WO2015011455A1

WO2015011455A1 - Medical device

Info

Publication number: WO2015011455A1
Application number: PCT/GB2014/052218
Authority: WO
Inventors: Susan Grant
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-07-24
Filing date: 2014-07-21
Publication date: 2015-01-29
Anticipated expiration: 2016-01-24

Abstract

A medical device for treating, preventing or ameliorating an eye condition comprises a bag filled or adapted to be filled with temperature control means. The bag is disposed within a removable cover which, in use, is arranged to contact a subject's eye and/or a surrounding area thereof. The temperature control means is configured to modulate the temperature of the cover to thereby treat or ameliorate the eye condition.

Description

MEDICAL DEVICE

The invention relates to medical devices, and particularly, although not exclusively, to devices for treating common conditions, injuries or ailments suffered in or on the eyes, and surrounding areas. The invention extends to the use of the medical devices for treating such conditions, for example styes and cysts, inflammation, dry eye syndrome/disease, grittiness and irritation, itchy eyes (e.g. caused by hay fever), Meibomian Gland Dysfunction (MGD), chalazion, blepharitis and conjunctivitis, and so on. The meibomian glands (or tarsal glands) are a special kind of sebaceous gland at the rim of the eyelids inside the tarsal plate, responsible for the supply of meibum, an oily substance that prevents evaporation of the eye's tear film. Meibum prevents tear spillage onto the cheek, trapping tears between the oiled edge and the eyeball, and makes the closed lids airtight. Dysfunctional meibomian glands often cause dry eyes, one of the more common eye conditions. They may also cause blepharitis, as the dry eyeball rubs off small pieces of skin from the eyelid, which may get infected.

Inflammation of the meibomian glands (also known as meibomitis, meibomian gland dysfunction, or posterior blepharitis) causes the glands to be obstructed by thick waxy secretions. Besides leading to dry eyes, the obstructions can be degraded by bacterial lipases, resulting in the formation of free fatty acids, which irritate the eyes and sometimes cause punctate keratopathy.

Numerous treatments for such common eye conditions are currently available, such as eyedrops and the like. However, there is still a need to provide a medical device for alleviating, treating or preventing eye conditions, which is safe, cheap and re-usable, and which can be self-applied to the patient at home.

Hence, according to a first aspect of the invention, there is provided a medical device for treating or ameliorating an eye condition, the device comprising a bag filled or adapted to be filled with temperature control means, the bag being disposed within a removable cover which, in use, is arranged to contact a subject's eye and/or a surrounding area thereof, and wherein the temperature control means is configured to modulate the temperature of the cover to thereby treat, prevent or ameliorate the eye condition. Advantageously, the medical device of the invention provides an effective means for naturally soothing, preventing or alleviating eye conditions suffered by the user, when either heated or cooled, depending on the condition being treated. Preferably, the device is used to prevent the eye condition from occurring in the first place or re- occuring, because it improves eyelid hygiene by ensuring that the meibomian glands are kept clean. It achieves this by effectively dissolves debris and bacteria etc. present within the oily meibum produced by the meibomian glands. It will be appreciated that use of the medical device of the invention is the first step in eye/eyelid hygiene followed by the application of eyedrops etc to treat an eye condition. Effective use of the device of the invention, therefore, improves eye hygiene such that the chances of many eye conditions occurring are significantly reduced.

The design of the device allows the temperature control means to be evenly distributed around the bag, thereby maximising the contact surface with the eye and surrounding areas, and therefore pain relief. Advantageously, the removable cover makes it possible to remove the bag containing the temperature control means prior to heating or cooling without damaging the cover. Furthermore, the outer cover can be easily cleaned without damaging the temperature control means, for example with water. The device may be used to alleviate or treat a condition selected from the group of: The device may be used to alleviate or treat a condition selected from the group of: styes, cysts, inflammation, dry eye syndrome/disease, grittiness, irritation, itchy eyes (e.g. caused by hay fever), Meibomian Gland Dysfunction (MGD), Meibomian Gland Disease, Meibomian Gland Inspissation, chalazion, blepharitis, hordeolum, conjunctivitis, hay fever, headaches, tired or sore eyes, swelling/puffy eyes, allergies, and migraines.

