• 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:
    wound dressing product, wound dressing material, and method of manufacturing a wound dressing material. a wound dressing product comprising: a substrate layer having an upper surface and a lower surface; a sticky silicone coating composition present on said upper surface and said lower surface; and the upper and lower release sheets covering said substrate and said sticky silicone coating composition on said upper and lower surfaces, respectively, and adhered to said surfaces by said sticky silicone coating composition, wherein said upper surface is less sticky than said lower surface whereby said upper release sheet can be removed from said upper surface more easily than said lower release sheet can be removed from said lower surface. The same silicone composition is used to form both upper and lower surface tanthol. Methods for making such dressings are also provided.
    公开号:BR112013005100B1
    申请号:R112013005100
    申请日:2011-08-22
    公开日:2019-01-02
    发明作者:Addison Deborah；Hadley Rachel；Stephens Sally
    申请人:Systagenix Wound Man Ip Co Bv；
    IPC主号:
    专利说明:

    “WOUND DRESSING PRODUCT, WOUND DRESSING MATERIAL, AND METHOD OF MANUFACTURING WOUND DRESSING MATERIAL”
    The present invention relates to wound dressings that comprise a substrate coated on both surfaces with a sticky silicone gel, where the surfaces have different payability, and methods of making such dressings.
    The dressing materials for application to the wound surface desirably should be non-adherent to the wet wound surface, but sufficiently sticky to allow the dressing to bond to the intact skin around the wound and to bond to the other dressing layers such as absorbent layers. For this purpose a soft or sticky hydrophobic material is suitable for the material. The material that contacts the wound should desirably be liquid-permeable to allow fluid to flow from the wound, especially to exudate heavily wounds such as burns. The material must also be non-irritating, inexpensive, and stable in common sterilization methods such as ionizing radiation.
    Traditional “fatty tulle” dressings generally consist of a layer of gauze coated with paraffin wax. Such dressings have several desired properties, and for this reason they have been used extensively for many years. Among these advantages are their high degree of conformability and deformability, and the fact that their stickiness makes them very easy to apply. That is to say, a fatty tulle dressing applied to a wound will usually remain in place simply by adhering the paraffin wax to the patient's skin (or himself in the case of a dressing wrapped around a finger, for example) although a closing bandage is applied. Greasy tulle dressings are also very cheap. However, fatty tulle dressings have several disadvantages. The main among these is that, although initially non-adherent, they often become “dry” (in the sense of losing their paraffin coating) and consequently adhere to the wound to which they are applied. This effect is due to the paraffin coating that becomes mobile at body temperatures and either migrates into the wound or is absorbed into the back layer of the dressing or bandage. In some cases, removing a fatty tulle dressing that has been dried in this way can cause considerable trauma. In fact, it is quite common to have to soak greasy tulle dressings in order to remove them. If fatty tulle dressings are changed more frequently, in an attempt to prevent them from becoming attached to the wound, this can delay wound healing and add nursing costs.
    Another disadvantage of traditional fatty tulle dressings is that the gauze fibers can become embedded in the wound, as can the paraffin dressing of the dressing. Some authorities see paraffin migration into a wound as an undesirable effect, and any paraffin found in a wound can be difficult to remove with normal aqueous wound cleaners. In addition, the pores of the gauze may become clogged if the paraffin coating is too heavy or as a result of paraffin mobility during the dressing. Although occlusive dressings are appropriate in some circumstances, it is undesirable that nursing personnel have no control over whether the dressing used is indeed occlusive.
    Other disadvantages of conventional fatty tulle dressings are that they are effectively opaque and somewhat ugly in appearance, and the paraffin can shift during storage, making them particularly difficult to apply.
    EP-A-0251810 describes wound dressing materials that overcome the above disadvantages by replacing the conventional fatty tulle paraffin wax coating with a sticky or non-sticky hydrophobic silicone coating, hydrophobic silicone coating on a gauze substrate or mesh. In certain embodiments, the gauze may be provided with a sticky silicone coating on one side and a non-sticky silicone coating having a different composition on the other side. Similar materials are described in WO-A-8705206.
