The DOVE Device to Prevent Opioid Overdose Deaths: An Armband That Senses Overdose and Automatically Injects Naloxone

防止阿片类药物过量死亡的 DOVE 装置：可感应过量并自动注射纳洛酮的臂带

• 批准号: 10485568
• 负责人: Jacob Brenner
• 金额: $ 31.99万
• 依托单位: ALTRUMED LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10485568
• 关键词: Academia; Accelerometer; Ankle; Antidotes; Asphyxia; Brain Injuries; Breathing; Businesses; Cadaver; Capital Financing; Cessation of life; Cities; Clip; Collaborations; Color; Country; Device Designs; Device or Instrument Development; Devices; Diagnosis; Dimensions; Docking; Drug usage; Dyes; Engineering; Epidemic; Event; FDA approved; Family suidae; Fatty acid glycerol esters; Feedback; Freedom; Frequencies; Goals; Grant; Harm Reduction; Heroin; Hospitals; Housing; Hypoventilation; Hypoxemia; Hypoxia; Hypoxic Brain Damage; Industry; Injections; Innovation Corps; Insurance; Insurance Carriers; Interview; Journals; Manuals; Marketing; Medical Device; Medicine; Modeling; Monitor; Morphine; Muscle; Naloxone; Needles; Obstructive Sleep Apnea; Opioid; Overdose; Paper; Patient Recruitments; Patients; Persons; Pharmaceutical Preparations; Phase; Philadelphia; Physicians; Physiologic pulse; Population; Positioning Attribute; Prevention; Probability; Public Health; Publishing; Pulse Oximetry; Reproducibility; Ring Finger Domain; Sales; Seasons; Secure; Series; Shapes; Shoulder; Skin; Sleep; Small Business Technology Transfer Research; Specific qualifier value; Structure; Target Populations; Technology; Testing; Time; Universities; Validation; Video Recording; addiction; compliance behavior; deltoid muscle; design; drug development; healthy volunteer; improved; interest; invention; meetings; opioid mortality; opioid overdose; opioid use; opioid user; parole; person centered; preference; prevent; programs; prototype; sensor; usability; wearable device

ABSTRACT / PROJECT SUMMARY Despite the wide availability of the antidote naloxone, fatal opioid overdoses still occur at a rate of ~50-70,000 / year in the US. The problem is that naloxone requires a bystander to find and diagnose the overdose, find someone who has naloxone, and then properly administer it. Unfortunately, if this does not occur within 5 minutes, the patient will suffer from brain damage, which is often considered the “hidden epidemic” underneath the opioid death epidemic. Additionally, ~52% of opioid overdose deaths occur when the patient is totally alone, without nearby bystanders around. To solve these problems, here we introduce the DOVE device, which is an armband that detects an opioid overdose via pulse oximetry and accelerometry, and then automatically injects an antidote. Our collaboration between industry and academia has already moved forward the DOVE technology significantly: We published a paper showing 76% of persons who use opioids (PWUOs) (n=97) expressed a strong desire for a device like DOVE, and showed a strong preference for an armband over many other device designs. We next preliminarily validated the other technical challenges of DOVE: we showed our sensor’s accuracy was high on healthy volunteers with induced hypoventilation; and our autoinjector injected reproducibly into bench-top models of skin/fat/muscle. Additionally we validated the market, reimbursement, sales channels, freedom-to-operate, and regulatory path. In this STTR grant, we will optimize & test the 3 major components of DOVE (harness, sensor, and injector): In Aim 1, we will optimize and validate the harness which keeps the device position on the deltoid muscle. We will do this with structured interviews and observations of PWUOs interacting with each of 6 harness prototypes. In Aim 2 we will test if the DOVE sensor can accurately detect hypoxemia in sleeping patients. Overdose events are relatively rare, so to increase the probability of detecting hypoxia using the DOVE’s pulse oximeter, we will apply 2 DOVE pulse-oximeter prototypes (a finger-ring, and one placed on the shoulder skin) to 20 obstructive sleep apnea (OSA) patients already undergoing sleep studies. We will compare the DOVE’s pulse oximeter and accelerometry traces vs. those of FDA-approved devices. Finally, in Aim 3 we will optimize the DOVE auto-injector to meet the size & shape constraints specified by PWUOs, and to accurately inject into fresh, cadaveric pigs.

摘要/项目总结 尽管解毒剂纳洛酮广泛可用，但致命的阿片类药物过量仍以约50- 70，000/ 年在美国。问题是，纳洛酮需要一个旁观者来发现和诊断过量， 有纳洛酮的人，然后适当地管理它。不幸的是，如果在5分钟内没有发生这种情况， 分钟，患者将遭受脑损伤，这通常被认为是“隐藏的流行病”之下 阿片类药物致死流行病此外，约52%的阿片类药物过量死亡发生在患者完全 独自一人，周围没有旁观者。 为了解决这些问题，在这里我们介绍DOVE设备，这是一种检测阿片类药物的臂章 通过脉搏血氧仪和加速度计过量，然后自动注射解毒剂。我们的合作 工业界和学术界之间的合作已经大大推进了DOVE技术：我们发表了 一篇显示76%的阿片类药物（PWUO）使用者（n=97）的论文表达了对此类器械的强烈需求， 鸽子，并表现出强烈的偏好臂章超过许多其他设备的设计。我们接下来 初步验证了DOVE的其他技术挑战：我们显示我们的传感器的精度很高， 诱导性肺换气不足的健康志愿者;我们的自动注射器可重复地注射到实验台上 皮肤/脂肪/肌肉模型。此外，我们还验证了市场、报销、销售渠道， 自由经营和监管路径。 在这次STTR资助中，我们将优化和测试DOVE的3个主要组件（线束、传感器和喷油器）： 目标1，我们将优化和验证将设备位置保持在三角肌上的安全带。我们 我将通过结构化访谈和观察PWUO与6个线束中的每一个的互动来做到这一点 原型在目标2中，我们将测试DOVE传感器是否可以准确检测睡眠患者的低氧血症。 过量事件相对罕见，因此为了增加使用DOVE脉冲检测缺氧的概率， 血氧计，我们将应用2个DOVE脉搏血氧计原型（一个指环，一个放置在肩部皮肤上） 20例阻塞性睡眠呼吸暂停（OSA）患者已经接受了睡眠研究。我们将比较鸽子的 脉搏血氧仪和加速度计跟踪与FDA批准的设备。最后，在目标3中，我们将优化 DOVE自动注射器满足PWUO规定的尺寸和形状限制，并准确注射到 新鲜的尸体猪