WO2015187632A1

WO2015187632A1 - Polymeric films comprising antimicrobial agents

Info

Publication number: WO2015187632A1
Application number: PCT/US2015/033689
Authority: WO
Inventors: Anne M. WIBAUX; Vicky VAN DE POL
Original assignee: Avery Dennison Corporation
Priority date: 2014-06-02
Filing date: 2015-06-02
Publication date: 2015-12-10

Abstract

The present invention relates to a film having an antimicrobial agent with improved resistance to microbial growth. The film can be incorporated into an adhesive construction or a non-adhesive construction. In one combination, a three-layer film can be formed having a first layer comprising a polymeric film, a second layer comprising a polymeric film comprising halogenated hexidines, and a third layer comprising an adhesive. The films are useful in various applications such as medical and health care applications.

Description

POLYMERIC FILMS COMPRISING ANTIMICROBIAL AGENTS

TECHNICAL FIELD

[0001] The present invention relates to polymeric films comprising an antimicrobial agent. The invention also relates to methods for increasing the effectiveness of such agents incorporated into polymeric films. The films are useful in various applications such as medical and health care applications.

BACKGROUND

[0002] Microbial contamination can pose a risk to human life and health. Microbial activity with concurrent microbial growth can lead to infection in some applications, including medical and health care applications. Contamination can come from the related articles or from exposure of an area to the atmosphere.

[0003] Silver ions are effective as an antimicrobial agent. However, compounds comprising such ions are also relatively expensive. Furthermore, most antimicrobial technologies using silver ions are limited by the amount of silver ion that can reach the surface of a polymeric film for exposure to microbes. Higher concentrations of silver ions in a polymeric film have limited effects, as the ions tend to block each other and prevent exposure of additional ions below the surface.

[0004] Chlorhexidine, a substituted diguanide, has a high degree of antimicrobial activity and low mammalian toxicity. These unique characteristics make it particularly attractiveas an active ingredient in antimicrobial skin preparations. In addition, the bactericidal activity of biguanide compounds are useful. Biguanide compounds include, but are not limited to, halogenated hexidine such as, but not limited to, chlorhexidine (l,l'-hexamethylene-bis-5-(4-chlorophenyl biguanide) and its salts.

[0005] In medical applications, adhesive films are often used as a patch to cover the surrounding area of skin that is to be examined, proved, incised, or otherwise contacted with a medical device, such as a scalpel, needle, etc. Such patches typically include an antimicrobial agent in the adhesive material that directly contacts the skin. The adhesive is often applied around the periphery of the patch such that it is not overlying or in contact with the area of skin that will be exposed to the medical device. Thus, the medical device might not come in contact with any antimicrobial agent when it is inserted through the patch. Alternatively, the antimicrobial agent often leaches out of the adhesive over time. Typically, the adhesion of the adhesive material decreases as the concentration of antimicrobial decreases, which can cause the patch to peel away or detach from the patient, exposing the area being treated to the atmosphere and microorganisms.

SUMMARY

[0006] The difficulties and drawbacks associated with previously known films and practices associated with antimicrobial agents are addressed in the present polymeric films.

[0007] In one aspect, the present invention provides a polymeric composition adapted for forming a film. The composition comprises at least one polymeric material and an antimicrobial agent disposed therein. In one aspect, the present invention provides a film comprising a polymeric film comprising an antimicrobial agent.

[0008] In another aspect, the present invention provides an adhesive sheet laminate comprising a polymeric film comprising an antimicrobial agent, and an adhesive layer overlying at least a portion of a surface of the polymeric film. The film has effective antimicrobial properties, in addition to effective adhesive properties. It is advantageous to include the antimicrobial agent in the film or carrier, instead of or together with the adhesive. Antimicrobial agents in the adhesive can undesirably decrease its adhesive efficacy.

[0009] In still another aspect, the present invention provides a first layer and a second layer.

The first layer comprising a polymeric film and the second layer comprising a polymeric film comprising halogenated hexidines.

[00010] In yet another em bodiment, a film comprises a first layer, a second layer, and a third layer. The first layer comprising a polymeric film, the second layer comprising a polymeric film comprising halogenated hexidines, and the third layer comprising an adhesive.

