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, cutaneous 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, infraorbital, 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   a cutaneous electrode assembly in electrical communication with the pulse generator, the assembly comprising:   a first electrode comprising at least one contact configured for cutaneous placement at a first region of a patient's face overlying the cutaneous distribution of at least one branch of the trigeminal nerve selected from the group consisting of: ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, supraorbital 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 or an infraorbital nerve, wherein the body system is a trigeminal nerve cardiac reflex and wherein stimulation of the ophthalmic 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 , wherein the assembly further comprises a second electrode comprising at least one contact configured for cutaneous placement at a second region of the patient's face, wherein the second electrode is configured to contact a portion of the patient's face overlying the cutaneous distribution of 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, infraorbital nerve, supraorbital 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 treating a medical disorder by trigeminal nerve stimulation, comprising:
 contacting a first region of a patient's face with a cutaneous electrode assembly with at least one branch of the trigeminal nerve to stimulate the trigeminal nerve for treatment of a medical disorder, the cutaneous electrode assembly comprising:
 a first electrode comprising at least one contact for cutaneous placement at a first region of the patient's face overlying the cutaneous distribution of 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 cutaneous placement at a second region of the patient's face, wherein the second electrode is configured to contact a portion of the patient's face overlying the cutaneous distribution of 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 0.05 to 5 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 - 46 . (canceled) 
     
     
         47 . A behind the ear device for polycranial nerve stimulation for treatment of a medical disorder, the device comprising:
 an external ear body including a pulse generator and a battery; and   an ear canal body including an electrode assembly in electrical communication with the pulse generator, the assembly comprising:
 at least one electrode comprising at least one contact configured to contact the cutaneous distribution of at least one branch of the trigeminal nerve at, in or about a patient's ear, and 
 wherein stimulation of the at least one branch of the trigeminal nerve modulates a system in the patient's body to treat a medical disorder. 
   
     
     
         48 . The device of  claim 47 , wherein the at least one branch of the trigeminal nerve is selected from the group consisting of: ophthalmic nerve, infraorbital nerve, supraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve. 
     
     
         49 . The device of  claim 47  or  48 , further comprising 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, infraorbital nerve, supraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve. 
     
     
         50 . The device of  claim 49 , wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a same branch of the trigeminal nerve. 
     
     
         51 . The device of  claim 50 , wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a different branch of the trigeminal nerve. 
     
     
         52 - 110 . (canceled)