Patent Publication Number: US-2012043346-A1

Title: Applicator tip

Description:
BACKGROUND 
     1. Technical Field 
     The present disclosure relates generally to devices for the application of sterile compositions, and more particularly to devices and methods for applying surgical sealants or adhesives with an improved applicator tip design. 
     2. Background of Related Art 
     Monomer and polymer adhesives are used in both industrial and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the α-cyanoacrylates. Medical applications of adhesive compositions include use as an alternate or an adjunct to surgical sutures and staples in wound closure as well as for covering and protecting surface wounds. When such an adhesive is applied, it is usually applied in its monomer form, and the resultant polymerization gives rise to the desired adhesive bond. 
     However, with the application of adhesive in a monomeric form, due to the rapid polymerization rate of the monomers, it has been challenging to design effective and commercially viable packaging and dispensing systems. Such packaging and dispensing systems must counterbalance the competing requirements that the monomer not prematurely polymerize, that the monomer be easily applied, that the monomer polymerize at a desired rate upon application, and that the sanitary and/or sterile properties of the monomer and applicator be maintained. 
     Various dispensing and packaging systems for adhesives have been proposed. One of the problems surgeons have faced with such dispensers is the lack of control of the dispensing rate of the adhesive, e.g., large amounts of the adhesive may be inadvertently dispensed and wasted. Furthermore, the adhesive may spill into areas of tissue or onto surfaces where it is not needed and can impede the success of the wound closure. 
     Further, a problem arises if the dispenser is to be used more than once, as is common. Over multiple uses, contaminants may be transferred from one surface to another surface. As is apparent, this is especially of concern with the application of compositions in the medical field. 
     Further, there are other problems associated with conventional techniques with the application of adhesive compositions in certain environments, particularly ones in which the surface is difficult to reach or is isolated and where the surgeon will not be able to visualize both the flow of the adhesive as well as the incision. 
     Another problem arising from known applicator tips is the reactive nature of the material of the tip with the adhesive composition which disrupts the uniform flow of the adhesive and affects the cure rate. Further, a problem arises when the tip clogs due to the non-uniform flow or premature curing of the adhesive. 
     Accordingly, a need exists for new applicator designs to expel the adhesive without wasting adhesive by filling useless areas of the applicator tips. A need also exists to expel the adhesive in a controlled manner and without expelling through an entire surface area of the tip, and to obtain precise placement of the applicator tip in tissue areas where it is difficult to reach or apply. Further, a need exists for applicator dispensing materials which allow the surgeon to visualize the flow of the adhesive through the applicator tip. Still further, a need exists for dispensing adhesive uniformly without affecting the cure rate and clogging the applicator tip. 
     Conventional devices fail to provide an applicator and/or an applicator dispensing system that is optimized for convenient dispensing and controlled application of adhesive materials on a variety of surfaces and structures. 
     SUMMARY 
     Accordingly, an applicator device in accordance with the present disclosure is provided to address the need for an easy to use and efficient assembly for dispensing and applying sterile compositions, such as during medical procedures. 
     In one embodiment, an applicator tip for selectively dispensing a sterile composition contained in a reservoir includes an opening offset from a distal end of the tip which provides a drip free seal in an un-deformed configuration and allows passage of the sterile composition when deformed. 
     In another embodiment, a method for dispensing a sterile composition includes providing an applicator tip as disclosed in embodiments affixed to a reservoir containing sterile composition and deforming the tip to selectively dispense the sterile composition. 
     In a still further embodiment, a kit includes a reservoir containing a sterile composition and at least one applicator tip in accordance with the embodiments of this disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Although specific embodiments of the present disclosure will now be described with reference to the drawings, it should be understood that such embodiments are by way of example only and merely illustrative of but a small number of the many possible specific embodiments which can represent applications of the principles of the present disclosure. Various changes and modifications obvious to one skilled in the art to which the present disclosure pertains are deemed to be within the spirit, scope and contemplation of the present disclosure as further defined in the appended claims. 
