Electro therapy method and apparatus

• US 20010031999A1
• Filed: 01/08/2001
• Published: 10/18/2001
• Est. Priority Date: 01/07/2000
• Status: Active Grant

• Current Assignee: Biowave Corporation
• Original Assignee: Biowave Corporation
• Inventors: Carter, John, Siff, Bradford
• Granted Patent: US 6,584,358 B2
• Time in Patent Office: Days
• US Class Current: 607/69
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

An electro-therapy apparatus and method for providing therapeutic electric current to a treatment site of a patient, having means for providing two oscillating or pulsing electric alternating currents, of frequencies which differ from each other by as little as 1 Hz and up to about 250 Hz, but each being of frequency at least about 1 KHz. The apparatus and method requires only one feed electrode adapted to feed the electric currents to selected feed sites on or beneath the epidermal or mucous surface of the patient, and only one return electrode adapted to be positioned on or beneath the epidermal or mucous surface of the patient, locally to the treatment site. The apparatus includes a feedback subsystem to detect impedance changes in the patient and accordingly adjust the output of the apparatus.

Claims

1. Electro-therapy apparatus for providing therapeutic electric current to a treatment site of a patient comprising:

a generator providing two oscillating or pulsing electric alternating currents, of frequencies which differ from each other by as little as 1 Hz and up to about 250 Hz, but each being of frequency at least about 1 KHz,

only one feed electrode adapted to feed said electric currents to selected feed sites on or beneath the epidermal or mucous membrane surface of the patient, and

a return electrode adapted to be positioned on or beneath the epidermal or mucous surface of the patient, locally to said treatment site.

2. Electro-therapy apparatus according to

claim 1

, wherein said generator comprises a microprocessor controlled frequency control system.

3. Electro-therapy apparatus according to

claim 1

, wherein said generator is adapted to provide said electric currents about 8 kHz with said difference electric currents being about between 80 and 130 Hz.

4. Electro-therapy apparatus according to

claim 1

wherein a summated area of said feed electrode exceeds the summated area of said return electrode.

5. Electro-therapy apparatus according to

claim 1

wherein said signals are generated under microprocessor controlled circuitry, custom medium or large scale integrated circuitry or by discrete and/or small scale integrated circuits based circuits.

6. Electro-therapy apparatus according to

claim 4

, wherein said feed electrode summated area exceeds said return electrode summated area by a factor of more than 2.

7. Electro-therapy apparatus according to

claim 6

, wherein feed electrode area exceeds said return electrode summated area by a factor of 8.

8. Electro-therapy apparatus according to

claim 1

, wherein said apparatus is portable and may be carried by said patient.

9. Electro-therapy apparatus according to

claim 1

, wherein said apparatus is wearable and/or may be strapped to said patient.

10. Electro-therapy apparatus according to

claim 1

wherein said apparatus includes a feedback system that reacts to a change in impedance presented by a patient'"'"'s body.

11. An apparatus for using a non-linear action of nerve fiber membranes that cause a mixing of said two independent high frequency signals in a volume of tissue surrounding and beneath a pain site pad along an axis between a pain site pad and an opposite pad and further wherein said mixing yields a distribution of synthesized sum and difference frequencies among which is a therapeutic low frequency equivalent to a beat frequency of said signals for providing therapeutic treatment of a patient, said apparatus comprising:

a generator providing two oscillating or pulsing electric alternating currents, of frequencies which differ from each other by as little as 1 Hz and up to about 250 Hz, but each being of frequency at least about 1 KHz;

only one feed electrode pad adapted to feed said electric currents to selected feed sites on or beneath the epidermal or mucous membrane surface of the patient; and

a return electrode pad adapted to be positioned opposite said feed electrode on or beneath the epidermal or muscular surface of the patient, located on a line vector between said electrode pads where such line vector is perpendicular to the skin surface on which the pads reside.

12. The apparatus of

claim 11

wherein said pads that connect said apparatus to said body are of a conductive material that allows propagation and field conductivity of said electric alternating currents.

13. The apparatus of

claim 11

wherein a connection between a lead wire and said electrodes is of a low profile design allowing easy connection and comfortable use under clothing.

14. The apparatus of

claim 11

wherein a ratio of pad sizes is at least 2:

1 with said pad closer to a pain area being a smaller pad.

15. The apparatus of

claim 14

wherein said ratio is 8:

1.

16. The apparatus according to

claim 11

, wherein said generator is microprocessor controlled.