    EP-A-0342950 describes similar wound dressings having a non-stick silicone coating. The adhesion of the silicone is reduced by the addition of an extended polyurethane with amine.
    US-B-6846508 describes medical adhesive devices having layers of sticky silicone on both surfaces of a substrate. The material of the sticky layers can be the same or different, and the stickiness of the layers can be the same or different.
    US-A-5891076 describes excoriation dressings comprising a carrier material embedded in a layer of silicone gel that is sticky, and cover sheets over the layers of silicone gel.
    JP-A-10095072 describes a double-sided silicone adhesive tape for non-medical adhesive applications and having release sheets over the silicone adhesive.
    The present invention provides a wound dressing product comprising: a layer of substrate having an upper surface and a lower surface; a sticky silicone coating composition present on said top surface and said bottom surface; and top and bottom release sheets covering said substrate and said sticky silicone coating composition on said top and bottom surfaces, respectively, and adhered to said surfaces by said sticky silicone coating composition, on said surface top is less sticky than said bottom surface by means of which said top release sheet can be removed from said top surface more easily than said bottom release sheet can be removed from said bottom surface.
    Suitably, the substrate is porous, whereby the substrate is permeable to the fluid. For example, the substrate may be a mesh or weft or cloth suitably formed from a woven, nonwoven or knitted textile product or a molded mesh.
    In certain embodiments the substrate is a cloth such as gauze, or a mesh, having an arrangement of openings. The size and shape of the openings in the substrate are not critical, but the openings must be suitably such as to ensure that the material can be properly coated with silicone gel without it becoming clogged. The openings in general have an aspect ratio of 1: 1 to 5: 1, and preferably 1: 1 to 2: 1. For example, the openings can be approximately circular or approximately square. The openings suitably have an average diameter of 0.3 to 4 mm, and more suitably 0.5 to 2 mm.
    The substrate is suitably formed from any medically acceptable material, such as cellulose, polyolefins, polyesters, or polyamides. An especially suitable material is cellulose acetate gauze. Substrates having a weight of 15 to 200 g / m 2 are generally found to be suitable for use in the products of the invention, and cloths weighing from 50 to 150 g / m 2 are most suitable. For example, certain embodiments
    A use a cloth of 80 to 120 g / m.
    Suitably, the silicone coated substrate product retains open openings to allow fluid from the wound to pass through the coated substrate. For example, an arrangement of openings may extend through said silicone coatings and the substrate layer. The open area of the coated substrate in the final product, for example, can be from about 1% to about 70%, for example from about 10% to about 50%.
    The dressing materials of the invention are characterized by the upper and lower sticky silicone coatings on the substrate, where the upper and lower silicone coatings have different payability. This provides the advantage that both surfaces can be protected before use by the covering sheets adhered to the coating by their stickiness, but one of the covering sheets can be removed more easily than the other through which the dressing is applied. easier. Not only is it easier to selectively remove the first cover sheet if it is less strongly adhered than the second cover sheet, but the resulting less exposed adhesive surface is more suitable for application to the wound surface. The second cover sheet can then be removed to expose a more adherent surface for the application of secondary dressing layers, such as absorbent layers.
    The difference in tackiness between the top and bottom silicone coatings is appropriately selected to optimize the above properties. For example, the tackiness of the bottom surface as measured by a loop adhesion test (described below) is suitably 5% to 50% greater than the tackiness of the top surface, more suitably 20% to 100% greater, for example about 30% to 70% higher. Suitably, the tackiness of the surfaces as measured by the loop adhesion test is greater than about 0.3 N. For example, it can be from about 0.4 N to about 2 N, more suitably about 0 , 5 N to about 1.5 N. In embodiments, the stickiness of one surface is about 0.4 N to about 1 N and the adhesion of the other surface is about 0.5 N to about of 1.5 N.
