Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets

优化的患者专用跨胫假肢接受腔的计算设计、制造和评估

基本信息

批准号：
9363821
负责人：
HUGH M HERR
金额：
$ 39.04万
依托单位：
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9363821
关键词：
3D Print Algorithms Amputation Amputees Anatomy Artificial Leg Cardiovascular Diseases Clinical Computer Simulation Computer-Aided Design Computer-Assisted Manufacturing Data Data Reporting Decubitus ulcer Dermatologic Dermatologist Dermatology Development Direct Expenditure Evaluation Exercise Financial cost Finite Element Analysis Geometry Goals Hour Human Image Impaired wound healing Indirect Calorimetry Knowledge Lower Extremity Magnetic Resonance Imaging Manuals Measures Mechanics Metabolic Methods Modeling Motion Musculoskeletal Nature Obesity Outcomes Research Participant Pathology Patients Performance Persons Population Price Printing Procedures Process Production Prosthesis Design Protocols documentation Qualitative Evaluations Quality of life Quantitative Evaluations Questionnaires Recruitment Activity Recurrence Report (document)Reporting Research Research Design Research Personnel Shapes Skin Skin Ulcer System Testing Tissues United States User-Computer Interface Veterans Walking Writing base biomechanical model chronic wound clinical efficacy cohort computer framework cost cost effective data acquisition design experience experimental study gait examination gait symmetry imaging Segmentation improved iterative design limb amputation mechanical properties model development non-invasive imaging novel pressure prevent prosthetic socket prototype research clinical testing sensor skin irritation socket design soft tissue tool virtual

项目摘要

Abstract Title: Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets Principle investigator: Dr. Hugh Herr Background: The overall goal of this application is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. Traditionally, prosthetic socket production has been a craft activity, based primarily on the experience of the prosthetist. Even with advances in computer-aided design and computer-aided manufacturing (CAD/CAM), the design process remains manual. The manual nature of the process means it is non-repeatable and currently largely non-data-driven, and quantitative data is either not obtained or insufficiently employed. Furthermore, discomfort, skin problems and pressure ulcer formation remain prevalent. Through the proposed computational modeling framework, a repeatable, data-driven and patient-specific design process is made available which is based on scientific rationale. Objective/hypothesis: The main hypothesis of this proposal is that a socket, designed using the novel computational design framework, is equivalent to, or better than, a conventional socket (designed by a prosthetist) in terms of: 1) skin contact pressures, 2) gait symmetry, 3) walking metabolic cost, 4) skin irritation levels as assessed by the dermatologist, and 5) comfort as evaluated from a questionnaire. Our hypothesis is supported by the presented pilot data which shows reduced or equivalent skin contact pressures and subject reported comfort levels for several critical anatomical regions. Specific Aims: 1) Subject-specific biomechanical modeling for N=18 subjects, 2) Computational design and fabrication of sockets for N=18 subjects, and 3) Clinical evaluation of novel sockets for N=18 subjects. Study Design: A cohort of 18 subjects will be recruited for this study. MRI data will be recorded for all subjects. Through image segmentation geometrically accurate 3D finite element analysis (FEA) models will be constructed. Further, non- invasive indentation testing will be performed which, through combination with inverse FEA, provides accurate subject- specific mechanical properties for all subjects. The resulting predictive FEA models will then be used in a novel, data- driven, and automated computational design framework for prosthetic sockets, to design prosthetic sockets for all subjects. The framework optimizes the socket designs, as assessed by skin contact pressures and internal tissue strain, through iterative adjustment of the virtual tests sockets. Final designs are subsequently 3D printed. To evaluate the prosthetic sockets with each of the subjects each subject will do a standing and walking exercise using their conventional sockets or the novel sockets. Meanwhile skin contact forces, walking metabolic cost, and gait symmetry are recorded. After the exercises, skin irritation will be assessed by a dermatologist, and socket comfort is assessed using a questionnaire. Together this data provides a quantitative and qualitative evaluation and comparison of the novel and conventional sockets.

抽象的标题：计算设计，制造和评估优化的患者特异性thrantibial假肢插座主要调查员：休·赫尔博士背景：此应用程序的总体目标是进一步开发和临床评估计算和数据驱动机械接口的设计和制造框架，以定量产生跨态假肢插座的设计和制造框架比传统流程更快，更具成本效益的方式。传统上，假肢的生产一直是手工艺活动，主要基于假肢的经验。即使在计算机辅助设计方面取得了进步计算机辅助制造（CAD/CAM），设计过程仍然是手动的。过程的手动性质意味着它是不可重复的，目前在很大程度上是非数据驱动的，并且定量数据不能获得或不足雇用。此外，不适，皮肤问题和压力溃疡的形成仍然普遍存在。通过拟议的计算建模框架，可重复的，数据驱动和特定于患者的设计过程基于科学原理。客观/假设：该提案的主要假设是使用新型计算设计设计的插座框架，相当于或比传统的插座（由假肢设计）更好或更好压力，2）步态对称性，3）步行代谢成本，4）皮肤科医生评估的皮肤刺激水平，5）从问卷进行评估的舒适性。我们的假设得到了提出的试验数据的支持，该数据显示出降低或等效的皮肤接触压力和受试者报告了几个关键解剖区域的舒适度。具体目的：1）n = 18受试者的主体特异性生物力学建模，2）计算设计和制造 n = 18个受试者的插座，3）n = 18个受试者的新插座的临床评估。研究设计：将为这项研究招募18名受试者的队列。将记录所有受试者的MRI数据。通过将构建图像分割几何准确的3D有限元分析（FEA）模型。此外，非将进行侵入性压痕测试，通过与FEA结合使用，该测试提供准确的受试者 - 所有受试者的特定机械性能。然后，由此产生的预测性FEA模型将用于新颖的数据 - 为假肢插座的驱动和自动化计算设计框架，以设计所有受试者的假肢插座。该框架通过皮肤接触压力和内部组织应变评估，优化套接字设计虚拟测试插座的迭代调整。最终设计随后打印。评估假肢插座对于每个主题插座。同时，记录了皮肤接触力，步行代谢成本和步态对称性。锻炼后，皮肤刺激将由皮肤科医生评估，并使用问卷进行评估插座舒适性。在一起数据提供了新颖和常规插座的定量和定性评估以及比较。