Smart Medical Devices Research Articles

Review of Medical Cyber Physical System based Infusion Pump-perception on control strategy

The revolutionary change in recent technologies has dominated the Medical field. Huge medical devices are deployed in hospitals and in-home environment. The innovations of smart medical devices are prominent which can be used in the fully automated and semi- automated environment. For several decades, numerous medical devices are designed and utilized effectively. These devices are designed for the past few years, manufactured in micro and nanotechnologies with smart sensing techniques. Such devices are network-enabled and integrated into the cyber world in physical means, leading to a medical cyber physical system. The design, working, and optimal control of smart medical devices are essential. In this paper, the emphasis on the review of infusion pump control mechanism with essential parameters such as drug delivery, flow rate, pump control has been considered.

Diffusion of the Digital Health Self-Tracking Movement in Canada: Results of a National Survey

BackgroundWith the ever-increasing availability of mobile apps, consumer wearables, and smart medical devices, more and more individuals are self-tracking and managing their personal health data.ObjectiveThe aim of this study was to investigate the diffusion of the digital self-tracking movement in Canada. It provides a comprehensive, yet detailed account of this phenomenon. It examines the profile of digital self-trackers, traditional self-trackers, and nontrackers, further investigating the primary motivations for self-tracking and reasons for nontracking; barriers to adoption of connected care technologies; users’ appreciation of their self-tracking devices, including what they perceive to be the main benefits; factors that influence people’s intention to continue using connected care technologies in the future; and the reasons for usage discontinuance.MethodsWe conducted an online survey with a sample of 4109 Canadian adults, one of the largest ever. To ensure a representative sample, quota method was used (gender, age), following stratification by region. The maximum margin of error is estimated at 1.6%, 19 times out of 20.ResultsOur findings reveal that 66.20% (2720/4109) of our respondents regularly self-track one or more aspects of their health. About one in 4 respondents (1014/4109, 24.68%) currently owns a wearable or smart medical device, and 57.20% (580/1014) use their devices on a regular basis for self-tracking purposes. Digital self-trackers are typically young or mature adults, healthy, employed, university educated, with an annual family income of over $80,000 CAD. The most popular reported device is the fitness tracker or smartwatch that can capture a range of parameters. Currently, mobile apps and digital self-tracking devices are mainly used to monitor physical activity (856/1669, 51.13%), nutrition (545/1669, 32.65%), sleep patterns (482/1669, 28.88%) and, to a much lesser extent, cardiovascular and pulmonary biomarkers (215/1669, 12.88%), medication intake (126/1669, 7.55%), and glucose level (79/1669, 4.73%). Most users of connected care technologies (481/580, 83.0%) are highly satisfied and 88.2% (511/580) intend to continue using their apps and devices in the future. A majority said smart digital devices have allowed them to maintain or improve their health condition (398/580, 68.5%) and to be better informed about their health in general (387/580, 66.6%). About 33.80% of our sample (1389/4109) is composed of people who do not monitor their health or well-being on a regular basis.ConclusionsOur study shows an opportunity to advance the health of Canadians through connected care technologies. Our findings can be used to set baseline information for future research on the rise of digital health self-tracking and its impacts. Although the use of mobile apps, consumer wearables, and smart medical devices could potentially benefit the growing population of patients with chronic conditions, the question remains as to whether it will diffuse broadly beyond early adopters and across cost inequities.

Biopolymer-based strategies in the design of smart medical devices and artificial organs.

Advances in regenerative medicine and in modern biomedical therapies are fast evolving and set goals causing an upheaval in the field of materials science. This review discusses recent developments involving the use of biopolymers as smart materials, in terms of material properties and stimulus-responsive behavior, in the presence of environmental physico-chemical changes. An overview on the transformations that can be triggered in natural-based polymeric systems (sol–gel transition, polymer relaxation, cross-linking, and swelling) is presented, with specific focus on the benefits these materials can provide in biomedical applications.

3D Printing of Highly Stretchable, Shape-Memory, and Self-Healing Elastomer toward Novel 4D Printing.