    Suitably, the above difference in tackiness can be obtained in materials in which the silicone on said upper and lower surfaces is substantially chemically homogeneous. That is to say, in which the same silicone prepolymer is coated on the upper and lower surfaces, but differences in the coating or curing conditions are used to obtain different payability on the upper and lower surfaces. Thus, both surfaces were formed by curing the same fluid silicone prepolymer.
    The term “chemically homogeneous” means that the chemical analysis (% by weight of silicon, carbon, oxygen, etc.) is the same on the upper and lower surfaces, but the tackiness may be different due to the different degrees or type of cure between the different surfaces and / or coating thicknesses on the two surfaces. Thus, the silicone material forms a chemically continuous homogeneous phase having different payability on its opposite surfaces.
    The total coating weight of the sticky silicone (combined top and bottom layers) is suitably from about 50 g / m 2 to about 500 g / m 2 , for example from about 80 g / m 2 to about 200 g / m m 2 , typically from about 100 g / m 2 to about 150 g / m 2 . The silicone is suitably a soft skin adhesive silicone composition. Suitably the chemistry is described below. The silicone is suitably hydrophobic.
    The effectiveness of encapsulation by silicone means that the substrate can be printed or dyed with decorative or informative material with little risk of the ink or dye being released into the wound to which the dressing is applied. Visible distinctive marks, such as a color or writing, can be provided on one or both of the substrate surfaces and / or on one or both cover sheets to indicate which side of the product has more / less sticky silicone coating and so indicate which cover sheet is removed first and which silicone surface is less sticky for application to the wound surface.
    The cover sheets may comprise a film of polyethylene, polypropylene or fluorocarbons and papers coated with these materials. Suitably, the cover sheet is a release-coating paper sheet, such as a silicone coating release paper sheet. Examples of silicone coated release papers are POLISLIK (Registered Trademark) provided by Η. P. Smith & Co., offered in various formulations to control the degree of adhesion of the paper to the adhesive surface.
    In certain embodiments, one or both cover sheets may comprise two or more parts, such as a first removable part having a first edge and a second removable part which meets the first part along the first edge. Suitably, along each of said edges where the parts meet, one of the parts is folded back to provide a folded back margin, and the other part overlaps said folded back margin. This provides an easy-to-hold margin on each part in the overlap region to assist the healthcare professional in removing the cover sheet.
    In other embodiments, one or both cover sheets may comprise three parts, for example as described in detail in EP-A-0117632.
    The products of the invention can be manufactured in wound dressings for application to the surface of a wound by removing the top and bottom cover sheets. Suitably, the products of the invention consist essentially of the substrate, silicone coatings, and cover sheets. Suitably, the products of the invention are sterile and packaged in a container impermeable to microorganisms.
    In another aspect, the invention provides a method of making a material wound dressing that comprises:
    providing a substrate layer having an upper surface and a lower surface;
    coating said upper and lower surfaces of said substrate layer with a fluid silicone prepolymer composition; followed by partial thermal curing of said silicone prepolymer composition to produce an intermediate material having a partially cured silicone composition on said upper and lower surfaces; followed by the storage of said intermediate material at a temperature below 50 ° C for at least 2 days to allow the balance of the silicone coatings on the upper and lower surfaces; followed by another cure of said silicone composition partially cured by exposing said intermediate material to ionizing radiation, to produce a final material having sticky silicone coatings on said upper and lower surfaces.
    In another aspect, the invention provides a method of making a wound dressing material that comprises:
    providing a substrate layer having an upper surface and a lower surface;
    coating said upper and lower surfaces of said substrate layer with a fluid silicone prepolymer composition; followed by partial thermal curing of said silicone prepolymer composition to produce an intermediate material having a partially cured silicone composition on said upper and lower surfaces; followed by further curing of said partially cured silicone composition by exposing said intermediate material to ionizing radiation, to produce a final material having sticky silicone coatings on said top and bottom surfaces, wherein (a) said coating step applies unequal weights of the silicone coating composition to said upper and lower surfaces, and / or (b) said partial thermal curing step applies different amounts of heat to said upper and lower surfaces, whereby said silicone coatings on said upper and lower surfaces have different payability after said additional curing step.
