A wearable device for continuous monitoring of methadone

阿片类药物过量是一个严重的公共卫生问题，近年来不断升级。基于 来自疾病控制和预防中心(CDC)的统计数据显示，与服药过量有关的死亡人数 从2020年4月到2021年4月超过10万人。这是与以下原因有关的服药过量病例的显著增加 天然和半合成阿片类药物、合成阿片类药物和精神刺激剂。令人震惊的是，在一年的时间里 截至2021年4月，芬太尼是18至45岁成年人的头号死因，超过 车祸、自杀、冠状病毒感染和癌症造成的死亡。美沙酮是一种成熟的药物， 几十年来一直被用于治疗阿片类药物使用障碍(OUD)。然而，目前没有连续的 一种可以提供体内美沙酮水平实时信息的监测装置。这一监测方面的差距 可能导致患者得不到最佳剂量的美沙酮，导致复发或过量服药。要解决这个问题 针对这一问题，我们提出了一种用于美沙酮连续监测的可穿戴设备。我们建议的设备是一种 可以佩戴在皮肤上的微创微针技术。该设备将持续监控 美沙酮在体内的水平，为患者和医疗保健专业人员提供实时反馈。该设备 小巧、谨慎、易于使用，是各种环境下使用的理想选择。拟议的SBIR项目旨在 利用我们的创新微针技术开发一种可穿戴设备，可以连续监测 间质液中美沙酮的治疗水平持续一周。为了实现这一目标，团队将执行 对传感器的表面结构进行了系统的优化研究，以实现高灵敏度、稳定和 选择性美沙酮传感性能。目标1构成体外可行性研究，以寻找最佳化学物质 具有高灵敏度的修改策略。目标2将涉及将传感器的稳定性延长至一周 连续运行。目标3将评估开发的基于MN的选择性、重复性和保质期 血清样本中的美沙酮传感器，并涉及电子学和 随附的设备应用程序。在第一阶段成功完成后，第二阶段将集中展示 通过在动物和人类中进行广泛的临床研究来确定传感器的实用性和可靠性 研究对象。该设备不仅将提供准确和个性化的美沙酮剂量，而且还有助于 当美沙酮水平下降或上升时，通过提醒患者和医疗专业人员来缓解OUD 高于治疗水平。这将使医疗保健提供者能够实时调整美沙酮剂量， 确保患者获得最佳剂量，以防止复发和过量用药。提议的可穿戴设备 因为持续监测美沙酮是一项关键的创新，将有助于解决阿片类药物的问题 服药过量。该设备将提供准确和个性化的美沙酮剂量，有助于缓解OUD，以及 可以在不同的人群中使用。我们提出的设备有可能提高人们的生活质量 患者，降低医疗成本，最终拯救生命。

Opioid overdose is a significant public health problem that has been escalating in recent years. Based on the statistics from the Centers for Disease Control and Prevention (CDC), the number of overdose-related deaths surpassed 100,000 from April 2020 to April 2021. This is a significant increase in overdose cases related to natural and semi-synthetic opioids, synthetic opioids, and psychostimulants. Alarmingly, in the one-year period leading up to April 2021, fentanyl was the top cause of death for adults between 18 and 45 years old, surpassing fatalities caused by car accidents, suicide, COVID, and cancer. Methadone is a well-established medication that has been used for decades to treat opioid use disorder (OUD). However, there is currently no continuous monitoring device that can provide real-time information on methadone levels in the body. This gap in monitoring can result in patients not receiving optimal doses of methadone, leading to relapse or overdose. To address this problem, we propose a wearable device for continuous monitoring of methadone. Our proposed device is a minimally invasive microneedle technology that can be worn on the skin. This device will continuously monitor methadone levels in the body, providing real-time feedback to patients and healthcare professionals. The device is small, discreet, and easy to use, making it ideal for use in various settings. The proposed SBIR project aims to leverage our innovative microneedle technology to develop a wearable device that can continuously monitor therapeutic levels of methadone in the interstitial fluid for a week. In order to achieve this, the team will perform systematic optimization studies on the surface architecture of the sensor to enable highly sensitive, stable, and selective methadone sensing performance. Aim 1 constitutes in-vitro feasibility studies to find the best chemical modification strategy with high sensitivity. Aim 2 will involve extending the stability of the sensor to one week of continuous operation. Aim 3 will assess the selectivity, reproducibility, and shelf life of the developed MN-based methadone sensors in serum samples and involves further developments in the electronics and the accompanying app of the device. Upon successful completion of Phase I, Phase II will focus on demonstrating the utility and establishing reliability of the sensor via extensive clinical studies in both animals and in human subjects. The device will not only provide accurate and personalized dosing of methadone but also help in mitigating OUD by alerting patients and healthcare professionals when levels of methadone fall below or rise above therapeutic levels. This will enable healthcare providers to adjust the methadone dose in real-time, ensuring that patients receive optimal dosages to prevent relapse and overdose. The proposed wearable device for continuous monitoring of methadone is a crucial innovation that will help to address the problem of opioid overdose. The device will provide accurate and personalized dosing of methadone, help to mitigate OUD, and can be used among different populations. Our proposed device has the potential to improve the quality of life of patients, reduce healthcare costs, and ultimately save lives.