PDF(Pubmed)
Abstract：
For decades, the advantages of rapid prototyping for clinical use have been recognized. However, demonstrations of potential solutions to treat spinal problems that cannot be solved otherwise are scarce. In this paper, we describe the development, regulatory process, and clinical application of two types of patient specific 3D-printed devices that were developed at an in-house 3D point-of-care facility. This 3D lab made it possible to elegantly treat patients with spinal problems that could not have been treated in a conventional manner. The first device, applied in three patients, is a printed nylon drill guide, with such accuracy that it can be used for insertion of cervical pedicle screws in very young children, which has been applied even in semi-acute settings. The other is a 3D-printed titanium spinal column prosthesis that was used to treat progressive and severe deformities due to lysis of the anterior column in three patients. The unique opportunity to control size, shape, and material characteristics allowed a relatively easy solution for these patients, who were developing paraplegia. In this paper, we discuss the pathway toward the design and final application, including technical file creation for dossier building and challenges within a point-of-care lab.
摘要：
几十年来,快速成型在临床上的优势已得到认可.然而,治疗无法解决的脊柱问题的潜在解决方案的示范很少。在本文中,我们描述了发展，监管过程,以及在内部3D护理点设施开发的两种患者特定3D打印设备的临床应用。这个3D实验室可以优雅地治疗患有脊柱疾病的患者，这些患者无法以常规方式治疗。第一个设备，应用于三名患者，是一个印刷尼龙钻指南，如此精确，它可以用于插入非常年幼的儿童的颈椎椎弓根螺钉，甚至在半急性环境中也得到了应用。另一种是3D打印的钛脊柱假体，用于治疗三名患者前柱溶解导致的进行性和严重畸形。控制大小的独特机会，形状,和材料特性为这些患者提供了相对容易的解决方案，他们正在发展截瘫。在本文中,我们讨论了设计和最终应用的途径，包括用于建立档案的技术文件创建和在护理点实验室中的挑战。
