Non-invasive method to treat urological and gastrointestinal disorders

Patent metadata

Field	Value
Publication number	US-11191958-B2
Application number	US-201916410206-A
Country	US
Kind code	B2
Filing date	May 13, 2019
Priority date	Oct 1, 2009
Publication date	Dec 7, 2021
Grant date	Dec 7, 2021

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.

First claim

What is claimed is:

1. A method of treating urinary urgency or urinary incontinence in a patient, comprising:
transcutaneously delivering pulsed electrical energy directly to a foot of the patient through a device comprising a plurality of electrodes placed on the skin of the patient's foot, the pulsed electrical energy comprising electrical pulses having a frequency ranging from 1 Hz to 500 Hz and a voltage ranging from 1 V to 50 V, wherein the electrodes are arranged such that:
two or more electrodes are in contact with the skin on a dorsal surface of the patient's foot, and at least two of the electrodes have opposite polarities;
two or more electrodes are in contact with the skin on a plantar surface of the patient's foot, and at least two of the electrodes have opposite polarities; or
at least one electrode is in contact with the skin on the dorsal surface of the patient's foot and at least one electrode is in contact with the skin on the plantar surface of the patient's foot, and at least one electrode in contact with the skin on the dorsal surface of the patient's foot has an opposite polarity from at least one electrode in contact with the skin on the plantar surface of the patient's foot.

2. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on the skin of the dorsal surface of the patient's foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on the skin of the plantar surface of the patient's foot about one or more metatarsal bones.

3. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on the skin of the dorsal surface of the patient's foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on the skin of the dorsal surface of the patient's foot about one or more of the talus, cuboid, intermediate cuneiform, lateral cuneiform, or navicular bones.

4. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on the skin of the plantar surface of the patient's foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on the skin of the plantar surface of the patient's foot about the calcaneous bone.

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

6. The method of claim 5 , in which the pulses are symmetrical, square, or rectangular.

7. The method of claim 5 , in which the pulses are charge balanced.

8. 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 between stimulation intervals.

9. 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.

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

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

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

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

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

15. The method of claim 1 , in which the voltage ranges from 0.5 T to 4 T, where T is a toe-twitch threshold of the patient.

16. The method of claim 1 , in which the duration of pulses ranges from 0.1 ms to 3 ms or from 0.2 ms to 1 ms.

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

18. The method of claim 1 , wherein the electrical pulses have a frequency of about 20 Hz.

19. A method of treating urinary urgency or urinary incontinence in a patient, comprising:
transcutaneously delivering pulsed electrical energy directly to a foot of the patient through a device, the device comprising:
an electrode assembly comprising a plurality of inward facing electrodes, the assembly configured such that one or more of the electrodes contacts the skin of the patient on a plantar surface of the patient's foot and/or one or more of the electrodes contacts the skin of the patient on the dorsal surface of the patient's foot, wherein at least one of the electrodes has a first polarity and another of the electrodes has an opposite polarity,
wherein the pulsed electrical energy comprises electrical pulses having a frequency ranging from 1 Hz to 500 Hz and a voltage ranging from 1 V to 50 V.

Assignees

• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education

Inventors

• Tai Changfeng

Classifications

• A61N1/36034

  specified by the stimulation parameters · CPC title

• A61N1/36007 Primary

  of urogenital or gastrointestinal organs, e.g. for incontinence control · CPC title