The three-dimensional (3D) printing of flexible and stretchable materials with smart functions such as shape memory (SM) and self-healing (SH) is highly desirable for the development of future 4D printing technology for myriad applications, such as soft actuators, deployable smart medical devices, and flexible electronics. Here, we report a novel ink that can be used for the 3D printing of highly stretchable, SM, and SH elastomer via UV-light-assisted direct-ink-write printing. An ink containing urethane diacrylate and a linear semicrystalline polymer is developed for the 3D printing of a semi-interpenetrating polymer network elastomer that can be stretched by up to 600%. The 3D-printed complex structures show interesting functional properties, such as high strain SM and SM -assisted SH capability. We demonstrate that such a 3D-printed SM elastomer has the potential application for biomedical devices, such as vascular repair devices. This research paves a new way for the further development of novel 4D printing, soft robotics, and biomedical devices.

High-Strain Shape-Memory Properties of Poly(Carbonate-Urea-Urethane)s Based on Aliphatic Oligocarbonates and L-Lysine Diisocyanate

ABSTRACTThe simultaneous capability of high-strain deformation and high shape recovery ratio constitutes a great challenge in design of the shape-memory polymers. Here we report on poly(carbonate-urea-urethane)s (PCUUs) synthesized by a precursor route, based on oligo(alkylene carbonate) diols, L-lysine diisocyanate (LDI), and water vapor. When programed with a strain of εprog = 800%, the PCUU networks exhibited a one-way shape-memory effect (1W-SME) with excellent shape fixity (> 97%) and shape recovery (> 99%) ratios. The switching temperatures (Tsw) varied between 50 and 56 °C and correlated to the melting transitions of the switching domains. The obtained PCUUs capable of high-strain are interesting candidate materials for degradable biomaterials as required in smart medical devices.

Study on the Factors Influencing User’s Acceptance Intention for Smart Medical and Health Care Equipment Based on UTAUT2

With the rapid development of mobile Internet technology and applications, more and more people begin to pay attention to and deepen the understanding of wearable devices, especially smart medical and health care devices. At the same time, as the extension of the traditional medical equipment, the market potential of smart medical and health care devices is huge, so it has also been paid more attention and promoted by many related industries and enterprises. However, according to the survey report, it shows that there is lower user adoption rate for the device's usage. In this study, we construct the user acceptance behavior model of smart medical and health care device, and analysis the factors influencing the adoption of smart medical and health care devices on the basis of UTAUT2 (the extended unified theory of acceptance and use of technology). In the study, we will pertinently modify the original UTAUT2 model, and add the two new constructs, including the health concern as the key features of health care equipment and the socio-economic status to carry on the research analysis. It aims to put forward suggestions on the operation and promotion of the future smart medical devices industry through the research in this paper.

Creating Smart and Adaptive Medical Devices: Device Data and Analytics

Creating Smart and Adaptive Medical Devices: Device Data and Analytics

Luminescent Poly(vinyl alcohol)/Carbon Quantum Dots Composites with Tunable Water-Induced Shape Memory Behavior in Different pH and Temperature Environments.

Luminescent water-induced shape memory polymer (SMP) composites with tunable shape recovery rate are developed by blending poly(vinyl alcohol) (PVA) and carbon quantum dots (CQDs). The oxygen and active hydrogen-rich CQDs can serve as extra physical cross-linking points in PVA via strong hydrogen bonding interaction, which largely improves the shape memory performances of PVA. At room temperature, water can successfully actuate the shape recovery of deformed PVA/CQDs composite. It is demonstrated that this water-induced shape recovery is mainly attributed to the plasticizing effect of water and its competitive hydrogen bonding. Furthermore, a quantitative bending test suggests that the shape recovery time of this water-induced SMP is tunable by altering the environmental pH value and temperature, and a relatively large shape recovery time window (from 20 to 200 s) can be achieved. In addition, the introduction of CQDs endows the PVA/CQDs SMP composites with excellent luminescent property, which makes the shape change of SMP visible under UV light. It should be noted that the mild stimulus condition and tunable shape recovery performances make the luminescent visible PVA/CQDs SMP feasible for diverse biological applications in smart medical devices, stimuli-responsive drug-release, and intelligent sensors in vivo and in vitro.

