Occlusion Device With Closed Proximal Wall for Septal Defects
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Solution Overview
Problem
Existing occlusion devices for septal defects suffer from complex implantation procedures, material fatigue, embolic complications, and incomplete endothelialization due to protruding components, particularly in cases of atrial fibrillation, necessitating multiple sizes and materials that increase the risk of thromboembolic events.
Innovation Solution
An occlusion device with a fully closed proximal retention area and continuous surface, made from a single material braiding, which self-adjusts to the septal defect without protruding components, using a braiding process that forms a ball-shaped or teardrop-shaped structure with a closed proximal end and a self-expanding design for minimally-invasive implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional double umbrella occlusion systems are used, then occlusion of septal defects can be achieved, but the implantation procedure becomes complicated and device complexity increases
Solution Approach 1:
The occlusion device is divided into two functional segments: a proximal retention area with a closed proximal wall and a distal retention area with an open distal end. This segmentation allows the device to occlude septal defects effectively while simplifying the implantation procedure, as each segment serves a specific function in the occlusion process
Solution Approach 2:
The single-piece occlusion device with a closed proximal wall serves multiple functions: it provides structural support, ensures complete endothelialization, prevents material fatigue, and simplifies implantation. This multi-functionality eliminates the need for complex double umbrella systems while maintaining occlusion effectiveness
2Reliability
If multiple materials and components are used in occlusion devices, then occlusion effectiveness is improved, but material fatigue and fragment fracture risk increase
Solution Approach 1:
The occlusion device is constructed as a single-piece structure made from homogeneous material throughout. This eliminates joints, connections, and material interfaces that would be susceptible to fatigue and fracture, while maintaining the mechanical strength needed for effective occlusion
3Reliability
If umbrellas are used in occlusion devices, then occlusion of septal defects is achieved, but thromboembolic complications and incomplete endothelialization occur due to protruding components
Solution Approach 1:
The open distal end of the retention area is removed or closed to eliminate protruding components that cause thromboembolic complications. This extraction of the harmful open structure while retaining the occlusion function allows complete endothelialization and reduces thromboembolic risks
Solution Approach 2:
The closed proximal wall design, which initially seems to add structural complexity, actually converts the harmful effect of protruding components into a benefit by providing a smooth, continuous surface that promotes complete endothelialization and reduces thromboembolic complications
4Adaptability or versatility
If multiple occluder sizes are used to accommodate different septal defect proportions, then adaptability is improved, but device complexity and manufacturing costs increase
Solution Approach 1:
The occlusion device incorporates adjustable parameters such as the size and configuration of the retention areas that can be modified to accommodate different septal defect proportions. This allows a single device design to adapt to various defect sizes, eliminating the need for multiple specialized occluder sizes
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 ensures complete endothelialization, reduces material fatigue and embolic risks, and simplifies implantation, while maintaining mechanical stability and compatibility with various defect sizes, minimizing manufacturing costs and thromboembolic complications.
Implementation Method 1
a self-expanding design for minimally-invasive implantation
Implementation Method 2
given a suitable form by means of a molding and heat treatment procedure
Data Source
AI summary
The present invention relates to an occlusion device (1) consisting of a braiding (2) of thin wires or threads (4) which is given a suitable form in a molding and heat treatment procedure. The occlusion device (1) has a proximal retention area (6) and a distal retention area (8), whereby the ends of the wires or threads (4) converge into a holder (5) in distal retention area (8). A cylindrical crosspiece (10) is furthermore disposed between the proximal and distal retention areas (6, 8). With the objective of providing an occlusion device which positions as flat as possible against the septum at the proximal side of a septal defect in the inserted state, the invention provides for the proximal retention area (6) of the braiding (2) to exhibit a completely closed proximal wall (112) disposed with a continuous surface at the proximal end of the occlusion device (1) which forms the proximal end (12) of said occlusion device (1).