Obstructive sleep apnea treatment devices, systems and methods
Inventors
Bolea, Stephen L. • Hoegh, Thomas B. • Kuhnley, Brian D. • Suilmann, Dale G. • Persson, Bruce J. • Beck, John P. • Hauschild, Sidney F. • Tesfayesus, Wondimeneh • Skubitz, Jason J. • Bosshard, Mark R. • Parrish, Daniel A. • Atkinson, Robert E.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12478782-B2
Publication Date
2025-11-25
Expiration Date
Abstract
Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient's nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.
Core Innovation
The invention provides an implantable neurostimulator connected to a stimulation delivery lead for delivering nerve stimulation therapy to a nerve of a subject for treating a respiratory condition. The neurostimulator delivers therapy within a first intensity range during a first therapy period, where the first intensity range is defined using an awake titration while the subject is awake. The first intensity range has a lower bound and an upper bound, and the upper bound is set as a discomfort threshold based on an indication from the subject of discomfort caused by the stimulation.
After the first therapy period, the system transitions to a second therapy period subsequent to the first therapy period, and the transitioning comprises a cessation of stimulation. During the second therapy period, the neurostimulator delivers therapy within a second intensity range defined using a sleep titration while the subject is asleep. The second intensity range includes an upper bound greater than the discomfort threshold, and the subject is asleep during at least an initial portion of the second therapy period.
Dependent claim language specifies that the cessation can be caused by subject action or by receiving a signal from a sensor, and the system can deliver at an increasing level of intensity between cessation and the second therapy period. The intensity ranges can correspond to an amplitude range of a current pulse.
Claims Coverage
The independent claims cover a nerve stimulation system and a method with two sequential titration periods: awake titration for a first intensity range capped by a subject-reported discomfort threshold, followed by sleep titration for a second intensity range with a higher upper bound, and a transition from the first period to the second by cessation of stimulation. The inventive content centers on subject-state-specific titration of intensity bounds and the transition mechanism by cessation of stimulation.
Awake-defined first intensity range capped by subject discomfort
The neurostimulator delivers nerve stimulation therapy within a first intensity range during a first therapy period, where the first intensity range is defined using an awake titration while the subject is awake and includes a lower bound and an upper bound determined based on an indication from the subject of discomfort caused by the stimulation.
Transition to second therapy period by cessation of stimulation
The neurostimulator transitions from the first therapy period to a second therapy period subsequent to the first therapy period, wherein the transitioning comprises a cessation of stimulation.
Sleep-defined second intensity range with higher upper bound
The neurostimulator delivers the nerve stimulation therapy within a second intensity range during the second therapy period, where the second intensity range is defined using a sleep titration while the subject is asleep and includes an upper bound greater than the discomfort threshold, with the subject asleep during at least an initial portion of the second therapy period.
Delivery of therapy to a nerve for treating a respiratory condition
The neurostimulator is configured to deliver the nerve stimulation therapy to a nerve of the subject for treating a respiratory condition of the subject.
The claims focus on subject-state-specific titration of stimulation intensity bounds, with awake titration using a subject discomfort indication for a first upper bound, followed by sleep titration with a higher upper bound, and a transition from awake to sleep therapy periods implemented by cessation of stimulation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?