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Publication Number
US-9956132-B2
Publication Date
2018-05-01
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 provides breathing-assistance methods and apparatuses for a subject with obstructive lung disease, where the subject’s expiratory phase is sensed and a stimulus is delivered to the thorax or abdomen during at least part of the expiratory phase in response to that sensing. The delivered stimulus is effective to cause a contraction in the subject’s abdominal muscle so as to assist the subject with ventilation. A proviso specifies that a stimulus is not delivered while the subject is inhaling.
The sensing detects an onset of the subject’s expiratory phase or when the subject is exhaling, using one or more sensors suitable for detecting exhalation. The disclosed sensor types include strain gauge, respiratory inductive plethysmography, impedance plethysmography, piezoelectric sensors, and pressure/temperature sensors for airflow signals, with thorax/abdomen respiratory movement monitoring. The stimulus is delivered in response to signals generated by the sensors, including stimulation mechanisms such as electrical stimulation and mechanical compression.
For the stimulus mechanism, the invention includes electrical stimulation to abdominal muscles, and may also include electrical stimulation to lower internal intercostal muscles of the anterior thorax. Mechanical compression is also disclosed for the abdomen or lower anterior thorax, including inflatable/pneumatic approaches and electroactive polymer approaches. The apparatus and methods can be implemented in wearable forms such as an adhesive patch or garment/belt integration and can operate with response options that include stimulus duration after onset of exhalation.
Claims Coverage
The provided independent claims are directed to sensing breathing phase and delivering thorax or abdomen stimulation timed to the expiratory phase, with a no-stimulus during inhalation proviso in the primary sensing method and apparatus. The claims also extend to methods for promoting increased abdominal muscle strength and to a ventilator-connected apparatus that delivers expiratory-phase stimulation for a stimulus duration after onset of exhalation. Across these independent claims, the main inventive features number four groups: sensing breathing phase, delivering thorax or abdomen stimulation, excluding stimulation during inhalation in the primary claims, and ventilator-triggered delivery with stimulus duration after onset.
Sensing expiratory phase onset and delivering thorax or abdomen stimulus to cause abdominal contraction
Sensing an onset of the subject's expiratory phase of breathing, and delivering a stimulus to the subject's thorax or abdomen during at least part of the expiratory phase of breathing in response to said sensing, said stimulus effective to cause a contraction in the subject's abdominal muscle so as to assist the subject with ventilation.
No stimulus delivered while the subject is inhaling
Delivering the stimulus during at least part of the expiratory phase of breathing in response to sensing with the proviso that a stimulus is not delivered while the subject is inhaling.
Sensors detecting exhaling and stimulus delivery to thorax or abdomen during expiratory phase
One or more sensors suitable for detecting when a subject is exhaling, and a device adapted to deliver a stimulus to the subject's thorax or abdomen during at least part of an expiratory phase of the subject's breathing in response to a signal generated by said one or more sensors, said stimulus effective to cause a contraction in the subject's abdominal muscle.
Apparatus exclusion of stimulation during inhalation
The apparatus does not include a device adapted to deliver a stimulus during inhalation.
Sensing inhaling and stimulating contraction of expiratory muscles during inhalatory phase
Sensing when a subject is inhaling, and stimulating contraction of at least one of the subject's expiratory muscles during at least part of the inhalatory phase of breathing in response to said sensing.
Ventilator-connected thorax or abdomen stimulation during expiratory phase with stimulus duration after onset
A device connected with a ventilator, wherein the device is adapted to deliver a stimulus to a subject's thorax or abdomen during at least part of an expiratory phase of the subject's breathing in response to a signal received from the ventilator, wherein the device is adapted to deliver the stimulus for a stimulus duration after onset of exhalation.
Sensing exhaling and stimulating contraction of expiratory muscles during expiratory phase
Sensing when a subject is exhaling, and stimulating contraction of at least one of the subject's expiratory muscles during at least part of the expiratory phase of breathing in response to said sensing.
Taken together, the claims cover sensing-based respiratory phase detection and timed thorax or abdomen stimulation that is effective to cause abdominal muscle contraction to assist ventilation, including a specific proviso excluding stimulus delivery during inhalation. The coverage also includes related methods for promoting increased abdominal muscle strength via stimulation of expiratory muscles in inhalatory or expiratory phases, and a ventilator-connected apparatus delivering expiratory-phase stimulation continued for a stimulus duration after onset of exhalation.
Stated Advantages
Reduced hyperinflation/EELV, including a decrease in EELV as compared with EELV without the stimulus.
Improved expiratory flow rate.
Training/strengthening of expiratory muscles.
Possible use with biofeedback prompting modes, including tactile cue prompting.
Documented Applications
Breathing assistance and/or training for subjects with obstructive lung disease, notably COPD, via expiratory-phase stimulation.
Ventilator weaning and ventilator assistance using an apparatus connected with a ventilator.
Monitoring and operation with breathing pattern/activity analysis and biofeedback prompting modes.
Use in clinical contexts including non-invasive ventilation, such as CPAP, and mechanically assisted breathing scenarios such as intubated or recently extubated subjects.
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