Document Detail


Penetration Force, Geometry, and Cutting Profile of the Novel and Old Ozurdex Needle: The MONO Study.
MedLine Citation:
PMID:  24801111     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract Objectives: To investigate the geometry, penetration force, and cutting profile of the novel and old needle of the drug delivery system (DDS) for Ozurdex injections in a standardized laboratory setting. Design: Experimental study. Methods: The normative geometrical data of the DDS needle were systematically analyzed according to nomenclature DIN 13097 (ISO 7864) and ISO 9626. The force to penetrate a standardized 0.4-mm-thick polyurethane foil was measured by a penetrometer, when the needle was piercing, cutting, and sliding through the foil and plotted as a load-displacement diagram. Magnified images of the consecutive cut were taken after the entire penetration through the foil. Results: The mean point length was equal to 3.34 mm (3.28-3.36 mm) for the old DDS needle versus 3.33 mm (3.30-3.36 mm) for the new DDS needle. The secondary bevel length was 1.64 mm (1.42-1.73 mm) for the new and 1.66 mm (1.62-1.69 mm) for the old needle. The primary angle was 9.2° (9.0°-9.5°) for the old and 8.9° (8.5°-9.0°) for the new needle, respectively. The secondary bevel angle was 117.2° (116°-118°) for the old and 111.4° (110°-113°) for the new needle. The mean penetration force of the old DDS needles was significant higher at all phases of the penetration experiment: The mean piercing force was 0.7 Newton (N) with the old and 0.47 N with the new DDS needle. The mean cutting force was remarkable higher with 1.1 N for the old DDS needle versus 0.78 N for the new DDS needle. The dilatation phase was not statistically significant between 0.94 and 0.99 N in both DDS needles. The friction phase was maintained at significantly higher levels with the old DDS needle of 0.47 N, whereas it returned to the lowest measurements of 0.11 N with the new DDS needle. Both DDS systems induced a characteristic chevron-shaped incision. Conclusion: A comparison of the old and new DDS needles demonstrated a reduced penetration force with the modified new DDS needle, which may help to achieve a smooth penetration through the human sclera.
Authors:
Carsten H Meyer; Zengping Liu; Christian K Brinkmann; Eduardo B Rodrigues; Thomas Bertelmann
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-5-6
Journal Detail:
Title:  Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics     Volume:  -     ISSN:  1557-7732     ISO Abbreviation:  J Ocul Pharmacol Ther     Publication Date:  2014 May 
Date Detail:
Created Date:  2014-5-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9511091     Medline TA:  J Ocul Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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