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Background: Medical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage a challenging patchwork of regulatory activities. A standalone regulatory agreement could clarify the relationships and responsibilities between companies working jointly on a single regulated product. This study explored the need for and current use of standalone regulatory agreements. Methods: A survey instrument was developed using an implementation framework and disseminated to mid- to senior-level employees and consultants for sponsor and vendor companies in the medical products sector. Results: Of 294 respondents, about half, primarily from companies with more than 200 employees, were familiar with standalone regulatory agreements, and half of this subgroup had moved forward to implement them. Such agreements were considered beneficial to clarify regulatory roles and responsibilities, standardize regulatory expectations between the companies, and stimulate earlier discussion about joint regulatory strategies. However, the development of regulatory agreements appears challenged by the fact that such agreements are not required by regulatory agencies overseeing medical products and have no standardized templates, agency or industry guidance. Respondents whose organizations do not now use regulatory agreements either had not considered or did not see a need for a standalone agreement. Conclusions: Standalone regulatory agreements are becoming more common but are not yet implemented fully by most companies. Their usefulness and content appeared to depend upon the type of partner, the complexity of the relationship and the availability of internal expertise and support. [ABSTRACT FROM AUTHOR]

Copyright of Lubrication Engineering (0254-0150) is the property of Editorial Office of LUBRICATION ENGINEERING and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Point-of-care testing (POCT) involves conducting diagnostic tests outside the laboratory. These tests are utilized for their quick and reliable results in detecting chronic diseases and acute infections. We examined the historical market value trends of the POCT industry and projected its future growth. POCT devices offer several advantages, such as portability, no specific storage requirements, and simplicity of use. However, issues such as inaccurate results can reduce demand for POCT compared to traditional laboratory testing alternatives. While the benefits of POCT are clear, it's important to acknowledge the challenges. The accuracy of POCT devices can be compromised due to factors such as user error, environmental conditions, and limitations in technology. Furthermore, the cost-effectiveness of these devices is often a concern, particularly in resource-limited settings. The regulatory landscape for POCT is also complex and varies by region, which can pose challenges for manufacturers and end-users. Improvements in POCT devices' sensitivity, specificity, cost, and turnaround time for test results could enhance their utility. Enhancements to a POCT device should be considered if they are economically viable and lead to a significant increase in demand. Our financial analysis of the POCT market revealed a positive growth trend. We identified potential areas for growth that could help the industry progress and expand in line with its projected growth in the coming years. The industry could focus on integrating intelligent technologies into POCT devices and collaborating with the innovative technology sector to increase revenue. It could also develop more sensitive and accurate POCT devices for non-communicable diseases. Another potential area of growth is in diseases that require continuous patient monitoring but where conventional clinical testing is time-consuming. Enhancing the POCT devices used in these areas could revolutionize medical diagnosis and potentially save many lives, provided they meet clinical standards. [ABSTRACT FROM AUTHOR]

Point-of-care testing (POCT) involves conducting diagnostic tests outside the laboratory. These tests are utilized for their quick and reliable results in detecting chronic diseases and acute infections. We examined the historical market value trends of the POCT industry and projected its future growth. POCT devices offer several advantages, such as portability, no specific storage requirements, and simplicity of use. However, issues such as inaccurate results can reduce demand for POCT compared to traditional laboratory testing alternatives. While the benefits of POCT are clear, it’s important to acknowledge the challenges. The accuracy of POCT devices can be compromised due to factors such as user error, environmental conditions, and limitations in technology. Furthermore, the cost-effectiveness of these devices is often a concern, particularly in resource-limited settings. The regulatory landscape for POCT is also complex and varies by region, which can pose challenges for manufacturers and end-users. Improvements in POCT devices’ sensitivity, specificity, cost, and turnaround time for test results could enhance their utility. Enhancements to a POCT device should be considered if they are economically viable and lead to a significant increase in demand. Our financial analysis of the POCT market revealed a positive growth trend. We identified potential areas for growth that could help the industry progress and expand in line with its projected growth in the coming years. The industry could focus on integrating intelligent technologies into POCT devices and collaborating with the innovative technology sector to increase revenue. It could also develop more sensitive and accurate POCT devices for non-communicable diseases. Another potential area of growth is in diseases that require continuous patient monitoring but where conventional clinical testing is time-consuming. Enhancing the POCT devices used in these areas could revolutionize medical diagnosis and potentially save many lives, provided they meet clinical standards.

