Method And Device For In-Home Sleep And Signal Analysis
Patent No. US10925535 (titled "Method And Device For In-Home Sleep And Signal Analysis") was filed by Cleveland Medical Devices Inc on Dec 27, 2018.
What is this patent about?
’535 is related to the field of sleep analysis and diagnostics, specifically addressing the challenges of conducting polysomnography (PSG) in a patient's home rather than a sleep laboratory. Traditional sleep labs are expensive, inconvenient, and can produce inaccurate results due to the "first night effect," where patients sleep differently in an unfamiliar environment. The patent aims to provide a more comfortable, cost-effective, and accurate method for diagnosing sleep disorders by enabling remote, attended sleep studies in the patient's home.
The underlying idea behind ’535 is to create a portable, wireless system that can collect physiological and kinetic data from a patient while they sleep at home, and transmit that data to a remote monitoring station in real-time. This allows for continuous monitoring and analysis of the patient's sleep patterns, as well as the ability to communicate with the patient to adjust sensors or address any issues that may arise during the study. The system also incorporates environmental sensors to capture data about the patient's sleeping environment, such as noise levels and light levels.
The claims of ’535 focus on a system comprising at least three sensors (a nasal cannula or facemask, a respiratory effort belt, and a fingertip pulse oximeter) connected to a portable patient interface box. This box, worn on the torso, includes a battery, a kinetic sensor, nonvolatile digital memory, a pressure transducer connected to the nasal cannula or facemask, and a transceiver. The system transmits data to a remote database, where software analyzes the data to identify physiological and technological events indicative of a sleeping disorder, and then displays or prints the data for further analysis.
In practice, the patient would be fitted with the sensors and the portable interface box, which would then wirelessly transmit data to a remote monitoring station. The kinetic sensor measures body position, while the pressure transducer, connected to the nasal cannula or facemask, measures airflow. The respiratory effort belt measures chest and abdominal movement, and the pulse oximeter measures blood oxygen saturation. This data is then analyzed remotely to identify sleep disturbances and potential disorders.
The key differentiation from prior approaches lies in the combination of portability, wireless data transmission, and remote monitoring capabilities. Unlike previous home PSG systems that stored data for later retrieval, ’535 enables real-time monitoring and intervention , allowing for adjustments to be made during the study to improve data quality and patient comfort. The use of a portable interface box worn on the torso, along with wireless connectivity, allows the patient to move freely during sleep, minimizing disruption and improving the accuracy of the results.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2000s when ’535 was filed, at a time when physiological data acquisition was typically implemented using wired connections to bulky recording devices, and when remote monitoring solutions commonly relied on periodic data uploads rather than continuous streaming due to bandwidth and power constraints, conducting comprehensive sleep studies outside of a clinical setting presented significant technical challenges.
Novelty and Inventive Step
The examiner approved the application because the prior art, whether considered individually or in combination, did not disclose a system for remote sleep analysis and diagnosis as described in the independent claims. Specifically, the prior art failed to teach a patient interface box with first and second pressure transducers, first and second air ports, a releasable sensor connector, and a kinetic sensor for detecting body orientation.
Claims
This patent contains 20 claims, of which claims 1, 8, and 15 are independent. The independent claims are directed to systems for conducting at-home sleep analysis using sensors, a portable interface box, a remote database, and analysis software. The dependent claims generally elaborate on and add detail to the elements and functionality described in the independent claims.
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Date
Description
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US10925535
- Application Number
- US16233520
- Filing Date
- Dec 27, 2018
- Status
- Granted
- Expiry Date
- Sep 13, 2027
- External Links
- Slate, USPTO, Google Patents