Novel Needle for Intravitreal Drug Delivery: Comparative Study of Needle Tip Aspirates, Injection Stream and Penetration Forces.

endophthalmitis injection stream intravitreal injection needle tip novel needle penetrating forces

Journal

Clinical ophthalmology (Auckland, N.Z.)
ISSN: 1177-5467
Titre abrégé: Clin Ophthalmol
Pays: New Zealand
ID NLM: 101321512

Informations de publication

Date de publication:
2021
Historique:
received: 12 12 2020
accepted: 21 01 2021
entrez: 1 3 2021
pubmed: 2 3 2021
medline: 2 3 2021
Statut: epublish

Résumé

To study the efficacy of a novel needle for intravitreal injection (IVI) in comparison to the conventional needle under experimental conditions. The newly designed 30-gauge (G) needle (NDN) (EP 18158 542.3, patent pending) with occluded outer orifice and a side port for drug delivery was compared to the conventional standard hypodermic 30 G needle for IVI (SHN). An animal study to obtain needle tip aspirates was performed on 10 albino rat eyes. During IVIs, cellular content, which was cut by the needle tip, was aspirated. Cellular material was studied in regard to cell types and their quantity. The injection stream was studied using trypan blue dye in vitro and pig cadaver eyes. The penetration force was tested on polyurethane Testing Foil Strips PU 04 (Melab, Leonberg, Germany) by applying a velocity of 100 mm/min. The results were analyzed using descriptive statistics, correlation matrices and Cytological analysis of the needle aspirates showed the presence of cellular content in each case. The amount of conjunctival, ciliary body epithelial cells and granulated basophilic protein sediments (sign of cellular damage) in the case of the NDN tips was significantly lower compared to the SHN. The average penetration force of the NDN was 0.791 N, and in the case of the SHN was 0.566 N. The injection stream study revealed a difference in the initial injection phase between the two needle types, although the diffuse filling of the vitreous area which surrounded the needle tip appeared to be similar. The NDN demonstrated superior performance with regard to a significantly reduced number of cells being captured by the needle tip. Delivery of the injected fluid into the vitreous cavity was comparable. In order to investigate superior properties of the NDN needle design, further studies with improved prototypes would be necessary.

Identifiants

pubmed: 33642853
doi: 10.2147/OPTH.S297139
pii: 297139
pmc: PMC7903950
doi:

Types de publication

Journal Article

Langues

eng

Pagination

723-734

Informations de copyright

© 2021 Lytvynchuk et al.

Déclaration de conflit d'intérêts

Lyubomyr M. Lytvynchuk reports a patent EP 18158 542.3 pending. The authors report no other conflicts of interest in this work.

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Auteurs

Lyubomyr M Lytvynchuk (LM)

Department of Ophthalmology, Justus-Liebig-University Giessen, Eye Clinic, University Hospital Giessen and Marburg GmbH, Campus Giessen, Giessen, Germany.
Karl Landsteiner Institute for Retinal Research and Imaging, Vienna, Austria.

Goran Petrovski (G)

Center of Eye Research, Department of Ophthalmology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Adien Dam (A)

Vitreq B.V., MG Vierpolders, the Netherlands.

Joep Hiemstra (J)

Vitreq B.V., MG Vierpolders, the Netherlands.

Tobias Wimmer (T)

Department of Ophthalmology, Justus-Liebig-University Giessen, Eye Clinic, University Hospital Giessen and Marburg GmbH, Campus Giessen, Giessen, Germany.

Iryna Savytska (I)

Department of Experimental Surgery, A.A.Shalimov National Institute of Surgery and Transplantology, National Academy of Medical Science of Ukraine, Kyiv, Ukraine.

Susanne Binder (S)

Karl Landsteiner Institute for Retinal Research and Imaging, Vienna, Austria.
Department of Ophthalmology, Sigmund Freud University, Eye Center Donaustadt, Vienna, Austria.

Knut Stieger (K)

Department of Ophthalmology, Justus-Liebig-University Giessen, Eye Clinic, University Hospital Giessen and Marburg GmbH, Campus Giessen, Giessen, Germany.

Classifications MeSH