Intravaginal device for electrically stimulating and/or for sensing electrical activity of muscles and or nerves defining and surrounding the intravaginal cavity

• US 20040030360A1
• Filed: 02/28/2003
• Published: 02/12/2004
• Est. Priority Date: 08/31/2000
• Status: Abandoned Application

• Current Assignee: Flexiprobe Limited
• Original Assignee: Flexiprobe Limited
• Inventors: Baur, Alfons Johannes, Sarig, Judith, Tamarkin, Dov, Eini, Meir
• Application Number:
  US10/362,369
• Publication Number:
  US 20040030360A1
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61N 1/0524 Vaginal electrodes

Abstract

A device for stimulating muscles and nerves defining and surrounding an intravaginal cavity of an individual and/or for sensing tonus and/or electrical activity of muscles defining and surrounding an intravaginal cavity is provided. The device includes (a) a body having memory properties such that when the body is contracted and positioned within an intravaginal cavity of the individual the body self expands to conform to a contour of the intravaginal cavity; and (b) at least one pair of electrodes being attached to an exterior surface of the body such that when the body is positioned within the intravaginal cavity, each electrode of the at least one pair of electrodes is biased against a wall of the intravaginal cavity. Thus they maintain electrical contact with the wall.

Claims

1. A device for interacting with muscles and nerves defining and surrounding an intravaginal cavity of an individual, the device comprising:

(a) a body having memory properties such that when said body is contracted and positioned within an intravaginal cavity of the individual said body self expands to conform to a contour of the intravaginal cavity; and

(b) at least one pair of electrodes being attached to an exterior surface of said body such that when said body is positioned within the intravaginal cavity, each electrode of said at least one pair of electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with said wall, wherein an electrical current providable from said at least one pair of electrodes serves for electrically stimulating the muscles and nerves defining and surrounding the intravaginal cavity.

2. The device of claim 1, placeable within the intervaginal cavity of an individual for treating a pelvic floor dysfunction in the individual.

3. The device of claim 1, further comprising a power and control unit being for providing said electrical current to said at least one pair of electrodes, said power and control unit being attachable to connectors being in electrical communication with said at least one pair of electrodes.

4. The device of claim 3, wherein said connectors are positioned on a portion of said body such that when said body is positioned within the intravaginal cavity and attached to said power and control unit, said power and control unit is positioned outside of the intravaginal cavity.

5. The device of claim 1, wherein said body is constructed of an elastic material selected from the group consisting of, rubber, latex and silicon.

6. The device of claim 1, wherein a width of said body when relaxed is at least 1.3-1.5 times larger than said width of said body when fully contracted.

7. The device of claim 1, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

8. The device of claim 1, wherein said at least one pair of electrodes includes an electrically conductive material selected from the group consisting of gold, carbon, stainless steel, silver and platinum.

9. The device of claim 3, wherein said power and control unit further includes a controller for controlling duration and/or intensity of electrical currents provided therefrom to said at least one pair of electrodes.

10. The device of claim 1, further comprising at least one sensor attached to said body, such that when said body is positioned within the intravaginal cavity, said at least one sensor is capable of sensing muscle activity of the muscles defining and surrounding the intravaginal cavity.

11. The device of claim 10, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor, or a displacement sensor.

12. The device of claim 10, wherein said at least one sensor attached to said body further includes a transmitter.

13. The device of claim 12, wherein said transmitter serves for transmitting a signal receivable outside the body, said signal including data pertaining to said muscle activity sensed by said at least one sensor.

14. The device of claim 12, further comprising at least a second sensor.

15. The device of claim 11, further comprising at least a second sensor.

16. The device of claim 11, said sensor comprising an oscillator having a frequency variable in response to pressure applied thereto.

17. The device of claim 1, wherein said body defines a substantially rounded diamond shaped frame when relaxed.

18. The device of claim 1, wherein said at least one pair of electrodes includes a plurality of electrode pairs, each pair of electrodes of said plurality of electrode pairs being attached to a specific region of said exterior surface of said body, such that each pair of electrodes is biased against a specific region of said wall of the intravaginal cavity when said body is positioned within the intravaginal cavity.

19. A device for interacting with muscles and nerves defining and surrounding an intravaginal cavity of an individual, the device comprising:

(a) a body having memory properties such that when said body is contracted and positioned within an intravaginal cavity of the individual said body self expands to conform to a contour of the intravaginal cavity; and

(b) at least two sensors attached to a surface of said body such that when said body is positioned within the intravaginal cavity, each sensor being positioned such that it is able to detect movement of at least one muscle defining and surrounding the intravaginal cavity.

20. The device of claim 19, said sensors comprising an oscillator having a frequency variable in response to pressure applied thereto.

21. The device of claim 20, further comprising a reference frequency generator for generating a reference frequency against which to measure variations of said sensor frequencies.

22. The device of claim 19 further comprising a biofeedback unit for providing a user sensible output indicative of sensed muscle activity.

