Fiber Tether Loading Tool With Plunger-Spool Catheter Feed
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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, which complicates the implantation process and increases the need for multiple catheters in 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, providing structural support and enabling automatic advancement, reducing the need for manual insertion and minimizing space requirements, while allowing for reloadability and cost-effectiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fiber-based tethers are used instead of metal tethers, then metal fatigue and cost are reduced, but the tether rigidity causes difficulty in loading and buckling under compression loads
Solution Approach 1:
A loading tool with a plunger and spool mechanism is introduced as an intermediary device to facilitate the loading of the fiber tether into the delivery catheter. The plunger pushes the tether through the catheter while the spool stores and feeds the tether, solving the loading difficulty without compromising the fiber tether's fatigue resistance
Solution Approach 2:
The fiber tether's physical parameters (flexibility, tensile strength) are optimized to balance compression load support with flexibility for loading. The tether is designed with specific material properties that allow it to be loaded easily while maintaining durability against metal fatigue
2Ease of manufacture
If fiber-based tethers are used, then cost is reduced, but operational complexity increases due to loading difficulties
Solution Approach 1:
The loading tool serves as a specialized intermediary device that simplifies the operational complexity of loading fiber tethers. By providing a dedicated plunger and spool mechanism, the system reduces the steps and difficulty involved in tether loading, making the process more manageable despite the inherent complexity of fiber-based systems
Solution Approach 2:
The spool mechanism is designed to automatically feed and store the tether during loading operations, reducing the need for manual manipulation and simplifying the operator's task. The system assists itself in managing the tether, reducing overall operational complexity
3Reliability
If multiple catheters are used for dual-chamber implantations, then procedural completeness is ensured, but surgical efficiency and cost increase
Solution Approach 1:
The delivery catheter is designed with universal capability to accommodate fiber tethers for multiple implantation sites. The same catheter can be used for both atrial and ventricular leadless pacemaker implantations by loading different tethers, eliminating the need for separate catheters and improving surgical efficiency without compromising procedural completeness
Data Source
AI summary
Embodiments are disclosed of a loading tool for a biostimulator transport system. The loading tool includes a plunger having a free end and a tether end. A tether is coupled to the tether end of the plunger and coupled to a biostimulator. The plunger is stored in a storage container and can exit the storage container through an outlet.