Deformed Spine Electrode Basket for Irreversible Electroporation
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Solution Overview
Problem
Current ablation methods for cardiac tissue, such as RF ablation, face challenges like thermal injuries and anatomical limitations, while cryoablation is more difficult to maneuver and not viable in all geometries, necessitating a more efficient and effective method for ablating cardiac tissue without thermal damage.
Innovation Solution
An expandable basket assembly for a multi-electrode catheter with deformed spines and integrated electrode assemblies, where the spines protrude radially and feature an insulating layer between the electrode layer and the spine, allowing for the delivery of high-voltage pulses for irreversible electroporation without the need for soldering or welding, using materials like carbon fiber, nitinol, or cobalt chromium, and a flexible circuit for electrical connectivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate electrode components are attached to spines using soldering, welding, or adhesive, then electrical connectivity is achieved, but manufacturing time and cost increase and reliability decreases due to improper bonds or misalignment
Solution Approach 1:
The electrode and spine are merged into a single integrated component where the electrode is formed as an extension or feature of the spine structure itself, eliminating the need for separate attachment processes. This integration ensures proper alignment and bonding while simplifying manufacturing.
Solution Approach 2:
The spine structure serves multiple functions: it provides structural support for the basket assembly and simultaneously functions as the electrode substrate. This multi-functionality eliminates the need for separate electrode components and their associated attachment processes.
2Reliability
If RF ablation is used to treat cardiac arrhythmia, then ablation of cardiac tissue is achieved, but thermal injuries such as tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula occur
Solution Approach 1:
The invention changes the ablation parameter from thermal energy (RF) to non-thermal energy (irreversible electroporation). By using high-voltage electrical pulses instead of continuous RF heating, the method achieves tissue ablation without the thermal injuries associated with traditional RF ablation.
Solution Approach 2:
The invention replaces the thermal mechanism of RF ablation with an electrical field-based mechanism (irreversible electroporation). This substitution eliminates thermal damage while maintaining the ability to ablate cardiac tissue effectively.
3Object-affected harmful factors
If cryoablation is used to reduce thermal risks, then thermal injuries are reduced, but device maneuvering becomes more challenging and anatomical geometries are limited
Solution Approach 1:
The invention moves away from both thermal approaches (RF and cryo) by using non-thermal irreversible electroporation. This parameter change allows for flexible catheter design that can navigate complex anatomical geometries while avoiding both thermal injuries and cryoablation's maneuvering limitations.
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
This solution enables efficient and precise delivery of electrical pulses for irreversible electroporation, reducing the risk of thermal damage and improving manufacturing efficiency by eliminating the need for separate electrode attachments, thus enhancing the viability of ablation procedures in complex anatomical geometries.
Implementation Method 1
IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes
Implementation Method 2
an insulating layer being disposed between the electrode layer and the spine protrusion
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3B
AI summary
The disclosed technology includes a medical probe including an expandable basket assembly. The basket assembly includes a spine, and the spine includes a deformed region, a spine protrusion, that can be used to deposit an electrode. The electrode can be formed of an electrode assembly that can include an insulative layer and an electrode layer. The electrode assembly is deposed on the spine protrusion so as to avoid the need of separate electrode components that must be positioned along the length of the spine.