Steerable Ablation Device Flexible Shaft Design
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Solution Overview
Problem
Current steerable medical devices, such as catheters used in atrial fibrillation treatments, face challenges in maintaining precise positioning on a beating heart, leading to difficulties in creating transmural lesions due to inadequate visualization and the need for high physician skill, especially during pulmonary vein isolation and mitral isthmus ablation procedures.
Innovation Solution
A steerable medical device with a flexible assembly featuring a coiled or interlocking flex support member and pull wires, allowing controlled deflection without crimping, breaking, or twisting, enabling precise placement and movement of ablation elements on cardiac or epicardial surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a steerable catheter device is used for ablation on a beating heart, then the ability to perform procedure on beating heart is improved, but maintaining precise positioning becomes difficult
Solution Approach 1:
The catheter incorporates a flexible shaft with a flexible distal region that can bend and adapt to the moving cardiac surface, allowing the device to maintain contact with the beating heart while preserving steerability and positioning capability through the flexible yet controllable shaft structure
Solution Approach 2:
The catheter employs a dynamic flexible region with coiled or interlocking support members that can adapt to the changing geometry of the beating heart, allowing the device to dynamically adjust its shape and position while maintaining controlled deflection through pull wires
2Ease of operation
If the catheter shaft is made flexible to allow deflection, then steerability is improved, but the shaft may crimp, break, or twist under excessive deflection
Solution Approach 1:
The flexible distal region uses a coiled or interlocking support member structure that provides controlled flexibility, allowing the shaft to bend without crimping or breaking while maintaining structural integrity through the geometric configuration of the coiled or interlocking elements
Solution Approach 2:
The flexible region incorporates pre-designed coiled or interlocking support members that anticipate and cushion against excessive deflection forces, preventing the shaft from crimping, breaking, or twisting by distributing mechanical stress through the geometric structure before damage can occur
3Ease of operation
If pull wires are used to control deflection, then steering control is improved, but the pull wires may interfere with each other or compromise shaft integrity
Solution Approach 1:
The flexible distal region is segmented into multiple sections with individual pull wires controlling deflection in different directions, allowing independent control of each segment while maintaining overall shaft integrity through the distributed structure of the coiled or interlocking support members
Solution Approach 2:
The flexible distal region with coiled or interlocking support members provides a structured pathway that guides and separates pull wires, preventing interference between wires while maintaining the flexibility and integrity of the shaft through the geometric configuration
Data Source
AI summary
The invention relates to a flexible assembly for use in a region of a medical or surgical device. In preferred embodiments, the flexible region comprises a set of pull wires for controllably moving a treatment end of the device, and elements to separate the pull wires and maintain the integrity of the shaft of the flexible region in order to improve the operating aspects of the device. The devices and methods can be especially useful in ablation treatments, such as ablation at cardiac or epicardial tissues.