The development of diagnostics and medical devices has historically been concentrated in high-income countries, despite a significant need to expand healthcare services to low- and middle-income countries (LMIC). Poor quality healthcare extends beyond LMIC to underserved communities in developed countries. This paper reviews diseases and conditions that have not received much attention in the past despite imposing a significant burden on healthcare systems in these circumstances. We review the underlying mechanism of action of these conditions and current technology in use for diagnosis or surgical intervention. We aim to identify areas for technological development and review policy considerations that will enable real-world adoption. Specifically, this review focuses on diseases prevalent in sub-Saharan Africa and south Asia: melioidosis, infant and maternal mortality, schistosomiasis, and heavy metal and pesticide poisoning. Our aim with this review is to identify problems facing the world that require the attention of the medical device community and provide recommendations for research directions for groups interested in this field.

Background: Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. Objectives: National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD. NIDA aims to support research and development of medical devices intended to monitor, diagnose, or treat substance use disorders. Results: NIDA participates in Blueprint MedTech program is part of the large NIH Blueprint for Neurological Research Initiative. It supports the research and development of new medical devices through product optimization, pre-clinical testing, and human subject studies, including clinical trials. The program is structured in two main components - Blueprint MedTech Incubator and Blueprint MedTech Translator. It offers free to the researcher services that are typically unavailable in academic environment - business expertise facilities and staffing to successfully develop minimum viable devices, pre-clinical bench testing, clinical studies, planning and executing in manufacturing, as well as regulatory expertise. Conclusions: Through Blueprint MedTech, NIDA provides innovators with expanded resources to ensure the success of the research. [ABSTRACT FROM AUTHOR]

The emerging use of low-temperature plasma in medicine, especially in wound treatment, calls for a better way of documenting the treatment parameters. This paper describes the development of a mobile sensory device (referred to as MSD) that can be used during the treatment to ease the documentation of important parameters in a streamlined process. These parameters include the patient's general information, plasma source device used in the treatment, plasma treatment time, ambient humidity and temperature. MSD was developed as a standalone Raspberry Pi-based version and attachable module version for laptops and tablets. Both versions feature a user-friendly GUI, temperature–humidity sensor, microphone, treatment report generation and export. For the logging of plasma treatment time, a sound-based plasma detection system was developed, initially for three medically certified plasma source devices: kINPen® MED, plasma care®, and PlasmaDerm® Flex. Experimental validation of the developed detection system shows accurate and reliable detection is achievable at 5 cm measurement distance in quiet and noisy environments for all devices. All in all, the developed tool is a first step to a more automated, integrated, and streamlined approach of plasma treatment documentation that can help prevent user variability. [ABSTRACT FROM AUTHOR]

New transapical minimally invasive artificial chordae implantation devices are a promising alternative to traditional open-heart repair, with the potential for decreased postoperative morbidity and reduced recovery time. However, these devices can place increased stress on the artificial chordae. We designed an artificial papillary muscle to alleviate artificial chordae stresses and thus increase repair durability. The artificial papillary muscle device is a narrow elastic column with an inner core that can be implanted during the minimally invasive transapical procedure via the same ventricular incision site. The device was 3-dimensionally printed in biocompatible silicone for this study. To test efficacy, porcine mitral valves (n = 6) were mounted in a heart simulator, and isolated regurgitation was induced. Each valve was repaired with a polytetrafluoroethylene suture with apical anchoring followed by artificial papillary muscle anchoring. In each case, a high-resolution Fiber Bragg Grating sensor recorded forces on the suture. Hemodynamic data confirmed that both repairs—with and without the artificial papillary muscle device—were successful in eliminating mitral regurgitation. Both the peak artificial chordae force and the rate of change of force at the onset of systole were significantly lower with the device compared with apical anchoring without the device (P <.001 and P <.001, respectively). Our novel artificial papillary muscle could integrate with minimally invasive repairs to shorten the artificial chordae and behave as an elastic damper, thus reducing sharp increases in force. With our device, we have the potential to improve the durability of off-pump transapical mitral valve repair procedures. [Display omitted] [ABSTRACT FROM AUTHOR]

We present a first in human clinical trial of a new rectoscope that shows, by means of transillumination, the optimal point of transection of the rectum in oncologic surgery. The device was developed together with a team of engineers and was manufactured by 3D printing. Eighteen patients with a mean age of 71 years and a mean distance from the tumor to the anal margin measured by colonoscopy of 10.4 ± 3.9 cm and by MRI of 10 ± 2.4 cm were included in the trial. Transillumination was feasible in all cases, and the use of the rectoscope was safe, as no adverse events due to its use were recorded., (Copyright © 2024 AEC. Published by Elsevier España, S.L.U. All rights reserved.)

