Convertible Basket Catheter Spine Deployment Control
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Solution Overview
Problem
Existing electrophysiology catheters face challenges in reliably deploying basket-shaped electrode assemblies to achieve specific spine configurations for uniform tissue coverage and accurate mapping or therapeutic procedures, particularly in achieving expanded arrangements that position electrodes correctly within the heart's anatomy.
Innovation Solution
The catheter design incorporates a pulling member with proximal and distal structural elements, including a cap and collar, to control the deployment of spines, ensuring a specific expanded configuration with radial spacing, utilizing shape memory materials and a continuous loop framework to facilitate accurate positioning and contact with heart tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a basket-shaped electrode assembly is designed to expand for tissue coverage, then the diagnostic and therapeutic capability is improved, but the reliability of achieving a specific spine configuration is insufficient
Solution Approach 1:
The spines are pre-formed with a specific bowed configuration that defines the desired expanded arrangement. The structural elements (collar and cap) are pre-positioned to guide and maintain this configuration during deployment, ensuring that when the basket expands, the spines automatically assume the pre-determined correct configuration for uniform tissue coverage.
Solution Approach 2:
The patent utilizes shape memory materials or elastic properties of the spines to enable transformation between collapsed and expanded states. When the pulling member is retracted, the spines utilize their inherent elastic recovery or shape memory effect to bow outward into the specific expanded configuration, reliably achieving the desired spine spacing and orientation.
2Ease of operation
If the basket assembly is designed to collapse for delivery, then the ease of insertion is improved, but the structural control over spine positioning is reduced
Solution Approach 1:
The basket assembly is designed to collapse into a compact configuration that nests within the catheter body during delivery. The spines are arranged along the longitudinal axis in a space-efficient manner, allowing the entire assembly to be delivered through the catheter and then deployed at the target site without losing the pre-defined spine configuration.
Solution Approach 2:
The collar and cap structural elements are pre-positioned on the spines before delivery to maintain their relative spacing and configuration. These elements remain in place during the collapsed delivery state and automatically guide the spines into the correct expanded arrangement when deployed, preserving positioning precision throughout the delivery and deployment process.
3Reliability
If structural elements are added to control spine deployment, then the deployment reliability is improved, but the device complexity increases
Solution Approach 1:
The control mechanism is divided into distinct functional segments: the collar that engages with proximal markers on the spines, the cap that engages with distal markers, and the pulling member that connects them. This segmentation allows each element to perform its specific function independently while working together to achieve reliable deployment, reducing overall system complexity through modular design.
Solution Approach 2:
The structural elements (collar and cap) are designed to automatically engage with the spines and maintain their configuration without requiring external control mechanisms. The spines themselves, through their elastic or shape memory properties, provide the force needed to bow outward and engage with the structural elements, making the system self-actuating and reducing the need for complex external control systems.
4Area of stationary object
If the spines are made to bow radially outward for expanded arrangement, then the electrode coverage is improved, but the control over relative spacing is insufficient
Solution Approach 1:
The collar and cap serve as intermediary structural elements that mediate between the spines and the pulling member. These intermediaries engage with markers on the spines at specific positions, controlling the relative spacing between spines as they bow outward. The collar maintains proximal spacing while the cap maintains distal spacing, ensuring uniform and precise relative positioning of all spines in the expanded configuration.
Solution Approach 2:
The patent employs shape memory materials or elastic properties of the spines to enable controlled radial bowing. The spines are engineered with specific mechanical properties that allow them to bow outward to a predetermined extent, achieving the desired radial spacing and coverage area while maintaining precise relative positioning controlled by the collar and cap structural elements.
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 allows for reliable and precise deployment of the basket-shaped electrode assembly, enabling rapid and accurate mapping of electrical activity and effective delivery of radiofrequency energy, improving diagnostic and therapeutic outcomes by ensuring optimal electrode contact with heart tissue.
Implementation Method 1
The pulling member is slidably disposed within the lumen
Implementation Method 2
utilizing shape memory materials and a continuous loop framework
Data Source
AI summary
This disclosure is directed to a catheter having a basket-shaped electrode assembly at the distal end of the catheter body formed from a plurality of spines with electrodes. The basket-shaped electrode assembly structural elements at the proximal and distal ends. The structural elements may maintain the spines in a desired spatial relationship with each other and/or may couple the distal ends of the spines to a pulling member. The basket-shaped electrode assembly has expanded arrangement in which the spines bow outwards and a collapsed arrangement in which the spines are arranged generally along a longitudinal axis of the catheter body.