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Title:
ANTIMICROBIAL CLOTHING AND GARMENTS
Document Type and Number:
WIPO Patent Application WO/2022/076441
Kind Code:
A1
Abstract:
An antiseptic polymer fiber, wherein an antimicrobial compound is covalently bonded to the polymer, and the fiber is used in order to produce a garment or fabric that may be used in the healthcare industry for disinfection, the suppression of, reduction in and/or maintenance of the microbial load on a surface, such as human or animal skin.

Inventors:
DEGALA SATISH (US)
THURMOND BRUCE (US)
MCGINLEY CHRISTOPHER (US)
Application Number:
PCT/US2021/053608
Publication Date:
April 14, 2022
Filing Date:
October 05, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
CAREFUSION 2200 INC (US)
International Classes:
A01N25/08; A01P1/00; A01P15/00; A61L15/16; A61L15/18; A61L15/20
Foreign References:
US20120328682A12012-12-27
US20150110843A12015-04-23
US20140235727A12014-08-21
Attorney, Agent or Firm:
BERMAN, Richard J. et al. (US)
Download PDF:
Claims:
WHAT IS CLAIMED:

1. An article of clothing comprising an antiseptic polymer fiber, wherein the antiseptic polymer fiber comprises: a thermoplastic polymer; and a covalently bound antimicrobial compound, wherein the antimicrobial compound is covalently bound to the thermoplastic polymer; wherein the covalently bound antimicrobial compound is presented on an outer surface of the article of clothing, and wherein antimicrobial activity of the covalently bound antimicrobial compound is maintained.

2. The article of clothing of Claim 1, wherein the covalently bound antimicrobial compound is present in an amount sufficient to provide at least a 1 logio reduction in microbial load after a period of less than or equal to 24 hours when the outer surface of the article of clothing is contacted with a first surface.

3. The article of clothing of Claims 1 or 2, wherein the first surface is human or animal skin.

4. The article of clothing of Claim 1, wherein the thermoplastic polymer comprises a combination of two or more thermoplastic polymers.

5. The article of clothing of Claim 1, wherein the thermoplastic polymer comprises a polyolefin.

6. The article of clothing of Claim 5, wherein the polyolefin comprises a polyethylene, a polypropylene, or a blend thereof.

7. The article of clothing of Claim 1, wherein the covalently bound antimicrobial compound comprises chlorhexidine or a salt thereof.

8. The article of clothing of Claim 1, wherein the covalently bound antimicrobial compound comprises olanexidine or a salt thereof.

9. The article of clothing of Claim 1, wherein the covalently bound antimicrobial compound comprises polyhexamethylene biguanide or a salt thereof.

10. The article of clothing of Claim 1, wherein the covalently bound antimicrobial compound comprises octenidine or a salt thereof.

11. The article of clothing of Claim 1, wherein the article of clothing is at least one member selected from the group consisting of shirts, pants, underwear, gloves, socks, surgical gowns, and robes.

12. The article of clothing of Claim 1, wherein the article of clothing is at least one member selected from the group consisting of masks, head covers, elastic bands, wraps and sleeves to cover a specific area on human or animal skin and further comprises a means for securing the article of clothing on human or animal skin.

13. A method of disinfecting human or animal skin comprising presenting a human or animal subject and donning the article of clothing of Claim 1 on the human or animal subject for a time sufficient to disinfect the skin in contact with the outer surface of the article of clothing.

14. The method of Claim 12, wherein the article of clothing is donned for a time sufficient to provide at least a 1 logio reduction in microbial load after a period of less than or equal to 24 hours.

15. A method of maintaining microbial load on human or animal skin comprising presenting a human or animal subject and donning the article of clothing of Claim 1 on the human or animal subject for a time sufficient to maintain microbial load on the skin in contact with the outer surface of the article of clothing.

Description:
ANTIMICROBIAL CLOTHING AND GARMENTS

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority from U.S. Provisional Application No. 63/088,293, entitled “ANTIMICROBIAL CLOTHING AND GARMENTS,” filed October 6, 2020, which is expressly incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present disclosure relates to an antiseptic polymer fiber, wherein an antimicrobial compound is covalently bonded to the polymer, and the fiber is used in order to produce a garment or fabric that may be used in the healthcare industry for disinfection, the suppression of, reduction in and/or maintenance of the microbial load on a surface, such as human or animal skin.

