Leadless Pacemaker Tethering Mechanism for Cyclic-Stress Reliability
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Solution Overview
Problem
Existing delivery systems for leadless pacemakers are prone to failure due to cyclical stress from a beating heart, necessitating a more reliable transport system.
Innovation Solution
A biostimulator transport system with a tethering mechanism, comprising a support wire, distal and proximal anchors, and a tethering mechanism that allows the tether to be moved between closed and open positions, ensuring secure attachment and release of the pacemaker during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid tether systems are used to connect leadless pacemakers to delivery systems, then the pacemaker can be retained during delivery, but the tether may fail under cyclical stress from a beating heart
Solution Approach 1:
The patent replaces rigid wire tethers with a flexible tether made of a soft, compliant material that can accommodate the cyclical stress of a beating heart. The flexible tether is attached to the pacemaker and can flex and move with the heart's motion, reducing the risk of failure compared to rigid wire systems.
2Reliability
If a tethering mechanism is used to secure the tether to the delivery system, then secure attachment is achieved, but the mechanism adds complexity to the delivery system
Solution Approach 1:
The patent extracts the tethering mechanism from the delivery system proper, making it a separate, self-contained component attached to the pacemaker itself. This allows the delivery system to remain relatively simple while the pacemaker carries its own tethering apparatus, including the flexible tether and anchoring elements.
Solution Approach 2:
The pacemaker is equipped with its own tethering mechanism that can independently secure and release the tether without requiring complex external equipment. The device includes components such as a tether attachment feature and anchoring elements that work together to provide reliable attachment and release functionality.
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
A tethering apparatus (300) is described. The tethering apparatus (300) includes a support wire (302) and a distal anchor (304) coupled to the support wire (302). The distal anchor (304) includes a tether attachment (308) adapted to secure a first end of a tether (310). A proximal anchor (306) is coupled to the support wire (302) proximal to the distal anchor (304). A tethering mechanism is coupled to the proximal anchor (306) and adapted to receive a second end of a tether (310). The tethering mechanism is movable between a closed position that retains the second end of the tether (310) and an open position that releases the second end of the tether (310).