Medical devices & sensors最新文献

{"title":"Additive manufacturing for paediatric medical devices","authors":"Anthony Atala MD,&nbsp;Roger J. Narayan MD, PhD","doi":"10.1002/mds3.10137","DOIUrl":"https://doi.org/10.1002/mds3.10137","url":null,"abstract":"<p>It should be noted that there is an absence of satisfactory medical devices for children with many types of medical conditions due to the relatively small size of the paediatric medical service market as compared with the adult medical service market, which does not incentivize many companies to focus on the particular characteristics and needs of children (Field et al., (<span>2006</span>). Five to six per cent of healthcare spending is for children despite the fact the children constitute 25 per cent of the overall population (Barbella, <span>2014</span>). In addition, “the reality of (the medical device companies’) business structures don't allow them to (work on paediatric products) because it's not going to be something that will help their bottom line, and they have to answer to their shareholders” according to Don Lombardi (former Chief Intellectual Property Officer, Boston Children's Hospital, and founder of the Institute for Pediatric Innovation) (Barbella, <span>2014</span>). The return on investment for a paediatric medical device falls below the profit goals of many medical device manufacturers (Crosse<span>2011</span>). In addition, medical devices are now being used with younger patients than in earlier years. Kurt Vedder (CEO, Fixes 4 Kids Inc.) noted that ‘surgeons are operating earlier in a child's life and because of that there's a need for technology, tools and devices (Barbella, <span>2014</span>)'. Another limitation to the development of paediatric medical devices is that each child exhibits a different activity level, chemical composition, height, heart rate and blood pressure from his or her peers; in addition, these values will vary in a given child over time (Barbella, <span>2014</span>). This limitation hinders the development of ‘generic’ medical devices for use over a wide paediatric population. Furthermore, medical device companies may not be able to readily obtain parental consent for a study; such ethical issues are considered a significant challenge to paediatric medical device development. Finally, there is also a perception of higher liability levels associated with paediatric medical devices (Barbella, <span>2014</span>).</p><p>Paediatricians and patient advocates have noted the possibility of adverse outcomes associated with the unavailability of paediatric medical devices (Food &amp; Drug Administration, <span>2004</span>). Many efforts at this time involve ‘working around’ the absence of an appropriate medical device for children with a repurposed adult medical device. For example, stents for use in the bile duct are repurposed for use in paediatric heart catheterization since no paediatric heart stents are available. Although FDA regulations permit ‘off-label’ or unlabelled uses of medical devices, many such devices do not precisely fit patient needs; for example, bile duct stents are associated with risk of either perforating or blocking the blood vessel undergoing treatment (Shaffer et al., <span>1998<","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10137","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92196652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A comparative study on silicon nitride, titanium and polyether ether ketone on mouse pre-osteoblast cells","authors":"Neelam Ahuja,&nbsp;Kamal R. Awad,&nbsp;Marco Brotto,&nbsp;Pranesh B Aswath,&nbsp;Venu Varanasi","doi":"10.1002/mds3.10139","DOIUrl":"10.1002/mds3.10139","url":null,"abstract":"<p>The current study provides more insights about the surface bioactivity of the silicon nitride (Si₃N₄) as a potential candidate for bone regeneration in craniofacial and orthopaedic applications compared with conventional implantation materials. Current skeletal reconstructive materials such as titanium and polyether ether ketone (PEEK) are limited by poor long-term stability, biocompatibility and prolonged healing. Si₃N₄ is an FDA-approved material for an intervertebral spacer in spinal fusion applications. It is biocompatible and has antimicrobial properties. Here, we hypothesize that Si₃N₄ was found to be an osteoconductive material and conducts the growth, differentiation of MC3T3-E1 cells for extracellular matrix deposition, mineralization and eventual bone regeneration for craniofacial and orthopaedic applications. MC3T3-E1 cells were used to study the osteoblastic differentiation and mineralization on sterile samples of Si₃N₄, titanium alloy and PEEK. The samples were then analysed for extracellular matrix deposition and mineralization by FTIR, Raman spectroscopy, SEM, EDX, Alizarin Red, qRT-PCR and ELISA. The in vitro study indicates the formation of collagen fibres and mineral