US20120143064A1 - Muscle function evaluating system - Google Patents

Muscle function evaluating system Download PDF

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Publication number
US20120143064A1
US20120143064A1 US13/289,775 US201113289775A US2012143064A1 US 20120143064 A1 US20120143064 A1 US 20120143064A1 US 201113289775 A US201113289775 A US 201113289775A US 2012143064 A1 US2012143064 A1 US 2012143064A1
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patient
sensor
processor
display
sets
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US13/289,775
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Charles Dean Cyphery
Marco VITIELLO
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Med Tek LLC
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Individual
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Priority to US13/289,775 priority Critical patent/US20120143064A1/en
Assigned to MEDICAL TECHNOLOGIES UNLIMITED, INC. reassignment MEDICAL TECHNOLOGIES UNLIMITED, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CYPHERY, CHARLES D., VITIELLO, MARCO N.
Publication of US20120143064A1 publication Critical patent/US20120143064A1/en
Assigned to MED-TEK LLC reassignment MED-TEK LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MEDICAL TECHNOLOGIES UNLIMITED, INC.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/389Electromyography [EMG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/22Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224Measuring muscular strength
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/742Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/743Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04Arrangements of multiple sensors of the same type
    • A61B2562/046Arrangements of multiple sensors of the same type in a matrix array
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022Monitoring a patient using a global network, e.g. telephone networks, internet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/22Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224Measuring muscular strength
    • A61B5/225Measuring muscular strength of the fingers, e.g. by monitoring hand-grip force

Definitions

  • the present disclosure relates to a system and a device for measuring a surface electromyography (EMG) signal, a gyroscopic motion sensor signal and a signal from a strain gauge testing apparatus to evaluate muscle functions of a patient.
  • EMG surface electromyography
  • Previously filed applications generally describe an EMG measuring system (e.g., U.S. patent application Ser. Nos. 10/504,031 and 11/914,385, the entire contents of which are incorporated by reference herein).
  • the present disclosure relates to a dynamic muscle function monitoring and evaluating system.
  • a number of sensors are attached to various parts of the subject's body (i.e., patient's body) for data collection.
  • the sensor data are then directly fed into a point of detection (POD) device for conditioning, acquiring, and transmitting the sensor data.
  • the sensors include, for example, but are not limited to, a surface EMG (sEMG) sensor, a motion detection sensor, and a muscle strength measurement sensor.
  • the POD device acquires continuous analog signals and then digitizes these signals by sampling at a rate of, for example, 2 kHz. These digital data are then transferred wirelessly to a computer system for processing using software.
  • the system can monitor and record the data measured by the sEMG sensors attached to various muscle groups in the human body. While acquiring the sEMG signals, the system can simultaneously acquire a motion sensor signal responsive to the body motion and/or a signal responsive to muscle strength.
  • the system in the present disclosure is used for muscular testing by acquiring muscle contraction patterns and /or testing range-of-motion and functional capacity using surface EMG electrodes.
  • the system can be specialized to test, for example, cervical, thoracic and lumbar spines as well as upper and lower extremities.
  • the system can collect and display muscle function data and characteristics including tone, fatigue, as well as other activities that take place in the muscle.
  • This system can be used in a number of arenas such as occupational and sports medicine, and rehabilitation clinics.
  • the present system uses a range of motion (ROM) device in combination with functional capacity evaluation devices and surface EMG electrodes to monitor muscle functions. Gyroscopic sensors are utilized to detect motion.
  • FCE functional capacity evaluation
  • a new functional capacity evaluation (FCE) device is also employed (the details of the functional capacity evaluation device are described in copending application filed on dd/mm/yyyy concurrently with this application (FUNCTIONAL CAPACITY EVALUATOR, the Attorney's Docket No. 085232-0030), the entire contents of which are incorporated by reference herein).
  • the signal conditioning in the present system takes place in two stages, one outside the POD device and close to the sEMG sensor leads, and the other inside the POD device itself.
  • the POD device is small and thin, and is battery powered rather than AC powered. Accordingly the POD device can be portable and wearable by the patient.
  • the POD device transmits all data wirelessly via an ad-hoc wireless network.
  • the present system also includes a program which will be executed by a processor in a computer to control the overall system, present instructions to the patient, manage patient information and record the measured data.
  • the present disclosure provides a comprehensive muscular function monitoring and evaluating system and devices used in the system.
  • a system in one example, includes a processor, a wireless interface coupled to the processor, a display coupled to the processor, a non-transit storage device coupled to the processor which stores a muscular function monitoring and evaluating program and sets of test procedures, a signal collection device wirelessly coupled to the processor via the wireless interface and a sensor connected to the signal collection device.
  • the program when executed by the processor, causes the system to perform the following functions.
  • the processor displays a patient information screen on the display for an operator to input patient's data for a patient to be tested.
  • the processor receives the patient's data input through the patient information screen.
  • the processor displays, on the display in accordance with one of the sets of test procedures, a muscle map indicating a place on a body to which the sensor is to be attached.
  • the processor instructs the patient in accordance with the one of the sets of test procedures, through at least one of instruction language displayed on the display, an animation or video image displayed on the display, and an audible instruction.
  • the processor receives a signal measured by the sensor, and records the signal into the storage device or transmits the signal to an outside server.
  • the storage device may be located in a local computer or in a server system or “cloud” accessible from the computer through a network.
  • the storage device may store a patient database
  • the program further causes the processor to obtain patient information by searching the patient database according to the input patient's data.
  • the processor selects one of the sets of test procedures in accordance with the obtained patient information.
  • one of the sets of test procedures is selected by an input by the operator.
  • the program further causes the processor to display on the display a test procedure selection screen displaying a list of the sets of test procedures.
  • the processor receives a selection of one of the sets of test procedures.
  • the muscle map is displayed on the display in accordance with the selected one of the sets of test procedures.
  • Any of the above systems optionally includes a camera, and the program further causes the processor to record a video image of the patient acquired by the camera and to display the video image on the display.
  • the program further causes the processor to display the received sensor signal on the display.
  • the sEMG surface electromyography
  • the muscle map indicates a place on a patient's body to which the one or more sEMG sensors are to be attached by different colors or numbers.
  • the senor includes one or more motion sensors utilizing one or more gyroscopes.
  • the senor includes a functional capacity sensor including a lift portion, a pinch portion and a grip portion.
  • the program further causes the processor to display an error message when the system detects a sensor error.
  • the sensor error is detected by the signal collection device or by the processor.
  • the program further causes the processor to calibrate the sensor.
