IKANKOGEI collaboration refers to collaborative activities in the medical-nursing-engineering-design field, which has expanded the scope of traditional medical-technical collaboration for contributing to medical device development. When commercializing specific medical needs, intellectual property knowledge plays an essential role in different specialized fields, and all individuals involved in the development process should obtain the minimum knowledge of intellectual property to protect. We examined the concept that visualization of the development process by designers promoted the efficiency of co-creation and facilitated collaboration between the medical-nursing-engineering-design fusion field smoothly. The features of our activities are not only to technically solve consumer needs with an engineering approach but also to visualize elements such as convenience, beauty, security with the power of artistic design. Based on the concept of "dialogue, empathy, and observation," we aim to develop innovative educational methods that foster intellectual property knowledge by linking the fields of medicine, nursing, engineering, and design.

Medical/healthcare innovation has been highly demanded in Japan, however, there have been not a few 'unsuccessful' cases so far. One of the biggest reasons for this situation is to focus on their own technology & solutions too much, and finally fail to create enough values for sustainable implementation. The objectives of this presentation is (1) to share the difficulties of collaborations in the interdisciplinary fields of medical-nursing-engineering-design (IKANKOGEI) to co-create the values, (2) discuss how we might well overcome it from the both educational & practical perspectives. Also, the possible options for effective collaboration in the 'New Normal (after covid-19)' setting will be discussed.

Medical professionals have national qualifications. Whether one is just getting one's national certification or a clinically highly experienced veteran, one would answer without hesitation that my speciality is nursing. IKANKOGEI education course is students with educational backgrounds in medicine, nursing, engineering, and the arts are trying to converge their ideas toward a goal through discussion together, not for graduate credit; however, my three graduate students participated in this course. One student entered the master's program directly after graduation without clinical experience. The next one entered the master's program immediately and, after getting a master's degree, worked more than three years in a clinical ward, then joined the doctoral program. And the last student who entered the master's program after more than 20 years of clinical experience after graduation participated in this course. I would like to give my personal opinion about this challenging course based on their situation.

Development of the medical device and the welfare equipment is based on the medical-engineering collaboration and industry-academia-government collaboration. The importance od research and development based on the needs from clinical sites and the need to develop human resources for corporate researchers have been proposed. Recently design thinking methods have been introduced into medical and welfare device development. In Oita University, aiming to integrate different industries beyond barriers of field difference, medical site tours, exchange meetings for exploration of medical equipment needs and direct discussions with medical staffs, medical business workshops, medical safety and the intellectual property educations for corporate researchers, and the website CENSNET aimed at improving the efficiency of medical needs seeds matching. In addition, we will also introduce the unique initiative of operating a manufacturing workshop within the medical school.

IKANKOGEI is an attempt to make effective use of design in projects to develop medical devices and services.In recent years, design thinking has been booming in Japanese society, and design has been attracting attention in the economic field. A narrow meaning of design is the color and shape of a product. The meaning of design in design thinking is to set a problem clearly and solve it beautifully. Design is a field that includes art. Art is the act of searching for beauty. Art also has the property of discovering and visualizing the problems of human society. Utilizing designs with these characteristics in the medical field will contribute to the improvement of the medical environment. In this presentation, I will introduce some examples of IKANKOGEI project.

Our department of (Management of Industry and technology) aims to nurture human resources who can facilitate the development of technological knowledge into a business. Extensive introduction of On-the-Job Education (OJE) exercise into the educational program fosters management ability as well as technical skills. By the collaboration with the graduate school of economics, a special course to take double major master degrees of engineering (ME) and business administration (MBA) for 3 school years.Through IKANKOGEI workshop, students learns the importance of interdisciplinary collaboration through practical experiences to explore medical needs and to visualize the development process.

Last year, in September 2020, the "Low Power Medical Telemetry Device Usage Regulations" established by the Japan Electronics and Information Technology Industries Association (JEITA) was revised for the first time in about 18 years, and AE-5201B was published. This Usage Regulations defines rules for the purpose of not causing problems in using Low Power Medical Telemetry Devices from multiple manufacturers at the same time in hospitals. The main purpose of this revision is to lower the order of using channels in the 3000 series, where interference with Telemeter / Telecontrol is a problem. Also, in order to disseminate the latest technical information and to make it consistent with the "Guide for Safe and Secure Use of Radio Waves in Medical Institutions" published by Electromagnetic Compatibility Conference Japan (EMCC) on April 4, 2016 in addition, a part was revised.

