Means for removing undesired substances and objects, such as metabolism waste products, pollutants, dust and cosmetic residues, from eye area and process for manufacturing thereof

A means for removing undesirable substances and objects, such as waste products of metabolism, impurities, dust and cosmetics residues, from the eye area and a method for its production

Technical field

The invention relates to a composition for removing unwanted substances and objects, such as waste products of the body in the areas of eye corners, to the removal of dust, sand grains, insects, fibers, dead cells and pollen in adults, children or animals, and with a reduced risk of injury or eye infection.

The solution is particularly suitable for removing cosmetic residues, mascara particles, liquid lines and the like from the make-up eye area without disturbing the make-up or even smearing of the make-up in the eye parts.

BACKGROUND OF THE INVENTION

Removal of undesirable objects or substances from the eye is performed in medicine mainly by irrigation with physiologically safe aqueous solutions (irrigation), often combined with suction. In addition to conventional techniques, such as syringes, syringes, and the like, a number of devices have been proposed for this operation, as described, for example, in U.S. Pat. 6,261,275, 6,602071 and 6,969,368. However, these compositions are usually impractical for use in everyday life, since excess liquid applied can wash cosmetics around the eyes, contaminate clothing, etc.

Therefore, in everyday life, people solve the common problem of removing drowsiness, dust, dirt, insects and cosmetics from the eye area by improvised means such as removing or wiping them with fingers, nails, cotton buds in the ears, handkerchief corners or rinsing them with eye drops. Improvised compositions may be contaminated, introduce other impurities (eg fibers, fragments, etc.) into the eye, irritate or even damage sensitive eye tissues.

Fingers and nails are often not washed and can irritate the eye area and can also infect the eye area (agents of infection: viruses, bacteria, parasites or fungi). Consequently, serious health problems such as conjunctivitis, corneal epithelium damage or uncertainties, the formation of barley grains and other problems that may require medical treatment may also occur. Another disadvantage of this solution is that when the eye area is worn, smearing occurs, which is a very unwanted result.

Cotton ear buds are made of cotton, which very often leave cotton fibers when used in the eye area and continue to irritate the eye area. They remain on the lashes and can cause blurred vision. A further disadvantage of this solution is that after using these dry sticks, the treated area burns very often and can cause unwanted tearing and again blurring of the make-up in the eye area.

Eye drops are usually safe (unless contaminated or expired) and a frequently used solution in the home if they are handy when needed. However, eye drops cannot be used well on the eye area if they are applied and we do not want this make-up to be blurred. It is too likely that the eye drops will flow out of the eye area of ​​the corner of the eye or any other place, which is makeup and will disrupt the entire makeup effect, sometimes very expensive.

The most common and relatively frequent injury to the eye is the clogging of foreign bodies. Foreign bodies are often found at the upper or lower eyelids, or in the corner of the eye, where they can be removed. However, if an unsuitable removal is attempted, the dirt may be pushed deeper, possibly

It is impossible to remove it in an improvised way. Even more complicated can be the removal of impurities in contact lens wearers. Often, mascara particles also collect around the eyes or around the corners of the eye and stain the corners of the eye. By disrupting the overall appearance of makeup. Very often this situation occurs when a person who is wearing eye areas cannot use the mentioned solutions eg. eye drops and needs quick help from irritating foreign bodies or cosmetic particles from the eye areas that negatively affect the appearance.

These drawbacks are largely eliminated by the means for removing substances and objects from the eye area of ​​the invention.

SUMMARY OF THE INVENTION

SUMMARY OF THE INVENTION The present invention provides a means for removing unwanted substances and objects, such as waste products of metabolism, impurities, dust and cosmetic residues, from the eye area, which consists of a functional portion of a porous polymer, in particular a hydrophilic polymer. adapted for non-aggressive contact with the cleaned eye area and porosity to remove non-toxic and non-irritating liquid.

