Implantable Lead Introducer With Non-Circular Lumen Orientation Control
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Solution Overview
Problem
Implantable medical leads require higher energy levels for extravascular or extracardiac delivery of pacing pulses or defibrillation due to improper electrode positioning and lead body orientation during implantation, leading to potential energy delivery to extracardiac tissues and increased surgical risks.
Innovation Solution
An introducer tool with a non-circular lumen is used to lock the lead's undulating configuration into a predetermined rotational orientation, ensuring proper electrode placement and minimizing rotation during implantation, thereby optimizing energy delivery to the heart while reducing extracardiac tissue stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a conventional circular lumen introducer tool is used, then the lead can be easily inserted, but the lead may rotate or flip during implantation causing improper electrode positioning
Solution Approach 1:
The introducer tool employs a non-circular lumen with an asymmetric cross-sectional shape (e.g., elliptical, rectangular, or polygonal) that corresponds to the asymmetric shape of the lead body. This asymmetric geometry prevents rotational movement of the lead within the lumen, ensuring that the electrodes maintain their intended orientation during implantation. The asymmetric fit between the lumen and lead body creates mechanical constraints that lock the lead in a specific rotational position, thereby eliminating the flipping problem while maintaining ease of insertion.
2Reliability
If higher energy levels are used for extravascular pacing or defibrillation, then adequate cardiac stimulation is achieved, but extracardiac tissue stimulation and surgical risks increase
Solution Approach 1:
The non-circular lumen introducer tool performs a preliminary action by constraining the lead's rotational orientation before the electrodes make contact with the cardiac tissue. By preventing rotation during the entire implantation process, the system ensures that electrodes are positioned at the optimal locations for cardiac stimulation from the outset. This preliminary positioning control allows the use of lower energy levels because the electrodes are already in the correct orientation, thereby avoiding the need for high energy that would otherwise be required to compensate for improper positioning.
Data Source
AI summary
A medical device system includes an implantable medical lead including a lead body defining a proximal end and a distal portion, and at least a part of the distal portion of the lead body defines an undulating configuration. The medical device system also includes an introducer tool defining a lumen configured to receive the distal portion, and the introducer tool is configured to limit rotation of the distal portion within the lumen.


