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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.

摘要