Electrode and electrode pad for the electrical stimulation of brain tissue or other tissue of a patient
Inventors
Remmert, Gregor • Menzl, Stefan
Assignees
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Publication Number
US-10737091-B2
Publication Date
2020-08-11
Expiration Date
Abstract
An electrode for the electrical stimulation of brain tissue or other tissue of a patient is configured for location between skull and scalp of the patient. The electrode has a stimulation surface which is configured for contacting the skull of the patient. The electrode is a disc-shaped electrode having a pre-shaped flat or concave stimulation surface.
Core Innovation
The invention relates to an extracranial neurostimulation electrode or electrode pad configured for placement between a patient’s skull and scalp. The electrode has a stimulation surface configured for contacting the skull and is disc-shaped with a pre-shaped stimulation surface that is flat or concave, thereby improving conformity to a non-planar skull curvature and reducing impedance and contact faults.
The electrode further includes at least one cutting site in the form of one or more of an incision and a cut-out. The cutting site allows the electrode to be more flexibly deformable for adaptation to an outer shape of the skull, while addressing edge effects and a non-uniform current density distribution, including perimeter current density peaks near a disc perimeter as described in simulations.
To mitigate the non-uniform current density distribution and edge effects, the document describes cutting-site designs that run generally in a radial direction of the disc-shape and/or generally in a spiral form. Examples include lily pad, oxeye daisy, and terrace-like electrode shapes, and disc segments with multiple electrode arms joined via one or more joining surfaces, with a mechanical supporting structure on a backside and insulation via a flexible biocompatible elastomer coating.
The disclosed concept extends to an electrode pad using one or more preassembled electrodes and leads connected between electrodes and a stimulating device, with electrodes mounted on or integrated with a surgical mesh and a flexible pad partially embedded or covered by silicone. An arrangement using pseudo-laplacian configurations is described, including a central stimulation disc between multiple secondary discs, and the document also references a fully implantable neurostimulation system context including fixation and sealing concepts.
Claims Coverage
The independent claims cover an electrode, an electrode pad, and methods of electrical stimulation and of applying or fixing the electrode or pad to the skull. Across these independent claims, the main inventive features are the disc-shaped pre-shaped stimulation surface configured to contact the skull, together with at least one incision and/or cut-out cutting site that generally runs radially and/or in a spiral to enable more flexibly deformable adaptation to the skull’s outer shape, plus associated fixation and integration aspects in the pad and method claims.
Disc-shaped electrode with pre-shaped stimulation surface for skull contact
The electrode is configured for location between skull and scalp of the patient and comprises a stimulation surface configured for contacting the skull, wherein the electrode is a disc-shaped electrode having a pre-shaped stimulation surface.
Cutting site for flexible deformability adaptation
The electrode comprises at least one cutting site in a form of one or more of an incision and a cut-out, allowing the electrode to be more flexibly deformable for adaption to an outer shape of the skull of the patient.
Radial and/or spiral cutting site orientation
The at least one cutting site generally runs in a radial direction of the disc-shape of the electrode, and/or generally runs in a spiral form.
Disc-shaped electrode pad with skull-contact stimulation surfaces
An electrode pad comprises one or more electrodes configured for location between the skull and the scalp, wherein the one or more electrodes have a stimulation surface configured for contacting the skull, wherein the one or more electrodes are disc-shaped having a pre-shaped stimulation surface.
Electrode pad cutting site enabling skull-shape deformability
The electrode pad includes at least one cutting site in a form of one or more of an incision and a cut-out, allowing the electrode to be more flexibly deformable for adaption to an outer shape of the skull of the patient.
Electrode pad radial and/or spiral cutting site orientation
The at least one cutting site generally runs in a radial direction of the disc-shape of the electrode, and/or generally runs in a spiral form.
Using an electrode or electrode pad with skull-contact stimulation surface and cutting sites for stimulation
A method for electrical stimulation comprises using an electrode or electrode pad configured for location between skull and scalp, having a stimulation surface configured for contacting the skull, wherein the electrode has at least one cutting site in a form of one or more of an incision and a cut-out, allowing the electrode to be more flexibly deformable for adaption to an outer shape of the skull of the patient.
Method cutting site running radially and/or spirally
In the method, the at least one cutting site generally runs in a radial direction of the disc-shape of the electrode, and/or generally runs in a spiral form.
Applying electrode between skull and scalp with fixation and cutting sites
A method of applying includes locating the electrode between skull and scalp of the patient and fixing the electrode to the skull via a mechanical fixation element and/or by chemical fixation means, wherein the electrode has at least one cutting site in a form of one or more of an incision and a cut-out, allowing the electrode to be more flexibly deformable for adaption to an outer shape of the skull of the patient.
Applied cutting site running radially and/or spirally
In the method of applying, the at least one cutting site generally runs in a radial direction of the disc-shape of the electrode, and/or generally runs in a spiral form.
Across the independent claims, coverage centers on disc-shaped electrodes and electrode pads with pre-shaped stimulation surfaces configured for contacting the skull, and cutting sites in the form of an incision and/or cut-out that generally run radially and/or in a spiral to enable more flexibly deformable adaptation to the skull’s outer shape. Method claims further require using the electrode or electrode pad for electrical stimulation and, in the application method, fixing the electrode to the skull via a mechanical fixation element and/or chemical fixation means.
Stated Advantages
Improves conformity to non-planar skull curvature.
Reduces impedance and contact faults.
Allows the electrode to be more flexibly deformable for adaption to an outer shape of the skull of the patient.
Addresses edge effects and a non-uniform current density distribution, including perimeter current density peaks near the perimeter of smaller discs.
Helps avoid sharp edges.
Documented Applications
Extracranial electrical stimulation of brain tissue using an electrode or electrode pad located between skull and scalp.
Use in a fully implantable neurostimulation system context with a power unit, battery, physician control center, and handheld command device referenced in the document.
Use of an electrode pad configured with a pseudo-laplacian arrangement including a central stimulation disc between multiple secondary discs.
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