Changes in the mechanical properties of single cells are related to the physiological state and fate of cells. The construction of cell constitutive equations is essential for understanding the material characteristics of single cells. With the help of atomic force microscopy, bio-image processing algorithms, and other technologies, research investigating the mechanical properties of cells during static/quasi-static processes has developed rapidly. A series of equivalent models, such as viscoelastic models, have been proposed to describe the constitutive behaviors of cells. The stress-strain relations under dynamic processes are essential to completing the constitutive equations of living cells. To explore the dynamic mechanical properties of cells, we propose a novel method to generate a controllable dynamical compression shear coupling stress on living cells. A CFD model was established to visualize this method and display the theories, as well as assess the scope of the application. As the requirements or limitations are met, researchers can adjust the details of this model according to their lab environment or experimental demands. This micro-flow channel-based method is a new tool for approaching the dynamic mechanical properties of cells.

Traumatic brain injury (TBI), which is mainly caused by impact, often results in chronic neurological abnormalities. Since the pathological changes in vivo during primary biomechanical injury are quite complicated, the in-depth understanding of the pathophysiology and mechanism of TBI depends on the establishment of an effective experimental in vitro model. Usually, a bomb explosive blast was employed to establish the in vitro model, while the process is complex and unsuitable in the lab. Based on water-hammer, we have developed a device system to provide a single dynamic compression stress on living cells. A series of amplitude (∼5.3, ∼9.8, ∼13.5 MPa) were generated to explore the effects of dynamic compression loading on primary microglia within 48 h. Apoptosis experiments indicated that primary microglia had strong tolerance to blast waves. In addition, the generation of intercellular reactive oxygen species and secretory nitric oxide was getting strongly enhanced and recovered within 48 h. In addition, there is a notable release of pro-inflammatory cytokine by microglia. Our work provides a reproducible and peaceable method of loading single dynamic compression forces to cells in vitro. Microglia showed an acute inflammatory response to dynamic loadings, while no significant cell death was observed. This insight delivers a new technological approach that could open new areas to a better understanding of the mechanism of cell blast injuries.

Abstract Objectives Endoscopic submucosal dissection (ESD) has become popular, but complications such as postoperative bleeding remain an issue. Although some methods of closing a mucosal defect with a snare and clips have been reported to be effective and safe, the snare is not a dedicated device, and the procedure is difficult and time‐consuming. We aimed to find an alternative method for defect closure after ESD by developing a dedicated device. Methods We have improved five prototypes. The load on the stopper when starting to tighten and loosen a loop and the maximum load on the stopper and the movement distance of the thread when sliding the stopper were measured five times for each prototype. With the 5th prototype, we finalized the design and named it FLEXLOOP. Additionally, the material and shape of the outer tube were improved. Then, the usability of FLEXLOOP was evaluated in pigs. The operation time for closing mucosal defects with the snare or FLEXLOOP was measured five times. Results We made FLEXLOOP, which had a lower load when sliding and a higher load when loosening than the snare. The improvement of the outer tube significantly reduced the load on the sheath when sliding it. We confirmed the feasibility of mucosal defect closure with FLEXLOOP in pigs. The median operation time was 563 s (range 340–679 s) with the snare and 355 s (range 303–455 s) with FLEXLOOP (p = 0.047). Conclusions FLEXLOOP can be a promising option for defect closure after ESD.

A shortage of medical devices designed for children persists due to the smaller pediatric population and market factors. Furthermore, pediatric device development is challenging due to the limited available funding sources. We describe our experience with pediatric device projects that successfully received federal grant support towards commercializing the devices that can serve as a guide for future innovators. The developmental pathways of pediatric device projects at a tertiary-care children's hospital that received NIH SBIR/STTR funding between 2016–2019 were reviewed. The clinical problems, designs, specific aims, and development phase were delineated. Pediatric faculty successfully secured NIH SBIR/STTR funding for five pediatric devices via qualified small business concerns (SBC's). Three projects were initiated in the capstone engineering design programs and developed further at two affiliated engineering schools, while the other two projects were developed in the faculty members' labs. Four projects received funding via established SBC's, while one was awarded funding via a newly established SBC. NIH SBIR/STTR grants are an essential source of external non-dilutive funding for pediatric device innovation and especially for academic-initiated projects. This funding can provide needed early-stage support to facilitate commercialization. In addition, these grants can serve as achievable accomplishments for pediatric faculty portfolios toward academic promotion. Our experience shows that it is possible to build a robust innovation ecosystem comprised of academic faculty (clinical/engineering) collaborating with local device development companies while jointly implementing a product development strategy leveraging NIH SBIR/STTR funding for critical translational research phases of pediatric device development. [ABSTRACT FROM AUTHOR]

