Combined physiological monitoring system

• US 6,678,549 B2
• Filed: 11/15/2001
• Issued: 01/13/2004
• Est. Priority Date: 03/26/2001
• Status: Expired due to Term

• Current Assignee: Emerge Diagnostics, Insight Diagnostics, Inc. (Victory Square Technologies, Inc.)
• Original Assignee: Phil Reaston
• Inventors: Zeff, Scott J., Cusimano, MaryRose
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/002,942
• Publication Number:
  US 20030135129A1
• Time in Patent Office: 789 Days
• Field of Search: 600/546, 600/595, 600/587, 600/300, 601/24, 482/4, 482/114, 482/120, 482/127, 482/51
• US Class Current: 600/546
• 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 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/224 Measuring muscular strength
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition

Abstract

A combined physiological monitoring system (CPMS) (10) which provides an electrodiagnostic functional assessment (EFA) to determine the relative age and severity of a myofasical injury. The EFA utilizes data serviced by electromyography (EMG) sensors which measures the amplitude and frequency of a muscle group; functional capacity evaluation (FCE) sensors, which measure the lift, pull and push capability; range-of-motion (ROM) sensors, which measure the range of motion in the cervical, thoraic, lubosacral, upper and lower extremities; and a grip and pinch sensor, which measures a person'"'"'s grip and pinch strength. The CPMS (10), allows the measurement to be conducted individually or be integrated and conducted simultaneously in combination with EKG activity, blood flow and nerve conduction velocity. The CPMS (10) which can be designed to be portable, operates in combination with a software program (80) which resides in a dedicated laptop computer (82).

Claims

1. A combined physiological monitoring system (CPMS) comprising:

a) a CPMS control circuit (CCC) having means for processing a set of signals which operate said CPMS,

b) a plurality of electromyography (EMG) sensors having means for sensing the amplitude and frequency of a person'"'"'s muscle groups, wherein the output from said EMG sensors are applied to and processed by said CCC,

c) a range-of-motion (ROM) arm having means for measuring the person'"'"'s range of motion, lateral movement, flexion, extension and rotation, wherein the output from said ROM arm is applied to and processed by said CCC,

d) a plurality of functional capacity evaluation (FCE) sensors having means for measuring the person'"'"'s lift, pull and push capability, wherein the output of said FCE sensors are applied to and processed by said CCC,

e) a grip sensor having means for measuring the person'"'"'s grip strength, wherein the output of said grip sensor is applied to and processed by said CCC,

f) a pinch sensor having means for measuring the person'"'"'s pinch strength, wherein the output of said pinch sensor is applied to and processed by said CCC,

g) a power supply having means for converting an input of 120-250 volts at a frequency between 50-60 HZ to a regulated d-c voltage which powers said CPMS, and

h) a computer which operates in combination with software to provide control and data collection for the CPMS.

2. A combined physiological monitoring system (CPMS) comprising:

a) CPMS control circuit having means for processing a set of signals which operate said CPMS, wherein said circuit is partitioned into;

(1) an analog section comprising;

(a) an electromyography (EMG) leads connection circuit having means for determining the structural integrity of the EMG leads, wherein said circuit is connected to a first signal, a second signal and a third signal,

(b) an EMG front end circuit having means for assessing EMG muscle activity, wherein said circuit is connected to the second signal, and to a fourth signal,

(c) a leads-off detection circuit having means for determining if the EMG leads are properly attached, wherein said circuit is connected to said EMG leads connection circuit via the third signal and to a fifth, sixth and seventh signal,

(d) a leads-off display circuit having means for producing a display when an electrode attached to a muscle or a surrounding skin area is not properly attached, wherein said circuit is connected to said leads off detection circuit via the sixth signal,

(e) range-of-motion (ROM)/functional capacity evaluation (FCE)/grip and pinch interface circuit having means for processing signals derived from a person'"'"'s range-of-motion, FCE, grip and pinch, wherein said circuit is connected to an eighth, ninth, tenth, eleventh and twelfth signal,

