Electrode for activating pelvic reflexes

• US 5,385,577 A
• Filed: 11/12/1992
• Issued: 01/31/1995
• Est. Priority Date: 11/12/1992
• Status: Expired due to Term

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: EMPI Incorporated (Enovis Corp.)
• Inventors: Maurer, Donald D., Lien, Mary M.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/975,518
• Time in Patent Office: 810 Days
• Field of Search: 128/788, 128/801, 128/802, 128/419 S, 128/401, 607/39-41, 607/66, 607/138
• US Class Current: 607/41
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61N 1/0512 Anal electrodes

Abstract

An electrode for activating pelvic reflexes in a patient is made of a molded elongated tubular member and a patient conforming handle member. The tubular member has a plurality of conductive polymer bands separated by at least one nonconductive polymer band. The patient conforming handle member connects to the distal end of the tubular member for properly positioning the electrode and for preventing movement of the electrode in either a proximal or a distal direction.

Claims

1. An electrode for controlling incontinence in a patient, the electrode comprising:

a molded elongated tubular member having a proximal end, a distal end, a longitudinal axis, first, second, and third conductive polymer bands, a first nonconductive polymer band positioned between the first and second conductive polymer bands, and a second nonconductive polymer band positioned between the second and third conductive polymer bands;

a patient conforming handle member connected to the distal end of the tubular member for properly positioning the electrode and for preventing movement of the electrode in either a proximal or a distal direction; and

wherein the first and second conductive polymer bands form a first electrical circuit and provide electrical stimulation at a first frequency and the first and third conductive polymer bands form a second electrical circuit and provide electrical stimulation at a second frequency, wherein the second frequency is different from the first frequency.

2. The electrode of claim 1 wherein the tubular member has an exterior diameter in the range of about 0.550 to 1.100 inches.

3. The electrode of claim 1 wherein the tubular member has a length in the range of about 2.000 to 3.500 inches.

4. The electrode of claim 1 wherein the patient conforming handle member comprises:

a body; and

a first wing.

5. The electrode of claim 4 wherein the angle between the first wing and the body is in the range of about 90 to 110 degrees.

6. The electrode of claim 4 wherein the patient conforming handle member further comprises:

a second wing.

7. The electrode of claim 6 wherein the angle between the second wing and the body is in the range of about 90 to 110 degrees.

8. The electrode of claim 6 wherein the angle between the first wing and the second wing is in the range of about 180 to 220 degrees.

9. The electrode of claim 1 wherein each conductive polymer band has a width and electrical coupling means at an interior surface of each conductive polymer band.

10. The electrode of claim 1 wherein the tubular member comprises:

an interior cavity;

an interior surface; and

an exterior surface.

11. The electrode of claim 10 wherein the interior cavity has a diameter in the range of about 0.400 to 0.450 inches.

12. The electrode of claim 10 wherein the tubular member has a wall thickness in the range of about 0.0625 to 0.250 inches.

13. The electrode of claim 10 wherein the conductive and nonconductive polymer bands have a durometer measurement in the range of about 30 to 90 shore A.

14. The electrode of claim 10 wherein the conductive and nonconductive polymer bands have a durometer measurement in the range of about 30 to 60 shore A.

15. The electrode of claim 1 wherein the conductive polymer bands have a volume resistivity in a range of about 1 to 500 ohm-centimeters.

16. The electrode of claim 1 wherein the conductive polymer bands have a volume resistivity in a range of about 1 to 100 ohm-centimeters.

17. The electrode of claim 1 wherein the conductive polymer bands have a volume resistivity in a range of about 5 to 20 ohm-centimeters.

18. The electrode of claim 1 wherein the first conductive polymer band is separated from the second conductive polymer band by a distance in the range of about 0.350 to 0.750 inches.

19. The electrode of claim 1 wherein the second conductive polymer band is separated from the third conductive polymer band by a distance in the range of about 0.075 to 0.250 inches.

