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 /项目摘要 尽管解毒剂纳洛酮的可用性广泛，但致命的阿片类药物过量仍以约50-70,000 /的速度发生 在美国。问题在于，纳洛酮要求旁观者查找和诊断过量，查找 具有纳洛酮的人，然后正确管理。不幸的是，如果这不在5之内 几分钟，患者会遭受脑损伤，通常被认为是下面的“隐藏流行病” 阿片类药物死亡流行。此外，约有52％的阿片类药物过量死亡发生时发生 独自一人，旁观者附近。 为了解决这些问题，我们在这里介绍了Dove设备，这是一个检测阿片类药物的臂章 通过脉搏血氧仪和加速度测定法过量，然后自动注入解毒剂。我们的合作 工业和学术界之间已经大大推动了鸽子技术：我们出版了 一篇论文显示76％使用阿片类药物的人（pwuos）（n = 97）表示对这样的设备的强烈渴望 鸽子，并且表现出对臂章的强烈偏爱，而不是许多其他设备设计。我们接下来 初步验证了Dove的其他技术挑战：我们表明传感器的准确性很高 健康的志愿者诱发不足；我们的自动注射器将其注入台式机 皮肤/脂肪/肌肉的模型。此外，我们验证了市场，报销，销售渠道， 自由运行和监管道路。 在此STTR赠款中，我们将优化和测试Dove（线束，传感器和喷油器）的三个主要组成部分： AIM 1，我们将优化和验证线束，以使设备保持在三角肌上。我们 将通过结构化的访谈和观察到与6条安全带相互作用的观察结果 原型。在AIM 2中，我们将测试Dove传感器是否可以准确检测到睡眠患者的低氧血症。 过量事件相对较少，因此增加使用鸽子脉搏检测缺氧的可能性 血氧仪，我们将应用2个鸽子脉搏 - 氧化型原型（手指环，一个放在肩部皮肤上） 到20名已经接受睡眠研究的阻塞性睡眠呼吸暂停（OSA）患者。我们将比较鸽子的 脉搏血氧仪和加速度计与FDA批准的设备的轨迹。最后，在AIM 3中，我们将优化 鸽子自动注射器满足PWUOS指定的尺寸和形状约束，并准确注入 新鲜的尸体猪。