Hence, according to a second aspect, there is provided the medical device of the first aspect, for use in treating, preventing or ameliorating an eye condition.

According to a third aspect of the invention, there is provided a method for treating, preventing or ameliorating an eye condition, the method comprising:

(i) modulating the temperature of a medical device according to the first

aspect; and

(ii) contacting the cover of the device with an eye and/ or a surrounding area thereof of a user in need of such treatment. According to a fourth aspect, there is provided a method of preparing the device of the first aspect for use, the method comprising modulating the temperature of the device, and manipulating the device to redistribute the temperature control means around the bag.

Preferably, the temperature control means comprises grain or seed. For example, the temperature control means may be selected from a group of grain or seed consisting of: millet, rapeseed, canary seed, flax seed and wheat. In some embodiments, the temperature control means may comprise one or more type of seed or grain. Preferably, the temperature control means comprises at least two, at least three, or at least four different types of seed or grain. For example, the temperature control means may comprise a combination of wheat and flax (e.g. 50% of each), or alternatively a combination of rapeseed, flax and millet (e.g. about 1/3 of each), and so on. Any combination of the seeds and grains described herein is envisaged. In a preferred embodiment, however, the temperature control means comprises a combination of canary seed, rapeseed and millet seed, more preferably about 10-50% of each of canary seed, rapeseed and millet, and most preferably, a combination of about 25-35% of each of canary seed, rapeseed and millet.

In another embodiment, the temperature control means may comprise tourmaline beads. Tourmaline is a crystalline boron silicate mineral which can be produced into small beads. In a most preferred embodiment, however, the temperature control means comprises silica beads or silica gel. The silica beads or gel may comprise an average diameter of at least 0.5mm, more preferably at least 2mm, and even more preferably at least 4mm. Preferably, the silica beads or gel may comprise an average diameter of less than 10mm, more preferably less than 8mm, and even more preferably less than 6mm. Preferably, the silica beads or gel may comprise an average diameter of between 0.5mm and

10mm, more preferably between imm and 7mm, and more preferably between imm and 6mm.

It will be appreciated that the optimum temperature of the eyelids does not exceed much more than 50°C. In one embodiment, the temperature control means is configured to be heated, preferably to above room temperature, i.e. above 2i°C. Preferably, the temperature control means is configured to be heated to above 30°C, more preferably above 40°C, and even more preferably above 50°C. Preferably, the temperature control means is configured to be heated to below 70°C, more preferably below 6o°C, and even more preferably below 55°C. Preferably, the temperature control means is configured to be heated to 30-70°C, more preferably to 40-6o°C, even more preferably to 50-55°C. The temperature control means may be heated by microwave energy, for example using a domestic microwave oven. When contacted with the user, the heat is suitably transferred from the device to the user's eye or surrounding area. Preferably, the device is heated to treat any of the following conditions: styes, cysts, dry eye syndrome/disease, grittiness, irritation, itchy eyes (e.g. caused by hay fever), Meibomian Gland Dysfunction (MGD), Meibomian Gland Disease, Meibomian Gland Inspissation, chalazion, blepharitis, and hordeolum. In an embodiment in which the temperature control means comprises silica beads or silica gel and is configured to be heated, preferably the silica comprises an average diameter of between 0.5mm and 5mm, more preferably between 0.5mm and 4mm, and more preferably between imm and 3mm. Advantageously, the silica fits better around the glands in the eyelid.

In another embodiment, the temperature control means is arranged, in use, to be cooled, preferably to less than room temperature, i.e. less than 2i°C. Preferably, the temperature control means is configured to be cooled to below 15°C, more preferably below io°C, even more preferably below 5°C, and most preferably below o°C.

Preferably, the temperature control means is configured to be cooled to above -io°C, and more preferably above -5°C, even more preferably above -3°C. The temperature control means may be cooled by placing the device in a domestic fridge or freezer.

Preferably, the device is cooled to treat any of the following conditions: inflammation, irritation, itchy eyes (e.g. caused by hay fever), conjunctivitis, hay fever, headaches, tired or sore eyes, swelling/puffy eyes, allergies, and migraines.

