Bio-Medical Materials and Engineering - Volume 23, issue 1-2
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Bio-Medical Materials and Engineering is to promote the welfare of humans and to help them keep healthy. This international journal is an interdisciplinary journal that publishes original research papers, review articles and brief notes on materials and engineering for biological and medical systems.
Articles in this peer-reviewed journal cover a wide range of topics, including, but not limited to: Engineering as applied to improving diagnosis, therapy, and prevention of disease and injury, and better substitutes for damaged or disabled human organs; Studies of biomaterial interactions with the human body, bio-compatibility, interfacial and interaction problems; Biomechanical behavior under biological and/or medical conditions; Mechanical and biological properties of membrane biomaterials; Cellular and tissue engineering, physiological, biophysical, biochemical bioengineering aspects; Implant failure fields and degradation of implants. Biomimetics engineering and materials including system analysis as supporter for aged people and as rehabilitation; Bioengineering and materials technology as applied to the decontamination against environmental problems; Biosensors, bioreactors, bioprocess instrumentation and control system; Application to food engineering; Standardization problems on biomaterials and related products; Assessment of reliability and safety of biomedical materials and man-machine systems; and Product liability of biomaterials and related products.
Abstract: Dr. Yukihiko Nosé made many contributions to medical science and in particular in the area of artificial organ technologies and their clinical applications. His passing was a great loss not only to many individuals but also to the field. His enthusiasm and passion for his work was very positive on those with whom he worked while inspiring others in friendly competition. It is very difficult to recount his many accomplishments. I have outlined those developments that I was directly involved with him at the Cleveland Clinic. These developments may be grouped under the heading of Metabolic and Immunologic Support, the…name given to our research team. I hope in some small way this review also gives credit to the contributions of the many scientific and clinical professionals that were part of our teams through the years as noted in the extensive reference list provided and the support of the many industrial and corporate sponsors that we were privileged to be associated with and their developments that we studied, improved on, and applied.
Abstract: We have developed a hydrodynamically levitated centrifugal blood pump with a semi-open impeller for long-term circulatory assist. The pump uses hydrodynamic bearings to enhance durability and reliability without additional displacement-sensors or control circuits. However, a narrow bearing gap of the pump has a potential for hemolysis. The purpose of this study is to develop the hydrodynamically levitated centrifugal blood pump with a semi-open impeller, and to evaluate the effect of a bearing gap on hemolytic property. The impeller levitates using a spiral-groove type thrust bearing, and a herringbone-groove type radial bearing. The pump design was improved by adopting a step…type thrust bearing and optimizing the pull-up magnetic force. The pump performance was evaluated by a levitation performance test, a hemolysis test and an animal experiment. In these tests, the bearing gap increased from 1 to 63 μm. In addition, the normalized index of hemolysis (NIH) improved from 0.415 to 0.005 g/100 l, corresponding to the expansion of the bearing gap. In the animal experiment for 24 h, the plasma-free hemoglobin remained within normal ranges (<4.0 mg/dl). We confirmed that the hemolytic property of the pump was improved to the acceptable level by expanding the bearing gap greater than 60 μm.
Abstract: The Gyro centrifugal pump developed as a totally implantable artificial heart was designed with a free impeller, in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet) in order to prevent thrombus formation and/or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller lifted off the bottom of the pump housing within a certain range…of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proved by observation of the impeller behavior using a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet–magnet coupling distance and rotational speed of the impeller. In order to keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving condition of right and left pump, the magnet–magnet coupling distance was altered by a spacer which was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist), by just changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller rev. It is called “the dynamic RPM suspension”.
Abstract: Extracorporeal life support (ECLS) and mechanical circulatory support (MCS) have become indispensable treatment tools for pediatric patients with congenital heart defects undergoing peri-operative or end-stage heart and/or lung failure. ECLS and MCS can serve as bridges to recovery, transplantation (heart or lung), destination therapy, or “bridge to bridge” long-term MCS. Dependent on patient condition, venoarterial ECMO (V-A ECMO) for heart and lung support, venovenous ECMO (V-V ECMO) for respiratory support, and MCS for uni- and biventricular support can be selected properly. Considering small patient body size, the access sites and cannulation should be selected carefully to obtain adequate blood flow,…minimum injury, and easy management. The applying equipment, including tubing, cannulae, oxygenator and blood pump, need to be selected optimally in order to enable rapid setup and priming, successful cannulation and early support, and to reduce the risk of device-related morbidity and mortality. The aim of this review manuscript was to discuss briefly the current devices for pediatric ECLS and MCS available in US.
