Vessel Sealing Device with Dual-Element Sandwich Seal
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Solution Overview
Problem
Current vessel-sealing devices for blood vessels require prolonged clotting time, are not true sealing devices, and often necessitate sheath changes, leading to bleeding and complications during and after procedures.
Innovation Solution
A seal assembly with a first sealing element, a flexible member, and a second sealing element that automatically deploys to sandwich the blood vessel wall, providing immediate and reliable hemostasis without relying on clotting, and can be deployed through a standard sheath without the need for sheath changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pressure application and clotting method is used to seal the puncture site, then hemostasis is achieved, but the patient requires prolonged bed rest (8-24 hours) and extended hospital stay
Solution Approach 1:
The seal assembly is pre-loaded into the sheath in a compressed, sterilized state before the procedure. The sealing elements are prepared in advance with the first sealing element positioned to engage the inner vessel wall and the second sealing element positioned to engage the outer vessel wall, enabling immediate sealing action when deployed without requiring prolonged clotting time
Solution Approach 2:
The seal assembly automatically deploys and self-actuates upon sheath removal. The first sealing element engages the inner vessel wall and the second sealing element engages the outer vessel wall, creating a sandwich structure that seals the puncture site without requiring external intervention or prolonged pressure application, allowing patients to ambulate sooner
2Reliability
If closure devices with pivoting seals or rotation mechanisms are used, then sealing capability is improved, but the device complexity increases and requires specially designed sheaths
Solution Approach 1:
The seal assembly is divided into distinct functional segments: a first sealing element for engaging the inner vessel wall, a second sealing element for engaging the outer vessel wall, and a connecting structure between them. This segmentation allows each element to be optimized for its specific function while maintaining overall simplicity and compatibility with standard sheaths
Solution Approach 2:
Instead of using complex pivoting or rotation mechanisms to achieve proper seal orientation, the invention inverts the approach by designing the sealing elements to automatically assume their correct functional positions through elastic recovery and geometric constraints upon deployment, eliminating the need for mechanical actuation mechanisms
3Reliability
If absorbable collagen plugs and intervascular anchors are used, then clotting enhancement is achieved, but the device requires sheath changes and rotation maneuvers
Solution Approach 1:
The seal assembly is designed to be universally compatible with standard vascular sheaths and can be deployed through常规 access procedures without requiring specialized sheath changes or rotation maneuvers. The assembly performs multiple functions including vessel wall engagement, puncture site sealing, and hemostasis maintenance through its dual sealing element configuration
Solution Approach 2:
The seal assembly uses absorbable materials for the sealing elements that degrade over time after performing their sealing function. This allows the device to be disposed of after use, eliminating the need for retrieval or complex manipulation, and simplifies the procedure by avoiding sheath changes or rotation requirements
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 solution achieves rapid and reliable hemostasis, reducing bleeding and complications, allowing for earlier patient ambulation and minimizing the need for sheath changes, thus improving procedural efficiency and patient recovery.
Implementation Method 1
a seal assembly with a first sealing element, a flexible member, and a second sealing element that automatically deploys to sandwich the blood vessel wall
Data Source
AI summary
A seal assembly that seals opening in the wall of a blood vessel has a first sealing element for placing inside the lumen of the blood vessel and to engage the interior wall surface, a shaft integrally formed with the first sealing element and fixed in a predetermined configuration relative to the first sealing element, an outer floating element slidingly movable along the shaft; and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the outer floating element and position the outer floating element against the exterior surface and the first sealing element against the interior surface of the blood vessel to seal the opening in the blood vessel.