EP3927295A1

EP3927295A1 - Device for facilitated administration of eye drops

Info

Publication number: EP3927295A1
Application number: EP20707324.8A
Authority: EP
Inventors: Massimiliano GIOVENALI; Gislero GRECHI
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-02-18
Filing date: 2020-02-13
Publication date: 2021-12-29
Also published as: WO2020170084A1; IT201900002327A1

Abstract

Device for facilitated administration of eye drops comprising a main housing element (100) with cylindrical shape, having the upper end (110) open for housing a common bottle (300) containing the eye drops, and the lower end made with a hole (120) capable of receiving the spout of said bottle (300), wherein the two stretching arms (200) for opening the eyelids have the compression protrusions (230) capable of pressing the bottle (300) so that it compresses it until it releases the ophthalmic solution by means of the spout thereof, wherein the lower ends of said stretching arms (200) have stretching portions (250) on which a comfortable shell (260) is applied which is capable of resting against the eyelids and synchronously opening the same with the approaching of the stretching arms (200), making them remain in open position until the administration has been completed.

Description

“Device for facilitated administration of eye drops”

Description Field of the application

The present invention patent application generally refers to the category regarding the instruments suitable for the administration of a medication, and more particularly refers to a device for facilitated administration of eye drops.

The invention is applicable to any sector where one such type can be advantageously used, but preferably this regards the ophthalmological field.

State of the art

Presently, millions of patients administer liquid eye drops for treating acute or chronic diseases diagnosed by one’s own ophthalmologist. In general, a bottle of liquid eye drop solution includes a drops dispenser incorporated on the release orifice of the container. In order to dispense the solution, the user compresses the bottle, forcing the solution to pass through the release orifice, which by falling is administered into the conjunctival sac of the eye. The aforesaid administration per se appears to be a very simple operation, but in reality on the field this should not be taken for granted. Such assertion derives from the fact that very often the drops do not fall in the conjunctival sac or on the cornea in an appropriate manner, since there lacks a correct coordination between the pressure of the fingers on the eye drops bottle and a simultaneous, synchronous opening of the eyelids.

It is undeniable that the method with the dropper, still used today for administering liquid eye drops to patients, has remained the same for many decades and has not undergone the innovative evolution that in the meantime has taken place for other devices dedicated to drug administration, such as syringes, gastro-resi stant tablets, asthma sprays etc.

Even if the pharmaceutical manufacturers have over the years developed containers with many different shapes, presently two main types of pressable containers for eye drops are known, i.e. multi dose botties and single-dose vials.

Field experience has brought to light the numerous difficulties of the single individual, when he/she must autonomously self-administer eye drops. It is estimated that a third of the population of patients who require drops for eyes are unable to correctly comply with the administration instructions.

The difficulties that can arise are of various type and frequently lead the patient to give up the administration, or they lead to a sporadic use of the eye drops themselves, which results in a lack of treatment actuation. Such difficulties include a movement coordination that is not easy, a psychological hostility, up to risking hitting the eye surface with the spout of the drug.

Presently, therefore, the experience of administering eye drops appears anything but pleasant and this particularly affects the statistics pertaining to the compliance of patients and the consequent adherence to chronic therapies. In addition, the low compliance by the patient and the product waste that is attained during several attempts to place the drops translate into a greater expense for the patient and on the other hand, in the case of unsuitable administration of antibiotic eye drops, they lead to the feared consequences due to the establishment of resistance to the drug.

Another relevant problem, associated with the devices of the prior art, consists of maintaining the sterility of ophthalmic solutions that are dispensed by the bottle through a dropper tip, which can be contaminated by means of exposure or contact. For such reason, all the currently-sold multidose bottles rather high amounts of antiseptic compounds, capable of protecting the solution against bacterial and viral contamination. Nevertheless, these antiseptics are often irritating and can be toxic for the sensitive tissues surrounding and within the eye.

Hence, one object of the present finding generally consists of making a device usable with the most common containers for liquid eye drops currently present on the market, or with the container for eye drops already integrated at its interior, capable of solving part of the abovementioned problems connected with the state of the art. In particular object of the present finding is that of administering the ophthalmic drops in a controlled manner, by delicately attaining the opening of the eyelids in a manner coordinated with the release of the solution itself.

