Intravaginal electrode and stimulation system for controlling female urinary incontinence

• US 4,881,526 A
• Filed: 05/27/1988
• Issued: 11/21/1989
• Est. Priority Date: 05/27/1988
• Status: Expired due to Term

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: EMPI Incorporated (Enovis Corp.)
• Inventors: Maurer, Donald D., Johnson, Michael T. V.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/200,037
• Time in Patent Office: 543 Days
• Field of Search: 128/788, 128/421, 128/422, 128/423 R, 128/24.1, 128/24.2, 128/24.5, 128/48, 128/49
• US Class Current: 601/15
• CPC Class Codes: A61H 19/40 Devices insertable in the genitals
• CPC Class Codes: A61H 19/44 Having substantially cylindrical shape, e.g. dildos
• 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: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61H 23/02 with electric or magnetic drive
• CPC Class Codes: A61H 23/0263 using rotating unbalanced masses
• 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

An intravaginal electrode and controller for preventing female urinary incontinence. The electrode includes an elongated and generally cylindrical carrier having a rounded tip, an extended lip, and a neck of reduced diameter located approximately eight centimeters from the lip. A pair of annular motor electrodes are positioned on an exterior surface of the carrier at longitudinally spaced locations on opposite sides of the neck. Sensory electrodes and an oscillatory transducer are mounted to the carrier adjacent the lip. Motor receptor electrical stimulation signals received from the controller are coupled to the motor electrodes and directly stimulate pelvic floor musculature. Sensory receptor electrical stimulation signals are coupled to sensory receptors through the sensory electrodes while tactile receptors are stimulated by mechanical oscillations from the oscillatory transducer. Stimulation of sensory and tactile receptors cause the central nervous system to contract the pelvic floor musculature and inhibit bladder wall muscle contraction. These stimulus combine for maximal activation of neural pathways.

Claims

1. An intravaginal electrode assembly including:

an elongated and generally cylindrical carrier having a tip at a distal end and an extended lip at a proximal end;

a pair of motor electrodes positioned adjacent one another on an exterior surface of the elongated carrier between the tip and lip approximately eight centimeters from the lip;

sensory stimulation means for stimulating sensory receptors mounted to the carrier adjacent the lip;

motor electrode terminal means coupled to the pair of motor electrodes, for receiving motor receptor electrical stimulation signals; and

sensory stimulation terminal means coupled to the sensory stimulation means, for receiving sensory receptor stimulation signals.

2. The electrode assembly of claim 1 wherein the carrier includes means forming a neck of reduced diameter located between the tip and lip and approximately eight centimeters from the lip.

3. The electrode assembly of claim 2 wherein the motor electrodes are positioned on opposite sides of the means forming the neck.

4. The electrode assembly of claim 1 wherein the motor electrodes are annular, extend around a circumference of the carrier, and are positioned at longitudinally spaced locations on the carrier.

5. The electrode assembly of claim 1 wherein:

the sensory stimulation means includes first and second sensory electrodes positioned on an exterior surface of the carrier with the first sensory electrode located adjacent the lip; and

the sensory stimulation terminal means is coupled to the sensory electrodes and receives sensory receptor electrical stimulation signals.

6. The electrode assembly of claim 5 wherein the sensory electrodes are annular, extend around a circumference of the carrier, and are positioned at longitudinally spaced locations on the carrier.

7. The electrode assembly of claim 6 wherein the first sensory electrode has a greater surface area than the motor electrodes.

8. The electrode assembly of claim 5 wherein the second sensory electrode is positioned adjacent the distal end of the carrier.

9. The electrode assembly of claim 1 wherein:

the sensory stimulation means includes an oscillatory transducer; and

the sensory stimulation terminal means is coupled to the oscillatory transducer and receives oscillatory transducer drive signals.

10. The electrode assembly of claim 9 wherein the oscillatory transducer is mounted within the carrier.

11. The electrode assembly of claim 1 wherein:

the sensory stimulation means includes;

first and second sensory electrodes positioned on an exterior surface of the carrier with the first sensory electrode located adjacent the lip; and

an oscillatory transducer; and

the sensory stimulation terminal means includes;

sensory electrode terminal means coupled to the sensory electrodes for receiving sensory receptor electrical stimulation signals; and

oscillatory transducer terminal means coupled to the oscillatory transducer for receiving oscillatory transducer drive signals.

12. The invention of claim. 11 and further including a controller comprising:

motor stimulation signal generation and control means coupled to the motor electrode terminal means for producing the motor receptor electrical stimulation signals;

sensory stimulation signal generation and control means coupled to the sensory stimulation terminal means for producing the sensory receptor stimulation signals; and

oscillatory stimulation signal generation and control means coupled to the oscillatory transducer terminal means for producing the oscillatory transducer drive signals.

13. The invention of claim 1 and further including a controller comprising:

motor stimulation signal generation and control means coupled to the motor electrode terminal means for producing the motor receptor electrical stimulation signals; and

sensory stimulation signal generation and control means coupled to the sensory stimulation terminal means for producing the sensory receptor stimulation signals.

