MXPA99001450A - Ostomy pouch having non-tacky fastener system - Google Patents

Abstract

A low profile, two-piece ostomy appliance is disclosed that has a contact responsive non-tacky fastener system comprising a fastener that is attached to the ostomy appliance and a landing zone component that is attached to the peristomal area of the user. The fastening layer of the fastener system is preferably multiply releasable and refastenable against the non-tacky target, and preferably has a 90 peel strength of less than about 3 kN/m and a dynamic shear strength of greater than 2 kN/m2 when in contact with the target surface.

Description

OSTOMY BAG OüE HAS A NON-ADHERENT BRAKE SYSTEM CAMPQ OF THE INVENTION This invention relates to fluid collection bags containing fastening systems that respond to contact, non-adherent. In particular, the restraint systems can be incorporated in two-piece, low-profile ostomy bags and incontinence devices.

An ostomy device is an accessory used to collect waste material that leaves a person's body through a stoma. The term "stoma" refers to an orifice surgically generated in the skin and the joined end of the bladder, duct or intestine. The stoma provides an open conduit through which a constant or intermittent flow of waste material occurs. The surrounding skin area is called the "peristomal area". There is a great challenge to connect a ostomy device comfortably and reliably to the peristomal area. Adhesive pressure-sensitive adhesive tapes can be used to attach ostomy bags to a patient. In a type of ostomy device, the REF: 29396 tapes are permanently attached to the ostomy device. The ostomy device is used only once and is discarded by removing the tape from the body. A "two-piece" ostomy device can also be used. A first part is adhesively attached to the skin area around the stoma and has a plastic snap ring that matches a snap-fit ring on the separate ostomy device. When the two parts fit under pressure, the rings form a leak tight seal around the stoma and attach the bag to the patient. Unfortunately, however, plastic rings are very bulky and uncomfortable. Other quick release / quick release mechanical fasteners are known. They can be opened and closed repeatedly and are often referred to as susceptible to being closed again. One such fastener, known as a hook and loop fastener, is available from Velero United States, Inc., Manchester, New Hampshire. Another such fastener is known as the mushroom fastener, and is sold as the reclosable fastener DUAL LOCK of 3M Company, St. Paul, Minnesota. Both fasteners have certain undesirable characteristics for use in ostomy applications. For example, the hooks of the fungus portions of the fasteners tend to bind fabric. In addition, both the hook and loop portions of the fasteners tend to collect lint and dust. In addition, these types of fasteners generally do not show a thin profile, which may eliminate aesthetic appearance, or may not provide a watertight seal to liquids or odors. Another feature of the hook and loop fastener is that it makes noise when it is opened. This makes it undesirable in any application where noise is a concern. Other known fastener systems such as adhesive tapes with glue on one side or on both sides also have various limitations. These limitations include the lack of susceptibility to being recycled, unwanted transfer of adhesive to a contact surface, and a tendency to irreversibly lose its adhesive properties when contaminated with lint or dust. In addition, adhesive adhesives tend to aggressively stick to latex surgical gloves which makes them difficult to handle. There is a great need for a reliable and inexpensive fastener system that is suitable for comfortably attaching a medical device to a patient's skin.

BRIEF DESCRIPTION OF THE INVENTION The invention provides a low profile, two-piece fluid collection bag, such as an ostomy bag or an incontinence device comprising a non-stick fastener system responsive to contact. The fastener of the non-adherent fastening system comprises a non-adherent surface, and preferably it is releasable and multiplely recoverable against a non-adherent surface of a laying area. The fastener may also comprise one or more layers in addition to the non-stick surface layer such as a mounting layer of a pressure sensitive adhesive. The nonadherent surface of the laying area may be a material different from the non-sticky surface layer of the fastener and preferably has a sufficiently different solubility parameter to avoid blocking of the two nonadherent surfaces. The target surfaces useful in the invention can generally be considered as uniform. However, they may have some surface texture. Preferably, the target surface is essentially uniform. A preferred contact-responsive fastener system achieves its resistance to optimum and maximum detachment relatively quickly so that the waiting time is essentially unnecessary, or is relatively imperceptible to the user of the fastening system. It is also desirable that the fastening system maintain a substantially constant peel strength for a prolonged period of time and show no significant accumulation of peel strength with respect to time. A preferred fastener system responsive to contact also achieves a high enough shear strength to allow the fastener system to support a device. For ostomy application, the most preferred fastener system has both an adequately low release resistance, ie, low enough that, if desired, the user can easily detach the fastener from the placement area, and a resistance to suitably elevated shear to reliably retain the ostomy device in place. The fastening systems of the present invention have application as a medical fastener in areas that require adaptation and where long-term use is desirable. One specific application is that this fastener system seems to be highly suitable as a system for fixing ostomy bags to the skin. The ostomies are located in the abdomen, and therefore require a bra system that will preferably adapt to the abdominal contour and preferably move with the skin as the skin moves. In addition, the fastener system used in ostomy bags should be attached to the pouch film in some way. The fastener system of the present invention can be sealed directly to the typical ostomy bag films (for example by heat sealing the fastener to the bag). Alternatively, an adhesive layer can be used to attach the fastener to the bag. The fastening system can be sterilized by gamma radiation, without loss or only with a minimal effect on its properties. This feature is a highly desirable attribute of medical devices and specifically of devices used to secure ostomy bags to the peristomal region immediately after surgery.

BRIEF DESCRIPTION OF THE DRAWINGS This invention will be better understood when considered in conjunction with the drawings, wherein: Figure 1 is a side view of a fastener of the fastening system; Figure 2 is a side view of a fastener of the fastening system with a removable cover layer; Figure 3 is a side view of a fastener of the fastening system with an interposed support layer; Figure 4 is a perspective view of an ostomy bag having a non-sticky fastening system; Figure 5a is a partial cross-sectional view of the bag of Figure 4, taken along the line 5a-5a, showing the fastening component of the fastening system, an adhesive layer joining the fastening component to the ostomy bag, and an optional liner that covers and protects the non-adherent surface layer of the fastening component; Figures 5b to 5f are cross-sectional, partial, alternative views of the ostomy bag of the present invention illustrating various layers of the fastener; Figure 6 is a perspective view of an alternative ostomy bag having a non-adherent fastening system, wherein the fastening system is attached to the ostomy bag so as to form a ridge; Figure 7 is a partial cross-sectional view of the bag of Figure 6, taken along line 7-7 showing the fastening component of the fastening system, an adhesive layer that partially attaches the fastening component to the ostomy pouch and forming a ridge, and an optional liner that covers and protects the non-adherent surface layer of the fastening component; Figure 8 is a cross-sectional, partial, alternative view of the ostomy bag of the present invention illustrating various layers of the flanged fastener; Figures 9a and 9b are alternative top views of positioning areas of the present invention, illustrating a non-adherent surface for the fastening system, and the adhesive layer used to attach the positioning area to a patient; Figure 10 is a cross-sectional view of the laying area of Figure 9, taken along line 10-10, illustrating a non-sticky surface layer, the layer of pressure-sensitive adhesive is used for attaching the area of placement to a patient, and the liner is used to protect and cover the pressure-sensitive adhesive before use; Figures 11 and 12 illustrate alternative cross-sectional views of the laying area of the present invention illustrating various layers of the laying areas shown; Figure 13 is a top view of an alternative positioning zone of the present invention, illustrating a non-adherent surface for the fastening system, the adhesive layer being used to attach the positioning area to a patient, and an adhesive collar that it surrounds the non-adherent surface and further helps to retain the area of placement in the patient; Fig. 14 is a cross-sectional view of the positioning area of Fig. 13, taken along line 14-14, illustrating the collar tape, the non-stick surface layer, a space filling layer Optional, a layer of pressure sensitive adhesive and the coating used to protect and cover the pressure sensitive adhesives, before use. The invention uses certain principles and / or concepts as set out in the appended claims to this specification. Those familiar with the art to which the invention pertains will realize that these principles and / or concepts are capable of being illustrated in a variety of modalities which may differ from the exact modalities used for illustrative purposes in this specification. For these reasons, the invention described in this specification should not be considered as limited to only the illustrative modalities, but should only be considered in view of the appended claims.

DEFINITIONS Unless otherwise specified, the terms "fastening systems" or "fastening system" in this specification refer to the combination of a fastener and a positioning zone. A "fastener" refers to that part of the fastening system of an ostomy device that is associated with the ostomy pouch. The fasteners include a non-stick surface and any optional mounting layer, supports or coatings that are associated with the non-stick surface. A "fastening component" refers to that part of the fastener that includes a non-sticky surface layer and any optional support that is bonded to the non-sticky surface layer. This does not include the mounting layer (eg, a layer of pressure sensitive adhesive, adherent) or any removable coating. A "positioning zone" refers to that part of the fastening system of an ostomy device that is designed to be attached to the peristomal region of a user.

The laying area includes a non-sticky surface and any optional mounting layer (e.g., a layer of pressure-sensitive adhesive, adherent), supports or coatings that are associated with the non-stick surface. A "fastening layer" refers to the non-adherent layer, which responds to the contact, of the fastening system which is placed in contact with a target surface. A "target surface" refers to the non-adherent layer of the fastening system that is placed in contact with a fastening layer.

