US20080040834A1

US20080040834A1 - Prophylactic article

Info

Publication number: US20080040834A1
Application number: US11/621,828
Authority: US
Inventors: Raimund Schaller; Gerhard Jirovsky
Original assignee: Semperit AG Holding
Current assignee: Semperit AG Holding
Priority date: 2006-01-11
Filing date: 2007-01-10
Publication date: 2008-02-21
Also published as: EP1808189A2; PL1808189T3; EP1808189B1; AT503090B1; AT503090A1; EP1808189A3

Abstract

The invention describes a multi-layered prophylactic article, in particular a medical glove, of at least one elastomeric base layer (1) and at least in some areas an anti-friction layer (2) with respectively one internal (3, 5) and one external surface (4, 6), whereby the external surface (4) of the anti-friction layer (2) is facing the internal surface (5) of the base layer (1) and microcapsules are contained in the anti-friction layer (2). At least 90% of the microcapsules (7) as singular capsules (8) have a diameter of less than 10 μm.

Description

BACKGROUND OF THE INVENTION

The instant application is based upon the Austrian priority Patent Application No. A 37/2006, filed Jan. 11, 2006, the disclosure of which is hereby expressly incorporated by reference thereto, and the priority of which is hereby claimed under 35 U.S.C. §119.

FIELD OF THE INVENTION

The invention relates to a multi-layered prophylactic article, in particular a medical glove, of at least one elastomeric base layer and at least in some areas an anti-friction layer with respectively one internal and one external surface, whereby the external surface of the anti-friction layer is facing the internal surface of the base layer and microcapsules are contained in the anti-friction layer, and a method for the production thereof, a composition for forming an anti-friction layer of a prophylactic article, in particular a glove, and the use thereof.

PRIOR ART

Medical gloves, whether in the form of examination gloves or in the form of surgical gloves, have by now become standard equipment used in medical care. Different problems arise in the use of medical gloves. On the one hand, some users of medical gloves exhibit allergic reactions to constituents of the internal layer, in particular of the anti-friction layer of the glove. On the other hand, it has proven to be problematic if the anti-friction properties of the anti-friction layer are too low, thus making it almost impossible for the user to pull on the glove, particularly with damp hands. Moreover there is the danger that if the surface of a medical glove is damaged, potentially dangerous microorganisms could pass through the protective layer of the prophylactic article onto the skin of the user of the glove.
Properties of a glove that are intended to make it easier to draw on are known from the prior art, such as, e.g., U.S. Pat. No. 5,395,666. In the gloves according to the invention microparticles with a size of 4 to 20 μm are applied to the inside of the glove, whereby the diameter of the microparticles is no more than 5% of the thickness of the flexible elastomer article. The microparticles are silica gel particles, preferably with a size of 5 to 12 μm. They have a regular shape without corners and edges and preferably exhibit amphoteric or cationic surface properties.
A coating with microcapsules for gloves is known from US 2005/0066414 A1, whereby the composition for the coating comprises microcapsules, water and polyurethane, and the microcapsules contain low-viscosity hydrocarbons, fragrances, vitamins and a microcapsule coating. The microcapsule coating comprises polyacetal urea. In an alternative embodiment the microcapsules comprise polyisobutene, vanilla fragrance, vitamin A, palmitate, vitamin E acetate, and a microcapsule coating, this being formed of polyoxymethylene urea. Microcapsules are added in the range from 1% by weight to 5% by weight of the dip solution comprising water and polyurethane.