[00011] An additional aspect of the invention is a film which is used in a medical or health care application.

BRIEF DESCRIPTION OF THE DRAWINGS

[00012] FIG. 1 is a schematic side view of a film construction in accordance with an embodiment of the present invention;

[00013] FIG. 2 is a schematic side view of a film and adhesive construction in accordance with an embodiment of the present invention;

[00014] FIG. 3 is a schematic side view of a multi-layer film in accordance with an embodiment of the present invention; and [00015] FIG. 4 is a schematic side view of a multi-layer adhesive film in accordance with an embodiment of the present invention.

[00016] Unless otherwise indicated, the illustrations in the above figures are not necessarily drawn to scale.

DETAILED DESCRIPTION

[00017] The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention.

[00018] The apparatuses and methods disclosed in this application are described in detail by way of various embodiments, examples, and with reference to the figures. Unless otherwise specified, like numbers in the figures indicate references to the same, similar, or corresponding elements throughout the figures. It will be appreciated that modifications to disclosed and described examples, arrangements, configurations, components, elements, apparatuses, methods, materials, etc., can be made and may be desired for a specific application. In this disclosure, any identification of specific shapes, materials, techniques, arrangements, etc., are either related to a specific example presented or are merely a general description of such a shape, material, technique, arrangement, etc. Identifications of specific details or examples are not intended to be, and should not be, construed as mandatory or limiting unless specifically designated as such.

[00019] The present invention provides a film comprising an antimicrobial agent. In one embodiment, the present invention provides a film. In another embodiment, the present invention provides and adhesive film comprising a film layer and an adhesive layer disposed on a surface of the film, where the film layer comprises an antimicrobial agent. In another embodiment, the present invention provides a multi-layer film having two or more film layers (and optionally an adhesive layer) where at least one film layer comprises an antimicrobial agent.

[00020] FIG. 1 illustrates an embodiment of a film 100 comprising an antimicrobial agent.

Polymeric film 110 comprises an antimicrobial agent.

[00021] FIG. 2 illustrates an adhesive or tape construction comprising a polymeric film layer 210 and an adhesive layer 220 disposed on a surface of the polymeric film 210. The polymeric film layer comprises an antimicrobial agent. [00022] FIG. 3 illustrates an embodiment of a multi-layer film 300 comprising a first layer 310 and a second layer 320. The first layer 310 comprises a polymeric film, and further includes a first surface 314 and a second surface 312. The second layer 320 comprises a polymeric film comprising an antimicrobial agent. The second layer 320 is disposed about the first surface 314. In one embodiment, the second layer 320 comprising the antimicrobial agent can form the upper or outer layer of the film construction.

[00023] FIG. 4 illustrates an embodiment of an adhesive 400 comprising a first layer 410, a second layer 420, and a third layer 430. The first layer 410 comprises a polymeric film having a first surface 414 and a second surface 412. The second layer 420 comprises a polymeric film comprising an antimicrobial agent. The second layer 420 is disposed about the first surface 414 of layer 410. The third layer 430 is an adhesive layer disposed about the second surface 412 of layer 410.

[00024] The polymeric film can comprise at least one antimicrobial agent. The polymeric film can be formed from any material suitable for forming films including, but not limited to, fabrics, woven cloth, woven fabric, non-woven cloth, non-woven fabric, breathable materials, sponges, dressings, joined fibers, paper, foamed plastic, etc.

[00025] The polymeric film can be formed from any suitable polymeric material. Examples of suitable materials for the film include, but are not limited to, a polyurethane, a polyolefin, a polyester, a polyamide, a styrene-based homopolymer or copolymer, a polycarbonate, a blend of a polyurethane and other materials, a halogen-containing polymer, an acrylate-based or methacrylate-based homopolymer or copolymer, an alkene-unsaturated carboxylic acid or unsaturated carboxylic acid derivative copolymer, a vinyl alcohol-containing homopolymer or copolymer, or a mixture of two or more of any of the foregoing polymers. In certain embodiments, the polymeric film comprises a polyethylene, an alkene-unsaturated carboxylic acid or unsaturated carboxylic acid derivative copolymer, or a mixture of two or more of any of the foregoing polymers.

