A NEW HYPOTHERMIC STORAGE SOLUTION FOR VENOUS SEGMENTS

在血管和心血管重建手术期间，通常在植入静脉移植物之前将自体静脉段储存一段时间。临床研究已经记录了这些静脉段对处理、温度和所用溶液的敏感性。我们建议对一种新的低温储存溶液Unisol（TM）进行可行性测试，Unisol（TM）最初被设计为组织和器官保存的通用解决方案，用于手术期间自体静脉段的短期储存。在I期研究中，将进行组织病理学和平滑肌/内皮细胞生理学的植入前研究，以比较新鲜兔静脉与在25 ℃或4 ℃下储存在Unisol溶液、Viaspan、生理盐水和自体血液中不同时间段的静脉。本研究将确定低温保存条件，以增强体外静脉段的内皮结构和功能。将在II期研究中提出在已建立的动物模型中进行植入实验。将在II期研究中进一步微调溶液组成、储存时间和温度的优化交互变量，旨在为大型动物临床前模型和最终临床应用提供有效和方便的移植物保存范例。拟议的商业应用：美国市场的静脉低温储存解决方案每年在30万至40万单位之间，即，进行所有冠状静脉移植和所有游离、反向外周静脉移植。

It is common practice to store autologous vein segments during vascular and cardiovascular reconstructive surgery for brief periods before implantation of vein grafts. Clinical studies have documented the sensitivity of these vein segments to handling, temperature and the solution employed. We propose feasibility testing of a new hypothermic storage solution, Unisol(TM), originally designed as a universal solution for tissue and organ preservation, for short-term storage of autologous vein segments during surgery. In a Phase I study, pre-implantation studies of histopathology and smooth muscle/endothelial cell physiology will be performed to compare fresh rabbit veins with veins stored in Unisol solutions, Viaspan, saline and autologous blood for varying periods of time at either 25 degrees C, or 4 degrees C. This study will determine the hypothermic storage conditions that enhance the endothelial structure and function of vein segments in vitro. Implantation experiments in established animal models will be proposed in a Phase II study. The optimized interactive variables of solution composition, time of storage and temperature will be further fine-tuned in a Phase II study designed to yield an effective and convenient paradigm for improved preservation of grafts for a large animal pre-clinical model and ultimately clinical application. PROPOSED COMMERCIAL APPLICATION: The US market for a hypothermic storage solution for veins is between 300,000 and 400,000 units annually, i.e., all coronary vein grafts and all free, reversed peripheral vein grafts performed.