System and method for nerve stimulation

• US 8,583,256 B2
• Filed: 04/26/2011
• Issued: 11/12/2013
• Est. Priority Date: 02/11/2004
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Tracey, Michael R., DiUbaldi, Anthony
• Primary Examiner(s): BEHRINGER, LUTHER G
• Application Number:
  US13/094,644
• Publication Number:
  US 20110264163A1
• Time in Patent Office: 931 Days
• Field of Search: 607/71
• 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 nerve stimulation device for a mammal comprising:

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;

an amplitude modulation device electrically coupled to the first and second waveform generators and adapted to multiply the first and carrier waveforms to create a modulated waveform that maintains a modulation envelope and frequency information of the first waveform and the carrier waveform and the carrier waveform;

the modulated waveform is capable of transdermally electrically stimulating the predetermined nerve; 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.

2. The nerve stimulation device according to claim 1, wherein the first and second waveform generators and the electrode are positioned within a patch device having an adhesive thereon for securing the patch to the skin.

3. The nerve stimulation device according to claim 1, further comprising an electrically conductive gel extending from a position substantially in electrical contact with the electrode, through a tract in the mammal'"'"'s tissue to a position closer to the predetermined nerve.

4. The nerve stimulation device according to claim 3, wherein the electrically conductive gel extends to a position within the mammal'"'"'s body that is substantially adjacent to the predetermined nerve.

5. The nerve stimulation device according to claim 1, wherein the predetermined nerve is the pudendal nerve, and the patch is positioned substantially at the abdominal or sacral regions of the mammal'"'"'s body.

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

7. The nerve stimulation device according to claim 6, wherein the first waveform is a square wave.

8. The nerve stimulation device according to claim 7, wherein the carrier waveform has a frequency substantially within the range of 10-400 kHz.

9. The nerve stimulation device according to claim 8, wherein the carrier waveform is a sinusoidal waveform.

10. The nerve stimulation device according to claim 1, further comprising a microprocessor adapted to control generation of the first and second carrier waveforms by the first and second waveform generators.

11. The nerve stimulation device according to claim 10, further comprising a receiving device adapted to wirelessly receive biofeedback data, the receiving device being electrically coupled to the microprocessor for providing the biofeedback data thereto.

12. The nerve stimulation device according to claim 11, further comprising at least one biofeedback device implanted within the mammal'"'"'s body, the at least one biofeedback device including at least one sensor device adapted to sense one or more physiological conditions within the mammal'"'"'s body.

13. The nerve stimulation device according to claim 12, wherein the biofeedback device further includes at least one transmission device electrically coupled to the sensor device, the biofeedback device being adapted to receive signals from the sensor device and wirelessly transmit to a point external of the mammal'"'"'s body biofeedback data representing the signals.

14. The nerve stimulation device according to claim 13, wherein the biofeedback data is transmitted to the microprocessor via the receiver device, and wherein the microprocessor controls the first and second waveforms generators based at least in part on the biofeedback data.

15. The nerve stimulation device according to claim 13, wherein the biofeedback data represents bladder pressure.

16. The nerve stimulation device according to claim 13, wherein the biofeedback data represents abdominal pressure.

17. A method for stimulating a predetermined nerve of a mammal comprising:

generating a first waveform laving a frequency capable of stimulating the predetermined nerve;

venerating a carrier waveform having a frequency capable of passing through tissue of the mammal;

amplitude modulating said first waveform with said carrier waveform to produce a modulated signal that maintains a modulation envelope and frequency information of the first waveform and the carrier waveform; and

the carrier waveform;

the modulated waveform is capable of transdermally electrically stimulating the predetermined nerve; and

applying the modulated signal to the mammal'"'"'s skin.

18. The method according to claim 17, wherein the modulated signal is applied to the mammal'"'"'s skin in the abdominal or sacral regions of the mammal'"'"'s body.

19. The method according to claim 17, wherein the first waveform has a frequency substantially within the range of 10-40 Hz, and the carrier waveform has a frequency substantially within the range of 10-400 kHz.