    The substrate layer is suitably as previously described for the products of the invention. Suitably, the substrate layer is permeable to the fluid silicone prepolymer composition. The coating step can be carried out in any conventional way, for example dipping, spraying, or doctor blade. The coating step suitably comprises passing the coated substrate through nip rollers to ensure smooth coating and penetration of the coating composition. Suitably, the coating step is followed by a step of blowing gas (such as air) through the substrate to ensure that the openings in the material are open after coating.
    The fluid silicone coating composition is suitably substantially or completely solvent free. Suitably, both surfaces are coated with the same silicone coating composition. The methods of the present invention allows products having different payability on the upper and lower surfaces to be manufactured with a single silicone coating composition on both surfaces.
    Suitably, the silicone composition is called a soft skin adhesive silicone elastomer. Such silicones can be manufactured by an addition reaction (hydrosilylation) between (a) a vinyl functional polydimethyl siloxane, such as bis-dimethyl vinyl PDMS, and (b) a hydrogen functional siloxane, such as dimethyl, methyl hydrogen copolymers siloxane, PDMS terminated in dimethylsiloxy hydrogen. The curing reaction is catalyzed by a hydrosilylation catalyst, such as a noble metal catalyst, suitably a platinum catalyst. Suitably the silicone prepolymer composition further comprises a polymerization inhibitor which is evaporated from said composition during said partial thermal curing step, for example 2-methyl-3-butin-2-ol. The polymerization inhibitor is suitably present in an amount from about 0.001% by weight to about 1% by weight, for example from about 0.01% by weight to about 0.1% by weight prior to curing.
    Silicone skin adhesive compositions are suitably supplied as two-part systems: Part A contains at least the vinyl prepolymer and the catalyst, while Part B contains the vinyl prepolymer and the crosslinked SiH siloxane. The components are mixed immediately before use, optionally with the addition of the polymerization inhibitor.
    In embodiments, the silicone coating composition essentially comprises or consists of the following components:
    (A) a diorganopolysiloxane having at least 2 alkenyl groups on each molecule;
    (B) an organohydrogen polysiloxane having at least 2 hydrogen atoms bonded by silicon in each molecule, in an amount sufficient for the ratio between the number of moles of hydrogen atoms bonded by silicon in this component and the number of moles of alkenyl groups in component (A) has a value of about 0.6: 1 to about 20: 1, (C) optionally a platinum group metal catalyst suitably in an amount to provide 0.1 to 500 parts by weight as metal from the platinum group per 1,000,000 parts by weight of component (A), and (D) a volatile polarization inhibitor, suitably selected from: alkaline alcohols such as 2-methyl-3-butin-2-ol, 3, 5-dimethyl-hexin-3-ol, and phenylbutinol; eneine compounds such as 3-methyl-3-penten-1-yne and 3,5-dimethyl-3-hexen-1-yne; tetramethyltetraexenylcyclotetrasiloxane; and benzotriazole.
    The diorganopolysiloxane, component (A), used in the present invention is the base component of the total composition. This diorganopolysiloxane must contain at least 2 alkenyl groups in each molecule so that the composition cures in a rubberized elastic silicone rubber coating composition.
