Peripheral nerve electrode array
Inventors
Shepherd, Robert K. • Fallon, James • Payne, Sophie • Burns, Owen • Furness, John Barton
Assignees
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Publication Number
US-11413452-B2
Publication Date
2022-08-16
Expiration Date
Abstract
The present disclosure relates to a peripheral nerve electrode array that includes a first, second and third pair of electrodes spaced from each other along a longitudinal axis of the electrode array, the second pair of electrodes being located between the first and third pairs of electrodes. The present disclosure further relates to method for treating or preventing a chronic inflammatory condition in a human subject in need thereof, comprising providing to the human subject a therapeutically effective electrical stimulation of the anterior central abdominal vagus nerve or the posterior central abdominal vagus nerve, wherein the electrical stimulation is provided through two or more previously implanted electrodes at a site below the cardiac branches and above the hepatic-celiac branches of the nerve; and whereby the chronic inflammatory condition is prevented or treated in the human subject. In addition, the present disclosure relates to a method for treating or preventing a chronic inflammatory condition in a human subject in need thereof.
Core Innovation
The invention relates to a peripheral nerve electrode array for a peripheral nerve. The array includes a lead whose distal end branches into at least first, second and third branch portions, and each branch portion carries a respective electrode mounting device with a pair of electrodes adapted to clamp around the peripheral nerve to electrically interface the electrodes with the peripheral nerve.
The electrode pairs are arranged along a longitudinal axis of the peripheral nerve with defined electrode spacing. A first electrode mounting device clamps around the peripheral nerve and the first electrodes are spaced from each other along the longitudinal axis; similarly, a second electrode mounting device clamps around the peripheral nerve and the second electrodes are spaced from each other along the longitudinal axis, and a third electrode mounting device clamps around the peripheral nerve and the third electrodes are spaced from each other along the longitudinal axis, with the second electrode pair located between the first and third electrode pairs.
The branch portions are resiliently flexible and configured so that the orientation and spacing between the first, second, and third electrode mounting devices is predetermined and maintained relative to each other prior to being mounted to the peripheral nerve and when mounted to the peripheral nerve. The disclosed therapeutic context uses implanted electrodes to electrically stimulate anterior or posterior central abdominal vagus (CAV) nerves to prevent or treat chronic inflammatory conditions while minimizing off-target effects, with monitoring that is resistant to stimulation artefacts.
Claims Coverage
The independent claim coverage concentrates on a branched, clamp-mounted electrode array with predetermined inter-electrode spacing and orientation maintained by resiliently flexible branch portions, and on the relative placement of first, second, and third electrode pairs along a longitudinal axis.
Branched lead with first, second, third electrode mounting devices
A lead whose distal end branches into at least first, second and third branch portions, with a first, second and third electrode mounting device connected to respective branch portions.
First, second, and third electrode pairs clamped to the peripheral nerve
A first electrode mounting device connected to the first branch portion and comprising a first pair of electrodes adapted to clamp around the peripheral nerve to electrically interface with the peripheral nerve, a second electrode mounting device comprising a second pair of electrodes adapted to clamp around the peripheral nerve to electrically interface with the peripheral nerve, and a third electrode mounting device comprising a third pair of electrodes adapted to clamp around the peripheral nerve to electrically interface with the peripheral nerve.
Predetermined spacing along a longitudinal axis with the second pair between the first and third
First electrodes spaced from each other along a longitudinal axis of the peripheral nerve, second electrodes spaced from each other along the longitudinal axis of the peripheral nerve, third electrodes spaced from each other along the longitudinal axis of the peripheral nerve, and the second pair of electrodes located between the first and third pairs of electrodes.
Resiliently flexible branches maintain predetermined orientation and spacing
The first, second, and third branch portions are resiliently flexible and configured such that the orientation and spacing between each of the first, second, and third electrode mounting devices is predetermined and maintained relative to each other prior to being mounted to the peripheral nerve and when mounted to the peripheral nerve.
The core claim coverage is a branched lead supporting multiple clamp-mounted electrode pairs positioned along the nerve’s longitudinal axis, with resiliently flexible branch portions maintaining predetermined orientation and spacing among the electrode mounting devices. The provided excerpt also refers to selective stimulation and monitoring roles and conditional monitoring behavior related to stimulation artefacts.
Stated Advantages
Minimize off-target effects for abdominal stimulation compared to other stimulation sites.
Manage stimulation artefacts for monitoring of fast and slow fibre responses.
Enable recording/monitoring resistant to stimulation artefacts, including relevant fibre responses such as ECAPs for C-fibre and A-delta fibre responses in the described context.
Reduce inflammatory/histological damage and reduce leukocyte infiltration and systemic CRP in the described therapeutic context.
Reduce off-target autonomic effects, including heart rate, breathing, and blood pressure, for abdominal versus cervical stimulation.
Documented Applications
Electrically stimulate anterior or posterior central abdominal vagus (CAV) nerves at a site below cardiac branches and above hepatic-celiac branches to prevent or treat chronic inflammatory conditions, particularly inflammatory bowel disease, including Crohn’s disease, ulcerative colitis, and TNBS ileitis.
Use implanted peripheral nerve electrode arrays to selectively stimulate and monitor peripheral nerve responses while managing stimulation artefacts in a therapeutic implant context.
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