WO2020003149A1 - Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci - Google Patents

Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci Download PDF

Info

Publication number
WO2020003149A1
WO2020003149A1 PCT/IB2019/055384 IB2019055384W WO2020003149A1 WO 2020003149 A1 WO2020003149 A1 WO 2020003149A1 IB 2019055384 W IB2019055384 W IB 2019055384W WO 2020003149 A1 WO2020003149 A1 WO 2020003149A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid
dispenser
dispensing
single drop
dispenser according
Prior art date
Application number
PCT/IB2019/055384
Other languages
English (en)
Inventor
Michał Chojnacki
Dariusz DANKOWSKI
Emil KLUCZ
Dominik MIESZKOWSKI
Krzysztof Rychławski
Joanna SICHEL
Adam Sikora
Wiktor SROKA
Original Assignee
Passio Biomaterials Spółka Z O.O.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Passio Biomaterials Spółka Z O.O. filed Critical Passio Biomaterials Spółka Z O.O.
Priority to EP19765549.1A priority Critical patent/EP3813743A1/fr
Publication of WO2020003149A1 publication Critical patent/WO2020003149A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0026—Ophthalmic product dispenser attachments to facilitate positioning near the eye
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein

Definitions

  • the subject matter of the invention is a dispenser for administration of a single drop of liquid for a pharmaceutical application, being registered as medicine or being a medical product, especially an ophthalmic liquid, a dispensing set, and use of said dispenser or set.
  • Some chronic pathological conditions require continuous use of selected pharmaceutical preparations. For example, patients with dry eyes or glaucoma need to regularly apply drops to their eyes.
  • preservatives are often used, including benzalkonium bromide, chlorhexidine acetate, b-phenethyl alcohol, phenylmercuric borate, phenylmercuric nitrate, chlorocresol, chlorobutanol, EDTA, and many others.
  • Studies have shown that long-term use of preparations containing preservatives may have a negative effect on the eye surface. Many preservatives may cause inflammation or have a toxic effect on the sight organ.
  • US 9402765 describes a bottle for packing of liquid distributed drop by drop, wherein bottle contains a tank that walls can be reversibly flexibly deformed by allowing air into the container, ended with a liquid dispensing head, containing a dropper nozzle that protrudes from the bottle and an antibacterial filtering membrane that is partly hydrophilic and partly hydrophobic and placed in the liquid and air path at the base of said nozzle.
  • the solution consists in separate forming a nozzle from a material that contains a bactericide and that prevents the creation of bacteria on the surface of said nozzle on the outside of the antibacterial membrane.
  • US 8454828 concerns a dispensing device designed for a liquid substance, containing a tank to hold the substance, having a dispensing opening for administering the substance from the tank, and having a pressure equalizing channel that opens into the tank and has a microbiologically active system of filters inserted into the tank.
  • the filter system has a liquid filter that is directed towards the tank, and a bacterial filter directed away from this tank.
  • EP2531 154 describes a bottle for the packing of a liquid dispensed drop by drop, containing a wall reservoir that can be reversibly flexibly deformed by taking air inside the container, wherein this bottle is ended with a liquiddispensing head that has a nozzle, a dropper element protruding beyond the bottle, and an antibacterial filter membrane partly hydrophilic and partly hydrophobic said bottle is placed across the flow of liquid and air.
  • US 2017096266 specifies a dispenser for administering a liquid or viscous product, containing a dosage valve.
  • Said dosage valve in turn contains:
  • the flexible return elements and at least some of the means for sealing and releasing the product are integrated in the same body.
  • the aim of the invention is to develop a new dispenser, also as a part of set, that will allow to eliminate above-mentioned problems, and will enable a quick and easy, an accurate and safe administration of liquid to a specific person, without a need to use any help of other people, and ensuring the elimination of any impurities or bacteria from a preparation.
