Field Of Medical Technology Research Articles

Experimental mechanical properties, nonlinear bending and instability analysis of 3D-printed auxetic tubular metastructures using multiscale finite element and Ritz methods

In the field of medical technology, specialized equipment utilizes tubular metastructures with a negative Poisson’s ratio in vascular stents to reduce the risk of embolism. The deliberate incorporation of auxetic structures into stent design offers several benefits over traditional stents. This study examines the nonlinear instability and bending responses of reentrant perfect and imperfect 3D-printed tubular metastructures. First, the governing equations for the auxetic tube with geometric imperfections under transverse and axial mechanical loads are derived using the von-Kármán nonlinear assumption and Timoshenko theory. Then, the equations are derived using the principle of virtual displacement. The physical characteristics of the reentrant structure are derived using Malek-Gibson relations, while tensile tests with digital image correlation (DIC) are used to determine the physical properties of polylactic acid (PLA). Scanning electron microscopy (SEM) images help investigate variations in modulus of elasticity and ultimate tensile strength in dogbone specimens, and the Ritz method with Chebyshev polynomials is employed to discretize the nonlinear equations. Second, two numerical algorithms are used to analyze the static behavior of the metatube within the nonlinear framework. The validation study is conducted for the auxetic tube and the representative volume element (RVE) of the unit cell based on the literature and finite element software Abaqus. Following the validation of the mathematical model, an extensive investigation is conducted to assess how differing parameters impact the mechanical bending and nonlinear instability analysis of the reentrant tube.

Potential of magnetic shape memory alloys in medical applications

Abstract Systems based on smart materials have become an increasing research focus in recent years, as their properties provide opportunity for higher functional integration, improved energy efficiency and completely new functionalities. Magnetic shape memory alloys (MSM) provide a promising option here. However, they have received limited attention in the field of medical engineering. This paper therefore aims to provide an introduction into the (magneto-mechanical) properties of MSM and to give an overview of existing applicationsoriented research, both in general and in medical engineering. In the reviewed literature, NiMnGa has been used in several prototypes of micro pumps for intracranial drug delivery and lab-on-a-chip systems. FePd, another MSM alloy, has aroused interest in research into temporary implants.

MHD double diffusive convective squeezing ternary nanofluid flow between parallel plates with activation energy and viscous dissipation

PurposeThis study aims to present the consequences of activation energy and the chemical reactions on the unsteady MHD squeezing flow of an incompressible ternary hybrid nanofluid (THN) comprising magnetite (FE3O4), multiwalled carbon nano-tubes (MWCNT) and copper (Cu) along with water (H2O) as the base fluid. This investigation is performed within the framework of two moving parallel plates under the influence of magnetic field and viscous dissipation.Design/methodology/approachDue to the complementary benefits of nanoparticles, THN is used to augment the heat transmit fluid’s efficacy. The flow situation is expressed as a system of dimensionless, nonlinear partial differential equations, which are reduced to a set of nonlinear ordinary differential equations (ODEs) by suitable similarity substitutions. These transformed ODEs are then solved through a semianalytical technique called differential transform method (DTM). The effects of several changing physical parameters on the flow, temperature, concentration and the substantial measures of interest have been deliberated through graphs. This study verifies the reliability of the results by performing a comparison analysis with prior researches.FindingsThe enhanced activation energy results in improved concentration distribution and declined Sherwood number. Enhancement in chemical reaction parameter causes disparities in concentration of the ternary nanofluid. When the Hartmann number is zero, value of skin friction is high, but Nusselt and Sherwood numbers values are small. Rising nanoparticles concentrations correspond to a boost in overall thermal conductivity, causing reduced temperature profile.Research limitations/implicationsDue to its firm and simple nature, its implications are in various fields like chemical industry and medical industry for designing practical problems into mathematical models and experimental analysis.Practical implicationsDeployment of the squeezed flow of ternary nanofluid with activation energy has significant consideration in nuclear reactors, vehicles, manufacturing facilities and engineering environments.Social implicationsThis study would be contributing significantly in the field of medical technology for treating cancer through hyperthermia treatment, and in industrial processes like water desalination and purification.Originality/valueIn this problem, a semianalytical approach called DTM is adopted to explore the consequences of activation energy and chemical reactions on the squeezing flow of ternary nanofluid.

