Patent No. US10028698 (titled "Method and device for sleep analysis") on Oct 15, 2015. The application was issued on Jul 24, 2018.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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