EP3554958B1 - Spender von ophthalmischen lösungen für einzeldosisbehälter - Google Patents

Spender von ophthalmischen lösungen für einzeldosisbehälter Download PDF

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Publication number
EP3554958B1
EP3554958B1 EP17826569.0A EP17826569A EP3554958B1 EP 3554958 B1 EP3554958 B1 EP 3554958B1 EP 17826569 A EP17826569 A EP 17826569A EP 3554958 B1 EP3554958 B1 EP 3554958B1
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EP
European Patent Office
Prior art keywords
dispenser
opening
fins
dispenser according
tip
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Active
Application number
EP17826569.0A
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English (en)
French (fr)
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EP3554958C0 (de
EP3554958A1 (de
Inventor
Stefano Barabino
Luigi Bisio
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Oftalab Srl
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Oftalab Srl
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Application granted granted Critical
Publication of EP3554958B1 publication Critical patent/EP3554958B1/de
Publication of EP3554958C0 publication Critical patent/EP3554958C0/de
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B65D47/18—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages for discharging drops; Droppers

Definitions

  • the present invention relates to a dispenser of ophthalmic solutions applicable to single-dose containers.
  • a sterile dispenser which is packaged individually and can be sold either individually or as a set, together with said single-dose containers.
  • the single-dose containers preferably contain an ophthalmic solution, for example, a lissamine green-based solution.
  • colouring agents are a group of substances used in the contact lens field for diagnostic purposes.
  • vital staining with sodium fluorescein and/or lissamine green is usually used in the diagnosis of corneal and conjunctival anomalies. While fluorescein predominantly shows a loss of epithelial cells, lissamine green identifies devitalized or suffering cells.
  • fluorescein and lissamine green are available in solutions contained in normal eye drop containers, or in the form of small paper strips soaked in the substance. More specifically, lissamine green is an organic acidic dye, which is produced synthetically; the staining properties thereof are very similar to those obtained when using rose bengal. However, unlike rose bengal, lissamine green is painless and offers a better colour contrast to vessels and bleeding. Lissamine green selectively stains suffering and dehydrated cells, guaranteeing observation of the conjunctival epithelium and highlighting abraded or desquamated epithelial areas.
  • dyes are administered to the patient's eye with the aid of commonly known dispensers, for example of the type coupled directly (as a top) to commonly known eye drop containers.
  • a large drop of dye is deposited on the cornea and much of the solution is lost through the tear duct or outside the eye.
  • the dye is lissamine green, which is a very strong dye, if one administers too large a drop of eye drop to the eye there is a risk of temporarily staining the skin on the patient's face.
  • the tip of the dispenser inadvertently touches the surface of the patient's cornea, thereby compromising the sterility of all the solution present in the container coupled directly to the dispenser.
  • the object of the present invention is to provide a dispenser of ophthalmic solutions applicable to single-dose containers which overcomes the drawbacks of the prior art.
  • a further object of the invention is to provide a dispensing device which allows the user to operate in total safety, preventing conveying contaminating agents to a patient.
  • the dispenser reduces the waste of ophthalmic solution and prevents dispensing a greater amount of solution than that required into the patient's eye. Furthermore, the invention allows precise and rapid dispensing of the solution, in exactly the spot desired by the doctor.
  • reference number 1 is used to denote, as a whole, a dispenser of ophthalmic solutions.
  • the dispenser 1 may be advantageously applied to single-dose containers of ophthalmic solutions, in particular those containing staining solutions, to be used during eye examinations.
  • a solution for which the dispenser 1 is particularly effective comprises lissamine green.
  • the single-dose container 2 may be a vial (possibly of the re-sealable type) made of polymeric material, of a soft, semi-transparent type, which contains an ophthalmic solution.
  • Such vials 2 may comprise a body 2A for containing the solution, with an elongated, tubular conformation, which has an end having a neck 2B, at the top of which a product dispensing outlet 2C is formed.
  • the opposite end of the vial to the neck 2B is sealed (e.g. by welding 2D which may be either of the hot or ultrasound variety) following insertion into the vial 2 of the ophthalmic solution 3.
  • the vials may further comprise sealing means, which can be removably coupled to the vial at the neck, to allow closure of the dispensing outlet 2C.
  • One type of these commonly known vials features the containment body and the sealing means made as a single piece, by means of injection moulding, and subsequently separated by the user, prior to use.
  • the sealing means may be removed by detachment from the containment body 2A, thereby forming the said dispensing outlet 2C.
  • One vial of this type features, at the dispensing outlet, an annular edge projecting inwardly and extending transversely to the containment body, said edge forming a central passage which allows the product to flow out.
  • each vial features a different passage section from the others.
  • the portion of vial bordering the dispensing outlet, following opening is jagged and may also feature plastic protrusions, which decrease the passage section for the solution 3.
  • the dispensing outlet 2C of a conventional vial 2 has a passage section which allows the dispensing of individual drops with an average volume of about 0.04 ml, but obviously this volume changes depending on the substance to be administered.
  • the present invention relates to a dispenser of ophthalmic solutions applicable to single-dose containers 2 similar to those disclosed above, i.e. which comprise a dispensing outlet 2C formed as a result of the mechanical breakage of the neck of the said container.
  • the single-dose containers 2 preferred for the use of the dispenser are made of a soft plastic (for example low-density polythene) and as a single, injection-moulded piece.
