Nerve cuff electrode locking mechanism

Abstract

A lead comprising a lead body, a lead connector terminal affixed to a proximal end of the lead body, and a cuff body affixed to a distal end of the lead body, an electrode contact affixed to the cuff body, and an electrical conductor between the connector terminal and electrode contact. The lead further comprises a strap extending from a first region of the cuff body, a buckle disposed on a second region of the cuff body, and a locking feature, e.g., protuberance, ring, or wrinkle, associated with the strap. The locking feature is configured for being pulled through the buckle to dispose the cuff body around a nerve in response to a tensile force applied to the strap. The locking feature is configured for abutting an edge of the buckle in response to a release of the tensile force to secure the cuff body around the nerve.

Description

RELATED APPLICATION DATA[0001]Pursuant to 35 U.S.C. § 119(e), this application claims the benefit of U.S. Provisional Patent Application 62 / 500,080, filed May 2, 2017, and U.S. Provisional Patent Application 62 / 500,091, filed May 2, 2017, which are expressly incorporated herein by reference. This application is also related to U.S. patent application Ser. No. ______ (Attorney Docket No. AMF-006US (A697-USA)), filed on the same date, which is expressly incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention generally relates to implantable neurostimulation leads, and specifically relates to implantable nerve cuff electrodes that can be used to stimulate nerves to treat ailments, such as obstructive sleep apnea (OSA).BACKGROUND OF THE INVENTION[0003]Obstructive sleep apnea (OSA) is a common disorder in which the upper airway of a patient can become obstructed (apnea) or partially obstructed (hypopnea) during sleep. It is highly prevalent, affecting 5%-10% of...

AI Technical Summary

Benefits of technology

[0009]In accordance with present invention, an electrode lead comprises an elongated lead body, at least one lead connector terminal affixed to the proximal end of the lead body, and a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, and at least one electrical conductor extending through the lead body between the connector terminal(s) and the electrode contact(s). The cuff body is configured for being circumferentially disposed around a nerve, and has opposing first and second regions. The cuff body may be composed of, e.g., silicone. The cuff body may be configured and sized for being placed around on a human hypoglossal nerve trunk or its branch nerve. The cuff body may be configured for expanding and accommodating both a normal-sized nerve diameter and then later, after implantation of the electrode lead, an increased nerve diameter due to swelling, thereby preventing nerve constriction due to the nerve swelling. In one embodiment, the electrode contact(s) is configured for being on an inner surface of the cuff body when secured around the nerve. The electrode lead further comprises a strap extending from the first region of the cuff body, and a buckle disposed on the second region of the cuff body. The strap may have, e.g., a thickness less than 1 mm.

[0010]In accordance with a first aspect of the present invention, the electrode lead comprises at least one raised protuberance (e.g., a button or a dome) disposed on a planar surface of the strap. The strap with the raised protuberance(s) is configured for being pulled through an aperture of the buckle to dispose the cuff body around the nerve in response to a tensile force applied to the strap, and one of the raised protuberance(s) is configured for abutting an edge of the buckle in response to a release of the tensile force to secure the cuff body around the nerve.

Problems solved by technology

It is highly prevalent, affecting 5%-10% of the adult population in the United States, and has serious effects and comorbidities, such as daytime sleepiness, snoring, poor sleep quality, and an increased risk of cardiovascular disease and motor vehicle accidents.

However, due to discomfort, CPAP has a low adherence rate over time, thereby limiting its effectiveness.

Alternatively, upper airway surgery is painful and requires a prolonged recovery period, and therefore is used as a last resort to the treatment of OSA, reserved for only extreme cases.

However, certain regions of the patient, such as the neck reg

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