Vol.5 No.1 2012
Research paper : Research and development of a monopivot centrifugal blood pump for clinical use (T. Yamane et al.)−22−Synthesiology - English edition Vol.5 No.1 (2012) 2011. The approval covers an extracorporeal pump use for cardiovascular surgery and the name “MP23” denotes monopivot bearing, which shows the contribution of AIST. The pump features silent operation and less wear. The necessary time for development was 9 years. We kept the number of animal experiments low and accumulated sufficient engineering data which could become bases of design and could be used as descriptive material for users. Though the approved duration of use was 6 hours, AIST has done research to verify the durability and hemocompatibility for 4 week use, and therefore, it is expected to be used in the future for the new, bridge-to-bridge care before the implantation of a long-term artificial heart. Further collaboration with hospitals would expand the application field. 6 Future contributions of AIST to industriesOur research made contributions not only to a company product but also to other facilities or companies with our technology evaluation technique. AIST also made contribution to the Guideline Program of METI/MHLW to promote speedy approvals of medical devices for industries.Among two implantable VADs approved in December 2010, we conducted flow visualization for EVAHEART by Sun Medical Technology Research and the data was submitted to premarket approval of PMDA and to the investigational device exemption (IDE) of FDA. The approvals have been successfully obtained. For DuraHeart of Terumo, we contributed to making VAD guidelines to establish a consensus for evaluating items and to shorten the review period.Recently our research collaboration has expanded to overseas companies. AIST will make contributions to domestic and overseas industries using our development technology as well as our evaluating technology.7 To the researchers who wish M/E collaborationOur experience clarified that the followings are necessary for making a product in medical engineering.1) Medical engineering researches are team studies which cover mechanics, fluid, material, and electo-mechanical engineering, as well as medicine, manufacturing, regulation, insurance reimbursement. The Japanese situation should be understood that instead of buyers the insurance pays for the devices based on the national health insurance.2) The project should have research leaders who watch the project and connect different teams with each other for a long period, though the administrators may change, since the development needs roughly a decade. As the results or remedies of medical or engineering subjects appear at random, synthesizing the solutions into a system is similar to building with blocks. We kept steady M/E leaders for twenty years.3) Research collaboration among a research institute, a medical facility, and a manufacturing company should be as equal partners. We see many cases where a medical team governs the project and where the project tends to do research instead of making products. However, balancing the purpose, design and materials is important to be accepted by the maximum number of patients. Therefore, the activity and the experience of the company should also be respected. The academia often tends to pay attention to a total replacement heart (TH) first, a VAD second, an extracorporeal pump third. The present case is a model case where the economic aspect was taken into account with assistance of academia or a research institute. 4) A good product goal should be made instead of a good research goal. AIST should seek for a goal of social needs instead of seeking its own research goal. Though obtaining research budget is important, “research for research sake” does not lead to social acceptance. Fig. 6 Animal experiment using monopivot centrifugal blood pumpConducted for 4 weeks at Tohoku University, paracorporeal application as left heart bypassReferencesT.Yamane: New aspect for artificial hearts, Special issue for cardiovascular biomaterials, Journal of Japanese Society for Biomaterials, Nihon-Igakukan, 29 (3), 199-203 (2011) (in Japanese).T.Yamane, M.Nishida, B.Asztalos, T.Tsutsui and T.Jikuya: Fluid dynamic characteristics of monopivot magnetic suspension blood pumps, ASAIO Journal, 43 (5), M635-M638 (1997).T.Yamane, O.Maruyama, M.Nishida, R.Kosaka, T.Chida, H.Kawamura, K.Kuwana, K.Ishihara, Y.Sankai, M.Matsuzaki, O.Shigeta, Y.Enomoto and T.Tsutsui: Antithrombogenic properties of a monopivot magnetic suspension centrifugal pump for circulatory assist, Artificial Organs, 32 (6), 484-489 (2008).