Reliability of plastic-encapsulated electronic components in supersaturated steam environments

Medical steam sterilizers use rapid cycles of temperature, humidity, and pressure to sterilize medical instruments. These cycles represent an exceptionally harsh environment for electronics and, currently, only metal can devices with high-reliability electronic components can be used to electronically monitor and verify the completeness of sterilization. The work presented in this paper has allowed the identification of a material set that allows plastic-encapsulated electronic modules with commercial-off-the-shelf electronic components and sensors, assembled on organic circuit boards, to survive over 100 sterilization cycles. In the course of the work, the failure mechanisms of the plastic-encapsulated modules and the deterioration of encapsulant adhesion over multiple sterilization cycles have been characterized. This opens the possibility of using plastic-encapsulated embedded electronics in smart medical and biomedical devices, which need resterilization after every use.

New risks inadequately managed: the case of smart implants and medical device regulation

ABSTRACTMany emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.

Cyber-Physical Systems: A Framework for Prediction of Error in Smart Medical Devices

The objective of medical care services is designed to bring improvement to the health of patients. This is pursued with great vigor today with the use of modern health care systems which include medical sensors and automatically controlled actuation to deliver smart and proactive health services. The embedded devices control Smart Medical Devices (SMDs) used by physicians, Nurses, and Medical Staff which continuously interact with the human body or patient in one form or another. Cyber-Physical Systems (CPS) are integrations of computation with physical processes which are monitored and controlled by the embedded systems. CPS has positively affected a number of application areas which include communication, consumer energy, infrastructure, healthcare, manufacturing, military, robotics and transportation. The inappropriate use of these SMDs generate errors which are under-emphasized by stakeholders. Most users are only interested on the benefits derived in the use of SMDs and care-less on the danger that these devices can contribute to patients when used inappropriately. The error tendencies, possible factors and way forward is the subject matter of this paper. In order to achieve the stated objective, Input data was provided through a critical incident analysis of online database which provide readings from medical experts. These readings were compared to the standard world benchmarks and best practices. The difference between the readings and the standard benchmark were used to validate the existence of errors. A framework was developed for error prediction to improve safety in the use of SMDs. Due to the complexity of the problem, an algorithm was further developed to obtain an optimal solution of P1 to P5 within an acceptable threshold runtime which shows the gravity of these challenges on patients.

Learning Analytics And Medical Education.

The number of courses delivered online or supported using learning management systems continues to rise; both in size and number, it is used by more students and employees to gain new knowledge, learn skills and earn degrees. (1)     In contrast to traditional methods of teaching that leave little trail behind, online learning has the potential to generate huge amounts of data about the students and their way of learning in terms of records, logs, interactions and digital footprint. (2)     The availability of huge datasets, increased computer power and the pressure towards better teaching and learning, personalization of the content and improving educational system has led to increased interest in learning analytics research. (3, 4, 5)     Learning analytics (LA) is an emerging and rapidly developing research discipline in the field of technology enhanced learning that -by definition- aims at “measurement, collection, analysis and reporting of these data and their contexts, for purposes of understanding and optimizing learning and the environments in which it occurs” . (2, 5)     Using analytics in the field of higher education can improve the decision making process based on actual data and real trends that are derived from students’ behavior and resource usage. LA can foster institutional growth, increase productivity, create innovative models and enable institutions to understand strengths and challenge. (5, 6) It can be used to predict students’ performance, personalize instruction, build adaptive systems and alarms of potential underachievement in real time. (3, 6, 7)     The future holds promise in bringing more sources of data that can add to the pool; from smartphones and smart watches, wearable technologies, Internet of Things (IoT), tracking devices, biometrics, sensors, smart medical training devices with logging modules, from RFID-Based attendance and beacon devices.     There is also a venue of a new category of smart and networked hardware; An example could be a microscope that records all data specific to students’ usage, these data will be later analyzed to better understand and identify the patterns that are best linked to effective training which can be used to create adaptive systems. This is will also be possible to stethoscopes, sphygmomanometers as well as many other tools.     Unlike other sectors that has made great strides in the field of analytics, the education sector is late in reaping the benefits and harnessing the developments of data science, and it is even worse in the case of medical education where research is very limited in number and quality. A fact that necessitates the development of skills in education analytics and data science, infrastructure to support it, modifications to the existing learning management systems and new tools designed for this specific task.