BACKGROUND OF THE INVENTION

[0003] Antimicrobial materials are used to make a variety of products for use in the healthcare industry. There remains a need, however, for such materials to eliminate microorganisms in various applications, including applications requiring an antimicrobial barrier. Existing materials rely on use of bactericides such as iodine, chlorine, alcohol, soap and silver. These materials, however, achieve only a limited antimicrobial protection and often are ineffective at eliminating airborne microorganisms.

[0004] Antimicrobial agents such as silver are commonly used in fabrics and materials to prevent and/or suppress the microbial growth on the fabric or potentially on the contacting surface. While the antimicrobial efficacy of silver has been established, there are some disadvantages with the use of this antimicrobial agent in fabrics. Specifically, silver has been demonstrated to leach from the fabrics during washing and over time, therefore exposing the subject to the silver, which is potentially toxic at high concentrations. In addition, the silver can have deleterious effects on the environment and is highly toxic to aquatic life. Therefore, the use of an alternative antimicrobial agent in fabrics is desired that would be amenable to the healthcare industry.

[0005] Within the health care setting, the microbial reduction on a subject’s skin prior to surgery is critical in reducing the potential for an infection. Multiple products can be provided to the subject in order to minimize the microbial load on their skin, including chi orhexi dine gluconate solutions for bathing and nasal products.

[0006] Chlorhexidine has a high level of antibacterial activity and low mammalian toxicity. Historically, it has been used in fluid treatment only in its water-soluble salt forms. Chlorhexidine gluconate and related salts are not currently added to garments in order to provide a microbial reduction on the subject’s skin. Similar to the silver impregnated fabrics, a fabric containing non-bound chlorhexidine would also likely have the antimicrobial leach out during washing and over time. This could have deleterious effects including potential toxicity to the subject and/or the aquatic life.

[0007] Antimicrobials like chlorhexidine and its related salts may be bound to fabrics by embedding them and physically entrapping them within a polymer fiber. But, as it is with silver impregnated fabrics, such chlorhexidine embedded fibers may also have the antimicrobials leach out over the course of regular use and time.

[0008] U.S. Patent 9,918,466 discloses the method of production of antimicrobial polymers through the incorporation of an antimicrobial ingredient such as chlorhexidine into the polymer by grafting, copolymerization, or via a combined antimicrobial/plasticizer ingredient. It discloses that the polymer may be produced as a masterbatch, or a ready to process polymer for producing antimicrobial products.

[0009] U.S. Patent 10,206,945 discloses antimicrobial and antithrombogenic polymer or polymeric blend, compounds, coatings, and materials containing the same, as well as articles made with, or coated with the same, and methods of making the same exhibiting improved antimicrobial properties and reduced platelet adhesion. It discloses embodiments like polymers with antimicrobial and antithrombogenic groups bound to a single polymer backbone, an antimicrobial polymer blended with an antithrombogenic polymer, and medical devices coated with the antimicrobial and antithrombogenic polymer or polymeric blend.

[0010] U.S. Patent 10,226,047 discloses antimicrobial materials prepared from bisguanide compounds blended with certain thermoplastic polymers. It discloses that chlorhexidine is distributed at the molecular level within a thermoplastic polymer such as a polyolefin to form a miscible blend. The patent discloses that these materials are particularly suitable for use in air and water filtration. [0011] U.S. Patent 10,322,954 discloses antimicrobial materials comprising miscible blends of chlorhexidine and a polyolefin. It discloses that these antimicrobial materials may be processed into particulate or fiber form for use in fluid treatment devices and processes. The patent discloses that these devices comprise a housing having inlet and outlet orifices, wherein the antimicrobial material is secured within the housing and configured to contact a fluid flowing through the housing between two orifices.

[0012] Synthetic reactions which may be used to attach an antimicrobial compound to a polymer are outlined in textbooks such as March's Advanced Organic Chemistry: Reactions, Mechanisms, and Structure. Sixth Edition By Michael B. Smith and Jerry March. John Wiley & Sons, Inc., Hoboken, NJ. 2007, and Organic Chemistry. 12th Edition by T. W. Graham Solomons. John Wiley & Sons, Inc., Hoboken, NJ. 2017, each of which is incorporated by reference in its entirety for such disclosure.

