Electro diagnostic functional assessment unit (EFA-2)

• US 20110201904A1
• Filed: 02/18/2010
• Published: 08/18/2011
• Est. Priority Date: 02/18/2010
• Status: Active Grant

• Current Assignee: Emerge Diagnostics
• Original Assignee: OKTX, LLC
• Inventors: Cusimano Reaston, Mary Rose, Reaston, Phil
• Granted Patent: US 8,535,224 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/225 of the fingers, e.g. by monitoring hand-grip force
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

An electro diagnostic functional assessment unit (EFA-2) that diagnoses age of and treats soft tissue injuries. The EFA-2 utilizes sensor(s) including EMG, Range of Motion, FCE, pinch and grip, and allows for monitoring of muscles and muscle groups to ascertain compliance, pain and function. The EFA-2 also monitors disc pathology and determines whether a person requires surgery or conservative care and, the age of the disc. Additionally, the EFA-2 monitors EEK activity and NCV, as well as invasive EMG that monitors nerve damage. Previously, with NCV the temperature and the position of electrodes would effect readings and produce false positive or false negative readings. The EFA-2 eliminates these problems by incorporating temperature sensor(s) and electrode placement sensor(s). The EFA-2 also provides direct treatment by means of ultrasound and electrical stimulation. Thus, the EFA-2 allows diagnosis any treatment by means of a single unit.

Claims

1. An Electro Diagnostic Functional Assessment Unit (EFA-2) that is comprised of:

a) a control circuit having means for processing signals which operate said EFA-2,

b) means for generating sensor(s) data,

c) means for generating EMG signals for a subject,

d) a computer that is operatively connected to said control circuit and having software capable of receiving, interpreting and storing data from said control circuit, and

e) a power supply having means for converting external power to a regulated d-c voltage which powers said EFA-2.

2. The EFA-2 as specified in claim 1 wherein said control circuit comprises a leads-off detection circuit for determining if leads are properly attached to a subject by measuring the impedance of the subject'"'"'s muscles and the surrounding skin area.

3. The EFA-2 as specified in claim 1 wherein said sensor(s) data is supplied from:

a) a plurality of EMG sensor(s) that have means for sensing the amplitude, frequency or conduction velocity of a person'"'"'s or animal'"'"'s muscle groups, wherein the output from said EMG sensor(s) is applied to and processed by said EFA-2,

b) a plurality of EMG/EKG sensor(s) having means for sensing cardiac response of a person'"'"'s or animal'"'"'s muscle groups, wherein the outputs from said EMG/EKG sensor(s) are applied to and processed by said EFA-2,

c) a plurality of EMG sensor(s) having means for producing a current for sensing the amplitude and frequency and conduction velocity of specific nerves of a person'"'"'s or animal'"'"'s muscle groups or nerve fibers, wherein the sensor(s) are applied to a processed by said EFA-2,

d) a plurality of EEG sensor(s) having means for sensing brain activity of a person or animal when the output of the EEG sensor(s) are applied to and processed by said EFA-2, and

e) a plurality of EMG sensor(s) having means for delivering a current for site-specific treatment, wherein the output from the EMG sensor(s) is processed by the EFA-2.

4. The EFA-2 as specified in claim 1 wherein said sensor(s) data is provided from a blood flow sensor(s) having means for monitoring blood flow of a person or animal, wherein the output from said sensor(s) is processed by the EFA-2.

5. The EFA-2 as specified in claim 1 wherein said sensor(s) data is provided from a heart rate sensor(s) having means for monitoring the rate of heart beats of a person or animal when the output from said sensor(s) is processed by the EFA-2.

6. The EFA-2 as specified in claim 1 wherein said sensor(s) data is provided from a nerve conduction velocity (NCV) sensor(s) having means for monitoring the nerve conduction velocity of a person or animal, wherein the output from said sensor(s) is processed by the EFA-2.

7. The EFA-2 as specified in claim 1 wherein said sensor(s) data is provided from an ultrasound sensor(s) having means for delivering site-specific ultrasound treatment.

8. The EFA-2 as specified in claim 1 wherein said sensor(s) data is provided from an electrical stimulation sensor(s) having means for delivering site-specific treatment.

9. The EFA-2 as specified in claim 1 wherein the sensor(s) are connected by cabling that incorporates twisted pairs with at least three twists per inch and with shielded cabling, wherein the cabling has the ability to pre-amplify at the sensor(s) site.

