Releasable adhesive having a multilayer substrate

[0001] The present application claims priority on the basis of US provisional application No. 61 / 172,956 made on April 27, 2009 and US provisional application No. 61 / 223,557 made on July 7, 2009.

[0002] The present invention relates to products adhered by means of glue, such as adhesive tapes, bandages, wound dressings, etc. that firmly adhere to a given substrate and which can be removed easily and painlessly.

[0003] Adhesives are commonly used to attach a variety of articles to substrates or substrates. In particular, self-adhesive adhesives (PSAs) are tested extensively by trying to adjust their properties so that they easily dry and quickly combine with a given surface after applying minimal pressure. It is often intended that products containing these adhesives can be finally separated as easily and cleanly from the surface on which they are located, i.e. leaving no adhesive residues and / or damages at the interface between the surface and the adhesive. This objective includes reaching a compromise between a series of seemingly contradictory properties on the surface of the adhesive, including (i) optimization of the range of viscoelastic parameters of the adhesive, (ii) assessment of the relevant chemical parameters and solubility of the adhesive components and

[0004] Although the separation of glue is widely discussed and considered a significant problem, few solutions have been proposed. Problems associated with the separation of glue have been well recognized, as noted in the article "Pain at Wound Dressing Changes", CJ Moffatt, PJ Franks, H. Hollinworth, Document containing the position, European Society for the Treatment of Wounds (EWMA), London, UK Medical Partnerships Ltd. , pages 1-17, 2002. Separating the glue, in particular with ease and when it is needed, is still a very important technological problem.

[0005] A number of medical products have been developed for the safe attachment to the skin and for the maintenance of a wide range of adverse conditions, including contact with water, which e.g. can occur during bathing, swimming, etc .; in contact with sweat, tallow or other body fluids; adhesion to uneven or uneven or complex surfaces related to the skin or the body, which are subject to variable deformation under mechanical stress; heat exposure, which, for example, can occur in the sauna; exposure to sunlight or other environmental factors; contact with other liquids, such as hot or cold beverages, and / or exposure to physical stress due to movement, for example during physical activity.

[0006] Although a number of commercially available products that seem to facilitate the removal of the adhesive article due to the adhesive to the wearer's skin are known, there remains an important and unmet need to easily, painlessly remove the product when it is needed and without causing injury. This necessity is particularly evident when the products adhering to the glue are detached from the skin of elderly patients, which is usually delicate and thin. In addition, there is a need for products that are easy to take off for use in children, oncology patients, in particular skin cancer patients, premature babies whose skin is not fully developed, in people with diseases that have a significant impact on the skin or have sensitive skin .

Switchable adhesives [0007] Adhesives having regulated or switchable adhesive properties are known in the art. Temperature-sensitive adhesives use crystallizable moieties in the adhesive matrix to provide heat-sensitive bonding and separation. Representative examples of these types of adhesives are described, for example, in U.S. Patents 5,156,911, 5,387,450 and 5,412,035.

[0008] A subsequent document, US Patent No. 7.399,800, describes the use of appropriately modified adhesive agents.

[0009] US Patent 6,610,762 describes the use of subsequent polymer crosslinking under the UV radiation of a pressure-sensitive adhesive, thereby reducing the force necessary for detachment and achieving an easy separation.

[0010] US Patent 5,032,637 describes adhesive adhesives that can be deactivated in contact with water by using water-soluble adhesive agents.

[0011] US patent 7,078,582 uses elastic deformation to allow easy removal of medical tapes. This strategy is similar to that used in some commercially available products containing adhesives and known in the prior art as "Command" adhesives.

Removal of adhesive in medical applications [0012] The main application of adhesives adhering in a selectively removable or variable manner is the field of medicine. Among the most commonly used methods for removing or separating the adhesive is contact of the adhesive with various readily available liquids, such as (i) oils, (ii) solvents such as isopropyl alcohol, acetone etc., or (iii) an auxiliary agent for removal, Uni-Solve example available from Smith & Nephew, Niltac® or Hollister No. 7731 medical glue remover, etc.

[0013] US patent 4,324,595 describes a process for removing viscous adhesives and articles joined by means of these adhesives, such as adhesive adhesives in bandages, surgical tape and the like. The method involves applying a volatile liquid methylsiloxane to a viscous adhesive, and then removing the bandage or tape from the substrate on which it is located. The '595 patent states in particular that the methylsiloxane-containing fluid is applied to the articles and allows it to penetrate through them to reach the surface with the adhesive.

[0014] US Patent 4,867,981 relates to a strip stripping composition for separating self-adhesive adhesive tapes or bandages from the substrate on which they are located. This patent teaches that after applying this composition, the liquid penetrates through the porous layer (tape or bandage) into the adhesive material, "thus reducing the binding force".

[0016] In consideration of these and other shortcomings, the experts are still seeking to develop improved methods and compositions allowing the selective removal of the articles adhered by the adhesive. Many of these attempts have focused on increasing the effectiveness of the glue remover.

[0017] Specific examples from the patent literature include the following. U.S. Patent 5,336,207 discloses the use of oxyalkylene ether and liquid rubbing hydrocarbons that allow removal of medical adhesives from the skin.

[0018] US Patent 5,004,502 describes the use of non-irritating peeling agents.

[0019] The publication of patent application 2007/0054821 A1 discloses the use of tetrahydrofurfuryl acetate for the efficient removal of medical adhesives. This publication also mentions "rubbing the surface remover to facilitate removal".

[0020] US Patent 6,436,227 discloses the use of soaking a tape for at least two minutes with limonene to remove adhesive bandages.

[0021] There is no data in the prior art to solve the problem of the inherent ineffectiveness of the method for providing an adhesive remover. This is especially important for impermeable products or systems. U.S. Patent 5,803,639 mentions this problem. The patent, however, attempts to solve the problems associated with providing the adhesive remover by constructing a special scraper to peel off the adhesive article with the adhesive on the edges, thereby exposing the adhesive. Then, the adhesive is applied to the product under the product.

[0022] Other inventors have developed a number of other devices and articles that are intended to facilitate the separation of the adhesive. U.S. Patent 5,843,018 describes the use of a disposable device with a sterile emollient carrier for the treatment of simple and complex skin injuries due to the use of an elongated, non-sticking element wrapped around various parts of the body, and removable and removable if desired.

[0023] US Patent 6,191,338 discloses a bandage construction minimizing pain when pulling out the hair while removing the bandage.

[0024] US Patent 7,396,976 describes the construction of a bandage that is easily detachable, comprising a plurality of pockets or microcapsules of the adhesive deactivating component. These microcapsules can be torn off, if necessary, by applying pressure, which makes it easy to detach. An important disadvantage of this method is premature tearing.

[0025] The 3M and Coloplast companies offer for sale products such as Cavilon® # 3343 (also known as a non-baking barrier film) or barrier type skin-protective products, such as Duoderm. These products, however, are attempts at simple prior skin coverage before contact with the adhesive, which are to minimize injuries and erythema of the skin. For this, see Dealy C., J. Wound Care, 1, 19 (1992). [0026] A number of patents describe tacky low-trauma chemicals that use hydrogels, hydrocolloids, soft silicone gels, additive formulations, etc. These methods, however, often cause unintended deterioration of one or more other desirable properties, such as maintaining an initial level of sticking, causing inadequate water vapor transmission factor (MVTR) and / or oxygen transfer factor (OTR) or causing other undesirable effects, etc. Because proper adhesion and easy separation are naturally contradictory properties, it is difficult to implement both these aspects simultaneously. In addition, it is extremely difficult to achieve both of these goals without impairing other important glue properties. For example, U.S. Patent 6,368,687 discloses a low-tack adhesive coated substrate comprising a pants substrate formed of an absorbent material with a water absorption capacity of at least 100% and a fibrous adhesive layer. it is difficult to implement both these aspects at the same time. In addition, it is extremely difficult to achieve both of these goals without impairing other important glue properties. For example, U.S. Patent 6,368,687 discloses a low-tack adhesive coated substrate comprising a pants substrate formed of an absorbent material with a water absorption capacity of at least 100% and a fibrous adhesive layer. it is difficult to implement both these aspects at the same time. In addition, it is extremely difficult to achieve both of these goals without impairing other important glue properties. For example, U.S. Patent 6,368,687 discloses a low-tack adhesive coated substrate comprising a pants substrate formed of an absorbent material with a water absorption capacity of at least 100% and a fibrous adhesive layer.

[0027] Therefore, despite the numerous and varied attempts of previous creators, there remains a need for a method whereby the adhesive adherence product can be easily and painlessly removed from the user's skin without causing injury and without any adverse effect on the adhesive or article before its removal . More specifically, there remains a need for a product, system, method and materials to obtain this unique feature. [0028] The embodiments of the present invention described below are not exhaustive and are not intended to limit the invention to the particular embodiments disclosed in the detailed description below. The embodiments were chosen rather and described so that other specialists in the field could understand and understand the principles and practice of the present invention.

[0030] In one aspect, the present invention discloses a system for selectively attaching to a substrate and selectively removing a multi-layer laminate from a substrate. This system comprises a multi-layer laminate comprising an inner layer comprising a plurality of fluid conduit lines extending through the inner layer. The inner layer has controlled flow properties through the thickness of the inner layer. The inner layer contains the underside surface and the top surface on the opposite side. The laminate also includes an adhesive layer along the bottom surface of the inner layer. In addition, the laminate also comprises a covering layer located on the surface of the top inner layer. The system also includes an agent deactivating the adhesive. As a result of contact between the adhesive layer and the substrate, the laminate adheres to the laminate due to the adhesive. When removing the covering layer from the laminate, the inner layer and a series of fluid transmission lines are exposed. After application of the adhesive deactivating agent to the top surface of the inner layer, the material is transported through the layer through a series of glue lines, with sufficient contact time between the medium and adhesive being a few seconds to several minutes, and the adhesive bond between the adhesive and the substrate is weakened, thanks to which the laminate adhering due to the adhesive can be easily removed from the substrate.

[0031] In yet another aspect, the present invention discloses a method for selectively attaching a multi-layer laminate to and from a substrate. The method includes providing a multilayer laminate comprising (i) an inner layer comprising a plurality of conduits or openings for fluid passage through the inner layer, the inner layer having controlled flow properties through the thickness of the inner layer, the inner layer comprising a bottom surface and located on the opposite side the top surface, (ii) an adhesive layer along the bottom surface of the inner layer and (iii) a support or covering layer along the top surface of the inner layer. The laminate also contains (iv) a release primer in contact with the adhesive layer. The method also includes contacting the adhesive layer of the laminate with the substrate, whereby the laminate adheres to the substrate. This is accomplished by removing the release primer from the adhesive layer of the laminate, thereby exposing the adhesive layer. The laminate is then applied to the substrate. In addition, the method also includes selectively releasing the adhesive laminate through the adhesive from the substrate by removing the cover layer therefrom and exposing the surface of the top inner layer, applying the adhesive deactivating agent to the inner layer, such that the agent moves through the inner layer, with sufficient contact time. between this adhesive deactivating agent and the adhesive is a few seconds to several minutes, and the adhesive bond between the adhesive and the substrate weakens,

The method involves placing a piece of thick material of a size and shape such that it covers the wound bed, on the wound bed and tearing the release liner from the adhesive layer of the laminate laminate. The multi-layer laminate is then applied to the wound bed, so that the cover layer is along the top surface of the inner layer of the multi-layer laminate. A hole is cut in the multilayer laminate and an insert is applied to this hole in the multilayer laminate. This insert allows connection of the vacuum used in therapy by vacuum wound closure and may include a related tube, a clamp and a connector. A preferred example of such an insert is the TRAC pad available from KCI Licensing, Inc. A vacuum source is connected to the insert. After application, the multilayer laminate is treated with an agent deactivating the adhesive, allowing the insert to be removed. The insert separates with the outer covering layer. [0033] In the following it will be shown that the present invention may comprise other and various embodiments, and that various details thereof may be modified in various aspects, always without departing from the invention. Therefore, drawings and descriptions are considered to be illustrative and not restrictive.

