Developing a Bespoke Incremental Sheet Forming Machine for Cranioplasty

颅骨成形术是一种外科手术，用于修复因脑瘤、中风或创伤性损伤造成的人类颅骨畸形。在所有可用的材料中，钛由于其优异的生物相容性、抗感染性、优异的材料性能和轻质而继续成为颅骨成形术中使用的主流材料。然而，尽管钛在颅骨重建中的广泛使用，但在颅骨板制造中常用的方法多种多样，包括铸造、手工成型和橡胶压制成型。即使在先进的CAD/CAM（计算机辅助设计和制造）以及计算机断层扫描（CT）和磁共振成像（MRI）技术的帮助下，目前通过传统方法制造定制的颅骨板的过程通常需要长达两周的时间才能完成，这主要是由于制造模具和工具所需的时间。基于3D打印或增材制造技术的最新进展使得在几个小时内完成颅骨或颌面假体部件的3D打印成为可能。然而，在其广泛的临床应用之前，仍然存在许多障碍，包括材料性质和成本问题需要克服。 该项目提出了一种新的替代解决方案，通过使用增量片材成形（ISF）技术，以更快，更经济的方法制造个性化颅骨板。我们最近的工作表明，一个典型的大尺寸颅骨板可以满意地使用ISF过程中，在7~8分钟，而不是小时或天。这一结果对潜在的技术进步和经济效益以及生活质量的改善具有相当大的影响。在这个项目中，我们的目标是开发新的基于ISF的颅骨成形术制造技术，设计和建造一个定制的桌面ISF机器，用于颅骨重建，具有完整的CT/MRI和CAD/CAM软件集成和ISF过程自动化。通过使用开发的定制ISF机器，我们将使用开发的定制ISF机器对3个示范病例研究进行一系列ISF基准测试和颅骨重建临床前试验。该项目将证明其技术可行性、经济效益和改善生活质量的潜力。到项目结束时，我们的目标是实现高达95%的制造提前期减少与相关的成本效益相比，传统的方法。我们还计划展示定制的ISF机器可以用作颅骨制造的新的可行的医疗设备，并且有一个快速商业开发的利基市场。

Cranioplasty is a surgical procedure for the repair of deformity of a human skull due to brain tumour, stroke or traumatic injuries. Among all available materials, titanium continues to be a main stream material used in cranioplasty surgeries because of its excellent biocompatibility, resistance to infection, excellent material properties and lightweight. However, in spite of the popular use of titanium in cranial reconstruction, there is a wide variety of methods including casting, manual shaping and rubber press forming commonly used in cranial plate manufacture. Even with the assistance of advanced CAD/CAM (computer-aided design and manufacture) and computed tomographic (CT) and magnetic resonance imaging (MRI) technologies, currently the process for manufacturing customised cranial plates by conventional methods normally takes up to two weeks to completion mainly due to the time required for the manufacture of dies and tools. Recent advances in 3D printing or additive manufacturing based techniques make it possible to complete the 3D printing of a cranial or a maxillofacial prosthetic part within several hours. However, there are still a number of impediments including material property and cost issues to be overcome before its wide clinical applications. This project proposes a novel alternative solution for an even faster and more cost effective method for the manufacture of personalised cranial plates by using the incremental sheet forming (ISF) technique. Our recent work has shown that a typically large size cranial plate can be made satisfactorily by using the ISF process in 7~8 minutes rather than hours or days. This outcome has considerable implications in potential technological advances and economic benefits as well as improvement to quality of life. In this project we aim to develop the new ISF based cranioplasty manufacturing technique, to design and build a bespoke desktop ISF machine for cranial reconstruction with full CT/MRI and CAD/CAM software integration and ISF process automation. By using the developed bespoke ISF machine, we will conduct a series of ISF benchmark testing and cranial reconstruction pre-clinical trials of 3 demonstration case studies using the developed bespoke ISF machine. The project will demonstrate its technical viability, economic benefit and potential improvement of quality of life. By the end of the project we aim to achieve up to 95% manufacturing lead time reduction with associated cost benefits as compared to the conventional methods. We also plan to show that the bespoke ISF machine can be used as a new and viable medical device for cranial manufacturing and there is a niche market place for speedy commercial exploitation.