The China State Council released the new generation artificial intelligence (AI) development plan, outlining China's ambitious aspiration to assume global leadership in AI by the year 2030. This initiative underscores the extensive applicability of AI across diverse domains, including manufacturing, law, and medicine. With China establishing itself as a major producer and consumer of medical devices, there has been a notable increase in software registrations. This study aims to study the proliferation of health care-related software development within China. This work presents an overview of the Chinese regulatory framework for medical device software. The analysis covers both software as a medical device and software in a medical device. A comparative approach is employed to examine the regulations governing medical devices with AI and machine learning in China, the United States, and Europe. The study highlights the significant proliferation of health care-related software development within China, which has led to an increased demand for comprehensive regulatory guidance, particularly for international manufacturers. The comparative analysis reveals distinct regulatory frameworks and requirements across the three regions. This paper provides a useful outline of the current state of regulations for medical software in China and identifies the regulatory challenges posed by the rapid advancements in AI and machine learning technologies. Understanding these challenges is crucial for international manufacturers and stakeholders aiming to navigate the complex regulatory landscape., (©Yu Han, Aaron Ceross, Jeroen Bergmann. Originally published in JMIR AI (https://ai.jmir.org), 29.07.2024.)

Copyright of Food & Machinery is the property of Food & Machinery Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The emerging use of low-temperature plasma in medicine, especially in wound treatment, calls for a better way of documenting the treatment parameters. This paper describes the development of a mobile sensory device (referred to as MSD) that can be used during the treatment to ease the documentation of important parameters in a streamlined process. These parameters include the patient’s general information, plasma source device used in the treatment, plasma treatment time, ambient humidity and temperature. MSD was developed as a standalone Raspberry Pi-based version and attachable module version for laptops and tablets. Both versions feature a user-friendly GUI, temperature–humidity sensor, microphone, treatment report generation and export. For the logging of plasma treatment time, a sound-based plasma detection system was developed, initially for three medically certified plasma source devices: kINPen® MED, plasma care®, and PlasmaDerm® Flex. Experimental validation of the developed detection system shows accurate and reliable detection is achievable at 5 cm measurement distance in quiet and noisy environments for all devices. All in all, the developed tool is a first step to a more automated, integrated, and streamlined approach of plasma treatment documentation that can help prevent user variability.

The colorimetric analysis of food has gained much popularity in the last few decades. The present study reports the development of a low‐cost food color quality testing and process monitoring system. The proposed device consists of a hardware and a software (Color Magic) combination, which may allow the hardware to be used either for quality testing or process monitoring applications. In the quality‐testing mode, the software captures the image of the food products through the imaging system. Subsequently, the software processes the acquired image and computes color parameters in RGB (red, green, blue), CIELAB, and HSI (hue, saturation, intensity) color spaces. The software also synthesizes and displays the perceived color information in the display panel. The datalog of the sample color information can be sent to the user. Further, a separate software (Color Process), which is installed in a central server, was developed to implement a wireless star network topology for multi‐node process monitoring. The "Color Process" software allows users to acquire color information from multiple hardware. The software monitors the Hue from all the devices. It alerts the user via email if the Hue is beyond the range in any of the nodes. Finally, the device was tested for quality testing and process monitoring applications using colored placards and apple slices. The implementation of the wireless sensor network (WSN) in designing the multi‐node process monitoring makes the proposed device a unique system. This further would allow the device to be used for process monitoring at multiple remote locations. [ABSTRACT FROM AUTHOR]

Background: Delivery of aerosols to isolated lobes of the lungs would be beneficial for diseases that have lobe-specific effects, such as cancer, pneumonia, and chronic obstructive pulmonary disorder. Recent computational fluid-particle dynamic (CFPD) modeling has demonstrated that in low flow rates, the inlet location of a particle at the mouth dictates the lobe into which it will deposit. However, realization of this lobe-specific deposition has yet to be attempted experimentally or in the clinic. To address this, we sought to develop a proof-of-concept in vitro model and targeting device for achieving lobe-specific delivery. Methods: Using 3D printing, a lung replica was created from a computed tomography scan of a healthy 47-year-old male volunteer and connected to a flow setup to control inlet flow rate and outlet airflow distribution to each lobe. A device was designed and fabricated that directs particles to an inlet location that is 5% of the total inlet area and described by radial coordinates (r,θ). Filter paper at sampling ports for each lobe was used to capture fluorescent polystyrene particles to quantify particle collection. We evaluated lobe-specific targeting at varied inlet coordinates, particle diameters, inlet flow rates, and disease lobe flow rate distribution profiles. Results: Guided by CFPD modeling, inlet locations were identified that increased particle collection to a target lobe between 63% and 90%. For example, release of fluorescent particles at the inlet location r = 4.67 mm, θ = 252° with respect to the center of the inlet using 1 μm particles, 1 L/min inlet flow rate, and healthy subject lobe flow distribution profile yielded 90% of the aerosol dose to the right upper lobe, corresponding to an increase of 4.6 × above the non-targeted percent particle collection. Particle size, inlet flow rate, and disease airflow distributions were all shown to generally decrease the efficiency of lobe-specific targeting. Conclusions: Our results indicate that aerosol targeting of a specific lobe is possible in vitro under optimized conditions and that controlling inlet locations could be a potentially useful method for treatment of lobe-specific diseases. This is the first demonstration of lobe-specific particle collection in a physical lung model and illuminates numerous challenges that will be faced as this method is translated to clinical applications. [ABSTRACT FROM AUTHOR]

