Ophthalmic fluid applicator

The present invention relates to an eye fluid applicator.

An eye fluid applicator is known from the prior art, comprising a hand grip and a container or receptacle, containing a bottle with a fluid or droplet delivery opening, which opening defines the axis and direction of fluid delivery along this axis from the bottle through the opening, while what this hole is close to one end of the handle, and at the hole there is an eye cup in the form of a wreath surrounding the cavity, which wreath defines the contact plane, a contact axis perpendicular to this contact plane and a contact direction located along this contact axis from the recess towards the wreath.

Applicators of this type for delivering fluids, in particular eye liquids, have long been used for a variety of purposes. Usually, eye wash for comfort, refreshment or rinsing may require the use of an anatomically shaped cup for dipping the eye. The supply of large amounts of fluid, usually by means of spray devices, has also been used to flush eyes, for example in an accident. A well-known application is eye medication. Usually, a specific drug must be administered in a fairly strict volume to ensure delivery or absorption of a specific dose of the drug. A larger excess of medication should not be allowed due to inappropriate physiological effects due to absorption from non-target tissues or the flow of excess amounts through the tear duct to the throat or due to the inconvenience caused by fluid flowing onto the face and clothing. Price considerations are also important for many expensive medicines. For example, glaucoma treatment requires frequent daily administration of prostaglandins, beta blockers, or other costly active ingredients, all of which have a non-desirable antihypertensive effect when absorbed by body tissues other than the eye. Furthermore, the proper administration of small amounts is complicated by the fact that the active ingredients only enter the eye through a limited area of ​​the cornea. Although the applicator described above can be used in combination with any fluid for any purpose, it will only be described below for its medical applications.

These circumstances impose serious requirements on the applicator regarding the fulfillment of general purposes. Necessarily a small amount of the preparation must be placed with great care in the eye so as not to miss the dosage, do not cause overflow, side effects and these target errors. Placement should be possible in at least one comfortable position of the patient's head, hand and arm. Stressed body positions are not only a problem for comfort or can cause increased errors due to stress and shaking hands. It is desirable that administration can be carried out in a variety of body positions, such as upright, sitting or lying down, and if possible also regardless of the orientation of the applicator. Equally important is the natural and relaxed position of the arm and handle when orienting, contacting and lowering. The device should also assist the user in providing the exact volume of the preparation and should not allow too small or too large accidentally repeated injections. Preferably, a single solution should be adapted to various anatomy without regulation and should not cause a fear of pain due to contact or discomfort. These requirements should be met both with patient self-service and with operator-assisted service. When self-service is required during administration, simplicity is important to allow administration also by children, the elderly and the disabled, possibly with reduced visual abilities and weak hand strength. On the other hand, an assistant might need to grasp the device from a different hand position compared to the patient and may need supportive support measures to replace the patient's tactile or visual experience. Finally, a functional and convenient feeding device should meet several secondary requirements, such as simple refilling of the container or replacement, easy opening and closing of the opening, easy control of bottle identification and filling level, open and cavity-free design for ordinary cleaning,

188 028 a total design suitable for use and carrying during the day and low manufacturing and assembly costs.

Known devices meet the given requirements only to a limited extent. In general, devices for delivering large volumes of fluid do little to solve the problems of convenience, positioning and dispensing problems when administering a small volume of fluid. For example, US Patent No. 1,846,763 discloses an ophthalmic scrubber for repeated use of an antiseptic flushing fluid, the device having a tilt between the bulb and the attached eye cup to free the eye from the weight of the bulb during use, but lacking the features to meet other requirements. Generally speaking, known eye fluid applicators for small volumes are based on the principle of instillation or spray delivery. Drop applicators are based on the use of gravity, usually after centering the eye with an eye cup or eyelid retaining handle, by administering fluid e.g. by squeezing a spring bottle. The drip method provides a concentrated delivery when properly positioned and is generally not felt uncomfortable, however it is not independent of the applicator orientation. The known solutions are not too complicated and provide little feeding control and allow limited changes in the order of feeding. Devices having portions designed to fit to face portions are described in U.S. Patent Nos. 3,872,866, 4,134,403 and 4,792,334, although without the possibility of relative orientation and without the hand gripping portion. An example of such a device is disclosed in EP 335,513, equipped with a minimum amount of support means with a hand grip type extrusion support, but without any other release and misalignment of the hand grip. A similar device is sold under the trade name "Opticare". Spray applicators use the effect of a jet, usually released by the use of a hand lever centered on the eye by means similar to drop applicators. The spraying method in itself is highly independent of the applicator orientation and can give a diffuse dosage, however, it is limited to very small therapeutic amounts before aerosol losses occur and administration will tend to release reflective reflections. Known solutions do not overcome these problems or the indicated general requirements. U.S. Patent 5,201,726 discloses an example of a device of this type having extensive means for draining unintentional and non-condensed excess fluid instead of preventing its occurrence. Although such a device is equipped with a hand grip and a trigger, it is not ergonomic for use by the patient or assistant.

The object of the invention is to provide an applicator for administering relatively small amounts of fluid to the eye, convenient to operate to facilitate or enable frequent use, also in situations requiring self-service, and fulfilling these tasks to a degree better than the devices known to date.

In particular, the purpose of the invention is to develop an applicator suitable for convenient and precise dosing of small volumes of eye fluid, avoiding the use of excess fluid, eliminating overflow or fluid loss, increasing the tolerance of placing the preparation in the target area of ​​the eye, enabling treatment in various body positions and freeing the patient from the need to assume strained body positions and from the requirements for professional and physical abilities.

