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Publication Number
US-10702445-B2
Publication Date
2020-07-07
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 a method of treating a subject by 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 in response to the sensing. The stimulus is effective to cause a contraction in the subject’s abdominal muscle so as to assist the subject with ventilation. At least one of the sensing and delivering is carried out by one or more implanted sensors and/or an implanted device adapted to deliver a stimulus.
The invention addresses an obstructive respiratory disease context, including COPD, hyperinflation, and dynamic hyperinflation, in which dynamic hyperinflation increases end expiratory lung volume (EELV) and functional residual capacity (FRC). By delivering a thorax or abdomen stimulus timed to at least part of expiration and effective to assist exhalation, the invention aims to decrease EELV compared with unassisted breathing. Stimulation is controlled to avoid delivering during inhalation.
In implementations, sensing and delivery can be performed using implanted sensors, including sensing intra-abdominal pressure and detecting respiratory movement based on one or more sensor types. The apparatus and method include control and adjustment based on breathing pattern and/or activity level and can operate in multiple modes, including tactile prompting mode in which tactile stimuli are felt by the subject but are not effective to affect expiratory muscle contraction.
Claims Coverage
The document includes two independent claims. Across the independent claims, the core coverage centers on detecting exhalation/expiratory onset and delivering a thorax/abdomen stimulus during at least part of the expiratory phase to cause abdominal muscle contraction, including embodiments where sensing and/or stimulus delivery are implanted and responsive to sensor-generated signals.
Sensing expiratory onset and delivering thorax/abdomen stimulus to cause abdominal muscle contraction
A method of treating a subject comprising: sensing an onset of the subject's expiratory phase of breathing; delivering a stimulus to the subject's thorax or abdomen during at least part of the expiratory phase in response to said sensing; the stimulus effective to cause a contraction in the subject's abdominal muscle so as to assist the subject with ventilation.
Implanted sensing and/or implanted stimulus-delivery responsive to expiratory phase
At least one of the sensing and delivering is carried out by one or more implanted sensors and/or implanted device adapted to deliver a stimulus.
Sensors for detecting exhaling and apparatus delivering expiratory-phase thorax/abdomen stimulus
An apparatus comprising: 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 in response to a signal generated by said one or more sensors; the stimulus effective to cause a contraction in the subject's abdominal muscle.
At least partly implantable apparatus in thorax or abdomen
The apparatus is at least in part implantable in the subject's thorax or abdomen.
The independent claims collectively cover a breathing-assistance approach in which exhalation/expiratory onset is detected and a thorax/abdomen stimulus is delivered during at least part of the expiratory phase to cause abdominal muscle contraction for ventilation assistance, including embodiments where the relevant sensing and/or stimulus-delivery functions are carried out by implanted sensors or an implanted device.
Stated Advantages
Decreased end expiratory lung volume (EELV) compared to unassisted breathing.
Improved expiratory flow.
Reduced dyspnea/effort.
Improved exercise tolerance.
Possible ventilator-weaning support.
Documented Applications
Assisting ventilation in subjects with obstructive respiratory disease, including COPD, hyperinflation, and dynamic hyperinflation.
Supporting breathing assistance where reducing end expiratory lung volume (EELV) and improving ventilation-related performance is desired, including improved expiratory flow and reduced dyspnea/effort.
Possible ventilator-weaning support.
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