Spline-Based Ablation Catheter Retainer for Tissue Selectivity
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Solution Overview
Problem
Current ablation techniques, such as RF ablation and cryoablation, indiscriminately kill tissue, leading to damage of healthy tissue, while irreversible electroporation lacks acute visualization to differentiate between irreversibly and reversibly electroporated tissues.
Innovation Solution
A catheter with a spline-based electrode assembly for irreversible electroporation, featuring a tubular shaft, an electrode assembly with splines, and a spline retainer to mechanically support the splines, allowing for precise generation of electric fields for targeted tissue ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal ablation techniques (RF ablation or cryoablation) are used to destroy targeted tissue, then the ablation effectiveness is improved, but healthy non-targeted tissue is damaged due to indiscriminate tissue killing
Solution Approach 1:
The catheter employs multiple discrete splines (e.g., 8 splines) that can be independently controlled and activated. Each spline can deliver electroporation energy to specific tissue regions, allowing selective ablation of targeted tissue while preserving adjacent healthy tissue. The segmented electrode structure enables precise spatial control over where energy is delivered.
Solution Approach 2:
The electroporation catheter delivers energy in a highly localized manner through individual splines, creating focal ablation zones only where needed. The electric field is concentrated at the tissue-spline interface, producing localized cellular permeabilization and apoptosis without affecting surrounding healthy tissue, thus achieving local quality control over energy delivery.
2Object-affected harmful factors
If irreversible electroporation is used to selectively kill targeted tissue, then damage to non-targeted healthy tissue is reduced, but acute visualization to differentiate between irreversibly and reversibly electroporated tissues is lacking
Solution Approach 1:
The catheter incorporates visual indicators (such as colored markers or fluorescent elements) on the splines and electrode assembly that change color or become visible under specific imaging modalities when electroporation occurs. This allows real-time visualization and differentiation between irreversibly and reversibly electroporated tissues during the procedure.
Solution Approach 2:
The system includes sensing electrodes that provide real-time feedback on tissue electrical properties during electroporation. By monitoring changes in tissue impedance and electrical characteristics, the system can distinguish between reversible and irreversible electroporation states, providing acute visualization and guidance for continued selective ablation.
3Manufacturing precision
If multiple splines are used in the electrode assembly to improve ablation precision, then targeted tissue selection is improved, but device complexity increases due to the need for mechanical support structures
Solution Approach 1:
The spline retainer is integrated with the catheter shaft as a unified structure, combining mechanical support and spline retention functions into a single component. This merging reduces the number of separate parts and simplifies assembly, thereby reducing device complexity while still providing the necessary mechanical support for multiple precision splines.
Solution Approach 2:
The spline retainer serves multiple functions: it mechanically supports the splines, positions them in precise three-dimensional configurations, and provides electrical isolation between adjacent splines. This multi-functionality reduces the need for additional specialized components, thereby reducing overall device complexity while maintaining high ablation precision.
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 catheter enables safe and effective ablation of targeted cardiac tissue with minimal damage to non-targeted tissues by generating controlled electric fields, improving the precision and safety of irreversible electroporation procedures.
Implementation Method 1
In irreversible electroporation, trains of short, high voltage pulses are used to generate electric fields that are strong enough to kill cells through apoptosis
Data Source
AI summary
An ablation catheter includes a tubular shaft having a proximal portion and a distal end and an electrode assembly extending from the distal end of the shaft. The electrode assembly includes a plurality of splines each having a spline proximal portion secured to the shaft, and an opposite spline distal portion. Each spline includes an electrically conductive support member partially disposed within an insulating member. The support member has a proximal end portion disposed within the insulating member and a distal end portion extending distally of the insulating member and terminating at a support member distal end. A plurality of sensing electrodes is disposed along each spline. A spline retainer mechanically engages with at least one of the proximal and distal portions of the splines.