Kentaro Ohnuma

Preparation of an autologous heart valve with a stent (stent-biovalve) using the stent eversion method

We designed a novel method for constructing an autologous heart valve with a stent, called a stent-biovalve. In constructing completely autologous heart valves, named biovalves, which used in-body tissue architecture technology, tissues for leaflets were formed via ingrowths into narrow apertures in the preparation molds, frequently leading to delayed or incomplete biovalve preparation. In this technique, self-expandable nitinol stents after everting were mounted on an acrylic column-shaped part and partially covered with an acrylic cylinder-shaped part with three slits. This assembled mold was placed into subcutaneous abdominal pouches in beagles or goats for 4 weeks. Upon removing the acrylic parts after harvesting and trimming of capsulated tissues, a tubular hollow structure with three pocket-flaps of membranous tissue rigidly fixed to the stents outer surface was obtained. Then, the stent was turned inside out to the original form, thus moving the pocket-flaps from outside to the inside. Stent-biovalves with a sufficient coaptation area were thus obtained with little tissue damage in all cases. The valve opened smoothly, and high aperture ratio was noted. This novel technique was thus highly effective in constructing a robust, completely autologous stent-biovalve with adequate valve function.

In Vitro Evaluation of a Novel Autologous Aortic Valve (Biovalve) With a Pulsatile Circulation Circuit

We have used in-body tissue architecture technology to develop an autologous valved conduit with intact sinuses of Valsalva (biovalve). In this study, we fabricated three different forms of biovalves and evaluated their function in vitro using a mock circulation model to determine the optimal biovalve form for aortic valve replacement. A cylindrical mold for biovalve organization was placed in a dorsal subcutaneous pouch of a goat, and the implant that was encapsulated with connective tissue was extracted 2 months later. The cylindrical mold was removed to obtain the biovalve (16 mm inside diameter) that consisted of pure connective tissue. The biovalve was connected to a pulsatile mock circulation system in the aortic valve position. The function of the three biovalves (biovalve A: normal leaflets with the sinuses of Valsalva; biovalve B: extended leaflets with the sinuses of Valsalva; biovalve C: extended leaflets without the sinuses of Valsalva) was examined under pulsatile flow conditions using saline. In addition, the mock circuit was operated continuously for 40 days to evaluate the durability of biovalve C. The regurgitation rate (expressed as a percent of the mean aortic flow rate during diastole) was 46% for biovalve A but only 3% for biovalves B and C. The durability test demonstrated that even after biovalve C pulsated more than four million times (heart rate, 70 bpm; mean flow rate, 5.0 L/min; mean aortic pressure, 92 mm Hg), stable continuous operation was possible without excessive reduction of the flow rate or bursting. The developed biovalve demonstrated good function and durability in this initial in vitro study.

Development and Hydrodynamic Evaluation of a Novel Inflow Cannula in a Mechanical Circulatory Support System for Bridge to Decision

Recent progress in the development of implantable rotary blood pumps realized long-term mechanical circulatory support (MCS) for bridge to transplant, bridge to recovery, or a destination therapy. Meanwhile, a short-term MCS system is becoming necessary for bridge to decision. We developed a novel inflow cannula for the short-term MCS system, which gives sufficient bypass flow with minimal invasion at insertion, and evaluated its hydrodynamic characteristics. The novel inflow cannula, named the Lantern cannula, is made of elastic silicone reinforced with metal wires. The cannula tip has six slits on the side. This cannula tip can be extended to the axial direction by using an introducer and can be reduced in diameter, and the Lantern cannula enables easy insertion into the left ventricle apex with minimal invasion. The sufficient bypass flow rate can be obtained due to low pressure loss. Moreover, this Lantern shape also resists suction complication around the cannula tip. The pressure loss through the Lantern cannula was measured using a mock circulation and compared with two commercially available venous cannulae (Sarns4882, Terumo, Tokyo, Japan and Stockert V122-28, Sorin Group, Tokyo, Japan), which have almost same diameter as the Lantern cannula. Moreover, the flow patterns around the cannula tip were numerically analyzed by computational fluid dynamics (CFD). Acute animal experiment was also performed to confirm the practical effectiveness of the Lantern cannula. The pressure loss of the Lantern cannula was the lowest compared with those of the commercially available venous cannulae in in vitro experiment. CFD analysis results demonstrated that the Lantern cannula has low pressure loss because of wide inflow orifice area and a bell mouth, which were formed via Lantern shape. The highest bypass flow was obtained in the Lantern cannula because of the low pressure loss under pulsatile condition in in vivo experiments. The Lantern cannula demonstrated superior hydrodynamic characteristics as the inflow cannula in terms of pressure loss due to its specially designed Lantern shape.

Application of a search algorithm using stochastic behaviors to autonomous control of a ventricular assist device.

A ventricular assist device (VAD) is a device with mechanical pumps implanted adjacent to the patients native heart to support the blood flow. Mechanical circulatory support using VADs has been an essential therapeutic tool for patients with severe heart failure waiting for a heart transplant in clinical site. Adaptive control of VADs that automatically adjust the pump output with changes in a patient state is one of the important approaches for enhanced therapeutic efficacy, prevention of complications and quality of life improvement. However adaptively controlling a VAD in the realistic situation would be difficult because it is necessary to model the whole including the VAD and the cardiovascular dynamics. To solve this problem, we propose an application of attractor selection algorithm using stochastic behavior to a VAD control system. In this study, we sought to investigate whether this proposed method can be used to adaptively control of a VAD in the simple case of a continuous flow VAD. The flow rate control algorithm was constructed on the basis of a stochastically searching algorithm as one example of application. The validity of the constructed control algorithm was examined in a mock circuit. As a result, in response to a low-flow state with the different causes, the flow rate of the pump reached a target value with self adaptive behavior without designing the detailed control rule based on the experience or the model of the control target.