Braided Heart Occluder Forming With Dissolvable Support Inserts
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Solution Overview
Problem
The complexity of braided medical device geometry poses challenges in manufacturing, particularly in placing and removing internal support inserts without causing distortion, deformation, or breaking of wires, which can compromise the integrity and performance of the device.
Innovation Solution
The use of frangible materials like gypsum for inserts within the braided medical device, which can be dissolved or crushed during the forming process, allowing for easier removal and reducing manufacturing complexities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional solid inserts are used during braided device forming, then structural support is provided during manufacturing, but wire breaking and device deformation occur during insert removal
Solution Approach 1:
The insert material transitions from solid to dissolved state by changing its chemical composition to be water-soluble. The insert is made from sugar-based materials (sucrose, glucose, fructose) that dissolve in water, allowing automatic removal during the aqueous heat treatment process without mechanical extraction that could damage wires
Solution Approach 2:
The insert is designed as a temporary, consumable component made from inexpensive sugar-based materials. It serves its structural support function during forming and then dissolves completely, eliminating the need for complex removal mechanisms and reducing device complexity
2Adaptability or versatility
If complex braided geometry is manufactured using traditional methods, then device functionality is achieved, but manufacturing complexity and scrap increase
Solution Approach 1:
The insert automatically removes itself through dissolution in water during the heat treatment process. The same aqueous environment used for heat treatment also dissolves the sugar-based insert, eliminating the need for separate removal steps and reducing manufacturing complexity
Solution Approach 2:
The insert is pre-designed with frangible properties (water solubility) so that it automatically dissolves during the subsequent heat treatment process. This preliminary design feature enables self-removal without requiring additional manufacturing steps
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
This method simplifies the manufacturing process, reduces scrap and cost, and maintains the integrity of the braided structure, enhancing the device's performance and effectiveness.
Implementation Method 1
The use of frangible materials like gypsum for inserts within the braided medical device, which can be dissolved or crushed during the forming process
Data Source
AI summary
A method for making a braided medical device may involve positioning an insert inside a braided material, processing the braided material to form the braided medical device, dissolving and/or crushing the insert into multiple pieces, and removing the multiple pieces from the braided medical device. In some embodiments, the insert is made of gypsum. A braided medical device for occluding a defect in a heart may include a right disc for residing in a right side of the heart, a left disc having a partially circular shape for residing in a left side of the heart, and a waist extending between the right disc and the left disc and having a smaller diameter than that of either the right disc or the left disc.