MOLDING OF A NEUROSTIMULATOR FOR DELIVERY INTO THE PTERYGOPALATINE FOSSA
A method and apparatus for molding a medical device utilizes a rigid outer stiffener and a flexible inner mold that nests with the outer stiffener. The medical device can be a stimulating apparatus used to deliver electrical stimulation to a peripheral, central or autonomic neural structure. More specifically, the medical device can be a neurostimulator apparatus designed to delivery electrical stimulation to the sphenopalatine ganglion (SPG) to treat primary headaches, such as migraines, cluster headaches and/or many other neurological disorders, such as atypical facial pain and/or trigeminal neuralgias.
1 . An apparatus for over-molding a medical device, the apparatus comprising:
a rigid outer stiffener; and
a flexible inner mold that nests with the outer stiffener.
2 . The apparatus recited in claim 1 , wherein the outer stiffener comprises first and second stiffener portions that fit together snuggly when closed.
3 . The apparatus recited in claim 1 , wherein the outer stiffener has a rigid metal construction.
4 . The apparatus recited in claim 1 , wherein the outer stiffener has a rigid hard plastic construction.
5 . The apparatus recited in claim 1 , wherein the outer stiffener is reusable and the inner mold is single use disposable.
6 . The apparatus recited in claim 1 , wherein the inner mold comprises first and second portions that which fit together snuggly when closed.
7 . The apparatus recited in claim 1 , wherein the inner mold is constructed of a flexible elastomer material that can be peeled away from the over-molded device.
8 . The apparatus recited in claim 1 , wherein the inner mold has a flexible construction that allows for extracting the inner mold and the molded medical device from the outer stiffener after molding.
9 . The apparatus recited in claim 1 , wherein the outer stiffener supports the flexible inner mold and helps maintain the form of the inner mold when the mold is in a closed condition.
10 . A method for molding a medical device, the method comprising the steps of:
providing a rigid outer stiffener;
providing a flexible inner mold;
placing the inner mold inside the outer stiffener;
placing a medical device inside the inner mold; and
injecting a mold material into the inner mold.
11 . The method recited in claim 10 further comprising the steps of:
removing the inner mold from the outer stiffener; and
extracting the over-molded medical device from the inner mold.