Substernal Pacing Lead Placement Without Cardiac Attachment
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Solution Overview
Problem
Existing cardiac pacing systems require at least two electrodes to be implanted inside or on the heart, which can be invasive and may lead to complications, and there is a need for a less invasive method to provide effective cardiac pacing.
Innovation Solution
A cardiac pacing system with a lead implanted in the anterior mediastinum, delivering pacing pulses to the heart without entering the vasculature or attaching to the heart, using electrodes positioned within the substernal space and a pacemaker implanted subcutaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cardiac pacing systems use multiple electrodes implanted within the vasculature or directly on the heart, then effective arrhythmia treatment is achieved, but the procedure becomes invasive and requires entering the pericardium or attaching to the heart
Solution Approach 1:
The patent introduces an intermediary approach by placing electrodes in the anterior mediastinum (substernal region) rather than directly in the heart or vasculature. This intermediate location allows electrical stimulation to reach the heart through the sternum and mediastinal tissues, effectively treating arrhythmias while avoiding the need to enter the pericardium or attach directly to cardiac tissue.
2Reliability
If electrodes are implanted within the vasculature or on the heart, then direct electrical stimulation is achieved, but the risk of extra-cardiac stimulation and complications increases
Solution Approach 1:
The patent applies local quality by positioning electrodes specifically in the anterior mediastinum with orientation and configuration optimized to direct electrical fields toward the heart. The substernal placement with specific electrode arrangements creates localized stimulation zones that target cardiac tissue while minimizing spread to extra-cardiac structures, thereby reducing the risk of unintended stimulation.
3Reliability
If traditional pacemaker leads are used requiring vascular access, then reliable electrode placement is achieved, but the procedure complexity and patient trauma increase
Solution Approach 1:
The patent extracts the electrodes from the traditional vascular/epicardial implantation pathway and relocates them to the anterior mediastinum. This extraction from the conventional approach eliminates the need for venous access, lead threading through the heart, or surgical epicardial attachment, thereby simplifying the overall implantation procedure while maintaining electrode placement reliability through direct substernal positioning.
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
Provides effective cardiac pacing with reduced invasiveness, avoiding complications associated with traditional implantation methods, and allows for multi-chamber pacing without requiring direct attachment to the heart.
Implementation Method 1
the pacemaker is configured to deliver pacing pulses to a heart of the patient
Data Source
AI summary
Implantable cardiac pacing systems and methods for providing substernal pacing are described. In one example, a cardiac pacing system includes a pacemaker implanted in a patient and an implantable medical electrical lead. The implantable medical electrical lead includes an elongated lead body having a proximal end and a distal portion, a connector configured to couple to the pacemaker at the proximal end of the elongated lead body, and one or more electrodes along the distal portion of the elongated lead body, wherein the distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the pacemaker is configured to deliver pacing pulses to a heart of the patient.