Electronic neuromuscular stimulation device

• US 5,562,718 A
• Filed: 06/03/1994
• Issued: 10/08/1996
• Est. Priority Date: 06/03/1994
• Status: Expired due to Term

• Current Assignee: Accelerated Care Plus Corp. (Hanger, Inc.)
• Original Assignee: Francis X. Palermo
• Inventors: Palermo, Francis X.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/253,415
• Time in Patent Office: 858 Days
• Field of Search: 607/46, 607/48, 607/61, 607/60, 607/66, 607/70, 607/72, 607/74, 607/75, 607/115, 607/2
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

An electronic neuromuscular stimulation device (10) that is operated by a computerized electronic control unit (20). The unit (20) includes at least two and preferably four output channels to which are connected a corresponding set of electrode output cables (12). Each cable has attached a positive electrode (12D) and a negative electrode (12E) that are attached to selected areas of a patient'"'"'s anatomy. The unit (20) also includes controls, indicators, and circuitry that produce nerve stimulation pulses that are applied to the patient through the electrodes (12D,12E). The nerve stimulation pulses consist of individual pulses that are arranged into pulse trains and pulse train patterns. The pulse train patterns, whose selection depends on the type of ailment being treated, includes sequential patterns, delayed overlapping patterns, triple-phase overlapping patterns, reciprocal pulse trains, and delayed sequenced "sprint interval" patterns. The overlapping patterns are particularly timed to take advantage of neurological enhancement.

Claims

1. An electronic neuromuscular stimulation device comprising:

a) a plurality of electrode output cables having a front section and a back section, where the front section has attached a pair of electrodes that are adapted to be attached to selectable areas of a living tissue, and

b) an electronic control unit attached to a power source and having circuit means for selectively producing a plurality of nerve stimulation pulses which are applied to the living tissue through at least two paired-dipole PLUS OUTPUT connectors, into which the back section of said electrode output cables are attached wherein said electronic control unit circuit means comprises;

(1) a power input circuit comprising a battery charger having an input that is applied an a-c power source and an output that is applied to a charge/run switch having a CHARGE contact and a RUN contact, where when said switch is placed in its CHARGE position, a rechargeable battery is maintained in a charged condition,

(2) a power application circuit comprising;

(a) a latching relay having a normally-open first contact a first coil and a second coil, and

(b) a normally open START switch that when closed, and the charge/run switch is in the RUN position, said relay is energized allowing the battery voltage to be applied to the input terminal of a voltage regulator and to a POWER ON indicator lamp,

(3) a power control circuit comprising a power control unit that is energized by a low voltage detector that senses when the battery voltage has dropped to an unacceptable operating level, at which time a LOW BATTERY indicating lamp illuminates, and by a treatment concluded output signal applied when a patient'"'"'s treatment has been concluded, when said power unit is energized, it produces an output that de-energizes said latching relay that terminates the power to said device.

(4) a PULSE PATTERN SELECT switch that produces an output signal corresponding to a specific pulse output pattern,

(5) a pulse-pattern generating circuit comprising a microprocessor that functions in combination with a programmable read only memory (PROM) and a firmware program, where said pulse-pattern generating circuit has a first input that is applied the energizing voltage from said voltage regulator, a second input from said PULSE-PATTERN SELECT switch that selects the specific pulse pattern that is to be processed, a plurality of pulse outputs, and a treatment concluded output signal that automatically de-energizes said power control unit when a patient'"'"'s treatment time has been concluded,

(6) a pulse driving circuit comprising a plurality of FET drivers that are applied the respective plurality of output signals from said pulse-pattern generating circuit and that produce a corresponding set of first and second output signals, where the second output signals are applied to an ORing circuit that when enabled, energizes a STIMULUS ON indicating lamp, and

(7) a pulse output circuit comprising a plurality of isolation and impedance matching transformers and a plurality of POWER SET switch/potentiometer units where the output signals from said pulse driving circuit are applied to a respective transformer and to the pole of the switch, where when the potentiometer is adjusted so that the switch is closed, the selected nerve stimulation pulse is routed through the potentiometer wiper and said coupling capacitor to the paired-dipole PULSE OUTPUT connector to where said electrode output cable attaches.

