Custom Length Stylet Assembly for Implantable Lead Tolerances
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Solution Overview
Problem
Manufacturing yield losses occur due to difficulty in matching the length of stylet wires with implantable leads within specified tolerances, particularly when components are produced at separate facilities and have custom lengths.
Innovation Solution
A custom length stylet assembly is designed with a stylet wire and handle, where the wire length is selected to conform to the lead's length within predefined tolerances, and a tab is melted into a track on the handle to securely fasten the wire, preventing rotation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If stylet wires and implantable leads are manufactured at separate facilities with custom lengths, then manufacturing flexibility and adaptability are improved, but length matching precision and manufacturing yield deteriorate
Solution Approach 1:
The patent applies preliminary action by pre-defining standardized length groups for stylet wires (e.g., 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm) that can be manufactured in advance at separate facilities. These pre-categorized lengths are then matched to corresponding lead lengths within specified tolerances (±5mm), eliminating the need for custom cutting or adjustment while ensuring compatibility. This resolves the contradiction by enabling flexible manufacturing of standardized components that still achieve precise length matching when assembled.
2Measurement precision
If stylet wire length is customized to match each lead, then positioning accuracy is improved, but manufacturing complexity and time increase
Solution Approach 1:
The patent applies local quality by creating specific length groups for stylet wires that correspond to specific lead length ranges. Instead of customizing every stylet to every lead, the system defines localized length categories (e.g., stylets of 20-50mm in 5mm increments) that are optimally suited for particular lead lengths. This localized standardization achieves sufficient positioning accuracy while dramatically simplifying manufacturing compared to fully customized production.
3Manufacturing precision
If strict length tolerances are enforced for stylet-lead matching, then assembly precision is improved, but manufacturing yield and productivity deteriorate
Solution Approach 1:
The patent applies parameter changes by establishing a tolerance range of ±5mm for length matching between stylets and leads, rather than enforcing strict zero-tolerance specifications. This parameter adjustment allows for greater variability in manufacturing while still ensuring functional compatibility and proper positioning. The tolerance-based approach maintains assembly precision (sufficient for clinical use) while significantly improving manufacturing yield by reducing the number of rejected components.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution ensures precise alignment of the stylet with the lead, reducing manufacturing waste and improving the positioning accuracy of implantable leads.
Implementation Method 1
The tab of the stylet handle can be melted into the track, thereby securely fastening the stylet wire to the stylet handle
Data Source
AI summary
A custom length stylet assembly for meeting medical device length tolerances. The custom length stylet assembly including a stylet wire having a length extending between a distal end and a proximal end, stylet handle defining a longitudinally oriented throughbore sized to retain a proximal portion of the stylet wire, the stylet handle further defining a proximately positioned track and tab, the track configured to retain a bent proximal end portion of the stylet wire, the length of the stylet wire selected during assembly of the stylet assembly to conform to the corresponding length of a body implantable lead within a predefined tolerance, the tab of the stylet handle melted into the track, thereby securely fastening stylet wire to the stylet handle to inhibit rotation or dislodgement.