Implantable neurostimulator with integral hermetic electronic enclosure, circuit substrate, monolithic feed-through, lead assembly and anchoring mechanism
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. An implantable medical device configured for delivery of electrical stimulation to the Sphenopalatine Ganglion (SPG), comprising:
an electronics enclosure;
a substrate integral to the electronics enclosure;
a monolithic feed-through integral to the electronics enclosure and the substrate;
a stimulation lead having at least one electrode coupled to the electronics enclosure with at least one electrode wire; and
a platinum/iridium tubing having at least one witness hole, the platinum/iridium tubing being configured to connect the at least one electrode wire to the monolithic feed-through.
2. The implantable medical device of claim 1 further comprising a fixation apparatus integral to the electronics enclosure.
3. The implantable medical device of claim 2 wherein the fixation apparatus comprises at least one preformed hole configured to accept a bone screw.
4. The implantable medical device of claim 2 wherein the fixation apparatus is malleable and configured to be formed around the zygomaticomaxillary buttress.
5. The implantable medical device of claim 1 wherein the electronics enclosure comprises an ASIC, an inductive coil, and a diode array.
6. The implantable medical device of claim 1 wherein the implantable medical device is sized and configured for implantation into the pterygopalatine fossa.
7. The implantable medical device of claim 1 wherein the implantable medical device is sized and configured for implantation on the posterior maxilla.
8. The implantable medical device of claim 1 wherein the stimulation lead is constructed to an angle off an axis of the electronics enclosure.
9. The implantable medical device of claim 8 wherein the angle is approximately 0 to 60 degrees.
10. The implantable medical device of claim 8 wherein the angle is approximately 30 degrees.
11. The implantable medical device of claim 8 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.
12. The implantable medical device of claim 8 further comprising a stiffening mechanism configured to increase the linear stiffness of the stimulation lead.
13. The implantable medical device of claim 12 wherein the stiffening mechanism comprises a malleable wire.
14. The implantable medical device of claim 12 wherein the stiffening mechanism comprises a coiled wire.
15. The implantable medical device of claim 12 wherein the stiffening mechanism comprises a tapered supporting wire.
16. The implantable medical device of claim 1 wherein the stimulation lead is sized and configured to pass through a lateral opening of the pterygopalatine fossa.
17. The implantable medical device of claim 16 wherein a diameter of the stimulation lead is approximately 2-12 mm.
18. 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.
19. The implantable medical device of claim 1 further comprising a protrusion feature disposed on the monolithic feed-through.
20. 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.
21. The implantable medical device of claim 1 wherein the electronics enclosure comprises an ASIC printed on the electronics enclosure.
22. The implantable medical device of claim 21 further comprising at least one annular ring coupled to the electronics enclosure and configured to receive exposed ends of the monolithic feed-through.