Obturator Side-Hole Redirection for Accurate SFA Guidewire Placement
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Solution Overview
Problem
Existing medical procedures for guidewire insertion into the superficial femoral artery (SFA) often result in accidental cannulation of the profunda femoris artery (PFA), leading to increased procedural time, radiation exposure, and risks of bleeding and pseudo-aneurysm formation, due to blind insertion techniques and anatomical challenges.
Innovation Solution
An obturator with a distal end hole and a side hole, allowing for guidewire redirection, and a sheath assembly with a similar configuration, enabling precise placement of the guidewire into the correct bodily lumen using contrast medium flow and minimal disruption to existing workflows.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If blind needle puncture and guidewire insertion is performed, then the procedure can be performed quickly, but the risk of accidental cannulation of PFA increases
Solution Approach 1:
The obturator is pre-formed with a specific curved configuration and orientation indicia before use. The curved distal portion is designed to automatically direct the guidewire into the SFA by bouncing off the back wall, eliminating the need for real-time operator judgment during insertion.
Solution Approach 2:
Orientation indicia (radiopaque markers or colored indicators) are provided on the obturator to visually indicate the correct orientation and target area for insertion. This allows rapid visual alignment and reduces the time needed to determine the correct insertion angle, improving both speed and accuracy.
2Reliability
If guidewire trajectory correction is performed, then accurate SFA access can be achieved, but procedural time and radiation exposure increase
Solution Approach 1:
The obturator's curved distal portion is pre-configured to create the correct guidewire trajectory upon insertion. The wire automatically follows the curved path and bounces off the back wall into the SFA, eliminating the need for post-insertion trajectory correction and reducing procedural time.
Solution Approach 2:
The obturator replicates the desired guidewire path through its pre-formed curved configuration. By copying the target trajectory into the device structure itself, the system ensures accurate SFA access without requiring real-time operator intervention or additional fluoroscopy guidance.
3Reliability
If repeated rewiring is performed to correct PFA cannulation, then SFA access can be achieved, but the risk of injury to PFA increases
Solution Approach 1:
The obturator is designed with a curved distal portion that pre-establishes the correct insertion path. This preliminary configuration ensures the guidewire enters the SFA on the first attempt, eliminating repeated rewiring operations that would otherwise injure the PFA.
Solution Approach 2:
The curved geometry of the obturator counteracts the natural tendency of the needle and wire to follow a straight path into the PFA. By pre-forming the opposite curvature, the device automatically redirects the trajectory away from the PFA and into the SFA, preventing injury before it occurs.
4Reliability
If puncture is performed more proximally on CFA to bounce wire off back wall, then SFA access may be achieved, but the risk of retroperitoneal haemorrhage increases
Solution Approach 1:
The obturator provides localized geometric features (curved distal portion, specific radius of curvature) at the critical insertion zone. This local quality ensures the wire bounces off the back wall at the correct angle and location, achieving SFA access without requiring proximal puncture that would risk retroperitoneal haemorrhage.
Solution Approach 2:
The obturator changes the physical parameters of the insertion path through its curved configuration. By controlling the radius of curvature and distal tip geometry, the device achieves the desired wire bounce into the SFA while maintaining safe insertion depth, avoiding the hazards of proximal puncture.
Data Source
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Figure 7
AI summary
An obturator comprising a hollow distal end portion, the distal end portion comprising a distal end and a side hole located proximally of the distal end, the side hole being for receipt of a guidewire and to direct the guidewire laterally from the obturator.