    Diorganopolysiloxane (A) essentially comprises straight chain organopolysiloxane with the average unit formula R n SiO4-n / 2, where R is selected from substituted and unsubstituted monovalent hydrocarbon groups and has a value of 1.9 to 2.1 . R can be exemplified by alkyl groups such as methyl, ethyl, propyl, and others; alkenyl groups such as vinyl, allyl, and others; aryl groups such as phenyl, and others; and haloalkyl groups such as 3,3,3-trifluoropropyl and others. The diorganopolysiloxane (A) must have a viscosity at 25 ° C of at least 100 centipoise (1 d Pa.s). When such factors as the strength of the silicone rubber coating membrane, and mixability are taken into account, the viscosity of the diorganopolysiloxane (A) at 25 ° C is preferably from 1,000 centipoise (1 Pa.s) to 100,000 centipoise (100 Pa.s). Diorganopolysiloxane (A) can be exemplified by the dimethylsiloxane-blocked end-dimethylpolysiloxanes, end-blocked dimethylsiloxane-methyl-vinylsiloxane copolymers, and dimethylsiloxy-methylsiloxy-siloxyoxy-siloxyoxy-siloxyoxy-endoxymethyloxyoxyoxyoxyoxyoxyoxyoxyoxyoxy-siloxyoxy-methylenedoxyoxy-siloxyoxy-methyl-siloxyoxy-methyl-siloxyoxy-methylenedioloxane.
    Component (B), an organopolysiloxane containing at least 2 hydrogen atoms bonded with silicon in each molecule, is a crosslinker for the composition of the present invention. Organopolysiloxane (B) can be exemplified by the methylhydrogen polysiloxanes end-blocked with trimethylsiloxy, dimethylsiloxanomethylhydrogenosiloxane copolymers end-blocked with trimethylsiloxy, methylphenylsiloxymethylhydro-siloxy units and methylphenylsiloxy-oxides and methylphenylsiloxy-oxides with dimethyls . The organohydrogenopolysiloxane (B) must be added in an amount that the ratio of the number of moles of hydrogen atoms attached to the silicon in this organohydrogenopolysiloxane to the number of moles of the alkenyl groups in component (A) has a value of 0.6 : 1 to 20: 1.
    The platinum group metal catalyst, component (C), used in the compositions is a curing catalyst. The platinum group metal catalyst (C) can be exemplified by the platinum micropowder, platinum black, chloroplatinic acid, platinum tetrachloride, chloroplatinic acid olefin complexes, alcoholic solutions of chloroplatinic acid complexes, complexes between chloroplatinic acid and alkenylsiloxanes, rhodium compounds, and palladium compounds. The platinum group metal catalyst (C) should be added in general from 0.1 to 500 parts by weight as platinum group metal per 1,000,000 parts by weight of component (A), and is preferably used from 1 to 50 parts by weight as a platinum group metal per 1,000,000 parts by weight of component (A). The reaction will not develop properly at less than 0.1 part by weight, while additions in excess of 500 parts by weight are not economical.
    The coated substrate is then subjected to thermal curing to partially cure the silicone. The thermal coating is properly carried out by continuously passing the coated substrate through an oven. Suitable thermal curing conditions include exposure to a temperature of about 80 ° C to about 200 ° C, for example from about 120 ° C to about 180 ° C for a time of about 1 minute to about 10 minutes, for example from about 1.5 minutes to about 5 minutes. The high temperature results in the evaporation of the polymerization inhibitor from the silicone composition and therefore in the polymerization of the silicone. The resulting material is chemically polymerized, but still capable of curing by ionizing radiation as explained below.
    The partially cured material has uneven stickiness of the silicone coating on the upper and lower surfaces. This uneven stickiness can be produced (1) by the uneven coating weight of the silicone on the top and bottom surfaces, and / or (2) the step of blowing air through the coated substrate to open the openings, which results in a more coating weight high silicon on the surface that is downstream of the air flow, and / or (3) uneven amounts of heat supplied to the upper and lower surfaces in the stove result in different degrees of curing on the two surfaces.
    The initial difference in tackiness of the upper and lower surfaces is typically much greater than desired for the final product. However, the present inventors have found that the tackiness of the upper and lower surfaces gradually evens out if the partially cured material is stored at temperatures below about 50 ° C, for example ambient or close to ambient temperatures such as 10 to 50 ° C , for a period of about 2 days to about 10 weeks. Therefore, suitably the partially cured material is stored at such temperatures for a period of at least about 2 days, suitably from about 2 weeks to about 10 weeks, for example from about 3 weeks to about 8 weeks before curing end with ionizing radiation.
