Catheter-Guided Helix Leads for Deep Septal Cardiac Pacing
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Solution Overview
Problem
Existing cardiac pacing technologies, such as right ventricular and biventricular pacing, often result in adverse outcomes like mitral and tricuspid regurgitations, atrial fibrillation, and pacing-induced cardiomyopathy due to unphysiological lead placement, while conduction system pacing (CSP) aims to overcome these issues by placing leads along the cardiac conduction system pathways.
Innovation Solution
The development of catheters and leads designed for deep seating into the ventricular septum, with features like helix electrodes, tapered tips, and adjustable spacers, allowing precise placement and minimization of tissue trauma, enabling stable electrical performance and physiological pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pacing leads are placed in right ventricular apex or biventricular positions, then pacing function is achieved, but adverse outcomes occur including mitral and tricuspid regurgitations, atrial fibrillation, and pacing-induced cardiomyopathy
Solution Approach 1:
The catheter system performs preliminary actions by delivering the lead to the correct anatomical position in the cardiac conduction system (His bundle, left bundle branch, or right bundle branch) before permanent implantation. The catheter enables pre-positioning and verification of lead location to ensure physiological pacing while avoiding adverse outcomes associated with conventional placement.
Solution Approach 2:
The catheter acts as an intermediary device that facilitates the delivery and positioning of the pacing lead through the vascular system to the target site in the cardiac conduction system. The catheter system includes the lead, electrodes, and delivery mechanism that together enable precise placement without direct surgical access to the conduction system.
2Reliability
If leads are placed deep in the ventricular septum for conduction system pacing, then physiological pacing is achieved, but implantation complexity increases
Solution Approach 1:
The catheter system is designed with multi-functionality to handle various aspects of conduction system pacing implantation. The system can deliver leads to multiple target sites (His bundle, left bundle branch, right bundle branch) through a single vascular access approach, and includes integrated features for lead positioning, electrical sensing, and fixation, thereby reducing overall implantation complexity despite the deep septal placement requirement.
3Ease of operation
If conventional leads are used in standard positions, then implantation is simple, but unphysiological pacing occurs leading to adverse cardiac outcomes
Solution Approach 1:
The catheter system segments the implantation process into distinct phases: vascular access, lead delivery through the catheter, positioning at the target site in the cardiac conduction system, and final implantation. This segmentation allows each step to be optimized independently, maintaining ease of operation while achieving physiological pacing through precise anatomical targeting.
Data Source
AI summary
A lead for cardiac conduction system includes a proximal end, a lead body extending from the proximal end, and a distal end extending from the lead body. The lead body includes a non-conductive spacer. The distal end includes a helix electrode distal to the spacer. The lead further includes a ring electrode proximal to the spacer and surrounding a portion of the lead body. The helix electrode includes a core disposed within a helical space of the helix electrode. Another lead for cardiac conduction system includes a proximal end, a lead body extending from the proximal end, and a distal end extending from the lead body. The distal end includes a first helix electrode extending from the lead body and a second helix electrode extending from the lead body. A tip of the first helix electrode is distal to a tip of the second helix electrode.