CA2261932A1 - 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

WO ~ ,7,.~ 1 PCT/US96/20229 Ostomy Pouch Having Non-tacky Fa~G~ System - Field This invention relates to fluid colleetion pouehes that contain non-taeky contaet responsive f~ct~nçr systems. In partieular, the f~ctPnin~ s~ s may be ineorporated into low profile, two-pieee ostomy pouehes and inCQn~inçnce deviees.
Background An ostomy appliance is a deviee used to eolleet waste material that exits a person's body through a stoma. The term "stoma" refers to the surgieally ereatedhole in the skin and the ~tt~che~d end of the bladder, eonduit, or intestine. The stoma provides an open eonduit through whieh a eonstant or intermittent efflux of waste m~ten~l oeeurs. The surrounding skin area is termed the "peristomal 15 area. " A great ch~ nge exists to eomfortably and reliably eonneet an ostomy applianee to the peristomal area.
Stieky piessuie sensitive adhesive tapes may be used for seeuring ostomy pouehes to a patient. In one type of ostomy appliance the tapes are permanently bonded to the ostomy appliance. The ostomy appliance is used once and spent 20 upon removal of the tape from the body.
A "two-piece" ostomy appliance may also be used. A first part is adhesively ~tt~hçd to the skin area around the stoma and has a snap ring of plastic that mates with a complemçnt~ry snap ring on the separate ostomy device.When the two parts are snapped together, the rings form a leak-tight seal around2s the stoma and attach the bag to the patient. Unfortunately, however, the plastic rings are quite bulky and uncomfortable.
Other quick close/quick release mechanical f~ctenPrs are known. They may be repeatedly closed and opened and are frequently referred to as being reclosable. One such f~ct~t~er~ known as a hook and loop fastener, is available 30 from Velcro U.S.A., Inc., Manchester, New Hampshire. Another such fastener, WO 98/07396 PCTrUS96t20229 known as a mushroom-shaped f~ctenPr, is sold as the DUAL LOCK Reclosable Fastener by 3M Company, St. Paul, ~innesota. Both of these f~ctPnPrs have certain undesirable char~cterictics for use in ostomy applications. For eY~mple,the hook or mushroom portions of the f~ctçnPrs tend to snag fabric. Moreover, s both the hook and loop portions of the f~ctPners tend to collect lint and dust.
Also, these types of f~ctenprs generally do not exhibit a thin profile, which may detract from an ~sthetic al,~dnce, or may not provide a liquid or odor tight seal. Another feature of the hook and loop factçnPr is that it makes noise when it is opened. This makes it undesirable in any application where noise is a concern.
Other known f~ctçning systems, such as single or double sided tacky adhesive tapes also have various limitations. These limitations include non-recyclability, undesired transfer of the adhesive to a contact surface, and a tendency to irreversibly lose their adhesive propellies when cont~min~tP~ with lint or dust. Also, tacky adhesives tend to aggressively stick to latex surgicalS gloves which makes them hard to handle.
A great need exists for a reliable and inexpensive f~ctening system that is suitable for comfortably securing a medical device to a patient's skin.

S~ ry The invention provides a low profile, two-piece fluid collection pouch, such as an ostomy pouch or incontinence device, that comprises a contact responsive non-tacky fastener system. The fastener of the non-tacky f~ctPning system comprises a non-tacky surface, and is preferably multiply releasable and ref~ctPn~hle against a non-tacky surface of a landing zone. The fastener may also 2s comprise one or more layers in addition to the non-tacky surface layer such as a mounting layer of a pressure sensitive adhesive. The non-tacky surface of the landing zone may be a dirrerent material than the non-tacky surface layer of thef~ctçnPr and preferably has a sufficiently different solubility parameter to prevent blocking of the two non-tacky surfaces. The target surfaces useful in the WO 9~ ,7J~G 3 PCT/US96t20229 invention may generally be considered to be smooth. However, they may have some surface texture. rrerel~bly, the target surface is e-ccP-nti~lly smooth.
A ~erelled contact responsive f~ctenPr system reaches its optimum and maximum peel strength relatively quickly so that a dwell time is either escçnti~lly 5 u~necec~.y, or is relatively unnoticeable to a user of the f~ctçnçr system. It is also desirable that the f~ctening system m~int~inc a subst~nti~lly constant peel~h~l gtil over a long time period and does not exhibit any signific~nt build-up of peel strength over time. A pl~relled contact responsive f~ctençr system also achieves a suffici~ntly high shear strength to enable the f~ctpner system to l0 support a device. For ostomy application, the most preferred fastener system has both a suitably low peel strength, i.e., low enough that, if desired, the user easily can sep~.nte the f~st~pner from the landing zone, and a suitably high shear strength to reliably hold the ostomy device in place.
The f~tening systems of the present invention have application as a 15 mPllic~l f~ctener in areas re~quiring conformability and where long term wear is desirable.
One specific application that this f~ctening system appears to be highly suited for is as a system to secure ostomy pouches to the skin. Ostomies are located on the abdomen, and therefore, require a fastener system that will 20 preferably both conform to the abdominal contours and preferably move with the skin as the skin moves. Further, the fastener system used on ostomy pouches must be :lt~ ed to the pouch film in some manner. The fastener system of the present invention can be directly sealed to typical ostomy pouch films (e.g., byheat sealing the f~ctPnl~r to the bag). Alternatively, an adhesive layer may be 2s used to attach the ~cten~pr to the bag. The f~ctening system can be sterilized by gamma irradiation, with no loss to or only minimal effect on its properties. This feature is a highly desirable attribute of medical devices and specifically devices used to secure ostomy pouches to the peristomal region immedi~t~PIy after surgery.

WO 981U7.)~C 4 PCT/US96/20229 Brief Des.~ ion of the Drawings This invention will be better understood when taken in conjunction with the drawings wherein:
FIG. 1 is a side view of a f~ctçnçr of the fActPning system;
s FIG. 2 is a side view of a f~ctener of the f~ctening system with a removable cover layer;
FIG. 3 is a side view of a fActenP~r of the factening system with an intel~osing b~ in& layer;
FIG. 4 is an pe.specli~/e view of an ostomy pouch having a non-tacky o f~ctener system;
FIG. Sa is a partial cross-section view of the pouch of FIG. 4, taken along line 5a-5a, showing the fAct-pning component of the f~ct~ning system, an adhesive layer that ~tt~-~hes the fActening component to the ostomy bag, and an optional liner that covers and protects the non-tacky surface layer of the fastening 15 co,l,l)ol-ent;
FIGS. 5b to 5f are Altern~tive partial cross-section views of the ostomy pouch of the present invention illustrating various layers of the fastener;
FIG. 6 is an perspective view of an alternative ostomy pouch having a non-tacky f~ctener system, wherein the fastener system is attached to the ostomy20 pouch so as to form a flange;
FIG. 7 is a partial cross-section view of the pouch of FIG. 6, taken along line 7-7, showing the fActçning component of the f~ctening system, an adhesive layer that partially attaches the fActening component to the ostomy bag and thatforms a flange, and an optional liner that covers and protects the non-tacky 25 surface layer of the fActening component;
FIG. 8 is an alternative partial cross-section view of the ostomy pouch of the present invention illustrating various layers of the flanged fActPnpr;
FIGS. 9a and 9b are alternative top views of landing zones of the present invention, illustrating a non-tacky surface for the fActening system, and the 30 adhesive layer used to attached the landing zone to a patient;

W O 98/07396 5 PCT~US96/20229 FIG. 10 is a cross-section view of the landing zone of FIG. 9a, taken along line 10-10, illustrating a non-tackv surface layer, the p,~ ,;,.lre sensitive adhesive layer used to attach the landing zone to a patient, and the liner used to protect and cover the ~)~s~ e sensitive adhesive prior to use;
FlGS. 11 and 12 illustrate alternative cross-section views of the landing zone of the present invention illustrating various layers of the landing zones depicted;
FIG. 13 is an top view of an alternative landing zone of the present invention, illustrating a non-tacky surface for the f~ctening system, the adhesive îo layer used to attach the landing zone to a patient, and an adhesive collar that surrounds the non-tacky surface and that further helps to hold the landing zone to the patient;
FIG. 14 is a cross-section view of the landing zone of FIG. 13, taken along line 14-14, illustrating the collar tape, the non-tacky surface layer, an optional gap filling layer, a pres:,ure sensitive adhesive layer, and the liner used to protect and cover the pressure sensitive adhesives prior to use.
This invention utilizes certain principles and/or concepts as are set forth in the claims appended to this specification. Those skilled in the art to which this invention pertains will realize that these principles and/or concepts are capable of being illustrated in a variety of embodiments which may differ from the exact embodiments utilized for illustrative purposes in this specification. For these reasons, the invention described in this specification is not to be construed asbeing limited to only the illustrative embodiments but is only to be construed in view of the appended daims.

Definitions Unless otherwise sper-if1ed~ the terms ~fa~tening system" or ~factener system" in this specification refers to the combination of a factçn~r and a landing zone.
A "fact~ne~" refers to that part of the factening system of an ostomy appliance that is ~csori~ted with the ostomy bag. The facten.o,r includes a non-tacky surface and any optional mounting layers, b~cking~, or liners that are ~cco~i?t~ with the non-tacky surface.
A "factening component" refers to that part of the factener that includes lo the non-tacky surface layer and any optional bacl~ing that is ~tt~hed to the non-tacky surface layer. This does not include any mounting layer (e.g., a tacky pressure sensitive adhesive layer) or any removable liners.
A ~l~n-ling zone" refers to that part of the factening system of an ostomy appliance that is meant to be ~tt~ched to the peristomal region of a user. The l~nrling zone includes a non-tacky surface and any optional mounting layers (e.g., a tacky pressure sensitive adhesive layer), backings or liners that are acsoci~ted with the non-tacky surface.
A "factening layer" refers to the contact responsive non-tacky layer of the f~ct~ning system that is placed in contact with a target surface.
A "target surface" refers to the non-tacky layer of the f~ctening system that is placed in contact with a f~ctening layer.

