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.

摘要 在美国，大约有60万人患有部分手部肢体丧失(Phll)，据估计 每年新增病例14,500例。尽管小型化电子产品和马达取得了进步，但仍有 对于这一服务不足的患者群体来说，机电假肢方面的进步微乎其微。事实上，为了 到目前为止，美国只有一种肌电假体可供PHLL患者选择。这个选择是脆弱的， 通常仅限于轻型任务，并且太大而不能用于大多数部分手丢失的情况。考虑到这一点，这是没有的 令人惊讶的是，只有不到一半的部分失手患者能够恢复到以前的状态 就业，而那些这样做的人必须经常对其与工作有关的任务做出重大改变。 因此，很有必要提供一种健壮、低调的肌电假体数字系统。致信地址 在这种需求下，我们成立了一个协同开发团队，已经成功推出了11款设备， 它已经适用于5500多名上肢缺失患者，并具有丰富的监管经验， 获得两项510(K)认证和九项上肢假肢设备CE认证。 我们资助的第一阶段项目专注于车架、变速器和电机驱动器的工程开发。 所有8个阶段I里程碑都已成功实现，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、实施和优化新型离合器设计；以及2)开发、实施和优化 用于部分手部肌电假体的模块化动力系统。目标1很重要，因为它将使手指 与主动使用时相比，可以承受10倍的被动载荷传递。目标2很重要，因为 目前没有一个现有电力系统满足用户需求分析确定的要求，包括： 1)低调设计；2)允许用户自己更换电池单元；3)兼容单电池单元 徒手使用。 Point Design的使命是帮助患有Phll的人重新获得他们之前失去的能力。 我们开发的产品为修复师和患者提供解决方案，以满足他们各自的独特需求 在这个充满活力和挑战的医疗保健环境中耐心等待。到目前为止，点设计公司已经为1100多家公司提供了服务 部分手部肢体丧失的患者(我们的协作小组已经为更多的人提供了服务，如所述 之前)。这项提议中提出的工作对我们开发肌电部分手的努力至关重要。 名为点动力的假体。我们相信这项技术将提供一种有效和持久的解决方案 对于许多失去手指的人，并确保他们能够最大限度地享受工作、家庭和生活。