Method And Apparatus For The Measurement Of Autonomic Function For The Diagnosis And Validation Of Patient Treatments And Outcomes
Patent No. US11497438 (titled "Method And Apparatus For The Measurement Of Autonomic Function For The Diagnosis And Validation Of Patient Treatments And Outcomes") was filed by Biotraceit Corp on Jun 30, 2019.
What is this patent about?
’438 is related to the field of pain measurement and diagnostics , specifically systems and methods for bioanalytical analysis of pain matrix activity and the autonomic nervous system. The background acknowledges the lack of reliable methods for objectively quantifying pain, despite its significant economic and social impact. Current methods rely on subjective patient reports, which are often inaccurate or difficult to obtain, especially from vulnerable populations. The invention aims to address this gap by providing objective measurements of pain to improve diagnosis, treatment, and patient outcomes.
The underlying idea behind ’438 is to use medical devices with sensors to measure electrical activity related to pain processing in the brain . By placing sensors contralaterally (on opposite sides of the body) and measuring the voltage or current differential, the system captures activity in the "pain matrix," a network of brain regions involved in pain perception. This data, combined with other physiological measurements and patient-specific factors, provides an objective assessment of pain intensity and modulation.
The claims of ’438 focus on an autonomic function monitoring device that includes a pain matrix activity measurement device. This device uses multiple sensors positioned contralaterally on the body to measure pain matrix activity. A key feature is the inclusion of a pressure measurement device on the sensors, allowing for adjustment to ensure equal pressure against the skin. The data acquisition system then identifies deflections in the sensor data as quantitative measures of pain, which are used to determine a patient's pain levels and overall health.
In practice, the invention involves placing sensors on the left and right sides of the body, ensuring equal pressure for accurate readings. The system then measures the voltage or current differential between the sensors, reflecting the activity of the pain matrix. This data is processed and displayed, providing a quantitative measure of pain that can be tracked over time. The system also incorporates data from ipsilateral sensors (on the same side of the body) to calibrate and validate the contralateral measurements, improving the reliability of the pain assessment.
The invention differentiates itself from prior approaches by integrating objective sensor measurements with patient-specific factors and other physiological data. Unlike existing methods that rely solely on subjective reports, ’438 provides a more comprehensive and objective assessment of pain. The use of contralateral sensors to measure pain matrix activity, combined with pressure sensors for accurate placement, allows for a more precise and reliable quantification of pain, leading to improved diagnosis, treatment monitoring, and patient management.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’438 was filed, at a time when physiological data was typically acquired using specialized medical devices and analyzed using dedicated software, integrating data from multiple sensors and correlating it with patient-specific information was a non-trivial task due to limitations in processing power and data storage capabilities. Wearable devices for continuous, at-home patient monitoring were emerging, but the ability to objectively measure subjective experiences like pain and integrate that data with other biophysical measurements and patient-reported outcomes was still an area of active development.
Novelty and Inventive Step
The examiner allowed the application because of amendments made during prosecution. Specifically, claim 2 was amended to clarify the function of the central processing units, and minor grammatical corrections were made to claims 3-6. Claim 8 was also cancelled.
Claims
This patent contains 20 claims, with independent claims 1 and 20 directed to an autonomic function monitoring device that measures pain matrix activity using sensors positioned contralaterally on the body. The dependent claims generally elaborate on the features and configurations of the sensors, measurement devices, and additional monitoring components of the autonomic function monitoring device.
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Date
Description
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US11497438
- Application Number
- US16458129
- Filing Date
- Jun 30, 2019
- Status
- Granted
- Expiry Date
- Jan 10, 2036
- External Links
- Slate, USPTO, Google Patents