Malleable Guide Balloon Dilation Catheter
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Solution Overview
Problem
Existing balloon dilation systems for anatomical passageways lack easy control over balloon inflation and deflation, particularly in single-operator procedures, and require multiple instruments for accessing different sinus ostia, which can be cumbersome.
Innovation Solution
A dilation catheter system with a malleable internal guide assembly that allows for adjustable bend angles and a guidewire with an illuminating fiber for precise positioning and visualization, enabling easy inflation and deflation of the balloon using a single instrument for various anatomical access points.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a variable direction view endoscope is used to provide visualization within the anatomical passageway, then viewing angles are improved without having to flex the shaft, but the device complexity increases
Solution Approach 1:
The endoscope incorporates a dynamic variable direction view mechanism that allows the viewing angle to be changed during the procedure without flexing the shaft. This enables the operator to view different angles (e.g., 0 degrees, 30 degrees, 60 degrees) by adjusting the internal optics, providing adaptability while maintaining a relatively simple external structure.
2Measurement precision
If an illuminating guidewire is used to provide visual confirmation of proper positioning, then positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The guidewire incorporates an illumination feature that emits light from its distal end, causing it to glow or change appearance when illuminated. This allows the operator to visually confirm the position of the guidewire and balloon through transcutaneous illumination (e.g., seeing the light through the patient's cheek), thereby improving positioning accuracy with a relatively simple modification to the guidewire structure.
3Adaptability or versatility
If multiple instruments are used to access different sinus ostia, then adaptability to different anatomical locations is improved, but the ease of operation deteriorates due to instrument management
Solution Approach 1:
The guide catheter incorporates a malleable guide member with a bend angle that can be dynamically adjusted during the procedure. The operator can change the bend angle to match different anatomical pathways required to access various sinus ostia (e.g., maxillary, frontal, sphenoid). This eliminates the need to exchange multiple pre-bent instruments, as a single instrument can be reconfigured to suit different anatomical access requirements, thereby improving ease of operation while maintaining adaptability.
4Ease of operation
If balloon inflation control is simplified for single-operator procedures, then ease of operation is improved, but the precision of inflation control may deteriorate
Solution Approach 1:
The system incorporates a self-inflating balloon mechanism where the balloon automatically inflates to a predetermined volume when fluid is introduced through the catheter. The design includes features such as a pre-formed balloon structure and controlled fluid delivery that enable the balloon to self-regulate its inflation, reducing the need for complex manual control mechanisms while maintaining adequate inflation precision for the intended medical application.
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
Facilitates precise and controlled dilation of anatomical passageways with improved visualization, allowing for efficient single-operator procedures and reducing the need for multiple instruments, enhancing procedural accuracy and ease of use.
Implementation Method 1
an illuminating guidewire. Such a guidewire may be positioned within the target area and then illuminated, with light projecting from the distal end of the guidewire
Implementation Method 2
deforming the malleable guide member to a desired bend angle
Implementation Method 3
expanding the expandable element in the targeted anatomical passageway
Data Source
AI summary
An apparatus includes a handle assembly, a guide assembly, and a dilation catheter. The guide assembly extends distally from the handle assembly. The guide assembly includes a malleable guide member and a flexible guide member. The distal end of the flexible guide member is distal to the distal end of the malleable guide member. The flexible guide member is positioned about the malleable guide member and is slidable along the malleable guide member. The dilation catheter is slidably disposed about the flexible guide member.