United States Patent (19)
`Poulsen et al.
`
`11
`45)
`
`4,367,732
`Jan. 11, 1983
`
`(54) SKIN BARRIER
`(75) Inventors: Finn Poulsen, Vaerlse; Peter
`Samuelsen, Rungsted Kyst, both of
`Denmark
`73) Assignee: Coloplast A/S, Espergaerde,
`Denmark
`21 Appl. No.: 325,788
`22). Filed:
`Nov.30, 1981
`(30)
`Foreign Application Priority Data
`Dec. 5, 1980 (DK) Denmark ............................ 5209/80
`51), Int. Cl.............................................. A61L 15/00
`52 U.S. Cl. ..................................... 128/156; 128/283
`(58) Field of Search ............... 128/155, 156, 283, 295;
`428/262; 260/29. 1 R, 31.8 N; 3/1
`References Cited
`U.S. PATENT DOCUMENTS
`3,908,658 10/1975 Marsan ................................ 128/283
`4,204,540, 5/1980 Cilento et al. ...................... 28/283
`4,253,460 3/1981 Chen et al........................... 128/283
`4,296,745 i0/1981 Raymond ............................ 128/283
`Primary Examiner-Dalton L. Truluck
`Assistant Examiner-T. J. Wallen
`
`(56)
`
`Attorney, Agent, or Firm-Lawrence Rosen
`57
`ABSTRACT
`A skin barrier consisting of an elastic film (16), secured
`to the film a layer (18) of at least weakly elastic adhesive
`material, these two components together having low
`resistance to quick deformation and rapid recovery to
`substantially the original shape after deformation, the
`plastic properties of the adhesive thereby being com
`pensated by the elasticity of the film. Optionally there
`may be a releasable protective cover (20,22) on the
`other side of the adhesive layer. The adhesive material
`consists of a hydrocolloid, preferably sodium carboxy
`methylcellulose, dispersed in a continuous phase con
`sisting of a mixture of (a) a physically cross-linked elas
`tomer which is a styrene-olefin-styrene block copoly
`mer, (b) a hydrocarbon resin tackifier which is a poly
`mer or copolymer of cyclopentadiene, dicyclopenta
`diene or a- or 6-pinene, (c) a plasticizer for the elasto
`mer which is compatible at least with the styrene blocks
`thereof and decreases the upper glass transition temper
`ature thereof, preferably dioctyl adipate, (d) an antioxi
`dant, and (e) optionally an oily extender compatible
`with the olefin blocks of the elastomer.
`
`10 Claims, 1 Drawing Figure
`
`aO.
`
`22
`
`46
`
`
`
`NYNYNYYY
`
`N NYYYN
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`NYYYYYYYYY
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`NYN
`7474.27427AZYZZZZZYZYZZYZZYZZYZZYZZYZZYZZYZZYZZYZZYZZYZZYZZYZZ
`
`
`
`
`
`(44.4.4.4.4.474474 12Y4747
`
`MacNeil Exhibit 2150
`Yita v. MacNeil IP, IPR2020-01139, Page 1
`
`

`

`U.S. Patent.
`
`oe
`
`Jan. 11, 1983
`
`4,367,732
`
`
` ViidlellsdiecigeceesOw”SSOgow
`Me
`
`
`
`- SESSSSISFMMEMMMMe
`
`
`VLALMMLM SDs
`
`aN
`
`Yita v. MacNeil IP, IPR2020-01139, Page 2
`
`MacNeil Exhibit 2150
`
`MacNeil Exhibit 2150
`Yita v. MacNeil IP, IPR2020-01139, Page 2
`
`

`

`1.
`
`SKIN BARREER
`
`1S.
`
`' ' '
`
`.
`
`FIELD OF INVENTION
`The present invention relates to a skin barrier consist
`ing of a layer of adhesive, on one side of this a non-adhe
`sive watertight film and on the other side optionally a
`detachable protective cover.
