Segmented Guidewire Proximal Distal Sections
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Solution Overview
Problem
Existing intracorporal medical devices, such as guidewires, face challenges in balancing pushability and torqueability at the proximal end with flexibility at the distal end, due to limitations in material properties and structural designs, which can lead to kinking and fracture during navigation through tortuous anatomy.
Innovation Solution
The development of elongated medical devices with distinct material compositions and structural features, including the use of linear elastic nickel-titanium alloys for the proximal section and superelastic or flexible materials for the distal section, along with advanced attachment techniques like LASER soldering, to create a seamless transition in stiffness and enhance pushability, torqueability, and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single material is used throughout the guidewire, then manufacturing is simple, but the device cannot simultaneously achieve high pushability/torqueability at the proximal end and high flexibility at the distal end
Solution Approach 1:
The guidewire is divided into multiple distinct sections (proximal section with first material, distal section with second material) that can be independently selected and optimized for specific functions. This segmentation allows the proximal end to provide pushability and torqueability while the distal end provides flexibility, resolving the contradiction between functional adaptability and structural simplicity.
Solution Approach 2:
Different materials are assigned to different locations along the guidewire based on local functional requirements. The proximal section uses materials optimized for pushability and torqueability, while the distal section uses materials optimized for flexibility. This local differentiation resolves the contradiction by allowing each region to have the specific properties needed for its function.
2Ease of operation
If the guidewire is made stiff to improve pushability and torqueability, then navigation through tortuous anatomy becomes difficult, but if made flexible, then pushability and torqueability decrease
Solution Approach 1:
The guidewire is segmented into proximal and distal sections with different stiffness characteristics. The proximal section is designed to be stiffer to provide adequate pushability and torqueability for operator control, while the distal section is designed to be more flexible to navigate tortuous anatomy. This segmentation resolves the contradiction between ease of operation and adaptability to complex anatomical paths.
Solution Approach 2:
The guidewire exhibits locally differentiated mechanical properties where the proximal region has higher stiffness for operator control and the distal region has lower stiffness for anatomical navigation. This local quality variation allows the device to simultaneously achieve both pushability/torqueability and flexibility for tortuous anatomy.
3Adaptability or versatility
If different materials are used in different sections, then optimal pushability, torqueability, and flexibility are achieved, but manufacturing precision requirements increase
Solution Approach 1:
The attachment features (such as crimped regions, interference fit structures, or bonding surfaces) are pre-formed during the manufacturing process before final assembly. This preliminary action ensures precise alignment and secure bonding between different material sections, reducing the precision requirements during final assembly while maintaining optimal performance characteristics.
Solution Approach 2:
Intermediary components or transition zones are introduced between sections made of different materials to facilitate secure attachment. These intermediaries may include bonding layers, mechanical interlocks, or transition structures that accommodate the different material properties while ensuring precise and reliable connection, thereby managing the manufacturing precision requirements.
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 solution provides a guidewire with improved pushability and torqueability at the proximal end while maintaining flexibility at the distal end, reducing the likelihood of kinking and fracture, thus facilitating smoother navigation through complex anatomical paths.
Implementation Method 1
attachment techniques like LASER soldering
Implementation Method 2
LASER soldering
Implementation Method 3
linear elastic nickel-titanium alloys for the proximal section
Implementation Method 4
superelastic or flexible materials for the distal section
Data Source
AI summary
Alternative designs, materials and manufacturing methods for guidewires. Some embodiments pertain to a composite guidewire having proximal and distal section, and a connector adapted and configured for permanently joining the proximal section to the distal section. In some embodiments, at least one of the sections is made of a linear-elastic nickel-titanium alloy. Several alternative guidewire tip constructions and/or designs including methods and techniques of construction are also disclosed.