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, auriculotermporal, 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.

What is claimed is: 
     
         1 . A method for treating a neurological disorder or condition by bilateral trigeminal nerve stimulation, comprising:
 implanting a subcutaneous electrode assembly in a patient to place a first electrode contact at a first location in proximity to a right supraorbital nerve on the patient's forehead and to place a second electrode contact at a different, second location in proximity to a left supraorbital nerve on the patient's forehead; and   applying electrical signals to the first electrode contact and the second electrode contact at specified operational parameters thereby stimulates the supraorbital nerve to treat seizures associated with the neurological disorder or condition, wherein the neurological disorder or condition is epilepsy.   
     
     
         2 . The method of  claim 1 , 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 . 
     
     
         3 . The method of  claim 1 , 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. 
     
     
         4 . The method of  claim 1 , 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. 
     
     
         5 . The method of  claim 1 , wherein the implanting comprises implanting the subcutaneous electrode assembly in the patient to place a third electrode contact at a third location in proximity to a right supratrochlear nerve on the patient's forehead and to place a fourth electrode contact at a different, fourth location in proximity to a left supratrochlear nerve on the patient's forehead. 
     
     
         6 . The method of  claim 5 , wherein the method further comprises applying electrical signals to the third electrode contact and the fourth electrode contact at specified operational parameters stimulates the supratrochlear nerve to treat the neurological disorder or condition. 
     
     
         7 . The method of  claim 1 , wherein the implanting comprises implanting the subcutaneous electrode assembly in the patient to place a third electrode contact at a third location in proximity to a right infraorbital nerve and to place a fourth electrode contact at a different, fourth location in proximity to a left infraorbital nerve. 
     
     
         8 . The method of  claim 7 , wherein the method further comprises applying electrical signals to the third electrode contact and the fourth electrode contact at specified operational parameters stimulates the infraorbital nerve to treat the neurological disorder or condition.