WO1996019177A1

WO1996019177A1 - Device for delivery of fluid to the eye

Info

Publication number: WO1996019177A1
Application number: PCT/EP1995/005131
Authority: WO
Inventors: Steven Battle; Nigel Colin Theobald
Original assignee: The Boots Company Plc
Priority date: 1994-12-22
Filing date: 1995-12-22
Publication date: 1996-06-27
Also published as: ZA9510967B; AU4434596A; GB9425903D0

Abstract

An apparatus for applying sterile fluid to the eye of a patient comprising a container (1) having an orifice and a chamber (2) containing sterile fluid (4) reversibly sealed from fluid connection with the orifice, the rim of the orifice comprising protruding resilient absorbent material (5) to provide a liquid resistant seal when presented to the patient's body. Preferably the apparatus is an eye bath for washing the eye and the orifice is shaped to fit within the orbit of an eye. The fluid containing chamber (2) may comprise a collapsible bottle, preferably of a bellows type construction. Further embodiments comprise a device which has a fluid atomiser to form a mist in the eye bath during use to bathe the eye, and an eye bath which comprises means to expand the container orifice to hold open the eyelid during application of fluid.

Description

DEVICE FOR DELIVERY OF FLUID TO THE EYE

The present invention relates to a device for delivering sterile fluid to a patient, in particular to the surface of the eye.

Eye hygiene is important as the visual sense is an important sense yet the eye is a delicate organ. Therefore, it is desirable to provide means to wash and irrigate the eye to remove irritants which collect over time and particularly for use in environments where the eye could be subject to splashes from corrosive chemicals, swarf or the like. It may also be desirable to apply fluid to the eye for other reasons (e.g. soothing agents or medicaments).

Lotions or other fluids which may be applied to the eye to wash and irrigate the eye and/or for other therapeutic reasons may comprise dilute aqueous solutions of salts such as sodium chloride which are isotonic with lachrymal secretions and may also comprise a pH adjusting agent (for example a borate phosphate salt buffer) to maintain the pH of the eye lotion within a particular pH range (for example 5 to 8). Such eye lotions can be difficult to apply to the eye with traditional methods such as eye droppers, which also compromise the sterility of the lotion even when prepared under sterile conditions. Therefore various devices have been developed to deliver such lotions to the eye.

US 4106673 (Donoghue) discloses a squeezable bottle opening into a cup shaped reservoir suitable for use as an eye bath. The cup has hollow sides which act as a measurement chamber before the washing liquid is introduced into the cup. The apparatus is expensive to make due to its complex construction, and the cup does not provide a good seal to the eye socket to prevent waste of liquid.

GB 1460064 (Optrex) discloses an eye bath containing an eye lotion sealed within it by a removable membrane. One disadvantage of this bath is that its smooth rim does not provide a good seal with the face when the eye bath is offered up to the eye socket and thus eye lotion can leak from the bath during use.

COHRR ΛΠON COW US 3871554 (Huck) discloses a portable eye wash station comprising a collapsible container holding eye lotion (e.g. of a bellows type construction) which is compressed by a spring automatically when the container is opened to deliver a continuous stream of eye lotion from the neck of the container. The disadvantage of such an eye washing apparatus is the rate of discharge of eye lotion is fixed and not in the control of the user and no means is provided for delivery of the lotion to the eye, without leakage.

US 4232671 (Crump) discloses a single use flexible eye wash pack comprising eye lotion sealed in a plastic envelope, which contains two sealed holes set approximately one eye width apart. On use the membrane seal to the holes is broken, the pack is presented to face and the eye lotion is squeezed out of the holes adjacent to each eye by pressing the pack. The disadvantage of such a pack is it can be used only once, it can only be used to wash one eye with messy leakage from the other hole and it can be easily damaged it transit.

US 4131115 (Peng) discloses an eye washing device comprising a bottle with separate reservoirs for clean and dirty eye lotion, connected to a cup for offering to the eye. The cup also comprising blades to remotely clip and hold open the eyelids. The construction of this device is complex and expensive to make. In addition, the eyelid opening device requires some manual dexterity to use and this would be unsuitable for use by some people. It could also be dangerous, it would be easy to accidentally poke the eye if the device was not aligned correctly. When abutting the eye socket the cup of this device would not provide a fluid resistant seal to prevent loss of eye lotion.

GB 2048074 (Katell) discloses an eye wash bottle having an angled top portion with an integral head for ease of use in applying eye lotion to the eye whilst squeezing the bottle situated vertically in a comfortable position. The frustoconcial head of this device would leak lotion in use when offered up to the eye socket.

US 4363146 (Liautand) discloses a portable eye wash fountain for use in emergencies. On operation, spaced angled heads direct eye lotion upwards fed by gravity from an integral container containing lotion within the device. There is a tray to collect the used lotion. This eye wash fountain assembly has a complicated construction and is wasteful of lotion much of which may not reach the eye. It is not suitable for washing the eye for other than rapid emergency use, as the eye is not in contact with the lotion very long.