Detailed Des~ )tion The invention relates to a novel low profile, two-piece fluid collection pouch (e.g., a two-piece ostomy pouch) having a new class of fact~ninp, system that has at least one contact responsive f~ctening layer which has essenti~lly no surface tack to paper or skin. The contact responsive f~ctening layer preferablyallows multiple factening and rel~cing cycles of the f~ctening layer with a target surface. The target surface may comprise either another essentially tack free surface or it may simply be a non-tacky smooth surface. The target surface WO 3v~ 7~v PCT/US96/20229 preferably has a solubility parameter or other charaçtt~rictic (such as surface roughness) which p~ s m~xirnum contact area with the f~ctenin~ layer and which allows the faQ~tenin~ layer to have a sPIect~' le and conQ-iQtently .t;~eatable low peel ~llen2~lh and a high shear strength. Preferably, the f~tenin~ layer may5 be cycled against the target surface numerous times without any noticeable transfer or migration of any part of either the f~ctening layer to the target surface or the target surface to the f~Q~fning layer. A presently prefelred factenin~
system of the present invention for use on ostomy appliances is a low profile faQ~t~ning system that has a total combined thic~n~osQ (including any adhesive lo layers used to attach the system to a patient, but not including any removable liners that protect the system prior to use) of no more than about 0.3 mm.
Either piece of the two-piece fluid collection pouch may comprise the f~o~tening layer. The other piece may comprise the target surface. For ex~mple, the f~o~enin~ layer may be ~n~he~ to or a part of the ostomy bag, and a target 15 surface layer may be ~tt~l~hed to or a part of the landing zone. Al~e,lla~ ely, the ostomy bag may comprise a target surface around the opening and the landing zone may comprise a f~ctenin~ layer.
Numerous polymeric materials may be used as the contact responsive fa~tPning layer. The polymeric material may be a homopolymer, a random 20 copolymer, a block copolymer, or a graft copolymer. It may be cros~linkP~ or uncros~link~A. Specific examples of polymers useful as the factening layer include ethylene-cont~ining copolymers, urethane polymers such as urethanes pre~ d by the reaction of an isocyanate and an isocyanate-reactive co",~und, acrylic and acrylate polymers, urethane-acrylate polymers, butyl rubber, 25 but~ ne-acrylonitrilepolymers, and butadiene-acrylonitrile-isoprenepolymers.
Blends and mixtures of polymeric materials may be used if desired.
Various other m~t~ri~l~ may be incorporated into the polymeric m~t~.ri~l.
For example, tackifiers may be used if desired. Additionally, fillers, pi~m~nt, plasticizers, antioxidants, ultraviolet light stabilizers, and so forth may be 30 employed. The exact quantity of these other materials may be varied to suit the . ~ . . ...

W 0 ~81'~7~9~ 8 PCTAUS96nO229 desires of the co-,-po.lllder, provided that the resulting contact responsive layer retains its e~Pnti~lly tack-free character. Thus, the ratio of the various otherm~trri~l~ (i.e., t~ifiPJ, filler, and/or pigment) may be varied as needed to in the tack-free nature of the contact responsive layer.
s Additional ~ cus~ion regarding polymers and col.. po~itions useful as the f~tening layer may be found in a number of publications. For example, Eurol)ean Patent Pub. No. EP 0443263 (Miller et al.) discloses tackified block copolymer m~teri~l~; U.s. Patent No. 5,196,266 (Lu et al.) discloses urethane-acrylate m~ri~ls; and U.S. Patent Nos. 5,114,763, 5,141,809, 5,141,981 and lo 5,147,708, each disclose polyethylene-containing polymers with t~r~ifi~rs, ethylene-vinyl acetate and acrylates.
Preferred polymers for use as the contact responsive f~tening layer are selected from the group con~i~ting of butadiene-acrylonitrile (hereinafter BACN)polymers, but~iene-acrylonitrile-isoprene (hereinafter BACNI) polymers, lS urethane acrylate (hereinafter UA) polymers, butyl rubber polymers, two-parturethane (hereinafter UR) polymers, styrene-isoprene-styrene (hereinafter SIS) block copolymers and styrene-buP-liene-styrene (hereinafter SBS) polymers.
BACN, BACNI, and UA polymers are presently most preferred for use as the contact responsive ~stçning layer.
The BACN and BACNI polymers typically have from 10 to 50% by weight acrylonitrile units. Additionally, the BACNI polymer typically contains from 2 to 20% by weight isoprene units. Either of these types of polymer may be proces~ed by solvent coating or hot melt extrusion. Hot melt extrusion is ple~lled because it obviates the necessity to use solvents during proce~ing; it provides an ability to coat the f~tening layer directly onto cloth or porous backings; it is a low cost process and uses low cost materials; and it is not necP~ry to add a crosslinker to further crosslink the composition, since hot melt extrusion of but~liene-cont~ining m~tPri~ls is known to cause some chemical cros~linking. The result is an essenti~lly tack free hot melt coated contact W O 98/07396 9 PCTrUS96/20229 responsive fActening layer with all of the above features as well as most of the~lecir~ble featul~s of hook and loop fA~tening systems.
The UA polymer is primarily decignP~ for AAhesion to itself but it also works very well with a variety of target surfaces. This polymer comprises (i) a one-part, ~re~el~ly solvent-free, radiation-curable, ~ ition-polymerizable~
cros~linkable, organic oligomeric resin having one or more like or different hard s~ s, one or more like or different soft segments, and one or more like or different monovalent m~ieti~os containing a radiation-sensitive, addition-polym~ri7Ahle, filnction~l group, and (ii) a photoinitiator.
o The butyl rubber polymers are preferably combined with a de-tackifying agent, such as talc, to decrease the tack of these compositions depçn-iing upon the target surface.
While the precise nature of the contact responsive layer may be varied to suit the particular application, it should be noted that for multiply releasable and refAc~enAhle applications the preferred layer does not block, i.e., form a permanent bond to a target surface. Preferably, the contact responsive fActeninglayer demonstrates 90~ peel strength values to a target surface of about 0.01 kN/m to about 3 kN/m, more preferably within a range of about 0.05 kN/m to about l.S kN/m, most 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 contact responsive fastening layer demonstrates 180~ peel strength values to a target surface of about 0.005 kN/m to about 3 kN/m, more preferably within a range of about 0.01 kN/m to about 1.5 kN/m, and most preferably within a range of about 0.01 kN/m to about 0.5 kN/m. Preferably, the contact responsive fac~ning layer demonstrates dynamic shear strength values to a targetsurface of greater than about 2 kN/m2, more preferably greater than about 4 kN/m2, and most preferably greater than 6 kN/m2. Preferably, the contact responsive f~ctening layer demonstrates static shear strength ("holding power") values to a target surface of greater than about 60 minutes, more preferably greater than about S00 minutes, most preferably greater than about 1100 minutes, WO ~ 7~,3~ 10 PCT/US96/20229 and optimally greater than about 1700 minutes. These strength values are measured according to the techniques described hereinafter. For ~,u~poses of CG~ ;COIl, peel strength and dynamic shear strength values are measured after about 10 minutes dwell at 21~C.
In some cases, it may be nece-cc~ry to adjust the coating weight/coating thic~ness to achieve the desired peel value. Furthermore, the polymer may be ~ddition~lly cros~link~ in order to further increase its internal strength and reduce peel values to a desired level. This is an espe~i~lly useful technique to use when the contact responsive layer and the target surface comprises BACN, lo BACNI, or a combination of each. In this in~t~nce, the BACN and/or BACNI
polymer is preferably modified by crosclinking in order to prevent blocking of the contact responsive layer to the target surface. Crocclinking is one method for increasing the internal strength of the BACN so that the f~ctening layer m~int~inc a relatively constant peel strength over repeated uses. Additionally, crocclinking provides a means for controlling the peel strength of the material against another m~t~ri~l .
The adhesive properties of the fastener system of the invention can also be controlled by a~ropliate selection of the target surface to which it is to bef~cten~d. It has been discovered that for some fastener systems, particularly a BACN system, as the difference between solubility parameter of the f~ctening layer and that of the target surface increases, the peel strength (e.g., as exemplified by 180~ peel strength) decreases.
Target surfaces useful in the invention may be selected from a wide variety of materials. F.~peci~lly useful target surfaces are materials that do not bond perm~n~ntly to the f~stening layer. Examples of useful target surfaces include those m~teri~l~ previously identified as being useful for the f~tening layer, as well as polyureth~nes, polycarbonate, polyacrylonitrile, but~ on~-styrene polymers, poly(methylmethacrylate), polyamide, ethylene vinylacetate copolymer, treated and untreated poly(ethylene terephthalate), olefinic ionomer resins such as "SURLYN" resins from E.I. Du Pont de Nemours and Company, W O 98/07396 11 PCTrUS96/20229 Wilmington, DE, polystyrene, acrylonitrile but~iene-styrene polymer, polypropylene, and polyethylene. Useful target surfaces may also include met~llic surfaces such as foils; coated paper; enamel coated subsLIates; low adhesive bac~i7~ coatin~-c (LABs); paints; inks; lacquers; etc. The exact choices of target surface to be used is dependent upon the needs of the user, provided however, that the target surface and f~ctening layer do not block.
It has also been discovered that the peel strength can be influenced by the nature of any mounting layer that may be used. For example, higher peel values are typically obtained when a stiff (i.e., rigid) mounting layer is utilized.
o An advantageous feature of this factening system is that it is cleanable, for eY~mple, with iso~l~anol or soap and water, in order to maintain/restore its f~ctening c~ .istics. This is a valuable consideration in view of the tendency of these co..,positions to eventually lose f~ctPning capability when contacted with certain cont~...in~nlc, such as oils. However, the rejuvenation of these f~ctçnP.r 15 systems results in a long useful life of products using these systems.
If desired, the f~stening conlponent of the present invention may comprise on the surface opposite the non-tacky surface layer a mounting layer such as a material capable of heat or sonic bonding. This enables the f~ctçn.or to be directly heat bonded to a structure such as a plastic film of an ostomy bag.
20 Alternatively, the factener may be directly laminated to the article or adhered to the article using a layer of a tacky pressure sensitive adhesive.
The f~tenPr and/or the landing zone can be coated with any conventional hot melt, solvent coated, or like adhesive. These adhesives can be applied by conventional techniques, such as solvent coating by methods such as reverse roll, 2s knife-over-roll, gravure, wire wound rod, floating knife or air knife, hot-melt coating such as by slot orifice coaters, roll coaters or extrusion coaters, at a~r~fiate coating weights. U.S. Patent No. 5,230,701 (Meyer et al.), discloses suitable adhesive coating methods. The adhesive may be first coated on a liner m~t~ l, using one of the aforementioned techniques, and then l~min~terl (e.g., 30 using a roller to apply pressure) to form the fastener or landing zone. Preferred , . , . . __ CA 02261932 1999-01-27' W 0 ~ /J~G 12 PCT~US96/20229 for most applications would be pressure sensitive adhesives. Suitabls pl~SS~
sensitive adhesives for use in the present invention include those pr~si,. re sensitive adhesives which are capable of providing the nece~c~ry amount of pcel strength and/or shear strength to function in the manner required (e.g., sufficietlt s shear strength to securely attach the ostomy appliance to the skin without uninlended det~c hmçnt). Suitable adhesives for use in the medical field should be non-toxic, preferably hypoallergenic, and are most preferably also environm~nt~lly safe.
Suitable ~l~S~,G sensitive acrylate adhesives for use in the present o invention, e.g., for use on the skin contacting surface of the landing zone con-~nent, include copolymers which are reaction products of the polymeri_ation of at least one "A" monomer and at least one "B" monomer to yield a copolymer preferably having an inherent viscosity of about 1.0 dl/g to about 2.0 dl/g. The A monomer is a polymerizable monomer comprising an acrylate or mP~hacrylate ester of a non-tertiary alcohol or a mixture of non-tertiary alcohols with the alcohols having from about 1 to 14 carbon atoms and desirably averaging about 4 to 12 carbon atoms. The B monomer is an ethylenically unsaturated compound and desirably may be acrylic acid, methacrylic acid, itaconic acid, acrylamide, methacrylamide, acrylonitrile, methacrylonitrile, vinyl acetate, N-vinyl pyrrolidone, or combinations thereof.
The A monomer is polymPri7~hle and contributes the viscoelastic ~lopellies of the plcs~lre sensitive adhesive copolymer. Non-limiting examples of such A
monomers include the esters of acrylic acid or methacrylic acid with non-tertiary alkyl alcohol such as l-butanol, 1-pentanol, 2-pentanol, 3-pentanol, 2-methyl-1-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, l-decanol, 1-dodecanol, and the like. Such monomeric acrylic or methacrylic esters are known in the art, and many are commercially available. The B monomer is an ethylenically unsaturated compound copolymerized with the A monomer to affect the physical properties WO ~'~.7.,SC ~3 PCT/US96/20229 of the r~sl-lting P1~S;~ G sensitive adhesive copolymer. In general, the presence of the B monomer will reduce the flexibility of the res~ ing pr~s~. 'e sensitiveadhesive copolymer. Thus, the weight ~~r~l.lages of the A monomer and the B
tnonomer should be b~l~need in order to provide a pressure sensitive adhesive 5 copolymer preferably having an inherent viscosity of from about 1.0 dl/g to about 2.0 dl/g. The weight p~ ,cellt~ge ratio of A monomer: B monomer ranges from about 85:15 to about 98:2 and desirably from about 90:10 to 97:3.
The ~>lCSs-~lc; sensitive adhesive copolymer should be tacky at room te~ ~ldlule as well as at skin tenll,~ldlllre of mammals. Also, the adhesive 10 should be hypoallergenic, i.e., after continuous contact with skin, there is no significant skin sensitization or irritation during adhesion. Presently preferred as an acrylate pressure sensitive adhesive for tapes used in the present invention is an isooctyl acrylate/acrylic acid copolymer in a weight ratio of about 94:6. Theinherent viscosity of the copolymer is about 1.4-1.6 dl/g. If desired, acrylate 5 pressure sensitive adhesives have a tackifier added to the formulation to improve tack. Commercially available tackifiers include "Foral" branded colophony acid rosins, such as "Foral AX" and "Foral 85" rosins, commercially available from Hercules Corporation, and partially hydrogenated methylstyrene hydrocarbon resins, such as "Piccol~s~ic A25" resin, also commercially available from 20 Hercules Co.~ldLion. Such tackifiers can be added during preparation of the acrylate ~ l[C sensitive adhesive in an amount of about 35-40 weight percent of the copolymer solids.
Alternate pressure sensitive adhesives useful in the present invention are hypoallergenic Kraton rubber-based pressure sensitive adhesives produced using 25 styrene-but~liçn~o or styrene-isoprene copolymers commercially available as Kraton branded copolymers from Shell Oil Company of Houston, Texas. A
variety of Kraton based ~less~le sensitive adhesives are disclosed in U.S. Pats.Nos. 5,019,071 (Bany et al.) and 5,158,557 (Noreen et al.). Preferred as Kraton rubber-based pressure sensitive adhesives are Kraton 1107, Kraton 1111, Kraton 30 1101, and Kraton D branded copolymers, tackified with compatible ~ckifi~rs W O 9X~'~/J~ 14 PCT~US96nO229 such as EscorezlM 1310LC branded t~-kifier commercially available from Exxon t~h~mi~lc, a solid Cs tackifying resin commercially available as WingtackrM
Plus brand tackifier from Goodyear Tire and Rubber Company, Akron, Ohio and naphthenic oils having 10% aromatics commercially available as ShellflexTM 371 5 from Shell Oil Company. Such t~cl~ifiers can comprise about 45 to about 70 weight percent of the press.lre sensitive adhesive, while the Kraton copolymer can comprise about 30 to 55 weight percent.
Ad-lition~l alternate pfes~ sensitive adhesives which may be useful in the present invention are the water-dispersible pressure sensitive adhesives disclosed 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 in European Patent Nos. 0 605 448 and 0 639 085.
Pressure sensitive adhesive copolymers can be copolymerized using known polymçri7~tion techniques such as emulsion polymerization and solution S polymerization. Sources of polymerization preparation and techniques includeOr~anic Polymer Chemistry, Sall~ders et al. (Halsted Publishing Company, New York 1973); Applied Polymer 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, acrylate pressure sensitive adhesive copolymers can be pr~ared according to U.S. Patent No. 2,884,126/RE 24,906 (Ulrich).

