airway by targeting only a specific portion of the hypoglossal nerve. Specifically, the approved claims involve applying an electric field to a single section of the medial branch of the hypoglossal nerve, located past the point where the nerve splits into lateral and medial branches, to achieve airway dilation.
Claims
This patent contains 8 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a system for treating sleep apnea using a flexible carrier with stimulation electrodes to stimulate a portion of the hypoglossal nerve. The dependent claims generally specify further details and limitations related to the location of the flexible carrier, adjacent muscles, electrode spacing, current usage, electric field orientation, and stimulation of terminal fibers.
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US9415216
- Application Number
- US14884977A
- Filing Date
- Oct 16, 2015
- Publication Date
- Aug 16, 2016
- External Links
- Slate, USPTO, Google Patents