The invention relates to a novel, low profile, two-piece fluid collection bag (for example, a two-piece ostomy bag), which has a new kind of fastening system having at least one layer of fluid. Clamping that responds to contact, which essentially is not a surface that adheres to paper or skin. The clamping layer responsive to contact preferably allows multiple clamping and releasing cycles of the clamping layer with a target surface. The target surface may be constituted either of another surface essentially free of adhesion or it may simply be a uniform non-adherent surface. The target surface preferably has a solubility parameter or other characteristic (such as surface roughness) which allows a maximum contact area with the clamping layer and which allows the cladding layer to have consistently repeatable low peel strength, and high resistance to shear stress. Preferably, the clamping layer can be cycled against the target surface numerous times without any noticeable transfer or migration of any part either from the clamping layer to the target surface or from the target surface to the clamping layer. A currently preferred fastening system of the present invention for use in ostomy devices is a low profile fastening system having a combined thickness total (which includes the adhesive layers used to attach the system to a patient, but which does not include any removable cover that protects the system before use) no greater than approximately 0.3 mm. Any of the pieces of the two-piece fluid collection bag may comprise the fastening layer. The other piece may comprise the target surface. For example, the fastening layer may be attached to all or a portion of the ostomy bag, and the target surface layer may be attached to all or a portion of the positioning area. Alternatively, the ostomy bag may comprise a target surface around the opening and the positioning area may comprise a fastening layer. Many polymeric materials can be used as the clamping layer that responds to the contact. The polymeric material can be a homopolymer, a random copolymer, a block copolymer or a graft copolymer. It can be crosslinked or non-crosslinked. Specific examples of polymers useful as the clamping layer include copolymers containing ethylene, urethane polymers such as urethanes prepared by the reaction of an isocyanate and a compound that reacts with isocyanate, acrylic and acrylate polymers, urethane-acrylate polymers, butyl rubber, butadiene-acrylonitrile polymers and butadiene-acrylonitrile-isoprene polymers. If desired, combinations and blends of polymeric materials can be used. Various other materials can be incorporated into the polymeric material. For example, substances that impart stickiness or improve adhesion can be used if desired. Additionally, fillers, pigments, plasticizers, antioxidants, ultraviolet light stabilizers and others can be used. The exact amount of these starting materials can vary to suit the wishes constituting the compound, with the proviso that the resulting layer responding to the contact retains its essentially adhesion-free character. Therefore, the proportion of the various starting materials (eg, tackifying substances, filler and / or pigment) can vary as needed to maintain the adhesion free nature of the contact-responsive layer. An additional discussion regarding the polymers and compositions useful as the fastening layer can be found in numerous publications. For example, published European patent number EP 0443263 (Miller et al.) Discloses block copolymer materials that improve adhesion; U.S. Patent No. 5,196,266 (Lu et al.) discloses urethane-acrylate materials; and U.S. Patent Nos. 5,114,763; 5,141,809; 5,141,981 and 5,147,708 each describes polymers containing polyethylene with tackifying substances, ethylene-vinyl acetate and acrylates. Preferred polymers for use as the contact-responsive clamping layer are selected from the group consisting of butadiene-acrylonitrile polymers (subsequently BACN) butadiene-acrylonitrile-isoprene polymers (subsequently BACNI), urethane acrylate polymers ( then UA), butyl rubber polymers, two-part urethane polymers (below UR), styrene-isoprene-styrene block copolymers (below SIS) and styrene-butadiene-styrene polymers (below SBS) . The BACN, BACNI and UA polymers are currently most preferred for use as the clamping layer that responds to contact. The BACN and BACNI polymers typically have from 10 to 50% acrylonitrile units. Additionally, the BACNI polymer typically contains from 2 to 20% by weight of isoprene units. Any of these types of polymer can be processed by solvent coating or hot melt extruder. Hot melt extrusion is preferred because it eliminates the need to use solvents during processing; provides a capability to coat the fastening layer directly on the garment or porous supports; it is a low cost process and uses low cost materials; and it is not necessary to add a crosslinker to further cross-link the composition, since hot melt extrusion of butadiene-containing materials is known to cause some chemical cross-linking. The result is a clamping layer, which responds to the contact, coated by hot melt, essentially free of adhesion with all of the above characteristics as well as most of the desirable characteristics of the hook and loop fastening systems. The UA polymer is designed primarily for self-adhesion, but also works very well with a variety of target surfaces. This polymer comprises: (i) an additive, radiation curable, solvent-free, radiation curable organic oligomeric resin, on the one hand, having one or more hard segments, the same or different, one or more smooth, equal segments or different, and one or more monovalent portions, the same or different, containing a functional group, addition polymerizable, radiation sensitive, and (ii) a photoinitiator. The butyl rubber polymers are preferably combined with an agent that removes the tackifying substance, such as talc, to decrease the adhesion of these compositions based on the target surface. Although the precise nature of the contact-responsive layer can be varied to suit the particular application, it should be noted that for multiple release and resurfacing applications, the preferred layer is not blocked, ie, it forms a permanent bond with a target surface. Preferably, the clamping layer responsive to contact demonstrates peel strength values at 90 ° to the target surface of about 0.01 kN / m at about 3 kN / m, more preferably within a range of about 0.05 kN / m at about 1.5 kN / m, more preferably within a range of about 0.1 kN / m to about 1 kN / m, and optimally within a range of about 0.2 kN / m to about 0.5 kN / m. Preferably, the clamping layer responsive to contact demonstrates peel strength values at 180 ° from a target surface of about 0.005 kN / m to about 3 kN / m, more preferably within a range from about 0.01 kN / m to approximately 1.5 kN / m, and much more preferably within a range of about 0.01 kN / m to about 0.5 kN / m. Preferably, the clamping layer responsive to contact demonstrates dynamic shear strength values at a target surface of more than about 2 kN / m2, more preferably greater than about 4 kN / m2, and much more preferably greater of 6 kN / m. Preferably, the clamping layer responsive to the contact demonstrates values of static shear strength ("holding power") to a target surface of more than about 60 minutes, more preferably greater than about 500 minutes, and much more preferably greater than about 1100 minutes, and optimally greater than about 1700 minutes. These resistance values are measured according to the techniques described in the following. For comparison purposes, the values of peel strength and dynamic shear strength are measured after approximately 10 minutes of standby at 21 ° C. In some cases, it may be necessary to adjust the coating weight / coating thickness to obtain the desired release value. In addition, the polymer can be further crosslinked in order to further increase its internal strength and reduce the release values to a desired level. This is a particularly useful technique to be used when the layer responding to the contact and the target surface comprises BACN, BACNI or a combination of each. In this case, the BACN and / or BACNI polymer is preferably modified by crosslinking in order to avoid blockage of the layer responding to contact with the target surface. Crosslinking is a method for increasing the internal strength of BACN, so that the clamping layer maintains a relatively constant release resistance to repeated uses. Additionally, the crosslinking provides a means to control the resistance to release of the material from another material. The adhesive properties of the fastening system of the invention can also be controlled by appropriate selection of the target surface to which it is to be fastened. It has been found that for some fastening systems, particularly a BACN system, as the difference between the solubility parameter of the clamping layer and that of the target surface increases, the detachment resistance decreases (eg, as exemplified by the peel strength at 180 ° The target surfaces useful in the invention can be selected from a wide variety of materials Particularly useful target surfaces are materials that do not permanently attach to the tie layer Examples of useful target surfaces include those materials previously identified as useful for the fastening layer, as well as polyurethanes, polycarbonate, polyacrylonitrile, polymers of butadiene-styrene, poly (methyl methacrylate), polyamide, ethylene-vinyl acetate copolymer, poly (ethylene terephthalate) treated and untreated, olefinic ionomer resins such as resins "SURLYN" from E. I. Du Pont de Nemours and Company, Wilmington, DE, polystyrene, acrylonitrile butadiene-styrene polymer, polypropylene and polyethylene. Useful target surfaces may also include metal surfaces such as sheets; coated paper; substrates coated with enamel; low adhesive support sizing coatings (LAB); paintings, inks; lacquers; etc. The exact choice of the target surface to be used depends on the needs of the user with the condition, however, that the target surface and the clamping layer do not become blocked. It has also been found that the peel strength can be influenced by the nature of any mounting layer that can be used. For example, higher release values are typically obtained when a hard (ie rigid) mounting layer is used. An advantageous feature of this fastening system is that it is cleanable, for example, with isopropanol or soap and water, in order to maintain / restore its holding characteristics. This is a valuable consideration in view of the tendency of these compositions to finally lose their holding capacity when they come into contact with certain contaminants, such as oils. However, the reactivation of these fastening systems results in a prolonged useful life of products that use these systems. If desired, the fastening component of the present invention may comprise, on the surface opposite the nonadherent surface layer, a mounting layer such as a material capable of heat or sound bonding. This allows the fastener to heat directly to a structure such as a plastic film of an ostomy bag. Alternatively, the fastener can be laminated directly to the article or it can be adhered to the article using a layer of a sticky, pressure sensitive adhesive. The fastener and / or the area of placement can be coated with any conventional hot-melt adhesive, solvent-coated or the like. These adhesives can be applied by conventional techniques, such as solvent coating, by methods such as reverse roller, knife roller, engraving, wire wound roller, floating knife or air knife, hot melt coating such as orifice coaters. grooves, roller coaters or extrusion coaters, at appropriate coating weights. U.S. Patent No. 5,230,701 (Meyer et al.), Discloses suitable methods of adhesive coating. The adhesive can be first coated on a coating material, using one of the techniques mentioned above, and then laminated (for example using a roller to apply pressure) to form the fastener or laying area. Preferred for most applications would be pressure sensitive adhesives. Pressure sensitive adhesives suitable for use in the present invention include those pressure sensitive adhesives which are capable of providing the necessary amount of peel strength and / or shear strength to function in the required manner (eg sufficient shear strength to securely attach the ostomy device to the skin without unwanted detachment). Adhesives suitable for use in the medical field must be non-toxic, preferably hypoallergenic, and more preferably also environmentally safe. Pressure-sensitive acrylate adhesives, suitable for use in the present invention, for example, for use on a surface in contact with the skin of the component of the placement zone, include copolymers which are reaction products of the polymerization of at least one monomer "A" and at least one monomer "B" to provide a copolymer which preferably has an inherent viscosity of about 1.0 dl / g to about 2.0 dl / g. Monomer A is a polymerizable monomer comprising an acrylate or methacrylate ester of a non-tertiary alcohol or a mixture of non-tertiary alcohols with alcohols having from about 1 to 14 carbon atoms and desirably averaging from about 4 to about 12 carbon atoms. Monomer B is an ethylenically unsaturated compound and may desirably be acrylic acid, methacrylic acid, itaconic acid, acrylamide, methacrylamide, acrylonitrile, methacrylonitrile, vinyl acetate, N-vinylpyrrolidone or combinations thereof. Monomer A is polymerizable and contributes to the viscoelastic properties of the pressure sensitive adhesive copolymer. Non-limiting examples of such monomers A include esters of acrylic acid or methacrylic acid with non-tertiary alkyl alcohol such as 1-butanol, 1-pentanol, 2-pentanol, 3-pentanol, 2-methyl-l-butanol, 1- methyl-1-butanol, 1-methyl-1-pentanol, 2-methyl-1-pentanol, 3-methyl-1-pentanol, 2-ethyl-1-butanol, 2-ethyl-1-hexanol, 3, 5, 5-trimethyl-1-hexanol, 3-heptanol, 2-octanol, 1-decanol, 1-dodecanol and the like. Monomeric acrylic or methacrylic esters are known in the art, and many are commercially available. Monomer B is an ethylenically unsaturated compound copolymerized with monomer A to affect the physical properties of the resultant pressure sensitive adhesive copolymer. In general, the presence of monomer B will reduce the flexibility of the resultant pressure sensitive adhesive copolymer. Therefore, the percentages by weight of monomer A and monomer B must be balanced in order to provide a pressure sensitive adhesive copolymer which preferably has an inherent viscosity of about 1.0 dl / g to about 2.0 dl / g. The weight percent ratio of monomer A to monomer B ranges from about 85:15 to about 98: 2, and desirably from about 90:10 to about 97: 3. The pressure-sensitive adhesive copolymer must be adherent at room temperature as well as at the skin temperature of mammals. In addition, the adhesive must be hypoallergenic, that is to say, after continuous contact with the skin it must not cause significant sensitization or irritation of the skin during adhesion. Presently preferred is an acrylate pressure sensitive adhesive for tapes used in the present invention an isooctyl acrylate / acrylic acid copolymer in a weight ratio of about 94: 6. The inherent viscosity of the copolymer is about 1.4-1.6 dl / g. If desired, acrylate pressure sensitive adhesives having a substance imparting added tack to the formulation to improve adhesion. Commercially available tackifying substances include rosin acids of "Foral" brand name such as "Foral AX" and "Foral 85" rosins, commercially available from Hercules Corporation, and partially hydrogenated methylstyrene hydrocarbon resins such as "Piccolastic A25" resin, also commercially available from Hercules Corporation. Such tackifying substances can be added during the preparation of the acrylate pressure sensitive adhesive in an amount of about 35-40 weight percent of the copolymer solids. The alternative pressure sensitive adhesives useful in the present invention are pressure-sensitive adhesives based on hypoallergenic Kraton rubber produced using styrene-butadiene or styrene-isoprene copolymers, commercially available as Kraton brand copolymers from Shell Oil Company of Houston Texas. A variety of pressure sensitive adhesives based on Kraton are described in U.S. Patent Nos. 5,019,071 (Bany et al.) And 5,158,557 (Noreen et al.). Preferred as pressure-sensitive adhesives based on Kraton rubber are Kraton 1107, Kraton 1111, Kraton 1101 and Kraton D brand copolymers, which become adherent with compatible tackifying substances such as the brand-imparting substance Escorez ™ 1 1310LC. commercially available from Exxon Chemicals, a solid C5 tack imparting resin commercially available as a Wingtack ™ Plus tackiness enhancing substance from Goodyear Tire and Rubber Company, Akron, Ohio and naphthenic oils having 10% aromatics, commercially available as Shellflex ™ 371 from Shell Oil Company. Such tackifying substances may comprise about 45 to about 70 weight percent of the pressure sensitive adhesive, while the Kraton copolymer may comprise about 30 to 55 weight percent. Additional alternative pressure sensitive adhesives which may be useful in the present invention are water-dispersible pressure sensitive adhesives described in U.S. Patent Nos. 3,865,770; 4,413,080; 4,569,960; 5,125,995; 5,270,111; and 5,397,614 and European Patent Nos. 0 605 448 and 0 639 085. The pressure sensitive adhesive copolymers can be copolymerized using known polymerization techniques such as emulsion polymerization and solution polymerization. The sources of preparation and polymerization techniques include Organic Polymer Chemistry. Saunders et al. (Halsted Publishing Company, New York 1973); Applied Polypmer Science, Tess et al. (American Chemical Society, Washington, D.C., 1981); Principles of Polymerization. Odien (John Wiley and Sons, New York, 1981); and the Handbook of Pressure-Sensitive Adhesive Technology, Second Edition, Satas, Ed., (Van Nostrand Reinhold Company, New York, 1989). Specifically, the pressure sensitive adhesive copolymers can be prepared according to U.S. Patent No. 2,284,126 / RE 24,906 (Ulrich).

