THE PROCESS OF LOWER LIMB PROSTHESIS CREATION USING CAD DESIGN AND FINITE ELEMENT ANALYSIS

Abstract

Research objective: The aim of this article is to illustrate how prostheses are made, the significance of strength analyses, and why they are produced in accordance with ISO standards. Methodology: Research methods employed include literature review and analysis of an original research. Main conclusions: CAD design and strength analyses are crucial aspects of creating prostheses as medical devices. Modern technology allows for tailoring the design to a specific case and the patient's needs, considering anatomy and specific functional requirements. Numerical analyses make it possible to identify the most vulnerable elements to potential damage and optimize these areas through geometry modifications, among other factors. Additionally, it is possible to simulate critical conditions in which the designed element may find itself. An essential part of the research is conducting strength analyses according to ISO standards, which precisely specify how they should be carried out and under what load. Successfully passing these stages ensures legal safety for the designer and the possibility of implementing the designed solutions throughout the European Union. Application of the study: Strength analyses allow for predicting the behavior of prostheses under load and real-world usage conditions, which is crucial for patient safety. The use of CAD design enables customization of medical devices to individual patient needs. Originality/Novelty of the study: The presented results provide insights into the prostheses design process. By outlining the creation process and conducting numerical analyses, the complexity of this issue becomes apparent. Designing prostheses requires collaboration among several scientific disciplines, including biomechanics, engineering, medicine, materials science, and computer science.