(f) a ROM front end circuit having means for further processing the signals applied from the ROM/FCE/grip and pinch interface circuit via the eleventh signal, wherein the applied signals are amplified and filtered prior to producing a corresponding digital thirteenth signal,

(g) an FCE/grip and pinch front end circuit having means for receiving and processing the signals applied from the ROM/FCE/grip and pinch interface circuit via the twelfth signal, wherein the data are amplified and filtered prior to producing a fourteenth output signal,

(h) a data acquisition circuit which includes a first DAQ module and a second DAQ module, wherein said circuit is applied the fourth signal from the EMG front end circuit, the fifth signal from the leads off detection circuit, the thirteenth signal from the ROM front end circuit and the fourteenth signal from the FCE/grip and pinch front end circuit, wherein the signals are processed by the data acquisition circuit in combination with the first and second DAQ modules to produce a fifteenth digital signal,

(2) a digital section comprising;

(a) an optical isolation circuit having means for isolating a patient from external electrical power sources, wherein said circuit is connected to said data acquisition circuit via the fifteenth signal, wherein said circuit is also connected to a sixteenth digital power signal, a seventeenth signal, and an eighteenth signal,

(b) a data processing circuit designed to process, transfer and store data wherein said circuit is connected to said optical isolation circuit via the seventeenth signal, wherein said circuit is also connected to a nineteenth signal,

(c) a computer interface circuit which is designed to interface with said CPMS, wherein said circuit is connected to the optical isolation circuit via the eighteenth signal and to said data processing circuit via the nineteenth signal, wherein said circuit is also connected to a twenty-seventh signal,

b) a power distribution circuit that is applied a twenty second analog power signal and a twenty fourth digital power signal, wherein said circuit having means for regulating and distributing digital power to the digital circuits in said CPMS control circuit via said optical isolation circuit which is applied the sixteenth signal from said power distribution circuit, and analog power to said analog section of said CPMS control circuit via a twentieth signal,

c) a leads-off circuit having means for determining if an electrode is improperly attached to a muscle, wherein said circuit is connected to said CPMS control circuit via the first signal,

d) a set of electromyography (EMS) sensors which sense the amplitude, frequency and ischemic changes of various muscle or muscle groups, wherein said sensors, are connected to the seventh signal which is applied to said CPMS control circuit,

e) a range-of-motion (ROM) arm having means for measuring a patient'"'"'s lateral movement, flexion, extension and rotation, each with six-degrees of freedom, wherein said ROM arm is connected to the eighth signal which is applied to said CPMS control circuit,

f) a set of functional capacity evaluation (FCE) sensors having means for measuring a person'"'"'s lift, pull and push capability, wherein said circuit is connected to the ninth signal which is applied to said CPMS control circuit,

g) a grip/pinch sensor having means for measuring a patient'"'"'s hand-grip strength and a pinch strength, wherein said circuit is connected to the tenth signal which is applied to the CPMS control circuit,

h) a power supply interface circuit having an input connected to an external utility power source, said circuit having means for receiving and processing 120-150 volts at 50 or 60 Hz, and means for producing a twenty-first analog power signal and a twenty-third digital power signal, said circuit also having circuit protection in the form of a circuit breaker or a fuse,

i) an analog power supply that when applied the twenty-first signal produces a twenty-second output signal consisting of a regulated 5-volt d-c which powers the analog circuits in said CPMS control circuit,

j) a digital power supply that is isolated from said analog power supply and that when applied the twenty-third output signal produces a twenty-fourth output signal consisting of a regulated 5-volt d-c which powers the digital circuits in said CPMS control circuit,

k) a computer connected to a twenty-fifth signal,

l) a Patient Data Acquisition System (PDAS) software program which resides in said computer, wherein said software provides control and data collection for said CPMS, and,

m) a computer/system interface circuit connected to said computer via the twenty-fifth signal, and to said CPMS control circuit via a twenty-sixth signal, wherein said circuit allows said computer to communicate with said CPMS system.

