Method and apparatus for treating or preventing a medical condition

• US 20080161884A1
• Filed: 07/27/2007
• Published: 07/03/2008
• Est. Priority Date: 12/23/2004
• Status: Abandoned Application

• Current Assignee: Wound Solutions Limited
• Original Assignee: Wound Solutions Limited
• Inventors: Rainey, Christopher John, Southgate, John Peter, Nagle, Richard, Moretti, Andrea, Chandler, Mark
• Application Number:
  US11/878,855
• Publication Number:
  US 20080161884A1
• Time in Patent Office: Days
• US Class Current: 607/50
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

A method of treating a wound or preventing injury to a region susceptible to injury comprising the steps of placing a pair of electrodes placed spaced apart in the region of a wound and applying a predetermined sequence of current waveforms across the electrodes. The sequence of current waveforms comprises a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μA, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms, a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μA, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms and a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μA, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms.

Claims

1. A method of treating injured tissue or preventing injury to tissue susceptible to injury, the method comprising:

positioning a plurality of electrodes spaced apart in the region of said tissue;

placing a compression covering over the plurality of electrodes and the region of said tissue to apply pressure in the region of said tissue; and

applying a sequence of electrical waveforms between at least two of the plurality of electrodes, the sequence of electrical waveforms comprising;

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms.

2. A method according to claim 1, wherein at least one of the first waveform, the second waveform and the third waveform comprises a first part comprising said pulses of a first polarity and a second part comprising pulses of a second polarity.

3. A method according to claim 2, wherein during application of at least one of the first waveform, the second waveform and the third waveform the polarity of the electrodes is reversed approximately every 5 to 15 seconds.

4. A method according to claim 3, wherein during application of at least one of the first waveform, the second waveform and the third waveform the polarity of the electrodes is reversed at substantially every 10 seconds.

5. A method according to claim 1, wherein

the first waveform comprises a series of current pulses having an amplitude of substantially 100 μ

A, a frequency of substantially 1 pulse per second and a pulse width of substantially 500 ms;

the second waveform comprises a series of current pulses having a amplitude of substantially 40 μ

A, a frequency of substantially 3 pulses per second and a pulse width of substantially 166 ms;

the third waveform comprises a series of current pulses having an amplitude of substantially 320 μ

A, a frequency of substantially 100 pulses per second and a pulse width of substantially 5 ms.

6. A method according to claim 1, wherein the electrodes are positioned in contact with skin peripheral to said tissue.

7. A method according to claim 6, wherein each electrode of a pair of electrodes is positioned on opposite sides of said tissue to one another.

8. A method according to claim 6, wherein each electrode is placed approximately 1 cm from an outer boundary of the area of said tissue.

9. A method according to claim 1, wherein the first waveform is generated over a period of time ranging from 2 to 8 minutes.

10. A method according to claim 9, wherein the first waveform is generated over a time period of substantially 5 minutes

11. A method according to claim 1, wherein the second waveform is generated over a period of time ranging from 25 to 45 minutes.

12. A method according to claim 11, wherein the second waveform is generated over a period of time of substantially 35 minutes.

13. A method according to claim 1, wherein the third waveform is generated over a period of time ranging from 20 to 35 minutes.

14. A method according to claim 13 wherein the third waveform is generated over a period of time of substantially 25 minutes.

15. A method according to claim 1, wherein the first waveform is generated over a period of time ranging from 5 to 10 minutes, the second waveform is generated over a period of time ranging from 25 to 50 minutes, and the third waveform is generated over a period of time ranging from 15 to 30 minutes.

16. A method according to claim 15, wherein the first waveform is generated over a period of time of substantially 5 minutes, the second waveform is generated over a period of time of substantially 35 minutes, and the third waveform is generated over a period of time of substantially 25 minutes.