OBJECTS AND ADVANTAGES OF THE INVENTION

The object of the invention is to provide a prophylactic article with improved properties. Furthermore, it is the partial object of the invention to improve the adhesion of the microcapsules to the inside the prophylactic article.
The object of the invention is attained, independently in each case, by a multi-layered prophylactic article, in particular a medical glove, a composition for the formation of an anti-friction layer of a prophylactic article, at least 90% of the microcapsules as singular capsules having a diameter of less than 10 μm, a method for producing the prophylactic article, and the use thereof. It is advantageous thereby that the sense of touch in the distal phalanges, in particular in the area of the finger pads, is fully preserved. Moreover, due to the small dimensions, the microcapsules are not subjected to excessive pressure during the production of the composition or the production of the prophylactic articles or before or while being drawn on and therefore do not burst in advance and the active substances contained therein are therefore not prematurely released.
Advantageously the diameter of the singular capsules is a value selected from a range with a lower limit of 0.1 μm, preferably 0.5 μm, in particular 1 μm, and an upper limit of 10 μm, preferably 9 μm, in particular 8 μm, whereby a simple processing of the microcapsules is achieved without thereby limiting the effectiveness of the same.
The diameter of the microcapsules is less than 50%, preferably 45%, in particular 40% of the thickness of the anti-friction layer, whereby the microcapsules, if they are arranged peripherally on the internal surface of the anti-friction layer, partially project over the surface of the anti-friction layer and thus give the internal surface of the prophylactic article a surface structuring in addition to the irregularity caused during the production process. Furthermore, it is advantageous that the dimensions of the singular capsules are smaller than the thickness of the anti-friction layer, because the sense of touch, in particular when microcapsules are located in the area of the fingertips, is preserved and the tactile sense is fully maintained despite, e.g., gloves being worn. It is also advantageous that the adhesion of the capsules in the anti-friction layer is higher when the dimensions of the singular capsule are smaller than the thickness of the anti-friction layer.
It is also advantageous that an active substance and/or dye with in particular antibacterial, antiviral, antiperspirant or spermicidal properties can be contained in the microcapsules. It is thereby advantageous that, through the antibacterial or antiviral effect, infections of a viral and bacterial nature can be prevented if the prophylactic article is torn or damaged. The antiperspirant effect reduces the formation of sweat by the user and thus the prophylactic article is more comfortable for the user to wear. The spermicidal effect of the active substances, for example, can preserve the contraceptive effect even if a condom is damaged or bursts. Through the dye, for example, the distribution of the microcapsules in the anti-friction layer can be followed and, when the microcapsules rupture, the distribution of the contents, thus the dye as well as the active substance, can be visually observed.
It is also advantageous that the active substance and/or dye is soluble at a temperature with an upper limit of 42° C., in particular 41° C., preferably 40°, and a lower limit of 28° C., in particular 32° C., preferably 36° C., whereby at physiological ambient temperatures, such as are present when a person is wearing a prophylactic article, in particular a glove, the substances can be dissolved by the heat produced or given off by the wearer of the prophylactic article and thus can develop their optimal effect.
The microcapsules can be integrated and/or arranged directly adjacent to the internal surface of the anti-friction layer in the direction of the base layer, whereby the active substance or dye released by the microcapsules can come in direct contact with the surface, in particular skin, of the user and does not first have to find a way through the anti-friction layer and thus can exit at the target location in a delayed manner.
It is provided in a further development of the invention that the proportion of microcapsules in the anti-friction layer is less than 1% by weight, whereby the original properties of the anti-friction layer, i.e., that it is easier to draw on, is not impaired by the microcapsules. On the one hand, the adhesion of the anti-friction layer, which includes the microcapsules as well, to the base layer improves with a lower capsule quantity, since an anti-friction layer with a large quantity of microcapsules does not sufficiently bond to the base layer, in particular adhere, due to the many contact points of the microcapsules that come into direct contact with the rubber and per se adhere poorly thereto. On the other hand, with this a very cost-effective production of the anti-friction layer of the prophylactic article can also be achieved, without having to forgo the properties of the microcapsules provided by the active substance or dye.