[0013] Accordingly, there remains a need for inexpensive and biocompatible antiseptic materials for use in the healthcare industry that can effectively inactivate microorganisms and disinfect human or animal skin. It would be desirable for the antiseptic material to work effectively as an antiseptic material without being solubilized in water. It would be further desirable for the material to be readily adaptable for use in various conventional nonwoven and woven applications such as clothing and garments.

SUMMARY OF THE INVENTION

[0014] The present invention is directed to garments and materials that contain a covalently bound antimicrobial compound. The invention uses an antiseptic polymer fiber, wherein an antimicrobial is covalently bound to a polymer. The antiseptic polymer fiber preferably comprises an antimicrobial compound covalently bound to a hydrophilic polymer.

[0015] The antiseptic polymer fiber may be used to produce an article of clothing such as a garment or fabric that can be utilized in the healthcare industry for disinfection, the suppression of, reduction in and/or maintenance of microbial load on a subject’s skin. This article of clothing has two outer surfaces. The covalently bound antimicrobial compound is presented on an outer surface of the article of clothing, preferably an outer surface that is in contact with the skin when the article is donned by a user. [0016] A method of suppressing, reducing and/or maintaining the microbial load on the skin involves having a human or an animal subject don an article of clothing made from the antiseptic polymer fiber for an amount of time which is sufficient to disinfect the skin in contact with the outer surface of article of clothing.

[0017] Maintaining the microbial load is defined to mean that upon donning the article of clothing, the microbial load does not change/does not return from/to its baseline level for a period of time after contact with the article of clothing. Preferably, the period of time is at least 6 hours. The period of time also may be at least 6, 12, 24 or 48 hours. The baseline level of the microbial load is defined as the pre-existing microbial load present on the skin prior to contact with the article of clothing.

DETAILED DESCRIPTION OF THE INVENTION

[0018] In an aspect of the invention, the antiseptic polymer fiber contains a covalently bound antimicrobial compound such as a biguanide compound. The biguanide compound may be selected from the group consisting of chlorhexidine, olanexidine, polyhexamethylene biguanide, polyaminopropyl biguanide, polyhexanide, and alexidine.

[0019] In yet another aspect of the invention, the antiseptic polymer fiber contains a covalently bound antimicrobial compound such as a quaternary ammonium compound. The quaternary ammonium compound may be selected from the group consisting of benzalkonium chloride, benzethonium chloride, alkyl dimethyl benzyl ammonium chloride, alkyl dimethyl ethylbenzyl ammonium chloride, didecyldimethylammonium chloride, dioctyldimethylammonium chloride, methylbenzethonium chloride, cetalkonium chloride, cetylpyridinium chloride, cetrimonium, cetrimide, dofanium chloride, tetraethylammonium bromide, domiphen bromide, babassuamidopropalkonium chloride, stearalkonium chloride, behentrimonium chloride, and behentrimonium methosulfate.

[0020] In another aspect of the invention, the antiseptic polymer fiber preferably contains a covalently bound antimicrobial compound such as chlorhexidine or a salt thereof.

[0021] In another aspect of the invention, the antiseptic polymer fiber preferably contains a covalently bound antimicrobial compound such as olanexidine or a salt thereof. [0022] In another aspect of the invention, the antiseptic polymer fiber preferably contains a covalently bound antimicrobial compound such as polyhexamethylene biguanide or a salt thereof.

[0023] In another aspect of the invention, the antiseptic polymer fiber preferably contains a covalently bound antimicrobial compound such as octenidine or a salt thereof.

[0024] In an aspect of the invention, the antiseptic polymer fiber preferably contains a hydrophilic polymer that is a combination of two or more hydrophilic polymers.

[0025] In an aspect of the invention, the antiseptic polymer fiber preferably contains a natural fiber and/or its blend. This natural fiber and/or its blend is preferably selected from the group consisting of cotton fibers, bamboo fibers, cotton / bamboo fibers, cotton polylactic acid (PLA), and cotton / polypropylene.