The management of the electromagnetic environment is very important for the safe operation of a wireless medical telemetry systems (WMTSs). For example, not only own frequency channel management but also invasion waves coming from other facilities or electromagnetic noise radiated from electrical devices such as LED lamps. The spectrum analyzer (SA) has been widely used in the investigation and evaluation of electromagnetic environments, including hospitals. In general, SA is an expensive, but frequency of usage is comparatively lower. Additionally, it is difficult to operate SA by medical staffs because of their skills. I propose two types of simple approach of electromagnetic environment measurement methods in hospitals; one is the simplified SA function that is often installed in WMTS receivers and the other is the SA formed by software-defined radio. In this study, I present summary of these approach and report evaluation results of measurement accuracy.

Medical institutions are rapidly introducing information and communication devices such as medical telemeters and electronic medical records that use radio waves, and their convenience is improving. On the other hand, Radio wave troubles such as radio waves not reaching have become apparent. This research group has developed a system that can automatically measure the radio wave environment and perform remote monitoring with the aim of providing technology that supports appropriate radio wave management in medical institutions.This time, the radio wave measurement system used for this monitoring was installed on the medical trolleys of the general wards of Shinshiro Municipal Hospital for about 4 weeks, and the radio wave intensity of the wireless LAN in each room was measured for a long period of time. The measurement data was sent to the database server and a demonstration experiment was conducted to remotely evaluate the radio wave environment.

The resolution and imaging depth show trade off relationships in both ultrasound and optical imaging. Optical resolution photoacoustic microscope (OR-PAM) shows better resolution than acoustical resolution photoacoustic microscope (AR-PAM) while the imaging depth of the OR-PAM is limited. We have developed an OR-PAM for cell imaging with the lateral resolution of 646 nm and the axial resolution of 18 micron with the ultrasound transducer of 75 MHz. Classical type scanning acoustic microscopy (SAM) shows C-mode imaging. Especially, SAM with very high frequency ultrasound (approximately 1 GHz) uses burst wave thus B-mode image is not available. We have been developing quantitative SAM for both C-mode and B-mode imaging. A single ultrasonic pulse with the central frequency of 350 MHz is transmitted to obtain C-mode image with the distribution of speed of sound and B-mode image with acoustic impedance. In this symposium, the comparison between quantitative SAM and OR-PAM is introduced.

Photoacoustic (PA) imaging is based on optical excitation and ultrasound detection through a thermoelastic process. The PA technique is characterized by the scalability of its spatial resolution and depth penetration across both the optical and ultrasonic dimensions. Depending on the system configuration and the imaging depth, the resolution can range from nanometer to millimeter. PA imaging, a sensitive modality for imaging rich optical absorption contras. It can visualize endogenous and exogenous optical absorbers. The endogenous contrast reveals anatomical, functional, metabolic, and histologic properties, and the exogenous contrast provides molecular and cellular specificity. Multi-modality imaging of the PA technique with ultrasound and/or fluorescence has big potential in clinical, microscopic and small animal application fields.

Photoacoustic imaging visualizes optical absorbers inside biological tissues with spatial resolution of ultrasound imaging by detecting ultrasound produced from the optical absorbers those absorbed excitation light. By using the excitation light with absorption wavelength of hemoglobin, the technique can offer high contrast image of vascular networks, and application for lesion detection have been discussed. Furthermore, photoacoustic imaging can detect also contrast agents and can offer additional information such as accumulation of the contrast agents in lesion. In addition, to visualize the lesions specifically, contrast agents those are targeted to specific molecules associated with lesions have been researched. Thus, we are developing multispectral photoacoustic method to separately image hemoglobin and the contrast agent. To sensitively image the contrast agents, imaging condition was discussed by evaluating photoacoustic signal generation characteristics of them. In this presentation we would like to talk about our current results and prospects.

