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

拟议项目的目标是开发一种纯机械的棘轮假体并将其商业化。 手指-点数字-1)具有行业领先的力量重量比，2)可以单边操作 (单手)，3)提供围绕患者掌指(MCP)关节的解剖旋转和屈曲， 4)可以使用先进的金属3D打印技术为每个患者量身定做。 上肢截肢者的护理需要高度个性化的医疗方法。每个病人都带着 对诊所的独特需求，包括不同程度的截肢、生活方式、个人体验等 医学指标。修复师和职业治疗师与每个患者合作，为他们提供个性化的 使用公开市场上可用的任何组件和技术的医疗解决方案。很多时候， 该系统的瓶颈是临床上良好的假体部件的开发，这些部件可以容易地 由假肢医生提供来源，以提供最佳假肢系统。 最大的上肢截肢者是那些手部分截肢的人。这群人 比所有其他水平的上肢截肢者多出10倍。因此，我们可以做出显著的 如果一种产品有效地服务于这一人群，就会产生临床影响。然而，目前的商业产品部分 手截肢者不能满足这些患者的所有需求；被动手指被视为脆弱和 很难使用，而电动手指价格昂贵，需要额外的组件，如电池和 对用户来说可能很麻烦的电子产品。 在这项快速跟踪工作中，我们建议1)通过一系列机械测试对点数字进行内部验证， 2)验证部分手部截肢者对Point Digit的用户需求，以满足法规要求；3)评估 通过对部分手截肢者的临床带回家研究来了解指点的使用情况。 Point Designs LLC的使命是创新上肢假肢领域的设备和算法 设计。我们开发的产品为假肢医生和患者提供解决方案，以满足 在这一充满活力和挑战的医疗保健环境中的每一位患者。点位数字将提供有效和 为许多失去手指的上肢截肢者提供持久的解决方案，并确保他们能够享受工作，家庭， 和最充实的生活。

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.