US 10,376,203 B2
Method and apparatus for the measurement of autonomic function for the diagnosis and validation of patient treatments and outcomes
Deborah Dullen, Philadelphia, PA (US)
Filed by Deborah Dullen, Philadelphia, PA (US)
Filed on Jan. 10, 2016, as Appl. No. 14/992,016.
Claims priority of provisional application 62/101,992, filed on Jan. 10, 2015.
Prior Publication US 2016/0198996 A1, Jul. 14, 2016
Int. Cl. A61B 5/00 (2006.01); A61B 5/0205 (2006.01)
CPC A61B 5/4824 (2013.01) [A61B 5/0024 (2013.01); A61B 5/02055 (2013.01); A61B 5/4848 (2013.01); A61B 5/6831 (2013.01); A61B 5/6832 (2013.01); A61B 2562/063 (2013.01); A61B 2562/066 (2013.01)] 36 Claims
OG exemplary drawing
 
1. A bioanalytical analysis system using a direct pain biosignal measurement to diagnose pain and measure the effectiveness of treatment outcomes, comprising:
a device for measuring pain matrix activity comprising a sensor set configured to be placed contralaterally on the body and at least one additional sensor configured to be placed ipsilaterally on the body, the device configured to measure differences in either voltage or current from measurements taken from the contralateral sensors to detect pain matrix response as deflections of the related biosignal indicating an increase or decrease of an individual's experience of pain; and
the device configured to measure differences in either impedance, conductance, voltage or current from measurements from one of the contralateral sensors and from the at least one ipsilateral sensor in order to calibrate and normalize the contralateral sensors' acquired biosignal;
a controller and/or processor configured to collect and derive pain matrix activity data from the contralateral and ipsilateral sensor signals;
a non-transitory computer readable medium within a network of central processing units having memory and data storage and having embodied thereon one or more computer programs causing one or more of the central processing units to execute certain steps of:
accessing the measured pain matrix activity and a plurality of BioTrace Factors related to biophysical, biological, psychological, social, environmental, and demographic information of the individual and of other individuals;
identifying a population having similar BioTrace Factors; and
identifying treatments and treatment outcomes of the individual and the similarly situated population and correlating these treatments and treatment outcomes to the biosignal deflections related to pain matrix activity to determine the effectiveness of the individual's treatment.