20. An electrode for activating pelvic reflexes in a patient, the electrode comprising:

a molded elongated tubular member having a proximal end, a distal end, a longitudinal axis, first, second, and third conductive polymer bands, a first nonconductive polymer band positioned between the first and second conductive polymer bands, and a second nonconductive polymer band positioned between the second and third conductive polymer bands;

a patient conforming handle connected to the distal end of the tubular member, wherein the handle comprises;

a body;

a first arm connected to the body at a first angle of about 90 to 110 degrees; and

a second arm connected to the body at a second angle of about 90 to 110 degrees; and

wherein the first and second conductive polymer bands form a first electrical circuit and provide electrical stimulation at a first frequency and the first and third conductive polymer bands form a second electrical circuit and provide electrical stimulation at a second frequency, wherein the second frequency is different from the first frequency.

21. An electrode for controlling incontinence in a patient, the electrode comprising:

a molded elongated tubular member comprising;

a first conductive polymer band for providing electrical stimulation at a first frequency;

a second conductive polymer band for providing electrical stimulation at a second frequency;

a third conductive polymer band wherein the first and third conductive polymer bands form a first electrical circuit and provide electrical stimulation at the first frequency and the second and third conductive polymer bands form a second electrical circuit and provide electrical stimulation at the second frequency; and

wherein the second frequency is different from the first frequency; and

a plurality of leads connected to respective first, second and third conductive polymer bands for providing energizing current to the first, second, and third conductive polymer bands.

22. The electrode of claim 21 and further comprising:

a patient conforming handle member connected to a distal end of the tubular member for properly positioning the electrode within a body cavity and for preventing movement of the electrode in either a proximal or a distal direction.

23. A system for controlling incontinence in a patient, the system comprising:

an electrode having an elongated tubular body, the elongated tubular body having an interior surface and an exterior surface, the tubular body further having first, second and third conductive regions, each conductive region separated by at least one non-conductive region, the first, second and third conductive regions configured to provide a first current path and a second current path, wherein the first and second current paths share one of the conductive regions; and

electrical stimulation means communicating with the first, second and third conductive regions, for delivering a first signal at a first frequency to the first current path, and for delivering a second signal at a second frequency, different from the first frequency, to the second current path.

24. The system of claim 23 wherein the first current path comprises:

the first conductive region and the second conductive region, and the first and second conductive regions are positioned at opposite ends of the tubular body.

25. The system of claim 24 wherein the second current path comprises:

the first conductive region and the third conductive region, and the third conductive region is positioned between the first conductive region and second conductive region.

26. The system of claim 25 wherein the tubular body has a length of about 2.00 to about 3.50 inches.

27. The system of claim 23 wherein the elongated tubular body has a durometer of between about 30 to about 90 shore A.

28. The system of claim 27 wherein the elongated tubular body has a durometer of between about 30 to about 60 shore A.

29. A dual channel stimulating system for controlling incontinence comprises:

an elongated tubular body, having first, second and third conductive regions longitudinally spaced along the tubular body, each conductive region separated from an adjacent conductive region by at least one non-conductive region; and

electrical stimulation means communicating with the first, second and third conductive regions for delivering a first signal at a first frequency to the first and third conductive regions, and for delivering a second signal at a second frequency, to the first and second conductive regions, wherein the second frequency is different from the first frequency.

30. The stimulation system of claim 29 wherein the first conductive region and the third conductive region are positioned at opposite ends of the tubular body.

31. The stimulation system of claim 30 wherein the second conductive region is positioned between the first conductive region and the third conductive region.

32. The stimulation system of claim 31 wherein the tubular body has a length of about 2.00 to about 3.50 inches.

33. The stimulation system of claim 29 wherein the elongated tubular body has a durometer of about 30 to about 90 shore A.

34. The stimulation system of claim 29 wherein the elongated tubular body has a durometer of about 30 to about 60 shore A.

35. A method of treating incontinence, the method comprising:

inserting into a body cavity an electrode comprising a tubular body having first, second and third conductive regions separated by at least one non-conductive region;

applying a first signal having a first frequency to a first electrode pair formed by the first and third conductive regions to provide electrical stimulation to tissue at the first frequency;

applying a second signal having a second frequency to a second electrode pair formed by the first and second conductive regions to provide electrical stimulation to tissue at the second frequency; and

wherein the second frequency is different from the first frequency.