Treatment of pain by vagal afferent stimulation

• US 5,330,515 A
• Filed: 06/17/1992
• Issued: 07/19/1994
• Est. Priority Date: 06/17/1992
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Rutecki, Paul, Terry, Reese S. Jr., Wernicke, Joachim F.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/900,007
• Time in Patent Office: 762 Days
• Field of Search: 128/419 C, 128/419 R, 128/421, 128/422
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Method and apparatus for treating severe chronic, persistent or recurring neuropathic or psychogenic pain, or pain which is nociceptive if the patient is suffering from terminal disease, by selectively applying a pulse waveform to a lead/electrode implanted on the patient'"'"'s cervical vagus nerve or other site preferably above the location of the pain to stimulate afferent fibers for activating a descending anti-nociceptive pathway and thereby blocking incoming pain signals. The pulse waveform has programmable pulse width, current level and frequency, and pulse sequence on and off time durations. The programmed pulse sequences are applied to the implanted electrode either on a continuous basis, or only during the period the patient is normally awake, or is initiated by the patient or automatically in response to the onset of pain. A method for use in advancing relief and control of pain includes providing the lead/electrode assembly to be implanted and the generator for the programmable pulse sequences, incorporating a connector on the generator to accommodate the lead, restricting the ranges of programmable values of the pulse sequences to values which in combination will stimulate the small afferent fibers of the vagus nerve to activate a descending anti-nociceptive pathway, and adapting the generator for physician selection of manner of control of commencement and cessation of the pulse sequences.

Claims

1. A method of treating patients suffering from chronic or persistent pain which is neuropathic or psychogenic, or which is nociceptive in the case of a patient with terminal disease, the method including the steps of:

implanting a nerve electrode assembly at a distal end of an electrical lead on the vagus nerve of the patient,

implanting a stimulus generator in the patient'"'"'s body for generating an output signal with variable electrical waveform parameters programmable externally of the body, and electrically connecting the generator to a proximal end of the lead internally of the patient to enable the generator, when activated, to selectively deliver a programmed electrical signal having predetermined electrical waveform parameters as a stimulus directly to the patient'"'"'s vagus nerve via the implanted nerve electrode assembly for modulating electrical activity of the nerve to stimulate afferent fibers thereof and alleviate the pain under treatment, and

selectively activating the generator to alleviate the pain under treatment.

2. The method of claim 1, including programming the electrical signal for selective stimulation of afferent fibers to activate a descending anti-nociceptive pathway to inhibit incoming pain signals to the brain.

3. The method of claim 2, including selectively applying the programmed electrical signal via said electrode assembly on the patient'"'"'s vagus nerve at a stimulation site above the patient'"'"'s sensed location of the pain to enhance inhibition of the pain signals.

4. The method of claim 3,

including selecting the stimulation site for implantation of the electrode assembly to be on the cervical vagus nerve.

5. The method of claim 3, including

delivering a pulse waveform having predetermined waveform parameters as the programmed electrical signal.

6. The method of claim 5, including

implementing the stimulus generator so that the programmable waveform parameters of the pulse waveform include pulse width, output current, output voltage, pulse frequency, and on time and off time durations of the waveform.

7. The method of claim 3, including

selectively applying the programmed electrical to the implanted electrode assembly on a continuous basis.

8. The method of claim 7, including

intermittently interrupting application of the programmed electrical signal to the implanted electrode assembly.

9. The method of claim 3, including

selectively applying the programmed electrical signal to the implanted electrode assembly substantially only during the period that the patient is normally awake according to the patient'"'"'s circadian cycle.

10. The method of claim 3, including

selectively applying the programmed electrical signal to the implanted electrode assembly automatically in response to detecting a physical manifestation of the pain.

11. The method of claim 3, including

providing a means for manual initiation of application of the programmed electrical signal to the implanted electrode assembly by the patient.

12. A method for use in advancing the relief and control of pain, which comprises:

providing an electrical lead having a proximal end and a distal end, with a stimulating electrode assembly at its distal end for implantation on a patient'"'"'s vagus nerve,

providing a stimulus generator for generating electrical pulse sequences with programmable values of electrical waveform parameters for selective application to the lead/electrode assembly when implanted on the vagus nerve,

incorporating an electrical connector in the stimulus generator to accommodate the proximal end of the electrical lead,

restricting the programmable ranges of values of the electrical waveform parameters of the electrical pulse sequences to values which in combination will stimulate the small afferent fibers of the vagus nerve when one or more programmed pulse sequences are applied directly to the nerve via the lead/electrode assembly, to activate a descending anti-nociceptive pathway and inhibit incoming pain signals,

restricting the stimulus generator to physician selection of the control of commencement and cessation of the programmed pulse sequences to be applied to the lead/electrode assembly, and

employing the stimulus generator together with the lead/electrode assembly for the relief and control of pain in sufferers of chronic pain.

13. The method of claim 12, including implementing the stimulus generator to make the electrical waveform parameters with programmable values include pulse width, amplitude and frequency, sequence duration and intervals.

14. A neurostimulator for treating persistent pain in human patients, comprising:

stimulus generator means structured to be implantable in the patient'"'"'s body and responsive to being energized for generating an electrical output waveform having programmable electrical parameter values,

lead/electrode means electrically connectable at a proximal end to said stimulus generator means and structured to be implantable in the patient'"'"'s body to be mounted at a distal end on the patient'"'"'s vagus nerve for delivering the electrical output waveform of the stimulus generator means to a preselected site along the vagus nerve,

programming means for tailoring the electrical output waveform of said stimulus generator means with electrical parameter values in a respective preset range of values of each parameter, the electrical parameter values of the electrical output waveform being selected to produce stimulation of the afferent fibers of the vagus nerve to activate a descending anti-nociceptive pathway of the nerve to block incoming pain signals, and

means for energizing said stimulus generator means to generate its electrical output waveform with pre-programmed electrical parameter values in each respective preset range selected to block incoming pain signals over predetermined intervals when pain is experienced.

15. The neurostimulator of claim 14, wherein

said electrical output waveform is a pulse waveform, and

said programming means allows selection of the electrical parameter values of the pulse waveform from among the respective preset range of values for each parameter, including at least the parameters of pulse width, pulse current level, pulse frequency, and on time and off time durations of the pulse waveform.

16. The neurostimulator of claim 15, wherein

said means for energizing said stimulus generator means includes at least one activating means selected from the group consisting of means for manual activation of the stimulus generator means by the patient, means for automatic activation of the stimulus generator means in response to detection of a physical manifestation of reaction by the patient to the onset of pain, means for automatic activation of the stimulus generator means to continuously generate the pulse waveform for periodic intervals of time determined by the selected values of on time and off time durations of the pulse waveform, and means for automatic activation of the stimulus generator means substantially only during a predetermined normal awake period for the patient according to the patient'"'"'s circadian cycle.