Expandable Sheath for Introducing Fluid Leakage Control
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Solution Overview
Problem
Existing introducer systems for minimally invasive procedures, such as transcatheter heart valve implantation, face challenges with fluid leakage, particularly blood, during insertion and withdrawal, which complicates the procedure and leads to messy conditions.
Innovation Solution
The introduction of an expandable sheath and a wiper body system that can be used with the introducer sheath to retain fluid within the sheath during withdrawal, reducing leakage by expanding to cover the seam and sliding against the sheath body to prevent fluid transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an introducer sheath is used for minimally invasive procedures, then patient trauma is reduced, but fluid leakage occurs during insertion and withdrawal
Solution Approach 1:
The expandable sheath is positioned in advance at the insertion site and expanded before the introducer sheath is withdrawn, creating a sealing barrier that prevents fluid leakage during the withdrawal process. This preliminary preparation of the sealing mechanism resolves the contradiction by maintaining minimal invasiveness while preventing fluid leakage.
Solution Approach 2:
The expandable sheath acts as an intermediary element between the introducer sheath and the external environment. When expanded, it forms a seal that mediates the transition, allowing the introducer sheath to be withdrawn without causing fluid leakage, thus resolving the contradiction between minimal trauma and fluid control.
2Productivity
If the introducer sheath is withdrawn from the insertion point, then the procedure is completed, but fluid leaks from the entry point
Solution Approach 1:
The expandable sheath is deployed and expanded before the introducer sheath withdrawal begins, establishing a sealing barrier in advance. This preliminary action ensures that when the introducer sheath is withdrawn to complete the procedure, fluid leakage is prevented by the pre-positioned seal.
Solution Approach 2:
The sealing function is extracted from the introducer sheath itself and implemented through a separate expandable sheath mechanism. This allows the introducer sheath to be simply withdrawn for procedure completion while the extracted sealing function remains in place to prevent fluid leakage.
3Ease of operation
If traditional introducer systems are used, then insertion is simple, but fluid transfer occurs during withdrawal
Solution Approach 1:
The expandable sheath serves as an intermediary sealing mechanism that does not complicate the insertion process. It is positioned and expanded after the introducer sheath is in place, maintaining insertion simplicity while preventing fluid transfer during the withdrawal phase.
Solution Approach 2:
The fluid control function is segmented into a separate expandable sheath component rather than being integrated into the introducer sheath design. This segmentation allows the introducer sheath to remain simple for easy insertion, while the separate expandable component handles the fluid prevention function during withdrawal.
Data Source
AI summary
The present disclosure generally relates to systems, devices, and methods for providing control of fluids from a subject, which may be utilized with an introducer system. Such fluids may comprise blood and may be produced during medical operation upon the subject. An expandable sheath may be provided that is configured to cover a portion of an introducer sheath body between the surface of the subject and a housing of the introducer sheath to retain fluid from the subject within the expandable sheath.