Expandable Plug Seals Access Site Gap in Medical Sheath
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Solution Overview
Problem
During medical procedures involving percutaneous circulatory devices, the transition from a larger introducer sheath to a smaller repositioning sheath can lead to bleeding at the access site due to the smaller diameter of the repositioning sheath being less than the access site, necessitating a solution to seal the gap and reduce ischemia.
Innovation Solution
A medical device delivery system featuring a sheath with a plug, where the plug is composed of an expandable material, such as a braided or self-expanding disc, positioned within the blood vessel to seal the access site, ensuring effective sealing of the gap between the sheath and the vessel wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a sheath of smaller diameter is used to increase blood flow, then blood flow through the blood vessel is improved, but bleeding at the access site occurs because the sheath size is less than the access site size
Solution Approach 1:
A sealing plug is introduced as an intermediary element between the smaller-diameter sheath and the access site. The plug fills the gap and seals the space between the sheath and the blood vessel wall, preventing blood leakage while allowing the smaller sheath to remain in place for improved blood flow.
Solution Approach 2:
The sealing plug provides localized sealing at the access site without requiring the entire sheath to have a larger diameter. This allows the sheath to maintain its smaller diameter for optimal blood flow while the plug locally addresses the bleeding issue at the access site interface.
2Reliability
If a sheath of smaller diameter is inserted, then ischemia issues are reduced, but a gap is formed between the sheath and the blood vessel wall allowing bleeding
Solution Approach 1:
The sealing plug acts as a mediator that fills the gap between the smaller sheath and the blood vessel wall. This intermediary element eliminates the space that would otherwise allow bleeding, while preserving the smaller sheath diameter needed for ischemia reduction.
3Object-affected harmful factors
If an expandable plug is added to seal the access site, then bleeding is stopped, but device complexity increases
Solution Approach 1:
The sealing plug utilizes parameter changes, specifically dimensional transformation from a compressed delivery state to an expanded deployed state. This allows the plug to be delivered through the smaller sheath in a compact form and then expand to fill the gap at the access site, achieving sealing without requiring a fundamentally complex device structure.
Solution Approach 2:
The sealing plug is designed with dynamic properties, transitioning from a compressed configuration during delivery to an expanded configuration during deployment. This dynamic transformation allows the device to adapt its size and shape to effectively seal the access site while maintaining a simple delivery mechanism.
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 expandable plug effectively seals the access site, reducing bleeding and enhancing blood flow by accommodating the smaller diameter of the repositioning sheath while maintaining contact with the blood vessel wall, thus addressing the bleeding issue and promoting better vascular dynamics.
Implementation Method 1
the plug is composed of an expandable material, such as a braided or self-expanding disc, positioned within the blood vessel to seal the access site
Data Source
AI summary
A medical device delivery system includes a sheath for insertion into an access site and for use in positioning a medical device within a blood vessel. The sheath including a sheath body extending between a distal end and a proximal end. The sheath body defines a sheath lumen for receiving the medical device. A plug is arranged around the sheath body, and the plug is defined by a first disc formed of an expandable material. The first disc is configured to be positioned within the blood vessel and against a wall of the blood vessel such that the plug can seal the access site.