Atraumatic Tip Basket Electrode Assembly for Faster Catheter Manufacturing
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Solution Overview
Problem
Current ablation methods for cardiac arrhythmias, such as RF and cryoablation, face challenges with thermal risks and anatomical limitations, while existing multi-electrode catheters face manufacturing difficulties due to complex assembly of electrodes on spines, leading to increased time and cost.
Innovation Solution
A single unitary expandable basket assembly with a central spine intersection and independently articulating layers, featuring electrodes on spines and a central electrode, made from materials like PEEK and LCP, allowing for efficient delivery of irreversible electroporation pulses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrodes are adhered to spines using soldering, welding, or adhesive, then electrical connection is achieved, but manufacturing time increases and bond reliability decreases
Solution Approach 1:
The electrode and spine are merged into a single monolithic structure formed by additive manufacturing, eliminating the need for separate attachment processes. The electrode is directly printed as part of the spine structure, removing soldering, welding, or adhesive bonding steps entirely.
Solution Approach 2:
Traditional mechanical attachment methods (soldering, welding, adhesive bonding) are replaced by additive manufacturing processes that directly form the electrode structure. This substitution eliminates the need for separate joining operations and reduces manufacturing complexity.
2Ease of manufacture
If multiple linear spines are assembled into a spherical basket, then the basket structure is formed, but manufacturing complexity and cost increase
Solution Approach 1:
Multiple linear spines and the spherical basket structure are merged into a single monolithic component manufactured through additive manufacturing. The spines are directly formed as integral parts of the spherical structure, eliminating separate assembly operations.
Solution Approach 2:
The complete spherical basket structure with all spines is pre-formed in a single additive manufacturing process, rather than assembling multiple components. This preliminary formation of the entire structure simplifies subsequent manufacturing steps.
3Manufacturing precision
If electrodes are attached to spines, then electrical function is achieved, but misalignment and bond failure risk increase
Solution Approach 1:
The electrode and spine are merged into a single monolithic structure where the electrode is directly formed as part of the spine. This integration eliminates misalignment issues entirely, as there is no separate attachment process that could result in positioning errors.
4Productivity
If traditional basket assembly methods are used, then catheter functionality is achieved, but manufacturing cost and time increase
Solution Approach 1:
Multiple discrete components (spines, electrodes, basket structure) are merged into a single monolithic structure manufactured through additive manufacturing. This integration dramatically reduces the number of manufacturing steps and assembly operations required.
Solution Approach 2:
Traditional mechanical assembly processes are replaced by additive manufacturing technology that directly forms the complete structure in one process. This substitution eliminates multiple manufacturing steps including cutting, bending, assembling, and bonding operations.
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 assembly reduces manufacturing time and cost, enhances electrode stability, and enables effective irreversible electroporation for cardiac tissue ablation with reduced thermal risks and improved anatomical reach.
Implementation Method 1
IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes
Data Source
AI summary
The disclosed technology includes an expandable basket assembly for a medical probe, which may include a single unitary structure comprising a plurality of spines converging at a central spine intersection, the central spine intersection being positioned on a longitudinal axis of the expandable basket assembly at a distal end thereof. The plurality of spines may include a first layer and a second layer attached to the first layer and including a central cutout about the central spine intersection that exposes the first layer at the central spine intersection. The plurality of spine may include a central electrode attached to the first layer at the central spine intersection via a central aperture in the first layer at the central spine intersection. The second layer may be configured to articulate independently of the first layer at the central spine intersection.