WO2013000122A1 - 功能性电刺激*** - Google Patents
功能性电刺激*** Download PDFInfo
- Publication number
- WO2013000122A1 WO2013000122A1 PCT/CN2011/076492 CN2011076492W WO2013000122A1 WO 2013000122 A1 WO2013000122 A1 WO 2013000122A1 CN 2011076492 W CN2011076492 W CN 2011076492W WO 2013000122 A1 WO2013000122 A1 WO 2013000122A1
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- WIPO (PCT)
- Prior art keywords
- electrical stimulation
- resistor
- stimulation system
- energy storage
- functional
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3782—Electrical supply producing a voltage above the power source level
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
Definitions
- the present invention relates to the field of medical device technology, and in particular, to a functional electrical stimulation system. Background technique
- Functional electrical stimulation therapy uses low-frequency currents to stimulate muscles that have lost innervation, causing them to contract to replace or correct the function that organs and limbs have lost.
- the research and application of functional electrical stimulation therapy has been involved in various fields of clinical medicine.
- Functional electrical stimulation devices are mostly two-channel to four-channel portable electrical stimulators.
- the diaphragmatic pacemaker used to control and regulate respiratory motion is a functional electrical stimulation system, which is mainly used for cerebrovascular diseases, brain trauma, and respiratory muscle paralysis caused by high spinal cord injury.
- the controller emits a radio pulse signal by implanting a pair of electrodes on the bilateral phrenic nerve, or by placing the body surface electrode on the bilateral cervical phrenic nerve movement point and connecting to a signal receiver fixed to the chest wall.
- the receiver turns it into a low-frequency current that excites the phrenic nerve through the electrodes, causing the diaphragm to contract.
- Functional electrical stimulation has also achieved good results in the treatment of urinary dysfunction.
- urinary incontinence is caused by lower motor neuron damage, causing weakness of the urethral sphincter and pelvic floor muscles, causing urination to drip, or a slight increase in abdominal pressure to urinate.
- Clinical use of functional electrical stimulation therapy to stimulate the urethral sphincter and pelvic floor muscles to enhance their muscle strength can significantly improve the degree of urinary incontinence in patients.
- Another example is when the medullary urinary center injury, bladder detrusor paralysis, urinary retention.
- the implanted electrode is used clinically to stimulate the detrusor muscle to contract to overcome the pressure of the urethral sphincter and to excrete the urine.
- Functional electrical stimulation therapy can also help patients with motor neuron injury to perform certain functional activities, such as walking, grasping, coordinating their movements, and accelerating the recovery of autonomic control.
- Upper motor neuron damage includes cerebrovascular disease, brain trauma, spinal cord injury, cerebral palsy, etc.
- spinal cord injury For such patients, especially those with spinal cord injury, limb movement is conducive to rehabilitation.
- electrical signals generated by physical activity can stimulate the spinal cord to achieve partial spinal cord continuity.
- Some scientists have proposed a functional electrical stimulation-assisted brake training method that not only restores muscle strength, but also promotes local tissue repair of spinal cord injury. Applicants have found that there are many shortcomings in the prior art functional electrical stimulation system: 1.
- the present invention provides a functional electrical stimulation system to increase the flexibility of its setup, enhance safety and reliability, and avoid danger to the user during use.
- a functional electrical stimulation system comprises: an initial power supply; a boosting module connected to the initial power supply for boosting an output voltage of the initial power supply to a first predetermined voltage; an energy storage module connected to the boosting module, And storing a power boosted to a first preset voltage; a central control unit for generating an electrical stimulation parameter data packet; an electrical stimulation output channel connected to the energy storage module for receiving an electrical stimulation parameter data packet,
- the electrical stimulation parameter is parsed in the stimulation parameter data packet; the electrical energy stored in the energy storage module is converted into an electrical stimulation pulse corresponding to the electrical stimulation parameter; and the electrical stimulation pulse is applied to the affected part of the patient.
- the electrical stimulation output channel comprises: an underlying controller for receiving an electrical stimulation data packet of the central control unit, parsing the electrical stimulation parameter from the electrical stimulation parameter data packet, and outputting the electrical output a forward control signal and a negative control signal corresponding to the stimulation parameter; a constant current source connected to the energy storage module for receiving the forward control signal and the negative control signal; and converting the stored energy stored in the energy storage module to the positive direction a bipolar electrical stimulation pulse corresponding to the control signal and the negative control signal; an electrode patch having positive and negative electrodes respectively connected to the two output ends of the constant current source for applying the bipolar electrical stimulation pulse to the patient's disease Part.
- the constant current source is a bridge constant current source, and the positive and negative electrodes of the electrode patch are respectively connected to the bridge arms of the bridge constant current source.