Imaging with photoacoustic techniques are broadly classified into two types (I. Microscope type and II. CT (Computed Tomography) type) according to their application. Among them, CT types such as a photoacoustic measurement dedicated type and a multimodality (ultrasonic / photoacoustic, fluorescence / emission / photoacoustic) measurement type have appeared on the market. Under these environment , US FDA approved Imagio (US / OA) of Seno Medical Instrument for the first time as a PMA (Pre Market Approval Application) device for breast cancer testing in Jan. 2021. So we will introduce the principle, function, various application examples, etc. including the data measured by TriTom imaging of PhotoSound Technologies in USA for measuring small animals with the multimodality function (fluorescence / emission / photoacoustic), which is one of the models, and its experience.

Consumption of raw fish products containing anisakis can engender a severe human disease known as anisakidosis. Conventional screening methods such as candling are not accurate or sufficiently sensitive to detect parasites that are embedded deeply in fish muscle. To resolve these shortcomings, we devised a method using photoacoustic imaging. As a fundamental study, we measured photoacoustic spectra of anisakis and mackerel (300-700 nm wavelengths). The spectrum for anisakis decreases monotonically, although the spectrum of mackerel increases moderately in 375-400 nm and 490-540 nm. There was the difference in the intensity ratio of the photoacoustic signals of anisakis and mackerel at 375nm and 400 nm (I_{375 nm} / I_{400 nm}) and 490 nm and 530 nm (I_{490 nm} / I_{530 nm}). These analyses demonstrated the possibility of detecting anisakis in mackerel using multi-wavelength analysis at wavelengths of 375-400 nm and 490-540 nm.

Cerebral blood circulation plays an important role in continuously supplying oxygen and glucose to brain tissue. A notable feature is cerebral autoregulation that maintains a constant cerebral blood flow regardless of mean arterial pressure. However, much is unknown about relationships between local and global cerebral blood flow, circulation field in the interstitial region and how they are related to physiological aspects. The author tackles this problem by numerical simulations for whole cerebral circulation and microcirculation by modeling blood flows, interstitial flows and oxygen transport in blood and tissue. In this presentation, basic formulations of the mathematical models and their numerical validities will be presented, and also future directions to handle physiological problems will be discussed.

Brain circulation is composed of three compartments: arterio-arterial anastomosis covering the brain surface, parenchymal microcirculation, and draining venous systems. In response to neural activation, brain blood flow focally increases in the activation foci (i.e., neurovascular coupling), which is mainly regulated by dilation of pial and penetrating arterioles. Recent studies also suggest a pivotal role of parenchymal microcirculation for further tuning of blood supply. The healthy brain relies on activity-dependent increases in blood flow. Under cerebrovascular disease conditions, impairment of neurovascular coupling leads to pathogenesis of neurodegenerative diseases, including cognitive decline. Although causal relationships between dysregulation of neurovascular coupling and neurodegeneration remain incompletely understood, improvement of parenchymal microcirculation is shown to rescue the brain activity. In this talk, I'll focus on regulatory mechanisms of parenchymal microcirculation in response to neural and glial activities based on experimental data obtained from small rodents.

Objectives: In the fluid dynamics of cerebral circulation and cerebrospinal fluid (CSF) motion, the computational simulation model has not been established. We conducted the multi-scale simulation in the cerebral circulation model. Therefore, we would like to integrate these two different fluid dynamics models.Methods & Results: Using the 3 tesla MRI and 3D workstation, the flow volumes of blood and CSF were measured in the 20 healthy volunteers. In addition, the 3D structures and movements of the brain, intracranial CSF spaces and major arteries were reconstructed for computational fluid dynamics.Conclusions: The CSF movements synchronized with a heartbeat were driven by the pulsation of large intracranial arteries and brain. In the current concepts of the cerebral circulation and fluid exchange of CSF and interstitial fluid, i.e., glymphatic system, the simulation model of the brain fluid dynamic is extremely complicated. There are many black boxes in this field.

There has been increasing evidences that water dynamics in the brain is closely related to the various disorders. However, little is known about intracranial water dynamics, including glymphatic system which is proposed as lymphatic system in the brain. We are trying to visualize the water dynamics in the brain using MRI and isotope-microscopy with stable isotope of oxygen as water tracer.After the intravenous and intrathecal injection of water tracer, significant changes in MRI signals are observed. These experiments were conducted not only in the animals, but also in the humans as clinical studies. In the animal studies, visualization of water distribution in the microscopic level can be achieved using isotope-microscopy.By using these methods, we aim to elucidate the normal and disturbed water dynamics in the various disorders, and finally, to establish early diagnosis and new therapeutic targets through the clarification of pathophysiology on water dynamics.

