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

The present invention provides an electrode lead for nerve stimulation that includes a biologically compatible cuff body with an elastic connector terminal and an electrical conductor extending through the lead body. The cuff body is designed to expand and accommodate the nerve diameter, preventing constriction due to swelling. The electrode lead also includes a strap with a raised protuberance or a ring incorporated into the strap, which secure the cuff body around the nerve in response to a tensile force applied to the strap. The strap may also have a wrinkle incorporated into it, which allows for secure tightening of the cuff body around the nerve. The technical effects of the invention include preventing nerve constriction, facilitating secure placement of the electrode lead around the nerve, and ensuring efficient and safe nerve stimulation.

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 region, are subject to various dynamic forces that may dislodge or otherwise cause an electrode to migrate from or otherwise temporarily move from its original or desired implantation site, which may have deleterious effect on the stimulation regimen, and thus, the treatment of the ailment, such as OSA.

For example, braided suture material easily attracts and retains contaminants, connective tissue can grow on the sutures making removal of the cuff difficult, and sutures tend to breakdown when exposed to a fluid environment, thereby resulting in failure of the sutures and potentially allowing the cuff to open.

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