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开源3D可打印自动注射器:设计,测试和监管限制

Anjutha Selvaraj1, Apoorv Kulkarni2, J M Pearce2,3

  • 1Faculty of Science, Medical Sciences and Environmental Sciences, Western University, London, ON, Canada.

PloS one
|July 14, 2023
PubMed
概括

这项研究介绍了一种开源的3D打印自动注射器,旨在提供负担得起的药物输送. 这种低成本的设备证明了有效的剂量传递,提高了自给药治疗的可访问性.

科学领域:

  • 生物医学工程 生物医学工程
  • 医疗器械设计 医疗器械设计
  • 开源硬件是开源的硬件.

背景情况:

  • 自动注射器越来越受欢迎用于药物输送,但其高成本限制了患者的可访问性.
  • 预计到2025年,自动注射器设备的全球市场将达到375亿美元.
  • 自治药物可以降低医疗保健成本,但设备费用仍然是一个障碍.

研究的目的:

  • 使用3D打印技术设计和制造一个低成本的,弹驱动的自动注射器.
  • 为了克服与商业自动注射器设备相关的经济可访问性挑战.
  • 为医疗器械的分布式制造提供开源硬件解决方案.

主要方法:

  • 一个弹驱动的自动注射器被设计和制造使用3D打印 (RepRap类合线材打印机).
  • 材料说明书和组装说明书详细说明了可复制性.
  • 剂量准确性和安全性根据ISO 11608-1:2022使用乙醇和各种BD胰岛素注射器进行了测试.
  • 对1mL,0.5mL和0.3mL注射器进行了剂量传递效率的评估.

主要成果:

  • 对于1mL和0.5mL注射器,3D打印的自喷器成功地在97.5%的时间内输送了整个剂量.
  • 该设备的弹力和尺寸与0.3mL或更小的注射器不兼容.

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  • 制造组件大约需要十二个小时.
  • 总材料成本为6.83加元,远低于商业替代品.

    • 结论:

    • 这种开源的3D打印自动注射器提供了一个有希望的,具有成本效益的解决方案,用于可访问的药物输送.
    • 进一步开发和监管部门的批准是必要的,以实现广泛采用.
    • 这些医疗器械的分布式制造可以支持面临高医疗费用的个人.