Urinary incontinence device and method

• US 8,369,953 B2
• Filed: 04/27/2012
• Issued: 02/05/2013
• Est. Priority Date: 06/17/2010
• Status: Active Grant

• Current Assignee: Incontrol Medical, Llc
• Original Assignee: Incontrol Medical, Llc
• Inventors: Peddicord, Herschel
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US13/458,857
• Publication Number:
  US 20120215280A1
• Time in Patent Office: 284 Days
• Field of Search: 607/104, 607/113, 607/41, 607/99, 607/96
• US Class Current: 607/41
• CPC Class Codes: A61H 19/00 Massage for the genitals; Devices for improving sexual intercourse penis erection devices A61F5/41; vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61H 19/34 For clitoral stimulation
• 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 2201/0103 inflatable
• CPC Class Codes: A61H 2201/0153 hand-held
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5046 Touch screens
• CPC Class Codes: A61H 2201/5048 Audio interfaces, e.g. voice or music controlled
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2230/65 Impedance, e.g. skin conductivity; capacitance, e.g. galvanic skin response [GSR]
• CPC Class Codes: A61H 2230/655 used as a control parameter for the apparatus
• 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 23/0263 using rotating unbalanced masses
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• 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

A method for treating urinary incontinence is provided. The method includes providing a device having an expandable portion having an outer surface, a first electrode, and a second electrode, the first and second electrodes coupled to the outer surface of the expandable portion and configured to cause a contraction of a muscle in communication with the electrodes. The method further includes causing the expandable portion to inflate such that the first and second electrodes contact vaginal walls and causing a contraction of a muscle in communication with the electrode.

Claims

1. A method for treating urinary incontinence comprising:

providing a device comprising;

an expandable portion having an outer surface; and

a first electrode and a second electrode, the first and second electrodes coupled to the outer surface of the expandable portion and configured to cause a contraction of a muscle in communication with the electrodes;

causing the expandable portion to inflate such that the first and second electrodes contact vaginal walls; and

causing a contraction of a muscle in communication with the electrode;

requesting a user to manually contract the muscle in communication with the electrode;

causing a response information to be recorded, the response information comprising an electric potential difference between the first electrode and the second electrode during the manual contraction by the user.

2. The method of claim 1 wherein the response information comprises a pressure inside the expandable portion.

3. The method of claim 1, wherein the response information comprises an electrical signal received from at least one of the first electrode and second electrode.

4. The method of claim 1, wherein the response information comprises a pressure inside the expandable portion during the contraction forced by the user.

5. The method of claim 1 comprising causing a baseline information to be recorded.

6. The method of claim 1 comprising causing the expandable portion to inflate to substantially contour to the anatomy of a user.

7. An apparatus for the treatment of urinary incontinence comprising:

a shaft;

a balloon surrounding at least a portion of the shaft;

an electrode coupled to a first portion of the balloon, the electrode configured to cause a contraction of at least one muscle in communication with the electrode;

a second portion of the balloon having a thickness less than the first portion of the balloon;

a second electrode coupled to a third portion of the outer surface of the balloon; and

process electronics configured to cause an electric potential difference between the first electrode and the second electrode and configured to control the electric potential difference;

wherein the balloon inflates in a radially non-uniform manner in response to the difference in thicknesses of the first portion and the second portion.

8. The apparatus of claim 7 comprising a pump in communication with the balloon and configured to cause inflation of the balloon such that the electrode presses against a vaginal wall of a user.

9. The apparatus of claim 7 comprising processing electronics configured to inhibit the electrode from causing a contraction of the muscle in communication with the electrode until the balloon has been inflated to a predetermined pressure.

10. The apparatus of claim 7 comprising processing electronics configured to cause an indication in response to a determination that a pressure inside the balloon has reached a predetermined value.

11. The apparatus of claim 7 comprising processing electronics configured to cause an indication in response to a determination that the balloon has been inflated to a pressure equal to or greater than a predetermined value.

12. The apparatus of claim 7 comprising processing electronics configured to cause inflation of the balloon.

13. The apparatus of claim 7 comprising processing electronics configured to cause a current of between 10 milliamps and 50 milliamps.

14. The apparatus of claim 7, wherein the electric potential difference is between 0 and 80 Volts.

15. The apparatus of claim 7, wherein the electric potential difference is between 10 Volts and 50 Volts.

16. The apparatus of claim 7, wherein the balloon inflates in a radially non-uniform manner in response to the difference in thicknesses of the second portion and the third portion.

17. The apparatus of claim 8, wherein the pump is configured to cause inflation of the balloon such that the second electrode presses against the vaginal wall of a user.

18. A system for treating urinary incontinence comprising:

a member comprising an expandable portion;

an electrode disposed on the expandable portion;

a memory; and

processing electronics configured to cause a stimulation of a user'"'"'s vaginal muscle in communication with the electrode in response to data stored in the memory;

wherein the processing electronics are configured to control the stimulation in response to a determination that a pressure inside the expandable portion has reached a predetermined value.

19. The system of claim 18, wherein the data is stored in the memory by a health care professional.

20. The system of claim 18, wherein the stimulation comprises a pattern of at least one of current, voltage, and frequency.

21. The system of claim 20, wherein the pattern comprises a biphasic pulse.

22. The system of claim 20, wherein the pattern comprises a biphasic pulse for six seconds at twelve cycles per second, six seconds of rest, a biphasic pulse for six seconds at twenty-five cycles per second, and six seconds of rest.

23. The system of claim 18, wherein the processing electronics are configured to cause a response information to be recorded, the response information generated in response to a user forcing a contraction of the vaginal muscle in communication with the electrode.

24. The system of claim 18, wherein the processing electronics are configured to control the stimulation in response to a conductivity of the environment of the electrode.

25. The system of claim 18, wherein the processing electronics are configured to control the stimulation in response to a determination that the member is properly positioned.

26. The system of claim 18 comprising a pump in communication with the expandable portion and configured to cause inflation of the expandable portion

wherein inflation of the expandable portion causes the electrode to press against a vaginal wall.

27. A system for treating urinary incontinence comprising:

a member comprising an expandable portion;

an electrode disposed on the expandable portion;

a memory; and

processing electronics configured to cause a stimulation of a user'"'"'s vaginal muscle in communication with the electrode in response to data stored in the memory;

wherein the stimulation comprises a pattern of at least one of current, voltage, and frequency, the pattern comprising a biphasic pulse.

28. The system of claim 27, wherein the data is stored in the memory by a health care professional.

29. The system of claim 27, wherein the pattern comprises a biphasic pulse for six seconds at twelve cycles per second, six seconds of rest, a biphasic pulse for six seconds at twenty-five cycles per second, and six seconds of rest.

30. The system of claim 27, wherein the processing electronics are configured to cause a response information to be recorded, the response information generated in response to a user forcing a contraction of the vaginal muscle in communication with the electrode.

31. The system of claim 27, wherein the processing electronics are configured to control the stimulation in response to a conductivity of the environment of the electrode.

32. The system of claim 27, wherein the processing electronics are configured to control the stimulation in response to a determination that the member is properly positioned.

33. The system of claim 27 comprising a pump in communication with the expandable portion and configured to cause inflation of the expandable portion.