Linear Spine Basket Assembly for Stable IRE Tissue Contact
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Solution Overview
Problem
Current ablation technologies for cardiac arrhythmias, such as RF and cryoablation, face challenges with thermal risks and anatomical limitations, while existing IRE catheters face difficulties in manufacturing complex basket assemblies with electrodes due to small size and alignment issues.
Innovation Solution
A medical probe with a tubular shaft and expandable basket assembly featuring spine sections, a loop retention hub, and electrodes, allowing for easy assembly and deployment of electrodes on a basket shape, facilitating IRE ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrodes are attached to small spines using soldering, welding, or adhesive, then electrical connection is achieved, but manufacturing time increases and reliability decreases due to improper bonds or misalignment
Solution Approach 1:
The device segments the electrode and spine into separate components that are assembled together, allowing for independent manufacturing and quality control. The electrode hub serves as a central assembly point where multiple electrodes are attached to multiple spines, enabling modular construction that reduces overall manufacturing complexity and time while maintaining bond reliability through standardized connection interfaces.
2Area of stationary object
If multiple linear spines are assembled into a spherical basket configuration, then complete tissue contact is achieved, but manufacturing complexity increases due to alignment requirements
Solution Approach 1:
The electrode hub serves as an intermediary component that simplifies the assembly of multiple spines into a spherical basket configuration. Instead of directly connecting spines to each other, the hub provides a central reference point and standardized attachment interfaces, making it easier to achieve proper alignment and spherical geometry while reducing overall assembly complexity.
3Reliability
If RF ablation is used to treat cardiac arrhythmias, then ablation effectiveness is achieved, but thermal risks increase leading to tissue injury
Solution Approach 1:
The device enables parameter changes by supporting multiple ablation modalities (RF and IRE) through the same electrode array. By switching between continuous RF energy delivery and pulsed IRE energy delivery, the system can adjust energy parameters to achieve effective ablation while minimizing thermal risks. The pulsed nature of IRE allows for intermittent energy delivery with cooling intervals, reducing cumulative thermal load on tissues.
4Object-affected harmful factors
If cryoablation is used to reduce thermal risks, then thermal safety is improved, but maneuverability decreases making it challenging in certain anatomical geometries
Solution Approach 1:
The catheter design achieves universality by creating a single device platform that can perform both RF ablation and IRE ablation. This multi-functional approach eliminates the need for separate cryoablation devices, maintaining the maneuverability advantages of the flexible catheter design while providing thermal safety through controlled energy delivery parameters and pulsed IRE cycles that prevent excessive heat accumulation.
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 electrode stability, and improves the effectiveness of IRE ablation by ensuring proper electrode placement and contact with cardiac tissue.
Implementation Method 1
IRE delivers short pulses of high voltage to tissues and generates an unrecoverable permeabilization of cell membranes
Data Source
Figure 1
Figure 2A~2C
Figure 2D~2E
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 planar sheet 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.