- the constant current source is a bridge constant current source
- the bridge The constant current source includes: a first operational amplifier UA, a second operational amplifier UB, a first resistor R1, a second resistor R2, a third resistor R3, a fourth resistor R4, a fifth resistor R5, and a sixth resistor R6, first Transistor Ql, second transistor Q2, patient's own equivalent resistance R7; wherein, the first operational amplifier UA, the first resistor R1, the second resistor R2, the third resistor R3 and the patient's own equivalent resistance R7 are negative
- the positive input terminal of the first operational amplifier UA is connected to the negative amplitude amplitude control signal generated by the bottom controller to control the amplitude of the negative pulse current
- the first resistor R1 is connected to the first operational amplifier UA.
- the output terminal and the base of the first transistor Q1, the second resistor R2 is connected to the negative input terminal of the first operational amplifier UA and the emitter of the first transistor Q1, and the third resistor R3 is connected to the first transistor
- the emitter and ground of Q1, the collector of the first transistor Q1 is connected to the output of the boost module through a forward polarity switch; the second operational amplifier UB, the fourth resistor R4, the fifth resistor R5, and the sixth resistor R6
- the patient's own equivalent resistance R7 constitutes a positive pulse constant current control circuit, according to the positive input of the second operational amplifier UB
- the forward amplitude control signal generated by the bottom controller controls the amplitude of the forward pulse current
- the fourth resistor R4 is connected to the output of the second operational amplifier UB and the base of the second transistor Q2, and the fifth resistor R5 Connecting the negative input terminal of the second operational amplifier UB to the emitter of the second transistor Q2, the sixth resistor R6 is connected to the emitter and ground of the second transistor Q2,
- the functional electrical stimulation system comprises: n sets of electrical stimulation output channels; a central control unit for generating electrical information with timing information corresponding to n sets of electrical stimulation output channels, respectively
- the parameter data packet is stimulated, and the electrical stimulation parameter data packet is sent to the corresponding electrical stimulation output channel.
- n 16.
- the functional electrical stimulation system further comprises: an active discharge circuit; a central control unit, configured to generate an active discharge signal in a system shutdown, pause or emergency stop state; One end is connected to the energy storage module, and the other end is connected to the ground for receiving an active discharge signal and releasing the electrical energy stored in the energy storage module.
- the active discharge circuit comprises: a third transistor Q3, an eighth resistor R8, a ninth resistor R9; a collector of the third transistor Q3 is connected to the eighth resistor R8
- the energy storage module has an emitter terminal connected to the ground and a base through the ninth resistor R9 is connected to the central control unit; when the system is in normal working state, the third transistor Q3 is in the off state; in the system shutdown, pause or emergency stop state, the central control unit sets the active discharge signal to the high level, the third The transistor Q3 is turned on, and the electric energy stored in the energy storage module is released through the eighth resistor R8.
- the functional electrical stimulation system of the present invention further includes: a power-off discharge circuit, wherein the control end is connected to the initial power source, and is configured to release the storage in the energy storage module when the voltage of the initial power source is lower than the first preset voltage value Electrical energy.
- a power-off discharge circuit wherein the control end is connected to the initial power source, and is configured to release the storage in the energy storage module when the voltage of the initial power source is lower than the first preset voltage value Electrical energy.
- the power-off discharge circuit comprises: a fourth transistor Q4, a fifth transistor Q5, a tenth resistor R10, an eleventh resistor R11, a twelfth resistor R12, a thirteenth resistor R13; the base of the fourth transistor Q4 is connected to the initial power supply voltage signal through the thirteenth resistor R13, and the collector is connected to the energy storage module through the tenth resistor R10, and the emitter thereof is connected to the ground; The base of the fifth transistor Q5 is connected to the collector of the transistor Q4 through the eleventh resistor R11, and the collector thereof is connected to the energy storage module through the resistor R12, and the emitter thereof is connected to the ground;
- the fourth transistor Q4 is turned on, and the fifth transistor Q5 is not turned on; when the voltage of the initial power source is lower than the first preset voltage value, the fourth transistor Q4 At the end, the fifth transistor Q5 is turned on,
- the functional electrical stimulation system of the present invention further includes: a fuse connected between the energy storage module and the electrical stimulation output channel, configured to cut off the energy storage module when the output current of the energy storage module is greater than the first preset current value The connection to the electrical stimulation output channel.
- the fuse is a 25 mA fast blow fuse.
- the functional electrical stimulation system of the present invention further comprises: a voice-activated emergency stop module, configured to generate a voice-activated emergency stop signal after receiving a sound higher than a preset intensity or frequency; and a central control unit for emergency stop by voice control The signal generates an active discharge signal; the active discharge circuit is configured to release the stored energy stored in the energy storage module after receiving the active discharge signal.