3. The system as specified in claim 2 wherein said EMG leads connection circuit can accommodate from one to nineteen leads.

4. The system as specified in claim 2 wherein said means in said leads-off detection circuit for determing if the leads are properly attached is by measuring the impedance of the muscles and the surrounding skin area.

5. The system as specified in claim 2 wherein said means in said leads-off display circuit for determining if said electrodes are on or off is by measuring the impedance of each electrode, wherein if the impedance is not at the correct level a corresponding LED illuminates and a signal is sent to said computer which then disables said CPMS.

6. The system as specified in claim 5 wherein a total of 32 electrodes can be utilized.

7. The system as specified in claim 2 wherein the muscle groups monitored by said system comprise:

a) cervical,

b) thoraic,

c) upper extremity,

d) lower extremity,

e) lumbosacral, and

f) chest, wherein data for each muscle group is collected while the muscle group is;

(1) at rest,

(2) going through a range of motions,

(3) at rest,

(4) being applied a gripping, lifting and pulling force, and

(5) at rest.

8. The system as specified in claim 7 wherein the cervical muscle group comprises:

a) fontalis,

b) massater,

c) sternocleidomastoid

d) scalene, and

e) para cervical.

9. The system as specified in claim 7 Wherein the thoraic muscle group comprises:

a) trapezii,

b) seratus

c) Terres,

d) latisimis dorsi, and

e) paraspinal muscles T1-T12.

10. The system as specified in claim 7 wherein the upper extremity muscle group comprises:

a) deltoid,

b) bicep

c) tricep,

d) flexors/extensors of wrist, and

e) thenar.

11. The system as specified in claim 7 wherein the lower extremity muscle group comprises:

a) quads,

b) hamstrings,

c) soleus

d) gastroc,

e) tibiliar anterior/posterior, and

f) ankle.

12. The system as specified in claim 7 wherein the lumbosacral muscle group comprises:

a) paraspinal muscles L1-S1,

b) quadratus lumborum,

c) gluteal,

d) abdominal, and

e) obliques.

13. The system as specified in claim 7 wherein the chest muscle group comprises:

a) pectoralis

b) rectus addomidus, and

c) obliques.

14. The system as specified in claim 2 wherein said means in said ROM arm for measuring the lateral movement, flexion, extension and rotation comprises a set of acceleronometers or potentiometers.

15. The system as specified in claim 2 wherein said means in said FCE sensors for measuring the lift, pull and push comprises a corresponding set of load cells.

16. The system as specified in claim 2 wherein said means for measuring the hand-grip strength in said grip/pinch sensor comprises a load sensor.

17. The system as specified in claim 16 wherein said means for measuring the pinch strength in said grip/pinch sensor comprises a load button-load cell.

18. The system as specified in claim 2 wherein said data processing circuit comprises a universal serial bus (USB).

19. The system as specified in claim 2 wherein said data processing circuit comprises a Firewire (IEEE 1394) or a parallel port.

20. The system as specified in claim 2 wherein said CPMS can be configured to function as an electrocardiagram (EKG) by monitoring the standard EKG placements via the EMG cable using the EMG sensors plus at least 2 channels of the EMG, sensors to look at vasocontriction which correlates to blood flow.

21. The system as specified in claim 2 wherein said CPMS further comprises a means for allowing the following additional physiological functions to be added:

a) temperature

b) heart rate, and

c) skin response,

d) nerve conduction velocity, and

e) blood flow.

22. The system as specified in claim 2 wherein CPMS comprises:

a) up to 32 channels of surface electromyography (EMG)

b) two functional capacity evaluation (FCE) sensors,

c) two channels of nerve conductive velocity (NCV), with temperature control and pre-set electrodes,

d) two channels of range-of-motion,

e) a grip and pinch strength sensor, and

f) up to 10 channels of EKG.

