Method And Device For Sleep Analysis
Patent No. US11202603 (titled "Method And Device For Sleep Analysis") was filed by Cleveland Medical Devices Inc on Oct 11, 2019.
What is this patent about?
’603 is related to the field of sleep disorder diagnosis, specifically addressing the limitations of traditional sleep laboratories. The background highlights the prevalence of sleep disorders, the costs associated with sleep deprivation, and the challenges in diagnosing these disorders using existing subjective and physiological methods. Traditional polysomnography (PSG) requires patients to visit specialized sleep labs, leading to long waiting lists and difficulties for patients with mobility issues or other medical conditions. Current attempts to conduct sleep studies outside the lab have been unsuccessful due to equipment limitations and the inability to transmit data during the test.
The underlying idea behind ’603 is to enable remote sleep analysis by using a portable, wireless data acquisition system. This system allows for the collection and transmission of physiological data from a patient in a non-traditional setting, such as a hospital room or nursing home, to a remote monitoring location. The key insight is to provide real-time data transmission and remote monitoring capabilities, allowing for timely intervention and adjustments during the sleep study, overcoming the limitations of unattended sleep tests.
The claims of ’603 focus on a sleep diagnostic system comprising a database, a computer or processor, and a portable, wearable patient interface box. The patient interface box includes a battery, nonvolatile digital memory, electronics with at least three input channels for receiving data from at least three sensors, and a transceiver or transmitter for uploading data to the database. The at least three sensors are selected from a group consisting of: accelerometer(s), fingertip pulse oximeter, pressure sensor, microphone, strain gauge and transducers, and are adapted to measure or derive at least the subject's respiratory effort, snore and blood oxygenation during testing.
In practice, the system involves applying sensors to the patient's finger and torso to measure respiratory effort, snore, and blood oxygenation. These sensors are connected to the portable patient interface box, which wirelessly transmits the data to a database accessible to a sleep analysis unit or lab. A computer or processor then automatically identifies and quantifies physiological events indicative of a sleeping disorder. The system also includes a two-way communication link to output the data and identified events for a professional medical diagnosis.
This approach differentiates itself from prior solutions by enabling real-time data transmission and remote monitoring, allowing for adjustments to sensor placement or test parameters during the study. Unlike unattended sleep tests, the system allows for continuous data quality checks and communication with the patient or caregiver. The use of a portable, wearable patient interface box also addresses the space constraints in hospital rooms and other non-traditional settings, making it feasible to conduct full polysomnography sleep studies outside of a sleep lab. The system can also use a cell phone to transfer data to the database.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2000s when ’603 was filed, at a time when sleep studies were typically conducted in specialized labs due to the complexity and bulkiness of the equipment. Systems commonly relied on wired connections to transmit data from sensors to monitoring stations. Hardware or software constraints made real-time wireless data transmission and remote monitoring of multiple physiological parameters non-trivial.
Novelty and Inventive Step
The examiner approved the patent because the prior art, whether considered individually or in combination, did not teach or suggest the remote sleep monitoring system and method described in the independent claims. Specifically, while some prior art disclosed remote monitoring systems with sensors for respiratory effort and blood oxygen, they lacked key features such as three data input channels, cellphone data transmission, snore or airflow monitoring, and the identification/quantification of physiological events for sleep apnea diagnosis. Other prior art systems lacked wired or wireless data transmission and a portable/wearable patient interface box.
Claims
This patent contains 20 claims, with independent claims numbered 1, 8, and 15. The independent claims generally focus on systems and methods for remote sleep analysis and diagnosis using a wearable patient interface box and various sensors to measure physiological data. The dependent claims generally elaborate on and refine the features and functionalities described in the independent claims, such as specific sensor types, data processing techniques, and communication methods.
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Date
Description
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US11202603
- Application Number
- US16599330
- Filing Date
- Oct 11, 2019
- Status
- Granted
- Expiry Date
- Jun 8, 2027
- External Links
- Slate, USPTO, Google Patents