Lead Electrode Marking System for Fluoroscopic Placement
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Solution Overview
Problem
Lead electrodes with minimal radiopacity or non-radiopaque materials pose challenges in visualization under fluoroscopy or x-ray, making it difficult to discern their placement during procedures like Interstim therapy.
Innovation Solution
A lead system with multiple electrodes at the distal end and a corresponding marking system on the lead body, where each mark is the same length as its corresponding electrode, spaced to match the operative length of a needle introducer, providing visual feedback on electrode placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If lead electrodes are made of non-radiopaque or minimal radiopacity materials, then patient safety and comfort are improved, but visualization of electrode placement under fluoroscopy or x-ray deteriorates
Solution Approach 1:
The lead body is segmented into distinct functional zones: electrode segments (non-radiopaque for patient safety) and marker segments (radiopaque for visualization). This segmentation allows each segment to fulfill its specific function without compromise - electrodes remain biocompatible while markers provide clear fluoroscopic visibility for precise placement detection
Solution Approach 2:
Radiopaque marker segments are introduced as intermediary elements that do not perform the primary electrode function but mediate the visualization problem. These markers act as visual proxies that allow physicians to track the position of non-radiopaque electrodes indirectly, solving the contradiction between patient safety (non-radiopaque materials) and detectability (fluoroscopic visibility)
2Reliability
If multiple electrodes are placed at the distal end of the lead, then therapeutic effectiveness is improved, but difficulty of detecting and measuring individual electrode positions deteriorates
Solution Approach 1:
Each electrode at the distal end is paired with its own corresponding radiopaque marker segment, creating individually detectable units. This one-to-one segmentation allows physicians to visualize and distinguish the position of each electrode separately under fluoroscopy, maintaining therapeutic effectiveness while solving the detection difficulty of multiple closely-spaced electrodes
Solution Approach 2:
Different segments of the lead body have different radiopacity qualities tailored to their specific functions: electrode portions use non-radiopaque materials for patient safety, while corresponding marker portions use radiopaque materials for individual position detection. This local differentiation of properties enables simultaneous visualization of multiple electrode positions
3Ease of operation
If lead markers are spaced to match the operative length of needle introducer, then ease of operation during lead insertion is improved, but device complexity deteriorates
Solution Approach 1:
The radiopaque marker segments are pre-positioned on the lead body at specific distances from the distal end that correspond to the operative length of the needle introducer. This preliminary configuration of marker positions allows physicians to easily determine electrode placement by simple visual alignment during insertion, without requiring complex measurement or calculation procedures
Solution Approach 2:
The marker segments serve multiple functions: they provide radiopaque visualization for position detection, serve as alignment references for different needle introducer lengths, and indicate the spatial relationship between electrodes and introduction point. This multi-functionality justifies the added structural elements while providing comprehensive operational guidance
Data Source
AI summary
A lead includes a lead body having at least two electrodes and a lead marker. The lead marker corresponds to a size and spacing of each of the at least two electrodes. The spacing between the electrodes and lead marker corresponds to an operative length of a first lead introducer configured to be used with the lead. Lead systems that include one or more lead introducers and kits including the same are also disclosed.