Furthermore it is provided for the proportion of microcapsules in the anti-friction layer to be selected from a range with a lower limit of 0.05% by weight, preferably 0.08% by weight, in particular 0.12% by weight, and an upper limit of 0.95% by weight, preferably 0.8% by weight, in particular 0.75% by weight, whereby on the one hand the anti-friction layer can be produced cost-effectively, and on the other hand, due to the small amount used, standardized methods for producing or mixing the anti-friction layer can continue to be used and an expensive conversion of the production process of the prophylactic article to the processing of microcapsules is therefore not necessary.
It is provided in a further development that the singular capsules form agglomerates whereby the ease of drawing on as well as the wet slipperiness can be improved through the increase in the surface roughness on the inside of the prophylactic article. Furthermore, it is advantageous that the agglomerates further intensify the effect of making it easier to draw on a prophylactic article, which can already exhibit a certain surface roughness due to the manufacturing process thereof. Yet another advantage is the fact that the surface roughness prevents a full-surface contact between the prophylactic article and the human skin, thereby reducing the formation of sweat, or the sweat that is produced can be more readily transported away, thereby making the prophylactic article more comfortable to wear for the wearer. The reduced contact surface between the prophylactic article and the human skin also increases the compatibility of the prophylactic article and reduces the incidence of allergic reactions, virtually avoiding them altogether if suitable substances are selected. Also of advantage is the fact that the prophylactic article stretches as it is being put on or pulled on, thus reducing the wall thickness thereof such that the surface roughness is reinforced due to the particles projecting further, also making it easier to put on.
Through the combination of 100 to 10000 singular capsules to form respectively one agglomerate, a larger volume of the effective substance and/or dye is available upon rupture, in particular at those locations that are exposed to higher pressure such as, e.g., in the knuckle area. These areas of the hand are predominantly at risk for suffering skin damage and thus can be protected in a targeted manner.
Furthermore, it is advantageous that the agglomerates are shaped in an approximately spherical manner and optionally have a soccer ball-like appearance, through which, i.a., the anti-friction properties of the anti-friction layer are improved. In addition, the soccer ball-like structure of the agglomerates makes it possible to arrange a maximum number of microcapsules and thus to increase the concentration of active substances or dyes.
It is provided in a further development for the agglomerates to be hollow, producing a greater circumference, consequently the irregularities on the surface of the anti-friction layer are enlarged and thus the anti-friction properties are further improved, because there is less direct contact surface between the internal surface of the anti-friction layer and the user's skin surface.
According to an embodiment variant, several agglomerates can join to one another, whereby a high concentration of the active substance and/or dye is available in a small space.
The size of the agglomerates is preferably selected from a range with a lower limit of 5 μm, preferably 10 μm, in particular 15 μm, and an upper limit of 100 μm, preferably 80 μm, in particular 70 μm, through which on the one hand through the surface roughness of the anti-friction layer obtained through the agglomerates, the prophylactic article, in particular a glove, is easier to draw on and the wet slipperiness is also improved. This provides the advantage that, compared to conventional gloves without this wet slipperiness, the active substances and/or dyes can be released onto the skin over a longer period and are not immediately released entirely when the glove is drawn on due to the mechanical stress, in particular friction. On the other hand, through the accumulation of many singular capsules to form agglomerates, a large quantity of the active substance or dye is released at the point subjected to pressure, i.e., at that point where the active substance or dye is also actually required.
In a further development it is provided that the singular capsules and/or agglomerates have a coating through which they can be provided with special properties, such as, e.g., antistatic properties, improved anti-friction properties, improved miscibility, etc., which properties improve the processing as well as the wearing comfort of the prophylactic article. Also, the agglomerates alone can have a coating, whereby a predefined number of singular capsules are thereby combined to form one unit, i.e., an agglomerate, and thus a defined quantity of the active substance or dye can be released.
