GB2451821A

GB2451821A - Eye bath with seal

Info

Publication number: GB2451821A
Application number: GB0715717A
Authority: GB
Inventors: Cassandra Parkin; Mark Anthony Ian Gidlow; Gerrit Jan Stegeman
Original assignee: Reckitt Benckiser Healthcare UK Ltd
Current assignee: Reckitt Benckiser Healthcare UK Ltd
Priority date: 2007-08-11
Filing date: 2007-08-11
Publication date: 2009-02-18
Anticipated expiration: 2027-08-11
Also published as: GB2451821B; GB0715717D0

Abstract

An eye bath comprises a reservoir (10) for containing an ophthalmic solution, the reservoir (10) having a mouth (30) as its only opening, the mouth having a rim (40), wherein a flexible lip (50) for substantially sealing the eye bath around the periocular region is attached to the rim (40). The invention also relates to a method of manufacture of the eye bath using a two step injection moulding process and a kit of parts having the eye bath fitting over the lid of a container.

Description

EYE BATH

The present invention relates to an eye bath. More particularly, the present invention relates to an eye bath which in use provides an improved seal around an eye. The present invention also relates to a method of manufacture of the said eye bath, and also to a kit of parts comprising the eye bath and a container.

Eye baths currently on the market are designed to be first charged with sterile ophthalmic solution before being placed around an eye in the periocular region to allow the eye to be washed. A problem has been identified with such eye baths in that they do not form a suitably effective seal, and consequential leakage of ophthalmic solution during use may result. This is especially the case when tilting back the head to allow the eye to be fully immersed in the ophthalmic solution.

An object of the present invention is to provide an eye bath which addresses at least one of the problems of

the prior art.

According to a first aspect of the present invention there is provided an eye bath for applying to a periocular region during eye washing, comprising a reservoir for containing an ophthalmic solution, the reservoir having a mouth as its only opening, the mouth having a rim, wherein a flexible lip for substantially sealing the eye bath around the periocular region is attached to the rim.

The flexible lip is preferably a band that substantially follows the circumference of the rim.

The flexible lip may project from the rim to flare outwardly when in a rest position. The flexible lip is preferably not folded in on itself.

The flexible lip may have a shape and profile that is arranged to complement the periocular region. Preferably the mouth of the reservoir flares outwardly in the region of the rim, and when the flexible lip is in a rest position it preferably projects from the said rim to flare outwardly in the same sense as the flaring of the mouth at the rim. Most preferably in the rest position the flexible lip flares outwardly to a greater extent towards the edge that in use is depressed against the periocular region.

In use, when depressed against the periocular region, the flexible lip preferably flexes to flare outwardly beyond its rest position, such that a restorative force provided by the flexible lip helps to maintain a seal around the periocular region.

The flexible lip is preferably attached to the rim at a bond region, wherein preferably the bond region is a non-planar joint. There may be keying at the bond region.

Preferably the bond region is corrugated, or is a step joint.

The reservoir may comprise a material that is a non- elastomeric thermoplastic polymer, wherein the non-elastomeric thermoplastic polymer is preferably selected from a group including polyethylene, polypropylene, and polybutylene, and is most preferably polypropylene.

The flexible lip may substantially comprise a material that is an elastomer, wherein the elastomer is preferably a thermoplastic elastomer. The thermoplastic elastomer is preferably selected from styrenic block copolymers (TPE-S), for example styrene butadiene (SBS), hydrogenated styrene block copolymer (HSBC) , hydrogenated styrene- ethylene/butylene styrene (SEES) , styrene-ethylene/propylene-styrene (SEPS) , thermoplastic polyolef ins (TPE-O or TPO), for example blends of polypropylene and non-crosslinked ethylene propylene diene monomer rubber (EPDM rubber) ; thermoplastic vulcanisates (TPE-V or TBV), for example polypropylene and EPDM rubber vulcanised during compounding; thermoplastic polyurethanes (TPE-U or TPU), for example polyether or polyester urethane types; thermoplastic copolyesters (TPE-E or COPE or TEEE); melt processable rubber (MPR); and thermoplastic polyether block amides (TPE-A) . Preferably the thermoplastic elastomer is hydrogenated styrene block copolymer(HSBC).

