Catheter End Effector with Resilient Nitinol Frame
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Solution Overview
Problem
Current catheter systems for cardiac ablation procedures face challenges in effectively mapping and ablating cardiac tissue due to limitations in electrode contact and flexibility, particularly in conforming to the varying geometries of cardiac structures, which can lead to incomplete or inefficient treatment of arrhythmias.
Innovation Solution
The development of a catheter end effector with a resilient frame and flexible interior, featuring a nitinol wire frame and a flex circuit assembly with electrodes and sensors, allows for enhanced contact with cardiac tissue, improved flexibility to adapt to anatomical shapes, and the ability to transition between deployed and retractable configurations, facilitating precise EP mapping and ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid electrode structure is used, then structural stability is improved, but flexibility and ability to conform to cardiac tissue geometries deteriorates
Solution Approach 1:
The end effector is divided into a resilient frame structure and a separate flexible interior assembly. The resilient frame provides structural stability while the flexible interior with electrodes can deform to conform to cardiac tissue geometries, resolving the contradiction between stability and adaptability.
Solution Approach 2:
The end effector combines a resilient frame material (providing structural stability) with flexible interior materials (providing conformability). This composite construction allows the device to simultaneously maintain structural integrity and adapt to varying cardiac tissue shapes.
2Adaptability or versatility
If the catheter is made more flexible to adapt to anatomical shapes, then adaptability is improved, but structural stability and electrode contact reliability deteriorates
Solution Approach 1:
By separating the resilient frame from the flexible interior, the patent ensures that the resilient frame maintains structural stability and provides reliable support for electrodes, while the flexible interior independently adapts to anatomical shapes without compromising contact reliability.
Solution Approach 2:
Different portions of the end effector have different properties: the resilient frame provides structural stability where needed, while the flexible interior provides adaptability where needed. This local differentiation resolves the contradiction between overall flexibility and local reliability.
3Ease of operation
If the end effector is designed to be retractable for storage, then ease of operation is improved, but structural stability during deployment deteriorates
Solution Approach 1:
The end effector transitions between a compressed retractable state for storage and an expanded stable state during deployment. The resilient frame enables this dynamic transformation, providing structural stability when deployed while allowing easy retraction when not in use.
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 enhances the ability to achieve full contact with cardiac tissue, improves the accuracy of EP mapping, and enables more effective ablation by allowing the catheter to conform to the complex geometries of cardiac structures, leading to more precise and efficient treatment of arrhythmias.
Implementation Method 1
a nitinol wire frame
Data Source
AI summary
An apparatus includes a catheter shaft assembly and an end effector. The end effector is configured to transition between a first configuration and a second configuration. The end effector is configured to fit within an outer sheath in the first configuration. The end effector is configured to expand outwardly away from the longitudinal axis in the second configuration when exposed distally relative to the distal end of the outer sheath. The end effector includes a resilient frame assembly that is configured to resiliently bias the end effector toward the second configuration. The end effector further includes a first flex circuit assembly secured to the resilient frame assembly. The first flex circuit assembly includes a first flexible substrate and a first plurality of electrodes positioned on the first flexible substrate. The electrodes are configured to pick up electrical potentials from tissue or blood or ablate tissue.