Vascular Closure Device Radial Compression Occlusion
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Solution Overview
Problem
Existing vascular occluders face challenges such as imprecise occlusion, migration, and leakage due to their vessel-size specificity, and require open surgical procedures for external compression, which are not always feasible, especially in tortuous or inaccessible vessels.
Innovation Solution
A vascular closure device with a radially compressible and expandable tubular frame, equipped with tissue grasping elements and a radial compression mechanism, allowing for endoluminal deployment and attachment to the vessel wall without the need for a plug, ensuring reliable occlusion without external surgical intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a vascular plug is compressed radially to an elongate form for delivery through small catheters, then the device can be deployed through tortuous and narrow vessels, but the plug cannot be positioned precisely in the vessel and is unsuitable for short treatment sites
Solution Approach 1:
The device is segmented into a delivery catheter portion and an expandable occluder portion. The occluder is divided into radial segments that can expand independently, allowing precise positioning while maintaining deliverability through narrow vessels.
Solution Approach 2:
The occluder transitions from a compressed dynamic state during delivery to an expanded static state at the treatment site. This dynamic transformation enables both easy deployment through narrow catheters and precise positioning once expanded.
2Reliability
If vascular plugs are designed with specific operating diameters for vessel-size specificity, then occlusion and fixation reliability are improved, but it is necessary to determine vessel size accurately and maintain a stock of different size plugs
Solution Approach 1:
The occluder is designed as a universal device that can adapt to different vessel sizes through radial expansion to multiple predetermined diameters. A single device type can serve multiple vessel sizes, eliminating the need for maintaining stocks of different sized plugs.
Solution Approach 2:
The device allows changing the operating diameter parameter by expanding the occluder to different predetermined diameters. This parameter adjustment capability enables a single device to reliably occlude vessels of varying sizes while maintaining fixation reliability.
3Reliability
If vascular plugs are used to occlude vessels, then occlusion is achieved, but the plugs are prone to leakage and recanalization, especially in larger vessels
Solution Approach 1:
The occluder employs a flexible mesh structure that conforms to the vessel wall, creating a secure fit that prevents leakage. The flexible nature allows the device to adapt to vessel movements and pressure changes, reducing the risk of recanalization.
Solution Approach 2:
The device incorporates biological coating materials that promote thrombosis by mimicking natural clotting processes. This biological copying approach enhances occlusion effectiveness and prevents recanalization by encouraging stable clot formation.
4Reliability
If external compression by ligation is used to close vessels, then vessel closure is achieved, but open surgical procedures are required which are not optimal and not always feasible
Solution Approach 1:
The invention replaces the mechanical external compression system (requiring open surgery) with an endoluminal expandable occluder that achieves vessel closure from within the bloodstream. This substitution eliminates the need for open surgical procedures while maintaining reliable vessel closure.
Solution Approach 2:
The expandable occluder acts as an intermediary device deployed through the bloodstream to achieve vessel closure. Instead of direct external surgical intervention, the intermediary occluder is delivered catheter-based and expanded within the vessel to achieve the desired closure effect.
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 provides consistent and reliable vascular occlusion across various vessel sizes, minimizing the risk of migration and leakage, and can be implanted permanently without open surgery, ensuring precise closure and immediate or gradual occlusion as needed.
Implementation Method 1
The closure device may be made from a shape memory alloy such as Nitinol which has a memorized shape at said small radius
Implementation Method 2
The frame may be made of spring material
Data Source
AI summary
A vascular closure device includes a frame to which there is fitted a plurality of anchor elements, spaced radially around the frame. The closure device includes a radial compression feature, which may be a memorized shape of the frame or non-sprung condition of the frame, having a small radius. The closure device is deployed in a vessel such that the anchor elements are embedded into the vessel wall. The radial compression feature causes the frame to compress radially, as a result of which the anchor elements will pull the vessel wall inwardly, thereby closing the vessel.