Detailed Des~ri~lion of the Drawings 2s A number of specific embodiments of the invention are illustrated in the Figures.
Figure 1 discloses multilayered tape 10 comprising contact responsive f~ctening layer 112 having a first surface 114 attached to an optional mounting layer 117. Mounting layer 117 preferably comprises a tacky pressure sensitive adhesive. Mounting layer 117 permits permanent mounting of tape 10 to another WO 3~J~7~ 15 PCT/US96/20229 s.~ te in a position which enables multiple releasable contact between l~cle~in~ layer 112 and a target surface. When the composition of f~ctening layer 112 is a ur~_lhane-acrylate polymer, it may be coated directly onto mounting layer 117 and cured with ultraviolet radiation. Alternately, when the composition of 5 f~ct~nin~ layer 112 is a but~liene-acrylonitrile polymer or a b~1t7~di~one-acrylonitrile-isoprene polymer, it may be hot melt or solvent coated onto Illounling layer 117. In either embodiment, as with other suitable compositions, a novel multilayered tape 10 results. F~ct~nine layer 112 may also be mounted directly to certain substrates without using a mounting layer comprising a o pressure sensitive adhesive. For example, fastening layer 112 may adhere directly to the substrate. Provided that the adhesion to the substrate is greater than the Mlhecion to the target surface, the f~ctening layer will remain ~tt~.~h~d to the substrate. Alternatively, the mounting layer 117 may comprisc a layer of material that can be heat sealed to a substrate. For example, mounting layer 117lS may comprise a polymeric film.
Figure 2 illustrates the tape of Fig. l having an additional layer of material. In this embodiment, a covering layer 120, such as a removable liner, is ~tt~rh~d to a second surface 122 of the fastening layer 112. After tape 12 is properly positioned, and optional mounting layer 117 is firmly attached to the 20 underlying sulJsllate~ the covering layer may be removed to allow placement of a target surface against f~tening layer 112. This sequence permits ease of pl~~ern~nt of tape 12 without cont~min~tin~ f~tening layer 112.
Figure 3 illustrates yet a further alternative tape 14. This tape is similar in use and structure to tape 12, but has an additional backing layer 131. Rac-king 2s layer 131 may comprise a scrim, a woven material, a non-woven material, paper, metal foil, or a polymeric material, such as a film. Other materials may also be used as b~ king layer 131 provided there is the desired level of adhesion to and material compatibility with both f~ctening layer 112 and mounting layer 117. Specific types of materials that are useful as the backing material 131 30 include polycarbonate, poly(methylmethacrylate), polypropylene, polyethylene, WO ~81'~7~)5G 16 PCT/US96/20229 polystyrene, acrylonitrile-but~iene styrene polymer, and polyester. Other usefulm~t~ri~l~ for b~ ing layer 131 include oriented poly(ethylene terephth~l~tp~) film with or without a corona treated surface, cellulose acetate butyrate, cellulose acetate propionate, poly(ether sulfone), polyurethane, poly(vinyl chloride), paper, fabric and metal. The presently most ~l~r~ d backing material is a polyester film which preferably has been corona treated.
Racking layer 131 should be of a thicknec~ to provide sufflcient support to f~ctening layer 112. Ra~(~king layer 131 is preferably at least 0.0125 mm thick, in order to provide both good strength and good handling prope~lies to the tape. Ito is prefe~led that the substrate comprising backing layer 131 have a tensile strength of at least about 1500 MPa. In many applications it is also prefelled that the b~ing layer be flexible, i.e., capable of being bent to a radius of 0.5 cm without breaking.
The embodiment of Figure 3 may be mounted directly to the substrate without the need for mounting layer 117. In Figures 1-3, an optional removable liner may be 7.tt~hed to an exposed second surface 137 of mounting layer 117.
Use of these tapes with appropliate liners permit bulk roll storage and rlispen~ing and provide ease of manufacture of articles using the tape.
FIG. 4 illustrates a pelsl,eclive view of an ostomy appliance (or "ostomy bag") 20 having a non-tacky f~ten~or 26. The ostomy pouch 20 is formed from two layers of a fluid impermeable material 32 such as a plastic film. The bag optionally has a layer of a comfort material 34 such as a non-woven fabric on the patient side of the bag. The layers of fluid impermeable material and optional comfort layer 34 may be sealed at edge 36 using, for example, an adhesive or a 2s heat sealing technique to form the pouch. Also shown in FIG. 4 are an optional drain 41 and an optional odor vent 30. Fastener 26 optionally and preferably hasa non-adherent tab 28 to facilitate removal of the f~cten~r system from a landing zone (e.g., by peeling). FIG. 4 further illustrates an opening 24 into the pouch.
If desired, the opening can be either pre-sized for a particular patient's need (i.e., the pouch may be manufactured with a variety of opening sizes) or may be r WO ~7J~6 17 PCT/US96/20229 a universal "starter" opening that is then enlarged by the user to fit their particular need. The factener 26 may be ~tt~hP~ to the ostomy bag in a variety of ways. As shown in FIG. 4, the facten~Pr is ~tt~hed to the bag from near the opening 24 to near the p~iphc.y of the f~t~nPr 26. In one pç~
embod;-,-ent, the ~tta-~hmçnt is achieved by heat sealing 38 the f~tenPr 26 to the bag m~eri~l 32. This may be accompli~he~1 using any of a variety of heat sealingpatterns, such as, for P~mrle, a series of circular lines of different rli~m~ters.
FIG. 5a illustrates a partial cross-section view of the pouch of FIG. 4, taken along line 5a-Sa, showing the f~ctening component 25 of the factPner 26, lo an adhesive layer 40 that ~tt~ches the fastening component 25 to the ostomy bag film 32, and a liner 42 that covers and protects the non-tacky surface layer 27 (e.g., a f~ctening layer) of the f~ctening component 25. FIG. 5a also illustrates optional comfort layer 34, optional tab 28, and opening 24. If desired, tab 28 may either be a sep~ piece of material that is ~tta~hP~l, e.g., by gluing, to the f~ctening co,l~ponent, or it may be an integral portion of the facteninE
co,-,~onent. In one embodiment, the f~ct~pner 26 is die cut to form both the generally circular periphery of the fastener and the finger sized tab. The tab portion of the die cut material may be coated or treated to inhibit its adhesion to the landing zone, or it may be covered with a second layer to prevent adhesion to the landing zone.
FIG. Sb is an alternative partial cross-section view of the ostomy pouch 20 of the present invention illustrating various layers of the fastener 26. In this embo-liment, the f~tenPr 26 is attached to the ostomy pouch by heat sealing 44 the f~ctenin~ co-"po,lent to the pouch film material 32.
2s FIG. Sc is an alternative partial cross-section view of the ostomy pouch 20 of the present invention illustrating various layers of the fastener 26. In this embodiment, the fact~Pner comprises a gap filling material 46, such as a foam, between the bag and the f~ctening component 25. The f~c~Pning component 25 may be adhered to the gap filling material by means of adhesive layer 48. The gap filling matPri~l may be attached to pouch film material 32 by means of an ..

