Leadless Pacemaker Delivery Catheter With Brake-Assisted Deflection
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Solution Overview
Problem
Current systems for delivering and retrieving leadless pacemakers face challenges in precise manipulation, leading to potential damage to the device, cardiac tissue, and venous system due to insufficient control and precision during implantation and retrieval processes.
Innovation Solution
A catheter-based system with a handle that includes a deflectable catheter section, pull wire, and a brake assembly, allowing for controlled deflection and rotation, along with retrieval features like snare and sheath mechanisms, to facilitate precise manipulation and retrieval of leadless pacemakers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional delivery systems are used for leadless pacemakers, then the implantation process can be completed, but precise manipulation is insufficient leading to potential damage to the device, cardiac tissue, and venous system
Solution Approach 1:
The catheter incorporates a deflectable section that can be dynamically adjusted during the procedure. The handle includes a deflection lever that allows the operator to change the catheter's shape in real-time, enabling precise navigation and manipulation of the leadless pacemaker during delivery and retrieval without causing damage to cardiac tissue or the venous system.
Solution Approach 2:
The delivery system is divided into distinct functional segments: a deflectable catheter section for navigation, a handle with independent control mechanisms for deflection and rotation, and retrieval features. This segmentation allows each component to be optimized for its specific function and provides the operator with granular control over the implantation and retrieval processes.
2Ease of operation
If the catheter is made more manipulative with multiple control features, then precision is improved, but device complexity increases
Solution Approach 1:
Multiple control functions are merged into a single integrated handle assembly. The deflection lever, rotation control, and retrieval mechanism are combined in one ergonomic unit that the operator controls with one hand. This merging reduces the number of separate components and control stations, simplifying the overall system while maintaining precise manipulation capabilities.
Solution Approach 2:
The handle is designed as a multi-functional control unit that performs deflection, rotation, and retrieval operations. The deflectable catheter section serves multiple purposes: navigation through the venous system, positioning of the leadless pacemaker, and facilitation of retrieval. This multi-functionality reduces the need for multiple specialized devices, lowering overall system complexity.
Data Source
AI summary
Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.