[00026] A polyurethane film, as noted above, is intended to cover any standard polyurethane- type extruded sheets of polyurethane or polyurethane-containing thermoset or thermoplastic. Such films are generally produced from long- chain, synthetic polymers comprised of at least 85% of a segmented polyurethane, such as those based on polyethers or polyesters. Polyurethanes can include polytetramethylene ether glycol diphenylmethane diisocyanate (MDI), polytetramethylene ether glycol tolylene diisocyanate (TDI), poly(l,4-oxybutylene) glycol diphenylmethane diisocyanate (MDI), poly(l,4- oxybutylene) glycol tolylene diisocyanate (TDI), poly(l,4-oxybutylene) glycol isoferrone isocyanate, polyethylene glycol diphenylmethane diisocyanate (M DI), polypropylene glycol tolylene diisocyanate (TDI), polycaprolactone diphenylmethane diisocyanate (MDI), polyethylene adipate diphenylmethane diisocyanate (M DI), polytetramethylene adipate diphenylmethane diisocyanate (MDI), and polyethylenepropylene adipate isophorone isocyanate polyurethanes, and the like, and mixtures thereof. The polyurethane film can be formed by any conventional method such as by extrusion, casting, injection molding, foaming, etc.

[00027] In an embodiment, the polyethylene is heat sealable and comprises a high density polyethylene, a medium density polyethylene, a low density polyethylene, a linear low density polyethylene, a very low density polyethylene, a polyethylene plastomer, or a mixture of two or more of any of the foregoing polyethylenes. The alkene-unsaturated carboxylic acid or unsaturated carboxylic acid derivative copolymer can also be heat sealable and comprises an ethylene vinyl acetate copolymer, an ethylene-methacrylic acid copolymer, an ethylene-acrylic acid copolymer, an ethylene-alkyl methacrylate copolymer, an ethylene-alkyl acrylate copolymer, an ionomer to include metal salts of ethylene-methacrylic acid copolymers, or a mixture of two or more of any of the foregoing copolymers. In certain embodiments, the ethylene vinyl acetate copolymer is heat sealable and on a weight basis has a vinyl acetate content of 10% to 40%, 16% to 36%, or 22% to 32%. Generally, the sealable organic polymer is present on a weight basis in the polymeric layer at 20% to 70%, 30% to 60%, or 40% to 50%. Useful sealable organic polymers are commercially available and include ethylene vinyl acetate (EVA) copolymers ATEVA^* 2810A from Celanese which have an ASTM D 792 density of 0.949 g/cm³ and an ASTM D 1238 melt index at 190°C/2.16 kg of 6 dg/minute and a vinyl acetate content of 28% by weight, and ELVAX^* 3182 from DuPont™ which has an ASTM D 792 density of 0.95 g/cm³ and an ASTM D 1238 melt index at 190°C/2.16 kg of 3 dg/minute and a vinyl acetate content of 28% by weight.

[00028] In certain embodiments, there can further comprise ethylene vinyl acetate in combination with a linear low density polyethylene, and even with a metallocene-catalyzed linear low density polyethylene (LLDPE). Examples of proportions of these components are as follows. The ethylene vinyl acetate can be used in an amount of from about 40% to about 50%, and at about 45%. And, the metallocene-catalyzed LLDPE is used in an amount of from about 6% to about 16%, and at about 11%.

[00029] In embodiments comprising multi-layer film applications, the layers can be made from the same or different materials. In one embodiment, the polymeric film can have a density of 0.6g/cm³ to about 2.0g/cm³; from about 0.75g/cm³ to about 1.25g/cm³; even from about 0.85g/cm³ to about 1.15g/cm³. [00030] The properties of the polymeric film can be selected as desired for a particular purpose or intended use. The polymeric film can have a thickness as desired for a particular purpose or intended application. In one embodiment, the polymeric film has a thickness of from about O.Olmil to about 8 mil; in another, from about 0.25 mil to about lOmil. In embodiments with multi-layer polymer layers, they can comprise layers individually having a thickness of from about 0.01 mil to about 2mil thickness for each layer; from about O.Olmil to about l.Omil; even from about 0.01 to about 0.5mil. The layer intended to be applied closest to the contact surface can have a thickness from about O.Olmil to about 4mil. The thicknesses of the layers may vary. The layer intended to be the outermost layer when applied to the contact surface can have a thickness from about O.Olmil to about 4mil. Layers disposed in between can have a thickness from about O.Olmil to about 4mil. Here as elsewhere in the specification and claims, numerical values can be combined to form new and non-disclosed ranges.