17. A method according to claim 1, wherein the pulses are substantially rectangular.

18. A method according to claim 1, wherein the sequence of waveforms is repeated.

19. A method according to claim 1, further comprising applying therapeutic energy to the region of said tissue.

20. A method according to claim 19, wherein applying therapeutic energy to the region of said tissue comprises applying at least one of vibratory, chemical, electromagnetic, heat, mechanical, ultrasonic, and magnetic energy to the region of injured tissue.

21. A method of treating injured tissue or preventing injury to tissue susceptible to injury, comprising:

placing a plurality of electrodes on the skin in an area of said tissue;

placing a compression covering over the electrodes and the area of said tissue to blood flow in the area of said tissue; and

applying an electrical current to pass from at least one electrode to at least one other electrode of the plurality of electrodes.

22. A method according to claim 21 wherein the electrodes are positioned on the skin on opposite sides of the area of said tissue to one another.

23. A method according to claim 22, wherein each electrode is placed approximately 1 cm from an edge of the area of said tissue.

24. A method according to claim 21, wherein opposing ends of each electrode extend beyond the outermost edges of the area of said tissue.

25. A method according to claim 24, wherein opposing ends of each electrode extend beyond the outermost edges of the area of said tissue by approximately 1 to 1.5 cm.

26. A method according to claim 25, further comprising applying therapeutic energy to the area of said tissue.

27. A method according to claim 26, wherein applying therapeutic energy to the area of said tissue comprises applying at least one of electromagnetic, heat, mechanical, ultrasonic, and magnetic energy to the area of said tissue.

28. A method according to claim 21, wherein at least three electrodes are placed in contact with skin in a region peripheral to the area of said tissue, the method further comprising switching the electrical current to flow between different electrodes of the at least three electrodes.

29. A method according to claim 21, further comprising at least one of measuring the pressure applied by the compression covering to the area of said tissue and measuring the angle of tilt at which a limb having the said tissue is held or moved with respect to the direction of gravitational force.

30. A method according to claim 21, wherein one or more of the electrodes is each provided on a flat substrate shaped as two substantially crescent shaped portions apically linked and having a concave inner circumferential edge and a convex outer circumferential edge, said outer circumferential edge having an indented region situated at the apically linked region between said substantially crescent shaped portions and the method includes placing each substrate close to the periphery of the injured tissue by selecting to place either the inner circumferential edges of said plurality of said electrodes adjacent to the said tissue, or the indented region of the outer circumferential edges of said plurality of said electrodes adjacent to the said tissue.

31. A method according to claim 21, wherein said electrodes are placed in contact with skin in a region peripheral to the area of said tissue.

32. A method of treating a wound, comprising:

placing a plurality of electrodes in contact with skin in a region peripheral to the wound; and

applying a sequence of current waveforms between the electrodes, the sequence of current waveforms comprising;

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms.

33. A method according to claim 32, wherein at least one of the first waveform, the second waveform and the third waveform comprises a first part comprising said pulses of a first polarity and a second part comprising pulses of a second opposite polarity.

34. A method according to claim 33, wherein during application of the at least one of the first waveform, the second waveform and the third waveform the polarity of the electrodes is reversed approximately every 5 to 15 seconds.

35. A method according to claim 34, wherein during application of at least one of the first waveform, the second waveform and the third waveform the polarity of the electrodes is reversed at substantially every 10 seconds.

36. A method according to claim 32, wherein:

the first waveform comprises a series of current pulses having an amplitude of substantially 100 μ

A, a frequency of substantially 1 pulse per second and a pulse width of substantially 500 ms;

the second waveform comprises a series of current pulses having a amplitude of substantially 40 μ

A, a frequency of substantially 3 pulses per second and a pulse width of substantially 166 ms;

the third waveform comprises a series of current pulses having an amplitude of substantially 320 μ

A, a frequency of substantially 100 pulses per second and a pulse width of substantially 5 ms.

37. A method according to claim 32, wherein each electrode of a pair of electrodes are positioned on opposite sides of the wound to one another.

