NON-INVASIVE METHOD TO TREAT UROLOGICAL AND GASTROINTESTINAL DISORDERS

• US 20130006322A1
• Filed: 09/30/2010
• Published: 01/03/2013
• Est. Priority Date: 10/01/2009
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Tai, Changfeng
• Granted Patent: US 9,878,154 B2
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

Provided herein are methods and devices useful for inhibiting or treating urological conditions, such as overactive bladder (OAB) symptoms including bladder overactivity, urinary frequency, urinary urgency, urinary incontinence, interstitial cystitis (IC), urinary retention, and pelvic pain; gastrointestinal conditions, such as fecal incontinence, irritable bowel syndrome (IBS), and constipation; and sexual conditions, such as premature ejaculation, erectile disorder, and female sexual arousal disorder by non-invasive transcutaneous electrical stimulation of the foot.

Claims

1. A method of stimulating a physiological response in a patient, comprising applying transcutaneous electrical pulses ranging from 1 HZ to 500 Hz and from 1V to 50V to the patient'"'"'s foot effective to stimulate a physiological response selected from the group consisting of inhibiting or treating in the patient one or more of:

bladder contractions;

rectum contractions;

bulbospongiosus and ischiocavernosus muscle contractions;

urological conditions;

overactive bladder (OAB) symptoms;

bladder overactivity;

urinary frequency;

urinary urgency;

urinary incontinence;

interstitial cystitis (IC);

urinary retention; and

pelvic pain;

gastrointestinal conditions;

fecal incontinence;

irritable bowel syndrome (IBS);

constipation;

sexual conditions;

premature ejaculation;

erectile disorder; and

female sexual arousal disorder.

2. The method of claim 1, comprising inhibiting bladder contractions in a patient, comprising applying transcutaneous electrical pulses ranging from 1 HZ to 500 Hz, 0.1 ms to 3 ms and from 1V to 50V to the patient'"'"'s foot effective to inhibit bladder contractions in the patient.

3. The method of claim 1, wherein the electrical pulses are applied by one or more electrodes on skin of the dorsal side of the foot about one or more metatarsal bones and one or more opposite electrodes on skin of the plantar side of the foot about one or more metatarsal bones.

4. The method of claim 1, wherein the electrical pulses are applied by one or more electrodes on skin of the dorsal side of the foot about one or more metatarsal bones and one or more opposite electrodes on skin of the dorsal side of the foot about one or both of the talus, cuboid, intermediate cuneiform, lateral cuneiform or navicular bones.

5. The method of claim 1, wherein the electrical pulses are applied by one or more electrodes on skin of the plantar side of the foot about the tarsal bones and one or more opposite electrodes on skin of the plantar side of the foot about the calcaneous bones.

6. The method of claim 1, in which the pulses are biphasic.

7. The method of claim 6, in which the pulses are symmetrical.

8. The method of claim 6, in which the pulses are square or rectangular.

9. The method of claim 6, in which the pulses are charge balanced.

10. The method of claim 1, wherein the pulses are applied in two or more stimulation intervals of from 0.5 to 200 seconds with a rest period of no electrical stimulation able to inhibit bladder or rectal contractions between stimulation intervals.

11. The method of claim 1, in which the pulses are applied at a voltage less than an intensity threshold to induce toe movement (T) in a patient.

12. The method of claim 1, in which the electrical pulses are applied by electrodes in a garment electrode.

13. The method of claim 1, in which the pulse frequency ranges from 1 to 50 Hz.

14. The method of claim 1, in which the pulse frequency ranges from 5 to 20 Hz.

15. The method of claim 1, in which the pulse frequency is approximately 5 Hz.

16. The method of claim 1, in which the voltage ranges from 3V to 12V.

17. The method of claim 1, in which the voltage ranges from 0.5 T to 2 T, where T is the toe -twitch threshold of a patient.

18. The method of claim 1, in which the duration of pulses ranges from 0.1 to 3 ms.

19. The method of claim 1, in which the duration of pulses ranges from 0.2 to 1 ms.

20. The method of claim 1, in which the duration of pulses is approximately 1 ms.

21. A device for use in stimulating a physiological response in a patient for inhibiting or treating in the patient one or more of:

bladder contractions;

rectum contractions;

bulbospongiosus and ischiocavernosus muscle contractions;

urological conditions;

overactive bladder (OAB) symptoms;

bladder overactivity;

urinary frequency;

urinary urgency;

urinary incontinence;

interstitial cystitis (IC);

urinary retention;

pelvic pain;

gastrointestinal conditions;

fecal incontinence;

irritable bowel syndrome (IBS);

constipation;

sexual conditions;

premature ejaculation;

erectile disorder; and

female sexual arousal disorder, the device comprising an electrical pulse generator, an electrode assembly comprising two or more skin surface electrodes configured to position electrodes on a patient'"'"'s foot such that the electrodes can be used to stimulate the physical response and leads connecting the electrodes to the pulse generator, wherein the pulse generator is configured to produce electrical pulses in the range of from 1 Hz to 500 Hz and from 1V to 50V to stimulate the physiological response in the patient.

22. The device of claim 21, wherein the electrode assembly is a garment electrode for the foot.

23. The device of claim 21, in which the pulse frequency ranges from 1 to 50 Hz.

24. The device of claim 21, in which the pulse frequency ranges from 5 to 20 Hz.

25. The device of claim 21, in which the pulse frequency is approximately 5 Hz.

26. The device of claim 21, in which the voltage ranges from 3V to 12V.

27. The device of claim 21, in which the voltage ranges from 0.5 T to 2 T, where T is the toe-twitch threshold of a patient.

28. The device of claim 21, in which the duration of pulses ranges from 0.1 to 3 ms.

29. The device of claim 21, in which the duration of pulses ranges from 0.2 to 1 ms.

30. The device of claim 21, in which the duration of pulses is approximately 1 ms.

31. The device of claim 21, wherein the pulse generator is attached to a garment electrode for a foot comprising the electrodes and comprises an antenna and the pulse generator is controllable by an external transmitter that transmits a signal that is received by the antenna of the pulse generator and data can be transmitted from the pulse generator to an external receiver.

32. The device of claim 31, wherein the external receiver is contained in a device comprising the transmitter.

33. The device of claim 31, in which the external transmitter transmits an identification signal to the pulse generator, the pulse generator requiring an appropriate identification signal from the transmitter to control output of the pulse generator.

34. The device of claim 31, in which one of the pulse generator and the transmitter comprises an RFID tag and the other of the pulse generator and the transmitter comprises an RFID reader and verification of the identity of the pulse generator and transmitter by RFID is required to control output of the pulse generator.

35. The device of claim 31, in which signals from the transmitter are encrypted and can only be decrypted by a matching pulse generator.

36. The device of claim 31, wherein one of the pulse generator and the transmitter require identification of the other before the transmitter can control output of the pulse generator.