         FIG. 1  is a side elevation view of one embodiment of the presently disclosed applicator tip constructed in accordance with illustrative the present disclosure; 
         FIG. 2  is a bottom plan view of the applicator shown in  FIG. 1 ; 
         FIG. 3  is a side perspective view of the applicator tip shown in  FIG. 1  as positioned on a reservoir; 
         FIG. 4  is a top plan view of an illustrative kit in accordance with the embodiments of the present disclosure; 
         FIG. 5  is a side elevation view of the kit embodiment of  FIG. 4  in accordance with the embodiments of the present disclosure; 
         FIG. 6A  is a side elevation view of a further illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the present disclosure; 
         FIG. 6B  is a longitudinal cross section taken along section A-A of  FIG. 6A ; 
         FIG. 7A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the present disclosure; 
         FIG. 7B  is a longitudinal cross section taken along, section A-A of  FIG. 7A ; 
         FIG. 8A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the present disclosure; 
         FIG. 8B  is a longitudinal cross section taken along section A-A of  FIG. 8A ; 
         FIG. 9A  is a side elevation view of yet another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with embodiments of the present disclosure; 
         FIG. 9B  is a longitudinal cross section taken along section A-A of  FIG. 9A ; 
         FIG. 10A  is a side elevation view of a further illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 10B  is a longitudinal cross section taken along section A-A of  FIG. 10A ; 
         FIG. 11A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 11B  is a longitudinal cross section taken along section A-A of  FIG. 11A ; 
         FIG. 12A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 12B  is a longitudinal cross section taken along section A-A of  FIG. 12B ; 
         FIG. 13A  is a side elevation view of a further illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 13B  is a longitudinal cross section taken along section A-A of  FIG. 13A ; 
         FIG. 14A  is a side elevation view of yet another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 14B  is a longitudinal cross section taken along section A-A of  FIG. 14A ; 
         FIG. 15A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 15B  is a longitudinal cross section taken along section A-A of  FIG. 15A ; 
         FIG. 16A  is a side elevation view of another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 16B  is a longitudinal cross section taken along section A-A of  FIG. 16A ; 
         FIG. 17A  is a side elevation view of a further illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; 
         FIG. 17B  is a longitudinal cross section taken along section A-A of  FIG. 17A ; 
         FIG. 18A  is a side elevation view of yet another illustrative embodiment of the presently disclosed applicator tip constructed in accordance with the embodiments of the present disclosure; and 
         FIG. 18B  is a longitudinal cross section taken along section A-A of  FIG. 18A . 
     
    
    
     DETAILED DESCRIPTION 
     In general, the present disclosure is directed to an applicator tip for selectively dispensing sterile composition contained in a reservoir, a method for dispensing a sterile composition and a kit comprising the applicator tip for dispensing a sterile composition in a reservoir. While the following description is presented in connection with the delivery of sterile surgical adhesive compositions, it should be understood that the present applicator tip may be employed to dispense any sterile composition, especially those useful in medical procedures. Illustrative examples of sterile compositions that may be dispensed using the present applicator tips include, but are not limited to, adhesives, sealants, antimicrobial compositions, wound healing compositions, diagnostic compositions, anti-adhesion compositions, and the like. 
     According to the present disclosure, an applicator tip is provided that can be used to more precisely and economically apply adhesive and sealant materials at a desired application site. Applicator tips of the present disclosure can be used on any of a wide variety of applicator devices, such as ampoules, vials, tubes and syringes, are also amenable to use in some embodiments of the present disclosure. 
     In general, applicator tips for selectively dispensing sterile surgical adhesive contained in a reservoir according to the present disclosure include an opening offset from a distal end of the tip to provide a drip free seal in an un-deformed configuration and allowing passage of the sterile surgical adhesive when deformed. A method for dispensing a sterile surgical adhesive includes providing an applicator tip in accordance the embodiments of the present disclosure affixed to a reservoir containing sterile surgical adhesive and deforming the tip to selectively dispense the sterile surgical adhesive. 