  • a non-transit recording medium stores a program which, when executed by a computer, causes the computer to perform the functions of displaying a patient information screen on a display coupled to the computer for an operator to input patient's data of a patient to be tested, receiving the patient's data input through the patient information screen, displaying, on the display in accordance with one of a plurality of sets of test procedures, a muscle map indicating a place on a patient's body to which a sensor is to be attached, instructing the patient in accordance with the one of the sets of test procedures, through at least one of instruction language displayed on the display, an animation or video image displayed on the display, and an audible instruction, receiving a signal measured by the sensor, and recording the signal into a storage device coupled to the computer or transmitting the signal to an outside server.
  • the non-transit recording medium is, for example, an optical disk such as CD-ROM, CD-RW, DVD-ROM, DVD-RW, DVD-R, DVD-RAM or Blu-Ray Disk, an EEPROM such as a flash memory or a hard disk drive.
  • an optical disk such as CD-ROM, CD-RW, DVD-ROM, DVD-RW, DVD-R, DVD-RAM or Blu-Ray Disk
  • an EEPROM such as a flash memory or a hard disk drive.
  • FIG. 1 shows an exemplary schematic overall view of the muscular function evaluating and monitoring system of the present disclosure.
  • FIG. 2 shows an exemplary block diagram of a computer used in the system of FIG. 1 .
  • FIG. 3 shown an exemplary block diagram of a POD device used in the system of FIG. 1 .
  • FIG. 4 shows an exemplary schematic view of an ROM sensor.
  • FIG. 5 shows an exemplary view of an sEMG sensor.
  • FIG. 6 shows an exemplary view of an FCE sensor.
  • FIG. 7 shows an exemplary operations flow chart within the computer 20 and the POD device 10 .
  • FIG. 8 shows an exemplary flow chart for measuring muscular function data through sEMG sensors, a ROM sensor and/or an FCE sensor.
  • FIG. 9 shows an exemplary screen view of a testing protocol selection screen.
  • FIG. 10 shows an exemplary patient information screen view.
  • FIG. 11 shows an exemplary main menu screen view.
  • FIG. 12 shows an exemplary muscle map view.
  • FIG. 13 shows an exemplary main menu screen view during a test.
  • FIG. 14 shows another exemplary flow chart for measuring muscular function data
  • FIG. 1 shows one exemplary schematic view of an overall muscular function monitoring and evaluating system according to the present disclosure.
  • the system includes a POD device 10 and a computer 20 .
  • the POD 10 is wirelessly connected to the computer 20 .
  • the computer 20 includes a processor 201 , an I/O interface 202 including a wireless network interface and a local area network (LAN) interface coupled to the processor (for example, via a bus line 203 ), a non-transitory storage device 204 such as a hard disk drive (HDD), memories 205 such as a ROM and a RAM and a display 206 .
  • the computer 20 can further include a optical disk drive and a printer.
  • the display 206 is optionally a touch sensitive display (i.e., a touch panel display).
  • the computer 20 optionally further includes a camera 207 and a microphone 208 for capturing real-time video clips of patient activities and for recording audio during testing.
  • the computer 20 communicates with a server or another computer 60 via a network 70 including an intranet and/or the Internet.
  • the HDD 204 stores a comprehensive muscular activity profiler (CMAP) program for controlling the overall system, presenting instructions to the patient, managing patient information and recording the measured data.
  • Sensors include surface EMG (sEMG) sensors 30 , range-of-motion (ROM) sensors 40 and a functional capacity evaluation (FCE) sensor 50 , all of which are connected to the POD device 10 .
  • FIG. 3 shows an exemplary block diagram of the POD device 10 .
  • the POD device 10 is a portable, wearable and non-invasive device that receives sEMG signals from the sEMG sensors 30 , the range-of-motion (ROM) signals from range of motion sensors 40 and the functional capacity evaluation signals from the FCE sensor 50 .
  • the signals from these sensors work in conjunction with one another to obtain a set of output signals, which relay information relating to the functional capability and characteristics of muscle groups and surrounding tissues.
  • the signals from all sensors are sent to the POD device 10 to be conditioned and, if necessary, A-D converted by circuitry in the POD device 10 and then transferred wirelessly over, for example, an ad hoc wireless network to the computer 20 .
  • the signals from the ROM sensors i.e., digital signals
  • SPI serial-peripheral interface
  • the signals from the ROM sensors may be digital signals.
  • the signals from the sEMG sensors are input to a multistage filter and amplifier circuit 106 and A-D converted by an AD-converter 103 after multiplexed by an analog multiplexer 105 .
  • the processor 102 processes the digital data and transmits the processed data to the computer 20 wirelessly via a wireless interface 104 .
  • the POD device 10 can connect three sEMG sensors 30 , two ROM sensors 40 and one FCE sensor 50 .
  • Each sEMG sensor can monitor eight sEMG signals (i.e., eight channels), and each ROM sensor outputs three signals (three channels) corresponding to three degrees of freedom. Therefore, the POD device 10 can simultaneously monitor up to 24 channels of sEMG signals, six (6) channels of ROM signals, and one (1) channel of FCE signal.
  • the POD device 10 may be powered by an internal rechargeable battery such as a polymer Lithium-ion battery.
  • the POD device 10 includes connectors for three sEMG sensors, two ROM sensors and one FCE sensor.
  • Each of the connectors for the sEMG sensor, the ROM sensor and the FCE sensor has a different size and/or shape so that the operator does not insert a sensor to a wrong connector. It is noted that since the FCE sensor of the present application is one integrated FCE sensor, the POD device 10 may have only one input port for the integrated FCE sensor.
  • FIG. 4 shows a schematic diagram of a ROM sensor 40 .
  • the ROM sensor 40 utilizes a combination of gyroscopic sensors 401 x , 401 y and 401 z to detect motion of the subject.
  • the ROM sensor 40 can detect and measure an angular rate of the subject (e.g., a head of the patient), e.g., how quickly the object rotates.
  • the ROM sensor 40 contains three gyroscopes 401 x , 401 y and 401 z for measuring three degrees of freedom (i.e., x, y and z directions).
  • iSensor® gyroscopes (ADIS16260/ADIS16265) made by Analog Devices can be used for the gyroscopes, which outputs digital sensor signals.
  • the three gyroscopes 401 x , 401 y and 401 z are mounted orthogonally to one another inside a plastic enclosure.
  • ROM sensors can be connected to the POD device 10 .
  • one ROM sensor is used at a time.
  • a “dual inclinometer arrangement” This arrangement allows for more accurate ROM data in an area like the lumbar spine where upper vertebrae move relative to the lower vertebrae.
  • both ROM sensors are read, and then one sensor's motion is subtracted from the other sensor's motion, which isolates one particular movement of the body.
  • the ROM sensor may be attached to the patient with a plastic and lycra harness, placed over the patient's clothing for most testing protocols.
  • FIG. 5 shows an exemplary schematic view of sEMG sensor 30 .
  • the sEMG sensor 30 is a one-piece reusable cable/lead assembly.
  • the sEMG sensor 30 is directly connected to the POD device 10 via a connector 301 , for example, manufactured by Hirose Corporation.
