Development of a cardiopulmonary support system with excellent antithrombogenicity and durability that enables continuous long-term perfusion with minimum anticoagulant therapy

开发具有优异抗血栓形成性和耐久性的心肺支持系统，能够以最少的抗凝治疗实现连续长期灌注

• 批准号: 13470247
• 负责人: TAKANO Hisateru
• 金额: $ 8.96万
• 依托单位: National Cardiovascular Center Research Institute
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 2001
• 资助国家: 日本
• 起止时间: 2001 至 2003
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-13470247/
• 关键词: Artificial lung; centrifugal pump; Cardiopulmonary support; anticoagulant therapy; Heparin bonding techenique; ヘパリン; 血液適合性; 人工心臓

We have develop a new ECMO system which has an excellent antithrombogenicity and durability, aiming at facilitating prolonged ECMO support using newly developed heparin bonding technique (T-NCVC), a newly-developed membrane oxygenator (Platinum Cube NCVC), and a long-term durable centrifugal blood pump. Our results indicated that our newly developed ECMO system possesses a potential to perform prolonged circulatory support with minimum anticoagulants. In the evaluation using animals, all the ECMO systems could be maintained in the stable condition at least up to 65 days without systemic anticoagulants. All the animals except for one were able to be preserved until scheduled termination of experiments. No serum leakage from the oxygenators was observed, and the gas exchange performance was constantly retained. The pump performance was also sustained to deep purposed blood flow, and no significant hemolysis was observed. The changes of blood components and coagulation relating factors were ranged within quite small extent, which indicates that this ECMO system provides high blood compatibility. This ECMO system is an innovative system which has a potential to realize long-term perfusion without anticoagulants and device exchanges. It will realize the improvement of clinical results in the treatment of severe respiratory and/or circulatory distress patients, and furthermore, this system should change the concept of ECMO due to its long-term durability and high antithrombogenicity, especially in the application for such patients with difficulty in the anticoagulant therapy.

我们开发了一种新的ECMO系统，该系统具有优异的抗血栓性和耐用性，旨在使用新开发的肝素结合技术（T-NCVC），新开发的膜式氧合器（Platinum Cube NCVC）和长期耐用的离心血泵来促进长期ECMO支持。我们的研究结果表明，我们新开发的ECMO系统具有潜力，以最少的抗凝剂进行长期的循环支持。在使用动物进行的评价中，所有ECMO系统均可以在不使用全身抗凝剂的情况下保持稳定状态至少长达65天。除1只动物外，所有动物均可保存至实验计划终止。未观察到氧合器的血清泄漏，并且始终保持气体交换性能。泵的性能也可持续用于深用途血流，未观察到明显的溶血。血液成分和凝血相关因子的变化范围很小，表明该ECMO系统具有良好的血液相容性。该ECMO系统是一种创新系统，具有实现长期灌注的潜力，无需抗凝剂和设备更换。它将实现对严重呼吸和/或循环窘迫患者治疗的临床效果的改善，并且由于其长期耐用性和高抗血栓性，该系统应改变ECMO的概念，特别是在抗凝治疗困难的患者中的应用。

项目成果

Katagiri N., Funakubo A., Tsukiya T., Tatsumi E., Nishinaka T., Takewa Y., Taenaka Y., Fukui Y., Takano H.: "Investigation of O2/CO2 gas transfer of an extracapillary flow type oxygenator using CFD."Membrane Oxygenator. 26. 30-37 (2003)

Katagiri N.、Funakubo A.、Tsukiya T.、Tatsumi E.、Nishinaka T.、Takewa Y.、Taenaka Y.、Fukui Y.、Takano H.：“毛细管外流型氧合器 O2/CO2 气体传输的研究

Katagiri N., Tatsumi E., Tsukiya T., Nishinaka T., Taenaka Y., Takano H., Sakai K., Matsuda T: "Investigations of an augmentative effects of diameter of a hollow fiber membrane on gas exchange capacity of an extracapillary flow type oxygenator."LST. 13-1.

Katagiri N.、Tatsumi E.、Tsukiya T.、Nishinaka T.、Taenaka Y.、Takano H.、Sakai K.、Matsuda T：“中空纤维膜直径对气体交换能力的增强作用的研究

片桐伸将, 巽 英介, 西中知博, 妙中義之, 高野久輝, 酒井一成, 松田智昌, 田中秀典, 柏原 進, 佐藤正喜: "血漿漏出を防止する非対称膜構造の中空糸膜を用いた人工肺のガス交換性能の向上と新規開発のヘパリンコーティングが人工肺に与える影響の評価"模型肺. 25. 47-52 (2002)

Nobumasa Katagiri、Eisuke Tatsumi、Tomohiro Nishinaka、Yoshiyuki Taenaka、Hisaki Takano、Kazunari Sakai、Tomomasa Matsuda、Hidenori Tanaka、Susumu Kashihara、Masaki Sato：“使用具有非对称膜结构的中空纤维膜来防止血浆泄漏” 改善气体交换人工肺的性能并评估新开发的肝素涂层对人工肺的影响”Model Lung. 25. 47-52 (2002)

西中知博, 巽 英介, 妙中義之, 片桐伸将, 大西裕幸, 押川満雄, 塩谷恭子, 福田敏秀, 築谷朋典, 本間章彦, 武輪能明, 高野久輝, 佐藤正喜, 柏原 進, 田中秀典, 酒井一成, 松田智昌: "優れた抗血栓性と長期耐久性を有する心肺補助システムの開発"模型肺. 25. 53-57 (2002)

西中智宏、辰巳荣介、田中义之、片桐信正、大西博之、押川光男、盐谷京子、福田利英、月谷智则、本间明彦、穆瓦义明、高野久树、佐藤正义、樫原进、田中秀则、酒井一成、松田智正：“开发具有优异抗血栓特性和长期耐用性的心肺支持系统”模型肺。 25. 53-57 (2002)

西中知博, 巽英介, 妙中義之, 片桐伸将, 大西裕幸, 押川満雄, 塩谷恭子 他: "優れた抗血栓性と長期耐久性を有する心肺補助システムの開発"膜型肺. Vol.25. 53-57 (2002)

Tomohiro Nishinaka、Eisuke Tatsumi、Yoshiyuki Taenaka、Nobumasa Katagiri、Hiroyuki Onishi、Mitsuo Oshikawa、Kyoko Shioya 等：“开发具有优异抗血栓特性和长期耐久性的心肺支持系统” 25. 53 卷。 -57 (2002)