Collapsible Plug Actuator for Vascular Puncture Sealing
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Solution Overview
Problem
Conventional methods for closing vascular punctures after medical procedures incompletely seal holes, leading to high rates of post-puncture hemorrhage, which can result in severe complications due to the high pressure of arterial systems and the use of anticoagulant medications.
Innovation Solution
A collapsible plug device with an actuator that transitions between a non-collapsed and collapsed state to seal tissue openings, utilizing a shaft and engaging element to ensure complete closure of the vascular puncture, accompanied by a deployment apparatus for precise positioning and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pressure bandages or compressive weights are applied to close vascular punctures, then the procedure is simple and quick, but the sealing is incomplete leading to high hemorrhage rates
Solution Approach 1:
The closure device is divided into distinct functional segments: a collapsible plug for sealing the puncture site, an actuator for controlling collapse, and a deployment apparatus for positioning. This segmentation allows each component to be optimized for its specific function while maintaining overall system reliability.
Solution Approach 2:
The plug transitions from an expanded configuration during deployment to a collapsed configuration for sealing. This dynamic transformation allows the device to adapt its shape and size to effectively seal the puncture site while passing through the vascular system, directly addressing the incomplete sealing problem of static conventional methods.
2Reliability
If manual pressure or simple bandages are used for closure, then the device complexity is low, but the rate of post-puncture hemorrhage is high
Solution Approach 1:
The collapsible plug acts as an intermediary element that is temporarily inserted into the vascular puncture site to facilitate sealing. The plug provides a mechanical barrier that prevents blood loss while the tissue naturally heals, offering reliable hemorrhage prevention without requiring complex external compression devices.
Solution Approach 2:
The plug's physical parameters (volume, shape, rigidity) are changed from an expanded deployable state to a collapsed sealed state. This parameter transformation enables the device to provide effective sealing with a relatively simple structure, improving hemorrhage prevention without proportionally increasing device complexity.
3Reliability
If a collapsible plug with actuator is used to achieve complete wound closure, then hemorrhage risk is reduced, but the device complexity increases
Solution Approach 1:
The actuator is nested within or integrated with the deployment apparatus, and the collapsible plug is nested within the actuator system. This nesting arrangement allows multiple functional components to be compacted into a single deployable unit, reducing the overall complexity footprint while maintaining complete wound closure capability.
Solution Approach 2:
The deployment apparatus and actuator are combined into an integrated system that works together to position and collapse the plug in a single coordinated action. This merging of functions eliminates the need for separate deployment and actuation mechanisms, achieving complete wound closure with a unified device rather than multiple separate components.
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 effectively reduces the risk of hemorrhage and catastrophic consequences by achieving complete wound closure, even in high-pressure arterial systems, and is suitable for various tissue openings beyond vascular punctures.
Implementation Method 1
The plug is collapsible between a non-collapsed state in which the lumen is open and a collapsed state in which the lumen is closed
Data Source
AI summary
A tissue closure device includes a collapsible plug and an actuator. The plug has a surface extending between a proximal face and an opposing distal face. A lumen extends through the plug between the proximal and distal faces along a longitudinal axis. The plug is collapsible between a non-collapsed state in which the lumen is open and a collapsed state in which the lumen is closed. The actuator is configured to move the plug between the non-collapsed state and the collapsed state by being pulled proximally, such as through the lumen.