DESCRIPTION D T? T.TiAPA W, LO DRAWINGS Numerous specific embodiments of the invention are illustrated in the figures. Figure 1 discloses a multi-layer tape 10 comprising a contact-responsive fastener layer 112, having a first surface 114 attached to an optional mounting layer 117. The mounting layer 117 preferably comprises a sticky, pressure sensitive adhesive, the mounting layer 117 allows permanent mounting of the tape 10 to another substrate in a position which allows multiple releasable contact between the holding layer 112 and a target surface. When the composition of the clamping layer 112 is a urethane-acrylate polymer, it can be coated directly on the mounting layer 117 and can be cured with ultraviolet radiation. Alternatively, when the composition of the clamping layer 112 is a butadiene-acrylonitrile polymer or a butadiene-acrylonitrile-isoprene polymer, it can be heat-melted or solvent-coated onto the mounting layer 117. In any embodiment, as with other suitable compositions, a novel multilayer tape 10 is obtained. The fastening layer 112 can also be mounted directly to certain substrates without using a mounting layer comprising a pressure sensitive adhesive. For example, the fastening layer 112 can be adhered directly to the substrate. Provided that the adhesion to the substrate is greater than the adhesion to the target surface, the clamping layer will remain attached to the substrate. Alternatively, the mounting layer 117 may comprise a layer of material that can be heat sealed to a substrate. For example, the mounting layer 117 may comprise a polymeric film. Figure 2 illustrates the tape of Figure 1 having an additional layer of material. In this embodiment, a cover layer 120, such as a removable cover, is attached to a second surface 122 of the fastening layer 112. After the tape 12 is properly placed, an optional mounting layer 117 is firmly attached to the underlying substrate, the cover layer can be removed to allow placement of a target surface against the fastening layer 112. This sequence allows easy placement of the tape 12 without contaminating the fastening layer 112. Figure 3 illustrates a further additional alternative tape 14. This synthesis is similar in use and structure to the belt 12, but has an additional support layer 131. The support layer 131 may comprise a gauze, a woven material, a nonwoven material, paper, metal foil or other polymeric material, such as a film. Other materials such as the support layer 131 may also be used provided that there is the desired level of adhesion and material compatibility with both the fastening layer 112 and the mounting layer 117. Specific types of materials that are useful as the support material 131 include polycarbonate, poly (methyl methacrylate), polypropylene, polyethylene, polystyrene, acrylonitrile-butadiene-styrene polymer, and polyester. Other useful materials for the support layer 131 include oriented poly (ethylene terephthalate) film, with or without a corona treated surface, cellulose acetate butyrate, cellulose acetate propionate, poly (ether sulfone), polyurethane, poly (chloride) of vinyl), paper, cloth and metal. The most preferred support material currently is a polyester film which has preferably been subjected to corona treatment. The support layer 131 must be of a thickness that provides sufficient support to the fastening layer 112. The support layer 131 is preferably at least 0.0125 mm thick, in order to provide good strength and handling properties to the belt. It is preferred that the substrate be formed of the support layer 131 and have a tensile strength of at least about 1500 MPa. In many applications it is also preferred that the support layer be flexible, that is, capable of bending at a radius of 0.5 cm without rupture. The embodiment of Figure 3 can be mounted directly to the substrate without the need for the mounting layer 117. In Figures 1 to 3, an optional removable cover can be attached to a second exposed surface 137 of the mounting layer 117. The use of these tapes with appropriate coatings allows the storage in bulk rollers and the supply, and provides ease of manufacture of articles using the tape. Figure 4 illustrates a perspective view of an ostomy device (or "ostomy bag") 20 having a non-stick fastener 26. The ostomy bag 20 is formed from two layers of a fluid impermeable material 32 such as a plastic film. Optionally, the bag has a layer of a comfort material 34 such as non-woven fabric on the patient side of the bag. The layers of fluid impervious material and the optional comfort layer 34 can be sealed at the edge 36 using, for example, an adhesive or a heat sealing technique to form the bag. Also shown in Figure 4 is an optional discharge tube 41 and an optional odor vent 30. The optional fastener 26 and preferably has a non-stick tab 28 to facilitate the removal of the fastener system from a location (e.g., detachment). Figure 4 further illustrates an opening 24 in the bag. If desired, the opening can be pre-dimensioned for the need of a particular patient (i.e., the bag can be manufactured with different opening sizes) or it can be a universal "start" opening which is then enlarged by the user to adapt to your particular need. The fastener 26 can be attached to the ostomy bag in various ways. As shown in Figure 4, the fastener is attached to the bag from near the opening 24 near the periphery of the fastener 26. In a preferred embodiment, the joint is obtained by heat sealing 38 from the fastener 26 to the material 32 of stock This can be carried out using any of a variety of heat sealing patterns such as, for example, a series of circular lines of different diameters. Figure 5a illustrates a partial cross-sectional view of the bag of Figure 4, taken along the line 5a-5a, showing the fastening component 25 of the fastener 26 a layer 40 of adhesive bonding the fastening component 25 to the ostomy pouch film 32 and a liner 42 that covers and protects the non-adherent surface layer 27 (e.g., a clamping layer) of the fastening component 25. Figure 5a also illustrates the optional comfort layer 34, the optional tab 28 and the opening 24. If desired, the tab 28 can be a separate piece of material that is attached, for example, by glue, to the fastening component, or it can be an integral portion of the fastening component. In one embodiment, the fastener 26 is cut by a die to form both the generally circular periphery of the fastener and the tab sized for the fingers. The tongue portion of the die-cut material can be coated or treated to inhibit its adhesion to the laying area, or it can be covered with a second layer to prevent adhesion to the laying area. Figure 5b is a partial, alternative cross-sectional view of the ostomy bag 20 of the present invention illustrating various layers of the fastener 26. In this embodiment, the fastener 26 is attached to the ostomy bag by heat sealing 44 to the component of the material 32 of the bag film. Figure 5c is a partial cross-sectional view, alternative, of the ostomy bag 20 of the present invention illustrating various layers of the fastener 26. In this embodiment, the fastener comprises a space filling material 46, such as a foam, between the bag and the fastening component 25. The fastening component 25 can be adhered to the space filling material by means of the adhesive layer 48. The space filling material can be attached to the bag film material 32 by means of an adhesive layer (not shown) or by other means such as heat sealing 44. A removable liner 42 can be used to protect the fastener. Figure 5d illustrates a fastener similar to that shown in Figure 5c, except that the non-sticky surface layer 27 is shown laminated directly to the space filling material 46. For example, the space filling material 46 may comprise a polymeric foam material or a foamed pressure sensitive adhesive. Figure 5e illustrates a fastener similar to that shown in Figure 5b, except that the fastening component 25 is shown laminated directly to the bag film 32. The fastening component 25 may comprise, for example, a non-stick surface layer 27 and a backing (as shown) or a single layer of a non-sticky surface layer 27. For example, the fastening component 25 may comprise a single layer of a fastening layer that is heat sealed directly or otherwise laminated to the bag. Figure 5f illustrates an alternative partial side view of an ostomy bag illustrating various layers of the bag. In this embodiment, the fastener comprises the non-adherent surface 27 of the pouch film near the opening 24. An optional comfort layer 34 is provided on the patient side of the pouch and away from the fastening area. Figure 6 illustrates a perspective view of an alternative ostomy bag 22 (or "ostomy bag") having a non-stick fastener 26. The fastener 26 of this embodiment is partially attached to the ostomy bag 22 so as to form a ridge 29. The ostomy bag 22 is formed from two layers of a fluid-impermeable material 32 such as a plastic film. Optionally the bag has a layer of a comfort material 34 such as non-woven fabric on the patient side of the bag. The fluid impermeable material layers and the optional comfort layer 34 are sealed at the edge 36 using an adhesive or a heat sealing technique to form the bag. The optional fastener 26 and preferably has a non-stick tab 28 to facilitate the removal of the fastener (eg by detachment) from the positioning area. Figure 6 further illustrates an opening 24 within the bag. The fastener 26 can be attached to the ostomy bag in various ways. As shown in Figure 6, the fastener is attached to the bag from near the opening 24 to the middle part to the periphery of the fastener 26. Preferably, the joint is obtained by heat sealing 38 of the central portion of the fastener 26 to bag material 32. This can be carried out using any of a variety of heat sealing patterns such as, for example, a series of circular lines of different diameters. The peripheral portion of the fastener that does not connect to the bag forms a flange 29. The flange 29 is designed to release tension when the bag is pulled hard. Essentially, flange 29 transmits pulling forces from the bag to the midpoint of the fastener. This helps to release stresses in the periphery that may otherwise initiate a delamination of detachment of the fastener from the area of placement. Instead, the pulling forces are distributed over a larger area of the fastening system. Figure 7 illustrates a partial cross-sectional view of the bag of Figure 6, taken along line 7-7, showing the fastening component 25 of the fastener 26, an adhesive layer 40 attaching a central portion of the fastening component 25 to the ostomy pouch film 32, and a coating 42 covering and protecting the non-adherent surface 27 of the fastening component 25. Figure 7 further illustrates the flange 29. Figure 8 is an alternative partial cross-sectional view of the ostomy bag 22 of the present invention illustrating various layers of the flanged fastener 26. In this embodiment, the fastener 26 is attached to the ostomy bag near the heat seal 44 of the central portion of the bag fastening component. Figures 9a and 9b are alternative top views of the positioning areas (60, 62) of the present invention, illustrating a non-adherent surface 68, and the adhesive layer 70 used to attach the positioning area 60 to a patient. As shown in Figure 9a, the positioning zone 60 has a central hole 72 and an optional tab 66 for separating a releasable liner 64 from the adhesive layer 70 for adherent skin. Alternatively, and as shown in Figure 9b, the liner 64 may be a slot 67. A first piece of the liner may be removed by folding the liner into the slot. If desired, the placement zone (60, 62) can be formed using a commercial medical tape material (for example TEGADERM, available from 3M, St. Paul, MN) or other material, as described herein. The precise shape of the placement area is not critical. Preferably, the positioning zone is dimensioned to coincide with the fastener. The shape of the positioning area and / or the fastener can be purposely misplaced, if desired, to create non-adherent regions that facilitate detachment by detachment of the components by the user. Figure 10 is a cross-sectional view of the laying area of Figure 9a, taken along line 10-10, illustrating the non-stick surface layer 68, the layer 70 of pressure sensitive adhesive used for attaching the placement area to a patient, and the covering 64 used to protect and cover the pressure sensitive adhesive before use. If desired, the coating material optionally can be grooved into two or more pieces, whereby removal is facilitated (for example by detachment) and / or application to the skin is facilitated (eg, where a portion of the coating material is first removed to expose adhesive and a second portion of the coating functions as a reinforcing ring which is removed after the exposed portion of the bonding means is pressed against the skin). Figures 11 and 12 illustrate alternative cross-sectional views of the laying area of the present invention illustrating several layers of the placement areas shown. In Figure 11, the positioning zone comprises a skin barrier adhesive 74. An example of such an adhesive is a hydrocolloid adhesive. Figure 12 illustrates a laying area having a thick foam material 76 between the non-stick surface layer 68 and the adhesive layer 70. The foam material 76 and / or the barrier adhesive 74 of Figure 11 can be used to provide a "space filling" function. These slightly thicker layers can help ensure a leak-free, watertight seal of the bag to the user. Figure 13 is a top view of an alternative positioning zone 80 of the present invention, illustrating the non-adherent surface layer 68 for the fastening system, and a collar tape 78 surrounding the non-adherent surface layer and which helps to retain the area of placement in the patient. In Figure 14 an adhesive layer is illustrated below the central portion of the placement area.