[0034] These and other objects and advantages of the present invention will be more fully understood and understood with reference to the following description of more specific preferred embodiments of the present invention along with the accompanying drawings, wherein:

Fig. 1 is a schematic illustration of a preferred embodiment of the laminate in accordance with the present invention.

Fig. 2 is a graph showing the peel strength measurements of several layers adhering due to the adhesive and suitable substrates.

Fig. 3 is a schematic illustration of a preferred configuration of a layer comprising a plurality of fluid transfer conduits used in a multilayer laminate in accordance with the present invention.

Fig. 4 is a different view of the layer shown in Fig. 3 with the effective, controlled penetration of the adhesive agent, in particular the bonding surface.

Fig. 5 is a schematic illustration of another preferred configuration of an adhesive layer used in a multi-layer laminate in accordance with the present invention.

Fig. 6 is a schematic assembly illustration of another preferred embodiment of a multilayer laminate in accordance with the present invention.

Fig. 7 is a schematic view of another preferred embodiment of the laminate in accordance with the present invention.

Fig. 8 is a schematic view of another preferred embodiment of the laminate in accordance with the present invention.

Fig. 9 is a schematic view of yet another preferred embodiment of a laminate according to the present invention.

Fig. 10 is a schematic view of another preferred embodiment of the multilayer laminate in accordance with the present invention.

Fig. 11 is a schematic view of still another preferred embodiment of a laminate according to the present invention.

Fig. 12 schematically illustrates an aspect of the present invention.

Fig. 13 is a schematic view of another aspect of the present invention.

Fig. 14 is a schematic illustration of another aspect of the present invention.

Fig. 15 is a schematic illustration of a method for increasing the ease of handling and the resulting laminate in accordance with the present invention.

Fig. 16 is a schematic illustration of another method and a resulting laminate in accordance with the present invention.

Fig. 17 is a schematic illustration of another method and a resulting laminate in accordance with the present invention.

Fig. 18 is a schematic illustration of another method and a resulting laminate in accordance with the present invention.

Fig. 19 is a schematic illustration of another method and a resulting laminate in accordance with the present invention.

Fig. 20 is a schematic illustration of another preferred embodiment of a multilayer laminate in accordance with the invention.

Fig. 21 is a schematic illustration of an aspect of the present invention.

Fig. 22 is an illustration of a component that can be used to study and analyze preferred laminates of the invention.

Fig. 23 is a schematic illustration of a test system that can be used to test and analyze preferred laminates of the invention.

Fig. 24 is an illustration of the components usually used in therapy by vacuum wound closure (VAC), to which some preferred embodiments of the invention may be suitable.

Fig. 25 is a graph of the peel force values ​​of the adhesive-bonded samples after the use of different release agents.

Fig. 26 schematically shows two types of samples that were used in various studies.

Fig. 27 is a graph showing increased fluid intrusion and retention times for a preferred laminate embodiment.

Fig. 28 is a graph of peel force values ​​for different samples.

Fig. 29 is a schematic illustration of another preferred embodiment of the laminate.

[0035] The present invention is discussed below in more detail based on the following detailed description constituting the best known presently embodiment of the invention. It should be understood, however, that the present specification should not be used to limit the present invention, but nevertheless in this case it is rather intended to illustrate the general features of the invention.

[0036] An important feature of the present invention is an effective improvement in the ease of carrying out the adhesive separation process with the aid of the agent only when it is necessary. This allows much greater freedom to design the laminate, e.g. a surface / adhesive / removable layer arrangement, while ensuring that other suitable properties are maintained in a stable manner. For example, an excessive level of adhesion to the skin may occur, which eventually causes pain during removal. This is explained in the Research Methods section in this document. This phenomenon can be eliminated or at least significantly reduced if the removal of an appropriate agent to the laminate used solely for removal is effective in separating the adhesive from the skin.

[0037] Another important feature of the present invention is to provide a laminate comprising at least one layer specifically designed to control the flow of a liquid or liquid medium therethrough by it rapidly. A number of the earlier patents described above utilize the penetration of the glue-removing liquid along the edges or side areas of the bandage or dressing, mainly due to capillary forces. Likewise, in the case of a few patents describing the use of a fluid on top of a dressing or medical tape method, these methods use the permeation efficiency supported by a suitable solubility parameter for easy filtration through one or more layers for transporting the fluid. None of these methods is effective,

[0038] Medical practitioners are well aware of the fact that the perception of pain related to skin detachment is complex and depends on a number of factors that go well beyond peel adhesion values. One of such factors is the simultaneous breakaway of corneocytes, i.e. superficial skin cells, resulting from mechanical detachment of the adhesive. This is discussed in the Research Methods section in this document. Therefore, it may be extremely beneficial to administer the agent specifically formulated to reduce these symptoms immediately prior to planned removal. At the border of or near the adhesive layer, other pain relief agents may also be advantageously and simultaneously used, including, but not limited to, anesthetics, cooling / warming agents,

[0039] In addition, it is envisaged to use many other beneficial agents if desired. Examples include, but are not limited to, agents that cause sterility or promote sterilization, for example by chemical methods, radiative methods, etc. Analytical studies are also provided, if necessary, for diagnostic control of important parameters such as temperature, histamine / heparin level, infection markers, erythematous edema (a rash resembling sunburn), etc., in particular due to the use of available laminated structures designed specifically, albeit non-exclusive, for the area around the wound. For additional examples of agents that can be used if necessary,

Multilayer Laminates [0040] A preferred embodiment in accordance with the present invention includes the sandwich construction of the multilayer illustrated in Fig. 1. This preferred embodiment includes a release liner along the bottom surface of the laminate; a co-adhesive, skin-friendly, self-adhesive adhesive layer that provides hermeticity; a perforated polyurethane inner layer allowing the penetration of fluid; a substantially continuous removable adhesive adhesive layer on the surface of the top inner layer and a cover layer having suitable properties such as a suitable water vapor transmission rate (MVTR), suitable optical properties, etc.

[0041] In particular, Fig. 1 schematically illustrates a preferred embodiment of a laminate according to the present invention. The laminate 10 comprises a release primer 20, a pressure-sensitive adhesive layer (PSA) 30, normally used in skin contact applications, an inner layer 40 with openings arranged to selectively direct the flow or transport agent or agent to the layer 30, a self-adhesive adhesive layer 50 removable together with a covering layer 60. Each of these layers is described in more detail below. It is to be understood that the present invention is by no means limited to this particular embodiment, its configuration and / or materials. The present invention includes instead a wide range of other laminates, configurations and materials,

[0042] An important feature of the present invention is to provide an inner layer in the multilayer laminates described herein, such as shown as layer 40 in Fig. 1. This layer comprises a series of wires, holes, perforations, gaps or other elements allowing a controlled flow of one or more of the layers. a number of means, such as an adhesive deactivating agent, from one surface of the layer through the thickness of this layer to the other surface of the layer on the opposite side. After passing through the layer to its opposite side, the means or means may then come in contact with the material adhering directly or, if necessary, going further through the interface and / or the laminate.

[0043] According to the present invention, this inner layer has controlled flow properties through the thickness of the inner layer. The term "controlled flow properties" as used herein means the arrangement, location, shape and configuration of passages or conduits extending through the inner layer. Preferably, but not necessarily, a relatively constant shape and configuration of each transition is maintained at the thickness of the inner layer. This aspect provides a much greater possibility of controlling the transport parameters of the agent (or analyte as in the case of sensor elements) from one to the other surface of the layer. In addition, this feature is readily distinguishable from prior art materials, such as porous paper or fibrous layers, in which blank areas may extend from one surface to the other. In the case of these materials, such natural internal voids have a large range of length, surface area, shapes and conglomeration, all having an effect on the transport of the agent. Such highly differentiated voids result in suboptimal control of the transport parameters by the material and rarely provide the desired control.

[0044] The size of the ducts or openings present in the inner layer of a preferred embodiment of multilayer laminates may be in the range of 12.7 μm (0.5 mils) to 50.8 mm (2000 mils), preferably from 25.4 pm (1 mils) ) up to 10.2 mm (400 mils) and more preferably from 254 pm (10 mils) to 7.6 mm (300 mils). These hole size dimensions are the diameter of round holes that potentially allow the fluid to escape evenly. For openings other than round, these values ​​are effective diameters. It is to be understood that the present invention includes sizes larger or smaller than those given.

[0045] Furthermore, all conduits or openings may be of the same or different shapes. Depending on the particular application and / or structure of the laminate, it may be desirable to create a set of holes of one size at a specific place or locations of the inner layer and to create a set of holes of another size at another location or locations of the inner layer. Furthermore, it is envisaged that only one or more parts of the inner layer may comprise openings and other parts may not have openings. In this case it may be advantageous to define the set of holes only in the middle part of the inner layer and leave the rest of the areas in the layer without holes or vice versa. [0046] These conduits or openings may be in almost any shape, e.g. circular, square, rectangular, triangular, polygonal, irregular, in this case, the specific choice of the shape or shape of the openings or the combination of shapes depends on the particular application and / or structure of the laminate. The conduits can furthermore comprise unique materials allowing selectively for easy transport of compatible liquid means.

[0047] The number of conductors or openings present in the inner layer can also be varied. A typical number, however, can range from 77.5 to 7775.9 per dm² (5 to 500 per square inch (in)), preferably from 155.0 to 3867.0 per dm (10 to 250 per in) and more preferably from 310.0 to 3100.0 per dm (20 to 200 on in) layers . It is to be understood that the present invention encompasses the use of a number of greater or lesser. It is further envisaged that the density of the openings, i.e. the number of openings per unit area of ​​the layer, can vary at different locations along the layer. For example, for some applications, it may be advantageous to achieve a relatively high hole density in a particular region of the layer and a lower hole density in other areas. The present invention includes a variable hole density.

[0048] The choice of the size, shape, number of openings and density of openings in the inner layer determines the percentage or proportion of the surface area of ​​the inner layer that allows the agent or agents or the analyte to pass through it. In many applications, the percent area of ​​the openings of the inner layer is generally at least 10% and typically from 10% to 90%, preferably 15% to 85% and most preferably from 0% to 80%. It is to be understood that the present invention includes laminates in which internal layers having a greater or lesser percentage of openings are used. Furthermore, it is to be understood that the present invention includes interior layers having a different percentage of openings along individual areas of the layer.

[0049] Additional details of a preferred embodiment of the multilayer laminate shown in Fig. 1 are as follows. The top or cover layer 60 may be in the form of a polyurethane film about 12.7 μm (0.5 mils) thick. In some embodiments, it may be desirable to use one or more protruding edges 62 of the cover film 60 to facilitate removal of the topsheet. The provision of one or more protruding tabs may provide an additional substrate comprising a mark or a typewriter that provides ease of removal of the overcoated glove and / or reduces the accumulation of dirt or other materials along areas on the edge of the laminate.

