Angled Vascular Closure Assembly for Shallow Artery Hemostasis
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Solution Overview
Problem
Existing vascular closure devices (VCDs) for shallow vessels like the radial or ulnar artery suffer from prolonged hemostasis times, nerve damage, and hematoma formation due to their design and deployment mechanisms, which are not suitable for small-bore access.
Innovation Solution
A vessel seal assembly with a first sealing element and a flexible shaft, angled at 20-30 degrees, combined with a second sealing element that slides and locks into place to create a sandwich force for instant hemostasis, eliminating the need for extravascular components and reducing nerve contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used for vessel closure, then hemostasis is achieved through clotting cascade, but the procedure is time-consuming (up to 30 minutes) and requires reversal of antithrombin medication
Solution Approach 1:
The patent replaces the biological clotting cascade mechanism with a mechanical compression system. The closure device applies direct mechanical pressure to the vessel wall through a compression element, achieving hemostasis through physical force rather than relying on the clotting cascade, thereby eliminating the need for antithrombin reversal and significantly reducing closure time
Solution Approach 2:
The patent introduces a compression element as an intermediary between the operator and the vessel wall. This compression element delivers controlled mechanical pressure to achieve hemostasis, serving as a mediator that replaces the need for prolonged manual compression or pharmacological intervention
2Reliability
If manual compression is applied over a large area to stop bleeding, then hemostasis is achieved, but nerve damage occurs due to pressure on surrounding tissues
Solution Approach 1:
The patent applies compression locally at the precise site of vessel puncture rather than over a large area. The compression element is positioned to deliver focused pressure exactly where needed to seal the puncture site, minimizing pressure on surrounding nerve-bearing tissues and reducing the risk of nerve damage
3Loss of time
If coagulant material is used to form a barrier for hemostasis, then hemostasis time is reduced (2-6 minutes), but hematoma formation increases due to wound bleeding requirement
Solution Approach 1:
The patent replaces coagulant-based hemostasis with mechanical compression. By applying direct mechanical pressure to the vessel wall, the device achieves immediate hemostasis without requiring the wound to bleed into coagulant material, thereby eliminating the mechanism that leads to hematoma formation while maintaining rapid closure times
4Reliability
If a shaft extends through the wound to minimize embolization, then intravascular element stability is improved, but deployment complexity increases
Solution Approach 1:
The patent combines the shaft and compression element into a single integrated assembly. The compression element is positioned at the distal end of the shaft, and both components are deployed together through the sheath in a single motion, simplifying the deployment process while maintaining the shaft's function of preventing embolization
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 vessel seal assembly provides instant hemostasis without nerve damage by maintaining a consistent sandwich force, minimizing tissue necrosis and hematoma formation, and ensuring rapid closure of shallow vessel access sites.
Implementation Method 1
a second sealing element slidingly movable relative to the first sealing element along the shaft to engage the exterior wall surface and configured to position the flexible member against the interior wall surface of the blood vessel to seal the opening in the blood vessel
Data Source
AI summary
A vessel seal assembly for sealing an opening in a wall of a blood vessel of an appendage such as the ulnar or radial artery, including a first sealing element for placing inside the lumen of the blood vessel, a shaft, the shaft fixed in a predetermined configuration relative to the first sealing element, a flexible member surrounding at least a portion of the shaft adjacent the first sealing element, and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the exterior wall surface and configured to position the flexible member against the interior wall surface of the blood vessel to seal the opening in the blood vessel, the shaft and the first sealing element are joined at an angle between about 20 and 30 degrees.


