Large-Bore Vascular Closure with Everted Tissue Stapling
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Solution Overview
Problem
Existing medical devices and methods for closing and sealing punctures in tissue and blood vessels are inadequate, requiring improved alternatives for efficient and effective closure.
Innovation Solution
A vascular closure system comprising an introducer sheath with a lumen and a shaping sheath having a split distal portion that everts tissue, combined with a stapler for deploying staples to secure the everted tissue, ensuring a transverse seam closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing medical devices and methods are used to close punctures in tissue and blood vessels, then the closure function is provided, but the effectiveness and efficiency are inadequate
Solution Approach 1:
The closure device is divided into multiple functional segments: a delivery catheter for insertion, a shaping sheath with radially expandable elements for tissue engagement, and a closure mechanism with deployable anchors or staples. This segmentation allows each component to perform its specific function optimally while maintaining overall system effectiveness for closing vascular access sites
Solution Approach 2:
The closure device employs a nested structure where the closure mechanism (anchors or staples) is contained within the shaping sheath, which itself is delivered through the introducer sheath. This nested configuration enables compact delivery through small punctures while allowing sequential deployment of components to achieve reliable closure without requiring overly complex external structures
2Device complexity
If a closure device is designed to be simple, then the device complexity is reduced, but the closure effectiveness and sealing capability are compromised
Solution Approach 1:
The shaping sheath incorporates radially expandable elements at its distal end that can be selectively deployed to engage with the vessel wall tissue. This localized structural feature provides enhanced sealing capability at the critical closure site without requiring the entire sheath structure to be complex, thus maintaining simplicity elsewhere while ensuring effective sealing where needed
Solution Approach 2:
The closure device performs preliminary actions by first deploying the shaping sheath with expandable elements to engage and shape the tissue, creating a prepared configuration before the actual closure mechanism (anchors or staples) is deployed. This preliminary tissue engagement and shaping ensures that the subsequent closure action is more effective and reliable, achieving good sealing without requiring an overly complex single-step device
Data Source
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AI summary
A vascular closure system for sealing an opening in a blood vessel may include an introducer sheath extending through the opening, the introducer sheath having a lumen extending through the introducer sheath, wherein partial withdrawal of the introducer sheath from the opening everts tissue of the blood vessel at the opening, and a shaping sheath slidably disposed over the introducer sheath, the shaping sheath having a split distal portion configured to engage the everted tissue.