Stylet Notch Alignment for Dynamic Flexibility Control
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Solution Overview
Problem
Current medical devices lack the ability to dynamically adjust flexibility and rigidity, making them inadequate for navigating complex anatomical paths and procedures such as ERCP, where they often become too rigid to penetrate or too flexible to transmit force effectively.
Innovation Solution
The Dynaflex technology allows for customizable notch designs and orientations in stylets and cannulas, enabling real-time adjustment of flexibility and rigidity by rotating the stylet within the cannula, thereby aligning notched and non-notched segments to achieve specific flexibility profiles at critical points along the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional flexible materials are used to allow device to traverse contorted paths, then flexibility is improved, but pushability and tip rigidity deteriorate
Solution Approach 1:
The device is divided into multiple segments with different flexibility characteristics. The stylet contains notched sections that can be independently activated, allowing different portions of the device to have different flexibility levels simultaneously, resolving the contradiction between overall flexibility and localized rigidity
Solution Approach 2:
The device transitions from static flexibility to dynamic flexibility through the ability to activate or deactivate notched sections on demand. This allows the device to adapt its mechanical properties in real-time during procedures, providing flexibility when needed and rigidity when needed
2Strength
If stainless steel is used to provide good rigidity and pushability, then tip rigidity and pushability are improved, but flexibility deteriorates
Solution Approach 1:
Different sections of the device have different material properties and structural characteristics. The stylet incorporates notched sections with varying degrees of flexibility, allowing the distal tip to be rigid for penetration while proximal sections remain flexible for navigation, resolving the contradiction between localized rigidity and overall flexibility
3Adaptability or versatility
If relief notches are added to stylet to increase flexibility, then flexibility is improved, but device complexity increases
Solution Approach 1:
The notched sections are designed with specific geometric parameters (depth, width, spacing) that can be adjusted to achieve desired flexibility characteristics. By optimizing these parameters, the device achieves the required flexibility without requiring excessive notching or complex structural modifications
Data Source
AI summary
Utilizing the technology and methods disclosed, the characteristics of flexibility and rigidity for intralumenal devices, including coaxial two piece devices such as stylet and needle sets, can be adapted by a physician or device manufacturer according to the type of procedure, the patient size and unique anatomical challenges of a given procedure. Rigidity and flexibility are actively controlled by the operator at predefined portions of a device through rotating the stylet within the cannula to bring about alignments of customized notches to impart target flexibility or rigidity profiles at specific spots on the device. The device operator is able to alter the relationship and orientation of specific notched and non-notched segments of either or both the stylet and cannula that are strategically located at said critical points along the length of the device.