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吴坷, 李俊杰, 张琳娟. 超声探头快速复用热封系统的设计与研发[J]. koko体育app 学报(医学版), 2024, 55(3): 762-768. DOI:
引用本文: 吴坷, 李俊杰, 张琳娟. 超声探头快速复用热封系统的设计与研发[J]. koko体育app 学报(医学版), 2024, 55(3): 762-768. DOI:
WU Ke, LI Junjie, ZHANG Linjuan. Design and Development of a Heat Sealing System for Rapid Reuse of Ultrasonic Probes[J]. Journal of Sichuan University (Medical Sciences), 2024, 55(3): 762-768. DOI:
Citation: WU Ke, LI Junjie, ZHANG Linjuan. Design and Development of a Heat ꧅Sealing System for Rapid Reuse of Ultrasonic Probes[J]. Journal of Sichuan University (Medical Sciences), 2024, 55(3): 762-768꧙. DOI:

超声探头快速复用热封系统的设计与研发

Design and Development of a Heat Sealing System for Rapid Reuse of Ultrasonic Probes

  • 摘要:
    目的 设计并验证快速复用热封系统对超声探头快速复用的应用效果。
    方法 ①通过医工结合的方式设计并检测快速复用热封系统的性能,主要包括防护膜(多层共挤聚烯烃热收缩膜)和热封主机,根据热缩原理使热缩膜快速热缩贴合于超声探头。在探头表面分别安装温度传感器,进行该系统隔热性能测试。②采用方便抽样法选取超声引导下动脉穿刺患者90例作为研究对象,每组30例,分别采用3种临床常用措施对探头进行保护,在使用前对穿刺部位周围进行水溶性荧光标记。实验组为热封系统组,采用快速复用热封系统标准操作方法保护超声探头。对照组1为消毒湿巾组,采用双链季铵盐消毒湿巾反复擦拭探头表面10~ 15次后待干;对照组2为保护套组,采用一次性使用腔镜保护套覆盖探头前端,手柄部位采用线绳结扎。对比探头使用前后,实验组与两个对照组超声探头表面水溶性荧光标记(反映探头表面菌落残留)和复用时间(第一次使用结束至第二次使用开始前所用时间)。
    结果 ①超声探头内部的温度均低于40 ℃,快速复用热缩系统尚不会影响超声探头性能;②热封系统组复用时间〔中位数(P25,P75)〕为〔8.00(7.00,10.00)〕 s,低于消毒湿巾组的〔95.50(8.00,214.00)〕 s和保护套组的〔25.00(8.00,51.00)〕 s,差异均有统计学意义(P<0.05)。热封系统组与保护套组使用后均未见荧光残留,热封系统组荧光残留少于消毒湿巾组(26例残留),差异有统计学意义(χ2=45.882,P<0.05)。
    结论 本研究设计研发的热缩膜可针对设备尺寸、大小随意切割剪裁,热缩后能对设备进行紧密贴附和包裹,牢固美观;热封系统实现热缩膜与主机的半自动化联动,减少耗时复杂的人为操作,缩短复用时间,应用方便快捷,能提高超声探头复用和运行效率。超声探头快速复用热封系统表面菌落残留少,能够为超声探头提供有效的物理屏障,且实验过程中未损坏探头性能,可以作为探头处理的新方法。
     