- a voice-activated emergency stop module configured to generate a voice-activated emergency stop signal after receiving a sound higher than a preset intensity or frequency
- a central control unit for emergency stop by voice control The signal generates an active discharge signal
- the active discharge circuit is configured to release the stored energy stored in the energy storage module after receiving the active discharge signal.
- the central control unit is configured to generate an alarm signal by the voice-activated emergency stop signal;
- the functional electrical stimulation system further includes: an alarm circuit, configured to generate a sound after receiving the alarm signal / or optical alarm signal.
- the functional electrical stimulation system of the present invention further comprises: a mechanical emergency stop module, the normally open end of which is connected between the energy storage module and the electrical stimulation output channel; the functional electrical stimulation system is normally enabled In use, the normally open end is turned on; in an emergency, the normally open end is disconnected, and the path between the energy storage module and the electrical stimulation output channel is disconnected.
- the mechanical emergency stop module is a push button switch; when the functional electrical stimulation system is in normal use, the user presses the switch by holding or stepping on, and the normally open end is turned on; in an emergency, the user releases the switch, often The beginning is broken.
- the functional electrical stimulation system of the present invention further comprises: a human-computer interaction module, configured to receive an electrical stimulation parameter input by the user; and a central control unit connected to the human-computer interaction module for generating an electrical stimulation parameter input by the user
- the electrical stimulation parameter data packet is transmitted to the electrical stimulation output channel.
- the functional electrical stimulation system of the present invention further comprises: a communication interface module, configured to receive an electrical stimulation parameter data packet input from the user terminal; and a central control unit coupled to the communication interface module for using the electrical stimulation parameter data packet Analyze and package the electrical stimulation parameter data packet that can be parsed by the electrical stimulation output channel.
- the electrical stimulation waveform parameter is modulated by an audio signal, a real-time myoelectric signal of the user, or a fixed waveform sequence.
- the communication interface module is an RS232 communication interface.
- the system can be used as a stand-alone device to implement simple fixed-parameter electrical stimulation, and as a computer peripheral to realize complex time-varying parameter electrical stimulation under the control of a computer.
- Figure 1 is a schematic structural view of a functional electric stimulation system
- FIG. 2 is a schematic structural view of a functional electrical stimulation system according to an embodiment of the present invention.
- FIG. 3 is a schematic diagram of an electrical stimulation output channel of a functional electrical stimulation system according to an embodiment of the present invention
- FIG. 4 is a circuit schematic diagram of DC boost, automatic discharge, and overcurrent protection of a functional electrical stimulation system according to an embodiment of the present invention
- 5 is a schematic structural diagram of a functional electrical stimulation system according to an embodiment of the present invention
- FIG. 6 is a schematic structural diagram of a functional electrical stimulation system according to an embodiment of the present invention
- FIG. 7 is a waveform diagram showing an output of an electrical stimulation channel in a functional electrical stimulation system according to an embodiment of the present invention.
- FIG. 8 is a control flow chart of a central controller of a functional electrical stimulation system according to an embodiment of the present invention.
- FIG. 9 is a control flow chart of a bottom controller of a functional electrical stimulation system according to an embodiment of the present invention.
- FIG. 1 is a schematic diagram of the structure of a functional electrical stimulation system.
- the functional electrical stimulation system of the embodiment includes: an initial power supply; a boosting module connected to the initial power source for boosting an output voltage of the initial power source to a first preset voltage; an energy storage module, Connected to the boost module for storing electrical energy boosted to a first predetermined voltage; central control unit for generating electrical stimulation parameter data packets; electrical stimulation output channel connected to the energy storage module for receiving electricity
- the stimulation parameter data packet parses the electrical stimulation parameter from the electrical stimulation parameter data packet; converts the electrical energy stored in the energy storage module into an electrical stimulation pulse corresponding to the electrical stimulation parameter; and applies the electrical stimulation pulse to the diseased part of the patient .
- the initial power source is a 12V lithium battery
- the boost module is a DC boost module
- the energy storage module is a high withstand voltage (400V) capacitor.
- the DC boost module boosts the voltage of the lithium battery to 200V to provide power to the electrical stimulation output channel.
- the electrical stimulation output channel outputs an electrical stimulation pulse according to the electrical stimulation parameter data packet sent by the central control unit, thereby enhancing the selection of the electrical stimulation pulse.
- the flexibility and autonomy of the punching are beneficial to the user to select the type of personalized electrical stimulation pulse according to their actual situation.
