Statement of problem

One of the most challenging aspects of auricular prosthesis design and fabrication is ensuring that the prosthesis fits the patient through a range of head and facial movements. Techniques used in conventional prosthetic treatment pathways account for issues of prosthesis fit, but this challenge has not been fully addressed in emerging treatment pathways that use digital technology.

Purpose

The purpose of this clinical study was to develop and evaluate a digital workflow by using surface scan data and incorporating the simulation of tissue movement into the design of auricular prostheses that fit the participant through a range of facial movements. An iterative design process was used to develop a design workflow through a sequential case series of participants with auricular prostheses.

Material and methods

Scan data were acquired from a case series of 5 participants with existing implant-retained auricular prostheses. An iterative design process was used to digitally design auricular prostheses that fit the participants through a range of jaw and facial movements. The fit, shape, and retention of the digitally designed and conventionally made prostheses were assessed and compared. Design considerations were identified and documented through the iterative design process.

Results

A final design workflow was iteratively developed based on the 5 participants. The shapes of the digitally designed prostheses were well matched to nontreatment anatomy overall. Prosthesis fit was variable: Some digitally designed prostheses fit the participant intimately through a range of movements, and others experienced significant gaps between the margins and the tissues.

Conclusions

An iterative design process provided a method of working toward quality improvement. Although the final design workflow provides a generally successful method of manipulating scan data in the design of auricular prostheses, the prosthesis fit at the anterior margin during facial movements remains variable and requires further development to achieve a consistently acceptable solution.

中文翻译：

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通过表面扫描和数字设计对耳假体进行组织假体边缘界面仿真

问题陈述

耳瓣假体设计和制造中最具挑战性的方面之一是通过一系列头部和面部运动来确保假体适合患者。传统假体治疗途径中使用的技术解决了假体适合性的问题，但是在使用数字技术的新兴治疗途径中，这一挑战尚未得到充分解决。

目的

这项临床研究的目的是通过使用表面扫描数据并将组织运动的模拟纳入耳廓修复体的设计中，以开发和评估数字工作流程，耳廓修复体可通过一系列面部运动使参与者适应。迭代设计过程用于通过一系列具有耳假体的参与者的连续病例系列开发设计工作流程。

材料与方法

扫描数据是从5名参与者的病例系列中获得的，这些参与者具有现有的植入物固定式耳廓假体。迭代设计过程用于通过各种下颌和面部运动来数字化设计适合参与者的耳形假体。评估并比较了数字化设计和常规制作的假体的配合，形状和保持力。通过迭代设计过程确定并记录设计注意事项。

结果

在5位参与者的基础上，迭代开发了最终设计工作流程。数字化设计的假体的形状与整体非治疗解剖结构非常匹配。假体的适应性是可变的：一些数字化设计的假体通过一系列运动而与参与者紧密贴合，而其他假体则在边缘和组织之间出现明显的间隙。

结论

迭代设计过程提供了一种致力于提高质量的方法。尽管最终设计工作流程提供了在耳形假体设计中操纵扫描数据的通常成功的方法，但是在面部运动过程中，在前边缘安装的假体仍然是可变的，并且需要进一步开发以实现始终可接受的解决方案。