Deflectable Catheter Shaft with Pull Wire Steering
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Solution Overview
Problem
Current methods for treating Eustachian tube blockages, such as those causing middle ear pressure imbalances and hearing impairments, lack effective and minimally invasive solutions, particularly for pediatric patients, due to anatomical challenges and the need for precise access.
Innovation Solution
A guide catheter system with a deflectable distal portion and a balloon dilation catheter that can be steered between straight and bent configurations to access and dilate the Eustachian tube, allowing for precise alignment and minimally invasive treatment, including the use of a visualizing distal tip with a camera and light sources for navigation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid catheter is used to access the Eustachian tube, then structural strength is maintained, but the ability to navigate curved anatomical paths and access pediatric patients is compromised
Solution Approach 1:
The catheter is divided into distinct segments: a rigid proximal portion for insertion and a deflectable distal portion for navigation. The deflectable distal portion includes an inner shaft and outer shaft with a pull wire that allows the distal end to be deflected laterally away from the central longitudinal axis, enabling access to the Eustachian tube in pediatric patients while maintaining overall catheter strength through the rigid proximal portion.
Solution Approach 2:
The distal portion of the catheter is designed to be dynamically deflectable rather than rigid. The pull wire mechanism allows real-time deflection and return to original position, enabling the catheter to adapt to the curved anatomy of pediatric Eustachian tubes while maintaining structural integrity when needed.
2Adaptability or versatility
If a deflectable catheter is used to access the Eustachian tube, then access to pediatric patients is improved, but the risk of damaging adjacent anatomical structures increases
Solution Approach 1:
The catheter is divided into a rigid proximal portion and a deflectable distal portion. The rigid proximal portion provides structural strength and stability during insertion, while the deflectable distal portion can be carefully maneuvered to access the Eustachian tube without damaging adjacent structures like the nasal cavity and pharynx.
Solution Approach 2:
A camera is integrated into the distal tip of the catheter, providing real-time visual feedback of the anatomical structures during navigation. This allows the operator to visualize the Eustachian tube opening and surrounding anatomy, enabling precise positioning and avoidance of adjacent structures while maintaining safe access to the pediatric patient's Eustachian tube.
3Reliability
If a balloon dilation catheter is used to dilate the Eustachian tube, then treatment effectiveness is improved, but the complexity of the device increases
Solution Approach 1:
The guide catheter and balloon dilation catheter are merged into a single integrated device. The balloon catheter is positioned within the lumen of the guide catheter, combining the navigation capabilities of the guide catheter with the dilation function of the balloon catheter. This integration reduces the need for multiple separate devices and simplifies the overall procedure.
Solution Approach 2:
The integrated catheter system performs multiple functions: the rigid proximal portion provides structural support for insertion, the deflectable distal portion enables navigation to the Eustachian tube, the camera provides visualization, and the balloon performs dilation. This multi-functionality in a single device reduces procedural complexity compared to using separate guide and dilation catheters.
Data Source
AI summary
Catheter shafts (such as guide catheter or dilation catheter shafts) disclosed herein can include a rigid proximal portion, a deflectable distal portion located distally from the proximal portion, and a pull wire extending from the deflectable distal portion along the proximal portion. The pull wire can drive the deflectable distal portion between a straight configuration and a bent configuration, which makes the catheter system adaptable for use with both pediatric and adult patients. Specifically, because the pull wire facilitates changing a bend angle of the deflectable distal portion of the catheter shaft, the catheter can fit in a wide variety of differently sized nasal cavities and Eustachian Tubes. Optionally, a visualizing distal tip can be positioned distally from the deflectable distal portion of the catheter shaft and include a distally facing camera that can be used to confirm that the deflectable distal portion is properly positioned in the patient.