  • the sEMG sensor 30 includes a small printed circuit board (PCB) 302 that includes an amplifier circuit for the first amplification stage of the signal conditioning.
  • the PCB 302 is encapsulated in a base portion 303 of the sEMG sensor 30 . From the base portion 303 , nine flexible leads extend, one of which is a ground lead. The other eight leads are paired and color-coded electrode leads, respectively.
  • PCB printed circuit board
  • the eight leads have different colors, for example, yellow, green, purple, orange, blue, white, red and brown. Black may be used for the ground line.
  • Each of the eight leads is to be affixed to a pair of FDA-approved surface electrodes 304 .
  • the signals detected by the sEMG sensors 30 are sent to the POD device 10 for the second stage amplification.
  • FIG. 6 shows an exemplary perspective view of a functional capacity evaluation (FCE) sensor 50 .
  • FCE functional capacity evaluation
  • IFT isometric functional test
  • pinch strength pinch strength
  • grip strength the present system utilizes an integrated measurement tool as shown in FIG. 6 .
  • the FCE sensor 50 is a combination of three different sensors. This combined sensor allows for the isometric functional dead-lift, pinch strength, and grip strength measurements with a lift portion 501 , a pinch portion 502 and a grip portion 503 , respectively, which are integrated in one device.
  • the FCE sensor 50 utilizes a single full bridge strain gauge mounted to allow accurate readings from all three exercises without sacrificing resolution between measurements of differing force levels.
  • the grip test allows adjustments to grip span with a finer resolution and wider and smaller span than a conventional device (e.g., a Jamar Grip).
  • the pinch test allows measurements to be made in a fashion similar to a load cell and can also be adjusted to different pinch spans.
  • the isometric function test measures, for example, asymmetric performance in one-tenth pound increments against an immovable footplate.
  • Software or a program to control the overall system is stored in a storage device such as HDD 204 of the computer 20 .
  • the software when executed by the CPU 201 , causes the CPU to perform at least two functions, i.e data acquisition and data management.
  • the executed software has no direct control over the hardware, but interacts with the hardware to read the conditioned data signals located in the POD device 10 .
  • the computer 20 on which the software runs is operated by trained technicians in the field.
  • the software presents a series of screen prompts which guide the technicians through the necessary steps to complete each step in the chosen protocol.
  • a “screen” generally refers to an image displayed on the display 206 including a “window” displayed on the display. These steps are defined by text, audio and/or video instructions in order to provide the clearest possible explanation. A video of the test will also be recorded in order to ensure proper test administration and compliance.
  • the computer 20 can collect the data simultaneously on a timing interval.
  • the computer 20 may stream the data to the outside server 60 during the measurement.
  • the data is also transferred in real-time to the computer 20 during a step from the POD device 10 so that the operator can monitor the quality of the data being acquired.
  • the computer 20 optionally detects sensor failures, such as a sensor not being connected, a sensor lead falling off or a sensor lead experiencing an inconsistent connection.
  • the sensor failures may be detected by the POD device 10 and sent to the computer 20 . If a sensor failure is detected, the computer 20 notifies the operator through a sensor failure screen, while suspending any data acquisition activity. Once the failed sensor is corrected, the test can be resumed or redone.
  • All data can be encrypted upon recording to the computer 20 .
  • the data will remain encrypted until it is transferred to the outside server 60 for further processing of the data.
  • the data may be recorded to multiple files due to the different file types. Each file may be encrypted and will remain encrypted until, for example, transfer to an outside server 60 for further data processing, archival, and analysis.
  • FIG. 7 shows an exemplary operations flow chart within the computer 20 and the POD device 10 .
  • FIG. 8 shows an exemplary flow chart for measuring muscular function data through sEMG sensors, ROM sensors and/or an FCE sensor.
  • An operator who wishes to run a specific testing protocol to measure muscular functions will first turn on computer 20 and execute the program. Usually, the operator is required to log-in to operate the program (Step 5801 ) so that only a certified operator accesses the system and data.
  • the computer 20 on which the program is now running displays a testing protocol selection screen on display device 206 , for example, an LCD touch panel screen (Step S 802 ).
  • a testing protocol selection screen is shown in FIG. 9 .
  • testing protocols include a Cervical Protocol, a Thoracic Protocol, a Carpal Tunnel & Epicondyle Protocol, a Shoulder & Epicondyle Protocol, a Lumbar Protocol, a Lower Extremities Protocol, a Hip/Groin Protocol, and a Custom Ankle Protocol.
  • a Cervical Protocol a Thoracic Protocol
  • a Carpal Tunnel & Epicondyle Protocol a Shoulder & Epicondyle Protocol
  • a Lumbar Protocol a Lower Extremities Protocol
  • Hip/Groin Protocol a Custom Ankle Protocol.
  • the testing protocols may include one or more subsets of the protocols.
  • the protocols may be provided as a pull-down menu.
  • Step S 803 the computer 20 next shows a patient information screen as shown in FIG. 10 on the LCD display 206 (Step S 804 ).
  • the patient information screen provides information to match “subjective” complaints of the patient with “objective” findings of the test.
  • the patient information screen prompts the operator to input, for example, but not limited to, the patient's personal information, physician's information, insurance information, test indication, etc.
  • Step S 805 the computer 20 displays a main testing protocol menu for the selected testing protocol, i.e., a menu for the Carpal Tunnel & Epicondyle Protocol, as shown in FIG. 11 (Step S 806 ).
  • the menu screen shows a muscle map 1102 illustrating positions of an sEMG sensor and a ROM sensor in a screen area 1103 .
  • FIG. 12 shows an enlarged view of the muscle map 1102 .
  • the muscle map 1102 shows three sEMG sensors by number (1-3) and two ROM sensor by a “MT” image. As set forth above, each of the sEMG sensors has eight leads with different colors.
  • the muscle map 1102 shows each position of a sensor head (a pair of sensors) by color and the number so that the operator can place the sensor heads on appropriate portions of the patient's body.
  • the operator attaches the respective sensors to the patient's body.
  • the operator is requested to connect the respective sensors to the POD device 10 .
  • the operator is instructed to calibrate the ROM sensors.
  • the operator is instructed to place the ROM sensors on a flat surface and to connect cables of the ROM sensors into the POD device 10 .
  • initialization begins. If re-calibration is necessary, the operator can repeat the calibration by touching a “Repeat” button. If the ROM sensors are calibrated correctly, the operator touches an “OK” button. Then, the ROM sensors are attached to designated places of the patient body by, for example, attachment pockets.
  • the FCE sensor is also calibrated.
  • the operator is instructed to place the FCE sensor on a flat surface and to connect a cable into the POD device. Then, the operator touches a “Proceed” button to begin initialization. If re-calibration is necessary, the operator can repeat the calibration by touching a “Repeat” button. If the FCE sensors are calibrated correctly, the operator touches an “OK” button.