When contacted with the user, the cooling energy is suitably transferred from the device to the user's eye or surrounding area. In this embodiment, the temperature control means may comprise seed or grain. Examples of grain and seed which may be used in the cooling embodiment are described above. However, in another embodiment, the temperature control means may comprise cooling crystals, which are configured to cool down when contacted with water.

In a preferred embodiment (when cooling is desired), the temperature control means comprises a cooling gel. The cooling gel preferably comprises silica beads or silica gel. The gel in the bag may be put into a fridge or freezer, and when it is removed, the user preferably manipulates it to loosen it and make it pliable so that the bag and cover mould around the eyes and surrounding areas. In an embodiment in which the temperature control means comprises silica beads or gel and is configured to be cooled, preferably the silica comprises an average diameter of between 3mm and 8mm, more preferably between 4mm and 7mm, and more preferably between 5mm and 6mm. Advantageously, this size of silica retains the cold better than smaller beads.

Suitably, at least 30%, preferably at least 40%, more preferably at least 50%, and even more preferably at least 55%, and most preferably at least 60% of the volume of the bag is filled with the temperature control means. Suitably, the temperature control means occupies less than 95%, preferably less than 90%, more preferably less than 80% of the volume of the bag. It is preferred that the temperature control means occupy about 40- 95%, more preferably about 50-80% of the volume of the space, most preferably about 55-70% of the volume of the space.

Advantageously, this allows the temperature control means to be easily redistributed around the bag after heating or cooling so that the user can ensure that there is an even distribution thereof to the eye and surrounding area (i.e. from above, below and either side of the eye socket), thereby maximising pain relief. Furthermore, it facilitates equalisation of the temperature throughout the mass of temperature control means, thereby reducing the risk of hotspots being created (when warmed), or ice "burn" occurring (when cooled), when the device is in use.

Preferably, the bag is made of a material which effectively dissipates heat through the cover and towards a user's eye and surrounding area, when the device is in use. For example, the bag may be made of a textile, such as cotton, silk, satin, or polyester. Cotton is preferred, especially in embodiments where the device is heated. However, in embodiments where the device is cooled, the bag may comprise a waterproof material, for example latex or rubber. The bag may comprise a label attached thereto, wherein the label comprises instructions for use of the device.

Preferably, the removable cover is made of a material which effectively dissipates heat to a user's eye and surrounding area, when the device is in use. A first side of the removable cover may be made of a first material, which dissipates heat to a user's eye and surrounding area when the device is in use, at a greater rate than that of a second side of the cover made of a second material. Advantageously, by having a different material on each side of the cover, the user is able to choose and vary treatment temperatures and heating/ cooling rates to the eye and surrounding area. For example, the first material may comprise synthetic or naturally occurring fibres. Preferably, the first material comprises naturally occurring fibres. Examples of the first material include cotton, silk, satin, or polyester. Silk is preferred. The second material may comprise velvet, velour or suede.

Advantageously, the material and shape of the cover is such that it fits comfortably over the subject's head and eyes, and moulds therearound providing effective heat transfer. The cover preferably comprises a central section which is arranged, in use, to overlie the subject's nose, and two side sections disposed either side of the central section, which are arranged, in use, to overlie the subject's eyes and surrounding areas.

Preferably, the maximum width of the central section is less than the maximum width of the side sections. For example, the width of the central section may be about 6cm- locm across, or about 7-9cm across. The width of each side section may be about 10- 15cm, or about 1013cm across. The maximum length of the cover is preferably at least 15cm, more preferably at least 18cm, and even more preferably at least 20cm.

The removable cover may comprise an opening through which the bag may pass. The opening may be disposed on an external surface of the cover, preferably on the first side thereof. The first side is generally regarded as being the rear surface of the device. The first side of the cover preferably comprises two pieces of material, which overlap each other thereby creating the opening. Preferably, the opening leads to a pocket disposed between the first and second sides of the cover, which pocket is configured to receive the bag containing the temperature control means. The opening preferably extends diagonally across the first side of the cover, preferably along a line which extends across one of the side sections. The diagonal arrangement allows easier access of the pocket without interfering directly with the eye.

Preferably, the device comprises retaining means for securing the device (preferably the cover thereof) to the user's head and in position over the eye and/ or surrounding area thereof. The retaining means may comprise at least one strap, which may be elasticated. Preferably, the retaining means comprises two straps, each strap being attached to mutually opposing ends of the cover, and arranged to be secured to each other to provide adjustability. Preferably, the retaining means comprises fastening means, for example one or more Velcro regions.