`The skin barrier according to the invention is usable,
`a.o. for bandaging purposes, especially on movable part
`10
`of the body such as joints, or on parts of the body hav
`ing shapes strongly differing from the planar, where it
`attaches to the curvature of the body surface; moreover
`for the protection of parts of the skin and for sealing
`around body openings, especially, around protruding
`body parts such as colostomies, ileostomies and urosto
`
`4,367,732
`2
`starch may be present. This composition has similar
`drawbacks as the bonding composition according to
`U.S. Pat. No. 3,339,546, yet has a bigger elongation at
`break.
`To remedy: these drawbacks, in British Pat. No.
`1,576,522, corresponding to U.S. Pat. No. 4,231,369,
`there has been proposed a sealing material for ostomy
`systems having low resistance to quick deformation and
`rapid recovery to the original shape after deformation,
`and which consists of a shaped, gel-like blend of a hy
`drocolloid dispersed in a continuous phase consisting of
`a physically cross-linked elastomer, viz, a styrene-ole
`fin-styrene block copolymer (or possibly an ethylene
`propylene block copolymer) and a hydrocarbon tacki
`fier, and optionally also an oil extender and an antioxi
`dant.
`This sealing material, which may also be used as skin
`barrier for other purposes, is splendidly elastic and flexi
`ble (whereby is meant bendable out of the plane), it
`adheres well to the skins and follows its movements and
`also movements of joints well only the movements are
`not too big. Because of the hydrocolloid the material
`absorbs secretions. However, adhesion defects may
`occur at big movements, e.g. when the material is used
`as or in bandages at joints. Especially such adhesion
`defects may occur where the material is used as skin
`barrier provided with a watertight film on the side
`turned away from the skin because normal films for the
`purpose are flexible but unelastic. Adhesion defects may
`also occur if the material absorbs much moisture, nota
`bly if the absorption is irregular. An irregular absorp
`tion of moisture may for instance occur at the use as skin
`barrier, over suppurating wounds where the wound
`itself will yield much liquid, the immediate surround
`ings less, viz, only sweat. Irregular absorption of mois
`ture may for instance also take place at the use of the
`material as sealing gasket around stomies, where the
`parts adjacent the ostomy absorbs liquid from the intes
`tinal discharges and the parts a little more distant only
`absorb sweat.
`By liquid absorption in the known material it causes
`the material to expand substantially uniformly in all
`three dimentions (longitudinal and transversal direc
`tion, thickness) and this causes a tendency of the mate
`rial to pucker and let the adhesive contact with the skin
`go in the areas where the moisture absorption is highest.
`When using it around ostomies there will occur puckers
`in the adhesive or sealing material just around the os
`tomy opening which may give rise to serious skin dis
`comforts because the often very agressive (enzyme-con
`taining) intestinal liquors thereby come into contact
`with the skin. Also at even supply of moisture the
`known sealing material just described has a tendency to
`partly let the skin go and form folds and puckers, espe
`cially at its use as bandage on joints because of its three
`dimensional expansion combined with the normal
`unelastic properties of the cover film. The adhesion to
`the skin is weaker than the forces causing the three-di
`mensional expansion.
`It has now surprisingly been found that the particular
`drawback of three-dimensional expansion and conse
`quent puckering can be met by the combined measure of
`reducing the elasticity of the sealing or adhesive mate
`rial disclosed in U.S. Pat. No. 4,231,369 and bonding
`that material to an elastic film. It has also been surpris
`ingly found that this reduction of the elasticity of the
`adhesive material can be achieved by the aid of a plasti
`
`15
`
`:
`
`"
`
`.
`
`35
`
`BACKGROUND AND OBJ ECT OF INVENTION
`Various skin barriers and similar materials are known
`20
`for these and similar purposes, and it is common for
`them all that they are adhering to the skin. However,
`they are not all provided with a watertight film. They
`all suffer from various drawbacks. Thus, from U.S. Pat.
