Adjustable Dilation Catheter with Deflectable Shaft
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Solution Overview
Problem
Current dilation instruments for anatomical passageways require multiple instruments and adjustments for different procedures, making them cumbersome and inefficient for single-operator use, especially in procedures where anatomical landmarks are difficult to visualize.
Innovation Solution
A dilation instrument with a guide shaft assembly and actuation assemblies that allow for adjustable exit angles and single-handed operation, featuring a guidewire and dilation catheter that can be advanced and inflated to dilate various anatomical passageways without the need for instrument exchange, utilizing a flexible shaft member with a deflection control knob and a shaft rotation control knob for precise positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple instruments and adjustments are used for different dilation procedures, then the ability to accommodate various anatomical passageways is improved, but the device complexity and ease of operation deteriorate
Solution Approach 1:
The guide shaft assembly is designed with a flexible shaft member that can be deflected to various angles using a deflection control knob, allowing a single instrument to accommodate multiple anatomical passageways including paranasal sinuses and Eustachian tube. The shaft can be rotated and positioned at different orientations, making one device universally applicable to different dilation procedures without requiring multiple specialized instruments.
Solution Approach 2:
The guide shaft assembly incorporates a flexible shaft member with a deflection control mechanism that allows dynamic adjustment of the shaft angle during the procedure. The deflection control knob enables the operator to adjust the exit angle of the guidewire in real-time, providing adaptability to different anatomical configurations without requiring multiple rigid instruments.
2Adaptability or versatility
If multiple instruments and adjustments are used for different dilation procedures, then the ability to accommodate various anatomical passageways is improved, but the ease of operation deteriorates
Solution Approach 1:
The guide shaft assembly combines the deflection control mechanism and shaft rotation control into a single integrated unit with a deflection control knob that can be operated with one hand. The actuation assemblies for advancing the guidewire and dilation catheter are also integrated into the handle assembly, allowing all critical functions to be controlled from a single location, thereby enabling single-handed operation while maintaining versatility.
3Measurement precision
If precise positioning is required in procedures where anatomical landmarks are difficult to visualize, then the measurement precision is improved, but the device complexity increases
Solution Approach 1:
The flexible shaft member with deflection control allows dynamic adjustment of the guidewire exit angle to precisely target anatomical landmarks that are difficult to visualize. The operator can adjust the shaft orientation in real-time based on feedback, enabling precise positioning without requiring complex pre-programmed navigation systems or multiple adjustment mechanisms.
Solution Approach 2:
The ability to dynamically adjust the shaft deflection angle provides real-time control feedback to the operator, allowing precise positioning of the guidewire tip at the target site. The operator can feel the resistance and adjust the angle accordingly, providing tactile feedback that complements visual guidance even when anatomical landmarks are difficult to see.
Data Source
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AI summary
An apparatus includes a body, a shaft assembly, a deflection actuation assembly, and a dilation catheter. The shaft assembly includes a rigid proximal portion and a flexible distal portion. The deflection actuation assembly includes a rotary actuator and a first translatable actuation member at least partially disposed within the first rotary actuator. A second translatable actuation member extends through the shaft assembly and couples the first translatable actuation member with the flexible distal portion of the shaft assembly. The first rotary actuator is rotatable about a longitudinal axis to thereby drive the first and second translatable actuation members longitudinally. The flexible distal portion is configured to deflect away from the longitudinal axis in response to translation of the first and second translatable actuation members longitudinally. The dilation catheter is slidable relative to the shaft assembly and includes an expandable dilator.