[0050] The release foundation 20 serves to protect the adhesive and can be torn off immediately before applying the laminate 10 to the wearer's skin. Although this primer is essentially imperforate, it can be perforated if necessary. Although the preferred multi-layer laminate has a perforated central or inner layer 40, the top continuous adhesive adhesive layer 50 assists in providing adequate water vapor transmission rate (MVTR) without adversely affecting the sealing performance of the area around the wound. Co-continuous (e.g., the one in which the adhesive forms a pattern, but still remains continuous) the adhesive-adhesive layer 50 is particularly important in the treatment of wounds using the VAC® vacuum wound closure method available from Kinetic Concepts, Inc. (KCI) from San Antonio, Texas and described in U. S. Patents 5,636,643 and 5,645,081 or fluid wound washings, e.g. KCI Instill ™ products. [0051] As stated above, it is believed that the present invention can be readily used in conjunction with therapy via vacuum (or vacuum assisted) wound closure (VAC), also known as Vacuum Wound Treatment (NPWT). Kinetic Concepts, Inc. (KCI) offers a wide range of products, systems and methods for using VAC or NPWT. Therapy by vacuum wound closure involves the creation and maintenance of a lower than atmospheric pressure around the wound area. It has been found that such a reduced pressure provides a number of benefits, such as wound closure by homogeneous edge approximation, granulation support,

[0052] Directly before the adhesion of the adhesive laminate is removed, it is advantageously possible to peel off the lidding foil 60. In this way, a certain percentage or ratio of the underlying adhesive 30 and, more importantly, adjacent skin can be easily exposed by a collection of perforations in the inner layer 40 or a suitable structure in direct contact with the skin or other adhering layers. In the case of vacuum wound closure (VAC) therapy, the cover or covering foils 60 should be optically transparent and very flexible and usually relatively thin, e.g. in the range of 5.1 to 50.8 μm (0.2 to 2 mils). It is to be understood, however, that the present invention includes layers 60 with a thickness greater than or less than this preferred range. These films or layers 60 may optionally include supporting backing films to provide easy application of such thin, flexible laminates. Once the top film has been removed, the adhesive layer 30 and parts of the adhering material are directly accessible through openings / wires in the layer 40 and can be easily treated with various means that can be adapted to quickly deactivate the connection and facilitate removal of the laminate with minimal pain or injury.

[0053] The laminates of the present invention described herein can be incorporated or used in combination with a wide variety of medical products. Representative examples of such products include, but are not limited to, bandages, dressings, gauze, tape and similar products, wound closure products, such as patches, covering materials, and the like, wound closure strips, foam inserts, surgical tapes and inserts. As explained herein, a number of applications are envisaged in which laminates of the present invention are introduced and / or used with products and therapies by vacuum wound closure (VAC).

[0054] The present invention envisages the selective use of one or more agents in the multilayer laminates described herein. The agent or agents are incorporated into laminates, exposing the interior of the laminate with openings and applying a suitable agent or agents to the top surface of the layer. Agents that can advantageously be incorporated into the laminate, if desired, may include, but are not limited to, preferred additives such as anesthetics, analgesics, and cooling / warming agents, etc. Although many different agents may be incorporated into the laminates described herein, it is preferred that the agent or agents contain at least one glue-inactivating agent. The deactivation of skin adhesives are particularly effective derivatives of silicones or perfluoroalkyls.

The use of this agent or agents can provide a greater order when administered by (i) additional carrier articles, e.g. aerosol, ball or brush containers, (ii) dispensers for wet wipes packaged singly, (iii) ) applications constituting a barrier layer on the skin, where the agent is provided in particular from below, and application to the skin for optimal retention, (iv) impregnated gaseous / foam carriers and / or (v) encapsulated centers allowing release when required that precisely dispense or measure the right amount. The coatings break apart if the laminate is stretched or subjected to any stress with the release of the adhesive deactivating agent, allowing the laminate to be easily removed. The use of this agent or agents can also be accomplished by providing them through the channels introduced in the adhesive layer of the laminated laminate, which allows the release agent to quickly enter the adhesive and ensures easy removal of the laminate. Many embodiments of the system and delivery methods can be used in the laminate system, e.g., the top covering layer can further comprise means encapsulated from the outside, so that it can be re-applied to its counter surface with adequate stimulation to facilitate the delivery of the agent to the wires present. in the inner layers of the laminate. One or more of these methods allows controlled and ordered, sterile dosing that can be adjusted to optimally co-operate with a given adhesive. assuming

[0056] The choice of one or more liquid agents depends on conditions such as good availability of the agents, safety of use, effective spreading / reaching the skin surface, fast deactivation of adhesion, but without adversely affecting the adhesive and / or carrier foil, which would result in a lack cohesion and disorder, without adversely affecting the surface of the skin, so that the adhesion of the next material would be weaker, for example leaving the coating with low adhesion, for example silicone, and in addition they can not cause allergic or other adverse reactions. [0057] The laminates of the present invention include almost any combination of permeable or impermeable pressure-sensitive adhesive layers (PSAs), e.g. the layer 30 in Fig. 1, and permeable or impermeable primer systems comprising a flow control layer, e.g., layer 40 in Fig. 1. For example, in one aspect, the present invention includes a laminate comprising a permeable PSA layer and a permeable undercoat. In another aspect, the invention includes a laminate comprising an impermeable PSA layer and a permeable undercoat. In another aspect, the present invention includes a laminate comprising a permeable PSA layer and an impervious backing. Furthermore, in another aspect, the present invention includes a laminate comprising an impermeable PSA layer and an impermeable backing. An example of an impermeable foundation is an occlusive laminate with a continuous surface. An example of an impermeable PSA is a conventional adhesive applied continuously.

[0058] The adhesion of the laminates of the present invention can be increased by extruding the adhesive through a multilayer backing. The extrusion process may include placing the mesh between the primer and the adhesive to form a texture on the adhesive. As a result, the adhesive can flow freely to the areas corresponding to the open area in the mesh, thereby increasing the mass of the coating in the multilayer laminate. Studies show that traction adhesion almost doubles. Although the adhesion is increased, it does not affect the ease of removing the laminate after the use of an adhesive deactivating agent. [0059] Adhesion may also be increased by increasing the weight of the adhesive coating. However, the adhesion is reduced if an agent deactivating the adhesive is used, for example HMDS (hexamethyldisiloxane),

[0060] An even higher level of adhesion of 90 or 120 gsm drops to about 0.12 N / cm (0.3 N / in) immediately after spraying with HMDS (hexamethyldisiloxane).

[0061] The laminates of the present invention are preferably adapted to adhere to a wide variety of substrates. The main example of such a substrate is mammalian skin. Although human skin is probably the basic embodiment of the invention, it should be understood that the invention can also be applied to the application of other animals to the skin and the external surface of the body. Therefore, many different applications are envisaged, much wider than just the field of medicine or veterinary medicine. The present invention can for example be used in the field of marking, removal of large adhesive laminates, such as reflective or graphic products developed by the present licensee, in other non-medical areas where there is a need for temporary bonding material, e.g. semiconductor devices,

Example 1 [0062] An adhesive commercial product available to a person skilled in the present patent for a production laminate of the designation & quot; I-1827A & quot; (breathable transparent polyurethane film (PU)) was pierced by hand to obtain about 10 holes (average diameter 0.16 cm (1 /) 16 in)) per cm² (63 per square inch), so that about 20% of the adhesive was removed. Fig. 2 shows that the measured adhesion at 90 ° peeling at room temperature on high density polyethylene (HDPE) substrates is reduced to about 0.4 N / cm (1 N / in) compared to the original value of 0, 75 N / cm (1.9 N / in) in the state without perforation. When the laminate was sprayed with hexamethyldisiloxane (HMDS) and immediately or at least in about 15 seconds the moisture was still torn off, the measured adhesion dropped sharply to about 0.12 N / cm (0.3 N / in). The peel adhesion quickly returned to about 0.4 N / cm (1 N / in) if the peel measurement was performed after the laminate was completely dry. Similarly, when using Nitac® TR101, a non-roasting medical glue remover available at Union Camp, the product or strip adhering through the adhesive should be removed in a moist state. When it was allowed to dry, the glue peel value was similar to the value before applying Nitac®.

[0063] This exceptional behavior of the deactivating agent such as HMDS is particularly noteworthy because it allows extremely effective separation of the adhesive in the wet state, but evaporates quickly leaving a minimal residue. This is particularly important because it is not always desirable to leave a coating with low adhesion, for example silicone, which can easily impair the adhesion of the next layer used in the same area of ​​the skin, which practice is often necessary, in particular for the treatment of chronic and serious wounds. that can heal for many days. Many other means may be used to optimize or further refine this feature.

Comparative Example [0064] Spraying laminate I-1827A with HMDS does not reduce peel force in the absence of perforation, confirming the importance of developing an effective delivery system.

Anti-activating agents [0065] The terms "adhesive deactivator" or "adhesive separating agent" as used herein means any agent or combination of agents for reducing and preferably abolishing the adhesive bond between the adhesive and the substrate, which is described herein generally as skin mammal. The adhesive deactivating agent is usually liquid and has a viscosity substantially under ambient conditions and other properties and characteristics such that it can pass through the various openings in the multilayer laminates described herein and also reach the adhesive and preferably at least a significant portion of the surface of the adhesive.

An important class of compounds for use as the silicone deactivating agent are silicones, including methoxone and dimethicone derivatives (also known as polydimethylsiloxane), e.g., Toray fluids available from Dow Chemical Corp., tetramethylsilane, hexamethyldisiloxane (HMDS) and their higher homologs . As stated above, the adhesive deactivating agent may also contain one or more perfluoroalkyl derivatives. Additional classes of compounds for use in the deactivating agents of the adhesive include, but are not limited to, low molecular weight oils; soapy water, pH modifiers and / or agents containing other modifiers and ingredients; preferred esters, e.g. isopropyl myristate, triglycerate capricates, tetrahydrofurfural acetate or other alkyl esters and esters; limonene derivatives; paraffinic solvents; hydrocarbon solvents; various alkyl ethers; aromatic esters, surfactants, agents usually used in chemical makeup remover / ink removal products; hairspray ingredients; medicines / lotions for the skin; anti-allergy / anti-inflammatory / anesthetic agents such as, for example, Medtech's Dermaplast aerosol and similar agents; and their combinations. Additional examples of compounds suitable for use as an agent for deactivating the adhesive or for use in conjunction with such an agent are given in U.S. Patents 3,998,654; 5,004,502; 5,336,207; 6,436,227 and 7,354,889. anti-allergy / anti-inflammatory / anesthetic agents such as, for example, Medtech's Dermaplast aerosol and similar agents; and their combinations. Additional examples of compounds suitable for use as an agent for deactivating the adhesive or for use in conjunction with such an agent are given in U.S. Patents 3,998,654; 5,004,502; 5,336,207; 6,436,227 and 7,354,889. anti-allergy / anti-inflammatory / anesthetic agents such as, for example, Medtech's Dermaplast aerosol and similar agents; and their combinations. Additional examples of compounds suitable for use as an agent for deactivating the adhesive or for use in conjunction with such an agent are given in U.S. Patents 3,998,654; 5,004,502; 5,336,207; 6,436,227 and 7,354,889.

