The Point Digit: A ratcheting prosthetic finger using advanced rapid manufacturing technology

The Point Digit：采用先进快速制造技术的棘轮假肢手指

• 批准号: 10028272
• 负责人: RICHARD Fergus ffrench WEIR
• 金额: $ 73.6万
• 依托单位: POINT DESIGNS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-21 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10028272
• 关键词: 3D Print; Algorithms; Amputation; Amputees; Anatomy; Award; Caring; Clinic; Clinical; Custom; Data Analyses; Data Set; Development; Devices; Digit structure; Economics; Electronics; Ensure; Environment; Equipment and supply inventories; Family; Fatigue; Feedback; Fingers; Goals; Hand; Home environment; Individual; Industry; Interview; Journals; Label; Laboratories; Life; Life Style; Limb Prosthesis; Manuscripts; Mechanics; Medical; Medical Device; Medicine; Metacarpophalangeal joint structure; Metals; Methods; Mission; Occupational Therapist; Outcome; Outcome Measure; Patients; Peer Review; Persons; Phase; Population; Prosthesis; Prosthesis Design; Quality Control; Quality of life; Rotation; Small Business Technology Transfer Research; Source; System; Technology; Testing; TimeLine; Torque; Upper Extremity; Validation; Weight; Work; arm; base; clinical development; cost; design; experience; functional outcomes; health care settings; improved; innovation; laboratory development; personalized approach; primary outcome; professional atmosphere; prosthetic hand; prototype; psychologic; psychosocial; recruit; satisfaction; simulation; sound; validation studies

The goal of the proposed project is to develop and commercialize a purely mechanical, ratcheting prosthetic finger – the Point Digit – 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 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 with partial hand amputations. 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 hand amputees do not satisfy all of the needs of these patients; passive fingers are seen as being fragile and difficult to use while powered fingers are expensive and require additional components like batteries and electronics that can be cumbersome to the user. In this Fast Track effort, we propose to 1) internally verify the Point Digit through a battery of mechanical tests, 2) validate the user needs of the Point Digit with partial hand amputees for regulatory requirements and 3) assess the utility of the Point Digit through a clinical take-home study of partial hand 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 Digit will provide an effective and durable solution for many upper limb amputees with finger loss and ensure their ability to enjoy their work, family, and life to the fullest.

该项目的目标是开发一种纯机械的棘轮假肢并将其商业化 手指-Point Digit -1）具有行业领先的强度重量比，2）可以单侧操作 （单手），3）提供围绕患者的掌指（MCP）关节的解剖学旋转和屈曲， 4）可以使用先进的金属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。每个病人都带来了 独特的需求，包括各种程度的截肢，生活方式，个人经验，和其他 医学指标修复师和职业治疗师与每位患者合作， 医疗解决方案使用任何组件和技术在公开市场上可用。很多时候 该系统的瓶颈是临床上可靠的假体部件的开发， 由假肢专家采购，以提供最佳的假肢系统。 最大的上肢截肢者是那些部分手截肢的人。该人群 比其他级别的上肢截肢者多10倍。因此，我们可以做一个重要的 如果产品有效地服务于该人群，则会产生临床影响。然而，目前部分商业产品 手部截肢者不能满足这些患者的所有需求;被动手指被认为是脆弱的， 难以使用，而动力手指是昂贵的，并且需要额外的部件，如电池， 这对用户来说可能很麻烦。 在这项快速通道工作中，我们建议1）通过一系列机械测试在内部验证Point Digit， 2)确认部分手部截肢者的Point Digit的用户需求符合法规要求，以及3）评估 通过对部分手部截肢者的临床带回家研究，了解Point Digit的实用性。 Point Designs LLC的使命是在上肢假肢领域创新设备和算法 设计我们开发的产品为假肢专家和患者提供解决方案，以满足以下方面的独特需求： 在这个充满活力和挑战的医疗环境中的每一位患者。点数字将提供一个有效的， 为许多失去手指的上肢截肢者提供持久的解决方案，确保他们能够享受工作、家庭， 和生命的充实。