A further object of the present finding consists of avoiding the contact of the aforesaid dispensing spouts and hence of protecting the solution contained in the container from possible inevitable microbial contaminations.

Another further possible object of the present invention is to attain a device capable of making a controllable dispensing of the eye drops themselves.

Other advantages of the invention will be clear from the detailed description of an exemplifying and non-limiting embodiment thereof, illustrated hereinbelow.

Brief description of the invention

The present industrial invention patent application intends to describe and claim an innovative device, or a system for administration of eye drops, capable of being used with the main categories of pressable containers for liquid eye drops existing on the market, i.e. with multidose bottles and the single-dose vials or with the container of the eye drops already integrated at its interior.

More specifically, our proposal assumes the design of an eye drop dispensing device, which allows being lightly rested against the closed eyelids and, due to the pressure exerted by the fingers on the device itself, executing a limited but sufficient opening of the eyelid edge synchronous with the dispensing of the eye drops and hence making the entrance of the eye drops in a facilitated and approached manner.

The innovative concept underlying the present invention specifically consists of providing for said innovative device made by means of two stretching arms for opening the eyelids, actuatable by the user, in which the relative bases can be rested against the eye socket of the user himself/herself. In particular said two stretching arms for opening the eyelids are shaped in a manner such that the simple pressure of the fingers thereon by the user is capable on one hand of actuating the opening of the eyelids and on the other hand simultaneously achieving the squeezing of the bottle housed therein, with consequent release of drops of the contained and hence administration of the ophthalmic solution into the eye. Such aforesaid synchronous action is in reality essential for the purposes of the present invention, since a desired and coordinated coordination will be actuated between the squeezing of the bottle and a limited but sufficient opening of the eyelid edge, thus enabling the correct administration of the eye drops in the conjunctival sac or on the cornea, minimizing all those problems connected with the devices of the prior art.

Another technical characteristic which diversifies the device, object of the present invention, is that, due to its shape once the administration is completed, the step of releasing the aforesaid stretching arms for opening the eyelids allows the nearly hermetic closure of the container, by means of lifting a lid which comes to press the spout of the aforesaid container. Such characteristic is in reality essential for the purposes of an optimal administration of the medication, i.e. of the ophthalmic solution, since by preventing any form of contact and hence of contamination of the spout and consequently of the liquid contained in the bottle, it is possible to considerably reduce the amount of antiseptics during the step of formulation of the ophthalmic preparation, as such antiseptics are often irritating and toxic for the surrounding tissues and within the eye.

Hence, entirely for the benefit of practical use and for cost savings, the present invention has as further objective that of proposing a device capable of being used with most of the eye drop containers of the prior art, also by means of the aid of suitable innovative adapters such as those necessary in the case of the single-dose vials.

A further objective is to propose a system of administration of eye drops which can be made on industrial scale, whose components are of standard and perfectly retrievable on the market and whose production is fully sustainable from an economical and environmental standpoint.

With regard to the materials forming said inventive device for facilitated administration of eye drops, these can be selected by the man skilled in the art so as to satisfy the technical characteristics in this particular field, including solidity, resistance, sterilizability and lightness; however said materials can comprise those of metal type, preferably steel and/or aluminum and/or polymers of plastic type. In addition, said plastic polymer materials or metal materials can comprise those having galvanized external finish and/or dyed external finish and/or having plasticized external finish.

As is inferred from the description made up to now, one of the advantages of the present device is that of allowing the administration of the eye drops with a single hand.

Other characteristics of the present invention are described in the following detailed description of one or more specific embodiments, protected by the various dependent claims. Brief description of the drawings

The preceding advantages, as well as other advantages and characteristics of the present invention, will be illustrated by making reference to the enclosed figures, which are to be considered merely exemplifying and non-limiting or non-binding for the purpose of the present patent application, in which:

- FIGURE 1 is a top perspective view of a device for facilitated administration of eye drops according to the present invention;

- FIGURE 2 is the top perspective view of the inventive device with the front portion sectioned for representative purposes;

- FIGURE 3 is a plan view of the inventive device;

- FIGURE 4 is a view of the lower part of the inventive device;

- FIGURE 5 is a top perspective view of a further embodiment of the inventive device;

- FIGURE 6 is a top perspective view of an alternative embodiment of the inventive device, for display purposes lacking the covering. Description of several embodiments of the invention

