Medical Devices-Evidence and Research最新文献

{"title":"Critical appraisal of the Spanner™ prostatic stent in the treatment of prostatic obstruction.","authors":"Patrick McKenzie, Gopal Badlani","doi":"10.2147/MDER.S7107","DOIUrl":"10.2147/MDER.S7107","url":null,"abstract":"<p><p>The Spanner™ stent was first used in patients to relieve bladder outlet obstruction (BOO), and has recently been used in patients following transurethral microwave thermotherapy and men unfit for surgical intervention. We review the current literature on the role of the Spanner stent in treating prostatic obstruction compared to previously reported cases involving the use of temporary stents. The Spanner stent has been found to be successful in treating patients with bladder outlet obstruction from benign prostatic hyperplasia and following high-energy transurethral microwave thermotherapy (TUMT). Patients with the Spanner stent had an increase in peak flow rate and a decrease in post void residual and International Prostate Symptom Scores. In patients treated with TUMT, quality of life measures indicate that the Spanner stent shows increased ease of bladder drainage, decreased leakage, and no adverse effect on daily activities. In patients unfit for surgery, however, there was increased retention and pain requiring stent removal in 63% of cases. The Spanner stent offers ease of insertion with a decrease in voiding symptoms in selected patients. Based on limited data, the Spanner stent has been recommended as a treatment option for men with BOO following TUMT. However, it is not a good treatment option for men unfit for surgery based on an increased incidence of urinary retention and dysuria. The Spanner stent is the only currently approved temporary stent and, based on a literature review, it does not offer significant advantage over previously used temporary stents. It is notable that most researchers have not evaluated the role of detrusor function on the outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"27-33"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853925","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":"Effects of a transmitted light device for pediatric peripheral venipuncture and intravenous cannulation.","authors":"Shinya Yamazaki,&nbsp;Shu Tomita,&nbsp;Masahiro Watanabe,&nbsp;Hiroyoshi Kawaai,&nbsp;Kazuhiro Shimamura","doi":"10.2147/MDER.S18497","DOIUrl":"https://doi.org/10.2147/MDER.S18497","url":null,"abstract":"<p><p>Pediatric peripheral venipuncture and intravenous cannulation are difficult. However, successful venipuncture and intravenous cannulation are absolutely required for pediatric clinical risk management. This study assessed the success rate of venipuncture and intravenous cannulation when transmitted light was applied to the pediatric dorsum manus. The subjects included 100 young children who were scheduled for dental treatment or oral surgery under general anesthesia. Anesthesia was induced, and insertion of an intravenous catheter into the dorsum manus was attempted with or without using transmitted light. The patients were evaluated to determine whether the venipuncture was successful, and whether the intravenous cannulation of the external catheter was successful. The success rate of venipuncture was 100% when transmitted light was used, and 83% when the transmitted light was not used (P = 0.000016). In addition, the success rate of intravenous cannulation was 88% when transmitted light was used, and 55% when the transmitted light was not used (P = 0.0000002). The shape of the vein in the dorsum manus can be clearly recognized when transmitted light is used. The use of light significantly increased the success rate of intravenous cannulation, because it allowed direct confirmation of the direction to push the intravenous catheter forward. The use of transmitted light allows for more successful venipuncture and intravenous cannulation in young children.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"189-92"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S18497","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30852074","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":"Development of a colonoscopy add-on device for improvement of the intubation process.","authors":"Jonathan D Litten,&nbsp;Junghun Choi,&nbsp;David Drozek","doi":"10.2147/MDER.S27728","DOIUrl":"https://doi.org/10.2147/MDER.S27728","url":null,"abstract":"<p><p>A colonoscopy add-on device has been developed to reduce intubation time without modification of the current colonoscope and peripheral devices. One of the main purposes of the system is to minimize trauma caused by the distal tip of the colonoscope. The detachable sensory fixture at the end of the distal tip measures the distance between the distal tip and the colon wall in three directions, and the actuation system attached at the base of the colonoscope controls the distal tip by rotating two dial knobs. The device controls the distal tip to minimize contact between the distal tip and the colon wall, and the distal tip ideally points out the next possible lumen. A compatibility test of the infrared sensory system was carried out, and the design of the actuation system was accomplished. The system is integrated and controlled by a microprocessor. The device was tested in a silicon colon and porcine intestine. The results showed that a colonoscopist successfully reached the cecum with the aid of the colonoscopy add-on device without significant contact between the colon wall and the distal tip. The colonoscopy aid device was very helpful for the novice colonoscopist.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"197-208"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S27728","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30852075","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":"Effects of a cellulose mask synthesized by a bacterium on facial skin characteristics and user satisfaction.","authors":"Thanaporn Amnuaikit,&nbsp;Toon Chusuit,&nbsp;Panithi Raknam,&nbsp;Prapaporn Boonme","doi":"10.2147/MDER.S20935","DOIUrl":"https://doi.org/10.2147/MDER.S20935","url":null,"abstract":"<p><strong>Background: </strong>Cellulose masks obtained from natural sources such as bacteria are of interest as cosmetic devices for the treatment of dry skin because they not only improve hydration of the skin, but have low toxicity and are biodegradable. The aims of this study were to determine the in vivo effects of a cellulose mask obtained from Acetobacter xylinum on skin characteristics and to evaluate user satisfaction with the product.</p><p><strong>Methods: </strong>Thirty healthy Thai volunteers aged 21-40 years participated in the study. The volunteers were randomly separated into a control group and an experimental group. For the control group, volunteers were assigned to apply moist towels to the face for 25 minutes. For the experimental group, the volunteers were assigned to apply the masks, ie, translucent patches which could be fitted onto the face for the same period. The following week, the groups were changed over to the alternative treatment. Skin moisture, sebum, elasticity, texture, dullness, and desquamation levels were assessed using a system used for routine skin counseling before applying the trial product and five minutes after its removal. Degree of satisfaction with use of the cellulose mask was investigated using a five-point rating scale.</p><p><strong>Results: </strong>The cellulose mask increased moisture levels in the skin significantly more than moist towels (P < 0.05) after a single application. No obvious effects on other skin characteristics were found. The cellulose mask product rated around 4/5 on the satisfaction rating scale.</p><p><strong>Conclusions: </strong>A single application of the trial cellulose mask enhanced moisture uptake by facial skin. Users also reported being satisfied with the trial product.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"77-81"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S20935","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853313","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":"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}