adhesive layer (not shown) or by other means such as by heat sealing 44. A
removable liner 42 may be used to protect the f~ctçner.
FIG. Sd illustrates a similar f~cten~r to that shown in FIG. 5c, except that non-t~cky surface layer 27 is shown directly l~min~t~d to gap filling m~tçri~l 46.
5 For example, gap filling material 46 may comprise a polymeric foam material or a foamed ~,ess.lre sensitive adhesive.
FIG. 5e illustrates a similar f~ten~r to that shown in FIG. Sb, exce,pt that f~ctçning co...l~nent 25 is shown directly l~min~tP~ to bag film 32. F~cte-ning co.-.pol-F,nt 25 may comprise, for example, a non-tacky surface layer 27 and a 0 backing (as shown) or a single layer of a non-tacky surface layer 27. For eY~mple, the f~cte,ning component 2S may comprise a single layer of a f~ctening layer that is directly heat sealed or otherwise laminated to the bag.
FIG. 5f illustrates an alternative partial side view of an ostomy pouch illustrating various layers of the pouch. In this embodiment, the f~ctener 15 comprises the non-tacky surface 27 of the bag film near the opening 24.
Optional comfort layer 34 is provided on the patient side of the pouch and away from the f~cte,ner area.
FIG. 6 illustrates a perspective view of an alternative ostomy pouch (or "ostomy bag") 22 having a non-tacky fastener 26. The fastener 26 of this 20 embolimP,nt is partially attached to the ostomy pouch 22 so as to form a flange 29. The ostomy pouch 22 is formed from two layers of a fluid impermeable m~tP,ri~l 32 such as a plastic film. The bag optionally has a layer of a comfortm7~teri~1 34 such as a non-woven fabric on the patient side of the bag. The layers of fluid impermeable m~tPri~l and optional comfort layer 34 are sealed at edge 25 36 using an adhesive or a heat sealing technique to form the pouch. Fastener 26 optionally and preferably has a non-adherent tab 28 to facilitate removal of thef~ct~ner (e.g., by peeling) from the landing zone. FIG. 6 further illustrates anopening 24 into the pouch. The fastener 26 may be attached to the ostomy bag in a variety of ways. As shown in FIG. 6, the fastener is attached to the bag from 30 near the opening 24 to midway to the periphery of the f~ctçnçr 26. Preferably, W O 98/07396 PCTrUS96120229 the ~tt~hm~nt is achieved by heat sealing 38 the central portion of the f~cten~r26 to the bag mat~ 32. This may be accompli~hed using any of a variety of heat sealing patterns, such as, for example, a series of circular lines of different ~i~meters. The ~I;1.hf ~dl portion of the f~tenPr not connected to the bag formsa flange 29. The flange 29 is de~ign~ to relieve stress when the bag is tugged.
F.ssPnti~lly, the flange 29 tr~n~rnitc tugging forces from the bag to the midpoint of the f~ten~r. This helps relieve stresses at the peliphery that might otherwise start a peeling del~min~tion of the f~sten~r from the landing zone. ~n~tea(l~ the tugging forces are distributed over a larger area of the f~ctening system.
o FIG. 7 illustrates a partial cross-section view of the pouch of FIG. 6, taken along line 7-7, showing the f~ctenjng component 25 of the f~tener 26, an adhesive layer 40 that att~ches a central portion of the f~stening component 25 to the ostomy bag film 32, and a liner 42 that covers and protects the non-tacky surface 27 of the f~tening co.,ll)onent 25. FIG. 7 further illustrates flange 29.
lS FIG. 8 is an alternative partial cross-section view of the ostomy pouch 22 of the present invention illustrating various layers of the flanged factener 26. In this embodime-nt, the f~teller 26 is attached to the ostomy pouch by heat sealing 44 the center portion of the f~tçnTng component to the pouch.
FIGS. 9a and 9b are alternative top views of landing zones (60, 62) of the 20 present invention, illustrating a non-tacky surface 68, and the adhesive layer 70 used to ~tt~''hed the landing zone 60 to a patient. As shown in FIG. 9a, the landing zone 60 has a central hole 72 and optional tab 66 for separating a releasable liner 64 from the tacky skin adhesive layer 70. Alternatively, and asshown in FIG. 9b, the liner 64 may be slit 67. A first piece of liner may be 25 removed by bending the liner at the slit. If desired, the landing zone (60, 62) may be formed using a commercial medical tape material (e.g., TEGADERM, available from 3M, St. Paul, MN) or another material as described herein. The precise shape of the landing zone is not critical. Preferably the landing zone is sized to mate with the fastener. The shape of the landing zone and/or fastener W O 98/07396 PCT~US96/20229 may be purposely mi~m~tt~.h~d, if desired, to create non-adhered regions that f~l~ilit~te peeling apart of the cG,.,~ ents by the user.
FIG. 10 is a cross-section view of the landing zone of FIG. 9a, taken along line 10-10, illustr~ting the non-tacky surface layer 68~ the p,~5~
5 sensitive adhesive layer 70 used to attach the landing zone to a patient, and the liner 64 used to protect and cover the pressure sensitive adhesive prior to use. If desired, the liner material may optionally be slit in two or more pieces, thus facilitating removal (e.g., by peeling) and/or also f~ilit~ting application to the skin (e.g., ~rhelein a portion of the liner material is first removed to expose lo adhesive and a second portion of the liner functions as a stif~ening ring which is removed after the exposed portion of the attachment means is pressed against theskin).
FIGS. 11 and 12 illustrate alternative cross-section views of the landing zone of the present invention illustrating various layers of the landing zones lS depicted. In FIG. 11, the landing zone comprises a thick skin barrier adhesive 74. An eY~mple of such an adhesive is a hydrocolloid adhesive. FIG. 12 illustrates a landing zone that has a thick foam material 76 between non-tacky surface layer 68 and adhesive layer 70. Foam material 76 and/or skin barrier adhesive 74 of FIG. 11 may be used to provide a "gap filling" function. These 20 somewhat thicker layers may help to ensure a tight leak-free seal of the bag to the user.
FIG. 13 is a top view of an alternative landing zone 80 of the present invention, illustrating the non-tacky surface layer 68 for the f~tening system, and a collar tape 78 that surrounds the non-tacky surface layer and that helps to 25 hold the landing zone to the patient. An adhesive layer under the central portion of the landing zone is illustrated in FIG. 14.
FIG. 14 is a cross-section view of the landing zone of FIG. 13, taken along line 14-14, illustrating the collar tape 78, the non-tacky surface layer 68, an optional gap filling layer 76, a pressure sensitive adhesive layer 70 used to30 help attach the landing zone to a patient, and the liner 64 used to protect and r wo ~~'~,7J5~ 21 PCT/US96/20229 cover the p.~ s~ sensitive adhesives 71 and 70 prior to use. Collar 78 may compri~e a b~ in~ 79 (e.g., a non-woven, elastic material) and a layer of p-cs~-lre sensitive adhesive 71.
The contact responsive f~tener system of the invention may be provided s as a premated structure or, alternatively, in the form of separate colllponents. In its various embo-limlont~, it is useful for llellllilling multiple f~tening and rel~cing of an article onto a structure, or for multiple f~ct~.ning and rele~cing of a first article to a second article. The facttonPr and landing zone components each comprise a non-tacky surface layer. At least one of these surface layers comprises a contact responsive f~ctenin~ layer.
Other uses include f~tçnings on disposable consumer goods requiring multiple closures, and clean room or medical and surgical garment f~ctening.~.
For example, they may be used with surgical gowns, drapes, and surgical gloves.
A non-tacky f~stençr of the invention may be used to form a fluid resistant sealS with a surgical glove. Drape uses include tube and cord organizers, repositionable plastic pouches, repositionable incisor areas, and attachments ofrepositionable drape parts. The advantages of the invention include low cost, non-tacky propt;lties, thin profiles, compatibility with latex gloves, and adjustable peel strength. The fasteners can be made adjustable to allow for goodfit and essentially complete seals at the junction of gloves and gowns to prevent cont~min~tion with bodily fluids. Non-tacky fasteners will not entangle the non-woven hair coverings worn by surgeons and nurses.

EXAMPLES
2s The following examples are offered to aid in the underst~nf~ing of thepresent invention and are not to be construed 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 reported in the e~r~mples W 098/07396 22 PCT~US96~0229 T-Peel Stren~th This test was used to determine the peel force re~uired to cause two f~ctening components to release from each other when the substrate of a co...~ e 1~ ing co~ one.lt was a flexible film having a length of at least 20 s cm and when pulling the edges of the f~tçner in opposite directions away from and per~xnf~icul~r to the interface of the f~tener bond. After two of the composite f~tening ccl"ponents were placed in contact, the two components were engaged by means of a 2-kg hard-rubber roller, one pass in each direction.
The engaged components were allowed to stand at ordinary room te."p~ldture lo (i.e., 22~C) for the specified time period (hereinafter dwell time), one end of each co",ponent was secured to a jaw of an Instron tensile tester, and the jaws were moved apart at a rate of 30 cm/min.

180~ Peel Stren~th This test was run according to ASTM D-1000 except that the f~ctçnçr component was applied to various surfaces using a 2-kg hard rubber roller, one pass in each direction. Samples were allowed to dwell for the specified time andte",p~ ~L~Ire before being separated at a rate of 30 cm/min.

20 90~ Peel Strength This was run according to PSTC-5 using various rigid target surfaces to which the fastener co",ponent was applied using a 2-kg hard-rubber roller, one pass in each direction. Samples were allowed to dwell for the specified time andte"~peldture before being sepaldt~d at a rate of 30 cm/min.

r -~

W O 9~ 7J5~ 23 PCT~US96/20229 Dynamic Shear Stren~th Unless otherwise noted, this test was used to determine the amount of shear force required to either cause two f~cteninp layers to release from each other or a f~ctenin~ layer and a target surface to release from each other. A pair s of 2.5 cm x 10 cm strips was secured together with a 6.25 square centim~er overlap. The strips were engaged by means of a 2-kg hard-rubber roller, one pass in each direction. After the engaged strips were allowed to stand at ordilla. y room ~e.~pe~i~t--re for at least 30 seconds, one end of each strip was secured to a jaw of an Instron tensile tester, and the jaws were s~araled at a rate of 30 cm/min.

Static Shear Stren~th This test was run essen~ y according to ASTM D-3654 and was used to delel"~ine the holding power of an assembled fastening layer to a target surfacethat was adhered to a rigid plate. A 2.5 cm x 10 cm strip of fastener was secured to the mounted target surface using a 6.25 square centimeter overlap. The f~ctçnçr and target surface were engaged by means of a 2-kg hard-rubber roller, one pass in each direction. The engaged strips were allowed to stand at ordinaryroom te,-~peldture for approximately 30 seconds. One end of each strip was secured to a 250 gram weight. The weight was allowed to hang supported by the f~ctener, and the amount of time until the sample fell was measured.