Abstract Carbon nanotube (CNT) devices and electronics are achieving maturity and directly competing or surpassing devices that use conventional materials. CNTs have demonstrated ballistic conduction, minimal scaling effects, high current capacity, low power requirements, and excellent optical/photonic properties; making them the ideal candidate for a new material to replace conventional materials in next‐generation electronic and photonic systems. CNTs also demonstrate high stability and flexibility, allowing them to be used in flexible, printable, and/or biocompatible electronics. However, a major challenge to fully commercialize these devices is the scalable placement of CNTs into desired micro/nanopatterns and architectures to translate the superior properties of CNTs into macroscale devices. Precise and high throughput patterning becomes increasingly difficult at nanoscale resolution, but it is essential to fully realize the benefits of CNTs. The relatively long, high aspect ratio structures of CNTs must be preserved to maintain their functionalities, consequently making them more difficult to pattern than conventional materials like metals and polymers. This review comprehensively explores the recent development of innovative CNT patterning techniques with nanoscale lateral resolution. Each technique is critically analyzed and applications for the nanoscale‐resolution approaches are demonstrated. Promising techniques and the challenges ahead for future devices and applications are discussed.

Carbon nanotube (CNT) devices and electronics are achieving maturity and directly competing or surpassing devices that use conventional materials. CNTs have demonstrated ballistic conduction, minimal scaling effects, high current capacity, low power requirements, and excellent optical/photonic properties; making them the ideal candidate for a new material to replace conventional materials in next‐generation electronic and photonic systems. CNTs also demonstrate high stability and flexibility, allowing them to be used in flexible, printable, and/or biocompatible electronics. However, a major challenge to fully commercialize these devices is the scalable placement of CNTs into desired micro/nanopatterns and architectures to translate the superior properties of CNTs into macroscale devices. Precise and high throughput patterning becomes increasingly difficult at nanoscale resolution, but it is essential to fully realize the benefits of CNTs. The relatively long, high aspect ratio structures of CNTs must be preserved to maintain their functionalities, consequently making them more difficult to pattern than conventional materials like metals and polymers. This review comprehensively explores the recent development of innovative CNT patterning techniques with nanoscale lateral resolution. Each technique is critically analyzed and applications for the nanoscale‐resolution approaches are demonstrated. Promising techniques and the challenges ahead for future devices and applications are discussed. [ABSTRACT FROM AUTHOR]

Objective: Although inferior vena cava (IVC) filters are commonly retrieved using a snare, lateral tilt and fibrosis around struts can complicate the procedure and sometimes require the use of off-label devices. We describe the development of a novel articulating endovascular grasper designed to remove permanent and retrievable IVC filters in any configuration., Methods: For in vitro testing, the IVC filters were anchored to the inner wall of a flexible tube in a centered or tilted configuration. A high-contrast backlit camera view simulated the two-dimensional fluoroscopy projection during retrieval. The time from the retrieval device introduction into the camera field to complete filter retrieval was measured in seconds. The control experiment involved temporary IVC filter retrieval with a snare. There were four comparative groups: (1) retrievable filter in centered configuration; (2) retrievable filter in tilted configuration; (3) permanent filter in centered configuration; and (4) permanent filter in tilted configuration. Every experiment was repeated five times, with median retrieval time compared with the control group. For in vivo testing in a porcine model, six tilted infrarenal IVC filters were retrieved with grasper via right jugular approach. Comparison analysis between animal and patient procedures was performed for the following variables: total procedure time, the retrieval time, and fluoroscopy time., Results: The in vitro experiments showed comparable retrieval times between the experimental groups 1, 2, and 4 and the control. However, grasper removal of a centered permanent filter (group 3) required significantly less time than in the control (29 vs 79 seconds; P = .009). In the animal model, all IVC filters were retrieved using the grasper with no adverse events. The total procedure time (21.2 vs 43.5 minutes; P = .01) and the fluoroscopy time (4.3 vs 10 minutes; P = .044) were significantly shorter in the animal model compared with the patient group. Moreover, in the patient group, 16.7% of retrievals required advanced endovascular techniques, and one IVC filter could not be retrieved (success rate = 91.7%), whereas all the IVC filters were successfully retrieved in the animal model without the use of additional tools., Conclusions: The novel endovascular grasper is effective in retrieving different types of IVC filters in different configurations and compared favorably with the snare in the in vitro model. In vivo experiments demonstrated more effective retrieval when compared with matched patient retrievals., Competing Interests: Disclosures None., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Copyright of Notfall & Rettungsmedizin is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose of Review: Innovation for transcatheter aortic valve replacement (TAVR) has transformed a medically complex treatment into a standardized procedure. While Edwards SAPIEN and Medtronic CoreValve occupy the market for TAVR in the United States (US), additional valve systems are being developed. The Boston Scientific Lotus Valve system was recently FDA-approved and will represent the third valve in the US market. This evidence-based review will summarize advantages, disadvantages, and projected impact of this new TAVR system. Recent Findings: The Lotus Valve system demonstrates superiority in terms of rates of paravalvular leak, with similar rates of mortality and disabling stroke. This benefit is at the expense of increased pacemaker implantation rates, though preliminary data from subsequent iterations of the Lotus Valve suggest decreasing rates over time. Summary: There is much anticipation from ongoing trials utilizing the Lotus Edge system, which may perform best for those with pre-existing pacemakers or anatomy that increases likelihood of paravalvular leak. [ABSTRACT FROM AUTHOR]