38. A method according to claim 37, wherein each electrode is placed approximately 1 cm from an edge of the wound.

39. A method according to claim 32, wherein the first waveform is generated over a period of time ranging from 2 to 8 minutes.

40. A method according to claim 39, wherein the first waveform is generated over a time period of substantially 5 minutes

41. A method according to claim 32, wherein the second waveform is generated over a period of time ranging from 25 to 40 minutes.

42. A method according to claim 41, wherein the second waveform is generated over a period of time of substantially 35 minutes.

43. A method according to claim 32, wherein the third waveform is generated over a period of time ranging from 15 to 35 minutes.

44. A method according to claim 43, wherein the second waveform is generated over a period of time of substantially 25 minutes.

45. A method according to claim 32, wherein the first waveform is generated over a period of time ranging from 2 to 8 minutes, the second waveform is generated over a period of time ranging from 25 to 40 minutes, and the third waveform is generated over a period of time ranging from 15 to 35 minutes.

46. A method according to claim 45, wherein the first waveform is generated over a period of time of substantially 5 minutes, the second waveform is generated over a period of time of substantially 35 minutes, and the third waveform is generated over a period of time of substantially 25 minutes.

47. A method according to claim 32, wherein the pulses are substantially rectangular.

48. A method according to claim 32, wherein the sequence of waveforms is repeated.

49. A method according to claim 32, further comprising applying therapeutic energy to the region of the wound.

50. A method according to claim 49, wherein applying therapeutic energy to the region of the wound comprises applying at least one of chemical, vibratory, electromagnetic, heat, mechanical, ultra sonic, and magnetic energy to the region of the wound.

51. A method according to claim 32, wherein at least three electrodes are placed in contact with skin in a region peripheral to the region of the wound, the method further comprising switching the electrical current to flow between different electrodes of the at least three electrodes.

52. A method according to claim 32, further comprising measuring at least one of the pressure applied by the compression covering to the region of the wound and measuring the angle of tilt at which a limb having the wound is held or moved with respect to the direction of gravitational force.

53. An apparatus for treating injured tissue, the apparatus comprising:

a waveform generator adapted to generate;

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 100 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms; and

output connectors for connection to an electrode arrangement for applying the waveforms through regenerative tissue underneath the injured tissue.

54. An apparatus according to claim 53, wherein said waveform generator includes a switch arrangement for switching the polarity of the pulses.

55. An apparatus according to claim 53, wherein the waveform generator is pre-programmed with one or more programs for generating one of said waveforms or a pre-determined sequence of said waveforms.

56. An apparatus according to claim 55, further comprising a user interface for selecting one of said waveforms or a predetermined sequence of said waveforms.

57. An apparatus according to claim 53, further adapted to generate:

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms;

the apparatus further comprising other output connectors for connection to another electrode arrangement for applying the waveforms across the wound.

58. A wound treatment arrangement for treating a wound in the skin of a patient, the wound treatment arrangement comprising:

a compression dressing arrangement applied to a limb of the patient and applying pressure thereto;

a plurality of electrodes for applying electrical signals to the skin of a patient wherein said electrodes are arranged in the area of said wound under said compression dressing arrangement; and

an electrical generator for generating electrical current to pass from one of the plurality of electrodes to another of the plurality of electrodes.

59. A wound treatment arrangement according to claim 58, wherein the electrical generator is attachable to the compression dressing arrangement.

60. A wound treatment arrangement according to claim 58, wherein the electrical generator is disposed in housing providing a low profile under the compression dressing arrangement.

61. A wound treatment arrangement according to claim 60, wherein the housing is operable to compress under the influence of pressure exerted by the compression dressing arrangement such that it fits around at least part of the limb of said patient.

62. A wound treatment arrangement according to claim 61, wherein the compressible housing is made of a flexible elastomeric material.

63. A wound treatment arrangement according to claim 61, wherein the compressible housing is made of foam material.

64. A wound treatment arrangement according to claim 60, wherein a side of the housing is contoured to fit around a least part of the limb.