     In embodiments, the opening is a slit and is positioned no more than 2 mm away from the distal end of the tip, from about 1.3 mm to about 1.8 mm away from the tip and from about 0.8 to about 1.5 away from the tip wherein the distal end of the tip forms an apex. The applicator tip has a width and the opening has a length that is from about 15% to about 100% of the width of the applicator tip. 
     The applicator tip is generally of a rigid or semi-rigid material, to permit controlled delivery of the adhesive material to the desired application site. Suitable materials for forming the applicator tip include, but are not limited to, natural materials such as cellulose, foams, rubber, cardboard, metal, ceramic, glass, thermoplastics, thermosets, plastics such as butyrate or high density polyethylene, polypropylene, polyester, for example, or any other suitable material. In one embodiment, the applicator tip is made of a non-porous material and has a decreased affinity for the adhesive. The applicator tip may be made of clear silicone which will allow the surgeon to visualize both the flow of the adhesive through the tip as well as the application site. In general, the only limitation on the materials used to fabricate the applicator tips is that the material must be sufficiently compatible with the composition to be dispensed therein, that undesirable effects on the composition do not occur during contact of the composition with the enclosure, and that the applicator tip opening or slit functions according to the present disclosure. Accordingly, the applicator tip will not clog the way current fiber applicators do. 
     In each of the embodiments, the applicator tip&#39;s opening remains closed when the applicator tip is un-deformed or when pressure is not applied to the applicator tip, or alternatively, to the reservoir. This eliminates dripping of the adhesive from the reservoir and allows a surgeon control over the amount of adhesive used in wound closure. In further embodiments, the applicator tip is configured and dimensioned so that the tip may reach hard to reach surfaces and areas. 
     The applicator tip according to the present disclosure can be used in conjunction with a wide variety of applications of biocompatible solvent composition materials, wherein it is necessary or desirable to efficiently and easily apply an adhesive material. Examples include, but are not limited to, those applicable to medical, industrial, and home use. For example, the applicator tip in accordance with the present disclosure may be used to apply a composition of solvent and moisturizing agent, for wound closure adhesives such as those used for surgically incised or traumatically lacerated tissues; retarding blood flow from wounds; dressing burns; dressing skin or treating stomatitis or other superficial or surface sores or wounds. 
     The applicator tip may be used to store and apply a wide variety of solvents, including but not limited to: isopropyl alcohol, benzyl alcohol, esters of acetic acid and/or mixtures thereof. The applicator tip may be used with a number of different adhesives including polymerizable liquid adhesives such as 1,1-disubstituted ethylene monomers and polymers, including cyanoacrylate monomers such as the α-cyanoacrylates. 
     The presently disclosed applicator tip and kit will be further described in conjunction with the accompanying figures showing exemplary embodiments of the present disclosure. In the figures, like numerals have been used to identify like components. 
       FIG. 1  shows an applicator tip  100  in accordance with an embodiment of the present disclosure for selectively dispensing sterile surgical adhesive contained in a reservoir conveniently, inexpensively and effectively. The applicator tip  100  contains a base portion  104  which includes a proximal end  210  (as shown in  FIG. 2 ), a distal end  108  and opening  114  offset from distal end  108  in an un-deformed configuration.  FIG. 3  shows an applicator tip  300  for dispensing adhesive contained in reservoir  310  with an opening  306  offset from distal end  308  which forms an apex  312 . Although tip  300  and reservoir  310  are illustrated as separate components, tip  300  may be permanently attached to or formed with body  310 . Opening  306  is offset from the distal end  308  of applicator tip  300  a distance  316  on face  314 . 