Fig. 14 is a cross-sectional view of the positioning area of Fig. 13, taken along line 14-14, illustrating collar tape 78, layer 68 of nonadherent surface, and layer 76 Optional space filling, a layer 70 of pressure-sensitive adhesive is used to assist in attaching the positioning area to a patient, and the coating 64 is used to protect and cover the pressure-sensitive adhesives 71 and 70 prior to its use. The collar 78 may comprise a support 79 (for example a nonwoven elastic material) and a layer of pressure sensitive adhesive 71. The contact responsive fastening system of the invention may be provided as a permeated structure or, alternatively, in the form of separate components. In the various embodiments, it is useful to allow the multiple attachment and release of an article on a surface or for multiple attachment and release of a first article to a second article. The fastener and positioning zone components each comprise a non-stick surface layer. At least one of these surface layers comprises a fastener layer that responds to contact. Other uses include fasteners for disposable consumer goods that require multiple closures, and fasteners for cleaning or medical or surgical garments. For example, they can be used with surgical gowns, canvases and surgical gloves. A non-stick fastener of the invention can be used to form a fluid resistant seal with a surgical glove. Uses with canvas include tube and rope organizers, relocatable plastic bags, recolocable incision areas and attachments to parts of resealable canvases. The advantages of the invention include low cost, non-adherent properties, thin profiles, compatibility with latex gloves and an adjustable release resistance. The fasteners can be manufactured adjustable to allow a good placement and essentially complete seals in the union of gloves and gowns to avoid contamination with body fluids. Non-adherent bras do not get entangled with non-woven hair covers transported by surgeons and nurses.

