Staples Anne-Sofie Madsen, Schwartz Julie, Præstmark Kezia Ann Friis, Traberg Marie Sand
Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
Devices and Delivery Solutions, Novo Nordisk A/S, Hillerød, Denmark.
J Diabetes Sci Technol. 2025 Mar;19(2):352-360. doi: 10.1177/19322968231190408. Epub 2023 Aug 9.
Pen needles and autoinjectors are necessary for millions of patients needing injectable drug treatment but pose economic and environmental burdens. A durable device with a multiuse needle could reduce cost and improve user experience. This study explores a novel robust needle tip (EXP) designed for multiple uses and durability against hooking.
Needle robustness was investigated through a structural analysis. Furthermore, EXP and control needles (NF30, NF28) were evaluated in an in-vivo porcine model as pen needles or embedded in autoinjectors to study the resulting increase in skin blood perfusion (SBP). The SBP was assessed by laser speckle contrast analysis (LASCA) of 192 randomized and blinded needle insertions.
Forming a 33 µm hook against a hard surface requires 0.92 N for the NF30 control needle and 5.38 N for EXP. The EXP did not induce more tissue trauma than the NF30. There was a positive relation between needle diameter and SBP ( < .05). Furthermore, the presence of an autoinjector shield and applied force of 10 N was found to significantly reduce SBP for worn EXP needles ( < .05) compared to insertions without autoinjector shield.
The investigated robust needle EXP is on par with the single-use needle NF30 in terms of tissue trauma, which is further reduced by combining the needle with a needle shield. These results should encourage the innovation and development of durable, reusable injection systems with pharmacoeconomic and environmental value and a simplified and enhanced user experience for patients.
对于数百万需要注射药物治疗的患者来说，笔式注射器针头和自动注射器是必需的，但它们会带来经济和环境负担。一种带有可多次使用针头的耐用设备可以降低成本并改善用户体验。本研究探索了一种新型的坚固针头尖端（EXP），其设计用于多次使用且具有抗钩挂的耐用性。
通过结构分析研究针头的坚固性。此外，在猪体内模型中评估EXP针头和对照针头（NF30、NF28）作为笔式注射器针头或嵌入自动注射器中，以研究由此导致的皮肤血流灌注（SBP）增加情况。通过对192次随机且盲法进行的针头插入操作进行激光散斑对比分析（LASCA）来评估SBP。
NF30对照针头在坚硬表面形成33 µm的钩子需要0.92 N的力，而EXP需要5.38 N的力。EXP诱导的组织创伤并不比NF30多。针头直径与SBP之间存在正相关关系（P <.05）。此外，与没有自动注射器护罩的插入操作相比，发现自动注射器护罩的存在和10 N的施加力可显著降低磨损的EXP针头的SBP（P <.05）。
所研究的坚固针头EXP在组织创伤方面与一次性针头NF30相当，将针头与针头护罩结合使用可进一步减少组织创伤。这些结果应鼓励创新和开发具有药物经济学和环境价值、为患者提供简化且增强的用户体验的耐用、可重复使用的注射系统。
