Wearable, Wireless Deep-tissue Sensing Patch for Continuous Monitoring of Recovery from Microsurgical Tissue Transfer

可穿戴式无线深层组织传感贴片，用于连续监测显微外科组织转移的恢复情况

• 批准号: 10637093
• 负责人: Wubin Bai
• 金额: $ 32.82万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10637093
• 关键词: Address; Adverse event; Animal Model; Arteries; Biocompatible Materials; Blood Vessels; Blood flow; Bluetooth; Bypass; Calibration; Cellular Phone; Cessation of life; Chronic; Clinical; Clinical Research; Cloud Computing; Complex; Creativeness; Cutaneous; Data; Data Display; Development; Device Safety; Devices; Diagnosis; Drug Delivery Systems; Ensure; Environment; Event; Failure; Fostering; Future; Glycolates; Goals; Health; Hour; Human Resources; Immunohistochemistry; Implant; Implantation procedure; Individual; Injectable; Intelligence; Light; Location; Measurement; Medical Technology; Microfabrication; Microsurgery; Monitor; Morbidity - disease rate; Mus; Muscle; Nature; Necrosis; Needles; Operative Surgical Procedures; Optics; Pain; Pathway interactions; Patients; Performance; Personal Satisfaction; Physical Examination; Physiologic Monitoring; Physiological; Physiology; Play; Polyvinyl Alcohol; Postoperative Care; Postoperative Period; Procedures; Reconstructive Surgical Procedures; Recovery; Rehabilitation therapy; Research; Respiration; Risk; Role; Safety; Scheme; Series; Signal Transduction; Skin; Surface; Surgical Flaps; Surgical Management; System; Techniques; Technology; Testing; Thrombosis; Time; Tissues; Toxic effect; United States National Institutes of Health; Vascular blood supply; Veins; Vision; Work; base; biomaterial compatibility; blood gas analyzer; design; diagnostic technologies; electronic sensor; fabrication; hemodynamics; histological studies; implantation; improved; innovation; instrumentation; lithography; multimodality; next generation; novel; personalized medicine; porcine model; prevent; real time monitoring; remote health care; sensor technology; skills; success; surgery outcome; technology platform; tissue oxygenation; waveguide; wearable device; wearable sensor technology; wireless; wireless communication; wound care; wound healing

Technologies that can closely monitor surgical recovery and wound healing for timely, proactive treatments represent an essential keystone to developing next-generation personalized medicine that can further reduce patient pain, prevent morbidity and death, and improve individual wellbeing. Microsurgical tissue transfer entails surgical elevation of a portion of tissue (or flap) based upon its defined vascular supply in the form of a single artery and vein. While this reconstructive strategy is well-accepted, failures do occur and almost always result from early microvascular thrombosis. This flap-threatening event occurs in 6-14% of cases, and if untreated flap necrosis and reconstructive failure are inevitable. The most common flap monitoring strategies is serial physical examination and external doppler examination. However, these strartegies are limited by its inherently subjective nature and the requirement for skilled bedside personnel to check the flap frequently. And the intermittent assessment is subject to delay in the diagnosis of malperfusion, since clear signs of malperfusion may take several hours to become obvious. Recent developments in wearable electronic sensors with built-in systems on chip enable opportunities for real-time monitoring of physiological conditions of targeted tissues. However, wearable biosensors that feature skin-interface pose a challenge: to sense physiological parameters such as oxygenation of tissue microenvironments at depth. In the case of flap monitoring, existing devices such as ViOptix are only able to monitor flaps which bear a cutaneous skin. This deficiency means that muscle flaps must be monitored with indirect sensing technology through neighboring skin, which is predisposed to delay recognition of muscle malperfusion. This absence of direct, real-time monitoring technology for muscle-only flaps gives rise to the fundamental and overarching unmet clinical need: to advance technological platforms for deep-tissue monitoring. We propose a soft wearable intelligent patch (SWIP) that incorporates microneedle waveguides to enable deep-tissue sensing of oxygenation without implantation procedures for continuous monitoring of recovery after microsurgical tissue transfer. We aim for the proposed device to enable physiological measurements from 4 different locations of skin to yield both local (tissue oxygenation, pulsation intensity, and blood flow rate) and global (pulsation rate and respiration rate) physiological information continuously and simultaneously. The sensing interface will rely on biocompatible, optical waveguides in the form of microneedles to enable light-matter interaction at deep tissue (~ 2 cm below the skin surface). The device will be equipped with a control module that provides a series of signal pre-processing and a Bluetooth Low Energy (BLE) interface to advertise the data for further processing by a cloud-based computing device. We envision that the proposed SWIP will advance diagnostic technology for reconstructive surgery and beyond, and offer real-time monitoring to facilitate precise customization and personalization in surgical recovery and rehabilitation.

可密切监控手术恢复和伤口愈合的技术，以便及时、主动地 治疗是开发下一代个性化药物的关键，这种药物可以进一步 减轻患者痛苦，防止发病和死亡，改善个人福祉。显微外科组织移植 需要手术抬高一部分组织(或皮瓣)，根据其定义的血管供应的形式 单一的动脉和静脉。虽然这种重建策略被广泛接受，但失败确实会发生，而且几乎总是 是早期微血管血栓形成的结果。这种威胁襟翼的事件发生在6%-14%的病例中，如果 未经处理的皮瓣坏死和重建失败是不可避免的。最常见的襟翼监测策略是 连续体检和体外多普勒检查。然而，这些战略受到其自身的限制 固有的主观性和对熟练床边人员频繁检查瓣的要求。和 间歇性评估可能会延迟诊断灌注不良，因为有明显的灌注不良迹象。 可能需要几个小时才能变得明显。内置可穿戴电子传感器的最新发展 片上系统使实时监测目标组织的生理状况成为可能。 然而，以皮肤界面为特征的可穿戴生物传感器构成了一个挑战：感知生理 深度组织微环境的氧合等参数。在襟翼监控的情况下， 现有的设备，如ViOptix，只能监测带有皮肤的皮瓣。这一缺陷 这意味着肌瓣必须通过邻近的皮肤通过间接传感技术进行监测，这是 倾向于延迟对肌肉灌注不良的识别。 由于缺乏对纯肌肉皮瓣的直接、实时监测技术，导致 尚未满足的基本和总体临床需求：推进深层组织技术平台 监控。我们提出了一种结合了微细波导的软可穿戴智能贴片(SWIP 无需植入程序即可实现深层组织氧合传感，以持续监测 显微外科组织移植术后恢复正常。我们的目标是使拟议的设备能够实现生理学 从4个不同的皮肤位置进行测量，得出局部(组织氧合、脉搏强度和 血流率)和全局(脉动率和呼吸率)生理信息连续和 同时。传感接口将依赖于生物兼容的微针形式的光波导 以在深层组织(皮肤表面下约2厘米)实现光与物质的相互作用。该装置将配备 具有提供一系列信号预处理的控制模块和蓝牙低能量(BLE)接口 以广告数据以供基于云的计算设备进一步处理。我们设想，拟议的 Swip将为重建手术和其他领域推进诊断技术，并提供实时监控 以促进外科康复和康复中的精确定制和个性化。