Automated zero lift device to reduce caregiver injury and support independent living

自动零升力装置可减少护理人员受伤并支持独立生活

• 批准号: 9202592
• 负责人: Andrew Hines
• 金额: $ 15万
• 依托单位: UNIQUE MOBILITY DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9202592
• 关键词: Accidental Falls; Accidents; Adult; Area; Back; Caregivers; Caring; Clinical Research; Communities; Data; Development; Devices; Engineering; Ensure; Evaluation; Exercise; Failure; Fall prevention; Familiarity; Feedback; Floor; Goals; Health Personnel; Health Professional; Healthcare; Home environment; Independent Living; Injury; Institutes; Institution; Lifting; Medical; Medical Device; Medical Staff; Modeling; Movement; Nurses; Operative Surgical Procedures; Patient Care Team; Patients; Performance; Persons; Phase; Physicians; Policies; Population; Positioning Attribute; Provider; Proxy; Recovery; Rehabilitation therapy; Resort; Safety; Self Care; Self-Help Devices; Services; Site; Small Business Innovation Research Grant; Somatotype; Source; Stress; Stress Tests; Structure; Surveys; System; Test Result; Testing; Therapeutic; Time; Training; Update; Weight; Work; abstracting; base; body position; design; engineering design; falls; high risk; interest; medical attention; meetings; member; novel; operation; performance tests; phase 1 study; physical therapist; post-operative rehabilitation; prevent; prototype; response

Abstract: This SBIR application supports the development of a fall recovery and patient mobility medical device to reduce medical professional and caregiver injuries caused by lifting patients. The SitAssist device is designed to recover a patient from a prone to sitting position (or vice versa) with minimal patient movement, force and effort. The device is designed both to assist the medical communities “no lift” policies to avoid work related injuries to health care professionals while supporting in home and self-care of limited mobility patients. Current fall recovery strategies require the use of a second, or third person fit enough to use a passive assistive device or knowledgeable enough to operate a Hoyer lift assist device. Beyond accidental falls, the need to move patients from a sitting position to the floor and back for rehabilitative services is increasingly necessary as care centers move to support post-accident/post operative rehabilitation to support better independent living. But direct care-giver lifting/moving of patients results in unacceptable levels of injury to care providers while improper use of lift devices can cause injury (and embarrassment) to the patient, the caregiver or both. To reduce health care worker related injuries and to support in-homecare and self care, Unique Mobility Devices has developed the SitAssist, a simple self-contained device that can lift a person from the floor to a seated position with little minimal patient movement, minimal force and minimal effort. This Phase I project will evaluate the product’s design and use in a commercial health care setting using professional care teams and patients to evaluate the products function, safety and utility. In Aim 1, stress testing of the prototype device will ensure that it is capable of managing a wide range of adult sizes and weights safely. This engineering exercise will test the capability, safety, performance and control of the device. Anthropomorphic models of differing weights (up to 300lbs) and sizes will be used to mimic patients. The device will be put under significant loads with body positioning to mimic maximum stress. An optimized design will then be built for testing in Aim 2. In aim 2, the optimized device will be evaluated by trained medical staff and by patients at a premiere rehabilitative center, Kessler. ~14 staff members (doctors, nurses, physical therapists) will physically test the device using both anthropomorphic models and staff members as proxy patients. All participating staff and ~20 patients will also provide feedback via surveys on device performance, ease of use, safety and potential for injury (patient or caregiver), interface design and operation, patient recovery requirements, managing the device (moving into position from storage), value and potential to reduce caregiver injury long term. The results of this Phase I study will be used to support a 510K filing with the FDA for approval to move into a clinical study in Phase II to evaluate the devices ability to reduce caregiver injury at home and at care facilities. The SitAssist device will be the first to lift a person from the floor to a seated position with little to no assistance from others; no other device can make this claim.

摘要：此SBIR应用程序支持秋季恢复和患者移动性医疗的发展 减少医疗专业人员和护理人员受伤的设备。 Sitassist设备是 旨在以最少的患者运动从容易坐姿到坐姿（反之亦然）恢复患者 力量和努力。该设备的设计既旨在帮助医疗社区“无升降”政策以避免工作 与医疗保健专业人员的相关伤害，同时支持有限的行动能力患者的家庭和自我保健。 当前的秋季恢复策略需要使用第二人或第三人称足以使用被动 辅助设备或知识渊博的设备足以操作Hoyer Lift辅助设备。超越意外跌倒， 需要将患者从坐姿转移到地板，然后返回康复服务 随着护理中心的搬迁以支持后犯/后运营康复以支持更好的必要 独立生活。但是直接护理人员提升/移动患者会导致不可接受的护理伤害水平 提供者在不当使用升力设备的同时可能会给患者造成伤害（和尴尬），但护理人员 或两者兼而有之。减少与医疗保健工作者相关的伤害并支持内科保健和自我保健，独特的 移动设备已经开发了Sitassist，这是一种简单的独立设备，可以使人从 地板至坐姿，几乎没有患者的运动，最小的力量和最小的努力。这个阶段第一 项目将使用专业护理评估产品在商业医疗保健环境中的设计和使用 团队和患者评估产品功能，安全性和实用性。 在AIM 1中，原型设备的应力测试将确保其能够管理广泛的成人 尺寸和重量安全。这项工程练习将测试能力，安全性，性能和控制 设备。不同权重（最多300磅）和尺寸的拟人模型将用于模仿 患者。该设备将被放置在带有身体定位的重大载荷下，以模仿最大应力。一个 然后，将在AIM 2中构建优化的设计。在AIM 2中，优化设备将由 在凯斯勒（Kessler）的首要康复中心培训了医务人员和患者。 〜14名工作人员（医生， 护士，物理治疗师）将使用拟人化模型和员工对设备进行物理测试 成员作为代理患者。所有参与人员和约20名患者也将通过调查提供反馈 设备性能，易用性，安全性和受伤的潜力（患者或护理人员），界面设计和 操作，患者恢复要求，管理设备（从存储中移至位置），价值和 长期减少护理人员伤害的潜力。该阶段I研究的结果将用于支持510K 向FDA提交批准，以在II期中进行临床研究，以评估设备的能力减少 护理人员在家和护理机构受伤。 Sitassist设备将是第一个将一个人从地板上抬起的装置 到达坐姿，几乎没有其他人的帮助；没有其他设备可以提出这一主张。