[0026] In another aspect of the invention, the antiseptic polymer fiber preferably contains a man-made fiber. This man-made fiber is preferably selected from the group consisting of acetates (cellulose acetates - silk), acrylics (polyacrylonitrile), azlon (regenerated, naturally occurring proteins such as casein, albumin, collagen), olefins, nylon (polyamides), polyester, rayon (regenerated cellulose), saran, spandex, and vinyon.

[0027] In another aspect of the invention, the antiseptic polymer fiber preferably contains other hydrophilic fibers. The hydrophilic fiber is preferably an acrylate polymer. The acrylate polymer is preferably selected from the group consisting of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate and 2- propenoic acid, 2- methyl-, 2-methylpropyl ester, polymer with 2-propenoic acid and N- (l,l,3,3,tetramethylbutyl)-2-propenamide.

[0028] The hydrophilic fiber is preferably selected from the group consisting of polyacyrlamides, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, polyethylene glycol ethers, polyamides, polyacrylic amides, polyurethanes with polyethylene glycol ether segments, polylactic acid (PLA), PLA/polyester fibers, polyoxazoline, N-(2-hydroxypropyl) methacrylamide (HPMA), amine-functional polymers such as Polyethylenimine (PEI), poly(N- isopropylacrylamide) (PNIPAM), polyacrylamide (PAM), and maleic anhydride polymers and copolymers. [0029] The hydrophilic fiber is preferably a hydrophilic polyethylene terephthalate (PET), such as PET/ethylene vinyl alcohol polymers. Examples include Sophista and Delcron Hydrotec fiber.

[0030] In an aspect of the invention, the antiseptic polymer fiber preferably contains a thermoplastic polymer. The antiseptic polymer fiber more preferably contains a thermoplastic polymer such as a polyolefin. This polyolefin is preferably selected from the group consisting of a polyethylene, a polypropylene and their blends. Suitable polyethylenes may comprise ethylene adipate, ethylene oxide, low density polyethylene, linear low density polyethylene, and high density polyethylene. Suitable polypropylenes may comprise high density polypropylene, low density polypropylene and linear low density polypropylene. Other examples include polyesters such as polyethylene terephthalate, hydrophilic polyethylene terephthalate, polybutylene terephthalate, polypropylene terephthalate, polytrimethylene terephthalate, poly-l,4-cyclohexylenedimethylene terephthalate, and polycaprolactone vinyl polymers such as ethyl vinyl ether, propyl vinyl ether, vinyl acetal, vinyl butyral, and butyl vinyl ether.

[0031] In another aspect of the invention, the article of clothing is selected from the group consisting of shirts, pants, underwear, gloves, socks, surgical gowns, robes and other nonlimiting embodiments.

[0032] In another aspect of the invention, the article of clothing is selected from the group consisting of elastic band, wrap or sleeve that may be used to cover a specific area of the skin, wherein the article of clothing additionally comprises features to secure the article of clothing on the human or animal subject. Such features may comprise clips, tapes, fasteners, hooks and loops, straps, adhesives, etc., as known in the art.

[0033] The antiseptic polymer fibers solve an unmet need by allowing clothing, garments, elastic bands, wraps or sleeves to be used in the healthcare industry without the deleterious effects of the prior art. The articles of clothing may be used as pre-operative and post-operative tools to reduce and/or maintain the microbial burden on the subject’s skin, while the elastic band/wrap or sleeves may be used pre-operative, intra-operatively and also in a post-operative setting. More specifically, the antiseptic polymer fibers may assist in the pre-surgical, intraoperative and/or post-operative steps within a surgical procedure. [0034] The articles of clothing may provide a significant benefit in the pre-operative preparation of the subject’s skin and reduce the likelihood of a hospital acquired infection. The articles of clothing may also be used in the post-operative setting to minimize the potential for microbial contamination prior to the healing of the surgical site. Due to the disadvantages associated with the prior art, the use of antiseptic polymer fiber containing garments is not common practice before or after a surgical procedure.

[0035] The present antiseptic polymer fibers operate by physical/mechanical contact between the fiber and the microorganisms on a surface to which it is exposed. Microorganisms can be inactivated by contact (e.g., transient contact) with the fiber.

[0036] The antiseptic polymer fibers are designed to disinfect and/or prevent the contamination of a subject’s skin upon wearing of the article of clothing containing the antiseptic polymer fibers. The antiseptic polymer fiber may be incorporated into a nonwoven or a woven material, and may be referred to herein as a “nonwoven material” or a “woven material,” respectively.