[0067] Particularly preferred silicones, or rather polysiloxanes, include, but are not limited to, dimethylsilicones or dimethyl polysiloxanes of the general formula (-CH3) 2-SiO)_x, cyclic or straight-chain, where x is a number between 2 and a few hundred. Trimethylsiloxy blocking end units can be used for stabilization.

[0068] The choice of this agent is particularly significant, as shown in the following Table 1, which gives the relative effect of the various release agents on the measured peel adhesion. More specifically, the samples were glued to the high-density polyethylene substrate (HDPE) and allowed to dry for three days. An effective amount of the adhesive separation agent listed in Table 1 was then applied. The peel force was then measured at 90 °. The data from Table 1 is shown graphically in Fig. 25.

Table 1: Effect of various glue separation agents

<td colspan="3">Separating agents</td>

<td>samples</td><td>Avg. tear strength [N / cm] (N / in)</td><td>95% CL</td>

<td>Control</td><td>0.981 (2.4925)</td><td>0.11</td>

<td>frizz gel</td><td>0.425 (1.079)</td><td>0.00</td>

<td>frizz spray</td><td>0.406 (1.0305)</td><td>0.01</td>

<td>Sephora demaquillant</td><td>0.393 (0.999)</td><td>0.04</td>

<td>Tetrahydrofurfuryl acetate</td><td>0.381 (0.969)</td><td>0.04</td>

<td>PEG400</td><td>0.367 (0.933)</td><td>0.00</td>

<td>Control with small holes</td><td>0.340 (0.863)</td><td>0.04</td>

<td>Uni-Solve</td><td>0.299 (0.76)</td><td>0.06</td>

<td>triacetin (glycerol triacetate)</td><td>0.297 (0.7555)</td><td>0.02</td>

<td>FZ-3196</td><td>0.259 (0.6575)</td><td>0.09</td>

<td>Sephora effaceur de maquillage</td><td>0.172 (0.4365)</td><td>0.02</td>

<td>HMDS</td><td>0.161 (0.4085)</td><td>0.02</td>

<td>Niltac wipes</td><td>0.155 (0.3935)</td><td>0.01</td>

<td>Dow Corning 2-1184</td><td>0.1128 (0.325)</td><td>0.02</td>

<td>Sephora Face</td><td>0.040 (0.1025)</td><td>0.02</td>

<td>Lancome</td><td>0.039 (0.098)</td><td>0.02</td>

<td>Niltac Spray</td><td>0.028 (0.072)</td><td>0.01</td>

[0069] With respect to the various separating means listed in Table 1, most names are obvious. "Frizz" products are commercially available hair care products. Sephora demaquillant is a make-up remover available at Sephora USA, Inc. from San Francisco, California. PEG 400 is poly (ethylene glycol) 400. Uni-Solve is available from Smith &amp; Nephew. FZ-3196 is a volatile liquid alkylene methyl siloxane from Dow Corning. Sephora effaceur de maquillage is a commercially available Sephora makeup remover. HMDS is hexamethyldisilazine, also known as bis (trimethylsilyl) amine. Dow Corning 2-1184 is a mixture of volatile linear polydimethylsiloxanes. Sephora Face is a Sephora make-up remover. Lancome is a commercial composition offered under this name.

[0070] It is envisaged that one or more agents may also be used in the present invention having a chemical composition allowing the hair to be coated, for example by coating with an aminopolidimethylsiloxane (PDMS), which can selectively adhere by forming quaternary amine salts with surface acid groups, which are thought to form as a result of the oxidation of cystine or fluroestres disulphides, etc. Such low-adhesive coatings can then relieve or relieve the pain of pulling the hair when tearing or otherwise removing the adhesive.

[0071] Other embodiments in accordance with the present invention include chemical agents that can be suitably combined with switchable adhesive technologies, for example using heat and / or water to facilitate separation, as described in U.S. Patents 5,183,841 and 5,385,965.

[0072] Another example of an adhesive deactivating agent is the de-coupling agent from reactive silicones. Additional glue-disintegrants come in many forms, including, but not limited to, wipes and aerosols that can be packaged individually and / or in a sterile container. This adhesive deactivating agent can be used in many different ways and use a variety of methods and techniques. For example, this agent can be used with an additional carrier product. The agent can also be used to provide a barrier layer on the skin. The agent can also be used with soaked gauze and / or foam carrier.

[0073] After applying an effective amount of an agent for deactivating the adhesive to the exposed surface of the laminate, the agent moves or is otherwise transported near the surface of the adhesive border along which the laminate and the substrate, e.g. A contact or exposure occurs between the deactivating agent and the adhesive, which, as explained herein, results in the reduction or removal of the prior adhesive connection. The time of contact between the agent and the adhesive necessary for the separation to take place depends on various factors related to the composition and the interaction between the agent and the adhesive. However, it is anticipated that in many applications, sufficient contact time can range from just a few seconds to several minutes. The present invention includes contact times that are shorter and longer than these representative times. [0074] Without adopting any particular theory, it is believed that the effective delivery of a liquid deactivating agent to the surface of the boundary of adhering material and adhesive can be the main factor important for easy and quick separation on this surface. A number of additional factors that may be important to maximize or further stimulate this desired effect include one or more of the following: [0075] Molecular weight: small molecules are expected to exhibit a higher level of diffusion at the interface than greater. that the effective delivery of a liquid deactivating agent to the surface of the boundary of adhering material and adhesive can be the main factor important for easy and quick separation on this surface. A number of additional factors that may be important to maximize or further stimulate this desired effect include one or more of the following: [0075] Molecular weight: small molecules are expected to exhibit a higher level of diffusion at the interface than greater. that the effective delivery of a liquid deactivating agent to the surface of the boundary of adhering material and adhesive can be the main factor important for easy and quick separation on this surface. A number of additional factors that may be important to maximize or further stimulate this desired effect include one or more of the following: [0075] Molecular weight: small molecules are expected to exhibit a higher level of diffusion at the interface than greater.

[0076] The roughness of the surface of the adhesive material and the surface of the adhesive: the rougher the separating surface is, the easier it will be to penetrate the interface at the interface, which is expected to contribute to a lower initial level of adhesion upon peeling.

[0077] Glue topology: voids, texture and / or channels contribute to the efficiency of fluid delivery to the interface.

[0078] Chemical properties of the adhesive: the relevant parameters are the nature of the adhesive, in particular with regard to its chemical / solubility parameters, cross-linking and phase structure.

[0079] Conformity: the agent should be sufficiently compatible to achieve favorable penetration into the laminate and the interface, but not compatible enough to have an adverse effect on the entire volume of the adhesive and resulting in a lack of cohesion potentially leading to residue. Effective interaction with the substrate (eg chemical, physiological and / or surface properties of the skin) may be particularly important.

[0080] Pain relief: relieving pain when taking off, preferably potentially as a result of interaction with the skin surface to dissolve / weaken exudates or connections at the interface, limiting irritation by inhibiting histamine release, covering hair to limit pulling, changing skin topology for easier separation, providing physiological or even psychological relief, e.g. as a result of cooling, warming and / or wetting.

[0081] In some applications, it may be advantageous to use a drug agent deactivating agent or a therapeutic anesthetic, analgesic, cooling and / or warming agent, or a combination thereof.

Additional Aspects [0082] In the following Figures, various operating mechanisms are provided that can efficiently provide an adhesive deactivating agent to the joining surface. Fig. 3 schematically illustrates a preferred inner layer 100 that can be used as the inner layer 40 shown in Fig. 1. The layer 100 includes a first surface 102, a second surface on the opposite side 104 and a series of wires, holes, perforations, gaps or wells 110 through the layer 100 and between the first and second surfaces 102, 104. The wells 110 in Fig. 3 show the perforations or pores allowing the fluids to flow quickly through the adhesive system. They can be easily produced by mechanical methods, such as, for example, the use of magnetic rotary dies available from Rotometrics in Eureka, Missouri,

[0083] In another preferred embodiment in accordance with the present invention, the configuration or arrangement of the perforations or openings in the applied inner film, for example in the layer 40 shown in Fig. 1, is adapted to the adhesive, for example shown as layer 30 in Fig. 1. This configuration provides greater accessibility and exposition of the adhesive surface to the adhesive deactivating agent. This configuration can provide shorter contact times between the adhesive deactivating agent and the adhesive.

[0084] In some embodiments, it may be desirable that the applied film or cover layer shown as layer 60 in Fig. 1 is porous or composed of nonwovens, etc. that allow free movement of the fluid. These features can easily be introduced in particular if the optical transparency of the film and / or the laminate is not very important. [0085] With reference to Fig. 4, the top surface 104 of the inner layer 100 of Fig. 3 is shown. The areas of the adjoining material 120, e.g. leather, are exposed and thus accessible to the fluid through the wells 110. Because the bottom of the wells 110 is an adherent material , for example, skin, liquids, such as an adhesive deactivating agent, then have the ability to rapidly diffuse or otherwise transport across the interface, helping to weaken the adhesive bond and help in easy,

[0086] A test method that potentially allows to determine the diffusion coefficient at the interface is the use of electrical capacitance measurements at a single frequency (SFCM) using an electrode array of sensor plates arranged in a finger-like configuration. This is described in more detail in the Research Methods section in this document.

[0087] In yet another preferred embodiment according to the present invention, there is a co-continuous hollow channel in the adhesive layer for efficient fluid distribution, as shown in Fig. 5. One way to obtain such channels in the adhesive or undercoat is mechanical extrusion. In particular, Fig. 5 shows an adhesive layer 130 formed with one or more channels, such as channels 136 and 138, which preferably extend at least partially through the layer 130 and are substantially flush with the layer. Fig. 5 shows a configuration in which the channel system comprises a first plurality of substantially parallel channels 136 and one or more transversal channels 138. After the fluid, such as an adhesive deactivating agent, has penetrated into one or more of the channels 136 and 138,

This configuration can be useful if sealing the perimeter around the wound is not particularly important, and it is not always possible for exudate discharge through such channels. An effective way to quantify the release of air through the area around the wound is to use a modified Sheffield smoothness test or air permeability. This is discussed in the Research Methods section in this document.

Although the invention is not limited by any particular amount of adhesive in layer 240, a typical amount is about 10 g / m2. You can choose the same adhesive as used for skin contact or other low / no-adhesion PSA, for example Airflex 920 or 7200 from Air Products. The inner layer 230 preferably comprises a plurality of openings 236, each having a diameter or span of from 12.7 to 254 [mu] m (0.5 to 10 mils). The adhesive layer 220 preferably includes a series of holes 226 with an arrangement identical or at least substantially similar to the arrangement of the openings 236 in the inner layer 230. Furthermore, the size of each opening 226 in the adhesive layer 220 is preferably identical to the corresponding opening 236 in the inner layer 230. Also in in this case, although the present invention is not limited by any particular amount of adhesive in layer 220, a typical amount is about 60 g / m2. This embodiment has the advantage of being used as a double-sided coated universal transfer belt with almost every kind of top / PSA laminate. Accordingly, the present invention can be readily used in a wide variety of products, systems and applications. [0090] In yet another embodiment of the present invention, the inner layer may be microporous, non-porous if the optical transparency is significant, and comprise a breathable fabric that allows fluids to be easily permeable through the adhesive layer comprising preferably channels, as shown in Fig. 5. that it is used as a double-sided coated universal transfer tape with almost any type of laminate with top foil / PSA. Accordingly, the present invention can be readily used in a wide variety of products, systems and applications. [0090] In yet another embodiment of the present invention, the inner layer may be microporous, non-porous if the optical transparency is significant, and comprise a breathable fabric that allows fluids to be easily permeable through the adhesive layer comprising preferably channels, as shown in Fig. 5. that it is used as a double-sided coated universal transfer tape with almost any type of laminate with top foil / PSA. Accordingly, the present invention can be readily used in a wide variety of products, systems and applications. [0090] In yet another embodiment of the present invention, the inner layer may be microporous, non-porous if the optical transparency is significant, and comprise a breathable fabric that allows fluids to be easily permeable through the adhesive layer comprising preferably channels, as shown in Fig. 5.