     The applicator tip  100  may be made of rubber, silicone or any other resilient material. The applicator tip  100  may be any of a variety of shapes and designs dependent on numerous factors including, for example, the specific contents of the container body  310  and the intended use of the adhesive contained within the container body  310 . The opening  106  may be configured and dimensioned into a variety of shapes and designs, more specifically into a shape of a slit, rectangle, circle, wedge, star, triangle or trapezoid. 
     When a user wants to apply the adhesive or sealant, for example, for wound closure, the user applies pressure to the applicator tip  100  along the tissue of a patient, or in the alternative, by applying pressure to reservoir  310  to change the configuration of applicator tip  100  from an un-deformed to a deformed configuration which allows for flow of the adhesive from reservoir  310  via base portion  104  and proximal end  210  and then through opening  106  to the wound. Because of the inherent resilience of applicator tip  100 , opening  106  will remain closed and un-deformed when no pressure is applied to applicator tip  100 , or in the alternative, when no pressure is applied to reservoir  310 . The dimensions of the applicator tip  300  allow it to be used to apply adhesives and sealants in a variety of environments and spatial constraints. 
     The presently disclosed applicator tip  400  and container body  410  may be included in a kit as shown in  FIGS. 4 and 5 . The kit may include one or more tips of the same or different sizes, one or more containers for adhesive or the like and an enclosure  403  for housing the various components of the kit. The kit can include any conventional enclosure or sealable pouch used for medical devices manufactured from any suitable material known to those skilled in the art. In one embodiment, an enclosure is formed by heat sealing two panels of aluminum foil coated on the interior surfaces thereof with a heat sealable polymeric composition. Other means for sealing the enclosure may be employed as are well known to those skilled in the art.  FIGS. 4 and 5  show kit  401  which includes at least one applicator assembly  405  comprising applicator tip  400  attached to reservoir  410  within an enclosure  403  in accordance with the embodiments of the present disclosure. 
       FIGS. 6A-18B  are alternative embodiments of the presently disclosed applicator tip in accordance with the embodiments of the present disclosure for selectively dispensing sterile surgical adhesive contained in a reservoir. In  FIG. 6A , opening  606  is at distance  616  from distal end  608  of apex  612  on face  614  of applicator tip  600 . Opening  606  is positioned no more than 2 mm away from distal end  608  of apex  612  of applicator tip  600  as shown in  FIGS. 6A-6B . 
     In  FIGS. 7A-7B , opening  706  is approximately 1 mm from distal end  708  on the opposite face of applicator tip  700  from stripe  707  located on face  714 . Stripe  707  extends towards distal end  708  and positioned centrally on applicator tip  700 . Opening  706  on the opposite face of face  714  is indicated by a dashed line. Stripe  707  is shown as a center line arc on the face opposite of opening  706  in  FIG. 7B . Stripe  707  allows for better dispersion of materials to a wound from applicator tip  700  as it used by the surgeon as a visual aid for pulling across the center of the wound. 
     In  FIGS. 8A-8B , opening  806  is approximately 1 mm from distal end  808  with stripe  807  located centrally on face  814  and extending toward distal end  808 . Stripe  807  is shown as a center line arc on the same side or face of opening  806  in  FIG. 8B . The smooth geometry of stripe  807  allows for restricted flexing of applicator tip  800  thereby allowing for even distribution of an adhesive via opening  806  of applicator tip  800  to a designated surface. 
     In  FIGS. 9A-9B , opening  906  is approximately 1 mm away from distal end  908  of apex  912  with stripes  901  on an opposite face  914  of opening  906  along each outer edge of applicator tip  900 . Stripes  901  are a visual aide to assist the surgeon in more even application of an adhesive material to a wound and provides for more rigid flexing of opening  906  for better distribution of adhesive. 
     In  FIGS. 10A-10B , opening  1006  is located directly on distal end  1008  of apex  1012  of applicator tip  1000 . The opening  1006  allows the surgeon to target areas that are not so easily accessible via other means. 