deposition on all three sample surfaces. There was more profound and faster ECM deposition and mineralization on Si₃N₄ surface as compared to titanium and PEEK. The FTIR and Raman spectroscopy show formation of collagen and mineral deposition at 30 days for Si₃N₄ and titanium and not PEEK. The peaks shown by Raman for Si₃N₄ resemble closely to natural bone. Results also indicate the upregulation of osteogenic transcription factors such as RUNX2, SP7, collagen type I and osteocalcin. The authors concluded that Si₃N₄ rapidly conducts mineralized tissue formation via extracellular matrix deposition and biomarker expression in mouse calvarial pre-osteoblast cells. Thus, this study confirms that the bioactive Si₃N₄ could be a potential material for craniofacial and orthopaedic applications leading to rapid bone regeneration that resemble the natural bone structure.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10139","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40408143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamic in vivo protein carbonyl biosensor for measuring oxidative stress","authors":"Roman Kostecki,&nbsp;Azim Arman,&nbsp;Bin Zhang,&nbsp;Kai-Hung Yang,&nbsp;Roger J. Narayan,&nbsp;Mark R. Hutchinson,&nbsp;Heike Ebendorff-Heidepriem","doi":"10.1002/mds3.10135","DOIUrl":"10.1002/mds3.10135","url":null,"abstract":"<p>Oxidative stress is intimately linked to cellular energy balance and occurs when there is an imbalance between production and accumulation of reactive oxygen species in cells and tissues and the ability of a biological system to keep in a redox steady state. While protein carbonyls are an easily detectable marker of oxygen metabolism and oxidative stress, all methods to date have required significant sample preparation and do not provide the ability to measure dynamic changes. To overcome this problem, we develop the first method for measuring in vivo concentration changes of protein carbonyls using a minimally invasive optical fibre biosensor. We use this biosensor to measure redox balance and oxidative stress within living systems by measuring dynamic in vivo concentration changes of protein carbonyls.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10135","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46315283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antifungal polymers for medical applications","authors":"Marlene Alejandra Velazco-Medel,&nbsp;Luis Alberto Camacho-Cruz,&nbsp;José Carlos Lugo-González,&nbsp;Emilio Bucio","doi":"10.1002/mds3.10134","DOIUrl":"10.1002/mds3.10134","url":null,"abstract":"<p>Fungi-associated infections are very common diseases in humans, and these have increased in immunocompromised population and hospitalized patients. Fungi grow almost in any environment, and they reproduce easily in dirt and wet spaces, and thus, the development of antifungal materials is focused on avoiding fungal infections or inhibiting growth. Polymers used for medical devices are susceptible to microorganism adhesion. Therefore, they have been treated and modified for the inhibition of fungi growth. There are two pathways to deal with these microorganisms, firstly, the synthesis of versatile polymeric materials with antifouling properties, and, secondly, the development of materials for controlled fungicide release. These two approaches have been used in the crafting of food packaging. Additionally, sophisticated polymeric drug delivery systems have allowed the systematic and localized administration of fungicides reducing doses with a prolonged delivery. This general purpose has been accomplished by the synthesis of polymeric composites, grafted polymers or the modification of polymeric fungicides, by the coupling of cationic moieties on polymers, using metallic salts and nanoparticles, and by the loading of fungicides in micelles and metallic nanoparticles. Most of the materials presented on this review are still at an early stage of development. This compilation intends to be a frame of reference for researchers willing to explore this topic since clinical applications of these materials are starting to be increasingly relevant.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10134","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"51382019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electrospinning for the manufacture of biosensor components: A mini-review","authors":"Jubair Ahmed","doi":"10.1002/mds3.10136","DOIUrl":"https://doi.org/10.1002/mds3.10136","url":null,"abstract":"<p>One of the key modern advancements of the biomaterial's world has been the recent progress with fibre manufacturing techniques which have allowed for novel approaches to biosensor fabrication. Electrospinning is capable of producing ultrafine and highly tailored fibres that can be made from a wide variety of natural and synthetic materials to be exploited for use as medical sensors. In recent years, electrospinning has been more widely researched and great strides have been made in its ability to produce fibres with more desirable properties. In this mini-review, the process of electrospinning is overviewed with an emphasis on its properties in producing biosensor components. It is seen how the advancements of nanotechnology allows for easier incorporation of bioreceptors to a larger range of membranes that are capable of higher sensitivity and broader applications. Furthermore, newer manufacturing techniques that are also capable of producing ultra-thin fibres are elaborated and the future of biosensor production in taking advantage of micro- and nano-scaled components are discussed.