Method and device for sleep analysis

Patent No. US10028698 (titled "Method and device for sleep analysis") on Oct 15, 2015. The application was issued on Jul 24, 2018.

What is this patent about?

’698 is related to the field of sleep medicine and remote diagnostic monitoring. Specifically, it addresses the logistical and clinical challenges of performing comprehensive sleep studies, such as polysomnography, on patients who are hospitalized for other conditions or are otherwise unable to travel to a specialized sleep laboratory. The invention seeks to bridge the gap between high-capacity clinical labs and the need for point-of-care diagnostics in non-traditional settings like nursing homes or general hospital wards.

The underlying idea behind ’698 is the miniaturization and wireless integration of complex polysomnography equipment into a portable patient interface box that eliminates the need for a tethered environment. By integrating a pressure transducer for airflow directly within the wearable box and utilizing a mobile device or cellular network for real-time data relay, the system allows for continuous, remote monitoring. This setup enables a remote technician to evaluate signal quality and patient safety without being physically present, effectively turning any hospital bed into a diagnostic sleep suite.

The claims of ’698 focus on a method for remote sleep analysis that utilizes a specific hardware configuration consisting of a portable interface box and a secondary electronic interface, such as a cellular phone. The independent claims require the use of at least two specific sensors: a respiratory belt sensor that is hardwired but releasably connected to the box, and an internal airflow sensor that receives pneumatic signals via a nasal cannula or mask connected to an integrated air port. The method further covers the real-time collection, wireless transmission, and automated analysis of this data to identify both physiological events and technological failures.

In practice, the invention functions by capturing high-fidelity physiological data and transmitting it through a multi-stage wireless link—first from the wearable box to a local mobile device, and then via cellular or satellite networks to a central database. A critical aspect of the implementation is the use of software to identify technological events, such as a displaced electrode or a blocked cannula, which allows remote medical personnel to intervene during the study. This real-time feedback loop ensures that the data collected is adequate for a formal medical diagnosis, reducing the high failure rates typically associated with unattended home sleep tests.

This approach differentiates itself from prior art by moving beyond simple data logging to a fully attended remote study model. Unlike traditional unattended systems that store data for later retrieval—often resulting in unusable results due to undetected sensor failure—this invention provides a live data stream that supports immediate clinical oversight. Furthermore, by integrating the airflow transducer into the wearable box rather than using bulky external carts, the system maintains a small footprint suitable for crowded clinical environments, allowing for the diagnosis of sleep disorders concurrently with the treatment of primary medical conditions.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2000s when ’698 was filed, clinical sleep studies were typically implemented using tethered polysomnography systems within dedicated laboratory environments. At a time when high-fidelity physiological data collection required bulky, stationary equipment wired to a central monitoring room, conducting comprehensive sleep analysis in non-specialized hospital wards or remote locations was often impractical. Systems commonly relied on local data storage or physical proximity between the patient and the technician rather than real-time wireless transmission, as bandwidth and hardware constraints made the continuous, synchronized streaming of multi-channel biometric data and video non-trivial. Consequently, unattended portable studies often suffered from high rates of signal failure because technicians lacked the means to verify data adequacy or interact with the patient during the recording period.

Prosecution Position

The disclosed invention represents a technical advancement in remote diagnostic systems through the integration of a compact wireless data acquisition architecture that enables real-time, attended sleep analysis outside of traditional laboratory settings. By utilizing a wireless system capable of transmitting multi-channel physiological and kinetic data at substantially the same time as collection, the architecture overcomes the technical constraint of signal loss inherent in unattended storage-based devices. The solution achieves a specific technical effect by synchronizing biometric signals with live video and accelerometer data, allowing for remote movement artifact correction and real-time adequacy checks. This architectural shift enables clinical-grade polysomnography to be performed in crowded or non-specialized environments, such as general hospital rooms or nursing homes, while maintaining the capability for remote intervention and sensor adjustment previously restricted to dedicated sleep labs.