ZA 82/3395 (Wolfson) discloses a device which forms a fluid tight seal between the face of the patient and the device (optionally shaped like a pair of goggles) with an inlet for clean eye wash liquid and an outlet for dirty eye wash liquid. The disadvantage of such a device is that it cannot be used to wash a single eye and requires connection to an external source of eye wash liquid and a container for disposal of the used eye wash liquid. As there is a continuous flow of eye wash liquid through the device, the device is wasteful of liquid.

It can be seen that none of these devices are entirely satisfactory. The prior art devices have some or all of the following disadvantages: they are expensive to manufacture, complicated and ineffective in use, wasteful of fluid and/or messy to use. A further disadvantage of the prior art is the difficulty of using these devices with one hand whilst holding open the eyelids with the other hand to expose the eye surface to the liquid. Attempts to solve this problem (e.g. Peng) are complicated and potentially dangerous to use particularly for self medication by patients. The prior art devices also require the patient to manipulate the device or move their head to ensure all the eye surface is washed with the fluid. This requires some degree of practise and manual dexterity to do correctly which is a particular disadvantage for some patients, for example the infirm. Furthermore, moving the head may result in leakage of fluid from the eye bath in use.

Therefore it is an object of the present invention to overcome some or all of the aforementioned disadvantages with the prior art devices and to produce a device which has some or all of the desirable features described herein.

Broadly in accordance with the present invention, there is disclosed a device for applying sterile fluid to the eye of a patient, the device comprising a container having an orifice and a closed chamber containing sterile fluid sealed from fluid connection with the container when the device is not in use, the rim of the orifice comprising resilient absorbent material to provide a fluid resistant seal when presented to the patient's body.

Preferably the orifice is shaped to fit against the orbit of the eye. Preferably the seal between the chamber and the container is capable of being ruptured by finger pressure applied to the chamber which may be elastically deformable.

Preferably the fluid contained within the chamber comprises a liquid, more preferably a single dose of eye lotion or medicament.

The resistant absorbent material may be any suitable soft absorbent material for example sponge. The soft rim provides an improved leak resistant seal with the variable contours of the face around the eye socket and allows use of a single size of eye bath with many different patients. This reduces manufacturing costs. In use, forming a good seal with the eye orbit reduces or eliminates fluid running down the face which makes use of the device less messy. The other seal between the device and the chamber comprising the fluid can be broken when the device is positioned within the eye orbit and sealed on the face. This maintains the sterility of the eye lotion. Thus optionally the device of the present invention can use fluids without preservatives which both reduces cost and is important for some classes of patients who may be allergic to common preservatives. The device of the present invention can be presented in a pre-sealed and sterilised package which does not require sterilisation just prior to use and is convenient to use as it is not necessary to carry a separate liquid container and eye bath.

Optionally, if the seal of the fluid containing chamber is re-sealable after use (for example a valve) the eye bath can be recycled or re-used after re-sterilisation, although preferably the device is designed and packaged for use once and subsequent disposal.

The fluid containing chamber may comprise a collapsible bottle, preferably elastically deformable, more preferably of a concertinaed construction, most preferably a bellows type construction.

Preferably the orifice of the device is expandable by finger pressure, more preferably by application of such pressure to a further portion of the device, and most preferably the expanded orifice may hold the eyelid open whilst the device is applied to the eye.

Preferably the device of the invention further comprises a conduit fluidly connecting the container with the fluid containing chamber, and a means for atomising a sterile fluid is positioned in the conduit. More preferably the fluid atomiser is also positioned within the container such that fluid entering the container is deflected off the walls of the container before leaving the orifice. This acts to further atomise the fluid entering the container. Thus a fine mist, is formed within the container when the spray hits the walls of the container. A mist diffuses over the surface of the whole eye more readily than a liquid. The volume of fluid required to generate a mist to coat the eye is less than that used in an eye bath which delivers fluid directly to the eye. This reduces cost as less fluid is used per eye treated. Suitable sources of atomised fluid comprise nebulisers, pump action sprays, pressurised aerosols and the like which are known in the art.

Prior to use the device of the invention may be presented in a sealed sterile pack (such as foil pouch). This ensures sterility of the whole device and not just the sealed sterile fluid chamber.

The devices of the invention may be used to deliver any sterile fluid which it may be beneficial to apply to the eye. Such fluids may be applied for many purposes for example any of the following : to clean, wash or irrigate the eye (e.g. an emergency eye bath), to bathe or soothe the eye (e.g. after wearing contact lens) and/or to apply medicament ocularly to treat either the eye directly (e.g. for glaucoma) or the patient systemically. The source of sterile fluid used in the devices of the present invention is preferably a liquid but may be any other fluid (e.g. powders, mists, sprays and/or pressurised gases) suitable for the desired purpose and which would provide a source of sterile fluid non-irritating to the eye. The patients on which the devices of the present invention are used are preferably human, but need not be so.

