The Point Powered: A Robust Actuated Prosthetic Finger for Partial Hand Amputation

Point Powered：用于部分手截肢的坚固驱动假肢手指

• 批准号: 10822123
• 负责人: Levin Sliker
• 金额: $ 114.29万
• 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: 2020-09-21 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10822123
• 关键词: Address; Algorithms; Amputation; Anatomy; Biological Sciences; Biomedical Technology; Budgets; Cells; Characteristics; Charge; Clinical; Complex; Development; Devices; Digit structure; Economics; Employment; Engineering; Ensure; Family; Fingers; Focus Groups; Funding; Goals; Hand; Hand functions; Health; Individual; Lead; Life; Light; Lithium; Measures; Medical Technology; Mission; Motor; Myoelectric prosthesis; National Institute of Biomedical Imaging and Bioengineering; Patients; Persons; Phase; Polymers; Prosthesis; Reporting; Resources; Series; Speed; Strategic Planning; System; Technology; Testing; Torque; United States; Upper Extremity; Vision; Work; battery life; commercialization; cost; design; experience; grasp; health care settings; improved; innovation; limb loss; manufacture; miniaturized device; novel; patient population; physical science; powered prosthesis; prosthetic hand; prototype; psychosocial; research and development; technological innovation; transmission process; voltage

ABSTRACT Approximately 600,000 people live with partial hand limb loss (PHLL) in the United States, with an estimated 14,500 new cases occurring each year. Despite the advances in miniaturized electronics and motors, there has been very little advancement in mechatronic prosthetic digits for this underserved patient population. In fact, to date, there is only one myoelectric prosthetic option for individuals with PHLL in the US. This option is fragile, often limited to light-duty tasks, and is too large to use on most partial hand loss cases. Considering this, it is no surprise that less than half of the individuals with partial hand absence are able to return to their previous employment, and those who do must often make considerable changes to their work-related tasks. Thus, there is a substantial need to deliver a robust, low-profile myoelectric prosthetic digit system. To address this need, we have formed a collaborative development team that has successfully launched eleven devices, which have been fit on over 5,500 patients with upper limb loss and has significant regulatory experience, having received two 510(k) approvals and nine CE marks for upper limb prosthetic devices. Our funded Phase I project was focused on engineering development of a frame, transmission, and motor driver. All eight Phase I milestones were successfully met, and we went further to complete a User Needs Analysis. Based on these results, we now propose a Phase II effort focused on two highly focused engineering aims: 1) To develop, implement and optimize a novel clutch design; and 2) To develop, implement, and optimize a modular power system for partial hand myoelectric prostheses. Aim #1 is important since it will enable the finger to tolerate a 10-fold increase in passive load transmission versus during active use. Aim #2 is important because no currently existing power system meets the requirements determined by the User Needs Analysis, including: 1) low profile design; 2) allows users to replace the battery units themselves; and 3) compatible with single- handed use. The mission of Point Designs is to help individuals with PHLL regain the abilities that they had previously lost. 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. To date, Point Designs has served over 1,100 individuals with partial hand limb loss (and our collaborative group has served an even greater number as noted previously). The work proposed in this proposal is critical to our efforts to develop a myoelectric partial hand prosthesis called Point Powered. We believe that this technology will provide an effective and durable solution for many people with finger loss and ensure their ability to enjoy their work, family, and life to the fullest.

抽象的 在美国，大约有 600,000 人患有部分手肢丧失 (PHLL)，估计 每年发生 14,500 起新病例。尽管微型电子和电机取得了进步，但 对于这一服务不足的患者群体来说，机电假肢方面的进展甚微。事实上，为了 迄今为止，美国 PHLL 患者只有一种肌电假肢选择。这个选项很脆弱， 通常仅限于轻型任务，并且太大而无法在大多数部分失手的情况下使用。考虑到这一点，不 令人惊讶的是，只有不到一半的手部部分缺失的人能够恢复到以前的状态 就业，而那些就业的人通常必须对其与工作相关的任务做出相当大的改变。 因此，迫切需要提供一种坚固、低调的肌电假肢手指系统。致地址 针对这个需求，我们组建了协作开发团队，目前已成功推出十一款设备， 已适用于超过 5,500 名上肢丧失患者，并具有丰富的监管经验， 获得两项上肢假肢装置 510(k) 批准和九项 CE 标志。 我们资助的第一阶段项目专注于车架、变速箱和电机驱动器的工程开发。 第一阶段的所有八个里程碑均已成功实现，我们进一步完成了用户需求分析。 基于这些结果，我们现在提出第二阶段的工作，重点关注两个高度集中的工程目标：1) 开发、实施和优化新颖的离合器设计； 2) 开发、实施和优化 用于部分手部肌电假肢的模块化电源系统。目标 #1 很重要，因为它将启用手指 与主动使用期间相比，可承受被动负载传输增加 10 倍。目标 #2 很重要，因为 目前现有的电力系统均无法满足用户需求分析确定的要求，包括： 1）薄型设计； 2）允许用户自行更换电池单元； 3）与单兼容 双手使用。 Point Designs 的使命是帮助 PHLL 患者重新获得之前失去的能力。 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 在这个充满活力且充满挑战的医疗环境中的患者。迄今为止，Point Designs 已服务超过 1,100 家 手部部分丧失的个人（我们的合作小组已经服务了更多的人，如上所述） 之前）。该提案中提出的工作对于我们开发肌电部分手的努力至关重要 称为“Point Powered”的假肢。我们相信这项技术将提供有效且持久的解决方案 对于许多失去手指的人来说，确保他们能够充分享受工作、家庭和生活。