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评估皮内注射装置中的力:流体动力学与人为因素。

Assessment of Forces in Intradermal Injection Devices: Hydrodynamic Versus Human Factors.

机构信息

Department of Product Development, Faculty of Design Sciences, University of Antwerp, Campus Mutsaard, Ambtmanstraat 1, 2000, Antwerpen, Belgium.

Novosanis, Wijnegem, Belgium.

出版信息

Pharm Res. 2018 Apr 18;35(6):120. doi: 10.1007/s11095-018-2397-2.

Abstract

PURPOSE

The force that has to be exerted on the plunger for administering a given amount of fluid in a given time, has an important influence on comfort for the subject and usability for the administrator in intradermal drug delivery. The purpose of this study is to model those forces that are subject-independent, by linking needle and syringe geometry to the force required for ejecting a given fluid at a given ejection rate.

MATERIAL AND METHODS

We extend the well-known Hagen-Poiseuille formula to predict pressure drop induced by a fluid passing through a cylindrical body. The model investigates the relation between the pressure drop in needles and the theoretic Hagen-Poiseuille prediction and is validated in fifteen needles from 26G up to 33G suited for intradermal drug delivery. We also provide a method to assess forces exerted by operators in real world conditions.

RESULTS

The model is highly linear in each individual needle with R-square values ranging from 75% up to 99.9%. Ten out of fifteen needles exhibit R-square values above 99%. A proof-of-concept for force assessment is provided by logging forces in operators in real life conditions.

CONCLUSIONS

The force assessment method and the model can be used to pinpoint needle geometry for intradermal injection devices, tuning comfort for subjects and usability for operators.

摘要

目的

在给定时间内给患者注射一定剂量的药物时,需要将药物注入体内的力会对患者的舒适度和施药者的易用性产生重要影响。本研究旨在通过将针和注射器的几何形状与以给定的射出速度射出给定剂量的药物所需的力联系起来,来对那些与受试者无关的力进行建模。

材料和方法

我们将著名的哈根-泊肃叶公式扩展到预测通过圆柱形物体的流体引起的压降。该模型研究了针内的压降与理论哈根-泊肃叶预测之间的关系,并在适用于皮内药物输送的 26G 至 33G 的 15 根针中进行了验证。我们还提供了一种方法来评估操作人员在实际条件下所施加的力。

结果

该模型在每根单独的针中都具有高度的线性,R 平方值范围从 75%到 99.9%。其中 10 根针的 R 平方值高于 99%。通过在实际生活条件下记录操作人员的力,提供了一种用于力评估的概念验证。

结论

力评估方法和模型可用于确定皮内注射装置的针几何形状,调整患者的舒适度和操作人员的易用性。

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