  • Step S 807 One testing protocol usually includes several sub steps.
  • FIG. 13 shows an exemplary screen view during the testing (Step S 808 ).
  • an animation area 1302 an animation is displayed to demonstrate and instruct the patient how to move body parts.
  • an instruction area 1303 detailed instructions on the command are shown so the operator or the patient can perform appropriate actions.
  • the instructions may be provided by audio.
  • a video screen area 1304 which can be the same area as the area 1103 , shows a live video image taken by a camera 207 attached to the computer 20 .
  • the computer 20 can record the video image of the patient taken by the camera 207 and audio taken by the microphone 208 throughout the testing.
  • the video image 1301 can be switched at any time with the muscle map 1102 , by touching a switch button.
  • the computer 20 acquires signals detected by each sensor via the POD device 10 (Step S 809 ).
  • the screen also shows a status of each sEMG sensor 1305 . If the system cannot correctly detect a signal, an error status will be shown at the corresponding sEMG sensor. For example, the POD device 10 can detect an error in the sensors. Further, when the operator touches one of the status monitors of the sEMG sensors, the currently received signals are shown in a signal area 1306 . At the same time, a corresponding muscle map may be shown on the area 1304 . Similarly, a ROM signal 1307 is also shown for monitoring the ROM sensors.
  • the screen of FIG. 13 also provides a note area 1308 so that the operator can input patient's comments, physician's comments and/or operator's comments.
  • the computer 20 stores such comments in the storage device or transfers them to the outside server 60 .
  • any sub-step of the testing protocol can be repeated by touching a “Repeat” button (Step S 810 ). If one sub step is completed, the operator may touch a “Next” button to proceed with the next sub step (S 811 ). If all sub steps are completed, the operator can finish the program (S 813 ), or can select a new testing protocol (S 812 ). Optionally, the program returns to the login screen.
  • the computer 20 may upload the acquired data to the outside server 60 in connection with the patient information, or may locally retain the acquired data in the storage device.
  • the data may include measured signal data, a video image acquired during the testing, and/or comments input to the note area 1308 .
  • the testing protocol is first selected (S 802 and 5803 ) and then the patient information is input to the computer 20 (S 804 and S 805 ). Alternatively, the patient information is input first and then the testing protocol is selected.
  • the system automatically runs the required testing protocol and in such a case, the operator does not need to select the testing protocol. For example, when the patient is tested more than one time, the system already knows the patient's information and tested protocol. As shown in FIG. 14 , when the operator starts the muscular evaluation program (S 1401 ), the system requires the operator input patient information, e.g., the name or any identification number of the patient (S 1402 ). If the patient record exists (S 1403 ), the system obtains the patient record from a database (S 1048 ). The database may be located in the computer 20 or in the outside server 60 . When the patient records indicate the testing protocol was previously applied to the patient, the system runs the testing protocol (S 806 ). The testing protocol can be automatically executed or executed by the operator's input. The system can further display patient information for the operator to confirm the patient's information and/or modify the patient's information.
  • the testing protocol can be automatically executed or executed by the operator's input.
  • the system displays the patient information screen requesting input of patient information (S 1404 ).
  • the system displays a protocol selection screen (S 1406 ).
  • a proper testing protocol is selected (S 1407 )
  • the system runs the testing protocol (S 806 ).
  • the foregoing muscular function monitoring and evaluating system may further include additional programs/modules.
  • the system may include a comprehensive impairment rating evaluation program that is designed to assist physicians in determining whether an injured patient has reached maximum medical improvement (MMI) and /or permanent and stationary (P&S) status based on the measured and acquired results by utilizing the muscular function monitoring and evaluating system.
  • MMI maximum medical improvement
  • P&S permanent and stationary
  • This program compares the measured results against, for example, the AMA guide for impairment rating, and provides the physicians with evaluation results.
  • Another example of the programs is a comprehensive pre-employment physical evaluation program that provides employers an objective assessment of an individual's ability to perform the physical job functions of the position for which he/she has been hired. This program can provide the assessment of the person tested by the muscular function monitoring and evaluating system.
  • muscular function monitoring and evaluating system may includes a comprehensive activity interactive program that is a tool for physical therapist or their assistant to assure patient compliance with their therapy regimen and its course.
  • This program allows the patient to place goals into the program and observe the performance against those goals.
  • This program can monitor progress of recovery of muscular function of the patient with respect to the set goals based on the measured results by utilizing the muscular function monitoring and evaluating system.
  • the program can also print out the progress for the patients' records.

Abstract

A muscular function monitoring and evaluating system includes a processor, a wireless interface, a display, a storage device storing a program and sets of test procedures, a signal collection device wirelessly coupled to the processor and a sensor connected to the signal collection device. The program, when executed by the processor, causes the system to display a patient information screen on the display for an operator to input patient's data of a patient to be tested, and receive the patient's data input through the screen. The processor displays, in accordance with one of the sets of test procedures, a muscle map indicating a place on the patient's body to which the sensor is to be attached. The processor instructs the patient through displayed instruction language, an animation or video image, or audible instructions.

Description

  • This application claims priority of U.S. provisional application No. 61/344,893 filed on Nov. 5, 2010, the entire contents of which are incorporated by reference herein.
  • TECHNICAL FIELD
  • The present disclosure relates to a system and a device for measuring a surface electromyography (EMG) signal, a gyroscopic motion sensor signal and a signal from a strain gauge testing apparatus to evaluate muscle functions of a patient. Previously filed applications generally describe an EMG measuring system (e.g., U.S. patent application Ser. Nos. 10/504,031 and 11/914,385, the entire contents of which are incorporated by reference herein).
  • The present disclosure relates to a dynamic muscle function monitoring and evaluating system. A number of sensors are attached to various parts of the subject's body (i.e., patient's body) for data collection. The sensor data are then directly fed into a point of detection (POD) device for conditioning, acquiring, and transmitting the sensor data. The sensors include, for example, but are not limited to, a surface EMG (sEMG) sensor, a motion detection sensor, and a muscle strength measurement sensor. The POD device acquires continuous analog signals and then digitizes these signals by sampling at a rate of, for example, 2 kHz. These digital data are then transferred wirelessly to a computer system for processing using software.
  • The system can monitor and record the data measured by the sEMG sensors attached to various muscle groups in the human body. While acquiring the sEMG signals, the system can simultaneously acquire a motion sensor signal responsive to the body motion and/or a signal responsive to muscle strength.
  • The system in the present disclosure is used for muscular testing by acquiring muscle contraction patterns and /or testing range-of-motion and functional capacity using surface EMG electrodes. The system can be specialized to test, for example, cervical, thoracic and lumbar spines as well as upper and lower extremities. The system can collect and display muscle function data and characteristics including tone, fatigue, as well as other activities that take place in the muscle. This system can be used in a number of arenas such as occupational and sports medicine, and rehabilitation clinics.