An eye fluid applicator, comprising a hand grip and a container or receptacle for the container, comprising a bottle with a fluid or fluid delivery opening, which opening defines the axis and direction of fluid delivery along that axis from the bottle through the opening, the opening being near one end of the handle, and at the opening is placed an eye cup in the form of a wreath surrounding the cavity, which wreath defines the contact plane, the contact axis perpendicular to this contact plane and the contact direction located along the contact axis from the recess towards the wreath, according to the invention is characterized in that the direction of the handle axis and the direction of the contact axis of the eye cup defining the handle / cup angle form an acute angle between them.

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The handle / cup angle is less than 85 °, preferably less than 80 °, and most preferably less than 75 °.

The handle / cup angle is at least 20 °, preferably at least 30 ° and most preferably at least 40 °.

The eye cup wreath fits the eye socket.

The eye cup wreath is in the form of a continuous or discontinuous ellipse.

The eye cup wreath includes at least one eyelid retracting member in the form of a projection.

The eye cup is attached to the hand grip.

At least the container bottle is separate from the hand grip and eye cup.

The container bottle has a cross section having a wide axis and a narrow axis, the narrow axis of the cross section of the bottle being more parallel to the handle axis than the wide axis of the cross section of the bottle.

The bottle of the container has an opening to deliver drops.

The handle includes a container socket.

The socket is located at the near end of the handle.

The socket has holes at least partially exposing the container.

The handle has an openable part revealing the socket.

The openable part of the handle is at the near end of the handle.

The handle has a foot at the distal end that allows the applicator to be positioned in a position where the handle axis is close to vertical.

The handle includes an opening or other recess adapted to contain the bottle cap.

The handle includes a pumping mechanism.

The pumping mechanism has a pusher exerting pressure on the elastic bottle.

The pumping mechanism includes a manual override arm.

The pumping mechanism includes a manual control arm as an intermediate assembly between the user and the pumping mechanism.

The manual control arm is located on the handle on the side of the eye cup.

The pumping mechanism includes a yoke system including a tilting lever assembly.

The pumping mechanism includes a dose limiter.

The pumping mechanism and / or bottle opening have a design enabling delivery of fluid droplets.

The pumping mechanism and / or opening of the bottle have a design that allows the kinetic delivery of fluid in the form of a spray jet.

The direction of the hand grip axis and the direction of fluid delivery, defining the handle / hole angle, form an acute angle between them.

The handle / hole angle is less than 85 °, preferably less than 80 ° and most preferably less than 75 °.

The handle / hole angle is at least 20 °, preferably at least 30 ° and most preferably at least 40 °.

The handle / hole angle is greater than the handle / cup angle, preferably by at least 5 °, and most preferably by at least 10 °, but preferably not more than 45 °, and most preferably not more than 30 °.

The direction of fluid delivery and the direction of the contact axis of the eye cup, defining the opening / cup angle, form an acute angle between them.

The opening / cup angle is at least 5 °, and most preferably at least 10 °, but preferably not more than 45 °, and more preferably not more than 30 °.

The direction of fluid delivery through the container opening is facing more towards the distant direction of the handle than the contact direction of the eye cup, which is facing more towards the near direction of the handle.

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The fluid delivery axis through the container opening and the eye cup contact axis are mutually eccentric, the container opening being positioned close to the eye cup contact axis.

The straight line distance between the contact axis and the tip of the container opening is at least 2 mm, preferably at least 3 mm, and most preferably at least 4 mm.

The distance in a straight line between the contact axis and the tip of the container opening is not more than 20 mm, preferably not more than 15 mm, and most preferably not more than 10 mm.

The distance in a straight line from the axis of the hand grip to the point of the contact curve or rim of the eye cup located closest to the distal end of the grip is at least 1 cm, preferably at least 2 cm, and most preferably at least 3 cm.

A second embodiment of an eye fluid applicator, comprising a hand grip and a container or receptacle for the container, comprising a bottle with a fluid or fluid delivery opening, which opening defines the axis and direction of fluid delivery along this axis from the bottle through the opening, the the hole is located near one end of the handle, and at the hole there is an eye cup in the form of a wreath surrounding the cavity, which wreath defines the contact plane, the contact axis perpendicular to this contact plane and the contact direction located along the contact axis from the recess towards the wreath, according to the invention is characterized in that the direction of the handle axis and the direction of fluid supply through the container opening defining the handle / hole form an acute angle between them.

The handle / hole angle is less than 85 °, preferably less than 80 ° and most preferably less than 75 °.

The handle / hole angle is at least 20 °, preferably at least 30 ° and most preferably at least 40 °.

The handle / hole angle is greater than the angle between the handle axis and the contact axis of the eye cup, forming the handle / cup angle, preferably by at least 5 ° and most preferably by at least 10 °, but preferably not more than 45 ° and most preferably not more than 30 °.

An eye fluid applicator, comprising a hand grip and a container or receptacle, containing a bottle with a fluid or fluid delivery opening, which opening defines the axis and direction of fluid delivery along that axis from the bottle through the opening, the opening being close to one handle, and at the opening is placed an eye cup in the form of a wreath surrounding the cavity, which wreath defines the contact plane, the contact axis perpendicular to this contact plane and the contact direction located along the contact axis from the cavity towards the wreath, according to the invention is characterized in that the direction of fluid delivery through the container opening and the direction of the contact axis of the eye cup, defining the angle of the hole / cup, form an angle between them sharp, the direction of fluid delivery through the container opening is facing more towards the distant direction of the handle than the contact direction of the eye cup, which faces more towards the near direction of the handle.

The opening / cup angle is at least 5 ° and most preferably at least 10 °, but preferably not more than 45 ° and most preferably not more than 30 °.