`No. 3,339,546 there is known askin barrier, in the speci
`25
`fication called a bandage, adapted to adhere to moist
`surfaces; especially the oral cavity is aimed at. This
`known bandage consists of a water-impervious film
`having secured to one surface thereof an adhesive gum
`like bonding composition consisting of a blend of a
`30
`water soluble or swellable hydrocolloid, e.g. polyvinyl
`alcohol, powdered pectin, gelatin or carboxymethylcel
`lulose, and a water insoluble viscous gum-like elastic
`binder, e.g. natural rubber, silicone rubber, polyure
`thane rubber or notably polyisobutylene. The bandage
`according to U.S. Pat. No. 3,339,546 is unelastic but to
`some degree plastic, and the bonding composition
`rather has the nature of a highly viscous fluid whereas
`the film is described as polyethylene, which is unelastic.
`The material is hard and needs substantial force to be
`deformed, it has a very low elongation at break and
`does not recover to the original shape after deforma
`tion. As it is highly viscous, it only partly follows body
`movements when placed on movable parts, and if it is
`used for sealing around ostomies there is a risk of leak
`45
`age. When using a bandage like this for very curved
`body parts, e.g. a heel, it is recommended to cut a num
`ber of incisions in the edge of a round bandage to enable
`it to follow the curvatuve of the part of the body; with
`out the incisions the bandage would pucker or go to
`50
`pieces if one seeks to deform it. The hydrocolloid in the
`bandage just described ensures that it can adhere to and
`retain contact with moist, e.g. sweaty surfaces. To im
`prove adhesion and give desired consistency there can
`optionally be a mineral oil or vaseline present; the vis
`55
`cous gum-like binder gives dry tack and coherence.
`From U.S. Pat. No. 3,908,658 there is known a clo
`sure and sealing composition for ostomies, also suitable
`for adhering ostomy-draining pouches to the skin, said
`composition being water-insoluble and essentially com
`posed of a pressure sensitive adhesion gel body having
`a uniform surface and internal properties of tack, cohe
`sive strength providing elasticity, flexibility, and com
`pressibility and manual kneadability, said gel consisting
`essentially of a mixture of mineral oil, styrene-isobuty
`lene copolymer and ethylene-vinyl acetate copolymer. 65
`The composition does not typically contain hydrocol
`loids, but hydrophilic substances such as pregelled
`
`MacNeil Exhibit 2150
`Yita v. MacNeil IP, IPR2020-01139, Page 3
`
`

`

`10
`
`35
`
`4,367,732
`3.
`cizer for the styrene-olefin-styrene block copolymer
`constituting the elastomer of the said material or at least
`for the hard styrene blocks thereof. When a materialso
`plasticized or softened absorbs moisture, it will be able
`to "flow' internally, which means that the forces caus
`ing the three-dimensional expansion become weaker
`because the internal flow may convert the three-dimen
`sional expansion into a largely uni-directional expansion
`provided that other circumstances favour this; and pre
`cisely this is favoured by the bonding of the adhesive
`material to the elastic film.
`In this connection it should be mentioned that U.S.
`Pat. No. 2,703,573 discloses, i.a., a self-adhering ban
`dage relatively non-adherent to human skin, comprising
`15
`a strip of fabric coated with an emulsion of styrene latex
`and a tackifier, said tackifier consisting essentially of an
`emulsion of polystyrene or a copolymer of styrene and
`a solvent plasticizer or, e.g., polyethylene glycol di-2-
`ethyl hexoate; alternatively, the emulsion may be an
`20
`emulsion of the styrene latex and an emulsified solvent
`plasticizer, e.g. dioctyl adipate. It is noteworthy that
`this prior art product is relatively non-adherent, to the
`skin, in contradistinction to the present material, which
`must be adherent to the skin. As the known material is
`25
`relatively non-adherent, the problem of losing contact
`with the skin locally, and puckering, does not exist.
`Should it exist, it could not be solved by the provisions
`of the patent; the reason is that the substance plasticized
`according to the patent is a styrene latex, i.e. a homoge
`30
`neous material, especially in dried condition when it is
`no longer a latex, except for variations in the molecular
`weight (degree of polymerization). The tackifier or
`plasticizer has the express purpose of retaining self
`cohesion at drying, i.e. to enable the emulsified particles
`of the styrene latex to unite so as to form a coherent
`mass is relatively non-adherent and free from stickiness.