EXAMPLES The following examples are offered to aid in the understanding of the present invention and are not considered as limiting the scope thereof. Unless otherwise indicated, all parts and percentages are by weight. The following tests were used to measure the various test results presented in the examples.

Resistance to detachment in T This test is used to determine the detachment force necessary to cause the fastening components to release each other when the substrate of a composite fastening component is a flexible film having a length of at least 20 cm and when the fasteners are pulled. fastener edges in opposite directions away and perpendicular to the interface of the fastener union. After two of the composite fastening components are placed in contact, the two components are coupled by means of a 2 kg hard rubber roller, one pass in each direction. The coupled components are allowed to stand at normal room temperature (ie, 22 ° C) for the specified period of time (then standby time), one end of each component is secured to a clamp of an Instron voltage tester, and the jaws move apart at a speed of 30 cm / min.

R sis to the 180 ° detachment This test is carried out in accordance with ASTM D-1000, except that the fastener component is applied to various surfaces using a 2 kg hard rubber roller, one pass in each direction. The samples are allowed to wait for the specified time and temperature before they are separated at a rate of 30 cm / min.

Resistance to 90 ° detachment This is run in accordance with PSTC-5 using several rigid target surfaces to which the fastener component is applied using a 2 kg hard rubber roller, one pass in each direction. The samples are allowed to wait for the specified time and temperature before they are separated at a rate of 30 cm / min.

Dynamic resistance to shear Unless otherwise indicated, this test is used to determine the amount of shear force necessary to either cause the two clamping layers to be released from each other or a clamping layer and a target surface to be released from the clamping layer. other. A pair of 2.5 cm x 10 cm strips are fixed together with an overlap of 6.25 square centimeters. The strips are attached by means of a 2 kg hard rubber roller, one pass in each direction. The coupled strips are then allowed to stand at ordinary room temperature for at least 30 seconds. One end of each strip is fixed to a jaw of an Instron tension tester, and the jaws are separated at a speed of 30 cm / min.

Static shear strength This test is carried out essentially in accordance with ASTM D-3654 and is used to determine the holding power of an assembled fastening layer to a target surface that adheres to a rigid plate. A 2.5 cm x 10 cm strip of fastener is secured to the target surface mounted using an overlay of 6.25 cm2. The fastener and the target surface are attached by means of a 2 kg hard rubber roller, one pass in each direction. The coupled strips are allowed to stand at ordinary room temperature for about 30 seconds. One end of each strip is fixed to a weight of 250 grams. The weight is allowed to hang supported by the fastener, and the amount of time until the sample falls is measured. The following abbreviations are used through the examples: ABS Acrylonitrile-butadiene-styrene polymer BACN Butadiene-acrylonitrile polymer BACNI Butadiene-acrylonitrile-isoprene polymer BOPP Biaxially oriented polypropylene film UA Urethane-acrylate polymer SBS Styrene-butadiene-styrene block copolymer SIS Styrene-isoprene-styrene block copolymer CA Cellulose acetate EVA Ethylene and vinyl acetate polymer HDPE High density polyethylene LDPE Low density polyethylene MEK Methyl ethyl ketone PA Polyamide PC Polycarbonate PE Polyethylene PET Poly (ethylene terephthalate) PMMA Poly (methyl methacrylate) PP Polypropylene PS Polystyrene PVC Poly (vinyl chloride) SS Stainless steel The following abbreviations represent the commercially available materials used in the examples: BACN-1 NipolMR DN-207, 33% acrylonitrile, Mooney viscosity of 43.

BACN-2 Nipol "* DN-004, 45% acrylonitrile, viscosity Mooney from 43. BACN-3 NipolMR DN-214, 33% acrylonitrile, viscosity Mooney of 80. BACN-4 NipolMR DN-401, 19% acrylonitrile, viscosity Mooney 65. BACN- 5 Goodyear N-206, 45% acrylonitrile, viscosity Mooney of 60. BACN-6 HYCARMR 1022. 33% acrylonitrile, Mooney viscosity of 50. BACNI-1 NipolMR DN-1201L, which is considered to be approximately 52% butadiene, 33% acrylonitrile, and 15% isoprene, Mooney viscosity 46 (mandrel shape).

BACNI-2 NipolMR DN-1201L (with talcum) which is considered to be approximately 52% butadiene, 33% acrylonitrile and 15% isoprene, Mooney viscosity 46 (lump form with 3-7% magnesium silicate).

SBS KratonMR 1101. SIS Kratonmr 1107.

Nipol ™ materials are available from Zeon Chemicals, Inc., and contain less than 1% antioxidant. Goodyear materials are available from Goodyear Chemical Co., and contain less than 1% antioxidant. The HYCARMR materials are available from B.F. Goodrich Chemicals and contain less than 1% antioxidant. Kraton ™ materials are available from Shell Chemical Company.

Example 1 BACN and BACNI-1 samples are dissolved, which contain an additional 1.5% by weight of antioxidant EthanoxMR 330 (Ethyl Coporation), in MEK solvent and then coated on a 0.05 mm polyester film backing, to provide a dry thickness of 0.83 mm. The samples vary in the proportion of acrylonitrile to butadiene and in the Mooney viscosity. The Mooney viscosity reflects the composition and molecular weight, that is, the degree of polymerization. Some of these samples contain 0.15% of 2- (4-methoxyphenyl) -4,6-bis (trichloromethyl) -1,3,5-triazine as a crosslinking agent. Some of the samples with the crosslinking agent are exposed to a medium intensity, high intensity mercury arc light (Sylvania H33C0-400 reinforced with a variable power source) at 600 + watts. The dose is 150-200 millijoules / cm2. The tests of detachment in T and dynamic shear are performed on the clamping layer to hold the layer samples. The first set of samples contains 33-34% acrylonitrile in the copolymer used as the clamping layer. It can be seen in table 1 that all of the non-crosslinked samples are blocked (irreversibly bound) after one hour of contact.

It is an effort to reduce the contact time of the polymer face to the polymer face (waiting time). * Blocked in less than one hour # 1. Release force in T after 1 minute of waiting time. #2. Joined again after # 1 and measured after 1 more minute of waiting time. #3. Joined again after # 2 and measured after 1 more minute of waiting time. United again after # 3 and measured after 4 more minutes of waiting time. #5. Joined again after # 4 and measured after 16 hours of waiting time. # 6 Release force in T measured after 4 minutes of waiting time. # 7 Release force in T measured after 16 hours of waiting time.

In a second set of samples, the acrylonitrile ratio of the polymer was varied from 19% to 45% and the Mooney viscosities varied from 43 to 65. The initial release forces do not vary significantly in short times between the crosslinked and uncrosslinked samples . For comparison, samples were made with block copolymers SBS and SIS. See the notches using SBS and SIS in Table 2.

* The shear stress is measured after 1 minute of waiting time. The crosslinking does not appear to decrease the T-detach resistance in the SBS and SIS samples after 22 hours of surface contact. No blockage is observed in the SBS and SIS samples after 22 hours.

Example 2 In these samples, an electron beam is used to crosslink the non-adherent clamping layer. The example uses non-crosslinked BACNI-2 and an additional antioxidant of 1.5% EthanoxMR 330 in each sample. The experiments were performed to examine the effects of voltage on the electron beam and the total electron dose. Samples 2A-2F were extruded by hot melting from a Haake extruder with a wide film die of 12.7 cm (5 inches). The temperature profile in the extruder was: die, 175-180 ° C; zone 1, 135-145 ° C; zone 2, 135-145 ° C; zone 3, 160-170 ° C. All samples hot melt coated were coated using these same extrusion conditions. The clamp layers responsive to the contact were coated in 0.127 mm thick spun-bonded HDPE, manufactured by DuPont under the tradename Tyvek ™ 1073D as films to a thickness of 0.127 mm (5 mils). Before the coating, the Tyvek ™ films were corona treated to improve the bonding of the rubber to the substrate. Table 3 provides the results of T-peel resistance for six samples. stored bra, mismatched. The tests were repeated 12 days later. ** Second repetition. The tests were repeated immediately after the first repetition. 2A Exposed to 1 Mrad at 150 keV 2B Exposed at 1 Mrad at 200 keV 2C Exposed at 3 Mrad at 175 keV 2D Exposed at 5 Mrad at 150 keV 2E Exposed at 5 Mrad at 200 keV 2F Exposed at 10 Mrad at 150 keV.

