Next-generation Medical Devices Research Articles

형상기억합금(SMA) 스티어링 카테터의 반응속도 향상을 위한 펠티어 열전소자의 열전기적 특성 평가

Actuation using a shape memory alloy (SMA) is considered to be an important technology that will play a leading role in market for next-generation medical devices because an SMA actuator can accurately imitate skillful and delicate hand movements. However, SMA actuators have not been successfully used because of problems in control design caused by the nonlinear hysteresis effect of SMA, which leads to inaccuracies in control systems. In order to overcome the effect, the authors invented a SMA actuator, which could actively and rapidly cool down and heat up, by combining a SMA catheter and a TE module using the Peltier effect. In order to evaluate the TE characteristics of our TE module system, the changes in the temperature with 1) incremental increases in a continuous electric current and 2) the appearance of a discontinuous constant or reverse current are discussed in this paper.

Assessing the antimicrobial activity of zinc oxide thin films using disk diffusion and biofilm reactor

The electronic and chemical properties of semiconductor materials may be useful in preventing growth of microorganisms. In this article, in vitro methods for assessing microbial growth on semiconductor materials will be presented. The structural and biological properties of silicon wafers coated with zinc oxide thin films were evaluated using atomic force microscopy, X-ray photoelectron spectroscopy, and MTT viability assay. The antimicrobial properties of zinc oxide thin films were established using disk diffusion and CDC Biofilm Reactor studies. Our results suggest that zinc oxide and other semiconductor materials may play a leading role in providing antimicrobial functionality to the next-generation medical devices.

Fibril Microstructure Affects Strain Transmission Within Collagen Extracellular Matrices

The next generation of medical devices and engineered tissues will require development of scaffolds that mimic the structural and functional properties of the extracellular matrix (ECM) component of tissues. Unfortunately, little is known regarding how ECM microstructure participates in the transmission of mechanical load information from a global (tissue or construct) level to a level local to the resident cells ultimately initiating relevant mechanotransduction pathways. In this study, the transmission of mechanical strains at various functional levels was determined for three-dimensional (3D) collagen ECMs that differed in fibril microstructure. Microstructural properties of collagen ECMs (e.g., fibril density, fibril length, and fibril diameter) were systematically varied by altering in vitro polymerization conditions. Multiscale images of the 3D ECM macro- and microstructure were acquired during uniaxial tensile loading. These images provided the basis for quantification and correlation of strains at global and local levels. Results showed that collagen fibril microstructure was a critical determinant of the 3D global and local strain behaviors. Specifically, an increase in collagen fibril density reduced transverse strains in both width and thickness directions at both global and local levels. Similarly, collagen ECMs characterized by increased fibril length and decreased fibril diameter exhibited increased strain in width and thickness directions in response to loading. While extensional strains measured globally were equivalent to applied strains, extensional strains measured locally consistently underpredicted applied strain levels. These studies demonstrate that regulation of collagen fibril microstructure provides a means to control the 3D strain response and strain transfer properties of collagen-based ECMs.

Biocompatibility: Meeting a Key Functional Requirement of Next-Generation Medical Devices

The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medical device. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medical devices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a "do no harm" mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing "good," that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medical devices will facilitate the use of existing and new biomaterials for new medical device designs.

Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: a survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems

A series of guidelines for development and assessment of next-generation medical devices has been drafted under an interagency collaborative project by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. The working group for assessment guidelines of next-generation artificial hearts reviewed the trend in the prevalence of heart failure and examined the potential usefulness of such devices in Japan and in other countries as a fundamental part of the process of establishing appropriate guidelines. At present, more than 23 million people suffer from heart failure in developed countries, including Japan. Although Japan currently has the lowest mortality from heart failure among those countries, the number of patients is gradually increasing as our lifestyle becomes more Westernized; the associated medical expenses are rapidly growing. The number of heart transplantations, however, is limited due to the overwhelming shortage of donor hearts, not only in Japan but worldwide. Meanwhile, clinical studies and surveys have revealed that the major causes of death in patients undergoing long-term use of ventricular assist devices (VADs) were infection, thrombosis, and mechanical failure, all of which are typical of VADs. It is therefore of urgent and universal necessity to develop next-generation artificial hearts that have excellent durability to provide at least 2 years of event-free operation with a superior quality of life and that can be used for destination therapy to save patients with irreversible heart failure. It is also very important to ensure that an environment that facilitates the development, testing, and approval evaluation processes of next-generation artificial hearts be established as soon as possible.

