Biased Tachy Lead Geometry for Synchronized Biventricular Pacing
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Solution Overview
Problem
Existing cardiac rhythm management systems face challenges in effectively pacing the native conduction system of the heart, leading to potential pacing-induced dyssynchrony, particularly with right ventricular apex pacing.
Innovation Solution
An implantable lead with a pre-formed distal portion featuring a helical electrode and a ring electrode, configured to target the left and right bundle branches of the heart, along with a shocking coil positioned for enhanced defibrillation, allowing precise placement and improved conduction system pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If right ventricular apex pacing is used, then pacing simplicity is maintained, but pacing-induced dyssynchrony occurs
Solution Approach 1:
The lead is segmented into multiple functional portions: a first portion for right ventricular septum engagement, a second portion for left ventricular engagement, and a third portion for additional positioning flexibility. This segmentation allows the lead to target multiple conduction system locations simultaneously, achieving synchronized biventricular pacing while maintaining procedural simplicity through a single lead insertion.
Solution Approach 2:
The lead transitions from a traditional single-plane configuration to a multi-planar structure with portions extending in different spatial dimensions. The first portion engages the right ventricular septum while the second portion extends to engage the left ventricle, creating a three-dimensional positioning capability that enables simultaneous targeting of multiple conduction system sites from a single access point.
2Reliability
If conduction system pacing is implemented, then ventricular synchrony is improved, but lead placement complexity increases
Solution Approach 1:
The lead incorporates pre-formed curves and a stylet lumen that allows insertion of a stylet during deployment. This preliminary structuring enables the lead to automatically assume its intended multi-planar configuration upon insertion, reducing the complexity of real-time manipulation during placement while ensuring accurate engagement of both right and left ventricular conduction systems.
Solution Approach 2:
A stylet is introduced as an intermediary tool to facilitate lead deployment. The stylet provides temporary structural support and guidance during insertion, allowing the lead to navigate complex vascular anatomy and achieve proper positioning in both ventricles. After deployment, the stylet is removed, leaving the lead in its functional configuration without requiring complex manipulation techniques.
3Ease of manufacture
If standard lead configuration is used, then manufacturing simplicity is maintained, but defibrillation performance is insufficient
Solution Approach 1:
The lead merges pacing and defibrillation functions into a single integrated device. Shocking coils are incorporated into the first, second, and third portions of the lead, combining the pacing electrodes with defibrillation capability. This merging allows the lead to deliver both low-voltage pacing pulses for conduction system stimulation and high-voltage shocks for defibrillation, maintaining manufacturing efficiency while enhancing therapeutic performance.
Solution Approach 2:
The lead is designed as a universal device that performs multiple functions: pacing the right ventricular septum, pacing the left ventricle, and delivering defibrillation shocks. The shocking coils distributed across multiple portions enable the lead to function as both a conduction system pacing lead and a defibrillation lead, eliminating the need for separate devices and simplifying the overall system while improving reliability.
Data Source
AI summary
An implantable lead for use with an implantable medical device (IMD) includes a tubular lead body having proximal end and a distal end opposite the proximal end. A proximal connector is located at the proximal end of the lead body and is configured for mechanically and electrically coupling the lead to the IMD. The lead includes a pre-formed distal portion having a first portion extending from the distal end to a first curve. The first portion is located in a first plane. A second portion extends from the first curve to a second curve, wherein the second portion and the second curve are located in a second plane that is generally orthogonal to the first plane. A helical electrode extends distally from the distal end of the tubular lead body and a ring electrode is located along the first portion.