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10136","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92303546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecularly Imprinted Polymer-based detection of creatinine towards smart sensing","authors":"Sumedha N. Prabhu,&nbsp;Subhas C. Mukhopadhyay,&nbsp;Chinthaka P. Gooneratne,&nbsp;Andrew S. Davidson,&nbsp;Guozhen Liu","doi":"10.1002/mds3.10133","DOIUrl":"10.1002/mds3.10133","url":null,"abstract":"<p>Creatinine is a biological metabolic waste which constantly gets diffused in the human blood. It is excreted by the kidneys to reduce levels of blood toxicity thus maintaining homeostasis. In this research, a synthetic polymer for determining the creatinine levels has been developed using Molecularly Imprinted Polymerization (MIP) synthesis protocol. The polymer is highly specific towards selective adsorption of creatinine molecules. The developed MIP is capable of determining concentrations of creatinine up to 50 parts per million (ppm) which is three times higher than the normal range of creatinine concentration in the human blood. The functioning of the sensor is checked with electrochemical impedance spectroscopy (EIS) technique. Although the purpose of this work is early diagnosis of creatinine rise and to monitor kidney health for avoiding further healthcare-associated complications, the results are accessed up to 50 ppm. The MIP functionality is accessed up to 50 ppm to confirm that even if the developed sensing technology is used for a patient having higher creatinine concentrations, the MIP polymer has the potential to adsorb creatinine and display the results. After the successful development of MIP polymer, a LoRaWAN (Long Range Wide Area Network)-based Point-of-Care (PoC) sensing device has been developed in this research and results are displayed. The portable device promotes early detection of kidney injury, which will help start the treatment early. The results obtained from the system will help doctors in taking necessary measures to avoid further kidney (renal) disorders including acute kidney failure and chronic kidney failure.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10133","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"98931763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biocompatible hydrogel ostomy adhesive","authors":"William Pan,&nbsp;Beverly Matsuda,&nbsp;Hyunwoo Yuk","doi":"10.1002/mds3.10132","DOIUrl":"10.1002/mds3.10132","url":null,"abstract":"<p>Ostomies are digestive and excretory surgeries where waste is redirected to the outside of the abdomen, requiring a bag to catch excretion. Current methods use adhesives to create adhesion for 24-h usage of the ostomy bag. However, current adhesives are weak and unstable, and often lead to leakages of ostomy effluents resulting in various clinical complications including irritant dermatitis and infection. Due to these challenges, no commercially available product provides strong enough adhesion nor mechanical softness to prevent skin damage from ostomy leaks. In this work, we introduce a hydrogel ostomy adhesive (HOA) made from a tough double-network hydrogel based on polyacrylamide and sodium alginate that strongly adheres onto the skin for over 24 h and prevents leaks by maintaining fluid-tight sealing against regular bodily movements. The adhesion of HOA to abdominal skin is achieved by the topological adhesion formed by a biopolymer chitosan solution. The HOA’s robust adhesion of an ostomy bag is demonstrated on <i>ex vivo</i> porcine skin and <i>in vivo</i> human skin and is compared with existing commercially available ostomy bag adhesives.