According to a fifth aspect, there is provided a pack comprising the medical device of the first aspect, and optionally instructions for use of the device. Preferably, the pack comprises a receptacle in which the medical device is received.

All of the features described herein (including accompanying claims, abstract and drawings), and/ or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and/ or steps are mutually exclusive.

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 drawings, in which: - Figure l is a plan view from above of an outer cover of a medical device of the invention, which is used for treating eye conditions;

Figure 2 is a plan view from below of the outer cover medical device shown in Figure i;

Figure 3 is a plan view of an inner pouch of the medical device; and

Figure 4 shows the complete medical device in use, when worn by a patient.

Example 1

Referring to the Figures, there is shown a medical device 2, which consists of an outer cover 3 and an inner pouch 38 disposed thereon. Figures 1 and 2 illustrate various views of the cover 3, Figure 3 shows the pouch 38, and Figure 4 shows the device 2 in position on a subject 32. In use, the device 2 is either heated by a conventional microwave, or cooled in a conventional fridge/freezer, and is effectively used to treat or even prevent a very wide range of eye conditions, such as styes and cysts, inflammation, dry eye syndrome, grittiness and irritation, itchy eyes (e.g. caused by hay fever), Meibomian Gland Dysfunction (MGD), chalazion, blepharitis and conjunctivitis, and so on, depending on whether heating or cooling of the eyes and the associated areas is desired. It will be appreciated however that this list of eye conditions is not exhaustive and that the device 2 can be used to treat or prevent any kind of eye pain or condition, or to soothe a headache, which may have been caused by eye strain. Use of the medical device 2 is the first step in eye/ eyelid hygiene followed by the application of eyedrops etc to treat an eye condition. Effective use of the device 2 improves eye hygiene such that the chances of many eye conditions occurring are significantly reduced or prevented.

Referring first to Figure l, the front of the outer cover 3 of the device 2 is shown, and is composed of a single piece of material 4, for example a soft velvet or velour material, or the like. The front piece of material 4 is generally dark or black in colour, and therefore emits heat well. Referring to Figure 2, the rear of the outer cover 3 of the device 2 is shown, and is composed of two pieces of material 6a, 6b, for example soft cotton or silk. The rear pieces of material 6a, 6b are generally light blue or white in colour, and so will not emit heat to the same extent as the front piece of material 4. The perimeter of the front piece of material 4 is stitched to the two rear pieces of material 6a, 6b by a line of stitching 8, and rear pieces 6a, 6b are stitched to each other only at their peripheral edges, as shown in Figure 2. As can be seen in Figures 1 and 2, an adjustable comfort strap 14 is secured to each side of the cover 3. Each strap 14 is approximately 20cm in length, and is stitched 16 to each side of a rear piece of material 6a, 6b. As can be seen in Figure 1, each end of the straps 14 distal from the stitching 16 is covered with an area of Velcro (RTM) 18. In use, the subject 18 can easily adjust the tightness of the outer cover 3 around the head and over the eyes 36 by varying the combined length of the straps 14 via the respective positioning of the Velcro (RTM) regions 18.

As shown in Figure 4, the shape of the cover 3 is such that it fits comfortably over the subject's head and eyes 36. The cover 3 has a narrow central section 10 which is arranged, in use, to overlie the subject's nose 34, and two wide side sections 26 disposed either side of the central section 10, which are arranged, in use, to overlie the subject's eyes 36. The diameter of the central section 10 is about 8cm across and is therefore narrower than the diameter of each side section 12, which is about 10cm across. The width of the entire cover 3 (excluding the straps 14) is approximately 25cm across.

As shown in Figure 2, the rear piece of material 6a forming the outer cover 3 extends across about 75% of the width of the rear of the cover 3, and over a small section of the rear piece of material 6b, thereby creating a small overlap. The pieces 6a, 6b are not stitched together at the overlap, and so an opening 20 is created, which leads to a pocket 21 that is disposed between the front piece of material 4 and the two rear pieces of material 6a, 6b. The opening 20 extends diagonally across the rear surface 6 of the cover 3, generally along a side region 12 thereof. The opening 20 is suitably sized to enable the insertion of the inner pouch 38, which is shown in detail in Figure 3, and described below.

