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

Abstract

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

1 . A system for trigeminal nerve stimulation for treatment of a medical disorder, the system comprising:
 a pulse generator; and   an implantable electrode assembly in electrical communication with the pulse generator, the assembly comprising:
 a first electrode comprising at least one contact configured for subcutaneous or percutaneous placement at a first region of the patient's face to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve selected from the group consisting of: ophthalmic nerve, supraorbital nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve, thereby stimulating the trigeminal nerve to modulate at least one body system for treatment of a medical disorder selected from the group consisting of: cardiac related disorders, fatigue, tinnitus, obesity, diabetes, dyslipidemia, metabolic syndrome, obstructive sleep apnea, arthritis, cachexia/anorexia, inflammation, asthma, inflammatory bowel disease, atopic dermatitis, sepsis, hepatitis, disorders of regulation of breathing, disorders of gastrointestinal function, gastroesophageal reflux, diarrhea and constipation, dysphagia and other disturbances of swallowing, gastroparesis, functional bowel syndromes, post-operative ileus, dyspepsia, motion sickness, chemotherapy-related nausea and emesis, autonomic regulation in menopausal hot flashes, regulation of hemostasis, sleep/insomnia and a neuropsychiatric disorder selected from the group consisting of attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism and autism spectrum disorders (ASD), substance use disorders and related behavioral addictions, eating disorders and obsessive compulsive disorder (OCD), psychotic disorders, dementing disorders, or a combination thereof. 
   
     
     
         2 . The system of  claim 1 , wherein the medical disorder is a cardiac related disorder selected from the group consisting of heart disease, cardiac arrhythmias, myocardial infarction, sudden cardiac death after myocardial infarction, heart failure, cerebral ischemia, sudden infant death syndrome (SIDS), impaired blood flow conditions, atrial fibrillation or sudden death in epilepsy. 
     
     
         3 . The system of  claim 2 , wherein the at least one branch of the trigeminal nerve is an ophthalmic nerve, supraorbital nerve or an infraorbital nerve, wherein the body system is a trigeminal nerve cardiac reflex and wherein stimulation of the ophthalmic nerve, supraorbital nerve, or the infraorbital nerve modulates or activates the trigeminal nerve cardiac reflex to treat or prevent a cardiac related disorder. 
     
     
         4 . The system of  claim 2 , wherein the body system is a vagus nerve circuit, and wherein stimulation of the at least one branch of the trigeminal nerve modulates the vagus nerve circuit to treat a cardiac related disorder. 
     
     
         5 . The system of  claim 1 , wherein the medical disorder is fatigue, wherein the body system is a locus coeruleus or a reticular activating system, and wherein stimulation of the at least one branch of the trigeminal nerve modulates the locus coeruleus or modulates the reticular activating system to treat fatigue. 
     
     
         6 . The system of  claim 1 , wherein the medical disorder is selected from the group consisting of obesity and other disorders related to weight and feeding, inflammation, disorders of regulation of breathing, disorders of gastrointestinal function, autonomic regulation in menopausal hot flashes, regulation of hemostasis and sleep/insomnia, wherein the body system is a vagus nerve circuit, and wherein stimulation of the at least one branch of the trigeminal nerve modulates the vagus nerve circuit to treat said medical disorder. 
     
     
         7 . The system of  claim 1 , wherein the medical disorder is a dementing disorder wherein the body system is a vagus nerve circuit or a trigeminal nerve cardiac reflex, and wherein stimulation of the at least one branch of the trigeminal nerve modulates the vagus nerve circuit or the trigeminal nerve cardiac reflex to treat said medical disorder. 
     
     
         8 . The system of  claim 1 , further comprising a second electrode comprising at least one contact for subcutaneous or percutaneous placement at a second region of the patient's face configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, selected from the group consisting of: ophthalmic nerve, supraorbital nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve. 
     
