Microneedle Insertion into Visco-Hyperelastic Model for Skin for Healthcare Application

Davira P. Widianto, Benjamin G. Stewart, Juan Mena-Lapaix, R. Shafer, A. Burns, M. Prausnitz, A. Alizadeh, S. Sitaraman
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引用次数: 1

Abstract

Recently, microneedle patches have been explored for extracting interstitial fluid with the goal of extracting temporally relevant, clinical-grade information for human health monitoring. As compared to traditional hypodermic needles, the sub-millimeter scale of microneedles allows for the creation of micropores providing access into human skin interstitial fluid while minimizing interactions with blood vessels and nerves, leading to painless insertion with little to no bleeding. An essential sub-component is the actuator, responsible for driving the microneedle into the skin with a precise force and velocity to ensure reliable insertion. Reliability, in this case, consists of two criteria: the ability of the microneedle to 1) penetrate the skin, and 2) withstand penetration forces without mechanical failure. Evaluation of these criteria requires a thorough understanding of the non-linear, time-dependent interactions between the microneedle and the skin during insertion, including rupture and tearing of the skin on the micron scale, and the resultant stresses on the microneedle. To this end, a comprehensive finite-element model was developed to simulate the microneedle insertion process. This analysis yielded a prediction of complete microneedle insertion without failure of the microneedle and an estimated insertion force of 0.055 N per microneedle, well within the capability of the actuator system considered. This insertion force was validated using experimental data obtained through microneedle insertion in whole skin samples. The model was then used to perform several parametric studies, yielding valuable insights for possible future design improvements.
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微针插入医疗应用皮肤粘弹性模型
最近,微针贴片已被探索用于提取间质液,目的是提取与人类健康监测有关的时间、临床级信息。与传统的皮下注射针头相比,亚毫米尺度的微针头允许创建微孔,提供进入人体皮肤间质液的通道,同时最大限度地减少与血管和神经的相互作用,从而实现无痛插入,几乎不出血。一个重要的子部件是执行器,负责以精确的力和速度驱动微针进入皮肤,以确保可靠的插入。在这种情况下,可靠性由两个标准组成:微针穿透皮肤的能力,以及2)承受穿透力而无机械故障的能力。对这些标准的评估需要对插入过程中微针与皮肤之间的非线性、随时间变化的相互作用有透彻的了解,包括微米尺度上皮肤的破裂和撕裂,以及微针上产生的应力。为此,建立了一个综合的有限元模型来模拟微针插入过程。该分析预测了微针完全插入而不损坏微针的情况,每个微针的插入力估计为0.055牛,完全在执行器系统的能力范围内。通过在整个皮肤样本中插入微针获得的实验数据验证了这种插入力。然后,该模型被用于执行几个参数研究,为可能的未来设计改进提供有价值的见解。
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