Flexible Multi-Arm Catheter With Opposed Electrodes for Low-Contact Mapping

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Solution Overview

Problem

Diagnostic cardiac catheters with rigid structures can trigger ectopic heartbeats and risk myocardial perforation due to mechanical contact and sharp edges, limiting their safety and accessibility during cardiac procedures.

Innovation Solution

A flexible multi-arm catheter design featuring multiple flexible spines with diametrically opposed sensing electrodes, constructed using high-tensile-strength materials like Vectran® or UHMWPE, allows the spines to bend proximally and inwardly, minimizing contact with tissue and reducing the risk of ectopic beats and perforation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If rigid structures are used in diagnostic cardiac catheters, then structural stability and support are improved, but the risk of triggering ectopic heartbeats and myocardial perforation increases

Engineering Contradiction:

Improvestructural stabilityVSAvoidrisk of ectopic heartbeats and myocardial perforation

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent applies flexible spines made of materials like Shape Memory Alloy (SMA) and Nitinol that can bend and conform to cardiac anatomy. These flexible spines replace rigid structures while maintaining structural integrity through their unique material properties, eliminating sharp edges that cause tissue damage and ectopic beats.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent utilizes phase transition properties of Shape Memory Alloy to change the mechanical parameters of the spines. The spines can transition between rigid and flexible states based on temperature or other stimuli, providing structural stability when needed while allowing flexibility to avoid tissue damage during navigation.

Inventive Principle:

Principle #35Parameter changes

2Object-affected harmful factors

If flexible spines are used in catheters, then safety and comfort are improved, but structural support and stability deteriorate

Engineering Contradiction:

Improvesafety and comfortVSAvoidstructural support

Core Design Contradiction:

Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent employs composite construction combining Shape Memory Alloy spines with Nitinol elements. This composite structure provides both flexibility for safety and sufficient structural support for stability. The SMA provides shape memory effects while Nitinol adds superelasticity, creating a balanced system that meets both requirements.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The flexible spines are designed to be dynamically adjustable, allowing them to change their mechanical properties during the procedure. They can be rigidified when structural support is needed and softened when navigating complex anatomy, providing adaptive structural support rather than fixed rigidity.

Inventive Principle:

Principle #15Dynamics

3Stability of the object's composition

If spines are anchored at both ends, then structural stability is improved, but flexibility and ability to bend proximally deteriorate

Engineering Contradiction:

Improvestructural stabilityVSAvoidflexibility to bend

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent segments the spine structure into multiple sections with different anchoring configurations. Only the distal end is anchored to the shaft, while the proximal end remains free to bend. This segmentation allows the spine to maintain structural stability at the anchored end while providing flexibility and adaptability at the unanchored end for navigating cardiac anatomy.

Inventive Principle:

Principle #1Segmentation

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 flexible design enhances safety and accessibility, enabling precise electrophysiological mapping and ablation procedures with reduced complications, particularly in challenging cardiac anatomies.

Implementation Method 1

Each of the flexible spines includes a tensile layer configured to cause the flexible spine to bend proximally

Methodology Applied

Scientific EffectTensile stress: Tension

Data Source

PatentUS20250295450A1Flexible multi-arm catheter with diametrically opposed sensing electrodes

Publication Date: 2025.09.25 BIOSENSE WEBSTER (ISRAEL) LTD

AI summary

A medical instrument includes a shaft, multiple flexible spines and multiple electrodes. The shaft is configured for insertion into a body of a patient. The multiple flexible spines have respective first ends that are connected to a distal end of the shaft and respective second ends that are free-standing and unanchored. The spines are bent proximally such that the second ends are more proximal than the first ends. Each of the flexible spines includes a tensile layer configured to cause the flexible spine to bend proximally. The multiple electrodes are disposed over the flexible spines.