- the electrical stimulation output channel includes: an underlying controller for receiving an electrical stimulation data packet of the central control unit, The electrical stimulation parameter is parsed from the electrical stimulation parameter data packet, and the forward control signal and the negative direction control signal corresponding to the electrical stimulation parameter are output; the constant current source is connected to the energy storage module for receiving the forward control signal and the negative direction Control signal; convert and store the electric energy stored in the energy storage module into a bipolar electric stimulation pulse corresponding to the forward control signal and the negative control signal; the electrode patch, the positive and negative electrodes are respectively connected to the two output ends of the constant current source , for applying a bipolar electrical stimulation pulse to a diseased part of a patient.
- the constant current source is a bridge constant current source, and two ends of the electrode patch are respectively connected to both ends of the bridge arm.
- the functional electrical stimulation system comprises: n sets of electrical stimulation output channels; a central control unit for generating electrical stimulation outputs corresponding to n sets respectively The electrical stimulation parameter data packet of the channel with timing information is sent to the corresponding electrical stimulation output channel.
- the functional electrical stimulation system includes 16 sets of electrical stimulation output channels.
- the polarity is controlled by a switch and the current is controlled by an analog quantity.
- the bridge constant current source includes: op amp UA, op amp UB, resistor Rl, resistor R2, resistor R3, resistor R4, resistor R5, resistor R6, transistor Ql, transistor Q2;
- the resistor R1, the resistor R2 and the resistor R3 form a constant current control circuit of the negative pulse.
- the forward input terminal of the UA is connected to the negative amplitude amplitude control signal generated by the bottom controller to control the amplitude of the negative pulse current, and the resistor R1 is connected.
- the output of UA and the base of Q1 is connected to the negative input of UA and the emitter of Q1
- the resistor R3 is connected to the emitter of Q1 and the ground
- the collector of Q1 is connected to the DC boost by the forward polarity switch.
- the output of the module; the operational amplifier UB, the resistor R4, the resistor R6 and the resistor R7 form a constant-current control circuit of the forward pulse, and the forward amplitude control signal generated by the underlying controller is connected according to the forward input terminal of the UB to control the forward pulse.
- the resistor R4 is connected to the output of UB and the base of Q2
- the resistor R5 is connected to the negative input of UB and the emitter of Q2
- the resistor R6 is connected to the emitter of Q2 and ground, and the collector of Q2
- the pole is connected to the output of the DC boost module through a negative polarity switch; the constant current control circuit of the negative pulse and the constant current control current of the forward pulse alternate to work to realize the bidirectional electrical stimuli output.
- the triode in the bridge constant current source circuit can be replaced by a field effect transistor, and the entire constant current source can be realized by the above discrete components or by an integrated chip having a constant current source function, and the same should be within the scope of protection of the present invention.
- the functional electrical stimulation system may further comprise: an active discharge circuit.
- the central control unit is configured to generate an active discharge signal in a system shutdown, pause or emergency stop state; the active discharge circuit has one end connected to the energy storage module and the other end connected to the ground for receiving an active discharge signal, releasing The energy stored in the energy storage module.
- the active discharge circuit includes: transistor Q3, resistor R8, resistor R9; the collector of transistor Q3 is connected to the energy storage module through resistor R8, its emitter terminal is connected to ground, and its base is controlled by resistor R9 and centrally.
- the unit is connected; in the default state, the triode is in an off state; in the system shutdown, pause or emergency stop state, the central control unit sets the active discharge signal to a high level, the triode is turned on, and the electric energy stored in the energy storage module passes. Resistor R8 is released.
- the above-mentioned transistors can also be replaced by other switching devices.
- the functional electrical stimulation system may further include: a power-off discharge circuit, wherein the control end is connected to the battery, and the power-off discharge circuit is not turned on during normal operation, and is used when the voltage of the battery is low.
- the energy stored in the energy storage module is released at a first predetermined voltage value (eg, 0.7V). Where the battery voltage is lower than the preset voltage value, the most typical case is when the battery is unexpectedly powered down.
- the power-off discharge circuit includes: a triode Q4, a triode Q5, a resistor R10, a resistor Rl l, a resistor R12, and a resistor R13; the base of the transistor Q4 is connected to the battery signal through a resistor R13, and the collector thereof passes through the resistor.
- R10 is connected to the energy storage module, and its emitter is connected to the ground; the base of the transistor Q5 is connected to the collector of the transistor Q4 through the resistor R11, The collector is connected to the energy storage module through a resistor R12, and the emitter thereof is connected to the ground; when the voltage of the initial power source is higher than the first preset voltage value (typically, for example, the battery is in a normal working state), the transistor Q4 is turned on, Transistor R5 is non-conducting; when the voltage of the initial power supply is higher than the first preset voltage value (typically, for example, the battery is unexpectedly powered down), transistor Q4 is turned off, Q5 is turned on, and the energy stored in the energy storage module is released through resistor R12.