[00031] The antimicrobial agent incorporated in the polymeric film can comprise an organic antimicrobial agent, an inorganic antimicrobial agent, or a mixture of two or more of any of the foregoing antimicrobial agents. The antimicrobial agent can be microbicidal and kill microbes, or can be microbistatic and prevent growth or reproduction of microbes. The term "microbes" as used herein refers to microorganisms which include bacteria, fungi, plants, and protozoans. Additional examples of microbes are included herein.

[00032] Examples of antimicrobial agents include, but are not limited to, halogenated hexidines, chlorhexidine gluconate (CHG), benzalkonium chloride (BZK), or iodopropynylbutyl carbamate (IPBC; Germall plus). Further examples of antimicrobial agents include, but are not limited to, iodophors, iodine, benzoic acid, dihydroacetic acid, propionic acid, sorbic acid, methyl para ben, ethyl para ben, propyl paraben, butyl paraben, cetrimide, quaternary ammonium compounds, including but not limited to benzethonium chloride (BZT), dequalinium chloride, biguanides such as chlorhexidine, PHMB (polyhexamethylene biguanide), chloroeresol, chlorxylenol, benzyl alcohol, bronopol, chlorbutanol, ethanol, phenoxyethanol, phenylethyl alcohol, 2,4-dichlorobenzyl alcohol, thiomersal, clindamycin, erythromycin, benzoyl peroxide, mupirocin, bacitracin, polymyxin B, neomycin, triclosan, parachlorometaxylene, foscarnet, miconazole, fluconazole, itriconazole, ketoconazole, and pharmaceutically acceptable salts thereof.

[00033] Pharmaceutically acceptable chlorhexidine salts that can be used as antimicrobial agents include, but are not limited to, chlorhexidine palmitate, chlorhexidine diphosphanilate, chlorhexidine digluconate, chlorhexidine diacetate, chlorhexidine dihydrochloride, chlorhexidine dichloride, chlorhexidine dihydroiodide, chlorhexidine diperchlorate, chlorhexidine dinitrate, chlorhexidine sulfate, chlorhexidine sulfite, chlorhexidine thiosulfate, chlorhexidine di-acid phosphate, chlorhexidine difluorophosphate, chlorhexidine diformate, chlorhexidine dipropionate, chlorhexidine di-iodobutyrate, chlorhexidine di-n-valerate, chlorhexidine dicaproate, chlorhexidine malonate, chlorhexidine succinate, chlorhexidine malate, chlorhexidine tartrate, chlorhexidine dimonoglycolate, chlorhexidine monodiglycolate, chlorhexidine dilactate, chlorhexidine di-alpha-hydroxyisobutyrate, chlorhexidine diglucoheptonate, chlorhexidine di-isothionate, chlorhexidine dibenzoate, chlorhexidine dicinnamate, chlorhexidine dimandelate, chlorhexidine di-isophthalate, chlorhexidine di-2-hydroxynapthoate, and chlorhexidine embonate. Chlorhexidine free base is a further example of an antimicrobial agent.

[00034] In an embodiment, the organic antimicrobial agent comprises a natural antimicrobial agent to include for example phytochemicals such as citric acid, a synthetic antimicrobial agent to include for example triclosan and quaternary ammonium halides, or a mixture of two or more of any of the foregoing organic antimicrobial agents.

[00035] The inorganic antimicrobial agent may comprise a metal ion-comprising composition. In an embodiment, the inorganic antimicrobial agent comprises a silver ion-containing composition, a zinc ion-containing composition, a copper ion-containing composition, a tin ion-containing composition, or a mixture of two or more of any of the foregoing compositions. The inorganic antimicrobial agent may be a silver-ion containing composition.

