• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a medical product, in particular a one-piece skin protection plate or condom formed of a polymeric material into which medical honey is incorporated, optionally formed together with an ostomy bag.
    公开号:DK201500056U1
    申请号:DK201500056U
    申请日:2015-04-17
    公开日:2015-07-24
    发明作者:
    申请人:Milacek Walter；
    IPC主号:
    专利说明:

    The present invention relates to medical products, e.g. peristomal skin protection plates or condoms as well as a method for their preparation.
    The prior art
    An enterostoma means an artificial bowel outlet that is produced surgically, a portion of the bowel being passed through an opening in the abdominal wall and stitched together with the abdominal wall.
    To protect the skin around such an enterostoma from the excrement coming out of the stoma, and to simultaneously fix the bag to accommodate these excrements, a thin plate referred to as a peristomal skin protection or base plate is adhered to the skin.
    This can be designed as a system in one part with the bag or in two parts, which means that the skin protection plate must also be renewed at every replacement of the bag or only a new bag must be attached to the plate. Which embodiment is used depends, inter alia, on also of the skin compatibility of the plate.
    Of course, the material of the skin protection plate should not irritate the skin and must, on the one hand, be sufficiently flexible to adapt to the body contours, but on the other hand also be sufficiently rigid to be able to carry the bag attached thereon. Nowadays, so-called hydrocolloids are often used, ie. gels of polysaccharides or proteins in water, including, for example, pectins or also modified polysaccharides such as carboxymethyl cellulose (CMC), and gelatin. In addition, various, possibly crosslinked rubber sugars and rubber-like polymers such as e.g. polyisobutylene or butyl rubber, and various additives and fillers such as cotton fibers.
    Recently, a stoma supply system has been offered with a skin protection plate containing as "skin friendly" termed Aloe vera extract. This is a heteropolysaccharides as well as several monosaccharides gel which may additionally contain water soluble vitamins, amino acids, amylase, alkaline phosphatase, lipase and salicylic acid. By topical application, this extract is attributed to anti-inflammatory, wound healing and immune stimulating properties, which is why it is often applied to it in cosmetics and folk medicine. A scientific demonstration of such effects, especially of the wound healing, is still missing (see, for example, W. Brodschelm, "Aloe vera auf dem Prijfstand", Pharmazeutische Zeitung online 04/2004).
    Apart from the undetected wound healing effect, the use of Aloe vera extract is problematic, first and foremost with skin protection plates, the material of which is also based on polysaccharides, since using such amounts of extract that could actually produce a physiological effect in the skin, may occur incompatibilities. Furthermore, the presence of amylases in such polysaccharide-based skin protective plates is highly undesirable since these enzymes definition breaks down polysaccharides. Both of these factors can significantly impair the strength and stability of the plate.
    From DE 38 27 561 C1 and DE 44 16 927 C1 are known as adhesives acting as gels for use in the medicine containing honey as adhesives or adhesive resins. Furthermore, WO 2007/009185 A1 includes the preparation and medical use of honey (Manuka honey) with non-peroxide-based antimicrobial activity. Manuka honey is also used by Welland under the trade name Aurum ™ as an adhesive for skin protection products and drainage bags for ostomy patients. Of course, this is also a superficial application, as is also known from CN 2887277 Y to honey-coated condoms on the outside.
    A disadvantage of such embodiments of medical products is admittedly that a layer of honey applied only to the surface can be easily removed, ie e.g. can be wiped off, thereby ensuring no lasting skin contact with the medical honey.
    The object of the invention has therefore consisted in at least partially removing the above disadvantages.
    Disclosure of the production
    The production achieves this goal in a first aspect of providing a medical product, especially a peristomal skin protection plate or condom, from a polymeric material into which the medical honey is incorporated.
    Here, medical honey means a honey quality approved as a medical product, e.g. the product negotiated under the name "Medihoney" since 2005. This particular honey is sterilized with gamma rays to kill any trace of germ therein, although it in itself has demonstrable antiseptic, anti-inflammatory and wound healing effects. For this reason, medical honey is utilized i.a. such as wound dressing.
