JP2015528069A - Nonwoven materials containing chlorohexazine acetate and triclosan - Google Patents

Abstract

The present invention provides a medical article having antimicrobial efficacy and good barrier properties. In particular, the medical article includes a nonwoven material and a coating comprising chlorohexazine acetate and triclosan.

Description

  The present invention relates to a medical article having an antimicrobial effect and good barrier properties.

  In the United States, hospital-acquired infections, also known as nosocomial infections, cause or contribute to nearly 100,000 deaths each year. In order to minimize the transmission of such infections, disposable medical articles such as gowns, drapes, shoe covers, wraps and hats are commonly used. These articles are often worn or used for a short period of time, for example, less than 10 minutes.

Many of these articles are made of nonwoven materials or nonwoven fabrics, such as spunbond / meltblown / spunbond (SMS) laminates of polypropylene fibers and can form a barrier to microorganisms and / or fluids. . The ability to block the entry of fluids, such as body fluids, is important in a medical environment. Some medical articles, such as medical gowns, are categorized by barrier property level based on the AAMI / ANSI PB70 standard developed by the American Medical Device Promotion Association and approved by the US National Standards Boundary. In the AAMI / ANSI PB70 standard, the key test for measuring the barrier properties of materials is water resistance: hydrostatic pressure test, AATCC test method 127, established by the American Textile Chemistry and Dyeing Technology Association. The hydrostatic pressure test measures the resistance of a material to water ingress under increasing pressure. The AAMI / ANSI PB70 standard has four levels of barrier properties. Materials with AAMI level 1 classification pass the spray impact test and are effective against impact penetration. Materials typically having an AAMI level 1 classification include basic cover gowns and isolation gowns. The AAMI level 2 classification requires a pressure of at least 20 cm H ₂ O for water to enter the material. Materials typically having the AAMI Level 2 classification include articles that provide basic protection and those that are commonly used when exposure to fluids is relatively low and short. The AAMI level 3 classification requires a pressure of at least 50 cm H ₂ O for water to enter the material. Materials typically having an AAMI level 3 classification include articles that provide increased barrier protection and those commonly used when fluid exposure is not very high. AAMI level 4 classification does not allow water to pass through. Surgical drapes and gowns often have an AAMI level 4 classification.

  Some nonwoven materials are coated with an antimicrobial material to kill microorganisms that contact the surface of the article. Antimicrobial activity is measured by determining the log reduction in the number of infectious microorganisms after exposure to antimicrobial substances. For example, a 3-log reduction means a 99.9% reduction, and a 4-log reduction refers to a 99.99% reduction. Although the use of an antimicrobial coating on the nonwoven material has the benefit of reducing the amount of microorganisms on the surface, the coating sometimes sacrifices the barrier properties of the nonwoven material and increases the likelihood of fluid ingress.

  There is a need in the field of nonwoven materials that have effective barrier properties and exhibit fast antimicrobial activity. Preferably, the medical article is capable of killing many microorganisms, such as a 3 or 4 log reduction (99.9% -99.99%) in a short period of time, such as 10 minutes or less. Since “rapid sterilization” can break the chain of infection from one surface to another, such materials will help reduce the transmission of hospital-acquired infections.

  US Pat. No. 6,146,651 relates to a nonwoven treated with a biocide composition comprising a halogenated phenolic biocide, a water-soluble film-forming polymer, and at least one surfactant.

  US Pat. No. 6,626,873 and US Pat. No. 5,772,640 relate to polymeric medical articles containing chlorohexazine and its salts and triclosan. US 6,626,873 and US 5,772,640 are medical articles such as catheters, wound drains, arterial grafts, soft tissue patches, gloves, shunts, stents, tracheal catheters, wound dressings, sutures, guide wires, and artificial Refers to organs.

  U.S. Patent No. 6,503,952 relates to an antimicrobial composition comprising, for example, an antimicrobial agent such as chlorohexazine free base, chlorohexazine salt, polyhexamethylene biguanide, and alexidine, a quaternary ammonium compound, and a chlorinated phenol compound. .

  US Patent Publication No. 2011/0150958 relates to an antiseptic cleaner comprising chlorohexazine acetate, a solvent such as alcohol and / or water, and a second biocide such as triclosan.

  All references cited are incorporated herein by reference in their entirety.

  The present invention relates to an article comprising a material, such as a nonwoven material, and a coating comprising chlorohexazine and triclosan. The article is preferably a medical article such as a gown, shoe cover, drape, wrap and hat.

  A coating comprising a combination of chlorohexazine acetate and triclosan on a material, such as a non-woven material, has an effective and fast acting antimicrobial action with minimal impact on the barrier properties of the material. Was found.

  The present invention relates to an article comprising a material such as a nonwoven material and a coating comprising chlorohexazine acetate and triclosan. The article is preferably a medical article, such as a gown, shoe cover, drape, wrap, hat, face mask, laboratory dress, or any other article that can be used to prevent fluid and / or microbial transmission. Good.