Certain non-limiting specific embodiments of the present invention will now be described with reference to the following examples and the drawings in which:-

Figure 1 shows a sectional view of one embodiment of an eye bath according to the invention removed from its external sterile packaging.

Figure 2 shows a sectional view of second embodiment of the present invention in which the chamber is a collapsible bottle. Figure 3 shows the embodiment shown in Figure 2 with the bottle collapsed, positioned on the eye.

Figure 4 shows a third embodiment of the invention, similar to the second embodiment with an angled eye bath, empty of liquid.

Figure 5 shows the third embodiment abutting the eye, after use, and viewed from the side of the view shown in Figure 4.

Figure 6 shows part of a fourth embodiment of the invention which delivers a mist rather than liquid bath.

Figure 7 shows a fifth embodiment of the invention which can be used to hold the eyelids open.

For clarity, similar features between different embodiments are given the same numbers as those for the first embodiment shown in Figure 1 plus an integer multiple of hundred: i.e. the 2nd embodiment in Figures 2 and 3 plus 100; the 3rd embodiment in

Figures 4 and 5 plus 200; the 4th embodiment in Figure 6 plus 300; and the 5th embodiment in Figure 7 plus 400.

With reference to Figure 1 , one embodiment of the invention comprises a device generally of frustoconcial shape comprising an eye bath upper portion (1) and a lower chamber (2) and a membrane seal (3) between them. The lower chamber (2) contains a suitable liquid eye lotion (4). Attached around the solid rim (6) of the orifice of the upper eye bath (1) is a sponge (5) to provide in use an absorbent, leak resistant, deformable material between the device and the orbit of an eye. The sponge (5) protrudes from the solid rim (6) of the upper bath (1) to provide the surface of contact between the device and the user.

In use the device is removed from its sterile packaging (not shown) and presented to the eye socket with the eye bath (1) forward so that the sponge (5) abuts the skin around the eye socket of the patient. Finger pressure is applied to the outside walls of the deformable lower chamber (2) (optionally constructed from injection moulded plastic) which breaks a membrane seal (3) by hydraulic pressure of the liquid (4) against the seal (3). The liquid eye lotion (4) thus enters the upper bath (1) to contact and wash the surface of the eye. After use the device can be discarded or optionally recycled for re-use. As the device is sealed to the face before the membrane (3) is broken the sterility of the eye lotion (4) is maintained.

With reference to Figures 2 and 3, a second embodiment of the present invention comprises a bottle (102) which is of a bellows-like construction (108), containing a liquid eye lotion (104). An eye bath (101 ) is detachably attached to the neck (107) of the bottle (102). The rim (106) of the eye bath (101) is covered with sponge (105) as before. The neck (107) of the bottle (102) is sealed by a membrane (103). If the bottle (102) contains enough eye lotion (104) for more than one dose and is to be reusable, it can be sealed by a valve (not shown) to prevent ingress of dirty liquid into the bottle (102) after use to keep the remaining eye lotion (104) sterile.

In use the eye bath (101) is placed against the eye socket and the bottle (102) is squeezed by collapsing the bellows (108) under finger pressure to reach the position shown in Figure 3 which causes liquid pressure to rupture the membrane seal (103) as shown. The bath (101) thus fills with liquid (104) which bathes the eye. The sponge (105) covering the solid rim (106) makes a liquid resistant seal with the face by deforming to its contours and also absorbs any drops of liquid (104) that might leak from the bath (102).

With reference to Figures 4 and 5 a third embodiment of the present invention is shown which operates in a similar manner to that shown in Figures 2 and 3. However, for ease of use the eye bath (201) is angled with respect to the bottle neck (207) to make the device easier to use whilst bathing the eye. The rim (hidden) is coated with sponge (205) to provide a good seal with the eye orbit when in use. Figure 4 shows an empty eye bath (201) with the bellows (208) of the bottle (202) fully extended, the position when the bottle

(202) is full of eye wash liquid. A detachable hinged cap (209) on the bottle neck (207) is shown in the open position in Figure 4, as for clarity the bottle is shown empty. A membrane seal (203) forms part of the detachable hinged cap (209) so that when the membrane seal (203) is broken liquid can flow through the cap (209). The bottle (202) may be reused and refilled after resterilisation, by replacing the cap (209) and the membrane (203). Figure 5 shows the eye bath in use, viewed from side of the position shown in Figure 4. The bath is shown abutting the orbit of the eye of a patient, with the bellows (208) of the bottle (202) manually compressed so as to rupture the membrane (203) and bathe the eye with the eye wash liquid (not shown).