  • the subject matter of the invention is a dispenser for a single drop administration of liquid having a pharmaceutical application registered as medicine or being a medical product, especially of an ophthalmic liquid, said dispenser enabling the administration of a preservative-free preparation, and comprises an immobilized in a package body of a compressible container for liquid and an outlet of drops, characterized in that between said compressible container for liquid and said outlet of drops a dispensing subassembly for dispensing a single drop of liquid is provided, and under said body of said liquid container a pressure spring is provided, wherein a hose for transporting a liquid is going upwards from said liquid container towards said dispensing subassembly for dispensing a single drop of liquid that outflows through an outlet nozzle upon activating a trigger, and above said outlet nozzle in said dispenser a stabilizing arm to stabilize an application of a single drop of liquid is provided.
  • a dispenser has a dispensing subassembly for dispensing a single drop of liquid that includes a reservoir made of elastically deformable material, This reservoir is delimited at the bottom by a bottom valve, and at the top passing into a hose with an outlet nozzle, closed by a top valve.
  • a bottom valve is delimited at the bottom by a bottom valve, and at the top passing into a hose with an outlet nozzle, closed by a top valve.
  • said top valve is simultaneously opened by means of a single activation of a trigger.
  • a dispenser has a dispensing subassembly for dispensing a single drop of liquid that includes a hose made of elastically deformable material, located near a spring-loaded element with a plastic clamp , equipped with a hook. Said hook is affected by a trigger in the form of a knob having a divided cam, wherein this cam is at least in a double, preferably in a triple form or a corrugated form.
  • said dispenser additionally contains a safety plug.
  • a compressible container for liquid has a body of any shape, preferably is in the form of a foldable bellows.
  • a compression spring is a conical spring.
  • Said dispenser has a stabilizing arm for stabilization of a single drop application of liquid, said arm having an elongated neck ended with a flat tip enabling said dispenser to rest against a patient’s forehead or brow ridge.
  • an outlet nozzle for the outflowing drop of liquid, located above the eye or conjunctival sac at the moment when liquid is being dispensed.
  • An outlet nozzle preferably has a thickening, protrusion, or edging part that prevents the liquid from flowing down a dispenser wall.
  • said dispenser has a release button that releases a single drop of liquid after being pressed or turned.
  • the next subject matter of the invention is a set dispensing a single drop of liquid, including a dispenser defined above, and an arm for pulling down the lower eyelid, wherein said arm is permanently connected to said dispenser, or is detachable.
  • the invention also concerns use of said dispenser or set according to the invention for administration of a pharmaceutical preparation being registered as medicine or a medical product, said preparation is especially an ophthalmic liquid.
  • the advantages of said dispenser or set according to the invention are: the fact that it maintains overpressure in a liquid container, as well as the use - in the structure of a dispenser - of a dispensing subassembly consisting of a reservoir, two valves, and hoses for liquid preferably being a medicine, or consisting of a hose closed with a spring- loaded element that is activated by a knob, for easy and simple administration of a single drop of liquid, preferably being a medicine.
  • a dispenser eliminates a need to vent a liquid container what in turn eliminates any need of using filters for air returning to the container with a preparation.
  • the end-nozzle is a non-return valve that prevents impurities, microorganisms, and air from entering the liquid container.
  • Another advantage of the invention is a design itself of the outer packaging that allows easy application of a preparation.
  • the system was designed bearing in mind an anatomical structure of the human face so as, during the application, a user has two places of support allowing to stabilize the container during the application, without completely blocking the access to light.
  • the stabilizing arm additionally allows to stretch the skin in such a way as to create space, next to the eye, for liquid drops being administered.
  • a dispenser according to the invention is designed to be easy used for children, adults, and elderly people who have problems with applying drops to eyes, as well as for the users who apply drops to eyes using only one hand.
  • Fig. 1 shows an exemplary dispenser, wherein Fig. 1 a presents a dispenser in a cross-sectional view, Fig. 1 b in a side view thereof, Fig. 1 c presents an enlarged fragment of element B from Fig. 1 a in a cross-sectional view, and Fig. 1 d presents an enlarged fragment of a dispensing subassembly of a dispenser according to Fig. 1 a.
