Extra-vascular Vascular Closure Device with Anchor and Suture
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Solution Overview
Problem
Current vascular closure devices for sealing puncture sites after catheter-based procedures are often cumbersome, uncomfortable for patients, and require significant nursing time, with limitations in use due to factors like peripheral vascular disease or small vessel size, and may leave components inside the vessel.
Innovation Solution
A vascular closure device that deploys bio-absorbable, extra-vascular components outside the vessel, using a vessel locator assembly, tamper assembly, and suture tightening mechanism to securely seal the puncture site without leaving any components inside the blood vessel, ensuring rapid hemostasis and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual compression is used to seal the artery after sheath removal, then the sealing method is simple, but it is uncomfortable for the patient and requires significant nursing time
Solution Approach 1:
The device enables self-sealing of the vascular puncture site through mechanical compression by the device itself rather than requiring continuous manual compression by nursing staff. The compression mechanism is integrated into the device structure, allowing it to maintain pressure on the puncture site autonomously after deployment
Solution Approach 2:
The sealing function is extracted from the manual compression process and embodied in a dedicated mechanical device. The device separates the sealing function from general nursing care, allowing patients to be discharged earlier while the device continues to perform the sealing function
2Productivity
If intra-vessel anchor and extra-vessel collagen sponge are used to achieve hemostasis, then the device is easy to use and seals quickly, but a substantial number of patients are ineligible due to peripheral vascular disease, poor needle stick location, or small vessel size
Solution Approach 1:
The device extracts the anchor component from the intra-vessel environment and relocates it to the extra-vessel space. The anchor is positioned in the tissue surrounding the vessel rather than inside the vessel lumen, eliminating the need for adequate vessel size and quality to support intra-vessel anchoring
Solution Approach 2:
The device introduces a tissue bridge or intermediary structure that connects the extra-vessel anchor to the vessel wall, providing a new mechanical pathway for sealing that does not depend on the vessel's intrinsic properties. This intermediary allows the sealing mechanism to function regardless of vessel size or quality
3Adaptability or versatility
If collagen is deposited outside the vessel with no component inside the vessel, then patient eligibility is improved, but the device requires consistently placing the collagen near the arterial wall and cannot allow compression or tamping due to embolization risk
Solution Approach 1:
The device merges the anchor and collagen sponge into a single integrated assembly where the collagen is pre-positioned and mechanically secured to the anchor. This combination allows the operator to manipulate and compress the collagen safely because the anchor provides a stable base that prevents embolization during compression
Solution Approach 2:
The anchor serves as an intermediary structure that secures the collagen to the vessel wall, providing a fixed reference point that ensures consistent placement. The anchor acts as a mechanical mediator that holds the collagen in the correct position and allows safe compression without risk of displacement into the vessel
4Reliability
If extra-vascular components are deployed outside the vessel, then no components are left inside the blood vessel, but the device complexity increases with vessel locator assembly, tamper assembly, and suture tightening mechanism
Solution Approach 1:
The device is segmented into distinct functional modules (vessel locator assembly, anchor with collagen, tamper assembly, suture tightening mechanism) that can be independently designed, manufactured, and operated. Each module performs a specific function, allowing the overall complex system to be managed through modular decomposition
Solution Approach 2:
The device employs a nested structure where the anchor is positioned within the tissue, the collagen is nested around the anchor, and the various assemblies are nested within each other during deployment. The vessel locator assembly nests the anchor assembly, which in turn nests the collagen, creating a compact multi-functional structure
Data Source
AI summary
Various embodiments of a device are shown and disclosed for closing a vascular access puncture site following percutaneous diagnostic or therapeutic interventional procedures. In one embodiment, the closure device includes a vessel locating member, an anchor and a sealing material. The closure device may be configured to deploy the anchor and the sealing material outside of a hole in a blood vessel to close the hole. The vessel locating member may be used to locate the blood vessel to ensure that the anchor and/or the sealing material are properly placed adjacent to the hole. The closure device may also include a tamper member configured to push or tamp the sealing material against the anchor. The closure device may also include a suture that is used to hold the sealing material and the anchor together adjacent to the hole in the blood vessel.