Flexible Tether Docking for Reliable Leadless Pacemaker Release
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Solution Overview
Problem
Existing biostimulator transport systems for leadless cardiac pacemakers are complex, expensive, and require precise mechanical tolerances, complicating the delivery and retrieval process due to cyclic loading within the target anatomy.
Innovation Solution
A biostimulator transport system with a flexible tether mechanism, including a handle, torque shaft, and docking cap, uses polymeric or metallic filaments for the tether to provide a simple, inexpensive, and reliable retention and release mechanism, allowing for easy detachment of the biostimulator from the tether.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex mechanisms with precise movements and fine mechanical tolerances are used for biostimulator retention and release, then retention reliability is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent employs a simple tether made of flexible material that can be easily severed to release the biostimulator. Instead of using complex mechanical retention mechanisms with moving parts, the system uses a disposable tether that is cut with a simple cutter, significantly reducing device complexity while maintaining reliable retention during the delivery process.
Solution Approach 2:
The patent extracts the retention function from complex mechanical mechanisms and implements it through a simple tether-cutter system. The tether is a separate, simple component that can be easily removed by cutting, separating the retention function from complex mechanical structures and thereby reducing overall device complexity.
2Reliability
If complex mechanisms with precise movements are used for biostimulator retention and release, then retention reliability is improved, but manufacturing cost increases
Solution Approach 1:
The tether is designed as a simple, inexpensive component made of flexible material that can be easily manufactured and disposed of after use. This eliminates the need for expensive precision-machined mechanical retention mechanisms, significantly reducing manufacturing costs while maintaining reliable retention during the critical delivery phase.
Solution Approach 2:
By extracting the retention function from expensive mechanical mechanisms and implementing it through a simple tether, the patent dramatically reduces manufacturing costs. The tether and cutter system requires minimal precision manufacturing compared to complex mechanical retention mechanisms.
3Reliability
If precise movements and fine mechanical tolerances are required for retention mechanisms, then retention reliability is improved, but the delivery process becomes more difficult under cyclic loading
Solution Approach 1:
The simple tether design eliminates the need for precise mechanical movements and fine tolerances during delivery. The tether maintains reliable retention through its flexible material properties and simple geometry, which are not affected by cyclic loading in the same way complex mechanical mechanisms would be.
Solution Approach 2:
By removing complex mechanical retention mechanisms that require precise movements, the patent eliminates the sensitivity to cyclic loading during delivery. The tether-cutter system operates reliably under cyclic loading conditions without requiring fine mechanical tolerances or precise movements.
Data Source
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AI summary
A biostimulator transport system (300) comprises a handle (304), a docking cap (320) having a docking cavity (404) to receive an attachment feature (220) of a biostimulator (100). The system (300) also comprises a torque shaft (602) having a distal shaft end (603) coupled to the docking cap (320) and a tether support (502) extending through the torque shaft (602) to a distal support end (604). The tether support (502) includes a tubular member (1802) having a support lumen (902), and a rod (1804) extending through the support lumen (902). A tether (504) has a tether bight (706) between a first tether leg (802) and a second tether leg (804), wherein the first tether leg (802) is coupled to the tubular member (1802) and the second tether leg (804) is releasably coupled to the rod (1804).