[00036] The antimicrobial agent can also be selected from a wide range of known antibiotics and antimicrobials. Suitable materials are discussed in "Active Packaging of Food Applications" A. L. Brody, E. . Strupinsky, and L. R. Kline, Technomic Publishing Company, Inc. Pennsylvania (2001). Additional examples of antimicrobial agents that can be suitable include benzoic acid, sorbic acid, nisin, thymol, allicin, peroxides, imazalil, triclosan, benomyl, antimicrobial metal-ion exchange material, metal colloids, metal salts, anhydrides, and organic quaternary ammonium salts.

[00037] In an embodiment, the antimicrobial agent is selected from metal ion-exchange materials that have been exchanged or loaded with antimicrobial ions. Metal ion-exchange materials can be selected from zirconium phosphates, metal hydrogen phosphates, sodium zirconium hydrogen phosphates, zeolites, clays such as montmorillonite, ion-exchange resins and polymers, porous alumino- silicates, layered ion-exchange materials, and magnesium silicates. Metal ion exchange materials can be zirconium phosphate, metal hydrogen phosphate, sodium zirconium hydrogen phosphate, or zeolite. Antimicrobial ions can be silver, copper, nickel, zinc, tin, and gold. In an embodiment the antimicrobial ions are selected from silver and zinc. The antimicrobial ion is the antimicrobial moiety of the antimicrobial agent. [00038] The antimicrobial compound is used in an effective amount. The term "effective amount" as used herein refers to any amount of the antimicrobial agent(s) such that when incorporated into a polymeric composition and film is formed therefrom, the presence of the agent along a face of the film kills or at least prevents growth or reproduction of microbes. In an embodiment, the concentration of the antimicrobial agent present in the polymeric film is from about 0.05% (w/w) to about 20% (w/w); even from about 0.05%(w/w) to about 10% (w/w).

[00039] The polymeric film(s) can also contain any combination of additional medicinal compounds. Such medicinal compounds include, but are not limited to, antimicrobials, antibiotics, antifungal agents, antiviral agents, antithrombogenic agents, anesthetics, anti-inflammatory agents, analgesics, anticancer agents, vasodilation substances, wound healing agents, angiogenic agents, angiostatic agents, immune boosting agents, growth factors, and other biological agents. Suitable antimicrobial agents include, but are not limited to, biguanide compounds, such as chlorhexidine and its salts; triclosan; penicillins; tetracyclines; aminoglycosides, such as gentamicin and Tobramycin™; polymyxins; rifampicins; bacitracins; erythromycins; vancomycins; neomycins; chloramphenicols; miconazole; quinolones, such as oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin, and ciprofloxacin; sulfonamides; nonoxynol 9; fusidic acid; cephalosporins; and combinations of such compounds and similar compounds. The additional antimicrobial compounds provide for enhanced antimicrobial activity.

[00040] Film surfaces can be rendered resistant to microbial growth. Some of the microbes which can be resisted include single cell organisms, e.g., bacteria, fungi, algae, and yeast, and mold. The bacteria can include both gram positive and gram negative bacteria. Some examples of gram positive bacteria include, for example, bacillus cereus, micrococcus luteus, and staphylococcus aureus. Some examples of gram negative bacteria include, for example, escherichia coli, enterobacter aerogenes, enterobacter cloacae, and proteus vulgaris. Strains of yeast include, for example, saccharomyces cerevisiae. It will be appreciated that killing or reducing growth and/or reproduction of a wide array of other microbes and microorganismscan beachieved. In no way is the invention limited to the particular examples of microbes presented herein.

[00041] In addition to the antimicrobial agent, the polymeric film can also comprise further additives, such as slip agents, blocking agents, nucleating agents, extrusion aids, antioxidants, flame retardants, colorants, or pigments. Examples of pigments are carbon black or titanium dioxide or graphite and other compounds known in the art. [00042] In embodiments for adhesive constructions, the adhesive layer can include a pressure sensitive adhesive or solvent adhesive, sealing via a lamination using a laminate adhesive and/or pressure and/or heat, sealing with heat, or any combination of the foregoing sealing methods. In one embodiment, the adhesive is formed by a heat sealing method. In certain embodiments the heat sealing method comprises sealing with a heated bar, sealing with hot air, sealing with an electromagnetic radiation source such as for example infrared radiation or radio frequency radiation, or a combination of any of the foregoing heat sealing methods.