Cellular and Molecular Responses of Smooth Muscle Cells to Surface Nanotopography

Recent studies have demonstrated that surface nano-topography affect cell responses and activities. However, the molecular mechanism of the nano-structures on cellular behavior is yet to be determined. To bridge this gap, the present study was aimed to investigate the cellular and molecular responses of smooth muscle cells (SMCs) to surface nano-topography in vitro using nano-porous alumina membranes with different sizes (200 nm- and 20 nm-pores). Cellular responses such as cell adhesion, morphology, and proliferation were assessed using scanning electron microscopy (SEM), hematoxylin and eosin (HE) staining, and cell counting. The molecular cell responses were also investigated using cDNA microarrays. Results from these studies showed an unchanged response in cell adhesion, an alteration in cell morphology, and an increase in cell proliferation for cells grown on 200 nm-pore surfaces than on 20 nm-pore surfaces. In addition, exposure of SMCs to larger nano-pores induced the expression of various genes involved in cell cycle, DNA replication, cell proliferation, and signaling transduction pathways. These findings demonstrated that cellular responses of SMCs are dependent on the underlying nano-topography, and thereby suggesting nano-dimensional surface is one of the most important considerations to design of the next generation of medical devices and tissue engineering scaffolds.

The use of functionally gradient materials in medicine

Functionally gradient materials are characterized by uniform changes in composition, crystallinity, and/or grain structure, which may provide unique biological, chemical, or mechanical functionalities in next-generation medical devices. In this article, the development of functionally gradient Zr−Nb alloys, hydroxyapatite coatings, and diamondlike carbon-metal coatings for medical applications is reviewed.

POLYMERS EXPLOITED FOR DRUG DELIVERY

POLYMERIC MATERIALS ARE PLAYing increasingly important roles in the development of novel medical devices and drug delivery systems. Polymer science and engineering have enabled the explosive growth in the medical device industry particularly in therapeutic-device combination products, noted Shrirang V Ranade, a senior research scientist at the medical device company Boston Scientific, in Natick, Mass. Ranade co-organized a symposium on the topic sponsored by the Division of Polymeric Materials: Science & Engineering at last month's national meeting of the American Chemical Society in San Diego. The other co-organizer was Signe E. Varner, director of ocular drug delivery for Doheny Retina Institute and Keck School of Medicine at the University of Southern California, Los Angeles. Biocompatibility is a key functional requirement of the next generation of medical devices and drug delivery systems, according to Michael N. Helmus, vice president for advanced biomaterials at Boston Scientific. Biocompatibili...

Demonstration and characterization of PZT thin-film sensors and actuators for meso- and micro-structures

Recent development of next-generation medical devices, such as endoscopes and hearing aids, call for PZT (lead zirconate titanate oxide) thin-film sensors and actuators with thickness in the range of 1–30 μm to enhance actuation strength and sensor sensitivity. Currently, sol–gel derived PZT films often have thickness less than 0.2 μm per coating. Moreover, thermal stresses in the films limit the crack-free area to less than 1 mm 2. This paper has four specific goals. The first goal is to demonstrate an improved sol–gel process using rapid thermal annealing and a diluted sealant coating. The resulting thickness can reach 2 μm in three coatings with a crack-free area as large as 5 mm×5 mm . The second goal is to characterize piezoelectric properties of the fabricated PZT films experimentally. The resulting piezoelectric constant d 33 is 120 pC/N and the dielectric constant ranges from 200 to 400. The third goal is to demonstrate the use of the PZT thin film as a calibrated sensor. The specimen is a silicon cantilever ( 30 mm×7.5 mm×0.4 mm ) with a PZT thin film ( 4 mm×4 mm×1 μm ). Moreover, a tiny shaker excites the cantilever at the fixed end, and a charge amplifier detects the charge accumulated in the PZT film. In the meantime, a laser vibrometer measures the deflection of the cantilever at three points along the PZT film, from which the strain is calculated using Euler–Bernoulli beam theory. Comparison of the strain and the charge amplifier voltage determines the calibration constant of the PZT thin-film sensor. The last goal is to demonstrate the use of the PZT thin film as a powerful actuator through active vibration control. In experiments, a tiny bulk PZT patch is first glued to the silicon cantilever. A function generator drives the bulk PZT simulating a source of disturbance exciting the silicon cantilever. In the meantime, a laser Doppler vibrometer (LDV) measures velocity of the cantilever tip. With a phase shifter as the controller, the LDV measurement is fed back to the PZT thin-film actuator to actively control the cantilever vibration. To evaluate the effectiveness of the active vibration control, a spectrum analyzer measures the frequency response functions (FRF) from the bulk PZT voltage to the LDV response. Experimental results show that the simple active vibration control scheme can reduce resonance amplitude of the first bending mode by 66%.