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Publication Number
US-10780238-B2
Publication Date
2020-09-22
Expiration Date
Abstract
In an alerting and controlling system, there is a measuring device and a controller. The measuring device is connectable to an endotracheal tube associated with a cuff inflatable below the vocal cords of a subject, for measuring at least one measure being indicative of the presence of leakage of secretions from above the cuff to the lungs of the subject. The controller adjusts inflation of the cuff responsively to the level of the at least one measure such as to reduce or prevent leakage of secretions from above the cuff to the lungs, and alerts that the endotracheal tube is malpositioned in the airway of the subject if an inflation pressure of the cuff exceeds a predetermined threshold.
Core Innovation
The invention provides an alerting and controlling system that measures a level indicative of leakage of secretions from above an endotracheal tube cuff to the lungs. The system includes a measuring device connectable to an endotracheal tube associated with a cuff inflatable below the vocal cords, and the measured level corresponds to at least one measure indicative of the presence of secretion leakage past the cuff.
A controller adjusts inflation of the cuff responsively to the measured level indicative of leakage. The controller alerts that the endotracheal tube is malpositioned in the airway if leakage of secretions is present and an inflation pressure of the cuff exceeds a predetermined threshold, and the approach compares the measured leakage-indicative level to an optimal or threshold value while using a reduced-then-raised control to minimize leakage and avoid cuff pressure-related tissue damage.
Embodiments assess leakage using carbon dioxide, acoustical data, pressure data, flow data, optical data, electrical characteristics, or other measurable proxies. Additional embodiments deliver at least one identifiable additive above or through the endotracheal tube and determine the presence or concentration of the additive at selected sampling locations, including locations above the cuff such as a nostril or oropharynx and below the cuff, with closed-loop cuff adjustment based on the monitored additive leakage information.
Claims Coverage
The document includes one independent claim directed to an alerting and controlling system for cuff inflation based on a leakage-indicative measurement, with malposition alerting when leakage is present and cuff pressure exceeds a predetermined threshold. The remaining claim set refines the leakage-indicative measurement and optionally adds an identifiable additive delivering and detection scheme.
Leakage-indicative measurement of secretions past an inflatable cuff
A measuring device connectable to an endotracheal tube associated with a cuff inflatable below the vocal cords, for measuring a level of at least one measure indicative of the presence of leakage of secretions from above the cuff to the lungs.
Responsive cuff inflation adjustment based on the leakage level
A controller configured to adjust inflation of the cuff responsively to the level of the at least one measure indicative of leakage.
Malposition alerting using leakage detection and a predetermined cuff pressure threshold
The controller configured to alert that the endotracheal tube is malpositioned in the airway if there is a leakage of secretions and an inflation pressure of the cuff exceeds a predetermined threshold.
Additive delivery and measurement of identifiable additive to indicate leakage
An additive delivering device delivering at least one identifiable additive through the endotracheal tube, wherein the at least one measure comprises presence or concentration of that additive.
CO2-based leakage indication
Measuring carbon dioxide concentration between the cuff and the vocal cords.
Acoustical leakage indication
At least one measure comprising acoustical data being indicative of leakage near the cuff outside the endotracheal tube.
Pressure-flow leakage indication near a cuff
At least one measure comprising pressure data being indicative of fluid flow in a leaking duct near the cuff outside the endotracheal tube.
Electric-property characterization of an identifiable additive
At least one identifiable additive whose characterization is based on measurable electric properties.
Across the independent claim and its refinements, the system centers on measuring a leakage-indicative level above an endotracheal cuff, adjusting cuff inflation responsively, and alerting malposition when leakage is present and cuff inflation pressure exceeds a predetermined threshold, with optional measurement modalities including CO2, acoustical/pressure/flow/optical/electrical characteristics, and embodiments using an identifiable additive with monitored measurable properties.
Stated Advantages
Minimizes secretion leakage while adjusting cuff inflation responsively to a leakage-indicative level.
Alerts that the endotracheal tube is malpositioned when leakage is present and cuff pressure exceeds a predetermined threshold.
Avoids cuff pressure-related tissue damage by minimizing leakage without excessive cuff inflation pressure.
Documented Applications
Use in endotracheal intubation where secretion leakage past a cuff below the vocal cords is assessed and used to control cuff inflation and to alert malposition.
Monitoring leakage using CO2 leakage information and comparing measured levels to an optimal or threshold value, including optional reference to ambient CO2 partial pressure.
Assessing leakage using identifiable additives delivered above or through the endotracheal tube and measured at selected sampling locations, including locations above the cuff (e.g., nostril or oropharynx) and/or below the cuff.
Use of modeled and experimental evaluation including a simulator, a porcine iodine leakage test, and a 60-patient clinical comparison demonstrating quantitative correlation between upper airway PCO2 leakage and cuff pressure.
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