23. A system for stimulating muscles and nerves defining and surrounding an intravaginal cavity of an individual, the system comprising:

(a) an intravaginal positionable device assembly including;

(i) a body having memory properties such that when said body is contracted and positioned within the intravaginal cavity of the individual said body expands to conform to a contour of the intravaginal cavity; and

(ii) at least one pair of electrodes being for providing an electrical current, said at least one pair of electrodes being attached to an exterior surface of said body such that when said body is positioned within the intravaginal cavity, each electrode of said at least one pair of electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with the intravaginal cavity wall, said electrical current providable from said at least one pair of electrodes serves for electrically stimulating muscles and nerves defining and surrounding the intravaginal cavity; and

(iii) a power and control unit being detachably attached to said body and being for providing electrical current to said at least one pair of electrodes; and

(iv) at least one sensor attached to said body, such that when said body is positioned within the intravaginal cavity, said at least one sensor is capable of sensing muscle activity of the muscles and nerves defining and surrounding the intravaginal cavity; and

(v) a transmitter being for transmitting a signal receivable outside the body, said signal including data pertaining to said muscle activity sensed by said at least one sensor; and

(b) an extracorporeal monitoring unit being for processing said signal received from said transmitter to thereby determine duration or intensity of said electrical current provided to said at least one pair of electrodes from said power and control unit.

24. The system of claim 23, wherein the system serves for treating or preventing a pelvic floor dysfunction in the individual.

25. The system of claim 23, wherein said body is constructed of an elastic material selected from the group consisting of silicon, rubber and latex.

26. The system of claim 23, wherein a width of said body when relaxed is at least 1-3-1.5 times larger than said width of said body when fully contracted.

27. The system of claim 23, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

28. The system of claim 23, wherein said at least one pair of electrodes include a conductive material selected from the group consisting gold, carbon, silver, stainless steel and platinum.

29. The system of claim 23, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor, or a displacement sensor.

30. The system of claim 23, wherein said power and control unit includes a receiver for receiving command signal from said extracorporeal unit, said command signals serving for modulating said duration or said intensity of said electrical current provided to said at least one pair of electrodes from said power and control unit.

31. The system of claim 23, wherein said body defines a substantially rounded diamond shaped frame when relaxed.

32. The system of claim 23, wherein said at least one pair of electrodes includes a plurality of electrode pairs, each pair of electrodes of said plurality of electrode pairs being attached to a specific region of said exterior surface of said body, such that each pair of electrodes is biased against a specific region of said wall of the intravaginal cavity when said body is positioned within the intravaginal cavity.

33. A method of stimulating muscles and nerves defining and surrounding an intravaginal cavity of an individual, the method comprising:

(a) positioning an intravaginal device within the intravaginal cavity of the individual, said intravaginal device including;

(i) a body having memory properties such that when said body is contracted and positioned within an intravaginal cavity of the individual said body self expands to conform to a contour the intravaginal cavity; and

(ii) at least one pair of electrodes being for providing an electrical current, said at least one pair of electrodes being attached to an exterior surface of said body such that when said body is positioned within the intravaginal cavity, each electrode of said at least one pair of electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with said wall, wherein said electrical current, providable from said at least one pair of electrodes, serves for electrically stimulating muscles and nerves defining and surrounding the intravaginal cavity; and

(b) providing said electrical current of a predetermined intensity, frequency and/or duration to said at least one pair of electrodes attached to said exterior surface of said body to thereby stimulate muscles and nerves defining and surrounding the intravaginal cavity of the individual.

34. The method of claim 33, wherein stimulation of the muscles and nerves defining and surrounding the intravaginal cavity serves for treatment or prevention of urinary incontinence in the individual.

35. The method of claim 33, wherein stimulation of the muscles and nerves defining and surrounding the intravaginal cavity serves for treatment or prevention of a female sexual arousal disorder.

36. The method of claim 33, wherein said device includes a plurality of electrode pairs, each pair of electrodes of said plurality of electrode pairs being positioned at a specific region of said exterior surface of said body, whereas each pair of said plurality of electrode pairs is independently provided with an electrical current of a specific frequency, intensity and/or duration.

37. A device for sensing electrical activity of muscles defining and surrounding an intravaginal cavity of an individual, the device comprising:

(a) a body having memory properties such that when said body is contracted and positioned within an intravaginal cavity of the individual said body self expands to conform to a contour of the intravaginal cavity; and

(b) at least one pair of electrodes being attached to an exterior surface of said body such that when said body is positioned within the intravaginal cavity, each electrode of said at least one pair of sensing electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with said wall.

38. The device of claim 37, wherein the device serves for treating or preventing a pelvic floor dysfunction in the individual.

39. The device of claim 37, further comprising a power and control unit being attachable to connectors being in electrical communication with said at least one pair of electrodes.

40. The device of claim 39, wherein said connectors are positioned on a region of said body such that when said body is positioned within the intravaginal cavity and attached to said power and control unit, said power and control unit is positioned outside of the intravaginal cavity.

41. The device of claim 37, wherein said body is constructed of an elastic material selected from the group consisting of, rubber, latex and silicon.

42. The device of claim 37, wherein a width of said body when relaxed is at least 1-3-1.5 times larger than said width of said body when fully contracted.

43. The device of claim 37, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

44. The device of claim 37, wherein said at least one pair of electrodes includes an electrically conductive material selected from the group consisting of gold, carbon, stainless steel, silver and platinum.

45. The device of claim 37, wherein said at least one pair of electrodes serve for sensing muscle activity of the muscles defining and surrounding the intravaginal cavity.

46. The device of claim 37, wherein said body defines a substantially rounded diamond shaped frame when relaxed.

47. The device of claim 37, further comprising at least one sensor for sensing muscle activity.

48. The device of claim 47, further comprising a biofeedback device for displaying output of said at least one sensor in user sensible manner.