Mathematical model and device for non-invasive diagnostics of fractional blood saturation level

Mathematical models describing the propagation of monochromatic radiation in biological tissues are considered. It is shown that existing models for assessing the level of blood oxygen saturation in transmitted light do not adequately describe the processes of interaction of optical radiation with biological tissue, do not take into account the absorption capacity of those blood fractions that do not participate in the transportation of oxygen, and, therefore, the obtained results are characterized by low accuracy. A mathematical model for assessing the level of fractional blood saturation by the photometric method in transmitted light using four sources of optical radiation with central wavelengths of 660, 805, 880 and 940 nm is developed. The principle of selection of spectral characteristics of artificial radiation sources is described. The structural and functional diagram of the device for assessing the level of fractional blood saturation is presented, and the principles of its operation are outlined. Using the prototype of the proposed device and an existing pulse oximeter, the levels of fractional blood saturation of 30 subjects were experimentally estimated. The results are presented showing a decrease in the relative error by 0.71 % compared to the certified device, which proves the effectiveness of the proposed prototype device. The obtained results relate to the field of medical technology and will be useful in designing devices for non-invasive diagnostics of physiological health indicators.

Evaluation of the level expression of the Russian clone of PD-L1 antibodies and comparison with validated clones from other manufacturers on stomach cancer material

The study of immunotherapeutic markers is one of the most popular and promising areas in oncology. One of the most studied targets of immunotherapy is the ligand of the programmed cell death protein 1 (PD-L1). All diagnostic kits for determining PD-L1 expression in tumors are of foreign origin. To ensure the technological sovereignty of the Russian Federation in the field of medical technologies, it is necessary to conduct research with a domestic clone of PD-L1 antibodies and compare the results with already validated analogues. The aim of the work was to evaluate the expression of a domestic clone of antibodies to PD-L1 (PBM-1A4), determine its relationship with the clinical and morphological parameters of gastric cancer and compare the expression of various PD-L1 clones in gastric cancer (SP142, SP263, 22C3 and PBM-1A4). The study was performed on samples of gastric cancer surgical material from 131 patients who had not received chemotherapy, radiation or immunotherapy before surgery. Results: PD-L1 expression detected by the PBM-1A4 antibody clone is present in 46.2% of gastric cancer samples. Among PD-L1(PBM-1A4)-positive tumors, neoplasms of the second macroscopic type according to R. Bormann and tubular adenocarcinomas significantly predominate. The SP142 clone shows the greatest consistency with PBM 1A4 expression (significant consistency, Cohen's kappa is 0.67335). Conclusion: This antibody clone undoubtedly represents an extremely promising development by Russian scientists, which makes it possible to make the molecular diagnosis of malignant neoplasms more accessible to Russian patients.

Printing study and design guideline for small hollow structures in medical technology

AbstractIn recent years, interest in additive manufacturing has increased. To overcome challenges such as the correct use of the technology, guidelines are needed to help the user in the fabrication process. However, such guidance is not currently available for all applications. This paper dives into design methods in AM and their transfer to an application example in the field of medical technology. The aim of this paper is to analyse the transferability of a design method for vessel models to small vessel models. To this end, an initial printing study is carried out on simplified hollow structures.

Microstructure and radiation shielding properties of lead-fiber reinforced high-performance concrete

The increasing application of nuclear technology in medical fields has amplified the demand for radiation shielding materials. Traditional large-volume concrete cannot simultaneously exhibit excellent neutron and gamma-ray shielding capabilities while ensuring superior mechanical properties. This study tailored a novel lead fiber-reinforced high-performance concrete (LFRHPC) with lead fibers and magnetite aggregates, focusing on radiation attenuation. The effect of lead fibers on the mechanical performance, microstructure and radiation attenuation characteristics for LFRHPC was comprehensively evaluated. The results indicate a significant improvement in the mechanical performance of LFRHPC compared to traditional radiation shielding concrete (RSC), due to the scientific skeleton design. Additionally, the pore structure in LFRHPC is refined by incorporating lead fibers. Moreover, the interfacial transition zone (ITZ) between the cementitious matrix and magnetite is improved because of the very low water-to-binder ratio. To assess the radiation attenuation ability of LFRHPC, both direct measurements and simulation models were utilized. The data reveals that the porosity of LFRHPC plays a crucial role in its shielding effectiveness against neutron and gamma radiation. Furthermore, the addition of lead fibers considerably boosts its neutron and gamma-ray shielding attenuation capabilities. In summation, LFRHPC combines excellent mechanical properties and radiation shielding capabilities, making it suitable for construction applications in medical settings.

