SELF CONTAINED DEVICE WITH TREATMENT CYCLE FOR ELECTROSTIMULATION

• US 20090222060A1
• Filed: 11/24/2006
• Published: 09/03/2009
• Est. Priority Date: 11/24/2005
• Status: Active Grant

• Current Assignee: Femeda Limited
• Original Assignee: Femeda Limited
• Inventors: Herbert, Julia Heather, Boyd, Graham Peter, Gregson, Ian
• Granted Patent: US 9,358,383 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

An electro-stimulation device for the stimulation of the musculature of the pelvic floor complex e.g. for the treatment of anterior and posterior pelvic floor muscle dysfunction is fully self-contained. The device requires no external power sources or control and may be inserted into the vagina or anus through the use of an applicator. The device uses a pre-programmed treatment cycle of stimulating pulses. The cycle comprises either a waveform with an initial phase where the current of the device is ramped from an initial level to a higher level, a second phase where the current is ramped from the higher level from the first phase to a second higher level and a third phase where the current is maintained at the second higher level, or a waveform comprising two or more components each component being a train of regularly spaced pulses or a combination of these two waveforms.

Claims

1. A vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, which comprises a body and at least two electrodes located at or on the external surface of the body, an internal power source and internal means for controlling the generation of electrical pulses for the electro-stimulation of the musculature of the pelvic floor complex via the electrodes, characterized in that the device is self-contained and is programmed to provide an electro-stimulating treatment cycle of waveform which comprises an initial phase where the current is ramped from an initial level to a higher level, a second phase where the current is ramped from the higher level from the first phase to a second higher level and a third phase where the current is maintained at the second higher level.

4. An electro-stimulation device as claimed in claim 1 wherein the waveform used comprises two or more components each component being a train of regularly spaced pulses.

2. A vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the muscles of the pelvic floor complex, which comprises a body and at least two electro-conductive elements located at or on the external surface of the body, an internal power source and internal means for the generation and control of electrical pulses for the neuromuscular electro-stimulation, the device being self-contained and programmed to provide an electro-stimulating treatment cycle of waveform comprising two or more components each component being a train of regularly spaced pulses.

5. An electro-stimulation device as claimed in claim 2 wherein the second component is combined with the first component but the second component has spacing between successive pulses that is less than the spacing between successive pulses in the first component.

6. An electro-stimulation device as claimed in claim 2 wherein there is a third component that has spacing between successive pulses that is less than the spacing between successive pulses in the second component.

7. An electro-stimulation device as claimed in claim 2 wherein there are periods of relaxation between sets of pulse trains.

8. An electro-stimulation device as claimed in claim 7 wherein the periods of relaxation are equal to or greater than the periods of stimulation.

9. An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 3 hours or less.

10. An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 2 hours or less.

11. An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 1 hour or less.

12. An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is less than 1 hour.

13. An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 45 minutes or less.

14. An electro-stimulation device as claimed in claim 2 wherein the first component has a pulse repetition frequency between 1 and 15 Hz.

15. An electro-stimulation device as claimed in claim 6 wherein the third component has a pulse repetition frequency between 80 and 300 Hz.

16. An electro-stimulation device as claimed in claim 2 wherein the pulses have a pulse width of 50 to 350 microseconds.

17. An electro-stimulation device as claimed in claim 2 wherein the pulse width may be varied during use of the device.

18. An electro-stimulation device as claimed in claim 2 wherein the amplitude of the pulses for each component is of the same magnitude.

19. An electro-stimulation device as claimed in claim 2 wherein the amplitude of the pulses for each component is of different magnitude.

20. An electro-stimulation device as claimed in claim 2 wherein the pulse amplitude for one or more of the components may be varied at one or more points in time throughout the treatment cycle.

21. An electro-stimulation device as claimed in claim 2 wherein at least one component consists of a series of pulses of pulse width 150 to 350 microseconds at a maximum voltage of 60 volts, and between each sequence of pulses there is a period or rest of between 5 to 10 seconds.

22. An electro-stimulation device as claimed in claim 2 wherein the current is applied regulated and increased throughout a treatment period.

25. A device as claimed in claim 2 wherein the device body is rigid or semi-rigid in construction.

26. A device as claimed in claim 2, wherein the device is compressible.

27. A device as claimed in claim 26 wherein the dimensions of the device in its non-compressed form are such that, when the device is in-situ in the desired location in the vagina or anus, the external surface of the device and the electro-conductive elements located at or on the surface of the device body are in contact with one or more surfaces of the vagina or anus.

28. An electro-stimulation device as claimed in claim 26 wherein the body is manufactured from resiliently deformable/compressible material.

29. An electro-stimulation device as claimed in claim 26 wherein the body may be compressible due to a combination of the use of a resiliently deformable/compressible material for its manufacture and the nature of the device structure.

30. An electro-stimulation device as claimed in claim 29 wherein the body is manufactured from resiliently deformable/compressible material and the interior of the electro-stimulation device body is hollow.

31. An electro-stimulation device as claimed in claim 2 wherein the body of the device is moulded around the interior components of the electro-stimulation device to encapsulate them.

32. An electro-stimulation device as claimed in claim 2 wherein the body has a hollow interior into which the interior components are placed during manufacture of the electro-stimulation device.

33. An electro-stimulation device as claimed in claim 2 wherein the shape of the electro-stimulation device, when viewed in a cross-section taken perpendicular to the axis of insertion into the anus or vagina, is such that the electro-stimulation device may not be freely rotated about that axis when in-situ.

34. An electro-stimulation device as claimed in claim 2 wherein the shape of the electro-stimulation device when viewed in a cross-section taken perpendicular to the axis of insertion into the anus or vagina is non-circular.