Furthermore, it is advantageous that during the use of the prophylactic article a change occurs in the surface structure of the anti-friction layer, whereby when pressure is applied the singular capsules or the agglomerates rupture and recesses remain in the surface of the anti-friction layer that leave behind a surface structure that, i.a., improves the wearing comfort of the prophylactic article.
In a further development the microcapsules can be marked with a dye whereby information on the distribution of the microcapsules in the anti-friction layer can be provided by the visual detectibility. Another advantage thereby is the fact that the rupturing of the particles when pressure is applied can be visually observed, as a result of which the user of the prophylactic article is assured that the active substances and/or dyes are released.
Another advantage is the fact that the singular capsules and/or agglomerates are insoluble in water, as a result of which they can be applied using a dipping process, and the active substances or dyes will not be released during the production of the prophylactic article in the dipping steps or subsequent washing steps.
According to an alternative embodiment it is provided for the singular capsules and/or agglomerates to be soluble in water, in which case they may also be applied by means of a spraying process, thereby offering another manufacturing process for producing the prophylactic article. It is also advantageous thereby that the active substances and/or dyes can already be released when the particles come into contact with, e.g., the sweat or sperm of the user and that there is no need to apply pressure to release the active substances and/or dyes, so that it is still possible to dispense the active substance even if the user selects a prophylactic article that is not the correct size.
The microcapsules are preferably arranged at least in some areas in the region of the distal forearm, the wrist, the carpalia, the metacarpal bones and/or the base, middle and terminal phalanges of the fingers of a medical glove, whereby the corresponding active substances and/or dyes are supplied in particular to those points where surgeons or medical staff are particularly exposed to the hazardous substances, i.e., microorganisms, or those points that are covered by the prophylactic article, and moreover this can occur in a targeted manner in that the microcapsules are predominately applied at the areas respectively under great stress.
According to a further development it is provided that the microcapsules are applied to both the palm and dorsal areas in at least a partial region of the prophylactic article, whereby not only can the increased moisture requirements of the dorsal side of the hand be met, but also increased perspiration on the palm side can be avoided.
The method for producing the prophylactic article can comprise the following steps: a) dipping a mold in a coagulant solution, b) surface drying, c) dipping in an elastomer mixture, d) surface drying, e) dipping in a composition with microcapsules (7) with a diameter of less than 10 μm, f) surface drying, g) leaching, h) drying, i) removal from the mold, j) washing, k) chloridizing and l) drying. Thus a standardized method is used as a basis which now needs only to be expanded by the steps according to the invention and subsequently can therefore be carried out in a fully automated manner.
The concentration of the microcapsules in the composition according to the invention is selected to be between 0.05% and 10%, whereby a sufficient quantity of active substances is provided to the user of the prophylactic article, however, a cost-conscious production of the prophylactic article also being rendered possible.
If further substances, such as at least one acrylate, carboxylated butadiene and or silicone, in particular self-crosslinking silicone, are used for the composition, desired properties, such as greater elasticity or better moldability can be achieved. If the silicone is already added to the composition, the method is made economical while in addition the prophylactic article is made easier to pull on. The following step to apply a silicone emulsion becomes obsolete.
The pH value of the composition is approximately neutral, whereby an additional irritation which can be caused just by wearing the prophylactic article, does not occur.
Preferably the pH value is selected from a range with a lower level of 5.5, preferably 6, in particular 6.5, and an upper level of 8, preferably 7.5, in particular 7.2, thereby preventing the above-mentioned additional irritation of the wearer's skin because the pH value of the anti-friction layer is approximately that of the wearer's skin, i.e., in the physiological range.

