Abstract：
There are no small-diameter, long artificial vascular grafts for below-knee bypass surgery in chronic limb-threatening ischemia. We have developed tissue-engineered vascular grafts called \"Biotubes®\" using a completely autologous approach called in-body tissue architecture (iBTA). This study aimed at pre-implantation evaluation of Biotube and its in vivo preparation device, Biotube Maker, for use in below-knee bypass surgery. Forty nine makers were subcutaneously embedded into 17 goats for predetermined periods (1, 2, or 3 months). All makers produced Biotubes as designed without inflammation over all periods, with the exception of a few cases with minor defects (success rate: 94%). Small hole formation occurred in only a few cases. All Biotubes obtained had an inner diameter of 4 mm and a length of 51 to 52 cm with a wall thickness of 594 ± 97 μm. All Biotubes did not kink when completely bent under an internal pressure of 100 mmHg and did not leak without any deformation under a water pressure of 200 mmHg. Their burst strength was 2409 ± 473 mmHg, and suture retention strength was 1.75 ± 0.27 N, regardless of the embedding period, whereas tensile strength increased from 7.5 ± 1.3 N at 1 month to 9.7 ± 2.0 N at 3 months with the embedding period. The amount of water leakage from the needle holes prepared in the Biotube wall was approximately 1/7th of that in expanded polytetrafluoroethylene vascular grafts. The Biotubes could be easily connected to each other without cutting or anastomosis leaks. They could be stored for at least 1 year at room temperature. This study confirmed that even Biotubes formed 1 month after embedding of Biotube Makers had properties comparable to arteries.
摘要：
没有小直径，用于慢性威胁肢体缺血的膝关节以下搭桥手术的长人造血管移植物。我们开发了组织工程血管移植物，称为“Biotubes®”，使用一种称为体内组织结构（iBTA）的完全自体方法。本研究旨在对Biotube及其体内制备装置进行植入前评价,Biotube制造商，用于膝下旁路手术。在预定的时间（1、2或3个月）内，将49个制造商皮下嵌入17只山羊中。所有制造商都按照设计生产了生物管，在所有时期都没有炎症，除了少数有轻微缺陷的情况（成功率：94％）。仅在少数情况下发生小孔形成。获得的所有生物管的内径为4mm,长度为51至52cm,壁厚为594±97μm。当在100mmHg的内部压力下完全弯曲时,所有生物管都没有扭结,并且在200mmHg的水压下没有任何变形而没有泄漏。他们的爆裂强度为2409±473mmHg，缝线固位强度为1.75±0.27N,无论嵌入周期如何，而抗拉强度从1个月时的7.5±1.3N增加到3个月时的9.7±2.0N。从Biotube壁中制备的针孔中的水泄漏量约为膨胀的聚四氟乙烯血管移植物的1/7。生物管可以容易地彼此连接而没有切割或吻合泄漏。它们可以在室温下储存至少1年。这项研究证实，即使在BiotubeMakers包埋后1个月形成的Biotube也具有与动脉相当的特性。