Penelitian ini bertujuan untuk menghasilkan perangkat pembelajaran matematika realistik yang baik untuk pokok bahasan Aljabar di kelas VII MTs.Daarussa’adah, mendeskripsikan keefektifan PMR dalam pembelajaran matematika untuk pokok bahasan Aljabar di kelas VII MTs.Daarussa’adah serta untuk mengetahui apakah hasil belajar siswa yang mengikuti PMR lebih baik daripada hasil belajar siswa yang mengikuti pembelajaran matematika konvensional untuk pokok bahasan Aljabar di kelas VII SLTP. Metode yang digunakan dalam penelitian ini adalah metode pengembangan dari perangkat yang sudah ada menggunakan model 4D-Thiagarajan yang dimodifikasi.kemudian perangkat divalidasi oleh tim ahli dan diujicobakan dikelas ujicoba,yaitu klas VII-1 untuk mendapatkan draft final dimana draft ini harus memenuhi syarat valid, reliable dan peka. Kemudian draft final digunakan untuk kelas eksperimen, yaitu VII-4. Kelas kontrol, diajar dengan metode konvensional. Sedangkan kelas Ujicoba dan kelas eksperimen diberikan metode PMR. Hasil dari eksperimen ini nantinya akan dianalisis secara deskriptif yaitu tentang aktivitas siswa dikelas, kemampuan guru mengelola kelas dan respon siswa terhadap pembelajaran. Data pretest-postes akan dianalisis dengan anakova. Penelitian ini sendiri saat ini masih sedang berlangsung sehingga belum mendapatkan hasil dari eksperimen. These research aims to produce a good Realistic Mathematic Education (RME) device for Algebra sub topic in VIIth class of MTs.Daarussa’adah, to describe the effectiveness of RME for Algebra sub topic in VIIth class of MTs.Daarussa’adah, and find out if the learning outcomes of student who take the learning to the RME better than the student who take mathematics to materials conventionally algebraic subtopics in VIIth class. The method which use in these research is development method from the device before by using 4D­Thiagarajan models which have been modified. Then the device will validate by profesional team and have trial in trial class, that is VII­1 class.To get final draft which one the draft is valid, reliable and sensitive qualified. And then final draft is used for the experiment class (VII­4). The control class is theached with conventional method. The trial class and experiment class is given RME method. The outcomes of these experiment will be analized descriptively about student activity in classroom, the theacher ability to manage of class and student respon for the learning. Data of pretest­postest will be analized by anakova. These research is still going for just moment so we will don’t know about the result yet.

