Alignment Adaptor for Guidewire Threading in Neonatal Catheterization
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Solution Overview
Problem
Existing medical devices are inadequate for catheterization of small vasculature in neonates and children, as they are complex and not specifically designed to minimize vessel trauma, and there is a need for miniature guidewires, vascu-sheaths, and dilators, as well as a method to facilitate the manipulation of these devices.
Innovation Solution
A specially adapted thin guidewire with a distal floppy tip and reinforced neck portion, a miniature tear-away vascular introducer sheath, and an alignment adaptor with a central channel and slit design to ease the threading of the sheath and dilator over the guidewire, allowing for easier placement in small and tortuous vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If existing guidewires and catheterization devices are used for small vasculature, then the procedure can be performed, but the devices are complex and increase the risk of vessel trauma
Solution Approach 1:
The guidewire is segmented into distinct functional zones: a soft distal tip for gentle vessel entry, a reinforced neck portion for structural support, and a flexible shaft for navigation. This segmentation allows each portion to be optimized for its specific function, reducing overall trauma while maintaining manageability.
Solution Approach 2:
Different portions of the guidewire have different mechanical properties tailored to their functions: the distal tip is soft and floppy to minimize vessel wall contact trauma, the neck portion is reinforced to prevent kinking during manipulation, and the shaft has intermediate properties for navigation. This local differentiation reduces overall device trauma potential.
2Object-affected harmful factors
If miniature guidewires and vascu-sheaths are used for neonatal and pediatric catheterization, then the risk of vessel trauma is reduced, but the devices are difficult to manipulate and thread
Solution Approach 1:
The alignment adaptor serves as an intermediary device that temporarily holds the guidewire and facilitates the threading of the vascu-sheath over it. The adaptor's aligned openings guide the sheath onto the guidewire without requiring complex manual dexterity, thus maintaining ease of operation while using miniature trauma-reducing devices.
Solution Approach 2:
The alignment adaptor replaces the need for complex manual manipulation skills with a mechanical guidance system. The pre-aligned openings and structural design of the adaptor provide automatic alignment and guidance, substituting operator skill requirements with a mechanical solution that simplifies the threading process.
3Ease of operation
If the distal tip of the vascu-sheath is threaded directly over the guidewire without alignment aid, then the procedure is simpler, but proper alignment is difficult to achieve in small vasculature
Solution Approach 1:
The alignment adaptor acts as an intermediary alignment aid between the guidewire and vascu-sheath. Its distal opening receives the guidewire while its proximal opening guides the vascu-sheath, ensuring proper alignment without requiring complex manual techniques. This maintains procedural simplicity while achieving precise alignment.
Solution Approach 2:
The alignment adaptor is prepared in advance with pre-aligned openings positioned at specific angles and locations. This preliminary preparation of the alignment geometry eliminates the need for complex real-time alignment maneuvers during the procedure, achieving both ease of operation and precision.
Data Source
Figure 1A~1F
Figure 1G~1K
Figure 2A~2C
AI summary
This invention provides a guidewire adapted for the catheterization of very small vasculature of the neonates, infants and children. In one embodiment of the invention, a guidewire of 0.010 inch diameter is described. The present invention also provides an alignment adaptor that facilitates catheterization of small vasculature utilizing said guidewire, and method of using the same.