Patent No. US11234637 (titled "Method And Device For In-Home Sleep And Signal Analysis") was filed by Cleveland Medical Devices Inc on Jun 14, 2021.
’637 is related to the field of sleep analysis and, more specifically, to methods and devices for conducting sleep studies in a patient's home. The background highlights the prevalence of sleep disorders and the limitations of traditional sleep lab polysomnography (PSG), including the cost, inconvenience, and the 'first night effect' that can skew results. Existing at-home PSG methods lacked real-time data transmission and remote monitoring capabilities, leading to unattended studies with potential signal failures.
The underlying idea behind ’637 is to enable a remotely attended, in-home sleep analysis that overcomes the limitations of prior art. This is achieved by collecting physiological and kinetic data from a subject at home using various sensors, and then transmitting this data wirelessly to a remote monitoring station in real-time. This allows for continuous monitoring, data quality checks, and communication with the subject to address any issues during the test, effectively replicating a sleep lab PSG in a more comfortable and convenient setting.
The claims of ’637 focus on a system for conducting a home sleep analysis , comprising a snore sensor and/or nasal cannula or facemask, a respiratory effort belt, a fingertip pulse oximeter, a kinetic sensor, and a portable patient interface box. The interface box is configured to be worn by the subject and connected to the sensors, and it includes a processor, memory, transceiver or transmitter, battery, pressure transducers, and air ports. The interface box obtains and transmits data related to airflow/snoring, respiratory effort, blood oxygenation, and body position to a remote database for analysis.
The system works by having the subject wear the sensors and the portable interface box while sleeping at home. The interface box collects data from the sensors, pre-processes it, and then transmits it wirelessly to a remote database. Software at the remote database analyzes the data to identify physiological or technological events indicative of a sleeping disorder. The results, including the raw data and identified events, are then output to facilitate a determination of whether the subject has a sleeping disorder. The use of a portable, battery-powered interface box allows the subject to move freely during sleep without being tethered to a bulky device.
The invention differentiates itself from prior approaches by enabling real-time remote monitoring and intervention . Unlike previous unattended home sleep studies, this system allows a remote monitor to continuously observe the data stream, communicate with the subject to adjust sensors or address other issues, and ensure data quality throughout the test. The system also incorporates features like motion artifact correction using video and accelerometers, and the ability to collect environmental data, providing a more comprehensive and accurate assessment of the subject's sleep patterns in their natural environment.
In the late 2000s when ’637 was filed, at a time when physiological data acquisition was typically implemented using wired connections, wireless data transmission was becoming more prevalent but hardware or software constraints made continuous, real-time remote monitoring of high-bandwidth data streams non-trivial. Systems commonly relied on storing data locally for later analysis rather than transmitting it live due to limitations in bandwidth and processing power.
The examiner allowed the claims because the prior art, taken alone or in combination, did not teach a system for remote sleep analysis that included a nasal cannula/facemask, a respiratory belt, a fingertip pulse oximeter, a kinetic sensor, and a portable patient interface box with specific components like air ports and pressure transducers. While some references taught certain elements, they did not disclose the specific combination and arrangement of components as claimed, particularly the air port within the patient interface box for connecting the nasal cannula or facemask to the pressure transducer.
There are 19 claims in total. Claim 1 is the only independent claim, and it is directed to a system for conducting a home sleep analysis. The dependent claims generally elaborate on and add detail to the elements and functionality described in the independent claim.
Definitions of key terms used in the patent claims.
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