Implantable pulse generators and methods for selective nerve stimulation

• US 8,352,026 B2
• Filed: 10/03/2007
• Issued: 01/08/2013
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: DiUbaldi, Anthony
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/866,588
• Publication Number:
  US 20090093858A1
• Time in Patent Office: 1,924 Days
• Field of Search: 607/2, 607/66
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• 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 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36196 Frequency modulation

Abstract

An Implantable Pulse Generator (IPG) includes a surgically implantable housing, a battery, a first waveform generator, a second waveform generator, a modulator, and electrodes. The IPG produces a pulse envelope, a carrier waveform, and a modulated waveform. The pulse envelope is a low frequency waveform with specific pulse width, amplitude and shape to selectively stimulate a target nerve or body part. The carrier waveform is a high frequency waveform with properties such as amplitude, frequency and the like chosen so as to overcome tissue impedance and the stimulation threshold of the target nerve. The modulated waveform is the waveform obtained by modulating the carrier waveform by the pulse envelope.

Claims

1. An implantable pulse generator for stimulating nerves comprising:

a first waveform generator adapted to generate a first waveform having a first frequency;

a second waveform generator adapted to generate a carrier waveform having a second frequency that is higher than said first frequency;

a modulator electrically coupled to said first and second waveform generators and adapted to modulate said first waveform and said carrier waveform to generate a modulated waveform;

a surgically implantable housing containing said first and second waveform generators and said modulator;

a lead electrically coupled with said modulator and extending from said surgically implantable housing; and

an electrode connected to a distal end of said lead and electrically coupled to said modulator for applying said modulated waveform transmitted through said lead.

2. The implantable pulse generator as claimed in claim 1, wherein said lead is a flexible lead, and wherein said first waveform has a frequency adapted to stimulate a target nerve.

3. The implantable pulse generator as claimed in claim 1, wherein said first waveform has a frequency substantially within the range of 10-40 Hz.

4. The implantable pulse generator as claimed in claim 1, wherein said carrier waveform has a frequency substantially within the range of 10-400 KHz.

5. The implantable pulse generator as claimed in claim 1, further comprising a microprocessor adapted to receive biofeedback data and control operation of said first and second waveform generators in response to said biofeedback data.

6. The implantable pulse generator as claimed in claim 5, further comprising a receiving device adapted to receive said biofeedback data, said receiving device being in communication with said microprocessor for providing said biofeedback data thereto.

7. The implantable pulse generator as claimed in claim 6, further comprising at least one sensor in communication with said receiving device, said at least one sensor being adapted to sense one or more physiological conditions of a mammal.

8. The implantable pulse generator as claimed in claim 7, further comprising a transmitter coupled with said at least one sensor for transmitting said one or more sensed physiological conditions.

9. The implantable pulse generator as claimed in claim 1, further comprising:

a third waveform generator adapted to generate a third waveform having a third frequency that is different from and out of phase with said first waveform;

said modulator being electrically coupled with said third waveform generator and being adapted to modulate said carrier, first and third waveforms to generate said modulated waveform.

10. The implantable pulse generator as claimed in claim 9, wherein said first waveform is adapted to stimulate a first target nerve and said third waveform is adapted to stimulate a second target nerve.

11. The implantable pulse generator as claimed in claim 9, wherein said first waveform is adapted to stimulate a first body part and said third waveform is adapted to stimulate a second body part.

12. The implantable pulse generator as claimed in claim 11 further comprising a power source disposed within said surgically implantable housing for providing power to said waveform generators and said modulator.

13. The implantable pulse generator as claimed in claim 9, wherein said first waveform has a frequency of approximately 20 Hz, said third waveform has a frequency of approximately 10 Hz, and said carrier waveform has a frequency of approximately 10-400 KHz.

14. The implantable pulse generator as claimed in claim 9, further comprising a fourth waveform generator adapted to generate a fourth carrier waveform having a frequency different than said second carrier waveform, and wherein said modulator further modulates said fourth carrier waveform to generate a modulated signal package.