BRIEF DESCRIPTION OF THE FIGURES

The invention is described in more detail below based on the exemplary embodiment shown in the drawing.
They show:
FIG. 1A section through a prophylactic article;
FIG. 2A section through the anti-friction layer of a prophylactic article according to the invention.

DETAILED DESCRIPTION OF PREFERRED EXEMPLARY EMBODIMENTS

By way of introduction it is noted that in the exemplary embodiments with differing descriptions the same parts are provided with the same reference numbers or the same component designations, whereby the disclosures contained in the entire specification can be applied analogously to identical parts with identical reference numbers or identical component designations. The indications of position selected in the specification, such as, e.g., above, below, at the side, etc. refer to the figure directly described and shown and are to be applied to the new position analogously with a change of position. Furthermore, individual features or combinations of features from the different exemplary embodiments shown and described can also represent individual inventive solutions or solutions according to the invention.
All the data on value ranges in the present specification should be understood as also covering any and all partial ranges thereof, e.g., 1 through 10 should be understood to also cover all the partial ranges, starting from the lower limit 1 and the upper limit 10, i.e., all partial range beginning with a lower limit of 1 or greater and ending with an upper limit of 10 or less, e.g., 1 to 1.7, or 3.2 to 8.1 or 5.5 to 10.
The present invention describes a multi-layered prophylactic article, in particular a medical glove, which is made up of several layers.
As shown in FIG. 1, the prophylactic article comprises at least one elastomeric base layer 1 and at least in some areas an anti-friction layer 2. Both layers have an internal surface 3, 5 and an external surface 4, 6, the external surface 4 of the anti-friction layer 2 facing the internal surface 5 of the base layer 1. The external surface 4, 6 of the two layers is respectively facing away from the user of the prophylactic article and the internal surface 3, 5 of the two layers is respectively facing the surface, i.e., the skin's surface of the wearer.
According to the invention microcapsules 7 are contained in the anti-friction layer 2. The microcapsules 7 can be present as singular capsules 8 as well as agglomerates 9.
The diameter of the singular capsule 8 is less than 10 μm. Specifically, the diameter of a singular capsule 8 has a value selected from a range with a lower limit of 0.1 μm, preferably 0.5 μm, in particular 1 μm, and an upper limit of 10 μm, preferably 9 μm, in particular 8 μm. No change or only a slight change occurs in the structure of the internal surface 3 of the anti-friction layer 2 because of the small dimensions of the diameter of the singular capsules 8.
The thickness of the anti-friction layer is selected such that the diameter of the microcapsules 7 is less than 50%, preferably 45%, in particular 40% of the thickness of the anti-friction layer 2. If several microcapsules 7 are combined to form agglomerates 9, the agglomerates 9 also have a smaller diameter than the thickness of the anti-friction layer 2. The agglomerates 9 have a diameter of 5 μm to no more than 100 μm and comprise a plurality of singular capsules 8. The number of the singular capsules 8 that form agglomerates 9 can differ, because it depends on many factors, such as, e.g., the nature of the substance to be packed in the microcapsules 7. According to the invention, the number of singular capsules 8 that form agglomerates 9 is selected from a range with a lower limit of 100, in particular 200, preferably 500 and an upper limit of 10,000, in particular 5,000, preferably 1,000.
The casing of the microcapsules 7 preferably comprises a formaldehyde resin and is preferably not water-soluble. The microcapsules 7, which are present as singular capsules 8 or as agglomerate 9, contain at least one active substance and/or dye which can be released as needed, in particular by applying pressure or by friction. The active substances can provide the prophylactic article with antibacterial, antiviral, antiperspirant and/or spermicidal properties. Thus protective substances not irritating to the skin such as glyceryl stearate, glyceryl laurate, octyl stearate, octyl palmitate, tocopheryl nicotinate, PEG, collagen, fruit acids, fatty acids, quercetin, aloe vera, etc., perfumes such as vanilla, etc. for example, can be packed in the microcapsules 7.
In a preferred embodiment the microcapsules 7 are closed. In an alternative embodiment variant it is also possible for the surface of the microcapsules 7 to be embodied, e.g., in a porous manner. The packed substances can be water-soluble and thus be dissolved and activated by contact with the skin surface and thus with sweat.
When the prophylactic article is worn or when the prophylactic article is pulled on, the singular capsules 8 or agglomerates 9 rupture, thus releasing the active substance or dye contained therein. A change in the surface structure of the internal surface 3 of the anti-friction layer 2 can thereby occur, as shown in FIG. 2.
At a temperature between 28° C. and 42° C. the active substance and/or dye is soluble, whereby this reflects a person's physiological temperature and the peripheral regions thereof and thus the effect of the active substance or the dye can develop fully in this temperature range.
