Urinary incontinence device and method

• US 8,818,512 B2
• Filed: 01/11/2013
• Issued: 08/26/2014
• 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:
  US13/739,750
• Publication Number:
  US 20130131772A1
• Time in Patent Office: 592 Days
• Field of Search: 607/41, 607/104
• 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, the device including 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. The method further includes causing the expandable portion to expand such that the first and second electrodes contact vaginal walls, and causing a contraction of a muscle in communication with the first and second electrodes.

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 expand such that the first and second electrodes contact vaginal walls; and

energizing the first and second electrodes sufficient to cause the contraction of the muscle in communication with the first and second electrodes.

2. The method of claim 1 comprising de-energizing the first and second electrodes to allow the muscle in communication with the first and second electrodes to relax.

3. The method of claim 1 comprising:

generating a response information in response to a pressure inside the expandable portion; and

causing the response information to be recorded.

4. The method of claim 1 comprising:

generating a response information in response to an electrical signal received from at least one of the first and second electrodes; and

causing the response information to be recorded.

5. The method of claim 1 comprising requesting a user to force a contraction of the muscle in communication with at least one of the first and second electrodes.

6. The method of claim 5 comprising:

generating a response information in response to a pressure inside the expandable portion during the contraction forced by the user; and

causing the response information to be recorded.

7. The method of claim 1 comprising causing a response information to be recorded;

wherein the response information comprises a baseline information.

8. The method of claim 1 comprising causing the expandable portion to expand in a radially non-uniform manner to substantially contour to the anatomy of a user.

9. The method of claim 8, wherein:

the first electrode is located on a portion of the expandable portion having a first thickness;

the second electrode is located on a portion of the expandable portion having a second thickness;

the expandable portion has a third portion having a third thickness;

the third thickness is less than each of the first thickness and the second thickness; and

the portions having the first, second, and third thicknesses cooperate to cause the expandable portion to expand in the radially non-uniform manner.

10. The method of claim 8, wherein:

the first electrode is located on a first portion of the expandable portion;

the second electrode is located on a second portion of the expandable portion;

the expandable portion comprises a third portion other than the first and second portions, the third portion having a plurality of folds; and

the plurality of folds cause the expandable portion to expand in the radially non-uniform manner.

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

a shaft comprising a proximal end and extending substantially along a longitudinal axis;

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;

a handle housing coupled to the proximal end of the shaft; and

a pump in communication with the balloon and configured to cause expansion of the balloon such that the electrode presses against a vaginal wall of a user, at least a portion of the pump disposed in the housing;

wherein the first and second portions of the balloon cooperate such that the balloon expands in a radially non-uniform manner relative to the longitudinal axis.

12. The apparatus of claim 11, wherein the radial thickness of the first portion is greater than the radial thickness of the second portion.

13. The apparatus of claim 11, wherein the second portion comprises folds, and the electrode is not coupled to the second portion.

14. The apparatus of claim 11 comprising processing electronics configured to inhibit the electrode from energizing until the balloon has been pressurized to a predetermined pressure.

15. The apparatus of claim 11, wherein the shaft comprises a distal end, the balloon surrounding at least a portion of the distal end of the shaft.

16. The apparatus of claim 15, wherein the pump comprises a bladder fluidly connected to a check valve, and wherein the pump is configured such that compression of the housing causes fluid to be forced from the bladder through the check valve into the balloon, thereby expanding the balloon.

17. The apparatus of claim 16 comprising processing electronics configured to determine if a pressure inside the balloon has reached a predetermined value and to cause an indication in response to the determination that the pressure inside the balloon has reached the predetermined value.

18. The apparatus of claim 11 comprising processing electronics configured to cause a current of between 10 milliamps and 50 milliamps to be provided to the electrode.

19. The apparatus of claim 11, wherein the electrode is a first electrode, and further comprising:

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

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

20. The apparatus of claim 19, wherein the electric potential difference is between 0 and 80 Volts.

21. The apparatus of claim 19, wherein the electric potential difference is between 10 Volts and 50 Volts.

22. A system for treating urinary incontinence comprising:

a member comprising an expandable portion having a first portion, a second portion, and a third portion located between the first portion and the second portion, wherein the third portion comprises at least one fold that allows for non-uniform expansion of the expandable portion;

a first electrode disposed on the first portion of the expandable portion;

a second electrode disposed on the second portion of the expandable portion;

a memory; and

processing electronics configured to cause a voltage between the first and second electrodes, the voltage causing contraction of a user'"'"'s vaginal muscle in communication with the first and second electrodes in response to data stored in the memory;

wherein at least one of the first and second electrodes are not disposed on the third portion.

23. The system of claim 22, wherein the data is stored in the memory by a health care professional.

24. The system of claim 22, wherein the voltage comprises a pattern including 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.

25. The system of claim 22, wherein the processing electronics are configured to generate a response information in response to a user forcing a contraction of the vaginal muscle in communication with at least one of the first and second electrodes and to cause the response information to be recorded.

26. The system of claim 22, wherein the processing electronics are configured to determine a conductivity of an environment of the first and second electrodes and to control the voltage in response to the conductivity of the environment of the first and second electrodes.

27. The system of claim 22, wherein the processing electronics are configured to determine whether the member is properly positioned and to control the voltage in response to the determination that the member is properly positioned.

28. The system of claim 22 comprising a pump in communication with the expandable portion and configured to cause expansion of the expandable portion;

wherein expansion of the expandable portion causes the first and second electrodes to press against a vaginal wall.

29. The system of claim 28 comprising a handle coupled to a first end of the expandable portion and configured to remain external the user when the expandable portion is inserted into the user, the handle configured to support the pump therein.

30. A system for treating urinary incontinence comprising:

a member comprising an expandable portion;

a first electrode disposed on a first portion of the expandable portion;

a second electrode disposed on a second portion of the expandable portion;

a handle coupled to a first end of the expandable portion and configured to remain external the user when the expandable portion is inserted into the user;

a pump supported in the handle, the pump in communication with the expandable portion and configured to cause expansion of the expandable portion wherein expansion of the expandable portion causes the first and second electrodes to press against a vaginal wall;

a memory; and

processing electronics configured to cause a voltage between the first and second electrodes, the voltage causing contraction of a user'"'"'s vaginal muscle in communication with the first and second electrodes in response to data stored in the memory.

31. A method for treating urinary incontinence comprising:

providing a device comprising;

an expandable portion having an outer surface including a first portion having a first thickness, a second portion having a second thickness, and a third portion having a third thickness less than each of the first thickness and the second thickness, wherein the portions having the first, second, and third thicknesses cooperate to cause the expandable portion to expand in a radially non-uniform manner; and

a first electrode located on the first portion of the expandable portion and a second electrode located on the second portion of the expandable portion, 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 expand in the radially non-uniform manner to substantially contour to an anatomy of a user such that the first and second electrodes contact vaginal walls; and

causing the contraction of the muscle in communication with the first and second electrodes.

32. A method for treating urinary incontinence comprising:

providing a device comprising;

an expandable portion having an outer surface and including a first portion, a second portion, and a third portion other than the first and second portions, the third portion having a plurality of folds, wherein the plurality of folds cause the expandable portion to expand in a radially non-uniform manner; and

a first electrode located on the first portion of the expandable portion and a second electrode located on the second portion of the expandable portion, 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 expand in the radially non-uniform manner to substantially contour to an anatomy of a user such that the first and second electrodes contact vaginal walls; and

causing the contraction of the muscle in communication with the first and second electrodes.