The following abbreviations are used throughout the examples:
ABS Acrylonitrile-but~iene-styrene polymer 2s BACN Rllt~ ene-acrylonitrile polymer BACNI B~ltadi~ne-acrylonitrile-isoprene polymer BOPP Biaxially oriented polypropylene film UA Urethane acrylate polymer SBS Styrene-b~lt~liene-styrene block copolymer SIS Styrene-isoprene-styreneblock copolymer CA Cellulose Acetate EVA Ethylene vinylacetate polymer HDPE High density polyethylene LDPE Low density polyethylene ~ _ .

wo 98/07396 24 PCT/US96/20229 MEK Methyl ethylketone PA Polyamide PC Polycarbonate PE Polyethylene PET Poly(ethylene terephth~l~t~) PMMA Poly(methyl methacrylate) PP Polypropylene PS Polystyrene PVC Poly(vinyl chloride) 0 SS S~inl~s~ steel The following abbreviations represent the commercially available materials used in the examples:
BACN-l NipolTM DN-207, 33% acrylonitrile, Mooney viscosity of 43.
BACN-2 NipolTM DN-004, 45% acrylonitrile, Mooney viscosity of 43.
BACN-3 NipolTM DN-214, 33% acrylonitrile, Mooney viscosity of 80.
BACN-4 NipolTM DN-401L, 19% acrylonitrile, Mooney viscosity of 65.
BACN-5 Goodyear N-206, 45% acrylonitrile, Mooney viscosity of 60.
BACN-6 HYCARTM 1022, 33% acrylonitrile, Mooney viscosity of 50.
BACNI-l NipolTM DN-1201L, believed to be approximately 52% bUt~ n~
33% acrylonitrile, and 15% isoprene, Mooney viscosity of 46 (chunk form).
BACNI-2 NipolTM DN-1201L (with talc), believed to be approximately 52%
b~lt~.1iene, 33% acrylonitrile, and 15 % isoprene, Mooney viscosity of 46 (crumb form with 3-7% magnesium silicate).
SBS KratonTM 1101.
SIS KratonTM 1107.

The NipolTM materials are available from Zeon Chemicals, Inc. and 30 contain less than 1 % antioxidant. The Goodyear materials are available from Goodyear ChPmic~l Co. and contain less than 1 % antioxidant. The HYCARTM
materials are available from B.F. Goodrich Chemicals and contain less than 1 %
antioxidant. The KratonTM materials are available from Shell Chemic~l Company.
Example 1 Samples of BACN and BACNI-1 which contained an additional 1.5% by weight EthanoxTM 330 antioxidant (Ethyl Corporation) were dissolved in MEK

-- r --solvent and then coated out onto a 0.05 mm primed polyester film b~ckin~ to give a dry thiekne.ss of 0.83 mm. The samples varied in the plopo~ion of acrylonitrile to bu~Ai~ne and in Mooney viscosity. The Mooney viscosity reflects compositiQn and molecular weight, i.e. extent of polymeri7~tion. Some of these samples cont~in~d 0.15% 2-(4-methoxyphenyl)-4, 6-bis (trichloromethyl)-1,3,5-triazine crosclinkin~ agent. Some of the sarnples with the crosclinking agent were exposed to a high intensity medium p~es~lle mercury arc light (Sylvania H33C0-400 boosted with a variable power source) at 600+ watts.
The dose was 150-200 millijoules/sq. cm.
o T-peel and dynamic shear tests were performed on f~ctenin~ layer to f~ct~nin~ layer samples. The first set of samples contained 33-34% acrylonitrilein the copolymer used as the f~ctening layer. It can be seen in Table 1 that all of the uncrosclink~d samples blocked (irreversibly bonded) within one hour of contact.

T-Feel Strength (kN/m) ~ ~ Dynamic She~r~
Cross- Strength~*

#~ A2 #3 A~4 ~5 #6 ~ ~7 ~
BACN-l No 0.68 0.82 0.89Blocked~ 1.090.61 1.31 338 Yes 0.28 0.26 0.21 0.18 365 BACN-6 No 0.30 0.53 0.77Blocked* 359 Yes 0.39 0.37 0.28 0.26 1.280.56 1.58 234 BACNI No 0.65 0.74 0.7Blocked~ 345 Yes 0.32 0.26 0.3 0.44 0.960.44 1.17 248 15 ** Dynamic shear is measured after l minute of polymer face to polymer face contact (dwell time).
* Blocked in less than one hour.
#1. T-peel force after 1 minute of dwell time.
#2. Rebonded after #l and measured after 1 more minute of dwell time.
20 #3. Rebonded after #2 and measured after 1 more minute of dwell time.
#4. Rebonded after #3 and measured after 4 more minutes of dwell time.
#5. Rebonded after #4 and measured after 16 hours of dwell time.

#6. T-peel force measured after 4 minutes of dwell time.
#7. T-peel force m~s.lled after 16 hours of dwell time.
In a second set of samples, the acrylonitrile proportion of the polymer was varied from 19% to 45% and the Mooney viscosities were varied from 43 to 5 65. Initial peel forces did not vary significantly at short times between the ~,o~linlred and the non-cros~linkPd samples.
For co...~. ;~on, samples were made with SBS and SIS block copolymers.
See the samples using SBS and SIS in Table 2.

: ~ Cross~ : T-peel Strength (kN/m) ~ Dynamic Shear ked ~ : Strength~ ~(kN/rn~
:: l m~n 2:min 3 rnin 22 hr BACN-2 No 0.46 0.57 0.61 Blocked 286 Yes 0.56 0.67 0.64 1.75 379 BACN-4 No 0.31 0.50 0.50 1.44 214 Yes 0.31 0.39 0.41 0.67 224 BACN-5 No 0.18 0.25 0.29 Blocked 265 Yes 0.30 0.36 0.37 1.23 259 SBS No 0.04 0.12 0.16 1.31 234 Yes 0.00 0.02 0.02 1.93 252 SIS No 0.05 0.07 0.07 0.65 225 Yes 0.04 0.05 0.06 0.65 241 * Shear is measured after 1 minute of dwell time.

Cros~linking did not appear to decrease T-peel strength in the SBS and SIS samples after 22 hours of surface contact. Blocking was not observed in the 15 SBS and SIS samples after 22 hours.

Example 2 In these samples, an electron beam was used to crosslink the non-tacky fastening layer. The example used uncrosslinked BACNI-2 and an additional r W O9X~'~7~3~ 27 PCTrUS96/20229 1.5% F.th~noxTM 330 ~ntio~ nt in each sample. Experiments were ~c.rol,lled to line the effects of the voltage of the electron beam and the total dose of electrons.
S~ml-les 2A-2F were hot melt extruded from a Haake extruder with a 5-s inch (12.7 cm) wide film die. The len,l)e.dture 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 hot melt coated ~n1pl~s were coated using these same extrusion conr1itions~ The contact responsive f~tening layers were coated onto a 0.127 mm thick spun bonded HDPE manufactured by DuPont under the trade name TyvekTM 1073D
o films at a thicknecc of 5 mils (0.127 mm). Prior to coating, the TyvekTM filmswere corona treated to improve the bonding of the rubber to the substrate. The T-peel strength results for six samples are given in Table 3:

T-Peel~Strength (kN/m) ~Dwell~ 2A~2B ~ 2C 2D 2E~ 2F
: :::: :: : :: ::::~: :
(mm) 0.5 0.10 0.15 0.04 0.04 0.01 0.00 0.17 0.18 0.05 0.06 0.02 0.00 2 0.23 0.26 0.07 0.07 0.04 0.00 0.52 0.36 0.11 0.08 0.06 0.00 12 Days Blocked Blocked Blocked Blocked 0.53 0.04 0.5* 0.13 0.19 0.07 0.03 0.04 0.00 1 * 0.13 0.25 0.10 0.06 0.05 0.00 2 * 0.16 0.27 0.13 0.08 0.05 0.00 5 * 0.23 0.25 0.14 0.08 0.07 0.00 0.5** 0.11 0.13 0.06 0.04 NT NT
1 ** 0.11 0.15 0.08 0.05 Nl' NT
2 ** 0.17 0.19 0.09 0.07 NT NT

W Og8/07396 28 PCT~S96/20229 * First Repeat. Surfaces of the f~ctener colllponent stored unm~te~ Test repe~ed 12 days later.
** Second Repeat. Test ~ ted immeAi~tely following first repeat.
2A FYrosed to 1 Mrad at 150 keV.
2B Exposed to 1 Mrad at 200 keV.
2C F~xposed to 3 Mrad at 175 keV.
2D FYros~d to 5 Mrad at 150 keV.
2E Exposed to 5 Mrad at 200 keV.
2F FYposed to 10 Mrad at 150 keV.

Exposure to 10 Mrad (106 rad) with an electron beam energy of 150 keV was suf~lcient to essentially remove all peel strength. Samples given lower exposures (i.e., less than 10 Mrad exposures) blocked after 12 days of surface contact except one sample given a dose of 5 Mrad with a beam energy of 200 keV.
lS Further experiments were pelro~ ed to measure the effect of dose on the T-peel strength at shorter times. These samples were hot melt coated at a thickness of about 0.127 mm onto a backing comprised of 60% polyester and 40% cellulose with an acrylic binder (lnternational Paper Co. Grade no.
1309215). The polymer in the samples contained 1.25% Agerite Staylite S
antioxidant (R. T. Vanderbilt Co., product code 02909). The results for doses from 0.0 to 1.4 Mrads and an electron energy of 175 keV are shown in Table 4.

r WO 98/07396 2~ PCTlUS96/20229 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 0.5 minute dwell time 2F had 1 minute dwell time 2G had 2 minutes dwell time s 2H had 5 minutes dwell time FY~mple 3 In another test to ascertain the effect of crosslinking, chunks of about 6 cm x 6 cm x 12 cm of partly crosclink~d BACN-4 were mixed with BACNI-2 in a ratio of 15~ by weight to 85% by weight, respectively. About 1.25% Agerite Staylite S antioxidant was also added. C~onsiderable mixing effort of the meltedpolymers was required to obtain uniform mixing of the two polymers. The mixture was hot melt coated as described in Example 2 at 5 mils (0.127 mm) thickness onto a b~ckin~ of polyvinyl chloride (0.03 mm thick). The polymer 15 face to polymer face T-peel strength (5 min. dwell time) was 0.48 kN/m for the mixture co-l,par~d to 0.66 kN/m without any crosslinked polymer. On a backing of 60% polyester and 40% cellulose with a dwell time of five minutes, the peel W O ~8,~7~3C 30 PCT~US96/20229 force was 0.46 lcN/m for the ~ Llu~ co...l)alcd with 0.70 kN/m without any crosslink~d polymer.

FY~rnP'e 4 A co---pa ison of four anti-blocking agents and samples with no anti-blocking agent was performed. Each sample used BACNI and a mixture of dry ingredients that included 1.5 % by weight CyanoxTM LTDP (American Cyanamid), 1.5% by weight IrganoxTM 1076 (Ciba Geigy), 0.25% by weight TinuvinTM 328 (Ciba Geigy), and 0.25% by weight TinuvinT~' 770 (Ciba Geigy).
A 0.127 mm thick f~ctening layer was hot melt coated as described in Example 2 onto about 0.05 mm primed PET film. Samples 4A, 4B, 4C and 4D used BACN-l. Sample 4E used BACN-2. Samples of BACNI-1 were used with the other anti-blocking agents. Unf~t~ned samples were exposed to air, fluorescent room light and dust for up to 7 days. The test results are shown in Table S are 15 based on a 5-minute room temperature dwell. Sample 4A employed no anti-blocking agent. Samples 4B, 4C, 4D and 4E employed 2.5% by weight Cab-O-SilTM, 1% by weight CaSiO4, 1 % by weight CaCO3 and 5 % extra talc, respectively.