More than 537 million adults worldwide are living with diabetes and navigating its health and lifestyle impact. People living with diabetes face unique challenges in managing their diet and exercise, monitoring their blood glucose, self-administering medications, and effectively integrating their disease into their social activities. In addition to diabetes being a challenging multifactorial disease, these challenges arise in part from patients having to navigate a complex ecosystem where sectors are siloed and its services, products, and environments are not designed with the patient in mind. To address these challenges, the ecosystem of diabetes care, including researchers, healthcare professionals, product and service developers, and policymakers, can adopt co-design methodologies providing patients and caregivers a seat at the table when creating solutions. Co-design in healthcare is an approach to problem-solving where patients are viewed as equal partners providing their own unique perspective and expertise, to design and develop devices, services, and environments. Co-design emphasizes the value of the user's insights and expertise. Incorporating patient perspective has been shown to increase patient empowerment and satisfaction, enhance healthcare technology value, and strengthen the collaboration between the patient and their interprofessional ecosystem. We describe opportunity spaces, successful examples, and strategies to better engage patients in research, policymaking, and healthcare product, service, and environment development through co-design methods. By incorporating co-design, the ecosystem of diabetes care can deliver more effective, high-quality patient-centered care, products, and services., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Advances in lower-limb prosthetic technologies have facilitated the restoration of ambulation; however, users of such technologies still experience reduced balance control, also due to the absence of proprioceptive feedback. Recent efforts have demonstrated the ability to restore kinesthetic feedback in upper-limb prosthesis applications; however, technical solutions to trigger the required muscle vibration and provide automated feedback have not been explored for lower-limb prostheses. The study’s first objective was therefore to develop a feedback system capable of tracking lower-limb movement and automatically triggering a muscle vibrator to induce the kinesthetic illusion. The second objective was to investigate the developed system’s ability to provide kinesthetic feedback in a case participant. A low-cost, wireless feedback system, incorporating two inertial measurement units to trigger a muscle vibrator, was developed and tested in an individual with limb loss above the knee. Our system had a maximum communication delay of 50 ms and showed good tracking of Gaussian and sinusoidal movement profiles for velocities below 180 degrees per second (error < 8 degrees), mimicking stepping and walking, respectively. We demonstrated in the case participant that the developed feedback system can successfully elicit the kinesthetic illusion. Our work contributes to the integration of sensory feedback in lower-limb prostheses, to increase their use and functionality.

Research into hand-sensing is the focus of various fields, such as medical engineering and ergonomics. The thumb is essential in these studies, as there is great value in assessing its opposition function. However, evaluation methods in the medical field, such as physical examination and computed tomography, and existing sensing methods in the ergonomics field have various shortcomings. Therefore, we conducted a comparative study using a carbon nanotube-based strain sensor to assess whether opposition movement and opposition impairment can be detected in 20 hands of volunteers and 14 hands of patients with carpal tunnel syndrome while avoiding existing shortcomings. We assembled a measurement device with two sensors and attached it to the dorsal skin of the first carpometacarpal joint. We measured sensor expansion and calculated the correlation coefficient during thumb motion. The average correlation coefficient significantly increased in the patient group, and intrarater and interrater reliability were good. Thus, the device accurately detected thumb opposition impairment due to carpal tunnel syndrome, with superior sensitivity and specificity relative to conventional manual inspection, and may also detect opposition impairment due to various diseases. Additionally, in the future, it could be used as an easy, affordable, and accurate sensor in sensor gloves.

Purposes: Modern electrosurgical tools have a specific coagulation mode called “soft coagulation”. However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the “Suction ball coagulator” (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings.Methods: SBC prototyping was performed with a bench test. Device optimization was performed in a preclinical study with a domestic swine bleeding model. Then, SBC was tested in a clinical setting during 17 clinical laparoscopic colorectal surgeries.Results: In the bench tests, two tip hole sizes and patterns showed a good suction capacity. The preclinical study indicated the best tip shape for accuracy. In clinical use, no device-related adverse event was observed. Moreover, the SBC was feasible for prompt hemostasis and blunt dissections. In addition, SBC could evacuate vapors generated by tissue ablation using electroprobe during laparoscopic surgery.Conclusions: We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it. [ABSTRACT FROM AUTHOR]

Background Three-dimensional printing (3DP) has become popular for development of anatomic models, preoperative planning, and production of tailored implants. A novel laparoscopic, transgastric procedure for distal esophageal mucosectomy was developed. During this procedure, a space holder had to be introduced into the distal esophagus for exposure during suturing. The production process and evaluation of a 3DP space holder are described herein. Materials and methods Computer-aided design software was used to develop models printed from polylactic acid. The prototype was adapted after testing in a cadaveric model. Subsequently, the device was evaluated in a nonsurvival porcine model. A mucosal purse-string suture was placed as orally as possible in the esophagus, in the intervention group with and in the control group without use of the tool ( n = 8 each). The distance of the stitches from the Z-line was measured. The variability of stitches indicated the suture quality. Results The median maximum distance from the Z-line to purse-string suture was larger in the intervention group (5.0 [3.3-6.4] versus 2.4 [2.0-4.1] cm; P = 0.013). The time taken to place the sutures was shorter in the control group ( P < 0.001). Stitch variance tended to be greater in the intervention group (2.3 [0.9-2.5] versus 0.7 [0.2-0.4] cm; P = 0.051). The time required for design and production of a tailored tool was less than 24 h. Conclusions 3DP in experimental surgery enables rapid production, permits repeated adaptation until a tailored tool is obtained, and ensures independence from industrial partners. With the aid of the space holder more orally located esophageal lesions came within reach. [ABSTRACT FROM AUTHOR]

