Fully implantable miniature neurostimulator for stimulation as a therapy for headache and/or facial pain

• US 6,735,475 B1
• Filed: 01/24/2002
• Issued: 05/11/2004
• Est. Priority Date: 01/30/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K., Woods, Carla Mann, Meadows, Paul M., McGivern, James P., Kuzma, Janusz A.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/057,088
• Time in Patent Office: 838 Days
• Field of Search: 607/1-114
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A small implantable stimulator(s) with at least two electrodes is small enough to have the electrodes located adjacent to a nerve structure at least partially responsible for headache and/or facial pain. The small stimulator provides a means of stimulating a nerve structure(s) when desired, and may be implanted via a minimal surgical procedure.

Claims

1. A method for treating a patient with headache and/or facial pain, comprising:

providing at least one leadless stimulator having at least two electrodes;

implanting the at least one stimulator adjacent to at least one nerve structure at least in part responsible for sensations in a region experiencing headache and/or facial pain;

providing operating power to the at least one stimulator;

using at least one external appliance to transmit stimulation parameters to the at least one stimulator;

receiving and storing the stimulation parameters;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerves adjacent to the at least one stimulator;

wherein the stimulator has a size and shape suitable for placement of the electrodes adjacent to the at least one nerve structure.

2. The method of claim 1 wherein the stimulation pulses are delivered at less than about 1-10 mA.

3. The method of claim 1 wherein the at least one nerve structure comprises at least one of a trigeminal nerve, a branch of the trigeminal nerve, a trigeminal ganglion, an ophthalmic nerve, a branch of the ophthalmic nerve, a maxillary nerve, a branch of the maxillary nerve, a mandibular nerve, a branch of the mandibular nerve, a greater occipital nerve, a branch of the greater occipital nerve, a lesser occipital nerve, a branch of the lesser occipital nerve, a third occipital nerve, a branch of the third occipital nerve, a great auricular nerve, a branch of the great auricular nerve, a transverse cervical nerve, a branch of the transverse cervical nerve, a supraclavicular nerve, and a branch of the supraclavicular nerve.

4. The method of claim 3 wherein the stimulation pulses are delivered at less than about 1-10 mA.

5. The method of claim 3 wherein the stimulation pulses are delivered at less than about 100 to 150 Hz.

6. The method of claim 3 wherein the stimulation pulses are delivered at greater than about 100 to 150 Hz.

7. The method of claim 1 further comprising providing at least one sensor;

using the at least one sensor to sense a physical condition; and

determining the stimulation parameters based upon the sensed condition.

8. The method of claim 7 wherein the at least one sensor is a part of the stimulator.

9. The method of claim 7 wherein the stimulation pulses are delivered at less than about 1-10 mA.

10. The method of claim 1 further comprising providing and implanting more than one stimulator.

11. A method for treating a patient with headache and/or facial pain comprising:

providing at least one leadless stimulator having at least two electrodes;

providing at least one sensor;

implanting the at least one stimulator adjacent to at least one nerve structure at least in part responsible for sensation in a region experiencing headache and/or facial pain;

providing operating power to the at least one stimulator;

using the sensor to sense a physical condition;

determining stimulation parameters based upon the sensed condition;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerve structures adjacent to the at least two electrodes;

wherein the stimulator has a size and shape suitable for placement of the electrodes adjacent to the at least one nerve structure.

12. The method of claim 11 wherein the at least one sensor is a part of the stimulator.

13. The method of claim 11 wherein the stimulation parameters are determined using at least one external appliance.

14. The method of claim 11 wherein providing power to the at least one stimulator comprises receiving power from at least one external appliance.

15. The method of claim 14 wherein providing power to the at least one stimulator further comprises storing the power received from the at least one external appliance.

16. The method of claim 11 further comprising providing and implanting more than one stimulator.

17. The method of claim 11 wherein the at least one nerve structure comprises at least one of a trigeminal nerve, a branch of the trigeminal nerve, a trigeminal ganglion, an ophthalmic nerve, a branch of the ophthalmic nerve, a maxillary nerve, a branch of the maxillary nerve, a mandibular nerve, a branch of the mandibular nerve, a greater occipital nerve, a branch of the greater occipital nerve, a lesser occipital nerve, a branch of the lesser occipital nerve, a third occipital nerve, a branch of the third occipital nerve, a great auricular nerve, a branch of the great auricular nerve, a transverse cervical nerve, a branch of the transverse cervical nerve, a supraclavicular nerve, and a branch of the supraclavicular nerve.

18. The method of claim 11 wherein the sensor senses at least one of electrical activity of a nerve, electrical activity of the brain, muscle activity, and patient mobility.

19. The method of claim 11 wherein the sensor senses at least one of sympathetic discharge, medication level, neurotransmitter level, hormone level, cytokine level, neuropeptide level, endorphin level, enzyme level, and level of a bloodborne substance.