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，以及时，积极主动 治疗代表开发下一代个性化药物的重要基石，可以进一步 减轻患者疼痛，预防发病率和死亡，并改善个人健康。显微外科组织转移 需要基于其定义的血管供应的一部分组织（或皮瓣）的手术抬高。 单动和静脉。尽管这种重建策略得到了很好的接受，但确实发生了失败，几乎总是 由早期微血管血栓形成产生。这种威胁性的事件发生在6-14％的案件中，如果 未经治疗的皮瓣坏死和重建衰竭是不可避免的。最常见的襟翼监测策略是 串行体格检查和外部多普勒检查。但是，这些努力受到其的限制 固有的主观性质以及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到溶质灌注的诊断，因为明显的造成损坏的迹象 可能需要几个小时才能变得明显。内置的可穿戴电子传感器的最新发展 芯片上的系统为实时监测靶向组织的生理状况提供了机会。 但是，具有皮肤界面的可穿戴生物传感器构成了一个挑战：感知生理 参数，例如深度为组织微环境的氧合。在襟翼监测的情况下， 现有的设备（例如Vioptix）只能监测带有皮肤皮肤的襟翼。这种缺陷 意味着必须通过邻近的皮肤使用间接传感技术对肌肉瓣进行监测， 倾向于延迟识别肌肉疏松率。 缺乏直接的实时监测技术仅用于肌肉襟翼 基本和总体未满足的临床需求：促进深度组织的技术平台 监视。我们提出了一个柔软的可穿戴智能贴片（SWIP），该补丁包含微针波导 为了在没有植入程序的情况下进行深度组织感测，以连续监测 显微外科组织转移后恢复。我们的目标是拟议的设备实现生理 来自4个不同位置的皮肤的测量，以产生局部（组织氧合，脉动强度和 血流量）和全球（脉动率和呼吸率）的生理信息不断， 同时地。传感界面将依赖于微针形式的生物相容性的光学波导 为了在深层组织（皮肤表面以下约2厘米）处启用光 - 物质相互作用。该设备将配备 使用控制模块，该模块提供一系列信号预处理和蓝牙低能（BLE）界面 宣传数据，以通过基于云的计算设备进行进一步处理。我们设想提出的 SWIP将推进重建手术及其他诊断技术，并提供实时监控 促进手术恢复和康复中的精确定制和个性化。