The eye bath preferably comprises a reservoir and a flexible lip wherein each comprises a material that is bondable to the other. Preferably the reservoir and the flexible lip each comprise a material that is naturally bondable to the other, without introducing an additional, adhesive, component. More preferably each material is capable of being naturally bonded to the other through being fused by heat welding. Most preferably each material is capable of being welded to the other through adding one material in its molten state to the other material in its solid state, and allowing both to cool.

The flexible lip is preferably a plain band of elastomeric material. Preferably there are no folds or crevices which could become contaminated with non-sterile matter during or following use.

According to a second aspect of the present invention there is provided a method for manufacturing an eye bath by bi-injection moulding, comprising: a) injecting a substantially molten form of a non-elastomeric thermoplastic polymer into a mould, whose shape defines a reservoir and a mouth, such that there remains an unfilled volume in the mouth region of the mould; and b) injecting a substantially molten form of an elastomer into the mould, so that the elastomer enters the unfilled volume in the mouth region of the mould and is brought into contact with a rim of the moulded reservoir so as to form a flexible lip at a bond region on the rim so that on cooling the flexible lip bonds to the non-elastomeric thermoplastic polymeric reservoir.

Preferably stage a) produced a stepped upper edge.

This may be achieved by use of stepped parts moveable inwards and outwards, to form the step shape. They are moved outwards once the step shape is shape-stable. Stage b) can then be carried out..

The mould is preferably adjusted between stages a) and b) to allow for injection of the elastomer.

The elastomeric flexible lip and the non-elastomeric thermoplastic polymeric reservoir may be bonded together by heat welding. The non-elastomeric thermoplastic polymer is preferably set, at least at its upper edge, when the elastomer is injected during stage b) Preferably during stage b) the molten elastomer softens the moulded non-elastomeric thermoplastic polymer at the rim so that the reservoir and flexible lip naturally bond together, but with retention of any step profile formed in stage a) Most preferably the molten elastomer softens the moulded non-elastomeric thermoplastic polymer by the temperature of the molten elastomer causing the moulded non-elastomeric thermoplastic polymer co partially melt, and thus ultimately mix with the molten elastomer.

According to a third aspect of the present invention there is provided a kit of parts, comprising: an eye bath in accordance with the first aspect of the present invention; a container with a lid for containing an ophthalmic solution; wherein the eye bath fits over the lid of the container such that the flexible lip forms a seal between the reservoir and the container.

Features of the first aspect of the invention, including preferred aspects, are preferred aspects of the second or third aspects.

For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example, to the accompanying diagrammatic drawings in which: Figure 1 is a perspective view from above of an eye bath relating to an exemplary embodiment of the present invention; Figure 2 is a side view thereof; and Figure 3 is a cross sectional view of the bond region shown in Figure 2.

Figures 1 and 2 show an eye bath of the present invention, comprising a reservoir 10 for containing an ophthalmic solution 20. The reservoir 10 has a wide mouth defined by a generally oval-shaped rim 40 which carries a flexible lip 50. There is no other opening into the reservoir; only the mouth 30. The reservoir 10 and flexible lip 50 are so shaped to permit ready application to the periocular region during eye washing.

The reservoir 10 comprises a base 60, a side wall 70 and the rim 40, all of which are integral. The base 60 is generally oval-shaped as is the perimeter of rim 40, albeit the diameter of the rim 40 is greater than that of the base 60. The side wall 70 defines a surface between the base 60 and the rim 40 that flares outwardly towards the rim 40.

The flexible lip 50 attached to the rim 40 provides' a cushioning effect that allows the eye bath to be effectively sealed against the periocular region of any eye regardless of the contours and profile in the periocular region.

