Novel Robust Needle Tip Design Enables Needle Reuse and Reduced Skin Trauma in Combination With Autoinjector Needle Shields

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Anne Sofie Madsen Staples
  • Julie Schwartz
  • Kezia Ann Friis Præstmark
  • Marie Sand Traberg

Background: 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. Method: 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. Results: 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 (P <.05). Furthermore, the presence of an autoinjector shield and applied force of 10 N was found to significantly reduce SBP for worn EXP needles (P <.05) compared to insertions without autoinjector shield. Conclusions: 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.

OriginalsprogEngelsk
TidsskriftJournal of Diabetes Science and Technology
Antal sider9
ISSN1932-2968
DOI
StatusE-pub ahead of print - 2024

Bibliografisk note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work is a part of a Danish Industrial PhD project which is funded by the Danish Innovation Fund and Novo Nordisk A/S.

Publisher Copyright:
© 2023 Diabetes Technology Society.

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