  • single-dose container should be understood as a container designed to hold ophthalmic solution in an amount ranging from 0.2 and 0.5 ml, but in this case the single dose will have a content of about 0.3 ml.
  • the dispenser 1 comprises a body 4 which defines a cavity 5 connected to a first opening 6; the first opening 6 is coupled, by means of sealing means 7, configured to cooperate, during use, with the neck 2B of said single-dose container 2.
  • the dispenser 1 furthermore comprises a dispensing tip 8 featuring a second opening 9, which is also connected to said cavity 5; the second opening 9 may be configured to dispense drops of a volume between 0.005 ml and 0.02 ml, preferably between 0.01 and 0.015 ml.
  • the second opening 9 (which can be seen in Figure 1A ) may be a hole with a diameter D2 of between 0.25 and 0.75 mm, preferably between 0.4 and 0.6 mm, again more preferably of 0.5 mm.
  • the second opening 9 may be defined by means of a first conical surface 10, which is inclined by 1° to 10°, more preferably by 2° to 4°, but still more preferably by 3°, with respect to a longitudinal axis A of said dispenser.
  • the first surface 10 may extend along the entire length B1 of the dispensing tip.
  • the first conical surface 10 may extend along an axial length of between 8 and 20 mm.
  • the first surface 10 may be followed (in the dispensing direction, Arrow E) by a second conical surface 11 inclined by 2° to 45°, more preferably by 8° to 12°, but still more preferably by 10°, with respect to said axis A.
  • the height HA of the second conical surface may be between 0.1 and 0.6 mm.
  • the first opening 6 may be coupled to sealing means, which may comprise, for example, at least one sealing ring 7, formed as a part of the dispenser body.
  • the sealing means 7 may be simply formed of a conical coupling wall suitable to couple, in a sealed fashion, with the neck of said single-dose container.
  • the material of which the single-dose container 2 is usually made is rather soft and elastic, as the user must be able to apply pressure to the outside of the container in order to dispense the ophthalmic solution. This material is therefore suitable to provide a good seal at the opening 6, even in the absence of sealing rings 7.
  • the said body features a plurality of gripping fins 13A, 13B, 13C ... (denoted, overall, as 13) which facilitate the handling of the dispenser 1.
  • the optimal number of fins is six, which should be spaced at 60 degree angles. However, it is also possible for a different number of fins to be present, for example from three to twelve.
  • a barycentre B of the dispenser may be positioned in a portion of the body 2 where the fins 13 are present.
  • the fins 13 have an external surface 14 which defines a support surface for the dispenser 1 (see Figure 2 ).
  • the outer surface 14 of each fin may be inclined with respect to the axis A so that when the said surface is resting on a surface P (for example a table), said dispensing tip is raised off said surface P, so as to prevent contamination.
  • the inclination ⁇ of the external surface 14 of the fins and the length B1, B2 of the tip are linked so as to prevent the tip (and in particular the second opening 9) coming into contact with the surface P when the surface 14 of the fins is resting on the surface P.
  • Figure 6 shows a variant of the dispenser in Figure 1 .
  • the main difference between the dispenser in Figure 1 and that in Figure 6 lies in the tip length.
  • the tip in Figure 1 has a length B1 of 10 mm, while the tip in Figure 2 has a length B2 of 15 mm.
  • the tip length takes on particular importance as a longer tip 8 provides greater precision when positioning the dispensing outlet within a desired area of the cornea.
  • a tip with the length described allows the doctor to administer a drop with minimal risk of contact with the patient's eye.
  • the fins 13 extend longitudinally beyond said first opening 6, in the opposite direction to the tip 8.
  • the dispenser 1 may also be placed on the surface P by making use of the base B of the fins 13.
  • the opening 6 remains spaced well apart from the support surface 6, and therefore the sterility of the dispenser is maintained.
  • the entire dispenser 1, and more specifically, the body 2, the tip 8, and the wings 13 are made, by injection moulding, as a single piece of sterilizable plastic.
  • Suitable plastics for manufacturing the dispenser preferably belong to the polyolefin family (PP, LDPE), but for some applications, other plastic materials such as PET may also be used.
  • One plastic material which is particularly suitable for manufacturing the dispenser 1 is that used for the single-dose container 2.
  • the dispenser 1 in a set, which comprises, in addition to the said dispenser (individually packaged in a sterile or sterilizable package 20), at least one single-dose container 2 of ophthalmic solution configured to cooperate with said dispenser.
  • a doctor or any personnel authorised to examine a patient, may prepare a single-dose container 2, by - for example - separating said container from the others connected thereto via the breakable portions 25A featured on the lugs 25 protruding laterally from the single-dose container 2 or vial.
  • the doctor can open the single-dose container by detaching a seal (not shown) from the vial 2.
  • the doctor subsequently (or even prior to the operations described), can open the sterile package 20 and prepare a dispenser 1. If the situation requires it, the doctor can place the dispenser on a flat surface P, maintaining the sterility thereof by virtue of the fins 13 (or bases B thereof).
  • the doctor can fit the dispenser 1 onto the neck of the single-dose container 2, thereby obtaining the configuration shown in Figure 3 .
  • the single-dose container 2/dispenser 1 assembly is ready for use and the doctor can easily administer to the patient's eye, in a precise area of the cornea, a drop of the solution contained in the single-dose container 2. This can be done by exerting slight pressure to the deformable body 2A of the single-dose container.
  • the dispensing 1 it is possible to administer, to the patient's eye, the exact amount of ophthalmic solution necessary for the examination to be carried out.
  • the dispenser makes it possible to administer, in a very precise way, solely the amount necessary to carry out the examination, thereby preventing the solution overflowing from the patient's eye and staining the skin of the face thereof.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (10)

