Apparatus and method for treating headaches

Abstract

The present disclosure generally relates to a system for treating headaches and other pain associated with the occipital nerves. More particularly, the disclosure relates to a system of treating pain by selectively activating specific nerve fibers with a single, fault-resistant contact situated proximate to, but not in direct contact with, portions of one or more the occipital nerves. Additional measures ensure the lead does not migrate or fracture, resulting in long-lasting pain relief.

1 . A method comprising:
 positioning a flexible, coiled neurostimulation lead having a single electrode proximate to, but not in direct physical contact with a targeted region of at least one occipital nerve;   providing an electrical stimulation device;   delivering pulsed electrical signals sufficient to activate the occipital nerve to provide pain relief while avoiding activation of non-target type III and IV nerve fibers within the occipital nerve due to the single electrode being proximate to but not in physical contact with the targeted region.   
     
     
         2 . The method of  claim 1 , wherein the pulsed electrical signals comprise a 15-20 μsec pulse duration. 
     
     
         3 . The method of  claim 2 , wherein the pulsed electrical signals comprise a frequency of 100 Hz. 
     
     
         4 . The method of  claim 3 , wherein the pulsed electrical signals comprise an amplitude of less then 20 mA. 
     
     
         5 . The method of  claim 1 , wherein the electrical stimulation device is an external electrical stimulation device. 
     
     
         6 . The method of  claim 1 , wherein the electrical stimulation device is a subcutaneous electrical stimulation device. 
     
     
         7 . The method of  claim 1  further comprising providing a plurality of leads and positioning each lead so that each lead is operatively associated with a plurality of targeted regions, said plurality of targeted regions in each located in separate occipital nerve. 
     
     
         8 . A method comprising:
 positioning a flexible, coiled neurostimulation lead having a single electrode proximate to, but not in direct physical contact with a targeted region of at least one occipital nerve;   delivering preliminary therapy for a period of time via the lead, the preliminary therapy comprising pulsed electrical signals sufficient to activate the occipital nerve to provide pain relief while avoiding activation of non-target type III and IV nerve fibers within the occipital nerve due to the single electrode being proximate to but not in physical contact with the targeted region; and   removing the lead after the period of time.   
     
     
         9 . The method of  claim 8  further comprising:
 monitoring pain reported by a patient subsequent to the preliminary therapy; 
 upon a report from the patient of pain that is similar to the preliminary therapy, providing a surgically implanted system comprising a second flexible, coiled neurostimulation lead positioned proximate to, but not in direct contact with, the targeted region and a subcutaneous electrical stimulation device located proximate to one of the patient's upper chest, clavicle, skull and neck; 
 connecting the second lead to the electrical stimulation device and subcutaneously fixing the electrical stimulation device within the patient; and 
 delivering therapy via the second lead and the electrical stimulation device. 
 
     
     
         10 . The method according to  claim 9 , wherein the electrical stimulation device is attached to the patient's fascia. 
     
     
         11 . The method of  claim 8 , wherein the pulsed electrical signals comprise a 15-20 μsec pulse duration. 
     
     
         12 . The method of  claim 11 , wherein the pulsed electrical signals comprise a frequency of 100 Hz. 
     
     
         13 . The method of  claim 12 , wherein the pulsed electrical signals comprise an amplitude of less then 20 mA. 
     
     
         14 . A method comprising:
 identifying a targeted region of at least one occipital nerve;   positioning a flexible, coiled neurostimulation lead having a single electrode proximate to and spaced a distance from, but not in direct physical contact with, the targeted region; and   delivering therapy for a period of time via the lead, the therapy comprising pulsed electrical signals sufficient to activate the occipital nerve to provide pain relief without stimulating muscle contractions, wherein the pulsed signals are directionally transmitted only to the targeted region while simultaneously preventing the pulsed signals from stimulating non-targeted type III and IV nerve fibers due to the single electrode being spaced the distance from the targeted region.   
     
     
         15 . The method of  claim 14 , wherein the pulsed electrical signals comprise a 15-20 μsec pulse duration. 
     
     
         16 . The method of  claim 15 , wherein the pulsed electrical signals comprise a frequency of 100 Hz. 
     
     
         17 . The method of  claim 16 , wherein the pulsed electrical signals comprise an amplitude of less then 20 mA. 
     
     
         18 . The method of  claim 14 , wherein the targeted region comprises first and second areas; wherein the single electrode includes a length of exposed conductive wires, said length having a first exposed end and a second opposed end with a middle length situated therebetween; and further comprising positioning the first exposed end proximate to and spaced a first exposed distance from, but not in direct physical contact with, the first area and the second exposed end proximate to and spaced a second exposed distance from, but not in direct physical contact with, the second area. 
     
     
         19 . The method of  claim 18 , wherein the pulsed electrical signals are adjusted so that appropriate levels of therapeutic current are delivered at the first and second exposed ends while current delivered by the middle length does not stimulate muscle contractions and sensations of discomfort. 
     
     
         20 . The method of  claim 18 , wherein the first area is located on a first occipital nerve and the second area is located on a second occipital nerve.