17. The apparatus of

claim 11

wherein said electric currents can be applied in sum to one pad with the other pad serving as the return path.

18. The apparatus of

claim 11

wherein a summated area of said feed electrode exceeds the area of said return electrode with a pain site located on a line vector in between said electrode pads wherein said line vector is perpendicular to each skin surface on which said pads reside.

19. The apparatus of

claim 11

, wherein said apparatus is portable.

20. The apparatus of

claim 11

, wherein said apparatus is wearable and/or strapped to said patient.

21. The apparatus of

claim 11

, wherein said signals comprise alternating current waveforms not containing any DC components.

22. The apparatus of

claim 21

, wherein said apparatus comprises balanced amplifiers to minimize the DC component on said signals.

23. The apparatus of

claim 21

wherein a capacitor is also included to eliminate any residual DC component on said signals.

24. The apparatus of

claim 11

, wherein said frequency difference may be adjusted to achieve maximum therapeutic effect.

25. The apparatus of

claim 11

, where therapeutic effects include pain suppression, pain management and increase in range of motion.

26. The apparatus of

claim 11

wherein said generator is adapted to provide said electric currents at about 8 kHz with said difference electric currents being between 80 and 130 Hz.

27. The apparatus of

claim 11

wherein an amplitude of said feed signals is adjustable and controlled by a user under treatment.

28. The apparatus of

claim 11

wherein said generator further comprises a feedback system that measures any change of the impedance in a circuit path including said patient'"'"'s body as connected and adjusts an output level to maintain a constant voltage level.

29. The apparatus of

claim 28

wherein said feedback system comprises a hardware portion controlled by a software portion.

30. The apparatus of

claim 29

wherein said software portion includes a collection of routines that determine if said measured impedances require any change to the device'"'"'s output level to maintain patient comfort.

31. The apparatus of

claim 30

wherein said hardware portion comprises:

a precision resistor that monitors the current level through the patient;

an amplifier for detecting a voltage developed by said current through said resistor and is differentially detected;

a gain block for further amplifying said detected voltage;

a buffered attenuator for sampling the voltage across the electrodes and to set its value to within the range of an Analog-to-Digital (ADC) circuit;

an analog multiplexer to select either the current or voltage representations for digitization by said Analog-to-Digital circuit;

a CPU for selecting current or voltage;

an output of said multiplexer being applied to a precision RMS to DC converter whose output is a DC level approximately equal to the RMS value of the applied signal;

said analog-to-digital converter digitizes an output of said multiplexer and is coupled to said CPU;

a digital attenuator that makes any changes to said output level that might be required by the feedback subsystem.

32. A method of electro therapy comprising:

providing a generator that generates two oscillating or pulsing electric alternating currents, of frequencies which differ from each other by as little as 1 Hz and up to about 250 Hz, but each being of frequency at least about 1 KHz,

providing a single feed electrode and a return electrode placed on or beneath the epidermal or muscular surface of a patient coupled to said generator feeding via said feed electrode two or more oscillating or complex morphology electric currents to a patient, to respective selected feed sites placed opposite one another on said patient'"'"'s body with a pain site located on a line vector in between said electrode pads wherein said line vector is perpendicular to each skin surface on which said pads reside, said currents each being of frequency at least about 1 KHz and differing as little as 1 Hz from each other by up to about 250 Hz, wherein a non-linear action of nerve fiber membranes causes a mixing of said two independent high frequency signals in a volume of tissue surrounding and beneath a pain site pad along an axis between a pain site pad and an opposite pad to produce a therapeutic effect and further wherein said mixing yields a distribution of synthesized sum and difference frequencies among which is a therapeutic low frequency equivalent to a beat frequency of said signals.

33. The method

claim 32

, wherein said electrodes further comprise pads that connect said apparatus to said body are of a conductive material that allows propagation and field conductivity of said electric alternating currents.

34. The method of

claim 32

wherein a connection between a lead wire and said electrodes is of a low profile design allowing easy connection and comfortable use under clothing.

35. The method of

claim 32

wherein a ratio of pad sizes is at least 2:

1 with said pad closer to a pain area being a smaller pad.

36. The method of

claim 32

wherein said ratio is 8:

1.

37. The method of

claim 32

, wherein said generator is microprocessor controlled.

38. The method of

claim 32

wherein said electric currents can be applied in sum to a first pad with the other pad serving as the return path or differentially with each pad conducting one signal or one group of super positioned signals.