[0091] In another preferred embodiment in accordance with the present invention, an adhesive adhesive with an open cell foam structure or composed of microfibers or any other three-dimensional structure allowing free fluid movement is used.

[0092] In yet another embodiment, according to the present invention, channels in the adhesive layer, e.g. shown in Fig. 5, are obtained by means of a suspension adhesive adhesive composition.

[0093] The structure and dimensions of the passageways or passageways are selected to achieve the right balance between the effective delivery of the adhesive deactivating agent without undue negative impact on the initial peel adhesion, so as to ensure firm adhesion to the adjoining material.

Example 2 [0094] Surgical wound closure dressings (VAC) must typically be optically transparent and flexible and resistant to underpressure. Fig. 7 shows another preferred embodiment providing painless separation if necessary.

More specifically, the embodiment 300 includes a central area 310 placed on the wound and a hermetic outer laminate for applying a vacuum. The outer region 320 of embodiment 300 may correspond to preferred embodiments of the laminates described herein. This band-type banding comprises the aforementioned produced laminate 1-1827A available from a person authorized herein, respectively perforated to provide initial adhesion and selective separation parameters. After applying this perforated laminate to the wound covered wound area after treatment according to VAC methods, another impermeable top laminate is applied on top to ensure sealing of the area and adequate maintenance of the necessary vacuum during therapy, optimal water vapor permeability coefficient (MVTR),

[0095] In yet another preferred embodiment in accordance with the present invention, the laminate 400 selectively perforated in the area around the wound comprises a central region for providing a suitable seal, as shown in Fig. 8. The central region 410 in the shape of a circle is placed over the wound area, it contains he foam suitable for the VAC method. This area does not contain glue. The outer ring 420 in the form of a ring may also include a wound area, therefore it does not contain glue. This annular region 420 can be optically transparent and impermeable to maintain vacuum and / or fluids. In the remaining outer area 430, a laminate configuration according to a preferred embodiment described herein is used. Although this embodiment is easier to apply, it requires the production of pre-determined quantities, and does not allow the specialist to cut the scarves to the size needed. See, for example, U.S. Patent 4,917,112.

[0096] Yet another preferred embodiment in accordance with the present invention includes wound coverage with foam in accordance with current practice in vacuum wound closure (VAC) therapy. The foam is then covered with a thin film laminate of low adhesion and a minimum size with impermeable layers. Low traction is enough to safely create a tent around the wound area and gently seal the skin around the wound. Subsequently, a selectively separated permeable laminate can be applied to finish the dressing and apply the vacuum starting therapy by vacuum wound closure (VAC).

[0097] Yet another embodiment in accordance with the present invention consists in using a variable combination of invoiced adhesives and film to provide various desirable properties such as adhesion control, selectively separated adhesion, airtightness, etc. Laminate 500 shown in Fig. 9 provides one possible method implementation. The circular area 510 in the middle is placed over the area of ​​the wound. The set of rings 510, 520, 530, 540, 550 and 560 in the form of rings has a size and texture providing airtightness and reduced adhesion as needed. In the remaining outer area 570, the preferred laminate configuration described herein is used. The person skilled in the art will understand that many combinations of textures, levels of adhesion can be combined and matched, outer film laminate structures, etc. to obtain a combination of user parameters desired by the end user. [0098] The present invention further discloses the following alternative delivery system. This delivery system includes the use of providing appropriately encapsulated means in combination with microigens of distribution and size to provide for perforation of the inner layer and adhesive if desired and timely. This is shown in Fig. 10. Generally, the adhesive deactivating agent described herein is applied to the inner layer 620 adhered by the adhesive to the underlying substrate via the adhesive layer 610. The agent is contained in microcapsules 630 broken or otherwise permited to release the agent surface 624 of the 620 layer. The microcapsules 630 can then be conveyed or otherwise incorporated into layer 640 and / or laminate 600. The microcapsules 630 can be attached to the surface 642 of the layer 640. One or more micro-balls 635 piercing the inner layer 620 can be used to further increase the delivery of the adhesive deactivating agent. the direction of arrow C to the glue. There may also be an optional covering layer 650 comprising an outer surface 654. Fig. 10 shows an adhesive layer 610 comprising one or more channels 605, as previously described with reference to Fig. 5. to further increase the delivery of the agent deactivating the adhesive in the direction of arrow C to the adhesive. There may also be an optional covering layer 650 comprising an outer surface 654. Fig. 10 shows an adhesive layer 610 comprising one or more channels 605, as previously described with reference to Fig. 5. to further increase the delivery of the agent deactivating the adhesive in the direction of arrow C to the adhesive. There may also be an optional covering layer 650 comprising an outer surface 654. Fig. 10 shows an adhesive layer 610 comprising one or more channels 605, as previously described with reference to Fig. 5.

[0099] This delivery system is particularly well suited for applying such laminates to a pre-applied adhesive bandage. If it is necessary to remove previously perforated bandages, as in the typical case of many commercially available products, simply apply one of the abrasion-free adhesive removal (AAR) laminations previously designed to allow the areas of the adhesive to match the areas of the support containing the facilitator removal of glue. Such laminates contain pre-coated adhesive layers that help to attach to an old bandage adhering to the skin for a predetermined period of time to allow effective penetration of the fluid necessary for painless removal. The possible microneedles shown are arranged to coincide with the arrangement of the adhesive areas on the bandage, if a pre-perforated top film is not available, e.g. for occlusive laminates. Example 3 [0100] In another embodiment of the invention that extends this concept, a material is also applied covering the area around the wound that is placed in the area surrounding the wound. This results in a surface to which the products, such as a vacuum therapy film (VAC), adhere. Since the glue in these products does not come into direct contact with the skin, pain, allergies, etc., can be further reduced by repeatedly applying the bonding and separation to the upper surface of the material covering the area around the wound. The sheath around the wound of a skin-like material can be designed like to firmly adhere to the skin for a much longer time than typical medical dressings. Since the present invention can be used for ultimate atraumatic removal, this can be a significant benefit to the nurse or patient.

[0101] The material used in such skin-like sheaths may optionally be designed to be selectively removed if necessary by means of selective adhesive separation methods. For example, with reference to Fig. 11, a laminate 700 comprising a central area 720, preferably a recess, and an outer area 730 is provided. This central area 720 is placed on the wound area and contains a sponge material 710 suitable for use with therapies by negative wound closure. (VAC). In other areas 730, a laminate construction as described herein can be used that provides multiple atraumatic use. The upper surface of area 730 can be advantageously designed to reduce the pain and discomfort associated with multiple connection and separation of products to the VAC, which can be placed on it. [0102] Another embodiment of the present invention utilizes a fractal channel system by which fluids can be easily delivered in whole volume from one or very few injection points. An example of a fractal pattern represented by the Lichtenberg figure is shown in Fig. 12. Those skilled in the art know that Figs. Lichtenberga are tree-like or fern-like patterns that appear similar at various magnification. This property, often referred to as self-similarity, is the main feature of fractals. With reference to Fig. 12, the main branch 810 comprises a plurality of branches of the second row 820. Each branch of the second row 820 includes a plurality of third order branches 830 and so on. These branches may be voids or channels located in the layer 850. For example, the previously described channels in the adhesive layer can be arranged in accordance with the fractal pattern. It is also envisaged that openings made in the inner layer of laminates according to a preferred embodiment may be arranged in such a pattern. [0103] The present invention further provides another method of providing a separation fluid, i.e. an agent for deactivating the adhesive. In this variation of the invention, one or more agents are administered in gas or air and then introduced by pumping gas or air using a vacuum wound closure therapy device (VAC). [0103] The present invention further provides another method of providing a separation fluid, i.e. an agent for deactivating the adhesive. In this variation of the invention, one or more agents are administered in gas or air and then introduced by pumping gas or air using a vacuum wound closure therapy device (VAC). [0103] The present invention further provides another method of providing a separation fluid, i.e. an agent for deactivating the adhesive. In this variation of the invention, one or more agents are administered in gas or air and then introduced by pumping gas or air using a vacuum wound closure therapy device (VAC).

[0104] The present invention envisages the possibility of providing a small amount of heat above the ambient temperature to the laminate so that the laminate adheres to the surface or shrinks the film or a combination thereof. In addition, a chemical treatment can be used to shrink the film and stick to the surface.

[0105] In a laminate according to a preferred embodiment, any of these structures and / or methods may be used to achieve selective separation of the adhesive or skin-like coating around the wound to activate the fluid.

Additional Uses for Easy Usage [0106] As a series of medical applications require the use of highly flexible, optically transparent adhesive dressings, the present invention further extends the applicability of U.S. Patent No. 6,541,098 to the present licensee. In particular, in the laminates according to the preferred embodiment described herein, the pressure-bonding function can be used. With reference to Fig. 13, a laminate 900 comprising one or more layers 920 and a recessed adhesive-adhesive layer 910 is provided. One or more openings 926 are formed in the layer or layers 920, so that the material from these layers protrudes over the exposed surface of the adhesive layer 910. The resulting bulges of the material 930 are protrusions or protrusions, which prevent or at least limit the degree of contact of the adhesive layer 910 with the substrate. After application of a pressure force on the surface 924 of the laminate 900, the adhesive layer 910 may contact the substrate, so that it is possible to adhere the laminate 900 due to the adhesive to the substrate. Details regarding these aspects are provided in the aforementioned US Patent 6,541,098. According to the present invention, the laminate 900 comprising embossments with an adhesive also comprises an inner layer with openings for transporting and permeating the adhesive deactivating agent. Details regarding these aspects are provided in the aforementioned US Patent 6,541,098. According to the present invention, the laminate 900 comprising embossments with an adhesive also comprises an inner layer with openings for transporting and permeating the adhesive deactivating agent. Details regarding these aspects are provided in the aforementioned US Patent 6,541,098. According to the present invention, the laminate 900 comprising embossments with an adhesive also comprises an inner layer with openings for transporting and permeating the adhesive deactivating agent.

[0107] The present invention further provides a thin, transparent, flexible laminate without difficulty to provide the advantage that it does not include a primer due to the extrusion produced. This construction with the use of appropriate medically acceptable adhesives solves a typical problem when using products sticking to each other. According to the invention, the surface is non-sticking unless proper pressure is applied. It should be noted that the adhesive is present in a continuous manner, thus ensuring adequate sealing around the wound for treatment by vacuum wound closure (VAC).

