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

Autor:	Staples AM; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.; Devices and Delivery Solutions, Novo Nordisk A/S, Hillerød, Denmark., Schwartz J; Devices and Delivery Solutions, Novo Nordisk A/S, Hillerød, Denmark., Præstmark KAF; Devices and Delivery Solutions, Novo Nordisk A/S, Hillerød, Denmark., Traberg MS; Ultrasound and Biomechanics, Department of Health Technology, Technical University of Denmark, Kongens Lyngby, Denmark.
Jazyk:	angličtina
Zdroj:	Journal of diabetes science and technology [J Diabetes Sci Technol] 2023 Aug 09, pp. 19322968231190408. Date of Electronic Publication: 2023 Aug 09.
DOI:	10.1177/19322968231190408
Abstrakt:	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. Competing Interests: Declaration of Conflicting InterestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A-SMS is employed as Industrial PhD student at Novo Nordisk A/S. JS and KAFP are full-time employees at Novo Nordisk A/S.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu