BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications ...BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.展开更多
It is known that fiber wastes (lint, down and seeds) produced at ginneries contain fibers that are suitable for spinning and can be used in industry, and their separation significantly increases the level of fiber pro...It is known that fiber wastes (lint, down and seeds) produced at ginneries contain fibers that are suitable for spinning and can be used in industry, and their separation significantly increases the level of fiber production (1.9% - 2.5%). Based on these analyzes, the study aimed to create a new device that separates long fibers from lint and down. As a result, the amount of fiber output in the enterprise will increase and the enterprise will have significant economic benefits. In addition, the introduction of the device will prevent the addition of long fibers (longer than 16 mm) that can be used in the textile industry to the waste. This article focuses on the creation of a fiber separation device suitable for the treatment and spinning of fibrous waste produced in ginneries. The study theoretically examined the main working bodies of the fiber separation device from waste. Theoretical research is devoted to the study of the strength of the main working body of the fiber separation device<span style="white-space:nowrap;">−</span>the separating saw drum and its shaft. In the study, the sawdust drum is a more stressed steel coating, and it was found that the strength reserve of this drum is [<span style="white-space:nowrap;"><em>δ</em></span><sub>Т</sub>] = 2.03 (where <em>δ</em><sub>Т</sub> = 0.8 - 2.5) was found to be. As a result of calculating the resistance of the saw drum shaft to stiffness and vibration, it was determined that the shafts are resistant to vibration under periodic loading and that the oscillation frequency along its axis through the critical rotation frequency is <em>v<sub>cr</sub></em>=10.3 Gts.展开更多
This article examines the technological parameters of the device for the separation of fibers suitable for spinning by processing fibrous waste from the technological processes of ginneries. Technological processes in...This article examines the technological parameters of the device for the separation of fibers suitable for spinning by processing fibrous waste from the technological processes of ginneries. Technological processes in the cotton ginning industry include a complex of physical and mechanical advantages, the successful study of which is possible only with the use of modern achievements in science and technology. Therefore, it is advisable to conduct scientific research based on mathematical modeling. To justify the effective operation of the selected design of the cotton fiber separation device, it is necessary to select its optimal technological parameters. Improving the efficiency of the process of separation of spinning fibers from the composition of fibrous waste depends directly on technological parameters. The application of mathematical methods in the planning and conduct of research allows for determining the individual effects of the interaction of several factors that characterize the combined parameters of the optimization parameters, in contrast to traditional computational methods of research. As a result, it will be possible to obtain a mathematical model of the object understudy in a relatively small number of tests, which will simultaneously serve to obtain optimal solutions.展开更多
文摘BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.
文摘It is known that fiber wastes (lint, down and seeds) produced at ginneries contain fibers that are suitable for spinning and can be used in industry, and their separation significantly increases the level of fiber production (1.9% - 2.5%). Based on these analyzes, the study aimed to create a new device that separates long fibers from lint and down. As a result, the amount of fiber output in the enterprise will increase and the enterprise will have significant economic benefits. In addition, the introduction of the device will prevent the addition of long fibers (longer than 16 mm) that can be used in the textile industry to the waste. This article focuses on the creation of a fiber separation device suitable for the treatment and spinning of fibrous waste produced in ginneries. The study theoretically examined the main working bodies of the fiber separation device from waste. Theoretical research is devoted to the study of the strength of the main working body of the fiber separation device<span style="white-space:nowrap;">−</span>the separating saw drum and its shaft. In the study, the sawdust drum is a more stressed steel coating, and it was found that the strength reserve of this drum is [<span style="white-space:nowrap;"><em>δ</em></span><sub>Т</sub>] = 2.03 (where <em>δ</em><sub>Т</sub> = 0.8 - 2.5) was found to be. As a result of calculating the resistance of the saw drum shaft to stiffness and vibration, it was determined that the shafts are resistant to vibration under periodic loading and that the oscillation frequency along its axis through the critical rotation frequency is <em>v<sub>cr</sub></em>=10.3 Gts.
文摘This article examines the technological parameters of the device for the separation of fibers suitable for spinning by processing fibrous waste from the technological processes of ginneries. Technological processes in the cotton ginning industry include a complex of physical and mechanical advantages, the successful study of which is possible only with the use of modern achievements in science and technology. Therefore, it is advisable to conduct scientific research based on mathematical modeling. To justify the effective operation of the selected design of the cotton fiber separation device, it is necessary to select its optimal technological parameters. Improving the efficiency of the process of separation of spinning fibers from the composition of fibrous waste depends directly on technological parameters. The application of mathematical methods in the planning and conduct of research allows for determining the individual effects of the interaction of several factors that characterize the combined parameters of the optimization parameters, in contrast to traditional computational methods of research. As a result, it will be possible to obtain a mathematical model of the object understudy in a relatively small number of tests, which will simultaneously serve to obtain optimal solutions.
