PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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 (χ 2=45.882, P<0.05).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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 (χ 2=45.882, P<0.05).
UNASSIGNED: 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.
摘要：
■超声诊断和治疗易于执行，花费的时间很少。由于其非侵入性，它在临床实践中被广泛使用，实时,和动态特性。在超声诊断和治疗过程中,探针可能会与皮肤接触，粘膜，甚至身体的无菌部分。然而,使用后难以对探头进行有效的实时消毒，并且经常重复使用，导致探针携带多种致病菌的可能性。目前,国内外探针的加工方法主要包括探针清洗、探头消毒,和物理隔离（使用探头盖或护套）。然而，每种方法都有其局限性，不能完全防止超声诊断和治疗引起的探头污染和感染。例如,当避孕套被用作探针鞘时，安全套破损率相对较高。保鲜膜或冷冻袋的切割和固定涉及复杂的程序并且难以执行。一次性塑料手套容易脱落并造成污染,因此不符合无菌原则。此外，一次性塑料手套的成像效果差。因此,迫切需要探索新材料，以制造不仅可以紧紧包裹超声探头的探头盖，还有助于实现有效保护和快速重用。基于物理障碍的概念，在这项研究中，我们开发了一种热密封系统，用于快速重复使用超声探头。该系统使用热封装置使保护膜收缩，使其紧贴超声探头表面，允许快速重复使用探针，同时降低医院感染的风险。目的设计超声探头快速复用热封系统,并验证其在超声探头快速复用中的应用效果。
■1）通过整合医学和工程方法，设计和测试了用于快速重复使用超声探头的热封系统。该系统包括保护膜（多层共挤出聚烯烃热收缩膜）和热密封装置，其中包括加热丝组件，鼓风机,一个光电开关，温度传感器,控制和驱动电路板，等。根据热收缩原理，快速加热配有热收缩膜的超声探头，膜将紧密包裹在放置在热封机顶部的超声探头周围。超声探头在热收缩过程完成后准备使用。在探头表面安装温度传感器,测试系统的隔热性能。该系统的操作程序如下：将覆盖有保护膜的超声探头放置在保护通风口上方的一定空间中，由光电开关检测；加热装置在设定温度值下，用恒定的热风流量对热收缩膜进行加热。然后，探针被旋转,使得热收缩膜将快速地缠绕在超声探针周围。热收缩完成后，探头可以直接使用。2)采用便利抽样方法，麻醉和围手术期医学部的90名患者，以西安交通大学第一附属医院为研究对象。所有患者均在超声引导下进行动脉穿刺。受试者分为3组,每组30名患者。使用临床上常用的三种方法对三组探针进行处理，并在使用前在穿刺部位周围进行水溶性荧光标记。在实验组中,探头用热封系统处理。执行用于快速重复使用超声探头的热密封系统的标准操作程序以覆盖超声探头并形成物理屏障以防止探头污染。有两个对照组。对照组1使用含双链季铵盐的消毒湿巾反复擦拭探头表面10-15次,然后探针一旦干涸就可以使用了。在对照组2中，使用一次性保护套覆盖探针的前端，并用螺纹将护套的手柄端绑住。使用前后探针表面的水溶性荧光标记（反映探针表面的菌落残基）和重复使用时间（即，从第一次使用结束到第二次使用开始的时间）在实验组和两个对照组之间进行。
■1）超声探头内部的温度低于40℃，用于快速重复使用的热封系统不影响超声探头的性能。2）热封系统组中的重复使用时间，表示为(中位数[P25，P75])，是(8.00[7.00,10.00])s，显著低于消毒擦拭组(95.50[8.00,214.00])s和保护套组(25.00[8.00,51.00])s,差异有统计学意义(P<0.05)。使用后，在热封系统组或保护护套组中的探针上均未发现荧光残留物。热封系统组的荧光残留量明显低于消毒湿巾组，差异有统计学意义(χ2=45.882,P<0.05)。
■本研究中设计和开发的热收缩膜可以根据设备的尺寸进行切割和修剪。当薄膜被加热时，它收缩并紧紧地包裹在设备上，形成坚固的保护层。随着超声波探头快速重复使用的热封系统，实现了热收缩膜与加热装置的半自动连接,减少了耗时和复杂的手工操作。此外，缩短了平均重用时间，系统易于使用，这有助于提高超声探头的重复使用和操作效率。热封系统减少了探针表面上的菌落残留,并在探针上形成有效的物理屏障。在研究中没有探针被损坏。超声探头快速重复使用的热封系统可作为超声探头加工的一种新方法。
■1）通过整合医学和工程方法，设计和测试了用于快速重复使用超声探头的热封系统。该系统包括保护膜（多层共挤出聚烯烃热收缩膜）和热密封装置，其中包括加热丝组件，鼓风机,一个光电开关，温度传感器,控制和驱动电路板，等。根据热收缩原理，快速加热配有热收缩膜的超声探头，膜将紧密包裹在放置在热封机顶部的超声探头周围。超声探头在热收缩过程完成后准备使用。在探头表面安装温度传感器,测试系统的隔热性能。该系统的操作程序如下：将覆盖有保护膜的超声探头放置在保护通风口上方的一定空间中，由光电开关检测；加热装置在设定温度值下，用恒定的热风流量对热收缩膜进行加热。然后，探针被旋转,使得热收缩膜将快速地缠绕在超声探针周围。热收缩完成后，探头可以直接使用。2)采用便利抽样方法，麻醉和围手术期医学部的90名患者，以西安交通大学第一附属医院为研究对象。所有患者均在超声引导下进行动脉穿刺。受试者分为3组,每组30名患者。使用临床上常用的三种方法对三组探针进行处理，并在使用前在穿刺部位周围进行水溶性荧光标记。在实验组中,探头用热封系统处理。执行用于快速重复使用超声探头的热密封系统的标准操作程序以覆盖超声探头并形成物理屏障以防止探头污染。有两个对照组。对照组1使用含双链季铵盐的消毒湿巾反复擦拭探头表面10-15次,然后探针一旦干涸就可以使用了。在对照组2中，使用一次性保护套覆盖探针的前端，并用螺纹将护套的手柄端绑住。使用前后探针表面的水溶性荧光标记（反映探针表面的菌落残基）和重复使用时间（即，从第一次使用结束到第二次使用开始的时间）在实验组和两个对照组之间进行。
■1）超声探头内部的温度低于40℃，用于快速重复使用的热封系统不影响超声探头的性能。2）热封系统组中的重复使用时间，表示为(中位数[P25，P75])，是(8.00[7.00,10.00])s，显著低于消毒擦拭组(95.50[8.00,214.00])s和保护套组(25.00[8.00,51.00])s,差异有统计学意义(P<0.05)。使用后，在热封系统组或保护护套组中的探针上均未发现荧光残留物。热封系统组的荧光残留量明显低于消毒湿巾组，差异有统计学意义(χ2=45.882,P<0.05)。
■本研究中设计和开发的热收缩膜可以根据设备的尺寸进行切割和修剪。当薄膜被加热时，它收缩并紧紧地包裹在设备上，形成坚固的保护层。随着超声波探头快速重复使用的热封系统，实现了热收缩膜与加热装置的半自动连接,减少了耗时和复杂的手工操作。此外，缩短了平均重用时间，系统易于使用，这有助于提高超声探头的重复使用和操作效率。热封系统减少了探针表面上的菌落残留,并在探针上形成有效的物理屏障。在研究中没有探针被损坏。超声探头快速重复使用的热封系统可作为超声探头加工的一种新方法。
