Compressible electrodes

• US 8,805,509 B2
• Filed: 11/24/2006
• Issued: 08/12/2014
• 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): Holmes, Rex R
• Application Number:
  US12/094,948
• Publication Number:
  US 20090228064A1
• Time in Patent Office: 2,818 Days
• Field of Search: 600/373, 607/41, 607115-116, 607/138, 607/148, 607/39
• US Class Current: 607/41
• 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

Abstract

A compressible electrode 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 reversibly compressible and has electro-conductive elements. The compressible electrode may be used with all the usual control units and treatment regimes for the electro-stimulation of the musculature and nerves of the vagina and/or anus. The compressible electrode may be inserted into the vagina or anus through the use of an applicator. In the compressed state the compressible electrode may be of tampon proportions and after use may easily be removed.

Claims

1. A compressible vaginal or anal electro-stimulation electrode for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, which comprises a deformable body of resiliently compressible foam material and at least two electro-conductive elements located at or on the external surface of the body, wherein the electrode body has two dimensions perpendicular to the axis of insertion that are of different dimension and different degrees of compressibility and may be reduced under compression of the foam body to dimensions that are reduced on compression by at least 15% and wherein the body is not freely rotatable about the axis of insertion when in-situ.

2. The electrode of claim 1, wherein the body is compressible due to a combination of the use of a resiliently deformable/compressible material for its manufacture and the nature of the electrode structure.

3. The electrode of claim 2, wherein the body is manufactured from resiliently deformable/compressible material and the interior of the electrode body is hollow.

4. The electrode of claim 1, wherein the body of the compressible electrode is moulded around the interior components of the compressible electrode to encapsulate them.

5. The electrode of claim 1, wherein the body has a hollow interior into which the interior components are placed during manufacture of the compressible electrode.

6. The electrode of claim 1, wherein the dimensions of the electrode body are greater along the axis of insertion compared to the dimensions perpendicular to that axis.

7. The electrode of claim 1, wherein the compressible electrode is compressed to relative dimensions that are different in proportion to the dimensions of the electrode in the non-compressed state.

8. The electrode of claim 1, wherein in the non-compressed state the electrode has a length in the range of from 30 to 120 mm.

9. The electrode of claim 1, wherein in the non-compressed state the electrode 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.

10. The electrode of claim 1, wherein the length of the electrode in the non-compressed state is equal to the length of the electro-stimulation electrode in the compressed state.

11. The electrode of claim 1, wherein at least one of the dimensions of the electrode perpendicular to the axis of insertion are reduced on compression by at least 20%.

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

13. The electrode of claim 1, wherein in the compressed state the dimensions of the electrode perpendicular to the axis of insertion are such that the width is in the range of 10 to 35 mm, and the height of the compressed electrode is within the range of 10 to 40 mm.

14. The electrode of claim 1, wherein the shape of the compressible electrode in the compressed form approximates to that of a tampon.

15. A compressible electrode as claimed in claim 1 further comprising an applicator for deployment of the compressible electrode, wherein the electrode is adapted for deployment into an anal or vaginal endocavity by

a. positioning of an applicator containing said electrode in compressed form at the opening of the vagina or anus, and

b. discharge of the electrode from the applicator into the vagina or anus allowing expansion of the electrode within the vagina or anus.

16. An electrode as claimed in claim 15 wherein the applicator has a hollow body to accommodate the compressed electrode.

18. The electrode of claim 1, wherein the electro-conductive elements are formed as part of interior components of the electrode and are exposed at the surface of the body of the electrode through defined orifices in the body.

19. The electrode of claim 1, wherein electro-conductive elements are approximately rectangular of approximate dimensions of 28 mm×

13 mm and are located at or upon opposite surfaces of the compressible electrode approximately 180 degrees apart.

20. The electrode of claim 1, wherein the electro-conductive elements are annular.

21. A method of stimulating the musculature of the pelvic floor complex, which method comprises providing stimulation to the musculature of the pelvic floor using a compressible electrode according to claim 1, with a treatment cycle waveform.

22. A method as claimed in claim 21 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction.

23. A method as claimed in claim 21 wherein the waveform used comprises two or more components each component being a train of regularly spaced pulses.

24. A method 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. A method as claimed in claim 23 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.

26. A method as claimed in claim 23, wherein there are periods of relaxation between sets of pulse trains.

27. A method as claimed in claim 26, wherein period of relaxation is equal to or greater than the period of stimulation.

28. A method as claimed in claim 21 wherein the treatment cycle is 3 hours or less.

29. A method as claimed in claim 28, wherein the treatment cycle is 2 hours or less.

30. A method as claimed in claim 28, wherein the treatment cycle is 1 hour or less.

31. A method as claimed in claim 28, wherein the treatment cycle is less than 1 hour.

32. A method as claimed in claim 28, wherein the treatment cycle is 45 minutes or less.

33. A method as claimed in claim 23, wherein the first component has a pulse repetition frequency between 1 and 15 Hz, wherein the second component has a pulse repetition frequency between 30 and 60 Hz.

34. A method as claimed in claim 23 wherein the pulses have a pulse width of 50 to 350 microseconds.

35. A method as claimed in claim 24 wherein the pulse width may be varied during use of the electrode.

36. A method as claimed in claim 24 wherein the amplitude of the pulses for each component is of the same magnitude.

37. A method as claimed in claim 24 wherein the amplitude of the pulses for each component is of different magnitude.

38. A method as claimed in claim 24 wherein the pulse amplitude for one or more of the components is varied at one or more points in time throughout the treatment cycle.

39. A method as claimed in claim 24 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.

40. A method as claimed in claim 21 wherein the current is applied regulated and increased throughout a treatment period.

41. A method as claimed in claim 21, wherein the treatment cycle is started at less than 45 mA and rises to 45 mA or more for the last ten minutes of the treatment cycle with a series of ramps in between.

42. A method as claimed in claim 21 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.

43. A method as claimed in claim 21 wherein the third component has a pulse repetition frequency between 80 and 300 Hz.

44. The electrode of claim 1, wherein the body of the device when viewed in a cross-section taken perpendicular to the axis of insertion into the anus or vagina is non-circular.

17. An electrode kit for the stimulation of the musculature of the pelvic floor complex which comprises a compressible electrode in combination with an applicator comprising an outer member and an inner member, the electrode being located within the outer member.