Miniature wireless transcutaneous electrical neuro or muscular-stimulation unit

• US 6,445,955 B1
• Filed: 07/08/1999
• Issued: 09/03/2002
• Est. Priority Date: 07/08/1999
• Status: Expired due to Fees

• Current Assignee: Foster Biodevice, LLC
• Original Assignee: Cyclotec Advanced Medical Technologies, Inc.
• Inventors: Leon, Robert, Mannheimer, Jeffrey S., Romero, Osvaldo D., Michelson, Stephen A., Selevan, Jerald A.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/350,426
• Time in Patent Office: 1,153 Days
• Field of Search: 607/30, 607/46, 607/72, 607/74, 607/68, 607/60, 607/59, 607/50, 607/2
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

A miniature wireless transcutaneous electrical neuro or muscular stimulation unit. The unit has a housing attached to a plurality of electrodes. An electronics module containing an electrical circuit is contained within the housing and provides a sequence of monophasic or biphasic pulses to a patient'"'"'s pain site via the electrodes. The electrodes can be disposable and come in a variety of shapes and sizes. The patient may select and control the intensity and the frequency of the pulses by choosing one of several TENS and microcurrent waveforms, as well as the orientation and quantity of the electrodes. The means for supplying power to the electronics module can be integrated with the electrodes in one detachable and disposable assembly. A worn-remote controller can send transmission signals to a receiver within the electronic module thereby allowing the patient to program specific units placed on the patient'"'"'s body to perform operations in a specified series of waveforms. The electrodes may be embedded in a splint, bandage, brace or cast, where wires or flex-circuit material connect the electrodes to the unit. The electrodes can be arranged in a grid-like manner to allow for programming of a specific firing order which provides for greater therapeutic effect to a pain site, and may also be embedded in adhesive strips, similar to a conventional Band-Aid.

Claims

1. A miniature transcutaneous electrical neuro or muscular-stimulation unit comprising:

a housing;

a plurality of electrodes attached to said housing;

an electronics module located within said housing and comprising an electrical circuit which provides a biphasic or monophasic sequence of pulses to said electrodes, wherein said sequence of pulses form a plurality of pre-programmable waveforms available for specific clinical needs;

means to restrict said waveforms available to those appropriate for said electrode and treatment;

means for allowing a user to select and control specific waveforms and intensities of said waveforms comprising a removable tether having a first and second end wherein said first end is affixed to said electrode assembly and said second end is affixed to said miniature transcutaneous electrical neuro or muscular-stimulation unit;

means to identify said waveform, its intensity and its duration; and

means for supplying power to said electronics module wherein said means for supplying power is integrated with said electrodes in one assembly.

2. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 wherein said means to restrict said waveforms comprises a series of one or more electrical contacts within said housing, wherein said electrical contacts interface with said electrodes and with said electronics module to identify the type of electrode and determine the allowable waveforms that can be used.

3. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 2 wherein said means for supplying power to said electronics module are a plurality of batteries.

4. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 3 where said batteries are replaceable or rechargeable.

5. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 2 wherein said electronics module applies voltage to said electrodes through said electrical contacts when said electrodes are attached to said housing.

6. The miniature transcutaneous electrical neuro-or muscular stimulation unit of claim 1 wherein said identifying means is an LCD digital readout display.

7. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 6 wherein said means for allowing said user to select and control specific waveforms and intensities of said waveforms is through a series of input devices that interface with the said electronic module which allows the user to vary said intensity of said waveforms.

8. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 wherein said electrodes are disposable.

9. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 wherein said electrodes are detachable and able to be snapped into and out of each said electronic module within said housing of said miniature transcutaneous electrical neuro or muscular-stimulation unit.

10. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 9 wherein said electrodes have integrated conducting leads, have varying shapes and sizes and can be affixed directly to a site or other area requiring electrical neuro or muscular-stimulation anywhere on said user'"'"'s body, said electrodes being positioned at a specified distance from said electronics module wherein said electrodes allow for optimal placement of said electrodes at said pain site or said area requiring electrical neuro or muscular-stimulation.

11. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 10 further comprising:

a gauze pad comprising an antibacterial agent positioned substantially adjacent to and substantially beneath said electronics module; and

a plurality of adhesive strips in which said plurality of electrodes are embedded.

12. The miniature transcutaneous electrical neuro-stimulation unit of claim 11 wherein said plurality of waveforms are comprised of a conventional or modulation low mode and a microcurrent mode.

13. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 12 wherein a conventional-low or modulation-low mode supplies to said plurality of electrodes said biphasic or monophasic pulses of about 0-60 milliamperes at a frequency of about 80-100 Hz having a pulse width of about 75 microseconds.

14. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 12 wherein said micro current mode supplies to said plurality of electrodes said biphasic pulse of about 0-100 microamperes at a frequency of about 0.3-100 Hz.

15. The miniature transcutaneous electrical neuro-stimulation unit of claim 1 wherein said plurality of waveforms are comprised of but not limited to, a conventional-low mode and a conventional-high mode, a modulation-low mode and a modulation-high mode, an acupuncture-like low mode and an acupuncture-like high mode, a microcurrent mode, a burst mode and a cycling mode.

16. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said conventional-low mode supplies to said plurality of electrodes said biphasic or monophasic pulses of about 0-60 milliamperes at a frequency of about 100 Hz having a pulse width of about 75 microseconds.

17. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said conventional-high mode supplies to said electrodes said biphasic or monophasic pulses of about 0-100 milliamperes at a frequency of about 100 Hz having a pulse width of about 125 microseconds.

18. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said modulation-low mode supplies to said electrodes said biphasic or monophasic pulses of about 0-60 milliamperes at a frequency of about 50-100 Hz having a pulse width of about 75-100 microseconds.

19. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said modulation-high mode supplies to said electrodes said biphasic or monophasic pulses of about 0-100 milliamperes at a frequency of about 75-125 Hz having a pulse width of about 100-125 microseconds.

20. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said acupuncture-like low mode supplies to said plurality of electrodes said biphasic pulses of about 0-60 milliamperes at a frequency of about 1 Hz having a pulse width of about 75 microseconds.

21. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said acupuncture-like high mode supplies to said electrodes said biphasic pulses of about 0-100 milliamperes at a frequency of about 2 Hz having a pulse width of about 125 microseconds.

22. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said microcurrent mode supplies to said plurality of electrodes said biphasic pulse of about 0.1-100 microamperes at a frequency of about 0.3-100 Hz.

23. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said burst mode supplies to said plurality of electrodes said biphasic or monophasic pulses of about 1-100 milliamperes at a frequency of about 100 Hz having a pulse width of about 75 microseconds for a duration of three seconds on and three seconds off.

24. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 15 wherein said cycling mode allows said user to program two or more said modes into an individualized program.

25. The miniature transcutaneous electrical neuro-stimulation unit of claim 1 wherein said plurality of waveforms are comprised of but not limited to, three unique muscle stimulation modes, a conventional mode, a modulation mode and three alternative cycling modes.

26. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said first muscle stimulation mode supplies to said plurality of electrodes said biphasic or monophasic pulses typically of about 1-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 5 minutes on and 5 minutes off.

27. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said second muscle stimulation mode supplies to said plurality of electrodes said biphasic or monophasic pulses typically of about 1-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 10 minutes on and 10 minutes off.

28. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said third muscle stimulation mode supplies to said plurality of electrodes said biphasic or monophasic pulses typically of about 1-100 milliamperes at a frequency of about 45 Hz at a pulse width of about 300 microseconds for approximately 10 minutes on and 50 minutes off.

29. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said conventional mode supplies to said plurality of electrodes said biphasic or monophasic pulses typically of about 1-100 milliamperes at a frequency of about 125 Hz at a pulse width of about 125 microseconds.

30. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said modulation mode supplies to said plurality of electrodes said biphasic or monophasic pulses typically of about 0-100 milliamperes at a frequency of about 75-125 Hz at a pulse width of about 100-125 microseconds.

31. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said first alternative cycling mode supplies to said plurality of electrodes a sequence of said biphasic or monophasic pulses comprised of said modulation mode for about 3 minutes followed by said first muscle stimulation mode for about 9 minutes, followed by said modulation for about 3 minutes.

32. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said second alternative cycling mode supplies to said plurality of electrodes a sequence of said biphasic or monophasic pulses comprised of said modulation mode for about 3 minutes followed by said first muscle stimulation mode for about 9 minutes, followed by said modulation mode for about 3 minutes.

33. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 25 wherein said third alternative cycling mode supplies to said plurality of electrodes a sequence of said biphasic or monophasic pulses comprised of said modulation mode for about 3 minutes followed by said third muscle stimulation mode for about 9 minutes, followed by said modulation mode for about 3 minutes.

34. A method of relieving acute or chronic body pain or muscle dysfunction requiring electrical neuro or muscular-stimulation on a user'"'"'s body using the miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 comprising the steps of:

affixing a plurality of electrodes to a treatment site or other area requiring electrical neuro or muscular-stimulation on a user'"'"'s body;

applying said biphasic or monophasic sequence of pulses to said electrodes via an electrical circuit;

providing a means for said user to select and control said plurality of waveforms and intensity of said waveforms;

providing a means for said user to identify said waveform, its intensity and its duration; and

providing a means for supplying power to said electronics module wherein said means for supplying power is integrated with said electrodes in one detachable assembly.

35. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 further comprising:

a remote controller wherein said controller includes a transmitting device with means to transmit signals denoting the desired waveform mode to said miniature transcutaneous electrical neuro-stimulation unit by a communication means; and

means within said electronics module for receiving and decoding said signals from said transmitting device and generating said desired waveforms.

36. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said communication means is achieved by capacitive coupling comprised of a plurality of conductive plates or transducers placed near the surface of said user'"'"'s skin wherein one of said conductive plates or transducers resides in said remote controller and the other said conductive plate or transducer resides in said miniature transcutaneous electrical neuro or muscular-stimulation unit, using the user'"'"'s body as a conductive medium to transmit said signals.

37. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said remote controller transmits said signals at a frequency of between 20-500 kHz from said remote controller through the user'"'"'s body to said transcutaneous electrical neuro-stimulation unit.

38. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said communication means is achieved by over-the-air RF transmission in the frequency range of 40 kHz to 915 MHz.

39. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said transmission signals are synchronized to said miniature transcutaneous electrical neuro or muscular-stimulation unit'"'"'s said monophasic or biphasic sequence of pulses to avoid interference of said transmission signals with said monophasic or biphasic sequence of pulses.

40. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 further comprising a means of synchronizing separate electrodes such that their polarities are 180 degrees out of phase.

41. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said remote controller is adapted to be worn on said user'"'"'s wrist.

42. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 where said electronics module is a remote module with display means which allows said remote module to be identified by said remote controller and which sets a software address thereby allowing said remote controller to send said signals to said identified remote module.

43. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 further comprising:

a standard splint, bandage, manufactured brace, or cast comprised of multiple layers;

said splint, bandage, brace or cast embedded with non-visible wires or flex-circuit material;

said electrodes are embedded in said splint, bandage, brace, or cast;

said wires or flex-circuit material to provide for connection between said plurality of electrodes and disposable said miniaturized transcutaneous electrical neuro-or muscular stimulation unit; and

said plurality of electrodes arranged in a grid-like manner to allow for programming of a specific firing order which can provide for greater therapeutic effect to said pain site.

44. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 further comprising:

a standard splint, bandage, manufactured brace, or cast comprised of multiple layers;

said splint, bandage, brace or cast embedded with non-visible wires or flex-circuit material;

said electrodes are embedded in said splint, bandage, brace, or cast;

said wires or flex-circuit material to provide for connection between said plurality of electrodes and disposable said miniaturized transcutaneous electrical neuro-or muscular stimulation unit; and

said plurality of electrodes arranged in a grid-like manner to allow for programming of a specific firing order which can provide for greater therapeutic effect to said pain site.

45. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 35 wherein said remote controller is adapted to be worn about said user'"'"'s neck as a pendant.

46. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 wherein said means for supplying power is integrated with said electrodes in one assembly.

47. The miniature transcutaneous electrical neuro or muscular-stimulation unit of claim 1 wherein said means for supplying power comprises at least one battery positioned in a battery housing within said housing.