Lead Paddle Positioning via Stylet Guiding Wire
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Solution Overview
Problem
Existing techniques face challenges in accurately and safely placing lead paddles in the epidural space, particularly for long and wide arrays, due to limitations in axial stiffness and radial flexibility, and difficulties in handling and steering during minimally invasive procedures, especially in cases with scar tissue, fibrosis, or calcification.
Innovation Solution
A lead paddle positioning and deployment system featuring a stylet with a guiding wire and a lead paddle with U-shaped guiding channels, allowing for enhanced axial stiffness and radial flexibility, along with a handle and fork-like form for improved maneuverability and safety, enabling precise placement through minimally invasive incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single lumen stylet is used for lead paddle insertion, then the insertion process is simplified, but the pushability and steerability are compromised due to stylet material stiffness and diameter limits
Solution Approach 1:
The stylet is divided into multiple lumens (first lumen and second lumen) instead of using a single lumen. Each lumen can receive its own guiding wire, allowing independent manipulation and control. This segmentation enables better pushability and steerability while maintaining ease of insertion through the lead paddle's multiple guiding channels.
Solution Approach 2:
Guiding wires are introduced as intermediary elements that extend through the stylet lumens and into the lead paddle's guiding channels. These guiding wires act as mediators that transmit steering forces and provide tactile feedback, enabling precise control of the lead paddle's position and orientation during insertion without requiring excessive stylet stiffness.
2Area of stationary object
If the lead paddle is made longer and wider to cover more epidural space, then the coverage area is increased, but the positioning accuracy and safety are reduced
Solution Approach 1:
The lead paddle is equipped with multiple guiding channels distributed across its structure, with each channel providing localized guidance. This allows different regions of the large paddle to be independently positioned and controlled, maintaining positioning accuracy even as the overall coverage area increases. The U-shaped configuration of guiding channels provides localized structural support while allowing radial flexibility.
Solution Approach 2:
Multiple guiding wires extending through the stylet lumens and into the lead paddle's guiding channels act as intermediaries that transmit control forces to specific locations on the large paddle. This enables precise positioning of each section of the extended paddle, maintaining manufacturing precision despite the increased size and coverage area.
3Object-affected harmful factors
If a minimally invasive incision is used for lead paddle implantation, then the patient trauma is reduced, but the maneuverability and handling of the system are limited
Solution Approach 1:
The stylet is segmented into multiple functional components including multiple lumens, each capable of receiving guiding wires. This segmentation allows the system to be introduced through a small incision while maintaining the ability to manipulate and steer the lead paddle once inside the epidural space, overcoming the limitations of minimally invasive access.
Solution Approach 2:
The system transitions from a static, rigid structure to a dynamic, adaptable configuration. The stylet with multiple lumens and guiding wires can be flexed and steered to navigate through the minimally invasive incision and position the lead paddle accurately in the epidural space, providing the necessary maneuverability despite the small access point.
Data Source
AI summary
The present invention relates to a lead paddle positioning and/or deployment system comprising at least a stylet and a lead paddle, wherein the lead paddle comprises at least one guiding channel and wherein the stylet comprises at least one guiding wire at its distal end, which is configured and arranged to be engaged and/or to be at least partially received in the guiding channel. The present invention relates further to a stylet for a lead paddle system comprising the stylet features. Furthermore, the present invention relates to a lead paddle for a lead paddle system comprising the lead paddle features.