An eye fluid applicator, comprising a hand grip having a distal end and a proximal end, the distal end and proximal end of the grip defining an axis and distant direction and proximate along this axis between them, and a container or receptacle for the container containing the bottle and delivery opening for delivering a stream or droplets, the opening defining the fluid delivery axis and the direction of fluid delivery along this axis from the bottle through the opening, and the container opening is closer to the near end than the distal end of the handle and containing an eye cup having a rim and a cavity, the rim defines a contact plane, a contact axis perpendicular to this contact plane, and a contact direction located along this contact axis, from the recess towards the wreath, wherein the eye cup is positioned at the opening according to the invention characterized by that the fluid delivery axis through the container opening and the contact axis of the cup

188 028 ophthalmic are mutually eccentric, the container opening being located close to the contact axis of the eye cup.

The straight line distance between the contact axis and the tip of the container opening is at least 2 mm, preferably at least 3 mm, and most preferably at least 4 mm.

The distance in a straight line between the contact axis and the tip of the container opening is not more than 20 mm, preferably not more than 15 mm, and most preferably not more than 10 mm.

The applicator according to the invention uses in the first place the main principle of delivering one or more drops directed towards the eye to allow delivery of small volumes. In general, the applicator includes a hand grip, a container and an eye cup, all having major axes and directions as mentioned above and explained below. By creating an acute angle between the close direction of the hand grip and the contact direction of the eye cup, an optimal relationship of two conflicting requirements is obtained, on the one hand, avoiding incorrect positioning of the anatomical lifting arm and hand, maximally aligning the coaxial part of the eye with the obtained direction of the eye, on the other hand, providing sufficient space between the hand grip and face for convenient maneuvering of the device and its control elements, such as the trigger button. In fact, if a person's hand in a completely relaxed state is placed in front of the face, then the hand grip will take exactly the position of the acute angle described in relation to the visual line of the eye. In addition, such a handle is not limited to one alternative, because several handles are available with approximately the same comfort for the user, like a handle with fingertips or closed with full hand contact, both with easy access to the trigger button located on each side hand grip. The relatively low position of the arm in relation to the body gives a lot of space and freedom to hold a relaxed grip when tilting the head back, for example to assist in drop delivery without the need to lie down. It should be noted that while the described handle is similar to a gun or tool handle, the current situation is completely different, since the position of the hand relative to the protruding eyeball is completely opposite. This circumstance allows adapting to the requirement of equal availability of the applicator for use by the assistant, because such an assistant will of course use a standard handle to direct the applicator towards the patient. Similar considerations apply to the angular relationship between the close direction of the hand grip and the direction of fluid delivery through the opening. If the opening is a part of the container separate from the hand grip, for example in the form of a miniature bottle, several of the secondary requirements imposed on the applicator are achieved. The bottle can easily be attached and replaced at the proximal end of the hand grip, having a free opening, and with at least the lateral and lower ends available for inspection. If the applicator is positioned so that its distal end is on the support, then the contents of the bottle will naturally flow out of the opening, reducing contamination problems. The acute angle between the direction of fluid delivery through the opening and the direction of contact with the eye cup is used to reduce the requirements for the positioning of the head when providing drops, improving comfort and expanding the range of applications. The essentially tangential rather than radial impact of the drop on the eye can additionally serve to reduce sensitivity and can advantageously be combined with a handle holding the lower eyelid to maintain fluid within the eye boundaries. The eccentric arrangement between the fluid delivery axis through the eye opening and contact axis of the eye cup, with closer placement of the opening significantly increases the possibility of proper fluid delivery by widening the acceptable target area over the entire surface between the eccentric and upward position of the eye down to the lower eyelid. It is clear that the described benefits can be used in a variety of combinations to achieve cumulative, synergistic or multiple benefits for different purposes.

These and other goals and benefits will be illustrated based on the detailed description below.

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As mentioned in the introduction, the applicator can be used for a variety of purposes within and outside of medical applications and for any type of preparation, such as chemicals, compositions or mixtures, in any container and delivered for any purpose. For the reasons given above, the applicator of the invention has particular value as a medical delivery device where design constraints are more severe than in most other applications, and the invention is mainly described in this context.

The principles of the invention may be applied to ophthalmic applicators and systems. The material constituting the contents of the container should be capable of delivery through the opening, with or without a pumping mechanism, and any material meeting this requirement may be used. Particle or powder compositions, with or without fluid or a gaseous carrier medium, can be delivered using known delivery mechanisms. Typically, however, the material is a liquid, and preferably a liquid, including materials that behave like liquids such as emulsions and suspensions. These statements relate to the final formulation, with other components namely solids also being present before the final formulation stage. The nature of the contents of the container should also be considered to include a broadly medical nature and to include, for example, natural components and body fluids pre-filled or withdrawn into the container, although most often the medicine is prepared at the factory. As mentioned in the introduction, the invention can be advantageously used in combination with, for example, preparations for the treatment of glaucoma.

The preparation can be delivered to the eye in the form of a coherent stream. However, it is recommended that the formulation be provided in the form of one, several or more discrete particles. Depending on the nature of the preparation as described, the particle may be a solid, but preferably a liquid, and the term "droplet" etc. should be regarded as also including particles. Common for such defined droplets is their shape, determined by intrinsic properties, solid particles are defined by their durable shape, and fluid droplets by their droplet shape determined by surface tension criteria. This is in contrast to the stream whose shape is determined by dynamic and unstable factors. The main force used to accelerate the drop towards the eye determines the general delivery principle used. Recommended principles are gravity delivery and kinetic delivery, with an initial trajectory determining drop velocity, especially for spray delivery, whose respective benefits have been considered and can be used in a variety of applications for a variety of purposes. Although spray delivery can be carried out completely independent of the orientation of the applicator, drop delivery due to gravity gives the advantages of ease of use and precision of administration, as in the invention.

Eye cup

Many of the benefits of the present invention are also obtained without an applicator eyecup, as long as the operator assumes responsibility for orienting and stabilizing the device. However, it is recommended that an eye cup be used to relieve the operator of this responsibility. A suitable applicator eye cup includes at least a wreath and recess.

