Intrafascicular Electrode Implant for Nerve Stimulation
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Solution Overview
Problem
Current peripheral nerve electrode interfaces face challenges in achieving stable and selective electrical contact with individual nerve fascicles, with existing devices either being non-selective but stable or selective but unstable, and lacking efficient implantation techniques for peripheral nerves.
Innovation Solution
A novel electrode interface featuring a rigid or semi-rigid blocking element that wraps around the nerve, with elongated electrodes inserted through holes in the blocking element, allowing for precise positioning and fixation, ensuring long-term mechanical and electrical stability and selectivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If FINE or CUFF electrodes are used to wrap around the nerve, then long-term stability is achieved, but selectivity is lost as they exchange information with multiple nerve fascicles simultaneously
Solution Approach 1:
The electrode array is segmented into multiple independent elongated electrodes (at least 3) that can be individually positioned and activated. Each electrode targets a specific nerve fascicle, allowing selective stimulation or recording from individual fascicles while maintaining the stability of the wrap-around configuration.
Solution Approach 2:
Different regions of the electrode array have different functional properties. The array includes both stimulating electrodes and recording electrodes distributed around the nerve circumference, with each electrode optimized for its specific function and positioned to contact specific fascicles locally.
2Manufacturing precision
If LIFE/TIME/Utah array electrodes are used to achieve selective contact with individual fascicles, then information transmission quality improves, but long-term mechanical stability deteriorates
Solution Approach 1:
The invention merges the selective contact capability of Utah array electrodes with the stable wrap-around configuration of CUFF electrodes. The elongated electrodes are inserted through the flexible printed circuit board that forms the CUFF structure, combining the advantages of both approaches into a single integrated device.
Solution Approach 2:
The elongated electrodes are nested within the flexible printed circuit board structure. The electrodes pass through holes in the FPCB and are secured within the wrap-around configuration, with the insulating coating providing additional structural support and electrical isolation.
3Ease of manufacture
If conventional implantation techniques are used, then electrode insertion is achieved, but the electrode moves after surgery compromising stability
Solution Approach 1:
The electrodes are pre-positioned and secured to the flexible printed circuit board before implantation. The wrap-around configuration is pre-formed to match the nerve circumference, and the electrodes are fixed in their final positions within the FPCB structure prior to surgical implantation, eliminating the need for post-implantation adjustment.
4Reliability
If the electrode array is made rigid to maintain position, then stability improves, but the ability to conform to nerve anatomy and reduce invasiveness deteriorates
Solution Approach 1:
The electrode array transitions from a rigid structure to a flexible, dynamic configuration. The flexible printed circuit board allows the electrode array to bend and conform to the nerve's shape and movements, reducing mechanical stress and invasiveness while maintaining electrode positions through the secure mounting structure and friction fit within the nerve fascicles.
Data Source
AI summary
An implantable device for intrafascicular stimulation and/or sensing of a peripheral nerve, including a blocking element adapted for wrapping a nerve, comprising an access point and an exit point, and an electrode adapted to traverse the blocking element via the access point and the exit point having a distal end, a proximal end and an elongated body in between, the electrode being electrically isolated from the surrounding environment except that for an active site. In another aspect, the invention features a system comprising the implantable device of the invention operably coupled with an external device such an electrostimulator and/or a sensing device for sensing and recording electrical nerve signals.