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https://www.readbyqxmd.com/read/28479938/statistical-shape-modeling-for-cavopulmonary-assist-device-development-variability-of-vascular-graft-geometry-and-implications-for-hemodynamics
#1
Jan L Bruse, Giuliano Giusti, Catriona Baker, Elena Cervi, Tain-Yen Hsia, Andrew M Taylor, Silvia Schievano
Patients born with a single functional ventricle typically undergo three-staged surgical palliation in the first years of life, with the last stage realizing a cross-like total cavopulmonary connection (TCPC) of superior and inferior vena cavas (SVC and IVC) with both left and right pulmonary arteries, allowing all deoxygenated blood to flow passively back to the lungs (Fontan circulation). Even though within the past decades more patients survive into adulthood, the connection comes at the prize of deficiencies such as chronic systemic venous hypertension and low cardiac output, which ultimately may lead to Fontan failure...
June 2017: Journal of Medical Devices
https://www.readbyqxmd.com/read/28457656/stimulating-patient-engagement-in-medical-device-development%C3%A2-in-kidney-disease-a-report-of-a-kidney-health%C3%A2-initiative-workshop
#2
Frank P Hurst, Dolph Chianchiano, Linda Upchurch, Benjamin R Fisher, Jennifer E Flythe, Celeste Castillo Lee, Terri Hill, Carolyn Y Neuland
New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders...
April 27, 2017: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/28446007/collaborative-efforts-among-the-fields-of-technology-device-development-and-medicine
#3
Tack Lee
No abstract text is available yet for this article.
April 2017: International Neurourology Journal
https://www.readbyqxmd.com/read/28413621/recent-advances-in-pediatric-ventilatory-assistance
#4
REVIEW
Nicolas Nardi, Guillaume Mortamet, Laurence Ducharme-Crevier, Guillaume Emeriaud, Philippe Jouvet
In this review on respiratory assistance, we aim to discuss the following recent advances: the optimization and customization of mechanical ventilation, the use of high-frequency oscillatory ventilation, and the role of noninvasive ventilation. The prevention of ventilator-induced lung injury and diaphragmatic dysfunction is now a key aspect in the management of mechanical ventilation, since these complications may lead to higher mortality and prolonged length of stay in intensive care units. Different physiological measurements, such as esophageal pressure, electrical activity of the diaphragm, and volumetric capnography, may be useful objective tools to help guide ventilator assistance...
2017: F1000Research
https://www.readbyqxmd.com/read/28394582/multiplex-paper-based-colorimetric-dna-sensor-using-pyrrolidinyl-peptide-nucleic-acid-induced-agnps-aggregation-for-detecting-mers-cov-mtb-and-hpv-oligonucleotides
#5
Prinjaporn Teengam, Weena Siangproh, Adisorn Tuantranont, Tirayut Vilaivan, Orawon Chailapakul, Charles S Henry
The development of simple fluorescent and colorimetric assays that enable point-of-care DNA and RNA detection has been a topic of significant research because of the utility of such assays in resource limited settings. The most common motifs utilize hybridization to a complementary detection strand coupled with a sensitive reporter molecule. Here, a paper-based colorimetric assay for DNA detection based on pyrrolidinyl peptide nucleic acid (acpcPNA)-induced nanoparticle aggregation is reported as an alternative to traditional colorimetric approaches...
April 27, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28381720/practice-of-regulatory-science-development-of-medical-devices
#6
REVIEW
Shingo Niimi
 Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28366058/novel-and-emerging-technologies-for-endovascular-thrombectomy
#7
REVIEW
Alexander G Chartrain, Ahmed J Awad, Justin R Mascitelli, Hazem Shoirah, Thomas J Oxley, Rui Feng, Matthew Gallitto, Reade De Leacy, Johanna T Fifi, Christopher P Kellner
Endovascular thrombectomy device improvements in recent years have served a pivotal role in improving the success and safety of the thrombectomy procedure. As the intervention gains widespread use, developers have focused on maximizing the reperfusion rates and reducing procedural complications associated with these devices. This has led to a boom in device development. This review will cover novel and emerging technologies developed for endovascular thrombectomy.
April 2017: Neurosurgical Focus
https://www.readbyqxmd.com/read/28363253/the-traumatic-brain-injury-endpoints-development-ted-initiative-progress-on-a-public-private-regulatory-collaboration-to-accelerate-diagnosis-and-treatment-of-traumatic-brain-injury
#8
Geoffrey T Manley, Christine L MacDonald, Amy Markowitz, Diane Stephenson, Ann Robbins, Raquel C Gardner, Ethan A Winkler, Yelena Bodien, Sabrina Taylor, John K Yue, Lakshmi Kannan, Allison Kumar, Michael McCrea, Kevin K W Wang
The Traumatic Brain Injury Endpoints Development (TED) Initiative is a 5-year, Department of Defense (DoD) funded project that is working toward the ultimate goal of developing better designed clinical trials, leading to more precise diagnosis, and effective treatments for traumatic brain injury (TBI). TED is comprised of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropists, working collaboratively with regulatory authorities, specifically the US Food and Drug Administration (FDA)...
