Optical Surgical Probe for Assessing Human Oral Mucosa Graft Vascularization

描述(申请人提供)：头部、颈部或乳房的癌症手术可导致严重的面部损伤和毁容，包括枪伤和机动车事故。最先进的重建程序包括远距离转移组织，包括骨、骨膜、皮肤、肌肉和血管，然后通过显微外科手术将原有的血管吻合到移植组织上，称为游离或埋藏的皮瓣。我们建议开发一种光学仪器来定量监测重建组织的血液灌流和氧合情况。放置在组织移植物内部(或顶部)的四个光纤组织贴片连接到血液动力学监测仪，测量每个位置的氧合和血流量：1.在供血动脉处；2.在退出静脉处；3.在FAP的毛细血管床内；以及4.在皮肤表面。每个探头将为外科医生提供血管流量、总血量(血红蛋白浓度)和血氧合度的直接测量。这些测量将使显微外科医生能够从主观的、非定量的皮瓣健康评估过渡到直接的皮瓣健康定量测量。将进行两项猪模型研究。第一项研究包括外科手术制造一块含有一条动脉供流入，一条静脉供流出的游离皮瓣。一种遮挡装置，适用于 动脉或静脉的闭塞量将被用来闭塞血管，同时将在皮瓣内的四个不同位置同时进行血流和氧合测量：动脉处、静脉处、瓣床内和皮肤处。这些研究将是短暂的非存活程序。在第二项研究中，将制作含有植入的光学装置的组织瓣，并像以前一样用于监测术后一周四个部位的皮瓣存活情况。

DESCRIPTION (provided by applicant): Devastating and disfiguring facial injuries can result from gunshot wounds and motor vehicle accidents as well as from cancer surgeries of the head and neck or breast. The most advanced reconstructive procedures involve distant transfer of tissue including bone, periosteum, skin, muscle and vasculature followed microsurgical anastomosis of pre-existing blood vessels to the grafted tissue, referred to as free or buried flaps. We propose to develop an optical instrument that quantitative monitoring of reconstructive tissue blood perfusion and oxygenation. Four fiberoptic tissue-patches placed within (or atop) tissue grafts connect to the hemodynamic monitor measuring oxygenation and blood flow rate at each location: 1. At a feeding artery; 2. At the exiting vein; 3. Within the capillary bed of the fap; and 4. At the surface of the skin. Each probe will provide the surgeon with direct measures of the rate of vascular flow, total blood volume (hemoglobin concentration) and the blood oxygenation. These measurements will enable the microsurgeon to transit from subjective, non-quantitative assessment of flap health to direct quantitative measurements of flap health. Two pig model studies will be performed. The first study involves surgical creation of a free flap containing a single artery for inflow and single vein for outflow. An occluding device that applies a well-defined amount of occlusion - either to the artery, or the vein - will be used to occlude th vessels while blood flow and oxygenation measurements will be obtained simultaneously at four different sites within the flap: at the artery, at the vein, within the flap bed, and at the skin. hese studies will be short non-survival procedures. In the second study, tissue flaps will be created containing the implanted optical devices and be used to monitor the flap viability at the four site as before, for one week post-surgery.