The intracranial region is filled in various kinds of fluids such as blood, cerebrospinal fluid, and interstitial fluid. It is commonly known that these fluids always satisfy a mechanical equilibrium state, however little is known about underlying mechanism to maintain this equilibrium state as a homeostasis. Recent experimental studies have revealed details of intracranial fluid circulation with exchanges among fluids. These findings potentially update conventional understanding of the physiological mechanism of the intracranial fluid circulation. As a tool to integrate and interpret these recent findings from mechanical viewpoint, we have begun to develop a computational mechanical model of the intracranial fluid circulation. This presentation introduces perspectives of the computational model to be developed and a personalized computational framework of the cerebrospinal fluid flow, as the first step.

The cerebral and cerebellar cortex have a unique convoluted morphology with an internal layered structure of neurons, which are closely related to advanced brain functions. These brain morphology and structure are the results of tissue growth and deformation caused by cooperative cellular activities including proliferation, migration, and differentiation. Therefore, to clarify the mechanism of brain morphogenesis, it is of great significance to integratively explore the mechanical state of brain tissue and the underlying multi-cellule dynamics. In this study, we have developed a continuum mechanics model of neuronal proliferation and migration to investigate brain morphogenesis. The proposed mathematical model was validated through a reproduction of neuronal lamination in cerebral cortex. Then, this model was applied to the simulation of folia formation in cerebellar cortex to reveal the importance of fiber-guided neuronal migration. Our computational approach will help us understand mechanical and biochemical aspects regarding the emergence of brain structure and function.

Society network is changing. Communication is no longer limited to face-to-face conversation. Technology including 5G, Human-Computer/Robot-Interaction, Wearable Device, et al. provides us more options to build a new social network.But, are we really ready for talking with a robot even it is connected with another people's brain (Human-Agent)? How can we know people's feelings only according to the image that is projected on the monitor screen (IP Virtual Human)? Missing and inaccurate information will mislead our feedback to other people and result in a communication gap.In this symposium, we intend to share our ideas, as well as concerns, for the potential issues that may occur in the future social network. Also, we look forward to the discussion about visible solutions to fill the gap in communication.

In the field of Information Science, few of previous methods analyze the discussion process which represents how the discussion was conducted. A Dialog act is an utterance, in the context of a conversational dialog, that serves a function in the dialog. Dialog acts are assigned to utterances as labels. Transitions of dialog acts with a high appearance rate are extracted. The transitions are connected if the same dialog act is in both transitions to make a directed graph of dialog acts. We assume that the directed graph represents a model of the discussion process. A directed graph for the high-quality discussion process is compared with that for the low-quality discussion process to investigate suggestions for low-quality discussions. We evaluated our method and verified the efficiency.

Technology has brought benefits to human, and brainstorming groups of the Moonshot R&D - MILLENNIA Program discussed the vision in 2050 with technology. For instance, they discussed the AI's potential to share emotions with others, realisation of ideal mental status, and technology which allows anyone to have and raise children. However, there are possible legal and ethical issues to these scenarios, such as privacy, freedom of thought, and life ethics. In order to deal with these legal and ethical issues, this presentation claims that the basis of law and ethics needs to be revisited. In this era of Anthropocene, which human makes a significant impact on the Earth, law and ethics need to consider the impact of human activities on biosystem and the environment to solve social problems.

Why I can't bear a child instead of my wife? Why childbirth is limited by age? Why only women bear the burden? Today's ultra-low birthrate society is abnormal for the nature? To grow children and to pass them to the next generation is a universal desire? I often find many pains in the scenes of pregnancy, childbirth, and child rearing. There is many sad news about postpartum depression and child abuse. What science and technology can do? Children are the future itself. Thus, science and technology to support fertility, childbirth, childcare etc. should be invested more. Of course, there are ways of life that do not involve having children. The important thing is to have choices. I would be happy if we could discuss what science and technology can do to realize "a society where everyone can have and raise children with peace of mind if they wish.

