Spline Electrode Circuit Layout for Selective PFA Catheters
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Solution Overview
Problem
Existing ablation techniques such as RF ablation and cryoablation indiscriminately damage healthy tissue, while irreversible electroporation can selectively target tissue but requires improved catheter designs for precise application.
Innovation Solution
A catheter with a set of splines that transition between collapsed and expanded configurations, each spline featuring a flexible circuit with electrodes for both ablation and sensing, allowing for precise tissue targeting and mapping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal ablation techniques (RF ablation, cryoablation) are used to destroy tissue, then tissue ablation is achieved, but healthy tissue is indiscriminately damaged or killed
Solution Approach 1:
The patent replaces thermal ablation mechanisms (heat-based destruction) with electrical field-based irreversible electroporation. This substitution allows selective tissue ablation through controlled electrical pulses that create pores in cell membranes, enabling precise targeting of cardiac tissue while sparing healthy structures such as the esophagus, phrenic nerve, and coronary arteries.
Solution Approach 2:
The patent utilizes changes in electrical field parameters (voltage, pulse duration, frequency) to achieve irreversible electroporation. By carefully controlling these parameters, the system can selectively destroy targeted cardiac tissue while maintaining safety margins for surrounding healthy tissue, thus resolving the contradiction between ablation effectiveness and tissue preservation.
2Reliability
If irreversible electroporation is used to selectively kill targeted tissue, then selectivity is improved, but precise application requires improved catheter designs
Solution Approach 1:
The catheter is divided into multiple functional segments including a flexible circuit board with integrated electrodes, splines for positioning, and a catheter shaft. This segmentation allows each component to be optimized independently - the flexible circuit provides precise electrical control, while the splines enable accurate positioning and contact with the target tissue, thereby achieving selective ablation without excessive overall complexity.
Solution Approach 2:
The catheter design integrates multiple functions into a single device: mapping, ablation, and sensing capabilities are combined. The flexible circuit board serves both as an electrical connection medium and as a structural support for electrodes, while the same catheter can perform both diagnostic mapping and therapeutic ablation, reducing the need for multiple separate devices.
3Measurement precision
If a catheter with flexible circuit and electrodes is used for irreversible electroporation, then precise tissue targeting is enabled, but device complexity increases
Solution Approach 1:
The patent merges the flexible circuit board directly with the catheter structure, integrating electrical connection and mechanical support functions. The electrodes are incorporated into the spline assembly, combining sensing and ablation capabilities in a single integrated unit. This merging approach enables precise tissue targeting through coordinated electrical and mechanical control while minimizing the number of separate components.
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 precise and targeted tissue ablation with reduced damage to non-targeted tissues by using irreversible electroporation, enhancing the accuracy and safety of cardiac ablation procedures.
Implementation Method 1
a flexible circuit within the spline, the flexible circuit including a plurality of lead traces electrically coupled to a plurality of electrodes on a surface of the spline
Implementation Method 2
an electrical field is applied to cells to increase the permeability of the cell membrane... 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
A catheter for ablating cardiac tissue through irreversible electroporation is disclosed. The catheter includes an elongated shaft having a distal region, in which the elongated shaft defining a longitudinal axis, and a set of splines extending from the distal region of the shaft. The set of splines are configured for translation along the longitudinal axis to transition between a collapsed configuration and an expanded configuration. Each spline forms a loop in the expanded configuration. Each spline of the set of splines includes an electrode assembly having a flexible circuit within the spline. The flexible circuit includes lead traces electrically coupled to electrodes on a surface of the spline.