Method and apparatus for stimulating pelvic floor muscles

• US 8,494,658 B2
• Filed: 01/08/2010
• Issued: 07/23/2013
• Est. Priority Date: 01/26/2009
• Status: Active Grant

• Current Assignee: Caldera Medical Incorporated, University College Dublin
• Original Assignee: Bio-Medical Research Limited, University College Dublin
• Inventors: Crowe, Louis, Caulfield, Brian, Maher, Ruth, Minogue, Conor
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US13/145,588
• Publication Number:
  US 20110276108A1
• Time in Patent Office: 1,292 Days
• Field of Search: 607 48- 51, 607/138, 607/2, 607/149
• US Class Current: 607/138
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• 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 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method of and apparatus for stimulating pelvic floor muscles in a patient comprises applying at least one electrode externally to each side of the patient'"'"'s body in the region of the pelvis, and energising the electrodes to apply a muscular stimulation current which flows laterally across the patient through the patient'"'"'s pelvic floor. Preferably a plurality of electrodes are applied symmetrically on each side of the body. The electrodes may be incorporated in a garment.

Claims

1. A method of stimulating pelvic floor muscles in a patient, comprising applying at least one electrode externally to each side of the patient'"'"'s body in the region of the pelvis, said electrodes cumulatively making an area of conductive contact with the body surface which substantially encircles the perineum, said area of contact including, on each side of the body, at least a part of each of the gluteal region, the hip, the upper front thigh and the upper back thigh, and energising the electrodes to apply a muscular stimulation current which flows laterally across the patient through the patient'"'"'s pelvic floor.

2. The method claimed in claim 1, wherein the electrodes are disposed at least approximately symmetrically relative to the patient'"'"'s midline.

3. The method claimed in claim 1, wherein the total area of the electrode(s) on each side of the body is at least about 500 cm2.

4. The method claimed in claim 1, wherein there are a plurality of electrodes on each side of the body.

5. The method claimed in claim 4, wherein the plurality of electrodes comprises, on each side of the body, a first electrode over the gluteal region, a second electrode on the hip, a third electrode on the upper front thigh, and a fourth electrode on the upper back thigh.

6. The method claimed in claim 1, wherein the electrodes are incorporated in a garment which locates the electrodes at desired positions against the patient'"'"'s skin.

7. The method claimed in claim 6, wherein the garment comprises two parts each of which is wrapped around a respective thigh of the patient, each part incorporating the electrode(s) on one side of the body.

8. The method claimed in claim 7, wherein each part comprises a main electrode-bearing portion having two lateral straps extending in the same direction from one edge of the main electrode-bearing portion and disposed one above the other.

9. The method claimed in claim 6, wherein the garment comprises one part incorporating the electrodes on both sides of the body.

10. The method claimed in claim 9, wherein the garment comprises a main electrode-bearing portion having a respective pair of lateral straps extending in opposite directions from opposite edges of the main electrode-bearing portion and disposed one above the other.

11. The method claimed in claim 9, wherein the garment comprises a pair of shorts.

12. The method claimed in claim 6, wherein the garment comprises at least one electrode-bearing flap which in use is tucked under an outer layer of material of the garment.

13. The method claimed in claim 6, wherein the garment comprises at least one closable slit.

14. The method claimed in claim 1, wherein the electrodes are energised with biphasic current pulses.

15. The method claimed in claim 14, wherein the electrodes are energised with a simple pulse technique.

16. The method claimed in claim 14, wherein the electrodes are energised by passing current selectively between one or more electrodes on one side of the patient'"'"'s body to one or more electrodes on the other side, either during every current phase or in selected current phases.

17. The method claimed in claim 14, wherein during each current pulse the total charge per phase is greater than 50 microcoulombs.

18. An apparatus for stimulating pelvic floor muscles in a patient, comprising at least one electrode for application externally to each side of the patient'"'"'s body in the region of the pelvis, said electrodes configured to cumulatively make an area of conductive contact with the body surface which substantially encircles the perineum, said area of contact including, on each side of the body, at least a part of each of the gluteal region, the hip, the upper front thigh and the upper back thigh, and drive circuitry arranged to energise the electrodes to apply a muscular stimulation current which flows laterally across the patient through the patient'"'"'s pelvic floor.

19. The apparatus claimed in claim 18, wherein the electrodes are incorporated in a garment worn by the patient.

20. The apparatus claimed in claim 19, wherein the garment comprises two parts each of which is wrapped around a respective thigh of the patient, each part incorporating the electrode(s) on one side of the body.

21. The apparatus claimed in claim 20, wherein each part comprises a main electrode-bearing portion having two lateral straps extending in the same direction from one edge of the main electrode-bearing portion and disposed one above the other.

22. The apparatus claimed in claim 19, wherein the garment comprises one part incorporating the electrodes on both sides of the body.

23. The apparatus claimed in claim 22, wherein the garment comprises a main electrode-bearing portion having a respective pair of lateral straps extending in opposite directions from opposite edges of the main electrode-bearing portion and disposed one above the other.

24. The apparatus claimed in claim 22, wherein the garment comprises a pair of shorts.

25. The apparatus claimed in claim 19, wherein the garment comprises at least one electrode-bearing flap which in use is tucked under an outer layer of material of the garment.

26. The apparatus claimed in claim 19, wherein the garment comprises at least one closable slit.

27. The apparatus claimed in claim 19, wherein when the garment is worn the electrodes are disposed at least approximately symmetrically relative to the patient'"'"'s midline.

28. The apparatus claimed in claim 18, wherein the total area of the electrode(s) on each side of the body is at least about 500 cm2.

29. The apparatus claimed in claim 18, wherein there are a plurality of electrodes on each side of the body.

30. The apparatus claimed in claim 29, wherein the plurality of electrodes comprises, on each side of the body, a first electrode over the gluteal region, a second electrode on the hip, a third electrode on the upper front thigh, and a fourth electrode on the upper back thigh.

31. The apparatus claimed in claim 18, wherein the drive circuitry energises the electrodes with biphasic current pulses.

32. The apparatus claimed in claim 31, wherein the drive circuitry energises the electrodes with a simple pulse technique.

33. The apparatus claimed in claim 31, wherein the drive circuitry energises the electrodes by passing current selectively between one or more electrodes on one side of the patient'"'"'s body to one or more electrodes on the other side, either during every current phase or in selected current phases.

34. The apparatus claimed in claim 31, wherein during each current pulse the charge per phase is greater than 50 microcoulombs.

35. The apparatus claimed in claim 18, wherein said drive circuitry includes means for measuring the impedance of each electrode and signalling a fault condition if pre-defined acceptance criteria for each electrode are not met.

36. The apparatus claimed in claim 18, wherein said drive circuitry includes means for estimating the area of surface contact of each electrode, or any set of electrodes, and signalling a fault condition if the estimated area of contact is below a pre-defined threshold, or lower by a pre-defined amount than another electrode of the same size.