  1. Spender (1) für ophthalmologische Lösungen, die auf Einzeldosisbehälter (2) anbringbar sind, der einen Körper (4), der einen Hohlraum (5) definiert, der mit einer ersten Öffnung (6) in Verbindung steht, wobei die erste Öffnung Dichtungsmitteln (7) zugeordnet ist, die konfiguriert sind, um im Gebrauch mit einem Hals des Einzeldosisbehälters zusammenzuwirken, und eine Abgabespitze (8) mit einer zweiten Öffnung (9) umfasst, die ebenfalls mit dem Hohlraum (5) in Verbindung steht, dadurch gekennzeichnet, dass der Schwerpunkt (B) des Spenders in einem Abschnitt des Körpers (2) positioniert ist, in dem sich Rippen befinden (13), wobei die Rippen eine Außenfläche (14) bereitstellen, die eine Stützebene des Spenders definiert, wobei die Außenfläche eine Neigung in Bezug auf eine Längsachse (A) des Spenders (1) aufweist, sodass, wenn die Außenfläche der Rippen auf einer Ebene (P) ruht, die Spenderspitze von dieser Ebene erhoben ist, um eine Kontamination zu vermeiden.
  2. Spender nach dem vorhergehenden Anspruch, wobei sich die Rippen (13) in Längsrichtung über die erste Öffnung (6) hinaus erstrecken, in einer Richtung, die der der Spitze (8) entgegengesetzt ist, und/oder bei der der Körper (2), die Spitze (8) und die Rippen (13) durch Spritzgießen aus einem einzigen Stück aus sterilisierbarem Kunststoff hergestellt sind.
  3. Spender nach Anspruch 1, wobei die zweite Öffnung (9) konfiguriert ist, um Tropfen mit einem Volumen zwischen 0,005 ml und 0,02 ml, vorzugsweise zwischen 0,010 und 0,015 ml, abzugeben.
  4. Spender nach dem vorhergehenden Anspruch, bei dem die zweite Öffnung (9) ein Loch mit einem Durchmesser zwischen 0,25 und 0,75 mm, vorzugsweise zwischen 0,4 und 0,6 mm, wiederum bevorzugter von 0,5 mm ist.
  5. Spender nach einem oder mehreren der vorhergehenden Ansprüche, wobei die zweite Öffnung (9) durch eine erste konische Fläche (10) definiert ist, die von 1° bis 10°, bevorzugter 2° bis 4°, noch bevorzugter 3° relativ zu einer Längsachse (A) der Dosiervorrichtung geneigt ist, gefolgt, im Sinne einer Abgabe (E), von einer zweiten konischen Fläche (11), die von 2° bis 45°, bevorzugter von 8° bis 12°, noch bevorzugter 10° in Bezug auf die Achse (A) geneigt ist.
  6. Spender nach dem vorhergehenden Anspruch, bei dem sich die erste konische Fläche (10) über eine axiale Länge zwischen 8 und 20 mm erstreckt.
  7. Spender nach einem oder mehreren der vorhergehenden Ansprüche, wobei die der ersten Öffnung zugeordneten Dichtungsmittel (7) eine konische Kopplungswand umfassen, die geeignet ist, mit einem Hals des Einzeldosisbehälters zusammenzuwirken.
  8. Spender nach einem oder mehreren der vorhergehenden Ansprüche, wobei die Dichtungsmittel mindestens einen einstückig im Spenderkörper ausgebildeten Dichtungsring (7) umfassen.
  9. Spender nach einem oder mehreren der vorhergehenden Ansprüche, wobei der Körper (2) an einem in Bezug auf die zweite Öffnung gegenüberliegenden Ende mehrere Greifrippen (13A, 13B, 13C ...) bereitstellt, die die Handhabung des Spenders (1) erleichtern.
  10. Set, umfassend mindestens einen Spender (1) nach einem oder mehreren der vorhergehenden Ansprüche, wobei der Spender einzeln in einer sterilen Verpackung (20) verpackt ist und mindestens ein Einzeldosisbehälter (2) der ophthalmoloischen Lösung konfiguriert ist, um mit dem Spender zusammenzuwirken.
EP17826569.0A 2016-12-15 2017-12-14 Spender von ophthalmischen lösungen für einzeldosisbehälter Active EP3554958B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000126907A IT201600126907A1 (it) 2016-12-15 2016-12-15 Dosatore di soluzioni oftalmiche applicabile a contenitori monodose
PCT/IB2017/057948 WO2018109712A1 (en) 2016-12-15 2017-12-14 Dispenser of ophthalmic solutions applicable to single-dose containers

