Screwing Stylet Coupling for Precise Cardiac Lead Torque Transfer
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Solution Overview
Problem
Existing cardiac pacing methods, such as traditional right ventricular apical pacing, lead to deleterious effects on left ventricular function and require improvements in minimizing septum impact, downsizing, and ensuring long-term reliability of pacing devices.
Innovation Solution
A screwing stylet and lead system design that facilitates direct torque transfer to the lead tip, enhancing control over the puncturing process and minimizing septum damage, with features like a conical portion for flexibility and a locking mechanism for secure engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional right ventricular apical pacing is used, then stable lead position is achieved, but left ventricular function deteriorates due to iatrogenic left bundle branch block
Solution Approach 1:
The patent inverts the traditional pacing approach by transitioning from right ventricular apical pacing to left bundle branch pacing. Instead of pacing the right ventricle apex (traditional approach), the lead is positioned at the left bundle branch via transseptal puncture from the right ventricle, achieving physiological activation patterns while maintaining stable lead positioning through the specialized screwing stylet mechanism
2Reliability
If transseptal approach for left bundle branch pacing is used, then physiological pacing pattern is achieved, but septum damage risk increases
Solution Approach 1:
The screwing stylet acts as an intermediary tool during the transseptal puncture process. It provides controlled torque transfer and mechanical support during lead insertion through the septum, enabling precise positioning while minimizing uncontrolled forces that could cause septal damage. The stylet's coupling mechanism with the lead tip allows for controlled advancement and securing of the lead at the target site
3Volume of moving object
If lead device size is reduced, then smaller puncture impact is achieved, but torque transfer capability deteriorates
Solution Approach 1:
The system segments the torque transfer function by introducing a separate screwing stylet component that couples with the lead tip. The stylet contains the torque transfer mechanism (coupling end with driver engagement) as a distinct element from the lead body, allowing the lead device itself to remain small while the stylet provides the necessary torque transfer capability during insertion and positioning
4Force
If screwing stylet is inserted into lead device, then torque transfer is improved, but device complexity increases
Solution Approach 1:
The screwing stylet is designed to be insertable into the lead device, with the coupling end of the stylet engaging with the driver at the lead tip. The stylet nests within the lead body during insertion, and the coupling mechanism (driver-coupling end interface) provides secure torque transfer without requiring external attachment mechanisms, thereby minimizing structural complexity while maximizing torque transfer efficiency
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
Improves handling and torque transfer efficiency, ensuring precise placement and long-term reliability of pacing leads, reducing the risk of septal damage and enhancing cardiac synchronization.
Implementation Method 1
pushing an operating handle fixed to the screwing stylet at a connector end opposite to the coupling end to generate a connecting force between the coupling end of the screwing stylet and the driver due to an elastic elongation of a lead body of the lead device
Data Source
AI summary
The invention relates to a screwing stylet for improving torque transfer from a physician's hand to a lead tip (e.g., helix) of a lead device. A lead tip is provided to facilitate handling and a screwdriver functionality of the screwing stylet is provided to improve torque transfer to the lead tip of the lead device for better control of a puncturing process. The screwing stylet can be engaged directly with the tip of the lead device, thereby allowing a direct and efficient torque transfer to the fixed helix at the tip.