Table 5 Inltial~T-~'eel~Strengti/% Initial T-Peel Strength After Exposure Exposure~
Time (l:)ay~ 4A~ 4B 4C 4D 4E
0 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%
4 0.0910/ 0.1401/ 0.0613/ 0.1050/ 0.1401/
17.3% 45.7% 14% 17.1% 18.8%
7 0.0088/ 0.0700/ 0.0175/ 0.0263/ 0.0193/
1.67% 22.9% 4.0% 4.3% 2.6%

T -Wo 3$,~7J~ 31 PCT/USg6/20229 The initial T-peel strength of these samples are shown as the top value (kN/m) in each box and the % of initial T-Peel strength is shown as the bottom number. These results demonstrate loss of initial T-peel strength with exposure.Sample 4B (2.5% Cab-O-SilTI~s SiO2, Cabot Corp.) anti-blocking agent gave the 5 best results. The other anti-blocking agents were CaSiO4 (Hubersorb 600, J.M.
Huber Corp.) and CaCO3 (Atomite, ECC International).
Some degree of crosclinking can be obtained by hot melt extruding BACN
or BACNI. The exact amount of cro~linking was not determined. This example demonstrates that low peel strengths can be obtained from hot melt extruded 0 samples with or without addition of antiblocking agents. Anti-blocking agents can ~e added to control the fastening properties. Combining partial cros~linkingfrom hot melt extrusion with the addition of fillers provides an easy way to obtain a greater range of fastening ~ropelLies than had been possible previously.

F.Y~mp'~ 5 The effect of the thickness of the fastening layer was measured. BACNI-2, which had 2~ Agerite Staylite S was hot melt coated as described irl Example 2 onto either 0.05 mm primed PET film or Guilford tricot knit cloth, style #15771. Ihe samples were tested after a 2 minute dwell time at room 20 tel.lpeldture. The results are shown in Table 6.

Table 6 R?~rking ~ ~ F~ctening Layer T-Peel Strength ~ ~Thickness (mm) (k/N/m) Primed PET 0.05 0.2854 Primed PET 0.075 0.3764 Primed PET 0.10 0.4464 Primed PET 0.13 0.5830 Tricot cloth 0.10 0.0735 Tricot cloth 0.13 0.1488 Tricot cloth 0.20 0.3501 W O ~51'~7_9C 32 PCTrUS96/20229 The results show linear increases in the value of peel strength with coating thickness over the thicknesses el~mine~

F.Y~mp't 6 Further experiments were ~)e,ro""ed to show the effect of surface texture on peel strength. BACNI-2 cont~ining 1.5% by weight CyanoxTM LTDP, 1.5%
by weight IrganoxTM 1076, 0.25 % by weight TinuvinTM 328 and 0.25 % by weight TinuvinTM 770 was hot melt coated as described in Example 2 to a thickness of 5 mils (0.127 mm) onto 0.05 mm thick primed PET film. The still hot polymer-coated film was passed between two rolls of a nip. A smooth surface was produced using a 0.051 mm BOPP film between the roller and polymer. A
"rubber roller matte" surface was introduced just by passing the hot polymer directly through the rubber rollers. An even rougher surface, i.e., textured matte, was produced by placing a textured film between the roller and the hot rubber. Table 7 compares T-peel strength at various dwell times up to five minutes. The smooth surface gives the highest strength, and the textured matte surface gives the lowest strength. These results indicate that the peel strengthvaries with the amount of surface contact.

wo 98/07396 PCT/USg6/20229 Dwell Time ~ ~-~Pe ~ Stren ;th Surface~ (Min) Smooth 0.5 0.5690 Smooth 1.0 0.8754 Smooth 2.0 0.9156 Smooth 5.0 0.9979 Rubber matte 0.5 0.4814 Rubber matte 1.0 0.6128 Rubber matte 2.0 0.7528 Rubber matte 5.0 0.7528 Textured matte 0.5 0.1751 Textured matte - 1.0 0.2171 Textured matte 2.0 0.2171 Textured matte 5.0 0.2171 Example 7 Guilford Knit cloth, style #15771, was hot melt coated as described in Example 2 with a 0.203 mm thick layer of BACNI-2 containing 2% Agerite StayliteTM S antioxidant. Half of the samples were covered with a 0.102 mm thick PE liner. The other half of the samples were left uncovered.
The covered (i.e., linered) and uncovered (i.e., unlinered) samples were tested for T-Peel strength under various conditions. In a first set of experiments, some of the unlinered samples were exposed to fluorescent room light, air and dust. Others of the unlinered samples were protected from fluorescent light and dust by being placed in a Bell Jar. Initially, all of the samples had a T-Peel strength of 0.79 kN/m. Those unlinered samples that were not protected from the exposure to fluorescent light and dust lost virtually all strength by 18 days. Those WO 9~7~5~ 34 PCT/US96/20229 unlinered samples that were in the Bell Jar retained a T-Peel strength of about 0.35 kN/m after 10 months.
In a second set of experimlQnt~, linered and unlinered samples were exposed to UV light (2 mW/cm2) for varying times and then tested for T-Peel 5 strength after a 5-minute dwell time. The results of these tests are shown in Table 8.

Ti ~e~Under UV Total Exposure T-Peel Strength Sample~ight (Hrs.) ~ (mJ) Linered 0 ~ 0 79 Linered 2 1,440 0.44 Linered 5.5 3,960 0.175 Linered 7 50,400 0.0875 Linered 9 64,800 0.0595 Linered 11 79,200 0.051 Unlinered 0 0 0.79 Unlinered 1.5 10,800 0.432 Unlinered 3 21,600 0.201 Unlinered 7 50,400 0.0928 The implic~tion is that a major part of the loss of peel strength with time o is due to ultraviolet light induced oxidation when a sufficient amount of an effective antioxidant is not present. A variety of antioxidants and UV stabilizers can be used to minimi7e or elimin~t~ UV light induced oxidation. Addition of stabilizers during the manufacture of the polymer would be the best approach forblending the antioxidant and UV stabilizers for hot melt extrusion or any type of 15 coating process.

r WO 98/07396 PCT/US96t20229 Fyt~n~r~ 8 This example illustrates that the peel strength of a f~ct~nPr system can be controlled by selecting the p-o~ellies of the target surface to which the contact responsive f~tenin~ layer is ~t~ ed. The example shows th~t varying the solubility parameter of the target surface by selecting the target surface from a range of materials permits one to control the peel strength of the f~ct~nin~
system.
BACN-6 was dissolved in MEK and then solvent-coated onto a 0.025 mm thick corona treated polyester b~kin~ to give a nominal dry thickness of lo 0.017 mm. The resulting f~tening layer was tested for 180~ peel strength from a variety of smooth target surfaces. A 10-minute dwell time at room temperature (21~C) was used. Table 9 demonstrates the variation of 180~ peel force as a function of the solubility parameter of the smooth target surface. Where available, single point values were used instead of ranges. The solubility lS parameter of BACN-6 was not itself measured. However, the solubility parameter for a 70% butadiene, 30% acrylonitrile is in the range of 9.38-9.48 (cal/ml)"2. It was assumed that the solubility parameter for BACN-6 would be essentially the same.

.

Solubility~Pa~amet~r, ~ St-ength~
Target Sur~ace~(cal/ml)~2 ~ ~/m' PE 7.9 0 PP 8.7* 0.197 PS 9.1 0.81 PMMA 9.2 1.1489 PVC 9.5 1.2583 PC 9.5 1.2583 PET 10.7 0.569 Epoxy 10.9 0.3392 CA 13.4 0.0547 Nylon 13.6 0.0438 * This r~ sent~ the mid-point of the range of solubility parameters found in the open literature.
s Table 9 demonstrates that the 180~ peel strength of a fastener prepared from BACN can be varied by approl,liate choice of solubility parameter of the target surface material used to attach to the non-tacky fastening layer.

o Example 9 BACNI-2 was hot melt coated onto a 1.7 mil (0.043 mm) thick unplasticized poly vinyl chloride (UPVC) film at a 7.3 mil (0.185 mm) coating thickness as described in Example 2. The polymer contained from 3-7% talc.
The resultant fasteners were then tested for 90~ peel strength after a 3-day dwell time against various target surfaces to study the effect of solubility parameter on peel strength. The DuPont Base Coat/Clear Coat 871/RK7103 and the White High Solids Enamel BASF E172 were tested after a somewhat different dwell WO 98/07396 37 PCTtUSg6/20229 time than the other c~mple~A. The 22~C dwell time was 24 hours. The elevated ~ ture dwell time was 46 hours at 70~C. Table 10 shows the variation of the 90~ peel strength d~pen-ling on the target surface mated with the non-tacky fact~ning layer at two different tel"~ldtures.
s Tablc 10 90~ Peel Strength (kN/m) Temperature Dwell~ Time T arget~Surfaces~ (Hr.j 22~C 4goC ~
PC 3.02 2.98 72 ABS 3.50 3.94 72 PMMA 2.98 3.37 72 PA 0.70 3.50 72 Glass 0.21 0.24 72 EVA 0.40 0.42 72 PET 0.32 0.39 72 Corona Treated PET 0.36 0.44 72 LDPE 0.03 0.04 72 HDPE 0.03 0.04 72 SurlynTM 0.09 0- 13 72 PS 0.03 0.04 72 DuPont Base Coat/ 0.23 0.2124 hr RT 46 Clear Coat 871/RK710324 hr. 46 hr.hr. 70~C
70~C

White High Solids Enamel 0.20 0.20 24 hr RT 46 BASF E172 24 hr. 46 hr.hr. 70~C
70~C

FY~-~1P~~ 10 Samples of uncrosslink~d BACNI-l containing 2% by weight IrganoxTM 1010 antioxidants were solvent coated as described in Example 1 onto W 098/07396 38 PCT~US96120229 one side of a 0.0021 mm thick primed PET which had a 0.05 mm thick tacky pressure sensitive adhesive. The adhesive was covered with a paper liner on the opposite side. The resultant f~tPn~rs were then tested for 90~ peel strength at room telllpt;ldture to various target surfaces after a one-day dwell time at 22~C
5 and 70~C to study the effect of solubility parameter on peel pelro~ ance. The results are given in Table 11.

Table ll 90~ Peel Strength (kN/m) ~Target~Surf ce~ 22~C 70~C
SS 0.236 0.336 PC 1.138 1.313 PMMA 1.138 1.251 PP 0.145 0.123 HDPE 0.053 0.053 LDPE 0.044 0.039 PS 0.648 0.648 ABS 1.750 1.260 Rigid Filled PVC 0.508 1.496 Glass 0.161 0.149 DuPont Base Coat/Clear Coat 0.34l 0.257 White High Solids F.n~mel 0.350 0.257 BOPP 0.123 0.136 r WO 9~ ,7J5G 39 PCT/US96/20229 F.Y~mp~e 11 A f~t~nin~ system according to the invention was ~ ar~d as follows.
A composition co~ in~ 70~O by weight acrylate capped polycaprol~t~tQne urethane oligomer, 30% by weight isooctyl acrylate, and 0.25%
s 1-hydroxycyclohexyl aceto~hcnone was coated onto one sid~ of a 0.036 mm UPVC film which had a 0.05 mm tacky pressure sensitive adhesive layer with a paper liner on the opposite side. The fActçnin~ layer was cured with 240-280 nLJof high intensity ultraviolet light through a filter which removed wavelengths below 300 nm. The samples were cured through a 0.05 mm BOPP cover film to 0 prevent oxygen inhibition.
The resultant f~ct~.nin~ system was tested for 90~ peel strength at room ture against various surfaces after a 24 hr dwell at 22~C and 46 hr dwell at 70~C. The results are ~iven in Table 12.