[0108] In yet another aspect of the invention, the feature can be extended to a laminate to additionally provide easy tearing characteristics. Fig. 14 depicts one selected suitable embodiment 1000. In this variation of the present invention, a series of disposed mounds or bulges 1012 are formed along the surface of the layer 1010. The unlabeled regions 1014 between the mounds contain adhesive adhesive. A perforated layer 1020 comprising a plurality of openings 1022 is provided such that the openings 1022 are aligned according to the bulges 1012. Preferably each opening 1022 is centered relative to the respective bulge 1012. A suitable laminate 1030 may be formed. It is to be understood that the present invention encompasses a wide variety of derivatives of laminated structures in which this configuration is used. [0109] The choice of chemical composition of the adhesive, coating weight, percentage of printed surface and other factors is preferably adapted to ensure adequate adhesion, airtightness, water vapor transmission factor (MVTR), wet adhesion properties and the like. Other embodiments corresponding to this strategy are envisaged.

[0110] Other strategies that provide potentially ease of use of adhesives, in particular if thin, include the following.

[0111] The application of a perforated film, as shown as the method 1100 in Fig. 15, can be used. In this method, the adhesive adhesive layer 1120 is between the flexible cover film 1110, e.g. made of polyethylene or polypropylene, and the perforated film 1130. After removing one or more perforated areas from the perforated film, the adhesive is exposed through the openings 1150. A stamping die 1140 comprising one or more bulges or terminals 1142, 1144 may be used to produce the openings 1150. This layered configuration may be used together with a selective layer with openings for transporting the deactivating agent glue. This method can be used to significantly increase the ease of use of the adhesive-containing laminates described herein.

[0112] A primer may be used with pre-printed non-tacky transfer areas as shown in Method 1200 in Fig. 16. In this method, printing or the process of applying another suitable material to embed material is performed.

1230, e.g., ink, onto the surface of the removable coating 1220 provided on the primer 1210. The embedded material 1230 on the backing 1210 is then contacted with the adhesive layer 1250 and the film 1260 or, as in the present invention, with a self-adhesive adhesive laminate as described herein. A transfer component 1240 may be used. Transfer of material 1230 to adhesive layer 1250 may greatly increase the ease of use of the adhesive-containing laminate.

[0113] The main application of this method is the production and manufacture of printed ink lines for delivering one or more agents deactivating the adhesive to a suitable location, i.e. such that the agent or agents can effectively tear the bonding of the substrate and adhesive or the joining surface. The printed ink conduits are preferably applied to a removable coating on the backing, as shown in Fig. 16. In some applications, the ink conduit on the backing provides a commercially applicable method of rapidly delivering an adhesive deactivating agent so that it can tear the substrate bond and glue or connecting surface.

[0114] Although various methods have been described herein for the production of printed ink lines, they are not limited to any specific ink formulation, and below are representative examples of preferred inks. For example, it has been found that ink available under the UV Cured Gravure Ink No. 982-64 by DAW Ink is suitable for these methods. Additional details and aspects of the methods and methods in accordance with Fig. 16 are given in US Patents 7,332,205; 7.344.618 and 6.630.049.

[0115] The ink is of such a composition that it can easily be printed on a surface with low adhesion, for example on a silicone material for release, and is also resistant to subsequent difficult technological conditions, e.g. exposure to moist solvents, other coatings, heat, pressure and other factors.

[0116] These methods described generally herein and particularly in connection with Fig. 16 allow the creation of a suitably printed padding or other element that can universally be used to transfer a pattern of wires to an ink onto any surface of an adhesive. The transfer method can be any suitable way, e.g. it helps in transporting a fluid that has penetrated the edge of the laminate or through another area, and its effective spread through a pattern of traces. In contrast, the discontinuous pattern of the ink conduits is a continuous adhesive contact surface that may be necessary if vacuum is attempted, e.g. in an NPWT / VAC therapy system.

Example 4 [0117] A series of studies was conducted on the effect of various surface printed patterns on adhesive ink on peeling of a multilayer laminate, including a medical acrylic adhesive.

[0118] Two categories of samples are shown schematically shown in Fig. 26. Each sample contained an exposed surface with printed areas of ink lines and adhesive areas. Fig. 26A and 26B show sample surfaces with adhesive regions "a" and printed ink areas "b". Sample A contains a printed area b occupying 66% of the total area. Sample B contains a printed area b occupying the same area percentage, i.e. 66%. However, it should be understood that the pattern on the printed areas b in sample A is discontinuous, while the pattern in sample B is continuous. The patterns of printed ink tubes preferably comprise a series of continuous fluid channels or, if necessary, a series of discontinuous fluid channels.

[0119] Samples were then subjected to tensile tests at ninety degrees tear relative to the control samples, i.e. the respective laminate, the surface of which was 100% glued, and the corresponding laminate, 20% of which was perforated. Samples were tested after different holding times using an Instron® instrument and tear adhesion measurements were taken at 4.7 cm (12 inches) per minute. The following Table 2 summarizes the results of this study. In addition, a second set of evaluation studies was carried out using skin-like models with polyurethane (PU).

Table 2: Comparison of peel adhesion values

<td>Id. samples</td><td>Adhesion at tearing at a 90-degree angle on the skin after holding for 2.5 hours. [N / mm] (pounds / cai)</td><td>Adhesion at tearing at a 90-degree angle on the skin after holding for 24 hours. [N / mm] (pounds / inch)</td><td>Adhesion at tearing at a 90-degree angle in the PU skin model after holding for 20 min [N / mm] (pounds / inch)</td>

<td>Control</td><td>0.61 (3.5)</td><td>0.79 (4.5)</td><td>1.31 (7.5)</td>

<td>Control with 20% of the perforated surface</td><td>0.33 (1.9)</td><td>0.75 (4.3)</td><td>1.12 (6.4)</td>

<td>Sample B</td><td>0.10 (0.6)</td><td>0.49 (2.8)</td><td>1.03 (5.9)</td>

<td>Sample A</td><td>0.07 (0.4)</td><td>0.47 (2.7)</td><td>1.12 (6.4)</td>

[0120] From the data presented in Table 2 it is clear that samples A and B exhibited significantly reduced peel adhesion values ​​compared to the control and control of which 20% of the surface area was perforated.

Example 5 [0121] Figure 27 shows the printed ink lines described herein and marked "RS" in Fig. 27. These printed ink conduits facilitate penetration and retention of the fluid as compared to the control. In particular, Fig. 27 shows gravimetrically how a volatile liquid, e.g. HMDS (hexamethyldisiloxane), penetrates quickly and still remains in the adjacent laminate over time.

Example 6 [0122] Another series of tests was performed in which 90 degree peel tests were carried out on samples using high density polyethylene (HDPE) and changing the coating weight with a retention time of 20 minutes.

[0123] Fig. 28 shows the various samples marked on the horizontal axis of the graph and the corresponding peel measurement at an angle of 90 degrees. Interestingly, a coating weight of 90 gsm with a perforation of 20% provides peel adhesion after being held for 20 minutes comparable to an unperforated coated product currently available at 60 gsm. The reduction in adhesion upon peeling after a longer holding time, i.e. above 24 hours, is much smaller and more proportional to the percentage of area lost per perforation. Regardless of the initial high adhesion at peeling, the use of a preferred glue-inactivating agent and the like liquid immediately reduced the adhesion upon peeling of HDPE to less than 0.12 N / cm (0.3 N / inch). It is important and unusual.

[0124] Without adopting any particular theory or parameters, it is believed that to obtain fast separation if necessary, e.g. in about 10 to 20 seconds, for separation, if desired, it is preferred to provide a flow area of ​​about 20% of the channels. Studies show that the value of 10% separation channels if necessary is too low, and 40% may be too high causing the laminate to become structurally unstable, but its properties are excellent. A suitable vacuum wound care (NPWT) wound was created with separation properties if necessary using a face laminate.

[0125] In an alternative embodiment, the system for NPWT covers wound beds containing wounds with a completely perforated laminate. Using the modification of the TRAC insert, the cut area of ​​the wound panel cut to size, can be covered with a non-perforated laminated foil. By covering the underlying perforations, this ensures adequate under-pressure in the wound bed, and also eliminates the need to pierce or otherwise access the vacuum line as required by current practice.

[0126] Fig. 29 is a schematic illustration of another preferred embodiment of a multilayer laminate or system 2100 in the following manner. The system 2100 includes a film layer 2110, an adhesive layer 2120, a controlled decay layer 2130 and a substrate 2140. The controlled decay layer 2130 is selectively broken and / or dissolved after exposure to the adhesive deactivating agent. This layer, for example layer 2130, has a number of advantageous properties, for example (i) no adverse effect on the adhesion of the adhesive and the substrate, i.e. layers 2120 and 2140, but also (ii) easily breaks and / or dissolves after applying a combined composition or agent deactivating the adhesive or the like liquid.

[0127] The controlled disintegration layer can be easily delivered in the form of an aerosol, a wet wipe etc. The controlled disintegration layer can be used in combination with the printed ink lines described herein. In some preferred embodiments and applications, the disintegrating layer is degraded, and so it can disintegrate and / or be gradually removed or otherwise eliminated, e.g. when removing the various multilayer laminates described herein.

[0128] The controlled disintegration layer may also contain a wide variety of other agents and / or components. For example, a controlled disintegration layer may also include medicaments, e.g. pain relieving agents, antiallergic agents, etc.

[0129] The controlled disintegration layer may additionally exhibit unique functional electrical features for easier diagnostics, for example regarding dielectric constants, conductivity, etc. An example of such a layer may be components for obtaining or combining with wireless vital monitoring patches. The disintegrating layer may be arranged such that it provides a suitable surface for receiving signals through the patch.

[0130] The disintegrating layer may be arranged to provide a switching function. In this embodiment, for example, a crystalline polymer with a temperature-sensitive side chain can be incorporated into the layer to obtain selective permeability of the active ingredients upon activation by stimuli, e.g. heat. The disintegrating layer may essentially have a switching function in that the physical property of the layer switches between at least two states as a result of a change in external stimuli.

[0131] In yet another embodiment, a system is provided to specifically relieve the pain associated with repeated peeling from the same area. In this embodiment, a strongly adherent recess forming a release layer is obtained in the area around the wound. These systems can be set up and designed to provide a reliable seal that is used for multiple connection and separation without adversely affecting the user's skin. In addition, using the appropriate methodology, this layer can be supplemented if necessary. Such an attached interface system can be used in a wide variety of medical applications in addition to NPWT. An example of such medical use is stoma hygiene.

[0132] Applied nonwoven can be used, as shown in Fig. 17. In this method 1300, a thin layer of non-woven fabric 1340 is applied to the adhesive surface 1330 of the adhesive 1310. The non-woven layer 1340 on the adhesive considerably increases the ease of use of the laminate.

[0133] Sputtering of the adhesive surface with Expancel beads (expanded or non-expanded) by Akzo Nobel, flexible microspheres, mica, ink, etc., as shown in Method 1400 in Fig. 18 can be used. In this method, the exposed surface of the adhesive 1420 is on the film. 1410, an effective amount of particulate material 1430 is applied. Those skilled in the art will understand that the microspheres can be expanded or otherwise treated to form or form a residue layer 1440. This practice can be used to increase the ease of use of an adhesive containing laminate.

[0134] It is also possible to apply a heat-, light- or fluid-activated adhesive layer as shown in Fig. 19. In this method 1500, for example, a flexible top layer 1510, e.g. made of polyethylene or polypropylene, an activated adhesive is applied. thermally, self-adhesive adhesive 1520. The selected area or regions of the adhesive are then heated, for example as a result of contact with the extrusion roller 1530 with hot tips 1532, 1534 to inactivate, activate or otherwise modify one or more adhesive properties or parameters.