Preferably, the device comprises a handle connected to the functional portion. Preferably, the composition is enclosed in a watertight container. Preferably, the porous polymer of the functional portion has an average porosity of 20 to 98% by volume, based on the total volume of the porous polymer. Preferably, the porous polymer of the functional portion has an average pore size of 0.1 to 250 microns. Preferably, the porous polymer of the functional portion is a deformable porous polymer adapted to displace the contained non-toxic and non-irritating liquid by deforming the active portion.

The invention also relates to a process for the production of a composition as defined above, characterized in that the functional part is obtained from the aqueous solution of the porous polymer precursor by eliminating the porous polymer by separating water from said solution. if necessary, seal in a watertight container. Preferably, the aqueous solution of the porous polymer precursor is an aqueous solution of polyvinyl alcohol and the porous polymer is precipitated from the solution by water separation by repeated freezing and melting of said solution.

The present invention also provides a process for the preparation of a composition as defined above, wherein the aqueous solution of a porous precursor polymerizes an aqueous solution containing a major portion of 2-hydroxyethyl methacrylate and a minor portion of a multifunctional crosslinker. whereupon the functional part obtained is optionally connected to the handle and is sealed itself or with the handle in a watertight container.

Preferably, the deposition of the porous polymer from the aqueous solution of the porous polymer precursor is carried out directly in the watertight container.

Preferably, the non-toxic and non-irritating liquid is at least one liquid selected from water, glycerol, 1,2-propylene glycol, triethylene glycols, dimethylsulfoxide, glycerol formal and sodium chloride. Preferably, the non-toxic and non-irritating liquid is an aqueous isotonic solution suitable for ophthalmic use. Preferably, the porous polymer is a hydrophilic polymer whose contact angle with the non-toxic and non-irritating liquid is less than 90 °, more preferably less than 75 ° C. Preferably, the porous polymer has a pore size with a substantially Gaussian distribution. Preferably, the pore size increases from the inside towards the surface of the functional portion. Preferably, a positive capillary pressure is established in the pores of the porous polymer upon contact with a non-toxic and non-irritating liquid. Preferably, the porous polymer is selected from the group consisting of polyurethane, polyurea, polyvinyl alcohol and derivatives thereof, and polyacrylic and polymethacrylic acid derivatives. Preferably, the porous poly-2C 304635 B6 mer is covalently crosslinked. Preferably the polyacrylic and polymethacrylic acid derivatives include amides, nitriles and esters of polyhydric alcohols. Preferably said esters are 2-hydroxyethyl methacrylate. Preferably, the functional portion has a rounded application end for non-aggressive contact with the eye area. Preferably, the functional portion has a cylindrical shape with a diameter of 3 to 8 mm, more preferably 4 to 6 mm, which at the end of the cone becomes a rounded application end with a diameter of 0.5 mm to 3 mm, more preferably 1 to 2 mm. Preferably, the non-toxic and non-irritating liquid at the time of non-aggressive contact with the eye area is present in an amount corresponding to 20 to 95%, more preferably 33 to 67% of the maximum retention capacity of the functional portion of the porous polymer. Preferably, the package is closed by a watertight plug which is connected at one end to the functional portion and on the other side to the holder.

Description of the drawings

In the attached drawings:

Fig. 1 shows schematically an exemplary embodiment of a device comprising a functional part including an application end IA and a handle 2;

Figures 2A to 2D show exemplary longitudinal and cross-sectional embodiments of the device for various cross-sections of the functional portion I and the handle 2, the designations of these parts being the same as in Figure 1;

Fig. 3 shows a longitudinal and cross-sectional view of a preferred shape of the functional portion 1 of the device with a rounded application end IA and a conical tapering cylindrical functional portion (1) enclosing the handle (2);

Fig. 4 shows a preferred embodiment of the device with its functional part i enclosed in a watertight container 3 which is closed by a watertight lid 4 through which the handle 2 is waterproof, wherein the handle 2 and the lid 4 preferably form a single integral part of the same material;

Fig. 5 shows an exemplary embodiment of a device with a disposable functional part 1 and a reusable handle 2, the functional part 1 being closed by a watertight lid 4 in the container 3, the lid integral with the inner part 2A of the handle 2 and provided with a nut part 5A; the handle 2 is provided with a corresponding socket part 5B; and Fig. 6 shows an exemplary embodiment of a device comprising only a functional portion with a rounded application member IA.

