Devices and methods for low current neural modulation

What is this patent about?

'183 is related to the field of implantable medical devices, specifically those used for neuromodulation. The background involves addressing various physiological conditions like obstructive sleep apnea (OSA), migraines, and hypertension by interacting with the body's nervous system. Existing treatments for OSA, such as CPAP, have limitations, creating a need for alternative solutions that directly modulate nerve activity.

The underlying idea behind '183 is to modulate a nerve using an implantable device that delivers a low-current electrical signal. The key inventive insight is that by carefully configuring the implantable electrodes to generate an electric field with field lines extending along the length of the nerve, effective neuromodulation can be achieved even with a current less than 1.6 milliamps. This approach allows for non-contact modulation, potentially improving long-term efficacy and reducing power consumption.

The claims of '183 focus on a sleep disordered breathing treatment device comprising an implantable circuit and at least one pair of implantable electrodes electrically connected with the implantable circuit. The circuit and the electrodes are configured for implantation in a subject proximal to a genioglossus muscle in the vicinity of a hypoglossal nerve. The claims cover the configuration of the circuit to deliver to the electrodes an electrical signal having a current less than about 1.6 milliamps, and the configuration of the electrodes to emit an electric field such that a portion of the field lines extend along a length of the hypoglossal nerve such that the delivery of the electrical signal of less than about 1.6 milliamps causes modulation of the hypoglossal nerve from a location spaced apart from the hypoglossal nerve and external to a blood vessel.

In practice, the device is implanted near the genioglossus muscle, close to the hypoglossal nerve. An external unit wirelessly transmits power to the implantable circuit, which then generates a low-current electrical signal. This signal is delivered to the electrodes, which are designed to create an electric field that extends along the nerve's length. This field modulates the nerve activity, ideally causing the genioglossus muscle to contract and open the airway, thereby treating OSA.

The differentiation from prior approaches lies in the low-current modulation and the specific electrode configuration. Traditional neuromodulation often requires higher currents and direct contact with the nerve. By using a parallel electric field and carefully positioning the electrodes, '183 achieves effective modulation with less power and without direct nerve contact, potentially leading to a more reliable and less invasive treatment option. The device's ability to function without direct contact also mitigates issues related to tissue growth or device migration over time.