Referring now to Figure 3, the inner pouch 38 consists of two pieces of thin material, such as cotton, which are stitched together to create a flexible sack or bag. The shape of the pouch 38 resembles that of the front 4 and rear 6 surfaces of the outer cover 3, although the dimensions are slightly less so that the pouch 38 can be easily removed and inserted though the opening 20 in the cover 3. Thus, as can be seen in the Figure, the pouch 38 has a narrow central region 24, which corresponds to the narrow central region 10 of the outer cover 3, and wider side regions 26, which correspond to the wider side regions 12 of the cover 3. Stitched to one of the side regions 26 of the pouch 38, there is provided a label 28 on which instructions 30 for use are clearly printed.

In a first embodiment of the device 2, the pouch 38 contains a plurality of

microwaveable grains or seeds 40. The grains 40 are a special mix of natural seeds (e.g. 33.3% canary seed, 33.3% rapeseed, and 33.3% millet seed), which has been developed to ensure that the device 2 warms to the correct temperatures in the least amount of time, and then retains the heat for as long as possible, and at a comfortable level when worn by the subject 32. Other grains 40 that are used are flax seed or wheat, either alone or in combination with the other grains 40 described herein. Silica beads can also be used, and are described in more detail in Example 2. This embodiment is used for micro waving and transferring heat to the subject 32, as will be described below. In a second embodiment of the device 2, where the subject's eyes require a cooling effect, instead of being filled with microwaveable grains or seeds 40, the pouch 38 contains a cooling gel or alternatively polymer cooling crystals, or the like (not shown). An example of a suitable cooling gel is available from Yangzhou Tianle Hot Water Bottle Factory (China). In use, when exposed to cold temperatures (i.e. from a conventional fridge or freezer), the gel cools down and retains the cool temperature. Suitable cooling crystals 32 (available from N-rit co., ltd, #223-427, Seoknam2-Dong, Seo-gu, Incheon City, Korea 404-825), can also be used to cool down the device 2, but without the need for a freezer. To cool the device 2, it is first immersed in cold water for 3-5 minutes until the high-tech polymer crystals 32 fully absorb the water and become "activated". It may be desirable to also place the activated crystals in a fridge for 30 minutes for an even greater cooling effect. The crystals 32 are made of a non-toxic crystal polymer, which becomes cold, and has a long-lasting cooling effect. The subject 32 can enjoy the soothing, cooling effect imparted by the crystals 32.

For clarity, Figure 3 does not show a full complement of grains/seeds 40 (or cooling gel/crystals); instead it shows, for illustrative purposes only, small groupings of grains 40 at various positions within the pouch 38. However, it should be appreciated that the pouch 38 contains enough grains 40 to be fully dispersed throughout, such that the subject's eyes 36 and surrounding areas are fully covered when the device 2 is placed in the correct position. Conversely, the pouch 38 is not completely filled with grains 40 so that the subject 32 can easily move them around the inside the pouch 38 to avoid hot/cold spots. Also, the subject 32 is able to easily insert the pouch 38 through opening 20 into the pocket area 21. As a guide, the pouch 38 is filled to about 50-70% of its capacity with the grain 40 (or cooling gel/crystals).

In use, the subject 32 must first remove the inner pouch 38 from the outer cover 3 by carefully pulling it out. The relatively sizes of the pouch 38 and cover 3 mean that it is not a very tight fit, and so there is no risk that the pouch would be ripped and lose its contents during the removal operation. The subject 32 then places the pouch 38 on a clean microwaveable plate, and heats it on full power (based on a 850-1000 Watt microwave) for approximately 30 seconds. Heating times should never be exceeded. The microwave energy is absorbed by the grains 40, which are therefore heated up to an elevated temperature of about 40-50°C. After heating, the pouch 38 is then inserted into the outer cover 3 through the opening 20 and then arranged such that it fits well within the pocket area 21, in an extended configuration therein, i.e. the positions of the central region 24 and side regions 26 of the pouch 38 correspond with the positions of the central region 10 and side regions 12 of the outer cover 3.