The present finding will now be described in detail with reference to the figures and to a preferred embodiment shown therein, in which for the same components, identical reference numbers were used. As is clear from Figs. 1-4, the device for facilitated administration of eye drops substantially comprises, in a preferred embodiment of the invention, a main housing element 100 with cylindrical shape, having the upper end 110 open in order to allow the introduction and removal of a common bottle 300 containing the eye drops, and the lower end made with a lower hole 120 (Fig. 2) capable of receiving the spout of said bottle 300 containing the eye drops. Within said main housing element 100, as specifically represented in Fig. 2, at least two upper stabilization teeth 180 of said bottle 300 are present at said open upper end 110. On the other hand, at said lower hole 120, at least two resilient stabilization fins 130 are present, capable of reversibly engaging and locking the aforesaid bottle 300 containing the eye drops. As represented in Figs. 1 and 2, in order to make more practical the display of the level of the liquid contained in the relative bottle 300 containing the eye drops, at least two longitudinal openings 170 are provided on the main housing element 100.

As represented in Figs. 1-4, in external position of said main housing element 100, the two stretching arms 200 for opening the eyelids are present in diametrically opposite positions. Said stretching arms 200 are each connected to the main housing element 100 by means of a common articulated connection system 140 (Fig. 1), capable of allowing a rotary motion around the axis thereof and characterized in that said articulated connection system 140 conceptually divides each of said stretching arms 200 into an upper arm 210 and into a lower arm 220. The ends 215 of said upper arms 210 terminate folded orthogonally towards the external, so as to form a valid support for the fingers of the user and a stable abutment base, when the device is placed overturned with the bottle 300 inserted.

It is noted that said upper arms 210 also have the compression protrusions 230 medially directed and capable, during the approaching of the stretching arms 200 or the closing thereof by the pressure exerted by the fingers of the user, of engaging and pressing by means of corresponding openings 160, made in the main housing element 100, the relative bottle 300 containing the eye drops and consequently compressing it so that it releases the ophthalmic solution by means of the spout thereof.

Also the lower arms 220 carry out a double function, since on one hand they attain, by means of the respective lower ends, the stretching portions 250 and on the other hand they support the system for closing the bottle 300 containing the eye drops. Said closing function occurs by means of the presence of the support elements 400 of the closing lid 450 directed medially; due to the inventive shape such elements attain a closing of the spout of the bottle 300 only when the two stretching arms 200 are in inoperative/rest position, i.e. with the two support elements 400 in lifted position. In addition, as can be observed in Fig. 1, if no external force acts on the aforesaid two stretching arms 200, the return and the maintenance in the inoperative/rest position will be facilitated by at least two return elements 190 made with material provided with a reversible elastic deformation, such as common helical springs.

With reference to Fig. 1-2 and 4, these show the two stretching portions 250 of said stretching arms 200, which due to the inventive shape, by resting against the eyelids of the user, operate a rather delicate opening of the same, maintaining them in open position until the eye drops have been administered. As can be specifically observed in Fig. 4, even if the stretching portions 250 of the device, which come into contact with the eyelids closed, are represented by a semi-lunar shape, such aforesaid shape must not be considered as limiting for the invention, since these can be made of any one shape and of such such to constitute a valid means capable of coming into contact with the eyelids and causing a controlled opening thereof. However, it is preferable that said stretching portions 250 be constituted by a rigid framework on which a comfortable shell 260 is applied that is made of semi-rigid and soft-rubbery resilient plastic material such as silicon and/or rubber and so forth, so as to allow a natural contact, also capable of imparting a pleasant sensation to the user.

In reality, the operation of said device is intentionally not complex, such that the closing of the stretching arms 200 by the user creates a synchronous action between the pressing of the bottle 300 containing the eye drops, by means of the compression protrusions 230 and a limited but sufficient opening of the eyelid edge by means of the stretching portions 250, thus enabling the correct administration of the eye drops in the conjunctival sac or on the cornea in a facilitated and approached manner. A further aspect, at the margin of all the technical solutions described up to now, but of particular importance in the attainment of the invention, is that in those cases where a container is used for liquid eye drops constituted by a single-dose vial 350, such as that represented in Fig. 5, it is necessary to have the assistance of an inventive adapter 500 in which aforesaid single-dose vial 350 is inserted. The right direction for inserting said adapter 500 in the main housing element 100 will be attained due to the correspondence between the aforesaid upper stabilization teeth 180 and the longitudinal guides 510 made on the aforesaid inventive adapter 500. Further characteristic regards the fact that the material constituting said adapter 500 must be such to easily transmit the compression forces exerted by the compression protrusions 230 on the aforesaid single-dose vial 350 housed within and for such purpose, advantageously, rigid elastic polymeric material such as natural and synthetic rubbers are used.

