Method And Apparatus For The Measurement Of Autonomic Function For The Diagnosis And Validation Of Patient Treatments And Outcomes
Patent No. US11653877 (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?
’877 is related to the field of pain measurement and diagnostics , specifically systems and methods for objectively quantifying pain and related physiological responses. The background acknowledges the lack of reliable methods for objectively measuring pain, despite its significant economic and social impact. Current methods rely heavily on subjective patient reporting, which can be unreliable due to communication barriers, cognitive impairments, and the complex interplay of biological, psychological, and social factors influencing pain perception.
The underlying idea behind ’877 is to use contralateral electrodermal activity (EDA) measurements to quantify pain matrix activity in the brain. The key insight is that asymmetric differences in EDA between the left and right sides of the body, measured using sensors, correlate with pain processing in the brain's pain matrix. By combining these objective physiological measurements with other relevant factors, a more accurate and reliable assessment of pain can be achieved.
The claims of ’877 focus on a method for quantitatively measuring pain using a pain measurement and diagnostic system (PMD) and data output from contralateral sensors. The method involves establishing a baseline pain matrix response, measuring pain matrix activity during a noxious stimulus, identifying deflections from the baseline, accessing and correlating BioTrace Factors (biological, psychological, social data), normalizing pain matrix response levels, determining a PainTrace Factor, monitoring pain matrix activity through treatment, and correlating measured deltas with self-report pain scales.
In practice, the invention involves placing sensors on contralateral sides of the body to measure EDA, then processing the signals to determine a baseline and identify changes in pain matrix activity. A key aspect is the integration of BioTrace Factors, which are used to normalize the pain measurements and account for individual differences in pain perception. This allows for a more personalized and accurate assessment of pain, as well as the ability to track treatment effectiveness over time.
The invention differentiates itself from prior approaches by combining objective physiological measurements with a comprehensive analysis of biopsychosocial factors. Unlike existing methods that rely solely on subjective patient reports, ’877 aims to provide a more objective and reliable assessment of pain. Furthermore, the use of contralateral EDA measurements to directly assess pain matrix activity in the brain is a novel approach that offers a more direct measure of pain processing than traditional methods.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’877 was filed, systems commonly relied on physiological sensors for monitoring patient health, at a time when data processing and analysis were typically implemented using cloud computing and integration with mobile devices. Wearable devices were becoming more prevalent, but hardware or software constraints made long-term, at-home patient monitoring and integration of diverse data streams non-trivial.
Novelty and Inventive Step
Claims were rejected under 35 U.S.C. 112(b) as being indefinite and under 35 U.S.C. 101 as being directed to an abstract idea without significantly more. Certain claims were withdrawn from consideration as being directed to a non-elected invention. The Office action was made final.
Claims
This patent contains 11 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a method of quantitatively measuring pain using contralateral sensors and analyzing pain matrix activity data, both with and without a noxious stimulus, and comparing the data to a population with similar characteristics. The dependent claims generally elaborate on and specify details of the method described in independent claim 1, including variations in data acquisition and specific BioTrace Factors.
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Date
Description
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US11653877
- Application Number
- US16458130
- Filing Date
- Jun 30, 2019
- Status
- Granted
- Expiry Date
- May 3, 2036
- External Links
- Slate, USPTO, Google Patents