[00043] Adhesive laminates suitable for use as medical tapes wound care dressings bandages and similar products are prepared by applying an adhesive copolymer to a flexible facestock having a high MVTR of 4,000 g/m2/d or higher. Non limiting examples of high MVTR materials include Medifilm 390TM a one mil thick film from Mylan Technologies St Albans Vt made with Hytrel 8206 resin a copolyester thermoplastic elastomer available from Du Pont de Nemours El Co. Wilmington Del Medifilm 390TM has a MVTR of 8,000 to 10,000. Other facestocks that have a high MVTR and are commonly used in medical products include polyurethanes film and foams Pebax a polyether block amide resin from Elf Atochem North America Philadelphia Pa and woven or non woven fabrics. The thickness of such high MVTR materials can vary from a few microns up to several millimeters. Depending on the end product application the adhesive can be coated on all or a portion of the facestock.

[00044] In one embodiment, the films can be applied to, and exhibit the adhesion characteristics described herein, when adhered to a surface having a surface energy of about 50 dynes per centimeter or less; about 45 dynes per centimeter or less; about 40 dynes per centimeter or less; even about 35 dynes per centimeter or less. In one embodiment, the surface has a surface energy of from about 5 dynes per centimeter to about 50 dynes per centimeter; about 10 dynes per centimeter to about 45 dynes per centimeter; about 15 dynes per centimeter to about 40 dynes per centimeter; even about 20 dynes per centimeter to about 35 dynes per centimeter. Here as elsewhere in the specification and claims, numerical values can be combined to form new and non-disclosed ranges.

[00045] The properties of the adhesive layer 120 can be selected as desired for a particular purpose or intended use. In one embodiment, the adhesive layer 120 can have a density of 0.70g/cm³ to about 2g/cm³; from about 0.75g/cm³ to about 1.5g/cm³; even from about to about. The adhesive layer 120 can have a thickness as desired for a particular purpose or intended application. In one embodiment, the adhesive layer 120 has a thickness of from about 10 m to about 200 m; from about 10 m to about 150 m; from about 25 m to about 100 m; even from about 25 m to about 75 m. Here as elsewhere in the specification and claims, numerical values can be combined to form new and non-disclosed ranges.

[00046] The adhesive tapes can be used in a variety of applications. In one embodiment, the adhesive tapes can be used in medical or health care applications. The film can be combined with any medical device to forma desired shape, size, or configuration such as a valve, pin, sleeve, prosthetic device, gloves, and the like. Medical devices include such invasive devices as intravenous and urinary catheters, test probes, peristaltic pump chambers, implant materials, arteriovenous shunts, gastroenteric feed tubes, endotracheal tubes, and the like. Other medical devices include films for burn and wound dressings, sponges for wound cleansing, condoms, and the like.

[00047] The films can be produced in a variety of methods. In one embodiment, the polymeric film is combined with a solvent-based solution, which includes an antimicrobial agent, such as, for example, chlorhexidine gluconate. The antimicrobial agent is used in a powdered form and formed into a solution by combination of the powder to a solvent-based solution. The film is then formed from the polymeric composition and cast into a film. Known extrusion or co-extrusion technique can be used to form the films from one or more polymeric compositions or polymer components, and additive components.

[00048] The polymeric films can have a combination of performance properties that makes the film useful in various applications, to include medical and health care applications, especially where microbial activity is involved. In an embodiment the film has a combination of flexibility and quietness, strength, and antimicrobial activity.