Hassle-Free Vitals: BioWireleSS for a Patient-Centric Health-Care Paradigm

Continuous monitoring of vital information via a wireless medium has become an integral part of next-generation health-care technologies. The benefits of a wireless monitoring technique include facilitating in-home care services, reduction of the cost of frequent visits to hospitals, and lightening of the burden to the elderly persons. The development of miniature, lightweight, and energy-efficient circuit solutions for biomedical sensor applications has been made possible by the tremendous recent advancements in health-care monitoring technologies, micro- and nanofabrication processes, and wireless communications. Exuberant growth of the wireless sensor networks has opened up a new and innovative application of wireless technology in health care. The advancement of wireless technology has led to the development of the recently proposed comprehensive patient monitoring systems such as wireless body area network (WBAN) and body sensor network (BSN). Implantable and wearable sensors are integral components of these networks and are employed for monitoring various levels of physiological activities. Wireless sensor technology provides an effective tool for instant access to patient data, laboratory test results, and clinical histories as well as insurance information, thereby ensuring immediate health care in case of emergency, eliminating the lengthy clinical decision. This biomedical wireless technology has resulted in a new health-care concept known as telemedicine, which facilitates the monitoring of in-home patient care by incorporating smart medical devices and WBANs. In this scheme, implantable and wearable sensors are placed within the vicinity of the patient's body and various physiological parameters are monitored and transmitted wirelessly to a nearby hub station and subsequently to the remote health-care provider via a secure wireless communication network. The telemedicine platform can also be configured for identification of the object location, medicine reminder, or emergency alert in case of any sign of fatal disease. As a result of the recent developments in biomedical wireless technologies, the traditional clinic-centric health care is giving way to a patient-care centric health-care concept. This translational health-care concept facilitates the multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. However, the successful integration of this new health-care paradigm hinges on the proper interpretation, storage, and dissemination of the large data sets generated by the all implantable and wearable devices within the wireless network.

'Stealth Licensing' - Or Antitrust Law and Trade Regulation Squeezing Patent Rights

A “stealth licensing” paradigm is emerging across the globe. It can be seen through subtle interventions from policy makers, judicial organs and administrative agencies. Those interventions seek to facilitate compulsory licenses outside the TRIPS agreement exceptions and/or to water down those exceptions. Altogether, they ramp up pressure on patent owners to give away their freedom – it is actually a “right” – to exploit their innovations as they see fit. The present paper submits that stealth licensing is a significant phenomenon that adversely impacts the social welfare functions of the patent system. It risks undermining investment in technology, technology creation and the dissemination functions of the patent system at a critical juncture in time, as new critical technologies like green technology, the internet of things, machine to machine technology, smart medical devices or biotechnologies are being called for, and rolled out, across the globe. Moreover, stealth licensing is occurring despite the fact that both private and public investment in RD and in antitrust law, where a distinct though equally problematic “undercover” licensing paradigm is gaining prominence (IV). Finally, it explains the perils of squeezing patent rights through stealth licensing with two metaphors: that of a black swan (V) and that of a butterfly (VI).

Water-induced shape-memory poly(d,l-lactide)/microcrystalline cellulose composites

Thermo-induced shape-memory polymers (SMPs) have been widely investigated, but their biomedical applications are limited because their switching temperature does not fall completely within the range of room temperature to body temperature. In this study, we prepared water-induced shape-memory composites composed of microcrystalline cellulose (MCC) and poly(d,l-lactide) (PDLLA). We observed that the composite with an MCC content of 35% (PDLLA-MCC-35) exhibited a good shape-memory effect upon exposure to water at 37°C. We also analyzed the mechanism of the water-triggered shape-memory effect by considering the microstructure, water contact angle, water uptake, thermal properties and static and dynamic mechanical properties of the composite. The results of in vitro degradation analysis demonstrate that the composites exhibited good biodegradation. In addition, Alamar blue assays based on osteoblasts indicate that the composites possess good cytocompatibility. Therefore, the water-induced shape-memory composite can potentially be developed into a new smart medical device.

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Stimuli-Responsive Polymer Brushes for Flow Control throughNanopores.