     In  FIGS. 11A-11B , openings  1106  are at a distance  1116  from distal end  1108  on face  1114  of applicator  1100 . Center line v-shaped wedge  1103  extends from distal end  1108  of apex  1112  penetrating both faces of applicator tip  1100 . Opening  1106  is not a contiguous opening across face  1114  and v-shaped wedge  1103  but rather comprises two separate openings  1106  which allows for more effective application of adhesive materials for particular wound closures. 
     In  FIGS. 12A-12B , opening  1206  is at a distance  1216  from distal end  1208  of apex  1212  on face  1214  of applicator  1200 . Center line tab  1205  extends from distal end  1208  but is not in contact with opening  1206 . Center line tab  1205  is selectively positioned in connection with opening  1206  so as to dispense adhesive from opening  1206  at a desired rate for the specific procedure being performed. 
     In  FIGS. 13A-13B , opening  1306  is at a distance  1316  from distal end  1308  on face  1314  of applicator  1300 . Spatula  1309  is located on face  1314  proximal to opening  1306 . Spatula  1309  allows for restricted flexing of applicator tip  1300  to control flow of adhesive through opening  1306  thereby allowing for even distribution of the material and for protection of surrounding tissue while the surgeon is applying the material to a wound. 
     In  FIGS. 14A-14B , opening  1406  is at a distance  1416  from distal end  1408  of apex  1412  at the base of v-shaped wedge  1403 . V-shaped wedge  1403  extends from distal end  1408  of apex  1412  and penetrates both faces of applicator tip  1400 . 
     In  FIGS. 15A-15B , opening  1506  is at a distance  1516  from distal end  1508  of apex  1512  on face  1514  of applicator  1500 . V-shaped wedge  1503  extends from distal end  1508  of apex  1512  penetrating below opening  1506  on face  1514  of applicator tip  1500 . 
     In  FIGS. 16A-16B , opening  1606  is at a distance  1616  from distal end  1608  of apex  1612  on face  1614  of applicator  1600 . Curved indent  1615  extends from one point of distal end  1608  to another point of distal end  1608  distal to opening  1606 . 
     In  FIGS. 17A-17B , multiple openings  1717  are at a distance  1716  from distal end  1708  of apex  1712  on face  1714  of applicator tip  1700  from which adhesive will flow through to the intended surface. 
     In  FIGS. 18A-18B , opening  1817  is at a distance  1816  from distal end  1808  of apex  1812  on face  1814  of applicator tip  1800  from which adhesive will flow through to the intended surface. 
     It should be recognized that the applicator tip shown in  FIGS. 1-18B  are only illustrative and not limiting. For example, the applicator may be a wide variety of shapes and sizes such as circular, elliptical, elongated, curved, tapered, chiseled or square depending on the particular area where the adhesive needs to be applied. Also, in alternative illustrative embodiments, the applicator tip could be in the form of a brush, sponge or constructed of foam. Further, the applicator tip may include a cover to protect the sterility of the applicator prior to use. 
     The adhesive contained in a reservoir may also contain suitable bioactive materials which include, but are not limited to, medicaments such as antibiotics, antimicrobials, antiseptics, bacteriocins, bacteriostats, disinfectants, steroids, anesthetics, fungicides, anti-inflammatory agents, antibacterial agents, antiviral agents, antitumor agents, growth promoting substances, moisturizing components, antioxidants, tackifiers, solubilizers, colorants, perfumes, surfactants, UV absorbers, inorganic fillers and pH adjusting agents or mixtures thereof. 
     Preferable medicaments are those that are anions or help in radical generation or that are ion pairs or are themselves radicals. In embodiments, the medicament includes, but is not limited to a quaternary ammonium halide such as alkylbenzyldimethylammonium chloride (benzalkonium chloride; BAC) with an alkyl containing 6-18 carbon atoms, its pure components, or mixtures thereof, or benzethonium chloride; or a salt of sulfadiazine, such as a silver, sodium, or zinc salt, water-soluble placenta extract, allantoin, lecithin, amino acids, kojic acid, proteins, saccharides, hormones, placenta extract, components extracted from various types of herbal medicine such as aloe, sponge gourd and liquorice, vitamin A, vitamin C, vitamin D, vitamin E and other vitamins, etc. or mixtures thereof. 
