Extravascular Closure Assembly for Large Bore Access Sealing
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Solution Overview
Problem
Current vascular closure devices do not meet full-size requirements and have high complication rates, including risks of embolization and blood loss, often necessitating multiple devices per procedure.
Innovation Solution
A large bore extravascular closure system with a radially adjustable occlusion device that deploys in the tissue tract, using a bioresorbable injectable filler to anchor and expand, avoiding intravascular placement and employing a control wire for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a vascular closure system is designed for large bore sheaths (e.g., 14 Fr or greater), then the system can accommodate larger vascular access needs, but the complexity of the device increases significantly
Solution Approach 1:
The closure system is divided into separate functional components: a first component that engages with the large bore sheath and a second component that engages with the closure device. This segmentation allows each component to be optimized independently for its specific function while reducing overall system complexity compared to a monolithic design.
Solution Approach 2:
The first and second components are designed to be insertable through each other, with the smaller second component fitting within the larger first component. This nested arrangement allows the system to accommodate large bore sheaths while maintaining a manageable profile and reducing operational complexity.
2Reliability
If conventional closure systems are used for large bore sheaths, then the system structure remains simple, but the system fails to provide adequate closure for larger vascular access
Solution Approach 1:
The closure system incorporates dynamic elements including a balloon that can be inflated to apply progressive compression force, and a screw mechanism that allows adjustable engagement. These dynamic components enable the system to adapt to varying vascular access sizes and provide reliable closure where static conventional systems fail.
Solution Approach 2:
The system includes a dilator that is inserted first to create a pathway and prepare the vessel for closure. This preliminary action facilitates the subsequent insertion of the closure components and ensures proper positioning, thereby improving closure reliability for large bore sheaths.
3Reliability
If a complex multi-component system is used for large bore closure, then closure reliability improves, but the ease of operation decreases
Solution Approach 1:
Multiple functional components (first component, second component, balloon, screw mechanism) are merged into an integrated assembly that can be manipulated as a coordinated unit. This merging reduces the number of separate operations required and simplifies the overall procedure while maintaining the reliability benefits of multi-component design.
Solution Approach 2:
The dilator serves as an intermediary tool that facilitates the insertion and positioning of the closure components. By providing a pre-formed pathway and alignment guide, the dilator simplifies the operation of the complex closure system and improves ease of use.
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 system reduces embolization risks and complication rates by securely closing large bore tissue tracts with a single device, adaptable to varying sizes, and minimizes blood loss.
Implementation Method 1
a balloon that can be inflated to apply compression force
Implementation Method 2
a screw mechanism that can be rotated to apply compression force
Data Source
Figure 1~2
Figure 3A~4C
Figure 5A~5B
AI summary
A large bore extra-vascular closure system comprises an introducer device (20) having a through lumen (23) and a handle (31) comprising an actuator (24), a fluid impermeable occlusion device (1) having a distal end (6), a proximal end (7), a sidewall section (8) comprising a waist section (9) configured for outward inflection upon axial compression of the device, and a through lumen (10), and an injectable filler material. The occlusion device (11) is configured for adjustment from an elongated delivery configuration in which the occlusion device is dimensioned to fit within the lumen (2) of the introducer device (1) and a squat deployed configuration in which the waist section of the occlusion device is expanded radially outwardly. The device comprises a control wire (40) operably connecting the actuator (24) of the introducer device and the distal end (4A, 31) of the occlusion device (1), wherein the actuator is configured upon actuation to pull the control wire proximally to deploy the occlusion device. The occlusion device (1), control wire (40) and injectable filler material are bioresorbable.