Neuromodulation Electrode Assembly Preventing Silicone Flash Contamination
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Solution Overview
Problem
Existing electrodes for neuromodulation can suffer from reduced electrochemical performance due to silicone flashes from the molding process, which block the charge injection surfaces and compromise therapy delivery.
Innovation Solution
The method involves assembling electrodes onto a first-shot of molded silicone with positioning-assist windows, securing them with implant-grade adhesive, electrically connecting them via laser or resistance welding, applying an adhesive backfill, and then a second-shot of material over the adhesive backfill and electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a two-shot molding process is used to manufacture electrodes, then the structural integrity and positioning accuracy are improved, but the risk of silicone flash formation increases
Solution Approach 1:
The first shot of silicone is molded with positioning-assist windows and features that pre-establish precise electrode placement geometry. This preliminary structuring ensures accurate electrode positioning while the controlled geometry minimizes flash formation by providing defined edges for the second shot material.
Solution Approach 2:
Positioning-assist windows and intermediate structural features act as mediators between the two shots of silicone. These intermediaries guide the second shot material flow and provide physical barriers that prevent flash formation while maintaining precise electrode positioning accuracy.
2Device complexity
If thin film technology is used to integrate electrodes directly onto the substrate, then manufacturing complexity is reduced, but the softness and proven reliability for chronic implant applications are compromised
Solution Approach 1:
The patent uses composite construction with a silicone substrate and separately integrated electrodes held in place by adhesive. This composite approach maintains the softness and biocompatibility of silicone while providing reliable mechanical attachment of electrodes, combining the benefits of both thin film integration and traditional molding without sacrificing chronic implant reliability.
3Reliability
If electrode material and charge injection capability are optimized, then electrochemical performance is improved, but the performance becomes highly variable when charge injection surfaces are blocked by contaminants
Solution Approach 1:
The patent converts the potential harm of silicone flash formation into a beneficial sealing mechanism. The second shot of silicone is specifically designed to flow into and seal around the electrodes, creating a protective barrier that prevents external contaminants from reaching the charge injection surfaces while the adhesive backfill provides additional contamination protection at the electrode-substrate interface.
4Ease of manufacture
If pressurized and heated silicone is used during molding, then the material fills and seals effectively, but silicone can leak around the edges of the electrode and form flashes
Solution Approach 1:
The first shot of silicone is molded in advance with positioning-assist windows and controlled geometry that pre-defines the electrode placement area. This preliminary structuring creates physical barriers and controlled flow paths that guide the pressurized second shot material, enabling effective filling and sealing while preventing leakage around electrode edges.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach effectively prevents silicone flashes from covering the electrode surfaces, ensuring consistent and optimized electrochemical performance for neuromodulation therapy.
Implementation Method 1
applying an adhesive backfill over the electrode(s) and interconnect; and applying a second-shot of material over the adhesive backfill and electrodes
Implementation Method 2
electrically connecting the electrode(s) via laser or resistance welding with an intermediate electrically conductive wire or coil
Implementation Method 3
electrically connecting the electrode(s) via laser or resistance welding with an intermediate electrically conductive wire or coil
Data Source
AI summary
A method for use in making an electrode assembly (20) comprises the steps of applying an electrode (24) on a first layer of material (22); laser welding a lead (23) to the electrode; applying an adhesive backfill (26) over the electrode and the lead; and applying a second layer of material (28) over the adhesive backfill and a portion of the first layer to prevent a leakage path between the electrode and the second layer.