  • The present system uses a range of motion (ROM) device in combination with functional capacity evaluation devices and surface EMG electrodes to monitor muscle functions. Gyroscopic sensors are utilized to detect motion. A new functional capacity evaluation (FCE) device is also employed (the details of the functional capacity evaluation device are described in copending application filed on dd/mm/yyyy concurrently with this application (FUNCTIONAL CAPACITY EVALUATOR, the Attorney's Docket No. 085232-0030), the entire contents of which are incorporated by reference herein).
  • The signal conditioning in the present system takes place in two stages, one outside the POD device and close to the sEMG sensor leads, and the other inside the POD device itself. The POD device is small and thin, and is battery powered rather than AC powered. Accordingly the POD device can be portable and wearable by the patient. The POD device transmits all data wirelessly via an ad-hoc wireless network.
  • The present system also includes a program which will be executed by a processor in a computer to control the overall system, present instructions to the patient, manage patient information and record the measured data.
  • SUMMARY
  • The present disclosure provides a comprehensive muscular function monitoring and evaluating system and devices used in the system.
  • In one example, a system includes a processor, a wireless interface coupled to the processor, a display coupled to the processor, a non-transit storage device coupled to the processor which stores a muscular function monitoring and evaluating program and sets of test procedures, a signal collection device wirelessly coupled to the processor via the wireless interface and a sensor connected to the signal collection device. The program, when executed by the processor, causes the system to perform the following functions. The processor displays a patient information screen on the display for an operator to input patient's data for a patient to be tested. The processor receives the patient's data input through the patient information screen. The processor displays, on the display in accordance with one of the sets of test procedures, a muscle map indicating a place on a body to which the sensor is to be attached. The processor instructs the patient in accordance with the one of the sets of test procedures, through at least one of instruction language displayed on the display, an animation or video image displayed on the display, and an audible instruction. The processor receives a signal measured by the sensor, and records the signal into the storage device or transmits the signal to an outside server. The storage device may be located in a local computer or in a server system or “cloud” accessible from the computer through a network.
  • Optionally, in the above system, the storage device may store a patient database, and the program further causes the processor to obtain patient information by searching the patient database according to the input patient's data. The processor selects one of the sets of test procedures in accordance with the obtained patient information.
  • Optionally, in any of the above systems, one of the sets of test procedures is selected by an input by the operator.
  • Optionally, in any of the above systems, the program further causes the processor to display on the display a test procedure selection screen displaying a list of the sets of test procedures. The processor receives a selection of one of the sets of test procedures. The muscle map is displayed on the display in accordance with the selected one of the sets of test procedures.
  • Any of the above systems optionally includes a camera, and the program further causes the processor to record a video image of the patient acquired by the camera and to display the video image on the display.
  • Optionally, in any of the above systems, the program further causes the processor to display the received sensor signal on the display.
  • Optionally, in any of the above systems, the sensor includes one or more surface electromyography (sEMG) sensors. The muscle map indicates a place on a patient's body to which the one or more sEMG sensors are to be attached by different colors or numbers.
  • Optionally, in any of the above systems, the sensor includes one or more motion sensors utilizing one or more gyroscopes.
  • Optionally, in any of the above systems, the sensor includes a functional capacity sensor including a lift portion, a pinch portion and a grip portion.
  • Optionally, in any of the above systems, the program further causes the processor to display an error message when the system detects a sensor error. The sensor error is detected by the signal collection device or by the processor.
  • Optionally, in any of the above systems, the program further causes the processor to calibrate the sensor.
  • In another example, a non-transit recording medium stores a program which, when executed by a computer, causes the computer to perform the functions of displaying a patient information screen on a display coupled to the computer for an operator to input patient's data of a patient to be tested, receiving the patient's data input through the patient information screen, displaying, on the display in accordance with one of a plurality of sets of test procedures, a muscle map indicating a place on a patient's body to which a sensor is to be attached, instructing the patient in accordance with the one of the sets of test procedures, through at least one of instruction language displayed on the display, an animation or video image displayed on the display, and an audible instruction, receiving a signal measured by the sensor, and recording the signal into a storage device coupled to the computer or transmitting the signal to an outside server.
  • The non-transit recording medium is, for example, an optical disk such as CD-ROM, CD-RW, DVD-ROM, DVD-RW, DVD-R, DVD-RAM or Blu-Ray Disk, an EEPROM such as a flash memory or a hard disk drive.
  • The system and methods of the present disclosure, together with further objects and advantages, are better understood by references to the following detailed description and the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 shows an exemplary schematic overall view of the muscular function evaluating and monitoring system of the present disclosure.
  • FIG. 2 shows an exemplary block diagram of a computer used in the system of FIG. 1.
  • FIG. 3 shown an exemplary block diagram of a POD device used in the system of FIG. 1.
  • FIG. 4 shows an exemplary schematic view of an ROM sensor.
  • FIG. 5 shows an exemplary view of an sEMG sensor.
  • FIG. 6 shows an exemplary view of an FCE sensor.
  • FIG. 7 shows an exemplary operations flow chart within the computer 20 and the POD device 10.
  • FIG. 8 shows an exemplary flow chart for measuring muscular function data through sEMG sensors, a ROM sensor and/or an FCE sensor.
  • FIG. 9 shows an exemplary screen view of a testing protocol selection screen.
  • FIG. 10 shows an exemplary patient information screen view.
  • FIG. 11 shows an exemplary main menu screen view.
  • FIG. 12 shows an exemplary muscle map view.
  • FIG. 13 shows an exemplary main menu screen view during a test.
  • FIG. 14 shows another exemplary flow chart for measuring muscular function data
  • DETAILED DESCRIPTION
  • In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent to those skilled in the art that the present teachings may be practiced without such details. In other instances, well known methods, procedures, components, and/or materials have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.
  • FIG. 1 shows one exemplary schematic view of an overall muscular function monitoring and evaluating system according to the present disclosure. The system includes a POD device 10 and a computer 20. The POD 10 is wirelessly connected to the computer 20. Known wireless communication methods may be utilized. As shown in FIG. 2, the computer 20 includes a processor 201, an I/O interface 202 including a wireless network interface and a local area network (LAN) interface coupled to the processor (for example, via a bus line 203), a non-transitory storage device 204 such as a hard disk drive (HDD), memories 205 such as a ROM and a RAM and a display 206. The computer 20 can further include a optical disk drive and a printer. The display 206 is optionally a touch sensitive display (i.e., a touch panel display). The computer 20 optionally further includes a camera 207 and a microphone 208 for capturing real-time video clips of patient activities and for recording audio during testing.
