Dual-Layer Braided Occluder Resolving Conformability and Radial Force Trade-Off
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Solution Overview
Problem
Existing occlusion devices experience issues with tissue erosion, device malformation, and leakage after deployment, which can be exacerbated by adjustments to one characteristic affecting other aspects of the device, necessitating a solution that optimizes conformability while maintaining occlusive functionality and ease of use.
Innovation Solution
A medical device with a dual-layer structure, featuring an inner layer of braided self-expanding material for radial strength and an outer layer with a higher wire count and smaller wire diameter for softness and conformability, optimized through specific wire count, diameter, and braid pattern selections, along with a pic transition to enhance deployment and tissue interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single-layer structure is used, then the device is simpler to manufacture, but the conformability to surrounding tissue is reduced
Solution Approach 1:
The patent employs a dual-layer composite structure where the inner layer uses a first braided self-expanding material optimized for radial strength, and the outer layer uses a second braided self-expanding material with different properties optimized for conformability. This composite construction allows each layer to contribute its specific functional advantages, resolving the contradiction between structural simplicity and tissue conformability.
Solution Approach 2:
The device is segmented into two distinct functional layers with different material properties. The inner layer provides structural support and radial strength, while the outer layer provides conformability and tissue compatibility. This segmentation allows independent optimization of each layer's characteristics without compromising the other.
2Adaptability or versatility
If the wire count in the outer layer is increased to improve conformability, then the softness increases, but the radial force may be reduced
Solution Approach 1:
Different regions of the device have different wire counts and material properties tailored to their specific functional requirements. The inner layer has a lower wire count for radial strength, while the outer layer has a higher wire count for conformability. This local differentiation of material properties resolves the contradiction between radial force and conformability.
Solution Approach 2:
The dual-layer composite structure allows the inner layer to provide radial force with fewer, stronger wires, while the outer layer provides conformability with more, softer wires. The composite construction ensures that the radial force from the inner layer is not compromised by the softer outer layer.
3Adaptability or versatility
If the wire diameter is decreased to increase softness, then the conformability improves, but the radial strength may be reduced
Solution Approach 1:
The device segments the wire structure into two layers with different wire diameters. The inner layer uses larger diameter wires for radial strength, while the outer layer uses smaller diameter wires for softness and conformability. This segmentation allows each layer to optimize its wire diameter for its specific function without compromising the other.
Solution Approach 2:
The wire diameter is locally optimized for each layer's function: larger wires in the inner layer where radial strength is critical, and smaller wires in the outer layer where conformability is critical. This local quality differentiation resolves the contradiction between radial strength and softness.
4Force
If the device is made stiffer to maintain radial force, then the occlusive functionality is maintained, but the tissue erosion risk increases
Solution Approach 1:
The dual-layer composite structure allows the inner layer to provide the necessary radial force for occlusive functionality, while the outer layer provides a softer, more compliant surface that reduces tissue erosion. This composite construction resolves the contradiction between maintaining radial force and reducing tissue damage.
Solution Approach 2:
The device has different material properties in different regions: the inner layer is stiffer to maintain radial force, while the outer layer is softer to reduce tissue erosion. This local differentiation of mechanical properties resolves the contradiction between occlusive functionality and tissue compatibility.
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 dual-layer structure reduces tissue erosion and leakage, improves conformability, and maintains occlusive functionality by distributing force effectively, reducing the risk of device deformation and enhancing patient outcomes.
Implementation Method 1
an inner layer formed from a first braided self-expanding material, and an outer layer formed from a second braided self-expanding material
Data Source
AI summary
A medical device for treating a target site includes a body extending from a proximal end to a distal end along a central longitudinal axis, the body including a proximal disc adjacent the proximal end, a distal disc adjacent the distal end, and a waist extending between and connecting the proximal and distal discs. The body further includes an inner layer formed from a first braided self-expanding material and an outer layer formed from a second braided self-expanding material, wherein the outer layer surrounds the inner layer and is independent from the inner layer. Each of the proximal disc, the distal disc, and the waist are defined in part by each of the inner layer and the outer layer. The first braided self-expanding material includes a first number of wires and the second braided self-expanding material includes a second number of wires greater than the first number of wires.