The flexible lip 50 is essentially a band of elastomeric material attached to the rim 40 at a bond region 80 such that the band follows the oval path of the rim 40. The flexible lip 50 in its rest position projects from the rim 40 to flare outwardly. In use when pressed against the periocular region the flexible lip is caused to flare outwardly to a greater extent, such that the resulting restorative force leads to enhanced sealing against a patient's skin in the periocular region.

Figure 3 shows a cross sectional view of the bond region 80 shown in Figure 2. The bond region 80 comprises a step joint 90, which is a particularly suitable joint to resist partial or total detachment of the flexible lip 50 from the rim 40 as a result of wear and tear through repeated use. This is particularly important for maintaining sterility at the bond region 80; and to the simplicity and robustness of the manufacturing process described below. However, it will be understood to those in the art that many other joints could be used to obtain a similar effect, albeit the manufacturing process may be more complex, slow and costly.

The reservoir 10 is in this embodiment comprised of polypropylene, although it will be understood that any number of materials would also suffice, including glass, polyethylene and polybutylene The flexible lip 50 is in this embodiment substantially comprises a thermoplastic elastomer, and preferably a hydrogenated styrene block copolymer (HSBC) sold under the trade mark THERMOLAST K. from Kraiburg TPE, GmbH, Germany, although it will be understood that any number of materials would also suffice. Preferably, however, the material comprising the flexible lip 50 is chosen to complement the material chosen for the reservoir 100 in so far as both can be welded together effectively in a simple manufacturing process, as described below.

The eye bath of the present embodiment is manufactured using bi-injection moulding. Firstly, polypropylene is injected into a mould and the reservoir 10 is moulded therein by a process well known to those skilled in the art. Inwardly movable shoes are employed to form the rim

B

of the bath into a step shape. Once the rim has set the shoes are withdrawn. A moving part of the mould is then spun by 180° on a turntable to allow the injection of a thermoplastic elastomer which is then moulded into the flexible lip 50 upon the rim 40. The polypropylene reservoir 10 and thermoplastic elastomeric flexible lip 50 naturally bond together because the heat of the molten thermoplastic elastomer softens and partially melts the polypropylene at the edge of the rim 40 and they bond and solidify during a cooling stage of the cycle.

The moulding process is particularly effective when the rim 40 is moulded into a step joint 90 as shown in Figure 2, before injecting the thermoplastic elastomer into the mould, since the increased surface area allows for greater contact between the transiently molten components, and the step provides a more robust joint that is not susceptible to breakage through wear and tear that may allow non-sterile contaminants to reside in any crevices that consequently result.

The eye bath of the present embodiment is used by a patient or a third party upon the patient by first introducing sterile ophthalmic solution 20 into the sterile reservoir 10 before placing the eye bath, more specifically the flexible lip 50, against the periocular region around the patient's eye. The avoidance of spillage of the ophthalmic solution 20 is preferably achieved by tilting the head of the patient substantially forward over the eye bath before lifting the eye bath against the periocular region of the patient and subsequently tilting the patient's head backwards so as to allow the eye to be thoroughly immersed in the ophthalmic solution.

The eyelid of the eye under treatment may be opened pre-immersion or post-immersion. The flexibility of the flexible lip 50 over a rigid rim allows the patient to open the eyelid post-immersion more readily and comfortably than they otherwise could, and furthermore the flexible lip substantially prevents leakage during opening of the eyelid.

Once open the eye is washed in the usual manner, ideally by rolling the eye. The eye bath reservoir 10 is preferably transparent so as to allow a third party to check that the eye has been opened and is therefore undergoing washing.

The eye bath is then removed after first tilting the head forwards to avoid unnecessary leakage. The eye bath should then be emptied and substantially sterilised through washing with hot water and then rinsing with some ophthalmic solution 20 before returning the eye bath to storage.

Eye baths of the present invention may also be supplied with a container with a cap (not shown) for containing an ophthalmic solution. In this case the container and the eye bath can be designed so that the eye bath comfortably fits over the cap of the container such that the flexible lip (50) forms a seal between the reservoir (10) and the container. This allows the eye bath to remain substantially sterile when stored with the container. An opposed pair of internal rnoulded pips (60) are provided on the wall of the eye bath to prevent the eye bath becoming jammed too firmly on the container.