14. The invention of claim 13 wherein the controller further includes motor/sensory phase control means coupled to the motor stimulation signal generation and control means and to the sensory stimulation signal generation and control means, for controlling a phase relationship between the motor receptor stimulation signals and the sensory receptor stimulation signals.

15. An intravaginal electrode assembly including:

an elongated and generally cylindrical carrier having a tip at a distal end, an extended lip at a proximal end, and means forming a neck of reduced diameter located approximately eight centimeters from the lip;

a pair of annular motor electrodes extending around a circumference of the carrier and positioned at longitudinally spaced locations on opposite sides of the means forming the neck;

first and second annular sensory electrodes extending around a circumference of the carrier with the first sensory electrode located adjacent the lip;

motor electrode terminal means coupled to the pair of motor electrodes, for receiving motor receptor electrical stimulation signals; and

sensory electrode terminal means coupled to the sensory electrodes, for receiving sensory receptor electrical stimulation signals.

16. The electrode assembly of claim 15 wherein the first sensory electrode has a greater surface area than the motor electrodes.

17. The electrode assembly of claim 15 wherein the second sensory electrode is positioned adjacent the distal end of the carrier.

18. The invention of claim 15 and further including a controller comprising:

motor stimulation signal generation and control means coupled to the motor electrode terminal means for producing the motor receptor stimulation signals; and

sensory stimulation signal generation and control means coupled to the sensory stimulation terminal means for producing the sensory receptor stimulation signals.

19. The invention of claim 18 wherein the controller further includes motor/sensory phase control means coupled to the motor stimulation signal generation and control means and to the sensory stimulation signal generation and control means, for controlling a phase relationship between the motor receptor stimulation signals and the sensory receptor stimulation signals.

20. An intravaginal electrode assembly including:

an elongated and generally cylindrical carrier having a tip at a distal end, an extended lip at a proximal end, and means forming a neck of reduced diameter approximately eight centimeters from the lip;

a pair of annular motor electrodes which extend around a circumference of the carrier and are positioned at longitudinally spaced locations on opposite sides of the means forming the neck;

an oscillatory transducer mounted to the carrier adjacent the lip;

motor electrode terminal means coupled to the pair of motor electrodes, for receiving motor receptor electrical stimulation signals; and

oscillatory transducer terminal means coupled to the oscillatory transducer for receiving oscillatory transducer drive signals.

21. The electrode assembly of claim 20 wherein the oscillatory transducer is mounted within the carrier.

22. The invention of claim 20 and further including a controller comprising:

motor stimulation signal generation and control means coupled to the motor electrode terminal means for producing the motor receptor electrical stimulation signals; and

oscillatory drive signal generation and control means coupled to the oscillatory transducer terminal means for producing the oscillatory transducer drive signals.

23. The invention of claim 22 wherein the controller further includes motor/sensory phase control means coupled to the motor stimulation signal generation and control means and to the oscillatory drive signal generation and control means, for controlling a phase relationship between the motor receptor stimulation signals and the transducer drive signals.

24. An intravaginal electrode assembly including:

an elongated and generally cylindrical carrier having a tip at a distal end, an extended lip at a proximal end, and means forming a neck of reduced diameter approximately eight centimeters from the lip;

a pair of annular motor electrodes which extend around a circumference of the carrier and are positioned at longitudinally spaced locations on opposite sides of the means forming the neck;

first and second annular sensory electrodes extending around a circumference of the carrier with the first sensory electrode located adjacent the lip;

an oscillatory transducer mounted to the carrier adjacent the lip;

motor electrode terminal means coupled to the pair of motor electrodes, for receiving motor receptor electrical stimulation signals;

sensory electrode terminal means coupled to the sensory electrodes, for receiving sensory receptor electrical stimulation signals; and

oscillatory transducer terminal means coupled to the oscillatory transducer for receiving oscillatory transducer drive signals.

25. The electrode assembly of claim 24 wherein the oscillatory transducer is mounted within the carrier.

26. The electrode assembly of claim 24 wherein the first sensory electrode has greater surface area than the motor electrodes.

27. The electrode assembly of claim 24 wherein the second sensory electrode is positioned adjacent the distal end of the carrier.

28. The invention of claim 24 and further including a controller comprising:

motor stimulation signal generation and control means coupled to the motor electrode terminal means for producing the motor receptor electrical stimulation signals;

sensory stimulation signal generation and control means coupled to the sensory stimulation terminal means for producing the sensory receptor electrical stimulation signals; and

oscillatory drive signal generation and control means coupled to the oscillatory transducer terminal means for producing the oscillatory transducer drive signals.

29. The invention of claim 28 and further including phase control means coupled to the motor stimulation signal generation and control means, to the sensory stimulation signal generation and control means, and to the oscillatory drive signal generation and control means, for controlling a phase relationship between the motor receptor stimulation signals, the sensory receptor electrical stimulation signals, and the oscillatory transducer drive signals.