Publications (3)

Publication Number Publication Date
EP3554958A1 EP3554958A1 (de) 2019-10-23
EP3554958B1 true EP3554958B1 (de) 2023-07-05
EP3554958C0 EP3554958C0 (de) 2023-07-05

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ID=58455549

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17826569.0A Active EP3554958B1 (de) 2016-12-15 2017-12-14 Spender von ophthalmischen lösungen für einzeldosisbehälter

Country Status (3)

Country Link
EP (1) EP3554958B1 (de)
IT (1) IT201600126907A1 (de)
WO (1) WO2018109712A1 (de)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060081726A1 (en) * 2004-10-14 2006-04-20 Gerondale Scott J Controlled drop dispensing tips for bottles
AU2007330356B2 (en) * 2006-12-07 2013-05-02 Sun Pharma Advanced Research Company Ltd Metered drop bottle for dispensing microliter amounts of a liquid in the form of a drop
IT1393560B1 (it) * 2009-01-21 2012-04-27 Lameplast Spa Contenitore per prodotti fluidi, particolarmente prodotti farmaceutici, cosmetici, medicali o simili

Also Published As

Publication number Publication date
IT201600126907A1 (it) 2018-06-15
WO2018109712A1 (en) 2018-06-21
EP3554958C0 (de) 2023-07-05
EP3554958A1 (de) 2019-10-23

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