[0037] Nonwoven materials, as used herein, include sheet or web-based structures prepared by bonding together fiber or filaments by chemical, mechanical, heat or solvent treatments known to those skilled in the art. Such materials may comprise flat, porous sheets made directly from fibers, molten plastic, or plastic film. Those of ordinary skill in the art will appreciate that unlike woven materials, nonwoven materials are not made by weaving or knitting, and do not require that the fibers be converted into yam. Woven materials, as used herein, include sheet or web-based structures that are prepared by weaving or knitting fibers or filaments that may be converted into yarn.

[0038] The nonwoven and woven materials provided herein may be engineered to have particular properties depending upon the properties required for a desired application. For example, the nonwoven and woven materials may be designed for a specific period of use (single-use or extended use) and/or with other specific features such as adsorbency, absorbency (e.g., by addition of absorbent particles), porosity, resilience, stretch, softness, strength, flame retardance, washability, cushioning, etc. In particular embodiments, the nonwoven and woven materials may be created to mimic the appearance, texture and strength of a woven fabric, and therefore can be used in a variety of different applications.

[0039] Accordingly, the nonwoven and woven material may be in essentially any structure or form depending on the particular application. For example, the nonwoven or woven material may be in the form of a barrier structure configured as a wound dressing in various geometries, face masks, protective clothing, sheet stock, or other structures capable of providing a structural barrier to protect a human or an animal from various microorganisms in a contaminated surface or fluid, whether liquid or gas.

[0040] The antiseptic polymer fiber may be prepared by presenting particles which comprise a covalently bound antimicrobial compound, bound to at least one thermoplastic polymer. The covalently bound antimicrobial compound and thermoplastic polymer may be combined in any amount in which the resulting antiseptic polymer fiber has sufficient antimicrobial activity and retains the structural integrity or porosity needed for a particular use of the antiseptic polymer fiber. In one embodiment, antiseptic polymer fiber comprises from about 0.01% to about 25% by weight covalently bound antimicrobial compound, preferably from about 0.01% to about 0.1%, from about 0.1% to about 1%, from about 1% to about 5%, from about 5% to about 10%, and from about 10% to about 15% by weight. Greater or lesser amounts of the covalently bound antimicrobial compound may be selected for use in the antiseptic polymer fiber, depending on the required mechanical characteristics (e.g., load bearing characteristics, porosity, etc.) that are specified for the particular application in which the antiseptic polymer fiber is to be used.

[0041] In another aspect, the antiseptic polymer fibers may be formed from two different polymers, called bi-component fibers. Herein, the bi-component fibers comprise a fiber having two different polymers in the cross-section in either staple or filament form.

[0042] In a particular embodiment, the antiseptic polymer fiber may be included in a multilayer structure having one or more layers of woven or nonwoven materials. The one or more layers of woven or nonwoven materials may comprise any woven or nonwoven material suitable for use in the particular application in which the multilayer structure is intended to be used. Those of ordinary skill in the art should appreciate that the one or more other layers of the structure may comprise any suitable woven or nonwoven material, and may include conventional materials used for surface, fluid or air treatment (e.g., activated carbon, wood fiber, etc.) or other antimicrobial compounds than those of the nonwoven antimicrobial materials. For example, in one embodiment the one or more layers of woven or nonwoven materials may be porous, allowing for the flow of moisture through the layer, or may be non-porous, acting as a vapor barrier. [0043] Suitable antimicrobial compounds exhibit antimicrobial activity. The term “antimicrobial activity” refers to the property or capability of a material to inactivate microorganisms. Non-limiting examples of microorganisms include bacteria, fungi, and viruses. Inactivation may render the microorganism incapable of reproducing and therefore incapable of infecting other organisms, or may occur by disruption of the bacteria, fungi or protozoa membrane, or by denaturization of the protein such as that which forms the protective capsid for viruses. While not wishing to be bound by any theory, it is believed that the antimicrobial activity of bisguanide compounds is due to their highly cationic nature. Generally, microorganisms have cell membranes composed of lipids and proteins. When the microorganisms are exposed to the bisguanide compounds, the microorganisms experience a change in surface charge in the cell membrane sufficient to disrupt the cell membrane and render the microorganisms incapable of reproduction.