     
         9 - 26 . (canceled) 
     
     
         27 . A method for treatment of a medical disorder by trigeminal nerve stimulation, comprising:
 implanting an implantable electrode assembly in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve to stimulate the trigeminal nerve for treatment of a medical disorder, the electrode assembly comprising:
 a first electrode comprising at least one contact for subcutaneous or percutaneous placement at a first region of a patient's face in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve selected from the group consisting of ophthalmic nerve, supraorbital nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve; and 
   applying electrical signals to the electrode assembly to stimulate the at least one branch of the trigeminal nerve to modulate a system of the patient's body for treatment of a medical disorder selected from the group consisting of: cardiac related disorders, fatigue, tinnitus, obesity, diabetes, dyslipidemia, metabolic syndrome, obstructive sleep apnea, arthritis, cachexia/anorexia, inflammation, asthma, inflammatory bowel disease, atopic dermatitis, sepsis, hepatitis, disorders of regulation of breathing, disorders of gastrointestinal function, gastroesophageal reflux, diarrhea and constipation, dysphagia and other disturbances of swallowing, gastroparesis, functional bowel syndromes, post-operative ileus, dyspepsia, motion sickness, chemotherapy-related nausea and emesis, autonomic regulation in menopausal hot flashes, regulation of hemostasis, sleep/insomnia and a neuropsychiatric disorder selected from the group consisting of attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism and autism spectrum disorders (ASD), substance use disorders and related behavioral addictions, eating disorders and obsessive compulsive disorder (OCD), psychotic disorders, dementing disorders or a combination thereof.   
     
     
         28 . The method of  claim 27 , wherein the assembly further comprises a second electrode comprising at least one contact configured for subcutaneous or percutaneous placement at a second region of the patient's face, wherein the second electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, wherein the at least one branch of the trigeminal nerve is selected from the group consisting of: ophthalmic nerve, supraorbital nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve. 
     
     
         29 . The method of  claim 27 , wherein the step of applying electrical signals comprises applying electrical signals at a frequency between approximately 20 and 300 Hertz, at a current of 0.1 to 3 milliamperes (mA) and at a pulse duration of less than or equal to 500 microseconds. 
     
     
         30 . The method of  claim 27 , wherein the step of applying electrical signals comprises applying electrical signals at a frequency between approximately 20 and 300 Hertz, at a pulse duration between approximately 50 and 500 microseconds, at an output current density of not greater than approximately 10 mA/cm 2  and a charge density of not greater than approximately 10 microCoulomb/cm 2  at the cerebral cortex. 
     
     
         31 . The method of  claim 27 , wherein the step of applying electrical signals comprises applying electrical signals at an output current density of not greater than approximately 10 mA/cm 2 . 
     
     
         32 . The method of  claim 27 , wherein the step of applying electrical signals comprises applying electrical signals at an output current density of between approximately 2.5 and 5 mA/cm 2 . 
     
     
         33 . The method of  claim 27 , wherein the step of applying electrical signals comprises applying electrical signals at an output current density of not greater than approximately 7 mA/cm 2 . 
     
     
         34 - 42 . (canceled) 
     
     
         43 . A method for initiation, activation or stimulation of a vagus nerve circuit by trigeminal nerve stimulation for treatment of a medical disorder, comprising:
 implanting an implantable electrode assembly in a patient, the electrode assembly comprising:
 a first electrode comprising at least one contact configured for subcutaneous or percutaneous placement at a first region of the patient's face and configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, which is an ophthalmic nerve, supraorbital nerve, or an infraorbital nerve; and 
   applying electrical signals to the electrode assembly to stimulate the at least one branch of the trigeminal nerve to modulate the vagus nerve circuit for treatment of a medical disorder which may benefit from vagus nerve stimulation via the trigeminal nerve.   
     
     
         44 . The method of  claim 43 , wherein the medical disorder is a cardiac related disorder selected from the group consisting of heart disease, cardiac arrhythmias, myocardial infarction, sudden cardiac death after myocardial infarction, heart failure, cerebral ischemia, sudden infant death syndrome (SIDS), impaired blood flow conditions, atrial fibrillation or sudden death in epilepsy. 
     
     
         45 . The method of  claim 43 , wherein the medical disorder is selected from the group consisting of neurological disorders, neuropsychiatric disorders, obesity and other disorders related to weight and feeding, inflammation, disorders of regulation of breathing, disorders of gastrointestinal function, autonomic regulation in menopausal hot flashes, regulation of hemostasis and sleep/insomnia, and wherein stimulation of the at least one branch of the trigeminal nerve modulates the vagus nerve circuit to treat said medical disorder. 
     
     
         46 . The method of  claim 43 , wherein the medical disorder is a dementing disorder and wherein stimulation of the at least one branch of the trigeminal nerve modulates the vagus nerve circuit to treat said medical disorder. 
     
     
         47 - 88 . (canceled)