Table 12 90~ Peel Strength (kNlm) Target Surfaces24 hr 22~C 46 hr 70~C
SS 0.324 0.560 PC 0.499 0.446 PMMA 0.481 0.450 PP 0.023 0.012 HDPE 0.026 0.013 LDPE 0.016 0.014 PS 0.219 0.096 ABS 0.494 0.502 Rigid Filled PVC 0.516 0.630 Glass 0.350 0.411 DuPont Base Coat/Clear Coat 0.205 0.288 White High Solids Enamel0.210 0.228 wo 98/07396 PCT/USg6/20229 ~Y5~mple 12 Butyl rubber (Chlorobutyl 1255, Polysar Rubber Corp.) was solvent coated from a 25 % solution in hexane to a thicknP~ of about 0.063 mm onto a 0.0254 mm thick corona treated PET. The resultant f~ctçner was then tested for 5 90~ peel strengths at room ~n.pe.ature against a variety of surfaces after a dwell time of 3 hours at 22~C. The results are given in Table 13.

90~ Peel Strength~
Target Surface ~ ~ (kN/m) White painted metal 0.4025*
Blue painted metal 0.21875 HDPE 0.0875 LDPE 0.0875 PVC 0. 105 PC 0.30625 PMMA 0.48125*
SS 0.245 Glass 0.21 * The peel strength was greater to the substrate than to the backing.

Table 13 shows the same principle of varying the adhesive force by altering the m~t~ri~l on the target surface. The factening layer exhibited slight finger tack.
Also, it should be noted that fillers may be added to reduce tackiness. This is ~spe~ lly true with butyl rubbers.
Example 13 Sample articles were made with hot melt extruded BACNI-2 and ultraviolet curable UA (Example 11). These samples had ~ti~f~ctory peel and wo 98/07396 41 PCT/USg6/20229 shear. The BACNI-2 can be mated to PET or BOPP if not sufficiently crosslink~d to prevent blocking to itself. The ultraviolet cured UA maintained adhesion after ETO (ethylene oxide gas) sterilization. Some peel pelru~ ance was lost after 2-3 Mrads of ~mm~ s~erili7~tiQn. The BACNI-2 had acceptable s fa~t~ner pelrollnallce after 10 Mrads of (:~mm~ sterilization when exposed while in contact with a liner or a BOPP target surface.

FY~mr!~ 14 A Quick Tack measuring system was utilized to measure the peel force of 10 a set of the non-tacky f~ctçning layer and certain pressure sensitive adhesives.
The peel force is measured at a ninety degree angle from the surface where any peel force results just from contact with essentially no external pless-~re added other than the weight of the tape. An IMASS tensile tester with a 0.455 kg load cell was employed. Several f~ct~ning layer materials disclosed above were tested:
(1) BACNI-l polymer, (Example 10 at 0.021 mm thickness), (2) UA
(Example 11) at 0.02 cm thickness, and (3) a tackified block copolymer comprising 75% by weight Kraton G1657 (styrene-ethylene-butadiene-styrene (SEBS)) and 25% by weight RegalrezTM 1085 at 0.013 cm thickness (M). In addition, the low tack repositionable pressure sensitive adhesive composition (Scotchbrand Differential Tack Double Coated Tape 9415 with Post-itTM adhesive on one side) from 3M was also tested. The results of these tests are set out in Table 14. These samples were also subjectively measured for their tack to skin.
As shown in Table 14, c~mples BACNI, UA, and M were non-tacky to skin.
The Post-ItlM adhesive, in contrast, felt tacky.

.

Bondp~l er(a) 0.0004 0.0000 0.0008 0.244 Newspaper(b) 0.0000 0.0000 0.0000 0.0152 Legal Pad(C) 0.0000 0.0000 0.0000 0-0044 SkinNon-tacky Non-tacky Non-tacky Tacky a. Bondpaper, 3M Copy White Bond Paper, Stock No. 78-6969-6135.
b. Newspaper, Minn~polis Star Tribune 2l22l93 non-inked portion.
c. Legal Pad, St. Paul Book and Stationary Stock No. 91242-969.
s This demonstrates the e~çnti~lly no-tack characteristic of the M, UA, and BACN fastener layer materials as compared with the tack (although generally known as an example of a low tack material) of the Post It~ adhesive.

o F.Y~mrle 15 Contact responsive &stener systems perform best when both the f~tening layer and target surface are smooth surfaces. A Surface Roughness Test was used to measure the smoothness. In Table 15 the averages of the absolute departures from the centerline of the roughn.-s~ profile of a surface for a variety of non-tacky fastener and target surfaces.

W O 98t07396 PCTAUS96120229 0.014 mm mil PET film 0.042 0.051 mm BOPP film 0.033 White bond copier paper 1.5 Glass 0.01 0.051 mm UV cured UA 0.297 0.021 mm mil solvent coated BACNI-I 0.376 0.127 mm hot melt coated BACNI-2 0.326 Texture hot melt coated BACNI-2 1.1 0.013 mm solvent coated SEBS (75/25 ratio) 0.12 Example 16 Tests were performed to examine the effect of a large number of s unfastening and ref~tening operations on the 90~ peel force. Tests were performed with non-tacky fastener coated onto 0.036 mm UPVC that was attached with 0.051 mm tacky pressure sensitive adhesive to a 0.014 mm PET
support. The 90~ peel forces were measured with a 2.54 cm wide strip of non-tacky f~ctener using a one minute dwell time. Table 16 shows the results for 10 0.021 mm thick solvent coated BACNI-l peeled from a glass target panel and 0.051 mm thick UA peeled from a PMMA target panel. After each one hundred peels, the adhesives were rolled against the desired target panel with a 2 kg.
roller using one pass in each direction.

.. . ~ . .. ..

wo 98/07396 PCT/USg6/20229 stener I~a:yerl; ~get Surface~
Cyclc~No~ BAC~/Glass ~ UA/PM~IA
0.11 0.20 100 0.11 0.18 200 0.11 0.16 300 0.13 0.15 400 0.14 0.25*
500 0.17 0.24 600 0.17 0.27 700 0.17 0.20 800 0.18 0.22 900 0.16 0.22 1000 0.17 0.19 1100 0.16 0.19 1200 0.16 0.18 1300 0.15 0.18 1400 0.15 0.17 1500 0.15 0.17 1600 0.16 0.16 1700 0.16 0.17 1800 0.15 0.15 1900 0.14 0.14 2000 0.14 0.15 * Test stopped after 300 cycles and restarted about 24 hours later.

W O 98~'~7~3~ PCTrUS96/20229 The data in this Table show the relatively low and constant peel strength over multiple releases and ref~tening~ of the f~ctening system of the invention.

Example 17 Two samples of urethane (UR) non-tacky f~teners were p.e~ared. The UR was coated out as a f~ctening layer on UPVC.
The urethanes were ~ d by heating polyol(s) in a glass jar at 70~C
until melted, adding an isocyanate-containing con"~ncnt with stirring until wellblended, and then adding 4 drops of a 1% solution by weight of dibutyltin o dilaurate (DBTDL) in propylene glycol monomethyl ether acetate (PM Acetate from Union Carbide). The resultant urethanes were cast as a 0.10 mm (4 mils) thick layer on one side of O.OS mm (2 mils) thick UPVC film that had a pressure sensitive adhesive on the other side. The resultant tape was then cured at 74~C
for 24 hours and allowed to dwell at room temperature for about 1 week before testing for 90~ peel against various target surfaces.
The ingredients used to make the UR and the 90~ peel test results are given in Table 17 below. The quantities of the ingredients are reported in partsby weight. The samples had no tack when tested against paper.

W O ~7~ PCTrUS96/20229 Ir;,re~dient~ Sample~A ~ ~S~mrl~B~
ToneTM 200100 36.7 ToneTM 310 -- 31.2 IPDI 39.9 --MPCHI -- 32.1 90~ Peel Strength (kN/m) 2 min. dwell ~ RT
(a) toself 0.028 0.016 (b) to glass 0.087 0.061 24 hr. dwell ~? RT
(a) to self 0.525 0.044 (b) to glass 0.096 0.105 (c) to SS 0.087 0.149 46 Hr. dwell ~ 70~C
(a) to self 1.93 0.121 (b) to glass 0.788 0.376 (c) to SS 1.24 0.481 ToneTM 200 is a difunctional caprolactone polyol, MW 530, commercially available from Union Carbide Corporation, Danbury, CT. Tone TM 310 is a 5 trifunctional caprolactone polyol, MW 900, commercially available from Union Carbide Corporation, Danbury, CT. IPDI is isosphorone diisocyanate, commercially available from Huls, Germany. MPCHI is methylene bis (4-cyclohexylisocyanate), commercially available as DesmodurTM W from Mobay Chemical Co~ ion (now known as Miles, Inc.), Pittsburgh, PA.

r W 0 9~J'~/~5~ 47 PCTrUS96/20229 Example 18 Six samples of acrylic (AC) non-tacky f~ctçners were pr~par~d. The AC
compositions were each coated out as a f~tlo,ning layer on primed PET.
The acrylic col~l~sitions were l,l~ared by solution polymerization as S outlined in U.S. Patent No. Re. 24,906 (Ulrich) using a 40% solids content solution of the monomers and ethyl acetate, 0.3% 2-2'-azobis(isobutyronitrile) initiator (Vazo~9 64, commercially available from E. I. duPont de Nemours) and heating the mixture at 55~C for 24 hours. The resultant acrylic compositions were each cast as a film which had a dry thickness of about 0.025 mm (1 mil) o onto a 0.038 mm (1.5 mils) primed PET. The resultant tape was allowed to equilibrate at RT for about 24 hours before testing for T-peel strength against various target surfaces.
The sample compositions are given in Table 18. F~cte,ning layers, target surfaces, and T-peel test results are reported in Table 19. The quantities of ingredients are .ep~lLed in parts by weight. The samples had no tack when testedagainst paper.

.

