Methods and applications for detection of breath flow and the system thereof
Inventors
Chen, Chung-Chu • Huang, Chen-Ning
Assignees
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Publication Number
US-10638971-B2
Publication Date
2020-05-05
Expiration Date
Abstract
The present invention provides methods for characterizing obstructive sleep apnea (OSA) patients in the treatment of OSA, and devices thereof. The methods comprise measuring polysomnography of said patients; analyzing polysomnography, and determining a characteristic of the polysomnography and selections of suitable treatments based on the patterns.
Core Innovation
The invention relates to treating an obstructive sleep apnea (OSA) patient using negative pressure treatment that delivers negative pressure to the patient's oral cavity. The method conducts polysomnography (PSG) testing during sleep and obtains PSG data. A processor analyzes the PSG data to classify the OSA patient into one of a plurality of predetermined flow limitations types, including Inspiratory Flow Limitation (IFL) type, Expiratory Flow Limitation (EFL) type, Mix Flow Limitation (MFL) type, and Not Classified (NC) type.
After classifying the OSA patient into the predetermined flow limitation type, the method determines whether the OSA patient is suitable for the negative pressure treatment based on the predetermined flow limitation type. If the processor unit determines the OSA patient is suitable, the processor activates a negative pressure source to provide the negative pressure to the oral cavity of the patient. In this way, the negative pressure treatment is activated based on PSG-derived flow limitation classification.
An additional aspect includes a system architecture configured to detect inspiratory and expiratory air flow and generate inspiratory and expiratory flow limitation signals, with conditioning and digitizing of the signals into digital data comprising inspiratory and expiratory air flow data. The processor unit analyzes the PSG data to classify the OSA patient into the predetermined flow limitation types and determines suitability for the negative pressure treatment. The processor unit couples to a negative pressure source and activates the negative pressure source to provide negative pressure to the oral cavity when suitable.
The document also describes an alternative upper-airway endoscopic imaging workflow using a Muller maneuver to characterize collapse patterns, and to classify an OSA patient into posteroanterior type, lateral type, or annular collapse type. In that workflow, the classification is used in determining suitability for the negative pressure treatment based on the endoscopic collapse type.
Claims Coverage
The independent claims are directed to a method and a system for treating an OSA patient with negative pressure delivered to the oral cavity, where PSG-derived flow limitation classification is used to determine suitability and control activation of the negative pressure source. Across the dependent claims referenced, the document further specifies quantitative percentage calculations and thresholds for classifying IFL/EFL/MFL types, and provides an alternative endoscopic Muller maneuver collapse-type classification path tied to suitability.
Negative pressure oral cavity treatment guided by PSG flow limitation type suitability
A method of treating an OSA patient using negative pressure treatment that includes delivering negative pressure to a patient's oral cavity, comprising conducting polysomnography testing during sleep; analyzing PSG data to classify the OSA patient as one of a plurality of predetermined flow limitations types comprising Inspiratory Flow Limitation (IFL) type, Expiratory Flow Limitation (EFL) type, Mix Flow Limitation (MFL) type, and Not Classified (NC) type; determining if the OSA patient is suitable for the negative pressure treatment based on the predetermined flow limitation type; and activating a negative pressure source to provide the negative pressure to the oral cavity if the processor unit determines the OSA patient is suitable.
Flow-limitation signal sensing and PSG-based suitability control for negative pressure oral delivery
A system for treating an OSA patient using negative pressure treatment that includes delivering negative pressure to a patient's oral cavity, comprising a sensor unit detecting inspiratory and expiratory air flow and generating inspiratory and expiratory flow limitation signals; a signal conditioning unit coupled to the sensor unit for amplifying the inspiratory and expiratory flow limitation signals and filtering out unwanted noises; a data acquisition unit for converting the inspiratory and expiratory flow limitation signals to digital data comprising inspiratory and expiratory air flow data; and a processor unit configured to analyze the PSG data to classify the OSA patient into the predetermined flow limitation types comprising IFL type, EFL type, MFL type, and NC type, and to determine if the OSA patient is suitable for the negative pressure treatment based on the predetermined flow limitation type, where the processor unit couples to a negative pressure source and activates the negative pressure source to provide negative pressure to the oral cavity if the processor unit determines the negative pressure treatment is suitable.
IFL decision using IFL percentage greater than 20% and greater than EFL percentage
The method checks whether an IFL percentage is greater than 20% and greater than an EFL percentage to classify an OSA patient as an IFL type under those conditions.
EFL suitability based on EFL type and EFL percentage below a predetermined threshold
Determining that a negative pressure treatment is suitable for an OSA patient is based on whether the patient is classified as EFL type and has an EFL percentage below a predetermined threshold.
Predetermined EFL percentage threshold set at 2%
The predetermined threshold for the EFL percentage is set at 2%.
MFL event-based calculation and classification with MFL percentage greater than 1%
The method analyzes inspiratory and expiratory airflow data to determine mixed flow limitation events, calculates an MFL percentage from the number of mixed flow limitation events over total breath cycles, checks whether the MFL percentage is greater than 1%, and classifies an OSA patient as an MFL type when the MFL percentage exceeds 1%.
Upper-airway endoscopic Muller maneuver collapse-type classification used for suitability
Taking endoscopic images of the upper airway with a Muller maneuver; analyzing the images to classify an OSA patient into a posteroanterior type, lateral type, or annular collapse type; and determining the patient is suitable for negative pressure treatment if classified as the posteroanterior type.
Across the independent claims, the core inventive coverage centers on PSG testing and processor-based classification of OSA patients into predetermined flow limitation types (IFL/EFL/MFL/NC) to determine suitability, followed by activating a negative pressure source to deliver negative pressure to the oral cavity. Dependent features further specify quantitative decision rules for IFL/EFL/MFL percentage-based classification and include an alternative Muller maneuver endoscopic collapse-type classification tied to suitability.
Stated Advantages
Provides a way to classify an OSA patient into predetermined flow limitation types (IFL, EFL, MFL, and NC) using PSG data and to use that classification to determine suitability for negative pressure treatment.
Activates the negative pressure source to provide negative pressure to the oral cavity when the processor unit determines the OSA patient is suitable for the negative pressure treatment.
Documented Applications
Treating an obstructive sleep apnea (OSA) patient with negative pressure delivered to the patient's oral cavity based on PSG-derived flow limitation type suitability.
Upper-airway endoscopic imaging workflow using a Muller maneuver to characterize collapse type and determine suitability for negative pressure treatment based on the posteroanterior classification.
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