The means comprises at least a substantial functional part 1 schematically shown in FIG. 1.

The functional portion 1 consists of a shaped, soft porous hydrophilic polymer portion which is at least partially saturated with a physiologically acceptable and non-irritating liquid prior to application to the eye area. The application end IA is intended for direct contact with the eye surface or its surroundings. The device further preferably comprises a handle 2 for introducing the device into the eye area and manipulating it. The handle 2 is at the same time the carrier a functional part 1 and preferably forms a single non-detachable part therewith. The handle 2 is generally made of a suitable plastic, but may also include other materials such as metals or wood.

The porous functional portion 1 has a shape optimized for contact with a selected area of ​​the eye, such as a corner or lid. For example, it may have a rectangular, semicircular, oval or circular cross-section. In the case of a rectangular or semi-circular profile, the functional part I is attached to the handle 2 on its flat side as shown in Figs. 2A and 2B. In the case of an oval or circular profile, the handle 2 can be positioned either inside the functional portion 1 as shown in FIG. 2C, or the functional portion 1 may be located within the handle 2 as shown in FIG. 2D.

-3 CZ 304635 B6

The functional part I and the handle 2 can be permanently connected in various ways, for example by gluing, welding, casting the functional part even around a suitably shaped handle 2 and the like. The connection may also be temporary in a suitable manner, such as by a thread, a bayonet or Luer coupling or the like.

Particularly preferred is the circular cross-section in Fig. 2C or 2D which allows application by "scrolling" over the surface of a portion of the contaminated area of ​​the eye. In such an application, the functional part I is circumferentially compressed and relaxed again, thus aiding the adhesion of the impurities. In this manner of application, the utilized area of ​​the functional portion 1 is also increased and its undesirable friction against the surface of the cleaned eye area is reduced. The application end IA of the functional part 1 is preferably rounded, e.g. the hemispherical, and cross-section of the functional portion 1 preferably tapers away from the handle 2 to the application end IA, as schematically shown in FIG. 3. The length of the functional portion i is preferably between about 3 mm and 30 mm, most preferably between 5 and 20 mm. The transverse dimension (eg maximum diameter) of the functional part I is preferably between 2 and 10 mm, most preferably between 4 and 8 mm. The length of the handle 2 can be from about 10 mm to about 100 mm, preferably between 30 and 65 mm.

The material of the functional portion 1 must be sufficiently soft, preferably deformable with a small force, to allow the liquid to be expelled from the pores without damaging or irritating the surface of the cleaned eye area. Therefore, the pore volume should exceed 20%, and preferably 30% of the hydrated volume of the portion

The porosity should be between 15% and 98%, preferably between 25% and 90% by volume.

Also important is the pore size, the mean diameter of which should be between about 0.1 micrometer to about 500 micrometers, preferably from about 1 to about 200 microns. It is preferred that the pore size is not uniform but has a certain diameter distribution corresponding, for example, to a Gaussian distribution. It is also possible to distribute the pores from the interior towards the surface, preferably so that both the porosity and the pore size increase towards the surface of the functional part 1.

Also important is the wettability of the pore surface in order to preferably create a positive capillary pressure in the pores. For this purpose, it is preferable to select polymers whose surface has a wetting angle of less than 90 [deg.] And preferably less than 75 [deg.] With respect to the physiologically acceptable liquid contained in the pores at room temperature. Particularly preferred are hydrogels, i.e. water-insoluble polymers, but absorbing water (swelling in the presence of water) up to a certain content. The hydrogels may be covalently or physically crosslinked polymers of different chemical compositions. Low to medium hydrophilic hydrogels having an equilibrium water content of from 20% by weight are particularly preferred for the purpose of the invention. up to 60% by weight, preferably between 30% and 50% by weight, which are compatible with delicate tissues and are able to adsorb surface impurities of both hydrophilic and hydrophobic character. They are also capable of binding an aqueous liquid in the pores which can be expelled by relatively low mechanical pressure, which can be controlled by the size and hydrophilicity of the pores. For application, the porous polymer of the functional portion should be at least partially moistened with a physiologically acceptable liquid.