39. The method of

claim 32

wherein an area of said feed electrode exceeds the area of said return electrode with a pain site located on a line vector in between said electrode pads wherein said line vector is perpendicular to each skin surface on which said pads reside.

40. The method of

claim 32

, wherein said generator is portable.

41. The method of

claim 32

, wherein said generator is wearable and/or strapped to said patient.

42. The method of

claim 32

, wherein said signals comprise alternating current waveforms not containing any DC components.

43. The method of

claim 32

, wherein said frequency difference may be adjusted to achieve maximum therapeutic effect.

44. The method of

claim 32

wherein said therapeutic effect is produced by a hyperpolarization mechanism.

45. The method of

claim 32

wherein said therapeutic effect is a produced by a frequency conduction block mechanism.

46. The method of

claim 32

wherein said therapeutic effect is produced by a gate control mechanism.

47. The method of

claim 32

wherein amplitude of said feed signals is adjustable and controlled by said patient.

48. The method of

claim 32

wherein said therapeutic effect includes a concomitant increase in blood flow in the volume of tissue where said electric field is present.

49. The method of

claim 32

wherein said therapeutic effect includes a concomitant increase in range of motion for up to 24 hours following the treatment.

50. The method of

claim 32

where said therapeutic effect includes symptoms selected from the group consisting of acute and traumaticpain, chronic and arthritic pain, surgical pain, post-surgical pain, and cancer pain.

51. The method of

claim 32

said therapeutic has effect in areas of the body selected from the group consisting of face, jaw, neck, back, shoulders, chest, abdomen, hips, arms, elbows, wrists, hands, fingers, legs, knees, ankles, feet, and toes.

52. An electro-therapy apparatus comprising:

means for generating two sine wave signals between 1 kHz and 250 kHz.;

means for mixing said sine wave signals;

means for controlling an output of said mixed signals;

means for coupling said mixed signals to a patient via electrodes and electrode pads; and

means for detecting an impedance change within said patient and modifying said output level, wherein said electrodes are placed or beneath the epidermal or muscular surface of a patient coupled to said generating means feeding via said electrodes two or more oscillating or complex morphology electric currents to a patient, to respective selected feed sites placed opposite one another on said patient'"'"'s body with a pain site located on a line vector in between said electrode pads wherein said line vector is perpendicular to each skin surface on which said pads reside, said currents each being of frequency at least about 1 KHz and differing as little as 1 Hz from each other by up to about 250 Hz, wherein a non-linear action of nerve fiber membranes causes a mixing of said two independent high frequency signals in a volume of tissue surrounding and beneath a pain site pad along an axis between a pain site pad and an opposite pad to produce a therapeutic effect and further wherein said mixing yields a distribution of synthesized sum and difference frequencies among which is a therapeutic low frequency equivalent to a beat frequency of said signals.

53. An electro therapy apparatus comprising:

a generator for generating a pair of signals greater than 1 KHz with the difference frequency of said pair of signals being greater than 1 Hz;

a single feed electrode; and

a return electrode, wherein said electrodes are coupled to said generator.

54. The electro therapy apparatus of

claim 53

further comprising a feedback system for controlling an output of said generator as a function of impedance presented to said generator by a patient using said apparatus.

55. A feedback control system for an patient electro therapy comprising:

a generator for outputting a pair of therapeutic currents;

a single feed electrode;

a return electrode, a measurement subsystem determining an impedance of said patient; and

a control mechanism controlling an output level of said generator.

56. A computer program product for use with an electro therapy device, said computer program product comprising:

a computer usable medium having computer readable program code means embodied in said medium for controlling an electro therapy device, said computer program product having;

computer readable program code means for causing a computer to control the generation of a pair of signals;

computer readable program code means for causing said computer to maintain a preset frequency difference said signals computer readable program code means for causing said computer to control an amplitude of said signals;

computer readable program code means for causing said computer to detect a changed impedance of an output of said device; and

computer readable program code means for causing said computer change an output of said device to maintain a preset output with changing impedance of a connected patient.

57. Electro-therapy electrodes for providing therapeutic electric current to a treatment site of a patient coupled to a generator providing two oscillating or pulsing electric alternating currents, of frequencies which differ from each other by as little as 1 Hz and up to about 250 Hz, but each being of frequency at least about 1 KHz comprising:

only one feed electrode adapted to feed said electric currents to selected feed sites on or beneath the epidermal or mucous membrane surface of the patient, and

a return electrode adapted to be positioned on or beneath the epidermal or mucous surface of the patient, locally to said treatment site.