Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints

摘要 NIA STTR商业化准备试点的目标是在早期穿越死亡之谷 健康设计商业化启动期，为老年人销售一种新的手臂约束方案 严重机械通风不良或神志不清的病人，增加活动能力；减少烦躁，使用 镇静药物和精神错乱；在医院工作人员和家庭中表现出很高的满意度和接受性 成员和病人。老年机械通气患者经常使用手腕约束来固定 防止自行拔管，并使用镇静剂，以减少因约束和气管插管而引起的骚动。 这种镇静和静止会导致并发症，包括精神错乱和肌肉无力，这是 与长期认知障碍、身体功能减退和死亡率独立相关。6-15 具体地说，ICU中精神错乱的发生率和持续时间与 类似于阿尔茨海默病和相关痴呆的长期认知障碍。 Healthy Design开发了新颖的Exerside™ReFraint™，它允许手臂移动，同时保持 患者免受连接在患者身上的重要管路的缠绕。162-164，因为它允许 机动性，Exerside™可能会减少焦虑和镇静剂的需要。在一项初步研究和第一阶段测试中， Exerside™已经展示了非常令人鼓舞的结果。此CRP项目的目标是创建 满足生产要求和维持独立增长所需的基础设施。现已进入阶段 II/第二年的临床试验，Health Design正在为即将推出的产品做准备。 该项目有很高的潜力导致老年危重病人或困惑患者的护理模式转变 展示了一种新型的约束装置，可以减少身体和认知障碍。

ABSTRACT The goal of this NIA STTR Commercialization Readiness Pilot is to traverse the Valley of Death in the early Launch period of Healthy Design’s commercialization to market a novel arm restraint alternative in older critically ill mechanically ventilated or confused patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long-term cognitive impairment, reduced physical functioning, and mortality.6-15 Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer’s Disease and Related Dementias.12,15 Healthy Design has developed the novel Exersides™ Refraint™ that allows arm mobility while keeping the patient safe from entanglement in the vital tubes and lines attached to the patient.162-164 Because it permits mobility, Exersides™ may reduce agitation and the need for sedatives. In a Pilot Study and a Phase I testing, Exersides™ has demonstrated very encouraging results. The objectives of this CRP project are to create the infrastructure necessary to meet production requirements and sustain independent growth. Now in Phase II/Year II of its clinical trial, Healthy Design is preparing for imminent Launch. This project has high potential to lead to a paradigm shift in the care of older critically ill or confused patients by demonstrating that a novel restraint device reduces physical and cognitive impairment.