- the first preset voltage value typically, for example, the battery is in a normal working state
- the functional electrical stimulation system may further include: a fuse connected between the energy storage module and the electrical stimulation output channel, when the output current of the energy storage module is greater than the first preset current value , disconnect the energy storage module from the electrical stimulation output channel.
- the fuse is a 25 mA fast blow fuse.
- the functional electrical stimulation system may also include an emergency stop protection device.
- the emergency stop protection device is designed to cope with sudden situations of the user. For example, the electrical stimulation therapy induces a heartbeat abnormality, and the electrical stimulation intensity is too large to cause the user to generate paralysis. When the user cannot turn off the system or get rid of the electrode, the output channel and the power supply are quickly cut off. At the same time, an audible and visual alarm signal is issued to protect the safety of the user.
- the emergency stop protection device mainly comprises: a voice-activated emergency stop module, a mechanical emergency stop module, and/or an alarm module. Each module will be described in detail below.
- FIG. 5 is a schematic structural diagram of a functional electrical stimulation system according to an embodiment of the present invention.
- the functional electrical stimulation system may further include: a voice-activated emergency stop module, configured to generate a voice-activated emergency stop signal after receiving a sound higher than a preset intensity or frequency; a central control unit, configured to The voice-activated emergency stop signal generates an active discharge signal; the active discharge circuit is configured to release the stored energy stored in the energy storage module after receiving the active discharge signal.
- the functional electrical stimulation system may further include: a mechanical emergency stop module, the normally open end of which is connected between the energy storage module and the electrical stimulation output channel; the functional electrical stimulation system is normally open when normally used. In an emergency, the normally open end is disconnected and the path between the initial power source and the electrical stimulation output channel is disconnected.
- the mechanical emergency stop module is a push button switch; when the functional electrical stimulation system is in normal use, the user presses the switch by holding or stepping on, and the normally open end is turned on; in an emergency, the user releases the switch, and the normally open end disconnect.
- any type of switching action will cut off the output of the electrical stimulus and alarm by sound and light.
- the functional electrical stimulation system can work in both "Stand-alone” and "PC-monitor” modes of operation.
- the functional electrical stimulation system may further comprise: a human-machine interaction module for receiving electrical stimulation parameters input by the user; a central control unit, connected to the human-machine interaction module, for The electrical stimulation parameter input by the user generates an electrical stimulation parameter data packet, and transmits the electrical stimulation parameter data packet to the electrical stimulation output channel.
- the functional electrical stimulation system may further include: a communication interface module for receiving an electrical stimulation parameter data packet input from the user terminal; a central control unit, connected to the communication interface module, The electrical stimulation parameter data packet is parsed and packaged into an electrical stimulation parameter data packet that can be parsed by the electrical stimulation output channel.
- the electrical stimulation waveform parameters are modulated by an audio signal, a real-time myoelectric signal of the user, or a fixed waveform sequence.
- the communication interface module is an RS232 communication interface.
- FIG. 6 is a schematic structural diagram of a functional electrical stimulation system according to an embodiment of the present invention.
- the functional electrical stimulation system includes a central control unit 33, a battery 40, a DC boost module 43, a storage capacitor 44, an active discharge circuit 39, a power-off automatic discharge circuit 41, a bridge constant current source 17-32, and a bottom controller 1 -16, Emergency stop protection module, human-computer interaction module, RS232 interface 37.
- the bridge constant current source and the bottom controller are paired one by one to form a 16-channel electrical stimulation output module, and the module applies electrical stimulation to the human body through a pair of electrode patches;
- the emergency stop protection module includes a mechanical emergency stop module 42 and a voice control emergency
- the human computer interaction module includes a keyboard 35 and a liquid crystal screen 36.
- the entire system is powered by a 12V lithium battery, and the DC boost module boosts the battery voltage to 200V to provide power to the constant current output circuit.
- the constant current output circuit uses a voltage controlled constant current source, and the output current is 0-100 mA.
- the bridge circuit consists of two sets of triodes. Their switching between turn-on and turn-off causes changes in current polarity.
- the required control signals are provided by the underlying controller.
- An underlying controller and a set of bridged constant current output circuits form an electrical stimulation output channel, and the underlying controller is controlled by the central control unit via the I2C bus.
- the system consists of 16 output channels, In order to simultaneously act on multiple muscles, the muscles are stimulated at corresponding timings to allow the user to perform certain actions.
- the central control unit 33 in FIG. 6 is a C8051F340 single-chip microcomputer, which is the main control chip of the whole system, and its main function is to drive the liquid crystal screen 36, read the information transmitted by the keyboard 35, and integrate the I2C bus and the underlying controller through the chip.