Further characteristic regards the possibility of selling said device in the form of a kit, which in addition to containing the aforesaid adapter 500 will also contain those spare parts mainly relative to the closing lid 450 and to the shells 260 of the stretching portions 250, which can be variously colored in order to increase the compliance of young patients.

Further alternative embodiment of the present invention, more elaborated and hence intended for more exclusive commercial purposes, provides that in place of the support elements 400 of the closing lid 450, there is an automated system of injection of the liquid eye drops, as well as a common electromechanical system for self-powered injection, also remotely manageable and automatically activatable by the closing of the two stretching arms 200.

The present invention provides for a further alternative embodiment at several variants of its structure and of the shape of its components, which however must not at all be considered less essential for the purposes of attainment of the same invention.

For example, even if up to now a device has been described that was infinitely reusable with the common types of containers of ophthalmic solutions present on the market, the alternative embodiment shown in detail in Fig. 6 provides that said device can be attained and sold as a single unit, or that said device is no longer usable once it has carried out its function. In reality such embodiment must be considered as an alternative embodiment of the preceding, which is however simplified and economically more advantageous, in which for the dispensing of the eye drops and the synchronous opening of the eyelids the same physical principle of the lever of the first order is exploited, previously referred to above. Therefore, said device container for eye drops 600 will be inventively constituted by a container having a shape such to allow the exact gripping or the immediate identification of the correct point where to place the user’s fingers, represented by the knurled area 610. Said stretching arms 200, as represented in Fig. 6, or the upper arms 210 and the lower arms 220, are entirely constituted by a rigid plastic polymer material and characterized in that the portions constituting the upper arms 210 are fully made in the wall of said container for eye drops 600, which is instead made of a semi-rigid plastic polymer material or provided in any case with a considerable elasticity. Such aforesaid elasticity will be such to allow the deformation thereof and hence the approaching of the upper arms 210, actively induced by the pressure of the user’s fingers on the knurled area 610 and consequently the release of the eye drops and the synchronous opening of the lower arms 220 and hence of the stretching portions 250 for opening the eyelids and vice versa a passive return into inoperative/rest position of the aforesaid stretching arms 200 once the aforesaid pressure has ceased.

Still by virtue of the practical use and low price concepts, the aforesaid container for eye drops 600 will be provided in a lower and central portion, at the lower arms 220 and just above the stretching portions 250 of the spout of the container 650. Said spout of the container 650 is advantageously made of silicone and is valve-like by means of a small medial slit forming the eye drops release orifice. Said spout of the container 650 will be opened by breaking a closure seal, along with a common tongue adhered to the same or by removing the relative closure cap.

Even if such invention has been described with reference to the specific and concrete embodiment shown in the present document, it must be considered as limited to the above- indicated details, and the patent must be considered as comprising the modifications and changes that can derive without this involving an extension beyond the inventive concept that underlies the following claims.

