醫用注射針頭之生化機械性能研究

Abstract

注射針頭在醫療上已被廣泛的使用，不論是皮內注射、皮下注射、肌肉注射或是靜 脈注射皆需要使用之。注射針頭在製造上是一項冗長而又繁雜的工程，因此影響針頭品 質的因素很多，每一個步驟都有可能影響針頭的性能。 在實際的注射過程中，注射針頭需要穿刺皮膚或肌肉組織，不同製造廠商所生產的 注射針頭即使號數相同，在針尖幾何外形、針頭斜面的研磨、針管的表面加工、外徑和 厚度方面皆有不同，這些因素對於針頭穿刺力之生化機械性能，也有相當程度的影響。 本研究先以注射針頭的穿刺力大小做為針頭生化機械性能優劣之判斷的依據，並經 由精密儀器的量測，得到針尖幾何外形、針體表面粗度、外徑和厚度，再分析其與穿刺 力之間的關係。此外也探討穿刺速度對於穿刺力的影響。最後將此結果做為日後注射針 頭在設計與製造上改進的參考。

Hypodermic needles have been used extensively in the medical treatment. Most injections have to use needles, such as intradermic injection, hypodermic injection, intramuscular injection and venipuncture. Manufacturing processes of needles are very complicate, a lot of factors will influence final performance of needles. In the injecting process, needles need to penetrate skin or muscular tissue. Even though it is of same gauge, needles made by different manufactures may be different in the needle geometries, grinding of the needle bevel, surface roughness, outer diameter and the thickness. These factors will certainly affect the biomechanical performance, such as the penetration force of needle. In this study, the penetration force is selected as the criterion of biomechanical performance. Precision instruments was used to measure the needle geometries, surface roughness, outer diameter and the thickness, its relations with the penetration force was discussed. The effect of penetration velocity on the penetration force was also considered. Hopefully, the findings of this study could provide some reference for the design and manufacturing of needle.