Method of determination of integral and differential nonlinearities of ADC by three histograms during tests of diagnostic channels in complex magnetotherapy

One of the most important components of modern electronic systems in the fields of medical technology, automotive, 5G communications, etc. are microchips containing analog-to-digital converters (ADCs) on a single chip. Aging effects, environment and mechanical vibrations have a significant impact on the operation of electronic systems, so microcircuits need to be periodically verified, calibrated and even replaced. For this reason, in order to control metrological and technical characteristics of hardware and software of the "Multimag-M" complex, which contains diagnostic channels for measuring pulse wave, respiration process, blood pressure and blood oxygen saturation (saturation), it was proposed to introduce an automated block of control, testing and self-calibration into the structure of the chronomagnetotherapy complex [1]. Application of BIST (Build-in Self Test) - built-in means of self-testing is a promising approach to solving problems of reliability improvement of modern microcircuits [2]. Most of the known BIST methods of ADCs require on-chip highly linear test signal generator (TS) [3-4], which is the most complex block. The ability to test ADCs with a large number of digits is limited by the linearity of the TS generator and as the resolution of ADCs increases, it becomes a difficult task to provide linear TS generation on-chip. The aim of the work is to develop a method for determining the integral and differential nonlinearities of ADC independent of the linearity of the test signal. A method for determining the integral and differential nonlinearities of the ADC, taking into account the nonlinear component of the TS, is proposed. This is achieved by sequentially feeding to the input of the tested ADC a periodic TS of triangular shape, a level-shifted down TS and a level-shifted up TS. The first histogram of ADC codes distribution at absence of TS offset, and also the second and the third histograms at TS downward and upward shifting. Using the three linked histograms, the contribution of the nonlinear component of the TS to the integral nonlinearity for each ADC code is determined. Given the nonlinear component of the TS, the integral nonlinearity for each ADC code is further determined, and then the differential nonlinearity of the ADC is determined from the integral nonlinearity. In addition, the method determines the displacement voltages of the TS, which reduces the requirements for the accuracy of the displacement signal reference. The practical value of the research result lies in the application of the method reducing requirements to TS linearity at self-diagnostics and self-calibration of microcircuits containing ADCs will allow to reduce the complexity of crystal design.

The influence of steam sterilization on the deflection of 3D printing shapes

The impact of testing loads and deflection of samples made of polymeric materials used in the field of medical engineering after the steam sterilization process were investigated. The research was carried out on samples with standard geometry, according to PN-EN ISO 179-1, which were produced in two different printing configurations relative to the coordinate system of 3D printers using the extrusion additive process. Polymers used are polyether ether ketone (PEEK), MED610, polylactide acid and photocurable resin. The results regarding strength properties were analysed based on measurements of the deflection arrow during straight bending. The photocurable resin showed the smallest deformation, polylactic acid the highest. It is worth noting, each material had a different dependencies during the load test. From results it is concluded, that print orientation, material type and sterilization have significant impact on strength and deformation of polymers.

공학계열 전공역량 진단도구의 타당화 연구 : 의학공학계열 사례를 중심으로

공학계열 전공역량 진단도구의 타당화 연구 : 의학공학계열 사례를 중심으로

Technology in anesthesiology: friend or foe?

The field of medical technology has undergone significant advancements over the years, from the use of ancient scalpels, forceps, and sutures to complex devices like intraoperative MRI suites, artificial intelligence-enabled monitors, and robotic surgical systems. These advancements have had a profound impact on the way we diagnose, treat, and prevent diseases, and have significantly improved the quality of life for millions of people around the world. As we move forward, it is important to reflect on the direction of medical technology and consider the potential risks and benefits of new advancements. We must also ensure that these technologies are accessible to all and that they are used ethically and responsibly. There is still much to be discovered and developed in the field of medical technology, and it is up to us to ensure that we are moving in a positive direction that benefits everyone.

