Method for manufacturing wound care product and wound care product

Abstract

A method of manufacturing a wound care product in which a fabric containing a water active ingredient, particularly a fiber, is processed, whereby processing the fabric includes applying an antimicrobial means to the water active ingredient.

Description

[Technical Field]

[0001] The present invention relates to a method for making wound care products in which fabrics containing water active ingredients, particularly fibers, are processed. [Background technology]

[0002] Bandages in the form of nonwoven materials, foams, sponges and cloths are used for wound care. These are usually fabrics. In the context of this specification and claims, a fabric is understood to be a three-dimensional product that, when laid flat, has a thickness elongation of no more than 20% of the elongation in the machine or cross direction.

[0003] According to Patent Document 1, wound care outcomes can be improved when a wound care product is saturated with an antimicrobial agent, such as an aqueous solution containing PHMB. The wound care product saturated in this way makes it possible to kill bacteria when caring for the wound. In the context of this specification and claims, any agent capable of killing bacteria is described as antimicrobial, and bacteria is understood to be any microorganism that causes disease (pathogens).

[0004] According to another treatment concept, a wound care product containing a water-active ingredient is used. In the context of this specification and claims, an ingredient is described as water-active if it forms a gel when it comes into contact with water. The water in the gel may form bonds through hydrogen bonds. When a wound care product has a water-active ingredient, it can create a desired wound environment that prevents both excessive drying and maceration of the wound, especially in the treatment of acute and chronic wounds. In the production of a wound care product containing a water-active ingredient, a fabric in the form of a woven or nonwoven material, or even a sponge with a water-active ingredient can be produced, and then cut to a specific size and then packed into a sterilized pack. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2017 / 137419 Brochure [Patent Document 2] US Patent Application Publication No. 2010 / 015208 [Patent Document 3] US Patent Application Publication No. 2009 / 306157 [Patent Document 4] US Patent Application Publication No. 2014 / 107555 [Patent Document 5] European Patent Application Publication No. 3088010 [Patent Document 6] International Publication No. 2003 / 022317 Pamphlet [Patent Document 7] US Patent Application Publication No. 2013 / 150451 Summary of the Invention

[0006] However, when conventionally manufactured wound care products containing water-active ingredients are used, it has been found that in the treatment of acute wounds, wounds are often observed to heal only slowly, while in the treatment of chronic wounds, the outcome is sometimes less than satisfactory.

[0007] Methods for manufacturing wound care products in which antimicrobial means are applied onto hydrolyzable components of fabrics are disclosed in US Pat. Nos. 5,629,599 to 5,729,599. Additionally, US Pat. No. 5,629,599 discloses antimicrobial compositions with synergistic biocidal activity.

[0008] In view of these problems in the prior art, it is an object of the present invention to provide a wound care product in the form of a fabric containing water-active ingredients that can provide satisfactory outcomes in the treatment of acute and chronic wounds.

[0009] According to the invention, the object is to Further development of the known method as defined in the characterizing part of claim 1. This is achieved by:

[0010] The present invention provides As defined in claim 1This results from the surprising discovery that the water active component of a wound care product provided with an antimicrobial means releases the antimicrobial component when in contact with wound fluid, before the fluid forms a gel. This result is unexpected, as stabilization, and therefore deactivation, of the antimicrobial means on contact with wound fluid or water as part of the gel formation of the water active component of the wound care product would be more likely. The actual observed release of the antimicrobial means applied to the water active component of the fabric when a wound care product made according to the present invention is used makes it possible to kill bacteria in the wound, thus improving wound healing.

[0011] Surprisingly, it has been found that the desired release of the antimicrobial means applied to the water-activated component is promoted when the antimicrobial means is applied to the fabric, preferably in an aqueous solution. The solution containing the antimicrobial means can be sprayed preferably on each side, i.e., both sides of the fabric, thereby, in the context of the present invention, it is particularly preferred when the solution is sprayed using at least one ultrasonic nozzle. In the context of this specification and claims, an ultrasonic nozzle that uses high-frequency vibrations to act on the nozzle tip and generate capillary waves in the fluid film is described as such a spray nozzle. As soon as the amplitude of the capillary waves reaches a critical height, these waves become too large to support themselves. This causes small droplets to fall from the tips of each wave, leading to atomization. The main factors affecting the size of the initially generated droplets are the vibration frequency, surface tension, and viscosity of the fluid. Compared to pneumatic spray systems, ultrasonic spray systems allow for better control of droplet size, distribution, and velocity.

