Patent Description:
Cracked heels are a common problem that primarily affect adults and the elderly and that may develop into fissures, fungal infections and ulcerations if left untreated. Problems that may contribute to heel fissures include, but are not limited to, age, diabetes, psoriasis, obesity, athlete's foot, eczema, prolonged standing, kidney disease, ill-fitting shoes and residing in a dry climate.

One of the first signs of cracked heels is the formation of thick, discolored callus tissue that may result in pain with common pressure-related activities like walking or running. If the callus is untreated and subjected to continuous pressure, small and/or deep breaks may occur, which leads to bleeding and possible infection.

A need therefore exists for an improved flexible adhesive heel patches for effectively and conveniently treating skin on the heel of a foot of a mammal in need thereof. The present invention addresses this need by providing a uniquely structured adhesive heel patch with a primary release liner that results in the rapid and consistently accurate positioning of the heel patch with minimal problems that is wearable over an extended period of time in the presence or absence of different types of footwear. <CIT> discloses a patch applicator for easy application of transdermal patches. <CIT> discloses a wound dressing for application to a protruding part of a joint of the body.

The present invention concerns a flexible adhesive patch arrangement comprising: a flexible adhesive patch comprising the features of claim <NUM>.

In an exemplary embodiment, the flexible adhesive patch arrangement forms a three-dimensional structure capable of cupping the heel.

In an exemplary embodiment, the means for separating is a perforated pattern or a slit that partially or completely penetrates the primary release liner.

In an exemplary embodiment, the first and the second portions of the primary release liner are different in size.

In an exemplary embodiment, the first and the second portions of the primary release liner are substantially similar in size.

In exemplary embodiments, the area of the primary release liner is equal to or larger than the area of the adhesive composition. In various particular embodiments, the adhesive composition covers <NUM> to <NUM> % of the surface area of the liner, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%, such as <NUM> to <NUM>%.

In an exemplary embodiment, the primary release liner comprises one or more of a polyester film, a polyolefin film, siliconized paper or a plastic laminated paper.

In an exemplary embodiment, the primary release liner has a thickness of about <NUM> to about <NUM>.

In an exemplary embodiment, the backing is porous and/or permeable. In another embodiment, the backing is occlusive. In a particular embodiment, the occlusive backing achieves a moisture vapor transmission rate (MVTR) < <NUM>/m<NUM>/<NUM>. In another embodiment, the backing is waterproof and breathable and achieves a MVTR > <NUM>/m<NUM>/<NUM>.

In an exemplary embodiment, the backing has a thickness of about <NUM> to about <NUM>.

In an exemplary embodiment, the backing comprises polycellulose fibers, polyester fibers, polyurethane fibers, polyolefin fibers, polyamide fibers, cotton fibers, copolyester fibers or any mixture thereof. In another exemplary embodiment, the backing comprises polycellulose film, polyurethane film, polyester film, polyethylene film, polyolefin film or any mixture thereof.

In an exemplary embodiment, the therapeutic adhesive composition comprises one or more of a polyacrylamide, xanthum gum, guar gum, a hydrocolloid, a starch, a vinyl acetate copolymer, polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene oxide, a polyacrylate, polymaleic acid, polymaleic anhydride, a polyurethane, a polyurea, maltodextrin, carboxymethyl cellulose and carboxypropyl cellulose.

In an exemplary embodiment, the therapeutic adhesive composition comprises one or more of a hydrocolloid, a hydrogel, rubber, an acrylic, a silicone and a polyurethane.

In an exemplary embodiment, the therapeutic adhesive composition has a thickness of about <NUM> to about <NUM>.

In an exemplary embodiment, the therapeutic adhesive composition comprises one or more of an emollient and a descaling (peeling) agent.

In an exemplary embodiment, the descaling agent is salicylic acid and/or urea, and the emollient is a synthetic oil, a plant oil, a wax, an animal oil or a combination thereof.

In an exemplary embodiment, the emollient or the descaling agent is present in an amount of about <NUM> wt. % to about <NUM> wt. % of the therapeutic adhesive composition.

In an exemplary embodiment, the therapeutic adhesive composition further comprises lactic acid, hydrocortisone, triamcinolone acetonide, betametasone, anthracene, polyethylene, polyvinyl chloride, gelatin, collagen, hexidine, chlorohexamine, sodium chloride, potassium chloride, water, an alcohol or combinations thereof.

In an exemplary embodiment, the alcohol is propylene glycol, glycerol, polyethylene glycol or ethylene glycol.

In an exemplary embodiment, the therapeutic adhesive composition comprises a skin conditioner.

In an exemplary embodiment, the therapeutic adhesive composition comprises an antimicrobial agent.

In an exemplary embodiment, the therapeutic adhesive composition comprises an antiseptic agent.