  In some embodiments, the material may comprise any fabric or material, including non-woven material or non-woven fabric. Nonwoven refers to a single web or a collection or laminate of multiple webs formed of individually randomly oriented fibers using processes such as spun raid, thermobond, spunbond, meltblown or bond card web. Nonwoven laminates, such as polypropylene fiber spunbond / meltblown / spunbond laminate (SMS), are examples of conventional fabrics that may be used in the surgical field. Another example is a spunbond / film / spunbond (SFS) laminate. In some embodiments, spunlace materials can also be used. In some embodiments, the material is about 1 to about 1000 grams per square meter, preferably 10 to 100 grams per square meter, more preferably 20 to 50 grams per square meter.

  Chlorohexazine acetate, also known as chlorohexazine diacetate, is an antimicrobial agent. Chlorohexazine acetate is effective against gram-positive and gram-negative bacteria along with chlorohexazine free base and other salts of chlorohexazine such as chlorohexazine gluconate, bactericidal and bacteriostatic Has both activities. Surprisingly, it has been found that chlorohexazine acetate in particular, in combination with triclosan, provides effective bactericidal activity while minimizing the impact on the barrier properties of the material.

  Triclosan, also known as 5-chloro-2- (2,4-dichlorophenoxy) phenol and 2,4,4'-trichloro-2'-hydroxydiphenyl ether, has both bactericidal and antibacterial activity.

  The combination of chlorohexazine acetate and triclosan has been found to provide an effective antimicrobial coating on materials such as nonwoven materials. The combination was found to provide a synergistic effect and a high log reduction of bacteria with minimal impact on the barrier properties (fluid permeability) of the material. In particular, the combination of chlorohexazine acetate and triclosan was measured in a hydrostatic pressure test in each case alone and compared to other combinations such as chlorohexazine free base and triclosan, and chlorohexazine gluconate and triclosan. Have been found to provide effective antimicrobial activity while maintaining the fluid penetration resistance of the material at an acceptable level.

  In some embodiments, the chlorohexazine acetate and triclosan preferably have a chlorohexazine acetate: triclosan ratio of about 25: 1 to about 1:25, more preferably about 10: 1 to about 1:10, More preferably from about 5: 1 to about 1: 5 and most preferably from about 3: 1 to 1: 3. In some embodiments, the combined amount (dry weight) of chlorohexazine acetate and triclosan is about 0.1% to about 70%, preferably 0.25% to 50%, more preferably about 0.35 of the coated fabric weight. % To 20%, and most preferably about 0.5% to 10%.

  Chlorohexazine acetate and triclosan may be applied to the material separately or together. For example, in certain embodiments, chlorohexazine acetate may be applied first, followed by triclosan. In some embodiments, chlorohexazine acetate and triclosan are mixed into one formulation and then the formulation is applied to the material. In certain embodiments, a liquid formulation comprising an antimicrobial agent is provided and applied to the material. The liquid formulation may contain one or more solvents such as alcohol and / or water. Examples of solvents include, but are not limited to water, ethanol, hexanol, acetone, isopropanol, benzyl alcohol, propylene glycol, glycerin, and polyethylene glycol. In a preferred embodiment, the liquid formulation comprises chlorohexazine acetate and triclosan in a solution of water and alcohol; preferred alcohols include ethanol, hexanol, octanol. An example of a liquid formulation is chlorohexazine acetate (0.3% w / w, 0.6% w / w, or 0.75% w / w), triclosan (0.60% w / w) and ethanol (70% w / w). Including.

  The coating of chlorohexazine acetate and triclosan may be applied to the material in any manner. Preferably, a coating solution comprising chlorohexazine acetate and triclosan is sprayed or kiss-gravure coated onto a material, such as a nonwoven material. The coating may be applied directly to the fibers before bonding. In a preferred embodiment, the coating is applied after the nonwoven web has been formed and bonded. Other additives include, but are not limited to, antistatic agents and coating aids for lowering surface tension, which may be added to the coating solution. In other embodiments, the fabric may be dip-coated using a chlorohexazine acetate and triclosan formulation or coated using a dip and squeeze padding process.

  After applying the coating, the coated material may be dried using air drying or a dryer. For example, a compressed air dryer and a flotation dryer can be used. The coated material may be dried by drawing a gas such as heated air while holding the material on a porous surface such as a drum or belt.

  In some embodiments, the articles of the invention have antimicrobial efficacy with at least 2 log reduction of bacteria, preferably at least 3 log reduction, and more preferably at least 4 log reduction. In certain embodiments, antimicrobial efficacy is achieved in less than about 60 minutes, preferably less than about 30 minutes, more preferably less than about 10 minutes, and most preferably less than about 5 minutes.

  In some embodiments, the articles of the invention include a coated material that has similar barrier performance as compared to the same material in an uncoated form. For example, in certain embodiments, application of chlorohexazine acetate and triclosan to an SMS nonwoven fabric results in an antihydrostatic pressure value of the SMS nonwoven fabric (in uncoated form) of at most about 50%, preferably Can be reduced by at most about 40%, more preferably at most about 30% and even more preferably at most about 0-10%.

