Sheathless Guide Catheter Assembly Minimizing Vessel Trauma
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Solution Overview
Problem
Current percutaneous transluminal catheterization procedures involve multiple steps and cause trauma to the vessel access site due to the use of introducer sheaths, which require larger puncture openings and longer closure times.
Innovation Solution
A sheathless guide catheter assembly comprising a dilator and a guide catheter, where the dilator has a side exit port and is sized to pass through the guide catheter, allowing for reduced steps and trauma by advancing the guide catheter over a guidewire with a tapered distal portion and a side exit port for guidewire management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an introducer sheath is used to reduce tissue damage from catheter exchanges, then tissue damage is reduced, but the sheath requires a larger puncture opening and takes longer to close after the procedure
Solution Approach 1:
The patent removes the introducer sheath from the procedure entirely, extracting this component that causes both tissue damage and prolonged closure time. The sheathless design allows direct access through a smaller puncture site without requiring the sheath to be in place during the procedure, thereby eliminating the trade-off between protection and closure time.
Solution Approach 2:
The procedure is segmented into distinct phases: initial access with a needle and guidewire, followed by sheathless catheter advancement. This segmentation allows the catheter to be advanced directly through the guidewire without requiring a sheath, reducing both the puncture size needed and the closure time required after the procedure.
2Area of stationary object
If a sheathless procedure uses smaller diameter introducer sheaths, then the puncture opening is smaller, but sheaths are still used which require additional exchanges and can cause trauma to the access site
Solution Approach 1:
The patent completely extracts the introducer sheath from the procedure, eliminating even the smaller diameter sheath option that would still require additional exchanges and cause trauma. The sheathless design allows direct catheter advancement through the guidewire, avoiding all sheath-related trauma and exchanges.
3Reliability
If multiple steps are used for vessel access including needle, guidewires, and sheath exchanges, then access can be achieved, but the number of steps increases causing more trauma
Solution Approach 1:
The patent merges the functions of multiple separate components (needle, guidewire, sheath) into a streamlined sequence where the guidewire serves both as the initial access guide and the final catheter support. The dilator combines the functions of sheath advancement and catheter positioning, reducing the number of discrete steps while maintaining reliable access.
Solution Approach 2:
The dilator is designed with a side exit port that allows the guidewire to be exchanged and positioned before the catheter is fully advanced. This preliminary action of wire exchange through the side port eliminates the need for subsequent sheath exchanges and reduces the overall number of steps required for access.
Data Source
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AI summary
A guide catheter assembly includes a dilator (150) and a guide catheter (110). The dilator includes a dilator lumen (156) extending from a distal opening (153) at a distal end to a proximal opening (156) at a proximal end, and a side exit port (158) proximal of the distal opening and in communication with the dilator lumen. The guide catheter includes a proximal end, a distal end, and a guide lumen extending therebetween. The dilator and the guide lumen are sized such that the dilator can pass through the guide lumen. The dilator and the guide catheter are sized such that with the proximal end of the dilator generally aligned along an axis with the proximal end of the guide catheter, the distal end of the dilator extends distally past the distal end of the guide catheter and the side exit port is disposed distal of the distal end of the guide catheter.