  • In certain embodiments, the computer 20 communicates with a server or another computer 60 via a network 70 including an intranet and/or the Internet. The HDD 204 stores a comprehensive muscular activity profiler (CMAP) program for controlling the overall system, presenting instructions to the patient, managing patient information and recording the measured data. Sensors include surface EMG (sEMG) sensors 30, range-of-motion (ROM) sensors 40 and a functional capacity evaluation (FCE) sensor 50, all of which are connected to the POD device 10.
  • FIG. 3 shows an exemplary block diagram of the POD device 10. The POD device 10 is a portable, wearable and non-invasive device that receives sEMG signals from the sEMG sensors 30, the range-of-motion (ROM) signals from range of motion sensors 40 and the functional capacity evaluation signals from the FCE sensor 50. The signals from these sensors work in conjunction with one another to obtain a set of output signals, which relay information relating to the functional capability and characteristics of muscle groups and surrounding tissues.
  • The signals from all sensors are sent to the POD device 10 to be conditioned and, if necessary, A-D converted by circuitry in the POD device 10 and then transferred wirelessly over, for example, an ad hoc wireless network to the computer 20. For example, the signals from the ROM sensors (i.e., digital signals) are received by a serial-peripheral interface (SPI) 101 and transferred to a processor 102. The signals from the ROM sensors may be digital signals. The signals from the sEMG sensors are input to a multistage filter and amplifier circuit 106 and A-D converted by an AD-converter 103 after multiplexed by an analog multiplexer 105. The processor 102 processes the digital data and transmits the processed data to the computer 20 wirelessly via a wireless interface 104.
  • In the present example, the POD device 10 can connect three sEMG sensors 30, two ROM sensors 40 and one FCE sensor 50. Each sEMG sensor can monitor eight sEMG signals (i.e., eight channels), and each ROM sensor outputs three signals (three channels) corresponding to three degrees of freedom. Therefore, the POD device 10 can simultaneously monitor up to 24 channels of sEMG signals, six (6) channels of ROM signals, and one (1) channel of FCE signal. The POD device 10 may be powered by an internal rechargeable battery such as a polymer Lithium-ion battery. The POD device 10 includes connectors for three sEMG sensors, two ROM sensors and one FCE sensor. Each of the connectors for the sEMG sensor, the ROM sensor and the FCE sensor has a different size and/or shape so that the operator does not insert a sensor to a wrong connector. It is noted that since the FCE sensor of the present application is one integrated FCE sensor, the POD device 10 may have only one input port for the integrated FCE sensor.
  • FIG. 4 shows a schematic diagram of a ROM sensor 40. The ROM sensor 40 utilizes a combination of gyroscopic sensors 401 x, 401 y and 401 z to detect motion of the subject. The ROM sensor 40 can detect and measure an angular rate of the subject (e.g., a head of the patient), e.g., how quickly the object rotates. The ROM sensor 40 contains three gyroscopes 401 x, 401 y and 401 z for measuring three degrees of freedom (i.e., x, y and z directions). For example, iSensor® gyroscopes (ADIS16260/ADIS16265) made by Analog Devices can be used for the gyroscopes, which outputs digital sensor signals. The three gyroscopes 401 x, 401 y and 401 z are mounted orthogonally to one another inside a plastic enclosure.
  • In the present example, up to two ROM sensors can be connected to the POD device 10. In most testing protocols, one ROM sensor is used at a time. However, there are a couple of testing protocols that require two ROM sensors, called a “dual inclinometer arrangement.” This arrangement allows for more accurate ROM data in an area like the lumbar spine where upper vertebrae move relative to the lower vertebrae. In this arrangement, both ROM sensors are read, and then one sensor's motion is subtracted from the other sensor's motion, which isolates one particular movement of the body. The ROM sensor may be attached to the patient with a plastic and lycra harness, placed over the patient's clothing for most testing protocols.
  • FIG. 5 shows an exemplary schematic view of sEMG sensor 30. The sEMG sensor 30 is a one-piece reusable cable/lead assembly. The sEMG sensor 30 is directly connected to the POD device 10 via a connector 301, for example, manufactured by Hirose Corporation. The sEMG sensor 30 includes a small printed circuit board (PCB) 302 that includes an amplifier circuit for the first amplification stage of the signal conditioning. The PCB 302 is encapsulated in a base portion 303 of the sEMG sensor 30. From the base portion 303, nine flexible leads extend, one of which is a ground lead. The other eight leads are paired and color-coded electrode leads, respectively. The eight leads have different colors, for example, yellow, green, purple, orange, blue, white, red and brown. Black may be used for the ground line. Each of the eight leads is to be affixed to a pair of FDA-approved surface electrodes 304. The signals detected by the sEMG sensors 30 are sent to the POD device 10 for the second stage amplification.
  • FIG. 6 shows an exemplary perspective view of a functional capacity evaluation (FCE) sensor 50. To measure isometric functional test (IFT), pinch strength, and grip strength, the present system utilizes an integrated measurement tool as shown in FIG. 6. The FCE sensor 50 is a combination of three different sensors. This combined sensor allows for the isometric functional dead-lift, pinch strength, and grip strength measurements with a lift portion 501, a pinch portion 502 and a grip portion 503, respectively, which are integrated in one device.
  • The FCE sensor 50 utilizes a single full bridge strain gauge mounted to allow accurate readings from all three exercises without sacrificing resolution between measurements of differing force levels. The grip test allows adjustments to grip span with a finer resolution and wider and smaller span than a conventional device (e.g., a Jamar Grip). The pinch test allows measurements to be made in a fashion similar to a load cell and can also be adjusted to different pinch spans. The isometric function test measures, for example, asymmetric performance in one-tenth pound increments against an immovable footplate.
  • Software or a program to control the overall system is stored in a storage device such as HDD 204 of the computer 20. The software, when executed by the CPU 201, causes the CPU to perform at least two functions, i.e data acquisition and data management. The executed software has no direct control over the hardware, but interacts with the hardware to read the conditioned data signals located in the POD device 10.
  • The computer 20 on which the software runs is operated by trained technicians in the field. The software presents a series of screen prompts which guide the technicians through the necessary steps to complete each step in the chosen protocol. In this disclosure, a “screen” generally refers to an image displayed on the display 206 including a “window” displayed on the display. These steps are defined by text, audio and/or video instructions in order to provide the clearest possible explanation. A video of the test will also be recorded in order to ensure proper test administration and compliance.
  • The computer 20 on which the software runs, through the POD device 10 and the sensors, collects the necessary data from the different sensor channels as set forth above. The computer 20 can collect the data simultaneously on a timing interval. The computer 20 may stream the data to the outside server 60 during the measurement. The data is also transferred in real-time to the computer 20 during a step from the POD device 10 so that the operator can monitor the quality of the data being acquired.