     With regard to the moisturizing components, an aqueous solution of succinylkefuran, an aqueous solution of acetylkefuran, an aqueous solution of maleylkefuran, malt sprout extract,  Rosae fructus  extract, orange extract, orange fruit juice, raspberry extract, kiwi extract, cucumber extract, gardenia extract, grapefruit extract,  Crataegus cuneata  extract, xanthoxylum extract,  Crataegus oxycantha  extract,  Juniperus communis  extract,  Zizyphi fructus  extract,  Ziziphus jujuba  extract, duke extract, tomato extract, grape extract, sponge gourd extract, lime fruit juice, apple extract, apple fruit juice, lemon extract, lemon fruit juice, etc. can be added singly or in combinations of two or more types. 
     With regard to the antioxidants, ascorbic acid, propyl gallate, butyl hydroxyanisole, dibutyl hydroxytoluene, nordihydroguaiaretic acid, tocopherol, tocopherol acetate, etc. or mixtures thereof can be added. 
     With regard to the tackifiers, casein, pullulan, agar, dextran, sodium alginate, soluble starch, carboxy starch, dextrin, carboxymethyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, polyvinyl alcohol, polyethylene oxide, polyacrylamide, polyacrylic acid, polyvinylpyrrolidone, carboxyvinyl polymer, polyvinyl ether, methyl vinyl ether-maleic anhydride copolymer, isobutylene-maleic anhydride copolymer, polyethyleneimine, etc. can be added. 
     With regard to the solubilizers, benzyl alcohol, pyrrothiodecane, peppermint oil, isopropyl myristate, crotamiton, etc. or mixtures thereof can be added. 
     With regard to the colorants, those that can have a large influence on the image of the preparation and contribute to an improvement in the user&#39;s feeling during use and a feeling of skin revitalization are preferred, for example, approved colorants such as Red No. 2 (amaranth), Red No. 3 (erythrosine), Red No. 102 (new coccine), Red No. 104 (1) (phloxine B), Red No. 105 (1) (rose bengal), Red No. 106 (acid red), Yellow No. 4 (tartrazine), Yellow No. 5 (sunset yellow FCF), Green No. 3 (fast green FCF), Blue No. 1 (brilliant blue FCF) and Blue No. 2 (indigo carmine) or mixtures thereof can be added, but they are not particularly limited thereby. 
     With regard to the surfactants, anionic surfactants such as sodium dioctylsulfosuccinate, alkylsulfate salts, 2-ethylhexylalkylsulfate ester sodium salt and sodium n-dodecylbenzenesulfonate, cationic surfactants such as hexadecyltrimethylammonium chloride, octadecyldimethylbenzylammonium chloride and polyoxyethylenedodecylmonomethylammonium chloride, nonionic surfactants such as polyoxyethylene stearyl ether, polyoxyethylene tridecyl ether, polyoxyethylene nonyl phenyl ether, polyoxyethylene octyl phenyl ether, polyoxyethylene monostearate, sorbitan monostearate, sorbitan monopalmitate, sorbitan sesquioleate, polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monooleate, glycerol monostearate, polyglycerol fatty acid esters and polyoxyethylene octadecylamine can be added. 
     With regard to the UV absorbers, p-aminobenzoic acid, p-aminobenzoate esters, amyl p-dimethylaminobenzoate, salicylate esters, menthyl anthranilate, umbelliferone, esculin, benzyl cinnamate, cinoxate, guaiazulene, urocanic acid, 2-(2-hydroxy-5-methylphenyl)benzotriazole, 4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone, dioxybenzone, octabenzone, dihydroxydimethoxybenzophenone, sulisobenzone, benzoresorcinol, octyldimethyl p-aminobenzoate, ethylhexyl p-methoxy cinnamate, etc. or mixtures thereof can be added. 