23. The system as specified in claim 22 wherein said CPMS is designed to conduct an electrodiagnostic functional assessment (EFA) integrated with:

a) electromyogrpah (EMG),

b) functional capacity evaluation (FCE),

c) range of motion,

d) grip and pinch strength, and

e) EKG.

24. The system as specified in claim 22 wherein each channel further comprises an analog-to-digital converter (ADC).

25. The system as specified in claim 2 wherein the signal consists of a cable assembly comprising:

a) two active electrodes,

b) a separation bar which can be locked at a distance between 3 to 5 inches to allow the two active electrodes to remain isolated from each other,

c) a temperature sensor, and

d) a ground connection.

26. The system as specified in claim 2 wherein said computer is comprised of a dedicated PC or laptop computer which operates at least 400 MHz and has at least 64 megabytes of RAM.

27. The system as specified in claim 2 wherein said PDAS software program which resides in said computer is comprised of the following major modules:

a) PDAS start,

b) location,

c) password,

d) reselected patient,

e) patient information

f) select protocol,

g) acquire,

h) scanEMG, and

i) test plot.

28. The system as specified in claim 2 wherein computer interface circuit provides communication control between said CPMS control circuit and said computer.

29. A process utilizing a combined physiological monitoring system (CPMS), to conduct an electrodiagnostic functional assessment (EFA) by analyzing a person'"'"'s muscle activity by attaching a set of electrodes from said CPMS to selected muscle groups and measuring their electrical activity, wherein the muscle groups and the measurement process comprises:

a) measure the cervical muscle group by, placing a range of motion (ROM) arm on the top of a person'"'"'s head, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

b) measure the thoracic muscle group by placing said ROM arm at the center of the person'"'"'s mid back and on the shoulders, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

c) measure the lumbosacral muscle group by placing said ROM arm at the center of a person'"'"'s low back, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

d) measure the lower extremities muscle group by placing bilateral sets of electrodes on the front and back of a person'"'"'s thigh and ankles;

place said ROM arm on each leg at the hip and knee joint, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

e) measure the foot muscle group by placing said ROM arm on the person'"'"'s ankle, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

f) measure the upper extremities muscle group by placing said ROM arm on the person'"'"'s head, on one shoulder and on one wrist, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest,

(4) performing a grip test utilizing a grip sensor,

(5) at rest,

(6) perform a pinch test utilizing a pinch sensor which is placed between the thumb and forefinger,

(7) at rest,

g) measure the hand muscle group by placing said ROM arm on the person'"'"'s wrist, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols,

(3) at rest,

(4) performing a pinch test utilizing a pinch sensor which is placed between the thumb and the forefinger,

(5) at rest, and

h) measure the face muscle group by placing said ROM arm on top of TMJ, take measurements while the person is;

(1) at rest,

(2) performing selected range of motion protocols, and

(3) at rest.

30. The system as specified in claim 29 wherein:

a) the cervical muscle group comprises;

sternocleidomastoid, scalene, paracervical, and upper trapzii,

b) the thoraic muscle group comprises;

mid trapezii, lower trapezii, paraspinal muscles T5-T8, T8-T12, terses, and seratus,

c) the lumbosacral muscle group comprises;

paraspinal muscles L1-L3, L5-L51, quaratus lumborum, gluteal muscles, abdominal, and hamstrings,

d) the lower extremities muscle group comprises;

e) the foot muscle group comprises;

all muscles in pelvis, leg and feet,

f) the upper extremities muscle group comprises;

bilateral SCM, scalene, deltoid, biceps, triceps, and wrist flexors/extensors,

g) the hand muscle group comprise;

all muscles in the hand,

h) the face muscle group comprise;

fontalis, massater TMJ.