Nerve cuff with pocket for leadless stimulator

Inventors

Faltys, Michael A. • Martin, Roy C. • Scott, Steven E. • Loeb, Gerald E.

Assignees

SetPoint Medical Corp

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Publication Number

US-12251558-B2

Patent

Publication Date

2025-03-18

Expiration Date


Abstract

An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.

Core Innovation

The described nerve cuff features an insulating, flexible cuff body with a longitudinal nerve channel and a pocket holding a leadless microstimulator. The cuff body encloses the nerve along its length, positioning the electrodes or internal electrical contacts of the microstimulator in electrical contact with the nerve for stimulation. The cuff body limits and prevents current leakage out of the cuff body to surrounding tissue during operation.

In an additional configuration, an oversized cuff body includes a pocket fully enclosing the leadless microstimulator while loosely surrounding the nerve along the length of the cuff body. The enclosed microstimulator maintains electrical contact with the nerve, and the cuff body prevents current leakage to surrounding tissue during operation. Described configurations include slit openings and closures, suture attachment, strain relief, conforming shielding, and uniform or variable wall thickness.

Claims Coverage

The claim coverage comprises two inventive features based on independent claims 1 and 9, which enclose a leadless microstimulator in relation to a nerve.

Pocketed cuff body for a leadless microstimulator

Claim 1 covers a cuff body with a pocket configured to hold a leadless microstimulator and a channel that encloses the nerve along the cuff body. The claim elements include electrical contact between one or more electrodes on the microstimulator and the nerve, and a cuff body that prevents current leakage out of the cuff body during operation.

Oversized cuff body loosely surrounding the nerve

Claim 9 covers an oversized cuff body with a pocket configured to fully enclose the leadless microstimulator while loosely surrounding the nerve along the cuff body's length. The claim elements specify maintaining electrical contact between the microstimulator and the nerve and preventing leakage of current out of the cuff body during operation.

The independent claims cover pocketed nerve-cuff configurations for a leadless microstimulator, including an oversized cuff that loosely surrounds the nerve, each maintaining electrical contact with the nerve and preventing current leakage during operation.

Stated Advantages

The cuff body prevents current leakage out of the cuff body to surrounding tissue during operation of the microstimulator.

The cuff stabilizes the microstimulator and positions its electrodes or internal electrical contacts for nerve stimulation.

Documented Applications

Use of a nerve cuff to place a leadless microstimulator in communication with a nerve, including specifically surrounding the vagus nerve.

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