Devices and methods for sleep disorder diagnosis and treatment

Patent No. US10076269 (titled "Devices and methods for sleep disorder diagnosis and treatment") on Apr 5, 2012. The application was issued on Sep 18, 2018.

What is this patent about?

’269 is related to the field of integrated sleep diagnosis and treatment systems, specifically focusing on devices that monitor and treat sleep apnea. Traditional sleep studies often require expensive, overnight stays in specialized clinics and rely on subjective questionnaires or static physiological tests that fail to account for real-time changes in a patient’s condition. The background context highlights a need for a more responsive, closed-loop system that can adjust therapeutic interventions—such as air pressure or medication—based on the immediate physiological state of the user during sleep.

The underlying idea behind ’269 is the integration of real-time diagnostic monitoring with active treatment delivery to create a dynamic feedback loop. By combining data from respiratory airflow sensors with other physiological inputs, such as pulse oximetry or EEG signals, the system can quantitatively determine the severity of apnea events as they occur. This inventive insight allows the device to not only record sleep architecture but to actively mitigate symptoms by adjusting the treatment intensity—whether through pneumatic pressure or chemical dosing—in direct response to the detected level of respiratory distress.

The claims of ’269 focus on a system architecture that pairs a data acquisition module with a positive airway pressure (PAP) device to calculate and transmit sleep disorder symptom data. Specifically, the independent claims describe a configuration where a signal processing module receives data from a pulse oximeter and feeds it to a PAP device, which contains its own internal airflow sensor. A processor then synthesizes these two distinct data streams to generate a severity index or symptom data, which is subsequently transmitted via a wireless transceiver to a remote location, such as a base station, PDA, or an internet site for clinical review.

In practice, the invention operates by utilizing a blower and a patient interface, such as a mask or nasal cannula, to deliver pressurized air while simultaneously monitoring the subject's oxygen saturation and breathing patterns. The system employs advanced signal processing, including recursively fit ARMAX models and time-frequency analysis, to predict the onset of apnea events before they fully manifest. This predictive capability enables the controller to preemptively adjust the blower's output or trigger a pharmaceutical dosing mechanism, ensuring that the treatment is precisely calibrated to the patient's needs at any given moment during the night.

This approach differs from prior solutions by moving beyond simple, fixed-pressure CPAP machines or standalone diagnostic recorders that require manual data retrieval. By integrating a wireless module transceiver directly into the treatment enclosure, the system facilitates the seamless transfer of both symptom severity and usage data to remote monitoring platforms. Furthermore, the ability to adjust chemical treatment via a pharmaceutical agent based on real-time physiological feedback represents a significant departure from traditional mechanical-only interventions, providing a multi-modal path to managing complex sleep disorders.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2000s when ’269 was filed, sleep disorder management was typically implemented using a bifurcated approach where diagnostic evaluation and therapeutic intervention were treated as distinct, sequential clinical events. At a time when systems commonly relied on subjective patient questionnaires or labor-intensive, all-day physiological monitoring in specialized clinics to determine treatment parameters, the adjustment of therapy was often decoupled from real-time physiological feedback. Furthermore, when hardware and software constraints made the high-speed processing of multi-modal biological signals non-trivial, therapeutic devices like positive airway pressure machines generally operated on fixed settings or basic flow-based sensors rather than integrating complex neurological or cardiovascular data to modulate treatment dynamically.

Prosecution Position

The disclosed invention represents a meaningful technical advancement through the architectural integration of real-time diagnostic sensing with dynamic therapeutic delivery in a closed-loop or semi-closed-loop system. By synthesizing physiological inputs—such as EEG, EKG, and blood gas levels—directly into the control logic of a treatment apparatus, the system overcomes the technical constraint of static therapy that fails to account for a patient's fluctuating physiological state. This architectural shift enables a predictive capability where the system can anticipate the onset of sleep disorder symptoms and adjust physical or chemical interventions accordingly. The resulting technical effect is a highly responsive treatment environment that optimizes therapeutic efficacy based on quantitative, real-time biological data rather than delayed clinical observations.

Claims

This patent contains 20 claims, including four independent claims numbered 1, 5, 8, and 15. The independent claims focus on a positive airway pressure (PAP) sleep disorder treatment system that integrates respiratory airflow data with physiological sensor data, such as pulse oximetry, to calculate and transmit sleep disorder severity levels or indices to remote locations, with one embodiment specifically incorporating pharmaceutical agent dosing based on these severity outputs. The dependent claims serve to further define the system by specifying wireless communication protocols like Bluetooth, detailing signal processing techniques such as wavelet analysis or Fourier transforms, identifying specific physiological sensors like respiratory effort sensors, and describing remote adjustment or reprogramming capabilities for the PAP device and its associated base station.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Airflow sensor
(Claim 1, Claim 5, Claim 15)
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, respiratory inductance plethysmography, thoracic impedance, expired carbon dioxide, tracheal sound and the like.A transducer or measurement component located within the PAP device enclosure that detects the subject's respiratory patterns to provide respiratory airflow data.
Module transceiver
(Claim 1, Claim 15)
The first radio frequency wireless module transceiver is adapted for receiving and transmitting the symptom data of the severity of the subject's sleep disorder symptoms and/or an index of a subject's symptoms measured during use of the PAP device and the data of usage to the base station, cellular phone or PDA. The base station, cellular phone, or PDA is adapted to display the symptom data and to retransmit the data to a remote internet site.A wireless communication component, such as a radio frequency module, integrated with the treatment system to transmit diagnostic severity data and usage data to remote locations or base stations.
Pharmaceutical agent
(Claim 8)
An example of chemically treating the subject's sleeping disorder would be to have a medication reservoir where a drug is delivered to the subject in order to treat symptoms of the sleeping disorder. The treatment device can either physically or chemically treat the subject's sleeping disorder.A chemical medication stored in a reservoir and delivered by the PAP apparatus to treat sleep disorder symptoms, with the dosage adjusted based on the diagnosed severity level.
Pulse oximeter sensor
(Claim 1, Claim 5)
Measurement of oxygenation and ventilation is preferably measured by pulse oximetry, transcutaneous oxygen monitoring, transcutaneous carbon dioxide monitoring, expired end carbon dioxide monitoring, and the like. The system includes a device for diagnosing and creating a quantitative output of a level of severity of a subject's sleeping disorder or symptoms comprising a pulse oximeter sensor.A physiological sensor used to measure oxygenation and ventilation levels, specifically oxygen saturation in the blood, to provide data for calculating sleep disorder severity.
Sleep disorder symptom data
(Claim 1, Claim 5, Claim 15)
Signals from these sensors are then analyzed to determine the level of severity of the symptoms of the subject's sleep disorder and in some cases to diagnose the sleep disorder itself. One particular embodiment involves diagnosing the level of severity of a subject's sleep apnea. The diagnostic part of the system can use many different types of sensors and methods for diagnosing the severity of the symptoms.Quantitative information representing the level of severity or a calculated index of a subject's sleep-related respiratory disturbances, derived from physiological sensor inputs such as airflow and pulse oximetry.

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.
1:22-cv-00794Jun 16, 2022Cleveland Medical Devices Inc. v. ResMed Inc.

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US10076269

Application Number
US13440116A
Filing Date
Apr 5, 2012
Publication Date
Sep 18, 2018
External Links
Slate, USPTO , Google Patents