2. The device as specified in claim 1 wherein said device incorporates four output channels comprising channel 1 through 4, where channels 1 and 3 are timed together, and channels 2 and 4 are timed together.

3. The device as specified in claim 1 wherein said device incorporates six output channels comprising channels 1 through 6, where channels 1, 3 and 5 are timed together and channels 2, 4 and 6 are timed together.

4. The device as specified in claim 1 wherein said rechargeable battery is comprised of a nickel-cadmium battery.

5. The device as specified in claim 1 wherein said pattern selector switch is comprised of a binary encoded switch.

6. The device as specified in claim 1 wherein said programmable read only memory is comprised of a replaceable electronic programmable read only memory (EPROM) having means for allowing said firmware program to be altered or changed to accommodate the parameters of a specific nerve stimulation pulse(s).

7. The device as specified in claim 1 wherein said programmable read only memory is comprised of a replaceable electronic programmable read only memory (EPROM) having means for allowing said firmware program to be altered or changed to accommodate the parameters of a specific nerve stimulation pulse(s), wherein said PROM or EPROM is programmed to provide the following nerve stimulation pulse parameters:

a) pulse width,

b) pulse train duration,

c) pulse train delay/overlap,

d) pulse train ramp (ramp frequency),

e) pulse train frequency,

f) pulse train repetition cycling, and

g) pulse train on-time.

8. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns.

9. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds.

10. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic symmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively.

11. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and wherein said pulse train pattern is comprised of a sequential pulse train pattern that utilizes output channels 1 and 2 to produce two pulse train patterns, a first pulse train pattern on channel 1 and a second pulse train pattern on channel 2, where the second pulse train pattern commences after the first pulse train pattern has ended.

12. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and said pulse train pattern is comprised of a sequential pulse train pattern that utilizes output channels 1 and 2 to produce two pulse train patterns, a first pulse train pattern on channel 1 and a second pulse train pattern on channel 2, where the second pulse train pattern commences after the first pulse train pattern has ended, and wherein a typical sequential pulse train pattern is comprised of a first pulse train pattern that lasts for 200 milliseconds, at the conclusion of the first pulse train pattern there is a time delay of between 60-200 milliseconds, typically 160 milliseconds, before the second pulse train pattern of 200 milliseconds commences.

13. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and said pulse train pattern is comprised of a delayed, overlapping pulse-train pattern that utilizes output channels 1 and 2 to produce two pulse train pattern;

a first pulse train pattern on channel 1 and a second pulse train pattern on channel 2, that commences at a specified time period prior to the termination of the first pulse train pattern on channel 1.

14. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and said pulse train pattern is comprised of a delayed, overlapping pulse-train pattern that utilizes output channels 1 and 2 to produce two pulse train pattern;

a first pulse train pattern on channel 1 and a second pulse train pattern on channel 2, that commences at a specified time period prior to the termination of the first pulse train pattern on channel 1 where a typical delayed, overlapping pulse-train pattern is comprised of a first pulse train pattern has reached a time period of between 140 and 190 milliseconds, typically 160 milliseconds, the second pulse train pattern of 200 milliseconds commences.

15. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, wherein said pulse train pattern is comprised of a triple-phase overlapping pulse-train pattern that utilizes channels 1 and 3 to produce three pulse train patters;

a first pulse train pattern on channel 1, a second pulse train pattern on channel 2 and a third pulse train pattern on channel 1, where the second pulse train pattern commences at a specified time period prior to the termination of the first pulse train pattern, then after a specified time period and prior to the termination of the second pulse train pattern, the third pulse train pattern, which has a shorter time duration than that of the first pulse train pattern commences.

16. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, wherein said pulse train pattern is comprised of a triple-phase overlapping pulse-train pattern that utilizes channels 1 and 3 to produce three pulse train patterns;

a first pulse train pattern on channel 1, a second pulse train pattern on channel 2 and a third pulse train pattern on channel 1, where the second pulse train pattern commences at a specified time period prior to the termination of the first pulse train pattern, then after a specified time period and prior to the termination of the second pulse train pattern, the third pulse train pattern, which has a shorter time duration than that of the first pulse train pattern commences, and wherein a typical triple-phase overlapping pulse-train pattern is comprised of a first pulse train pattern that lasts for 200 milliseconds, when this pulse train pattern has reached a timer period of between 150 and 170 milliseconds, typically 160 milliseconds, the second pulse train pattern of 200 milliseconds commences which provides a first overlap of 40 milliseconds, when the second pulse train pattern has reached a time period of between 170 and 190 milliseconds, typically 180 milliseconds, the third pulse train pattern which has a time period of 100 milliseconds commences prior to the termination of the second pulse train pattern to provide a second overlap of 20 milliseconds and a time lapse of 120 milliseconds between the termination of the first pulse train pattern and the beginning of the third pulse train pattern.