[0044] In one embodiment, the covalently bound antimicrobial compound exhibits broad spectrum antimicrobial activity. The term “broad spectrum antimicrobial activity” refers to the property or capability of a material to inactivate numerous different types of microorganisms including bacteria (and its corresponding spores), fungi, protozoa and viruses. An antimicrobial agent that inactivates only a select group of microorganisms (e.g., either only gram positive cells or only gram negative cells) does not have broad spectrum antimicrobial activity.

[0045] In another embodiment, the antiseptic polymer fibers may include at least one of the bisguanide hydrates, bisguanide compounds, or their tautomers as described in the U.S. Pat. No. 10,226,047, the disclosure of which is incorporated herein by reference.

[0046] The thermoplastic polymer of the antiseptic polymer fiber generally is selected taking into consideration its ability to form a covalent bond. That is, the thermoplastic polymer and covalently bound antimicrobial compound should have sufficient molecular interactions with each other to permit distribution and immobilization of the covalently bound antimicrobial compound between the polymer chains. The molecular interactions, as used herein, include covalent bonds. In a preferred embodiment, the covalently bound antimicrobial compound and the thermoplastic polymer are substantially miscible with one another. In this way, the covalently bound antimicrobial compound can be distributed at the molecular level throughout the polymer. That is, the antiseptic polymer fiber may include a molecular mixture of these two components. [0047] The covalently bound antimicrobial compound and thermoplastic polymer may be combined in any amounts in which the resulting antiseptic polymer fiber has sufficient antimicrobial activity when used in an article of clothing while not substantially impairing the structural integrity of resulting antiseptic polymer fiber when embodied in an article of clothing. Thus, the covalently bound antimicrobial compound should be present in an amount sufficient to facilitate contact between any microorganisms which may come into contact with the antiseptic polymer fiber. Those skilled in the art will appreciate, however, that the amount of covalently bound antimicrobial compound can be selected for use in the antiseptic polymer fiber, depending for example on the required mechanical characteristics (e.g., load bearing characteristics, porosity, etc.) that are specified for the particular application in which the antiseptic polymer fiber is to be used.

[0048] The antiseptic polymer fiber optionally may further include one or more additional components. In one embodiment, the additional component is a plasticizer.

[0049] The one or more additional components may be miscible or immiscible in the antiseptic polymer fiber.

[0050] The one or more additional components may be, for example, in particulate or fiber form. The additional components may, for example, be useful in fluid purification, such as carbon, zeolites, etc. They may be homogeneously or heterogeneously distributed in the antiseptic polymer fiber. Those skilled in the art, however, will appreciate that the addition of one or more additional components should not substantially reduce the surface area of the antimicrobial compound in the antiseptic polymer fiber or otherwise impair the antimicrobial activity of the antiseptic polymer fiber.

[0051] The articles of clothing are prepared from suitable antiseptic polymer fibers using methods known to those skilled in the art.

[0052] The covalently bound antimicrobial compound and thermoplastic polymer may be combined by any suitable means known to those of ordinary skill in the art. The resulting antiseptic polymer fiber preferably is substantially free of destabilized antimicrobial compound or its degradants.

[0053] The antiseptic polymer fibers may be processed into a nonwoven or woven structure (e.g., web, mat, and the like) using methods well known to those of skill in the art. Such methods are described, for example, in U.S. Pat. Nos. 6,548,431; 5,853,883; 5,853,641; 5,633,082; 5,632,944; 4,181,640; and 3,751,332; and U.S. Patent Publication No. 2004/0097158, the disclosures of which are incorporated herein by reference.

[0054] In an embodiment, the processing temperature of any process is such that there is substantially no degradation of the covalently bound antimicrobial compound, i.e. less than 25%, wherein the covalently bound antimicrobial compound still maintains its antimicrobial properties and efficacy. The degradation temperature of the covalently bound antimicrobial compounds may be evaluated by considering the TGA and DSC thermograms of the compound.

