COMPRESSIBLE DEVICE

• US 20090228067A1
• Filed: 11/24/2006
• Published: 09/10/2009
• Est. Priority Date: 11/24/2005
• Status: Active Grant

• Current Assignee: Femeda Limited
• Original Assignee: Femeda Limited
• Inventors: French, Edward Michael, Herbert, Julia Heather, Boyd, Graham Peter, Gregson, Ian
• Granted Patent: US 8,509,900 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0512 Anal 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 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An electro-stimulation device for the treatment of anterior and posterior pelvic floor muscle dysfunction is reversibly compressible and 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. In the compressed state the device may be of tampon proportions and after use may easily be removed. The device utilizes a compressible electrode component.

Claims

1. A self-contained vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, which device comprises a body being reversibly compressible in at least one dimension 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 of the musculature of the pelvic floor complex via the electro-conductive elements.

2. A device as claimed in claim 1, 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.

3. The device of claim 1, wherein the body is manufactured from resiliently deformable/compressible material.

4. The device of claim 1, wherein the body may be compressible due to a combination of the use of a resiliently deformable/compressible materials for its manufacture and the nature of the device structure.

5. The device of claim 4, wherein the body is manufactured from resiliently deformable/compressible material and the interior of the electro-stimulation device body is hollow.

6. An The device of claim 1, wherein the body of the device is moulded around the interior components of the electro-stimulation device to encapsulate them.

7. The device of claim 1, wherein the body has a hollow interior into which the interior components are placed during manufacture of the electro-stimulation device.

8. The device of claim 1, 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.

9. The device of claim 8, wherein the shape of the electro-stimulation device when viewed in a cross-section taken perpendicular to the axis of the insertion into the anus or vagina is non-circular.

10. The device of claim 8, wherein the dimensions of the electro-stimulation device body are greater along the axis of insertion compared to the dimensions perpendicular to that axis.

11. The device of claim 1, 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.

12. The device of claim 1, wherein the device has at least two dimensions perpendicular to the axis of insertion that have different degrees of compressibility.

13. The device of claim 1, wherein in the non-compressed state the electro-stimulation device has a length in the range of from 30 to 120 mm.

14. The device of claim 1, 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 the insertion that are within the range of 30 to 60 mm.

15. The device of claim 1, 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.

16. The device of claim 1, 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%.

17. The device of claim 1, 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%.

18. The device of claim 1, wherein the volume of the device in the compressed state is reduced by at least 20% compared to that in the non-compressed state.

19. The device of claim 1, 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.

20. The device of claim 1, wherein the shape of the electro-stimulation device in the compressed form approximates to that of a tampon.

21. The device of claim 1, 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.

22. The device of claim 21, wherein the applicator has a hollow body to accommodate the compressed device.

52. A pack of electro-stimulation devices comprising two or more electro-stimulation devices according to claim 1.

53. A pack as claimed in claim 52 wherein the devices are all identical.

54. A pack as claimed in claim 52 wherein pack comprises electro-stimulation devices that produce different treatment waveforms.

55. A method of stimulating 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.

56. A method as claimed in claim 55, wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.

57. A method as claimed in claim 55 wherein the device is utilized with an applicator.

59. A device as claimed in claim 1 wherein the electro-stimulation device comprises one-time activation/deactivation mechanisms associated with the internal components of the device.

60. A device as claimed in claim 59, wherein the activation/deactivation mechanism comprises a movable switch component captive within the device and having at least one of its surfaces exposed to the exterior of the device, the activation mechanism being capable of activation through movement of the switch component by the applicator on expulsion of the device from the applicator.

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

24. The device of claim 23, 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.

25. The device of claim 23, 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.

26. The device of claim 23, wherein the electro-conductive elements are approximately rectangular in shape and are of approximate dimensions of 28 mm×

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

27. The device of claim 23, wherein the electrodes are annular.

28. The device of claim 23, wherein the electrodes are sprung to maintain corrected pressure on the wall of the vagina or anus during use.

29. The device of claim 23, wherein the output from the circuitry is a pre-defined waveform that is used to provide neuromuscular electro-stimulation of the musculature of the pelvic floor complex.

30. The device of claim 29, wherein the waveform characteristics of the electrical stimulation signal are not alterable by the user, the waveform being pre-determined and pre-programmed.

31. The device of claim 29, wherein the circuitry is pre-programmed to provide the desired waveform before assembly of the electro-stimulation device.

32. The device of claim 23, wherein the waveform used comprises two or more components each component being a train of regularly spaced pulses.

33. The device of claim 32, 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 pulse in the first component.

34. The device of claim 32, 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.

35. The device of claim 32, wherein there are periods of relaxation between sets of pulse trains.

36. An The device of claim 35 wherein the periods of relaxation are equal to or greater than the periods of stimulation.

37. The device of claim 32, wherein the treatment cycle is 3 hours or less.

38. The device of claim 37, wherein the treatment cycle is 2 hours or less.

39. The device of claim 37, wherein the treatment cycle is 1 hour or less.

40. The device of claim 37, wherein the treatment cycle is less than 1 hour.

41. The device of claim 37, wherein the treatment cycle is 45 minutes or less.

42. The device of claim 32, wherein the first component has a pulse repetition frequency between 1 and 15 Hz, more preferably between 1 and 6 Hz or between 5 and 15 Hz, wherein the second component has a pulse repetition frequency between 30 and 60 Hz, more preferably between 40 and 60 Hz and wherein the third component when present may have a pulse repetition frequency between 80 and 300 Hz, more preferably between 80 and 200 Hz.

43. The device of claim 32, wherein the pulses have a pulse width of 50 to 350 microseconds.

44. The device of claim 32, wherein the pulse width may be varied during use of the device.

45. The device of claim 32, wherein the amplitude of the pulses for each component is of the same magnitude.

46. The device of claim 32, wherein the amplitude of the pulses for each component is of a different magnitude.

47. The device of claim 32, 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.

48. The device of claim 32, 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.

49. The device of claim 32, wherein the current is applied regulated and increased throughout a treatment period.

50. The device of claim 32, wherein the treatment cycle is started at 45 mA or less, preferably 40 mA or less and rises to 40 mA or more preferably 45 mA or more for the last ten minutes of the treatment cycle with a series of ramps in between.

51. The device of claim 32, wherein at a pulse frequency of 35 Hz and pulse width of 250 microseconds, the 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.

58. A device as claimed in claim 28 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences.

61. An electro-stimulation device for stimulating 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.

62. A device as claimed in claim 61, wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.