Less invasive and improved peripheral nerve stimulators for obstructive sleep apnea and other applications
Neural stimulator systems with an external magnetic coil to produce changing magnetic fields is applied on the neck, in conjunction with one or more tiny injectable objects that concentrates the induced electric or magnetic field to the hypoglossal nerve and protects the user by limiting and charge-balancing the output. Additional and non-invasive neural stimulator systems apply alternating current at one skin electrode and receive oppositely rectified currents at two other skin electrodes.
1 . A neuromodulation system for obstructive sleep apnea, comprising:
a. an elongate device configured for injection about a hypoglossal nerve; the elongate device comprising:
a stimulating electrode;
a return electrode;
an elongated receiver coil;
a set of rectifying diodes;
a Zener diode, a resistor; and
a capacitor; and
wherein the elongate device does not contain a battery; and
b. a wearable device comprising a field-generating coil connected to the capacitor and configured together to freely resonate during repetitive stimulations of the hypoglossal nerve;
wherein the elongate device is configured so that a voltage applied to the stimulating electrode is configured to be rectified by the rectifying diodes, to be limited by the Zener diode, and to average to zero before a start of a free resonance between the field-generating coil and the capacitor.
2 . The neuromodulation system of claim 1 , wherein the wearable device contains at least one button battery.
3 . The neuromodulation system of claim 1 , wherein the wearable device is configured to allow adjustment of an amplitude of stimulation by setting an initial electrical current flowing in the field-generating coil prior to the start of the free resonance.
4 . The neuromodulation system of claim 3 , wherein setting of the initial electrical current of the wearable device is based on the length of time that the field-generating coil is connected between a power supply and a ground.
5 . The neuromodulation system of claim 1 , wherein the set of rectifying diodes, the Zener diode, the resistor, the capacitor and any interconnections therebetween are coated with a moisture barrier with a thickness between 5 and 50 microns and comprising parylene or parylene C.
6 . The neuromodulation system of claim 1 wherein the set of rectifying diodes, the Zener diode, the resistor, the capacitor and any interconnections therebetween are housed inside of a tube comprising polyimide or PEEK, the tube filled with biocompatible epoxy, and the tube is coated on the inside or the outside with a moisture barrier comprising parylene or parylene C.
7 . The neuromodulation system of claim 1 , wherein the stimulating and return electrodes are made from a biocompatible metal.
8 . The neuromodulation system of claim 7 , wherein the electrodes comprise platinum, iridium, or an alloy of platinum and iridium.
9 . The neuromodulation system of claim 1 , wherein the elongate device further comprises a tether attached to the elongate device at a location spaced apart from the stimulating electrode and configured for removability, the tether comprising polyester, polypropylene, ultrahigh molecular weight polyethylene, a tissue-absorbable synthetic material, or a combination thereof.
10 . The neuromodulation system of claim 1 wherein the rectifying diodes are configured as a full-wave rectifier or a half wave rectifier.
11 . The neuromodulation system of claim 1 , further comprising an introducer needle, and wherein the elongate device is located inside the introducer needle, and a tip of the needle is configured to be electrically connected to a stimulation device.
12 . The neuromodulation system of claim 1 , further comprising: a sensor for sensing breathing motion, the sensor comprising:
a pouch;
a piezoelectric disk;
a support disk; and
a pivot therebetween contained in the pouch;
wherein the support disk is located on a first side of the pouch configured for contact against a body of a user and wherein the piezoelectric disk is located on a second side of the pouch opposite the support disk, and is configured to be strapped toward the body.
13 . The sensor of claim 12 , wherein the sensor is electrically connected by a connector to the wearable device.
14 . The sensor of claim 13 , wherein the connector is a wire.
15 . The sensor of claim 13 , wherein the connector is a wireless link.