Guidewire Curved Deflection Section for SFA Cannulation
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Solution Overview
Problem
Current methods for antegrade insertion of a guidewire into the superficial femoral artery (SFA) require monitored manipulation and fluoroscopic screening, leading to prolonged procedures and increased radiation exposure for operators.
Innovation Solution
A guidewire with a curved deflection section and a rotation preventer that allows easy control of the guidewire's direction without X-ray vision, reducing the need for fluoroscopic monitoring and contrast medium injections, enabling reliable entry into the SFA without monitored manipulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fluoroscopic monitoring is used to guide guidewire manipulation into the SFA, then the reliability of guidewire insertion is improved, but operator radiation exposure increases and procedure time increases
Solution Approach 1:
The guidewire is pre-shaped with a curved deflection section at its distal end before insertion. This preliminary configuration allows the guidewire to automatically deflect into the SFA upon insertion without requiring fluoroscopic monitoring or manual manipulation near the bifurcation, thereby eliminating operator radiation exposure while maintaining reliable insertion
Solution Approach 2:
The curved deflection section enables the guidewire to self-direct into the SFA through its inherent geometric configuration. The guidewire automatically navigates the arterial bifurcation based on its pre-formed curvature, eliminating the need for external fluoroscopic guidance and manual steering, thus reducing both radiation exposure and procedure time
2Reliability
If prolonged manipulation is performed to gain access to the SFA, then the reliability of guidewire insertion is improved, but procedure time increases and operator radiation exposure increases
Solution Approach 1:
The curved deflection section is pre-formed on the guidewire before insertion, allowing the tip to automatically follow the correct path into the SFA. This eliminates the need for prolonged manual manipulation and fluoroscopic monitoring, significantly reducing procedure time while maintaining high reliability of insertion
Solution Approach 2:
The guidewire's pre-configured curvature enables it to self-navigate into the SFA without requiring prolonged manual steering or fluoroscopic guidance. This self-directing capability dramatically reduces procedure time while ensuring reliable guidewire placement
3Device complexity
If the guidewire is inserted without a curved deflection section, then the device complexity is reduced, but the ability to reliably enter the SFA without fluoroscopic monitoring is lost
Solution Approach 1:
A curved deflection section is incorporated into the distal end of the guidewire. This geometric modification, while adding some structural complexity, enables the guidewire to automatically deflect into the SFA upon insertion, dramatically improving ease of operation by eliminating the need for fluoroscopic monitoring and complex manual manipulation
Data Source
AI summary
A guidewire for antegrade guidance of vascular interventions of a lower limb artery via a common femoral artery into a superficial femoral artery of a human patient. When in unloaded condition, the guidewire has, at its distal end, a rounded or floppy tip (4). A curved deflection section (5) is located closely proximal of the tip (4) and extends over an angle of curvature such that the rounded tip (4) is spaced from a continuation of an axis of a section proximally neighboring the curved deflection section (5). The curved deflection section (5) has a flexibility causing the curved deflection section (5) to spring back to substantially its original shape after elastic deformation to a straightened condition. A rotation preventer, a kit and a method for facilitating insertion of a guidewire into the superficial femoral artery are also described.