A ratcheting pediatric prosthetic finger using advanced rapid manufacturing technology

采用先进快速制造技术的棘轮儿童假肢手指

• 批准号: 10760098
• 负责人: Levin Sliker
• 金额: $ 27.58万
• 依托单位: POINT DESIGNS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-12 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760098
• 关键词: 3D Print; Adult; Algorithms; Amputation; Anatomy; Caring; Child; Child Health; Childhood; Clinic; Clinical; Colorado; Communities; Custom; Data Set; Development; Devices; Digit structure; Disabled Persons; Economics; Electronics; Emotional; Ensure; Environment; Face; Failure; Family; Fingers; Friction; Goals; Hand; Home; Impairment; Individual; Industry; Interview; Laboratories; Lactation; Lateral; Length; Life; Life Style; Limb Prosthesis; Limb structure; Measurement; Measures; Mechanics; Medical; Metacarpophalangeal joint structure; Metals; Mission; National Institute of Child Health and Human Development; Occupational Therapist; Outcome Measure; Parents; Patients; Persons; Phase; Population; Prosthesis; Prosthesis Design; Protocols documentation; Psychological Impact; Quality of life; Rotation; Social Impacts; Source; Strategic Planning; System; Technology; Testing; Titanium; Torque; Universities; Upper Extremity; Weight; Woman; Work; adolescent health; cohort; commercialization; cost; design; design verification; disability; economic impact; efficacy evaluation; experience; functional improvement; hand dysfunction; health care settings; improved; indexing; innovation; limb loss; manufacture; manufacturing technology; patient population; pediatric patients; personalized approach; pregnant; primary outcome; prosthetic hand; prototype; psychosocial; recruit; satisfaction; simulation; social; sound; therapeutically effective; validation studies; verification and validation

A ratcheting pediatric prosthetic finger using advanced rapid manufacturing technology ABSTRACT The goal of the proposed project is to develop and commercialize a purely mechanical, ratcheting pediatric prosthetic finger – the Point Mini – which 1) has an industry leading strength to weight ratio, 2) can be operated unilaterally (one-handed), 3) offers anatomical rotation and flexion around the patient’s metacarpophalangeal (MCP) joint, and 4) can be custom-made for each patient using advanced metal 3D printing technology. The care of pediatric patients with partial hand limb absence requires a highly individualized approach. Each child and their family bring 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 and their family to provide a personalized medical solution using whatever components and technologies are available. Very often, the bottleneck in this system is the availability of clinically sound prosthetic components that can be readily sourced by the prosthetists to provide an optimal prosthetic limb system, especially for the pediatric patient population. The largest population of people with upper limb loss are those with partial hand limb absence. This population outnumbers all other levels of people with upper limb loss 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 pediatric patients with partial hand limb absence do not satisfy all the needs of these patients; passive fingers are seen as being fragile and difficult to use while powered fingers are not indicated for use with the pediatric population. In this Fast Track effort, we propose to 1) internally verify the Point Mini through a battery of mechanical tests, 2) validate the user needs of the Point Mini for regulatory requirements by engaging pediatric subjects with partial hand limb loss and 3) assess the utility of the Point Mini through a clinical take-home study with pediatric patients who have partial hand limb loss. The mission of Point Designs 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 Mini will provide an effective and durable solution for children with partial hand limb loss and ensure their ability to enjoy their childhood, family, and life to the fullest.

采用先进技术的棘轮儿童假肢手指 快速制造技术 抽象的 该项目的目标是开发一种纯机械的棘轮儿科产品并将其商业化。 假肢手指 – Point Mini – 1) 具有行业领先的强度重量比，2) 可以操作 单侧（单手），3) 提供围绕患者掌指骨的解剖旋转和屈曲 (MCP) 关节，4) 可以使用先进的金属 3D 打印技术为每位患者定制。 部分手肢缺失的儿科患者的护理需要高度个体化的方法。 儿童及其家人给诊所带来了独特的需求，包括不同程度的截肢、生活方式、个人需求 经验和其他医疗指标与每位患者一起工作。 他们的家人使用任何组件和技术提供个性化的医疗解决方案 通常，该系统的瓶颈是临床上可靠的假肢组件的可用性。 假肢师可以很容易地找到这些材料来提供最佳的假肢系统，特别是对于 儿科患者群体。 上肢缺失的人群中，手部部分缺失的人群最多。 上肢丧失的人数是所有其他级别的人数的 10 倍。因此，我们可以做出重要的 如果产品有效地服务于该人群，则会产生临床影响然而，目前的儿科商业产品。 部分手部肢体缺失的患者不能满足这些患者被动手指的所有需求； 由于其易碎且难以使用，而电动手指不适合儿科人群使用。 在这项快速通道工作中，我们建议 1) 通过一系列机械测试对 Point Mini 进行内部验证， 2) 通过让儿科受试者参与部分试验来验证 Point Mini 的用户需求是否符合监管要求 手肢丧失；3) 通过儿科患者的临床带回家研究评估 Point Mini 的实用性 手部肢体部分丧失的人。 Point Designs 的使命是创新上肢假肢设计领域的设备和算法。 我们开发的产品为假肢师和患者提供解决方案，以满足每个人的独特需求 在这种充满活力且充满挑战的医疗保健环境中，The Point Mini 将为患者提供有效且持久的治疗。 为手部部分丧失的儿童提供解决方案，确保他们能够享受童年、家庭和生活 最完整的。