US2021085243A1PendingUtilityA1

Apparatus, system, and method for the objective evaluation of corporeal pain and autonomic nerve dysfunction

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Assignee: EPISCAN GLOBAL LLCPriority: Dec 14, 2016Filed: Dec 14, 2018Published: Mar 25, 2021
Est. expiryDec 14, 2036(~10.4 yrs left)· nominal 20-yr term from priority
G16H 20/10G16H 50/70G16H 20/40G16H 10/40G16H 20/30A61B 5/4041G16H 10/60A61B 8/08A61B 5/14532A61B 5/0022A61B 5/14546A61B 5/01G16H 15/00A61B 5/053A61B 5/14551A61B 5/4266A61B 2560/0214A61B 2503/40A61B 5/4824
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Claims

Abstract

Various methods and machines have been used in the past to measure electrical characteristics of living tissue for purpose of locating an area of abnormal nervous system activity. However, whereas prior art methodologies merely allow for the detection of pain, the apparatus, system and method of the present invention allow for the objective assessment of autonomic nerve function and/or pain severity. As such, the present invention finds utility not only the initial diagnosis, including the early diagnosis of generally asymptomatic autonomic dysfunction, but also the on-going treatment of any disease, disorder or injury associated therewith. To that end, the apparatus, system and method of the present invention allows medical practitioners to non-invasively and quantitatively distinguish the organic from the psychosomatic and legitimate pain patients from drug seekers and opioid addicts, as well as to directly and objectively compare the efficacy of different drug regimens and therapy protocols.

Claims

exact text as granted — not AI-modified
1 - 22 . (canceled) 
     
     
         23 . A method for calculating the intensity of P and S imbalance exhibited by a subject, wherein said method comprises the following steps:
 a. identify a local area of tissue to be analyzed;   b. using the device of claim  21 , apply the entire active surface of the sensor head to a series of aligned target sites within said local area;   c. compare the absolute STC values for each target site and identify one or more sites of asymmetry;   d. optionally further compare the absolute STC value obtained at said one or more sites of asymmetry to a reference STC value obtained from (a) a prior reading for said subject at said identical local area; (b) a database of STC data collected from disease and/or normal patients; or (c) a combination thereof; and   e. analyzing and transducing the degree of difference between the absolute STC value at said one or more sites of asymmetry and the reference values in steps (e) and (f) to determine the presence and calculate the intensity of autonomic dysfunction exhibited at said one or more sites of asymmetry within said local area of tissue.   
     
     
         24 . The method of  claim 23 , wherein said subject is a non-human animal. 
     
     
         25 . The method of  claim 23 , wherein said subject is a non-verbal human. 
     
     
         26 . The method of  claim 23 , further comprising the step of monitoring changes in absolute STC values at said one or more sites of asymmetry over time, before, during, and after the application of a first prescribed therapeutic regimen to determine the efficacy of said first therapeutic regimen in treating the underlying sympathetic nerve dysfunction associated therewith. 
     
     
         27 . The method of  claim 23 , further comprising the step of monitoring changes in absolute STC values at said one or more sites of asymmetry over time, before, during, and after the application of a second prescribed therapeutic regimen to determine the efficacy of said second therapeutic regimen relative to said first therapeutic regimen. 
     
     
         28 . The method of  claim 23 , further comprising the step of (a) analyzing differences in unilateral STC to discriminate among, diagnose and treat transient ischemic attacks (“TIA”), reversible ischemic neurological deficits, and completed unilateral hemispheric stroke, or (b) analyzing STC regional differences to discriminate among, diagnose and treat various forms of migraine, cluster, tension, and other headache types. 
     
     
         29 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of a disease or disorder selected from the group consisting of psychological and neurochemical disorders such ADD/ADHD, anxiety, bipolar disease, depression; coronary disorders such as angina, coronary artery disease (CAD), atherosclerosis, cardiac dysrhythmias, cardiomyopathy, congestive heart failure, acute and post myocardial infarction, tachycardia; respiratory disorders such as asthma and COPD; gastrointestinal disorders such as gastroparesis; and other localized and systemic disorders such as diabetes, chronic hypertension, chronic fatigue syndrome, edema, vertigo, fibromyalgia, Parkinson's disease, polyneuropathy, renal failure, sleep disorders, syncope and collapse, tension headache, and thyroid disease. 
     
     
         30 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of cardiovascular autonomic neuropathy in said subject. 
     
     
         31 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of endocrinal autonomic neuropathy in said subject. 
     
     
         32 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of neurological autonomic neuropathy in said subject. 
     
     
         33 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of pulmonary autonomic neuropathy in said subject. 
     
     
         34 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of early stage arrhythmia in said subject. 
     
     
         35 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of early stage COPD in said subject. 
     
     
         36 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of sleep apnea in said subject. 
     
     
         37 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of depression in said subject. 
     
     
         38 . The method of  claim 23 , further comprising the step of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of vertigo, syncope, and dizziness in said subject. 
     
     
         39 . The method of  claim 23 , further comprising the steps of correlating the intensity of P and S imbalance calculated in step (g) to the diagnosis of chronic disease in said subject and the efficacy of therapies applied to said subject for the treatment of said chronic disease. 
     
     
         40 . The method of  claim 39 , wherein said chronic disease is diabetes mellitus. 
     
     
         41 . The method of  claim 39 , wherein said chronic disease is hypertension. 
     
     
         42 . The method of  claim 39 , wherein said chronic disease is heart disease.

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