In order to distribute the heat effectively, and to prevent any "hot spots" developing, the device 2 can be shaken during (e.g. about half-way) through the heating period, and again after heating, but before use. Once fully heated, the subject 32 then carefully checks the temperature of the grains 40 by touching the outer cover 3 (now containing the heated pouch 38) on to the inside of the wrist, before putting on the eyes. To avoid damage to the eyeball, the subject 32 must close the eyes 36 prior to gently resting the outer cover 3 of the device 2 in place, as illustrated in Figure 4. Depending on the subject's 32 preference, either the front 4 or rear 6 of the outer cover 3 can be contacted on the subject's eyes. More heat is radiated by the front piece of material 4, as it is darker in colour than the rear of the cover 3. The straps 14 are then fastened together via the Velcro (RTM) 18 forming a headband. The pressure that is applied by the device 2 to the subject's eyes 36 can be adjusted by tightening or loosening the straps 14 to suit personal comfort. The device 2 gently conforms and moulds to the contours of the eyes 36 and shape of the subject's face, and is left in position for as long as necessary, until the pain has subsided or until the grains 40 have cooled down. The straps 14 provide tight support and even distribution of the grain 40 to the eyes and surrounding areas, thereby maximising pain relief.

After using the device 2, with the eyes closed, the subject 32 then gently massages the upper eyelid by smoothing a finger from the inner corner of the eye 36 to the outer corner just above the lashes. This procedure is then repeated just below the lashes on the lower lid. The exercise should be repeated for about a minute on both eyes. The device can be used two or three times a day, but can be reduce to 2-3 times a week once the symptoms improve. It is widely recognised and accepted that warmth eases pain and helps movement in muscles and joints, by increasing vasodilation and therefore blood flow to restricted areas. Accordingly, the device 2 is useful for treating a range of conditions, which would benefit from such soothing heat treatment. However, it is also possible to use the device 2 when it is cold, rather than warm (following microwaving). Applying the device 2 when cold reduces pain and swelling by causing blood vessels to vasoconstrict. It has also been demonstrated by hayfever sufferers that cooling the eyes 36, especially the corners thereof, results in a satisfying reduction in itchiness and irritation.

When wishing to cool the eyes 36, instead of grain 40, the inner pouch 38 contains a cooling gel (e.g. available from Yangzhou Tianle Hot Water Bottle Factory, China) or numerous tiny polymer cooling crystals (not shown). The pouch 38 is first removed from the outer cover, and then placed inside a receptacle, such as a clean plastic bag (not shown), and left in the fridge or freezer for at least an hour. The cooled pouch 38 is then inserted back into the outer cover 3, which is then gently placed over the eyes 36 and nose 34. The subject 32 then increases the pressure of the device 2 over the eyes via the straps 14, as described above, and allows the cool soothing effect to act. It is highly unlikely that the user would get ice burns from using the device 2 when chilled.

However, for safety, it is preferred that the device 2 is not used for more than 10 minutes at any one time.

It is important that the pouch 38 is not washed or allowed to get wet. The outer cover 3 can be washed in warm water and dried flat. After washing and drying, the inner pouch 38 is inserted into the cover 3 and then heated by microwave for 1 minute, 10 seconds. It is then allowed to cool down in the microwave for at least 5 minutes, before it is removed. This process ensures thorough cleaning of the entire device 2.

Advantages of the device 2 reside in the effective manner in which it naturally soothes pain and can be used to treat a wide variety of eye conditions. The device 2 can be used either hot/warm or cold/cool. The special mix of grains/seeds 40 (e.g. 33.3% canary seed, 33.3% rapeseed, and 33.3% millet seed) display excellent heat retention properties. The design of the device 2, with the inner pouch 38 disposed inside the outer cover 3 allows the grain/seeds 40 or cooling gel/crystals to be evenly distributed over the eyes 36 and surrounding areas, maximising the contact surface and therefore pain relief areas. The device 2 is a cost-effective, natural home treatment, and is a registered Class 1 medical device with the Medicines & healthcare Products Regulatory Agency (MHRA). It is convenient and easy to use, and one side fits all. It is provided with a carry case (not shown) for safe, clean and dry storage.