Regardless of whether they are present as singular capsules 8 or as agglomerate 9, the microcapsules 7 are arranged either on the internal surface 3 of the anti-friction layer 2 or directly beneath the internal surface 3 of the antifriction layer 2 in the direction of the external surface 4, in order to be able to quickly release the active substance packed in the microcapsules at the location of the action and thus cause the necessary effect or dyeing.
Regardless of the arrangement of the agglomerates 9 in the prophylactic article, several agglomerates can also adhere to one another, whereby coils of agglomerates 9 are formed.
The proportion of microcapsules 7 in the anti-friction layer 2 or the composition for producing the anti-friction layer 2 is less than 1% by weight and is preferably selected from a range with a lower limit of 0.05% by weight, preferably 0.08% by weight, in particular 0.12% by weight, and an upper limit of 0.95% by weight, preferably 0.8% by weight, in particular 0.75% by weight.
The singular capsules 8 as well as the agglomerates 9 can have a coating whereby the microcapsules can be provided with additional desired properties through the selection of the corresponding coating.
In appearance the agglomerates 9 according to the invention are preferably embodied in a spherical manner, in particular they resemble the shape of a soccer ball and are hollow.
In addition to the dye which they contain inside, the microcapsules 7 can also have a dye on the external surface in order to make it possible to better observe the distribution thereof in the anti-friction layer 2.
The singular capsules 8 and/or agglomerates 9 can be water-soluble or water-insoluble as needed. If they are water-insoluble, the active substances and/or dyes cannot be already released during the production process. With water-soluble particles the action of sweat can also cause the singular capsules 8 and/or agglomerates 9 to dissolve, thus releasing the active substance and/or dye.
If the prophylactic article is embodied in the form of a medical glove, the microcapsules 7 are distributed either as singular capsules 8 or as agglomerate 9 throughout the anti-friction layer or, as required, can be arranged in areas in the region of the distal forearm, the wrist, the carpalia, the metacarpal bones and/or the base, middle and terminal phalanges of the fingers.
With medical gloves that are preferably used by microsurgeons who come most in contact with the surface of the patient, i.e., the potentially infectious agent, the addition of the microcapsules 7 provided with active substance, e.g., in the area of the fingertips is sufficient. However, if puncture wounds occur, the arrangement of the microcapsules 7 in other areas as well can prove to be advantageous.
As already mentioned above, depending on the stress, the arrangement of the microcapsules 7 can be made in both the palm and dorsal areas.
In the method that is used to produce the prophylactic article according to the invention, at least 90% of the microcapsules 7 are used as singular capsules 8 with a diameter of less than 10 μm.
It has long been known among experts that in order to be able to produce reproducible layers of the base material 1 from at least one elastomer on a mold, a coagulant is applied to the mold, for example, to a ceramic mold with an appropriate roughness or with a smooth surface. To this end, the mold is usually dipped into a tank or container in which the coagulant is present in liquid form. This coagulant may be of any composition known from the prior art, such as alcohol solutions of calcium salts or the like, for example. The coagulant may also contain a separating substance such as talcum or calcium carbonate, for example, which if it is soluble in acid, can be dissolved out of the surface layers during subsequent acid treatments to produce a so-called powder-free glove. The coagulant is then dried.
The mold with the preferably dried coagulant is then dipped into a container in which a supply of elastomer is placed in the form of a dispersion or liquid. In order to increase the layer thickness, the mold can be dipped several times after briefly surface-drying the latex layer.
The elastomer applied in liquid form hardens due to the chemical reaction of the elastomer with the coagulant. The mold is preferably surface-dried for a brief period with hot air immediately after the elastomer has been applied to the mold so that the surfaces of the base layer 1 become solid or gel whereby they may be dried in an oven or a container through which hot air is fed at a temperature between 70° C. and 140° C. for 15 sec. to 60 sec.
After the intermediate drying, the anti-friction layer 2 made from microcapsules 7 containing polymeric material is applied to the base layer 1 at least in a partial region of the surface of the base layer 1, preferably to the entire surface, by dipping or spraying onto the surface-dried base layer 1 in one or more steps. The microcapsules 7 can be already dispersed beforehand, e.g., in an acrylic lacquer, or can be added directly from the aqueous slurry of the production process without a drying step. The diameter of the microcapsules 7 can be selected from a range with an upper limit of 10 μm, in particular 9 μm, preferably 8 μm and a lower limit of 0.1 μm, preferably 0.5 μm, in particular 1 μm. The diameter of the microcapsules 7 may also have a value selected from a range with an upper limit of 7 μm, preferably 6 μm, in particular 5 μm, and a lower limit of 1.2 μm, preferably 1.5 μm, in particular 2 μm.