The task of the wreath is to make contact between the applicator and the face to self-center the applicator in the intended position relative to the eye. Contact can be on any part of the face, such as the forehead, nose and cheeks, but generally the best centering is obtained when the wreath contacts the eye socket. The term "wreath" can be understood in a broad sense as a point or points of contact and does not need to be shaped as an edge or other elongated part, but should provide at least one point of contact, and preferably two, three or more points distributed in two dimensions for better centering . These points should preferably be formed as one or more continuous edges and most preferably as a continuous loop. For the purposes of this description, it is assumed that a line can be dragged to connect the contact points into a "contact curve" also representing the theoretical contact points of the face.

188 028 currently in contact with the wreath and in the case of a closed continuous wreath the contact curve and the edge of the wreath are in principle compatible. The plane drawn through the contact curve forms the theoretical 'contact plane'. A line perpendicular to this plane forms the "contact axis" and "contact direction" along this axis from the applicator towards the eye, or in other words from the recess towards the wreath. The contact axis and direction of contact can be considered "symmetrical" if, in terms related to the device, they are centered within the contact curve or "in terms related to the patient", they are radial to the eyeball. Suitable wreath forms are known in the art and are not critical to the invention. It is recommended to use the wreath shape with right / left symmetry to make it equally useful for both eyeballs with a similar grip. For example, you can use a wreath having a contact curve essentially in the form of an ellipse, adapted in size and shape to the eye socket. The contact plane through this generally elliptically shaped form can be flat, although often slightly curved along an axis parallel to the short axis of the ellipse. The wreath may have known recommended eyelid retractions, preferably in the direction of contact for specific contact with at least the lower eyelid, but preferably also with the upper for displacement and retention of the eyelids. Structurally, the wreath may have a soft edge for comfort and a constructive material characterized by high friction, at least on one of the retractable eyelid parts. The wreath can be a whole with a cavity, however, it is preferably a separate part attached, glued or melted with the cavity for the freedom of the material or the contrast of color.

The cavity performs the task of providing space within the contact curve boundaries for the protruding eyeball and also to provide a safe distance to the eyeball for any part due to this eyeball, especially the opening, as will be explained below. Thus, the recess should in a broad sense cover any structure fulfilling these tasks. The cavity can be a bowl, as in known eye washes, however, it does not have such a function as such and it is recommended that it has a more open design, e.g. to allow access to the opening for opening and closing, to avoid accumulation of preparation and for ease of use. purification, to allow the assistant to observe the orientation of the opening and delivery, to facilitate manufacturing.

The minimum requirement is that the recess structure forms a support and attachment for the rim, e.g. a single arm or rod extending from the rim in the opposite direction of contact, although, for example, two or more arms may be used in a flap pattern. The eye cup may be positioned at the container opening in a manner that allows fluid to be delivered to the eye, and in particular within the wreath contact curve. This relationship may be from the delivery principle used, with particular freedom in droplet delivery, however, it is generally recommended that the opening be located behind the contact curve, looking opposite to the contact direction, and with a protrusion along the contact direction within this curve. The opening may preferably face or be located within the cavity, and preferably with at least a fluid delivery direction component parallel to the contact direction. It is recommended that a certain safety distance be maintained between the apex of the hole and the contact plane to avoid contact with the eyeball for any anatomy of the individual that may occur and to avoid fear of such contact by the patient, e.g. a distance of at least 5 mm should be maintained, preferably at least 8 mm and most preferably at least 10 mm. The abovementioned support and connection of the wreath by means of the recess structure can be made in relation to the container or its opening, however it is recommended to attach the wreath to the hand grip, e.g. to allow uninterrupted exchange of the container.

Container

The formulation container may contain a single dose for single delivery to the eye, e.g., separate disposable single dose containers each or tape of such containers for periodic administration to the dispensing position in the device, optionally

188 028 connected to a counting device, known e.g. from GB 2,255,918 or WO 96/06581. Usually and preferably the container contains several multiple-dose doses. The container generally comprises a bottle and an opening for the formulation to allow the formulation to pass into the eye.

The aperture can have several different designs, depending on which dispensing principle is used. In general, the last portion of the opening may be regarded as a channel defining the direction in the last portion, thereby forming a "fluid delivery axis" centered within that channel and its flow, and a "fluid delivery direction" along this axis in the direction of flow from the bottle through the opening towards eye. For kinetic delivery, such as jet or spray delivery, the formulation should typically move toward the eye in the direction of fluid delivery also when released from the orifice. The stream should move concentrated along the fluid delivery axis. The showers should have different spray shapes and divergence angles, depending on the type of nozzle and delivery pressure, and the spray should be centered around the fluid delivery axis. The nozzle may require the use of separate inlets for carrier media, e.g. gas under pressure, if required and if it has not been used previously in the flow sequence. In contrast, when droplet delivery, the droplet or droplets released at the opening should move further in the gravitational direction, allowing relatively free positioning of the fluid delivery direction relative to the eye cup, however, in the fluid delivery direction only when it is facing vertically downwards, which is recommended for the simplest solution and safest placement of the released droplet. When delivering in the form of drops, the physical design of the bore can be very simple, e.g. a bore narrow enough not to release more than one drop at a time, for control preferably only after some pumping action, as will be described below.