    Suitably, the method of the invention further comprises applying top and bottom release sheets over said silicone composition to the top and bottom surfaces. Suitably, the upper and lower release sheets are applied between said partial thermal curing and storage steps, by means of which, for example, the partially cured material having the cover sheets can be rolled up for the storage step.
    The partially cured material is then subjected to final curing with ionizing radiation. Ionizing radiation is suitably selected from beam and gamma radiation. A variety of curing procedures for E-beam and gamma ray are well known. The cure depends on the specific equipment used, and those skilled in the art can define a dose calibration model for the specific equipment, geometry, and line speed, as well as other well-understood process parameters.
    Equipment that generates commercially available electron beam is readily available. For example, a Model CB-300 electron beam generating apparatus (available from Energy Sciences, Inc. (Wilmington, MA). In general, a backing film (for example, polyester terephthalate backing film) works through In general, the chamber is flushed with an inert gas, for example nitrogen, while the samples are cured with a beam and multiple passes through the beam sterilizer and may be necessary.
    Commercially available gamma irradiation equipment includes equipment frequently used for gamma irradiation sterilization of products for medical applications. Cobalt 60 sources are appropriate. The total absorbed doses are suitably 20 to 60 kGy, more suitably about 35 to 50 kGy and dose rates are suitably around 7 to 8 kGy / hour.
    Suitably, the method further comprises the step of packaging the intermediate material in a container impermeable to microorganism before said step of further curing, and wherein said step of further curing also sterilizes the material.
    The methods of the invention can be used to manufacture any of the products according to the invention. Any feature disclosed herein in relation to any one or more aspects of the invention is suitable for use in any of the other aspects defined herein.
    Specific embodiments of the invention will now be described further, by way of example, with reference to the accompanying drawings, in which:
    Fig. 1 shows a perspective view of a product according to the invention packaged in a bag impermeable to microorganisms;
    Fig. 2 shows an exploded perspective view of a product according to the invention;
    Fig. 3 shows a top plan view partially cut out of the product of Fig. 2;
    Fig. 4 shows a partial cross section enlarged through the product of Fig. 2;
    Fig. 5 shows a schematic view of an apparatus for manufacturing a product according to the method of the invention;
    Fig. 6 shows a schematic diagram of the apparatus used for the loop grip measurement test; and
    Fig. 7 shows a graph of the adhesion on the loop grip measured for the upper and lower surfaces of materials manufactured in accordance with the present invention, in which the samples were stored for different times before the irradiation curing step.
    Referring to Figs. 1 to 4, product 1 according to the invention comprises a substrate 2 of cellulose acetate gauze of nominal density of 107 grams per square meter, having upper and lower 4.5 surfaces coated with a sticky, hydrophobic silicone gel, reticulate. The silicone composition penetrates the gauze substrate to form a single silicone layer, chemically homogeneous on the upper and lower surfaces. The coated substrate 6 has an arrangement of openings that extend through the substrate and the silicone to allow fluid from the wound to pass through the material. The tackiness of the coated top surface 4 is approximately 50% greater than the tackiness of the coated bottom surface 5, as determined by the loop adhesion test described below. The total nominal coating weight of the silicone is 120 to 130 grams per square meter.
    The identical coated sheets for release 7,8 are applied to the upper and lower silicone coated surfaces 4,5. In use, the bottom release sheet 8 is removed first to expose the less sticky bottom surface 5 of the dressing material. It is relatively easy to selectively remove the lower release sheet 8 because of the lower adhesion of this sheet to the material compared to the upper release sheet 7. The lower and / or upper release sheets may further comprise distinctive marks to identify the release sheet to be removed first. The lower surface 5 can then be applied to a wound surface, followed by removing the upper release sheet 7 and applying secondary dressing elements such as an absorbent layer.
    Referring to Fig. 1, product 1 is shown sterile and packaged in a microorganism-impermeable envelope 3 having a transparent window 10.
