Segmented Stimulation Lead Fabrication via Recessed Substrate
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Solution Overview
Problem
The fabrication of deep brain stimulation leads with segmented electrodes is challenging due to the small size of the leads, making it difficult to precisely control the electrical field and avoid undesired tissue stimulation, which can result in side effects such as mood and behavior dysregulation in Parkinson's patients.
Innovation Solution
A method for fabricating stimulation leads with segmented electrodes involves creating recessed features on a substrate, applying conductive material, and using mechanical processing to isolate electrodes, followed by plating and insulating to ensure precise electrical control, allowing for more targeted tissue stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If segmented electrodes are implemented to precisely control the electrical field, then the precision of tissue stimulation control is improved, but the manufacturing difficulty increases due to the small size of the lead body
Solution Approach 1:
The lead body is divided into multiple segmented electrodes at different longitudinal positions, allowing independent control of electrical stimulation fields. Each segment can be selectively activated to target specific tissue regions while avoiding undesired areas, thereby improving precision of tissue stimulation control despite the small overall lead size.
Solution Approach 2:
The patent introduces angular positioning of electrodes around the circumferential direction in addition to longitudinal positioning. This adds a rotational dimension to electrode arrangement, enabling precise spatial control of stimulation fields by selecting specific angular segments, which helps achieve manufacturing precision goals through multi-dimensional electrode configuration.
2Object-affected harmful factors
If the outer diameter of the lead is reduced to minimize tissue trauma, then the invasiveness is reduced, but the difficulty of securing and isolating electrodes increases
Solution Approach 1:
The patent embeds multiple electrodes and insulating layers within each other in a nested configuration. Conductive elements are positioned within recesses of the lead body, surrounded by insulating material, creating a compact nested structure that secures electrodes firmly while maintaining a small outer diameter to minimize tissue trauma.
Solution Approach 2:
The patent employs thin insulating films and flexible lead body materials that can be conformally applied over electrode structures. These thin layers provide electrical isolation and mechanical securing without significantly increasing the outer diameter, thus maintaining minimal invasiveness while solving electrode securing challenges.
3Reliability
If segmented electrodes are used to avoid stimulation of undesired tissue, then the safety is improved, but the device complexity increases
Solution Approach 1:
The lead body incorporates multiple segmented electrodes that can be independently controlled, allowing selective stimulation of target tissue while avoiding adjacent undesired regions. This segmentation enables safer stimulation by spatially isolating electrical fields, improving reliability through precise field confinement to intended targets.
Solution Approach 2:
Different segments of the lead body are designed with locally optimized electrode configurations tailored to specific stimulation requirements. Each segment can have unique electrical and mechanical properties suited for its intended function, allowing customized local quality that enhances safety for different tissue targets while managing overall device complexity through modular design.
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
The method enables precise control of the electrical field, reducing the stimulation of undesired tissue and minimizing side effects by allowing for selective electrode activation, thereby improving the efficacy of deep brain stimulation.
Implementation Method 1
subjecting the surface of the substrate to mechanical processing to remove conductive material from portions of the substrate disposed above the plurality of recessed features
Implementation Method 2
electrically plating second conductive material over the first conductive material
Implementation Method 3
providing insulative material over the plurality of electrical traces
Data Source
AI summary
In one embodiment, a method of fabrication of a stimulation lead for electrical stimulation of tissue of a patient, the method comprises: providing a substrate of non-conductive material for a stimulation portion of the stimulation lead; processing the substrate to create a plurality of recessed features into a surface of the substrate, wherein the plurality of recessed features comprise a plurality of paths for electrical traces and a plurality of surfaces for electrodes with each of the surfaces being connected to one of the traces; providing first conductive material over the surface of the substrate; subjecting the surface of the substrate to mechanical processing to remove conductive material from portions of the substrate disposed above the plurality of recessed features, wherein each respective connected electrode and trace is electrically isolated from the other electrodes and traces after the mechanical processing; electrically plating second conductive material over the first conductive material; providing insulative material over the plurality of electrical traces; and electrically connecting conductive material of electrical traces with conductor wires of a lead body.