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 尽管解毒剂纳洛酮随处可得，致命的阿片类药物过量仍以大约50-70,000/的比率发生 在美国度过了一年。问题是纳洛酮需要旁观者来发现和诊断服药过量，找到 有人服用纳洛酮，然后适当地给它用药。不幸的是，如果这种情况没有在5分钟内发生 几分钟后，患者就会遭受脑损伤，这通常被认为是隐藏在背后的流行病 阿片类药物死亡的流行。此外，约52%的阿片类药物过量死亡发生在患者完全 孤身一人，没有附近的旁观者。 为了解决这些问题，我们在这里介绍了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检测过量，然后自动注射解毒剂。我们的协作 产业界和学术界之间已经显着地推进了DOVE技术：我们发表了 一篇论文显示，76%的使用阿片类药物(PWUO)的人(n=97)表达了强烈的愿望，比如 DOVE，并表现出对臂章的强烈偏好，而不是许多其他的设备设计。我们是下一个 初步验证了DOVE的其他技术挑战：我们显示出我们的传感器的准确度很高 患有诱发性低通气量的健康志愿者；我们的自动注射器可重复地注射到工作台上 皮肤/脂肪/肌肉的模特。此外，我们还验证了市场、报销、销售渠道、 经营自由和监管路径。 在这项STTR拨款中，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)： 目的1、优化和验证三角肌上保持装置位置的背带。我们 我将通过结构化采访和观察PWUO与6条马具中的每一条相互作用来实现这一点 原型。在目标2中，我们将测试DOVE传感器是否可以准确地检测睡眠患者的低氧血症。 过量事件相对罕见，因此增加使用鸽子脉搏检测到缺氧的可能性 血氧计，我们将应用两个鸽子脉搏血氧计原型(一个指环，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。我们会比较鸽子的 脉搏血氧仪和加速度计的轨迹与FDA批准的设备的轨迹对比。最后，在目标3中，我们将优化 DOVE自动喷射器，满足PWUO指定的尺寸和形状限制，并准确地喷射到 新鲜的身体猪。