In an exemplary embodiment, the therapeutic adhesive composition is thicker at the center than at the edges. In a particular embodiment, the thickness of the edge is <NUM> to <NUM>, such as <NUM> to <NUM>, such as <NUM> to <NUM>, such as <NUM> to <NUM>, of the thickness of the center.

In an exemplary embodiment, the backing and the therapeutic adhesive composition have an oval shape.

In an exemplary embodiment, the adhesive patch arrangement has a substantially oval shape with a width of about <NUM> to about <NUM> inches (about <NUM> to about <NUM>), such as about <NUM> to about <NUM> inches (about <NUM> to about <NUM>), such as about <NUM> to about <NUM> inches (about <NUM> to about <NUM>), such as about <NUM> to about <NUM> inches (about <NUM> to about <NUM>); and a length of about <NUM> to about <NUM> inches (about <NUM> to about <NUM>), such as about <NUM> to about <NUM> inches (about <NUM> to about <NUM>), such as about <NUM> to about <NUM> inches (about <NUM> to about <NUM>).

In the preferred embodiment, four secondary removable liners are present in the patch arrangement.

In the preferred embodiment, the four secondary removable liners appear at the edges of the surface of the therapeutic adhesive composition.

The flexible adhesive heel patch of the invention can be applied to the heel of a mammal in need thereof, by a method comprising: detaching the first portion of the primary release liner from the adhesive patch arrangement to expose a first portion of the adhesive composition surface and the secondary removable liners present underneath the first portion of the primary release liner; attaching the first portion of the adhesive composition to the bottom of the heel; removing the readily detached secondary removable liners uncovered by the detachment of the first portion of the primary release liner; attaching the surface of the adhesive composition uncovered by removal of the secondary removable liners in the previous step to both sides of the heel; detaching the second portion of the primary release liner from the adhesive patch arrangement to expose the remaining portion of the adhesive composition surface and the secondary removable liners present underneath the second portion of the primary release liner; attaching the second portion of the adhesive composition to the back of the heel; removing the secondary removable liners uncovered by the detachment of the second portion of the primary release liner; and attaching the surface of the adhesive composition uncovered by removal of the secondary removable liners in the previous step on top of the patch previously attached to both sides of the heel to complete attachment of the patch to the heel.

In an exemplary embodiment, the mammal is a human.

The flexible adhesive patch of the present invention can be used in a method for treating or preventing a disorder or condition of the heel of a mammal in need thereof, comprising applying to the affected skin surface an adhesive patch of the invention as described herein for an period of time effective to treat or prevent the heel disorder or condition.

In an exemplary embodiment, the disorder is a cracked heel or a heel fissure.

The following drawings illustrate specific embodiments of the present invention and are not intended to otherwise narrow the scope of the invention as described herein.

The backing layer comprises may comprise any suitable material known for use in the preparation of wound dressings and includes, but is not limited to, a foam, a polyurethane, a polyethylene, a polyester, a polyamide, polycellulose, cotton, or any mixture thereof. In an exemplary embodiment, the backing is flexible, pliable, and/or stretchable. In an exemplary embodiment, the backing contains two sides, a front side and a back side. In an exemplary embodiment, the backing layer is vapor or moisture permeable, but is liquid impermeable. In an exemplary embodiment, the backing layer is continuous (e.g., no holes, perforations or indentations) or is discontinuous (e.g., containing holes, perforations or indentations). In an exemplary embodiment, the backing contains a hydrophobic sizing agent.

The backing layer has a suitable thickness for the intended use. In an exemplary embodiment, the backing layer has a thickness of <NUM> to about <NUM>, such as <NUM> to about <NUM>, such as about <NUM> to about <NUM>, such as about <NUM> to about <NUM>, such as about <NUM> to about <NUM>.

In an exemplary embodiment, the backing and the therapeutic adhesive composition have a substantially circular or triangular or rectangular or square or oval shape or the like.

The therapeutic adhesive composition of the present invention consists of or comprises any skin-friendly adhesive composition known for use in medical articles which contact mammalian (e.g., human) skin. Exemplary adhesive compositions may suitably be, but are not limited to, the types disclosed in <CIT>; <CIT>; <CIT>; and <CIT>.

In an exemplary embodiment, the therapeutic adhesive composition is a pressure sensitive therapeutic adhesive composition and may comprise one or more of a polyacrylamide, xanthum gum, guar gum, a hydrogel, a hydrocolloid, a starch, a vinyl acetate copolymer, polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene oxide, a polyacrylate, polymaleic acid, polymaleic anhydride, a polyurethane adhesive, an acrylic adhesive, silicone, a polyurea, maltodextrin, carboxymethyl cellulose, polyisobutylene, rubber, polybutene, carboxypropyl cellulose, polydimethylsiloxane, polystyrene-polybutadiene-polystyrene, polystyrene-polyisoprene-polystyrene, polystyrene-poly(ethylene-butylene)-polystyrene block polymers or any combination thereof.

