Magnetic Catheter Alignment for Transmural Cardiac Ablation

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Solution Overview

Problem

Current catheter-based treatments for atrial fibrillation have limited success rates due to the inability to create full-thickness, continuous ablation lesions, particularly in patients with persistent AF, and often require multiple procedures with higher costs and inconvenience.

Innovation Solution

A magnetic-draw element coupled with a catheter having an expandable portion allows for simultaneous endocardial and epicardial ablation, aligning the catheters on either side of the heart tissue to create transmural lesions through magnetic attraction, mimicking the success of open-heart surgery without the need for invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current catheter-based treatments are used for atrial fibrillation ablation, then the procedure is less invasive compared to open-heart surgery, but the success rate remains below 50% at one year due to inability to create full-thickness continuous ablation lesions

Engineering Contradiction:
Improvesuccess rate of ablation treatmentVSAvoidcomplexity of achieving full-thickness lesions
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The ablation procedure is segmented into two simultaneous actions: endocardial ablation from inside the heart and epicardial ablation from outside the heart. The catheter system is divided into separate endocardial and epicardial components that work together to create complete transmural lesions, with each component performing a specific portion of the ablation task

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Magnetic elements serve as intermediaries to couple the endocardial and epicardial catheters. These magnetic elements attract and align the two catheters across the heart wall, enabling precise coordination of ablation lesions without direct mechanical connection, thus facilitating full-thickness lesion creation

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If open-heart surgery Cox-Maze procedure is performed to create full-thickness ablation lesions, then success rate reaches 80-90% at one year, but the procedure becomes highly invasive requiring almost no patients to undergo it

Engineering Contradiction:
Improvesuccess rate of ablation treatmentVSAvoidinvasiveness of procedure
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The procedure merges minimally invasive catheter-based endocardial ablation with epicardial ablation through magnetic coupling. This combination achieves the full-thickness lesion creation capability of surgery while maintaining the minimally invasive nature of catheter procedures, eliminating the need for open-heart surgery

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces the mechanical surgical incision system with a magnetic field-based catheter coupling system. Instead of using surgical knives and direct mechanical contact to create lesions, the system uses magnetic attraction to position and coordinate catheter-based ablation elements that create lesions through energy delivery

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of manufacture

If separate procedures are performed for endocardial and epicardial ablation, then each procedure can be optimized independently, but alignment and control for interactive manipulation are poor leading to multiple procedures required

Engineering Contradiction:
Improveease of independent procedure optimizationVSAvoidtime for multiple procedures and recovery periods
Core Design Contradiction:
Ease of manufactureVSLoss of time

Solution Approach 1:

The magnetic coupling enables continuous coordination between endocardial and epicardial catheters during a single procedure. The magnetic attraction maintains constant alignment and interaction between the two catheter systems throughout the ablation process, allowing simultaneous and coordinated lesion creation without interruption or need for repositioning

Inventive Principle:
Principle #20Continuity of useful action

4Manufacturing precision

If magnetic elements are used to align catheters on either side of heart tissue, then transmurality of ablation lesions is enhanced, but device complexity increases with expandable portions and magnetic coupling mechanisms

Engineering Contradiction:
Improvealignment precision of ablation lesionsVSAvoidcomplexity of catheter system with magnetic coupling
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The catheter system incorporates dynamic expandable portions that can transition between collapsed and expanded states. The expandable distal portion and intermediate portion allow the catheter to adapt its shape and size during navigation and deployment, enabling the magnetic elements to align precisely while maintaining flexibility for complex anatomical navigation

Inventive Principle:
Principle #15Dynamics

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 approach enhances the alignment and transmurality of ablation lesions, improving the success rate of catheter-based treatments for atrial fibrillation by allowing for full-thickness ablation across heart tissue, reducing the need for multiple procedures and minimizing tissue damage.

Implementation Method 1

moves the procedure-specific tool, in part by the first magnetic element moving via magnetic attraction. While the first magnetic element and the magnetic-draw element align on either side of the biological tissue

Methodology Applied
Scientific EffectMagnetic attraction: Magnetism

Data Source

PatentUS20220378500A1Devices and methods involving transmural-capable tissue procedures
Publication Date: 2022.12.01 THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIV
  • US20220378500A1 patent drawing
  • US20220378500A1 patent drawing
  • US20220378500A1 patent drawing

AI summary

In certain examples, aspects are directed to an ablation tool or other procedure-specific tool to treat or assess biological tissue (e.g., ablate cardiac tissue) having a first tissue side and a second, opposite tissue side at which a magnetic-draw element is to be located. In a specific example, a first magnetic element is associated with or coupled to a catheter tool having an expandable portion to transition from a first state towards a second state for providing an expanded girth, so that the expandable portion surrounds the first magnetic element and moves the procedure-specific tool, in part by the first magnetic element moving via magnetic attraction. While the first magnetic element and the magnetic-draw element align on either side of the biological tissue, the procedure-specific tool may be used for the procedure.