Claims

1. Device for facilitated administration of eye drops characterized in that it comprises a cylindrical-shaped main housing element (100), having the upper end (110) open in order to allow the introduction and removal of a common bottle (300) containing the eye drops and the lower end obtained with a lower hole (120) capable of receiving the spout of said bottle (300) containing the eye drops, in that present inside said main housing element (100) at said open upper end (110) are at least two upper teeth (180) for the stabilization of said bottle (300), in that present at said lower hole (120) are at least two resilient stabilization fins (130) capable of engaging and reversibly locking the aforesaid bottle (300) containing the eye drops, in that provided for on the main housing element (100) is at least one longitudinal opening (170), in that present in the external position of said main housing element (100) in diametrically opposite positions are two stretching arms (200) for opening the eyelids each connected to the main housing element (100) by means of a common articulated connection system (140) capable of allowing a rotary motion around the axis thereof and wherein said articulated connection system (140) conceptually divides each of said stretching arms (200) into an upper arm (210) and into a lower arm (220), in that said upper arms (210) have compression protrusions (230) directed medially and capable of, during the mutual approaching of the stretching arms (200) or the closure thereof by the pressure exerted by the fingers of the user, to engage and press through the corresponding openings (160), obtained in the main housing element (100), the relative bottle (300) containing the eye drops and thus compress it until it releases the ophthalmic solution through the spout thereof, in that said lower arms (220) provide, at the lower ends, the stretching portions (250) directed medially and positioned almost orthogonally, consisting of a semi-lunar-shaped rigid framework applied on which is a comfortable shell (260) capable of resting against the eyelids of the user and carrying out a very delicate opening of the same in synchrony with the mutual approaching of the stretching arms (200), making them remain in the open position until the eye drops have been administered, in that said lower arms attain the system for closing the bottle (300) through the presence, in medial position, of the support elements (400) which lift the closing lid (450) up to bringing it into contact, closing the spout of said bottle (300) containing the eye drops and lastly in that when any external force acts on the aforesaid two stretching arms (200), the return or maintenance in inoperative/rest position, which coincides with the shutting of the eyelids, will be facilitated by at least two return elements (190).

2. Device according to claim 1, characterized in that if a liquid eye drops container is used consisting of a single-dose vial (350), an adapter (500) is used into which the aforesaid single-dose vial (350) is inserted, in that the correct direction for inserting said adapter (500) into the main housing element (100) is actuated due to the correspondence between the aforesaid upper stabilization teeth (180) and the longitudinal guides (510) obtained on the aforesaid inventive adapter (500) and in that the material constituting said adapter (500) is capable of transmitting the compression forces exerted by the compression protrusions (230) onto the aforesaid single-dose vial (350) housed in the main housing element (100) without any hindrance.

3. Device according to claim 1, characterized in that the ends (215) of the aforesaid upper arms (210) terminate folded orthogonally towards the external.

4. Device according to claim 1, characterized in that the shells (260) covering the stretching portions (250) are made of semi-rigid and soft-rubbery resilient plastic material such as silicon and/or rubber.

5. Device according to claim 1, characterized in that the two return elements (190) are constituted by common helical springs.

6. Device according to claim 2, characterized in that the adapter (500) is made of rigid elastic polymeric material such as natural and synthetic rubbers.

7. Device according to any one of the preceding claims characterized in that the stretching portions (250) consist of a semi-lunar shape or consist of any shape and size such to obtain a valid means capable of coming into contact with the eyelids and determining the controlled opening thereof.

8. Device according to any one of the preceding claims, characterized in that it is in form of a kit, containing the aforesaid adapter (500) and the spare parts regarding the closing lid (450) and the shells (260) of the stretching portions (250) and in that said spare parts can be variously colored.

9. Device according to any one of the preceding claims, characterized in that instead of the support elements (400) of the closing lid (450) there is an automated system for injecting the liquid eye drops, such as a common self-driven injection electromechanical system even manageable remotely and automatically activatable by the closure of the two stretching arms (200).

10. Device according to any one of the preceding claims, characterized in that it is obtained as a single unit or in that said device will no longer be used once it has exhausted its function, in that said eye drops container (600) consists of a container shaped in a manner such to allow exact gripping or immediate identification of the exact point where to position the fingers by the user and represented by the knurled area (610), in that said stretching arms (200) or upper arms (210) and lower arms (220) are entirely made of rigid polymeric material and wherein the portions constituting the upper arms (210) are wholly obtained in the wall of said eye drops container (600), in that the wall of said eye drops container (600) consists of semirigid plastic material or material with considerable elasticity, in that the aforesaid elasticity is such to allow the deformation and thus the approaching of the upper arms (210) actively induced by the pressure of the fingers of the user on the knurled area (610) and thus the release of the eye drops and the synchronous stretching of the lower arms (220) and thus the portions (250) for opening the eyelids and vice versa a passive return of the aforesaid arms to the inoperative/rest position once the aforesaid pressure ceases, in that said eye drops container (600) is provided, in lower and central position, at the lower arms (220) and slightly above the stretching portions (250) with the spout of the container (650) made of silicon and shaped in a valve-like manner through a small medial slit constituting the eye drops release orifice and lastly in that said spout of the container (650) is opened by breaking a closure seal, such as common tongue adhering thereto or alternatively by removing a relative sealing cap.