Exposure to 10 Mrad (106 rad) with an electron beam energy of 150 keV was sufficient to remove essentially all the peel strength. Samples provided with minor exposures (ie, less than 10 Mrad exposure) were blocked after 12 days of surface contact except one sample that was given a dose of 5 Mrad with a beam energy of 200 keV. Additional experiments were performed to measure the effect of the dose on the resistance to the release in T at shorter times. These samples were hot-melt coated to a thickness of approximately 0.127 mm on a support consisting of 60% polyester and 40% cellulose with an acrylic binder (International Paper Co. Grade No. 1309215). The polymer in the samples contains 1.25% antioxidant Agerite Stalyte S (R. T. Vanderbilt Co., product code 02909). The results for doses from 0.0 to 1.4 Mrads and an electron energy of 174 keV are shown in Table 4.

Table 4 Resistance to detachment in T (kN / m) Dosage (Mrad at 175 2E 2F 2G 2H keV) 0 0.5690 0.7002 0.7002 0.7002 0. 2 0.3764 0.4377 0.4814 0.5690 0. 4 0.5515 0.6128 0.6303 0.7002 0. 6 0.4814 0.5515 0.5952 0.6653 0. 8 0.2801 0.3939 0.3939 0.5515 1. 0 0.3939 0.4814 0.5252 0.6565 1. 2 0.3064 0.3501 0.4027 0.5690 1. 4 0.1751 0.2188 0.2451 0.2451 2E had a waiting time of 0.5 minutes 2F had a waiting time of 1 minute 2G had a waiting time of 2 minutes 2H had a waiting time of 5 minutes Example 3 In another test to determine the effect of crosslinking, mandrels of approximately 6 cm x 6 cm x 12 cm of partially crosslinked BACN-4 were mixed with BACNI-2 in a proportion of 15% by weight to 85% by weight, respectively. Approximately 1.25% of Agerite Staylite S antioxidant was also added. Considerable mixing effort is required from the melted polymers to obtain uniform mixing of the two polymers. The mixture is hot-heat coated as described in example 2 at 0.127 mm (5 mils) thick on a polyvinyl chloride support (0.03 mm thick). The polymer-to-polymer face-to-face T-peel resistance (5 minute hold time) is 0.48 kN / m for the blend, compared to 0.66 kN / m without any cross-linked polymer. On a support of 60% polyester and 40% cellulose with a waiting time of 5 minutes, the release force was 0.46 kN for the mixture, compared to 0.70 kN / m without any cross-linked polymer.

Example 4 A comparison of four antiblock agents and samples without antiblocking agent was made. Each sample used BACNI and a mixture of dry ingredients that included 1. 5% by weight of Cyanox ™ LTDP (American Cyanamid), 1.5% by weight of Irganox ™ 1076 (Ciba Geigy), and 0.25% by weight of Tinuvin ™ 328 (Ciba Geigy), and 0.25% by weight of Tinuvin "11770 (Ciba Geigy). A 0.127 mm thick clamping layer was hot melt coated as described in Example 2 on a PET film of approximately 0.05 mm. samples 4A, 4B, 4C and 4D used BACN-1, sample 3E used BACN-2, BACNI-1 samples were used with other antiblocking agents, unbound samples were exposed to air, fluorescent light and powder for up to 7 days The test results are shown in Table 5 and are based on an ambient holding temperature of 5 minutes Sample 4A did not use antiblocking agent Samples 4B, 4C, 4D and 4E used 2.5% in Cab-0-SilMR weight, 1% by weight of CaSi04, 1% by weight of CaCo3 and 5% of additional talc, respectively.

Table 5 Resistance to detachment Initial T /% of initial tear resistance T after exposure Time of 4A 4B 4C 4D 4E exposure (day 0.5252 / 0.3064 / 0.4377 / 0.6128 / 0.7441 / 100% 100% 100% 100% 100% 0. 1751 / 0.1313 / 0.3501 / 0.1663 / 0.6128 / 33% 42.9% 80% 27.1% 82.4% 0. 0910 / 0.1401 / 0.0613 / 0.1050 / 0.1401 / 17.3% 45.7% 14% 17.1% 18.8% 0. 0088 / 0.0700 / 0.0175 / 0.0263 / 0.0193 / 1.67% 22.9% 4.0% 4.3% 2.6% The initial tear resistance in these samples is shown as the upper value (kN / m) in each cell, and% resistance the initial T-drop is shown as the lower number. These results demonstrate the loss of resistance to initial T detachment with exposure. The antiblocking agent of sample 4B (2.5% Cab-0-SilMR Si02, Cabot Corp.) provides the best results. The other antiblock agents were CaSi04 (Hubersob 600, J.M. Huber Corp.) and CaC03 (Atomite, ECC International). Some degree of crosslinking can be obtained by hot melt extrusion of BACN or BACNI. The exact amount of crosslinking was not determined. This example demonstrates that low release resistances can be obtained from samples extruded by hot melt or without the addition of antiblocking agents. Anti-blocking agents can be added to control the holding properties. Combining the partial lattice of the hot melt extrusion with the addition of fillers provides an easy way to obtain a wider range of clamping properties than was previously possible.

Example 5 The effect of the thickness of the clamping layer was measured. Hot-melt BACNI-2, which contained 2% Agerite Staylite S, as described in Example 2, was coated on either a 0.05 mm film of PET primed on a Guilford knitted cloth style # 15771. The samples were tested after a waiting time of 2 minutes at room temperature. The results are shown in table 6.

The results show linear increases in the value of the peel strength with coating thicknesses over the thickness examined.

Example 6 Additional experiments were performed to demonstrate the effect of the surface texture on the peel strength. Hot-melt BACNI-2 containing 1.5% by weight of CyanoxMR LTDP, 1.5% by weight of Irganox® 1076, 0.25% by weight of Tinuvin® 328 and 0.25% by weight of Tinuvin® 770, as described in Example 2, was coated. , to a thickness of 0.127 mm (5 mils) on a 0.05 mm thick primed PET film. The polymer-coated film, still hot, is passed between two nip rolls. A uniform surface is produced using a 0.051 mm BOPP film between the roller and the polymer. A "matte roller rubber" surface is introduced only by passing the hot polymer directly through the rubber rollers. An even rougher surface is produced, that is, with a textured matte, by placing a textured film between the roller and the hot rubber. Cutting 7 compares the resistance to detachment in T in different waiting times of up to 5 minutes. The uniform surface provides the highest strength, and the textured matte surface provides the lowest resistance. These results indicate that the peel strength varies with the amount of surface contact.

Example 7 A Guilford woven fabric, style # 15771, is coated by hot melt, as described in Example 2 with a 0.203 mm thick layer of BACNI-2 containing 2% antioxidant Agerite Staylite ™ * S. Samples were covered with a 0.102 mm thick PE coating. The other half of the samples was left uncovered. Samples covered (ie, coated) and not covered (ie, without coating) were tested to determine the tear resistance in T under various conditions. In a first set of experiments, some of the uncoated samples were exposed to fluorescent light, air and dust. Other uncoated samples were protected from fluorescent light and dust when placed in a Bell container. Initially, all the samples had a T-peel strength of 0.79 kN / m. Those uncoated samples that were not protected from exposure to fluorescent light and dust virtually lost all resistance in 18 days. The uncoated samples that were in the Bell vessel retained a T-peel strength of approximately 0.35 kN / m after 10 months. In a second set of experiments, coated and uncoated samples were exposed to UV light (2 mW / cm2) for varying times and then tested for T-strip resistance after a 5 minute standby period. Table 8 shows the results of these tests.

The implication is that most of the loss of peel strength over time is due to ultraviolet light inducing oxidation when a sufficient amount of an effective antioxidant is not present. Various antioxidants and UV light stabilizers can be used to minimize or eliminate oxidation induced by UV light. The addition of stabilizer during polymer fabrication could be a better approach to mix the antioxidant and the UV stabilizers for hot melt extrusion of any type of coating process.

Example 8 This example illustrates that the detachment resistance of a fastener system can be controlled by selecting the properties of the target surface to which the fastening layer responding to contact is attached. The example shows that by varying the solubility parameter of the target surface by selecting the target surface of a range of materials, it allows to control the detachment force of the fastening system. BACN-6 is dissolved in MEK from the solvent and coated on a 0.025 mm thick, corona treated polyester backing to provide a nominal dry thickness of 0.017 mm. The resulting clamping layer is tested for 180 ° peel strength from a variety of uniform target surfaces. A waiting time of 10 minutes at room temperature (21 ° C) is used. Table 9 shows that the variation of the peel force at 180 ° as a function of the solubility parameter of the uniform target surface. When available, single point values are used instead of intervals. The solubility parameter of BACN-6 is not measured by itself. However, the solubility parameter for 70% butadiene, 30% acrylonitrile is in the range of 9.38-9.48 (cal / ml) 1 /. The assumption is made that the solubility parameter for BACN-6 is essentially the same.

* This represents the midpoint of the range of solubility parameters found in public literature.

Table 9 demonstrates that the 180 ° peel strength of a fastener prepared from BACN can be varied by appropriate choice of solubility parameter of the target surface material used to bond the non-adherent fastening layer.

