APPARATUS AND METHOD FOR INCONTINENCE CONTROL

• US 3,800,800 A
• Filed: 01/24/1972
• Issued: 04/02/1974
• Est. Priority Date: 09/20/1968
• Status: Expired due to Term

• Current Assignee: Dietmar Rudolf Garbe, Harry Mcdonnell
• Original Assignee: Dietmar Rudolf Garbe, Harry Mcdonnell
• Inventors: Garbe, Dietmar Rudolf, McDonnell, Harry
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/220,341
• Time in Patent Office: 799 Days
• Field of Search: 128/38R,404,407,405,408,421,422,423
• US Class Current: 607/72
• CPC Class Codes: A61F 5/48 Devices for preventing wetting or pollution of the bed
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• 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

The apparatus is operable to control female urinary incontinence and includes an elongated, generally finger shaped insert which is made from an electrical insulating material, which is substantially rigid, which is sized to fit completely within a vagina and which is adapted to be worn completely within a vagina for an extended period of time. A pair of electrodes are spaced apart along the length of the insert and connections are provided for connecting the electrodes to a source of electric potential located within or without the insert. Each one of the electrodes is located on the periphery of the insert so as to be in position to contact internal surface areas of the vagina when the insert is placed therein for the purpose of applying an electric signal to surface areas for tetanizing relevant muscle tissue located within the body proximate vaginal surface areas located between the surface areas contacted by the electrodes. The method includes the steps of inserting the insert completely within the vagina of an incontinent female and retaining the insert in the vagina for an extended period of time while simultaneously applying to the electrodes on the insert a signal which is defined by a plurality of pulses each having a peak voltage of up to 20 volts and a duration of from 10 to 300 microseconds. Preferably the pulses are generated at a frequency of from 25 to 200 pulses per second.

Claims

1. Apparatus for the control of female urinary incontinence, said apparatus comprising:

an elongate, generally finger-shaped insert which is made from an electrical insulating material, which is substantially rigid, which is generally cylindrical and has a diameter ranging from 5 millimetres to 40 millimetres and a length ranging from 3 centimetres to 12 centimetres so as to fit completely within a vagina and so as to support most vaginas against deformation by the pressure of adjacent organs, which is adapted to be worn completely within a vagina for an extended period of time and which has a pair of electrodes spaced apart along the length of said insert, means connected to said electrodes for generating a signal which is applied to said electrodes and which is defined by a plurality of pulses generated at a frequency of from 25 to 200 pulses per second, each pulse having a peak voltage of up to 20 volts and a duration of from 10 to 300 microseconds, and means for connecting said signal-generating means to a voltage source, each one of said electrodes being located on the periphery of said insert so as to be in position to contact internal surface areas of the vagina when the insert is placed therein for the purpose of applying said electric signal to said surface areas for tetanizing relevant muscle tissue located within the body proximate vaginal surface areas located between the surface areas contacted by said electrodes.

2. The apparatus as claimed in claim 1 wherein said electrodes are flush with the periphery of said insert.

3. The apparatus as claimed in claim 1 wherein said insert is generally cylindrical with a diameter of approxImately 16.5 millimetres.

4. The apparatus as claimed in claim 1 wherein said length of said insert is between 5.5 centimetres and 8.5 centimetres.

5. The apparatus as claimed in claim 1 wherein said length of said insert is approximately 7 centimetres.

6. The apparatus as claimed in claim 1 wherein the spacing between said electrodes is equal to approximately 35 percent of the length of said insert.

7. The apparatus as claimed in claim 1 wherein the spacing between said electrodes is approximately 2.5 centimetres.

8. The apparatus as claimed in claim 1 wherein each one of said electrodes is generally ring-shaped and has a width between 2 millimetres and 8 millimetres.

9. The apparatus as claimed in claim 1 wherein said electrodes totally encircle said insert and said insert includes at least two sections held together by at least one of said electrodes.

10. The apparatus as claimed in claim 1 wherein said insert is rounded at one end to facilitate insertion thereof into and within a vagina.

11. The apparatus as claimed in claim 1 wherein said signal generating means generates positive pulses.

12. The apparatus as claimed in claim 1 wherein said signal generating means generates pulses with a peak voltage between 0 and 10 volts.

13. The apparatus as claimed in claim 1 wherein said signal generating means generates pulses with a peak voltage of approximately 5.5 volts positive.

14. The apparatus as claimed in claim 1 wherein said signal generating means generates pulses with a pulse duration between 100 and 300 microseconds.

15. The apparatus as claimed in claim 1 wherein said signal generating means generates pulses having a pulse duration of approximately 200 microseconds.

16. The apparatus as claimed in claim 1 wherein said signal generating means generates said pulses for a portion of a cycle of operation of said apparatus.

17. A method for controlling female urinary incontinence including the steps of:

inserting completely within the vagina of an incontinent female, an elongate finger-shaped device having a pair of electrodes spaced apart along its length;

retaining said device in said vagina for an extended period of time; and

, simultaneously, applying to said electrodes a signal which is defined by a plurality of pulses generated at a frequency of from 25 to 200 pulses per second, each pulse having a peak voltage of up to 20 volts and a duration of from 10 to 300 microseconds.

18. The method as claimed in claim 17 wherein said pulses are positive pulses.

19. The method as claimed in claim 17 wherein said peak voltage is between 0 and 10 volts.

20. The method as claimed in claim 17 wherein said peak voltage is approximately 5.5 volts positive.

21. The method as claimed in claim 22 wherein said pulse duration is approximately 200 microseconds.

22. In an apparatus which is utilized for controlling female urinary incontinence and which includes means for generating a signal which is defined by a plurality of pulses generated at a frequency of from 25 to 200 pulses per second, each pulse having a peak voltage of up to 20 volts and a duration of from 10 to 300 microseconds, the improvement comprising, an elongate, generally finger-shaped insert which is substantially rigid which is generally cylindrical having a diameter ranging from 5 millimetres to 40 millimetres and a length ranging from 3 centimetres to 12 centimetres such that said insert is sized to fit completely within a vagina and sized to support most vaginas against deformation by the pressure of adjacent organs, which is adapted to be worn completely within a vagina for an extended period of time, which has a pair of electrodes spaced apart along the length of said insert, each one of said electrodes being located on the periphery of said insert so as to be in position to contact internal surface areas of the vagina when said insert is placed therein, and which has means for connecting said electrodes to said signal generating means.

23. The insert as claimed in claim 22 wherein the spacing between said electrodes is equal to approximately 35 percent of the length of said insert.

24. The insert as claimed in claim 22 wherein the spacing between said electrodes is approximately 2.5 centimetres.

25. The insert as claimed in claim 22 wherein said electrodes totally encircle said insert and said insert includes at least two sections held together by at least one of said electrodes.

26. The insert as claimed in claim 22 wherein said insert is rounded at one end to facilitate insertion thereof into and within a vagina.