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10132","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42782910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A versatile reactive oxygen species-responsive gels sensor for analysis of metabolic species","authors":"Samuel M. Mugo,&nbsp;Weihao Lu","doi":"10.1002/mds3.10131","DOIUrl":"10.1002/mds3.10131","url":null,"abstract":"<p>We report a flexible redox responsive polymer-based sensor for detection of reactive oxygen species (ROS). The sensor comprises multilayers of silver nanoparticles (AgNPs), carbon nanotube/cellulose nanocrystal (CNT/CNC) and a redox responsive poly (glycidyl methacrylate-<i>co</i>-ethylene glycol dimethacrylate-<i>co</i>-vinyl ferrocene), herewith called poly (GMA-<i>co</i>-EGDMA-<i>co</i> Fc) nanoferrogels. These sensor layers were printed on a micropillared polydimethylsiloxane (PDMS) substrate. The nanoferrogel sensor versatility has been demonstrated in its effective detection of ROS species, specifically H₂O₂, peroxylipids, and oxidative deriving species such as cholesterol and unsaturated triglycerides. The nanoferrogel ROS sensor rapidly (~1 min) responds to both H₂O₂ and peroxylipids with a limit of detection (LOD) of ~0.060 ± 0.001 µg/ml) and 0.012 ± 0.001 µg/ml, respectively. The cholesterol oxidase and lipoxygenase-based nanoferrogel sensor were successfully evaluated for the detection of cholesterol (LOD of 0.12 ± 0.02 µg/ml) and glyceryltrilinoeate (LOD of 1.8 ± 0.2 ng/ml) standards, respectively. These enzyme-loaded ROS nanoferrogel sensors were also evaluated for quantification of cholesterol and glyceryltrilinoeate in bacon lard and olive oils. The fabricated flexible ROS sensors are versatile for quantitation of oxidative stress biomarkers, useful in myriad applications including clinical, environmental, food, and plant physiology.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10131","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43637782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances and current challenges in non-invasive wearable sensors and wearable biosensors—A mini-review","authors":"Caio Carvalho dos Santos,&nbsp;Guilherme N. Lucena,&nbsp;Gabriel C. Pinto,&nbsp;Miguel J. Júnior,&nbsp;Rodigo F.C. Marques","doi":"10.1002/mds3.10130","DOIUrl":"https://doi.org/10.1002/mds3.10130","url":null,"abstract":"<p>Flexible wearable sensors and wearable biosensors have attracted considerable interest in the scientific community. They have shown relevant potential for continuous monitoring of physiological functions in real-time and non-invasively using biofluids. Recent nanotechnology advances in sensor miniaturization and lower costs have driven the development of new flexible sensors. These new materials make sensors and biosensors promising and will cause a substantial impact on society by providing an improvement in the quality of life, as well as in a faster diagnosis and early treatment. However, considerable challenges still need to be overcome for these sensors to reach their totality, as such as improving available power supplies, low power data transmission mode, problems with device deformation and contaminated, continuous wear, understanding the correlations between analytes in biofluids and blood to validate results, and issues of security and privacy. Overcoming these challenges will allow, through the diffusion of this technology, to modify how the disease can be monitored in the future. Due to this, systematic studies should be conducted to elucidate and enhance the understanding of the current challenges for the development and implementation of wearable sensors (WS) and wearable biosensors (WBS). In this mini-review, we discuss the state of the art of these devices, critically addressing the advances by debating the current gaps and the challenges that need to overcome this science area.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92199285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent advances of medical biosensors for clinical applications","authors":"Yeşeren Saylan,&nbsp;Erdoğan Özgür,&nbsp;Adil Denizli","doi":"10.1002/mds3.10129","DOIUrl":"https://doi.org/10.1002/mds3.10129","url":null,"abstract":"<p>The determination of clinically important biomolecules such as proteins, amino acids, antibodies, enzymes, nucleic acids, hormones and cells is necessary to figure out the physiological and biological functions and also to develop the diagnostics platforms. The improvement of medical biosensors for highly selective, sensitive and rapid biomolecule detection has fundamental significance for clinical diagnostics. Many potential analytical complexities can be smoothly sorted by the biosensors. Health problems have appeared due to the rising population with a risk of chronic diseases such as tuberculosis, prostate, stroke, cardiovascular disease and cancer that require to be deciphered for common health. This review summarizes the importance of medical biosensors for clinical applications, and the use of medical biosensors in the diagnosis of various diseases is extensively discussed with different types of biosensors. Conclusion and future outlooks are mentioned at the end of the review.</p>","PeriodicalId":87324,"journal":{"name":"Medical devices & sensors","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/mds3.10129","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92371034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}