Example 9 Hot-melt BACNI-2 over a non-plasticized polyvinyl chloride (UPVC) film of 0.043 mm (1.7 mil) thick with a coating thickness of 0.185 mm (7.3 mils), as described in example 2. The polymer contains 3-7% talc. The resulting fasteners are then tested for 90 ° peel resistance, after a 3-day holding time against various target surfaces, to study the effect of the solubility parameter on peel strength. The basecoat / clearcoat of DuPont 871 / RK7103 and the high-solids enamel BASF E172 white were tested after a slightly different wait time compared to the other samples. The waiting time at 22 ° C was 24 hours. The waiting time at elevated temperature was 46 hours at 70 ° C. Table 10 shows the variation of the 90 ° peel strength based on the target surface which becomes matte with the non-adherent clamping layer at two different temperatures.

Example 10 Solvents were coated with solvent of non-crosslinked BANCI-1 containing 2% by weight of antioxidants IrganoxMR 1010, as described in example 1, on a side of 0.0021 mm thick primed PET, which has an adhesive sensitive to the adhesive pressure with a thickness of 0.05 mm. The adhesive is coated with a paper coating on the opposite side. The resulting fasteners are then tested for 90 ° peel resistance at room temperature on various target surfaces after a one day standby time at 22 ° C and 70 ° C to study the effect of the solubility parameter on performance of the detachment. Table 11 provides the results.

Ejeaxplo 11 A fastening system according to the invention is prepared as follows. A composition containing 70% by weight of urethane oligomer and polycaprolactone topped with acrylate, 30% by weight of isobutyl acrylate and 0.25% of 1-hydroxycyclohexyl acetophenone is coated on one side of a UPVC film of 0.036 mm, which has a layer of adhesive, pressure sensitive, adherent, 0.05 mm with a paper coating on the opposite side. The clamping layer is cured with 240-280 mJ of high intensity ultraviolet light through a filter which removes wavelengths below 300 nm. Samples are cured through a 0.05 mm BOPP cover film to prevent oxygen inhibition. The resulting fastening system is tested for resistance to peeling at 90 °, at room temperature against various surfaces after a 24 h wait at 22 ° C and a 46 h wait at 70 ° C. Table 12 provides the results.

Example 12 Butyl rubber (Chlorobutyl 1255, Polysar Rubber Corp.) is coated with solvent from a 25% solution in hexane, to a thickness of approximately 0.063 mm on 0.0254 mm thick corona treated PET. The resulting fastener is then tested for 90 ° peel resistance at room temperature, against a variety of surfaces after a waiting time of 3 hours at 22 ° C. Table 13 provides the results.

* The resistance to detachment was greater to the substrate than to the support.

Table 13 shows the same principle by varying the adhesive force by altering the material on the target surface. The clamping layer shows a light grip on the fingers. In addition, it can be noted that filler materials can be added to reduce adhesive capacity. This is especially true with butyl rubbers.

Example 13 Sample articles were manufactured with BACNI-2 extruded by hot melt and ultraviolet curable UA (Example 11). These samples have a satisfactory shear and shear stress. The BACNI-2 becomes matte for PET or BOPP if it is not reticulated enough to avoid blocking itself. UA cured with ultraviolet maintains adhesion after sterilization with ETO (gaseous ethylene oxide). Some detachment performance is lost after 2-3 Mrads of gamma sterilization. BACNI-2 has an acceptable fastener performance after 10 Mrads of gamma sterilization when exposed, while in contact with a coating or a BOPP target surface.

Example 14 A Quick Tack measuring system is used to measure the detachment force of a non-adherent clamping layer assembly and certain pressure sensitive adhesives. The peel force is measured at a 90 ° angle from the surface where any peel force results just from the contact essentially without added external pressure in addition to the weight of the belt. An IMASS voltage tester with a load of 0.455 kg cell is used. Various clamping layer materials described above were tested: (1) BACNI-1 polymer (example 10, at 0.021 mm thickness), (2) UA (example 11) at 0.02 cm thickness, and (3) a copolymer of block that has become adherent, comprising 75% by weight of Kraton G1657 (styrene-ethylene-butadiene-styrene)) (SEBS)) and 25% by weight of Regalrez ™ 1085, with a thickness of 0.013 cm (M). In addition, the composition of low-adhesion, reclosable pressure-sensitive adhesive (Double Scotchbrand 9415 differential adhesive coated tape with Post-itTM adhesive on one side), 3M was also tested. Table 14 shows the results of these tests. These samples were also subjectively measured to determine their adherence to the skin. As shown in Table 14, the BACNI, UA and M samples were non-adherent to the skin. In contrast, the Post-it11® adhesive feels sticky. to. Bond paper, 3M white copy paper, batch No. 78-6969-6135. b. Newspaper, Minneapolis Star Tribune 2/22/93, portion without ink. c. Legal Remainder, St. Paul Book and Stationary Stock No. 91242-969.

This demonstrates the essentially non-sticky characteristic of the fastener layer materials M, UA and BACN compared to the tack (although it is generally known as a low adhesion material) of the adhesive Post-itMR Example 15 Clamping systems that respond to contact work best when both parts, both the clamping layer and the target surface, are uniform surfaces. A surface roughness test was used to measure the uniform condition. In Table 15, the averages of the absolute deviations of the centerline of the roughness profile of a surface for a variety of fasteners and nonadherent target surfaces.

Example 16 Tests were conducted to examine the effect of a large number of detachment and repositioning operations on the 90 ° peel force. The tests were performed with a 0.036 mm UPVC coated non-stick fastener that was bonded with a 0.051 mm adherent, pressure sensitive adhesive to a 0.014 mm PET support. The peel forces at 90 ° were measured with a strip of 2. 54 cm wide for a non-stick fastener using a one minute wait time. Table 16 shows the results for BACNI-1 coated with 0.021 mm thick solvent, detached from a 0.051 mm thick UA and glass objective panel detached from a PMMA target panel.

After one hundred detachments, the adhesives were rolled up again against the desired target panel with a roller 2 kg using one pass in each direction.

* The test was stopped after 300 cycles and restarted approximately 24 hours later.

The data in this table shows a relatively low and constant peel strength during multiple releases and repositions of the fastening system of the invention.

Example 17 Two samples of non-adherent urethane (UR) fasteners were prepared. The UR is covered outside as a clamping layer on UPVC. The urethanes are prepared by heating polyol or polyols in a glass vessel at 70 ° C until they melt, an isocyanate-containing component is added, with stirring, until they combine well, and then 4 drops of a 1-solution are added. % by weight of dibutyltin dilaurate (DBTDL) in propylene glycol monomethyl ether acetate (PM Acétate by Union Carbide). The resulting urethanes are punched as a 0.10 mm (4 mil) thick layer on one side of a 0.05 mm (2 mil) thick UPVC film that has a pressure sensitive adhesive on the other side . The resulting tape is then cured at 74 ° C for 24 hours and allowed to wait at room temperature for about 1 week before performing the 90 ° peel test against various target surfaces. The ingredients used to make the UR and the results of the 90 ° peel test are given in Table 17 below. The amounts of the files are reported in parts by weight. The samples did not have adhesion when tested against paper.

Tone ™ 200 is a difunctional caprolactone polyol, p.m. 530, commercially available from Union Carbide Corporation, Danbury, CT. ToneMR 310 is a trifunctional caprolactone polyol, p.m. 900, commercially available from Union Carbide Corporation, Danbury, CT. IPDI is isophorone diisocyanate, commercially available from Hüls, Germany, MPCHI is methylene bis (isocyanate 4-cyclohexyl), commercially available as Desmodur ™ from Mobay Chemical Corporation (now known as Miles, Inc.), Pittsburgh, P.A.

Example 18 Six samples of non-adherent acrylic fasteners (AC) were prepared. Each of the AC compositions was applied as a coating on the outside, as a clamping layer on primed PET. The acrylic compositions were prepared by solution polymerization as indicated in U.S. Patent No. Re 24,906 (Ulrich) using a solution containing 40% solids content of the monomers and ethyl acetate, 0.3% 2-2 '- azobis (isobutyronitrile) as initiator (Vazo ™ 64, commercially available from E. I. duPont de Nemours) and by heating the mixture to 55 ° C for 24 hours. Each of the resulting acrylic compositions was punched out as a film which has a dry thickness of about 0. 025 mm (1 thousandth of an inch) on PET primed from 0. 038 mm (1.5 mils). The resulting tape is allowed to equilibrate at room temperature for approximately 24 hours before testing to determine the tear resistance in T against various target surfaces. The sample compositions are given in Table 18. The clamping layers, the target surfaces and the results of the T-peel test are reported in Table 19. The amounts of ingredients are reported in parts by weight. The samples are not adherent when tested against paper.

