Endocardial Lead with Transeptal Microcable for Left Ventricular Stimulation
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Solution Overview
Problem
Current techniques for endocardial stimulation of the left ventricle are invasive, risky, and difficult to implement, with high operative risks such as accidental perforation, air embolism, and thromboembolism, due to the need for precise puncture and anchoring through the septum, and are not reversible or efficient in terms of electrical performance.
Innovation Solution
A novel system involving a modified lead with a partially isolated transeptal microcable that is extended through the septum to contact the left ventricle, allowing for direct endocardial stimulation with reduced invasiveness, using a guide catheter and RF puncture generator to minimize tissue damage and facilitate controlled electrode placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lead is introduced through the septum to stimulate the left ventricle, then direct endocardial stimulation is achieved, but operative risks such as accidental perforation and air embolism increase
Solution Approach 1:
The lead is divided into two separate parts: a first part introduced through the septum and a second part placed in the left ventricle. This segmentation allows the first part to serve as a guide catheter for safe septal penetration while the second part provides the stimulation function, thereby reducing operative risks associated with single-piece leads.
Solution Approach 2:
A guide catheter is introduced as an intermediary element to facilitate the passage of the lead through the septum. The guide catheter acts as a mediator that enables controlled penetration of the septal wall while minimizing the risks of perforation and embolism, before the actual stimulation lead is deployed.
2Ease of operation
If a hollow catheter is used to introduce the lead through the septum, then the lead can be anchored in the left ventricle, but the risk of air embolism increases
Solution Approach 1:
The harmful hollow catheter structure is extracted and replaced with a solid lead design. The lead is modified to have a non-hollow structure that eliminates the risk of air embolism while maintaining the capability to anchor in the left ventricle through the septum.
Solution Approach 2:
A disposable stylet is used temporarily during the insertion process to facilitate lead placement through the septum. The stylet is removed after guiding the lead into position, eliminating the need for a permanent hollow catheter structure and thereby removing the air embolism risk.
3Manufacturing precision
If precise positioning of the needle for piercing the septum is ensured, then successful lead placement is achieved, but the procedure becomes extremely difficult to implement
Solution Approach 1:
A guide catheter is introduced as an intermediary tool to facilitate precise and safe septal penetration. The guide catheter provides a stable pathway that simplifies the positioning process compared to using a needle directly, making the procedure more implementable while maintaining precision.
Solution Approach 2:
The guide catheter is first positioned and anchored in the septum before the lead is introduced. This preliminary action establishes a secure pathway and reference point that simplifies subsequent lead placement, reducing the difficulty of the overall procedure.
4Reliability
If a lead is anchored in the left ventricle through the septum, then direct stimulation is possible, but subsequent extraction of the lead becomes impossible
Solution Approach 1:
The lead is segmented into a first part remaining in the septum and a second part in the left ventricle. This segmentation allows the first part to serve as a permanent anchor while the second part can be selectively removed or repositioned, maintaining stimulation capability while enabling future extraction if needed.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system reduces the size and risk of puncture, minimizes tissue damage, and enhances electrical performance with lower power consumption, allowing for effective and reversible stimulation of the left ventricle with reduced thromboembolic risk and simplified implantation.
Implementation Method 1
using a guide catheter and RF puncture generator to minimize tissue damage and facilitate controlled electrode placement
Implementation Method 2
at least one electrically conductive microcable (42) having a distal free end portion (58) emerging in the cavity of the left ventricle (16)
Data Source
AI summary
A system for the endocardial stimulation/defibrillation of the left ventricle. This system includes a generator (60) and an endocardial lead. The lead includes a lead body (26) whose distal end (30) extends into the right ventricle (14) and is provided with a mechanism to anchor (32) the distal end to the interventricular septum (20). The lead body carries on it a stimulating and/or defibrillation electrode (38) (64, 66). A microcable (42) extends into the lead body and beyond, with an intermediate portion (56) crossing from one side of the interventricular septum (20) to the other, and an active free portion (58) that emerges in the left ventricle (16). The microcable is coupled to the generator, to produce an electric field (62) between, on one hand, the stimulation electrode (38) or defibrillation electrode (64, 66) of the lead body and, on the other hand, a bare region of the active free portion (58) of microcable (42).