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 such that a first electrode contact is in contact with a first supraorbital nerve on one side of the patient's forehead and such that a second electrode contact is in contact with a second supraorbital nerve on an opposing side of the patient's forehead; and   applying electrical signals to the subcutaneous electrode assembly so that current flows between the first electrode contact and the second electrode contact at specified operational parameters to treat the neurological disorder or condition.   
     
     
         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 C/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 neurological disorder or condition is selected from the group consisting of epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache, and movement disorders. 
     
     
         26 . A method for treating a neurological disorder or condition by trigeminal nerve stimulation, comprising:
 implanting a first subcutaneous electrode assembly in a patient to place a first electrode contact laterally to a first supraorbital nerve on one side of the patient's forehead and to place a second electrode contact medially to the first supraorbital nerve; and   applying electrical signals to the first subcutaneous electrode assembly at specified operational parameters to treat the neurological disorder or condition.   
     
     
         27 . The method of  claim 26 , further comprising:
 implanting a second subcutaneous electrode assembly in the patient to place a third electrode contact laterally to a second supraorbital nerve on an opposing side of the patient's forehead and to place a fourth electrode contact medially to the second supraorbital nerve;   wherein the applying of the electrical signals comprises applying the electrical signals to the second subcutaneous electrode assembly to treat the neurological disorder or condition.   
     
     
         28 . The method of  claim 26 , 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/cm2. 
     
     
         29 . The method of  claim 26 , 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. 
     
     
         30 . The method of  claim 26 , 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. 
     
     
         31 . The method of  claim 26 , wherein the neurological disorder or condition is selected from the group consisting of epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache, and movement disorders. 
     
     
         32 . A method for treating a neurological disorder or condition by trigeminal nerve stimulation, comprising:
 implanting a first subcutaneous electrode assembly in a patient to align a first electrode contact and a second electrode contact longitudinally with a first supraorbital nerve on one side of the patient's forehead; and   applying electrical signals to the first subcutaneous electrode assembly at specified operational parameters to orthodromically stimulate the first supraorbital nerve to treat the neurological disorder or condition.   
     
     
         33 . The method of  claim 32 , further comprising:
 implanting a second subcutaneous electrode assembly in the patient to align a third electrode contact and a fourth electrode contact longitudinally with a second supraorbital nerve on an opposing side of the patient's forehead;   wherein the applying of the electrical signals comprises applying the electrical signals to the second subcutaneous electrode assembly to orthodromically stimulate the second supraorbital nerve to treat the neurological disorder or condition.   
     
     
         34 . The method of  claim 32 , 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 . 
     
     
         35 . The method of  claim 32 , 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. 
     
     
         36 . The method of  claim 32 , 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. 
     
     
         37 . The method of  claim 32 , wherein the neurological disorder or condition is selected from the group consisting of epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache, and movement disorders.