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Publication Number
US-11529283-B2
Publication Date
2022-12-20
Expiration Date
Abstract
The present invention provides, among other things, apparatus and methods of use for treating a subject in need of assistance with breathing. In some embodiments the subject suffers from airflow obstruction. In some embodiments, the subject suffers from chronic obstructive pulmonary disease.
Core Innovation
The invention describes breathing-assistance for obstructive lung disease by delivering a stimulus to the subject’s thorax or abdomen during at least part of an expiratory phase. It uses one or more sensors suitable for detecting when a subject is exhaling and, in response to a signal generated by the sensors, activates an electrode to deliver the stimulus during the expiratory portion of the respiratory cycle.
The apparatus architecture includes sensors that provide sensor output, signal conditioning, a controller, and a stimulator with electrode(s), configured for external delivery of the stimulus to the lower thorax and/or abdomen. The sensing and stimulus timing are arranged to deliver stimulus during exhalation and to avoid effective stimulation during inhalation, including within a given respiratory cycle.
The disclosed stimulus modalities include externally applied transcutaneous electrical stimulation to expiratory/abdominal muscles and, optionally, efferent nerve stimulation, as well as mechanical compression such as pneumatic compression via an inflatable compartment. The disclosure further describes configurable protocols and modes, including a prompting mode in which a tactile stimulus is perceptible to the subject but not effective for expiratory muscle contraction, and control strategies that adjust stimulation based on breathing pattern and activity.
Claims Coverage
The independent claim defines an adhesive-patch apparatus that detects exhalation and delivers a thorax/abdomen stimulus during at least part of the expiratory phase in response to the sensor-generated signal. The dependent claims further refine timing within inspiration/expiration, add mode-based operation including tactile prompting, constrain physiological effects, and specify stimulus delivery characteristics.
Exhalation detection with skin-placed adhesive patch and expiratory-phase thorax/abdomen stimulation
An apparatus including at least one adhesive patch configured for placement on a subject’s skin, the patch comprising one or more sensors suitable for detecting when a subject is exhaling and an electrode adapted to deliver a stimulus to the subject’s thorax or abdomen during at least part of an expiratory phase in response to a signal generated by the sensors.
Stimulation delivered as an electrical pulse train with constrained parameters
The electrode delivers an electrical stimulus as a pulse train having frequency in a range of 1-200 Hz, amplitude in a range of 30-500 mA, and pulse width in a range of 10-100 μs, with pulse duration in a range of 0.1 s-2 s.
Expiratory-phase timing coverage of stimulus delivery
The stimulus is delivered during a first half of the expiratory phase, or during a second half of the expiratory phase, or substantially throughout the entire expiratory phase.
Termination before inspiration based on a second sensor signal within the same respiratory cycle
The apparatus terminates the stimulus before the start of inspiration in response to a second signal from one or more sensors within the same respiratory cycle.
Tactile prompting mode perceptible but not effective for expiratory muscle contraction
The apparatus is operable in two or more modes and includes a mode delivering tactile stimuli triggered by sensor-generated signals, wherein the tactile stimuli are perceptible to a subject but not effective to affect expiratory muscle contraction.
Decreasing end expiratory lung volume compared with no-stimulus condition
The stimulus decreases the subject’s EELV compared with EELV without the stimulus.
Overall, the claim set centers on an adhesive-patch system that detects exhalation and delivers a thorax/abdomen stimulus during the expiratory phase, with dependent claims refining expiratory-phase timing, adding multi-mode operation including a tactile prompting mode, constraining electrical pulse-train delivery characteristics, and specifying a comparative physiological effect targeting decreased EELV.
Stated Advantages
Decreases the subject’s EELV compared with EELV without the stimulus.
Documented Applications
Breathing-assistance for obstructive lung disease, including chronic obstructive pulmonary disease (COPD), by assisting exhalation and reducing hyperinflation.
Use in a ventilator weaning bridge as a potential application described in the disclosure.
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