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

• 批准号: 9753235
• 负责人: HUGH M HERR
• 金额: $ 46.52万
• 依托单位: MASSACHUSETTS INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9753235
• 关键词: 3-Dimensional; 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; 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; 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; recruit; research clinical testing; sensor; skin irritation; socket design; soft tissue; tool; virtual

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：优化的患者专用经胫骨假肢接受腔的计算设计、制造和评估 首席研究员：Hugh Herr 博士 背景：该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的 机械接口的设计和制造框架，可定量生产经胫骨假肢接受腔 比传统流程更快、更具成本效益的方式。传统上，假肢接受腔的生产一直是 工艺活动，主要基于假肢师的经验。即使计算机辅助设计和技术不断进步 计算机辅助制造（CAD/CAM），设计过程仍然是手动的。该过程的手动性质意味着 它是不可重复的，目前很大程度上是非数据驱动的，定量数据要么没有获得，要么不充分 受雇。此外，不适、皮肤问题和压疮形成仍然普遍存在。通过提议的 计算建模框架是一个可重复的、数据驱动的、针对患者的设计过程， 是有科学依据的。 目标/假设：该提案的主要假设是使用新颖的计算设计设计的套接字 框架，在以下方面相当于或优于传统接受腔（由假肢专家设计）：1）皮肤接触 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，以及 5) 通过问卷评估的舒适度。我们的假设得到了所提供的试点数据的支持，该数据显示减少或 等效的皮肤接触压力和受试者报告的几个关键解剖区域的舒适度。 具体目标：1) 针对 N=18 名受试者的受试者特定生物力学建模，2) 计算设计和制造 N=18 名受试者的插座，以及 3) N=18 名受试者的新型插座的临床评估。 研究设计：本研究将招募 18 名受试者。所有受试者的 MRI 数据都会被记录。通过 将构建图像分割几何精确的 3D 有限元分析 (FEA) 模型。此外，非 将进行侵入性压痕测试，通过与反向有限元分析相结合，提供准确的主题 所有科目的特定机械性能。由此产生的预测 FEA 模型将用于一种新颖的数据- 驱动的、自动化的假肢接受腔计算设计框架，为所有受试者设计假肢接受腔。 该框架通过皮肤接触压力和内部组织应变评估，优化了插座设计 虚拟测试插座的迭代调整。最终设计随后进行 3D 打印。评估假肢接受腔 每个受试者将使用他们的传统插座或新颖的插座进行站立和行走练习 插座。同时记录皮肤接触力、步行代谢成本和步态对称性。运动后皮肤 皮肤科医生将评估刺激性，并使用问卷评估插座舒适度。综合这些数据 提供新型插座和传统插座的定量和定性评估和比较。