Expandable Probe Basket Cloverleaf Structure for Stronger Distal Ends
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Solution Overview
Problem
Current ablation technologies for cardiac arrhythmias, such as RF and cryoablation, face challenges including thermal risks and anatomical limitations, while existing IRE catheters face manufacturing difficulties due to complex electrode attachment and assembly of spines into a spherical basket.
Innovation Solution
A medical probe with an expandable basket assembly featuring a cloverleaf structure and sinusoidal-like members, which includes side connectors and retention members to enhance strength and ease of assembly, allowing for efficient deployment and electrical isolation of electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional electrode attachment methods (soldering, welding, adhesive) are used on small spines, then electrical connection is achieved, but manufacturing complexity and time increase significantly
Solution Approach 1:
The basket assembly is divided into modular components: a tubular shaft and separate spines with electrodes. The spines are detachable and can be independently manufactured and assembled, reducing the complexity of creating a monolithic structure while maintaining reliable electrical connections through standardized attachment interfaces.
Solution Approach 2:
Electrodes are pre-attached to spines during spine manufacturing before final basket assembly. This preliminary electrode attachment allows for quality control and optimization of the electrode-spine interface without adding complexity to the final assembly step, where spines are simply inserted into the tubular shaft.
2Reliability
If multiple linear spines are assembled into a spherical basket, then electrode coverage is achieved, but manufacturing time and cost increase
Solution Approach 1:
The spherical basket is segmented into multiple identical or standardized spines that can be manufactured independently using automated processes. These pre-fabricated spines with integrated electrodes are then assembled into the spherical configuration, significantly reducing manufacturing time compared to forming a monolithic basket structure.
Solution Approach 2:
The spines are designed as universal components that can be manufactured using standardized processes and then configured in the spherical basket arrangement. This universality allows for efficient mass production of individual spines and simplifies the final assembly process, increasing overall productivity while maintaining comprehensive electrode coverage.
3Ease of operation
If small spines with electrodes are used, then catheter flexibility is improved, but assembly precision requirements increase
Solution Approach 1:
By segmenting the basket into separate spines with standardized attachment interfaces, the design maintains catheter flexibility through the modular architecture while reducing alignment precision requirements. The standardized interfaces provide built-in alignment features that simplify the assembly process compared to precision-critical monolithic structures.
Solution Approach 2:
The tubular shaft acts as an intermediary component that receives and positions the spines. This intermediate structure provides a standardized mounting interface that accommodates the small spines with electrodes, maintaining flexibility while reducing the precision requirements for direct spine-to-shaft alignment through the use of standardized retention mechanisms.
4Reliability
If RF ablation is used, then tissue ablation is achieved, but thermal risks increase
Solution Approach 1:
The device is designed for irreversible electroporation (IRE) ablation, which changes the fundamental parameter of energy delivery from thermal (RF) to non-thermal electrical pulses. This parameter change maintains effective tissue ablation while eliminating thermal injury risks such as charring, burning, and steam pop that are characteristic of RF ablation.
Solution Approach 2:
The patent replaces the thermal ablation mechanism (RF energy causing heat) with an electrical mechanism (IRE delivering high voltage pulses). This substitution eliminates the thermal field that causes harmful effects while achieving the same tissue ablation outcome through irreversible electroporation, thereby removing thermal risks from the ablation process.
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 design reduces manufacturing time and costs, enhances structural integrity, and facilitates effective IRE ablation by ensuring proper electrode alignment and electrical isolation, thereby improving procedural efficacy and safety.
Implementation Method 1
The sinusoidal-like member can be configured to provide a lateral stiffness of the expandable basket assembly within a predetermined range
Implementation Method 2
The cloverleaf structure may include one or more side connectors to connect two or more distal facing portions of the cloverleaf structure to one another to increase the strength of the distal end of the spine and prevent breakage
Implementation Method 3
a maximum peak stress during retraction of the expandable basket assembly into an intermediate catheter such that the maximum peak stress is less than a predetermined threshold
Data Source
AI summary
An example expandable basket assembly for a medical probe may include a plurality of spines extending along a longitudinal axis from a proximal central proximal spine portion to a distal spine portion. The distal spine portion may define a cloverleaf structure disposed radially around the longitudinal axis. The cloverleaf structure may define a central cutout with a central area disposed about the longitudinal axis. The cloverleaf structure may include a sinusoidal-like member extending from one spine to an adjacent spine in a direction around the longitudinal axis. The sinusoidal-like member may include a plurality of distal facing portions, a plurality of proximal facing portions, and at least one side connector connecting two adjacent distal facing portions to one another. The at least one side connector may strengthen a distal end of the expandable basket.