Implantable neurostimulator with integral hermetic electronic enclosure, circuit substrate, monolithic 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.

What is claimed is: 
     
         1 . An implantable medical device configured for delivery of electrical stimulation to a Sphenopalatine Ganglion, comprising:
 an electronics enclosure;   a substrate housed in the electronics enclosure;   a monolithic feed-through coupled to the electronics enclosure and the substrate; and   a stimulation lead coupled to the electronics enclosure with at least one electrode wire, wherein the stimulation lead is constructed to an angle off an axis of the electronics enclosure.   
     
     
         2 . The implantable medical device of  claim 1 , further comprising an integral fixation apparatus attached to the electronics enclosure. 
     
     
         3 . The implantable medical device of  claim 2  wherein the integral fixation apparatus further comprises an attachment plate coupled to the electronics enclosure, the attachment plate configured to accept a bone screw for attachment to bone. 
     
     
         4 . The implantable medical device of  claim 1  wherein the stimulation lead includes malleable wire configured give the stimulation lead rigidity to penetrate tissue and malleability to conform to a target anatomy. 
     
     
         5 . The implantable medical device of  claim 2  wherein the integral fixation apparatus comprises at least one preformed hole configured to accept a bone screw. 
     
     
         6 . The implantable medical device of  claim 1  wherein the electronics enclosure comprises an ASIC, an inductive coil, and a diode array. 
     
     
         7 . The implantable medical device of  claim 1  wherein the angle is approximately 0 to 60 degrees. 
     
     
         8 . The implantable medical device of  claim 1  wherein the angle is approximately 30 degrees. 
     
     
         9 . The implantable medical device of  claim 1  wherein a diameter of the stimulation lead is approximately 2-12 mm. 
     
     
         10 . The implantable medical device of  claim 1  further comprising a thin-film flex circuit configured to connect the at least one electrode wire to the monolithic feed-through. 
     
     
         11 . The implantable medical device of  claim 1  further comprising a protrusion feature disposed on the monolithic feed-through. 
     
     
         12 . The implantable medical device of  claim 1  further comprising an inductive coil configured to receive power and communication from an external controller at a depth of approximately 1-3 cm. 
     
     
         13 . The implantable medical device of  claim 1  wherein the electronics enclosure comprises an ASIC printed on the electronics enclosure. 
     
     
         14 . The implantable medical device of  claim 1  further comprising at least one annular ring coupled to the electronics enclosure and configured to receive exposed ends of the monolithic feed-through. 
     
     
         15 . The implantable medical device of  claim 1  further comprising a stiffening mechanism configured to increase a linear stiffness of the stimulation lead. 
     
     
         16 . The implantable medical device of  claim 15  wherein the stiffening mechanism comprises a malleable wire. 
     
     
         17 . The implantable medical device of  claim 15  wherein the stiffening mechanism comprises a coiled wire. 
     
     
         18 . The implantable medical device of  claim 15  wherein the stiffening mechanism comprises a tapered supporting wire. 
     
     
         19 . An implantable medical device configured for delivery of electrical stimulation to a Sphenopalatine Ganglion, comprising:
 an electronics enclosure;   a substrate housed in the electronics enclosure;   a monolithic feed-through coupled to the electronics enclosure and the substrate; and   a stimulation lead having at least one electrode coupled to the electronics enclosure with at least one electrode wire, wherein the implantable medical device is configured to lay flat against the posterior maxilla, and the stimulation lead is angled so as to maintain contact with the posterior maxilla as it extends to the pterygopalatine fossa.   
     
     
         20 . An implantable medical device configured for delivery of electrical stimulation to a Sphenopalatine Ganglion, comprising:
 an electronics enclosure;   a substrate housed in the electronics enclosure;   a monolithic feed-through coupled to the electronics enclosure and the substrate; and   a stimulation lead having at least one electrode coupled to the electronics enclosure with at least one electrode wire, wherein the stimulation lead is sized and configured to pass through a lateral opening of the pterygopalatine fossa.