    Referring to Fig. 5, the process according to the invention starts from a continuous web of cellulose acetate gauze 12 which is passed through a fluid silicone coating composition 14 and nip rollers 15 to coat and impregnate the gauze with the silicone composition. The silicone coating composition is prepared by mixing Components A and B of a soft silicone skin adhesive silicone elastomer kit supplied by Dow Coming under product reference Q7-9177. The components are mixed in the weight ratio of
    50:50. Component A comprises a bis-dimethylvinyl-terminated polydimethylsiloxane and a platinum catalyst. Component B comprises a bishydride-terminated polydimethylsiloxane. To the mixture is added the 2-methyl-3-butin-2-ol inhibitor in a concentration of 0.02% by weight.
    The coated substrate then passes through a blower 17 to open the openings of the coated substrate that may have been blocked by the silicone.
    The coated gauze is then passed through an oven 18 maintained at 150 ° C. Typical conditions are 5 passes at 4.2 m / min, the total residence time is 1.5 minutes. This results in partial thermal curing of the silicone coating. The coated material is then allowed to cool, and the released coated paper cover sheets (not shown) are then continuously applied to the upper and lower surfaces at the location 20 and the material is wound onto the roller 22 for balance.
    The rolls 22 of the thermally cured and interleaved material are left to equilibrate at a controlled temperature (20 to 25 ° C) for 4 to 6 weeks. The material is then cut and packed as shown in Fig. 1, followed by gamma irradiation with 35 to 50 kGy of Cobalt 60 radiation from 7 to 9 kGy / h to sterilize the products and complete the curing. The irradiation cure results in an additional increase in both the hardness and the tackiness of the silicone coating.
    Procedure 1: Measurement of surface stickiness by the loop adhesion test
    The tackiness of the silicone coatings produced by the methods of the invention was measured on a voltage tester, such as an Instron tester, using the assembly shown in Fig. 6.
    Samples of the fully cured coated gauze having the release cover sheets attached were cut to 5 x 9.5 cm dimensions. The 1 cm margins were marked along the long edges by drawing straight lines 1 cm from the long edges. The cover sheets were removed, and the coated gauze sheet 30 was looped around and the 1 cm 32.34 margins on the opposite edges of a surface (opposite the surface being measured) were applied firmly to the opposite sides of a bar 2 mm thick metal spacer 38. Strips of 40 cm polypropylene film 40.42 were then applied to the opposite surfaces of the coated gauze opposite the spacer bar 38 to prevent the coated gauze from adhering to the jaws of the measurement.
    The assembly of polypropylene strips, coated gauze and spacer bar was then attached to the jaws 44 of the Instron tester. The coated gauze handle 30 having the outermost test surface was then lowered onto a clean polycarbonate surface 46 of dimensions 15.5 cm x 3.8 cm so that the handle adheres to the surface, and raised to detach the handle the surface. Lowering and lifting are performed at 300 mm / min and the minimum distance between the jaws 44 and the polycarbonate surface 46 is 15 mm. The measured grip (in Newtons) is the maximum force measured while taking the handle off the surface. The average of three measurements was used.
    Fig. 7 shows the adhesion data obtained by the samples above the coated gauze obtained according to the invention. The coating weight was 118 grams per square meter. Measurements were made on the sterile samples after storage at 25 ° C and 4% relative humidity for 0, 2, 4, 6, and 8 weeks. The upper and lower surfaces initially have very different adhesion as evidenced by the two groups of measurements around 0.4 N and 1.1 N, but the adhesion converges in storage after about 4 weeks such that the final adhesion of the upper surface is about 1.0 N and the final adhesion of the bottom surface is about 0.7 N.
    The above examples have been described by way of illustration only. Many other embodiments that fall within the scope of the attached claims will be evident to the qualified reader.