Example 19 A sample of a polyethylene copolymer (P) blend composition is extruded as a clamping layer. The composition is prepared by dry mixing, together, equal parts by weight of polyethylene copolymer (85% ethylene and 15% butene in 0.8% by weight microtalc) (DFDB 1085, commercially available from Union Carbide, Danbury, CT. ) and polyethylene copolymer (96% ethylene and 4% octene) (LLDPE 6806, commercially available from Dow Chemical Co., Midland, Michigan) and the mixture is fed through an extruder and a single layer die (both the extruder as the die is at a temperature of about 220 ° C) to provide a 0.076 mm thick layer. From the die, the layer is carried out on a chrome die roll (roll temperature, 10 ° C to 23 ° C) to a roll up roll where the layer is wrapped around a paper core. The resulting roller is allowed to stand at room temperature for approximately 4 months before performing the test for 90 ° peel resistance against various target surfaces. The target surfaces and the results of the 90 ° peel test are reported in Table 20 below. The samples did not show adhesion when tested against paper.

Example 20 It is hot-melt BACNI-1 coated on a silicone coated paper liner at a coating thickness of 0.064 mm (2.5 mils). The BACNI-1 layer is then laminated on one side of a 0.023 mm (0.92 mil) thick white PET film. The support side of the PET film is then coated with a 0.05 mm coating layer of a pressure sensitive adhesive. The resulting clamping component ("F-20") is then tested to determine its peel strength, dynamic shear strength, and static resistance to constant stress against various target surfaces. The above fastening components were tested immediately after being placed in contact with the target surface and after 48 hours of standby time. A variety of two-piece ostomy bags were made using commercially available ostomy bags to which the anterior fastening component, F-20, was attached by means of a layer of adherent pressure-sensitive adhesive. The clamping component was cut to form a circle 67 mm in diameter with a small "start hole", which is placed in the center. Various different laying area materials were evaluated. Some of these placement zone materials have use in other existing medical products and are considered to be safe and effective for use in contact with the skin. These different materials were selected so that it is possible to evaluate a variety of different adhesion levels for use in ostomy application. If desired, the level of adhesion can be adjusted alternately by varying the clamping layer of the clamping component. Each prototype device consists of a sack, a fastener and a placement area material. A commercially available adherent tape material having a polyethylene / EVA copolymer backing and an adherent acrylate adhesive (available from 3M Co., St. Paul, MN as # 9835) was chosen as a control. This adhesive tape has been shown to provide acceptable adhesion for ostomy bags. Two prototype sacks were filled with 200 ml of water and suspended vertically on a target surface to determine the resistance of the slip connection due to the shear forces and to determine the sack removal capacity of the laying area multiple times over a period of several days. Both prototype sacks were constructed using the F-20 fastener. A prototype used the "ribbon 9835" for the area of placement. This prototype is also subjected to manual "movement" of water in the bag, so that the interface of the fastener / laying area is exposed to moisture. A second prototype uses a laying area that has a polyurethane support. Both prototypes worked extremely well in terms of retention of the bag for several days. The first prototype also worked well even when the water had splashed on the interface. The fastener of the second prototype showed a very high detachment force, necessary to remove it from the polyurethane laying area after 24 hours. The fastener of this first prototype was easily removed, and reattached to the placement area "# 9835" multiple times over a period of two weeks. A test was also carried out in which various laying area materials were attached with the F-20 fastener. As a control, the various materials of the placement zone were also adhesively coupled with the adherent adhesive surface of medical tape # 9835. Peel strength, dynamic shear strength and static shear strength were measured at the initial bond. The peel strength and dynamic shear strength were also tested after the compositions were exposed at 38 ° C for 48 hours to simulate the body temperature when the collection device is used. The identification of the test sample and the results of the tests are shown in the following tables. x Ribbon 9835 has a polyethylene / EVA copolymer backing, and an adherent acrylate pressure sensitive adhesive layer (available from 3M, St Paul, MN). The tape 1516 has a polyester film backing with a release liner, and an adherent acrylate pressure sensitive adhesive (available from 3M). 3The MSX-1389 tape has a polyurethane backing, and an adherent acrylate pressure sensitive adhesive (available from 3M). 4The MSX-3076 tape has a polyurethane backing with release liner, and an adherent acrylate pressure sensitive adhesive (available from 3M).

Values with "P" indicate that abrupt release occurred before a clean failure of the sample. The term "blocked" describes when two components can not be separated without destruction of one or more components. * One of the triplicates fails at 6 minutes, the other two stay at least 1700 minutes.

In general, the operation of the F-20 fastener with the various laying areas was excellent. Resistance to shear stress, very high, is measured for all the different areas of placement. Each combination is expected to meet the operating requirements for ostomy applications. Various modifications of alterations of this invention will be apparent to those familiar with the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not limited to the illustrative embodiments set forth herein. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims (20)

2. Having described the invention as above, property is claimed as contained in the following: 1. An article of ostomy device, characterized in that it comprises: a bag with an opening for receiving material from a stoma, and a fastening system comprising: (i) a fastener attached to the bag circumscribing the opening, and (ii) a positioning area, the fastening system has a non-adherent target surface layer, a non-adherent clamping layer, which responds to contact, which is adheres to the non-sticky target surface layer, and means to attach the fastening system to the peristomal area of a user. An article, characterized in that it comprises: a bag with an opening for receiving material from a hole, and a fastening system comprising: (i) a laying area having a non-sticky target surface layer and an adhesive layer for joining the positioning area to the hole area of a user, and (ii) a fastener attached to the pocket circumscribing the opening having a non-adherent clamping layer, which responds to the contact, which adheres to the target surface layer non-adherent, wherein the clamping layer demonstrates properties of: essentially no adhesion to paper; it is multiplely relocatable against the nonadherent target surface; and has a substantially constant low 90 ° peel strength of less than about 3 kN / m and a dynamic shear strength of more than 2 kN / m2 when in contact with the target surface, wherein the target surface is a material different from that of the clamping layer and has a solubility parameter that is sufficiently different from the parameter of the polymer clamping layer to prevent blocking.
3. 3. The article according to claim 1, characterized in that the means for attaching the fastening system to the peristomal area of a user comprises a layer of a sticky adhesive.
4. 4. The article according to any of the preceding claims, characterized in that the clamping layer is releasable and multiplely resiscutable against the target surface layer, and wherein the clamping layer has a peel strength at 90 ° less than or approximately 3 kN / m, and a dynamic shear strength of more than kN / m2 when in contact with the target surface.
5. 5. The article according to any of the preceding claims, characterized in that the clamping layer can be cleaned, with retaining holding characteristics.
6. The article according to any of the preceding claims, characterized in that the clamping layer comprises a composition that is selected from the group consisting of homopolymers, random copolymers, block copolymers and graft copolymers.
7. The article according to any of the preceding claims, characterized in that the clamping layer comprises a polymer from about 10 to about 50 weight percent acrylonitrile and about 50 to about 90 weight percent of at least one of butadiene and isoprene, the polymer has a Mooney viscosity from about 20 to about 95.
8. The article according to any of the preceding claims, characterized in that the clamping layer comprises a crosslinked oligomeric resin having one or more hard segments the same or different, and one or more same or different soft segments, and one or more monovalent portions, the same or different, containing an addition-polymerizable, radiation-sensitive functional group.
9. The article according to any of the preceding claims, characterized in that the clamping layer comprises a material that is selected from the group consisting of a cross-linked butadiene-acrylonitrile polymer, and butadiene-acrylonitrile-isoprene polymer.
10. The article according to any of the preceding claims, characterized in that the fastening layer is permanently attached to the bag and forms the fastener, and the target surface and the adhesive layer are provided as a separable component of the positioning area. .
11. 11. The article according to any of the preceding claims, characterized in that the fastener comprises the non-adherent clamping layer, which responds to the contact, a mounting layer comprising a pressure-sensitive adhesive and a support layer interposed between the Clamping layer and mounting layer.
12. 12. The article according to any of the preceding claims, characterized in that the fastener is attached to the bag so as to form a rim.
13. 13. The article according to any of the preceding claims, characterized in that the fastener further comprises a space filling material.
14. The article according to claim 1, characterized in that the positioning zone comprises: a non-adherent surface layer selected from the group consisting of a target surface layer and a clamping layer which responds to the contact; a layer of adhesive; and a coating to protect the adherent adhesive layer.
15. 15. The article according to any of the preceding claims, characterized in that the positioning zone comprises the target surface layer, a layer of a skin barrier adhesive, and a coating to protect the adherent adhesive layer.
16. 16. The article according to any of the preceding claims, characterized in that the laying area further comprises a foam space filling material.
17. 17. The article according to claim 1, characterized in that the bag further comprises at least one of a discharge tube, an odor vent and a comfort layer.
18. 18. The article according to claim 1, characterized in that the target surface is permanently attached to the bag and forms the fastener, and the fastening layer and the adhesive layer are provided as a separable positioning zone component.
19. 19. The article according to claim 1, characterized in that the surface of the bag that surrounds the opening is a target surface and forms the fastener, and the fastening layer and the adhesive layer are provided as an area component of the fastener. separable placement.
20. 20. A method for using an article of ostomy device having a fastener system responsive to contact, non-adherent, the method is characterized in that it comprises the steps of: a) providing a bag with an opening for receiving material from a stoma that it has a fastening system, comprising: (i) a fastener attached to the bag that circumscribes the opening, and (ii) a positioning area, the fastening system has a non-adherent objective surface layer, a fastening layer not adherent, which responds to contact, which adheres to the nonadherent target surface layer, and an adhesive layer; b) attaching the adhesive layer to the peristomal area of a user; and c) joining the non-adherent clamping layer, which responds to the contact, to the non-adherent target surface layer.