Feasibility Study of Advanced Circulatory Support Devices that Enable Recovery and Optimal Therapy of Heart Failure in Pediatric and Adult Patients

先进循环支持装置的可行性研究，使儿童和成人心力衰竭患者能够康复并获得最佳治疗

• 批准号: 18300149
• 负责人: TAKATANI Setsuo
• 金额: $ 11.18万
• 依托单位: Tokyo Medical and Dental University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 2006
• 资助国家: 日本
• 起止时间: 2006 至 2007
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-18300149/
• 关键词: Heart Failure; Heart-lung machine; ECMO; Pediatric heart disease; Centrifugal blood pump; Mag-lev centrifugal pump; Left ventricular assist device; Priming volume; 小児用人工心臓; 模擬循環回路; 心機能; 心臓移植; 左心補助人工心臓; 膜型人工肺

This study addresses design and development of advanced circulatory support devices intended for short and intermediate duration of at least one month without requiring anti-coagulation therapy in children and adults, for allowing complete recovery, or for bridging to more advanced treatment modalities such as implantable devices or heart transplantation.To achieve the goal, for adult applications a disposable, magnetically levitated (Mag-lev) centrifugal blood pump having a prime volume of 23ml was designed by utilizing a compact magnetic bearing. The compact magnetic bearing was implemented by combining two-degree-of freedom active magnetic bearing in X- and Y- directions with permanent magnets passively restoring the position of impeller rotor in the axial and tilting axes. The rotation of impeller was attained through radial magnetic coupling between the inner driver magnet mounted on the motor shaft and the follower magnet molded inside the impeller-rotor. The pump performance ana … More lysis showed the maximum head pressure of 800mmHg against the pump flow of 5L/min at the rotational speed of 4500rpm. The hemolysis study revealed that the mechanical damage to blood cell elements was about the half that of the clinically used BioPump BPX-80. To date in vivo study using calves has shown that the pump system can meet requirements for one-week circulatory support in adult patients with minimum requirement of anti-coagulation therapy.As for pediatric application, a miniature centrifugal blood pump TinyPump having prime volume of 5ml and stable low flow control capability to 0.2L/min has been designed for 3-10Kg neonates and infants. The diameter of the impeller rotor is 30mm with six straight vanes resulting in the external diameter of the pump to be 50mm. The pump head is disposable, and easily attached and detached from the re-usable motor driver unit. The impeller rotor is rotated by radial magnetic coupling force between the 6 pole external drive magnets mounted on the motor shaft and the magnets molded inside the impeller-rotor. The impeller-rotor is supported by a hydrodynamic bearing at its center. The gap clearance of 150μm in the bearing of the impeller-rotor resulted in the secondary flow through the bearing area to be about 10% of the external flow. The application of the TinyPump for heart-lung bypass studies in 3Kg piglets revealed superior performance in comparison against the pediatric BioPump BP-50. The TinyPump was also used to support lung circulation in the single ventricle model to show stable pulmonary circulation. The TinyPump has also been used as a left ventricular assist device in the 3.5Kg swine and 10Kg Shiba-goats, demonstrating stable low flow, non-hemolytic and biocompatible support of circulation to the period up to two weeks. The study continues to demonstrate the stable and biocompatible performance in 10Kg Shiba-goats for the duration of 1-2 months. Less

这项研究致力于设计和开发先进的循环支持装置，旨在为儿童和成人提供至少一个月的短期和中期持续时间，无需抗凝治疗，以实现完全康复，或过渡到更先进的治疗方式，如植入式装置或心脏移植。 23ml 采用紧凑型磁力轴承设计。紧凑型磁力轴承是通过将X和Y方向的二自由度主动磁力轴承与永磁体相结合来实现的，永磁体被动地恢复叶轮转子在轴向和倾斜轴上的位置。叶轮的旋转是通过安装在电机轴上的内部驱动磁体和模制在叶轮转子内部的从动磁体之间的径向磁耦合来实现的。泵性能分析显示，在转速为 4500rpm 时，泵流量为 5L/min，最大水头压力为 800mmHg。溶血研究显示，对血细胞元素的机械损伤约为临床使用的BioPump BPX-80的一半。迄今为止，小牛体内研究表明，该泵系统可以满足成年患者一周循环支持的要求，且抗凝治疗的最低要求。在儿科应用方面，专为3-10Kg新生儿和婴儿设计了一款微型离心血泵TinyPump，其灌注量为5ml，稳定的低流量控制能力为0.2L/min。叶轮转子直径为 30mm，带有六个直叶片，因此泵的外径为 50mm。泵头是一次性的，并且可以轻松地与可重复使用的电机驱动器单元连接和拆卸。叶轮转子通过安装在电机轴上的 6 极外部驱动磁体和模制在叶轮转子内部的磁体之间的径向磁耦合力来旋转。叶轮-转子由位于其中心的流体动压轴承支撑。叶轮-转子轴承间隙为150μm，导致通过轴承区域的二次流量约为外部流量的10%。 TinyPump 在 3 公斤仔猪心肺旁路研究中的应用表明，与儿科 BioPump BP-50 相比，其性能更优越。 TinyPump 还用于支持单心室模型中的肺循环，以显示稳定的肺循环。 TinyPump 还被用作 3.5 公斤猪和 10 公斤柴山羊的左心室辅助装置，在长达两周的时间内表现出稳定的低流量、非溶血性和生物相容性循环支持。该研究继续证明了 10 公斤柴山羊的稳定性和生物相容性，持续时间为 1-2 个月。较少的

项目成果

Efficacy of a miniature centrifugal rotary pump (TinyPump) for transfusion-free cardiopulmonary bypass in neonatal piglets

微型离心旋转泵 (TinyPump) 对新生仔猪免输血体外循环的功效

• 发表时间: 2007
• 期刊: ASAIO J 53
• 作者: Ugaki S;Ishio K;Osaki S;et. al.
• 通讯作者: et. al.

Presidential address ; Progress of rotary blood pumps

总统致辞；

• 发表时间: 2006
• 作者: 高谷節雄;安田利貴;谷城博幸;大内克洋;高谷節雄;Takatani S
• 通讯作者: Takatani S

Development of a reflected optical fiber system for measuring oxygen saturation in an integrated artificial heart-lung system

开发用于测量集成人工心肺系统中氧饱和度的反射光纤系统

• 发表时间: 2008
• 期刊: Artif Organs 32(8)
• 作者: Yasuda T;Saito T;Kihara T;Takatani S;Funakubo A
• 通讯作者: Funakubo A

Feasibility of a tiny centrifugal blood pump (TinyPump) for pediatric extracorporeal circulatory support.

• DOI: 10.1111/j.1525-1594.2007.00401.x
• 发表时间: 2007-05
• 期刊: Artificial organs
• 影响因子: 2.4
• 作者: K. Ohuchi;H. Hoshi;Y. Iwasaki;K. Ishihara;M. Yoshikawa;S. Ugaki;K. Ishino;S. Osaki;Y. Kotani;S. Sano;S. Takatani

A compact highly efficient and low hemolytic centrifugal blood pump with a magnetically levitated impeller.

具有磁悬浮叶轮的紧凑型高效低溶血离心血泵。

• 发表时间: 2006
• 期刊: Artif Organs 30(3)
• 作者: Asama J;Shinshi T;Hoshi H;Takatani S;Shimokohbe A
• 通讯作者: Shimokohbe A