`In connection with the present invention, however,
`the purpose of the plasticizer is to soften a heterogenous
`material, the styrene-olefin-styrene block copolymer
`the blocks of which are mutually incompatible, so that
`the adhesive material can "flow' internally.
`In case there is used a styrene copolymer according
`to the disclosure of U.S. Pat. No. 2,703,573, it is part of
`the tackifier and plasticizer emulsion and not a part of
`45
`the component being plasticized. Apart from this, it is
`not disclosed what the styrene may be copolymerized
`with in order to form the copolymer.
`BRIEF DISCLOSURE OF INVENTION
`50
`In accordance with the invention, the skin barrier
`essentially consists of the following elements in combi
`nation:
`(A) a non-adhesive, substantially water-impervious,
`elastic film, secured to one of the faces of an adhesive
`layer of
`W
`(B) an adhesive material which is a gel-like, at least
`weakly elastic mixture consisting of
`(I) a continuous phase consisting of
`(a) at least one physically cross-linked elastomer
`selected from the group consisting of styrene
`olefin-styrene block copolymers,
`(b) at least one hydrocarbon tackifier resin selected
`from the group consisting of polymers and co
`polymers of cyclopentadiene, dicyclopenta
`65
`diene, a-pinene and g-pinene,
`(c) a polar plasticizer for the elastomer, being com
`patible at least with its styrene blocks and de
`
`4.
`creasing the upper glass transition temperature
`of the styrene blocks of the elastomer,
`(d) an antioxidant, and
`(e) 0–25%, based on the weight of the adhesive
`material, of an oily extender,
`(II) dispersed in the continuous phase (I) a discontinu
`ous phase consisting of at least one hydrocolloid
`which is swellable in water, and
`(C) optionally a dethachable protective cover secured
`to the other face of the adhesive layer,
`the aggregate of said water-impervious elastic film (A)
`and the adhesive material (B) adhering thereto, but
`without the optional protective layer (C), having a low
`resistance to quick deformation and after deformation a
`rapid recovery to substantially its original shape.
`BRIEF DESCRIPTION OF DRAWING
`The drawing in large scale schematically shows a
`longitudinal section of a piece of the skin barrier ac
`cording to the invention. The claimed skin barrier con
`sists of an elastic film 16 (element (A) above) secured to
`a layer 18 of elastic material as described above (as
`element B), the latter optionally secured to a protective
`cover consisting of paper 20 coated with silicone wax
`22.
`Elements 10, 12 and 14 are not a part of the skin
`barrier but serve purposes in connection with its manu
`facture; they are described later.
`The drawing does not necessarily show the correc
`relative thicknesses of the several layers.
`DETAILED DESCRIPTION OF INVENTION
`The adhesive layer is deformable under the influence
`of weak and rapidly acting forces, thus having a low
`elasticity modulus and a large elongation. It has a very
`low flowing when dry and not exposed to outer forces.
`With the expression that the elastomer must be physi
`cally cross-linked is meant that the cross links in the
`polymer of which it consists is not of a chemical (cova
`lent) nature but of a physical nature which means that
`there are areas or domains within the elastomer which
`have a high crystallinity, i.e. a high glass transition
`temperature. Precisely this property of the material
`known from U.S. Pat. No. 4,231,369 causes that when
`absorbing moisture it expands largely uniformly in all
`three dimensions. It has surprisingly been found that a
`limited plastification of the physical cross-links in the
`elastomer with the plasticizer mentioned under (c),
`which must be compatible with the styrene domains of
`the elastomer, causes that absorption of moisture in the
`adhesive material in use precominantly expresses itself
`as an increase in dimension in the thickness direction
`and only very small expansion in the two other dimen
`sions. Thereby the puckering of the adhesive material,
`discussed hereinabove, is avoided even at high moisture
`absorption, and hence also that the adhesion gets lost in
`parts of the adhesive material. Especially it is obtained
`that sealing problems when using the material for os
`tomy adhesive and sealing gaskets are avoided. The
`lesser elasticity and higher plasticity of the material
`caused by the plasticizer, which may give a tendency to
`some degree of permanent change of shape or "set"
`after deformation is counteracted thereby that the wa
`tertight film is elastic, whereby the combination adhe
`sive layer-film has the desired properties with respect to
`a low elasticity modulus and a small or no permanent
`change of shape or "set' after deformation.
