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

能够密切监测手术恢复和伤口愈合的技术， 治疗代表了开发下一代个性化医学的重要基石， 减轻患者疼痛，预防发病和死亡，并改善个人健康。显微外科组织移植 需要基于其限定的血管供应，以外科手术的方式提升组织（或皮瓣）的一部分， 单一动脉和静脉。虽然这种重建策略被广泛接受，但失败确实发生，而且几乎总是如此 是由早期微血管血栓形成引起的这种威胁皮瓣的事件发生在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 系列体格检查和体外多普勒检查。然而，这些策略受到其 固有的主观性质和要求熟练的床边人员经常检查皮瓣。和 间歇性评估容易延迟灌注不良的诊断，因为灌注不良的明显体征 可能需要几个小时才能变得明显。可穿戴电子传感器的最新发展 片上系统使得能够实时监测目标组织的生理状况。 然而，具有皮肤接口的可穿戴生物传感器提出了一个挑战：感知生理 参数，例如在深度处的组织微环境的氧合。在襟翼监测的情况下， 诸如ViOptix的现有装置仅能够监测带有皮肤的皮瓣。这一缺陷 这意味着肌肉瓣必须通过邻近的皮肤用间接传感技术进行监测， 容易延迟识别肌肉灌注不良。 这种缺乏直接的，实时监测技术的肌肉只有皮瓣引起了 未满足的基本和首要临床需求：推进深部组织的技术平台 监测.我们提出了一个软可穿戴智能贴片（SWIP），结合微针波导 为了能够在没有植入程序的情况下进行氧合的深层组织感测， 显微外科组织移植后的恢复。我们的目标是所提出的设备，使生理 测量从4个不同的皮肤位置，以产生局部（组织氧合，脉动强度， 血流速率）和全局（脉动速率和呼吸速率）生理信息， 同步传感接口将依赖于生物相容性，微针形式的光波导 以使光-物质在深层组织（皮肤表面以下约2 cm）相互作用。该装置将配备 控制模块提供一系列信号预处理和蓝牙低功耗（BLE）接口 以通告该数据以供基于云的计算设备进一步处理。我们设想， SWIP将推进重建手术及其他领域的诊断技术，并提供实时监测 以促进手术恢复和康复中的精确定制和个性化。

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.