In the MILLENNIA Program of Moonshot R&D, presenters have been conducting research on science and technology to achieve "Harmony of Humankind". 1. At the individual level, we investigated technologies for reading and communicating information such as thoughts and experiences that cannot be put into words, and real-space interfaces, such as filters that allow us to avoid seeing things we do not want to see. 2. At the group level, we examined a social system that can coordinate small opinions sensing from whole cities, and technologies to control the distribution of information in such a way as to promote the most mutual understanding. These visions were clarified through co-creation with science fiction writers, and through discussions with academics and experts, as well as research of patents and publications. In this lecture, we will introduce how to bridge the gap between the present and the envisioned future.

As a vision of society in 2050, the research team of the speaker proposed a society where physical and mental burdens are reduced, and well-being and vitality are generally enjoyed by bringing together the wisdom of scientists to elucidate the definition, measurement, guidance, and social implementation of ideal mental states. We aim to establish a "Psyche Navigation System" that systematizes traditional wisdom and mental-physical transformation techniques into society efficiently and robustly with the aid of advanced science and technology. In this presentation, the speaker will introduce the new concept CPMS (Cyber Physical Mental System) which integrates "Cyberspace," "Physical Space," and "Mental Space" and the technology of "Psyche Navigation System" especially from points of view of Buddhism which is the speaker's research field.

The social systems have been shifting to balance work with child or elderly care, or to decentralize services from major cities. The concept of where and when to work is changing. The acceleration of declining birthrate and aging population, shortage of doctors in depopulated areas, have created a craving for telemedicine at home. In addition, scientific advances will enable drug discovery based on individual DNA information, personalized medicine with fewer side effects and higher therapeutic efficacy. In view of these social trends, we propose the development of "Intelligent Living (iL)-Cell," a small cell-like organism (Living) with advanced functions (Intelligent). The iL-Cell must be equipped with functions not found in conventional cells, such as energy production and storage, and sensing of biomolecules. In this symposium, we would like to discuss what should be researched for the construction of iL-Cells and the society in 2050 that iL-Cells will open up.

The Clinical Engineering Engineer Law was enacted in line with the needs of the times, where there is an urgent need to operate complex and advanced medical devices safely and efficiently in the field. So, of course, CEs have to keep up with technological advances. It also means that it is a job type that should build a job system that takes into account academic activities and research activities in addition to daily work. In the first place, the significance of conducting research activities is to scientifically prove the truth of things. It is necessary to have the ability to feel questions from what is being done and the things that exist, and the ability to extract questions as problems. In this presentation, as the beginning of this session, we will explain the points that CE should be aware of in order to carry out research activities in clinical practice.

The significance of clinical research in clinical engineering engineers leads to improvement of knowledge level and motivation, development and dissemination of new technologies and indicators, and activation of organizations. Furthermore, we believe that continuing it will lead to high public interest results. This paper reports an example.

Development of medical devices includes processes such as basic research, applied research, non-clinical research, clinical research (clinical trials), and practical application, as well as verification of safety and efficacy based on the Pharmaceutical and Medical Device Law. Engineering researchers, medical specialists (clinical engineers), R & D support organizations, companies, governments, etc. need to cooperate in research and development in order to socially implement medical devices to be developed.

Background

In November 2019, the Executive Committee of the Science Council of Japan issued a statement on balancing the "work style reform" of researchers by securing sufficient time for research . This points to an increased interest in securing time for research. Therefore, we conducted a survey on the present status of securing time for research in the medical field.

Method

A questionnaire was sent to 25 clinical engineers at multiple facilities.

Results

The questionnaire results showed that 20/24 (83.3%) respondents did not have time for clinical research during working hours, 14/24 (58.3%) respondents did not have time for research outside working hours, and 17/25 (68.0%) respondents understood those who found time for research during working hours.

Discussion

Clinical engineers working at hospitals were unable to find time for research during working hours, but they understood those who did find time for research during working hours.

