Balloon Deflection via Pull Wire for Catheter Steerability
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Solution Overview
Problem
Current catheters face challenges in navigating through irregularly shaped pulmonary veins and accurately positioning within them for procedures like pulmonary vein isolation, due to limited steerability and difficulty in seating the balloon for effective tissue contact and occlusion.
Innovation Solution
A balloon catheter design with enhanced steerability, featuring a pull wire system that allows for deflection at a point proximal to the balloon lumen, enabling precise alignment and occlusion without altering the balloon's shape or size, facilitating navigation through complex vasculature and accurate positioning within pulmonary veins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional balloon catheter is used, then the balloon can maintain its shape for tissue contact, but the catheter lacks steerability and cannot be accurately positioned within irregularly shaped pulmonary veins
Solution Approach 1:
The catheter is divided into distinct functional segments: a steerable shaft portion with pull wires for navigation, and a separate balloon portion for tissue contact. This segmentation allows the shaft to be highly steerable while the balloon maintains its shape for effective tissue engagement, resolving the contradiction between steerability and shape maintenance.
Solution Approach 2:
The pull wire acts as an intermediary element that transmits control forces from the proximal end to the distal balloon portion. By attaching the pull wire to the shaft within the balloon, it enables precise control of balloon positioning and orientation without requiring the balloon itself to be complex, thus maintaining both steerability and shape integrity.
2Measurement precision
If the balloon is made more steerable through structural changes, then positioning accuracy improves, but the balloon shape and size may be altered affecting tissue contact
Solution Approach 1:
Different portions of the catheter have different mechanical properties: the shaft portion is designed for high steerability with pull wire attachment, while the balloon portion is designed for shape consistency and tissue contact. This local differentiation of properties allows each segment to optimize its function without compromising the other, maintaining both positioning accuracy and shape consistency.
3Ease of operation
If the catheter is designed for high steerability with pull wire attachment, then navigation through complex vasculature improves, but the device complexity increases
Solution Approach 1:
The pull wire system serves multiple functions: it provides steerability control, enables positioning accuracy, and maintains balloon orientation during procedures. This multi-functionality justifies the added complexity by delivering multiple operational capabilities through a single integrated mechanism, improving navigation capability while managing device complexity through functional consolidation.
Data Source
AI summary
A medical device having enhanced steerability for navigation through a patient's vasculature and for positioning the device for performing a medical procedure, such as pulmonary vein isolation. The device generally includes an elongate body, a balloon defining a proximal neck that is affixed to the distal end of the elongate body such that the neck and elongate body are coterminous, a shaft disposed at least partially within the elongate body and at least partially within the balloon, and a pull wire affixed to a distal portion of the shaft, such that pulling the pull wire will cause deflection of the balloon at a point that is immediately distal of the proximal neck of the balloon. Further, the shape of the balloon when deflected and when in a neutral configuration may be substantially the same.