Intravascular Sheath Control via Tapered Guide Assembly
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Solution Overview
Problem
Current methods for introducing and exchanging sheaths in complex vascular geometries, such as acute angled and tortuous aortoiliac bifurcations, face challenges due to poor sheath support, leading to intravascular trauma and limited revascularization options, which are difficult even for highly skilled medical personnel.
Innovation Solution
A guide assembly with a tapered, flexible body that can bend and accommodate different sheath diameters, equipped with a marker for tracking and a lubricant to facilitate smooth movement within the vessel, allowing for controlled advancement and withdrawal of sheaths while maintaining wire position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sheath introduction methods are used in complex vascular geometries, then sheath delivery can be attempted, but poor sheath support leads to intravascular trauma and limited revascularization options
Solution Approach 1:
A guide assembly is introduced as an intermediary device between the operator and the sheath. The guide assembly includes a guide wire and a guide catheter that provide structural support and a pathway for sheath delivery. This intermediary structure enables controlled sheath advancement through complex vascular geometries while preventing direct contact between the sheath and vascular walls, thereby reducing intravascular trauma.
Solution Approach 2:
The guide assembly is advanced into the target vascular location before the sheath is introduced. The guide wire and guide catheter are positioned in advance to establish a stable pathway and provide support structures. This preliminary positioning enables subsequent sheath delivery to proceed with proper support and control, preventing trauma during the sheath introduction process.
2Ease of operation
If highly skilled medical personnel attempt complex sheath introduction procedures, then contralateral sheath positioning can be achieved, but procedure times become undesirably long
Solution Approach 1:
The guide assembly serves as a mediator that simplifies the manipulation process. The guide wire provides a tactile and visual reference for sheath positioning, while the guide catheter offers a pre-formed pathway that reduces the complexity of sheath advancement. This intermediary system enables less experienced operators to perform procedures with comparable ease to highly skilled personnel, while reducing overall procedure time.
Solution Approach 2:
The guide assembly is pre-positioned in the target location before sheath introduction begins. This preliminary action establishes all necessary support structures and pathways in advance, allowing the sheath to be advanced along a predetermined trajectory. By preparing the vascular pathway beforehand, the procedure eliminates time-consuming trial-and-error maneuvers and reduces overall procedure duration.
3Adaptability or versatility
If sheaths are directed into complex vascular networks, then access to target locations can be achieved, but sheath migration and exchanges become difficult
Solution Approach 1:
The guide assembly acts as a stable intermediary platform within the complex vascular network. The guide wire and guide catheter provide a fixed reference framework that remains in place during sheath migration and exchange procedures. This intermediary structure enables operators to easily transition between different sheaths by providing continuous support and a known pathway, making sheath exchanges straightforward even in tortuous vascular anatomy.
4Reliability
If alternative vascular access strategies are used due to failed sheath delivery, then revascularization options are limited, but procedure success rate decreases
Solution Approach 1:
The guide assembly provides a reliable intermediary pathway that ensures successful sheath delivery to target locations in complex vascular networks. By establishing a stable guide wire and guide catheter framework first, the system guarantees proper sheath positioning and support, eliminating delivery failures that would otherwise require alternative access strategies and limit revascularization options.
Data Source
AI summary
A method of controlling intravascular sheaths including the steps of: a) obtaining a guide assembly having a body with a tubular wall bounding a passageway, the body having a length between axially spaced ends and an outer surface that tapers towards each of the spaced ends, the body flexible at each of the spaced ends to allow the spaced ends to bend transversely to the length of the body; b) directing the guide assembly into an operative state within a human body vessel; c) obtaining a first sheath having a tubular body extending around a passageway; and d) relatively moving the guide assembly body and first sheath to thereby direct the guide assembly body into the passageway on the first sheath and thereafter guidingly sliding the first sheath lengthwise against the outer surface of the guide assembly body to: a) advance the first sheath into the human body vessel; or b) withdraw the first sheath.