Axial Closure Device for Vascular Puncture Sealing
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Solution Overview
Problem
Conventional methods for closing vascular punctures are time-consuming and prone to complications such as hematoma and thrombosis, with high rates of postpuncture hemorrhage and failure, especially in cases of vascular disease like atherosclerosis and calcification.
Innovation Solution
A closure device comprising a handle with a tip portion having proximal and distal elements that expand into three-dimensional shapes to occlude anatomical passages, allowing for axial movement and locking mechanisms to secure the device in place, facilitating effective sealing of punctures or defects without losing access until confirmation of occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional methods for closing vascular punctures are used, then the procedure can be performed, but it is time-consuming and prone to complications such as hematoma and thrombosis
Solution Approach 1:
The closure device is divided into multiple independent elements (first closure element and second closure element) that can be deployed separately across the vascular puncture site. Each element can be positioned and secured independently, allowing for reliable closure while maintaining procedural efficiency. The segmentation enables the device to address the puncture from multiple points simultaneously, reducing overall closure time while improving reliability.
Solution Approach 2:
The closure elements are designed with dynamic characteristics, including expandable structures that can transition from a compressed delivery state to an expanded closure state. The elements incorporate movable components and adaptive features that allow them to respond to the vascular anatomy and achieve optimal sealing position, thereby reducing closure time while enhancing the reliability of the closure procedure.
2Reliability
If conventional closure methods are used, then vascular punctures can be closed, but complications such as postpuncture hemorrhage and failure occur at high rates
Solution Approach 1:
The closure device incorporates elements with different local properties and characteristics tailored to specific regions of the vascular puncture site. The first and second closure elements can be designed with different materials, geometries, or mechanical properties suited to their respective positions, optimizing the closure effectiveness at each location and reducing the risk of hemorrhage and thrombosis while maintaining high success rates.
Solution Approach 2:
The closure elements are designed with features that provide preemptive protection against complications. The expandable structures and positioning mechanisms ensure proper sealing before blood flow is fully restored, preventing postpuncture hemorrhage. The device incorporates features that reduce thrombus formation risk by ensuring smooth, complete closure without creating turbulence or stagnation zones, thereby cushioning against potential thrombotic events.
3Ease of operation
If conventional closure methods are used, then punctures can be sealed, but the access site cannot be maintained for continued procedures
Solution Approach 1:
The closure device incorporates dynamic elements that allow the access site to remain patent and accessible during the procedure. The closure elements can be positioned and secured in a manner that maintains open access pathways, enabling continued procedural operations without requiring complete closure of the puncture site. This dynamic approach allows the access site to serve dual purposes: maintaining procedural access while providing the necessary closure function, thereby extending operational ease without significantly increasing procedure duration.
Data Source
AI summary
A device is disclosed for occluding an anatomical passage between first and second anatomical structures. The device includes a tip portion having a proximal element connected to a distal element through a member. The proximal element and/or distal element is movable axially along the tip portion while the other element preferably remains fixed in place. A handle is coupled to a proximal end of the tip portion through a shaft. The tip portion is positioned across the anatomical passage so that the proximal element occludes a first side of the passage and the distal element occludes a second side of the passage. A locking structure, such as a nut, is positioned or crimped against the proximal element, and, once done, the tip portion is released at the occluded passage.