Abstract: A magnetic fluid (MF) seal has excellent durability. The performance of an MF seal, however, has been reported to decrease in liquids (several days). We have developed an MF seal that has a shield mechanism. The seal was perfect for 275 days in water. To investigate the effect of a shield, behaviors of MFs in a seal in water were studied both experimentally and computationally. (a) Two kinds of MF seals, one with a shield and one without a shield, were installed in a centrifugal pump. Behaviors of MFs in the seals in water were observed with a video camera…and high-speed microscope. In the seal without a shield, the surface of the water in the seal waved and the turbulent flow affected behaviors of the MFs. In contrast, MFs rotated stably in the seal with a shield in water even at high rotational speeds. (b) Computational fluid dynamics analysis revealed that a stationary secondary flow pattern in the seal and small velocity difference between magnetic fluid and water at the interface. These MF behaviors prolonged the life of an MF seal in water.
Keywords: Magnetic fluid, magnetic fluid seal, rotary blood pump, computational fluid dynamics
Abstract: Previously, I* parameter has been proposed to diagnose noninvasively the progressive degree of atherosclerosis which is considered to concern the discrimination of the progressive degree of visco elasticity of blood vessel wall. However, the detailed physical meaning of this parameter has not yet been clarified. In this paper, the theoretical analysis and experiments were conducted and the detailed physical meaning of I* parameter was clarified. The following results were obtained. I* parameter was found to well correlate with the progressive degree of visco elasticity of blood vessel wall characterized by the Ith * parameter derived based…on the analysis of visco elasticity in this paper. That is, I* was found to have the physical meaning of representing the progressive degree of visco elasticity of blood vessel wall. On the basis of this results, using clinical data, two dimensional representation between the progressive degree of visco elasticity of blood vessel wall by I* and the decrease in the rigidity of blood vessel wall by PWV was found to be useful to conduct much more detailed diagnosis of atherosclerosis.
Abstract: BACKGROUND: Access to peripheral veins is necessary for sample collection, transfusion and infusion of fluids or medications. The peripheral intravenous catheterization (PIVC) procedure is the introduction of a short catheter into a peripheral vein and can be problematic, leading to multiple failed attempts. PURPOSE: To analyze scientific literature regarding difficulties in establishing peripheral intravenous access and the currently utilized improvement strategies. METHOD: A literature search was undertaken and secondary references were retrieved from the papers obtained from the initial search. A total of 128 papers published from 1975 to 2011 were reviewed. RESULTS: The first attempt of…PIVC fails in 12–26% of adults and 24–54% of children. Factors associated with PIVC success include: (1) patient's characteristics such as age, gender, race, weight/BMI, co-existing medical conditions and skin/vein characteristics, (2) procedure related factors such as the insertion site and catheter caliber, and (3) the operator's expertise. Strategies to improve PIVC success include: (1) bedside techniques such as venodilation, vascular visualization and vein entry indication, (2) pain management and (3) engagement of expert health care providers. CONCLUSION: Bedside techniques have shown more improvement in PIVC success rates as opposed to pain management. Expert health care providers have shown higher performance levels with regard to the difficult cases of PIVC.
Abstract: I dedicate this paper to the late Prof. Yukihiko Nosé with all my heart. In 2001, under the direction of Prof. Nosé and Prof. Brunicardi at Baylor College of Medicine, we published a review article entitled “Artificial endocrine pancreas” in JACS. Subsequently, we reported that perioperative tight glycemic control (TGC) using an artificial pancreas (AP) with a closed-loop system could stably maintain near-normoglycemia in total-pancreatectomized dogs. Based on this experimental study in Houston, since 2006, we have introduced perioperative TGC using an AP into clinical use in Kochi. As of 2011, this novel TGC method has provided safe and stable…blood glucose levels in more than 400 surgical patients. In this paper, we report new clinical findings regarding perioperative TGC using an AP in total-pancreatectomized patients. TGC using an AP enables us to achieve stable glycemic control not only without hypoglycemia and hyperglycemia but also with less variation in blood glucose concentration from the target blood glucose range, even in patients with the most serious form of diabetes, so-called “brittle diabetes”, undergoing total pancreatectomy. To the best of our knowledge, this is the first clinical report of TGC using an AP in patients undergoing total pancreatic resection.