The Clinical Research Law was enacted for the improvement of health and hygiene by promoting the clinical research through ensuring the credibility of clinical research.The supplementary provisions of the law stipulate that a review shall be conducted within five years after the law comes into effect. A review was initiated at the Clinical Research Subcommittee of the Council for Health Sciences in January of this year. Specific clinical research covers medical devices that have not been approved, certified, or notified under the Pharmaceutical and Medical Devices Law. On the other hand, risks of medical devices are various, and medical devices are to be constantly improved and upgraded. While maintaining reliability, and giving consideration to ensuring the safety of study subjects, a review will be conducted to promote clinical research by increasing international consistency and reducing the burden of administrative procedures that do not affect the essence of the trial.

The Clinical Research Act enforced in April 2018 states that only those with a doctor's license can carry out clinical research. Therefore, to clarify whether a research is categorized as clinical research or not is quite important issue for biomedical engineering researchers. In October 2019, JSMBE issued guideline to Classify Biomedical Engineering Research under the act. In this guideline, the two conditions of 1) not including prevention / diagnosis / treatment and 2) not affecting the structure or function of the body are used as criteria. Since detailed judgment criteria of condition 2 may differ, it is required to create an attached table to show the criterion for each individual field. In this panel discussion, we will discuss how the activities can affect the ongoing amendment of the act with an MHLW personnel.

We will present outline of Tohoku University Hospital Bedside Solution Program and how we are defining the problem worth solving with our stakeholders.

In a medical information bank demonstration project, Osaka University Hospital provides medical information to the Personal Health Record (PHR) contracted by patients themselves. In a Society 5.0 realization project, we are attempting to accumulate patient life log data in the Personal Life Record (PLR) infrastructure. The PHR and PLR infrastructures will be integrated, enabling the patient centered information sharing. With the PHR-PLR infrastructure, medical professionals are expected to provide medical services based on lifelog data, such as lifestyle guidance for patients with lifestyle diseases. In the future, patients will only need to go to the hospital for a medical inspections, and the results will be explained to the patient online and returned to the PHR. It is also assumed that regular visits will become on online based and the patients will only visit a medical institution when their condition is detected to be worsening by their lifelog data.

As new leaders in international cooperation, various programs to support the overseas expansion of the clinical engineering workforce have begun in earnest. We have invited Mr. Yoshioka (Sendai Red Cross Hospital, Chairman of the International Committee, Japan Association for Clinical Engineering) and Dr. Naramura (Department of Life Science, Kurashiki University of Science and the Arts, Director of Clinical Engineering Global Promotion Foundation) to this symposium. These guests will discuss their international cooperation experiences, the state of clinical engineering in developing countries, and how to approach international cooperation and current issues, under the theme of the Field of International Cooperation of Clinical Engineers. We hope that numerous clinical engineers will learn about the state of international cooperation and that the experience they have cultivated will constitute an opportunity to contribute to the development of clinical engineering in Japan and globally.

In recent year, the economic growth of developing and emerging countries has been remarkable, and it seems that the level of medical care has been improving year by year. With the advancement of medical care and globalization, demand for various medical equipment are rapidly increasing in these countries. On the other hand, in these countries, the current situation is that the development of specialists who appropriately operate and maintain medical equipment has not kept up. Therefore, to further enhance international activities, we have established the Clinical Engineering Global Promotion Foundation. In this time, I'd like to introduce the activities of the Clinical Engineering Global Promotion Foundation, focusing on the activities in Myanmar.

Japan association for clinical engineers (JACE) has the International Exchange Committee (IEC) has three main aims. First, closer communication with other industrialized nations and information collection through positive participation in international programs. Next, technological cooperation in the areas of CE and blood purification, including transfer of CE systems and exchange with China. And last, dissemination of a CE mind-set and development of an international orientation through participating in Japan Overseas Cooperation Volunteers Program as well as the Senior Volunteers Program of Japan International Cooperation Agency. Additionally, IEC has made presentations at educational sessions presented by Association for the Advancement of Medical Instrumentation Annual Conference and Expo from 2005 to present and returns a lot of useful information to JACE's members. IEC supports CEs who want to spread their wings around the world, and is determined to further safety management and HTM.