17. The device of specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and wherein said pulse train pattern is comprised of a reciprocal pulse train having a second pulse train pattern on channel 2 that commences before the termination of first pulse train pattern on channel when the second pulse train pattern commences with an overlapping ramp that begins at a low voltage amplitude and ramps up to the maximum voltage amplitude that is available at the termination of the first pulse train pattern.

18. The device as specified in claim 1 wherein said nerve stimulation pulses are comprised of individual pulses that are arranged into pulse trains and a pulse train patterns, wherein said individual pulses are comprised of either a monophasic square wave or a biphasic asymmetric square wave, where the monophasic square wave has an amplitude that ranges between 0 and 150 volts and a pulse duration that ranges between 40 and 50 microseconds;

and the biphasic asymmetric square wave has an amplitude that ranges between 0-150 volts and a positive-phase pulse duration that ranges between 40 and 50 microseconds, and where said pulse trains operate at a pulse rate interval of between 10 and 30 milliseconds which corresponds to a frequency of between 50 Hz and 100 Hz respectively, and wherein said pulse train pattern is comprised of a delayed sequenced "spring interval" pulse train on channel 1 that switches from one pulse train rate and pulse train duration to another pulse train pattern having a different pulse train rate and pulse train duration, concurrently with the pulse train pattern on channel 1 there is on channel 2, similar but staggered pulse train patterns.

19. An electronic neuromuscular stimulation device comprising:

a) a plurality of electrode output cables with each cable having a front section that splits into a first end and a second end with each end having respectively attached a positive transcutaneous electrode pad and a negative transcutaneous electrode pad, where the pads are adapted to be attached to selectable areas of a human body and where the back section has attached at male jack,

b) a utility power cable having on a first end an a-c male connector that plugs into a 120-volt a-c utility power receptacle and on a second end a female connector, and

c) an electronic control unit housed within an enclosure having a male power input receptacle that receives the female connector on said utility power cable, a plurality of PULSE OUTPUT connectors that internally interface with output channels where each connector externally interfaces with a respective male jack on one of said plurality of electrode output cables, said electronic control unit having circuit means for selectively producing a plurality of nerve stimulation pulse train patterns which are applied to the patient through the PULSE OUTPUT connectors and said plurality of electrode pads on said electrode output cables, wherein said electronic control unit circuit means comprises;

(1) a power input circuit that is applied 120-volt a-c when the female connector on said utility power cable is inserted into a male-power input receptacle on said enclosure, where said a-c power input is conditioned by and applied through a battery charger that is connected to a CHARGE contact of a single-pole double-throw charge/run switch also having a RUN contact and a pole, where the pole is connected to the positive terminal of a rechargeable battery that has its negative terminal connected to circuit ground,

(2) a power application circuit comprising;

(a) a latching relay having a pole, a normally-open first contact, a second contact, a first coil having a first end and a second end, and a second coil having a first end and a second end, where the relay pole and the first end of the first coil are connected to the RUN contact of the charge/run switch and the first end of the second coil is connected to a first junction to which is also connected the second contact of the relay

(b) a normally open push-button START switch having a first contact connected to the second end of the first coil and a second contact connected to circuit ground,

(c) a POWER-ON indicator lamp having a first terminal connected to the first junction and a second terminal connected to circuit ground, and

(d) a voltage regulator having an input terminal and an output terminal where the input is connected to the first junction, and

(3) a power control circuit comprising;

(a) a power control unit having an output terminal, a first input terminal and a second input terminal, where the output terminal is connected to the second end of the second coil, and

(b) a low-voltage detector having an input terminal that is connected to the first junction, a first output terminal that is connected to the first input terminal of said power control unit and a second output terminal that is connected to a LOW-BATTERY indicating lamp,