[0012] When an aqueous solution of the antimicrobial means is sprayed onto the water active component, the droplet size can be set so that a sufficiently small amount of water used as a solvent evaporates, which means that premature swelling or premature gel formation of the water active component of the fabric can be inhibited, with the simultaneous effect that although the antimicrobial means is bound to the water active component, the binding strength remains so low that, contrary to expectations, upon contact with wound fluid or water, release of the antimicrobial means occurs before a gel is formed under the influence of wound exudate.

[0013] In particular, for fabrics comprising more than 50% by weight, especially about 80% by weight, of water active ingredients, the antimicrobial means is preferably applied to at least 1 cm of each surface of the fabric. 2 Win, 10 -4 mg or more, especially 4 × 10 -3 It has been found to be particularly advantageous in the context of the present invention when the antimicrobial means is applied in amounts of 1 mg or more. If the antimicrobial means is applied in smaller amounts, the desired antimicrobial effect is hardly observed.

[0014] Taking into account the stability of the aqueous solution used to apply the antimicrobial means, it is recommended that the antimicrobial means be applied to at least 1 cm of each side of the fabric. 2 It has been found to be advantageous when the antimicrobial agent is applied in an amount of 1.0 mg or less, particularly 0.7 mg or less, per 1000 ml of fabric. Because the solubility of conventional antimicrobial agents, such as PHMB (polyhexanide), in water is limited, it can be difficult to apply larger amounts of the antimicrobially effective agent, and therefore application of larger amounts of the antimicrobial agent would be associated with greater penetration of fluid into the water-active components of the fabric, which would in turn result in premature gel formation.

[0015] Book The antibacterial means in carrying out the method according to the invention is 、P The PHMB in the aqueous solution may be present at a concentration in the range of 0.1 to 9% by weight, particularly in the range of 4 to 9% by weight, whereby 1 cm 2 Preferably, 0.1 to 8 mg, especially 2 to 8 mg, of solution is applied per 100 ml of water-active ingredient. If PHMB is present at lower concentrations, applying a sufficient amount to the water-active ingredient may require excessive fluid, which may result in premature gel formation. If the concentration of PHMB in the solution exceeds 9% by weight, the solution begins to become unstable overall.

[0016] Bacteria that impair the healing of chronically infected wounds often exist in what is known as a biofilm. Excreted extracellular polymeric substances (EPS) combine with water to form a hydrogel, creating a mucus matrix in which nutrients and other substances are dissolved. In many cases, inorganic particles or air bubbles are also encapsulated by the matrix. In this form, bacteria are protected from external influences, such as attacks by the immune system or antibiotics or antimicrobial agents. Considering the protection of bacteria by the extracellular matrix, wound care products that act against biofilms must meet the following requirements: 1. Break down the extracellular matrix 2. Kills bacteria

[0017] Since conventional antimicrobial means exhibit poor properties for degrading the extracellular matrix, it has been found to be particularly advantageous for the present invention when a wound care product is produced which contains, in addition to the antimicrobial means, a water-active ingredient, if a chelating agent is also applied to the water-active ingredient.

[0018] The chelating agent makes it possible to weaken the extracellular matrix, in particular by binding cations, so that bacteria living in the matrix can be killed with the aid of antibacterial means. In the context of the present invention, the chelating agent is preferably applied in an aqueous solution, preferably also containing antibacterial means, and is in particular sprayed onto the water-active components of the fabric, more preferably sprayed using at least one ultrasonic nozzle.

[0019] The chelating agent is conveniently applied to 1 cm 2 of each side of the fabric. 2 Win, 5 x 10 -4 mg or more, especially 10 -2 The amount of chelating agent applied is preferably 1 mg or more. If the amount of chelating agent is too small, the desired matrix weakening effect is hardly achieved. Further improvement in the weakening effect on the biofilm matrix can be achieved by applying the chelating agent to 1 cm of each side of the fabric. 2 It has been observed that little is achieved when the chelating agent is applied in amounts greater than 1.2 mg per cm of each side of the fabric.2 It has also proven advantageous in the context of the present invention if the water active ingredient is applied in an amount of 1.2 mg or less, in particular 0.8 mg or less, per 100g of fabric. In this regard, too, the stated limits are particularly preferred for fabrics in which more than 50% by weight of the fabric is formed by the water active ingredient, in particular when the water active ingredient forms about 80% by weight of the fabric.