  • The computer 20 optionally detects sensor failures, such as a sensor not being connected, a sensor lead falling off or a sensor lead experiencing an inconsistent connection. The sensor failures may be detected by the POD device 10 and sent to the computer 20. If a sensor failure is detected, the computer 20 notifies the operator through a sensor failure screen, while suspending any data acquisition activity. Once the failed sensor is corrected, the test can be resumed or redone.
  • To ensure data integrity, all data can be encrypted upon recording to the computer 20. The data will remain encrypted until it is transferred to the outside server 60 for further processing of the data. The data may be recorded to multiple files due to the different file types. Each file may be encrypted and will remain encrypted until, for example, transfer to an outside server 60 for further data processing, archival, and analysis.
  • FIG. 7 shows an exemplary operations flow chart within the computer 20 and the POD device 10. FIG. 8 shows an exemplary flow chart for measuring muscular function data through sEMG sensors, ROM sensors and/or an FCE sensor.
  • An operator who wishes to run a specific testing protocol to measure muscular functions will first turn on computer 20 and execute the program. Usually, the operator is required to log-in to operate the program (Step 5801) so that only a certified operator accesses the system and data. The computer 20 on which the program is now running displays a testing protocol selection screen on display device 206, for example, an LCD touch panel screen (Step S802). One example of the testing protocol selection screen is shown in FIG. 9.
  • In the example shown in FIG. 9, eight (8) testing protocols are available, which include a Cervical Protocol, a Thoracic Protocol, a Carpal Tunnel & Epicondyle Protocol, a Shoulder & Epicondyle Protocol, a Lumbar Protocol, a Lower Extremities Protocol, a Hip/Groin Protocol, and a Custom Ankle Protocol. Of course, other testing protocols can be employed. Further, the testing protocols may include one or more subsets of the protocols. The protocols may be provided as a pull-down menu.
  • If the operator chooses the Carpal Tunnel & Epicondyle Protocol by, for example, clicking the carpal tunnel portion of the illustrated body as shown in FIG. 9 (Step S803), the computer 20 next shows a patient information screen as shown in FIG. 10 on the LCD display 206 (Step S804).
  • The patient information screen provides information to match “subjective” complaints of the patient with “objective” findings of the test. The patient information screen prompts the operator to input, for example, but not limited to, the patient's personal information, physician's information, insurance information, test indication, etc.
  • When the operator inputs the required information and hits a proceed button (Step S805), the computer 20 displays a main testing protocol menu for the selected testing protocol, i.e., a menu for the Carpal Tunnel & Epicondyle Protocol, as shown in FIG. 11 (Step S806).
  • When the operator touches a muscle map icon 1101, the menu screen shows a muscle map 1102 illustrating positions of an sEMG sensor and a ROM sensor in a screen area 1103. FIG. 12 shows an enlarged view of the muscle map 1102.
  • In the Carpal Tunnel & Epicondyle Protocol, three sEMG cable assemblies and two ROM sensor are utilized. More specifically, 8 leads each on three sEMG sensors are utilized in this protocol. The muscle map 1102 shows three sEMG sensors by number (1-3) and two ROM sensor by a “MT” image. As set forth above, each of the sEMG sensors has eight leads with different colors. The muscle map 1102 shows each position of a sensor head (a pair of sensors) by color and the number so that the operator can place the sensor heads on appropriate portions of the patient's body.
  • According to the instruction shown in the area 1103 of the screen, the operator attaches the respective sensors to the patient's body. Of course, the operator is requested to connect the respective sensors to the POD device 10.
  • For the ROM sensors, the operator is instructed to calibrate the ROM sensors. The operator is instructed to place the ROM sensors on a flat surface and to connect cables of the ROM sensors into the POD device 10. When the operator touches a “Proceed” button, initialization (calibration) begins. If re-calibration is necessary, the operator can repeat the calibration by touching a “Repeat” button. If the ROM sensors are calibrated correctly, the operator touches an “OK” button. Then, the ROM sensors are attached to designated places of the patient body by, for example, attachment pockets.
  • If the FCE sensor is also used in the test, the FCE sensor is also calibrated. The operator is instructed to place the FCE sensor on a flat surface and to connect a cable into the POD device. Then, the operator touches a “Proceed” button to begin initialization. If re-calibration is necessary, the operator can repeat the calibration by touching a “Repeat” button. If the FCE sensors are calibrated correctly, the operator touches an “OK” button.
  • After the sEMG sensors are attached and the ROM sensors are calibrated and attached (and if necessary, the FCE sensor is appropriately placed), the operator can touch a “Start” button to proceed with the test (Step S807). One testing protocol usually includes several sub steps.
  • FIG. 13 shows an exemplary screen view during the testing (Step S808). In an animation area 1302, an animation is displayed to demonstrate and instruct the patient how to move body parts. In an instruction area 1303, detailed instructions on the command are shown so the operator or the patient can perform appropriate actions. The instructions may be provided by audio.
  • A video screen area 1304, which can be the same area as the area 1103, shows a live video image taken by a camera 207 attached to the computer 20. The computer 20 can record the video image of the patient taken by the camera 207 and audio taken by the microphone 208 throughout the testing. The video image 1301 can be switched at any time with the muscle map 1102, by touching a switch button.
  • The computer 20 acquires signals detected by each sensor via the POD device 10 (Step S809). The screen also shows a status of each sEMG sensor 1305. If the system cannot correctly detect a signal, an error status will be shown at the corresponding sEMG sensor. For example, the POD device 10 can detect an error in the sensors. Further, when the operator touches one of the status monitors of the sEMG sensors, the currently received signals are shown in a signal area 1306. At the same time, a corresponding muscle map may be shown on the area 1304. Similarly, a ROM signal 1307 is also shown for monitoring the ROM sensors.
  • The screen of FIG. 13 also provides a note area 1308 so that the operator can input patient's comments, physician's comments and/or operator's comments. The computer 20 stores such comments in the storage device or transfers them to the outside server 60.
  • It is noted that any sub-step of the testing protocol can be repeated by touching a “Repeat” button (Step S810). If one sub step is completed, the operator may touch a “Next” button to proceed with the next sub step (S811). If all sub steps are completed, the operator can finish the program (S813), or can select a new testing protocol (S812). Optionally, the program returns to the login screen.
  • Upon completion of one testing protocol, the computer 20 may upload the acquired data to the outside server 60 in connection with the patient information, or may locally retain the acquired data in the storage device. The data may include measured signal data, a video image acquired during the testing, and/or comments input to the note area 1308.
  • In the above example, the testing protocol is first selected (S802 and 5803) and then the patient information is input to the computer 20 (S804 and S805). Alternatively, the patient information is input first and then the testing protocol is selected.