15. The implantable pulse generator as claimed in claim 14, wherein said modulator further comprises:

a first modulator for modulating said first waveform and said second carrier waveform to generate a first modulated signal;

a second modulator for modulating said third waveform and said fourth carrier waveform to generate a second modulated signal; and

a third modulator for modulating said first and second modulated signals to generate a modulated signal package.

16. An implantable system for stimulating nerves comprising:

a first waveform generator adapted to generate a first waveform having a frequency capable of stimulating a body part;

a second waveform generator adapted to generate a carrier waveform having a second frequency capable of passing through tissue of a mammal;

a modulator electrically coupled to said first and second waveform generators and adapted to modulate said first waveform and said carrier waveform to generate a modulated waveform;

a power source for operating said system;

a surgically implantable housing containing said first and second waveform generators, said modulator, and said power source;

a lead electrically coupled with said modulator and extending from said surgically implantable housing; and

an electrode connected to a distal end of said lead and electrically coupled to said modulator for applying said modulated waveform transmitted through said lead.

17. The implantable system as claimed in claim 16, wherein said lead is a flexible lead, and wherein said first waveform has a frequency substantially within the range of 10-40 Hz, and said carrier waveform has a frequency substantially within the range of 10-400 KHz.

18. The implantable system as claimed in claim 16, further comprising:

a microprocessor adapted to receive biofeedback data and control operation of said first and second waveform generators in response to said biofeedback data; and

at least one sensor in communication with said microprocessor and being adapted to sense one or more physiological conditions of a mammal.

19. The implantable system as claimed in claim 16, further comprising:

a third waveform generator adapted to generate a third waveform having a third frequency that is different from and out of phase with said first waveform;

said modulator being electrically coupled with said third waveform generator and being adapted to modulate said carrier, first and third waveforms to generate said modulated waveform.

20. The implantable system as claimed in claim 19, wherein said first waveform is adapted to stimulate said first body part and said third waveform is adapted to stimulate a second body part.

21. A method for stimulating body parts comprising:

providing an implantable pulse generator including

a first waveform generator adapted to generate a first waveform having a first frequency capable of stimulating a body part,

a second waveform generator adapted to generate a carrier waveform having a frequency capable of passing through tissue of a mammal,

a modulator electrically coupled to said first and second waveform generators and adapted to modulate said first waveform and said carrier waveform to generate a modulated waveform,

a power source for providing power to said first and second waveform generators and said modulator,

a housing containing said first and second waveform generators, said modulator and said power source,

a flexible lead electrically coupled with said modulator and extending from said housing, and

an electrode connected to a distal end of said flexible lead and electrically coupled to said modulator for applying said modulated waveform;

surgically implanting said housing in a mammal;

generating said first waveform and said carrier waveform;

modulating said first waveform with said carrier waveform to produce a modulated signal;

transmitting said modulated signal through said flexible lead to said electrode;

applying said modulated signal through said electrode to said body part.

22. The method as claimed in claim 21, wherein said first waveform has a frequency substantially within the range of 10-40 KHz, and said carrier waveform has a frequency substantially within the range of 1-0-400 KHz.

23. The method as claimed in claim 21, further comprising:

implanting a sensor in said mammal;

obtaining biofeedback data using said sensor; and

using said biofeedback data for controlling generation of said first and second waveforms by said first and second waveform generators.

24. The method as claimed in claim 21, wherein said implantable pulse generator includes a third waveform generator adapted to generate a third waveform having a frequency capable of stimulating a second target nerve, the method further comprising:

generating said third waveform out of phase with said first waveform;

modulating said first waveform, said carrier waveform, and said third waveform to create a modulated signal package; and

applying said modulated signal package to one or more body parts of said mammal.

25. The method as claimed in claim 24, further comprising generating a fourth carrier waveform having a frequency different than said second carrier waveform, wherein the modulating step comprises modulating said first waveform and said second carrier waveform to create a first modulated signal, and modulating said third waveform and said fourth carrier waveform to create a second modulated signal.

26. The method as claimed in claim 21, further comprising applying a conductive tract subcutaneously between said electrode and said body part.