March 31, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/28351879/a-non-gas-based-cryotherapy-system-for-the-treatment-of-cervical-intraepithelial-neoplasia-a-mixed-methods-approach-for-initial-development-and-testing
#9
Miriam Cremer, Proma Paul, Katie Bergman, Michael Haas, Mauricio Maza, Albert Zevallos, Miguel Ossandon, Jillian D Garai, Jennifer L Winkler
BACKGROUND: Gas-based cryotherapy is the most widely used treatment strategy for cervical intraepithelial neoplasia (CIN) in low-resource settings, but reliance on gas presents challenges in low- and middle-income countries (LMICs). Our team adapted the original CryoPen Cryosurgical System, a cryotherapy device that does not require compressed gas and is powered by electricity, for use in LMICs. METHODS: A mixed-methods approach was used involving both qualitative and quantitative methods...
March 24, 2017: Global Health, Science and Practice
https://www.readbyqxmd.com/read/28349598/ultra-light-extensometer-for-the-assessment-of-the-mechanical-properties-of-the-human-skin-in-vivo
#10
E Jacquet, S Joly, J Chambert, K Rekik, P Sandoz
BACKGROUND/PURPOSE: This paper aims to present an ultra-light extensometer device dedicated to the mechanical characterization of the human skin in vivo. METHODS: The device developed was conceived to be non-invasive, to work without any stand and to perform various uniaxial tensile tests with either effort or displacement control. We also use specific guarding tabs to make in vivo extension tests analogous to traction tests. RESULTS: Force-displacement curves are derived from the data provided by the device's sensors...
March 28, 2017: Skin Research and Technology
https://www.readbyqxmd.com/read/28343699/operative-innovation-and-device-development-a-trainee-s-perspective
#11
Farokh R Demehri
Farokh R. Demehri, MD, is a chief resident in general surgery and Pediatric Innovation Fellow at the University of Michigan. As a trainee, he has worked on device development in pediatric enteral access with James D. Geiger, MD, and device solutions for short bowel syndrome under the mentorship of Daniel H. Teitelbaum, MD.
April 2017: Surgery
https://www.readbyqxmd.com/read/28343621/fixed-flexion-knee-radiography-using-a-new-positioning-device-produced-highly-repeatable-measurements-of-joint-space-width-elsa-brasil-musculoskeletal-study-elsa-brasil-msk
#12
Rosa Weiss Telles, Luciana Costa-Silva, Luciana A C Machado, Rodrigo Citton Padilha Dos Reis, Sandhi Maria Barreto
OBJECTIVE: To describe the performance of a non-fluoroscopic fixed-flexion PA radiographic protocol with a new positioning device, developed for the assessment of knee osteoarthritis (OA) in Brazilian Longitudinal Study of Adult Health Musculoskeletal Study (ELSA-Brasil MSK). MATERIAL AND METHODS: A test-retest design including 19 adults (38 knee images) was conducted. Feasibility of the radiographic protocol was assessed by image quality parameters and presence of radioanatomic alignment according to intermargin distance (IMD) values...
March 2017: Revista Brasileira de Reumatologia
https://www.readbyqxmd.com/read/28324184/early-outcomes-of-spinal-growth-tethering-for-idiopathic-scoliosis-with-a-novel-device-a-prospective-study-with-2-years-of-follow-up
#13
M Boudissa, A Eid, E Bourgeois, J Griffet, A Courvoisier
QUESTIONS/PURPOSES: Adolescent idiopathic scoliosis is a 3D spine deformity that worsens during the whole growth. New methods for spinal growth modulation with flexible spinal implants have been described to avoid progression of the deformity during growth spurt. The main limitations are that no specific ancillaries and devices are available, which makes the surgery technically demanding. METHODS: We have developed a new method of spinal growth tethering using minimal invasive videothoracoscopic approach...
March 21, 2017: Child's Nervous System: ChNS: Official Journal of the International Society for Pediatric Neurosurgery
https://www.readbyqxmd.com/read/28302745/current-status-and-future-potential-of-transcatheter-interventions-in-congenital-heart-disease
#14
REVIEW
Damien P Kenny, Ziyad M Hijazi
Percutaneous therapies for congenital heart disease have evolved rapidly in the past 3 decades. This has occurred despite limited investment from industry and support from regulatory bodies resulting in a lack of specific device development. Indeed, many devices remain off-label with a best-fit approach often required, spurning an innovative culture within the subspecialty, which had arguably laid the foundation for many of the current and evolving structural heart interventions. Challenges remain, not least encouraging device design focused on smaller infants and the inevitable consequences of somatic growth...