[00049] The films or adhesive constructions can be used as part of or to form an article suitable for use in a variety of applications. The inventive film and articles comprising the inventive film are useful in various applications as described hereinabove, especially those that require or benefit from antimicrobial activity. In an embodiment, an article comprises an antimicrobial film that can be used in a medical or health care application. The films and adhesive constructions can be used, for example, in a medical device such as a wound dressing or a medical appliance, an incontinence device, or other device such as a catheter; a medical device may comprise a stabilized composition having antibacterial, antiviral and/or antifungal activity. For example, the film can be used in a medical or health care application, comprising an ostomy pouch, a urine bag, an ulcer dressing, or a dialysis material used for disease treatment.

[00050] Many other benefits will no doubt become apparent from future application and development of this technology. [00051] All of the features disclosed in the specification, including the claims, abstract, and drawings, and all of the steps in any method or process disclosed, can be combined in any combination, except com binations where at least some of such features and/or steps are mutually exclusive. Each feature disclosed in the specification, including the claims, abstract, and drawings, can be replaced by alternative features serving the same, equivalent, or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

[00052] The foregoing detailed description of the present invention is provided for purposes of illustration, and it is not intended to be exhaustive or to limit the invention to the particular embodiments disclosed. The embodiments can provide different capabilities and benefits, depending on the configuration used to implement the key features of the invention. Accordingly, the scope of the invention is defined only by the following claims.

Claims

CLAIMS What is claimed is:

1. A polymeric film comprising an antimicrobial agent dispersed throughout the film.

2. The polymeric film of claim 1, further comprising an adhesive layer disposed on a surface of polymeric film.

3. The film of claim 1, wherein the film comprises:

a first polymeric film layer having a first surface and a second surface opposite the first surface; and

a second polymeric film layer disposed about the first surface of the first film layer, the second layer comprising a polymeric film comprising an antimicrobial agent disposed within the polymeric film.

4. The film of claim 3, further comprising a third layer disposed about the second surface of the first layer, the third layer comprising an adhesive.

5. The film of any of claims 1-4, wherein the antimicrobial agent is chosen from a quaternary ammonium compound, a biguanide compound, benalkonium chlorides, alcohols, hydrogen peroxide, or a combination of two or more thereof.

6. The film of any of claims 1-5, wherein the antimicrobial agent comprises a halogenated hexidine.

7. The film of claim 7, wherein the halogenated hexidine is chosen from chlorhexidine, chlorhexidine gluconate, chlorhexidine acetate, or a combination thereof.

8. The film of any of claims 1-4, wherein the polymeric film is a polyurethane polymer.

9. The film of any of claims 1-4, wherein the polymeric film has a thickness of about O.Olmil to about 8mil.

10. The film of any of claims 1-4, wherein the polymeric film has a further comprises an indicator dye.

11. The film of any of claims 3 or 4, wherein the first layer is chosen from polyurethane, polyethylene, ethyl methyl acrylate.

12. The film of any of claims 3 or 4, wherein the first layer has a thickness of about O.Olmil to about 8 mil.

13. The film of any of claims 3 or 4, wherein the second layer has a thickness of about 0.25 to about 4mil.

14. The film of any of claims 3 or 4, wherein the third layer has a thickness of about 0.25mil to about 2mil.

15. The film of any of claims 2 or 4, wherein the adhesive has a thickness of from about 0.25mil to about lmil.

16. The film of any of claims 2 or 4, wherein the adhesive is chosen from acrylic, polyurethane, silicone, rubber or any hybrid chemistry.

17. The film of any of claims 1-4, wherein the antimicrobial agent comprises a biguanide compound, and the polymeric layer comprising the antimicrobial agent is formed by:

providing the biguanide compound as a solvent based composition comprising a powder form of the biguanide compound dissolved in a solvent;

adding the solvent based composition to a solution comprising the polymeric material; and casting the polymeric film layer and evaporating the solvent.

18. The film of claim 17, wherein the solvent is methanol.

19. The film of claims 17 or 18, wherein the polymeric material comprises a polyurethane.

An article comprising the film of any of claims 1-19.

21. The article of claim 20 where the article is a medical device.

22. The article of claim 21, wherein the medical device is chosen from a medical tape, a medical dressing, surgical drape, negative wound pressure therapy drape, covering film, ostomy bag.

23. The film of any of claims 1-4, wherein the film is used in a medical or health care application.

24. A film as shown and described herein.