  • Fig. 2 shows a dispenser according to the second embodiment, wherein Fig. 2a shows a dispenser in a lateral sectional view with an outlet nozzle made visible, Fig. 2b in its cross-sectional view with a knob and trigger cam made visible, and Fig. 2c presents another variant of a trigger equipped with a trigger cam, while Fig. 2d illustrates exemplary cams that can be used in a knob of a dispenser according to Fig. 2b. Fig. 2e presents an enlarged fragment of a dispensing subassembly of a dispenser according to Fig. 2b.
  • Fig. 3 shows example views of an arm for pulling down the lower eyelid, where Fig. 3a shows this arm in a side view, Fig. 3b shows this arm from the top, Fig. 3c shows an example shape of an elongated neck of a stabilizing arm to stabilize the application of a single drop of liquid.
  • Fig. 4 shows a dispenser with or without a protective cap.
  • Fig. 5 illustrates a use of a dispensing set for applying drops of liquid to an eye.
  • a dispenser 1 comprises a body 2 of a liquid container 5, in this case in the form of a foldable bellows, a conical pressure spring 3, liquid transporting hoses 4a, 4b I, a top valve 8b and a bottom valve 8a, a reservoir 6 for liquid, an outlet nozzle 7, a trigger 9, and a stabilizing arm 10 for stabilization of a single drop application of liquid. It is preferable to flatten a structure of this elongated neck of a stabilizing arm 10, what further improves a stabilization of a dispenser according to the invention as a result of the supporting.
  • a dispenser 1 also includes a permanently connected or detachable arm 1 1 for pulling down the lower eyelid. In addition, this device includes a safety plug.
  • a dispenser 1 according to the invention shown in Fig. 1 is based on the fact that - by means of a pressure spring 3 - overpressure is generated in a liquid container, (preferably being a foldable bellows). The pressure is maintained by a spring 3 for an entire period of time when liquid is used.
  • the overpressure in a liquid container, in a hose 4a, 4b, and in a reservoir 6 ensures sterility of the liquid. This overpressure forces the flow of the liquid from a container to the outside through hoses 4a and 4b and a reservoir 6, thus preventing air and microorganisms from entering a liquid tank.
  • a dispensing subassembly 2a In order to prevent continuous outflow of liquid from a container, a dispensing subassembly 2a has been designed to release a single drop of liquid.
  • a dispensing subassembly 2a consists of a reservoir 6 made of elastically deformable material, limited from below by a bottom valve 8a and from above passing into a hose 4b with an outlet nozzle 7, closed by a top valve 8b.
  • a bottom valve 8a When releasing a trigger 9, a bottom valve 8a opens, and a reservoir 6 gets filled with liquid. A top valve 8b is closed what prevents liquid from escaping.
  • a bottom valve 8a When said trigger 9 is pressed, firstly a bottom valve 8a is closing, and then immediately said top valve 8b is opening to allow a single drop of liquid to be dispensed.
  • This sequence therefore ensures that a single drop of liquid is dispensed from a reservoir 6 that - when a top valve 8b is opened - pushes out precisely a single drop of liquid.
  • the structure of an outlet nozzle 7 ensures that the entire dispenser is sterile - even the small amount of liquid that is remaining behind a top valve 8b.
  • a dispensing subassembly 2a that enables dispensing of a single drop of liquid, shown in Figs. 1 a and 1 b, can be constructed as follows.
  • a preparation in a container under pressure is transported via a silicone hose 4a with an exemplary internal diameter of 0.1 to 0.4 mm to an outlet.
  • a valve 8a at the outlet works based on compression of a hose 4a.
  • a distance between the outlet and the place where said hose 4a is compressed is minimized so that as little preparation as possible comes into contact with any external impurities.
  • a spring-loaded element 12 that compresses a hose is made of plastic. The shape of a clamp is selected in such a way as to achieve complete tightness of said valve 8a.
  • a valve 8b for a specific period of time. After pressing a trigger 9, a valve 8b is opening, and liquid starts to escape from a container through a hose 4b.
  • a container with a preparation is located in the lower part of a body 2 - where a catch 14 is located, designed for fixing said container.
  • a preparation in a container under pressure is transported via a silicone hose with an exemplary internal diameter of 0.1 -0.5mm to an outlet.
  • a valve at this outlet works based on compression of a hose by means of a cam actuated by a knob (Fig. 2b) or a trigger (Fig. 2c).
  • the shape of a clamp is such that the whole preparation is‘squeezed out’ of the end of a hose.
