Devices and methods for sleep disorder diagnosis and treatment

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.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical Landscape

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.

Prosecution Position

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Airflow sensor internal to the PAP device
(Claim 1)
Measurement of airflow is preferably measured using sensors or devices such as a pneumotachometer, strain gauges, thermal sensors, transducers, piezo sensors, magnetometers, pressure sensors, static charge-sensitive beds, and the like. These sensors or devices also preferably measure nasal pressure and respiratory inductance plethysmography. The treatment device can be adjusted by a closed loop control system which uses data or signals from the diagnosis device.A component located within the housing of the pressure therapy apparatus specifically configured to measure or derive the subject's respiratory airflow during use.
Data of severity of sleep disorder symptoms
(Claim 1)
Signals from sensors are analyzed to determine the level of severity of the symptoms of the subject's sleep disorder. One particular embodiment involves diagnosing the level of severity of a subject's sleep apnea. Measurement of airflow is preferably measured using sensors or devices such as a pneumotachometer, thermal sensors, or pressure sensors.Quantitative information regarding the intensity or frequency of sleep-disordered breathing events, such as apnea levels, calculated based on respiratory airflow measurements.
Data of usage
(Claim 1)
The system includes a device for diagnosing and creating an output of a level of severity of a subject's sleeping disorder and a device for treating the disorder. Signals from the sensors can be saved on a medium in order to be retrieved and analyzed at a later date. Media include hard drives, optical storage, and solid-state memory.Information recorded by the PAP device tracking the extent, duration, or frequency of the subject's utilization of the treatment apparatus.
Index of treatment efficacy
(Claim 1)
The system uses a diagnosis device to perform various forms of analysis to determine or diagnose a subject's sleeping disorder or symptoms. This analysis is used to treat the subject and improve the sleeping disorder or the symptoms. The level of severity of the symptoms and the diagnosis itself are used to determine the effectiveness of the treatment.A calculated metric representing how effectively the PAP device is addressing the subject's sleep disorder, derived from a combination of symptom severity data and device usage data.
Radio frequency wireless transceiver
(Claim 1)
The system can use a diagnosis device to perform various forms of analysis and can treat the subject either physically or chemically. Data can be saved on media including computer networks. The treatment device can be adjusted by a closed loop control system or an open loop control system which can alert a human.A hardware component capable of both transmitting and receiving data via radio frequency signals to facilitate communication between the PAP device, a cell phone, and a remote internet site.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-01351Nov 5, 2025Cleveland Medical Devices Inc. v. ResMed Inc.

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US11602284

Application Number
US17825266A
Filing Date
May 26, 2022
Publication Date
Mar 14, 2023
External Links
Slate, USPTO , Google Patents