什么是醫(yī)療連接器接頭 What are medical connectors
Posted by Mary Gannon on Monday, December 8, 2014
醫(yī)療設(shè)備中的連接包括多種類型，包括在醫(yī)療機(jī)器和系統(tǒng)中進(jìn)行電氣連接的連接，以及用于鎖定和解鎖醫(yī)療設(shè)備中管道的連接。連接器用于傳輸電源、信號(hào)、數(shù)據(jù)或介質(zhì)，可設(shè)計(jì)為僅用于其中一種操作或作為混合系統(tǒng)。無論是哪種類型，它們都必須安全衛(wèi)生。
電氣連接
醫(yī)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(jī)、外科、診斷和治療系統(tǒng)等。因此，可靠性至關(guān)重要。這些連接器必須便于經(jīng)過培訓(xùn)的專業(yè)人員使用、連接和斷開，但也必須是傻瓜式的，以防止未經(jīng)培訓(xùn)的用戶損壞或錯(cuò)誤匹配電纜。
除防水密封等級(jí)為IP68外，大多數(shù)可重復(fù)使用的連接器（用于手術(shù)室或類似環(huán)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(yī)療連接需要大量的交配周期，從5000個(gè)周期或更多，例如一臺(tái)超聲波機(jī)，操作員在一天中多次更換電纜。醫(yī)療連接器制造商已經(jīng)開發(fā)了特定的配合接觸系統(tǒng)，以適應(yīng)許多配合周期。
一些來自LEMO的連接器組件采用二次成型設(shè)計(jì)，以提供防潮和應(yīng)變消除密封，并防止不匹配和閉鎖。
醫(yī)療應(yīng)用中的大多數(shù)連接器都有一個(gè)推拉鎖定機(jī)制，可防止在有人絆倒或越過電纜時(shí)意外斷開。因?yàn)樵S多設(shè)計(jì)都是定制或半定制的，所以可以使用各種觸點(diǎn)，從公頭和母頭焊料、壓接和PCB端接到多極2到64觸點(diǎn)。
醫(yī)用電纜通常非常靈活。靈活性的關(guān)鍵是使用小型導(dǎo)體，使用絞合線和電介質(zhì)配方優(yōu)化靈活性。模壓電纜有助于保持這種靈活性，同時(shí)提供防潮和應(yīng)力消除密封，防止錯(cuò)配和鎖定。
油管接頭
應(yīng)用的操作要求決定了油管和連接器的參數(shù)。管件、魯爾管接頭和快速斷開管接頭是低壓環(huán)境中使用的常見的管接頭。它們是可靠、經(jīng)濟(jì)高效、重量輕的設(shè)計(jì)，設(shè)計(jì)時(shí)應(yīng)減少甚至消除用戶故障的可能性�；旌线B接器設(shè)計(jì)有助于在一個(gè)設(shè)備中傳輸液體和空氣介質(zhì)以及電信號(hào)。雖然每種都適用于某些應(yīng)用，但它們不一定是可互換的。例如，在需要防泄漏的應(yīng)用中，帶閥門的連接器比luer更好（見圖1和圖2）。如果應(yīng)用涉及頻繁的連接和斷開，為長期可靠性設(shè)計(jì)的快速斷開是一個(gè)不錯(cuò)的選擇。
醫(yī)療設(shè)備上使用的這些插銷和解鎖聯(lián)軸器和配件通常為快速斷開設(shè)計(jì)，允許快速、安全的連接和斷開。它們用于防止安全機(jī)器和系統(tǒng)設(shè)計(jì)的意外錯(cuò)誤連接。
多功能連接器，如CPC的混合連接器，可將介質(zhì)、氣體和/或電信號(hào)的連接整合到單個(gè)裝置中。
設(shè)計(jì)包括用于空氣和流體處理的通用聯(lián)軸器，通過模塊化方法和無泄漏功能簡化設(shè)計(jì)。其次，使用醫(yī)用級(jí)材料制成的連接器符合USP六級(jí)、MEM洗脫和其他規(guī)定。它們還必須是安全、干凈的設(shè)計(jì)，便于連接。后，一些制造商為血壓計(jì)等應(yīng)用提供了特定的連接器。
在選擇用于醫(yī)療應(yīng)用的連接器時(shí)，考慮以下因素是重要的，因?yàn)檫@些因素都會(huì)影響您的選擇：
-管道尺寸，包括內(nèi)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(nèi)徑尺寸、推入式管件的外徑以及壓縮管的內(nèi)徑和外徑
-閥門設(shè)計(jì)，如整體式閥門、平面設(shè)計(jì)、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(zhì)量即使是微小的缺陷或鋸齒狀邊緣也可能導(dǎo)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?yàn)獒t(yī)療應(yīng)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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