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

摘要：此SBIR应用程序支持跌倒恢复和患者移动性医疗的开发 减少抬起病人对医疗专业人员和护理人员造成的伤害的装置。SitAsset设备是 旨在以最小的患者移动将患者从俯卧状态恢复到坐姿(反之亦然)， 力量和努力。该设备的设计既是为了帮助医疗界避免工作，也是为了帮助他们避免工作 对行动不便的患者进行居家支持和自我护理时，与医护人员相关的伤害。 目前的跌倒恢复策略需要使用第二个或第三个人，足够适合使用被动 辅助装置或有足够知识操作霍耶升降机辅助装置。除了意外跌倒， 将患者从坐姿移到地板和背部以进行康复服务的需求日益增加 随着护理中心转移到支持事故后/手术后康复以更好地支持 独立生活。但是，护理者直接抬起/移动患者会导致不可接受的护理伤害程度 虽然不恰当地使用电梯设备可能会对患者、照顾者造成伤害(和尴尬)，但提供电梯的人员 或者两者都有。为了减少医护人员的伤害并支持居家护理和自我护理，独一无二 移动设备公司开发了SitAsset，这是一种简单的自给自足的设备，可以将人从 将地板移至坐姿，几乎不需要病人移动，最小的力量和最小的力气。此阶段I Project将使用专业护理评估该产品在商业医疗保健环境中的设计和使用 团队和患者对产品的功能、安全性和实用性进行评估。 在目标1中，原型设备的压力测试将确保它能够管理范围广泛的成人 安全的尺寸和重量。这项工程演习将测试能力、安全性、性能和控制 这个装置。不同重量(最多300磅)和不同大小的拟人模型将被用来模拟 病人。该装置将被置于巨大的载荷下，身体定位以模拟最大应力。一个 然后将在目标2中构建用于测试的优化设计。在目标2中，将通过以下方式评估优化的设备 训练有素的医务人员和患者在一流的康复中心凯斯勒。~14名工作人员(医生、 护士、理疗师)将使用拟人模型和工作人员对该设备进行物理测试 作为代理患者的成员。所有参与的工作人员和约20名患者也将通过调查提供反馈 设备性能、易用性、安全性和受伤可能性(患者或护理人员)、接口设计和 操作、患者恢复需求、管理设备(从存储设备移到适当位置)、价值和 从长远来看，有可能减少照顾者受伤。此第一阶段研究的结果将用于支持510K 向FDA提交申请，批准进入第二阶段的临床研究，以评估该设备降低 照顾者在家中和护理机构受伤。SitAsset设备将是第一个将人从地板上抬起的设备 在没有或几乎没有别人帮助的情况下回到座位上；没有其他设备可以提出这种要求。

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.