Vascular Closure Plug With Barbs for Secure Hemostasis
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Solution Overview
Problem
Current vascular closure devices are inadequate in securely sealing vascular punctures, often requiring manual compression, which is uncomfortable for patients and time-consuming for medical staff, and may not be effective in all cases due to factors like peripheral vascular disease or small vessel sizes.
Innovation Solution
A vascular closure device that deploys a plug outside the blood vessel with projections or barbs to prevent movement and includes a sealing material that expands or swells to secure the puncture site, ensuring quick and secure sealing without leaving components inside the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to seal the artery, then hemostasis can be achieved, but it is uncomfortable for the patient and requires significant nursing staff time
Solution Approach 1:
The closure device is self-contained and self-operating once deployed. The plug automatically seals the puncture site without requiring continuous manual compression or nursing intervention, allowing patients to ambulate early and reducing nursing time while maintaining hemostasis effectiveness
Solution Approach 2:
The invention extracts the sealing function from the vessel interior (no intra-arterial components) and places it entirely in the extra-vascular space. This eliminates the need for manual compression while achieving reliable hemostasis through the plug's mechanical sealing action at the puncture site
2Ease of operation
If a plug is deposited outside the vessel to seal the puncture, then the device is easier to use and leaves no component inside the vessel, but the plug may move away from the hole due to pressure resulting in hemotoma or leakage
Solution Approach 1:
The plug incorporates asymmetric features including one-way barbs that allow insertion in the correct direction but prevent removal or movement away from the puncture site. This asymmetric design ensures the plug remains securely positioned despite blood pressure while maintaining ease of deployment
Solution Approach 2:
The plug utilizes a curved or angled deployment path that follows the natural trajectory of the puncture tract. This curved approach allows the plug to be inserted smoothly along the tract while the barbs engage the tissue wall, preventing migration and ensuring reliable sealing
3Reliability
If the plug is positioned to seal the puncture hole, then sealing effectiveness improves, but pressure from blood may push the plug away causing hemotoma
Solution Approach 1:
The one-way barbs on the plug are designed to prevent movement in the direction of blood pressure before the sealing is complete. This preliminary anti-action counteracts the harmful force of blood pressure, preventing plug migration and subsequent hemotoma formation while maintaining sealing effectiveness
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 device effectively seals vascular punctures quickly and securely, reducing patient discomfort and nursing time, and is suitable for various vessel sizes, preventing hematomas and leakage.
Implementation Method 1
The sealing material may be configured to expand or swell upon contact with blood to assist in holding the plug in place and sealing the puncture tract
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. The vascular closure device includes an improved plug that is configured to be positioned adjacent to the hole in the vasculature. The plug may be shaped to prevent the plug from moving away from the hole in the blood vessel due to pulsatile pressure from the blood. In one embodiment, the plug may include a plurality of projections that extend outward from the plug and contact surrounding tissue in the tissue puncture tract to prevent the plug from moving away from the hole in the blood vessel.