10. The EFA-2 as specified in claim 1 having a ROM that generates data from a human or animal through the use of potentiometers, goniometers, accelerometers, video or electro magnetic sensor(s), wherein said ROM having means for measuring a person'"'"'s or animal'"'"'s range of motion, lateral movement, flexion, extension, rotation, abduction, adduction, joint capabilities, speed and consistency in either upper or lower extremities or spine, wherein the output from said ROM is processed by the EFA-2.

11. The EFA-2 as specified in claim 1 having a plurality of FCE sensor(s) having means for measuring a person'"'"'s or animal'"'"'s lift, push or pull capability, wherein the output of said FCE sensor(s) is processed by the EFA-2.

12. The EFA-2 as specified in claim 1 having a grip sensor(s) having means for measuring a person'"'"'s grip strength, wherein the output of said grip sensor(s) is processed by said EFA-2.

13. The EFA-2 as specified in claim 1 having a pinch sensor(s) having means for measuring a person'"'"'s pinch strength, wherein the output of said pinch sensor(s) is processed by said EFA-2.

14. The EFA-2 as specified in claim 1 having a temperature sensor(s) having means for measuring a person'"'"'s or animal'"'"'s temperature, wherein the output of said temperature sensor(s) is processed by said EFA-2.

15. The EFA-2 as specified in claim 1 having a blood flow sensor(s), wherein the output of said blood flow sensor(s) is processed by said EFA-2.

16. The EFA-2 as specified in claim 1 wherein the power supply having means for covering an input of 120-250 volts a-c at a frequency between 50-60 Hz to a regulated d-c voltage which powers said EFA-2.

17. The EFA-2 as specified in claim 1 wherein the power supply having means for converting a battery input to a regulated d-c voltage which powers said EFA-2.

18. The EFA-2 as specified in claim 1 wherein the computer interface to sensor(s) data is via a single data acquisition device.

19. The EFA-2 as specified in claim 1 wherein the computer software having means for transferring the collected data over the Internet or through magnetic media for remove processing on a further computer.

20. The EFA-2 as specified in claim 1 wherein stored data is processed locally and the results displayed on the computer.

21. The EFA-2 as specified in claim 1 wherein the computer software having means for allowing remote control of the system.

22. The EFA-2 as specified in claim 1 further comprising EMG leads connection circuitry that can accommodate from one to 100 leads.

23. The EFA-2 as specified in claim 1 further comprising sensor(s) having means for delivering site-specific electrical stimulation treatment.

24. The EFA-2 as specified in claim 1 further comprising a Galvanic Skin Response (GSR) sensor(s) for measuring galvanic skin response, wherein the output from the sensor(s) is processed by the EFA-2.

25. The EFA-2 as specified in claim 1 further comprising level sensor(s) to determine the height of the other sensor(s).

26. The EFA-2 as specified in claim 1 further comprising lead control circuitry to ensure the integrity of the lead contacts.

27. The EFA-2 as specified in claim 1 further comprising means for determining the age of an injury.

28. The EFA-2 as specified in claim 1 further comprising means for determining compliance malingering and pain.

29. The EFA-2 as specified in claim 2 further comprising proprietary algorithms.

30. An Electro Diagnostic Functional Assessment Unit (EFA-2) that specifically monitors muscle functions, cardiac functions, nerve functions, nerve conductions, temperature, heart rate, blood flow and brain activity simultaneously with range of motion including lifting, pulling, pushing, gripping and pinching, wherein said EFA-2 also provides direct treatment by means of electrical simulation and ultrasound, wherein said EFA-2 is comprised of:

a) a plurality of electromyograph (EMG) sensor(s),

b) a plurality of electrocardiogram (EKG) sensor(s),

c) a plurality of human range of motion (ROM) sensor(s),

d) a plurality of animal range of motion (ROM) sensor(s),

e) a temperature sensor(s),

f) a plurality of functional capacity evaluation (FCE) sensor(s),

g) a galvanic skin response (GSR) sensor(s),

h) a grip strength sensor(s),

i) a pinch strength sensor(s),

j) a plurality of nerve conduction velocity (NCV) sensor(s),

k) a level sensor(s),

l) a heart rate sensor(s),

m) a plurality of electroencephalogram (EEG) sensor(s),

n) a blood flow sensor(s),

o) an electrical stimulation sensor(s)/delivery mechanism,

p) an ultrasound sensor(s)/delivery mechanism,

q) a plurality of sensor(s) for detecting lead-fail conditions,

r) a control circuit having means for processing signals which operate said EFA-2,

s) a computer that is operatively connected to said control circuit and having software that is capable of receiving, interpreting and storing signals from said control circuit, and

t) a power supply having means for converting external power to a regulated d-c voltage which powers said EFA-2.