A wearable device for continuous monitoring of methadone

阿片类药物过量是近年来不断升级的一个重大公共卫生问题。基于 美国疾病控制和预防中心（CDC）的统计数据显示， 2020年4月至2021年4月超过10万人。这是一个显着增加过量的案件有关， 天然和半合成阿片类药物、合成阿片类药物和精神兴奋剂。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岁成年人死亡的首要原因， 车祸、自杀、新型冠状病毒和癌症造成的死亡。美沙酮是一种公认的药物， 几十年来一直用于治疗阿片类药物使用障碍（OUD）。然而，目前还没有连续的 监测设备，可以提供有关美沙酮在体内的水平的实时信息。监测方面的差距 可能导致患者无法接受最佳剂量的美沙酮，导致复发或过量。为了解决这个 问题，我们提出了一种可穿戴设备，用于持续监测美沙酮。我们提出的设备是一个 微创微针技术，可以佩戴在皮肤上。这个装置将持续监测 美沙酮在体内的水平，提供实时反馈给病人和医疗保健专业人员。设备 体积小、不显眼且易于使用，是各种环境中使用的理想选择。拟议的SBIR项目旨在 利用我们创新的微针技术开发一种可穿戴设备， 组织液中美沙酮的治疗水平一周。为了实现这一目标，团队将 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、稳定性和 选择性美沙酮敏感性能。目标1构成体外可行性研究，以找到最佳的化学品 高灵敏度的改性策略。目标2将涉及将传感器的稳定性延长到一周， 连续运行。目标3将评估开发的基于MN的选择性、重现性和保质期 美沙酮传感器在血清样本，并涉及进一步发展的电子和 设备的附带应用程序。在第一阶段成功完成后，第二阶段将重点展示 通过对动物和人体的广泛临床研究，确定传感器的实用性和可靠性 科目该设备不仅可以提供准确和个性化的美沙酮剂量， 通过在美沙酮水平低于或升高时提醒患者和医疗保健专业人员来减轻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， 确保患者接受最佳剂量，以防止复发和过量。所提出的可穿戴设备 持续监测美沙酮是一项重要的创新，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，有助于减轻OUD， 可以在不同人群中使用。我们提出的设备有可能提高生活质量的 降低医疗成本，最终挽救生命。

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.