1520. Heated or otherwise treated areas of adhesive 1520 are shown as areas 1510. This method can be used in the various laminates described herein.

[0135] Furthermore, methods can be used to ensure greater usability of the variable module film.

[0136] Furthermore, polyvinyl chloride films (PVC) with a Z module may be used, rigid in one direction and very flexible in the other, as shown in Fig. 20. In this method, a sandwich configuration 1600 is obtained, such that the laminate is relatively stiff in one direction and relatively flexible in the other direction. The laminate 1600 includes alternating layers of polymeric material, e.g. polyvinyl chloride), with an effective amount of plasticizer, as shown in layers 1610, 1630 and 1650; wherein each layer is separated by a polymer layer, moreover it is preferably the same polymer as used in layers 1610, 1630 and 1650, but without a plasticizer. These layers are designated as layers 1620 and 1640. As shown in the data in Table 3 below, the laminate 1600 is significantly stiffer in the lateral direction (CD) than in the longitudinal direction (LD).

Table 3

<td>Orientation</td><td>Young's modulus [MPa] (psi)</td><td>% strain at break</td><td>Stress strain by 8%</td><td>Residual stress [MPa] (psi)</td>

<td>LD</td><td>7.37 (1.069)</td><td>270</td><td>82</td><td>0.61 (88)</td>

<td>CD</td><td>58.0 (8.416)</td><td>271</td><td>482</td><td>1.47 (213)</td>

[0137] In addition, multi-phase extruded film systems may be used in the laminates of the present invention. Fig. 21 shows a layer 1700 of a multiphase adhesive system comprising a matrix phase 1710 and an adhesive phase 1720, usually dispersed therein. For example, a two-phase system including an adhesive phase may be used, e.g. available from Capitol Plastic Technology.

materials

Perforated inner layer [0138] The inner layer of preferred laminates, such as for example layer 40 in Fig. 1, layer 100 in Fig. 3 and layer 230 in Fig. 6, can be made from a variety of materials. Preferred materials include, but are not limited to, elastomeric polyurethane, polyester or polyether films. Desired properties include high water vapor and oxygen permeability, flexibility, flexibility and transparency. For extra ease of use, you can use disposable backing films, for example polypropylene (PP) or polyethylene (PE), for single use. Alternatively, breathable paper or fabric foundations may also be suitable for use. Additional examples of such paper sleepers or fabrics are given in "A Review on Designing the Waterproof Breathable Fabrics", A. Mukhopadhyay; VK Midha,

Coating Layer [0139] In one or more cover or backing layers, for example layer 60 in Fig. 1 or layer 250 in Fig. 6, a variety of materials may be used, e.g. polyurethane, paper, polyethylene, polypropylene and polyurethane film layers, among others. other polymers. The beneficial aspects of each of these materials are as follows.

[0140] Polyurethane - Blown non-woven fibrous materials composed of three-layered polymeric fibers with a middle layer of a mixture of polyethylene and plastic KRATON, adhesive adhesive and outer layers of polyurethane; prepared as described for Sample No. 16 in US Patent 6,107,219 to Joseph et al .; they are a suitable elastic, non-tearing undercoat or covering layer.

[0141] Paper - Hammermill Laserprint Paper (thickness 0.11 mm, product No. 00460-4, International Paper, Memphis, TN); is a typical unstretchable, tearing undercoat.

[0142] Polyethylene - Blown polyethylene nonwoven (thickness 0.04 mm, type No. TM07-27-98-02, Trans Web LLC, Vineland, NJ); is a typical stretchable, tearing base.

[0143] Polypropylene - Blown polypropylene nonwoven (basis weight 20 g / m2, Kimberly Clark, Irving, TX); is a typical unstretchable, tearing undercoat. [0144] Film - A polymer film containing 60% ethylene / vinyl acetate copolymer, 35% linear low density polyethylene, 5% stabilizers and other additives (PGI, product No. 6012, Polymer Group, Inc., Gainesville, GA); the film had a weight of 27 g / m (1.15 oz / yd) and a thickness of 0.13 mm (5 mililicals) and oval-shaped holes (about 0.2 mm wide and 0.3 mm long in the longest dimensions), with the longitudinal dimension of the oval holes was parallel to the direction of the device during film production. The foil contained approximately 530 holes / cm² arranged in a pattern of alternating lines. One side of the film was smooth (micro-gravure / extruded for smoothness) and the other side was rough (side with material pushed as a result of punching holes).

[0145] Additional details regarding various materials suitable as cover layers are described in U.S. Patent 7,078,582.

Adhesive [0146] The adhesive used in different laminates according to a preferred embodiment, e.g. in layers 30 and / or 50 in Fig. 1, layer 130 in Fig. 5 and layers 220 and / or 240 in Fig. 6, may be solvent-like in nature. , emulsion, suspension, completely solid or hot melt. For medical use, compliance with the law may be necessary, for example in accordance with ISO 10993. The adhesive may be in the form of hydrogels, hydrocolloids, soft silicone gels and may additionally include the switching characteristics described earlier herein. In principle, it is preferred that the adhesive is an adhesive adhesive.

[0147] The acrylic solvent adhesive may be any pressure-sensitive adhesive that adheres to the skin of a mammal and does not contain ingredients known to cause undesirable irritation or toxicity to mammals. Useful acrylate copolymers may or may not be self-crosslinking and are obtained from at least two monomers selected from the following: (1) hydroxyalkyl esters of acrylic or methacrylic acid in which the alkyl group contains 2 to 4 carbon atoms, e.g. 2-hydroxyethyl acrylate , 2-hydroxyethyl methacrylate, 2-hydroxypropyl acrylate and 2-hydroxypropyl methacrylate; (2) alkyl esters of acrylic or methacrylic acid in which the alkyl ester group contains 4 to 18 carbon atoms, e.g. n-butyl acrylate or methacrylate, isopropyl acrylate or methacrylate, n-hexyl methacrylate and 2-ethylhexyl acrylate; (3) α, β-unsaturated monocarboxylic or dicarboxylic acids, their anhydrides and their alkyl or alkenyl esters in which the alkyl group contains from 1 to 3 carbon atoms and the alkenyl group contains from 2 to 5 carbon atoms, such as acrylic acid, itaconic acid, maleic acid, maleic anhydride, alkyl methacrylate and diethyl esters of fumaric or maleic acid; (4) vinyl monomers such as vinyl acetate, acrylonitrile, vinyl propionate, vinylpyrrolidone and styrene; (5) functional group-containing monomers selected from amide, amino and epoxy groups, e.g. acrylamide, N-butylacrylamide, alkylaminoalkyl and aminoalkyl derivatives of acrylic or methacrylic acid, e.g. aminoethyl acrylate, aminoethyl methacrylate and 2- (dimethylamino) ethyl methacrylate, methacrylate glycidyl and glycidyl acrylate; (6) alkoxyalkyl esters of acrylic or methacrylic acid, e.g. methoxyethyl acrylates or methacrylates, butoxyethyl acrylates or methacrylates, methoxypropylene glycol methacrylates and methoxypolyethylene glycol acrylates or methacrylates; and (7) hexamethylene glycol dimethacrylate. Since these copolymers may be self-crosslinking, they may also contain a crosslinking agent selected from those commonly used by those skilled in the art, such as organic peroxides, polyisocyanates, chelates or metals, e.g. titanium or aluminum, or metal acetylacetonates, e.g. zinc, magnesium and aluminum. . methoxypropylene glycol acrylates or methacrylates and methoxypolyethylene glycol acrylates or methacrylates; and (7) hexamethylene glycol dimethacrylate. Since these copolymers may be self-crosslinking, they may also contain a crosslinking agent selected from those commonly used by those skilled in the art, such as organic peroxides, polyisocyanates, chelates or metals, e.g. titanium or aluminum, or metal acetylacetonates, e.g. zinc, magnesium and aluminum. . methoxypropylene glycol acrylates or methacrylates and methoxypolyethylene glycol acrylates or methacrylates; and (7) hexamethylene glycol dimethacrylate. Since these copolymers may be self-crosslinking, they may also contain a crosslinking agent selected from those commonly used by those skilled in the art, such as organic peroxides, polyisocyanates, chelates or metals, e.g. titanium or aluminum, or metal acetylacetonates, e.g. zinc, magnesium and aluminum. .

[0148] These acrylate adhesive copolymers may be in the form of solutions in a solvent system consisting of a single organic solvent or a mixture of several solvents which contain 25% to 55% by weight of the copolymers. Examples of suitable solvents include aromatic solvents, e.g. toluene, xylene, etc. Suitable aliphatic solvents include esters, e.g. ethyl acetate, propyl acetate, isopropyl acetate, butyl acetate, etc .; ketones, such as methyl ethyl ketone, acetone etc .; aliphatic hydrocarbons, e.g. heptanes, hexane, pentane, etc. They can be used in additive materials for an adhesive composition that do not affect the basic properties of the adhesive. Fillers, adhesives, antioxidants, stabilizers and the like can be added to the adhesive formulation.

[0149] An example of a commercially available adhesive is DUROTAK 380-2819 available from National Starch, which is self-crosslinking solvent acrylic pressure sensitive adhesive containing 40% by weight solids in an ethyl acetate / isopropanol / heptane / toluene / pentanedione solvent mixture.

[0150] Additional examples of adhesives and their aspects that may be suitable for use in the present invention include those described in U.S. Patent 7,078,582. Specific examples of potentially suitable adhesives include the adhesives listed below and labeled AF adhesives.

[0151] Adhesive A - Fibers containing polyacrylate pressure-sensitive adhesive (PSA) with a thickness of 0.13 mm (5 mils) obtained as described in Example 20 of US Patent Application No. serial 09 / 764,478 entitled "Pressure Sensitive Adhesives and a Fibrous Reinforcing Material", made on January 17, 2001 and published as 2002/0164446. [0152] Adhesive B - Adhesive adhesive with plastic KRATON and an adhesive agent containing 50% by weight of KRATON 1107 (thermoplastic elastomer constituting a copolymer of styrene and isoprene, available from Shell Chemical Co., Houston, TX) and 50% by weight ESCO- adhesive agent REZ 1310 (aliphatic resin available from Εχχοη Chemical

Co., Houston, TX); applied hot with 0.2 mm (8 mils) thick layer on a standard release coat.

[0153] Adhesive C - A mixture of self-adhesive adhesive (75/25) with an adhesive of isooctyl acrylate / acrylic acid and plastic KRATON D1107P (block copolymer of styrene, isoprene and styrene) obtained as described in example 1 of international publication WO 96/25469 for Hyde et al. Adhesive adhesive was extruded to give a thickness of 0.12 mm.

[0154] Adhesive D - A multilayer co-extruded adhesive adhesive material made from alternating AB AB A layers, A being an acrylic adhesive adhesive, and B being a hydrophilic polyurethane described in Example 11 of US Patent No. 6,045,895 to Hyde et al. Two extruded layers 0.06 mm thick of this adhesive adhesive material was laminated together to give adhesive D (0.12 mm thick). [0155] Adhesive E - A multilayer co-extrusion adhesive adhesive material made from alternating ABABA layers, wherein A is an acrylic adhesive and B is a polyether block amide as described in example 12 of US Patent No. 6,045,895 to Hyde et al. Two layers extruded with a thickness of 0,

[0156] Adhesive F - A polyacrylate self-adhesive adhesive containing a fiber obtained as described in Example 28 of US Patent Application No. serial 09 / 764,478, titled "Pressure Sensitive Adhesives and a Fibrous Reinforcing Material", made on January 17, 2001 and published as 2002/0164446.