They also facilitate the removal of the eye bath from the mould, during manufacture, and stacking of the eye baths.

An advantage of eye baths of the present invention is that a flexible rim 3 provides an improved non-leaking simple and affordable eye wash product for patients that may suffer from dexterity problems such as AltzheimerS, Parkinson's disease or other conditions that inhibit manual dexterity. This is equally applicable to patients dependent on third parties for treatment, such as children or pet animals, since they are less likely to remain still during treatment. In these circumstances additional movement between the patient and the third party can compound the problem of leakage, which is addressed by embodiments of the present invention.

Another advantage is that eye baths comprising more than one moulded component are manufactured using a simple and inexpensive method, where usually an additional Another advantage is that a non-planar joint -typically a step joint 90 -between the rim 40 and the flexible lip 50 ensures the joint is robust and does not suffer from potential contamination of crevices formed at the joint during routine wear and tear.

It will be understood by those skilled in the art that the invention is in no way limited to the present embodiment, since the eye bath may be provided with a reservoir 10 in a range of shapes, colours and levels of transparency, and in a range of materials. Ideally materials of the reservoir 10 and flexible lip 50 are chosen to be complementary for bi-injection moulding, but this is not intended to be limiting.

Likewise the flexible lip 50 may be formed in a variety of shapes, colours and with a variety of materials. Preferably the shape of the lip follows substantially the same profile and contours as the rim 40, but this again is not intended to be limiting.

The nature of the joint at the bond region 80 is preferably a non-planar joint and more preferably a step joint 90, but again this is not intended to be limiting a joints such as shear joints, tongue and groove joints, and butt joints may be used, although the step joint 90 is particularly useful in this case owing to the relative complexity of other joints when moulding together two annular bodies.

Although a few preferred embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope of the invention, as defined in the appended claims.

Claims

1. An eye bath for applying to a periocular region during eye washing, comprising a reservoir for containing an ophthalmic solution, the reservoir having a mouth as its only opening, the mouth having a rim, wherein a flexible lip for substantially sealing the eye bath around the periocular region is attached to the rim.

2. The eye bath according to claim 1 wherein the flexible lip is a band that substantially follows the circumference of the rim

3. The eye bath according to claim 2 wherein the flexible lip has no folds or crevices which could become contaminated with non-sterile matter during or following use.

4. The eye bath according to claim 2 or 3 wherein the flexible lip projects from the rim to flare outwardly when in a rest position.

5. The eye bath according to any preceding claim wherein the mouth of the reservoir flares outwardly in the region of the rim.

6. The eye bath according to any preceding claim wherein in use, when depressed against the periocular region, the flexible lip flexes to flare outwardly beyond its rest position, such that a restorative force provided by the flexible lip helps to maintain a seal around the periocular region.

7. The eye bath according to any preceding claim wherein the flexible lip is attached to the rim at a bond region.

8. The eye bath according to claim 7 wherein the bond region is a non-planar joint.

9. The eye bath according to claim B wherein the bond region is a step joint.

10. The eye bath according to any preceding claim wherein the reservoir and the flexible lip are bonded together without introducing an additional bonding material.

11. A method for manufacturing an eye bath by bi-injection moulding, comprising: a) injecting a substantially molten form of a non-elastomeric thermoplastic polymer into a mould, whose shape defines a reservoir and a mouth, such that there remains an unfilled volume in the mouth region of the mould; and b) injecting a substantially molten form of an elastomer into the mould, so that the elastomer enters the unfilled volume in the mouth region of the mould and is brought into contact with a rim of the moulded reservoir so as to form a flexible lip at a bond region on the rim so that on cooling the flexible lip bonds to the non-elastomeric thermoplastic polymeric reservoir.

12. A kit of parts, comprising: an eye bath in accordance with any of claims 1 to 11; a container with a lid for containing an ophthalmic solution; wherein the eye bath fits over the lid of the container such that the flexible lip forms a seal between the reservoir and the container.