35. An electro-stimulation device as claimed in claim 2 wherein the dimensions of the electro-stimulation device body are greater along the axis of insertion compared to the dimensions perpendicular to that axis.

36. An electro-stimulation device as claimed in claim 2 wherein the electro-stimulation device may be compressed to relative dimensions that are different in proportion to the dimensions of the device in the non-compressed state.

37. An electro-stimulation device as claimed in claim 2 wherein the device has at least two dimensions perpendicular to the axis of insertion that have different degrees of compressibility.

38. An electro-stimulation device as claimed in claim 2 wherein in the non-compressed state the electro-stimulation device has a length in the range of from 30 to 120 mm.

39. An electro-stimulation device as claimed in claim 2 wherein in the non-compressed state the electro-stimulation device has at least two equal dimensions or at least two non-equal dimensions perpendicular to the axis of insertion that are within the range of 30 to 60 mm.

40. An electro-stimulation device as claimed in claim 2 wherein the length of the electro-stimulation device in the non-compressed state is equal to the length of the electro-stimulation device in the compressed state.

41. An electro-stimulation device as claimed in claim 2 wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion may be reduced on compression by at least 20%.

42. An electro-stimulation device as claimed in claim 2 wherein all of the dimensions of the electro-stimulation device perpendicular to the axis of insertion may be reduced on compression by at least 15%.

43. An electro-stimulation device as claimed in claim 2 wherein the volume of the device in the compressed state is reduced by at least 20% compared to that in the non-compressed state.

44. An electro-stimulation device as claimed in claim 2 wherein in the compressed state the dimensions of the electro-stimulation device perpendicular to the axis of insertion may be such that the width is in the range of 10 to 35 mm and the height of the compressed electro-stimulation device is within the range of 10 to 40 mm.

45. An electro-stimulation device as claimed in claim 2 wherein the shape of the electro-stimulation device in the compressed form approximates to that of a tampon.

46. An electro-stimulation device as claimed in claim 2 wherein the electro-stimulation device is adapted for deployment into an anal or vaginal endocavity by

a. positioning of an applicator containing said electro-stimulation device in compressed form at the opening of the vagina or anus, and

b. discharge of the electro-stimulation device from the applicator into the vagina or anus allowing expansion of the electro-stimulation device within the vagina or anus.

47. An electro-stimulation device as claimed in claim 46 wherein the applicator has a hollow body to accommodate the compressed device.

48. A device for the stimulation of the musculature of the pelvic floor complex, which comprises an electro-stimulation device according to claim 2 in combination with an applicator comprising an outer member and an inner member, the electro-stimulation device being located within the outer member.

49. A device as claimed in claim 48 wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.

50. An electro-stimulation device as claimed in claim 2 wherein the electro-conductive elements may be provided upon and attached to the surface of the electro-stimulation device and connected to the interior circuitry via conductive paths.

51. An electro-stimulation device as claimed in claim 2 wherein the electro-conductive elements may be formed as part of the interior components of the electro-stimulation device and may be exposed at the surface of the body of the electro-stimulation device through defined orifices in the body.

52. An electro-stimulation device as claimed in claim 2 wherein the electro-conductive elements are approximately rectangular in shape and are of approximate dimensions 28 mm×

13 mm and are located at or upon opposite surfaces of the electro-stimulation device approximately 180 degrees apart.

53. An electro-stimulation device as claimed in claim 2 wherein the electrodes are annular.

54. An electro-stimulation device as claimed in claim 2 wherein the electrodes are sprung to maintain correct pressure on the wall of the vagina or anus during use.

55. A pack of electro-stimulation devices comprising two or more electro-stimulation devices according to claim 2.

56. A pack as claimed in claim 55 wherein the devices are all identical.

57. A pack as claimed in claim 55 wherein pack comprises electro-stimulation devices that produce different treatment waveforms.

58. A method of stimulation of the musculature of the pelvic floor complex, which method comprises providing electro-stimulation to the musculature of the pelvic floor complex using a device according to claim 2.

60. A method as claimed in claim 58 wherein the device is utilized with an applicator.

61. A device as claimed in claim 2 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences.

62. A device as claimed in claim 2 wherein the electro-stimulation device comprises one time activation/deactivation mechanisms associated with the internal components.

65. A method as claimed in claim 57 wherein the treatment cycle is started at 35 mA or less and rises to 45 mA or more for the last ten minutes of the treatment cycle with a series of ramps in between.

66. A method as claimed in claim 57 wherein, at a pulse frequency of 35 Hz and pulse width of 250 microseconds, a current is applied at 6 mA and rises to 12 mA over the first 10 minutes, then the current is ramped from 12 mA to 40 mA over the next 10 minutes, then the current is held at 40 mA over the next 10 to 15 minutes.

3. A vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the muscles of the pelvic floor complex, which comprises a body and at least two electro-conductive elements located at or on the external surface of the body, an internal power source and internal means for the generation and control of electrical pulses for the neuromuscular electro-stimulation, the device being self-contained and programmed to provide an electro-stimulating treatment cycle of waveform comprising an initial phase where the current is ramped from an initial level to a higher level, a second phase where the current is ramped from the higher level from the first phase to a second higher level and a third phase where the current is maintained at the second higher level and the waveform having two or more components each component being a train of regularly spaced pulses.

23. (canceled)

24. (canceled)

59. A method as claimed in claim 59 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction.

63. An electro-stimulation device for the stimulation of the musculature of the pelvic floor complex comprising a device body and at least two electro-conductive elements, located at the device surface that are anchored to and resiliently biased against a point located within the interior of the device such that the electro-conductive elements may be reversibly compressed towards the interior of the device.

64. A device as claimed in claim 63 wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.