`
`55
`
`60
`
`MacNeil Exhibit 2150
`Yita v. MacNeil IP, IPR2020-01139, Page 4
`
`

`

`4,367,732
`5
`6
`Because of this the skin barrier according to the in
`propylene glycols with carboxylic acids, for the above
`vention is not only suited as sealing and adhesive gasket
`reason preferably aliphatic acids. Particularly suitable
`for ostomy pouches and other ostomy closure means,
`are dioctyl, adipate and dioctyl pthalate and of these
`but also for bandaging purposes where skin, mucous
`dioctyl adipate is preferred according to the invention,
`membranes or wounds are to be protected against the
`firstly because it has been found to give to the invention,
`immediate surroundings such as intestinal, wound or
`firstly because it has been found to give the best results
`glandular secretions or again bacterial attack, the action
`with respect to a moderate decrease of the elasticity of
`of the air, evaporation, light, impact and pressure. If the
`the elastomer, and secondly as a consequense of agen
`skin barrier is to be used in connection with real ban
`eral tendency to prefer aliphatic to aromatic com
`dages change of these may take place without disturb
`10
`pounds for materials for use on the human body. For the
`ing the surface of the skin or wound since the skin bar
`same reasons.esters of the said acids with phenols are
`rier is retained on the skin at the change, and moreover
`avoided. .
`it will in itself limit bandage changes to a minimum. The
`The tackifier resin is necessary to give the needful
`material is skin and wound friendly and because of the
`adhesion to the skin and is an integral component of the
`elastic properties it may in many cases draw edges of 15
`continuous phase.
`wounds together and render superfluous the use of
`The antioxidant is necessary to maintain the proper
`clips, which may give a less visible wound healing than
`ties of the elastomer; some commercial elastomers of the
`would otherwise be the case. By use around movable
`type concerned incidentally contain antioxidant from
`parts of the body, e.g. joints, or on soft parts of the
`the factory. The type of antioxidant is not critical and
`body, which for instance are apt to form folds, the mo
`20
`ordinary reference books will give examples. Suitable
`bility is preserved and the skin barrier follows the
`antioxidants are butylated hydroxy toluenes such as
`movements. The skin barrier seals well around protrud
`methylene-bis-(4-methyl-6-t-butylphenol)
`O
`1
`ing part of the body, e.g. ostomies.
`hydroxy-2,6-di-t-butyl-4-methylbenzene.
`As elastomer there is used as mentioned styrene-ole
`Apart from the above described plasticizer there may
`fin-styrene block copolymers. They are A-B-A block
`25
`be an oily extender present. It is substantially incompati
`copolymers having polystyrene end blocks which are
`ble with the styrene domains of the elastomer but com
`thermodynamically incompatible with the polyolefin
`patible with the soft olefin moiety. As oily extender
`rubber middle blocks. Consequently there is phase sepa
`there may especially be used paraffinic oils or vaseline.
`ration in the solid state. The polystyrene constitutes
`If desired vegetable oils may be used but since they
`about a third of the molecule and hard polystyrene
`30
`domains are therefore a kind of discontinuous phase
`have a somewhat polar nature they may also act on the
`styrene domains and thereby increase the effect of the
`distributed in a rubber matrix. The hard areas constitute,
`plasticizer to a degree not fully clear; they are therefore
`the physical cross-links which bind the ends of the mol
`ecules together to a network reminding of that formed
`preferably, avoided.
`.
`The discontinuous phase consists of the hydrocolloid.
`by a conventional vulcanized rubber (caoutchouc).