March 17, 2017: Circulation Research
https://www.readbyqxmd.com/read/28300033/-current-status-of-extracorporeal-shock-wave-lithotripsy-in-urinary-lithiasis
#15
Jose Gregorio Pereira-Arias, Mikel Gamarra-Quintanilla, Luis Felipe Urdaneta-Salegui, Jorge Alberto Mora-Christian, Andrea Sánchez-Vazquez, Ander Astobieta-Odriozola, Gaspar Ibarluzea-González
Over the last decade, urinary lithiasis' prevalence has dramatically increased due to diet and lifestyle changes, growing 10.6% and 7.1% in men and women respectively. Extracorporeal shock wave lithotripsy has lost relevance in current practice due to endoscopic device development and unpredictability of results. Instrument miniaturization is leading to an increase of the percutaneous approach of increasingly smaller stones, while most flexible ureteroscopes durability and digitalization has allowed urologists to address larger stones...
March 2017: Archivos Españoles de Urología
https://www.readbyqxmd.com/read/28299697/monitoring-the-cellular-binding-events-with-quartz-crystal-microbalance-qcm-biosensors
#16
Abdul Rehman, Xiangqun Zeng
Quartz crystal microbalance (QCM) biosensors have been demonstrated as noninvasive and label-free tools for cell based measurements. However, the complexity of biofilms composed of cells with the associated liquid environments is preventive towards forming explicit relationship between the added mass and the change in the frequency output signal. Therefore, the protocols of interface design (surface chemistry, interaction mechanism, and data acquisition), data interpretation, and device fabrication, all need to be finely refined in order to make these biosensors prevail in real life...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28287582/polydimethylsiloxane-polycarbonate-microfluidic-devices-for-cell-migration-studies-under-perpendicular-chemical-and-oxygen-gradients
#17
Hung-Ju Chiang, Sih-Ling Yeh, Chien-Chung Peng, Wei-Hao Liao, Yi-Chung Tung
This paper reports a microfluidic device made of polydimethylsiloxane (PDMS) with an embedded polycarbonate (PC) thin film to study cell migration under combinations of chemical and oxygen gradients. Both chemical and oxygen gradients can greatly affect cell migration in vivo; however, due to technical limitations, very little research has been performed to investigate their effects in vitro. The device developed in this research takes advantage of a series of serpentine-shaped channels to generate the desired chemical gradients and exploits a spatially confined chemical reaction method for oxygen gradient generation...
February 23, 2017: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/28285169/microbial-profiling-of-cpn60-universal-target-sequences-in-artificial-mixtures-of-vaginal-bacteria-sampled-by-nylon-swabs-or-self-sampling-devices-under-different-storage-conditions
#18
John J Schellenberg, Angela Yena Oh, Janet E Hill
The vaginal microbiome is increasingly characterized by deep sequencing of universal genes. However, there are relatively few studies of how different specimen collection and sample storage and processing influence these molecular profiles. Here, we evaluate molecular microbial community profiles of samples collected using the HerSwab™ self-sampling device, compared to nylon swabs and under different storage conditions. In order to minimize technical variation, mixtures of 11 common vaginal bacteria in simulated vaginal fluid medium were sampled and DNA extracts prepared for massively parallel sequencing of the cpn60 universal target (UT)...
March 9, 2017: Journal of Microbiological Methods
https://www.readbyqxmd.com/read/28269239/use-of-activity-theory-based-need-finding-for-biomedical-device-development
#19
Shalaleh Rismani, Matt Ratto, H F Machiel Van der Loos
Identifying the appropriate needs for biomedical device design is challenging, especially for less structured environments. The paper proposes an alternate need-finding method based on Cultural Historical Activity Theory and expanded to explicitly examine the role of devices within a socioeconomic system. This is compared to a conventional need-finding technique in a preliminary study with engineering student teams. The initial results show that the Activity Theory-based technique allows teams to gain deeper insights into their needs space...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28266047/-how-much-realism-is-needed-the-wrong-question-in-silico-imagers-have-been-asking
#20
Aldo Badano
PURPOSE: To discuss the use of realism as a first approximation for assessing computational imaging methods. METHODS: Although in silico methods are increasingly becoming promising surrogates to physical experimentation for various stages of device development, their acceptance remains challenging. Realism is often considered as a first approximation for assessing computational imaging methods. However, realism is subjective and does not always ensure that key features of the methodologies reflect relevant aspects of devices of interest to imaging scientists, regulators, and medical practitioners...
March 7, 2017: Medical Physics
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