The bottle may be integral with other parts of the applicator such as an eye cup, however, preferably with a part of the hand grip, e.g., such that the hand grip has a known formulation cavity. However, it is recommended that the bottle be a separate part that can be replaced in the machine. Also, the part with the bore can be separate and replaceable, especially if the bore construction is as straight as in droppers, while many more time-consuming designs can be used, e.g. kinetic nozzles. A tube, such as a tube, can be used between the bottle and the opening, e.g. a tube reaching the bottom of the bottle to allow free placement relative to the opening. The simplest solution is obtained in the case of a bottle having an outlet connected directly to the opening. The shape of the bottle is not critical, however, in general terms the bottle has a symmetry axis running from below towards its outlet. This axis may have any angle relative to the fluid delivery axis as defined, for example a right angle or an obtuse angle. However, it is recommended that the symmetry axis of the bottle be substantially parallel and preferably coaxial with the fluid delivery axis, which helps to completely empty the bottle and reduce contaminant flows around the bottle. The bottle design is not critical. However, there are some advantages in using bottle designs with a non-cylindrical section perpendicular to the axis of symmetry and preferably a non-rotational section of symmetry having a wide axis and a narrow axis, which represents, but is not limited to, an approximately rectangular section. These bottle designs provide better emptying and prevent contamination, and in addition provide better bottle identification and refilling benefits, as will be explained below.

In addition to the minimum requirements discussed above, the container may also have other features that determine its convenience of use. Typically, the opening is closed between each dispense, typically by screwing the cap onto the opening to avoid leakage or contamination. Even this simple operation can cause problems for disabled patients with limited hand strength. Thus, it is known to use in any bottle with a cap opener formulation, integral or separate from the cap and generally enabling lever action to reduce the patient's force needed to open and close the bottle. According to the invention, support has been developed in this respect, e.g. by providing an opening through an open cavity design

188 028 eyeball as described above or by the use of means, e.g., on a hand grip to facilitate opening of the bottle, as will be described below.

Hand grip

The hand grip is used to comfortably grip the user and create a connection to at least one other part. The hand grip can have any shape such as spherical in two or three dimensions, finger loops or the whole hand, etc. It is recommended that the hand grip be generally elongated, which can be taken in a closed hand or held with the tips of the fingers. Similarly to the eyeball, it is also recommended to use general left / right symmetry, looking in the direction of contact, for use in any hand and for both eyes. The elongated form is to be understood in a broad sense, from the form of a symmetrical cylinder to a form more or less compatible with the anatomy of the hand or hand or having aesthetic or practical features that go beyond the features of the handle as such. Regardless of the shape, one part of the hand grip should be held closer to the eye and the other part away from the eye and these parts will be referred to as the "near end" and "distant end" respectively, with the corresponding "near direction" and "distant direction". These ends will form the "hand grip axis" between them. In terms of position statements, the axis of the hand grip should be considered as being essentially centered inside the hand grip. For very complex hand grip shapes, centering the axis may not be easy, however, in terms related to the device, centering should be related to parts designed specifically for grasping or otherwise, generally the parts closest to the eye cup that are most easily used for grasping. In terms related to the user, centering can be referenced to the handle axis by hand when using the device.

The eye cup should be placed closer to the proximal end of the hand grip than to the distal end, and preferably at its extremely near end. It is also recommended that the eye cup be positioned laterally to the hand grip to create a space between the hand and face, i.e. the eye cup is displaced in the direction of contact from the hand grip axis. Expressing this as a distance perpendicular to the axis of the hand grip to the point of the contact curve or rim located nearest the distal end, this distance may be at least 1 cm, preferably at least 2 cm, and most preferably at least 3 cm. This distance is generally less than 15 cm, preferably less than 12 cm, and most preferably less than 10 cm. For elongated handgrip designs, these distances preferably relate to the front of the handle relative to the eye cup, not to the axis of the handle. Since the container opening may be directed into the eye cup, similar conditions apply to the opening, e.g. it is also recommended that the hole be located closer to the proximal end of the hand grip and with a lateral distance to the hand grip axis, however this distance may be smaller at the safety distances as described above. If the container is attached to the eye cup, it does not require attachment to the hand grip, but it is generally recommended that the container be attached to the hand grip, directly or indirectly, e.g. through the orifice. The recess inside the hand grip can serve as a container or at least as a bottle part. For re-use of the applicator, it is recommended that the container or at least its bottle part be a separate and replaceable part. In the latter case, it is recommended that the hand grip contain a receptacle for a container located on or preferably inside the hand grip. It is recommended that the bottle be placed so that it is at least partially exposed, and preferably so that its label, and preferably its filling level can be read and monitored by the user, for which purpose openings or transparent windows should be in critical places on manual handle. The most flexible container placement is possible when there is a conduit between the bottle part of the container and the opening, e.g. suction tube, and when the bottle can be placed virtually anywhere. However, it is recommended especially if the bottle forms a direct continuation of the opening, such as in delivery

188 028 drops or when the axis of symmetry of the bottle and the axis of the opening are coaxial, so that the receptacle of the container is located at the near end of the hand grip. This position is suitable for the aforementioned drainage and accessibility as well as for exposing the bottle. In addition, if a flat model with a wide and narrow axis is used, insertion is facilitated and larger side and bottom surfaces can be exposed, especially if the bottle is positioned such that its narrow section axis is more parallel to the hand grip axis than its wide axis. axis.

When the container or bottle is attached to the hand grip, it is recommended to use measures that allow simple replacement. When the orifice portion is more or less permanently positioned on the applicator and only the bottle portion is replaced, then it may be sufficient to attach the bottle to the orifice by any known closure, such as by thread, bayonet connection, luer, friction, snap connection or any other fit. In the event that the bottle is replaced with the opening, the bottle and / or the opening portion may need to be seated. In both situations, it is advantageous to enclose at least a portion of the container within a portion of the hand grip, for example to save space, protect the bottle and its position, allow squeeze bottles, etc. For this reason, the container can be inserted into the hand grip through the opening therein, however, it is generally recommended to divide the hand grip into at least two parts that can be separated and reclosed, e.g. by means of a spacer or preferably by a hinged mechanism. When the bottle seat is deeply embedded in the hand grip, it may be desirable to divide it over the entire section, e.g. substantially perpendicular to its axis, but preferably in a plane along its axis. When the container seat is at the proximal end, a preferred solution, facilitated by the angular conditions of the invention, is to form a near top portion as an openable portion, e.g. through a cross section substantially orthogonal to the axis of the hand grip, and most preferably as a cross section having substantially the same angular arrangement to the hand grip axis as the fluid supply axis or the bottle axis relative to the hand grip axis. The connection between the openable parts of the hand grip may be of any known type, such as completely separate, hinged mechanism or rail mechanism for dividing movement of parts in this cross section or a combination thereof. Preferably, the opening assembly comprises a known locking and release mechanism, e.g. comprising a release key. Various cross-sections and divisions, alone or in combination, can additionally serve to facilitate the opening of the hand grip for cleaning or inspection.

