Steerable Guide Catheter Partial Sleeve Balloon Protection
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Solution Overview
Problem
Current methods for dilating anatomical passageways, such as sinus ostia, lack effective visualization and positioning techniques for inflatable balloons, leading to potential misplacement and inefficiency in dilation procedures.
Innovation Solution
A steerable guide catheter system with a guidewire assembly and dilation catheter assembly, featuring a flexible guide shaft with articulation and rotation capabilities, and an illuminating guidewire for precise balloon placement and visualization, along with a partial sleeve to prevent fluid loss and protect the balloon during articulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Difficulty of detecting and measuring
If a variable direction view endoscope is used to provide visualization within the anatomical passageway, then viewing capability is improved, but additional visual confirmation of proper balloon positioning is still insufficient
Solution Approach 1:
An illuminating guidewire is introduced as an intermediary device between the endoscope and the target tissue. The guidewire contains an internal lumen through which light can be transmitted to illuminate the target area from within, providing direct visual confirmation of guidewire and subsequently balloon positioning that the endoscope alone cannot achieve.
Solution Approach 2:
The mechanical visualization system (endoscope) is supplemented by an optical illumination system integrated into the guidewire. Light transmitted through the guidewire's internal lumen replaces the need for external illumination and provides internal lighting that confirms proper positioning of the guidewire and balloon within the anatomical passageway.
2Adaptability or versatility
If a flexible guide shaft is used to access anatomical passageways, then adaptability to different anatomical structures is improved, but fluid communication may be lost during articulation
Solution Approach 1:
The guide shaft is segmented into multiple articulation sections that can independently flex and articulate. This segmentation allows the guide shaft to navigate complex anatomical pathways while maintaining continuous fluid communication through each segment, preventing fluid loss that would occur with a single rigid or uniformly flexible structure.
Solution Approach 2:
The guide shaft incorporates dynamic articulation capabilities with multiple degrees of freedom, allowing it to adapt its configuration during insertion while maintaining sealed fluid pathways. The articulation joints are designed to preserve fluid communication between proximal and distal portions even when the guide shaft is flexed into various positions.
3Measurement precision
If the guidewire is illuminated for transcutaneous visualization, then positioning confirmation is improved, but the complexity of the guidewire structure increases
Solution Approach 1:
The guidewire is designed with multi-functionality, serving both as a positioning device and an illumination conduit. The internal lumen of the guidewire, necessary for its structural integrity and fluid passage, is also utilized to transmit light, eliminating the need for separate illumination components and reducing overall device complexity while maintaining positioning confirmation capability.
4Reliability
If a partial sleeve is added to protect the balloon during articulation, then balloon protection is improved, but the device complexity increases
Solution Approach 1:
The partial sleeve is nested within the catheter structure, specifically positioned to cover only the critical portions where the balloon is vulnerable during articulation. This nested configuration provides targeted protection without requiring a complete outer covering, thereby protecting the balloon while minimizing the increase in overall device complexity.
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
Enables precise and efficient dilation of anatomical passageways by allowing flexible access and visualization, ensuring accurate balloon placement and maintaining fluid communication while preventing damage to the balloon during articulation.
Implementation Method 1
Such a guidewire may be positioned within the target area and then illuminated, with light projecting from the distal end of the guidewire
Data Source
AI summary
A catheter system includes a body, a guide member assembly, an articulation assembly, and a partial sleeve. The guide member assembly extends distally from the body and includes a proximal rigid portion defining a longitudinal axis, a distal flexible portion, and an open distal end. The guide member assembly defines a lumen in communication with the body and the open distal end. The articulation section can flex the distal flexible portion and the open distal end relative to the longitudinal axis between a straight configuration and an articulated configuration. The partial sleeve is disposed within a portion of the lumen defined by the distal flexible portion. The partial sleeve also defines a longitudinally extending gap.