Flexible Electrode Assembly for Cardiac Ablation Catheters
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Solution Overview
Problem
Current medical devices for cardiac mapping and ablation lack effective alternatives in design and manufacturing methods, which restrict their performance and versatility.
Innovation Solution
A catheter design featuring an elongate shaft with a distal ablation electrode region and an electrode assembly comprising a flexible circuit with electrodes, where the electrode assembly extends through openings on the catheter shaft, providing mechanical locking and improved tissue contact, while allowing for flexible placement and reduced RF edge effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the electrode assembly is rigidly fixed to the distal ablation electrode region, then mechanical stability is improved, but tissue contact flexibility and ability to conform to cardiac surfaces deteriorates
Solution Approach 1:
The electrode assembly is designed with dynamic characteristics, allowing it to flex and conform to the irregular surfaces of cardiac tissue while maintaining stable electrical connections. The assembly can dynamically adjust its shape during catheter manipulation and ablation procedures.
Solution Approach 2:
The electrode assembly utilizes flexible circuit boards and thin-film electrode structures that can bend and conform to tissue surfaces. These flexible components maintain electrical connectivity while adapting to the complex geometry of cardiac chambers, resolving the contradiction between mechanical stability and tissue contact flexibility.
2Reliability
If the electrode assembly extends through multiple openings in the distal ablation electrode region, then mechanical locking and secure attachment are improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The electrode assembly is segmented into multiple sections that can be independently positioned through separate openings in the distal ablation electrode region. This segmentation allows each section to be securely locked in place while maintaining overall structural integrity, achieving reliable mechanical attachment without excessive complexity.
Solution Approach 2:
The electrode assembly components are nested within the catheter shaft and distal ablation electrode region, with elements arranged in a hierarchical structure. This nesting approach allows multiple components to be integrated through multiple openings in a organized manner, improving mechanical locking while managing device complexity through systematic arrangement.
3Area of stationary object
If the electrode assembly is designed to bow radially outward from the distal ablation electrode region, then tissue contact area is improved, but structural integrity and risk of damage increase
Solution Approach 1:
The electrode assembly exhibits local quality variations, with different sections having different structural properties. Regions requiring flexibility and tissue contact are designed with lower stiffness, while regions requiring strength maintain higher structural integrity. This localized differentiation allows radial bowing for increased tissue contact area without compromising overall structural strength.
Solution Approach 2:
The electrode assembly utilizes composite material structures combining flexible substrates with reinforced elements. This composite construction enables the assembly to bow radially outward for enhanced tissue contact while the reinforcing components maintain structural integrity and prevent damage during manipulation and use.
Data Source
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AI summary
Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter for use in cardiac mapping and/or ablation. The catheter may include an elongate catheter shaft having a distal ablation electrode region capable of ablating tissue. An electrode assembly may be coupled to the distal ablation electrode region. The electrode assembly may include a flexible circuit having one or more electrodes disposed thereon.