iBTA-Induced Biotube® Blood Vessels: 2020 Update

Abstract

Blood access is a lifeline for dialysis patients. However, serious problems such as stenosis or obstruction of access blood vessels, which are life-threatening conditions in daily clinical practice, still remain. One of the most promising candidates for solving these problems may be Biotube blood vessels. More than 20 years have passed since the development of in-body tissue architecture (iBTA), a technology for preparing tissues for autologous implantation in patients. The tissues obtained by iBTA do not elicit immunological rejection, which is one of the ultimate goals of regenerative medical engineering; however, their practical applications were quite challenging. The seemingly unorthodox iBTA concepts that do not follow the current pre-established medical system may not be readily accepted in general medicine. In contrast, there are many diseases that cannot be adequately addressed even with the latest and most advanced medical technology. However, iBTA may be able to save patients with serious diseases. It is natural that the development of high-risk medical devices that do not fit the corporate logic would be avoided. In order to actively treat such largely unattached diseases, we started Biotube Co., Ltd. with an aim to contribute to society. Biotubes induced by iBTA are collagenous tubular tissues prepared in the patient’s body for autologous implantation. The application of Biotubes as tissues for vascular implantation has been studied for many years. Biotubes may have excellent potential as small-diameter artificial blood vessels, one of the most difficult to clinically achieve. Their possibility is currently being confirmed in preclinical tests. Biotubes may save hundreds of thousands of patients worldwide annually from amputation. In addition, we aim to eliminate the recuring access vascular problems in millions of dialysis patients. This study provides an update on the current development status and future possibilities of Biotubes and their preparation molds, Biotube Makers.

Pre‐implantation evaluation of a small‐diameter, long vascular graft (Biotube®) for below‐knee bypass surgery in goats

“…The two sizes of Biotube Maker (5th generation, diameter 86 mm or 97 mm, thickness 5.4 mm, Biotube Co., Ltd., Tokyo, Japan) 12 have a thin, porous disc shape, assembled by sandwiching a spiral plastic rod (polyolefin resin) between two stainless steel round plates (Figure 1A–D). The maker was designed to form Biotube with a length of 40 cm or 55 cm, an inner diameter of 4 mm with one end tapering to a diameter of 3 mm, and a thickness of 0.85 mm.…”

“…In addition, long‐term patency can be expected to be achieved if the Biotubes regenerate into blood vessels in‐situ. In this study, we present detailed results of comprehensive non‐clinical studies using goats to perform pre‐implantation evaluation of Biotubes <4 mm in diameter prepared by using the latest Biotube Maker (5th generation) 12 for the realization of an investigator‐initiated clinical trial.…”

“…8,9 On the other hand, using our in-Body Tissue Architecture (iBTA), 10,11 a long autologous tubular tissue, called Biotube ® , with various diameters can be prepared by embedding a specially designed mold, called Biotube Maker, subcutaneously for 1 and 2 months. 12 Biotube Maker was designated as a medical device in the SAKIGAKE program of the Japanese Ministry of Health, Labour and Welfare in 2019 to surgically relieve patients with chronic limb-threatening ischemia from amputation. 13 We have improved the Biotube Maker to make long Biotubes rapidly and reliably.…”

First-in-human results of an in-body tissue architecture-induced tissue-engineered vascular graft “Biotube” for application in distal bypass for chronic limb-threatening ischemia

“…In accordance with a previous report, 5,6 a Biotube was prepared using spiral molds (Biotube Maker, Biotube Co., Ltd., Tokyo, Japan). Under general anesthesia, two Biotube Makers were subcutaneously embedded at the left antero-lateral potion of the chest with a 10-cm incision (Fig 2).…”

A Novel Method for Urinary Tract Reconstruction in Transplanted Embryonic Kidneys Using the Hybrid Stent: A Pig Study

“…A nickel-titanium stent with an outer diameter of 3.0 mm and a length of 5.0 mm was embedded in pig subcutaneous tissue for >1 mo and covered with a "biotube" composed of a collagen-rich extracellular matrix (Figure 1B). 3 Before surgery, an immunosuppressive agent, rapamycin, was applied to the outside to avoid the recipient's rejection against the cloaca.…”