`35
`Since the high cohesive strength of the block copoly
`Its purpose first and foremost is to ensure the adhesion
`mer originates from the physical cross-links (instead of
`of the skin barrier to skin and mucous membranes even
`when they are moist. It is well-known that conventional
`from the chemical cross-links as in vulcanized materials)
`it is easy to work. In comparison with conventional
`plasters lose the grip and adherence to the skin when
`exposed to moisture.
`rubbers the styrene-olefin-styrene block, copolymers
`40
`The hydrocolloid must be capable of swelling rapidly
`have low molecular weights, of the A-blocks around
`under the influence of water, and of transporting water
`2000-100,000 and of the
`B-blocks
`around
`rapidly. It should preferably also be soluble in water.
`25,000-200,000. The content of styrene units is normally
`Suitable hydrocolloids are carboxymethyl celluloses
`below 40%. These block copolymers have two glass
`transition temperatures, one below, the other considera
`and carboxymethyl starches and alkali metal derivatives
`45
`bly above room temperature.
`thereof, polyvinyl alcohol, gelatin, powdered pectin,
`vegetable guns such as gum guar, gum arabic, locust
`The aliphatic blocks may be based on isoprene, buta
`bean gum, karaya, high molecular weight polyethylene
`diene, other short chain alkadienes or alkenes such as
`or polypropylene glycols, polyoxymethylene and simi
`mixtures of ethylene and butylene, or polyisobutylene.
`lar polymers. According to the invention sodium car
`It has been found according to the invention that the
`elastomer particularly advantageously is a styrene-iso
`boxymethylcellulose is preferred; also a blend of sodium
`prene-styrene block copolymer. Very suitable is the
`carboxymethylcellulose and gum guar in the proportion
`material sold under the registered trade mark "Cariflex'
`about 36:16 by weight is suitable.
`Tr-1107, which contains about 28% by weight styrene
`In the continuous phase or as a further dispersed
`phase additives having various skin-friendly and/or
`units.
`As softener for the two types of blocks of the elasto
`therapeutic purposes may be present. Such additives
`mer, or at least for the hard styrene blocks a plasticizer
`may for instance be pH controlling systems such as
`must be present. The plasticizer especially has to de
`sodium, potassium or magnesium citrates, or bacterioci
`crease the higher of the glass transition temperatures.
`dal, bacterostatic, fungicidal or fungistatic agents and
`As this plasticizer in principle may be used a series of
`special proteins which might contribute to a fast wound
`60
`healing, e.g. collagen.
`substances having polar nature to a substantial degree,
`thus for instance naphthenic oils, which however
`As mentioned it is important that the watertight film
`should be avoided because they may be cancerogenic
`is elastic. Comparatively few plastic foil materials are
`and/or allergenic.
`elastic but suitable films for the purpose consist of poly
`The best suitable are esters of di- and polybasic or
`urethane, styrene-isoprene copolymers, styrene-butadi
`65
`ganic acids which have been fully esterified with ali
`ene block copolymers, butadiene rubbers, isoprene rub
`phatic monovalent alcohols, especially those having.
`bers, neoprene rubbers, silicone rubbers, butyl rubbers,
`6-12 carbon atoms, and esters of polyethylene and poly
`chloroprene rubbers or mixtures thereof. According to
`
`50
`
`55
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`10
`
`25
`
`30
`
`4,367,732
`7
`the invention it is particularly preferred that the water
`tight elastic film is a polyurethane film.
`The proportions of the several components may vary
`within rather wide limits. The amount of the elastomer,
`however, is normally somewhat higher than in the ma
`terial known from U.S. Pat. No. 4,231,369 and accord
`ing to the invention constitutes 10-40% by weight of
`the adhesive layer, preferably 20-40%. According to
`the invention the composition of the adhesive layer
`expressed in % by weight may be: elastomer 10-40%,
`preferably 20-40%; tackifier resin 15-45%, preferably
`30-40%; plasticizer for the two domains of the elasto
`mer as defined 2-12%, preferably 8-12%; antioxidant
`0.5-2.5%; oily extender 0-25% and hydrocolloid
`15
`10-55%, preferably 20-40%.
