Patent No. US10478118 (titled "Method and device for sleep analysis") on Jun 21, 2018. The application was issued on Nov 19, 2019.
’118 is related to the field of remote sleep diagnostics and physiological monitoring. Traditionally, sleep studies require patients to visit specialized laboratories where they are tethered to bulky equipment and monitored by on-site technicians. This process is often limited by facility capacity, high costs, and the difficulty of transporting immobile or acutely ill patients to a dedicated sleep center.
The underlying idea behind ’118 is the decentralization of sleep analysis through a portable, wireless acquisition system that enables clinical-grade monitoring in non-traditional settings like hospital rooms or nursing homes. By integrating multiple physiological sensors into a compact, battery-powered interface, the system allows for the continuous collection and transmission of data without restricting patient mobility or requiring expensive facility retrofitting.
The claims of ’118 focus on a specific hardware configuration and method for remote diagnosis involving a portable patient interface box equipped with integrated pressure transducers and a nonvolatile digital memory. The system specifically requires the simultaneous collection of airflow via a nasal cannula or mask, respiratory effort through a belt, oxygenation via a fingertip pulse oximeter, and body orientation using a kinetic sensor, all of which are digitized and stored locally before being transferred for professional analysis.
In practice, the invention functions by capturing high-fidelity respiratory and positional data while the patient remains in their own bed or a standard hospital room. The interface box utilizes a dual-port pressure transducer system to distinguish between nasal/oral airflow and thoracic effort, while an internal accelerometer tracks movement to identify sleep posture. This data is then moved to a database where a computer identifies specific physiological or technological events, such as oxygen desaturation or sensor displacement, to streamline the physician's review.
This approach differs from prior solutions by combining local nonvolatile buffering with the ability to transmit data to a remote lab for near-real-time evaluation. Unlike unattended home tests that often suffer from high failure rates due to lost signals or disconnected leads, this method allows remote technicians to verify data adequacy and communicate with the patient or caregiver to correct sensor issues during the study, ensuring a diagnostic-quality result without the need for a dedicated sleep lab environment.
In the mid-2000s when ’118 was filed, clinical sleep studies were typically implemented using fixed polysomnography installations within dedicated laboratory environments. At a time when diagnostic hardware was bulky and required extensive cabling to tether a patient to stationary monitoring equipment, system architectures commonly relied on local data storage or hard-wired transmission to an adjacent control room rather than real-time wireless telemetry. Technical constraints related to signal stability and bandwidth made the remote, simultaneous transmission of high-fidelity physiological data, synchronized video, and audio non-trivial, often resulting in unattended studies that suffered from high rates of data loss due to unmonitored sensor failures.
The disclosed invention represents a technical advancement through the integration of a compact wireless data acquisition system designed for use in non-specialized clinical environments, such as general hospital rooms or nursing homes. This architectural shift enables the continuous, real-time transmission of multi-channel physiological and kinetic data to a remote monitoring station at substantially the same time it is collected. The system achieves a significant technical effect by enabling remote technicians to verify data adequacy and sensor integrity during the study, overcoming the constraint of unusable data common in unattended portable testing. Furthermore, the solution incorporates software-based synchronization of video and physiological signals alongside motion artifact correction, facilitating a comprehensive diagnostic capability that was previously restricted to fixed laboratory settings.
The patent contains a total of 7 claims, with claim 1 serving as the sole independent claim. This independent claim focuses on a method for remote sleep analysis and diagnosis using a portable patient interface box equipped with multiple sensors, including pressure transducers and kinetic sensors, to collect and transfer physiological data to a remote lab for identifying sleep disorders. The dependent claims serve to further specify the process by adding steps for verifying sleep patterns, checking data adequacy at the patient's location, enabling two-way communication, utilizing algorithms to remove movement artifacts, and defining various electronic or wireless transmission methods for data transfer.
Definitions of key terms used in the patent claims.
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