    Due to the direct incorporation of the honey into the medical product, no wiping, washing or trimming of the honey from the surface of the medical product can occur as the honey continuously migrates out of the polymeric material and can contact the skin of the user for an extended period of time. of the medical product.
    By incorporating medical honey into a skin protection plate for the stoma supply, which may be integrally formed with an ostomy bag, or in a condom, the effects of the honey may advantageously unfold on the wearer's skin, with corresponding active ingredients of the honey migrating from the polymeric material into the wearer's skin. as this will be explained in more detail below.
    However, when used in a polymeric material for a condom, the medical honey serves not only as a skin care agent, but also on the inside as an adhesive that prevents the condom from being stripped off during use, as well as on the outside as a bactericide (e.g. in combination with a optionally silver chloride-containing coating) and as a flavoring agent.
    In addition, the honey, especially when used in a skin protection plate according to the invention, provides nutrients for the skin cells, which e.g. results in faster post-operative regeneration of the skin at the edge of the stoma, but also a supply and thus retention of the skin under the skin protection plate, which is particularly important in two-part embodiments of the stoma supply system, where the peristomal skin protection plate is worn for an extended period of time, and only the pouch replaced at short intervals. The skin under the skin protection plate thus remains more elastic, more supple and more resistant than is the case with skin protection plates according to the prior art.
    Among the nutrients released to the skin are primarily sugars, such as fructose and glucose, which are the main constituents of honey, but also minerals, proteins, vitamins and amino acids. Thus, unlike the polysaccharides which are major constituents of Aloe vera extract, honey consists predominantly of monosaccharides as well as other low molecular weight components that are capable of migrating within a carrier or matrix layer and can penetrate upon contact with the skin. in this.
    In addition, the medical honey may also be contained in a layer of a skin-compatible adhesive on the surface of the medical product. Thus, both the polymeric material of the medical product and the adhesive layer can simultaneously serve as matrix layers for the medical honey. Whether such an adhesive layer is applied depends on skin protection plates first and foremost on whether the stoma supply system is one or two parts, ie how long the skin protection plate is continuously worn by the patient.
    In one-part systems where the skin protection plate is usually changed several times daily with the bag, preferably an adhesive layer is provided, since the time for migrating components of the honey from the polymeric material of the plate to the skin is very short.
    However, in two-part systems where the skin protection plate is worn for an extended period of time and only the bag is changed at short intervals, it is sufficient only to place the medical honey in the polymer material of the plate itself.
    Of course, the skin-compatible adhesive, for which an acrylate or polysaccharide-based adhesive is usually used, must be compatible with the medical honey so that they form a stable mixture in which no phase separation occurs. For this reason, according to the present invention, preferably a starch or cellulose adhesive is used, e.g. carboxymethyl cellulose.
    The amount of medical honey is not very limited as long as the mode of action of the matrix in which it is incorporated, ie. the polymeric material of a skin protective plate itself and, optionally, the adhesive, does not deteriorate, and components of the honey which exhibit an advantageous effect in the skin may pass to the skin in sufficient quantity. For the latter purpose, a very small amount of medical honey, e.g. only 0.5 or 1% by weight, be sufficient, especially where the skin protection plate is not changed daily, ie. is available in a two-part stoma supply system.
    In preferred embodiments, the honey is contained in proportions of up to 10% by weight in the polymeric material of the medical product and - first and foremost by skin protection plates - possibly also in an additional adhesive layer, since the strength and stability of the polymeric material or the adhesive strength of the adhesive could diminish in larger quantities. It is true that one skilled in the art will be able to find the optimal amount of medical honey for a defined medical product without the excessive experimentation of simple series tests and migration tests with standardized artificial skin or pig skin or other test systems.
    In another aspect, the present invention relates to a process for preparing the above-mentioned medical products according to the first aspect, the method comprising the steps of: a) mixing a curable polymer composition with medical honey, the honey optionally being mixed with the polymer composition in the form of a composition; which includes medical honey; b) forming the mixture; and c) curing the mixture to obtain the skin protection plate.
