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We have been developed this stent with domestically produced technology and attempted to transmit the style of "medical-engineering-industry-academia collaboration" from Japan. To date, we have been involved in the development of various devices related to systemic IR, including a new lower extremity stent (in the shallow femoral artery region and below the knee artery: a national project by AMED), and microspheres for hepatic artery chemoembolization and other embolization (CIRSE2019, Cum Laude award), and contrast agents that can image the lymphatic system. we are constantly working on the research and development of products that people would want to use in the medical field.

THEME 01
Development of below-the-knee (BTK) stent system for small-caliber atherosclerotic arteries

As the leg is called "the second heart," if blood flow is interrupted due to narrowing of blood vessels caused by arteriosclerosis in the leg, it may lead to difficulty walking or even amputation of the leg. In recent years, with the increase of lifestyle-related diseases such as diabetes, the number of cases of severe ischemia has been increasing every year. In the past, the only option would have been to immediately amputate the foot. The five-year survival rate is lower than that of some types of cancer when it leads to amputation of the lower limb. Reopening the blood flow is thus very important.

In recent years, advances in endovascular treatment have been remarkable, and catheterization has become common. There are two methods of vasodilation: vasodilatation, in which a balloon catheter is used to temporarily widen a narrowed blood vessel, and stenting, in which a metal stent is placed to physically widen the blood vessel even after surgery.

The arteries below the knee are narrower than 4 mm, and there are no suitable stents available. Our research group has been developing a stent that can be used for these small arteries below the knee. So far, we have developed a unique stent design that can ensure sufficient blood flow even when implanted in a small diameter artery. This stent is equipped with a coating that prevents thrombus and foreign body reaction, thus improving biocompatibility. Therefore, it can be safely implanted in the blood vessel and is expected to secure blood flow for a long period of time and avoid amputation of the leg.

THEME 02
X-Ray Visible, Bioabsorbable, and Drug Eluting Microbeads for Chemoembolization Therapy

According to the International Agency for Research on Cancer (IARC) (GLOBOCAN 2020), liver cancer affects approximately 900,000 people, ranking 6th among all cancer types (4.7%). Hepatocellular carcinoma (HCC), which accounts for about 80% of all liver cancer, is treated with transarterial chemoembolization (TACE), in which a thin tube (several millimeters in diameter) called a catheter is inserted into the hepatic artery near the tumor, and drug-eluting beads (DEBs) with a diameter of several hundred micrometers are injected. The blood flow in the hepatic artery that supplies nutrients to the tumor is blocked, aiming for an anti-tumor effect.

Our research group is developing novel DEBs for safer and more effective TACE. The new DEBs are made from X-ray contrast media and bioabsorbable polymers, and are both visible under X-ray irradiation and bioabsorbable. Therefore, the embolization site can be seen through X-ray fluoroscopy and CT scan, allowing intraoperative and postoperative follow-up.
In addition, by changing the size of the new DEB and the type of the contained drug, we expect it to be used for a wide range of embolization procedures beyond TACE.

THEME 03

Maximum-value projection (MIP) image created from multislice CT after classical lymphangiography

MRI contrast agent capable of high-definition contrast of the lymphatic system
Nanodiamond-gadolinium composites

There is a wide range of diseases that alter the structure and function of the lymphatic system, including trauma, infection, malignancy, congenital diseases, and medical origin. Among the imaging technologies, magnetic resonance imaging (MRI), which does not expose patients to radiation unlike X-ray computed tomography (CT), has shown particular promise in imaging the lymphatic system. The use of gadolinium (Gd) contrast agents to improve the diagnostic performance of MRI has been attempted, but there are a number of technical barriers to high resolution imaging of the lymphatic system.

Currently, the only way to image lymphatic vessels is to inject contrast media into lymphatic vessels of about 1 mm in diameter, and since the contrast media quickly drains out of the lymphatic vessels, it is not possible to obtain detailed images.
Our research group has been developing a Gd contrast agent using nanodiamond particles, focusing on the fact that contrast agent molecules are selectively transported from the interstitium to the lymphatic system when they are combined with nanoscale particles and injected intradermally. The new MRI contrast agent, which is a composite of nanodiamond particles with excellent biocompatibility and Gd complexes with excellent MRI contrast capability, will enable minimally invasive and simple imaging of the lymphatic system by intradermal injection, and is expected to lead to the diagnosis and elucidation of the pathogenesis of various diseases of the lymphatic system that have been considered unknown until now.

Large Research Grants
2018/8 - 2022/3
"Medical Reseach and Development Programs Forcused on Technology Transfer: Development of Advanced Measurement and Analysis Systems, Japan Agency for Medical Research and Development (AMED)"
Development of below-the-knee (BTK) stent system for small-caliber atherosclerotic arteries
Principle investigator : Terumitsu Hasebe
2018/4 - 2020/3
Japan Agency for Medical Research and Development (AMED)
Keio University Hospital Clinical and Translational Research Core Center
Strategic Promotion Program for Bridging Research Seeds A
課題名「X 線視認性を有する肝臓がん治療用の新規生分解性マイクロビーズ開発」
Principle investigator : Terumitsu Hasebe
2020/4 - 2021/3
"Strategic Promotion Program for Bridging Research Seeds PreB,Japan Agency for Medical Research and Development (AMED)"
Gadolinium-conjugated nanoparticles for high-resolution magnetic resonance lymphatic system imaging
Principle investigator : Terumitsu Hasebe
課題名「高視認性新規ナノ粒子 MRI 造影剤の開発」
Principle investigator : Terumitsu Hasebe
2014/10 - 2016/3
Problem-solving medical device development business, Ministry of Economy, Trade and Industry
課題名「脳血管血栓除去マイクロステントシステムの製造に向けた研究開発」
Principle investigator : World Medish K.K. (currently Biomedical Solutions, Inc.)
Sub Leader: Terumitsu Hasebe
2007/4 - 2010/3
"Nanotech Advanced Component Utilization Research and Development, New Energy and Industrial Technology Development Organization (NEDO)"
ナノテク・先端部材実用化研究開発
課題名「ボトムアップ構造制御ナノカーボン・ポリマー複合化薄膜を用いた抗血栓性医療機器の開発」
Principle investigator : The University of Tokyo Hospital
Sub Leader: Terumitsu Hasebe, Atsushi Hotta, Kawasumi Laboratories, Inc, and Terumo Clinical Supply Co., Ltd.