- the communication is performed; when the system enters the shutdown state and the suspended state, the active discharge circuit 39 is activated to prevent the power from continuously accumulating; in response to the emergency interrupt signal generated by the voice-activated emergency stop 38, and the sound and light alarm module 34 is driven, and the active discharge circuit 39 is also activated. Stop the electrical stimulation; When the system is in the "PC-monitor" state, communicate with the computer through the RS232 interface 37, continuously receive the control signal from the computer, parse and distribute it to the underlying microcontroller 1-16 of the corresponding channel.
- the electrical stimulation output for each channel in Figure 6 consists of an underlying controller 1-16 and a bridge constant current source 17-32.
- the underlying controller is a C8051F410 microcontroller, which integrates dual DA functions to facilitate control of the constant current source.
- the schematic diagram of the bridge constant current source can be seen in Figure 3.
- the bridge structure is primarily intended to achieve bipolar electrical stimulation output.
- the load resistance that is, the stimulated muscle of the human body, is connected in series to the bridge arm of the H-bridge through the electrode patch, and the current flows through the direction of the load resistance by controlling the conduction of the polarity switch and the triode.
- the forward polarity switch and Q2 are on, the negative polarity switch and Q3 are off, the current flows from the left end to the right end of the load resistor R7, and is set to the positive direction; the forward polarity switch and the Q2 cutoff, the negative polarity switch With Q1 turned on 3, the current flows from the right end of the load resistor R7 to the left end, and is set to the negative direction.
- Transistor Q1 and op amp UA, triode Q2 and op amp UB constitute two sets of constant current sources. Among them, the UA and UB of the operational amplifier use the LM358 universal operational amplifier.
- the forward amplitude control signal generated by the bottom controller C8051F410 is input through the positive terminal of the operational amplifier UB.
- the control signal is an analog quantity of 0-3V.
- the pair of sampling resistor R6 can be considered.
- the ground voltage is approximately equal to the forward amplitude control signal.
- the sampling resistor R6 is 30 ohms, the current flowing through R6 is 0-100 mA. Since the current flowing to R6 through R4 and R5 is small, it can be considered that the current flowing through R7 is approximately equal to the current flowing through R6, that is, 0- 100mA.
- the load resistance R7 is the muscle of the human body that needs stimulation.
- the resistance value varies with the environment. It is about 1K-2K when it is wiped by alcohol to reduce the contact resistance. It is required to provide 100mA constant current stimulation in the maximum 2K calculation.
- the voltage is 200V, so the boost module needs to have at least the battery voltage Rose to 200V.
- the first stage single chip C8051F410 turns on the forward polarity switch, outputs the forward amplitude control signal according to the positive pulse amplitude a, turns off the negative polarity switch, and sets the negative amplitude control signal to zero, thereby realizing the current according to the The amplitude needs to flow forward through the load resistor.
- the duration of this phase is tl to output a positive pulse with a pulse width of tl.
- the second phase turns the negative polarity switch on, and outputs a negative amplitude according to the negative pulse amplitude a2.
- the value control signal turns off the positive polarity switch and sets the forward amplitude control signal to zero, so that the current flows negatively through the load resistor according to the required amplitude.
- the duration of this phase is t2, and the output pulse width is t2.
- the positive and negative switches in the third stage are all cut off, the positive and negative amplitude control signals are all zero, no current flows through the load resistor, and the duration is t3, realizing the interval between the two electric stimuli.
- the sum of the three phases of time T is the time of one pulse period, and the reciprocal is the pulse frequency.
- the setting parameters of each electrical stimulation channel are: positive pulse width 0-1000 ⁇ 8, negative pulse width 0-3000 ⁇ 8 , positive pulse amplitude 0-100mA, negative pulse amplitude 0-50mA, electrical stimulation frequency 0- 100Hz.
- the system Since the 200V high voltage required by the bridge constant current output circuit is stored by the high-capacity large-capacity electrolytic capacitor, the system will automatically discharge before the shutdown, the rest period between the two electrical stimulations, and the accidental power failure. The circuit releases the electrical energy stored in the capacitor, preventing the electrical energy from being stored in the capacitor for a long time and causing an accident.
- FIG. 4 is a circuit schematic diagram of DC boost, automatic discharge, and overcurrent protection of a functional electrical stimulation system according to an embodiment of the present invention.
- the voltage of the battery is DC boosted to 200V through the inductor, and the rear end is connected with 10 F high-voltage electrolytic capacitor of 400V, so that the voltage is stable when the electrical stimulation pulse is output.
- the triode Q3 of the active discharge circuit is controlled by the active discharge signal provided by the central control chip, which is usually low, and the transistor Q3 is turned off.
- the active discharge signal is set high by the central control unit, Q3 is turned on, and the current is formed into the ground loop through R8, thereby releasing the high voltage power stored in the capacitor C1. .
