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3D Printer-based Molding For The Preparation Of Biovalve Family In In-body Tissue Architecture Technology
Yasuhide Nakayama1, Yoshiaki Takewa1, Masami Uechi2, Keiichi Kanda3, Takeshi Moriwaki1, Tomonori Oie4, Takaharu Tanaka5, Hisashi Sugiura5.
1National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan, 2Nihon University, Kanahgawa, Japan, 3Kyoto Prefectural University of Medicine, Kyoto, Japan, 4Shinkan Co, Osaka, Japan, 5Goodman Co, Nagoya, Japan.

Purpose: Our in body tissue architecture technology, as novel and practical regeneration medicine, can prepare completely autologous heart valves, called Biovalves, consisting of only recipient's own tissue according to the shape of mold faithfully. In this study, 3D printer was used for design of the preparation molds for Biovalve family and valvular function was evaluated in vitro and in vivo. Methods and Results: 3D printers (Projet or Objet) could reproduce easily the 3D-shape and size of native heart valves regardless of types within several hours. Only 1-month subcutaneous embedding of the assembling of 2 conduit parts and 3 sinus parts produced aortic or pulmonary valve-shaped Biovalves from completely autologous connective tissue with collagen and fibroblasts. As an aortic valve Biovalve in vitro evaluation using a pulsatile circulation circuit showed excellent valvular functions. Mean flow was maintained up to 10 days in the saline solution at 37°C with high durability. Upon implantation of the Biovalves in a beagle or a goat model good valvular function was obtained for 6 months. Combination with stents (Goodman Co.) at the mold embedding formed stent-impregnated Biovalves. By catheter-induced implantation of the Biovalves TAVI in a goat model or TPVI in a canine model were performed. In addition, mitral-type and tricuspid-type Biovalves were similarly formed by 3D molding in body. Their leaflets and tendinous cords were connected robustly and seamlessly. In a canine model, after surgical replacement postoperative echocardiography showed smooth movement of the leaflets with little regurgitation under systemic circulation. In all implantation study, the luminal surface after implantation was very smooth and fully covered with thin neointima including endothelial cells without thrombus formation. Conclusion: Functional, autologous, 3D-shaped, aortic, pulmonary, mitral, and tricuspid valves with clinical application potential were formed by only in body embedding of specially designed molds, which could be prepared by 3D printer within several hours.

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