Steerable Stylet Handle Assembly for Spinal Cord Stimulation
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Solution Overview
Problem
The handling of stylet insertion tools for spinal cord stimulation is cumbersome and difficult, especially due to the need for two-handed operation and the slippery nature of gloves during procedures, making precise positioning of electrode leads challenging.
Innovation Solution
A steerable stylet handle assembly with a housing, button, and stylet subassembly, where the button moves within the channel to selectively expose and cover the pre-curved distal portion of the inner stylet wire with the outer tubing, allowing for easier and more precise positioning of stimulating members within the patient.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional stylet with pre-curved wire and tube is used, then the stylet can be used for spinal cord stimulation procedures, but the handling becomes cumbersome and difficult requiring two hands
Solution Approach 1:
The stylet is divided into two functional components: an inner stylet wire with pre-curved distal portion and an outer flexible tube. The inner wire provides the steering curvature while the outer tube provides protection and flexibility. This segmentation allows the curved portion to be contained within the tube during insertion, enabling one-handed operation while maintaining the steering capability when needed.
Solution Approach 2:
The inner stylet wire is nested within the outer flexible tube, with the pre-curved distal portion of the wire contained inside the tube. This nesting allows the curved wire to be protected and controlled within the tube during insertion procedures, while still allowing the curve to be exposed when steering is required, simplifying the handling mechanism.
2Measurement precision
If both hands are required to adjust the stylet position, then precise positioning can be achieved, but the operation becomes more difficult especially with slippery gloves
Solution Approach 1:
The handle assembly incorporates a button mechanism that automatically controls the exposure and retraction of the pre-curved wire portion. When the button is pressed, the outer tube retracts to expose the curved wire for steering; when released, the tube advances to cover the wire. This self-service mechanism eliminates the need for two-handed manipulation and provides precise control even when wearing slippery gloves.
Solution Approach 2:
The button mechanism serves as an intermediary control element between the operator and the stylet wire. By pressing the button, the operator indirectly controls the exposure of the curved wire through the intermediate action of the button mechanism, which in turn moves the outer tube relative to the inner wire. This intermediary mechanism provides precise control with minimal direct manipulation.
3Measurement precision
If the pre-curved wire is exposed for steering, then positioning accuracy improves, but the wire becomes less protected and more difficult to control
Solution Approach 1:
The system dynamically transitions between two states: when the button is pressed, the outer tube retracts to expose the pre-curved wire for accurate positioning and steering; when the button is released, the outer tube automatically advances to cover and protect the wire. This dynamic state change allows the system to provide both protection and exposure as needed, maintaining reliability while enabling precision when required.
Data Source
AI summary
An exemplary steerable stylet handle assembly includes a housing having first and second side walls defining a channel therebetween, a button in communication with the first and second side walls and configured to move distally and proximally within the channel, and a stylet subassembly having an inner stylet wire located at least partially within an outer tubing. The inner stylet wire has a pre-curved portion and is coupled to a proximal portion of the housing. The outer tubing is coupled to the button. Movement of the button within the channel is configured to selectively expose and cover at least a portion of the pre-curved distal portion of the inner stylet wire with the outer tubing.