[0157] Although adhesive adhesives are preferred, it should be understood that the present invention is not limited thereto.

Releasing backing [0158] Suitable backing materials for preferred laminates, for example layers 20 in Fig. 1 and layers 210 in Fig. 6, include materials made of wrapping paper, polyester, polypropylene (PP), polyethylene (PE), or other structures. composite. The release coatings are preferably coated with low-adhesion materials, e.g. silicone, fluorine chemicals, etc., which provide advantageous performance parameters. Examples of representative silicone materials are given in Chapter 18 of Handbook of Pressure Sensitive Adhesives, Van Nostrand Reinbhold, 1982, page 384. Examples of suitable fluoro chemicals are described in U.S. Patent 4,472,480.

[0159] The present invention includes various combinations of these materials. The concrete choice and application will be understandable to specialists in the field of functional laminate design using the optimal combinations of topcoat, glue and primer.

Research Method

Adhesion at Tightening 90 Angle after holding for 20 min / 24 hours.

[0160] To measure adhesion, the laminate structure (top layer and PSA) was cut into a strip with a suitable size of 25 x 204 mm (1 x 8 in) with a die. These strips were then placed centered along the longitudinal direction of the test pieces. These elements were washed with acetone and isopropyl alcohol. Each element had dimensions 50 x 152 mm (2 x 6 in) and was an annealed, highly polished, tested stainless steel or HDPE. The strips were rolled with a roller having a rubber surface with a weight of 9.9 kg (4.5 lb.), a value of 5.45 and a Shore A hardness of 65, rolling once back and forth at a rate of 30 cm / min (12 in / min). Samples were conditioned for 20 minutes or 24 hours in a test room in a controlled environment in which conditions of 21 ° C (70 ° F) and relative humidity of 50% were maintained. After conditioning, the test strips were removed from the test piece using the Instron universal testing device according to the modified version of the standard tape test method defined by the Adhesive Tape Board, PSTC-1 (version 1992), according to the requirements for adhesion in peeling single-coated tape at an angle of 180 °, wherein the peel angle was 90 °, i.e. perpendicular to the surface of the element, at a rate of 30 cm / min (12 in / min). To estimate the values ​​given in N / cal, a pressure sensor connected to the computer was used. All tests were performed in triplicate. according to the adhesion requirements for peeling the coated tapes individually at a 180 ° angle, the peel angle being 90 °, i.e. being perpendicular to the surface of the element, at a rate of 30 cm / min (12 in / min). To estimate the values ​​given in N / cal, a pressure sensor connected to the computer was used. All tests were performed in triplicate. according to the adhesion requirements for peeling the coated tapes individually at a 180 ° angle, the peel angle being 90 °, i.e. being perpendicular to the surface of the element, at a rate of 30 cm / min (12 in / min). To estimate the values ​​given in N / cal, a pressure sensor connected to the computer was used. All tests were performed in triplicate.

[0161] For some applications, the corresponding wet and dry adhesion values ​​were also measured.

Sheffield Smoothness Test / Air Permeability [0162] The measurement of surface roughness due to a suitably modified Sheffield smoothness test (TAPPI T 538 om-96 test method) is also a good way to assess the air-tightness or leakage properties of the adhesive article due to the adhesive. This measurement also allows a relative ranking of the possibility of assessing the penetration / leakage of the fluid in the structure using air as a probe. The samples were analyzed using the Hagerty Technologies model 538 smoothness tester. The range of measured values ​​falls within the 95% confidence limits defined by the Student's t test. A higher value in Sheffield units means a more coarse surface, and therefore more easier to get out of the fluid. [0163] The air permeability test was carried out using instruments such as those available from Frazier Instruments and according to the ASTM 3574 method. Phase Diffusion Speed ​​[0164] A test method that allows to determine the diffusion coefficient at the interface is the use of measurements single-frequency electrical capacitance (SFCM) using an array of electrode sensor plates arranged in a finger-like configuration as shown in Fig.eh 22 and 23. Detailed information on this test method is given in the publication "Interfacial Diffusion of Fluids in Pressure Sensitive Adhesives", EP 0'Brien; TC Ward, Journal of ASTM International, 2, 1-8 (2005). Fig. 22 shows a substantially electrode substrate 1800 including a series of electrical contacts 1810 and a series of separated ones, essentially parallel electric paths running between the contacts in the U-shaped form. In the case of a pair of contacts, such as the contacts designated as "1" and "10", the two tracks 1820 run parallel to the contact 10. In addition, the track 1830 extends from the contact 10 between two tracks 1820 towards contact 1.

[0165] The penetration of the test fluid through side edges or side regions of the system can be monitored by monitoring the change in capacitance measured using an impedance analyzer. The analysis of normalized capacitance as a function of time and spatial resolution of the conductive path tells the diffusion velocities at the interface. These data in turn can be used to determine the optimal number and arrangement of wells or openings in the inner layer of the laminates described herein. Too many holes or wells may adversely affect the integrity of the laminate, and too few wells may be ineffective for full and uniform diffusion of the fluid. Potential alternative methods for the quantification of this value are optical microscopy with image analysis (OM / IA) and infrared analysis of the weakened total reflectance with the Fourier transformation (ATR-FTIR). Fig. 23 is a schematic representation of a representative arrangement 1900 comprising a substrate with electrodes or tracks 1800 including electrical contacts 1810. A substrate 1900 is then applied to a substrate with electrodes 1800, which is applied to the tracks in the fingers-like configuration. The electrode and tape system is then placed in a container 1910, e.g. in a 40 ml glass vial, and partially immersed in a fluid 1920 as shown in Fig. 23. A matching cap 1930, e.g. made of silicone rubber, is used to seal the container. . which allows access to groups of contact pads 1810 for later analysis. As stated above, it is easy to judge the penetration of the fluid 1920 in the direction of the arrows D.

Skin Peeling, Corneocytes Peeling, and TEWL [0166] Skin detachment can be performed on adults who have agreed, using adhesive test strips that are torn off by measuring traction at 90 ° peeling at approximately 10 cm / min ( 4 inches / min). Detailed information about this study is provided in the publication "Experiments on Peeling Adhesive Tapes from Human Forearms", AC Karwoski; RH Plaut, Skin research and technology, 10, 271-277 (2004). To measure the number of detached corneocytes, the surface of the strip is stained with a cationic dye (crystalline violet, 1%, brilliant green, 0.5% and distilled water, 98.5%) and the ratio of detached corneocytes to the total surface area measured using an optical surface analyzer .

[0167] In the same study area, it is also possible to measure the loss of water through the epidermis (TEWL) and hydration of the stratum corneum using the TEWAMETER instrument available from Courage + Kbazaka Electronics GmbH, Germany) and the Comeometer CM820 instrument (Courage + Khazaka). For details, see "Skin Irritation Due to Repetitive Application of Adhesive Tape; the Influence of Adhesive Strength and Seasonal Variability ", F. Tokumura; K. Umekage; M. Sado; S. Otsuka, S. Suda; M. Taniguchi; A. Yamori; A. Nakamura; J. Kawai; K. łka, Skin research and technology, 11, 102-106 (2005). Water vapor permeability coefficient (MVTR) [0168] The water vapor permeability (MVTR) ratio is expected to be substantially above about 300 g / m2 / day measured by the ASTM E 96-80 method at 40 ° C.

Additional Aspects [0169] In some applications, the following additional aspects may be considered or used in a different manner in connection with the present invention.

[0170] In one aspect, a system with a microneedle or a large needle can be used to quickly and efficiently pierce and then attach to a polyurethane foam is used in therapy by vacuum wound closure (VAC). This allows eliminating the hole cutting process using scissors, as suggested by 3M in the KCI product manual for SIMPACE 2000, as shown in Fig. 24. In this connection, the laminate system described herein for the selective application of an adhesive deactivating agent is combined with the microneedle system used for sampling.

A number of microneedles provide a capillary force. Such microneedles may be of the type available from Pelikan in Palo Alto, California and / or Kumetrix from Union City, California or as described in US Patent 6,503,231.

[0171] In another aspect, a time indicator is obtained that can be used in conjunction with medical bandages and bandages to alert or alert a nurse or other worker that it is necessary to change the bandages at appropriate intervals. This can easily be done, for example, by changing the color. Accordingly, it is envisaged, for example, that one or more of the preferred laminate systems described herein may comprise a layer or area of ​​the layer visible from outside of the laminate I constituting a temporary color indicator. Chemical systems that change color over time are well known in the art, e.g. as described in U.S. Patents 5,990,199 and 6,794,318.

[0172] In yet another aspect, the liquid bandages known in the art can be metered out via a crushable capsule. Accordingly, in this variant of the present invention, tear capsules, e.g. microcapsules containing a liquid bandage composition, can be introduced into the laminate system, e.g. as described herein. The layer or area of ​​the filled capsules are located along the surface (or in its vicinity) that can be placed in contact in the wound region. After applying pressure, these microcapsules break up, thanks to which the flowing liquid bandage composition is released. Liquid or flexible bandage compositions are well known in the art and are described, for example, in U.S. Patents 5,725,491; 4,987,893; 5,103,812; 4,584,192 and in the publication of US patent application 2006/0030808.

[0173] In yet another aspect, the present invention discloses the preparation of adhesive patterns to limit pain. The production of patterns can potentially limit the accumulation of stress during peeling due to an irregular peel line. This was confirmed quantitatively. In such applications including adhesives that take on the pattern, it is anticipated that the hole layer described herein may be above or adjacent to the adhesive layer, and the holes formed in this layer have a similar pattern to the adhesive.

[0174] It is further envisaged that the present invention may also be used in combination with adhesive films or layers for fixing catheters for intravenous (iv) or surgical film applications.

[0175] In many or all of the various embodiments and aspects described herein it is important to provide a barrier for the bacteria. Therefore, it is envisaged to use or otherwise insert different barrier films into different laminate arrangements.

[0176] Within still another feature in accordance with the present invention, one or more sensors are introduced into the laminates. It is envisaged that a variety of sensors, sensor components and related elements may be incorporated into the multilayer structure to obtain information about the condition of the wound or other relevant area, conditions in the substrate or skin, conditions or condition of the adhesive layer in contact with the skin and the condition of other laminate layers. For example, monitoring or transmitting sensors (e.g., recording and transmitting data using technologies such as integrated RFID) can be introduced into the laminate, such as, for example, assessing the level of proteases entering the sensors in the area around the wound. Other relevant parameters may include any combination of wound condition data, including skin temperature,

[0177] Many other benefits will undoubtedly become apparent on the basis of future applications and the development of this technology.

[0178] Further, it is to be understood that any one or more features, details or aspects of one embodiment described herein may be combined with one or more other features, details or aspects of another example or embodiments described herein. The present invention is by no means limited to one particular embodiment described herein.

[0179] As described hereinabove in the present document, the present invention solves a number of problems associated with devices of prior types and methodologies. It is to be understood, however, that those skilled in the art can make various changes to details, materials and configurations as described herein and to illustrate the nature of the invention, without departing from the spirit and scope of the invention as defined in the appended claims.