Department of Chemical Engineering, Loughborough University, Loughborough LE11 3TU, United Kingdom.
J Pharm Sci. 2013 Apr;102(4):1209-21. doi: 10.1002/jps.23439. Epub 2013 Jan 28.
Insertion behaviour of microneedle (MN) arrays depends upon the mechanical properties of the skin and, MN geometry and distribution in an array. In addressing this issue, this paper studies MN array insertion mechanism into skin and provides a simple quantitative basis to relate the insertion force with distance between two MNs. The presented framework is based on drawing an analogy between a beam on an elastic foundation and mechanism of needle insertion, where insertion force is separated into different components. A theoretical analysis indicates that insertion force decreases as interspacing increases. For a specified skin type, insertion force decreased from 0.029 to 0.028 N/MN when interspacing at MN tip was increased from 50 μm (350 μm at MN base) to 150 μm (450 μm at MN base). However, dependence of insertion force seems to decrease as the interspacing is increased beyond 150 μm. To assess the validity of the proposed model, a series of experiments was carried out to determine the force required for skin insertion of MN. Experiments performed at insertion speed of 0.5 and 1.0 mm/s yielded insertion force values of 0.030 and 0.0216 N, respectively, for 30 μm interspacing at MN base (330 μm interspacing at tip) and 0.028 and 0.0214 N, respectively, for 600 μm interspacing at MN base (900 μm interspacing at tip). Results from theoretical analysis and finite element modelling agree well with experimental results, which show MN interspacing only begins to affect insertion force at low interspacing (<150 μm interspacing at MN base). This model provides a framework for optimising MN devices, and should aid development of suitable application method and determination of force for reliable insertion into skin.
微针(MN)阵列的插入行为取决于皮肤的机械性能,以及 MN 在阵列中的几何形状和分布。在解决这个问题时,本文研究了 MN 阵列插入皮肤的机制,并提供了一个简单的定量基础,将插入力与 MN 之间的距离联系起来。所提出的框架是基于将梁在弹性基础上的类比和针插入机制,其中插入力被分解为不同的分量。理论分析表明,插入力随着间隔的增加而减小。对于特定的皮肤类型,当 MN 尖端的间隔从 50μm(MN 基底 350μm)增加到 150μm(MN 基底 450μm)时,插入力从 0.029N/MN 减小到 0.028N/MN。然而,当间隔增加到超过 150μm 时,插入力的依赖性似乎会减小。为了评估所提出模型的有效性,进行了一系列实验来确定 MN 皮肤插入所需的力。在插入速度为 0.5 和 1.0mm/s 的情况下,对于 MN 基底 30μm 的间隔(尖端 330μm 的间隔),分别得到 0.030 和 0.0216N 的插入力值,对于 MN 基底 600μm 的间隔(尖端 900μm 的间隔),分别得到 0.028 和 0.0214N 的插入力值。理论分析和有限元建模的结果与实验结果吻合较好,表明 MN 间隔仅在低间隔(MN 基底 <150μm 的间隔)下开始影响插入力。该模型为优化 MN 器件提供了一个框架,应有助于开发合适的应用方法和确定可靠插入皮肤的力。