Multi-layer Braided Vascular Occluder with Variable Strand Diameter
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Solution Overview
Problem
Current intravascular occlusion devices face challenges in precise positioning, dislodgment, and manufacturing costs due to their size and complexity, particularly when treating congenital defects like ASD and VSD, and require additional occluding fabrics for rapid occlusion, which complicates deployment and increases costs.
Innovation Solution
A collapsible medical device with multiple braided metal layers, where the outer layer has fewer strands of larger diameter and the inner layers have more strands of smaller diameter, allowing for immediate occlusion without sewn-in fabrics, and featuring clamps for secure deployment and retrieval through a catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single-layer braided structure is used, then the device structure is simpler and manufacturing is easier, but rapid occlusion cannot be achieved and additional occluding fabrics are required
Solution Approach 1:
The patent applies composite materials by combining multiple braided layers with different strand configurations. The outer layer uses fewer strands of larger diameter for structural support, while inner layers use more strands of smaller diameter for rapid occlusion. This composite structure eliminates the need for separate occluding fabrics while achieving both manufacturing feasibility and rapid occlusion performance.
Solution Approach 2:
The patent segments the braided structure into multiple functional layers, each with specific strand counts and diameters optimized for different purposes. The outer layer provides structural integrity and deliverability, while inner layers provide rapid occlusion capability. This segmentation allows each layer to be optimized independently for its specific function.
2Reliability
If the device size is increased to improve occlusion effectiveness, then occlusion reliability is improved, but device complexity and difficulty of delivery increase
Solution Approach 1:
The patent uses a nested structure where multiple braided layers are concentrically arranged, with inner layers positioned within the outer layer. This nesting allows the device to maintain a compact overall size for easy delivery while containing multiple functional layers that collectively provide reliable occlusion when expanded at the target site.
Solution Approach 2:
The patent transitions from a single-dimensional approach to a multi-layered three-dimensional structure. By adding layers in the radial dimension, the device achieves enhanced occlusion reliability without proportionally increasing the overall device size, maintaining deliverability through small catheters.
3Reliability
If more braided strands are used to improve occlusion effectiveness, then occlusion reliability is improved, but manufacturing complexity increases
Solution Approach 1:
The patent applies local quality by varying the strand characteristics in different regions and layers. The outer layer has fewer strands of larger diameter optimized for structural support and deliverability, while inner layers have more strands of smaller diameter optimized for rapid occlusion. Each layer's strand configuration is locally optimized for its specific function, reducing overall manufacturing complexity while maintaining high reliability.
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 rapid and secure occlusion of vascular defects with improved positioning and reduced manufacturing costs, enabling effective treatment of congenital defects like ASD and VSD without the need for additional occluding fabrics, and can be deployed through smaller catheters for use in smaller patients.
Implementation Method 1
Both the outer and inner metal fabrics have a memory property such that the medical device tends to return to the expanded preset configuration when unconstrained
Implementation Method 2
proximal and distal ends each incorporating clamps for securing the plurality of braided strands that comprise the inner and outer metal fabrics together
Data Source
AI summary
A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.