  • a spring-loaded element 12 that compresses a hose is made of plastic.
  • the shape of a clamp is selected in such a way as to achieve complete tightness of a valve.
  • the dispensing of a single drop is carried out in a dispenser in Fig. 2b by opening a valve for a specific period of time what action is controlled by a knob 17 of a cam 16. After turning said knob 17 of a trigger, said cam 16 pulls a hook 18 of a compression spring, and said valve is opened for a short time. The opening time is matched using the outline of said cam 16 so that exactly one drop of a preparation escapes.
  • the opening time of said valve depends on the shape of said cam 16 as well as the position of said hook 18 of the spring.
  • a container with the preparation is located in the lower part of a body - where a catch 14 is located, designed for fixing said container.
  • the spring pushes against the bottom of said container thereby increases pressure in this liquid container.
  • Figs. 3a and Fig. 3b show exemplary views from side and from top of an arm 1 1 for pulling down the lower eyelid
  • Fig. 3c presents the enlarged shape of an arm 1 1 for pulling down the lower eyelid, in side view.
  • an arm 1 1 for pulling down the lower eyelid contains a saddle-shaped resting member 13 connected with a rim 15 for docking a dispenser using a latch 14.
  • Fig. 4 shows a dispenser with or without a protective cap being a detachable element.
  • Fig. 5 shows a set dispensing a single drop of liquid, said set comprising a dispenser 1 according to the invention, and an arm 1 1 for pulling down the lower eyelid, thus illustrating a space next to the eye created in order to facilitate an application of liquid drops.
  • said procedure of using this set is as follows: said arm is placed against to the lower eyelid or the upper part of the cheek. By gently pressing said arm against the face, a downward motion is made in order to pull the skin down so that the lower eyelid is pulled down too and a space is created next to the eye for a preparation being applied in drops.
  • the head of a dispenser 1 is rested on the patient’s brow ridge or forehead.
  • the outlet point that is located on the neck shall be above the conjunctival sac of the eye.
  • a trigger 9 is pressed to release a single drop of liquid.
  • a dispenser and a set according to the invention are used for an easy, safe, and accurate application of a liquid, especially being medicine, to the patient’s eye.
  • a liquid especially being medicine
  • other applications may also be considered, e.g. an application of medical products not being any medicine.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un distributeur (1) pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, ledit liquide étant enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ledit distributeur permettant l'administration d'une préparation sans conservateur, et comprend un élément immobilisé dans un corps d'emballage d'un récipient compressible pour liquide et une sortie de gouttes, caractérisé en ce qu'entre ledit récipient compressible pour liquide et ladite sortie de gouttes se trouve un sous-ensemble de distribution (2a) destiné à distribuer une seule goutte de liquide, et sous ledit corps (2) d'un récipient de liquide (5) se trouve un ressort de pression (3), avec un tuyau (4a) pour le transport de liquide, ledit tuyau (4a) destiné au transport de liquide étant dirigé vers le haut à partir dudit récipient de liquide (5) vers ledit sous-ensemble de distribution (2a) pour distribuer une seule goutte de liquide s'écoulant par une buse de sortie (7) lors de l'activation d'une gâchette (9), et au-dessus de ladite buse de sortie (7) dans ledit distributeur, se situe un bras de stabilisation (10) pour stabiliser une application d'une seule goutte de liquide. De plus, l'invention concerne un ensemble de distribution d'une seule goutte de liquide, comprenant ledit distributeur (1), et un bras (11) pour tirer vers le bas la paupière inférieure, ledit bras étant relié à demeure au distributeur, ou pouvant être détaché. L'invention concerne également l'utilisation de ce distributeur ou ensemble pour l'administration d'une préparation pharmaceutique enregistrée en tant que médicament ou d'un produit médical, notamment d'un liquide ophtalmique.
PCT/IB2019/055384 2018-06-26 2019-06-26 Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci WO2020003149A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19765549.1A EP3813743A1 (fr) 2018-06-26 2019-06-26 Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PLPL426067 2018-06-26
PL426067A PL426067A1 (pl) 2018-06-26 2018-06-26 Dozownik do podawania pojedynczej kropli płynu o zastosowaniu farmaceutycznym zarejestrowanym jako lek lub wyrób medyczny, zwłaszcza okulistycznym, zestaw dozujący i zastosowanie