- the central control unit and the output circuit of the back end cannot work normally because there is no power supply. At this time, the power will be stored in the capacitor and will not be released. Safety hazards, especially the power-off automatic discharge circuit.
- the battery voltage signal is 12V, which makes Q4 turn on, and the voltage of the collector of Q4 is the turn-on voltage of the three-stage tube is about 0.2V, which is not enough to make Q5 turn on.
- RIO is a high-impedance resistor. The current flowing is only ⁇ . ⁇ , which will not cause discharge.
- Q4 is cut off, and the collector of Q4 is pulled up to 200V by R10, which is enough Q5 is turned on, and the stored electric energy is released through the loop formed by R12 to the ground.
- F1 in Figure 4 is a 25 mA fast-blow fuse.
- the pulse current is up to 100 mA, because the duty cycle is very small, the average current flowing through the human body is within 1 - 2 mA, lower than the safe current, the fuse Will not blow.
- a large current continues to flow through the body, and the fuse is quickly blown, cutting off the passage and protecting the user's safety.
- the average current flowing through the human body is 90-100 mA, the person will have respiratory paralysis. After 3 minutes or more, the heart palsy or the atrium stops beating, and the average current flowing through the human body is 20-25 mA.
- the finger feels pain, the burning sensation increases, the hand muscles begin to squat, and it does not quickly cause serious life threats. Therefore, the 25 mA fuse has a high safety margin.
- the emergency stop protection device in the system is designed to cope with the sudden situation of the user.
- the electrical stimulation therapy induces abnormal heartbeat, and the electrical stimulation intensity is too large, causing the user to generate paralysis.
- the output channel is quickly cut off.
- the power supply and at the same time emits an audible and visual alarm signal to protect the safety of the user.
- the emergency stop protection module of FIG. 6 includes a voice-activated emergency stop 38, a mechanical emergency stop 42 and an audible and visual alarm 34.
- the voice-activated emergency stop is essentially a voice-activated switch that generates a hopping signal when a certain intensity of sound is emitted.
- the signal is connected to the interrupt pin of the central control unit 33 to trigger an emergency stop.
- voice-activated emergency stop is fast. When the user or medical staff finds an emergency, it is often impossible to shut down the device immediately, causing the user to continue to be hurt.
- the voice-activated emergency stop can be activated only by loud shouting, and the electrical stimulation can be stopped quickly.
- the voice-activated emergency stop depends on the normal operation of the central control unit. However, when the system is affected by external electromagnetic interference and other uncertainties, the central control unit program will not play a normal role. At this time, the mechanical emergency stop 42 is used to protect the user. Safety.
- the mechanical emergency stop is a push button switch.
- the normally open end is connected in series between the energy storage module and the electric excitation output channel, and the normally closed end is connected with the sound and light alarm.
- the user presses the switch by holding or stepping on.
- the normally open end is connected, the battery is connected with the DC boost module; the normally closed end is disconnected, and the sound and light alarm does not work.
- the user releases the button the normally open end is disconnected, the passage of the battery and the DC boost module is cut off, so that the electrical stimulation cannot be output, and the normally closed end is closed, so that the sound and light alarm module obtains a Start signal, sound and light alarm.
- the system can work in both "stand-alone” and "PC-monitor” modes to suit the needs of different work environments.
- the two working modes are prepared the same before use.
- the electrode patches of each channel are attached to the muscles that the user needs to stimulate. If the lower limbs are electrically stimulated, the hand-held mechanical emergency stop switch is used; if the upper limbs are electrically stimulated, the pedal-type mechanical emergency stop switch is used.
- the system initializes each peripheral and displays the prompt message for selecting the operation mode on the LCD screen. If the user selects the "Stand-alone" operating mode, the system prompts the user to enter the electrical stimulation parameters for each channel.
- the electrical stimulation parameters including frequency, positive and negative pulse width and positive and negative pulse amplitude according to previous experience. These setting parameters are first generated by the central control unit and sent to the underlying controller of the corresponding channel by connecting the underlying controller data bus. After the underlying controller parses the data packet, it outputs the electrical stimulus according to the corresponding timing. During the operation of the system, if the user feels uncomfortable and needs rest, the output of the electric stimulation can be suspended through the keyboard, and the rest will be continued for a while.
- the user can yell to activate the voice-activated emergency stop circuit, immediately stop the output of the electrical stimulation and automatically release the stored electrical energy by the system; the user can also make the machine Emergency stop and shut off the action, directly cut off the power to stop the electrical stimulation.
- the sound and light alarm circuit is activated regardless of the mechanical emergency stop or the voice-activated emergency stop action, which can quickly attract the attention of the surrounding people.
