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

Area of Science:

• Biomaterials Science
• Medical Device Engineering
• Pharmacoeconomics

Background:

• Injectable drug delivery using pen needles and autoinjectors presents significant economic and environmental challenges.
• A multi-use, durable needle could mitigate these burdens, reduce costs, and enhance patient experience.
• This study introduces a novel robust needle tip (EXP) engineered for durability and repeated use.

Purpose of the Study:

• To evaluate the structural robustness and in-vivo performance of a novel durable needle tip (EXP).
• To compare the tissue trauma and skin blood perfusion (SBP) induced by the EXP needle against conventional needles (NF30, NF28).
• To assess the impact of autoinjector shields and applied force on SBP with worn EXP needles.

Main Methods:

• Structural analysis was performed to assess needle robustness against hooking.
• An in-vivo porcine model was used to evaluate EXP and control needles in pen needle and autoinjector configurations.
• Skin blood perfusion (SBP) was quantified using laser speckle contrast analysis (LASCA) following 192 randomized, blinded needle insertions.

Main Results:

• The EXP needle demonstrated superior resistance to forming a hook (5.38 N) compared to the NF30 control (0.92 N).
• EXP needles showed comparable tissue trauma to NF30 needles; increased needle diameter correlated positively with SBP (P < .05).
• Autoinjector shields and a 10 N applied force significantly reduced SBP for worn EXP needles (P < .05).

Conclusions:

• The robust EXP needle tip performs comparably to single-use needles regarding tissue trauma.
• Combining the needle with a shield further reduces tissue trauma.
• These findings support the development of reusable injection systems for pharmacoeconomic, environmental, and user experience benefits.