With reference to Figure 6 a fourth embodiment is shown which uses a pump spray to deliver a mist to the eye bath (301 ) through an extended actuator arm (310). The rim of the eye bath (301) is coated with sponge (305). When the eye bath (301) is in place over the eye socket, the top (31 ) of a pump action spray is depressed and liquid eye lotion (not shown) enters the eye bath (301) from a liquid reservoir (302) through a small nozzle hole (313) in the end of the actuator arm (310) which atomises the liquid eye lotion. The spray thus formed is released from the actuator nozzle (313) and deflected from the opposite side of the bath (301) to creates a mist within the bath (301). The mist coats the eye surface more effectively than a liquid (for example under the eye lid) to ensure a more complete washing of the eye. The liquid lotion will remain sterile within the liquid reservoir (302). The eye bath (301) can be sealed within a sterile pack before use. Preferably an assembly comprising the eye bath (301) attached to the actuator arm (310), is packed together so that a sterile bath / actuator assembly can be attached to the top

(311) of the pump action spray just before use. Optionally, the bath or bath / actuator assembly can be resterilised and reused after each eye wash, alternatively they may be disposable for single use only.

A fifth embodiment of the present invention is described with reference to Figure 7. The device comprises an upper eye bath (401) having an orifice shaped to fit against the orbit of an eye. The container is separated from a closed lower chamber (402) by a membrane seal (403). The lower chamber (402) contains eye wash liquid (not shown).

The walls of the lower chamber (402) are inwardly compressible due to indentations (415)

(V-shaped in plan view) formed on opposite sides of the lower chamber (402). The orifice of the upper eye bath (401) can change shape (expandable along one axis) as the sides of the eye bath (401) are constructed from a suitably flexible material (e.g. plastics material), particularly the outward protrusions (417) of the upper walls (also V-shaped in plan view). The walls of the lower chamber (402) and upper eye bath (401) are able to pivot about the membrane (403), such that when the indentations in the lower walls (415) are pushed inwards, the protruding upper walls (417) move apart, widening the orifice.

In use this embodiment of the eye bathing device is positioned in the eye socket. The orifice rim is covered in sponge (405) which forms a liquid resistant seal with the eye socket. When finger pressure is applied to the lower chamber in the direction of the arrow A, the hydraulic pressure bursts the membrane (403) and allows liquid to fill the bath (401) bathing the eye. Simultaneously as the side walls of the upper eye bath (401) are pivotably connected to the lower walls, the protruding upper walls (417) move outwardly about the position of the (now broken) membrane (403) in the direction of the arrow B. If the device is placed in the eye socket with the longer sides of the orifice resting on the eyelid, squeezing the lower chamber (402) moves the upper protruding walls (417) of the eye bath (402) in a direction which forces the eyelid open whilst retaining a liquid resistant seal with the eye. This allows liquid to bathe the eye more completely as liquid more readily reaches the eye surface under the eyelid. The device can be used with one hand if necessary.

Claims

1. A device for applying sterile fluid to the eye of a patient, the device comprising a container having an orifice and a closed chamber containing sterile fluid sealed from fluid connection with the container when the device is not in use, the rim of the orifice comprising resilient absorbent material deformable to fit within the orbit of the eye to provide a fluid resistant seal when presented to the eye.

2. A device as claimed in claim 1 , in which the container is an eye bath for washing the eye, the orifice being shaped to fit against the orbit of the eye.

3. A device as claimed in either preceding claim, in which the chamber comprises a collapsible bottle.

4. A device as claimed in any preceding claim, in which the orifice is expandable by finger pressure to hold the eyelid open whilst the device is applied to the eye.

5. A device as claimed in any preceding claim, in which a conduit fluidly connects the container with the source of sterile fluid, a means for atomising a sterile fluid is positioned in the conduit .

6. A device as claimed in claim 5, in which the fluid atomiser is positioned within the container such that atomised fluid entering the container is deflected off the walls of the container before leaving the orifice of the container.

7. A device as claimed in either claim 5 or 6, in which the means for atomising fluid is selected from one or more of a pump action spray, pressurised aerosol and a nebuliser.

8. A device as claimed in any preceding claim in which the seal between the chamber and the container is capable of being ruptured by finger pressure applied to the chamber.

9. A device as claimed in any preceding claim in which the seal between the chamber and the container is a valve means permitting fluid flow from the chamber into the container but not in the reverse direction.

10. A device as claimed in any preceding claim in which the container is of frustoconical shape the orifice being at is widest end.

11. A device as claimed in any preceding claim in which the resilient absorbent material is a spongy material.

12. A device substantially as described herein with reference to Figures 1 or Figures 2 and 3 or Figures 4 and 5 or 6 or 7.

13. A sealed package comprising a device according to any preceding claim enclosed within a sterile sealed package.