医工领域研究生教育国际化新思维：来自全英文课程建设实践的思考

医工领域研究生教育国际化新思维：来自全英文课程建设实践的思考

Analog Front-End Pre-Amplifiers for Portable Capacitive ECG Monitoring Applications Analysis

In today's field of medical technology, the development of Electrocardiogram (ECG) monitoring systems is increasingly receiving attention. ECG, as a crucial tool for assessing cardiac function and heart health, plays an irreplaceable role in clinical diagnosis, health monitoring, and disease prevention. However, ECG signals are inherently low in amplitude and susceptible to interference, making the advancement of ECG electrode technology and Analog Front End (AFE) technology essential for achieving accurate and reliable monitoring. This research underscores the pivotal role of ECG electrode technology and the significance of the Analog Front End (AFE) in enabling efficient wireless ECG monitoring systems. With ECG signals being inherently low amplitude and prone to interference, the technology and choice of electrodes are crucial. This study dives deep into the evolution of ECG electrode technology, reviewing the pros and cons of wet, dry, and capacitive electrodes. The primary focus of the paper revolves around the IA-based pre-amplifier design, detailing its challenges and offering innovative solutions. Novel architectures utilizing capacitors, MOSCAPs, and CMRR improvement techniques are presented. The paper concludes by emphasizing the importance of accurate gain configuration, noise reduction, layout efficiency, and adherence to relevant standards.

Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas

Regenerative medicine solutions for type 1 diabetes are a rapidly developing field of medical technology. So far, these solutions have been principally cell-based treatments and, at present, in Europe, are regulated under the European Union regulations for Advanced Therapy Medicinal Products (ATMPs). But now, new, emerging technology combining cellular therapy with medical devices is under development. The potential of this novel hybrid model to create a bioartificial pancreas is tantalising. However, incorporating medical devices creates a further layer of complexity to an already challenging product development process. Moreover, it raises important questions about how bioartificial organs should be regulated. This article seeks to expose the complexity of the legal and regulatory landscape relating to such products, focusing on the laws of the European Union and, where appropriate, bringing in examples from other jurisdictions. We set out the role of the European Medicines Agency (EMA) and review the classification of existing ATMPs and those proposed for type 1 diabetes to highlight the potential consequences and effects of nomenclature and classifications. We argue that emerging hybrid regenerative medicine solutions at the intersection of cellular and medical device therapies, in which medical devices are integral to and facilitate the cell therapy mechanism of action, are not satisfactorily accounted for in the existing legal paradigm regulating regenerative medical therapies. We suggest that these functional hybrid products, currently in their infancy, may yet have far-reaching implications for the interface of law, regulation and technology. For example, they are likely to challenge the conventional discourse related to a market in (bioartificial) organs. We recommend that the EMA, national competent authorities for medical devices, national transplantation authorities and those responsible for overseeing translational clinical research respond to this by developing the existing regulatory framework in such a way that captures the essence of these hybrid products as a single entity. Issuing guidance on updated regulations to researchers engaged in this emerging technology will be key to the success of its translation into human therapies.

