Shapeable Guide Catheter with Malleable Shaping Member
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Solution Overview
Problem
There is a need for further development of guide catheters that can be pre-shaped prior to insertion into a patient's body and their methods of manufacture and use for transnasal and/or other applications, as existing shapeable catheters lack versatility and precision in accessing complex anatomical locations.
Innovation Solution
A shapeable guide catheter device comprising a tubular member with a shapeable region, a malleable shaping member, and a tubular outer and inner jacket, where the shapeable region is formed by cuts or weakenings in the tubular member to allow plastic deformation and retention of a desired shape, enabling precise curvature and access to specific locations within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a malleable element is inserted into a flexible catheter to enable shaping, then the catheter can be manually shaped into a desired form, but the device complexity increases due to additional components
Solution Approach 1:
The patent extracts the shaping function from a separate malleable element and integrates it directly into the catheter wall through localized heat treatment. This eliminates the need for separate stylets or malleable inserts, reducing device complexity while maintaining shaping capability. The catheter wall itself becomes the shaping element through modified material properties in specific regions.
Solution Approach 2:
The patent combines the structural function of the catheter wall with the shaping function by applying heat treatment to specific regions. This merging of functions allows the catheter to be shaped directly without requiring separate shaping components, thereby reducing overall device complexity while achieving the desired adaptability.
2Ease of operation
If the catheter is made fully flexible to navigate complex anatomy, then it can access difficult locations, but it loses the ability to maintain a stable predetermined shape
Solution Approach 1:
The patent applies local quality by creating regions of different material properties within the catheter wall. Specific segments undergo heat treatment to reduce crystallinity and increase flexibility, while other regions maintain higher crystallinity and rigidity. This spatial variation in material properties allows the catheter to be navigable in flexible regions while maintaining shape stability in structured regions.
Solution Approach 2:
The patent segments the catheter into distinct functional zones with different material characteristics. By dividing the catheter wall into treated and untreated segments, it achieves a balance between navigability (in flexible segments) and shape retention (in rigid segments), allowing the catheter to both navigate complex anatomy and maintain its predetermined configuration.
3Adaptability or versatility
If cuts or weakenings are made in the tubular member to create a shapeable region, then the catheter can be more easily deformed, but the structural strength is reduced
Solution Approach 1:
The patent changes the material parameter (crystallinity) of the catheter wall through controlled heat treatment rather than making physical cuts or weakenings. This parameter change reduces the melting temperature and increases deformability in specific regions while maintaining the integrity and strength of the overall tubular structure, avoiding the structural compromise that would result from cuts or thinning.
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
The device allows for precise positioning of guide catheters in complex anatomical locations, such as paranasal sinuses, with minimal damage to normal structures, and can be reused for multiple access points, offering improved flexibility and accuracy in medical procedures.
Implementation Method 1
a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to and will thereafter substantially hold the shapeable region in such second shape
Data Source
AI summary
Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.) to a desired location within the nose, throat, ear or cranium of the subject.