Self contained device with treatment cycle for electrostimulation

• US 9,358,383 B2
• Filed: 11/24/2006
• Issued: 06/07/2016
• Est. Priority Date: 11/24/2005
• Status: Active Grant

• Current Assignee: Femeda Limited
• Original Assignee: Femeda Limited
• Inventors: Boyd, Graham Peter, Gregson, Ian, Herbert, Julia Heather
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US12/094,941
• Publication Number:
  US 20090222060A1
• Time in Patent Office: 3,483 Days
• Field of Search: 607/41, 607/116, 607/138
• US Class Current: 1/1
• 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 self-contained vaginal or anal electro-stimulation device, which comprises a device body and at least two electrodes located at or on the external surface of the device body, components internal to the device body comprising an internal power source and internal microprocessor controlled circuitry to control the generation of electrical pulses for the neuromuscular electro- stimulation of the musculature of the pelvic floor complex via the device electrodes and a one-time device activation/deactivation mechanism within the body of the device, the internal controlling means within the device body being pre-programmed with an electro-stimulating treatment cycle waveform not alterable by the user, wherein the device does not include means for reprogramming the internal microprocessor controlled circuitry, and wherein the waveform comprises a series of ramps with 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.

2. 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 and each component having different pulse repetition frequencies.

3. 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.

4. An electro-stimulation device as claimed in claim 2 wherein there is a third component being a train of regularly spaced pulses and the third component having a different pulse repetition frequency that has spacing between successive pulses that is less than the spacing between successive pulses in the second component.

5. An electro-stimulation device as claimed in claim 4 wherein the third component has a pulse repetition frequency between 80 and 300 Hz.

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

7. An electro-stimulation device as claimed in claim 6 wherein the periods of relaxation are equal to or greater than the periods of stimulation.

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

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

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

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

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

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

14. An electro-stimulation device as claimed in claim 2 wherein the second component has a pulse repetition frequency between 30 and 60 Hz.

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

16. An electro-stimulation device as claimed in claim 2 wherein the pulse width is varied during use of the device.

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

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

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

20. 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 of rest of between 5 to 10 seconds.

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

22. A device as claimed in claim 1 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences.

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

47. 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 1.

48. A method as claimed in claim 47 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction.

49. A method as claimed in claim 47 wherein the device is utilized with an applicator.

23. A self-contained vaginal or anal electro-stimulation device, which comprises a device body and at least two electrodes located at or on the external surface of the device body, components internal to the device body comprising an internal power source and internal microprocessor controlled circuitry to control the generation of electrical pulses for the neuromuscular electro- stimulation of the musculature of the pelvic floor complex via the device electrodes and a one-time device activation/deactivation mechanism within the body of the device, the internal controlling means within the device body being pre-programmed with an electro-stimulating treatment cycle waveform not alterable by the user, wherein the device does not include means for reprogramming the internal microprocessor controlled circuitry, and wherein the waveform comprises two or more components each component being a train of regularly spaced pulses and each component having different pulse repetition frequencies.

24. An electro-stimulation device as claimed in claim 23 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.

25. An electro-stimulation device as claimed in claim 23 wherein there is a third component being a train of regularly spaced pulses and the third component having a different pulse repetition frequency that has spacing between successive pulses that is less than the spacing between successive pulses in the second component.

27. An electro-stimulation device as claimed in claim 23 wherein there are periods of relaxation between sets of pulse trains.

28. An electro-stimulation device as claimed in claim 27 wherein the periods of relaxation are equal to or greater than the periods of stimulation.

29. An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 3 hours or less.

30. An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 2 hours or less.

31. An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 1 hour or less.

32. An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is less than 1 hour.

33. An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 45 minutes or less.

34. An electro-stimulation device as claimed in claim 23 wherein the first component has a pulse repetition frequency between 1 and 15 Hz.

35. An electro-stimulation device as claimed in claim 23 wherein the pulses have a pulse width of 50 to 350 microseconds.

36. An electro-stimulation device as claimed in claim 23 wherein the pulse width is varied during use of the device.

37. An electro-stimulation device as claimed in claim 23 wherein the amplitude of the pulses for each component is of the same magnitude.

38. An electro-stimulation device as claimed in claim 23 wherein the amplitude of the pulses for each component is of different magnitude.

39. An electro-stimulation device as claimed in claim 23 wherein the pulse amplitude for one or more of the components is varied at one or more points in time throughout the treatment cycle.

40. An electro-stimulation device as claimed in claim 23 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 of rest of between 5 to 10 seconds.

41. An electro-stimulation device as claimed in claim 23 wherein the current is applied regulated and increased throughout a treatment period.

42. A device as claimed in claim 23 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences.

43. An electro-stimulation device as claimed in claim 23 wherein the second component has a pulse repetition frequency between 30 and 60 Hz.

44. 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 23.

45. A method as claimed in claim 44 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction.

46. A method as claimed in claim 44 wherein the device is utilized with an applicator.