Method And Device For In-Home Sleep And Signal Analysis

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.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical landscape at the time

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.

Novelty and Inventive Step

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Fingertip pulse oximeter
(Claim 1)
“Various embodiments of the present invention include the step of applying at least two sensors to the subject. The sensors can be applied at any location, such as a physician's office or place of business, or the subject's home or other sleeping location. The subject's sleeping location includes but is not limited to the subject's home, apartment, or the like, as well as a hotel, nursing home, or other location where an individual could sleep and where this analysis could be done more controllably and/or less expensively than in an attended sleep lab or hospital setting.”A device configured to be applied to a fingertip of the subject to measure blood oxygenation of the subject.
First pressure transducer
(Claim 1)
“The software used in various steps of the present invention allows the in-home data acquisition system to perform a number of operations that other systems cannot accomplish with the same type of hardware. The use of software filtering allows determination of airflow, tidal volume, ventilation rate, and snore detection from a single pressure transducer.”A component of the portable patient interface box, used in conjunction with a first air port to obtain airflow data and/or snore data from the nasal cannula or facemask.
Kinetic sensor
(Claim 1)
“The present invention provides a method of conducting a sleep analysis by collecting physiologic and kinetic data from a subject, preferably via a wireless in-home data acquisition system, while the subject attempts to sleep at home. The sleep analysis, including clinical and research sleep studies and cardiorespiratory studies, can be used in the diagnosis of sleeping disorders and other diseases or conditions with sleep signatures, such as Parkinson's, epilepsy, chronic heart failure, chronic obstructive pulmonary disorder, or other neurological, cardiac, pulmonary, or muscular disorders.”A sensor for measuring movement of the subject.
Portable patient interface box
(Claim 1)
“In one embodiment, the present invention includes the steps of applying two or more sensors to a subject; connecting the sensors to an in-home data acquisition system capable of transmitting the signals from the sensors or retransmitting a signal based at least in part on at least one of the signals from the sensors; collecting signals from the sensors while the subject attempts to sleep at home; and analyzing the signals to determine whether the subject has a sleeping disorder.”A device configured to be worn by the subject while the subject sleeps in the subject's home, and configured to be connected to the snore sensor, respiratory effort belt, and fingertip pulse oximeter. It comprises a processor, memory, transceiver or transmitter, battery, first and second pressure transducers, and first and second air ports.
Respiratory effort belt
(Claim 1)
“The present invention provides a method of conducting a sleep analysis by collecting physiologic and kinetic data from a subject, preferably via a wireless in-home data acquisition system, while the subject attempts to sleep at home. The sleep analysis, including clinical and research sleep studies and cardiorespiratory studies, can be used in the diagnosis of sleeping disorders and other diseases or conditions with sleep signatures, such as Parkinson's, epilepsy, chronic heart failure, chronic obstructive pulmonary disorder, or other neurological, cardiac, pulmonary, or muscular disorders.”A sensor or belt configured to be applied to the subject for measuring respiratory effort of the subject.

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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US11234637

CLEVELAND MEDICAL DEVICES INC
Application Number
US17346640
Filing Date
Jun 14, 2021
Status
Granted
Expiry Date
Jun 8, 2027
External Links
Slate, USPTO, Google Patents