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Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints

Exersides 的商业化、采用、许可和制造

基本信息

批准号：
10260567
负责人：
Marie Pavini
金额：
$ 149.02万
依托单位：
HEALTHY DESIGN, LTD. CO.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10260567
关键词：
Address Adoption Agitation Alzheimer&apos s Disease Alzheimer&apos s disease related dementia American Medical Association Amputation Anatomy Blood Vessels Breathing Caregivers Caring Cessation of life Chemicals Clinical Clinical Trials Code Cognitive Collaborations Communication Consult Consultations Contracts Counseling Critical Illness Delirium Dementia Development Device Designs Devices Distance Education Early Mobilizations Education Elderly Engineering Enteral Feeding Environment Equipment Excision Exhibits Family Nursing Family member Feedback Freedom Goals Growth Hospitals Human Immobilization Impaired cognition Incidence Industrialization Infrastructure Intensive Care Intensive Care Units International Intervention Intravenous Lead Legal Legal patent Licensing Market Research Mechanical ventilation Medical Medical Device Methods Modeling Movement Muscle Weakness Outcome Patients Pharmaceutical Preparations Phase Physical Function Physical Restraint Pilot Projects Positioning Attribute Prevention Process Production Readiness Research Resources Risk Risk Factors Sedation procedure Small Business Technology Transfer Research Source Specialist Syndrome System Testing Tube Wrist arm clinical practice commercialization cost effective decubitus ulcer design economic outcome endotracheal experience improved innovation modifiable risk mortality multi-site trial new technology novel pandemic disease phase 1 testing phase I trial prevent response restraint safe patient satisfaction sedative tool usability

项目摘要

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.

摘要这个NIA STTR商业化准备试点的目标是在早期穿越死亡谷，健康设计商业化的启动期，在老年人中销售一种新颖的手臂约束替代品重症机械通气或意识模糊的患者，增加活动性;减少躁动，使用镇静药物和谵妄;并在医院工作人员、家属和患者中表现出较高的满意度和可接受性。成员和病人。老年机械通气患者通常用腕部限制器固定，防止自行拔管，并使用镇静剂以减少由其约束和气管内导管引起的躁动。这种镇静和不动导致并发症，包括谵妄和肌肉无力，与长期认知障碍、身体功能下降和死亡率独立相关。6 -15 具体而言，ICU中谵妄的发生率和持续时间与以下因素强烈且独立相关：类似于阿尔茨海默病和相关痴呆症的长期认知障碍12，15 Healthy Design开发了一款新颖的Risksides ™ Refraint™，在保持手臂灵活性的同时，患者不会被附着在患者身上的重要管道和线路缠住。162 -164因为它允许活动性，Eschersides ™可以减少躁动和对镇静剂的需求。在试点研究和I期测试中， Escherosides ™已经展示了非常令人鼓舞的结果。该CRP项目的目标是创建满足生产需要和维持独立增长所必需的基础设施。目前阶段 II/第二年的临床试验，健康的设计是准备即将推出。该项目有很大的潜力，导致一个范式的转变，在照顾老年危重病或混乱的病人，证明了一种新型的约束装置减少了身体和认知障碍。