Catheter Assembly with Segmented Return Array for PFA Lesion Control

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Solution Overview

Problem

Existing PFA systems face challenges in minimizing skeletal muscle recruitment while achieving effective lesion depth and avoiding bubble formation, particularly when comparing monopolar and bipolar catheter approaches.

Innovation Solution

A catheter assembly with a lesion generating electrode and a remotely positioned return array, including return electrodes, is configured to apply energy between the lesion generating electrode and a return patch and the return electrodes, facilitating deeper and larger lesions while minimizing unwanted effects at the return locations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of stationary object

If monopolar catheter is used to deliver PFA energy, then lesion depth is improved, but skeletal muscle recruitment increases

Engineering Contradiction:

Improvelesion depthVSAvoidskeletal muscle recruitment

Core Design Contradiction:

Length of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The return electrode is segmented into multiple discrete electrodes arranged in an array configuration, allowing selective activation of specific return electrodes to shape and confine the electric field, thereby preventing widespread skeletal muscle recruitment while maintaining effective lesion depth at the target site

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system applies different electrical properties to different regions: the lesion generating electrode delivers high-voltage pulses for deep lesion creation, while the return electrode array provides distributed current return paths with lower current density, creating localized effects that achieve deep lesions without triggering skeletal muscle recruitment

Inventive Principle:

Principle #3Local quality

2Object-affected harmful factors

If bipolar catheter is used to deliver PFA energy, then skeletal muscle recruitment is minimized, but lesion depth is reduced

Engineering Contradiction:

Improveskeletal muscle recruitmentVSAvoidlesion depth

Core Design Contradiction:

Object-affected harmful factorsVSLength of stationary object

Solution Approach 1:

The return electrode array acts as an intermediary between the lesion generating electrode and the body's natural current return paths. By providing a controlled, distributed return path through multiple electrodes, it enables monopolar-style deep lesion formation while maintaining bipolar-style control over current distribution to minimize skeletal muscle recruitment

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system transitions from the two-electrode bipolar configuration to a multi-electrode array configuration, adding spatial dimensionality to the current return path. This allows the electric field to be shaped and directed to achieve deep lesions while distributing return current to avoid skeletal muscle recruitment

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Area of moving object

If monopolar catheter is used to deliver PFA energy, then lesion size is improved, but bubble formation increases

Engineering Contradiction:

Improvelesion sizeVSAvoidbubble formation

Core Design Contradiction:

Area of moving objectVSObject-generated harmful factors

Solution Approach 1:

The return electrode is divided into multiple segmented electrodes in the array, allowing the current return path to be distributed across multiple locations. This segmentation prevents concentrated current density that would generate excessive heat and steam bubbles, while still enabling large lesion formation through coordinated activation of multiple electrodes

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system changes the electrical parameters at the return electrode by distributing current across multiple electrodes in the array, reducing current density and associated thermal effects that cause bubble formation, while maintaining the overall energy delivery needed for effective lesion creation

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20250120763A1Systems and methods for energy delivery

Publication Date: 2025.04.17 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A catheter assembly is provided. The catheter assembly includes a catheter including at least one lesion generating electrode, the at least one lesion generating electrode configured to be positioned within a patient, and at least one return array configured to be positioned within the patient and remote from the at least one lesion generating electrode, the at least one return array including at least one return electrode, wherein the catheter assembly is configured to apply energy between i) the at least one lesion generating electrode and ii) a return patch and the at least one return electrode to generate lesions proximate the at least one lesion generating electrode.