Patent No. US11602284 (titled "Devices and methods for sleep disorder diagnosis and treatment") on May 26, 2022. The application was issued on Mar 14, 2023.
’284 is related to the field of integrated sleep diagnosis and treatment systems, specifically focusing on obstructive and central sleep apnea. The technology addresses the limitations of traditional clinical sleep studies, such as the Multiple Sleep Latency Test, by providing a more objective, real-time assessment of a patient’s physiological state. By integrating diagnostic sensors with therapeutic hardware, the system aims to bridge the gap between identifying sleep-disordered breathing and delivering immediate, calibrated intervention.
The underlying idea behind ’284 is the creation of a closed-loop therapeutic environment that dynamically adjusts treatment based on the real-time severity of symptoms. Rather than relying on static pressure settings or subjective patient questionnaires, the invention utilizes continuous physiological monitoring to identify the onset of apnea events. By applying advanced signal processing to data from airflow sensors and brainwave monitors, the system can predict or detect respiratory distress and command a treatment device to respond instantly, ensuring the therapy is precisely tuned to the patient's immediate needs.
The claims of ’284 focus on a positive airway pressure (PAP) system that leverages mobile technology and remote data management to track and display treatment efficacy. The independent claim describes a PAP device equipped with an internal blower and airflow sensor that calculates both the severity of sleep disorder symptoms and usage metrics. This data is transmitted via a wireless transceiver to a cell phone running specialized software, which generates a visual index of treatment efficacy for the user while simultaneously syncing with a remote internet site for clinical oversight.
In practice, the system functions by using an internal processor to derive respiratory patterns from airflow sensor data, effectively quantifying the patient's condition throughout the night. This information is not just stored locally but is converted into a treatment efficacy index that provides a clear, quantitative picture of how well the PAP device is alleviating symptoms. The use of a cell phone as a primary interface allows the patient to engage with their own health data, while the backend connection to a remote site ensures that healthcare providers can monitor progress without requiring the patient to visit a specialized sleep clinic.
This invention differs from prior approaches by moving away from basic, manually adjusted devices toward a highly integrated, data-driven ecosystem. Traditional CPAP machines often lack the sophisticated diagnostic integration required to distinguish between different types of apnea or to provide meaningful feedback to the user. By combining real-time symptom calculation with mobile display and cloud-based reporting, the ’284 patent provides a comprehensive solution that automates the feedback loop between diagnosis, treatment, and long-term efficacy tracking.
In the mid-2000s when ’284 was filed, sleep disorder assessment was typically implemented using subjective patient questionnaires or resource-intensive, all-day physiological evaluations conducted in specialized clinical settings. At a time when therapeutic intervention for conditions like sleep apnea commonly relied on basic positive airway pressure devices with fixed or rudimentary flow adjustments, the integration of real-time diagnostic feedback into treatment delivery was limited. Systems of this era generally functioned as discrete diagnostic tools or standalone treatment hardware, where software and hardware constraints made the automated, high-resolution adjustment of therapy based on a patient’s immediate physiological state non-trivial.
The disclosed invention represents a technical advancement through the architectural integration of a diagnostic system and a treatment system into a unified, responsive framework. By utilizing a multi-sensor array—including EEG, ECG, and blood gas sensors—to generate a quantitative output of a subject's current physiological state, the system enables a dynamic control loop for physical or chemical therapy. This shift from static treatment to a closed-loop or predictive model overcomes the technical constraint of diagnostic 'floor effects' and allows for the precise titration of treatment, such as continuous positive airway pressure or medication delivery, in direct response to real-time symptoms or anticipated sleep disorder events.
The patent contains a total of 20 claims, with claim 1 serving as the sole independent claim. This independent claim focuses on a positive airway pressure sleep disorder treatment system that integrates a blower device, a mobile phone application, and a remote internet site to calculate and display treatment efficacy indices based on symptom severity and usage data. The dependent claims serve to further define the system by specifying wireless communication protocols like Bluetooth and cellular networks, detailing signal processing techniques such as Fourier transforms for airflow data analysis, and describing remote software reprogramming, automated blower adjustments via predictive controllers, and clinician reporting features.
Definitions of key terms used in the patent claims.
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