The main condition in the choice of polymers for functional part 1 is their health safety, in particular that they do not contain toxic or irritant substances nor can they be released under storage and use conditions. Those skilled in the art can design a variety of polymers and copolymers meeting the functional conditions of the invention. For example, polyurethanes and polyureas, including their polyol sequential copolymers, may be used. Another preferred group of polymers are vinyl polymers and copolymers, e.g. polymers and copolymers of polyvinyl alcohol or vinyl acetate. Another preferred group are polymers and copolymers of acrylates and methacrylates, such as polymers of amides and esters of acrylic and methacrylic acid. For example, a thinly crosslinked copolymer of 2-hydroxyethyl methacrylate (HEMA) and a small amount of bis-ethylene glycol dimethacrylate may be exemplified. Also preferred are polymers containing ionic groups such as, for example, carboxylic, sulfone, tertiary amine, and the like. Some of the possible compositions will be listed in the Examples. The liquid contained in the pores is a non-toxic and non-irritating liquid, preferably an aqueous solution of salts or water-miscible organic non-toxic compounds. Such organic compounds are, for example, compounds with two or more hydroxyl groups, such as sugars, glycerin, 1,2 propylene glycol, triethylene glycol and the like. Other suitable compounds may be dimethylsulfoxide

-4E 304635 B6 or glyceryl formal. Such compounds may be present in solution up to a concentration of about 80% by weight, but as a rule, they may be present in minor amounts. Particularly preferred are isotonic solutions of e.g. suitable salts such as NaCl. This solution may further contain suitable antiseptics or other active substances customary in ophthalmic formulations, e.g. in so-called pine water. It is important that they do not cause eye irritation and are sufficiently stable during storage and use of the composition. For application, it is preferred that the total amount of liquid present in the functional portion be reasonably less than its maximum containment capacity for the liquid. The retention capacity of a porous hydrogel is understood to mean the total liquid content retained both in the hydrogel structure and contained in fully filled pores. If the liquid content was too high, the liquid would be expelled from the pores during application and could leak out of the eye area, wash make-up and the like. If it is too low (e.g., significantly lower than the equilibrium water content of the hydrogel), then the surface of the functional portion could be too rough and damage or irritate the eye surface, lid edges, and the like. According to our experience, said liquid at the time of contact with the eye region should be present in an amount corresponding to 20% to 95% and preferably 33% to 67% of the maximum retention capacity of the functional portion of the porous polymer. The liquid content may be adjusted just before application (e.g. by squeezing the excess liquid, or by wetting the dry preparation in the liquid), but it is preferable to store and deliver the composition suitably packaged with the optimum amount of liquid.

Therefore, in addition to the functional part 1 and the handle 2, the device is preferably provided with a waterproof cover 3 protecting the functional part from drying out and soiling. The package 3 may comprise more than one composition which is sequentially withdrawn therefrom for use. Such a container may be, for example, a wide-necked vial with a screw cap, or a plastic sleeve and the like. However, individual packages for each individual composition that are more convenient to use and better guarantee the purity of the composition are preferred. Such an individual wrapper 3 may consist, for example, of a plastic "blister" covered with a removable foil or a wrapper of the whole composition of welded plastic foil. Especially preferred is a plastic-shaped casing 3 according to the shape of the functional part 1, as shown in FIG. 4. The package is preferably sealed by a lid 4 attached to the handle 2, possibly forming a non-detachable part therewith.

The composition may also be completely enclosed in an impermeable package protecting the composition from contamination and retaining said aqueous, physiologically acceptable liquid. In a disposable embodiment, the container may be formed by, for example, a water vapor-impermeable plastic film which can be torn to remove the composition. Plastic films particularly suitable for use are, for example, polyethylene, polyethylene terephthalate (PET) or even metallized plastic films. The handle 2 may have an end adapted to easily tear the package.

