Tripodic Basket Electrode Assembly for Cardiac IRE Contact
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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 multi-electrode catheters for irreversible electroporation (IRE) face manufacturing difficulties due to complex assembly of tripodic structures with electrodes.
Innovation Solution
A medical probe with a tubular shaft and expandable basket assembly, featuring unitary tripodic structures with electrodes, is constructed by cutting planar sheets to form spines that converge at central intersections, allowing for easier assembly and deployment, and includes electrodes with lumens for spine insertion, facilitating IRE ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multi-electrode catheters with tripodic structures are assembled by attaching electrodes to spines and then forming a spherical basket, then the device can achieve effective tissue contact and current delivery, but the manufacturing time and cost increase and the chances of electrode failure due to improper bond or misalignment increase
Solution Approach 1:
The patent combines the electrode and spine into a single integrated component where the electrode is formed directly on the spine surface as a continuous structure rather than attaching separate electrodes to spines. This merging eliminates the bonding step entirely, removing the source of bond failures and misalignments while reducing manufacturing complexity and time.
Solution Approach 2:
The tripodic structure is formed from a single planar sheet that is segmented into three spines during the forming process, rather than assembling multiple separate components. This segmentation approach maintains manufacturing simplicity while achieving the desired three-dimensional basket configuration with integrated electrodes.
2Adaptability or versatility
If RF ablation is used to treat cardiac arrhythmias, then the procedure can be performed with existing technology, but thermal risks such as tissue charring, burning, steam pop, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistula increase
Solution Approach 1:
The patent changes the fundamental parameter of energy delivery from thermal (RF) to non-thermal (IRE). By using irreversible electroporation with short high-voltage pulses instead of continuous RF heating, the system achieves tissue ablation without the thermal risks of charring, burning, and steam pop, while preserving surrounding structures like the phrenic nerve and esophagus.
Solution Approach 2:
The patent replaces the thermal mechanism of RF ablation with an electrical field-based mechanism (IRE). Instead of using heat to destroy tissue, the system uses controlled electrical pulses to create irreversible permeabilization of cell membranes, achieving ablation through electrochemical changes rather than thermal mechanical effects.
3Object-affected harmful factors
If cryoablation is used to reduce thermal risks, then thermal injury is reduced, but the challenge of maneuvering the device and selectively applying cryoablation increases making it non-viable in certain anatomical geometries
Solution Approach 1:
The patent changes the energy delivery parameter from thermal (cryoablation) to electrical (IRE). By using short high-voltage electrical pulses instead of extreme cold, the system achieves tissue ablation without the maneuvering challenges of cryoablation devices while maintaining selectivity through controlled pulse application and multi-electrode configurations.
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 assembly precision, and enables effective IRE ablation with reduced thermal risks and improved anatomical reach, providing a more reliable and efficient treatment for cardiac arrhythmias.
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 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 first unitary tripodic structure and a second unitary tripodic structure, each tripodic structure formed from a respective planar sheet of material that includes three linear spines converging at a respective central spine intersection and one or more electrodes coupled to each of the spines, each electrode defining a lumen through the electrode so that the spine extends through the lumen of each of the one or more electrodes. Each tripodic structure formed from a respective planar sheet of material that includes three linear spines converging at a respective central spine intersection.