This article reviews third-generation blood pumps, focusing on the magnetic-levitation (maglev) system. The maglev system can be categorized into three types: (i) external motor-driven system, (ii) direct-drive motor-driven system, and (iii) self-bearing or bearingless motor system. In the external motor-driven system, Terumo (Ann Arbor, MI, U.S.A.) DuraHeart is an example where the impeller is levitated in the axial or z-direction. The disadvantage of this system is the mechanical wear in the mechanical bearings of the external motor. In the second system, the impeller is made into the rotor of the motor, and the magnetic flux, through the external stator, rotates the impeller, while the impeller levitation is maintained through another electromagnetic system. The Berlin Heart (Berlin, Germany) INCOR is the best example of this principle where one-axis control combination with hydrodynamic force achieves high performance. In the third system, the stator core is shared by the levitation and drive coil to make it as if the bearing does not exist. Levitronix CentriMag (Zurich, Switzerland), which appeared recently, employs this concept to achieve stable and safe operation of the extracorporeal system that can last for a duration of 14 days. Experimental systems including HeartMate III (Thoratec, Woburn, MA, U.S.A.), HeartQuest (WorldHeart, Ottawa, ON, Canada), MagneVAD (Gold Medical Technologies, Valhalla, NY, U.S.A.), MiTiHeart (MiTi Heart, Albany, NY, U.S.A.), Ibaraki University’s Heart (Hitachi, Japan) and Tokyo Medical and Dental University/Tokyo Institute of Technology’s disposable and implantable maglev blood pumps are also reviewed. In reference to second-generation blood pumps, such as the Jarvik 2000 (Jarvik Heart, New York, NY, U.S.A.), which is showing remarkable achievement, a question is raised whether a complicated system such as the maglev system is really needed. We should pay careful attention to future clinical outcomes of the ongoing clinical trials of the second-generation devices before making any further remarks. What is best for patients is the best for everyone. We should not waste any efforts unless they are actually needed to improve the quality of life of heart-failure patients.

Third-generation blood pumps with mechanical noncontact magnetic bearings.

Ventricular Assist Devices (VADs) provide long- and short-term support to chronically-ill heart disease patients; these devices are expected to match the remarkable functionality of the natural heart, which makes their design a very challenging task. Blood pumps, the principal component of the VADs, must operate over a wide range of flowrates and pressure heads, and minimize the damage to blood cells in the process. They should also be small to allow easy implantation in both children and adults. Mathematical methods and Computational Fluid Dynamics (CFD) have recently emerged as a powerful design tool in this context; a review of the recent advances in the field is presented here. This review focuses on the CFD-based design strategies applied to blood flow in blood pumps and other blood-handling devices. Both simulation methods for blood flow and blood damage models are reviewed. The literature is put into context with a discussion of the chronological development in the field. The review is illustrated with specific examples drawn from our group’s Galerkin/LeastSquares (GLS) finite element simulations of the basic Newtonian flow problem for the continuous-flow centrifugal GYRO blood pump. The GLS formulation is outlined, and modifications to include models that better represent blood rheology are shown. Hemocompatibility analysis of the pump is reviewed in the context of hemolysis estimations based on different blood damage models. Our strainbased blood damage model that accounts for the viscoleasticity associated with the red blood cells is reviewed in detail. The viability of trial-and-error based design improvement and complete simulation-based design optimization schemes are also discussed.

https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S0956792509007839

A review of computational fluid dynamics analysis of blood pumps

Even though clinical acceptance of a nonpulsatile blood flow was demonstrated almost 45 years ago, the development of a nonpulsatile blood pump was completely ignored until 20 years ago. In 1979, the first author's group demonstrated that completely pulseless animals did not exhibit any abnormal physiology if 20% higher blood flows were provided to them. However, during the next 10 years (1979-1988), minimum efforts were provided for the development of a nonpulsatile, permanently implantable cardiac prosthesis. In 1989, the first author and his team at Baylor College of Medicine initiated a developmental strategy of various types of nonpulsatile rotary blood pumps, including a 2-day rotary blood pump for cardiopulmonary bypass application, a 2 week pump for ECMO and short-term circulatory assistance, a 2 year pump as a bridge to transplantation, and a permanently implantable cardiac prosthesis. Following the design and developmental strategy established in 1989, successful development of a 2-day pump (the Nikkiso-Fairway cardiopulmonary bypass pump) in 4 years (1989-1993), a 2 week pump (Kyocera gyro G1E3 pump) in 6 years (1992-1998), and a bridge to transplant pump (DeBakey LVAD-an axial flow blood pump) in 10 years (1988-1998) was made. Currently, a permanently implantable centrifugal blood pump development program is successfully completing its initial Phase 1 program of 5 years (1995-2000). Implantation exceeded 9 months without any negative findings. An additional 5 year Phase II program (2000-2005) is expected to complete such a device that will be clinically available.

Development of rotary blood pump technology: past, present, and future.

https://deepblue.lib.umich.edu/bitstream/handle/2027.42/29115/0000154.pdf;sequence=1

Cardiovascular implant calcification: a survey and update

For many years, it was thought that nonpulsatile perfusion produced physiological and circulatory abnormalities. Since 1977, Yukihiko Nose and his colleagues have challenged this misconception. Toward that end, they did show that if a 20% higher blood flow uses more than that required for a pulsatile blood pump, then there would be no circulatory or physiological abnormalities. These experimental findings confirm that there is no difference in clinical outcome using either a pulsatile or nonpulsatile blood pump. Furthermore, the nonpulsatile rotary blood pump demonstrates efficient and reliable performance in various clinical situations. The nonpulsatile blood pump is a simple and reliable design that is manufactured easily and that has several desirable features. There is no need to incorporate heart valves, which are the most thrombogenic and blood trauma-inducing component. A continuous flow pump does not require a large orifice inflow conduit and proves to be easier to implant in patients with minimal damage to the myocardium. There is no need to incorporate a compliance volume-shifting device, which is essential for a pulsatile blood pump. The nonpulsatile device is a continuous blood pumping system; therefore, the control system is simpler and more reliable than that of a pulsatile pump. Because of the rotary blood pump's structure, only one moving part is necessary for the blood-pumping motion. By using durable components for this moving part, a durable system becomes possible. Because the electrical motor operates continuously, the on-and-off motion required for a pulsatile pump is not necessary; therefore, it is a more efficient and durable system. Thus, this group is working on the development of a nonpulsatile blood pump as a permanently implantable assist device. To achieve this goal, it is necessary to incorporate seven features into the system: small size, atraumatic features, antithrombogenic features, antiinfection features, a simple and durable design, and low energy requirement with easy controllability.

Ozawa K

Papers

Comparative evaluation of nonpulsatile and pulsatile cardiac prostheses.

Transient and permanent problems associated with the total artificial heart implantation.

Comparative study of flocked vs biolized surface for long-term assist pumps.

Totally implantable left ventricular assist device for human application.

Powdered metal surface for blood pump