A ratcheting prosthetic partial finger using advanced rapid manufacturing technology

采用先进快速制造技术的棘轮式假肢部分手指

基本信息

批准号：
10011496
负责人：
Levin Sliker
金额：
$ 74.95万
依托单位：
POINT DESIGNS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10011496
关键词：
3D Print Algorithms Amputation Amputees Anatomy Award Caring Clinic Clinical Cosmetics Custom Data Analyses Data Set Development Devices Economics Electronics Engineering Ensure Environment Equipment and supply inventories Family Fatigue Fingers Goals Home environment Individual Industry Instruction Joints Journals Label Laboratories Life Life Style Limb Prosthesis Manuals Manuscripts Measures Mechanics Medical Medicine Metals Methods Mission Occupational Therapist Outcome Outcome Measure Output Patients Peer Review Persons Phase Population Production Prosthesis Prosthesis Design Protocols documentation Quality Control Quality of life Rotation Sales Source System Technology Testing TimeLine Torque Upper Extremity Validation Vendor Weight Work arm clinical development cost design experience functional outcomes health care settings improved innovation laboratory development personalized approach primary outcome professional atmosphere prosthesis wearer prototype psychologic psychosocial recruit satisfaction simulation sound validation studies

3D Print Algorithms Amputation Amputees Anatomy Award Caring Clinic Clinical Cosmetics Custom Data Analyses Data Set Development Devices Economics Electronics Engineering Ensure Environment Equipment and supply inventories Family Fatigue Fingers Goals Home environment Individual Industry Instruction Joints Journals Label Laboratories Life Life Style Limb Prosthesis Manuals Manuscripts Measures Mechanics Medical Medicine Metals Methods Mission Occupational Therapist Outcome Outcome Measure Output Patients Peer Review Persons Phase Population Production Prosthesis Prosthesis Design Protocols documentation Quality Control Quality of life Rotation Sales Source System Technology Testing TimeLine Torque Upper Extremity Validation Vendor Weight Work arm clinical development cost design experience functional outcomes health care settings improved innovation laboratory development personalized approach primary outcome professional atmosphere prosthesis wearer prototype psychologic psychosocial recruit satisfaction simulation sound validation studies

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项目摘要

A Ratcheting Prosthetic Partial Finger Using Advanced Rapid Manufacturing Technology Project Summary / Abstract The goal of the proposed project is to develop and commercialize a purely mechanical, ratcheting prosthetic partial finger – the Point Partial – which 1) has an industry leading strength to weight ratio, 2) can be operated unilaterally, 3) offers anatomical rotation and flexion around the patient’s proximal interphalangeal joint, and 4) can be custom-made for each patient using advanced metal 3D printing technology. The care of upper limb amputees requires a highly individualized approach to medicine. Each patient brings unique needs to the clinic including various levels of amputation, lifestyles, personal experience, and other medical indicators. Prosthetists and occupational therapists work with each patient to provide a personalized medical solution using whatever components and technologies are available on the open market. Very often, the bottleneck in this system is the development of clinically sound prosthetic components that can be readily sourced by the prosthetists to provide an optimal prosthetic limb system. The largest population of upper limb amputees are those missing full or partial fingers. This population outnumbers all other levels of upper limb amputees by a factor of 10. Therefore, we can make a significant clinical impact if a product serves this population effectively. However, current commercial products for partial finger amputees do not satisfy all of the needs of these patients; body-powered fingers are seen as being weak and tiresome to use while cosmetic fingers cannot be used for manual tasks required by many prosthetic users. In this Phase 2 effort, we propose to 1) scale the production of the Point Partial for commercial sale, 2) validate the user needs of the Point Partial with partial finger amputees for regulatory requirements and 3) assess the utility of the Point Partial through a clinical take-home study of partial finger amputees. The mission of Point Designs LLC is to innovate devices and algorithms in the field of upper limb prosthetic design. We develop products that provide prosthetists and patients with solutions to meet the unique needs of each patient in this dynamic and challenging healthcare setting. The Point Partial will provide an effective and durable solution for many upper limb amputees with partial finger loss and ensure their ability to enjoy their work, family, and life to the fullest.

使用高级的棘轮假肢部分手指快速制造技术项目摘要 /摘要拟议项目的目的是开发和商业化纯机械的赛车假肢部分手指 - 部分部分 - 哪个1）具有行业的重量比率，2）可以操作单方面，3）在患者近端的指间关节周围提供解剖旋转和屈曲，4）可以使用高级金属3D打印技术为每位患者定制。上肢截肢者的护理需要高度个性化的医学方法。每个患者都带来诊所的独特需求包括各种截肢，生活方式，个人经验和其他医疗指标。假肢主义者和占领治疗师与每个患者合作提供个性化使用任何组件和技术的医疗解决方案都可以在公开市场上提供。经常，该系统中的瓶颈是临床上可观的假肢组件的开发由假肢者提供的，提供最佳的假肢系统。上肢截肢者最大的人口是那些缺少全手指或部分手指的人。这个人口人数超过所有其他级别的上肢截肢者的距离为10倍。因此，我们可以做出重要的如果产品有效地为该人群服务，则临床影响。但是，当前的部分商业产品手指截肢者不满足这些患者的所有需求；人体动力的手指被视为虚弱而且，对于许多假肢用户所需的手动任务，使用化妆品的使用时很累。在这阶段2的工作中，我们建议1）扩展商业销售点部分的生产，2）验证该点的用户需求部分与部分手指截距有关监管要求，3）评估该点部分通过对部分手指截肢者进行的临床临时研究的效用。 Point Designs LLC的使命是上肢假肢领域的创新设备和算法设计。我们开发了为假肢和患者提供解决方案的产品，以满足在这种动态和挑战医疗环境中的每个患者。部分部分将提供有效的和耐用的解决方案，用于部分手指损失的许多上肢截肢者，并确保其享受工作的能力，家庭，充实的生活。