[0055] In embodiments in which the covalently bound antimicrobial compound comprises chlorhexidine or a chlorhexidine-based compound, it is desirable to utilize a high purity chlorhexidine so as to minimize the amount of impurities such as para-chloroaniline and other chlorhexidine related substances that may be present during production of the fibers or incorporated into the fibers. Herein, high purity chlorhexidine is defined as chlorhexidine with at least a 98% purity. Those skilled in the art will further appreciate, however, that numerous commonly used methods (e.g., venting and use of masks or other respiratory devices) may be used to guard against exposure to any para-chloroaniline that is present in the starting materials or that may be formed as a by-product during the production of the fibers.

[0056] The antiseptic polymer fibers described herein have numerous applications. Advantageously, the antiseptic polymer fiber may be capable of inactivating a broad spectrum of microorganisms. Generally, the antiseptic polymer fibers can be used in applications where it is desirable to reduce and/or eliminate microorganisms on a surface or in a fluid such as an aqueous solution, water, air, and other gases. In embodiments, the antiseptic polymer fiber exhibit at least a 1 logio reduction of microorganisms within a period of less than or equal to about 24 hours after contact with the article of clothing. In an embodiment, the antiseptic polymer fibers exhibit at least a 1 logio reduction of microorganisms within a period of less than or equal to about 1 hour after contact with the article of clothing. In an embodiment, the antseptic polymer fibers exhibit at least a 1 logio reduction of microorganisms within a period of less than or equal to about 6 hours after contact with the article of clothing. In an embodiment, the antiseptic polymer fibersexhibit at least a 1 logio reduction of microorganisms within a period of less than or equal to about 12 hours after contact with the article of clothing. [0057] Preferably, the covalently bound antimicrobial compound is present in the article of clothing in an amount sufficient to provide a log reduction in microbial load of 1 logio reduction of microorganisms after a period of 30 minutes when the outer surface of the article of clothing is contacted with the subject’s skin.

[0058] In certain embodiments, the antiseptic polymer fibers are incorporated into other nonlimiting examples including articles of clothing such as surgical gown, robe, masks, head covers, shoe covers, gloves, surgical drapes, surgical fenestration or cover, sheets, bedclothes, padding, gauze dressings, or disposable cloth for use in personal care applications like sponges, baby wipes, personal wipes, facial wipes, etc. These materials may be prepared from the nonwoven materials or from woven materials prepared from the antiseptic polymer fibers using processes and procedures generally known to those skilled in the art.

[0059] In one embodiment, the antiseptic polymer fiber is in the form of articles of clothing that contain the covalently bound antimicrobial compound. Examples of these articles of clothing include pants, shirts, underwear, gloves, socks, etc. They may be worn by the subject prior to surgery and thus support the reduction in and/or maintenance of the microbial load on the subject’s skin. This pre-operative approach may be used by the subject at their own home, in transport to the hospital or in the hospital itself. The articles of clothing may also be used post-operatively to reduce and/or maintain the microbial load during surgical site healing.

[0060] In yet another aspect of the invention, the articles of clothing are designed to allow for heat transfer to avoid overheating of the subject and allow the maintenance of required contact to achieve the targeted microbiological effect.

[0061] Additional articles of clothing such as gloves, socks, and underwear may be provided for specific surgical procedures that would benefit from microbial load reduction and/or maintenance in areas covered by these articles of clothing or for more high-risk surgical subjects.

[0062] The antiseptic polymer fibers for the claimed articles of clothing may comprise, consist essentially of or consist of chlorhexidine or a salt thereof covalently bound to a hydrophilic polymer that is a combination of two or more hydrophilic polymers.

[0063] The antiseptic polymer fibers for the claimed articles of clothing may comprise, consist essentially of or consist of chlorhexidine or a salt thereof covalently bound to a natural fiber and/or its blend. This natural fiber and/or its blend is preferably selected from the group consisting of cotton fibers, bamboo fibers, cotton / bamboo fibers, cotton polylactic acid (PLA), and cotton / polypropylene.

[0064] The antiseptic polymer fibers for the claimed articles of clothing may comprise, consist essentially of or consist of chlorhexidine or a salt thereof covalently bound to a man-made fiber. This man-made fiber is preferably selected from the group consisting of acetates (cellulose acetates - silk), acrylics (polyacrylonitrile), azlon (regenerated, naturally occurring proteins such as casein, albumin, collagen), olefins, nylon (polyamides), polyester, rayon (regenerated cellulose), saran, spandex, and vinyon.