  • Further, if the patient information indicates a required testing protocol, the system automatically runs the required testing protocol and in such a case, the operator does not need to select the testing protocol. For example, when the patient is tested more than one time, the system already knows the patient's information and tested protocol. As shown in FIG. 14, when the operator starts the muscular evaluation program (S1401), the system requires the operator input patient information, e.g., the name or any identification number of the patient (S1402). If the patient record exists (S1403), the system obtains the patient record from a database (S1048). The database may be located in the computer 20 or in the outside server 60. When the patient records indicate the testing protocol was previously applied to the patient, the system runs the testing protocol (S806). The testing protocol can be automatically executed or executed by the operator's input. The system can further display patient information for the operator to confirm the patient's information and/or modify the patient's information.
  • If the patient is a first-time patient (S1404), the system displays the patient information screen requesting input of patient information (S1404). When the patient information is input, the system displays a protocol selection screen (S1406). When a proper testing protocol is selected (S1407), the system runs the testing protocol (S806).
  • The foregoing muscular function monitoring and evaluating system may further include additional programs/modules. For example, the system may include a comprehensive impairment rating evaluation program that is designed to assist physicians in determining whether an injured patient has reached maximum medical improvement (MMI) and /or permanent and stationary (P&S) status based on the measured and acquired results by utilizing the muscular function monitoring and evaluating system. This program compares the measured results against, for example, the AMA guide for impairment rating, and provides the physicians with evaluation results.
  • Another example of the programs is a comprehensive pre-employment physical evaluation program that provides employers an objective assessment of an individual's ability to perform the physical job functions of the position for which he/she has been hired. This program can provide the assessment of the person tested by the muscular function monitoring and evaluating system.
  • Further, muscular function monitoring and evaluating system may includes a comprehensive activity interactive program that is a tool for physical therapist or their assistant to assure patient compliance with their therapy regimen and its course. This program allows the patient to place goals into the program and observe the performance against those goals. This program can monitor progress of recovery of muscular function of the patient with respect to the set goals based on the measured results by utilizing the muscular function monitoring and evaluating system. The program can also print out the progress for the patients' records.
  • Although certain specific examples have been disclosed, it is noted that the present teachings may be embodied in other forms without departing from the spirit or essential characteristics thereof. The present examples described above are considered in all respects as illustrative and not restrictive. The patent scope is indicated by the appended claims, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
  • Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.
  • The scope of protection is limited solely by the claims that now follow. That scope is intended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows and to encompass all structural and functional equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 101, 102, or 103 of the Patent Act, nor should they be interpreted in such a way. Any unintended embracement of such subject matter is hereby disclaimed.
  • Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.
  • It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.
  • The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

Claims (21)

1. A system, comprising:
a processor;
a wireless interface coupled to the processor;
a display coupled to the processor;
a non-transit storage device coupled to the processor, the storage device storing a program and sets of test procedures;
a signal collection device wirelessly coupled to the processor via the wireless interface; and
a sensor connected to the signal collection device,
wherein the program, when executed by the processor, causes the system to perform the functions of:
displaying a patient information screen on the display for prompting an operator to input patient's data of a patient to be tested;
receiving the patient's data input through the patient information screen;
displaying, on the display in accordance with one of the sets of test procedures, a muscle map indicating a place on a patient's body to which the sensor is to be attached;
instructing the patient in accordance with the one of the sets of test procedures, through at least one of an animation or video image instruction displayed on the display and an audible instruction;
receiving a signal measured by the sensor; and
recording the signal into the storage device or transmitting the signal to an outside server.
2. The system of claim 1, wherein:
the storage device stores a patient database, and
the program further causes the processor to perform the functions of:
obtaining patient information by searching the patient database according to the input patient's data; and
selecting one of the sets of test procedures in accordance with the obtained patient information.
3. The system of claim 1, wherein the one of the sets of test procedures is selected by an input by the operator.
4. The system of claim 1, wherein:
the program further causes the processor to perform the functions of:
displaying on the display a test procedure selection screen displaying a list of the sets of test procedures;
receiving a selection of one of the sets of test procedures, and
the muscle map is displayed on the display in accordance with the selected one of the sets of test procedures.
5. The system of claim 1, wherein:
the system further includes a camera, and
the program further causes the processor to perform a function of recording a video image of the patient acquired by the camera and displaying the video image on the display.
6. The system of claim 1, wherein the program further causes the processor to perform a function of displaying the received sensor signal on the display.
7. The system of claim 1, wherein the sensor includes one or more surface electromyography (sEMG) sensors.
8. The system of claim 7, wherein the muscle map indicates a place on the patient's body to which the one or more sEMG sensors are to be attached by different colors or numbers.
9. The system of claim 1, wherein the sensor includes one or more motion sensors utilizing one or more gyroscopes.
10. The system of claim 1, wherein the sensor includes a functional capacity sensor including a lift portion, a pinch portion and a grip portion.
11. The system of claim 1, wherein the program further causes the processor to perform a function of displaying an error message when the system detects an error of the sensor.
12. The system of claim 11, wherein the error of the sensor is detected by the signal collection device.
13. The system of claim 1, wherein the program further causes the processor to calibrate the sensor.
14. A non-transit recording medium storing a program, wherein the program, when executed by a computer, causes the computer to perform the functions of:
displaying a patient information screen on a display coupled to the computer for prompting an operator to input patient's data of a patient to be tested;
receiving the patient's data input through the patient information screen;
displaying, on the display in accordance with one of a plurality of sets of test procedures, a muscle map indicating a place on a patient's body to which a sensor is to be attached;
instructing the patient in accordance with the one of the sets of test procedures, through at least one of an animation or video image instruction displayed on the display, and an audible instruction;
receiving a signal measured by the sensor; and
recording the signal into a storage device coupled to the computer or transmitting the signal to an outside server.
15. The non-transit recording medium of claim 14, wherein the program further causes the processor to perform the functions of:
obtaining patient information by searching a patient database according to the input patient's data; and
selecting one of the sets of test procedures in accordance with the obtained patient information.
16. The non-transit recording medium of claim 14, wherein the program further causes the processor to perform the functions of:
displaying on the display a test procedure selection screen displaying a list of the sets of test procedures;
receiving a selection of one of the sets of test procedures, and
the muscle map is displayed on the display in accordance with the selected one of the sets of test procedures.
17. The non-transit recording medium of claim 14, wherein the program further causes the processor to record a video image of the patient acquired by a camera and to display the video image on the display.
18. The non-transit recording medium of claim 14, wherein the program further causes the processor to perform display the received sensor signal on the display.
19. The non-transit recording medium of claim 14, wherein the muscle map indicates a place on the patient's body to which the one or more sEMG sensors are to be attached by different colors or numbers.
20. The non-transit recording medium of claim 14, wherein the program further causes the processor to display an error message when the system detects an error of the sensor,
21. The non-transit recording medium of claim 14, wherein the program further causes the processor to calibrate the sensor.
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