When the eye cup is attached to the hand grip, the physical connection can be made anywhere on the hand grip, but preferably at a near portion. When the hand grip is divided to insert the container, it is recommended to attach the eye cup to the close part of the split. The eye cup may generally be an integral part of the hand grip or parts thereof, but is preferably made as a separate element, permanently attached or removable, e.g. for separation in connection with cleaning, transport, replacement or for setting, for example the distance of the eye to the hole to adapt for various anatomy or safety requirements.

The hand grip may contain additional supporting details. It is recommended to design the distal end so that it has a foot enabling stable placement of the applicator on a flat horizontal support preferably so that the axis of the hand gripper, and most preferably its symmetry axis has a substantially vertical component within the stability requirement. The foot may comprise a flat portion at the distal end, possibly with widening or with increased weight to lower the center of gravity. The hand grip may have internal volume and external surfaces that are not used for its main task and can be used for other tasks. A cup or other handle adapted to the bottle cap can be used as a tool to assist in opening and closing, preferably located at the distal end and under the foot when used. The hand grip may also advantageously comprise a pumping mechanism as described below.

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Pumping mechanism

The described applicator can be used without any pumping mechanism, e.g. by gravitational delivery from a hole of sufficient width to discharge the stream or individual droplets. However, it is recommended to use a pumping mechanism in the applicator, e.g. to achieve better control of the release movement and dose amount, or to allow for alternative delivery methods.

The pumping mechanism for delivering a formulation through the container opening should primarily include at least one type of pump that may need to be matched to the particular type or container and type of formulation used. The pump may contain any type of pressure source, such as a mechanical unit or pressure electrolytic unit, in a container and a suitable valve for control, which method can be used in any type of container and any type of product, including powders, when they are conveyed through means and supplied by fluid jets or drops. If the bottle is at least partly and preferably substantially completely elastic, then it is preferable to use a known compression method to establish overpressure, especially in cases of applications that do not require special precision, such as delivering droplets at a low speed. In more complex applications, e.g. in terms of dosing, delivery speed, atomization, preparation viscosity etc., as in the case of spray delivery, it is recommended to use a pump based on controlled forced displacement, e.g. a pump based on peristaltic interaction, a diaphragm type pump, and preferably a pump based on piston interaction, with unidirectional interaction as in a syringe or with repetitive interaction as in suction and ejection pumps. Most of these types of pumps are compatible with the tubular connection between the opening and the next part of the container, or with the direct connection between the bottle and the opening, as long as these parts are maintained in proper relationship to the fluid flow in the direction of the opening. Several containers may be used with the same or different pumping mechanisms, for example, for separate delivery of formulation and carrier or propellant and spraying means. The energy needed for the pumping action can be accumulated in any known form, such as gas pressure, vacuum, hydraulic energy, elastic energy etc., however manual operation is most adequate and recommended.

The pumping mechanism may also include manual control, which is an intermediate set between the user and the actual movement of the pump. In the case of accumulated energy, this control can take the form of a trigger, releasing e.g. a valve or a mechanical blockage. In the case of manual actuation, the control can be in the form of an actuating member, either directly or through a yoke system carrying out the pumping movement. Preferably, the yoke system includes a lever that can be used to reduce the applied manual force, e.g. in the case where the formulation is too easily excreted or when a limited stroke length is desired, but is preferably used to increase the manual force or increase the stroke length of the actuating member . Manual control may include known safety devices such as arm locks or child safety devices.

It is recommended that the pumping mechanism also contain means for controlling the delivered dose and for reducing the risk of undesirable overdosing, underdosing and repeated dosing. The dose control can be placed in the pump itself, especially when stored energy is used. The valve can be controlled by the opening time or the volume of the passage, and the moving parts of the pump by the allowed range of displacement. Dose control can alternatively and advantageously be implemented by manual controls, especially when they are in the form of an actuating member, similarly by limiting stroke length or pressure. A recommended yoke system of this type includes a type of thickened lever initially having a curved configuration that is adjusted by lateral forces applied to the bend, which mechanism

188 028 provides a pre-determined limited possible extension in addition to the lever system and possibly a touch-sensitive release after undergoing critical displacement.

The pumping mechanism can be placed on or near the container, although it is generally recommended to place it next to or in a handgrip, e.g. to facilitate container replacement. Manual control can be located basically anywhere on the hand grip, conveniently accessible to the user, e.g. on the distal side of the position of the eye cup, however, it is generally recommended to place it on the side closer to the eye cup.

Arrangement of parts

The main parts of the applicator according to the invention may have at least one of several possible spatial relationships to achieve the indicated benefits. The angles described below are based on a 360-degree scale and are given as the smallest angles between the vectors of defined directions.

It is recommended that the near direction of the hand grip axis and the eye cup contact direction (handle / cup) create an acute angle, e.g., less than 90 degrees. Preferably, this angle is less than 85 degrees, more preferably less than 80 degrees, and most preferably less than 75 degrees. Preferably, this angle is at least 20 degrees, preferably at least 30 degrees, and most preferably at least 40 degrees. This acute angle condition means that the distant direction of the hand grip axis will run between the eye contact direction and the direction perpendicular to it down the face, both extremes being inappropriate for the reasons described.

