Extracranial implantable devices, systems and methods for the treatment of neurological disorders

Abstract

The present disclosure relates to methods, devices and systems used for the treatment of neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

1 - 20 . (canceled) 
     
     
         21 . A method for treating a neurological disorder or condition by trigeminal nerve stimulation, comprising:
 implanting a subcutaneous electrode assembly in a patient to place a first electrode contact at one side of a supraorbital nerve on the patient's forehead and to place a second electrode contact at an opposing side of the supraorbital nerve on the patient's forehead; and   applying electrical signals to the subcutaneous electrode assembly so that current that flows between the first electrode contact and the second electrode contact at specified operational parameters stimulates the supraorbital nerve to treat the neurological disorder or condition, wherein the neurological disorder or condition is epilepsy.   
     
     
         22 . The method of  claim 21 , wherein the electrical signals are applied to minimize current penetration into the patient's brain such that a charge density at a surface of the patient's brain does not exceed 20 μC/cm 2 . 
     
     
         23 . The method of  claim 21 , wherein the step of applying electrical signals comprises applying electrical signals at a frequency between approximately 20 and 300 Hz, at a current of 0.1 to 3 mA, and at a pulse duration of less than or equal to 500 μs. 
     
     
         24 . The method of  claim 21 , wherein the step of applying electrical signals comprises applying electrical signals at a frequency between approximately 20 and 300 Hz, at a pulse duration between approximately 50 and 500 μs, at an output current density of not greater than approximately 25 mA/cm 2 , and a charge density of not greater than approximately 10 μC/cm 2  at the patient's cerebral cortex. 
     
     
         25 . The method of  claim 21 , wherein the implanting comprises implanting the subcutaneous electrode assembly in the patient to place a third electrode contact at one side of a supratrochlear nerve on the patient's forehead and to place a fourth electrode contact at an opposing side of the supratrochlear nerve on the patient's forehead. 
     
     
         26 . The method of  claim 25 , wherein the method further comprises applying electrical signals to the subcutaneous electrode assembly so that current that flows between the third electrode contact and the fourth electrode contact at specified operational parameters stimulates the supratrochlear nerve to treat the neurological disorder or condition. 
     
     
         27 . The method of  claim 21 , wherein the implanting comprises implanting the subcutaneous electrode assembly in the patient to place a fifth electrode contact at one side of an infraorbital nerve and to place a sixth electrode contact at an opposing side of the infraorbital nerve. 
     
     
         28 . The method of  claim 27 , wherein the method further comprises applying electrical signals to the subcutaneous electrode assembly so that current that flows between the fifth electrode contact and the sixth electrode contact at specified operational parameters stimulates the infraorbital nerve to treat the neurological disorder or condition.