FREEFORM FABRICATION OF TRANSTIBIAL PROSTHETIC SOCKET - PHASE II

自由形状制造经胫假肢接受腔 - 第二阶段

• 批准号: 7718744
• 负责人: NICOLAS Eugene WALSH
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718744
• 关键词: Address; Affect; Amputees; Case-Control Studies; Clinical; Clinical effectiveness; Complex; Computer Retrieval of Information on Scientific Projects Database; Computer-Aided Design; Custom; Development; Effectiveness; Elements; Ensure; Evaluation; Funding; Goals; Grant; Hand; Healthcare; Healthcare Systems; Indium; Individual; Industry; Institution; Lasers; Limb structure; Lower Extremity; Methods; Modeling; Molds; Nature; Pain; Phase; Population; Procedures; Process; Prosthesis; Prosthetic rehabilitation; Provider; Rehabilitation therapy; Research; Research Personnel; Residual state; Resources; Solid; Source; Standards of Weights and Measures; System; Techniques; Technology; Training; United States National Institutes of Health; Veterans; Work; base; cost; design; engineering design; improved; older patient; research clinical testing; success

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Successful rehabilitation for the majority of lower extremity amputees includes prosthetic limb fitting and training. Critical to the success of prosthetic fitting is a comfortable, well fitting socket, but accomplishing this remains a clinical challenge with residual limb pain and socket discomfort affecting 20-55% of lower limb amputees. Achieving an acceptable socket fit using conventional prosthetic techniques requires individual custom molding and fabrication in a labor intensive, costly process that is dependent on the availability of an increasingly limited supply of skilled prosthetics. Alternative methods of fabricating prosthetic sockets that can improve efficiency in prosthetic provision, enhance comfort and fit, or reduce cost are needed to ensure the continued optimal rehabilitation of the amputee. This project will continue the development of a new promising method of socket fabrication using solid freeform fabrication (SFF) based on selective laser sintering (SLS) technology. SFF allows the direct manufacture of a prosthetic socket without the intermediate molds and laminating process required with conventional techniques. The overall long-term goal of this project is the development of a clinically practical system for rapid prosthetic limb provision that integrates computer-aided design with solid freeform fabrication techniques. This proposal builds on our previous successful demonstration of the feasibility of SFF socket fabrication and will address several key issues that underlie its clinical viability. The specific objectives of the proposed work are: (1) to develop improved designs for SFF transtibial prosthetic sockets that allow the use of industry standard pylon mounts and incorporate variable compliance elements; (2) determine the clinical effectiveness of variable wall compliance elements in enhancing the comfort and fit of transtibial prosthetic sockets; and (3) determine the durability and functionality of SFF sockets during extended clinical use. The initial phase of the proposed work will use an iterative engineering design-modeling-evaluation process to develop variable compliance elements and an industry standard pylon mount adapter. During the second phase of the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The effectiveness of variable compliant elements in enhancing comfort and fit will be determined using a within-subject case comparison study of SFF sockets with conventional laminated sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting system will be determined during a 12-month clinical field trial. The Veterans Health Care System by nature of its elderly patient population, is one of the nation's major providers of amputee health care and has been a leader in improving the rehabilitation and prosthetic technology needed to serve both new and existing lower extremity amputees. The VA has pioneered the development and implementation of CAD/CAM and automated fabrication of prosthetic limbs. The proposed study builds on this prior research by establishing the clinical viability of using SFF for prosthetic sockets. Successful SFF has the potential to create a major paradigm shift in the provision of prosthetic sockets. SFF of prosthetic sockets using SLS would eliminate the need for molds, hand lamination, and finishing procedures enabling a major step forward toward the goal of an integrated CAD/CAM system of rapid prosthetic limb provision. SLS freeform fabrication is particularly attractive because it is commercially available and has ability to create complex geometries with minimal cost penalty. This unique advantage significantly expands the options for developing alternate socket designs.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 大多数下肢截肢者的成功康复包括假肢装配和训练。 假肢装配成功的关键是一个舒适、良好的承窝，但要做到这一点仍然是一个临床挑战，20-55%的下肢截肢者会受到残肢疼痛和承窝不适的影响。 使用传统的假体技术实现可接受的承窝配合需要在劳动密集型、昂贵的过程中进行单独的定制模制和制造，这取决于日益有限的熟练假体供应的可用性。 需要制造假肢接受腔的替代方法，其可以提高假肢提供的效率，增强舒适性和适合性，或降低成本，以确保截肢者的持续最佳康复。 该项目将继续开发一种基于选择性激光烧结（SLS）技术的新的有前途的插座制造方法，使用固体自由成型（SFF）。 SFF允许直接制造假肢接受腔，而无需传统技术所需的中间模具和层压过程。 该项目的总体长期目标是开发一种临床实用的系统，用于快速提供假肢，该系统将计算机辅助设计与固体自由成型制造技术相结合。 该提案建立在我们之前成功证明SFF插座制造的可行性的基础上，并将解决其临床可行性的几个关键问题。 提出的工作的具体目标是：（1）开发SFF经胫骨假肢接受腔的改进设计，允许使用行业标准的pylon安装件并包含可变顺应性元件;（2）确定可变壁顺应性元件在增强经胫骨假肢接受腔的舒适性和适合性方面的临床有效性;和（3）确定SFF插座在长期临床使用期间的耐用性和功能性。 建议工作的初始阶段将使用迭代工程设计-建模-评估过程来开发可变柔度元件和行业标准塔架安装适配器。 在拟议工作的第二阶段，将研究SFF假肢接受腔的临床评价。 将通过对SFF窝与传统层压窝进行受试者内病例比较研究，确定可变柔顺元件在增强舒适度和贴合性方面的有效性。 将在为期12个月的临床现场试验期间确定包含行业标准塔架安装系统的SFF插座的耐久性。 退伍军人医疗保健系统的性质，其老年患者人口，是全国截肢者医疗保健的主要提供者之一，并一直在改善康复和假肢技术需要为新的和现有的下肢截肢者。 VA率先开发和实施了CAD/CAM和假肢的自动化制造。 拟议的研究建立在这一先前的研究基础上，建立了使用SFF进行假肢接受腔的临床可行性。 成功的SFF有可能在提供假肢接受腔方面创造一个重大的范式转变。 使用SLS的假肢接受腔的SFF将消除对模具、手工层压和精加工程序的需要，从而朝着快速假肢提供的集成CAD/CAM系统的目标迈出了重要一步。 SLS自由成形制造是特别有吸引力的，因为它是商业上可获得的，并且能够以最小的成本代价创建复杂的几何形状。 这一独特的优势大大扩展了开发替代插座设计的选择。