Medical Devices-Evidence and Research最新文献

{"title":"Development of Respimat(®) Soft Mist™ Inhaler and its clinical utility in respiratory disorders.","authors":"Richard N Dalby, Joachim Eicher, Bernd Zierenberg","doi":"10.2147/MDER.S7409","DOIUrl":"10.2147/MDER.S7409","url":null,"abstract":"<p><p>The Respimat(®) Soft Mist™ Inhaler (SMI) (Boehringer Ingelheim International GmbH, Ingelheim, Germany) was developed in response to the need for a pocket-sized device that can generate a single-breath, inhalable aerosol from a drug solution using a patient-independent, reproducible, and environmentally friendly energy supply. This paper describes the design and evolution of this innovative device from a laboratory concept model and the challenges that were overcome during its development and scaleup to mass production. A key technical breakthrough was the uniblock, a component combining filters and nozzles and made of silicon and glass, through which drug solution is forced using mechanical power. This allows two converging jets of solution to collide at a controlled angle, generating a fine aerosol of inhalable droplets. The mechanical energy comes from a spring which is tensioned by twisting the base of the device before use. Additional features of the Respimat(®) SMI include a dose indicator and a lockout mechanism to avoid the problems of tailing-off of dose size seen with pressurized metered dose inhalers. The Respimat(®) SMI aerosol cloud has a unique range of technical properties. The high fine particle fraction allied with the low velocity and long generation time of the aerosol translate into a higher fraction of the emitted dose being deposited in the lungs compared with aerosols from pressurized metered dose inhalers and dry powder inhalers. These advantages are realized in clinical trials in adults and children with obstructive lung diseases, which have shown that the efficacy and safety of a pressurized metered dose inhaler formulation of a combination bronchodilator can be matched by a Respimat(®) SMI formulation containing only one half or one quarter of the dose delivered by a pressurized metered dose inhaler. Patient satisfaction with the Respimat(®) SMI is high, and the long duration of the spray is of potential benefit to patients who have difficulty in coordinating inhalation with drug release.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"145-55"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853711","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":"Mechanical performances of elastomers used in diffusers.","authors":"Gérard Guiffant,&nbsp;Jean-Jacques Durussel,&nbsp;Patrice Flaud,&nbsp;Jean-Pierre Vigier,&nbsp;Christian Dupont,&nbsp;Philippe Bourget,&nbsp;Jacques Merckx","doi":"10.2147/MDER.S18633","DOIUrl":"https://doi.org/10.2147/MDER.S18633","url":null,"abstract":"<p><p>The use of elastomeric diffusers (EDs) has grown together with the expansion of home care. In these devices, the fill volume of the drug reservoir and the flow rate are preset and cannot be modified. The elastomer, which makes up the reservoir walls, is what makes the infusate flow due to the pressure it exerts. The purpose of this work was to quantify, under standardized experimental conditions and following recommended conditions of use, the mechanical performances of the 2 commonly used elastomers (silicone and polyisoprene) and their impact on infusion flow rate consistency. Results show that they exhibit different mechanical performances which leads to concerns regarding the use of these devices for some intravenous (IV) therapies.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"71-6"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S18633","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853312","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":"Preliminary development of the Active Colonoscopy Training Model.","authors":"Junghun Choi,&nbsp;Kale Ravindra,&nbsp;Randolph Robert,&nbsp;David Drozek","doi":"10.2147/MDER.S20479","DOIUrl":"https://doi.org/10.2147/MDER.S20479","url":null,"abstract":"<p><p>Formal colonoscopy training requires a significant amount of time and effort. In particular, it requires actual patients for a realistic learning experience. The quality of colonoscopy training varies, and includes didactic courses and procedures proctored by skilled surgeons. A colonoscopy training model is occasionally used as part of the training method, but the effects are minute due to both the simple and tedious training procedures. To enhance the educational effect of the colonoscopy training model, the Active Colonoscopy Training Model (ACTM) has been developed. ACTM is an interactive colonoscopy training device which can create the environment of a real colonoscopy procedure as closely as possible. It comprises a configurable rubber colon, a human torso, sensors, a display, and the control part. The ACTM provides audio and visual interaction to the trainee by monitoring important factors, such as forces caused by the distal tip and the shaft of the colonoscope and the pressure to open up the lumen and the localization of the distal tip. On the computer screen, the trainee can easily monitor the status of the colonoscopy, which includes the localization of the distal tip, maximum forces, pressure inside the colon, and surgery time. The forces between the rubber colon and the constraints inside the ACTM are measured and the real time display shows the results to the trainee. The pressure sensors will check the pressure at different parts of the colon. The real-time localized distal tip gives the colonoscopy trainee easier and more confident operation without introducing an additional device in the colonoscope. With the current need for colonoscopists and physicians, the ACTM can play an essential role resolving the problems of the current colonoscopy training model, and significantly improve the training quality of the colonoscopy.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"59-70"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S20479","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853311","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":"Bioresorbable adhesion barrier for reducing the severity of postoperative cardiac adhesions: Focus on REPEL-CV(®).","authors":"Martin Haensig,&nbsp;Friedrich Wilhelm Mohr,&nbsp;Ardawan Julian Rastan","doi":"10.2147/MDER.S7957","DOIUrl":"https://doi.org/10.2147/MDER.S7957","url":null,"abstract":"<p><p>Treatment of a number of congenital heart defects often necessitates staged surgical intervention. In addition, substantial improvements in postoperative cardiac care and more liberal use of biological valve substitutes have resulted in many adult patients surviving to become potential candidates for reoperations to repair or replace valves or to undergo additional revascularization procedures. In all these scenarios, surgeons are confronted with cardiac adhesions, leading to an increased surgical risk. Thus, bioresorbable adhesion barriers had become of increasing interest because they are easy to use, and safe and effective. This review focuses on the mechanisms by which REPEL-CV(®) prevents adhesive processes, as well as the development, design, and materials used, and also summarizes efficacy studies, clinical data, safety, and current role in therapy.