Vascular Sheath and Dilator Alignment for Precise Guidewire Access
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Solution Overview
Problem
Current vascular sheaths and dilators lack features for precise navigation and alignment during antegrade access to the femoral artery, particularly in patients with complex vascular histories, leading to increased procedural complexity and risk.
Innovation Solution
A vascular sheath and dilator assembly with aligned side ports and a deflecting portion in the dilator lumen, along with radio-opaque markers for precise guidewire alignment, facilitating controlled access to side vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional vascular sheaths and dilators are used for antegrade access to the femoral artery, then basic vascular access can be achieved, but precise navigation and alignment at the point of entry are lacking, leading to increased procedural complexity
Solution Approach 1:
The device is segmented into distinct functional components: a sheath with side ports for access, a dilator with a deflecting portion for guidewire navigation, and alignment features. This segmentation allows each component to perform its specific function optimally while maintaining overall system manageability
Solution Approach 2:
The deflecting portion in the dilator acts as an intermediary element that mediates between the guidewire and the side vessel entrance. It actively redirects the guidewire into the side vessel, solving the navigation precision problem without requiring complex external guidance systems
2Manufacturing precision
If the dilator is inserted into the vascular sheath without alignment features, then assembly is simple, but the side ports of the sheath and dilator do not align, preventing controlled access to side vessels
Solution Approach 1:
The patent employs visual indicators (radio-opaque markers visible under fluoroscopy and/or color-coded features) to indicate proper alignment of side ports. This allows operators to achieve precise alignment through visual feedback without requiring complex alignment mechanisms or specialized manufacturing processes
Solution Approach 2:
The sheath and dilator are designed with pre-configured alignment features and positioned side ports during manufacturing. This preliminary action ensures that when the dilator is inserted into the sheath, the side ports are already aligned, eliminating the need for complex intra-procedural alignment adjustments
3Ease of operation
If the distal end of the dilator is open, then guidewire insertion is straightforward, but the guidewire can exit through the distal end instead of being directed into the side vessel
Solution Approach 1:
The deflecting portion within the dilator creates a dynamic guidance system that actively redirects the guidewire as it progresses through the dilator lumen. The geometry of the deflecting portion works with the open distal end to channel the guidewire toward the side port alignment, maintaining ease of insertion while ensuring reliable direction control
Solution Approach 2:
The deflecting portion serves as an intermediary structure between the open distal end and the side port. It intercepts the guidewire path and redirects it into the side vessel, solving the direction control problem while maintaining the simplicity of an open distal end design
Data Source
AI summary
The invention provides an improved vascular sheath and dilator assembly designed to enhance maneuverability, procedural accuracy, and safety during vascular access. The assembly includes a vascular sheath with a side port and a dilator featuring a closed distal end and a deflecting portion within its lumen. This deflecting portion smoothly redirects a guidewire towards a side port in the dilator aligned with the side port of the vascular sheath when the dilator is properly positioned within the vascular sheath, thus facilitating precise navigation of the guidewire into side vessels of a vascular structure. The assembly also incorporates visual markers on both the vascular sheath and the dilator to ensure accurate alignment of the side ports. These features collectively improve overall efficacy and safety in vascular procedures.