     With regard to the inorganic fillers, titanium oxide, talc, zinc oxide, hydrated silica, magnesium carbonate, calcium hydrogenphosphate, magnesium silicate, diatomaceous earth, silicic anhydride, bentonite, etc. or mixtures thereof can be added. 
     With regard to the pH adjusting agents, acetic acid, formic acid, lactic acid, tartaric acid, oxalic acid, benzoic acid, glycolic acid, malic acid, citric acid, hydrochloric acid, nitric acid, sulfuric acid, sodium hydroxide, potassium hydroxide, methylamine, ethylamine, propylamine, dimethylamine, diethylamine, dipropylamine, trimethylamine, triethylamine, tripropylamine, monomethanolamine, monoethanolamine, monopropanolamine, dimethanolamine, diethanolamine, dipropanolamine, trimethanolamine, triethanolamine, tripropanolamine, etc., or mixtures thereof can be added. 
     Another optional ingredient is selected from essential fatty acids (EFAs), i.e., those fatty acids which are essential for the plasma membrane formation of all cells, in keratinocytes EFA deficiency makes cells hyperproliferative. Supplementation of EFA corrects this. EFAs also enhance lipid biosynthesis of epidermis and provide lipids for the barrier formation of the epidermis. The essential fatty acids are preferably chosen from linoleic acid, Y-linolenic acid, homo-Y-linolenic acid, columbinic acid, eicosa-(n-6,9,13)-trienoic acid, arachidonic acid, Y-linolenic acid, timnodonic acid, hexaenoic acid and mixtures thereof. 
     Antimicrobial and antifungal actives can be effective to prevent the proliferation and growth of bacteria and fungi. Non-limiting examples of antimicrobial and antifungal actives include antibiotic drugs, quaternary ammonium compounds such as benzalkonium chloride; benzethonium chloride; triclosan; triclocarban; and mixtures thereof and the like. Anti-wrinkle, anti-skin atrophy and skin repair actives can be effective in replenishing or rejuvenating the epidermal layer. These actives generally provide these desirable skin care benefits by promoting or maintaining the natural process of desquamation. Non-limiting examples of anti-wrinkle and anti-skin atrophy actives include retinoic acid and its derivatives, and the like. Skin barrier repair actives are those skin care actives which can help repair and replenish the natural moisture barrier function of the epidermis. Non-steroidal cosmetic soothing actives can be effective in preventing or treating inflammation of the skin. The soothing active enhances the skin appearance benefits of the present disclosure, e.g., such agents contribute to a more uniform and acceptable skin tone or color. Benefit agents in the present disclosure may also include anti-itch ingredients. Suitable examples of anti-itch ingredients which are useful in the compositions of the present disclosure include hydrocortisone, and the like. 
     Various sterilization processes may be used for the separate components of the package assembly or kit. Examples include, but are not limited to, chemical sterilization (e.g., exposure to ethylene oxide or hydrogen peroxide vapor), physical sterilization (e.g., dry or moist heat) or other techniques such as microwave irradiation, gamma radiation, ionizing radiation, and electron beam irradiation. It will be understood that the same or different sterilization technique may be used to sterilize different components of the package assembly. 
     According to illustrative embodiments of the present disclosure, sequential sterilization can be performed with substantially no resulting change to the adhesive. Accordingly, the sterilized adhesive compositions can have a satisfactory shelf life. 
     While the present disclosure presents specific embodiments outlined above, it is evident that many alternatives, modifications and variations may be apparent to those skilled in the art. For example, various different combinations, and shapes, sizes and arrangements, of the described features are contemplated. Accordingly, the embodiments of the present disclosure as set forth herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the present disclosure.