Another alternative is a divided container comprising the composition, preferably a two-piece container of a suitable plastic such as polypropylene (PP), both parts being injection molded and interconnected by a watertight releasable joint such as a fitting, Luer lock or bayonet closure. Such a package may serve both for single and repeated use of the composition, or for its hygienic storage prior to disposal.

Another preferred arrangement with a handle 2 comprised of two parts, the inner part 2A and the outer part 2B, is schematically shown in Fig. 5. The plastic container 3 has a watertight lid 4 and are in which the functional part 1 and the inner part 2A of the handle 2 of the device. The outer part 2B of the handle 2 is not permanently attached to the inner part 2A, but is attached just before use after opening the lid 4. The lid 4 and the inner part 2A of the handle 2 preferably form one piece. After use, the outer portion 2B is detached from the inner portion 2A, which is discarded with the attached functional portion and the casing 3, while the outer portion 2B of the handle 2 is stored for further use. The inner portion 2A and the outer portion 2B are provided with a suitable quick-connect and disconnect system such as a bayonet lock, Luer Lock, a pen closure customary and the like, and which is schematically indicated in Fig. 5 by the nut portion 5A and the socket portion 5B.

-5GB 304635 B6

A preferred method of manufacturing the functional part I is to cast the liquid precursor into a mold under conditions suitable for forming a porous polymer. Such processes are well known to those skilled in the art of plastics. The casting mold preferably forms a shell 3. The composition of the liquid precursor is preferably chosen such that the solidification result is non-toxic and non-irritating and does not need to be extensively washed or otherwise cleaned. This eliminates various manufacturing operations and reduces production costs. In addition, the possibility of contamination will be reduced by reducing the number of manufacturing operations. A preferred material for functional part I is a porous hydrogel. The formation of a sponge-like gel structure can be achieved, for example, in that the precursor contains more aqueous liquid than the hydrogel formed can absorb by equilibrium swelling. In this case, so-called "syneresis" occurs, in which the polymer and the liquid are separated from each other to form a sponge-like structure. This effect is well known to polymer chemists who can find a number of specific systems that meet this condition. Examples of the formation of a porous hydrogel by a physical process include repeated freezing and melting of aqueous polyvinyl alcohol solutions which, by freezing and subsequent melting, form a fine sponge-like gel structure whose consistency, porosity and the like can be controlled by e.g. Another example may be copolymerization of HEMA with a suitable crosslinker in sufficiently dilute aqueous solutions. Initiation of polymerization by radical initiators such as organic or inorganic peroxides or azo compounds is suitable. The initiators are decomposed by heat, UV radiation or by reaction with suitable reducing compounds (so-called redox initiation systems). Especially preferred are those water-soluble initiators whose reaction products are harmless to health and need not be carefully removed from the reaction product. Examples are hydrogen peroxide or ammonium persulfate.

The solidification of the liquid precursor is preferably carried out in the presence of a handle 2 in a mold which is thus incorporated into the hydrogel functional part I without the need for further operations. Alternatively, however, an opening or dimple can be formed in the functional portion 1 as a receptor of the handle 2, and the functional portion 2 can be glued into the receptor with a suitable adhesive, e.g., a cyanoacrylate adhesive.

The basic function of the device is to remove impurities from the eye area as described above. However, the composition may also be used for other hygiene purposes, such as cleaning other body cavities, applying or removing or repairing cosmetic compositions, aspirating excess liquids, and the like. The basic particle function of the device can be described as follows:

the device is removed from the package 3, the liquid content is optionally treated therein, and is then introduced into the eye area so that the application end 1A of its functional part 1 touches the dirt area to be removed;

- the impurity adheres to the porous polymer without contacting or irritating the ocular tissue;

- the device is removed from the eye area with the impurity.

