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We have developed tissue\u2010engineered vascular grafts called \u201cBiotubes\u00ae\u201d using a completely autologous approach called in\u2010body tissue architecture (iBTA). This study aimed at pre\u2010implantation evaluation of Biotube and its in vivo preparation device, Biotube Maker, for use in below\u2010knee bypass surgery.\u00a0Forty nine makers were subcutaneously embedded into 17 goats for predetermined periods (1, 2, or 3\u00a0months). 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\u2009mm and a length of 51 to 52\u2009cm with a wall thickness of 594\u2009\u00b1\u200997\u2009\u03bcm. All Biotubes did not kink when completely bent under an internal pressure of 100\u2009mmHg and did not leak without any deformation under a water pressure of 200\u2009mmHg. Their burst strength was 2409\u2009\u00b1\u2009473\u2009mmHg, and suture retention strength was 1.75\u2009\u00b1\u20090.27\u2009N, regardless of the embedding period, whereas tensile strength increased from 7.5\u00a0\u00b1\u20091.3\u00a0N at 1\u00a0month to 9.7\u00a0\u00b1\u20092.0\u00a0N at 3\u00a0months 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\u00a0year at room temperature. This study confirmed that even Biotubes formed 1\u00a0month after embedding of Biotube Makers had properties comparable to arteries.<\/jats:p>","DOI":"10.1002\/jbm.b.35084","type":"journal-article","created":{"date-parts":[[2022,5,13]],"date-time":"2022-05-13T13:12:38Z","timestamp":1652447558000},"page":"2387-2398","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Pre\u2010implantation evaluation of a small\u2010diameter, long vascular graft (Biotube\u00ae) for below\u2010knee bypass surgery in goats"],"prefix":"10.1002","volume":"110","author":[{"given":"Yasuhide","family":"Nakayama","sequence":"first","affiliation":[{"name":"Osaka Laboratory Biotube Co., Ltd  Osaka Japan"},{"name":"Department of Cardiovascular Surgery Oita University Hospital  Oita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryosuke","family":"Iwai","sequence":"additional","affiliation":[{"name":"Institute of Frontier 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