`An especially preferred composition is about 25%
`styrene-isoprene block copolymer (notably one contain
`ing about 20% styrene unites, "Cariflex” (R) TR 1107),
`about 35% tackifier resin, about 9% dioctyl adipate,
`20
`about 1% antioxidant and about 30% sodium carboxy
`methylcellulose.
`For special purposes the adhesive layer in the skin
`barrier may have a high thickness, e.g. up to 6 mm or
`more, but according to the invention the thickness is
`normally 0.25-3 mm, preferably about 1.1 mm, and the
`thickness of the elastic watertight film normally accord
`ing to the invention 10-15u, preferably about 30l.
`In practice the skin barrier is prepared by pouring the
`adhesive material in molten condition on the film, after
`which there is rolled to the desired thickness of the
`adhesive layer. If desired the adhesive material may be
`rolled onto the film in a non-molten state, but softened
`by heat. During the application of the adhesive layer the
`35
`film must be supported on a suitable material because
`the film will absorb plasticizer from the adhesive mate
`rial and swell; because of physical forces (e.g. van der
`Waal's forces) the swelling only takes place in the thick
`ness dimension when the film is fixed to the backing, but
`40
`otherwise may take place in all directions and involve
`puckering. When the adhesive layer is cold the connec
`tion between the same and the film will remain smooth,
`even if the film has swelled. Some films when supplied
`by the manufacturer are supported on a suitable mate
`45
`rial and a particularly suitable material is paper coated
`with polyethylene on the side facing the adhesive mate
`rial and on the other side with a silicone wax. This
`support material may remain on the skin barrier as a
`protective cover which is only removed when it is to be
`taken into use.
`The adhesive material may be prepared in a manner
`similar to that described in U.S. Pat. No. 4,231,369.
`Preferably the physically cross-linked styrene-olefin
`styrene elastomeric copolymer is mixed with the antiox
`idant (if not present from the factory of the copolymer),
`the hydrocarbon resin tackifier, the plasticizer and op
`tionally the oily extender, after which the blend is
`heated at a suitable temperature, normally within the
`range of 80-170° C. When the desired temperature has
`been reached and the blend is homogenuous, optionally
`by agitation, the hydrocolloid is added at the same tem
`perature and the mixture stirred until the hydrocolloid
`has been evenly dispersed in the mixture of the other
`components. Thereafter the mass is cooled for later
`used, or directly used for pouring onto the supported
`fiom as described above.
`
`8
`EXAMPLE
`A skin barrier having the structure schematically
`shown in the drawing was prepared in the following
`male
`A web of paper 10 which on the underside 12 had
`silicone wax and on the top side was coated with a thin
`film 14 of polyethylene, and above that an elastic film 16
`of polyurethane having a thickness of about 28, was
`coated with a melt of adhesive material having the
`following composition: 25.1% "Cariflex" (R) TR 1107,
`35.1% “Arkon' (R) P90 (a hydrogenated polycyclopen
`tadiene adhesive from Arkawa Forest Chemical Indus
`tries Ltd.), 8.8% dioctyl adipate, 30% sodium carboxy
`methylcellulose and 1.0% antioxidant, viz, methylene
`bis-(4-methyl-6-t-butylphenol). After partial solidifica
`tion the melt was rolled to a thickness of 1.1 mm
`whereby the adhesive material constituted a layer 18.
`After cooling the whole was wound to a roll of the web.
`The paper with polyethylene layer and silicone wax
`layer is an extra protective cover to be removed when
`the skin barrier, consequently consisting of the layers 16
`and 18, is taken into use.
`On top of the adhesive layer a protective cover may
`be placed, consisting of a paper web 20 coated on the
`side facing the adhesive layer with a layer of silicone
`was 22.
`When the skin barrier is taken into use, pieces of
`desired shape and size are cut out.
