Assessment of Reconstructive Surgical Flaps Using Spatially Resolved Tissue Oxima

使用空间分辨组织 Oxima 评估重建手术皮瓣

基本信息

批准号：
8201170
负责人：
David John Cuccia
金额：
$ 75.47万
依托单位：
MODULATED IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-19 至 2013-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8201170
关键词：
Adult Algorithms Arteries Asses Biological Blood Vessels Blood capillaries Blood flow Calibration Caring Clinic Clinical Clinical assessments Complication Computer software Consultations Data Data Analyses Dermal Development Devices Diabetic Angiopathies Diffuse Dorsal Early Diagnosis Early treatment Electronics Enrollment Esthetic Surgery Evaluation Excision FDA approved Failure Family suidae Fatty acid glycerol esters Feedback Fiber Gold Healed Height Hemoglobin Hemorrhage Hydration status Image Imagery Imaging Device Injury Institutes Investigation Ischemia Lead Length of Stay Lighting Location Maintenance Malignant Neoplasms Maps Marketing Measurement Measures Mechanics Medical Medical Device Medical center Methods Microsurgery Modeling Monitor Motion Near-Infrared Spectroscopy Necrosis Operative Surgical Procedures Optics Outcome Oxygen saturation measurement Patients Pattern Performance Perfusion Phase Pilot Projects Plastic Surgical Procedures Postoperative Period Procedures Process Property Protocols documentation Reconstructive Surgical Procedures Recovery Recruitment Activity Reperfusion Injury Research Risk Rodent Model Services Simulate Site Skin Spectrum Analysis Surgeon Surgical Flaps System Techniques Technology Testing Time Tissue Grafts Tissues Trauma Uncertainty Variant Veins Venous Water animal facility artery occlusion base capillary chromophore commercialization cost digital experience healing human subject image registration imaging modality improved in vivo insight instrument reconstruction sensor skin color tissue oxygenation tissue reconstruction

项目摘要

DESCRIPTION (provided by applicant): The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries & veins to the blood vessels at the recipient site. These procedures enable reconstructive surgery after trauma, as well as after surgical resection of cancer. Flap transfer surgery is subject to failure via a number of modes including vascular insufficiency caused by mechanical obstruction of the artery or vein, injury caused to the transferred tissues due to the lack of blood flow during the flap transfer, or due to ischemia-reperfusion injury. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap viability. Several studies have demonstrated that frequent monitoring and early detection of compromise results in earlier intervention which reduces the number of devastating complications that lead to tissue loss. Early in the era of microsurgery, flap monitoring was performed with only clinical observation of skin color, capillary refill, and dermal bleeding. However, issues related to staffing and subjective variations in clinical assessment of a flap's perfusion have led to the search for objective methods of flap monitoring. One promising technology for measuring local tissue oxygenation in-vivo is diffuse optical spectroscopy (DOS). DOS is a quantitative near-infrared (NIR) spectroscopy technique that can determine absolute concentrations of chromophores such as oxy & deoxy hemoglobin, fat and water. Modulated Imaging (MI) is a NIR imaging method invented at BLI that is based on the principles of DOS and employs patterned illumination to interrogate biological tissues. This non-contact approach enables rapid quantitative determination of the optical properties and in-vivo concentrations of chromophores over a wide field-of-view. The central aim of the proposed research is to further the development of Modulated Imaging and to assess the viability of this as a means to determine status of tissue reconstruction flaps. In Phase I, we carried out an in-vivo MI study using a dorsal pedicle flap rodent model. The dorsal pedicle flap is easily implemented to establish controlled ischemia and re-perfusion of the wounds. This allowed us to employ MI to deduce spatially resolved maps of tissue hemoglobin, oxygenation and hydration over the course of several days. In Phase II we propose to develop and validate an MI instrument for clinical use. Investigations will first evaluate the performance of MI in a controlled model of partial vascular congestion using adult Yorkshire pigs. This will be followed by a study in which MI and a potentially competing FDA cleared device will be employed in a clinical situation in order to assess local flap status. In parallel with the Phase II research outlined herein, we will aggressively pursue commercialization of a medical device based on MI. PUBLIC HEALTH RELEVANCE: The use of tissue transfer flaps is a method of moving tissue from a donor location to recipient location and re-attaching the arteries & veins to the blood vessels at the recipient site. The medical utility of this process is to allow for reconstructive surgery after trauma, as well as after surgical resection of cancer. This type of reconstructive surgery is subject to failure caused by to mechanical obstruction of the artery or vein; injury caused to the transferred tissues due to the lack of blood flow when a free tissue flap is performed, (the tissue is disconnected prior to re-attaching the blood vessels); or due to a type of injury call ischemia- reperfusion injury, which is a type of injury that results after blood flow has been returned to the transferred tissue. Tissue oxygenation and maintenance of microvascular blood flow in grafted tissues are crucial for flap to survive. The first postoperative days after free tissue transfer are characterized by the risk of microvascular complications and loss of transferred tissue by necrosis. Loss of a free flap is a devastating experience to both the surgeon and the patient. In this proposal we will develop and validate an instrument that has the potential to identify flap failure earlier than is currently achievable. A successful effort has the potential to enable development of a new medical device that will have the capability to guide reconstructive surgery and post-surgical recovery, both reducing post-surgery complication rate and reducing uncertainty in flap healing. This may shorten the duration of hospital stay and associated heath care costs in addition to improving surgical outcomes.