Biomechanical characterization of the passive porcine stomach

The complex mechanics of the gastric wall facilitates the main digestive tasks of the stomach. However, the interplay between the mechanical properties of the stomach, its microstructure, and its vital functions is not yet fully understood. Importantly, the pig animal model is widely used in biomedical research for preliminary or ethically prohibited studies of the human digestion system. Therefore, this study aims to thoroughly characterize the mechanical behavior and microstructure of the porcine stomach. For this purpose, multiple quasi-static mechanical tests were carried out with three different loading modes, i.e., planar biaxial extension, radial compression, and simple shear. Stress-relaxation tests complemented the quasi-static experiments to evaluate the deformation and strain-dependent viscoelastic properties. Each experiment was conducted on specimens of the complete stomach wall and two separate layers, mucosa and muscularis, from each of the three gastric regions, i.e., fundus, body, and antrum. The significant preconditioning effects and the considerable regional and layer-specific differences in the tissue response were analyzed. Furthermore, the mechanical experiments were complemented with histology to examine the influence of the microstructural composition on the macrostructural mechanical response and vice versa. Importantly, the shear tests showed lower stresses in the complete wall compared to the single layers which the loose network of submucosal collagen might explain. Also, the stratum arrangement of the muscularis might explain mechanical anisotropy during tensile tests. This study shows that gastric tissue is characterized by a highly heterogeneous microstructure with regional variations in layer composition reflecting not only functional differences but also diverse mechanical behavior. Statement of SignificanceUnfortunately, only few experimental data on gastric tissue are available for an adequate material parameter and model estimation. The present study therefore combines layer- and region-specific stomach wall mechanics obtained under multiple loading conditions with histological insights into the heterogeneous microstructure. On the one hand, the extensive data sets of this study expand our understanding of the interplay between gastric mechanics, motility and functionality, which could help to identify and treat associated pathologies. On the other hand, such data sets are of high relevance for the constitutive modeling of stomach tissue, and its application in the field of medical engineering, e.g., in the development of surgical staplers and the improvement of bariatric surgical interventions.

Unveiling the Absence of a Local Medical Device and Biomaterials Manufacturing Industry in Zimbabwe: A Literature Review

Medical devices and biomaterials play pivotal roles in the provision of healthcare and advancements in medicine. Zimbabwe, a low-income country in Southern Africa, faces resource constraints while combating both communicable and non-communicable diseases, which significantly contribute to the nation’s disease burden. The lack of a medical device and biomaterials manufacturing industry in Zimbabwe is a critical issue with profound implications for the country’s healthcare system and economic development. This literature review comprehensively examines the current state of medical device and biomaterials manufacturing in Zimbabwe, focusing on historical perspectives, health infrastructure, challenges, and the importance of establishing a local manufacturing industry. By analyzing barriers and constraints hindering industry growth and conducting international comparisons, successful strategies implemented by other countries are explored. Additionally, the review investigates ongoing research and development efforts, including collaborations between academic institutions and industries in the medical technology field. Furthermore, the impact of existing government policies and initiatives on the growth of the medical device and biomaterials manufacturing sector is evaluated. The review emphasizes the significance of a local manufacturing industry, as it enhances healthcare accessibility, reduces dependency on imports, and unlocks potential economic benefits. By identifying potential opportunities and providing recommendations for policymakers, investors, and stakeholders, this study advocates concerted efforts to address challenges and capitalize on growth opportunities in this critical sector. The call to action seeks to foster collaboration among relevant stakeholders to support the development of a thriving medical device and biomaterials manufacturing industry in Zimbabwe, ultimately contributing to improved healthcare outcomes and overall national progress.

Biocompatibility and antibacterial activity of MgO/Ca3(PO4)2 composite ceramic scaffold based on vat photopolymerization technology

Recent advancements in medical technology and increased interdisciplinary research have facilitated the development of the field of medical engineering. Specifically, in bone repair, researchers and potential users have placed greater demands on orthopedic implants regarding their biocompatibility, degradation rates, antibacterial properties, and other aspects. In response, our team developed composite ceramic samples using degradable materials calcium phosphate and magnesium oxide through the vat photopolymerization (VP) technique. The calcium phosphate content in each sample was, respectively, 80 %, 60 %, 40 %, and 20 %. To explore the relationship between the biocompatibility, antibacterial activity, and MgO content of the samples, we cultured them with osteoblasts (MC3T3-E1), Escherichia coli (a gram-negative bacterium), and Staphylococcus aureus (a gram-positive bacterium). Our results demonstrate that as the MgO content of the sample increases, its biocompatibility improves but its antibacterial activity decreases. Regarding the composite material samples, the 20 % calcium phosphate content group exhibited the best biocompatibility. However, after 0.5 h of co-cultivation, the antibacterial rates of all groups except the 20 % calcium phosphate content group co-cultured with S. aureus exceed 80 %. Furthermore, after 3 h, the antibacterial rates against E. coli exceed 95 % in all groups. This is because higher levels of MgO correspond to lower pH values and Mg2+ concentrations in the cell and bacterial culture solutions, which ultimately promote cell and bacterial proliferation. This elevates the biocompatibility of the samples, albeit at the expense of their antimicrobial efficacy. Thus, modulating the MgO content in the composite ceramic samples provides a strategy to develop gradient composite scaffolds for better control of their biocompatibility and antibacterial performance during different stages of bone regeneration.

