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Efficacy of a Novel Prefilled, Single-Use, Needle-Free Device (Zeneo(®)) in Achieving Intramuscular Agent Delivery: An Observational Study
BACKGROUND: It is recognized that, as a result of variation in tissue anatomy, current auto-injectors may have insufficient needle length to achieve successful intramuscular agent delivery in a number of patients. The Zeneo(®) auto-injector is a novel prefilled, single-use, needle-free device curren...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5216060/ https://www.ncbi.nlm.nih.gov/pubmed/27928757 http://dx.doi.org/10.1007/s12325-016-0452-0 |
Sumario: | BACKGROUND: It is recognized that, as a result of variation in tissue anatomy, current auto-injectors may have insufficient needle length to achieve successful intramuscular agent delivery in a number of patients. The Zeneo(®) auto-injector is a novel prefilled, single-use, needle-free device currently in development for intradermal, subcutaneous, and intramuscular agent delivery across a variety of clinical indications. We aimed to evaluate delivery depth of the device calibrated at pressure appropriate for intramuscular (IM) administration. METHODS: This was a prospective single-center study in healthy adult volunteers, in whom each received a single injection of saline into the anterolateral thigh. Using sequential MRI scans, we measured skin-to-muscle distance (STMD) agent delivery depth, and the success of IM agent penetration. Device dynamic pressure measurements were also recorded. RESULTS: Results are reported for 37 subjects with evaluable MRI scans; 19 men, 18 women; mean age 38 years (range 20–58); mean BMI 27.0 kg/m(2) (range 21.2–30.8 kg/m(2)). Mean STMD values were 18.6 mm (range 13.4–23.6 mm) in women and 10.0 mm (range 5.0–21.7 mm) in men, with gender differences due primarily to greater subcutaneous thickness in women. A trend for greater STMD in subjects with BMI greater than 25 kg/m(2) was seen. Mean injectate penetration depths of 30.1 mm (range 20.2–45.6 mm) were observed with values similar in male and female subjects. Successful IM delivery was reported in 95% of subjects. When failure occurred, this was not due to inadequate injection depth. Device pressure (P (max)) had the greatest influence on injectate muscle penetration. CONCLUSION: Use of the Zeneo(®) auto-injector achieves delivery depth that ensures intramuscular delivery in both men and women, regardless of BMI. Consistent with other reported data, STMD is greater in women. FUNDING: Crossject. |
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