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什么是醫療連接器接頭 What are medical connectors
Posted by Mary Gannon on Monday, December 8, 2014

 

醫療設備中的連接包括多種類型,包括在醫療機器和系統中進行電氣連接的連接,以及用于鎖定和解鎖醫療設備中管道的連接。連接器用于傳輸電源、信號、數據或介質,可設計為僅用于其中一種操作或作為混合系統。無論是哪種類型,它們都必須安全衛生。

電氣連接

醫用電氣連接器和電纜通常用于MRI、超聲波、除顫器、心電圖、心肺機、外科、診斷和治療系統等。因此,可靠性至關重要。這些連接器必須便于經過培訓的專業人員使用、連接和斷開,但也必須是傻瓜式的,以防止未經培訓的用戶損壞或錯誤匹配電纜。

除防水密封等級為IP68外,大多數可重復使用的連接器(用于手術室或類似環境中的連接器)必須是可高壓滅菌的,在121°C以上的溫度下可存活20分鐘。如果不是,它們必須足夠便宜,一次使用后即可處理。常見的材料有不同類型的塑料(PEEK、PVC等)和不銹鋼。

一些醫療連接需要大量的交配周期,從5000個周期或更多,例如一臺超聲波機,操作員在一天中多次更換電纜。醫療連接器制造商已經開發了特定的配合接觸系統,以適應許多配合周期。

一些來自LEMO的連接器組件采用二次成型設計,以提供防潮和應變消除密封,并防止不匹配和閉鎖。

醫療應用中的大多數連接器都有一個推拉鎖定機制,可防止在有人絆倒或越過電纜時意外斷開。因為許多設計都是定制或半定制的,所以可以使用各種觸點,從公頭和母頭焊料、壓接和PCB端接到多極2到64觸點。

醫用電纜通常非常靈活。靈活性的關鍵是使用小型導體,使用絞合線和電介質配方優化靈活性。模壓電纜有助于保持這種靈活性,同時提供防潮和應力消除密封,防止錯配和鎖定。

油管接頭

應用的操作要求決定了油管和連接器的參數。管件、魯爾管接頭和快速斷開管接頭是低壓環境中使用的常見的管接頭。它們是可靠、經濟高效、重量輕的設計,設計時應減少甚至消除用戶故障的可能性。混合連接器設計有助于在一個設備中傳輸液體和空氣介質以及電信號。雖然每種都適用于某些應用,但它們不一定是可互換的。例如,在需要防泄漏的應用中,帶閥門的連接器比luer更好(見圖1和圖2)。如果應用涉及頻繁的連接和斷開,為長期可靠性設計的快速斷開是一個不錯的選擇。

醫療設備上使用的這些插銷和解鎖聯軸器和配件通常為快速斷開設計,允許快速、安全的連接和斷開。它們用于防止安全機器和系統設計的意外錯誤連接。

多功能連接器,如CPC的混合連接器,可將介質、氣體和/或電信號的連接整合到單個裝置中。

設計包括用于空氣和流體處理的通用聯軸器,通過模塊化方法和無泄漏功能簡化設計。其次,使用醫用級材料制成的連接器符合USP六級、MEM洗脫和其他規定。它們還必須是安全、干凈的設計,便于連接。后,一些制造商為血壓計等應用提供了特定的連接器。

在選擇用于醫療應用的連接器時,考慮以下因素是重要的,因為這些因素都會影響您的選擇:

-管道尺寸,包括內徑和外徑

-終端類型,包括軟管倒鉤、壓縮配件和推接

-流量和壓力,

-軟管倒鉤的內徑尺寸、推入式管件的外徑以及壓縮管的內徑和外徑

-閥門設計,如整體式閥門、平面設計、提升閥類型等。

-安裝和配置,如面板安裝或直接安裝到NPT螺紋或端口

-接頭質量即使是微小的缺陷或鋸齒狀邊緣也可能導致其他材料泄漏或撕裂。

后,還必須考慮使用的連接器材料,因為醫療應用中使用各種流體和氣體,并且流體必須與熱塑性塑料、氟聚合物、金屬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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