Publications (1)

Publication Number Publication Date
WO2020003149A1 true WO2020003149A1 (fr) 2020-01-02

Family

ID=67875781

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/055384 WO2020003149A1 (fr) 2018-06-26 2019-06-26 Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci

Country Status (3)

Country Link
EP (1) EP3813743A1 (fr)
PL (1) PL426067A1 (fr)
WO (1) WO2020003149A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3439674A (en) * 1966-02-18 1969-04-22 Jhon Lelicoff Liquid eyewash dispensing device including eyelid engaging means
US20100286633A1 (en) * 2008-02-05 2010-11-11 Marx Alvin J Precision Lid Retracting Eyedropper Device
WO2016081955A2 (fr) * 2014-11-19 2016-05-26 Nigel Kelly Administration de dosage dans des pompes de distribution miniatures

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3439674A (en) * 1966-02-18 1969-04-22 Jhon Lelicoff Liquid eyewash dispensing device including eyelid engaging means
US20100286633A1 (en) * 2008-02-05 2010-11-11 Marx Alvin J Precision Lid Retracting Eyedropper Device
WO2016081955A2 (fr) * 2014-11-19 2016-05-26 Nigel Kelly Administration de dosage dans des pompes de distribution miniatures

Also Published As

Publication number Publication date
EP3813743A1 (fr) 2021-05-05
PL426067A1 (pl) 2020-01-02

Similar Documents

Publication Publication Date Title
US5578021A (en) Eye medicament dispensing device
US5040706A (en) Liquid droplet dispensing apparatus
US5875931A (en) Double dispenser for medicinal liquids
US5382243A (en) Apparatus with indicator for administration of eye medication
US8246589B2 (en) Precision lid retracting eyedropper device
US7527613B2 (en) Therapeutic solution drop dispenser
US20090182291A1 (en) Eye medicament dispenser
EP0677015B1 (fr) Dispositif pour la distribution goutte a goutte d'un liquide contenu dans une fiole flexible
JPH10225516A (ja) 非経口施与用販売ユニット、非経口施与を実施するための装置並びに上記販売ユニットのための再充填ユニット
US20190358083A1 (en) Apparatus for eye treatment
JPH0337066A (ja) 目薬用点眼具
US10299959B2 (en) Eyedropper with improved stability and method of administering a liquid onto the surface of an eye
US6010488A (en) Lower eyelid retractor and method for applying medication to the eye
KR100555606B1 (ko) 안구용 유체 도포기
KR101789278B1 (ko) 안약 투약기
US20220233350A1 (en) Ocular medication delivery apparatus
WO2020003149A1 (fr) Distributeur pour l'administration d'une seule goutte de liquide pour une application pharmaceutique, enregistré comme médicament ou étant un produit médical, notamment un liquide ophtalmique, ensemble de distribution et utilisation de celui-ci
US5020526A (en) Eye bottle
KR20160001595U (ko) 점안액 투약 유닛 및 이를 포함하는 점안액 투약 장치
US20170224532A1 (en) Metered dose eyedropper and method of administering a metered dose onto the surface of the eye
US5342327A (en) Eye bottle
KR101957834B1 (ko) 나노패턴을 이용한 점안액의 응집력이 향상된 배출부를 갖는 점안액 용기
KR20200039532A (ko) 안약 또는 인공눈물의 투약이 편리한 나노패턴형 점안액 용기
CA3143648A1 (fr) Appareil d'administration de medication oculaire
RU2407556C1 (ru) Капельница для лекарственных препаратов

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19765549

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2019765549

Country of ref document: EP

Effective date: 20210126