Responsive polymers attached to the inside of nano/micro-pores have attracted great interest owing to the prospect of designing flow-control devices and signal responsive delivery systems. An intriguing possibility involves functionalizing nanoporous materials with smart polymers to modulate biomolecular transport in response to pH, temperature, ionic concentration, light or electric field. These efforts open up avenues to develop smart medical devices that respond to specific physiological conditions. In this work, an overview of nanoporous materials functionalized with responsive polymers is given. Various examples of pH, temperature and solvent responsive polymers are discussed. A theoretical treatment that accounts for polymer conformational change in response to a stimulus and the associated flow-control effect is presented.

‘Where IT Meets IV’ Integrating Intravenous Infusion Devices With Hospital Information Systems

Tim Vanderveen is vice president of The Center for Safety and Clinical Excellence for CareFusion. E-mail: tim.vanderveen@ carefusion.com Since 2001, “smart” intravenous (IV) infusion pumps with dose-error-reduction software (DERS) have provided hospitals with critical safeguards against potentially fatal pump programming errors and a treasure trove of previously unavailable information on patient safety, IV practices, and quality of care. Nevertheless, IV infusion errors that result in harmful and even fatal adverse drug events (ADEs) are a continuing concern. In response to numerous safety and performance issues with IV infusion pumps, the Association for the Advancement of Medical Instrumentation (AAMI) joined with the Food and Drug Administration (FDA) to host a summit on infusion devices in October 2010. As described in the subsequent conference report, Infusing Patients Safely, a multidisciplinary steering committee was formed to lead a number of working groups in establishing priorities, developing guidelines, and identifying and sharing best practices to improve the safety of IV infusions. Although the agendas of the various working groups are still being developed, the steering committee has adopted a set of future vision statements to help guide it and the working groups in their efforts to make IV infusions safer. The vision boldly describes an attainable state and sets an aggressive national agenda to capitalize on the present opportunities, stating as its mission that “no patient will be harmed from a drug infusion.” The vision starts with establishing wireless connectivity between a hospital’s hundreds of infusion pumps and the hospital’s wireless network. Without this connectivity, other significant advances for improving infusion safety will be impossible to achieve. With this connectivity, an exciting new state of greatly improved safety, quality and productivity can be attained. This article is based on vendor experience in working with hospital partners to implement wireless connectivity for more than 300,000 infusion devices on wireless networks across hospitals of all sizes and levels of complexity. The benefits, challenges and opportunities of integrating infusion devices into hospitals’ health information technology (HIT) systems will be addressed, along with ways to meet the challenges. The potential impact of the continuing convergence of clinical engineering and information technology (IT) will also be covered.

Nanoporous materials for biomedical devices

Nanoporous materials are currently being developed for use in implantable drug delivery systems, bioartificial organs, and other novel medical devices. Advances in nanofabrication have made it possible to precisely control the pore size, pore distribution, porosity, and chemical properties of pores in nanoporous materials. As a result, these materials are attractive for regulating and sensing transport at the molecular level. In this work, the use of nanoporous membranes for biomedical applications is reviewed. The basic concepts underlying membrane transport are presented in the context of design considerations for efficient size sorting. Desirable properties of nanoporous membranes used in implantable devices, including biocompatibility and antibiofouling behavior, are also discussed. In addition, the use of surface modification techniques to improve the function of nanoporous membranes is reviewed. An intriguing possibility involves functionalizing nanoporous materials with smart polymers in order to modulate biomolecular transport in response to pH, temperature, ionic concentration, or other stimuli. These efforts open up avenues to develop smart medical devices that respond to specific physiological conditions.

Wireless smart implants dedicated to multichannel monitoring and microstimulation

Innovative circuits and systems techniques are required to build advanced smart medical devices (SMD). The high reliability and very low power consumption are among the main criteria that must be given priority to implement in such implantable and wirelessly controlled microsystems. A typical device is composed of several integrated modules to be assembled on a thin substrate providing placement flexibility in the body. Monitoring of electrode-tissue interface condition is needed for enhanced safety, and for enabling troubleshooting after implantation. In order to improve controllability and observability, fully integrated binary phase-shift-keying (BPSK) demodulation combined with a passive modulation method allows full-duplex data high data rate communication between external controllers and implants. Case studies such as peripheral nerve interfaces to recuperate bladder functions, cortical multichannel stimulator, as well as cortical monitoring devices are reported.