Linear Spine Spherical Basket for IRE Tissue Contact
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Solution Overview
Problem
Current catheter technologies for inducing irreversible electroporation (IRE) in cardiac tissues face challenges such as increased manufacturing time and cost due to the difficulty in attaching electrodes to spines and forming a spherical basket assembly, which can lead to improper bonding and misalignment, and are not viable in certain anatomical geometries.
Innovation Solution
A medical probe with an expandable basket assembly comprising a plurality of spines and electrodes, where the electrodes are coupled to a polymer tube and feature catalytic materials like platinum, zirconium, or ruthenium, allowing for efficient delivery of electrical pulses for IRE, and the basket assembly can be compressed into a smaller form factor for easier deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrodes are attached to spines using traditional methods (soldering, welding, or adhesive), then electrical connection is achieved, but manufacturing time increases and bonding reliability decreases
Solution Approach 1:
The patent replaces traditional mechanical attachment methods (soldering, welding, adhesive bonding) with an interference fit mechanism. The electrode is formed with a reduced diameter portion that mechanically engages within a corresponding expanded portion of the spine, creating a secure connection through elastic deformation and friction without requiring thermal or chemical bonding processes.
Solution Approach 2:
The patent integrates the electrode and spine into a unified assembly where the electrode's expanded portion is permanently deformed to fit within the spine's corresponding cavity. This merging of components eliminates the need for separate attachment steps and ensures reliable electrical connection while reducing manufacturing complexity.
2Shape
If multiple linear spines are assembled into a spherical basket by attaching both ends to a tubular shaft, then the basket structure is formed, but manufacturing complexity increases and misalignment risks increase
Solution Approach 1:
The patent divides the basket assembly into discrete modular components: individual spines with integrated electrodes, a tubular shaft, and a closure member. Each component can be manufactured and assembled separately, allowing for quality control and reducing overall assembly complexity while maintaining the spherical geometry.
Solution Approach 2:
The patent introduces a closure member as an intermediary component that secures the spines to the tubular shaft. This closure member simplifies the assembly process by providing a standardized interface between the spines and shaft, reducing misalignment risks and manufacturing complexity while maintaining structural integrity.
3Reliability
If the basket assembly is made larger to improve tissue contact, then ablation effectiveness increases, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The patent designs the basket assembly with flexible spines that can dynamically adapt to the curvature of cardiac tissues. The spines are constructed with appropriate rigidity to maintain contact with irregular tissue surfaces while remaining manageable during deployment, effectively increasing tissue contact area without proportionally increasing device complexity.
Solution Approach 2:
The patent varies the properties of different basket components to optimize tissue contact. The spines have specific flexibility and rigidity characteristics that allow them to conform to tissue geometry, while the closure member and shaft maintain structural integrity. This localized optimization of material properties enables effective tissue contact without requiring uniform complexity throughout the entire device.
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 solution reduces manufacturing time and cost, enhances the reliability of electrode attachment, and enables effective IRE ablation in various anatomical geometries by providing a flexible and efficient basket assembly for delivering high-voltage electrical pulses.
Implementation Method 1
Each electrode can comprise a substrate and catalytic material coating at least a portion of the substrate. The catalytic material can be selected from the group consisting of platinum (Pt), zirconium (Zr), hafnium (Hf), ruthenium (Ru), rhodium (Rh), palladium, (Pd), osmium (Os), iridium (Ir), gold (Au), Fe—N—C materials, and combinations thereof.
Data Source
AI summary
The disclosed technology includes a medical probe comprising a tubular shaft extending along a longitudinal axis and including a proximal end and a distal end. The medical probe further comprises an expandable basket assembly proximate the distal end of the tubular shaft. The basket assembly comprises a single unitary structure that includes a plurality of linear spines formed from a single piece of material and one or more electrodes coupled to each of the spines, each electrode defining a lumen through the electrode so that a spine extends through the lumen of each of the one or more electrodes. The spines converge at a central spine intersection at a distal end of the basket assembly. The central spine intersection includes one or more cutouts that allows for bending of the spines. Each spine comprises a respective end connected to the distal end of the tubular shaft.