Claims

This patent contains 20 total claims, with claims 1, 7, and 14 serving as the independent claims. The independent claims focus on a method for remote sleep analysis and diagnosis that utilizes a portable interface box connected to a respiratory belt and an internal airflow sensor to collect real-time physiological data, which is then transmitted wirelessly or via various networks to a remote facility for medical review and diagnosis. The dependent claims serve to add specific technical refinements, such as data adequacy checks, the removal of movement artifacts using frequency analysis, the inclusion of additional sensors like accelerometers and pulse oximeters, and protocols for remote communication with the patient during the study.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Airflow sensor internal
(Claim 1, Claim 7, Claim 14)
The use of software filtering allows determination of airflow, tidal volume, ventilation rate, and snore detection from a single pressure transducer. The airflow sensor is internal to the same patient interface box and adapted to be applied to the patient through a nasal cannula or breathing mask, which is connected to the patient interface box by an air port.A pressure transducer or sensing component located inside the patient interface box rather than at the patient's airway, connected via tubing to a nasal cannula or mask.
Airflow sensor internal to the same patient interface box
(Claim 1, Claim 7, Claim 14)
The use of software filtering allows determination of airflow, tidal volume, ventilation rate, and snore detection from a single pressure transducer. The airflow sensor is internal to the same patient interface box and adapted to be applied to the patient through a nasal cannula or breathing mask, which is connected to the patient interface box by an air port.A pressure transducer or similar sensing component located inside the interface box housing rather than at the patient's airway, measuring breathing via a pneumatic connection.
Facility remote to a sleep analysis unit or lab
(Claim 1, Claim 7, Claim 14)
The present invention provides a method of conducting a sleep analysis... in a non-traditional location such as a hospital room, nursing home, a satellite hospital, hotel, and the like. The method allows for hospital in-patient sleep analysis where the patient is admitted for diagnosis or treatment to a general medical or surgical unit, to a cardiac unit, to a respiratory unit, or the like. This expands the capacity of a sleep analysis unit or laboratory.A non-traditional clinical setting for sleep studies, such as a general hospital room, nursing home, or patient's location, where the patient is not physically present in a dedicated sleep laboratory.
Patient interface box
(Claim 1, Claim 7, Claim 14)
The patient wireless acquisition system of the present invention is preferably small and compact resulting in ease of use and improved patient mobility by eliminating the need to tether the patient. The use of software filtering allows determination of airflow, tidal volume, ventilation rate, and snore detection from a single pressure transducer. The patient interface box further comprises electronics, which are programmed to collect and transmit data.A portable, wearable, or patient-carried housing that integrates internal sensors (like an airflow transducer) and external sensor connections to collect and transmit physiological data.
Physiological and technological events
(Claim 1, Claim 7, Claim 14)
With automatic or computer-assisted scoring, the software can alert an individual performing remote monitoring when a physiological event (such as a drop in oxygen saturation) or a technological event (such as an electrode becoming disconnected) occurs. The software is used to identify and draw attention to these events in the data.Specific occurrences in the data stream representing either a patient's medical condition (e.g., oxygen desaturation) or a hardware/connectivity failure (e.g., a disconnected electrode).
Substantially the same time as it is collected
(Claim 1, Claim 7)
The present invention preferably contains the step of wirelessly transmitting data from the sensors for the sleep analysis at substantially the same time as it is collected. With continuous data transmission, the sleep test can be remotely monitored from anywhere around the world. The data from the acquisition system is available for remote monitoring in real time, it can be saved and scored later, or may be quantitatively analyzed and scored.The transmission of physiological data in real-time or near real-time during the sleep study to allow for continuous monitoring and remote intervention.
Wireless data acquisition system
(Claim 1)
The present invention provides a method of conducting a sleep analysis by collecting physiologic and kinetic data from a subject with a wireless data acquisition system. The patient wireless acquisition system of the present invention is preferably small and compact resulting in ease of use and improved patient mobility by eliminating the need to tether the patient. It includes electronics programmed to collect and transmit data to a cellular phone.A compact assembly comprising a patient interface box and a mobile transmission device (like a cellular phone) designed to collect and send sleep data without physical tethers to a monitoring room.

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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US10028698

Application Number
US14883687A
Filing Date
Oct 15, 2015
Publication Date
Jul 24, 2018
External Links
Slate, USPTO , Google Patents