System and method for nerve stimulation

• US 7,979,137 B2
• Filed: 06/07/2005
• Issued: 07/12/2011
• Est. Priority Date: 02/11/2004
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: DiUbaldi, Anthony, Tracey, Michael R.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/146,522
• Publication Number:
  US 20050277998A1
• Time in Patent Office: 2,226 Days
• Field of Search: 607/2, 607/40, 607/41, 607/133, 607/138, 607/66, 607 68- 71, 600/14
• US Class Current: 607/71
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A system and method for stimulating a nerve, wherein the system includes a first waveform generator adapted to generate a first waveform having a frequency capable of stimulating a predetermined nerve of the mammal, a second waveform generator adapted to generate a carrier waveform having a frequency capable of passing through tissue of the mammal, a modulation device electrically coupled to the first and second waveform generators and adapted to modulate the first and carrier waveforms to create a modulated waveform, and an electrode electrically coupled to the modulation device and positioned substantially adjacent to skin of the mammal, and adapted to apply the modulated waveform thereto.

Claims

1. A transdermal stimulation device for selectively stimulating a predetermined nerve of a mammal, comprising:

a first waveform generator configured to generate a first analog waveform having a selected amplitude and frequency capable of stimulating the predetermined nerve, wherein the generated first waveform is itself incapable of transdermally stimulating the predetermined nerve;

a second waveform generator configured to generate a second analog carrier waveform having a selected amplitude and frequency, wherein the frequency of the second carrier waveform is greater than that of the first waveform, wherein the second carrier waveform is capable of passing through the mammal'"'"'s skin and tissue to reach the predetermined nerve, and wherein the frequency of said generated carrier waveform is itself incapable of electrically stimulating the predetermined nerve;

an amplitude modulation device electrically coupled to the first and second waveform generators and configured to multiply the second carrier waveform and the first waveform to create a modulated signal that maintains the modulation envelope and frequency information of the first waveform and second carrier waveform, and that is capable of transdermally electrically stimulating the predetermined nerve, wherein the predetermined nerve is the pudendal nerve; and

an active electrode electrically coupled to the modulation device and positioned substantially adjacent to the skin of the mammal, the active electrode being configured to apply the modulated signal to the skin.

2. The device according to claim 1, wherein the active electrode is contained within a patch capable of being affixed to the mammal'"'"'s skin.

3. The device according to claim 1, wherein the first waveform has a frequency within the range of 10-40 Hz.

4. The device according to claim 3, wherein the second waveform has a frequency within the range of 10-400 kHz.

5. A method for selectively stimulating a predetermined nerve of a mammal, comprising:

providing a transdermal stimulation device having a first waveform generator configured to generate a first analog waveform having a selected amplitude and frequency capable of stimulating the predetermined nerve, wherein the first waveform is itself incapable of transdermally stimulating the predetermined nerve, a second waveform generator configured to generate a second analog carrier waveform having a selected amplitude and frequency, the frequency of the second carrier waveform being greater than that of the first waveform, wherein the frequency of the second carrier waveform is such that it is capable of passing through the mammal'"'"'s skin and tissue to reach the predetermined nerve, but is itself incapable of electrically stimulating the predetermined nerve, an amplitude modulation device electrically coupled to the first and second waveform generators and configured to multiply the second carrier waveform and the first waveform to create a modulated signal that maintains the modulation envelope and frequency information of the first waveform and second carrier waveform, an active electrode electrically coupled to the modulation device, the active electrode being adapted to apply the modulated signal to the skin;

positioning the active electrodes substantially adjacent to skin of the mammal; and

applying the modulated signal to the mammal'"'"'s skin via the active electrode to electrically stimulate the predetermined nerve;

wherein the predetermined nerve is the pudendal nerve.

6. The method according to claim 5, wherein the active electrode is contained within a patch.

7. The method according to claim 6, wherein the positioning step further comprises placing the patch substantially in an abdominal or sacral region of the mammal.

8. The method according to claim 5, wherein the first waveform has a frequency within the range of 10-40 Hz.

9. The method according to claim 8, wherein the second waveform has a frequency within the range of 10-400 kHz.