Vessel Seal Assembly with Floating Outer Element
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Solution Overview
Problem
Current sealing devices for blood vessels require prolonged pressure application to achieve hemostasis, often necessitating sheath changes and relying on clotting times, which can lead to bleeding and complications, and existing designs face challenges in deploying seals larger than the sheath ID without compromising mechanical properties or causing embolization.
Innovation Solution
A seal assembly with a first sealing element inside the blood vessel, a shaft, an outer floating element, and a second sealing element that deploy to sandwich the vessel wall, using a bio-absorbable material and a mechanism that automatically actuates to break the shaft and exert sealing pressure, allowing for rapid hemostasis without sheath change and minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a seal assembly with two sealing elements is deployed to sandwich the vessel wall for immediate sealing, then sealing reliability is improved, but device complexity increases
Solution Approach 1:
The seal assembly is divided into two separate sealing elements (first sealing element and second sealing element) that are deployed on opposite sides of the vessel wall. This segmentation allows each element to independently contact and seal against the vessel wall, creating a more reliable double-seal configuration that prevents bleeding from both the inner and outer surfaces of the puncture site.
Solution Approach 2:
The first sealing element is nested within the sheath during delivery, and the second sealing element is positioned outside the sheath. Upon deployment, the first sealing element exits the sheath and contacts the inner surface of the vessel wall, while the second sealing element contacts the outer surface, creating a nested deployment sequence that achieves reliable bilateral sealing.
2Reliability
If a larger diameter sheath is used to deploy seals larger than the sheath ID, then sealing effectiveness is improved, but procedural complexity and patient discomfort increase
Solution Approach 1:
The first sealing element is designed with dynamic deployment characteristics, transitioning from a compressed state within the sheath to an expanded state upon exit. The sealing element automatically expands to its full sealing diameter as it is pushed out of the sheath by the pusher, eliminating the need for sheath changes while achieving effective sealing contact with the vessel wall.
Solution Approach 2:
The sealing elements are designed with specific dimensional parameters that allow them to be contained within the sheath during delivery and then expand to their functional sealing size upon deployment. The first sealing element has a compressed diameter suitable for sheath passage and expands to a larger sealing diameter upon exit, achieving effective sealing without requiring a larger sheath.
3Device complexity
If manual pressure application is used to achieve hemostasis, then equipment simplicity is maintained, but treatment time and patient immobilization duration increase
Solution Approach 1:
The seal assembly is designed as a self-deploying, self-actuating device that automatically performs the sealing function upon insertion. The pusher mechanism automatically pushes the first sealing element out of the sheath and against the vessel wall upon entry into the blood vessel, eliminating the need for prolonged manual pressure application and enabling immediate hemostasis.
Solution Approach 2:
The sealing elements are pre-positioned and pre-loaded within the delivery system before patient insertion. The first sealing element is contained within the sheath in a ready-to-deploy state, and the second sealing element is pre-positioned outside the sheath. This preliminary preparation allows for immediate sealing action upon deployment, eliminating the need for prolonged manual compression.
4Device complexity
If a single sealing element is used to seal the puncture site, then device simplicity is improved, but sealing reliability decreases due to potential leakage
Solution Approach 1:
The sealing function is segmented into two separate sealing elements that operate independently on opposite sides of the vessel wall. The first sealing element contacts the inner surface to prevent internal bleeding, while the second sealing element contacts the outer surface to prevent external bleeding, creating a redundant sealing system that significantly reduces leakage risk.
Solution Approach 2:
Each sealing element is specifically designed with local sealing properties optimized for its position. The first sealing element has surface characteristics optimized for contact with the inner vessel wall, while the second sealing element has surface characteristics optimized for contact with the outer vessel wall and surrounding tissue, ensuring reliable sealing at each interface.
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.