- the central control unit of the system is a single-chip microcomputer
- the operation speed and storage space are limited, only a few limited and relatively simple waveforms can be output, which limits the application of the system, so in the "PC-monitor" operation mode, by the computer
- Real-time electrical stimulation waveform parameters are generated and forwarded by the central control unit to the underlying controller of each channel for complex control.
- the workflow of "PC-monitor” is as follows. The preparation work before the electric stimulation is the same as the "Stand-alone" operation mode. After the prompt message for selecting the operation mode is displayed on the LCD, the user selects the "PC-excited" mode. The central control unit will wait for packets from the computer.
- the entire transmission and resolution process is within 100 ⁇ ⁇ , and the reaction time relative to human muscle can be considered as real-time control.
- the expected waveform of the final output is generated in two ways. The first one is a pulse signal modulated by music. The advantage is that it has a certain randomness, and avoids the sensitivity of the muscle to the electrical stimulation of the parameter after long-term use of fixed electric stimulation. , reducing the therapeutic effect.
- the second is modulated by myoelectric signals.
- the pulse signal, the myoelectric signal is collected by the electromyography instrument connected to the computer.
- the advantage is that the intensity of the electrical stimulation can be controlled by the user's partial autonomic motion. For example, the hemiplegia patient can control the iliac crest on one side of the healthy side. Excitation intensity.
- FIG. 8 is a control flow chart of a central controller of a functional electrical stimulation system according to an embodiment of the present invention. As shown in FIG. 8, the control flow of the central controller includes - step S802, initializing the peripheral;
- Step S804 selecting a working mode, that is, selecting whether the mode is independent or controlled by the user terminal;
- Step S806 determining whether the working mode selected by the user is an independent operation mode, if yes, executing step S808, otherwise, executing step S820;
- Step S808 obtaining stimulation parameters of each channel through a human-computer interaction module; the central controller sends an instruction to the bottom controller to output electrical stimulation;
- Step S810 transmitting a stimulation parameter to the bottom controller
- Step S812 determining whether the keyboard inputs an instruction to suspend operation, and if yes, executing step S804, otherwise, executing step S814;
- Step S814 it is determined whether a voice-activated emergency stop signal is generated, and if yes, step S816 is performed; otherwise, step S818 is performed;
- Step S816 issuing an emergency stop alarm signal, issuing an active discharge signal, executing step S832; step S818, determining whether the keyboard inputs an instruction to stop running, and if so, executing step S832; otherwise, executing step S812;
- Step S820 determining whether the data packet input by the user terminal is received, and if yes, executing step S822; otherwise, repeatedly determining whether the data packet input by the user terminal is received;
- Step S822 parsing the data packet
- Step S824 determining whether it is a stop command sent by the upper computer, if yes, executing step S832; otherwise, executing step S826;
- Step S830 issuing an emergency stop alarm signal, issuing an active discharge signal, executing step S832; step S832, transmitting a stop command to the bottom controller, and the process ends.
- 9 is a control flow chart of an underlying controller of a functional electrical stimulation system according to an embodiment of the present invention. As shown in Figure 9, the control flow of the underlying controller includes:
- Step S902 determining whether the data packet transmitted by the user terminal is received, and if yes, executing step S904, otherwise, repeatedly determining whether the data packet transmitted by the user terminal is received;
- Step S904 parsing the data packet
- Step S906 determining whether a stop command is received, if yes, performing an exit step, the process ends, otherwise, executing step S908;
- Step S908 obtaining parameters of an electrical stimulation pulse in a cycle
- Step S910 output a positive pulse according to the obtained positive pulse parameter
- Step S912 outputting a negative pulse according to the obtained negative pulse parameter
- Step S914 stopping outputting
- Step S916 determining whether a new data packet is received, and if yes, executing step S904, otherwise, executing step S910;
- the embodiment improves the number of working channels of the electrical stimulation output, increases the safety protection measures, can alleviate the psychological pressure of the user during use, and effectively avoids the user due to the functional electrical stimulation. Secondary injuries, such as abnormal heartbeats and muscle spasms.
- the two working modes enable the present embodiment to implement both simple fixed parameter electrical stimulation and complex time varying parameter electrical stimulation.
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Abstract
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PCT/CN2011/076492 WO2013000122A1 (zh) | 2011-06-28 | 2011-06-28 | 功能性电刺激*** |
US13/994,051 US8983621B2 (en) | 2011-06-28 | 2011-06-28 | Functional electrical stimulation system |
CN201180037866.4A CN103068440B (zh) | 2011-06-28 | 2011-06-28 | 功能性电刺激*** |
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CN103068440A (zh) | 2013-04-24 |
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US20140100638A1 (en) | 2014-04-10 |
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