(4) a PULSE-PATTERN SELECT switch having means for providing logic level signals that function to select a plurality of output pulse trains and train patterns,

(5) a pulse pattern generating circuit that includes a microprocessor that functions in combination with a programmable read only memory (PROM) and a firmware program, with said pulse pattern generating circuit having;

(a) a first input supplied from the output of said voltage regulator, that energizes said pulse pattern generating circuit,

(b) a second input supplied from said pulse-pattern selector switch that allows the selection of the specific pulse train and train pattern that is to be processed by said pulse pattern generating circuit,

(c) a plurality of pulse outputs, and

(d) a treatment concluded output signal that is automatically applied to said power control unit to turn said device off when a patient'"'"'s treatment has been concluded,

(6) a pulse driving circuit comprising;

(a) a plurality of FET drivers having input terminals that are applied the respective output signals from said pulse-pattern generating circuit, with each said FET driver having a first output terminal and a second output terminal, and

(b) an ORing circuit having a plurality of input terminals that are applied the first inputs from said FET drivers, with said ORing circuit having an output terminal that is connected to a STIMULUS ON indicating lamp, and

(7) a pulse output circuit comprising;

(a) a plurality of isolation and impedance matching transformers where each said transformer has a primary winding having a first terminal and a second terminal, and an isolated secondary winding having a first terminal and a second terminal,

(b) a plurality of PULSE SET switch/potentiometer units, where each switch consists of a single-pole single-throw switch having a pole and a contact, where the contact of each switch is connected to a second junction to which is also connected the third input of said microprocessor, and where each potentiometer has a wiper, a first terminal and a second terminal, where the first terminal of the transformer'"'"'s primary winding is connected to the battery voltage V_B and to the pole of each switch, and the second terminal of the primary winding is connected to the output of a respective FET driver, and where the first terminal and second terminal of the secondary winding is connected respectively across the first and second terminals of the potentiometer, with the wiper of each potentiometer is capacitively coupled through a capacitor to a positive contact of a respective PULSE OUTPUT connector on said enclosure, where said electronic control circuit operates said electronic neuromuscular device as follows;

the input power into said electronic control unit is applied from said utility power cable through said battery charger to said charge/run switch, and when said charge/run switch is placed in the CHARGE position, the rechargeable battery is charged through the pole of said switch, where when said switch is placed in the RUN position, the battery voltage is applied to the pole of said latching relay which is normally in contact with the normally open contact of said relay, when said push-button START switch is depressed, the battery voltage energizes said relay causing the relay pole to make contact with the second contact of said relay, at this occurrence, the battery voltage is applied to a first junction to which is also connected the input terminal of said 5-volt voltage regulator and the POWER-ON indicator lamp, where the power-on mode of said relay is controlled by said relay'"'"'s second coil which is connected to the output terminal of said power control unit, when the low voltage detector senses that the voltage level of said battery voltage has dropped to a level of 8.5 volts, it energizes the LOW-BATTERY indicating lamp, when the battery voltage drops to an unacceptable level of 7.5 volts, the detector energizes said power control unit which then de-energizes said relay and causes said device to turn off, the power control unit is also energized to turn said device off when the treatment concluded output signal is applied by said pulse processing circuit when a patient'"'"'s treatment has been concluded;

the power output from said voltage regulator is applied to said pulse-pattern generating circuit where said microprocessor in combination with said PROM and said firmware produces a plurality of output signals as selected by said PULSE-PATTERN SELECT switch, the output signal from said pulse-pattern generating circuit are each applied through the respective FET drivers which have an output that is connected to the respective primary winding of said isolation and impedance matching transformer, to said ORing circuit that when enabled, causes said STIMULUS ON indicating lamp to illuminate, and to the pole of the switch on said PULSE SET switch/potentiometer unit;

the secondary winding of said transformer is connected across the respective potentiometer of said PULSE SET switch/potentiometer unit, when the potentiometer is adjusted so that the switch is closed, the selected pulse output can be adjusted and routed through the potentiometer wiper and said coupling capacitor to the PULSE OUTPUT connector that attaches to said electrode output cable from where the nerve stimulation pulse is applied to the patient via said electrode output cable.