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.

可以密切监测手术恢复和伤口愈合的技术，以便及时、主动 治疗是开发下一代个性化医疗的重要基石，可以进一步 减轻患者痛苦，预防发病和死亡，并改善个人福祉。显微外科组织转移 需要根据组织（或皮瓣）的定义血管供应以手术形式抬高一部分组织（或皮瓣） 单动脉和静脉。虽然这种重建策略被广泛接受，但失败确实会发生，而且几乎总是会发生 是早期微血管血栓形成的结果。这种皮瓣威胁事件发生在 6-14% 的病例中，如果 未经治疗的皮瓣坏死和重建失败是不可避免的。最常见的皮瓣监测策略是 系列体检和外部多普勒检查。然而，这些策略都受到其自身的限制。 其固有的主观性以及需要熟练的床边人员经常检查皮瓣的要求。和 间歇性评估可能会延迟灌注不良的诊断，因为灌注不良的明显迹象 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 片上系统可以实时监测目标组织的生理状况。 然而，具有皮肤界面的可穿戴生物传感器提出了一个挑战：感知生理 参数，例如深度组织微环境的氧合。在皮瓣监测的情况下， ViOptix 等现有设备只能监测带有皮肤的皮瓣。这个不足 意味着肌肉皮瓣必须通过邻近的皮肤利用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，导致了 未满足的基本和总体临床需求：推进深层组织的技术平台 监控。我们提出了一种结合微针波导的软可穿戴智能贴片（SWIP） 无需植入程序即可实现深部组织氧合传感，从而连续监测 显微手术组织移植后的恢复。我们的目标是使所提出的设备能够实现生理功能 从皮肤 4 个不同位置进行测量，以产生局部（组织氧合、脉动强度和 连续地采集血流速率）和全局（脉搏速率和呼吸速率）生理信息 同时地。传感接口将依赖于微针形式的生物相容性光波导 以实现深层组织（皮肤表面以下约 2 厘米）的光与物质相互作用。该设备将配备 带有提供一系列信号预处理和蓝牙低功耗 (BLE) 接口的控制模块 公布数据以供基于云的计算设备进一步处理。我们预计拟议的 SWIP 将推进重建手术及其他领域的诊断技术，并提供实时监控 促进手术恢复和康复的精确定制和个性化。