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

• US 6,432,037 B1
• Filed: 08/31/2000
• Issued: 08/13/2002
• Est. Priority Date: 08/31/2000
• Status: Expired due to Term

• Current Assignee: Flexiprobe Limited
• Original Assignee: Flexiprobe Limited
• Inventors: Tamarkin, Dov, Eini, Meir
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): VENIAMINOV, NIKITA R
• Application Number:
  US09/653,263
• Time in Patent Office: 712 Days
• Field of Search: 600/375, 600/373, 600/29, 600/38, 600/41, 600/549, 607/138, 607/116, 128/898
• US Class Current: 600/29
• 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 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.

Claims

1. A device for stimulating 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;

wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

2. The device of claim 1, wherein the device serves for treating or preventing urinary incontinence 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 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.

5. 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.

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

7. 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.

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 and platinum.

9. 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.

10. The device of claim 9, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor.

11. The device of claim 9, wherein said at least one sensor attached to said body further includes a transmitter.

12. The device of claim 11, 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.

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

14. 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;

wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

15. The system of claim 14, wherein the system serves for treating or preventing urinary incontinence in the individual.

16. The system of claim 14, wherein said body is constructed of an elastic material selected from the group consisting of silicon, rubber and latex.

17. The system of claim 14, 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.

18. The system of claim 14, wherein said at least one pair of electrodes include a conductive material selected from the group consisting gold and platinum.

19. The system of claim 14, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor.

20. The system of claim 14, 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.

21. The system of claim 14, wherein said body defines a substantially rounded diamond shaped frame when relaxed.

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

(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, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted; 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 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.

23. The method of claim 22, wherein stimulation of the muscles and nerves defining and surrounding the intravaginal cavity serves for treatment or prevention of urinary incontinence in the individual.

24. 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 electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with said wall;

wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

25. The device of claim 24, wherein the device serves for treating or preventing urinary incontinence in the individual.

26. The device of claim 24, further comprising a power and control unit being attachable to connectors being in electrical communication with said at least one pair of electrodes.

27. The device of claim 26, 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.

28. The device of claim 24, wherein said body is constructed of an elastic material selected from the group consisting of, rubber, latex and silicon.

29. The device of claim 24, 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.

30. The device of claim 24, wherein said at least one pair of electrodes includes an electrically conductive material selected from the group consisting of gold and platinum.

31. The device of claim 24, wherein said at least one pair of electrodes serve for sensing muscle activity of the muscles defining and surrounding the intravaginal cavity.

32. The device of claim 24, wherein said body defines a substantially rounded diamond shaped frame when relaxed.

33. A device for stimulating 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;

wherein said body defines a substantially rounded diamond shaped frame when relaxed.

34. The device of claim 33, wherein the device serves for treating or preventing urinary incontinence in the individual.

35. The device of claim 33, 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.

36. The device of claim 35, 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.

37. The device of claim 35, 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.

38. The device of claim 33, wherein said body is constructed of an elastic material selected from the group consisting of rubber, latex and silicon.

39. The device of claim 33, 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.

40. The device of claim 33, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

41. The device of claim 33, wherein said at least one pair of electrodes includes an electrically conductive material selected from the group consisting of gold and platinum.

42. The device of claim 33, 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.

43. The device of claim 42, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor.

44. The device of claim 42, wherein said at least one sensor attached to said body further includes a transmitter.

45. The device of claim 44, 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.

46. 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;

wherein said body defines a substantially rounded diamond shaped frame when relaxed.

47. The system of claim 46, wherein the system serves for treating or preventing urinary incontinence in the individual.

48. The system of claim 46, wherein said body is constructed of an elastic material selected from the group consisting of silicon, rubber and latex.

49. The system of claim 46, 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.

50. The system of claim 46, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

51. The system of claim 46, wherein said at least one pair of electrodes include a conductive material selected from the group consisting gold and platinum.

52. The system of claim 46, wherein said at least one sensor attached to said body is a pressure sensor or an electrical activity sensor.

53. The system of claim 46, 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.

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

(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, wherein said body defines a substantially rounded diamond shaped frame when relaxed; 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 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.

55. The method of claim 54, wherein stimulation of the muscles and nerves defining and surrounding the intravaginal cavity serves for treatment or prevention of urinary incontinence in the individual.

56. 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 electrodes is biased against a wall of the intravaginal cavity to thereby maintain electrical contact with said wall;

wherein said body defines a substantially rounded diamond shaped frame when relaxed.

57. The device of claim 56, wherein the device serves for treating or preventing urinary incontinence in the individual.

58. The device of claim 56, further comprising a power and control unit being attachable to connectors being in electrical communication with said at least one pair of electrodes.

59. The device of claim 58, 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.

60. The device of claim 56, wherein said body is constructed of an elastic material selected from the group consisting of rubber, latex and silicon.

61. The device of claim 56, 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.

62. The device of claim 56, wherein a length of said body when relaxed is 1.3-1.7 times shorter than said length of said body when fully contracted.

63. The device of claim 56, wherein said at least one pair of electrodes includes an electrically conductive material selected from the group consisting of gold and platinum.

64. The device of claim 56, wherein said at least one pair of electrodes serve for sensing muscle activity of the muscles defining and surrounding the intravaginal cavity.