Multi-Electrode Basket Catheter Spine Segmentation
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Solution Overview
Problem
Current multi-electrode catheters for cardiac tissue mapping and ablation face challenges in manufacturing complexity, increased time and cost due to the difficulty in adhering electrodes to spines and forming a spherical basket assembly, and are limited by anatomical geometries, particularly with cryoablation methods which are more challenging to maneuver and apply selectively.
Innovation Solution
The design features an end effector with multiple spines that expand to form a basket shape, including frame loops with angled portions and a retainer, allowing for a collapsed configuration for delivery and an expanded configuration at the treatment site, enabling electrodes to be positioned effectively for irreversible electroporation, with the ability to rotate between non-contacting and contacting configurations for tissue interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional methods of adhering electrodes to spines and forming spherical basket assemblies are used, then manufacturing precision can be maintained, but manufacturing time and cost increase significantly
Solution Approach 1:
The basket assembly is divided into multiple linear spines that can be manufactured separately and then assembled. Each spine is a discrete component that can be prepared independently, allowing parallel manufacturing processes and reducing overall production time while maintaining precision through standardized components.
Solution Approach 2:
Multiple linear spines are combined to form the complete basket assembly. By designing the spines to be assembled into a spherical basket configuration, the manufacturing process is simplified compared to forming an entire spherical structure as a single piece, reducing both time and complexity.
2Object-affected harmful factors
If cryoablation devices are used to treat cardiac tissue, then thermal risks are reduced, but maneuverability and selective application become more challenging
Solution Approach 1:
The catheter system incorporates expandable basket structures that can transition between collapsed and expanded states, allowing the device to be navigated through vasculature in a compact form and then deployed at the target site. This dynamic configuration enables better maneuverability while maintaining the ability to apply cryoablation selectively at the intended location.
Solution Approach 2:
The cryoablation capability is localized to specific electrodes positioned at the distal end of the catheter, allowing selective application of cold energy only at the target tissue site while the rest of the catheter body remains flexible for navigation. This localized approach maintains maneuverability while reducing thermal risks to surrounding tissues.
3Reliability
If multiple linear spines are assembled to form a spherical basket, then electrode support is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The basket is segmented into multiple linear spines that serve as individual support structures for electrodes. Each spine can be manufactured with consistent precision using standardized processes, and the modular nature reduces overall manufacturing complexity compared to forming a complete spherical structure in one piece.
Solution Approach 2:
The linear spines serve multiple functions: they provide structural support for electrode attachment, maintain the spherical basket geometry when assembled, and offer pathways for electrode positioning. This multi-functionality reduces the need for additional specialized components, simplifying the overall device structure.
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
This design reduces manufacturing time and cost, enhances the ability to support various electrode shapes and sizes, and improves the maneuverability and effectiveness of catheter geometries for both mapping and ablation procedures, particularly in complex anatomical geometries.
Implementation Method 1
a plurality of spines configured to expand away from a longitudinal axis of the end effector to form a basket shape
Implementation Method 2
the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation
Data Source
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AI summary
Examples presented herein illustrate various end effector designs with multiple spines that can expand from a collapsed configuration as the end effector traverses vasculature to an expanded configuration when the end effector is at a treatment site. In some examples, the end effector includes three frame loops which each include a pair of spines. At least one of the three frame-loops can have a bend at a distal end of the end effector so that the spines of the frame loop are not directly opposite each other with respect to the longitudinal axis. In some examples, the end effector includes an inner and an outer frame, each having multiple spines and configured such that one or both of the frames can rotate from an aligned configuration to an unaligned configuration.