65. A wound treatment arrangement according to claim 58, further comprising at least one of a tilt sensor for measuring the tilt of the limb relative to the direction of gravitational force and a pressure sensor for measuring the pressure applied by the compression dressing.

66. A wound treatment arrangement according to claim 58, further comprising a display operable to provide a reading visible through the compression dressing arrangement.

67. A wound treatment arrangement according to claim 58, further comprising a treatment device operable to apply a therapeutic form of energy to said limb.

68. A wound treatment arrangement according to claim 67, wherein the treatment device is operable to apply at least one of chemical, vibratory, heat, mechanical, ultrasound, electromagnetic and magnetic energy to a region of the wound.

69. A wound treatment arrangement according to claim 58, further comprising electrode connectors for relaying electrical signals from the electrical generator to the plurality of electrodes, wherein each of the electrical connectors has a first end adapted to pierce through the compression dressing arrangement for connection to the electrical generator.

70. A wound treatment arrangement according to claim 58, further comprising an electrically non-conductive sealing arrangement for preventing ingress of moisture to electrically conductive portions of the plurality of electrodes and the electrical generator.

71. A wound treatment arrangement according to claim 69, further comprising an electrically non-conductive sealing arrangement for preventing ingress of moisture to electrically conductive portions of the plurality of electrodes, the electrical generator and the electrode connectors.

72. A wound treatment arrangement according to claim 70, wherein said electrically non-conductive sealing arrangement is arranged to effectively seal under a pressure of up to 50-60 mmHg constant pressure for up to 7 to 9 days.

73. A wound treatment arrangement according to claim 58, wherein each electrode is provided on a flat substrate shaped as two substantially crescent shaped portions apically linked and having a concave inner circumferential edge and a convex outer circumferential edge, said outer circumferential edge having an indented region situated at the apically linked region between said substantially crescent shaped portions.

74. A wound treatment arrangement according to claim 58, wherein said electrodes are arranged on said skin adjacent said wound.

75. A kit of parts for treating a wound in the skin of a patient, the kit comprising

a compression dressing arrangement for application to the limb of the patient to apply pressure thereto;

a plurality of electrodes for applying electrical signals to the skin of the patient; and

an electrical generator for generating electrical current to pass from one of the plurality of electrodes to the other of the plurality of electrodes.

76. An apparatus for treating a wound, comprising:

a pair of electrodes; and

means to generate a waveform for applying across said pair of electrodes;

wherein the means to generate a waveform is adapted to generate a sequence of waveforms comprising;

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms.

77. An apparatus according to claim 76, further comprising polarity switching means.

78. An apparatus according to claim 76, further comprising user interface means for selecting one of said waveforms or a predetermined sequence of said waveforms.

79. An apparatus according to claim 76, wherein the apparatus is operable to detect a high resistance condition between the pair of electrodes indicating poor electrical contact between one or both electrodes and the skin of a patient.

80. A method of treating a medical condition on the surface of or under the surface of a region of tissue, the method comprising:

positioning a plurality of electrodes spaced apart in the region of tissue;

placing a compression covering over the plurality of electrodes and the region of said tissue to apply pressure in the region of said tissue; and

applying a sequence of electrical waveforms between at least two of the plurality of electrodes, the sequence of electrical waveforms comprising;

a first waveform comprising a series of current pulses having an amplitude in a range of from 80 to 300 μ

A, having a frequency in a range from 0.5 to 1.5 pulses per second and a pulse width in a range from 333 to 1000 ms;

a second waveform comprising a series of current pulses having an amplitude in a range of from 20 to 60 μ

A, having a frequency in a range from 2 to 4 pulses per second and a pulse width in a range from 125 to 250 ms; and

a third waveform comprising a series of current pulses having an amplitude in a range of from 250 to 640 μ

A, having a frequency in a range of from 80 to 120 pulses per second and a pulse width in a range from 4 to 6 ms.