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

翻译后摘要：这SBIR应用程序支持跌倒恢复和患者移动医疗的发展 该装置可减少医疗专业人员和护理人员因提升患者而造成的伤害。SitAssist设备是 设计成以最小的患者移动将患者从俯卧位置恢复到坐姿（或反之亦然）， 力量和努力。该设备的目的是既协助医疗界的“无电梯”政策，以避免工作 在家中支持时对医疗保健专业人员造成的相关伤害以及行动不便患者的自我护理。 目前的秋季恢复策略需要使用第二个或第三个人适合使用被动 辅助设备或有足够的知识来操作霍耶升降机辅助设备。除了意外的福尔斯， 需要将患者从坐姿移动到地板上并返回以进行康复服务 必要的护理中心移动，以支持事故后/术后康复，以支持更好的 独立生活。但是，护理人员直接提起/移动患者会导致不可接受的护理损伤 虽然移位装置的不正确使用会对患者、护理人员和/或护理人员造成伤害（和尴尬）， 或两者为了减少与卫生保健工作者相关的伤害，并支持家庭护理和自我护理， Mobility Devices开发了SitAssist，这是一种简单的独立设备，可以将人从 以最小的患者移动、最小的力和最小的努力将患者从地板移动到坐姿。这项I期 该项目将评估产品的设计和使用在商业卫生保健设置使用专业护理 团队和患者评估产品功能、安全性和实用性。 在目标1中，原型装置的压力测试将确保其能够管理广泛的成人患者。 尺寸和重量安全。这项工程演习将测试的能力，安全，性能和控制， 设备.将使用不同重量（高达300磅）和尺寸的拟人模型来模拟 患者将器械置于显著载荷下，身体定位以模拟最大应力。一个 然后将构建优化设计以用于目标2中的测试。在目标2中，将通过以下方式评价优化器械： 训练有素的医务人员和病人在一个首屈一指的康复中心，凯斯勒。~14名工作人员（医生， 护士、物理治疗师）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。所有参与的工作人员和约20名患者还将通过调查提供反馈， 器械性能、易用性、安全性和潜在损伤（患者或护理人员）、接口设计和 操作、患者恢复要求、管理器械（从存储位置移动到位）、价值和 长期减少护理人员受伤的可能性。本I期研究的结果将用于支持510 K 向FDA申请批准进入II期临床研究，以评估器械降低 在家中和护理设施中的护理人员受伤。SitAssist设备将是第一个将人从地板上抬起的设备 到一个坐着的位置，很少或没有其他人的帮助;没有其他设备可以作出这种声明。

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.