However, after removal from the eye area, the composition can be cleaned, soaked with fresh aqueous liquid, and reused. However, it is preferred from the point of view of hygiene, safety and convenience of the user to eject the composition after first use.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

The 1.5 ml polyethylene container with lid, primarily used as a mini tube or small sample container (FISCHER SCIENTIFIC, Catalog No. 2103.3502), is used both as a casting mold and as a watertight container 3 (see Fig. 4 and Fig. 5) for the hydrogel functional part i. The mold is modified by cutting off the lid, which is then replaced by a polyethylene part serving as an anchoring part of the inner part 2A, the lid 4 and the nut part 5A with the bayonet connection shown in Fig. 5. The mold is filled with a solution of 10% PVA and 0.8% NaCl in water, sealed with the aforementioned polyethylene portion and subjected to 3 cycles of freezing to -20 ° C and heating to + 20 ° C. The solution is prepared by dissolving 80 kD Dalton PVA and a degree of hydrolysis of over 99% in an isotonic NaCl solution at a temperature of over 95 ° C. By repeated freezing and thawing, the polymer separates in insoluble form from the water to form a porous, open-pore hydrogel from which excess water can be easily squeezed out at low pressure. The product is stored in this form. Prior to use, the metal outer portion 2B of the handle 2 of Fig. 5 is attached to the cap 4, which is end-capped with a socket portion 5B of the bayonet connector, and the porous hydrogel functional portion 1 is withdrawn from the package 3 and used to clean the eye area. Then, the handle 2 is detached and stored for future use, while the used functional part 1 is returned to the package 3 and discarded.

Example 2

The polyethylene form of Example 1 is partially filled with a deaerated solution of 30% by weight of HEMA in an aqueous solution of 1% ammonium persulfate. HEMA contains 0.25% by weight ethylene glycol dimethacrylate and 5% by weight triethylene glycol dimethacrylate. The filled mold is then closed with a rubber lid 4, which is tightly passed through the polypropylene handle 2 of Fig. 4. The closed molds are heated in a water bath at 80 ° C for 3 hours, after which they are cooled and stored in a plastic container. By thermal polymerization, a hydrogel sponge forming the functional portion 1 of FIG. 4 is formed in the mold 3 of the casing 3. Before use, the hydrogel functional portion 1 is withdrawn from the casing 3 by the handle 2 and used to round the application area IA of the functional portion to clean the eye area. After cleaning, the functional part is returned to the packaging 3 with the handle 2 and the lid 4, which is discarded at a suitable moment.

Example 3

The procedure of Example 2 is repeated until the thermal polymerization is complete. Then, the functional part 1 with the lid 4 and the handle 2 of Fig. 4 is removed from the mold, the lid 4 is removed and recycled for further use. The functional part 1 with the attached handle 2 are then washed in distilled water and soaked in a 30% glycerin solution in water. After 24 hours the excess solution is removed by centrifugation and the parts are air dried for 12 hours. The water is partially evaporated from the functional part 1 leaving concentrated glycerin, which serves as a plasticizer and partly as a hydrogel preservative. The finished product is sealed in polyethylene foil. Before use, the film is torn, the product is removed and used to clean the eye area either directly or after moistening with an ophthalmic solution. If dust, foreign bodies, cosmetics or mascara particles are found in the make-up eye areas, the composition is removed from the plastic bag according to the example and possibly moistened with an eye solution. The stick is lightly applied with the hydrogel part to the impurity and removed by rotary motion. This will not blur the make-up of the eye areas.

The same procedure can be used for eyelashes. The means for removing impurities from the eye area is applied to the algae with the hydrogel functional portion and removed by rotary motion. This prevents further eye irritation.

When it finds waste products of the organism (sleeper) in the corners of the eye (some people suffer from the formation of these sleepers several times a day), they comfortably rotate without blurring make-up with a product moistened with an ophthalmic solution without causing irritation and clogging of infection.

In the case of animal drowning, the same procedure is followed, but with a larger functional hydrogel portion. The rotating functional part, which is moistened in the eye solution, can also soak the sticky hair around the eyes, which also irritates the eye area.