Implantable electrode device and a method for manufacturing thereof
Inventors
Assignees
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Publication Number
US-11523763-B2
Publication Date
2022-12-13
Expiration Date
Abstract
An implantable electrode device includes a carrier made of a polymer material, at least one measurement electrode formed by an electrically conducting pad located on the carrier, wherein the electrically conducting pad has a contact surface, a barrier layer enclosing the carrier by covering all surfaces of the carrier, wherein the contact surface of the electrically conducting pad is exposed to an outside environment, at least one electrically conducting trace, and at least one electrically conducting terminal. The electrically conducting trace can electrically connect the measurement electrode to the electrically conducting terminal. A surface of the implantable electrode device on a side on which the measurement electrode is located can have a maximum valley depth or a maximum peak height between the contact surface of the measurement electrode and a meanline of a surface of the implantable electrode device, excluding measurement electrodes, being equal to or smaller than 100 micrometres.
Core Innovation
The invention relates to an implantable electrode device with a flexible and electrically isolating polymer carrier and at least one measurement electrode formed by an electrically conducting pad located on the carrier. The electrically conducting pad has a contact surface that is exposed to an outside environment, and the device further includes at least one electrically conducting trace and at least one electrically conducting terminal, where the electrically conducting trace electrically connects the measurement electrode to the terminal.
A barrier layer encloses the carrier by covering all surfaces of the carrier while keeping the contact surface of the electrically conducting pad exposed to the outside environment. In embodiments, the barrier layer is electrically isolating and provides a moisture barrier that limits encapsulation growth. Material examples are given for the carrier and barrier layer, including a PDMS carrier and a parylene barrier layer.
The device is constrained by mechanical and surface-profile limitations to improve retraction/removal safety and reduce encapsulation growth. The measurement-electrode side is defined with a maximum valley depth or a maximum peak height relative to a meanline, and embodiments also limit the maximum linear extension of the contact surface. Manufacturing is outlined as forming a flexible polymer carrier on a substrate, depositing and structuring electrically conducting material to define measurement electrode pads, traces, and terminals, coating the barrier layer to enclose the structure, and providing exposure at the contact surfaces.
Claims Coverage
The document includes four independent claim sets centered on an implantable flexible polymer electrode with an exposed measurement-electrode contact surface and an enclosing barrier layer, connected by conductive traces and terminals, together with a layered construction defined by thicknesses and Young’s modulus relations (Ybelow·dbelow = Yabove·dabove). Additional claim coverage specifies surface-profile constraints in device refinements and an interface-equipment communication arrangement in system claims.
Barrier-enclosed flexible polymer carrier with exposed contact surface
An implantable electrode device comprising a flexible and electrically isolating polymer carrier, at least one measurement electrode formed by an electrically conducting pad with a contact surface, and a barrier layer enclosing the carrier by covering all surfaces of the carrier so that the contact surface of the electrically conducting pad is exposed to an outside environment.
Conducting trace and terminal electrically connecting the measurement electrode
The implantable electrode device includes at least one electrically conducting trace and at least one electrically conducting terminal, wherein the electrically conducting trace electrically connects the measurement electrode to the electrically conducting terminal.
Layered Young’s modulus and thickness relationship around conductive elements
A material below an electrically conducting material forming the measurement electrode and forming at least one element selected from the group consisting of the electrically conducting trace and the electrically conducting terminal has a thickness dbelow, and a thickness of a material above the electrically conducting material has a thickness dabove, where the material above is a layered material comprising at least two layers with different Young’s moduli, and where the thicknesses and Young’s moduli fulfill Ybelow·dbelow = Yabove·dabove.
Interface-equipment communication with implantable electrode device
A system comprising a data processor and an implantable electrode device, where the data processor comprises a first interface equipment in communication with a second interface equipment of the implantable electrode device when in use.
Manufacturing method for barrier-enclosed implantable electrode device
A method for manufacturing an implantable electrode device comprising providing a substrate, applying and curing a liquid polymer material to form a solid flexible electrically isolating carrier, depositing an electrically conducting material on the carrier, structuring the electrically conducting material to define a measurement electrode with a contact surface, at least one electrically conducting trace, and at least one electrically conducting terminal, removing the substrate, and coating a barrier layer onto the structure so that the barrier layer encloses the structure by covering all surfaces of the structure, with the same layered Young’s modulus and thickness relationship.
Across the independent claims, the coverage focuses on a flexible electrically isolating polymer carrier with an enclosing barrier layer that keeps the measurement-electrode contact surface exposed, conductive trace and terminal interconnection, and a defined layered mechanical relationship expressed as Ybelow·dbelow = Yabove·dabove. System claims add a data processor with interface equipment in communication with interface equipment of the implantable electrode device, and the method claim adds manufacturing steps that create the carrier, structure the conductive elements, and enclose the result with the barrier layer.
Stated Advantages
Reduce encapsulation growth.
Improve retraction/removal safety.
Documented Applications
Integrated in an EEG system via terminals to interface equipment outside the head.
Implantable in a human or animal body, including being inserted between two skin layers.
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