Method and device for sleep analysis

Patent No. US10478118 (titled "Method and device for sleep analysis") on Jun 21, 2018. The application was issued on Nov 19, 2019.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical Landscape

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.

Prosecution Position

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Kinetic sensor
(Claim 1)
The various embodiments of the present invention include a step for including a subject's body motion. The software corrects motion artifacts by using data acquired from accelerometers and video. The kinetic sensor is used for measuring body position or orientation.A sensor, such as an accelerometer, integrated into the patient interface box to measure and record the subject's body motion, position, or orientation.
Nonvolatile digital memory
(Claim 1)
The various embodiments of the present invention include a step for using removable memory for data buffering and storage. The method includes digitizing and storing the collected data from the patient in the nonvolatile digital memory of the patient interface box. This allows for data to be stored during the test and read later or transmitted.A digital storage medium within the interface box that retains collected physiological data even when power is removed, used for data buffering and storage during the sleep study.
Portable patient interface box
(Claim 1)
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 software used in various steps of the present invention allows the patient data acquisition system to perform a number of operations that other systems cannot accomplish with the same type of hardware. The system includes a step for using removable memory for data buffering and storage.A small, battery-powered, wearable device containing sensors and memory that serves as the central hub for collecting and storing physiological and kinetic data from a patient.
Pressure transducers
(Claim 1)
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 comprises first and second pressure transducers, a first air port for connecting the nasal cannula or the facemask to the first pressure transducer, and a second air port for connecting the respiratory effort belt to the second pressure transducer.Sensors within the interface box that convert physical pressure signals from a nasal cannula or respiratory belt into electrical signals to measure airflow and respiratory effort.
Technological events
(Claim 1)
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 computer or processor analyzes the transferred collected data to identify and draw attention to these events. This helps address problems where data from patients were unusable due to missing channels.Non-physiological occurrences related to the integrity of the data collection equipment, such as a sensor becoming disconnected or a signal failure.

Litigation Cases New

US Latest litigation cases involving this patent.

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

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US10478118

Application Number
US16014002A
Filing Date
Jun 21, 2018
Publication Date
Nov 19, 2019
External Links
Slate, USPTO , Google Patents