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什么是医疗连接器接头 What are medical connectors
Posted by Mary Gannon on Monday, December 8, 2014

 

医疗设备中的连接包括多种类型,包括在医疗机器和系统中进行电气连接的连接,以及用于锁定和解锁医疗设备中管道的连接。连接器用于传输电源、信号、数据或介质,可设计为仅用于其中一种操作或作为混合系统。无论是哪种类型,它们都必须安全卫生。

电气连接

医用电气连接器和电缆通常用于MRI、超声波、除颤器、心电图、心肺机、外科、诊断和治疗系统等。因此,可靠性至关重要。这些连接器必须便于经过培训的专业人员使用、连接和断开,但也必须是傻瓜式的,以防止未经培训的用户损坏或错误匹配电缆。

除防水密封等级为IP68外,大多数可重复使用的连接器(用于手术室或类似环境中的连接器)必须是可高压灭菌的,在121°C以上的温度下可存活20分钟。如果不是,它们必须足够便宜,一次使用后即可处理。常见的材料有不同类型的塑料(PEEK、PVC等)和不锈钢。

一些医疗连接需要大量的交配周期,从5000个周期或更多,例如一台超声波机,操作员在一天中多次更换电缆。医疗连接器制造商已经开发了特定的配合接触系统,以适应许多配合周期。

一些来自LEMO的连接器组件采用二次成型设计,以提供防潮和应变消除密封,并防止不匹配和闭锁。

医疗应用中的大多数连接器都有一个推拉锁定机制,可防止在有人绊倒或越过电缆时意外断开。因为许多设计都是定制或半定制的,所以可以使用各种触点,从公头和母头焊料、压接和PCB端接到多极2到64触点。

医用电缆通常非常灵活。灵活性的关键是使用小型导体,使用绞合线和电介质配方优化灵活性。模压电缆有助于保持这种灵活性,同时提供防潮和应力消除密封,防止错配和锁定。

油管接头

应用的操作要求决定了油管和连接器的参数。管件、鲁尔管接头和快速断开管接头是低压环境中使用的常见的管接头。它们是可靠、经济高效、重量轻的设计,设计时应减少甚至消除用户故障的可能性。混合连接器设计有助于在一个设备中传输液体和空气介质以及电信号。虽然每种都适用于某些应用,但它们不一定是可互换的。例如,在需要防泄漏的应用中,带阀门的连接器比luer更好(见图1和图2)。如果应用涉及频繁的连接和断开,为长期可靠性设计的快速断开是一个不错的选择。

医疗设备上使用的这些插销和解锁联轴器和配件通常为快速断开设计,允许快速、安全的连接和断开。它们用于防止安全机器和系统设计的意外错误连接。

多功能连接器,如CPC的混合连接器,可将介质、气体和/或电信号的连接整合到单个装置中。

设计包括用于空气和流体处理的通用联轴器,通过模块化方法和无泄漏功能简化设计。其次,使用医用级材料制成的连接器符合USP六级、MEM洗脱和其他规定。它们还必须是安全、干净的设计,便于连接。后,一些制造商为血压计等应用提供了特定的连接器。

在选择用于医疗应用的连接器时,考虑以下因素是重要的,因为这些因素都会影响您的选择:

-管道尺寸,包括内径和外径

-终端类型,包括软管倒钩、压缩配件和推接

-流量和压力,

-软管倒钩的内径尺寸、推入式管件的外径以及压缩管的内径和外径

-阀门设计,如整体式阀门、平面设计、提升阀类型等。

-安装和配置,如面板安装或直接安装到NPT螺纹或端口

-接头质量即使是微小的缺陷或锯齿状边缘也可能导致其他材料泄漏或撕裂。

后,还必须考虑使用的连接器材料,因为医疗应用中使用各种流体和气体,并且流体必须与热塑性塑料、氟聚合物、金属合金和密封材料兼容。


Connections in medical devices encompass a variety of styles, including those that make electrical connections within medical machines and systems, as well as those used to latch and unlatch tubing in medical devices. Connectors are used to transfer power, signal, data or media and can be designed for just one of these operations or as hybrid systems. No matter what type, they must all be safe and hygienic.

Electrical connections
Electrical medical connectors and cables are often used in MRI, ultrasound, defibrillators, EKG, heart-lung machines, surgical, diagnostic and therapy systems, to name a few. As a result, reliability is critical. These connectors must be easy for trained professionals to use and connect and disconnect, but also fool-proof to prevent untrained users from damaging or mating cables incorrectly.

In addition to being IP68-rated for watertight sealing, most reusable connectors (those used in operating rooms or similar environments) must be autoclavable, surviving temperatures above 121° C for 20 minutes. If not, they must be inexpensive enough to be disposed after a single use. Common materials are different types of plastics (PEEK, PVC, etc.) and stainless steel.

Some medical connections require high numbers of mating cycles, from 5,000 cycles or more, such as an ultrasound machine where the operator changes the cable many times during the day. Medical connector manufacturers have developed specific mating contact systems to accommodate many mating cycles.

Some connector assemblies like these from LEMO feature an overmolded design to provide a seal against moisture and strain relief and prevent mismating and latching.

Most connectors in medical applications feature a push-pull locking mechanism that prevents accidental disconnection if someone trips or runs over a cable. Because many designs are custom or semi-custom, a variety of contacts are available, ranging anywhere from male and female solder, crimp and PCB termination to multipole 2 to 64 contacts.

Medical cables are usually very flexible. The key to flexibility is the use of small conductors using stranded wire and dielectric recipes optimized for flexibility. Over-molded cables help maintain this flexibility while providing a seal against moisture and strain relief and preventing mismating and latching.

Tubing connections
The operative demands of your application determine the parameters for tubing and connectors. Fittings, luers and quick disconnect couplings are the most common tubing connectors used in low-pressure environments. They are reliable, cost-efficient, low-weight designs and should be designed to reduce or even eliminate the potential for user fault. Hybrid connector designs help transfer liquid and air media, as well as electrical signals, in one device. While each is appropriate for certain applications, they are not necessarily interchangeable. For example, in applications where spill prevention is desired, a valved connector is a better choice than a luer (see figures 1 and 2). If the application involves frequent connecting and disconnecting, a quick disconnect designed for long-term reliability is a good choice.

These latch and unlatch couplings and fittings used on medical equipment are often of the quick-disconnect design, allowing for quick and secure connections and disconnections. They are used to prevent accidental misconnections for safe machine and system designs.

Multifunction connectors, such as CPC’s Hybrid Connectors, can consolidate the connections for media, gasses and/or electrical signal, into a single unit.

Designs include general-purpose couplings for air and fluid handling to simplify design with a modular approach and non-spill features. Next, connectors made with medical-grade materials meet USP Class VI, MEM elution and other regulations. They must also be safe and clean designs that allow for easy connections. Finally, several manufacturers provide specific connectors for applications such as blood pressure machines.

It is important to consider the following when selecting a connector for use in medical applications, as these factors will all impact your choice:
- tubing size, both inner and outer diameter
- termination type, including hose barb, compression fittings and push-to-connect
- flow rate and pressure,
- ID size for hose barbs, OD for push-in fittings and tube ID and OD for compression
- valve designs, such as integral valves, flush-face designs, poppet-style, etc.
- mounting and configuration, such as panel mount or direct mounting into NPT thread or ports
- connector quality—even the most minute defect or jagged edge could lead to leaks or tears in other materials.

Finally, connector materials used must also be considered, as a variety of fluids and gases are used in medical applications and the fluid must be compatible with the thermoplastics, fluoropolymers, metal alloys and sealing materials.

 

 




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