描述（由申请人提供）：使用组织转移皮瓣是一种将组织从供体位置移至接受者位置并将动脉和静脉重新连接到受体部位的血管的方法。这些程序能够在创伤后以及癌症外科切除后重建手术。皮瓣转移手术可能会通过多种模式发生故障，包括由动脉或静脉的机械阻塞引起的血管功能不全，由于皮瓣转移过程中缺乏血液流量或缺血 - 再灌注损伤，导致转移的组织造成的损伤。自由组织转移后的第一个术后几天的特征是微血管并发症的风险和因坏死而转移的组织的丧失。对于外科医生和患者来说，自由皮瓣的损失都是毁灭性的经历。组织氧合和移植组织中微血管血流的维持对于襟翼生存能力至关重要。几项研究表明，频繁的监测和早期检测会导致较早的干预导致较早的干预，从而减少了导致组织损失的毁灭性并发症的数量。在显微外科手术时代的早期，仅在临床观察肤色，毛细血管填充物和皮肤出血时进行皮瓣监测。但是，与皮瓣灌注的临床评估中的人员配备和主观变化有关的问题导致寻找客观的皮瓣监测方法。测量局部组织氧合体内的一种有希望的技术是弥漫性光谱（DOS）。 DOS是一种定量的近红外（NIR）光谱技术，可以确定氧气和脱氧血红蛋白，脂肪和水等发色团的绝对浓度。调制成像（MI）是BLI上发明的NIR成像方法，它基于DOS的原理，并采用了图案化的照明来询问生物组织。这种非接触方法可以在广泛的视野中快速定量确定光学特性和体内浓度。拟议研究的核心目的是进一步开发调制成像的发展，并评估其可行性，以此作为确定组织重建皮瓣状态的一种手段。在第一阶段，我们使用背椎弓根啮齿动物模型进行了体内MI研究。易于实施背椎弓根皮瓣，以建立受控的缺血并重新灌注伤口。这使我们能够在几天的时间内采用MI推断组织血红蛋白，氧合和水合的空间分辨图。在第二阶段，我们建议开发和验证用于临床使用的MI仪器。调查将首先评估使用成人约克郡猪的部分血管充血模型中MI的性能。随后将进行一项研究，其中MI和潜在竞争的FDA清除装置将在临床情况下采用，以评估局部皮瓣状态。与本文概述的II期研究并行，我们将积极地基于MI的医疗设备进行商业化。公共卫生相关性：使用组织转移皮瓣是一种将组织从供体位置移至受体位置，并将动脉和静脉重新连接到受体部位的血管的方法。此过程的医疗实用性是允许创伤后的重建手术以及癌症手术切除后。这种重建手术可能会因动脉或静脉的机械阻塞而导致失败。由于缺乏血流而导致自由组织皮瓣的缺乏引起的损伤（在重新连接血管之前断开组织）；或由于一种损伤呼叫缺血 - 再灌注损伤，这是一种损伤，在血流已恢复到转移的组织后导致。组织的氧合和移植组织中微血管血流的维持对于瓣生存至关重要。自由组织转移后的第一个术后几天的特征是微血管并发症的风险和因坏死而转移的组织的丧失。对于外科医生和患者来说，自由皮瓣的损失都是毁灭性的经历。在此提案中，我们将开发和验证一种具有比目前可实现的工具，该工具有潜力识别襟翼故障。成功的努力有可能使开发一种新的医疗设备，该设备将有能力指导重建手术和手术后恢复，既可以降低手术后并发症发生率，又降低了皮瓣愈合的不确定性。除了改善手术结果外，这可能会缩短住院和相关的卫生保健费用的持续时间。