Funding of research & innovation in the field of medical technologies and biomedical engineering over the different European framework programmes.

To demonstrate the role of the European Framework Programmes for Research & Innovation in supporting the field of Medical Technologies and Biomedical Engineering and to show which types of medical technologies and which funding instruments are the preferred ones. Based on data available in the European Commission data warehouse for the past two Framework Programmes, funded projects addressing a Medical Technology were identified. This enabled to categorize the projects according to the intended use and to classify into different types. Moreover, the main instruments in the Framework Programme acting as funding sources were explored. The increase in R&I support led to 1961 projects and a total financing of € 3.2 bllion under the last Framework Programme. The categorization showed a balanced funding in terms of intended use, the detailed classification revealed that in-vitro-diagnostics and imaging equipment prevail in the diagnostic category, tissue-engineering products, implants and robotics in the therapeutic domain and ICT or software-based technologies in the miscellaneous category. As to funding sources, the classical health-oriented collaborative research scheme was on top, followed by instruments like the European Research Council, the Future and Emerging Technologies activities and the European Innovation Council, and completed by the Public-Private Partnerships. The European Framework Programmes are key on the global landscape for financing Research & Innovation of Medical Technology and the breadth of supported technologies is equally reflected by the different funding instruments involved.

Legal and Regulatory Challenges for Emerging Regenerative Medicine Solutions for Diabetes.

Regenerative medicine solutions for type 1 diabetes are a rapidly developing field of medical technology. To date, these solutions have been principally cell-based treatments and at present, in Europe, these therapies are regulated under European Union regulations for advanced therapy medicinal products. But now, new emerging technology combining cellular therapy with medical devices is under development. The potential of this novel hybrid model to create a bioartificial pancreas to treat type 1 diabetes is tantalizing. However, incorporating medical devices creates a further layer of regulatory complexity. This article seeks to expose the complexity of this legal and regulatory landscape and demonstrate how evolving technology could challenge the entire existing legal paradigm. We start by summarizing the status of the only established cell-based therapy-transplantation. We set out the regulation of cellular therapies, their classification, and the role of statutory bodies. We examine the bottleneck of therapies moving from bench to bedside, and we consider the additional challenges of products, which use a combination of cells and medical devices. Finally, we argue that for the potential of this rapidly growing area of technology to be realized a seismic shift in how we regulate frontier cellular therapies will be required.

Trends in Development of Applied Social and Communication Technol-Ogies in Medical Field: Mobile Applications and Programmes in Healthcare

The purpose of the article is to conduct a comprehensive analysis of the trends in the development of applied social and communication technologies in the medical sector, in particular, to trace dynamics of growth in the number of mobile applications and programmes in healthcare sector. The research methodology is formed by general scientific and special methods of studying the problem, the use of which allowed the authors to achieve the goal. The combination of the methods used helped to clarify the logical sequence and trends in the development of applied social and communication technologies in the modern information space of society. The basic principle was the principle of historicism, which implies consideration of any phenomenon in its self-development under the influence of various factors. The historical and systemic method is aimed to analyse society as a whole and the transformations within it caused by changes in the information and communication space. Quantitative methods are used to process the results of analytical research and to diagnose the phenomena under study. The scientific novelty of the work is to expand the understanding of the trends in the development of applied social and communication technologies in the medical field. The authors' study analysed modern domestic medical information systems, the possibilities of their interaction with eHealth, and identified priority technological areas in the medical sector, such as virtual reality, 3D printing, robotics, artificial intelligence, augmented reality, a global network of medical facilities, wearable devices, smart technologies, and precision (personalised) medicine. The authors state that in recent years, attention has increased to applications, mobile sensors and digital media in order to get help in maintaining one's health. Conclusions. The study has proved the positive dynamics in the growth of mobile applications and programmes in healthcare sector and determined the trends of the further development of information technologies in the medical sector. Key words: healthcare system, information technologies, medical information systems, mobile applications in healthcare.