Similarly, it is recommended that the near direction of the hand grip axis and the direction of fluid delivery through the hole (handle / hole) form an acute angle with each other. The recommended general limits for this angle are the same as those given in the previous paragraph for the handle / cup relationship. However, it is recommended that the handle / hole angle be greater than the handle / cup angle, preferably at least 5 degrees, and most preferably at least 10 degrees larger, but preferably not more than 45 degrees larger and most preferably not more than 30 degrees. This requirement for a larger angle means that the direction of the fluid through the opening will be oriented more towards the distant direction and the direction of contact with the eye cup will be directed more towards the near direction.

So, it is recommended that the direction of fluid delivery through the hole and the contact direction of the eye cup (hole / cup) form an acute angle between them, with the recommended limits as given for the "larger" angle in the previous paragraph, with the same recommended contact direction of the cup of the eye on the proximal side and the direction of fluid delivery through the opening on the side distant to the hand grip.

It is recommended that the fluid delivery axis through the eye cup contact axis and be eccentric to each other and that the hole is positioned close to the eye cup contact axis. Preferably, the normal distance between the contact axis and the apex of the hole is 2-20 mm, preferably 4-15 mm, and most preferably 6-10 mm.

Practical application

The applicator's practical application is clear from the description of its components with comments. First, the formulation is filled with the container as a whole with the device or as a separate bottle inserted into the socket on the device, possibly after the initial stages of preparation of the preparation, such as dissolution of solids and preferably with the label of the bottle exposed by any window used. The removable bottle may have its own opening or may need to be connected to the opening of the device. Then the split hand grip may need to be closed and locked. Before or after insertion, you may need to remove the cap on the bottle or on the opening, e.g. by any of the described auxiliaries. The user grips the hand grip and places the eye cup on the eye in a manner that secures contact between the wreath and the entire face. If the device operates on the basis of gravitational delivery, then the user provides a substantially vertical hole pattern that may require head or body positioning. If the device works on the principle of kinetic delivery, it can work in any position of the head and body. If the device is equipped with manual control, such as a button, the user activates this control element as needed after the applicator is properly oriented to deliver the dose of the preparation and the button is released. These actions are similar for both self-dispensing and dispensing with the help of an assistant, however the way of gripping the hand grip may be slightly different. After use, the applicator is preferably positioned on the foot of its distal end or held so that its hand grip axis is vertical to allow fluid to drain from the opening. In general, the container contains multiple doses of the formulation, and it is preferred to replace the lid or protective cap on the opening to allow transport of the applicator. With repeated use, it may be desirable to confirm the type of preparation by examining the label of the bottle and its filling level by examining its bottom end through any window intended for this purpose. Again, any opening protection is removed and the process repeated. When the container is emptied, the bottle is removed by opening any separation on the hand grip, possibly after releasing the key of the closing mechanism. Before inserting a fresh bottle, it may be desirable to check the applicator for contamination and perform cleaning, for example, by passing the device through the dishwasher, followed by reassembly of the parts, e.g., by closing the hinges.

The subject of the invention is shown in the embodiment in the drawing, in which Fig. 1A is a front view, Fig. IB is a top view and Fig. 1C is a side view of a schematic eye cup with a wreath and a recess, Fig. 2A is a diagram of a container for gravity delivery, Fig. 2B - diagram of the container for kinetic spray delivery, Fig. 3 - diagram of the main parts of the applicator and their general spatial configuration, Fig. 4 - diagram of the applicator with an alternative container configuration in relation to the eye cup, Fig. 5 - diagram of possible hand positions for self-dispensing and assisted dispensing, Fig. 6A - applicator in side view with the container socket exposed, Fig. 6B - applicator in view from side in the ready to use position, and Fig. 6C is a cross-section through the applicator shown in Fig. 6B.

Fig. 1A shows an eye cup 10 having a wreath 11 and a cavity 12. The wreath 11 is generally elliptical in shape adapted to contact the eye socket. The dashed line 13 indicates the theoretical contact curve. Points 14 indicate the possibility of using discontinuous contact points for the orbital outline instead of the closed and continuous crown shown, which does not change the shape of the theoretical contact curve. In fig. IB, showing the eye cup in a top view, shows that the rim is slightly curved, with a straight short axis maintained and with a curved axis of the long ellipse, to bring the part of the ellipse along the long axis closer to the eye. The dashed line 15 indicates the theoretical contact plane, here perpendicular to the drawing plane, in which plane the contact curve lies, indicated in Fig. 1A by the dashed line 13, whereby the contact plane also becomes curved. The contact plane 16 is perpendicular to the contact axis 16 centered within the wreath and shown in FIGS. IB and 1C with a dashed line with an arrow 17 indicating the direction of contact towards the hypothetical eye. The wreath also becomes curved in the side view of the eye cup, as shown in Fig. 1C. The schematic arms 18 extend from the rim 11 in the opposite direction of contact and serve as attachment to the rim. In fig. 1A is also a schematic member for retracting eyelids 19.

Figs. 2A and 2B schematically show a container 20 for gravity delivery (Fig. 2A) and for kinetic spray delivery (Fig. 2B). The container 20 comprises a bottle 21 and an orifice 22, the orifice defining the fluid supply axis working for gravity delivery, as shown in the form of drops 25. Although the drop path 25 here follows the direction of fluid delivery in the opening, this is not always the case if the container 20 is tilted from the position shown

188 028 vertical. The dashed line 26 illustrates that the bottle may have any angular position relative to the opening, although a configuration in which the axis of symmetry of the bottle is coaxial with the axis of fluid delivery is recommended. The container in Fig. 2B operates for kinetic delivery as shown by the spray cone 27, in which cone the fluid supply axis 23 and the fluid delivery direction indicated by arrow 24 are centered. A suction tube 28 extending from the opening 22 to the bottom of the bottle is also shown. It is assumed that the schematic actuating member is activated to generate the spray stream, either directly or through the zygomatic system.