Exemplary hydrocolloids include, but are not limited to, alginic acid and salts thereof, chitin, chitosan, pectin, cellulose and cellulose derivatives (such as cellulose ethers or cellulose esters), linked or cross-linked carboxyalkylcellulose or hydroxyalkylcellulose, polyvinyl alcohol, polyvinyl pyrrolidone, agar and gelatin.

Other exemplary hydrocolloids include, but are not limited to, polyacrylates or their salts may further be used as a hydrocolloid where the polyacrylate may be present as a homopolymer, copolymer or block polymer.

Suitable active agents present in the therapeutic adhesive composition include, but are not limited to, one or more of an emollient (such as a synthetic oil, a plant oil, a wax, an animal oil or a combination thereof), an antiseptic a descaling (peeling) agent (such as salicylic acid or urea), lactic acid, hydrocortisone, triamcinolone acetonide, betametasone, anthracene, polyethylene, polyvinyl chloride, gelatin, collagen, hexidine, chlorohexamine, sodium chloride, potassium chloride, water, an alcohol or combinations thereof.

In an exemplary embodiment, the therapeutic adhesive composition comprises a solvent, which includes, but is not limited to, an alcohol (such as a polyhydric alcohol), water, or a combination thereof. In an exemplary embodiment, the polyhydric alcohol is propylene glycol, ethylene glycol, or a combination thereof. In an exemplary embodiment, the solvent is present in an amount of about <NUM> to about <NUM> wt. %, such as about <NUM> to about <NUM> wt. %, such as about <NUM> to about <NUM> wt. %, of the therapeutic adhesive composition.

In an exemplary embodiment, the adhesive composition is positioned on an entire side of the backing. In an exemplary embodiment, the adhesive composition is positioned on only a portion of an entire side of the backing. In an exemplary embodiment, the adhesive composition is affixed or coated only on the surface of the backing. In an exemplary embodiment, the adhesive composition is partially embedded in at least a portion of the backing.

In an exemplary embodiment, the adhesive composition comprises at least one of glycerin, pectin, a skin conditioner (such as vitamin E, aloe, lanolin, calamine or any combination thereof), an antimicrobial agent (such as antifungal agent), an antiseptic agent (such as iodine or triclosan), an antimicrobial agent (such as erythromycin, tetracycline or cephalosporin), a carotenoid, an analgesic and a hemostyptic in an amount of about <NUM> to about <NUM> wt. %, such as about <NUM> to <NUM> wt. %, such as about <NUM> to <NUM> wt. %, such as about <NUM> to about <NUM> wt. %, such as about <NUM> to about <NUM> wt. %, such as about <NUM> to about <NUM> wt. %, of the adhesive composition.

In an exemplary embodiment, the therapeutic adhesive composition has a thickness in an amount of <NUM> to about <NUM>, such as about <NUM> to about <NUM>, such as about <NUM> to about <NUM>, including other ranges described herein.

In an exemplary embodiment, the present invention also provides for a method for treating or preventing cracked heel (such as heel fissures) in a mammal (e.g., a human) in need or risk thereof, by applying to the heel of the mammal an adhesive patch of the present invention for an period of time effective to treat or prevent the heel disorder. In an exemplary embodiment, the effective period of time is about <NUM> minutes to about <NUM> hours, such as about <NUM> minutes to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to about <NUM> hours, such as about <NUM> to <NUM> hours.

The thickness of the adhesive composition layer of the patch of the present invention may be substantially constant over the surface or the adhesive composition layer or alternatively, the adhesive composition layer may have a thicker portion at the center of the composition compared to the edges of the composition layer - i.e., a beveled edge, where in various particular embodiments, the thickness of the edge is <NUM>% or <NUM>% or <NUM>% or <NUM>% of the thickness of the center.

Any suitable amount of a pressure sensitive adhesive can be present in the therapeutic adhesive composition, provided the amount of pressure sensitive adhesive effectively provides the requisite adhesiveness to the backing and/or the primary release liner and remains stable in the therapeutic adhesive composition over a prolonged period of time. Typically, the therapeutic adhesive composition includes a pressure sensitive adhesive in an amount of about <NUM> wt. % to about <NUM> wt. % of the therapeutic adhesive composition, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt. %, such as about <NUM> wt. % to about <NUM> wt.

The primary release liner in the adhesive patch arrangement of the present invention is to coat and protect the adhesive composition of the adhesive patch to prevent the surface of the adhesive composition from being contaminated before attachment. The primary release liner is provisionally attached to the adhesive composition in a readily detachable state, typically requiring only a peeling force to detach.

