Paddle Lead Insertion Tool Stylet Steering Mechanism
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Solution Overview
Problem
Current implantable electrical stimulation systems face challenges in efficiently and accurately inserting paddle leads into target sites within the body, particularly due to anatomical obstructions and the need for precise positioning and steering during implantation procedures.
Innovation Solution
The development of a paddle lead insertion tool with a stylet channel and actuator assembly that allows the stylet wire to transition between retracted and extended positions, enabling the tool to guide and steer the paddle lead into place, and a mechanism for releasing the lead body from the insertion tool once implanted.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a paddle lead is inserted manually without guidance tools, then the procedure is simpler and faster, but the positioning accuracy and ability to navigate anatomical obstructions deteriorates
Solution Approach 1:
The patent introduces an insertion tool as an intermediary device between the operator and the paddle lead. This tool includes a stylet channel and actuator assembly that provides controlled guidance and steering capability, enabling precise positioning while navigating anatomical obstructions without requiring the operator to directly manipulate the lead through difficult passages.
Solution Approach 2:
The patent replaces manual mechanical manipulation with a controlled mechanical system. The actuator assembly converts operator input into controlled stylet wire movement, which in turn steers the paddle lead. This substitution provides more precise and reproducible positioning while reducing the skill threshold for navigating complex anatomical pathways.
2Ease of operation
If the stylet wire is extended to steer the paddle lead, then the steering capability and positioning accuracy improve, but the risk of tissue damage and procedural complexity worsen
Solution Approach 1:
The patent implements a dynamic stylet wire system that can transition between retracted and extended positions based on operational needs. The stylet wire is extended only when steering capability is required and retracted when not needed, minimizing the time the lead is in a steerable but potentially damaging configuration. This dynamic adjustment reduces overall tissue disruption risk while maintaining steering capability when necessary.
Solution Approach 2:
The insertion tool is designed with the stylet wire and actuator assembly pre-configured and pre-loaded. The stylet wire is positioned within the stylet channel in a retracted state ready for deployment. This preliminary preparation allows for controlled, incremental extension only when needed, rather than having the lead continuously in a high-risk steerable state throughout the procedure.
3Measurement precision
If the stylet wire is kept extended for continuous steering, then the lead positioning is more accurate, but the time the lead is exposed to damage risks and tissue disruption increases
Solution Approach 1:
The patent employs a dynamic stylet wire system that transitions between extended and retracted states based on real-time operational requirements. The wire is extended only during steering maneuvers and retracted during insertion or repositioning phases, minimizing the cumulative time the lead is in a configuration susceptible to tissue damage while maintaining positioning accuracy when steering is needed.
Solution Approach 2:
The stylet wire extension follows a periodic pattern of deployment and retraction synchronized with the insertion steps. The wire is extended periodically when steering is required and retracted otherwise, creating discrete intervals of steerable positioning rather than continuous exposure. This periodic action reduces cumulative damage risk while achieving necessary positioning accuracy through repeated controlled extensions.
Data Source
AI summary
An insertion tool for a paddle lead includes an insertion tool body having a receiving end portion; a stylet channel extending along the insertion tool body; a stylet disposed in the stylet channel; and an actuator assembly disposed along the handling end portion of the insertion tool body and coupled to the stylet. The actuator assembly controls transitioning of the stylet between a first position and a second position. In some instances, the stylet can be a wire stylet that is inserted into a lumen in the paddle body of the paddle lead. In some instances, the stylet of the insertion tool pushes lead bodies of the paddle lead out of the insertion tool to release the paddle lead. In some instances, the insertion tool includes a paddle envelope to hold the paddle lead.