    Abstract:
    Objective Ultrasound diagnosis and treatment is easy to perform and takes little time. It is widely used in clinical practice thanks to its non-invasive, real-time, and dynamic characteristics. In the process of ultrasound diagnosis and treatment, the probe may come into contact with the skin, the mucous membranes, and even the sterile parts of the body. However, it is difficult to achieve effective real-time disinfection of the probes after use and the probes are often reused, leading to the possibility of the probes carrying multiple pathogenic bacteria. At present, the processing methods for probes at home and abroad mainly include probe cleaning, probe disinfection, and physical isolation (using probe covers or sheaths). Yet, each approach has its limitations and cannot completely prevent probe contamination and infections caused by ultrasound diagnosis and treatment. For example, when condoms are used as the probe sheath, the rate of condom breakage is relatively high. The cutting and fixing of cling film or freezer bags involves complicated procedures and is difficult to perform. Disposable plastic gloves are prone to falling off and causing contamination and are hence not in compliance with the principles of sterility. Furthermore, the imaging effect of disposable plastic gloves is poor. Therefore, there is an urgent need to explore new materials to make probe covers that can not only wrap tightly around the ultrasound probe, but also help achieve effective protection and rapid reuse. Based on the concept of physical barriers, we developed in this study a heat sealing system for the rapid reuse of ultrasound probes. The system uses a heat sealing device to shrink the protective film so that it wraps tightly against the surface of the ultrasound probe, allowing for the rapid reuse of the probe while reducing the risk of nosocomial infections. The purpose of this study is to design a heat sealing system for the rapid reuse of ultrasound probes and to verify its application effect on the rapid reuse of ultrasound probes.
    Methods 1) The heat sealing system for the rapid reuse of ultrasound probes was designed and tested by integrating medical and engineering methods. The system included a protective film (a multilayer co-extruded polyolefin thermal shrinkable film) and a heat sealing device, which included heating wire components, a blower, a photoelectric switch, temperature sensors, a control and drive circuit board, etc. According to the principle of thermal shrinkage, the ultrasound probe equipped with thermal shrinkable film was rapidly heated and the film would wrap closely around the ultrasound probe placed on the top of the heat sealing machine. The ultrasound probe was ready for use after the thermal shrinkage process finished. Temperature sensors were installed on the surface of the probe to test the thermal insulation performance of the system. The operation procedures of the system are as follows: placing the ultrasound probe covered with the protective film in a certain space above the protective air vent, which is detected by the photoelectric switch; the heating device heats the thermal shrinkable film with a constant flow of hot air at a set temperature value. Then, the probe is rotated so that the thermal shrinkable film will quickly wrap around the ultrasound probe. After the heat shrinking is completed, the probe can be used directly. 2) Using the convenience sampling method, 90 patients from the Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Xi’an Jiaotong University were included as the research subjects. All patients were going to undergo arterial puncture under ultrasound guidance. The subjects were divided into 3 groups, with 30 patients in each group. Three measures commonly applied in clinical practice were used to process the probes in the three groups and water-soluble fluorescent labeling was applied around the puncture site before use. In the experimental group, the probes were processed with the heat sealing system. The standard operating procedures of the heat sealing system for rapid reuse of ultrasonic probes were performed to cover the ultrasonic probe and form a physical barrier to prevent probe contamination. There were two control groups. In control group 1, disinfection wipes containing double-chain quaternary ammonium salt were used to repeatedly wipe the surface of the probe for 10-15 times, and then the probe was ready for use once it dried up. In the control group 2, a disposable protective sheath was used to cover the front end of the probe and the handle end of the sheath was tied up with threads. Comparison of the water-soluble fluorescent labeling on the surface of the probe (which reflected the colony residues on the surface of the probe) before and after use and the reuse time (i.e., the lapse of time from the end of the first use to the beginning of the second use) were made between the experimental group and the two control groups.
    Results 1) The temperature inside the ultrasound probe was below 40 ℃ and the heat sealing system for rapid reuse did not affect the performance of the ultrasound probe. 2) The reuse time in the heat sealing system group, as represented by (median P25, P75), was (8.00 7.00, 10.00) s, which was significantly lower than those of the disinfection wipe group at (95.50 8.00, 214.00) s and the protective sleeve group at (25.00 8.00, 51.00) s, with the differences being statistically significant (P<0.05). No fluorescence residue was found on the probe in either the heat sealing system group or the protective sheath group after use. The fluorescence residue in the heat sealing system group was significantly lower than that in the disinfection wipes group, showing statistically significant differences (χ2=45.882, P<0.05).
    Conclusion The thermal shrinkable film designed and developed in this study can be cut and trimmed according to the size of the equipment. When the film is heated, it shrinks and wraps tightly around the equipment, forming a sturdy protective layer. With the heat sealing system for rapid reuse of ultrasonic probes, we have realized the semi-automatic connection between the thermal shrinkable film and the heating device, reducing the amount of time-consuming and complicated manual operation. Furthermore, the average reuse time is shortened and the system is easy to use, which contributes to improvements in the reuse and operation efficiency of ultrasound probes. The heat sealing system reduces colony residues on the surface of the probe and forms an effective physical barrier on the probe. No probes were damaged in the study. The heat sealing system for rapid reuse of ultrasonic probes can be used as a new method to process the ultrasonic probes.
     

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