Introducer Sheath Holder With Offset Adhesive Fixation
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Solution Overview
Problem
Conventional introducer sheaths tend to slip or back out of the vasculature during medical procedures due to factors like patient movement and blood flow dynamics, causing disruptions, vessel damage, and increased exposure to radiation, and adhesion issues compromise the stability and security of the fixation component.
Innovation Solution
A sheath holder system with a clip and adhesive fixation mechanism that secures the introducer hub to the patient's skin, allowing adjustable angles of insertion and preventing slippage, while maintaining adhesive integrity by positioning the adhesion component away from the insertion site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If adhesion is used to fix components close to the insertion site, then fixation strength is improved, but adhesive integrity is compromised by fluids leaking from the insertion site
Solution Approach 1:
The device is divided into distinct functional segments: an adhesion component for securing the device, an insertion site interface for fluid management, and a structural body. This segmentation allows the adhesion component to be positioned optimally for bonding strength while the insertion site interface manages fluid leakage separately, preventing fluid compromise of the adhesive bond.
Solution Approach 2:
The insertion site interface acts as an intermediary element between the adhesion component and the external environment. It manages fluid leakage and creates a barrier that protects the adhesive bond from fluid compromise, allowing strong adhesion near the insertion site without sacrificing adhesive integrity.
2Ease of operation
If the sheath is allowed to move freely in the vasculature, then ease of manipulation is improved, but slippage and backout occur causing procedure disruptions
Solution Approach 1:
The device incorporates dynamic elements that allow controlled movement during manipulation while maintaining stable positioning during the procedure. The adhesion component provides secure anchoring that prevents slippage and backout, while the overall structure allows for necessary adjustments and manipulations during the procedure without compromising stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system stabilizes the introducer sheath, reducing slippage and complications, minimizing procedure disruptions, and ensuring secure adhesion without compromising the adhesive bond, thus reducing patient discomfort and radiation exposure.
Implementation Method 1
a distal end of the base is configured to adhere to an exterior surface of a body of a patient
Data Source
AI summary
A sheath holder is provided, including a clip including a first receptacle configured to secure a sheath or hub of an introducer system to the clip, and a first anchoring portion. The sheath holder further includes a base configured to secure the first anchoring portion of the clip to an exterior surface of a body of a patient.