Plunger-Spool Loading Tool for Biostimulator Fiber Tethers
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Solution Overview
Problem
Existing tethering systems for leadless pacemakers face issues with metal fatigue, high cost, and difficulty in loading fiber-based tethers due to their rigidity and inability to support compression loads without buckling, complicating the implantation process and requiring multiple catheters for dual-chamber cases.
Innovation Solution
A novel loading tool using a plunger and spool mechanism to support and load fiber tethers into a delivery catheter, allowing for reloadability and minimizing space requirements, while using cost-effective materials like Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyester (PE) for increased fatigue resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fiber-based tethers are used instead of metal tethers, then cost is reduced and fatigue resistance is increased, but loading difficulty increases due to rigidity and inability to support compression loads
Solution Approach 1:
A spool mechanism is introduced as an intermediary device to facilitate the loading of fiber tethers. The spool allows the tether to be wound and unwound in a controlled manner, providing mechanical advantage and enabling the operator to manage the tether's rigidity and compression load issues during the loading process into the delivery catheter.
Solution Approach 2:
The loading process utilizes parameter changes by controlling the tension and positioning of the fiber tether during spooling. By adjusting the winding tension and rotational speed of the spool, the system overcomes the fiber's inherent rigidity and inability to support compression, enabling successful loading without buckling.
2Productivity
If a plunger and spool mechanism is used to load fiber tethers, then loading efficiency is improved and space requirements are minimized, but device complexity increases
Solution Approach 1:
The plunger and spool mechanisms are merged into a single integrated loading device. The plunger is positioned within the spool assembly, allowing both components to work together in a compact configuration. This combination achieves efficient tether loading while minimizing the overall device footprint and reducing the number of separate components that would increase complexity.
Solution Approach 2:
The plunger is nested within the spool structure, with the plunger fitting inside the central hub area of the spool. This nesting arrangement minimizes space requirements and allows the loading mechanism to be compact while maintaining the functional independence of both components during operation.
3Adaptability or versatility
If multiple catheters are used for dual-chamber cases, then implantation flexibility is improved, but procedure complexity and cost increase
Solution Approach 1:
The spool-based loading device is designed as a universal platform that can accommodate different types of fiber tethers and deliver them to various target sites including both atrial and ventricular chambers. By using the same spool mechanism with appropriate tether configurations, the system provides dual-chamber capability without requiring separate specialized devices, thereby reducing procedure complexity while maintaining implantation flexibility.
Data Source
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Figure 3A~3C
AI summary
Embodiments are disclosed of a loading tool (600, 650, 700, 800) for a biostimulator transport system (202). The loading tool (600, 650, 700, 800) includes a plunger (302) having a free end (302f) and a tether end (302t). A tether (606) is coupled to the tether end (302t) of the plunger (302) and coupled to a biostimulator (316). The plunger (302) is stored in a storage container (602, 608, 704) and can exit the storage container (602, 608, 704) through an outlet (610, 706).