Pacing Lead Stylet Retainer for Stable Distal Implantation Force
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Solution Overview
Problem
Existing pacing lead systems face issues with the stylet being pulled proximally out of the lead lumen during implantation, compromising the ability to provide the necessary distal force for burrowing into tissue, due to the weight of the cap and cable components.
Innovation Solution
A pacing lead tool with a retainer mechanism that secures the stylet within the tool lumen, resisting proximal movement and ensuring the stylet remains in position to apply the required distal force for implantation, using various retainer designs such as inserts, slits, arms, plugs, and coils to engage the stylet.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the stylet is left free in the lead lumen during implantation, then the lead can be delivered to the target site, but the stylet may be pulled proximally out of the lead lumen due to the weight of the cap and cable components, compromising the ability to provide necessary distal force for burrowing into tissue
Solution Approach 1:
The retainer acts as an intermediary component between the stylet and the tool body, providing a simple mechanical engagement feature that prevents proximal movement of the stylet without requiring complex locking mechanisms or additional active components.
Solution Approach 2:
The retainer is designed to automatically engage and disengage the stylet based on its position and the forces applied during implantation, without requiring external control or additional actuators. The stylet's own movement and the implantation forces drive the engagement and disengagement of the retainer.
2Reliability
If the retainer mechanism is added to secure the stylet, then the stylet position stability is improved, but the device complexity increases
Solution Approach 1:
The retainer is designed as a simple, potentially disposable component that can be easily manufactured and integrated into the tool. Its simplicity allows for cost-effective production and potential single-use disposal, eliminating the need for complex, expensive, reusable mechanisms with multiple moving parts.
3Force
If the stylet is constrained by the retainer, then the ability to apply distal force is improved, but the ease of operation is reduced
Solution Approach 1:
The retainer is designed with dynamic characteristics that allow it to adapt to different operational phases: it provides strong constraint during the implantation phase when distal force is needed, but allows easy release during insertion and removal phases. The retainer's engagement and disengagement are driven by the natural forces and movements of the implantation process.
Data Source
AI summary
Embodiments are disclosed of a pacing lead tool. The pacing lead tool has a tool body with a proximal body end, a distal body end, and a lumen extending from the proximal body end to the distal body end. The lumen is adapted to receive a proximal lead end of a pacing lead, and is also adapted to receive a stylet therein. A retainer is coupled to, or formed in, the tool body and adapted to engage the stylet when the stylet is inserted in the lumen. The retainer substantially prevents proximal movement of the stylet until a proximal force applied to the stylet exceeds a threshold force.