Aims: Pre- and post-evaluations of implantable cardiac devices require innovative and critical testing in all phases of the design process. The Visible Heart® Project was successfully launched in 1997 and 3 years later the Atlas of Human Cardiac Anatomy website was online. The Visible Heart® methodologies and Atlas website can be used to better understand human cardiac anatomy, disease states and/or to improve cardiac device design throughout the development process.Methods and Results: To date, Visible® Heart methodologies have been used to reanimate 75 human hearts, all considered non-viable for transplantation. The Atlas is a unique free-access website featuring novel images of functional and fixed human cardiac anatomies from >400 human heart specimens. Furthermore, this website includes education tutorials on anatomy, physiology, congenital heart disease and various imaging modalities. For instance, the Device Tutorial provides examples of commonly deployed devices that were present at the time of in vitro reanimation or were subsequently delivered, including: leads, catheters, valves, annuloplasty rings, leadless pacemakers and stents. Another section of the website displays 3D models of vasculature, blood volumes, and/or tissue volumes reconstructed from computed tomography (CT) and magnetic resonance images (MRI) of various heart specimens. A new section allows the user to interact with various heart models.Conclusion: Visible Heart® methodologies have enabled our laboratory to reanimate 75 human hearts and visualize functional cardiac anatomies and device/tissue interfaces. The website freely shares all images, video clips and CT/MRI DICOM files in honour of the generous gifts received from donors and their families. [ABSTRACT FROM AUTHOR]

The old creep testing machine has large experimental error in the actual measurement process hence it can’ l achieve constant loading. It is improved by a new type of constant stress creep lest machine design. The structure of constant stress creep loading arm model was calculated and the reliability design of the loading arm was analyzed. The creep curves of G1I4169 alloy were tested using the test machine. The results show that the new creep test machine can keep constant stress in test and can achieve more accurate measurement of creep properties of metallic materials. The development of the loading arm solves the difficult problem of constant loading operation in the process of creep test of metallic materials, and provides experimental support for the development of experimental teaching and scientific research work. [ABSTRACT FROM AUTHOR]

Background Intracerebral hemorrhage (ICH) is a stroke subtype with the highest mortality rate. Hematoma expansion and re-bleeding post-ICH are common and exacerbate the initial cerebral insult. There is a need for continuous monitoring of the neurologic status of patients with an ICH injury. New method A prototype device for non-invasive continuous monitoring of an ICH was developed and tested in vivo using a porcine ICH model. The device consists of receiving and transmitting antennae in the 400–1000 MHz frequency range, placed directly in line with the site of the ICH. The device exploits the differences in the dielectric properties and geometry of tissue media of a healthy brain and a brain with an ICH injury. The power received by the receiving antenna is measured and the percent change in power received immediately after infusion of blood and 30 min after the infusion, allowing for the blood to clot, is calculated. Results An increase in the received power in the presence of an ICH is observed at 400 MHz, consistent with previous in vitro studies. Frequency sweep experiments show a maximum percent change in received power in the 750–1000 MHz frequency range. Comparison with existing methods Currently, CT, MRI and catheter angiography (CA) are the main clinical neuroimaging modalities. However, these techniques require specialized equipment and personnel, substantial time, and patient-transportation to a radiology suite to obtain results. Moreover, CA is invasive and uses intra-venous dye or vascular catheters to accomplish the imaging. Conclusions The device has the potential to significantly improve neurologic care in the critically ill brain-injured patient. [ABSTRACT FROM AUTHOR]

Trunk torque is typically quantified in a single plane. This is not ideal since any unmeasured coupled trunk kinetics in other directions, than the intended one, could affect the accuracy and reliability of the strength measurements as well as the ability to corroborate findings with electromyographic recordings. Therefore, an isometric device that simultaneously records trunk kinetics across planes has been developed to aid in the research of trunk control in both the healthy or impaired populations. This device utilizes a six degree-of-freedom load cell and custom designed frame to attach individuals while in the sitting position. The performance of the device was tested in six healthy controls and while using two protocols. The device was able to detect coupled trunk kinetics during maximum lateral flexion and axial twisting torque generation. It also allowed the implementation of a multi-axis isometric protocol showing that subjects were able to generate larger amounts of axial torque during sub-maximal trunk extension compared to sub-maximal trunk flexion. In conclusion, the device and mechanical transformations discussed in this article will aid in the interpretation of multi-directional isometric trunk kinetics in a wide range of populations. [ABSTRACT FROM AUTHOR]