W O 98/07396 PCT~US96120229 Parts bv~Weight:~on~..r~

Cl ~ AC2 ~ AC3 ~ AC4 ~ACS~ ~ AC6~ A~
Ethyl acrylate 70 60 -- -- -- -- --Butyl acrylate 20 30 40 40 20 10 --Acrylic acid 10 10 -- -- -- -- --Isobornyl acrylate -- -- 50 50 -- -- --2-Sulfoethylmeth- -- -- 10 -- -- -- --acrylate - 2-Acrylamido-2- -- -- -- 10 -- -- --methyl-propane sulfonic acid Methyl acrylate -- -- -- -- 70 80 --Dimethylamino- -- -- -- -- 10 10 10 ethylmetl~ rylate Ethyl acrylate -- -- -- -- -- -- 90 : :: ~:: :: : : : ~:
Table 19 c~.nin ~ Layer/:~ ;~ T-Peel Strength (kN/m) ~Target Surface :~
2 minute RT dwell 1 week RT dwell ACl/ACl 0.289 0.641 AC2/AC2 0.287 0.588 AC3/AC3 0.737 0.852 AC4/AC5 0.238 0.334 AC4/AC6 0.238 0.3185 AC4/AC7 0.229 0.313 r W 0 9~ 7~ PCTrUS96/20229 FY~~, 'e 19 A sample of a polyethylene copolymer blend co."position (P) was extruded out as a f~ct~ning layer.
The composition was prepared by dry mixing together equal parts by s weight polyethylene copolymer (85 % ethylene and 15 % butene with 0. 8 % by weight of microtalc) (DFDB 1085, commercially available from Union Carbide, Danbury, CT) and polyethylene copolymer (96% ethylene and 45~ octene) (LLDPE 6806, commercially available from Dow Chemical Co., Midland, l!~ichig~n) and feeding the mixture through an extruder and single layer die (both lo extruder and die at a temperature of about 220~C) to yield a 0.076 mm thick layer. From the die the layer was carried on a chrome casting roll (roll temperature 10~C to 23~C) to a windup roll where the layer was wound around a paper core. The resultant roll was allowed to dwell at RT for about 4 months before testing for 90~ peel strength against various target surfaces.
Target surfaces and 90~ peel test results are reported in Table 20 below.
The samples had no tack when tested against paper.

.

W o 98107396 pcTruss6l2o229 90~ Peel~S~rengh (kN/m, 2 m~tc RT ~ week~RT dwell~

Self 0.083 0.072 PC 0.039 0.038 PVC 0.013 0.0185 SS 0.0375 0.021 ABS 0.011 0.027 HDPE 0.002 0.014 LDPE 0.014 0.024 PP 0.019 0.15S
PS 0.000 nottested Example 20 BACNI-l was hot melt coated onto a silicone coated paper liner at a coating thickness of 2.5 mil (0.064 mm). The BACNI-1 layer was then l~min~ttod to one side of a 0.92 mil (0.023 mm) thick white PET film. The backside of the PET film was then coated with a 0.05 mm thick layer of a pressure sensitive adhesive. The resultant f~cterling component ("F-20") was then tested for peel strength, dynamic shear strength, and static shear strength against various target surfaces. The above fa~tening components were tested immediately after being o placed in contact with the target surface and after 48 hours dwell time.
Several two-piece ostomy bags were made using commercially available ostomy pouches to which the above fastening component, F-20, was attached via a }ayer of tacky pres~lre sensitive adhesive. The fastening component was cut toform a 67 mm diameter circle in which a small "starter hole" was placed at the center. Several different landing zone materials were evaluated. Some of these landing zone materials have found use in other existing medical products and arebelieved to be safe and efficacious for use on skin. These different materials WO ~8~7~ 51 PCT/US96120229 were selected so as to be able to evaluate a variety of different adhesion levels for use in ostomy application. If desired, one could altematively adjust the adhesion level by varying the f~tening layer of the factening component.
Each prototype device consists of a pouch, a f~ctener and a landing zone 5 material. A commercially available tacky tape material having a polyethylene/EVA copolymer b~clring and a tacky acrylate adhesive (available from 3M Co., St. Paul, MN as #9835) was chosen as a control. This tacky tape has been shown to provide acceptable adhesion for ostomy pouches.
Two prototype pouches were filled with 200 ml of water and vertically 10 ~uspen-l~l on a target surface to assess the resistance of the connection to slippage due to shear forces and to determine the removability of the pouch fromthe landing zone multiple times over a several-day period. Both prototype pouches were constructed using the F-20 fastener. One prototype used the "9835 tape" for the landing zone. This prototype was also subjeceed to manual 15 Usloshing" of the water in the pouch so that the fastener/landing zone interface was exposed to moisture. A second prototype utilized a landing zone that has a polyurethane backing. Both prototypes performed extremely well in the holding of the pouch for several days. The first prototype also performed well even whenwater was sloshed on the interface. The fastener of the second prototype showed 20 a very high peel force necçs.s~ry to remove it from the polyurethane landing zone after 24 hours. The fastener of the first prototype was easily removed from and re~tt~ed to the "#9835" landing zone multiple times during a two-week period.
Testing was also done in which various landing zone materials were coupled with the F-20 f~tener. As a control, the various landing zone materials 2s were also adhesively coupled with the sticky adhesive surface of the #9835 medic~l tape. Peel strength, dynamic shear strength and static shear strength were measured at initial bonding. Peel strength and dynamic shear strength were also tested after the compositions were exposed to 38~C for 48 hours to simulatethe body te~ )erdture when a collection device is worn. The test sample identification and the results of the testing are shown in the following tables.

W O 98/07396 PCT~US96120229 Pa~ T ~nd~ -~one F-20 983sl 19835 tape has a polyethylene/EVA copolymer backing, and a layer of a tacky acrylate p-es~u~e-sensitive adhesive (available from 3M, St. Paul, MN).
21516 tape has a polyester film backing with release coating, and a tacky acrylate 5 ~ s~u,~-sensitive adhesive (available from 3M).
MSX-1389 tape has a polyurethane backing, and a tacky acrylate pressure-sensitive adhesive (available from 3M).
4MSX-3076 tape has a polyurethane baclcing with release coating, and a tacky acrylate pressure-sensitive adhesive (available from 3M).
Table 22 Initial Testing Results at R.T.
Run 1~0~ Peel~ Dynamic Shear Static Shear m)~Stren~th (kN/m2) Strength (Minutes) 0.011 42.4 P > 1100*
2 0.011 105.4 P > 1700 3 0.013 82.7 P > 1700 4 0.011 6.9 P > 1700 S 0.900 blocked > 1700 C1 0.08 blocked > 1700 C2 0.07 52.4 l P > 1700 C3 0.14 blocked > 1700 C4 0.05 31.7 P > 1700 C5 0.09 56.5 P > 1700 wo 98/07396 pcTluss6l2o22s Tab ë~23 T~ ting~esults~Aft~-r 48 Hours at 38~C~
Run~#~ 180~~Peel StrengthDynamic Shear~
m)~ Strength~ ~(kN/m2)~
0.044 42.0 P
2 0.022 128.8 P
3 0.292 blocked 4 0.039 blocked 1.740 blocked blocked Cl 0.30 53.1 P
C2 0.16 62.0 P
C3 1.33 blocked blocked C4 0.22 blocked C5 0.12 blocked Values with up,, indicate that pop-off occurred before clean failure of sample.
UBlocked" describes when two components cannot be separated without destruction of one or more co~llponents.
One of trip}e replicates failed at 6 minutes, the other two held at least 1700 minutes.
Table 24 90~ Peel Strength ~kN/m) Run # ~10 minutes dwell 21 hours dwell 0.82 1.57 3 0.62 11.8 4 0.30 0.42 Cl 8.7 12.7 C3 5.5 > 19.6 C4 3.3 19.6 Overall the pe~ro~ ance of the F-20 fastener with the various landing zones was excellent. Very high shear strengths were measured for all the dirr~lent landing zones. Each combination is expected to meet the pelrol,l,ance 10 requirements for ostomy applications.
Various modifications and alterations of this invention will be apparent to those skilled in the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not limited to theillustrative embodiments set forth herein.

Claims (20)

What is claimed is:

1. An ostomy appliance article, comprising:
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 landing zone, the fastening system having a non-tacky target surface layer, a contact responsive non-tacky fastening layer that adheres to the non-tacky target surface layer, and a means for attaching the fastening system to the peristomal area of a user.

2. An article, comprising:
a bag with an opening for receiving material from an orifice, and a fastening system comprising (i) a landing zone having a non-tacky target surface layer and an adhesive layer for attaching the landing zone to the orifice area of a user and (ii) a fastener attached to the bag circumscribing the opening having a contact responsive non-tacky fastening layer that adheres to the non-tacky target surface layer, wherein the fastening layer demonstrates properties of:
essentially no adhesion to paper; multiply repositionable against the non-tacky target surface; and a substantially constant low 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, wherein the target surface is a different material than the fastening layer and has a solubility parameter that is sufficiently different from that of the polymer fastening layer to prevent blocking.

3. The article of claim 1, wherein the means for attaching the fastening system to the peristomal area of a user comprises a layer of a tacky adhesive.

4. The article of any preceding claim, wherein the fastening layer is multiply releasable and refastenable against the target surface layer and wherein the fastening layer 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.

5. The article of any preceding claim, wherein the fastening layer is cleanable with retention of fastening characteristics.

6. The article of any preceding claim, wherein the fastening layer comprises a composition selected from the group consisting of homopolymers, random copolymers, block copolymers, and graft copolymers.

7. The article of any preceding claim, wherein the fastening layer comprises a polymer of from about 10 to about 50 weight percent of acrylonitrile and about50 to about 90 weight percent of at least one of butadiene and isoprene, the polymer having a Mooney viscosity of from about 20 to about 95.

8. The article of any preceding claim, wherein the fastening layer comprises a crosslinked oligomeric resin having one or more like or different hard segments, and one or more like or different soft segments, and one or more like or different monovalent moieties containing a radiation-sensitive, addition-polymerizable, functional group.

9. The article of any preceding claim, wherein the fastening layer comprises a material selected from the group consisting of crosslinked butadiene-acrylonitrile polymer and butadiene-acrylonitrile-isoprene polymer.

10. The article of any preceding claim, wherein the fastening layer is permanently attached to the bag and forms the fastener, and the target surface and adhesive layer are provided as the separable landing zone component.

11. The article of any preceding claim, wherein the fastener comprises the contact responsive non-tacky fastening layer, a mounting layer comprising a pressure sensitive adhesive, and a backing layer interposed between the fastening layer and the mounting layer.

12. The article of any preceding claim, wherein the fastener is attached to the bag so as to form a flange.

13. The article of any preceding claim, wherein the fastener further comprises a gap filling material.

14. The article of claim 1, wherein the landing zone comprises: a non-tacky surface layer selected from the group consisting of a target surface layer and acontact responsive fastening layer; a layer of adhesive; and a liner for protecting the tacky adhesive layer.

15. The article of any preceding claim, wherein the landing zone comprises the target surface layer, a layer of a skin barrier adhesive, and a liner for protecting the tacky adhesive layer.

16. The article of any preceding claim, wherein the landing zone further comprises a foam gap filling material.

17. The article of claim 1, wherein the bag further comprises at least one of a drain, an odor vent and a comfort layer.

18. The article of claim 1, wherein the target surface is permanently attached to the bag and forms the fastener, and the fastening layer and adhesive layer are provided as the separable landing zone component.

19. The article of claim 1, wherein the surface of the bag surrounding the opening is a target surface and forms the fastener, and the fastening layer and adhesive layer are provided as the separable landing zone component.

20. A method of using an ostomy appliance article having a non-tacky contact responsive fastener system comprising the steps of:
a) providing a bag with an opening for receiving material from a stoma that has a fastening system comprising (i) a fastener attached to the bag circumscribing the opening and (ii) a landing zone, the fastening system having a non-tacky target surface layer, a contact responsive non-tacky fastening layer that adheres to the non-tacky target surface layer, and an adhesive layer;
b) attaching the adhesive layer to the peristomal area of a user; and c) attaching the contact responsive non-tacky fastening layer to the non-tacky target surface layer.