This paper presents a cell stretching system which can stretch cardiomyocytes synchronizing with the autonomous beating. The objective of our study is to elucidate the cellular response to mechanical stress behind the development of heart failure. In the system, heart beats are detected from microscopy images using optical flow techniques and piezo actuators apply stretch with high-speed responsiveness. The prototype system realized 20ms response time. Also, we conducted cyclic stretch experiments and the system was confirmed to be useful in observing cellular response to stretching. Furthermore, we demonstrated the capability of beat-synchronized stretch. Abnormal beatings were induced by stimulation during specific phase window of the autonomous beating, and this result suggests that the system can be used as an in vitro commotio cordis model.

Bioresorbable Mg-alloy scaffolds expand stenotic lesions and theoretically resolve after lesion healing. In this study, we newly developed a durability test system which simulates biomechanical loads and biochemical fluids conditions in vivo. The Mg-alloy scaffolds were deployed in the elastic artery model which diameter stenosis is 75 %. A two peaked LAD flow waveform with mean flow rate of 60 mL/min and mean coronary artery pressure of 120/80 (100) mmHg was duplicated. Concentrations of chloride ion, proteins, as well as pH in accordance with human blood were duplicated using fetal bovine serum, and using a CO2 gas concentration adjustment device. Our study elucidated that adjustment of pulsatile circulation and radical force by stenotic artery model in a corrosive environment could be essential to conduct reliable in vitro tests. The in-vivo simulated durability tester and test method can be used for pre-clinical evaluation of fracture resistance of bioresorbable magnesium-alloy scaffolds.

We reproduce chemical reactions of blood vessels by a flexibly deformable collagen tube device. The device is composed of an unfixed collagen hydrogel tube, enabling the reproduction of both macro and micro scale deformation of the vessel tissue. The fabrication of the device is a simple molding process. Also, the device is easily perfused because the collagen hydrogel tube is directly attached to silicone tubes. We succeeded in demonstrating the chemical deformation of vessel tissue and endothelial cells by inflammatory mediators. Moreover, the drug testing was presented by anti-inflammatory chemicals. We believe that our flexible culturing device could help the construction of functional blood vessels reproducing in vivo chemical reactions in high similarity, and contribute to biomedical researches and pharmacokinetic testing.

Early detection of chronic kidney disease (CKD) promotes early intervention to prevent renal failure. Although recommended by a CKD guideline 2018, screening using dipstick urinalysis remains suboptimal. One obstacle is that patients may not be screened for urine abnormalities at a primary care clinic. This report proposes a low-cost, simple, and accurate system of dipstick urinalysis judgment with image analysis. We prepared four different concentration samples by diluting urine pool products with distilled water. We placed a urine dipstick on a color chart and then photographed it using a smartphone. To acquire color information from images, we developed an image-analyzing system and judged the dipstick of urine albumin. Results from the original and conventional systems were then compared. In conclusion, this system has the potential to be used for dipstick urinalysis judgment.

We studied the new cardiac tissue monitoring modality during arrhythmia catheter ablation using local impedance measurement. Devices that allow local impedance monitoring by catheters equipped with microelectrodes have become used in recent years during arrhythmia ablation. This monitoring provides useful intra-treatment diagnostic information such as the distance between myocardial tissue and catheter tip, and tissue information. However, the impedance may be sensitive to the contact condition of the catheter, which may lead to underestimation of the therapeutic effect. In this study, we evaluated the effect of contact angle and contact pressure on the local impedance using ex vivo porcine myocardial tissue. A new monitoring modality for mechanical properties of myocardial tissue would be suggested.

It has been reported that human skin suffers disorders associated with oxidative stress, but in vivo evaluation of oxidative stress remains difficult. Therefore, we focused on the measurement of ultra-weak photon emission (UPE) derived from reactive oxygen species and we examined the possibility of an in vivo evaluation for oxidative stress. It is suggested that the emissions originate from both the epidermis and the dermis. In addition, it was considered from spectrum analysis that emissions from the skin were an aggregate of photons generated from biomolecules. Further, oxidative stress in human facial skin was evaluated by UPE, and it was confirmed that oxidative stress is high in nasal skin where a higher incidence of skin cancer has been reported. Also, it was confirmed that oxidative stress is related to wrinkle and porphyrin generation. Through this research, we believe that UPE measurement will become a useful tool for biological skin diagnosis.