Fig. 3 schematically shows the main parts of the applicator and their general spatial arrangement. The applicator is generally designated 300. It includes a hand grip 301 having a distal end 302 and a near end 303 defining an axis 304 between them, and a near direction represented by a full arrow 305, and a distant direction represented by an incomplete arrow 306. The applicator 300 further includes a container 307, the opening of which defines the fluid supply axis 308 and the direction of fluid delivery, shown by arrow 309. The applicator 300 further includes an eye cup 310, shown here with a flat contact surface and a cup-shaped cavity in which the contact plane defines the contact axis 311 and contact direction as shown by arrow 312. The main angles shown are the angle between the close direction of the hand grip axis 304 and the contact direction 312 of the eye cup i.e. handle / cup angle 313, handle / hole angle 314 between the hand grip axis and the direction of fluid delivery through the hole, and the angle of delivery hole / cup 315 fluid through the opening and direction of contact of the eye cup. In the drawing, all these angles, namely the handle / cup angle 313, the handle / hole angle 314 and the hole / cup angle 315 are shown as acute angles, and furthermore the handle / hole angle 314 is greater than the handle / cup angle 313 and the direction of fluid delivery through the opening 309 is facing more towards the distant direction 306 and the contact direction of the eye cup 310 is facing more towards the near direction 305, although other relationships are also within the scope of the invention.

Fig. 4 schematically shows an applicator with an alternative container configuration relative to the eye cup. The applicator 40 includes a handle 41, a container 42 having a fluid delivery axis 43 through the fluid delivery opening and direction 44, and an eye cup 45 with a contact axis 46 and a contact direction 47. The top of the container opening 42 is 48 to the contact axis 46. It is further shown that the fluid supply axis 43 and the contact axis 46 are substantially parallel and eccentric, with the fluid delivery axis 43 being closer than the contact axis 46.

Figure 5 schematically illustrates possible hand positions for self-dispensing and, accordingly, for assisted dispensing. Although the arm positions are different at around 90 degrees, the handles are equally natural and free.

Figures 6a, 6B and 6C show the recommended applicator solution, Figure 6A shows the applicator in a side view with the container receptacle exposed, Figure 6B shows the applicator in a side view in the position of use, and Figure 6C a cross-section by the applicator shown in Fig. 6B. Figures 6A, 6B and 6C show an applicator close to its natural size. The applicator 600 has main parts consisting of a 610 hand grip, container 630, eye cup 650 and pumping mechanism 670. Hand grip 610 forms the distal end 611, near end 612, hand grip axis 613 with distant direction 614 1 and close direction 615. The distal end 611 of hand grip 610 is designated as a foot 616 for placing the applicator so that the hand grip axis is in a substantially position upright. In the recommended solution, the underside of the foot 616 is provided with an opening adapted to the lid of the bottle to assist in its removal and attachment. At the proximal end, the hand grip is divided into an openable portion 617 having slots 618, substantially parallel to the axis of the bottle, which slots cooperate with stationary pins 619. From the open position shown in Fig. 6A, the openable portion 617 is rotated around pins 619 and then axially pushed. in contact with the stationary rails 620 and corresponding structures on the inner surfaces of the openable portion 617 to the position shown in Fig. 6B and 6C, with studs 619 at the other end of slot 618.

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Opening the openable portion 617 exposes the socket 621 to the container 630 allowing it to be inserted or removed. The socket has a rear opening 622 revealing the bottom of the bottle, allowing the contents of the bottle to be examined, and the openable part 617 has an upper opening 623, allowing the side of the bottle, and especially the label thereon, to be checked. An eye cup 650 is attached to the openable portion 617 described below. The seat 621 receives and, after closing the openable portion 617, locks the container 630 by enclosing it in the cavity and by connecting the collar 624 under the opening portion of the container. The container 630 generally comprises a bottle 631 and an orifice portion 632 that defines the fluid supply axis 633 and fluid delivery direction 634. The symmetry axis of the bottle (not shown) is substantially coaxial with the fluid supply axis. The 650 eye cup has a wreath 651 and a recess 650. Wreath 651 is substantially elliptical and slightly curved along an axis parallel to short axis 652 and defines contact axis 653 and contact direction 654. Projection 655 serves as a retractive member of the lower eyelid of the eye. The cavity 660 defines the space for the eyeball and a safe distance to the opening 632. The side arms 661 connect the wreath 651 with the openable part 617 constituting its integral part. The upper cavity opening 662 and the lower cavity opening 663 causes the cavity and the opening area to be accessible. In the applicator shown, the angles handle / cup, handle / hole and hole / cup are as specified, the sharp tip of the hole is slightly displaced in a close direction relative to the contact axis. The applicator also includes a pumping mechanism 670 comprising a manual control arm 671, forming part of the arm 672 extending distally to the shaft 673 of the stationary axis around which the arm is tiltable, and in a close direction from the movable hinge 674 on the inside of the manual control arm 671 through the pusher 675 to the bottom side of the bottle 631. Activation of the manual control arm 671 causes the pusher 675 to exert pressure on the elastic bottle 631 to expel fluid therefrom, followed by the expulsion of part of the pumping mechanism by a coarse motion. It is clear that the maximum displacement of the pusher is limited to the full extension of the arm 672 and the pusher 675 and that the movements give the lever reinforcement of the applied hand force. The applicator described can preferably be made of moldable plastics. Preferably, the integral openable part 617 and eye cup 650 are formed as one part, optionally with the addition of separate material for the wreath 651. The hand grip can be made e.g. as two halves, separate or hinged, with separation as in Fig. 3C and optionally with pumping mechanism 670 as the next part.

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