`We claim:
`1. A skin barrier, essentially consisting of the follow
`ing elements in combination:
`(A) a non-adhesive, substantially water-impervious,
`elastic film, secured to one of the faces of an adhe
`sive layer of
`(B) an adhesive material which is a gel-like, at least
`weakly elastic mixture consisting of
`(I) a continuous phase consisting of
`(a) at least one physically cross-linked elastomer
`selected from the group consisting of styrene
`olefin-styrene block copolymers,
`(b) at least one hydrocarbon tackifier resin se
`lected from the group consisting of polymers
`and copolymers of cyclopentadiene, dicyclo
`pentadiene, a-pinene and S-pinene,
`(c) a polar plasticizer for the elastomer, being
`compatible at least with its styrene blocks and
`decreasing the upper glass transition tempera
`ture of the styrene blocks of the elastomer,
`(d) an antioxidant, and
`(e) 0-25%, based on the weight of the adhesive
`material, of an oily extender,
`(II) dispersed in the continuous phase (I) a discon
`tinuous phase consisting of at least one hydrocol
`loid which is swellable in water,
`the aggregate of said water-impervious elastic film (A)
`and the adhesive material (B) adhering thereto having a
`low resistance to quick deformation and after deforma
`tion a rapid recovery to substantially its original shape.
`2. The skin barrier claimed in claim 1, wherein the
`water-impervious elastic film (A) is a polyurethane film.
`3. The skin barrier claimed in claim 1, wherein the
`elastomer (a) is a styrene-isoprene-styrene block co
`polymer.
`4. The skin barrier claimed in claim 1, wherein the
`plasticizer (c) compatible both with the styrene and
`olefin domains of the elastomer (a) and is selected from
`the group consisting of esters of polyethylene glycol
`
`50
`
`55
`
`60
`
`65
`
`MacNeil Exhibit 2150
`Yita v. MacNeil IP, IPR2020-01139, Page 6
`
`

`

`
`
`
`
`5
`
`10
`
`15
`
`4,367,732
`9
`10
`and polypropylene glycol with aliphatic carboxylic
`9. The skin barrier claimed in claim 1, wherein the
`acids and esters of di- or polybasic carboxylic acids with
`layer of adhesive has a thickness of 0.25-3 mm and the
`aliphatic alcohols.
`elastic film a thickness of 10-50.
`5. A skin barrier as claimed in claim 4, wherein the
`10. A skin barrier, essentially consisting of the follow
`plasticizer is dioctyl adipate.
`ing elements in combination:
`(A) a non-adhesive, substantially water-impervious,
`6. A skin barrier as claimed in claim 1, wherein the
`hydrocolloid (II) dispersed in the contiguous phase () is
`elastic film, secured to one of the faces of an adhe
`sive layer of
`sodium carboxymethylcellulose.
`(B) an adhesive material which is a gel-like, at least
`7. The skin barrier claimed in claim 1, wherein the
`weakly elastic mixture consisting of
`gel-like, at least weakly elastic mixture constituting the
`(I) a continuous phase consisting of
`elastic layer (B) has the following composition, the
`(a) at least one physically cross-linked elastomer
`percentages all being based on the weight of the mate
`selected from the group consisting of styrene
`rial:
`olefin-styrene block copolymers,
`(I) 45-90% continuous phase consisting of
`(b) at least one hydrocarbon tackifier resin se
`(a) 10-40% physically cross-linked elastomer, .
`lected from the group consisting of polymers
`(b) 15-45% hydrocarbon tackifier resin,
`and copolymers of cyclopentadiene, dicyclo
`(c) 2-12% polar plasticizer for the elastomer,
`pentadiene, a-pinene and s-pinene,
`(d) 0.5-2.5% antioxidant,
`(c) a polar plasticizer for the elastomer, being
`(e) 0-25% oily extender, and
`copatible at least with its styrene blocks and
`(II) 10-55% hydrocolloid as discontinuous phase.
`decreasing the upper glass transition tempera
`8. The skin barrier claimed in claim 7, wherein the
`ture of the styrene blocks of the elastomer,
`gel-like,