The layer thickness of the anti-friction layer 2 can be determined on the basis of different requirements, in particular the desired roughness depth and the size of the particles, and can also be applied until this thickness has been obtained.
The anti-friction layer 2 may be made from a heterogeneous mixture of at least one polymer material, such as an aqueous polyurethane dispersion, for example, and particles, in particular microcapsules 7, liposomes, etc.
Depending on the intended application, the polymeric material can be a polyacrylate, a polysiloxane, a poly(meth)acrylate, a carboxylated styrene-butadiene copolymer, a polyvinyl pyrolidone, a cationic polyurethane and mixtures thereof, e.g. with a molecular weight of at least 100,000 Da, as well as non-ionic or anionic variants of the materials listed above. The heterogeneous mixture, in particular the aqueous dispersion of the polymeric materials and microcapsules 7 and any mixtures thereof, forms layers or films with good mechanical base properties and preferably has expansion properties similar to those of the base layer 1. The concentration of the microcapsules 7 in the heterogeneous mixture may be selected from a range with a lower limit of 0.05% by weight, in particular 0.08% by weight, preferably 0.12% by weight, and an upper limit of 1% by weight, preferably 0.95% by weight, in particular 0.8% by weight. The concentration of microcapsules 7 in the heterogeneous mixture is preferably selected from a range with a lower limit of 0.15% by weight, preferably 0.2% by weight, in particular 0.3% by weight and an upper limit of 0.6% by weight, preferably 0.5% by weight, in particular 0.4% by weight.
After the mold carrier with the dipping molds is lifted out of the heterogeneous mixture of polymeric material and microcapsules 7 to produce the anti-friction layer 2, the applied anti-friction layer 2 is dried, preferably with hot air, for example at a temperature of between 70° C. and 140° C., preferably 90° C. to 110° C., for a period of 15 sec. to 60 sec. The temperature and duration of the hot air treatment are preferably adjusted so that the surface of the anti-friction layer 2 changes to a gel-like or solid state.
Immediately afterwards, the dipping molds with the rough parts of the prophylactic articles, in particular gloves, located thereon are dipped in another dipping bath in which the anti-friction layer 2 is sprayed or rinsed with water, preferably hot water at a temperature of between 40° C. and 95° C., preferably 70° C. to 90° C. This operation is known as “leaching” in technical terminology.
The chemical reaction in the anti-friction layer 2 and the base layer 1 is initiated or assisted by this hot water treatment, so that the initiation of coagulation or full coagulation occurs in this layer.
After the specified drying operation, the prophylactic articles are drawn off the molds, washed if necessary “offline,” chloridized in order to change the surface structure and dried again.
In an alternative embodiment, the microcapsules 7 can also be applied, e.g., by spraying, to the anti-friction layer 2 after bonding thereof with the base layer 1.
The anti-friction layer is formed by a composition that is composed of a mixture comprising water, polyurethane and microcapsules 7, whereby 90% of the microcapsules 7 have a diameter of less than 10 μm.
The composition can furthermore contain at least one acrylate, carboxylated butadiene and silicone, in particular self-crosslinking silicone.
The pH value of the composition is approximately neutral and preferably selected from a range with a lower limit of 5.5 and an upper limit of 8 in order to come as close as possible to the physiological conditions of the skin's surface.
The prophylactic article, in addition to gloves, in particular medical surgical gloves and examination gloves, can also be a catheter, condom, finger-stall, bathing cap, flippers or protective gloves for working in clean room environments, etc.
With regard to the detailed structure of the glove, the materials used, the production process and the active substances to be packed in the microcapsules 7, reference is made in addition to the applicant's published Austrian application no. A 786/2003.
The exemplary embodiments show possible embodiment variants of the prophylactic article, whereby it is noted at this point that the invention is not restricted to the embodiment variants specifically shown, but rather diverse combinations of the individual embodiment variants with one another are also possible and this possibility of variation based on the directive for technical actions through the present invention lies within the ability of one skilled in the art in this field. All the conceivable embodiment variants that are possible by combining individual details of the embodiment variant shown and described are thus also covered by the scope of the application.
As a matter of form, it is noted in conclusion that to aid better understanding of the structure of the prophylactic article, the article or its components have been shown in part not to scale and/or enlarged and/or reduced.
The object on which the independent inventive solutions are based can be taken from the specification.

