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

本研究旨在设计和开发先进的循环支持装置，用于儿童和成人的短期和中期治疗，至少一个月，无需抗凝治疗，允许完全恢复，或过渡到更先进的治疗方式，如植入式装置或心脏移植。为了实现这一目标，对于成人应用，一次性，利用磁悬浮轴承设计了一台预充容量为23 ml的磁悬浮离心血泵。将X、Y方向的两自由度主动磁轴承与永磁体被动恢复叶轮转子在轴向和倾斜轴上的位置相结合，实现了紧凑型磁轴承。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。泵的性能分析 ...更多信息 在4500 rpm转速下，最大压头为800 mmHg，泵流量为5L/min。溶血研究表明，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，在小牛体内的研究表明，泵系统可以满足一个星期的循环支持在成人患者的要求，最低要求的抗凝治疗。至于儿科应用，微型离心血泵TinyPump具有预充容量为5 ml和稳定的低流量控制能力，为3- 10公斤的新生儿和婴儿设计。叶轮转子的直径为30 mm，带有六个直叶片，导致泵的外径为50 mm。泵头是一次性的，并且容易地附接到可重复使用的马达驱动器单元和从可重复使用的马达驱动器单元拆卸。叶轮转子通过安装在电机轴上的6极外部驱动磁体与叶轮转子内部模制的磁体之间的径向磁耦合力旋转。叶轮转子在其中心由流体动力轴承支撑。叶轮-转子轴承中150μm的间隙差距导致通过轴承区域的二次流约为外部流的10%。TinyPump应用于3 Kg仔猪心肺旁路研究显示，与儿科BioPump BP-50相比，TinyPump具有上级性能。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3.5Kg猪和10 Kg芝山羊的左心室辅助装置，证明了稳定的低流量、非溶血性和生物相容性循环支持长达两周。该研究继续证明了在10 Kg Shiba山羊中持续1-2个月的稳定和生物相容性性能。少

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