[0020] According to the present invention, chelating agents teeth EDTA (ethylenediaminetetraacetic acid), especially the disodium salt of EDTA (ethylenediaminetetraacetic acid disodium salt dihydrate (C 10 H 14 N2Na2O82H2O) 。

[0021] two The sodium salt has been found to be particularly preferred in the context of the present invention. This salt of ethylenediaminetetraacetic acid can be used to achieve a pH value of less than 7 in aqueous solutions with the desired solubility (high concentration). With other EDTA variants, higher pH values ​​are typically observed along with lower solubility. The color change is also achieved when the final product is stored at temperatures above 40°C. Setting a low pH enhances the desired antibacterial effect. Furthermore, when EDTA, particularly its disodium salt, is used, the independent antibacterial effectiveness of this chelating agent is also observed. EDTA may have a bacterial killing effect where PHMB has only a slightly lower effect. However, the primary purpose of adding EDTA to the solution used to manufacture the wound care product according to the present invention is to weaken the matrix and stabilize the formulation and process. According to the present invention, In addition to antibacterial measures Teki rate It is a drug EHG (Ethylhexyl Monoglycerin Ether) and Bipo resolvates, That is,It has proven advantageous, if Tween 20 is also applied to the water active component, both with regard to the application of the antimicrobial means and chelating agent to the water active component of the fabric, and with regard to the stabilization of the aqueous solution produced using the method according to the invention for the application of the described substances. Preferably, the surfactant in the aqueous solution can be applied, in particular sprayed, more preferably sprayed using at least one ultrasonic nozzle.

[0022] In the context of the present invention, particularly when fabrics are used that are composed of more than 50% by weight of water active ingredients, the surfactant should be applied to at least 1 cm of each side of the fabric. 2 per, preferably 10 -4 mg or more, especially 5 × 10 -4 mg or more, more preferably 10 -3 The surfactant is applied in an amount of 1 mg or more on each side of the fabric. If the at least one surfactant is applied in a smaller amount, the desired effect is no longer achieved. In order to avoid inactivating other substances in the solution and taking into account biocompatibility, in particular the avoidance of the formation of formaldehyde, in the context of the present invention, the surfactant is applied in an amount of 1 mg or more on each side of the fabric. 2 More preferably, it is applied in an amount of 0.6 mg or less, especially 0.1 mg or less, per unit area.

[0023] In carrying out the method according to the invention, the surfactant in the aqueous solution may be present in a concentration ranging from 0.1 to 7.5% by weight, in particular from 0.1 to 5% by weight, so that 1 cm of each side of the fabric is 2 Preferably, 0.1 to 8 mg, especially 2 to 8 mg, of the aqueous solution is applied per 100 ml of the solution. When EHG is used as a surfactant, the concentration of this surfactant in the aqueous solution is preferably 0.1 to 5% by weight. teeth addition World It is added to aqueous solutions as a surfactant. R, The concentration of this surfactant is 、0.5 ~2.5% by weight. Addition of higher concentrations of EHG can lead to the formation of formaldehyde. Addition of higher concentrations of Tween 20 can lead to the inactivation of antimicrobial measures such as PHMB.

[0024] If the surfactant is applied in amounts less than those indicated, this leads to a loss of regularity in the spraying process. A loss of the solution's stabilizing effect is also observed. Both EHG and Tween 20 exhibit an antibacterial effect in addition to solution stabilization. As soon as the concentration falls below the indicated lower limit, this leads to a loss of the antibacterial effect. Furthermore, in the case of Tween 20, a destabilizing effect on the extracellular matrix of the biofilm is also observed. If the amount of Tween 20 in the aqueous solution falls below 0.5% by weight, this effect is no longer observed.

[0025] To carry out the method according to the invention Water The solution preferably contains the following components: 1. PHMB: 0.1 to 9% by weight, preferably 4 to 9% by weight 2. EDTA: 0.5 to 15% by weight, preferably 5 to 10.4% by weight 3. EHG: 0.1 to 5% by weight, preferably 2 to 5% by weight 4. Tween20 :0 .5~2.5% by weight 5. Water: Residual and unavoidable contamination

[0026] In carrying out the method according to the invention, it has surprisingly been found that the desired success in treating chronic wounds involving biofilm formation is particularly well achieved when the ratio of the concentration of the antimicrobial means, such as PHMB, in the aqueous solution to the concentration of the chelating agent, such as EDTA disodium salt, in the aqueous solution is 0.6 or greater. A relatively high ratio of the antimicrobial means, such as PHMB, results in the release of a sufficient amount of the antimicrobial means, upon contact of the water active component of the fabric with water, that is available after the biofilm matrix has been weakened by the chelating agent to kill the bacteria.

