Segmented Mold for Custom Intraluminal Endoprosthesis Manufacturing
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Solution Overview
Problem
Current methods for manufacturing endoprostheses, such as stents, often result in suboptimal fit with patient anatomy due to cylindrical shapes and require hazardous materials or heat treatments, leading to issues like turbulence, vessel injury, and endoprosthesis migration.
Innovation Solution
The development of molds comprising multiple pieces joined by weakened seams, allowing for controlled breaking and personalized endoprosthesis production using 3D modeling and additive manufacturing, enabling precise fit to patient anatomy without hazardous materials or heat treatments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a cylindrical shape is used for endoprostheses, then manufacturing is simplified, but the fit with patient anatomy becomes suboptimal
Solution Approach 1:
The endoprosthesis is divided into multiple modular segments that can be independently manufactured and then assembled. Each segment can be customized to match specific anatomical features, allowing both simplified manufacturing of individual components and precise overall anatomical fit when assembled.
Solution Approach 2:
The endoprosthesis incorporates adjustable parameters such as variable diameter, curvature, and segment length that can be customized during manufacturing to match patient-specific anatomy. This allows deviation from standard cylindrical shapes while maintaining manufacturability through parameterized design.
2Ease of manufacture
If hazardous acids are used to dissolve the mandrel, then the mandrel can be removed, but safety risks and material limitations increase
Solution Approach 1:
The mandrel is designed with a specific structural feature (such as a soluble core or mechanically separable components) that allows it to be removed through non-hazardous means. The mandrel structure is extracted into removable parts that can be taken out without requiring hazardous chemical dissolution.
Solution Approach 2:
The mandrel is designed as a disposable component made from materials that can be easily discarded or removed after serving their purpose. This eliminates the need for hazardous removal processes, as the mandrel is simply discarded after the endoprosthesis is formed.
3Reliability
If heat treatment is applied to super-elastic wire, then the desired shape is restored, but process complexity and time increase
Solution Approach 1:
The endoprosthesis is pre-shaped during manufacturing to its final desired configuration using a mandrel or forming tool. This preliminary shaping eliminates the need for subsequent heat treatment to restore the shape, as the shape is already set in the correct configuration before deployment.
Solution Approach 2:
The thermal process (heat treatment) is replaced with a mechanical forming process during manufacturing. The endoprosthesis is mechanically shaped to the desired form using a mandrel or molding technique, substituting the need for thermal energy and heat treatment steps.
Data Source
AI summary
The application provides molds for the manufacture of intraluminal endoprostheses and methods for their manufacture. In particular embodiments, the methods comprise the steps of providing a 3D model of the mold, meshing the model, manufacturing a mold based on said meshed 3D model. Also provided herein are methods for manufacturing an endoprosthesis using said mold.