[0065] The antiseptic polymer fibers for the claimed articles of clothing may comprise, consist essentially of or consist of chlorhexidine or a salt thereof covalently bound to other hydrophilic fibers. This hydrophilic fiber is preferably an acrylate polymer. The acrylate polymer is preferably selected from the group consisting of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate and 2- propenoic acid, 2-methyl-, 2- methylpropyl ester, polymer with 2-propenoic acid and N-(l, 1,3,3, tetramethylbutyl)-2- propenamide.

[0066] The hydrophilic fiber is preferably selected from the group consisting of polyacyrlamides, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, polyethylene glycol ethers, polyamides, polyacrylic amides, polyurethanes with polyethylene glycol ether segments, polylactic acid (PLA), PLA/polyester fibers, polyoxazoline, N-(2-hydroxypropyl) methacrylamide (HPMA), amine-functional polymers such as Polyethylenimine (PEI), poly(N- isopropylacrylamide) (PNIPAM), polyacrylamide (PAM), and maleic anhydride polymers and copolymers.

[0067] The hydrophilic fiber is preferably a hydrophilic polyethylene terephthalate (PET), such as PET/ethylene vinyl alcohol polymers. Examples include Sophista and Delcron Hydrotec fiber.

[0068] The antiseptic polymer fibers for the claimed articles of clothing may consist essentially of or consist of chlorhexidine or a salt thereof covalently bound to a thermoplastic polymer, preferably a polyolefin. This polyolefin is preferably selected from the group consisting of low melt temperature polymers such as polyethylene, polypropylene or their blends. Suitable polyethylenes may comprise ethylene adipate, ethylene oxide, low density polyethylene, linear low density polyethylene, and high density polyethylene. Suitable polypropylenes may comprise high density polypropylene, low density polypropylene and linear low density polypropylene. Other examples include polyesters such as polyethylene terephthalate, hydrophilic polyethylene terephthalate, polybutylene terephthalate, polypropylene terephthalate, polytrimethylene terephthalate, poly-1, 4-cyclohexylenedimethylene terephthalate, and polycaprolactone vinyl polymers such as ethyl vinyl ether, propyl vinyl ether, vinyl acetal, vinyl butyral, and butyl vinyl ether.

[0069] In an aspect of the invention, the antiseptic polymer fiber may be subsequently converted into articles of clothing with a range of sizing which would allow the covering of different body sizes, which articles may be packaged together in a kit.

[0070] In still another embodiment, the covalently bound antimicrobial compound may be incorporated into any antiseptic polymer fiber that would prevent the sufficient degradation to eliminate the antimicrobial characteristics, the release of the covalently bound antimicrobial compound during manufacturing and throughout the life of the product. The selection of the thermoplastic polymer itself could be determined by the physical properties of the resulting fibers. A specific polymer may be selected that provides the most advantageous characteristics for the articles of clothing, such as elasticity, heat transfer through the article of clothing, manufacturing advantages, feel of the material on subject’s skin, etc.

[0071] Another embodiment of the invention may be the use of the antiseptic polymer fiber for the generation of bandages, sleeves or wraps. Differing from the other articles of clothing, these bandages, sleeves or wraps may be applied by the subjects themselves or by the healthcare practitioner upon admission to the hospital. These articles of clothing specifically cover a surgical site and its proximal areas to help maintain a minimal microbial load or otherwise provide a cover for a high-risk area of the subject’s skin.

[0072] In yet another embodiment of the invention, the subject’s skin may be wet with a liquid such as water and/or bodily fluids such as sweat, blood, etc. and/or any topically administered medication and/or other non-limiting embodiments.

[0073] The maintaining/maintenance of the antimicrobial activity of the antimicrobial compound is defined to mean that the antimicrobial properties of the antimicrobial compound are not lost and the said compound remains active in terms of its antimicrobial activity. [0074]U S Patents 9,918,466, 10,206,945, 10,226,047, and 10,322,954, and their disclosures are incorporated herein by reference.

[0075] Publications cited herein and the materials for which they are cited are specifically incorporated herein by reference. Modifications and variations of the methods and devices described herein will be obvious to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to come within the scope of the appended claims.