Example 2

In Example 1, the device 2 was filled with a special mix of grains/seeds 40 for heating purposes, or a cooling gel or polymer cooling crystals for cooling purposes, both of which worked very well. However, the inventor has also prepared an effective device 2 in which the seeds 40 are replaced with silica beads 40 or silica gel.

Silica gel is manufactured by the interaction of sodium silicate and sulphuric acid, and is available from GeeJay Chemicals Ltd, GB. Under certain conditions this forms a gel like product (hence the name). This is 'aged', dried, and broken up to give the granular forms of silica gel. Different processing after formation gives the beaded forms. Made in this way, the silica gel has pores in its structure which will trap water molecules. By varying the process conditions these pores can be 'narrow' (0.5 - 6.0 microns) which will adsorb moisture in the gaseous form or 'wide' (6 - 30 micron) to adsorb liquid water. The desiccant silica gels are the narrow pored type. Silica gel is silica (silicon dioxide) with the chemical formula S1O2.

It is 98% plus pure. Small percentages of impurity in the raw materials of manufacture may be carried through to the final product. It may still contain up to 2% w/w (weight for weight) moisture. By using other process conditions silica can be precipitated as a granule or powder. This would not have the properties of a desiccant or water adsorbing silica gel. Silica gel is a harmless, non-toxic, non-flammable material. It is insoluble in water and other solvent and liquids. It only reacts with hydrofluoric acid and concentrated sodium hydroxide solution. It is not regulated as dangerous goods by any form of transport. It requires no special labelling or warnings concerning health or environmental hazards.

A non-indicating silica gel was used made from i-3mm crushed silica beads (available from GeeJay Chemicals Ltd, GB). A narrow pored form of amorphous silica free from extraneous matter was used. The crushed/broken beads were white/translucent in colour and remain physically unchanged when dry and when saturated with water. Beads size: less than imm = 7.5% max, and greater than 3mm = 7.5% max. The inventor has found that silica beads of average diameter i-3mm or a gel comprising beads of this size are useful for treating eye conditions, which require heat to be applied thereto. The pouch 38 is filled with either beads or gel and then microwaved to a temperature of about 40-50°C. The pouch 38 is then inserted into the outer cover 3, and gently placed onto the eyelids or the affected area for treatment to occur as described in Example 1. The i-3mm sized beads fit better around the glands of the eyelid. The inventor has also found that silica beads of average diameter 5mm or above, or a gel comprising beads of this size are useful for treating eye conditions, which require cold treatment. The pouch 38 is filled with either beads or gel and then cooled down by being left in the fridge or freezer for at least an hour to a temperature of about o-io°C. The pouch 38 is then inserted into the outer cover 3, and gently placed onto the eyelids or the affected area for treatment to occur as described in Example 1. The 5mm sized beads retain the cold better than the smaller beads, and do not need to fit neatly into the eye socket around the eye.

Example 3

The inventor carried out some heating tests on the grain/seed mix 40 described in Example 1, and the silicon beads/gel of Example 2 to determine how resistant they were to microwave heating.

(i) Seed mix fill

The inner pouch 38 filled with grains/seeds 40 was heated continuously in a 1000W microwave for 20 minutes. The contents 40 were evenly distributed in the pouch insert 38, which was then placed into the microwave and directly onto the glass turntable, with the label not tucked underneath the insert. The 1000W microwave was set to run for 20 minutes without disturbance. After 5 minutes, there were popping sounds and the smell of hot grain or seeds. After 7V2 minutes black acrid smoke was being given off and the test room quickly filled with smoke. Testing was stopped and the insert removed to prevent damage to the equipment. The insert was badly damaged and was giving off smoke and/ or steam.

(ii) Silicone fill

The inner pouch 38 filled with silicone filling was heated continuously in a 1000W microwave for 20 minutes. The silicone fill was evenly distributed in the pouch 38 which was then placed in a glass dish and then into the microwave. The 1000W microwave was then allowed to run for 20 minutes without disturbance. After 20 minutes the microwave was stopped and the insert was removed. Although slightly scorched and discoloured on the outside, the insert pouch 38 remained intact and retained the heating medium. There was no obvious smell of burning during the 20 minute assessment. - ι₅ -

In conclusion, therefore, the inventor believes that use of silicon beads or gel is very useful when used for treating conditions requiring heat-treatment. Silica is also especially useful for treating eye conditions which require cooling treatment, for example hay fever, tired or sore eyes, swelling, allergies, headaches, puffy eyes.