20. The method according to claim 19, wherein the first waveform is a square wave.

21. The method according to claim 20, wherein the carrier waveform is a sinusoidal waveform.

22. The method according to claim 17, further comprising:

implanting at least one sensor within the mammal'"'"'s body;

using the implanted sensor sensing one or more physiological properties within the body;

wirelessly transmitting biofeedback data representing the sensed physiological properties; and

using the biofeedback data to control generation of the first and carrier waveforms by the first and second waveform generators.

23. The method according to claim 22, wherein the biofeedback data is transmitted to a microprocessor that is electrically coupled to and controls the first and second waveform generators.

24. The method according to claim 17, further comprising the step of, prior to the applying step, injecting an electrically conductive gel into a tract within the mammal'"'"'s body, the tract extending, from a first end substantially at a surface of the skin of the mammal to second end positioned closer to the predetermined nerve, wherein the applying step further comprises applying the modulated waveform at a location substantially in electrical contact with the electrically conductive gel within the first end of the tract.

25. The method according to claim 24, wherein the second end of the tract is positioned substantially adjacent to the predetermined nerve, and wherein the electrically conductive gel substantially fills the tract.

26. The method according to claim 25, wherein the predetermined nerve is the pudendal nerve.

27. A nerve stimulation device comprising:

a first waveform generator adapted to generate a first waveform having a frequency substantially within the range of 10-40 Hz;

a second waveform generator adapted to generate a carrier waveform having a frequency substantially within the range of 10-400 KHz;

an amplitude modulation device electrically coupled to the first and second waveform generators for multiplying the first and carrier waveforms to thereby create a modulated waveform that maintains a modulation envelope and frequency information of the first waveform and the carrier waveform and the carrier waveform;

the modulate waveform is capable of transdermally electrically stimulating a predetermined nerve; and

an electrode electrically coupled to the modulation device and positioned substantially adjacent to the skin of a mammal for applying the modulated waveform to the skin of the mammal.

28. The nerve stimulation device according to claim 27, wherein the first and second waveform generators and modulation device are positioned within a patch having an adhesive surface for securing the patch to the skin.

29. The nerve stimulation device according to claim 27, wherein the first waveform is a square wave.

30. The nerve stimulation device according to claim 29, wherein the carrier waveform is a sinusoidal waveform.

31. The nerve stimulation device according to claim 27, further comprising:

a microprocessor electrically coupled to the first and second waveform generators; and

a receiver device electrically coupled to the microprocessor and adapted to receive transmitted biofeedback data and provide the biofeedback data to the microprocessor.

32. The nerve stimulation device according to claim 31, further comprising:

at least one biofeedback device implanted within the mammal, the biofeedback device including at least one sensor adapted to sense one or more physiological properties within the body of the mammal, and at least one transmitter electrically coupled to the sensor and adapted to receive signals representing the sensed physiological properties and transmit biofeedback data representing the sensed physiological properties to a second location.

33. A transdermal stimulation device for selectively stimulating a predetermined body part 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 body part, wherein the generated first waveform is itself incapable of transdermally stimulating the predetermined body part;

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 body part, and wherein the frequency of said generated carrier waveform is itself incapable of electrically stimulating the predetermined body part;

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 a modulation envelope and frequency information of the first waveform and second carrier waveform, and that is capable of transdermally electrically stimulating the predetermined body part; 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.

34. The device according to claim 33, wherein the active electrode is contained within a patch capable of being affixed to the mammal'"'"'s skin.

35. The device according to claim 33, wherein the predetermined body part is a nerve or a portion of a nerve.

36. The device according to claim 33, wherein the first waveform has a frequency within the range of 10-40 Hz.

37. The device according to claim 36, wherein the second waveform has a frequency within the range of 10-400 kHz.

38. A method for selectively stimulating a predetermined body part 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 body part, wherein the first waveform is itself incapable of transdermally stimulating the predetermined body part, 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 body part, but is itself incapable of electrically stimulating the predetermined body part, 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 a 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 body part.

39. The method according to claim 38, wherein the active electrode is contained within a patch.

40. The method according to claim 39, wherein the positioning step further comprises placing the patch substantially in an abdominal or sacral region of the mammal

41. The method according to claim 38, wherein the predetermined body part is a nerve, or a portion of a nerve.

42. The method according to claim 38, wherein the first waveform has a frequency within the range of 10-40 Hz.

43. The method according to claim 42, wherein the second waveform has a frequency within the range of 10-400 kHz.