Segmented Stimulation Lead Fabrication via Substrate Recesses
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Solution Overview
Problem
Deep brain stimulation leads with conventional electrodes face challenges in precise targeting due to their size, making it difficult to fabricate and secure segmented electrodes that can control the electrical field effectively, leading to undesired side effects from stimulation of surrounding tissue.
Innovation Solution
A method of fabricating stimulation leads with segmented electrodes involves creating an elongated cylindrical substrate with recesses for electrodes and traces, coating with conductive material, patterning for electrically isolated features, and coupling these to a lead body using insulative material and conductive wires, allowing for precise control of the electrical field.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If segmented electrodes are implemented to control electrical field precisely, then stimulation precision is improved, but manufacturing difficulty increases due to small lead size
Solution Approach 1:
The electrode is divided into multiple segmented electrodes (e.g., three electrodes spaced 120 degrees apart) around the lead body, allowing independent activation of each segment. This segmentation enables precise control of the electrical field by selecting specific electrode combinations, thereby improving stimulation precision while maintaining a manageable manufacturing process through modular construction.
Solution Approach 2:
The segmented electrodes are integrated into the lead body structure with electrodes nested within or on the surface of the lead body. The electrodes are positioned at specific angular intervals around the longitudinal axis, with each electrode occupying a fraction of the outside diameter. This nested arrangement allows precise electrode positioning without requiring excessive lead diameter, resolving the manufacturing challenge of fitting segmented electrodes on small leads.
2Measurement precision
If lead outer diameter is reduced for better targeting, then implantation precision is improved, but electrode fabrication difficulty increases
Solution Approach 1:
Each segmented electrode is designed with specific local properties including angular positioning (e.g., 120-degree spacing), individual surface area, and electrical isolation from adjacent electrodes. The electrodes are fabricated with precise local geometries that allow independent control of electrical field distribution, enabling accurate targeting with minimal lead diameter while keeping fabrication complexity manageable through standardized local electrode designs.
3Object-affected harmful factors
If segmented electrodes are used to avoid stimulating undesired tissue, then side effects are reduced, but electrical field control complexity increases
Solution Approach 1:
The system provides dynamic control of the electrical field by enabling selective activation of different electrode segments based on the specific clinical requirement. The pulse generator can independently stimulate individual electrodes or combine specific electrodes to shape the electrical field, allowing real-time adaptation to avoid undesired tissue stimulation. This dynamic electrode selection capability reduces side effects while maintaining manageable control complexity through programmable stimulation patterns.
Data Source
AI summary
In one embodiment, a method of fabrication of a stimulation lead comprising a plurality of segmented electrodes for stimulation of tissue of a patient, the method comprises: providing an elongated, substantially cylindrical substrate, the substrate comprising a plurality of recesses defined in an outer surface of the substrate; coating the substrate with conductive material; patterning conductive material on the substrate to form a plurality of electrode surfaces for at least the plurality of segmented electrodes and a plurality of traces connected to the plurality of electrode surfaces, wherein each electrode surface and its corresponding trace are defined in the recesses on the outer surface of the substrate and are electrically isolated from other electrode surfaces and traces; providing insulative material over at least the plurality of traces; and electrically coupling the plurality of traces to conductive wires of a lead body.