    权利要求:
    Claims (9)
    [1]
    1. Wound healing product, comprising:
    a substrate layer having an upper surface and a lower surface;
    a sticky silicone coating composition present on said top surface and said bottom surface; and top and bottom release sheets covering said substrate and said sticky silicone coating composition on said top and bottom surfaces, respectively, and adhered to said surfaces by said sticky silicone coating composition, on said surface top is less sticky than said bottom surface by means of which said top release sheet can be removed from said top surface more easily than said bottom release sheet can be removed from said bottom surface, and wherein said silicone on said upper and lower surfaces were formed by curing the same silicone prepolymer composition, characterized by the fact that the stickiness of said lower surface as measured by a loop adhesion test is 20% to 100% higher than the stickiness of said upper surface.
    [2]
    2. Wound dressing material according to claim 1, characterized in that an arrangement of openings extends through said silicone liners and said substrate layer.
    [3]
    Wound dressing material according to claim 1 or 2, characterized in that said substrate layer comprises or consists essentially of a woven, non-woven or interlaced mesh.
    [4]
    4. Wound dressing material according to any one of claims 1 to 3, characterized in that said silicone
    Petition 870180129747, of 9/13/2018, p. 6/8 on said upper and lower surfaces is substantially chemically homogeneous.
    [5]
    5. Method of making a wound dressing material as defined in any one of claims 1 to 4, characterized in that it comprises:
    providing a substrate layer having an upper surface and a lower surface;
    coating said upper and lower surfaces of said substrate layer with a fluid silicone prepolymer composition; followed by partial thermal curing of said silicone prepolymer composition to produce an intermediate material having a partially cured silicone composition on said upper and lower surfaces; followed by another cure of said partially cured silicone composition by exposing said intermediate material to ionizing radiation, to produce a final material having sticky silicone coatings on said upper and lower surfaces, wherein (a) said coating step applies unequal weights of the silicone coating composition to said upper and lower surfaces, and / or (b) said partial thermal curing step applies different amounts of heat to said upper and lower surfaces, whereby said silicone coatings on said upper and lower surfaces have different payability after said additional curing step.
    [6]
    6. Method according to claim 5, characterized in that said fluid silicone prepolymer composition comprises:
    a vinyl functional polydimethylsiloxane, a hydrogen functional siloxane, a hydrosilylation catalyst, and a polymerization inhibitor that is evaporated from said composition during said step of
    Petition 870180129747, of 9/13/2018, p. 7/8 partial thermal cure.
    [7]
    Method according to claim 5 or 6, characterized in that it further comprises applying the upper and lower release sheets over said silicone composition on the upper and lower surfaces.
    5
    [8]
    Method according to any one of claims 5 to
    7, characterized by the fact that it also comprises applying the upper and lower release sheets over said silicone composition on the upper and lower surfaces, in which said upper and lower release sheets are applied between said partial thermal curing steps and 10 storage.
    [9]
    9. Method according to any of the claims of
    5 to 8, characterized by the fact that it further comprises the step of packaging the intermediate material in a container impermeable to microorganism before said additional curing step, and wherein said additional curing step 15 also sterilizes said material.
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    同族专利:
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    EP2611468A1|2013-07-10|
    US20160250077A1|2016-09-01|
    US20190290497A1|2019-09-26|
    US10314748B2|2019-06-11|
    CA2809753C|2020-09-22|
    EP3583959A1|2019-12-25|
    EP2611468B1|2019-06-05|
    US9295749B2|2016-03-29|
    BR112013005100A2|2016-05-03|
    GB201014705D0|2010-10-20|
    CA2809753A1|2012-03-08|
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    法律状态:
    2018-04-03| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2018-07-17| B06T| Formal requirements before examination|
    2018-11-06| B09A| Decision: intention to grant|
    2019-01-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/08/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    GBGB1014705.6A|GB201014705D0|2010-09-03|2010-09-03|Silicone gel-coated wound dressing|
    PCT/GB2011/001258|WO2012028842A1|2010-09-03|2011-08-22|Double- sided adhesive silicone gel -coated wound dressing|
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