Data for: Design and technical validation of a low-cost, titanium sheet metal TORP (SM-T) for manufacturing and use in LMICs

Total Ossicular Replacement Prosthesis (TORPs) are common practice to restore hearing in conductive hearing impaired. However, TORPs are expensive and scarcely available in Low and Middle Income Countries (LMICs). Therefore, the aim of this article was to develop and validate an open-source design of a TORP that can be produced locally in LMIC hospitals. This study showed that a 9 EURO titanium sheet metal TORP (SM-T) that is bend into shape can easily and reliably be formed by local surgeons. Tests showed accurate dimensions and short learning curves for SM-T production by surgeons. Tests also showed that complete re-bending cycles for corrections can be safely done multiple times. Moreover, sound transmission tests showed comparable properties with commercial TORPs. Cadaver ear fitting showed a good fit in the middle ear, without conflicts between SM-T and anatomical features. In conclusion, this SM-T design has proved to be feasible for implementation in LMICs.

This repository holds design files (SolidWorks file, STEP file, DXF file, PDF drawing, and bending instructions) required to reproduce the design, and the relevant test results. The sheet metal part needs to be cut with a high precision laser cutter. Our parts were produced by Laser Technology Janssen, Wijchen, the Netherlands. PETG 3D printed parts were FDM printed on a Prusa iMK3s printer.

The design is further described in a journal publication (currently under review) under a similar title.

听骨链全置换假体（Total Ossicular Replacement Prosthesis, TORPs）是恢复传导性听力损失患者听力的常规临床方案。然而，TORPs成本高昂且在中低收入国家（Low and Middle Income Countries, LMICs）中供给匮乏。因此，本文旨在开发并验证一款开源TORP设计，使其可在中低收入国家的医院本地生产。本研究证实，一款售价9欧元的钛金属薄板型听骨链全置换假体（sheet metal TORP, SM-T），经弯折成型后，可由当地外科医生轻松且可靠地制作。测试结果显示，外科医生制作SM-T的尺寸精度符合要求，且学习曲线较短。同时测试表明，用于修正的完整再弯折流程可安全重复多次。此外，传声性能测试显示其特性与商用TORPs相当。尸体耳适配实验表明，该假体可良好适配中耳腔，且与耳部解剖结构无冲突。综上，这款SM-T设计已被证实可在中低收入国家推广应用。
本仓库包含复刻该设计所需的全部文件（SolidWorks文件、STEP文件、DXF文件、PDF工程图及弯折操作指南），以及相关测试数据。该薄板部件需通过高精度激光切割机进行裁切，本研究中的样品由荷兰韦亨市Laser Technology Janssen公司制作。PETG材质的3D打印部件采用FDM工艺，在Prusa iMK3s打印机上完成打印。
该设计的详细内容已投稿至某学术期刊（目前处于审稿阶段），标题与本文近似。