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"17-25"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S7957","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853924","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":"Towards Reconfigurable Embedded Medical Systems","authors":"T. Massey, F. Dabiri, H. Noshadi, P. Brisk, W. Kaiser, M. Sarrafzadeh","doi":"10.1109/HCMDSS-MDPNP.2007.7","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.7","url":null,"abstract":"Traditional embedded systems require flexibility and reconfigurable for effective operation. Devices used in medical systems that are life critical must be able to take the necessary action in response to an anomaly, such as the patient undergoing a heart attack or a stroke. Overly complicated operational requirements will be a clear barrier to their adoption, unless sound system-level design techniques can guarantee that these requirements will be met. The key to meeting these requirements is automated adaptability, meaning that the system must be able to reconfigure itself in response the environment. Unfortunately, dynamic reconfiguration itself is non- negligible in terms of both performance and power consumption. We present several reconfigurable design techniques for light-weight medical systems that demonstrate how one can make efficient use of limited resources and balance the tradeoffs between power consumption, memory consumption, and interoperability in an heterogeneous environments.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"4 1","pages":"178-180"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87662321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Alternative Signal Sampling and Reconstruction Strategy for Low Power Embedded Sensors","authors":"T. J. Petelenz, C. Sikorski","doi":"10.1109/HCMDSS-MDPNP.2007.32","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.32","url":null,"abstract":"In this research we are investigating the possibility of using alternative signal sampling and reconstruction strategies based on the optimal signal sampling and reconstruction theory that, if successful, would require a smaller number of data points for signal recovery, reduce data transmission bandwidth required for wireless data transmission and lower overall power consumption of a sensor.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"57 1","pages":"194-198"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88343813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Intensive Care Specific Electronic Medical Record: Is There Transparency?","authors":"F. Sites, V. Rich, C. Hanson","doi":"10.1109/HCMDSS-MDPNP.2007.17","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.17","url":null,"abstract":"Intensive care units (ICUs) are high-intensity patient care locations, and consequently contribute both to medical costs and errors. Computerization of order and documentation systems is one way to reduce both. One such solution is telemedicine based intensive care (eICUreg) whereby remote consultation is combined with intelligent data analysis. There are a number of technical and human factor elements that must be considered in deploying an eICUreg. Technical challenges include system interfaces, equipment choice, and integration of the electronic medical record with the pre-existing record. Human factor challenges consist of competing internal interests, haphazard approaches with no common workflow, and selective adoption of the technology. At a minimum, there is a triad of barriers that prevent fluid interoperability between systems. Those barriers comprise of the complexities in the clinical paradigm, technical innovation, and human factor best practices which industry developers need to be innately aware of.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"2 1","pages":"137-139"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89631329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designing and Developing Medical Device Software Systems Using the Model Driven Architecture (MDA)","authors":"Amen Ra Mashariki, L. Bronner, Peter Kazanzides","doi":"10.1109/HCMDSS-MDPNP.2007.26","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.26","url":null,"abstract":"On the surface, model-driven architecture (MDA) appears to be a fundamentally new paradigm compared to traditional software development. Upon closer examination, however, MDA mainly shifts the focus of iterative development to a higher level of abstraction. The traditional waterfall software development process (and its variations) dictates that the system development be driven by low-level design and coding. This can introduce many productivity, maintenance and documentation issues into the process. Using the MDA pushes development to a higher level, where platform-independent analysis and detailed platform-specific design modeling make it easier to trace back to the requirements, thereby introducing a more stringent governance over the project. Also, it introduces a technology and platform independent standardized development process, system interoperability internally as well as the ability to provide communication bridges with external systems. The systems can be portable, which allows for what the creators of the MDA, the object management group (OMG), refer to as \"future proofing\" of software systems. This is the ability to have long-lived models that can be applied to any new implementation technologies that will ultimately be created and introduced to the software development world. This paper seeks to introduce and demystify MDA concepts and features, and show how their application can be used to develop highly interoperable and robust medical device software systems. In particular, if medical devices are designed using the MDA approach, they can quickly be adapted to utilize any interoperability (or \"plug and play\") standard that evolves in the future.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"3 1","pages":"156-159"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89641300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cyber-Physical System Software for HCMDSS","authors":"C. Gill","doi":"10.1109/HCMDSS-MDPNP.2007.30","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.30","url":null,"abstract":"The state of the art in operating systems and middleware is currently insufficient, and must be evolved, to meet the needs of envisioned next-generation cyber-physical systems, in which interactions among system components and the physical world are (1) ubiquitous, (2) domain-specific, (3) heterogeneous, and (4) semantically rich. This position paper offers a vision for how that evolution can be achieved, and describes several research challenges that will need to be addressed in order to do so.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"16 1","pages":"176-177"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88100080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Device Interoperability-Assessing the Environment","authors":"Kathy A. Lesh, RN Sandy Weininger, J. Goldman, B. Wilson, Glenn Himes","doi":"10.1109/HCMDSS-MDPNP.2007.22","DOIUrl":"https://doi.org/10.1109/HCMDSS-MDPNP.2007.22","url":null,"abstract":"As we know, interoperability is an almost nonexistent feature of medical devices. This paper defines interoperability; discusses why the lack of medical device interoperability is a problem, and the scope of the problem. Possible reasons for the lack of medical device interoperability are explored. Numerous benefits to medical device interoperability are outlined and possible risks of maintaining the status quo are predicted.","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"91 1","pages":"3-12"},"PeriodicalIF":1.3,"publicationDate":"2007-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86457754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}