In some embodiments, the hydrostatic pressure of the coated material (eg, measured by water resistance: hydrostatic pressure test, AATCC test method 127) is preferably at least 20 cmH ₂ O, more preferably at least 30. cmH ₂ O. In certain embodiments, for example, when a coated material is used for a surgical gown, the hydrostatic pressure of the coated material is at least about 50 cmH ₂ O.

The effects of the combination of chlorohexazine acetate (CHA) and triclosan were: (1) chlorohexazine free base (CH), chlorohexazine acetate, chlorohexazine gluconate (CHG), polyhexamethylene biguanide (PHMB ) And triclosan alone, and (2) a combination of CH and triclosan, CHG and triclosan, and PHMB and triclosan. Prepare the following coating with deionized water and use a disposable atomizing hand spray on an 8 x 8 inch fabric piece of 34 gsm spunbond / meltblown / spunbond (SMS) nonwoven. Sprayed.
-Formula A: CHA (0.6% w / w), triclosan (0.60% w / w), and ethanol (70%)
-Formula B: CHA (0.3% w / w), triclosan (0.60% w / w), and ethanol (70%)
-Formula C: CHA (0.75% w / w), triclosan (0.60% w / w), and ethanol (70%)
-Formula D: Uncoated control
-Formula E: Ethanol (70%)
-Formulation F: CH (0.30% w / w) and ethanol (70%)
-Formula G: CH (0.60% w / w) and ethanol (70%)
-Formulation H: CH (1.20% w / w) and ethanol (70%)
-Formula I: CHA (0.30% w / w) and ethanol (70%)
-Formula J: CHA (0.30% w / w) and ethanol (70%)
-Formula K: CHG (1.0% w / w) and hexanol (0.6%)
-Formula L: CHG (1.0% w / w) and hexanol (0.6%)
-Formulation M: PHMB (1.0% w / w) and ethanol (70%)
-Formulation N: PHMB (1.0% w / w) and hexanol (0.6%)
-Formula O: Triclosan (0.3% w / w) and ethanol (70%)
-Formulation P: Triclosan (0.6% w / w) and ethanol (70%)
-Formula Q: CH (0.30% w / w), triclosan (0.6% w / w) and ethanol (70%)
-Formula R: CH (0.60% w / w), triclosan (0.6% w / w) and ethanol (70%)
-Formulation S: CHG (0.35% w / w), triclosan (0.6% w / w) and ethanol (70%)
-Formula T: PHMB (0.15% w / w), triclosan (0.6% w / w) and ethanol (70%)
-Formulation U: PHMB (0.45% w / w), triclosan (0.6% w / w) and ethanol (70%)
-Formula V: PHMB (0.75% w / w), triclosan (0.6% w / w) and ethanol (70%)

  Each formulation was sprayed onto the fabric sections until the fabric sections were uniformly saturated. The saturation point was determined by visual observation that the coating agent wets the fabric section and becomes translucent when fully saturated. The sections were then placed horizontally on a wire rack and air dried in a fume hood. In some cases, samples were placed in an oven to dry.

  Samples were tested for antimicrobial efficacy using Gram-negative E. coli, ATCC # 11229, and Gram-positive S. aureus, MRSA (methicillin-resistant Staphylococcus aureus), ATCC # 43300 using AATCC test method 100 . The log reduction of E. coli and MRSA was determined after 5 minutes. The barrier properties of the samples were also tested using water resistance: hydrostatic pressure test, AATCC test method 127. The hydrostatic pressure was read and the pressure values were averaged. The results are shown in the table below.

The results show that the combination of chlorohexazine acetate and triclosan on SMS nonwovens resulted in a high log reduction for both E. coli and MRSA, indicating effective antimicrobial activity. Furthermore, the barrier properties measured in the hydrostatic pressure test of the coated SMS nonwovens remained high. In contrast, samples coated with each antimicrobial agent alone or with other combinations of antimicrobial agents have good antimicrobial activity but poor barrier properties, good barrier properties but poor antimicrobial activity, Or it showed both poor antimicrobial activity and poor barrier properties. For example, a sample coated only with triclosan had high barrier properties but very low microbial activity. For example, a sample coated with chlorohexazine free base had high antimicrobial effectiveness but poor barrier properties. In addition, the sample coated with chlorohexazine acetate alone showed poor antimicrobial activity and poor barrier properties against MRSA.

Claims (6)

  An article comprising a nonwoven material and a coating comprising chlorohexazine acetate and triclosan.   The article of claim 1, wherein the nonwoven material comprises spunbond meltblown spunbond polypropylene.   The article of claim 1, wherein the coating comprises chlorohexazine acetate and triclosan in a ratio of about 25: 1 to about 1:25.   The article of claim 1, wherein the coating comprises chlorohexazine acetate and triclosan in a ratio of about 5: 1 to about 1: 5.   The article of claim 1, wherein the coating comprises chlorohexazine acetate and triclosan in a ratio of about 3: 1 to about 1: 3.   The article of claim 1, wherein the article is a medical article selected from the group consisting of a gown, a shoe cover, a drape, a wrap, a hat, a lab coat and a face mask.