This talk overviews methods of biosignal processing from the engineering point of view. Biosignals are categorized as either continuous or discrete processes. There are some cases where the same phenomenon could be processed as either a continuous or discrete process. If a signal is stationary, the family of joint probability distribution functions completely characterizes the signal. In practice, the joint moment functions of order up to four and their variants are commonly used for signal characterization. For nonstationary biosignals, adaptive signal processing techniques such as RLS or LMS algorithms are applied for the analysis. Signal decomposition by Kalman filter is also useful for the nonstationary analysis. For system identification based on observed signals, either linear or non-linear methods are utilized. This talk introduces useful signal analysis methods applicable to various kinds of biosignals, aiming to envision the rich field of biosignal interpretation and understanding.

Among biological signal fluctuations obtained by wearable devices, heart rate variability (HRV) is the most widely studied and successful. HRV researches have focused on two basic propositions: (1) HRV reflects autonomic function, and (2) HRV predicts prognosis. While PubMed's more than 50,000 HRV research papers present vast supportive evidence for these propositions, they still raise questions about their limitations and necessary conditions. The focus of the discussion is on the biological necessity of the association between HRV and autonomic function, the presence of HRV not mediated by autonomic nerves, the problems of autonomic function evaluation by HRV, and the validity of pulse rate variability as a surrogate of HRV, and exploration of new information value of HRV beyond autonomic nervous function and prognostic index. Based on recent researches on these topics, I would like to discuss the future of biological signal measurement and interpretation researches.

I will introduce an approach to construct tissue models to recapitulate the interface between organ cells and vascular networks using microfabrication technology as Microphysiological Systems (MPS). To fabricate the interface, we co-cultured organ cells and endothelial cells using a porous membrane and created self-organizing vascular network. In the former, we constructed a co-culture system of proximal tubular epithelial cells and vascular endothelial cells. We demonstrated the reabsorption of albumin from the urinary side to the vascular side. As for the latter, we have established a technique to create a vascular network on a chip and perfuse the inside of the network using the angiogenic and vascular forming abilities of HUVECs. Furthermore, by optimizing the culture conditions of spheroids that resemble tissues and the conditions for angiogenesis, we succeeded in creating a vascular network inside the spheroids. We are now applying these techniques to organoids, and will report on the progress.

In this talk, photonic information technology promising for the design of medical transducers are introduced. Light functions as a probe for observing various substances and biological activities. An arbitrary light wave distribution can be controlled to generate sub-diffraction array spots using inter-spot interference. The state of cells and tissues are detected as an optical signal via fluorescent molecules. These fluorescent molecules can be freely arranged using sequence-designed DNA, and even logical operations depending on the state can be achieved. Forster resonance energy transfer enables to generate various response characteristics with several kinds of fluorescent molecules. The imaging system TOMBO, inspired by the compound eyes of insects, can be used to capture such optical signals effectively. By integrating optical systems with different properties, 3D shape measurement, multispectral imaging, etc. can be performed. Furthermore, various imaging modalities are achieved by signal processing such as compressed sensing and machine learning.

In diagnosis/assay of complex samples from living bodies, total evaluations are often difficult because of their diversity. Omics studies for total assays of the specific components or immunoassays for specific analysis of target molecules have been employed, while the issue related to the difficulty of total assays for whole components still remain. In this study, a method for selection of aptamers based on microscale electrophoretic filtering was newly developed to propose a novel total assay of them based on aptamer sequence fingerprinting. In the preliminary study using model proteins, some of the sequences obtained by the developed method were similar to the reported one. It suggests that the proposed method provides effective separation of nucleic acids specifically binding with target proteins.

Some of medical transducers are passive such as electrocardiogram electrodes and others are active such as ultrasoound transducers. For medical purposes, some of them are used inside body, these are subject to various conditions, Furthermore, size is also an important for insertion into a body. So, we have been studying chemical transducers with solving these conditions. We have tried to use chemical quantities directly convert to mechanical actuation without electricity and control system. And we applied this for diabetes treatment. We have proposed a mechanism for injecting insulin that makes lower the blood glucose concentration, by increasing the blood glucose concentration which causes an increase in osmotic pressure. And the device automatically stops insulin injections when blood sugar concentration redused. This device has the characteristic that the efficiency becomes higher by smaller. This also matches for the body. We have confirmed that this device works in animal experiments.