[0027] This is also surprising in view of the known compositions of aqueous solutions used to saturate conventional dressings. In these known solutions, a significantly larger proportion of chelating agent is required. The advantage arising in the method according to the invention from setting the ratio of the concentration of the antimicrobial means to the concentration of the chelating agent in the aqueous solution can be explained by the fact that the chelating agent is surprisingly better released from the water active components of the fabric on contact with water or wound exudate than the antimicrobial means.

[0028] In all embodiments of the present invention, it is particularly preferred if the aqueous solution used to apply the antimicrobial means during the spraying process is kept at a constant temperature of between 35°C and 70°C to enhance solubility and is kept in a container where the aqueous solution is continuously stirred.

[0029] Having a fabric containing a water-active component 、 According to the present invention Obtained by a method The wound care product is essentially characterised in that the water active component is provided with an antimicrobial means. In a preferred embodiment of the wound care product according to the invention, the amount of antimicrobially active means is 1 / cm 2 of each side of the fabric. 2 Win, 10 -4 mg to 1.0 mg, preferably 4 × 10 -3 The antimicrobial means may comprise PHMB. Furthermore, the wound care product according to the present invention may also comprise a chelating agent in the region of the water active component. The amount of chelating agent is 0.01 mg to 0.7 mg per 1 cm of each side of the fabric. 2 per, preferably 5 x 10 -4 mg to 1.2 mg, especially 10 -2 In the context of the present invention, the chelating agent in the wound care product according to the present invention is 、E It is DTA disodium salt.

[0030] In addition to, or as an alternative to, a chelating agent, the water active ingredients of the wound care product according to the present invention may also be applied to 1 cm 2 of each side of the fabric. 2 Win, 10 -4 ~0.6 mg, especially 5 × 10 -4 a surfactant, which may be applied in an amount of 0.1 mg; That is, It may comprise EHG or polysorbate.The fabric of the wound care product according to the invention preferably comprises more than 50% by weight, especially about 80% by weight, of water active ingredients.

[0031] The water active ingredient of the wound care product according to the present invention is , Se Cellulose ethyl sulfonate fiber and / or Is carboxymethyl cellulose fiber be The fabric may further comprise cellulosic fibers.

Claims

1. 1. A method for manufacturing a wound care product in which a fabric containing a water active ingredient is processed, comprising: the water active component is carboxymethyl cellulose fiber and / or cellulose ethyl sulfonate fiber, said treating said fabric comprises applying an antimicrobial means to said water active component; 1. A method according to claim 1, wherein the antimicrobial means is applied in an aqueous solution containing 0.1 to 9% by weight of polyhexanide (PHMB), 0.5 to 15% by weight of EDTA disodium salt, 0.1 to 5% by weight of ethylhexyl monoglycerin ether (EHG), and 0.5 to 2.5% by weight of Tween® 20.

2. 2. The method of claim 1, wherein the solution containing the antimicrobial means is sprayed onto both sides of the fabric using at least one ultrasonic nozzle.

3. 1 cm of each side of the fabric 2 Win, 10 -4 3. The method according to claim 1 or 2, characterized in that the antimicrobial means is applied in an amount of 1 mg or more.

4. 1 cm of each side of the fabric 2 4. The method according to claim 1, wherein no more than 1.0 mg of the antimicrobially effective means is applied per 100 ml of the antimicrobially effective means.

5. PHMB is present in an aqueous solution at a concentration ranging from 4 to 9% by weight, whereby 1 cm 2 5. The method according to claim 1, wherein 0.1 to 8 mg of said solution are applied per 100 ml of the solution.

6. EDTA is present in the aqueous solution at a concentration ranging from 0.5 to 15% by weight, whereby 1 cm 2 6. The method according to claim 1, wherein 0.1 to 8 mg of said solution are applied per 100 ml of the solution.

7. 1 cm of each side of the fabric 2 Win, 10 -4 7. The method according to claim 1, wherein an EHG of at least 100 mg is applied.

8. 1 cm of each side of the fabric 2 7. The method according to claim 1, wherein not more than 0.6 mg of EHG is applied per 100 ml of water.

9. 9. The method according to claim 1, wherein the proportion of water active components in the fabric is 50% by weight or more.