Implantable neurostimulator with integral hermetic electronic enclosure, circuit substrate, monolythic feed-through, lead assembly and anchoring mechanism

Abstract

An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

1 - 20 . (canceled) 
     
     
         21 . A system for treating a medical condition in a patient, the system comprising:
 an isodiametric neurostimulator sized and dimensioned for insertion into a pterygopalatine fossa (PPF) of the patient comprising:
 a stimulator body comprising a hermetic electronics enclosure housing 
 an electrical circuit; and 
 a stimulation lead extending from the hermetic electronics enclosure and 
 comprising electrodes integral with the electrical circuit, wherein the size of the isodiametric neurostimulator is maintained or decreases from a proximal-most portion of the stimulator body to a distal-most portion of the stimulation lead; and 
 an external controller in electrical communication with the neurostimulator and programmed to deliver electrical current to the patient. 
   
     
     
         22 . The system of  claim 21 , wherein the stimulator body and a portion of the stimulation lead comprises a biocompatible outer layer. 
     
     
         23 . The system of  claim 22 , wherein the biocompatible outer layer is molded to the stimulatory body and the portion of the stimulation lead. 
     
     
         24 . The system of  claim 21 , wherein the isodiametric neurostimulator has a diameter between about 1 millimeter (mm) to about 10 mm. 
     
     
         25 . The system of  claim 21 , wherein the isodiametric neurostimulator has a length of between about 1 mm to about 25 mm. 
     
     
         26 . A method of treating a medical disorder in a patient comprising:
 receiving an isodiametric neurostimulator within a pterygopalatine fossa (PPF) of the patient, the isodiametric neurostimulator comprising:
 a stimulator body comprising a hermetic electronics enclosure housing an electrical circuit; and 
 a stimulation lead extending from the hermetic electronics enclosure and comprising electrodes integral with the electrical circuit, wherein the size of the isodiametric neurostimulator is maintained or decreases from a proximal-most portion of the stimulator body to a distal-most portion of the stimulation lead; and 
   delivering an electrical signal to a neural structure of the patient to treat the medical disorder.   
     
     
         27 . The method of  claim 26 , wherein the medical disorder is pain, a movement disorder, epilepsy, a cerebrovascular disease, an autoimmune disease, a sleep disorder, an autonomic disorder, an abnormal metabolic state, a disorder of the muscular system, or a neuropsychiatric disorder. 
     
     
         28 . The method of  claim 26 , wherein the medical disorder is a neurological or behavior disorder. 
     
     
         29 . The method of  claim 28 , wherein the neurological disorder is a primary headache, atypical facial pain, or trigeminal neuralgia. 
     
     
         30 . The method of  claim 29 , wherein the primary headache is a migraine or a cluster headache. 
     
     
         31 . The method of  claim 26 , wherein the neural structure is a peripheral neural structure. 
     
     
         32 . The method of  claim 26 , wherein the neural structure is an autonomic neural structure. 
     
     
         33 . The method of  claim 32 , wherein the autonomic structure is a sphenopalatine ganglion. 
     
     
         33 . The method of  claim 26 , wherein the neural structure is a central neural structure. 
     
     
         34 . The method of  claim 26 , wherein delivering an electrical signal comprises delivering an electrical signal from an external controller.