Suitable compositions of the primary release liners of the present invention include those that are generally known to be used with skin-friendly adhesive compositions, such as primary release liners produced by subjecting a surface of a plastic sheet or a film of a polyolefin (such as polyethylene or polypropylene or a laminate of a plastic film and paper) to a silicone release treatment. In an exemplary embodiment, the primary release liner has a thickness of about <NUM> to about <NUM>, such as about <NUM> to about <NUM>, such as about <NUM> to about <NUM>, such as about <NUM> to about <NUM>.

In an exemplary embodiment, the area of the primary release liner is larger than the area of the adhesive patch - i.e., the area of the combined backing and the adhesive composition. In the exemplary embodiment where the primary release liner is larger than the adhesive patch, the portion of the primary release liner that extends beyond the adhesive patch may be held (gripped) by using the fingers of one hand and peeled away from the therapeutic adhesive composition to detach the primary release liner from the therapeutic adhesive composition. In an exemplary embodiment, the primary release liner covering the therapeutic adhesive composition contains a perforated pattern or a slit that allows for facile separation (peeling away) of the primary release liner (in two portions) from the therapeutic adhesive composition.

In an exemplary embodiment, the slit that forms the slit line in a single adhesive patch of the present invention partitions the primary release liner into two portions, thus allowing for a tandem (two-step) application of the adhesive patch on the skin of a mammalian subject. In an exemplary embodiment, the primary release liner is cut to a depth in the range of at least <NUM>%, such as <NUM>% or <NUM> % or <NUM>% or <NUM>% or <NUM>% or <NUM>% or <NUM>% or up to <NUM>% of the thickness of the primary release liner to allow ready removal of the primary release liner from the therapeutic adhesive composition.

In addition to a straight line, the slit line may be in any shape that allows for facile separation of the primary release liner into multiple portions. For example, the shape may be a curve, a zigzag line, an arc shape, a wave shape or a saw-tooth shape.

In an exemplary embodiment, the primary release liner is perforated to also facilitate a tandem (two-step) application of the adhesive patch on the skin of a mammalian subject. In addition to a straight line, the perforation may be in any shape that allows for facile separation of the primary release liner into multiple portions. For example, the shape may be a curve, a zigzag line, an arc shape, a wave shape or a saw-tooth shape.

In an exemplary embodiment, the primary release liner contains a combination of a perforated section and a slit.

The secondary removable liners in the adhesive patch arrangement of the present invention coat and protect the adhesive composition of the adhesive patch to prevent the surface of the adhesive composition from being contaminated before attachment. In particular, the secondary removable liners are removed subsequent to the primary release liner during application of the adhesive patch and are integral to the ease of application of the adhesive patch of the invention to the heel of a subject in need thereof and to the snug fit of the patch once the patch is applied. As with the primary release liner, the secondary removable liners are provisionally attached to the surface of the adhesive composition in a readily detachable state, requiring only a peeling force to detach. There is no limit on the number of secondary removable liners present on the surface of the adhesive composition. In an exemplary embodiment, there are four secondary removable liners present on the surface of the adhesive composition. In an exemplary embodiment, the secondary removable liners are substantially transparent. In an exemplary embodiment, the secondary removable liners are embossed with arrows to facilitate ease of application of the adhesive patch. In an exemplary embodiment, the secondary removable liners are the same or similar in composition to that of the backing.

The following non-limiting exemplary formulations illustrate suitable adhesive compositions for use in the therapeutic adhesive compositions of the present invention.

where the total weight percent of components (a) through (d) is <NUM>%.

In exemplary embodiments of the above formulation of Example <NUM>, the elastomer is selected from the group consisting of Kraton SEBS, Kraton SIS, Kraton SBS and mixtures thereof; the mineral oil plasticizer is selected from the group consisting of mineral oil, plant oil, hydrogenated botanical oil and mixtures thereof; the tackifier is selected from the group consisting of acrylic resin, c5 tackifier, hydrogenated hydrocarbon resin and mixtures thereof; and the absorbent is selected from the group consisting of carboxymethylcelluose, gelatin, SAP super absorbents and mixtures thereof.

where the total weight percent of components (a) and (b) is <NUM>%.

Claim 1:
A flexible adhesive heel patch arrangement comprising:
a flexible adhesive patch comprising:
a backing having two sides;
a therapeutic adhesive composition coated on at least a portion of one side of the backing;
four secondary removable liners in contact with a surface of the therapeutic adhesive composition and configured to facilitate application of the heel patch to the heel of a mammal in need thereof, where the secondary removable liners contact less than the total surface of the surface of the therapeutic adhesive composition and wherein the four secondary removable liners appear at the edges of the surface of the therapeutic adhesive composition; and
a primary release liner completely covering the therapeutic adhesive composition and the secondary removable liners, where the primary release liner contains a means for readily separating the primary release liner into a first and a second portion, with each portion remaining in contact with the adhesive composition.