LIST OF REFERENCE NUMBERS

1 Base layer
2 Anti-friction layer
3 Internal surface
4 External surface
5 Internal surface
6 External surface
7 Microcapsule
8 Singular capsule
9 Agglomerate

Claims

1. Multi-layered prophylactic article, in particular a medical glove, of at least one elastomeric base layer and at least in some areas an anti-friction layer with respectively one internal and one external surface, whereby the external surface of the anti-friction layer is facing the internal surface of the base layer and microcapsules are contained in the anti-friction layer, characterized in that at least 90% of the microcapsules as singular capsules have a diameter of less than 10 μm.

2. Prophylactic article according to claim 1, characterized in that the microcapsules as singular capsules have a diameter selected from a range with a lower limit of 0.1 μm, preferably 0.5 μm, in particular 1 μm, and an upper limit of 10 μm, preferably 9 μm, in particular 8 μm.

3. Prophylactic article according to claim 1, characterized in that at least one active substance, in particular an antibacterial, antiviral, antiperspirant or spermicidal active substance, and/or a dye is contained in the microcapsules.

4. Prophylactic article according to claim 3, characterized in that the active substance and/or dye is soluble at a temperature with an upper limit of 42° C., in particular 41° C., preferably 40° C., and a lower limit of 28° C., in particular 32° C., preferably 36° C.

5. Prophylactic article according to claim 1, characterized in that the proportion of microcapsules in the anti-friction layer is less than 1% by weight.

6. Prophylactic article according to claim 5, characterized in that the proportion of microcapsules in the anti-friction layer is selected from a range with a lower limit of 0.05% by weight, preferably 0.08% by weight, in particular 0.1% by weight, and an upper limit of 0.95% by weight, preferably 0.8% by weight, in particular 0.75% by weight.

7. Prophylactic article according to, characterized in that the singular capsules are arranged as agglomerates.

8. Prophylactic article according to claim 7, characterized in that a defined number of singular capsules with a lower limit of 100, in particular 200, preferably 500, and an upper level of 10,000, in particular 5,000, preferably 1,000, respectively form one agglomerate.

9. Prophylactic article according to claim 7, characterized in that the agglomerates are shaped in an approximately spherical manner, optionally in a soccer ball-like manner.

10. Prophylactic article according to claim 7, characterized in that the agglomerates are hollow.

11. Prophylactic article according to claim 7, characterized in that several agglomerates are joined together.

12. Prophylactic article according to claim 7, characterized in that the agglomerates have a size/diameter selected from a range with a lower limit of 5 μm, preferably 10 μm, in particular 15 μm, and an upper limit of 100 μm, preferably 80 μm, in particular 70 μm.

13. Prophylactic article according to claim 1, characterized in that the diameter of the singular capsules and/or agglomerates is less than 50%, preferably 45%, in particular 40% of the thickness of the anti-friction layer.

14. Prophylactic article according to claim 1, characterized in that the microcapsules and/or agglomerates are integrated into the internal surface and/or arranged directly adjacent to the internal surface of the anti-friction layer in the direction of the base layer.

15. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates have a coating.

16. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates are marked with a dye.

17. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates are water-insoluble.

18. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates are water-soluble.

19. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates are arranged at least in some areas in the region of the distal forearm, the wrist, the carpalia, the metacarpal bones and/or the base, middle and terminal phalanges of the fingers of a medical glove.

20. Prophylactic article according to claim 1, characterized in that the singular capsules and/or agglomerates are arranged at least in some regions in both the palm and dorsal areas.

21. Prophylactic article according to claim 1, characterized in that during use a change occurs in the surface structure of the anti-friction layer.

22. Method for the production of a prophylactic article according to claim 1, characterized in that for the anti-friction layer at least 90% of the microcapsules are used as singular capsules with a diameter of less than 10 μm.

23. Method according to claim 22, comprising the steps a) dipping a mold in a coagulant solution, b) surface drying, c) dipping in an elastomer mixture, d) surface drying, e) dipping in a composition with microcapsules (7) with a diameter of less than 10 μm, f) surface drying, g) leaching, h) drying, i) removal from the mold, j) washing, k) chloridizing and l) drying.

24. Composition for the production of an anti-friction layer of a prophylactic article, in particular a glove, comprising a mixture of water, polyurethane and microcapsules, whereby 90% of the microcapsules have a diameter of less than 10 μm.

25. Composition according to claim 24, characterized in that the concentration of the microcapsules is selected from a range with a lower limit of 0.01%, preferably 0.1%, in particular 0.5%, and an upper limit of 10%, preferably 5%, in particular 1%.

26. Composition according to claim 24, characterized in that acrylate and/or carboxylated butadiene and/or silicone are contained.

27. Composition according to claim 26, characterized in that the silicone has self-crosslinking properties.

28. Composition according to claim 24, characterized in that the pH value is approximately neutral.

29. Composition according to claim 28, characterized in that the pH value is selected from a range with a lower limit of 5.5, preferably 6, in particular 6.5, and an upper limit of 8, preferably 7.5, in particular 7.2.

30. Use of the composition according to claim 24 as an anti-friction layer for a prophylactic article, in particular a medical glove.