Abstract: The study of magnetic effects on biological system was started in response to Dr. Nose's wish for the development of extracorporeal immunomodulation therapy. In the extracorporeal immunomodulation system, monocytes or lymphocytes in blood are stimulated by the interactions with immune-active materials. The concept of magnetic field application was introduced in order to enhance the cell activation. Therefore, the applicability of magnetic field was studied. This paper was concerned with in vitro study of magnetic field effects on macrophage/monocytes and lymphocytes activations. Time-varying magnetic field could enhance macrophages/monocytes and lymphocytes activations.
Keywords: Extracorporeal immunomodulations, magnetic field, macrophages/monocyte, lymphocytes, augmentation of cell activation
Abstract: Bioengineers have contributed to biocompatibility research. Many materials have been designed, synthesized and characterized by use of various analytical instruments. The blood compatibility of materials has been studied by focusing on the blood–material interfacial reactions. Although much information has been accumulated regarding such local reactions, understanding of biocompatibility is still limited. A more global approach to study is needed. A new approach to understanding biocompatibility is proposed and discussed. Three points are stressed: interaction within body's defense system and its effect on blood–material reactions; induction of a systemic reaction by a local reaction, which then affects the blood–material interaction; the…time sequence of such interactions between local and systemic reactions. To establish a logical approach to study biocompatibility is most important at this moment for the future progress in biocompatibility research.
Keywords: Biocompatibility, blood–material interactions, local reactions, systemic reactions, body defense system
Abstract: The stem cell niche is crucial to the control of stem cell fate determination in vitro as well as in vivo, and an understanding of these niches is required for the progression of stem cell and tissue engineering. The goal of our study was to commit human mesenchymal stem cells (hMSCs) to the epithelial lineage. To do this, we cultured bone marrow-derived mesenchymal stem cells (MSCs) on plates coated with type I collagen gel with or without 10 μM all-trans retinoic acid (ATRA). We found depth-dependent differentiation of hMSCs to the epithelial lineage, with the thick collagen gel (1900…μm) generating more than 80% cytokeratin-18 (CK-18)-positive cells, whereas the thin collagen gel (100 μm) generated significantly fewer CK-18-positive cells. In addition, we found that supplementation of 10 μM ATRA enhanced CK-18 expression and induced cluster-formation in cells grown on the thick collagen gel. The effect of gel depth on hMSC differentiation appears to be caused by partial cytoskeletal disruption. These results suggest that ATRA and a collagen extracellular matrix may have a synergistic effect on differentiation of human mesenchymal stem cells to epithelial lineage.
Keywords: Mesenchymal stem cell, type I collagen gel, epithelial differentiation, all-trans retinoic acid, cytokeratin-18
Abstract: We developed a new transcutaneous communication system (TCS) that uses the human body as a conductive medium for monitoring and controlling artificial hearts and other artificial organs in the body. In this study, the physiological effect of data current discharged into the body during data transmission was evaluated by an animal experiment using a goat. The external and internal units of the new TCS each mainly consist of a data transmitter and a data receiver. The data transmitter has an amplitude shift keying (ASK) modulator (carrier frequencies: 4 and 10 MHz) and an electrode. The internal unit of…the TCS was fixed on the pericardium and the external unit was placed on the left ear, and each transmitter discharged an ASK-modulated current of 7 mA (RMS) into the conscious goat. The TCS was able to transmit data for 4 weeks under full duplex communication with a transmission rate of 115 kbps. On the 28th postoperative day, an electrocardiogram was measured during data transmission. Cardiac rhythm and waveform of the electrocardiogram were not changed before and during bidirectional data transmission. Also, no adverse effect on the heart was observed by autopsy.
Keywords: Artificial heart, monitoring, transcutaneous communication, intrabody communication