    The polymer composition is not particularly restricted as long as it is compatible with the medical honey mentioned above. In order to improve the medical honey's incorporability in the polymer composition and miscibility thereof, the medical honey can be used in the form of a honey-containing composition, ie. for example as a solution, suspension or dispersion in water and / or a solvent or solvent mixture. This composition may also be an adhesive comprising medical honey and which, in addition to the honey itself, comprises a polymer moiety, e.g. on the basis of natural latex, mastix, acrylate or starch, and together with the honey is incorporated into the polymeric material of the medical product.
    Specifically, but not only in the latter embodiments, there may be a curing step prior to the subsequent forming of the mixture which, like the later curing step c), may, for example, be selected from evaporation of any solvents, e.g. by drying, thickening the mixture, e.g. by gelation, and (for) crosslinking the polymer moiety in the mixture, e.g. by irradiation or heating.
    The mixing of the mixture may take place simultaneously with any curing step or simultaneously with the curing step or separated therefrom, depending on the consistency of the mixture at that particular time. The molding process is not very limited and may include any plastic processing methods such as extrusion, injection molding or dipping. Preferably, a skin protection plate according to the manufacture is produced by a rolling press / punching method in which the pulp is rolled by (hot) rolls to a web of the desired thickness - and thereby possibly simultaneously cured - from which the skin protection plates are then punched in the desired shape. A condom, on the other hand, is preferably made by a conventional dipping method and subsequent curing (vulcanization), adding to the mass of the polymeric material to be cured (latex, silicone or the like), simply adding the desired percentage of honey before dipping the molding bodies and thus molding the molding body. with the pulp coated surface (hot) is vulcanized.
    As mentioned above, the medical honey is preferably mixed in a proportion of up to 10% by weight of the polymer portion with the polymer composition. When using a honey-containing composition, ie. of course, a solution, suspension or dispersion, as mentioned above, is of course mixed in a correspondingly larger amount.
    Thus, in the present invention, there is provided a medical product, e.g. a skin protection plate as part of a stoma supply system or a condom which exhibits various exceedingly beneficial effects on the wearer's skin.
    权利要求:
    Claims (7)
    [1]
    1. Medical product of a polymer material which is new in that medical honey has been incorporated into the polymer material.
    [2]
    A medical product according to claim 1, which is new in that it is a one-piece optionally formed with an ostomy pouch or a condom.
    [3]
    The medical product of claim 1 or 1, which is new in that it has on the surface contacting the skin with a layer of skin-compatible adhesive which also comprises medical honey.
    [4]
    A medical product according to any one of claims 1 to 3, which is new in that the medical honey is contained in a proportion of up to 10% by weight in the polymeric material and optionally also in the optional adhesive layer.
    [5]
    A medical product according to any one of claims 1 to 4 prepared from a polymeric material into which the medical honey is incorporated, by the following steps: a) mixing a curable polymer composition with medical honey, optionally in the form of a composition comprising medical honey; b) forming the mixture; and c) curing the mixture to obtain the medical product.
    [6]
    A medical product according to claim 5, which is new in that prior to the forming of the mixture in step b) a hardening has taken place.
    [7]
    Medical product according to claim 5 or 6, which is new in that the medical honey is mixed with the polymer composition in a proportion of up to 10% by weight of the polymer proportion.
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    同族专利:
    公开号 | 公开日
    AT14961U1|2016-09-15|
    FR3019990B3|2016-06-17|
    DK201500056Y3|2015-08-28|
    DE202015101903U1|2015-05-04|
    FR3019990A3|2015-10-23|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    DE3827561C1|1988-08-13|1989-12-28|Lts Lohmann Therapie-Systeme Gmbh & Co Kg, 5450 Neuwied, De|
    DE4416927C1|1994-05-13|1995-08-31|Lohmann Therapie Syst Lts|Device for release of active agents from melt-type adhesive|
    HU225388B1|2001-05-31|2006-11-28|Viola Dr Szabo|Rubber device for preventing infections and reducing spread of infections|
    WO2007009185A1|2005-07-19|2007-01-25|Honey Research & Development Pty Ltd|Therapeutic honey and method of producing same|
    法律状态:
    2018-11-14| UBP| Utility model lapsed|Effective date: 20180417 |
    优先权:
    申请号 | 申请日 | 专利标题
    AT1672014|2014-04-17|
    AT16714|2014-04-17|
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