Braided Heart Occluder Forming With Dissolvable Gypsum 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 compromises the device's integrity and performance.
Innovation Solution
The use of frangible materials like gypsum for inserts within the braided medical device during the forming process, which can be dissolved or crushed for removal, along with a dual-layer braid structure where the inner layer is stiffer than the outer layer to maintain structural support while minimizing damage to the ventricular septum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional methods are used to place and remove internal support inserts from braided medical devices, then the device geometry can be formed, but wire distortion, deformation, or breaking occurs compromising device integrity
Solution Approach 1:
The patent applies preliminary action by pre-forming the braided structure with inserts in place during the braiding process itself, rather than attempting to insert supports after braiding is complete. This preliminary integration of supports during manufacturing prevents wire distortion and breaking that would occur with post-formation insertion attempts.
Solution Approach 2:
The patent uses temporary placeholder elements as intermediaries during the braiding process. These placeholders serve as mediators that allow the braiding machinery to form the device geometry without direct contact between the wires and the final support inserts, preventing wire damage while achieving the desired formed structure.
2Shape
If complex braided device geometry is manufactured using traditional methods, then the required shape can be achieved, but manufacturing complexity and scrap increase
Solution Approach 1:
The patent merges the braiding process with the form-setting process into a single integrated operation. By incorporating support placeholders directly into the braiding machinery system, the device is both braided and formed to its final geometry simultaneously, eliminating the need for separate forming operations and reducing manufacturing complexity.
Solution Approach 2:
The patent utilizes parameter changes in the braiding process itself to achieve complex geometries. By adjusting braiding parameters such as wire feed rates, braid angles, and placeholder positioning during manufacturing, the desired complex shapes are achieved directly during braiding rather than requiring multiple post-processing forming steps.
3Ease of operation
If internal supports are removed from braided devices after formation, then the device can be deployed, but wire breaking and device failure may occur
Solution Approach 1:
The patent applies the taking out principle by extracting the support function from permanent inserts and replacing it with temporary placeholders that are deliberately designed to be removed or dissolved after serving their form-holding purpose. This extraction allows the supports to be eliminated once no longer needed, enabling device deployment without compromising wire integrity.
Solution Approach 2:
The patent implements discarding and recovering by using temporary placeholder elements that are discarded after their form-holding function is complete. These placeholders are designed to be easily removed or dissolved, allowing the braided device to be deployed without the risk of wire breaking associated with removing permanent supports.
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 reduces manufacturing complexity, minimizes scrap and cost, and ensures the integrity and effectiveness of the braided medical device by allowing for precise shaping and easy removal of inserts without compromising the device's performance or stability during implantation.
Implementation Method 1
The insert is made of a frangible material such as gypsum and can be dissolved or crushed for removal
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.