Claims

1. A medical device for treating or ameliorating an eye condition, the device comprising a bag filled or adapted to be filled with temperature control means, the bag being disposed within a removable cover which, in use, is arranged to contact a subject's eye and/or a surrounding area thereof, and wherein the temperature control means is configured to modulate the temperature of the cover to thereby treat, prevent or ameliorate the eye condition.

2. A medical device according to claim 1, wherein the device is used to alleviate or treat a condition selected from the group of: styes, cysts, inflammation, dry eye disease, grittiness, irritation, itchy eyes (e.g. caused by hay fever), Meibomian Gland

Dysfunction (MGD), Meibomian Gland Disease, Meibomian Gland Inspissation, chalazion, blepharitis, hordeolum, conjunctivitis, hay fever, tired or sore eyes, swelling/puffy eyes, allergies, headaches and migraines.

3. A medical device according to either claim 1 or 2, wherein the temperature control means comprises silica beads or silica gel.

4. A medical device according to claim 3, wherein the silica beads or gel comprise an average diameter of between 0.5mm and 10mm, more preferably between imm and

7mm, and more preferably between imm and 6mm.

5. A medical device according to any preceding claim, wherein the temperature control means is configured to be heated to above 30°C, or above 40°C, or above 50°C.

6. A medical device according to claim 5, wherein the temperature control means comprises silica beads or silica gel, wherein the silica comprises an average diameter of between 0.5mm and 5mm, more preferably between 0.5mm and 4mm, and more preferably between imm and 3mm.

7. A medical device according to any one of claims 1-4, wherein the temperature control means is configured to be cooled to below 15°C, or below io°C, or below 5°C, or below o°C.

8. A medical device according to claim 7, wherein the temperature control means comprises a cooling gel.

9. A medical device according to claim 8, wherein the cooling gel comprises silica beads or silica gel, wherein the silica comprises an average diameter of between 3mm and 8mm, more preferably between 4mm and 7mm, and more preferably between 5mm and 6mm.

10. A medical device according to any preceding claim, wherein temperature control means occupy about 40-95%, or about 50-80%, or about 55-70% of the volume of the space in the bag.

11. A medical device according to any preceding claim, wherein the bag is made of a textile, such as cotton, silk, satin, or polyester.

12. A medical device according to any preceding claim, wherein a first side of the removable cover is made of a first material, which dissipates heat to a user's eye and surrounding area when the device is in use, at a greater rate than that of a second side of the cover made of a second material.

13. A medical device according to any preceding claim, wherein the first material comprises cotton, silk, satin, or polyester, and wherein the second material comprises velvet, velour or suede.

14. A medical device according to any preceding claim, wherein the cover comprises a central section which is arranged, in use, to overlie the subject's nose, and two side sections disposed either side of the central section, which are arranged, in use, to overlie the subject's eyes and surrounding areas, wherein the maximum width of the central section is less than the maximum width of the side sections.

15. A medical device according to any preceding claim, wherein the removable cover comprises an opening through which the bag may pass.

16. A medical device according to claim 15, wherein a first side of the cover comprises two pieces of material, which overlap each other thereby creating the opening, which opening leads to a pocket disposed between the first and second sides of the cover, wherein the pocket is configured to receive the bag containing the

temperature control means.

17. A medical device according to claim 16, wherein the opening extends diagonally across the first side of the cover along a line which extends across one of the side sections.

18. A medical device according to any preceding claim, wherein the device comprises retaining means for securing the device to the user's head and in position over the eye and/or surrounding area thereof.

19. A medical device according to claim 18, wherein the retaining means comprises two straps, each strap being attached to mutually opposing ends of the cover, and arranged to be secured to each other to provide adjustability.

20. The medical device according to any preceding claim, for use in treating, preventing or ameliorating an eye condition.

21. A method of preparing the device according to any of claims 1-19 for use, the method comprising modulating the temperature of the device, and manipulating the device to redistribute the temperature control means around the bag.

22. A pack comprising the medical device according to any one of claims 1-19, and optionally instructions for use of the device.