Left Atrial Endocardial Electrodes for Low-Energy Cardioversion
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Solution Overview
Problem
Current cardiac pacing and defibrillation technologies face challenges in safely placing wires on the left side of the heart due to the risk of thrombus formation and detachment, leading to potential strokes, and require high energy defibrillation causing patient discomfort and battery wear.
Innovation Solution
Low profile electrodes and restraining devices are designed to attach to the endocardium, eliminating free-floating wires and allowing for low energy sensing, pacing, and defibrillation of the left atrium, using shape memory metals to maintain contact with the heart tissue and prevent thrombus formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If wires are placed on the left side of the heart for sensing and pacing, then atrial arrhythmia detection and treatment capability is improved, but the risk of thrombus formation and stroke increases
Solution Approach 1:
The patent introduces an intermediary substance (thrombus-resistant coating or thrombus trap) between the wire and blood flow. This intermediary layer prevents direct contact between the wire surface and circulating blood, thereby eliminating thrombus formation while allowing the wire to remain in place for sensing and pacing functions.
Solution Approach 2:
The patent extracts or removes the harmful thrombus formation capability from the system by using wires that are either coated with thrombus-resistant materials or designed to trap and contain thrombi in a controlled manner, preventing them from detaching and causing strokes while maintaining the wire's functional presence in the left atrium.
2Reliability
If high energy defibrillation is used to treat atrial fibrillation, then arrhythmia termination effectiveness is improved, but patient discomfort and battery wear increase
Solution Approach 1:
The patent applies local quality by placing sensing and defibrillation electrodes specifically in the left atrium, the precise location where arrhythmias originate. This localized placement allows for targeted low-energy defibrillation of only the affected area rather than requiring high-energy shocks of the entire heart, thereby reducing energy consumption while maintaining arrhythmia termination effectiveness.
Solution Approach 2:
The patent segments the defibrillation approach by separating the sensing and treatment functions into distinct localized electrodes within the left atrium. This segmentation enables independent optimization of sensing sensitivity and defibrillation energy delivery, allowing low-energy shocks to effectively terminate arrhythmias without requiring high total energy input.
3Ease of operation
If wires are allowed to float freely in the heart chamber, then ease of placement is improved, but thrombus detachment and stroke risk increase
Solution Approach 1:
The patent applies dynamics by allowing the wire to be initially flexible and movable during placement, then transitioning to a fixed or semi-fixed state through thrombus-resistant coatings or trapping mechanisms. This dynamic approach maintains ease of placement during insertion while preventing thrombus detachment during the critical functional phase.
Solution Approach 2:
The patent applies beforehand cushioning by pre-coating the wire with thrombus-resistant materials or pre-positioning thrombus trap structures before blood flow begins. This protective measure is established in advance to prevent thrombus formation and detachment, thereby maintaining wire placement ease while eliminating the harmful effect of thrombus detachment.
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
Enables safe and effective low-energy defibrillation and sensing of the left atrium, reducing patient discomfort and extending battery life, while minimizing thrombus risk through secure attachment to the heart tissue.
Implementation Method 1
using shape memory metals to maintain contact with the heart tissue
Data Source
AI summary
Disclosed are various configurations of electrodes with accompanying extensions and wires configured to be attached at or near the left atrium of a heart to allow the device to be held snug against the endocardium and out of the blood flow for low energy defibrillation of the atria in response to atrial fibrillation or other atrial arrhythmias. The portion of the lead internal to the atrium (e.g., the left atrium) is restrained against the endocardium of the left atrium by way of a restraint mechanism. In one example, the electrode is configured to attach to the atrial septum, with wires containing memory-shaped metal to keep the wires against the heart wall. In yet another example, the electrode is configured to be part of a mitral valve device.